Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021, 15680-15844 [2019-06822]
Download as PDF
<![CDATA[
15680
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Executive Summary and Background
2. Summary of the Major Provisions
A. Executive Summary
Centers for Medicare & Medicaid
Services
1. Purpose
a. Requirements for Medicare Advantage
Plans Offering Additional Telehealth
Benefits (§§ 422.100, 422.135, 422.252,
422.254, and 422.264)
Section 50323 of the Bipartisan
Budget Act of 2018 (Pub. L. 115–123)
created a new section 1852(m) of the
Social Security Act (the Act), which
allows MA plans the ability to provide
‘‘additional telehealth benefits’’
(referred to as ‘‘MA additional
telehealth benefits’’ in this rule) to
enrollees starting in plan year 2020 and
treat them as basic benefits. The statute
limits these authorized MA additional
telehealth benefits to services for which
benefits are available under Medicare
Part B, but that are not payable under
section 1834(m) of the Act and have
been identified for the applicable year
as clinically appropriate to furnish
through electronic information and
telecommunications technology
(referred to as ‘‘electronic exchange’’ in
this rule). Under this final rule, MA
plans will be permitted to offer—as part
of the basic benefit package—MA
additional telehealth benefits beyond
what is currently allowable under the
original Medicare telehealth benefit
(referred to as ‘‘Medicare telehealth
services’’ in this rule). In addition, MA
plans will continue to be able to offer
MA supplemental benefits (that is,
benefits not covered by original
Medicare) via remote access
technologies and/or telemonitoring
(referred to as ‘‘MA supplemental
telehealth benefits’’ in this rule) for
those services that do not meet the
requirements for coverage under
original Medicare or the requirements
for MA additional telehealth benefits.
Section 1852(m)(4) of the Act
mandates that enrollee choice is a
priority. If an MA plan covers a Part B
service as an MA additional telehealth
benefit, then the MA plan must also
provide access to such service through
an in-person visit and not only through
electronic exchange. The enrollee must
have the option whether to receive such
service through an in-person visit or, if
offered by the MA plan, through
electronic exchange. In addition, section
1852(m)(2)(A)(ii) of the Act excludes
from MA additional telehealth benefits
capital and infrastructure costs and
investments relating to such benefits.
These statutory provisions have guided
our rule.
In this final rule, we establish
regulatory requirements that will allow
MA plans to cover Part B benefits
furnished through electronic exchange
but not payable under section 1834(m)
of the Act as MA additional telehealth
42 CFR Parts 422, 423, 438, and 498
[CMS–4185–F]
RIN 0938–AT59
Medicare and Medicaid Programs;
Policy and Technical Changes to the
Medicare Advantage, Medicare
Prescription Drug Benefit, Programs of
All-Inclusive Care for the Elderly
(PACE), Medicaid Fee-For-Service, and
Medicaid Managed Care Programs for
Years 2020 and 2021
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
AGENCY:
This final rule will revise the
Medicare Advantage (MA) program (Part
C) regulations and Prescription Drug
Benefit program (Part D) regulations to
implement certain provisions of the
Bipartisan Budget Act of 2018; improve
quality and accessibility; clarify certain
program integrity policies for MA, Part
D, and cost plans and PACE
organizations; reduce burden on
providers, MA plans, and Part D
sponsors through providing additional
policy clarification; and implement
other technical changes regarding
quality improvement. This final rule
will also revise the appeals and
grievances requirements for certain
Medicaid managed care and MA special
needs plans for dual eligible individuals
to implement certain provisions of the
Bipartisan Budget Act of 2018.
DATES: Effective Dates: These
regulations are effective on January 1,
2020, except for the amendments to
§§ 422.107(c)(9), (d), (e)(2), 422.560(a)(4)
and (b)(5), 422.566(a), 422.629 through
422.634, 422.752(d), 438.210, 438.400,
and 438.402, which are effective January
1, 2021, and for the amendments to
§§ 422.222(a)(2), 423.120(c)(6)(iv), and
498.5(n)(1), which are effective June 17,
2019.
FOR FURTHER INFORMATION CONTACT:
Theresa Wachter, (410) 786–1157, or
Cali Diehl, (410) 786–4053, MA/Part C
Issues. Elizabeth Goldstein, (410) 786–
6665, Parts C and D Quality Ratings
Issues. Kari Gaare, (410) 786–8612,
Prescription Drug Plan Access to Parts
A and B Data Issues. Vanessa Duran,
(410) 786–8697, D–SNP Issues. Frank
Whelan, (410) 786–1302, Preclusion List
Issues.
SUPPLEMENTARY INFORMATION:
khammond on DSKBBV9HB2PROD with RULES2
SUMMARY:
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
The primary purpose of this final rule
is to revise the Medicare Advantage
(MA) program (Part C) and Prescription
Drug Benefit Program (Part D)
regulations based on our continued
experience in the administration of the
Part C and Part D programs and to
implement certain provisions of the
Bipartisan Budget Act of 2018. The
changes are necessary to—
• Implement the Bipartisan Budget
Act of 2018 provisions;
• Improve program quality and
accessibility;
• Clarify program integrity policies;
and
• Implement other changes.
This final rule will meet the
Administration’s priorities to reduce
burden across the Medicare program by
reducing unnecessary regulatory
complexity, and improve the regulatory
framework to facilitate development of
Part C and Part D products that better
meet the individual beneficiary’s
healthcare needs. Because the
Bipartisan Budget Act of 2018 requires
the Secretary to establish procedures, to
the extent feasible, for integration and
unification of the appeals and grievance
processes for dual eligible individuals
who are enrolled in Medicaid and in
MA special needs plans for dual eligible
individuals (D–SNPs), this final rule
also includes provisions to revise the
appeals and grievances requirements for
Medicaid managed care and MA D–
SNPs. While the Part C and Part D
programs have high satisfaction among
beneficiaries, we continually evaluate
program policies and regulations to
remain responsive to current trends and
newer technologies, and provide
increased flexibility to serve patients.
Specifically, this final rule meets the
Secretary’s priorities to: (1) Reform
health insurance by increasing access to
personalized health care, (2) transform
our healthcare system to be value-based
and innovative by promoting health
information technology, and (3) support
boosting transparency around price and
quality. These changes being finalized
will promote more convenient, costeffective access to care within Part C
and D plans, improve accountability
and bolster program integrity, allow
plans to innovate in response to
patients’ needs, and promote
coordination within MA D–SNPs.
PO 00000
Frm 00002
Fmt 4701
Sfmt 4700
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
benefits—and as part of the basic
benefits defined in § 422.101 instead of
separate MA supplemental benefits. We
believe MA additional telehealth
benefits will increase access to patientcentered care by giving enrollees more
control to determine when, where, and
how they access benefits. We solicited
comments from stakeholders on various
aspects of our proposal, which informed
how we are implementing the MA
additional telehealth benefits in this
final rule.
khammond on DSKBBV9HB2PROD with RULES2
b. Dual Eligible Special Needs Plans
Provisions (§§ 422.2, 422.60, 422.102,
422.107, 422.111, 422.560 Through
422.562, 422.566, 422.629 Through
422.634, 422.752, 438.210, 438.400, and
438.402)
Section 50311(b) of the Bipartisan
Budget Act of 2018 amends section 1859
of the Act to require integration of the
Medicare and Medicaid benefits
provided to enrollees in Dual Eligible
Special Needs Plans (D–SNPs). In
particular, the statute requires: (1)
Development of unified grievance and
appeals processes for D–SNPs; and (2)
establishment of new standards for
integration of Medicare and Medicaid
benefits for D–SNPs.
The statute specifies a number of key
elements for unified D–SNP grievance
and appeals processes and grants the
Secretary discretion to determine the
extent to which unification of these
processes is feasible. In particular, the
unified processes must adopt the
provisions from section 1852(f) and (g)
of the Act (MA grievances and appeals)
and sections 1902(a)(3) and (5), and
1932(b)(4) of the Act (Medicaid
grievances and appeals, including
managed care) that are most protective
to the enrollee, take into account
differences in state Medicaid plans to
the extent necessary, easily navigable by
an enrollee, include a single written
notification of all applicable grievance
and appeal rights, provide a single
pathway for resolution of a grievance or
appeal, provide clear notices, employ
unified timeframes for grievances and
appeals, establish requirements for how
the plan must process, track, and
resolve grievances and appeals, and
with respect to benefits covered under
Medicare Parts A and B and Medicaid,
incorporate existing law that provides
continuation of benefits pending appeal
for items and services covered under
Medicare and Medicaid. The statute
requires the Secretary to establish
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
unified grievance and appeals
procedures by April 1, 2020 and
requires D–SNP contracts with state
Medicaid agencies to use the unified
procedures for 2021 and subsequent
years.
Regarding the establishment of new
standards for integration of Medicare
and Medicaid benefits, the statute
requires that all D–SNPs meet certain
new minimum criteria for such
integration for 2021 and subsequent
years, either by covering Medicaid
benefits through a capitated payment
from a state Medicaid agency or meeting
a minimum set of requirements as
determined by the Secretary. The law
also stipulates that for the years 2021
through 2025, if the Secretary
determines that a D–SNP failed to meet
one of these integration standards, the
Secretary may impose an enrollment
sanction, which would prevent the D–
SNP from enrolling new members. In
describing the ‘‘additional minimum set
of requirements’’ established by the
Secretary, the statute directs the
Federally Coordinated Health Care
Office in CMS to base such standards on
input from stakeholders. We implement
these new statutory provisions and
clarify definitions and operating
requirements for D–SNPs in this final
rule.
c. Medicare Advantage and Part D
Prescription Drug Plan Quality Rating
System (§§ 422.162(a) and 423.182(a),
§§ 422.166(a) and 423.186(a), §§ 422.164
and 423.184, and §§ 422.166(i) and
423.186(i))
In the Medicare Program; Contract
Year 2019 Policy and Technical
Changes to the Medicare Advantage,
Medicare Cost Plan, Medicare Fee-forService, the Medicare Prescription Drug
Benefit Programs, and the PACE
Program Final Rule (hereafter referred to
as the April 2018 final rule), CMS
codified at §§ 422.160, 422.162, 422.164,
and 422.166 (83 FR 16725 through
16731) and §§ 423.180, 423.182,
423.184, and 423.186 (83 FR 16743
through 16749) the methodology for the
Star Ratings system for the MA and Part
D programs, respectively. This was part
of the Administration’s effort to increase
transparency and advance notice
regarding enhancements to the Part C
and D Star Ratings program.
At this time, we are finalizing
enhancements to the cut point
methodology for non-Consumer
Assessment of Healthcare Providers and
PO 00000
Frm 00003
Fmt 4701
Sfmt 4700
15681
Systems (CAHPS) measures. We are also
making substantive updates to the
specifications for a few measures for the
2022 and 2023 Star Ratings, and
finalizing rules for calculating Star
Ratings in the case of extreme and
uncontrollable circumstances. Data
would be collected and performance
measured using these final rules and
regulations for the 2020 measurement
period and the 2022 Star Ratings, except
for the Plan All-Cause Readmission
measure where the applicability date is
the 2021 measurement period as
described in section II.B.1.d.(1).(c) of
this final rule.
d. Preclusion List Requirements for
Prescribers in Part D and Individuals
and Entities in MA, Cost Plans, and
PACE (§§ 422.222 and 423.120(c)(6))
In the April 2018 final rule, CMS
removed several requirements
pertaining to MA and Part D provider
and prescriber enrollment that were to
become effective on January 1, 2019. We
stated in that final rule our belief that
the best means of reducing the burden
of the MA and Part D provider and
prescriber enrollment requirements
without compromising our payment
safeguard objectives would be to focus
on providers and prescribers that pose
an elevated risk to Medicare
beneficiaries and the Trust Funds. That
is, rather than require the enrollment of
MA providers and Part D prescribers
regardless of the level of risk they might
pose, we would prevent payment for
MA items or services and Part D drugs
that are, as applicable, furnished or
prescribed by demonstrably problematic
providers and prescribers. We therefore
established in the April 2018 final rule
a policy under which: (1) Such
problematic parties would be placed on
a ‘‘preclusion list’’; and (2) payment for
MA services and items and Part D drugs
furnished or prescribed by these
individuals and entities would be
rejected or denied, as applicable. The
MA and Part D enrollment
requirements, in short, were replaced
with the payment-oriented approach of
the preclusion list.
This final rule will make several
revisions and additions to the
preclusion list provisions we finalized
in the April 2018 final rule. We believe
these changes will help clarify for
stakeholders CMS’ expectations
regarding the preclusion list.
3. Summary of Costs and Benefits
E:\FR\FM\16APR2.SGM
16APR2
15682
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Provision
Description
Impact
Requirements for Medicare Advantage Plans
Offering Additional Telehealth Benefits
(§§ 422.100, 422.135, 422.252, 422.254, and
422.264).
Consistent with section 50323 of the Bipartisan Budget Act of 2018, MA plans have
the ability to provide ‘‘additional telehealth
benefits’’ to enrollees starting in plan year
2020 and treat them as basic benefits.
Integration Requirements for Dual Eligible Special Needs Plans (§§ 422.2, 422.60, 422.102,
422.107, 422.111, and 422.752).
Consistent with section 50311(b) of the Bipartisan Budget Act of 2018, we are establishing, effective 2021, Medicare and Medicaid integration standards D–SNPs. Effective 2021 through 2025, we will require the
imposition of an intermediate sanction of
prohibiting new enrollment into a D–SNP if
CMS determines that the D–SNP is failing
to comply with these integration standards.
Finally, we are creating new and modifying
existing regulatory definitions that relate to
D–SNPs.
Consistent with section 50311(b) of the Bipartisan Budget Act of 2018, we are unifying
Medicare and Medicaid grievance and appeals procedures for certain D–SNPs that
enroll individuals who receive Medicare and
Medicaid benefits from the D–SNP and a
Medicaid managed care organization offered by the D–SNP’s MA organization, the
parent organization, or subsidiary owned by
the parent organization. Medicare and Medicaid grievance and appeals processes differ in several key ways, which in effect creates unnecessary administrative complexity
for health issuers participating across product lines. This will allow enrollees to follow
one resolution pathway at the plan level
when filing a complaint or contesting an adverse coverage determination with their
plan regardless of whether the matter involves a Medicare or Medicaid covered
service.
We are finalizing several measure specification updates, adjustments due to extreme
and uncontrollable circumstances, and an
enhanced cut point methodology. The
measure changes are routine and do not
have a significant impact on the ratings of
contracts. The policy for disasters will hold
contracts harmless from decreases in ratings from the prior year when there are extreme and uncontrollable circumstances affecting them. The methodology to set Star
Ratings cut points will help increase the
stability and predictability of cut points from
year to year.
We are making several revisions to the MA
and Part D preclusion list policies that we finalized in the April 2018 final rule.
MA additional telehealth benefits are expected
to produce $557 million in savings for enrollees over 10 years from reduced travel
time to and from providers. The impact of
paying for MA additional telehealth benefits
out of the Medicare Trust Fund (as basic
benefits) versus out of the rebates (as supplemental benefits) results in a transfer of
$80 million from the Medicare Trust Fund to
enrollees over 10 years.
For the initial year of implementation, we estimate a $3.4 million cost to MA plans and a
$0.5 million cost to state Medicaid agencies, half of which is transferred to the federal government, in order to transition to the
new requirements. After that, we estimate
that impact will be negligible.
Unified Grievances and Appeals Procedures for
Dual Eligible Special Needs Plans and Medicaid Managed Care Plans at the Plan Level
(§§ 422.560–562, 422.566, 422.629–422.634,
438.210, 438.400, and 438.402).
MA and Part D Prescription Drug Plan Quality
Rating
System
(§§ 422.162(a)
and
423.182(a), 422.166(a) and 423.186(a),
422.164 and 423.184, and 422.166(i)(1) and
423.186(i)(1)).
Preclusion List Requirements for Prescribers in
Part D and Individuals and Entities in MA,
Cost Plans, and PACE (§§ 422.222 and
423.120(c)(6)).
khammond on DSKBBV9HB2PROD with RULES2
B. Background
We received approximately 180
timely pieces of correspondence
containing multiple comments on the
proposed rule titled ‘‘Medicare and
Medicaid Programs; Policy and
Technical Changes to the Medicare
Advantage, Medicare Prescription Drug
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Benefit, Program of All-Inclusive Care
for the Elderly (PACE), Medicaid Feefor-Service, and Medicaid Managed Care
Programs for Years 2020 and 2021’’
which published November 1, 2018, in
the Federal Register (83 FR 54982).
While we intend to address the Risk
Adjustment Data Validation (RADV)
proposals in subsequent rulemaking
PO 00000
Frm 00004
Fmt 4701
Sfmt 4700
The provision gives rise to both savings, from
the increased efficiency of a unified process, and costs from the requirement to provide benefits while appeals are pending.
Over 10 years there are three anticipated
effects: (1) Plans will save $0.7 million from
the increased efficiency of unified appeals
and grievance processes; this savings is
passed to the Medicare Trust Fund; (2) the
Medicare Trust Fund will incur a $4.2 million expense for providing benefits while appeals are pending; and (3) enrollees will
incur an extra $0.7 million in cost sharing
for benefits while appeals are pending.
Negligible impact.
Negligible impact.
(due to an extended comment period for
these proposals until April 30, 2019, per
83 FR 66661), we are finalizing all other
provisions with changes varying from
minor clarifications to more significant
modifications based on comments
received. We also note that some of the
public comments received were outside
of the scope of the proposed rule. These
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
out-of-scope public comments are not
addressed in this final rule. Summaries
of the public comments that are within
the scope of the proposed rule and our
responses to those public comments are
set forth in the various sections of this
final rule under the appropriate
headings. However, we note that in this
final rule we are not addressing
comments received with respect to the
RADV provision of the proposed rule
that we are not finalizing at this time.
Rather, we will address these comments
in subsequent rulemaking, as
appropriate.
II. Provisions of the Proposed Rule and
Analysis of and Responses to Public
Comments
A. Implementing the Bipartisan Budget
Act of 2018 Provisions
1. Requirements for Medicare
Advantage Plans Offering Additional
Telehealth Benefits (§§ 422.100,
422.135, 422.252, 422.254, and 422.264)
khammond on DSKBBV9HB2PROD with RULES2
Technologies that enable healthcare
providers to deliver care to patients in
locations remote from the providers
(hereinafter referred to as ‘‘telehealth’’)
are increasingly being used to
complement face-to-face patientprovider encounters. Telehealth visits
among rural Medicare beneficiaries
participating in original Medicare have
increased more than 25 percent a year
from 2004 to 2013.1 In Medicare
Advantage (MA), about 81 percent of
MA plans offered supplemental
telehealth benefits in the form of remote
access technologies in 2018, an increase
from 77 percent in 2017.2 This shows
that the healthcare industry has made
significant advances in technology that
enable secure, reliable, real-time,
interactive communication and data
transfer that were not possible in the
past. Moreover, the use of telehealth as
a care delivery option for MA enrollees
may improve access to and timeliness of
needed care, increase convenience for
patients, increase communication
between providers and patients,
enhance care coordination, improve
quality, and reduce costs related to inperson care.3
MA basic benefits are structured and
financed based on what is covered
under Medicare Parts A and B (paid
1 Mehrotra, A., Jena, A., Busch, A., Souza, J.,
Uscher-Pines, L., Landon, B. (2016). ‘‘Utilization of
Telemedicine Among Rural Medicare
Beneficiaries.’’ JAMA, 315(18): 2015–2016.
2 https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-and-Reports/
MCRAdvPartDEnrolData/
3 Medicare Payment Advisory Commission
(MedPAC), Report to the Congress: Medicare
Payment Policy, March 2018.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
through the capitation rate by the
government) with coverage of additional
items and services and more generous
cost sharing provisions financed as MA
supplemental benefits (paid using rebate
dollars or supplemental premiums paid
by enrollees). Traditionally, MA plans
have been limited in how they may
deliver telehealth services outside of the
original Medicare telehealth benefit
under section 1834(m) of the Act
(hereinafter referred to as ‘‘Medicare
telehealth services’’) because of this
financing structure; only services
covered by original Medicare under
Parts A and B, with actuarially
equivalent cost sharing, are in the basic
benefit bid paid by the capitation rate.
Section 1834(m) of the Act and § 410.78
generally limit payment for Medicare
telehealth services by authorizing
payment only for specified services
provided using an interactive audio and
video telecommunications system that
permits real-time communication
between a Medicare beneficiary and
either a physician or specified other
type of practitioner, and by specifying
where the beneficiary may receive
telehealth services (eligible originating
sites). Eligible originating sites are
limited as to the type of geographic
location (generally rural) and the type of
care setting. The statute grants the
Secretary the authority to add to the list
of Medicare telehealth services based on
an established annual process but does
not allow for exceptions to the
restrictions on types of practitioners that
can furnish those services or on the
eligible originating sites. Because
sections 1852(a), 1853, and 1854 of the
Act limit the basic benefits covered by
the government’s capitation payment to
only Parts A and B services covered
under original Medicare with actuarially
equivalent cost sharing, telehealth
benefits offered by MA plans in addition
to those covered by original Medicare
are currently offered as MA
supplemental benefits and funded
through the use of rebate dollars or
supplemental premiums paid by
enrollees.
On February 9, 2018, President
Trump signed the Bipartisan Budget Act
of 2018 (Pub. L. 115–123) into law.
Section 50323 of the Bipartisan Budget
Act of 2018 created a new section
1852(m) of the Act, which allows MA
plans the ability to provide ‘‘additional
telehealth benefits’’ (hereinafter referred
to as ‘‘MA additional telehealth
benefits’’) to enrollees starting in plan
year 2020 and treat them as basic
benefits (also known as ‘‘original
Medicare benefits’’ or ‘‘benefits under
the original Medicare fee-for-service
PO 00000
Frm 00005
Fmt 4701
Sfmt 4700
15683
program option’’). The statute limits
these authorized MA additional
telehealth benefits to services for which
benefits are available under Medicare
Part B but that are not payable under
section 1834(m) of the Act and have
been identified for the applicable year
as clinically appropriate to furnish
through electronic information and
telecommunications technology
(hereinafter referred to as ‘‘electronic
exchange’’). While MA plans have
always been able to offer more
telehealth services than are currently
payable under original Medicare
through MA supplemental benefits, this
change in how such MA additional
telehealth benefits are financed (that is,
accounted for in the capitated payment)
makes it more likely that MA plans
would offer them and that more
enrollees would use the benefit.
We are adding a new regulation at
§ 422.135 to implement the new section
1852(m) of the Act and amending
existing regulations at §§ 422.100,
422.252, 422.254, and 422.264.
Specifically, we are codifying a new
regulation at § 422.135 to allow MA
plans to offer MA additional telehealth
benefits, to establish definitions
applicable to this new classification of
benefits, and to enact requirements and
limitations on them. Further, we are
amending § 422.100(a) and (c)(1) to
include MA additional telehealth
benefits in the definition of basic
benefits and adding a cross-reference to
new § 422.135 to reflect how these
benefits may be provided as part of
basic benefits. Finally, we are amending
the bidding regulations at §§ 422.252,
422.254, and 422.264 to account for MA
additional telehealth benefits in the
basic benefit bid.
We proposed that, beginning in
contract year 2020, MA plans will be
permitted to offer—as part of the basic
benefit package—MA additional
telehealth benefits beyond what is
currently allowable under Medicare
telehealth services. Pursuant to section
1852 of the Act and the regulation at
§ 422.100(a), MA plans are able to offer
Medicare telehealth services including
those described in existing authority at
section 1834(m) of the Act and
§§ 410.78 and 414.65 of the regulations.
We proposed that in addition to
Medicare telehealth services, MA plans
will be able (but not required) to offer
MA additional telehealth benefits
described in this final rule and at
section 1852(m) of the Act. In addition,
we proposed to continue authority for
MA plans to offer MA supplemental
benefits (that is, benefits not covered by
original Medicare) via remote access
technologies and telemonitoring (as
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15684
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
currently named in the plan benefit
package (PBP) software; hereinafter
referred to as ‘‘MA supplemental
telehealth benefits’’) for those services
that do not meet the requirements for
coverage under original Medicare (for
example, for Medicare telehealth
services under section 1834(m)) or the
requirements for MA additional
telehealth benefits, such as the
requirement of being covered by Part B
when provided in-person. For instance,
an MA plan may offer, as an MA
supplemental telehealth benefit, a
videoconference dental visit to assess
dental needs because services primarily
provided for the care, treatment,
removal, or replacement of teeth or
structures directly supporting teeth are
not currently covered Part B benefits
and thus would not be allowable as MA
additional telehealth benefits.
We proposed to establish regulatory
requirements that will allow MA plans
to cover Part B benefits furnished
through electronic exchange but not
payable under section 1834(m) of the
Act as MA additional telehealth
benefits—and as part of the basic
benefits defined in § 422.101 instead of
separate MA supplemental benefits. We
believe MA additional telehealth
benefits will increase access to patientcentered care by giving enrollees more
control to determine when, where, and
how they access benefits.
Section 1852(m)(2)(A)(i) of the Act, as
added by the Bipartisan Budget Act of
2018, defines ‘‘additional telehealth
benefits’’ as services—(1) for which
benefits are available under Part B,
including services for which payment is
not made under section 1834(m) of the
Act due to the conditions for payment
under such section; and (2) that are
identified for the applicable year as
clinically appropriate to furnish using
electronic information and
telecommunications technology (which
we refer to as ‘‘through electronic
exchange’’) when a physician (as
defined in section 1861(r) of the Act) or
practitioner (described in section
1842(b)(18)(C) of the Act) providing the
service is not at the same location as the
plan enrollee. In addition, section
1852(m)(2)(A)(ii) of the Act excludes
from ‘‘additional telehealth benefits’’
capital and infrastructure costs and
investments relating to such benefits.
This statutory definition of ‘‘additional
telehealth benefits’’ guided our
proposal.
We proposed a new regulation at
§ 422.135 to authorize and govern the
provision of MA additional telehealth
benefits by MA plans, consistent with
our interpretation of the new statutory
provision. First, we proposed
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
definitions for the terms ‘‘additional
telehealth benefits’’ and ‘‘electronic
exchange’’ in § 422.135(a). We proposed
to define ‘‘additional telehealth
benefits’’ as services that meet the
following: (1) Are furnished by an MA
plan for which benefits are available
under Medicare Part B but which are
not payable under section 1834(m) of
the Act; and (2) have been identified by
the MA plan for the applicable year as
clinically appropriate to furnish through
electronic exchange. For purposes of
this specific regulation and addressing
the requirements and limitations on MA
additional telehealth benefits, we
proposed to define ‘‘electronic
exchange’’ as ‘‘electronic information
and telecommunications technology’’ as
this is a concise term for the statutory
description of the means used to
provide the MA additional telehealth
benefits. We did not propose specific
regulation text that defines or provides
examples of electronic information and
telecommunications technology because
the technology needed and used to
provide MA additional telehealth
benefits would vary based on the service
being offered. Examples of electronic
information and telecommunications
technology (or ‘‘electronic exchange’’)
may include, but are not limited to, the
following: Secure messaging, store and
forward technologies, telephone,
videoconferencing, other internetenabled technologies, and other
evolving technologies as appropriate for
non-face-to-face communication. We
believe this broad and encompassing
approach will allow for technological
advances that may develop in the future
and avoid tying the authority in the
regulation to specific information
formats or technologies that permit nonface-to-face interactions for furnishing
clinically appropriate services.
We did not propose specific
regulation text defining ‘‘clinically
appropriate;’’ rather, we proposed to
implement the statutory requirement for
MA additional telehealth benefits to be
provided only when ‘‘clinically
appropriate’’ to align with our existing
regulations for contract provisions at
§ 422.504(a)(3)(iii), which requires each
MA organization to agree to provide all
benefits covered by Medicare ‘‘in a
manner consistent with professionally
recognized standards of health care.’’
We proposed to apply the same
principle to MA additional telehealth
benefits, as MA additional telehealth
benefits must be treated as if they were
benefits under original Medicare per
section 1852(m)(5) of the Act.
The statute limits MA additional
telehealth benefits to those services that
are identified for the applicable year as
PO 00000
Frm 00006
Fmt 4701
Sfmt 4700
clinically appropriate to furnish through
electronic exchange. The statute does
not specify who or what entity identifies
the services for the year. Therefore, we
proposed to interpret this provision
broadly by not specifying the Part B
services that an MA plan may offer as
MA additional telehealth benefits for
the applicable year, but instead allowing
MA plans to independently determine
each year which services are clinically
appropriate to furnish in this manner.
Thus, our definition of MA additional
telehealth benefits at § 422.135(a)
provides that it is the MA plan (not
CMS) that identifies the appropriate
services for the applicable year. We
believe that MA plans are in the best
position to identify each year whether
MA additional telehealth benefits are
clinically appropriate to furnish through
electronic exchange. MA plans have a
vested interest in and responsibility for
staying abreast of the current
professionally recognized standards of
health care, as these standards are
continuously developing with new
advancements in modern medicine. As
professionally recognized standards of
health care change over time and differ
from practice area to practice area, our
approach is flexible enough to take
those changes and differences into
account.
Furthermore, § 422.111(b)(2) requires
the MA plan to annually disclose the
benefits offered under a plan, including
applicable conditions and limitations,
premiums and cost sharing (such as
copayments, deductibles, and
coinsurance) and any other conditions
associated with receipt or use of
benefits. MA plans satisfy this
requirement through the Evidence of
Coverage, or EOC, document provided
to all enrollees. This disclosure
requirement would have to include
applicable MA additional telehealth
benefit limitations. That is, any MA
plan offering MA additional telehealth
benefits must identify the services that
can be covered as MA additional
telehealth benefits when provided
through electronic exchange. We believe
that it is through this mechanism (the
EOC) that the MA plan would identify
each year which services are clinically
appropriate to furnish through
electronic exchange as MA additional
telehealth benefits.
We solicited comment on this
proposed implementation of the statute
and our reasoning. We noted in the
proposed rule how we had considered
whether CMS should use the list of
Medicare telehealth services payable by
original Medicare under section
1834(m) of the Act as the list of services
that are clinically appropriate to be
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
provided through electronic exchange
for MA additional telehealth benefits. In
that circumstance, services on the list
could be considered as clinically
appropriate to be provided through
electronic exchange for MA additional
telehealth benefits without application
of the location limitations of section
1834(m) of the Act. However, we do not
believe that is the best means to take full
advantage of the flexibility that
Congress has authorized for the MA
program. The list of Medicare telehealth
services for which payment can be made
under section 1834(m) of the Act under
the original Medicare program includes
services specifically identified by
section 1834(m) of the Act as well as
other services added to the Medicare
telehealth list using criteria and an
annual process established by CMS. We
stated in the proposed rule that we
believe these limitations and criteria
should not apply to MA additional
telehealth benefits under new section
1852(m) of the Act for MA plans.
The statute requires the Secretary to
solicit comment on what types of items
and services should be considered to be
MA additional telehealth benefits.
Therefore, we also solicited comments
on whether we should place any
limitations on what types of Part B
items and services (for example,
primary care visits, routine and/or
specialty consultations, dermatological
examinations, behavior health
counseling, etc.) can be MA additional
telehealth benefits provided under this
authority.
An enrollee has the right to request
MA additional telehealth benefits
through the organization determination
process. If an enrollee is dissatisfied
with the organization determination,
then the enrollee has the right to appeal
the decision. We believe these rights
help ensure access to medically
necessary services, including MA
additional telehealth benefits offered by
an MA plan as described in this rule. In
addition, CMS audits plan performance
with respect to timeliness and clinical
appropriateness of organization
determinations and appeals.
While the MA plan would make the
‘‘clinically appropriate’’ decision in
terms of coverage of an MA additional
telehealth benefit, we note that each
healthcare provider must also provide
services that are clinically appropriate.
We acknowledge that not all Part B
items and services would be suitable for
MA additional telehealth benefits
because a provider must be physically
present in order to properly deliver care
in some cases (for example, hands-on
examination, administering certain
medications). As stated earlier, we
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
proposed that MA plans would
independently determine each year
which services are clinically
appropriate to furnish in this manner.
Behavioral health, in particular, is a
prime example of a service that could be
provided remotely through MA plans’
offering of MA additional telehealth
benefits under this rule. The President’s
Commission on Combating Drug
Addiction and the Opioid Crisis
recommends telehealth as useful in the
effort to combat the opioid crisis when
clinically appropriate, especially in
geographically isolated regions and
underserved areas where people with
opioid use disorders and other
substance use disorders may benefit
from remote access to needed
treatment.4
We proposed in paragraph (b) the
general rule to govern how an MA plan
may offer MA additional telehealth
benefits. Specifically, we proposed that
if an MA plan chooses to furnish MA
additional telehealth benefits, the MA
plan may treat these benefits as basic
benefits covered under the original
Medicare fee-for-service program as long
as the requirements of proposed
§ 422.135 are met. We also proposed in
§ 422.135(b) that if the MA plan fails to
comply with the requirements of
§ 422.135, then the MA plan may not
treat the benefits provided through
electronic exchange as MA additional
telehealth benefits, but may treat them
as MA supplemental telehealth benefits,
subject to CMS approval of the MA
supplemental telehealth benefits. For
example, a non-Medicare covered
service provided through electronic
exchange cannot be offered as an MA
additional telehealth benefit because it
does not comply with § 422.135, which
is limited to furnishing through
electronic exchange otherwise covered
Part B covered services, but it may be
offered it as an MA supplemental
telehealth benefit.
Section 1852(m)(4) of the Act
mandates that enrollee choice is a
priority. If an MA plan covers a Part B
service as an MA additional telehealth
benefit, then the MA plan must also
provide access to such service through
an in-person visit and not only through
electronic exchange. We proposed to
codify this statutory mandate preserving
enrollee choice in regulation text at
§ 422.135(c)(1), which requires that the
enrollee must have the option to receive
a service that the MA plan covers as an
MA additional telehealth benefit either
4 Retrieved at: https://www.whitehouse.gov/sites/
whitehouse.gov/files/images/
Meeting%20Draft%20of%20Final%20Report%20%20November%201%2C%202017.pdf.
PO 00000
Frm 00007
Fmt 4701
Sfmt 4700
15685
through an in-person visit or through
electronic exchange. Section 1852(m)(5)
of the Act mandates that MA additional
telehealth benefits shall be treated as if
they were benefits under the original
Medicare fee-for-service program
option. In proposed regulation text at
§ 422.135(f), we proposed to allow MA
plans to maintain different cost sharing
for the specified Part B service(s)
furnished through an in-person visit and
the specified Part B service(s) furnished
through electronic exchange.
We proposed § 422.135(c)(2) to
require MA plans to use their EOC (at
a minimum) to advise enrollees that
they may receive the specified Part B
service(s) either through an in-person
visit or through electronic exchange. We
proposed, at § 422.135(c)(3), that MA
plans would have to use their provider
directory to identify any providers
offering services for MA additional
telehealth benefits and in-person visits
or offering services exclusively for MA
additional telehealth benefits. We stated
in the proposed rule that these
notifications in the EOC and the
provider directory are important to
ensure choice, transparency, and clarity
for enrollees who might be interested in
taking advantage of MA additional
telehealth benefits. We requested
comments on what impact, if any, MA
additional telehealth benefits should
have on MA network adequacy policies.
Specifically, we were looking for the
degree to which MA additional
telehealth benefit providers should be
considered in the assessment of network
adequacy (including for certain provider
types and/or services in areas with
access concerns) and any potential
impact on rural MA plans, providers,
and/or enrollees.
Section 1852(m)(3) of the Act requires
the Secretary to specify limitations or
additional requirements for the
provision or furnishing of MA
additional telehealth benefits, including
requirements with respect to physician
or practitioner qualifications, factors
necessary for the coordination of MA
additional telehealth benefits with other
items and services (including those
furnished in-person), and other areas
identified by the Secretary. We
recognize the potential for MA
additional telehealth benefits to support
coordinated health care and increase
access to care in both rural and urban
areas. We stated in the proposed rule
how we expect MA plans would use
these types of benefits to support an
effective, ongoing doctor-patient
relationship and the efficient delivery of
needed care.
We proposed in regulation text at
§ 422.135(c)(4) to require an MA plan
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15686
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
offering MA additional telehealth
benefits to comply with the provider
selection and credentialing
requirements provided in § 422.204. An
MA plan must have written policies and
procedures for the selection and
evaluation of providers and must follow
a documented process with respect to
providers and suppliers, as described in
§ 422.204. Further, we proposed that the
MA plan, when providing MA
additional telehealth benefits, must
ensure through its contract with the
provider that the provider meet and
comply with applicable state licensing
requirements and other applicable laws
for the state in which the enrollee is
located and receiving the service. We
recognize, however, that it is possible
for a state to have specific provisions
regarding the practice of medicine using
electronic exchange; our proposal
reflected our intent to ensure that MA
network providers comply with these
laws and that MA plans ensure
compliance with such laws and only
cover MA additional telehealth benefits
provided in compliance with such laws.
We solicited comment on whether to
impose additional requirements for
qualifications of providers of MA
additional telehealth benefits, and if so,
what those requirements should be.
In order to monitor the impact of the
MA additional telehealth benefits on
MA plans, providers, enrollees, and the
MA program as a whole, we also
proposed to require MA plans to make
information about coverage of MA
additional telehealth benefits available
to CMS upon request, per proposed
§ 422.135(c)(5). We proposed that this
information may include, but is not
limited to, statistics on use or cost of
MA additional telehealth benefits,
manner(s) or method(s) of electronic
exchange, evaluations of effectiveness,
and demonstration of compliance with
the requirements in § 422.135. We
explained in our proposed rule that the
purpose of requiring MA plans to make
such information available to CMS upon
request would be to determine whether
CMS should make improvements to the
regulation and/or guidance regarding
MA additional telehealth benefits.
In § 422.135(d), we proposed to
require that MA plans furnishing MA
additional telehealth benefits may only
do so using contracted (that is, network)
providers. We believe limiting service
delivery of MA additional telehealth
benefits to contracted providers offers
MA enrollees access to these covered
services in a manner more consistent
with the statute because plans would
have more control over how and when
such services are furnished. The
regulation at § 422.204 requires MA
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
plans to have written policies and
procedures for the selection and
evaluation of providers and that such
policies conform with MA specific
credentialing requirements outlined in
§ 422.204. We explained in the
proposed rule that these policies would
also be a means to ensure additional
oversight of providers’ performance,
thereby increasing plans’ ability to
provide covered services such as MA
additional telehealth benefits. We also
proposed to specify that if an MA plan
covers benefits furnished by a noncontracted provider through electronic
exchange, then those benefits may only
be covered as MA supplemental
telehealth benefits. These benefits are
not MA additional telehealth or basic
benefits if furnished by a non-contracted
provider through electronic exchange.
We requested comment on whether the
contracted providers’ restriction should
be placed on all MA plan types or
limited only to certain plan types, such
as local/regional preferred provider
organization (PPO) plans, medical
savings account (MSA) plans, and/or
private fee-for-service (PFFS) plans.
Currently, pursuant to § 422.4(a)(1)(v),
PPO plans must provide reimbursement
for all plan-covered medically necessary
services received from non-contracted
providers without prior authorization
requirements. We explained in the
proposed rule our view that without an
opportunity to review the qualifications
of the non-contracted provider and to
impose limits on how only clinically
appropriate services are provided as MA
additional telehealth benefits, PPO
plans would not be able to meet the
proposed requirements. Therefore, we
solicited comment on whether to
require just PPOs (or MSA plans, PFFS
plans, etc.), instead of all MA plan
types, to use only contracted providers
for MA additional telehealth benefits.
Per section 1852(m)(2)(A)(ii) of the
Act, the term ‘‘additional telehealth
benefits’’ does not include capital and
infrastructure costs and investments
relating to such benefits. We proposed
to codify this requirement in
§ 422.254(b)(3)(i) as a restriction on how
MA plans include MA additional
telehealth benefits in their bid
submission. We stated that we believe
that the statutory limit is tied only to the
cost to the government, which is tied to
how MA additional telehealth benefits
may be included in the bid as basic
benefits. Therefore, our proposal was to
eliminate from the basic benefit bid
those capital and infrastructure costs
and investments that are required or
used to enable the provision of MA
additional telehealth benefits. We did
PO 00000
Frm 00008
Fmt 4701
Sfmt 4700
not propose specific definitions of
capital and infrastructure costs or
investments related to such benefits
because the costs and investments
needed and used to provide MA
additional telehealth benefits would
vary based on the individual MA plan’s
approach to furnishing the benefits. In
the proposed rule, we provided some
examples of capital and infrastructure
costs, including, but not limited to,
high-speed internet installation and
service, communication platforms and
software, and video conferencing
equipment. We also solicited comment
on what other types of capital and
infrastructure costs and investments
should be excluded from the bid and
how CMS should operationalize this
statutory requirement in the annual bid
process. We proposed to provide a more
detailed list of examples in this final
rule, based on feedback received from
stakeholders.
We explained in the proposed rule
that our proposal at § 422.254(b)(3)(i)
meant that MA plans must exclude any
capital and infrastructure costs and
investments specifically relating to MA
additional telehealth benefits from their
bid submission for MA additional
telehealth services offered directly by
the plan sponsor and by a third party
provider. Accordingly, we explained
our proposal meant that the projected
expenditures in the MA bid for services
provided via MA additional telehealth
benefits must not include the
corresponding capital and infrastructure
costs and that any items provided to the
enrollee in the administration of MA
additional telehealth benefits must be
directly related to the care and
treatment of the enrollee for the Part B
benefit. In the proposed rule, we
provided an example of this provision,
noting that MA plans would not be able
to provide enrollees with internet
service or permanently install
telecommunication systems in an
enrollee’s home as part of
administration of MA additional
telehealth benefits.
In addition to our proposal at
§ 422.135, we also proposed to amend
paragraphs (a) and (c)(1) of § 422.100 to
explicitly address how MA additional
telehealth benefits may be offered by an
MA plan. Section 1852(a)(1)(A) of the
Act requires that each MA plan shall
provide enrollees benefits under the
original Medicare fee-for-service
program option. As amended by the
Bipartisan Budget Act of 2018, section
1852(a)(1)(B) of the Act defines
‘‘benefits under the original Medicare
fee-for-service program option’’ to
mean—subject to subsection (m)
(regarding provision of MA additional
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
telehealth benefits)—those items and
services (other than hospice care or
coverage for organ acquisitions for
kidney transplants) for which benefits
are available under Parts A and B to
individuals entitled to benefits under
Part A and enrolled under Part B. Since
this definition is subject to the statutory
provision for MA additional telehealth
benefits, this means that all of the same
coverage and access requirements that
apply with respect to basic benefits also
apply to any MA additional telehealth
benefits an MA plan may choose to
offer. Therefore, we proposed to amend
§ 422.100(c)(1) to include MA additional
telehealth benefits in the definition of
basic benefits and to cross-reference
§ 422.135, which provides the rules
governing MA additional telehealth
benefits. We proposed to further clarify
the regulation text in § 422.100(c)(1) to
track the statutory language described
earlier more closely in addressing both
kidney acquisition and hospice in the
definition of basic benefits. Finally, we
proposed to make corresponding
technical revisions to § 422.100(a) to
reference the new paragraph (c)(1) for
basic benefits (clarifying that MA
additional telehealth benefits are
voluntary benefits for MA plans to offer
but are not required) and paragraph
(c)(2) for MA supplemental benefits
(instead of § 422.102 because MA
supplemental benefits are listed as a
benefit type in (c)(2)). We also proposed
a small technical correction in the last
sentence of § 422.100(a) to replace the
reference to § 422.100(g) with ‘‘this
section’’ because there are a number of
provisions in § 422.100—not just
paragraph (g)—that are applicable to the
benefits CMS reviews.
Additionally, we proposed
amendments to the bidding regulations
at §§ 422.252, 422.254, and 422.264 to
account for MA additional telehealth
benefits and to correct the inconsistent
phrasing of references to basic benefits
(for example, these regulations variously
use the terms ‘‘original Medicare
benefits,’’ ‘‘benefits under the original
Medicare program,’’ ‘‘benefits under the
original Medicare FFS program option,’’
etc.). In order to make the MA
additional telehealth benefits part of the
basic benefit bid and included in the
‘‘monthly aggregate bid amount’’ as part
of the original Medicare benefits that are
the scope of the basic benefit bid, we
proposed to update these various
phrases to consistently use the phrase
‘‘basic benefits as defined in
§ 422.100(c)(1).’’ We also proposed a
few minor technical corrections to the
bidding regulations. Finally, we
proposed a paragraph (e) in new
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
§ 422.135 to state that an MA plan that
fully complies with § 422.135 may
include MA additional telehealth
benefits in its bid for basic benefits in
accordance with § 422.254. This
provision means that inclusion in the
bid is subject to the bidding regulations
we proposed to amend.
In offering MA additional telehealth
benefits, MA plans must comply with
existing MA rules, including, but not
limited to: Access to services at
§ 422.112; recordkeeping requirements
at § 422.118 (for example,
confidentiality, accuracy, timeliness);
standards for communications and
marketing at § 422.2268 (for example,
inducement prohibition); and nondiscrimination at §§ 422.100(f)(2) and
422.110(a). Further, in addition to
§§ 422.112, 422.118, 422.2268,
422.100(f)(2), and 422.110(a), MA plans
must also ensure compliance with other
federal non-discrimination laws, such as
Title VI of the Civil Rights Act of 1964,
section 504 of the Rehabilitation Act of
1973, and section 1557 of the Affordable
Care Act. We did not propose specific
reference to these existing requirements
in new § 422.135 because we do not
believe that to be necessary. Compliance
with these existing laws is already
required; we merely note, as an aid to
MA plans, how provision of MA
additional telehealth benefits must be
consistent with these regulations. We
solicited comment on this policy choice,
specifically whether there were other
existing regulations that CMS should
revise to address their application in the
context of MA additional telehealth
benefits.
Finally, section 1852(m)(2)(B) of the
Act instructed the Secretary to solicit
comments on the implementation of
these MA additional telehealth benefits
by November 30, 2018; in addition to
the proposed regulations to implement
section 1852(m) of the Act, we used the
proposed rule and the associated
comment period to satisfy this statutory
requirement. We thank commenters for
their input to help inform CMS’s next
steps related to implementing the MA
additional telehealth benefits. We
received the following comments on
this proposal, and our response follows:
Comment: Many commenters
suggested that CMS’s approach to MA
additional telehealth benefits align with
CMS’s existing approaches to what is
currently available via telehealth under
original Medicare. These commenters
referenced the ‘‘Medicare telehealth
services’’ definition in section 1834(m)
of the Act, payment for remote patient
monitoring (RPM) services outside of
section 1834(m) of the Act, as well as
the new communication technology-
PO 00000
Frm 00009
Fmt 4701
Sfmt 4700
15687
based services not subject to section
1834(m) restrictions, described in the
Medicare Program; Revisions to
Payment Policies Under the Physician
Fee Schedule and Other Revisions to
Part B for CY 2019 (83 FR 59452, Nov.
23, 2018; hereinafter referred to as the
Calendar Year 2019 Physician Fee
Schedule final rule). Commenters also
requested that CMS clarify the
distinction between MA additional
telehealth benefits and the various
services in original Medicare that use
communications technology (including
Medicare telehealth services under
section 1834(m) of the Act).
Specifically, some commenters
recommended that CMS state in the
final rule that MA additional telehealth
benefits are subject to the technological
specifications for Medicare telehealth
services furnished under section
1834(m) of the Act, that is, two-way
audio and visual real-time and
interactive services. Further,
commenters requested that CMS
explicitly state that under current
original Medicare rules, MA plans may
already include other clinically
appropriate virtual services that are not
subject to the location limitations of
section 1834(m) of the Act—such as
RPM technology—as part of basic
benefits because such services are
payable under Part B for original
Medicare.
Response: We understand
commenters’ concerns that differences
between telehealth services under
original Medicare and MA additional
telehealth benefits be clearly
distinguished and explained. We
appreciate the input offered by
commenters and provide a thorough and
clear discussion here.
First, we must emphasize that the
term ‘‘additional telehealth benefits’’ is
a term of art with a specific meaning in
the MA program; it is defined in section
1852(m)(A) of the Act and in the
regulation we finalize here at
§ 422.135(a). We are finalizing the
regulatory definition with changes from
the proposed rule to delete ‘‘are
furnished by an MA plan’’ and to
include the statutory provisions that
MA additional telehealth benefits are
services for which benefits are available
under Part B and are provided when
specific healthcare providers and
enrollees are in different locations. As
finalized, the definition reads that
additional telehealth benefits means
services:
(1) For which benefits are available
under Medicare Part B but which are
not payable under section 1834(m) of
the Act; and
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15688
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
(2) That have been identified by the
MA plan for the applicable year as
clinically appropriate to furnish through
electronic exchange when the physician
(as defined in section 1861(r) of the Act)
or practitioner (described in section
1842(b)(18)(C) of the Act) providing the
service is not in the same location as the
enrollee. We are focused here on the
first part of this definition.
Second, determining whether a
service may be offered by an MA plan
as part of basic benefits requires
addressing two questions: (1) Is the
service covered and payable under Part
A or Part B?; and (2) if not, is the reason
it is not payable under Part B solely
because of the limits in section 1834(m)
of the Act? If the answer to the first
question is yes, then the service is
already a benefit under the original
Medicare fee-for-service program option
and, unless it is hospice care or
coverage for organ acquisitions for
kidney transplants, must be provided
under current law at section 1852(a) of
the Act and the MA regulations in 42
CFR part 422. If the answer to the
second question is yes, then provision
of the service through electronic
exchange may be covered as an MA
basic benefit under section 1852(m) of
the Act, as added by the Bipartisan
Budget Act of 2018, and the regulations
(at §§ 422.100, 422.135, 422.252,
422.254, and 422.264) we are finalizing
in this rule. We note that these
regulations include other conditions
that must also be satisfied in order for
the service to be MA additional
telehealth benefits that may be included
as basic benefits, but our focus for this
specific discussion is on the
relationship to Part B coverage. We turn
now to Part B coverage of telehealth
services.
Under original Medicare, Part B
provides for coverage and payment of
services (and items, which are not
relevant for purposes of this discussion),
including services furnished in an inperson encounter between a physician
or other practitioner, services furnished
as Medicare telehealth services as
specified under section 1834(m) of the
Act, and certain other services that can
be furnished in full without the patient
being present. ‘‘Medicare telehealth
services,’’ as defined in section 1834(m)
of the Act and the implementing
regulations at §§ 410.78 and 414.65
include professional consultations,
office visits, office psychiatry services,
and other similar services that must
ordinarily be furnished in-person but
instead may be furnished using
interactive, real-time
telecommunication technology subject
to the restrictions on Medicare
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
telehealth services specified under
section 1834(m) of the Act. Also under
section 1834 of the Act, synchronous
‘‘store and forward’’ telehealth services
may be furnished as part of federal
telemedicine demonstration projects in
Alaska and Hawaii. Medicare telehealth
services under section 1834(m) of the
Act are limited in that they must only
be furnished by physicians and other
specified types of practitioners, and can
be furnished and paid only when the
beneficiary is located at an eligible
originating site.
As we explained in the Calendar Year
2019 Physician Fee Schedule final rule,
we have generally regarded the
Medicare telehealth services for which
payment can be made under section
1834(m) of the Act as being limited to
services that must ordinarily be
furnished in-person during an
encounter between a clinician and the
patient, but are instead furnished using
telecommunication technology as a
substitute for that in-person encounter
(83 FR 59482–59483). There are other
services under original Medicare that
use telecommunication technology, but
are not considered Medicare telehealth
services as defined under section
1834(m) of the Act, for example, RPM
and remote interpretation of diagnostic
tests, chronic care management services,
transitional care management services
(other than the included evaluation and
management service), and behavioral
health integration services.
Additionally, as established in the
Calendar Year 2019 Physician Fee
Schedule final rule, effective January 1,
2019, original Medicare now makes
separate payment for new
‘‘communication technology-based
services.’’ These services are not subject
to the limitations of section 1834(m) of
the Act because they are not a substitute
for an in-person, face-to-face encounter
between a clinician and a patient. As
such, these services are inherently nonface-to-face, are paid under the
Physician Fee Schedule like other
physicians’ services, and are not subject
to the restrictions on Medicare
telehealth services specified under
section 1834(m) of the Act. The
communication technology-based
services include brief communication
technology-based service (virtual checkin), remote evaluation of pre-recorded
patient information, and
interprofessional internet consultation.
These three services and their
corresponding Healthcare Common
Procedure Coding System (HCPCS)
codes are described in detail in the
Calendar Year 2019 Physician Fee
Schedule final rule at 83 FR 59482
through 59491. That rule also finalized
PO 00000
Frm 00010
Fmt 4701
Sfmt 4700
separate payment under the Physician
Fee Schedule for chronic care remote
physiologic monitoring services.
In the Calendar Year 2019 Physician
Fee Schedule final rule, CMS also
implemented sections 50302 and 50325
of the Bipartisan Budget Act of 2018 to
remove certain section 1834(m)
limitations on geography and
originating site (patient setting) for
certain services. Specifically, the
policies under section 50302 of the
Bipartisan Budget Act of 2018 added
renal dialysis facilities and the homes of
beneficiaries as allowable originating
sites and removed the geographic
restrictions for hospital-based or critical
access hospital-based renal dialysis
centers, renal dialysis facilities, and
beneficiary homes, for purposes of
monthly ESRD-related clinical
assessments for patients receiving home
dialysis. The policies under section
50325 of the Bipartisan Budget Act of
2018 added mobile stroke units as
allowable originating sites and removed
the originating site type and geographic
restrictions, for acute stroke-related
telehealth services. Both are effective
January 1, 2019.
Additionally, CMS revised the
Medicare telehealth regulations to
reflect the amendments made to section
1834(m) of the Act by section 2001(a) of
the Substance Use-Disorder Prevention
that Promotes Opioid Recovery and
Treatment for Patients and Communities
Act (SUPPORT Act) (Pub. L. 115–271) to
remove the originating site geographic
requirements for all originating sites
described in section 1834(m)(4)(C)(ii) of
the Act, except for renal dialysis
facilities that are only permissible
originating sites for purposes of monthly
ESRD-related clinical assessments for
patients receiving home dialysis, and to
add the home of an individual as a
permissible originating site, with
respect to telehealth services furnished
for purposes of the treatment of an
individual with a substance use
disorder diagnosis or co-occurring
mental health disorder, effective July 1,
2019 (83 FR 59494 through 59496).
All of the telehealth services and
other non-face-to-face services furnished
via communication technology
described earlier are covered and paid
under original Medicare. Therefore, MA
plans must cover these services because
they are required basic benefits. Any
services falling outside the scope of
these services that an MA plan wishes
to offer may potentially be covered as
MA additional telehealth benefits,
effective January 1, 2020, assuming they
meet the requirements under section
1852(m) of the Act. In other words, MA
additional telehealth benefits can
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
include an even broader range of
telehealth services for enrollees in an
MA plan offering MA additional
telehealth benefits, beyond original
Medicare benefits. An examination
conducted using videoconferencing
and/or other telecommunications
systems to relay information (such as
images and vital signs) may be covered
as a primary care visit when the
physician (as defined in section 1861(r)
of the Act) or practitioner (described in
section 1842(b)(18)(C) of the Act) and
enrollee are in different locations that
do not meet the requirements under
section 1834(m) of the Act. As a
practical matter, we do not expect MA
plans to find implementation and
compliance difficult because, if a
service provided by the physician or
practitioner is a Part B covered service
for which payment could be made, but
for the limitations in section 1834(m) of
the Act, it may be an MA additional
telehealth benefit if the MA plan
complies with § 422.135 as finalized. If
a service or item provided by a
physician or practitioner is covered
under Part B by the original Medicare
program and payment is not prohibited
based on the limitations in section
1834(m) of the Act, then the service or
item is a basic benefit without
consideration of whether § 422.135
could apply. Finally, if a service is not
covered under Part B, even if the
limitations in section 1834(m) of the Act
are taken into account, then the service
may only be covered by an MA plan as
an MA supplemental telehealth benefit,
and not offered as an MA additional
telehealth benefit. In addition, we
clarify in this final rule that if a service
is covered under Part B and provided
through electronic exchange but
otherwise does not comply with
§ 422.135 (for example, if it is provided
by an out-of-network healthcare
provider), then the service may be
covered only as an MA supplemental
telehealth benefit per § 422.135(b). For
example, a nursing hotline staffed by
nurses, that are not practitioners
specified in section 1842(b)(18)(C) 5 of
the Act, that provides assistance in
identifying when to seek additional
medical help would not be covered
under Part B even if the assistance were
provided in person. We discuss these
5 Such practitioners include: (i) A physician
assistant, nurse practitioner, or clinical nurse
specialist (as defined in section 1861(aa)(5)) of the
Act; (ii) A certified registered nurse anesthetist (as
defined in section 1861(bb)(2)); (iii) A certified
nurse-midwife (as defined in section 1861(gg)(2));
(iv) A clinical social worker (as defined in section
1861(hh)(1)); (v) A clinical psychologist (as defined
by the Secretary for purposes of section 1861(ii))
and (vi) A registered dietitian or nutrition
professional.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
issues in more detail in our responses to
comments below.
We thank commenters for their
feedback on how to reconcile the
telehealth differences between MA and
original Medicare, and we hope our
response provides adequate clarification
and removes any misinterpretation.
Please note, CMS intends to release
more detailed sub-regulatory guidance
relating to telehealth for both the
original Medicare and MA programs.
Comment: Several commenters
supported CMS’s explicit recognition
that MA plans may continue to offer
other telehealth services through MA
supplemental telehealth benefits. A
commenter questioned whether noncontracted providers will be allowed to
provide MA additional telehealth
benefits as supplemental benefits.
Response: We thank commenters for
their support for continuing to allow
MA plans to offer MA supplemental
telehealth benefits for those services
that do not meet the requirements for
coverage under original Medicare or as
MA additional telehealth benefits. We
are finalizing our proposal, at
§ 422.135(d), to require that MA
additional telehealth benefits only be
furnished using contracted providers.
As discussed in the preamble of the
proposed rule, an MA plan may still
cover out-of-network services that
would be considered MA additional
telehealth benefits (and thus offered as
MA basic benefits) when provided by a
contracted provider, but these out-ofnetwork services may only be covered
as MA supplemental telehealth benefits
because the MA plan has not complied
with § 422.135(d). These services are not
MA additional telehealth benefits if
furnished by a non-contracted provider
through electronic exchange.
Comment: Many commenters
supported CMS’s proposed definition
for the term ‘‘electronic exchange’’ in
proposed regulation text at § 422.135(a).
The commenters stated that CMS’s
broad definition, which defines
electronic exchange as ‘‘electronic
information and telecommunications
technology,’’ is reasonable as it allows
MA plans to use evolving technology to
provide MA additional telehealth
benefits. Further, some commenters
strongly urged CMS to rescind the
electronic exchange examples listed in
the proposed rule preamble, but finalize
as proposed the definition of ‘‘electronic
exchange’’ in the regulation text at
§ 422.135(a). Commenters stated CMS
could not provide a list of electronic
exchange examples that adequately
takes in to account future technological
innovation. Commenters also explained
that a limited list of electronic exchange
PO 00000
Frm 00011
Fmt 4701
Sfmt 4700
15689
examples would cause confusion in the
marketplace because plans and
providers would be uncertain about
permissible forms of electronic
exchange technology.
Response: We appreciate all of the
comments received on the proposed
definition for the term ‘‘electronic
exchange.’’ Our definition is based on
how section 1852(m)(2) of the Act uses
the phrase ‘‘electronic information and
telecommunications technology’’ to
describe how the services are provided
when the physician or practitioner and
the patient are not in the same location.
In § 422.135(a) as finalized, we define
‘‘electronic exchange’’ as ‘‘electronic
information and telecommunications
technology.’’ We agree that this
definition of ‘‘electronic exchange’’
allows MA plans the use of various
forms of technology to provide MA
additional telehealth benefits to
enrollees. Our purpose in defining
‘‘electronic exchange’’ in this manner is
to allow modernization in the MA
program and the provision of evidencebased, effective health care. As noted in
the proposed rule, we did not propose
specific regulation text that defines or
provides examples of electronic
information and telecommunications
technology. We stated that we believe
this broad and encompassing approach
will allow for technological advances
that may develop in the future.
While our list of electronic exchange
examples in the proposed rule preamble
was not intended to be a comprehensive
list for purposes of the final rule, we
acknowledge that the list of electronic
exchange examples does not take into
account future technological innovation,
and we seek to allow plans the
flexibility to develop forms of electronic
exchange without unnecessary burden.
We are finalizing as proposed the
definition of ‘‘electronic exchange’’ in
the regulation text at § 422.135(a). We
believe this more general approach
allows for MA plan flexibility and
innovation, does not inadvertently
restrict MA plans to certain forms of
electronic exchange, and avoids the
possibility of overlap with original
Medicare telehealth coverage. We
explicitly clarify here that future
technology that is within the scope of
the phrase ‘‘electronic information and
telecommunications technology’’ as
used in the statute may be used for
purposes of providing MA additional
telehealth benefits.
Comment: Many commenters
supported CMS’s decision not to
propose specific regulation text that
defines or provides examples of
electronic information and
telecommunications technology because
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15690
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
the technology needed and used to
provide MA additional telehealth
benefits will vary based on the service
being offered. A commenter suggested
there be a governing body to review and
certify the telehealth technology used
and to ensure proper telehealth provider
training.
Response: We agree with commenters’
position that specific regulation text that
defines or provides examples of
electronic information and
telecommunications technology should
not be included in the final rule. We do
not include this specific regulation text
in the final rule because technology will
vary based on user and over time. As
discussed earlier, we believe this broad
and encompassing approach will allow
for technological advances that may
develop in the future and avoid tying
the authority in the new regulation to
specific information formats or
technologies.
We appreciate the commenter’s
suggestion that there be a governing
body to review and certify the telehealth
technology used and to ensure proper
telehealth provider training. We are not
requiring a governing body to conduct
oversight of telehealth technology and
providers at this time, but we will use
authority codified in this final rule at
§ 422.135(c)(4) to review information
about coverage of MA additional
telehealth benefits, which may include,
but is not limited to, statistics on use or
cost, manner(s) or method of electronic
exchange, evaluations of effectiveness,
and demonstration of compliance with
the requirements of this final rule.
Comment: Many commenters
supported CMS allowing MA plans to
independently determine each year
which services are clinically
appropriate to furnish through
electronic exchange as MA additional
telehealth benefits. These commenters
stated that MA plans should have
authority to make these determinations
because plans and healthcare providers
work directly with enrollees and are
more aware of evolving methods of
delivering care. A few commenters
recommended that CMS authorize
healthcare providers, rather than or in
addition to MA plans, to make the
annual determination of which services
are clinically appropriate to furnish
through MA additional telehealth
benefits.
Response: We are finalizing our
proposal that MA plans have the
discretion to determine which Part B
services are clinically appropriate to
provide through electronic exchange
and to make that determination for each
applicable plan year. Such services,
when the other requirements in
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
§ 422.135 are met, would be permissible
MA additional telehealth benefits. As
professionally recognized standards of
health care change over time, we believe
MA plans have an interest in working
with providers to develop and use the
methods of modern medicine necessary
to provide MA additional telehealth
benefits to enrollees who choose to have
their health benefits delivered in this
manner. MA plans are required, per
§ 422.202(b), to consult with their
contracted network providers regarding
the MA plan’s medical policy; this
would include any applicable MA
additional telehealth benefits policy,
and we believe that is sufficient for
establishing the required involvement of
healthcare providers. We encourage MA
plans to involve their contracted
providers when making determinations
about which services are clinically
appropriate to furnish through MA
additional telehealth benefits beyond
the consultation required under that
regulation, but we are not adopting such
a requirement in this final rule.
Furthermore, we note that in
accordance with § 422.112(b)(3), all MA
coordinated care plans are required to
coordinate MA benefits with
community and social services generally
available in the plan service area.
Therefore, we expect MA coordinated
care plans offering MA additional
telehealth benefits to coordinate care for
enrollees receiving the specified Part B
service(s) through electronic exchange
in the same manner as for enrollees
receiving the service in-person.
Comment: Many commenters opposed
CMS placing limitations on the types of
Part B items and services that can be
MA additional telehealth benefits.
Specifically, commenters urged CMS to
use only the MA plan annual
determination and medical review to
define the types of items and services to
be included as MA additional telehealth
benefits. They explained that any
definition of items or services will lock
CMS into an approach supported by
today’s evidence, which will hinder
CMS’s ability to update its policies for
future evidence-based innovation.
Response: We agree with the
commenters that adopting a specific list
of services that could be MA additional
telehealth benefits when provided
through electronic exchange creates a
risk of not being sufficiently flexible in
the future. We proposed and are
finalizing regulation text that allows MA
plans flexibility to determine which
services are clinically appropriate to
furnish through MA additional
telehealth benefits on an annual basis
consistent with the limits in the statute
and § 422.135.
PO 00000
Frm 00012
Fmt 4701
Sfmt 4700
Comment: Some commenters
supported CMS’s proposal to allow MA
plans offering MA additional telehealth
benefits to maintain different cost
sharing for in-person visits and visits
through electronic exchange, while
several commenters opposed differential
cost sharing. Commenters expressed
concerns that low-income enrollees
living in rural, underserved areas
without internet access may be
disadvantaged because they would have
to choose the in-person option, which
may have higher cost sharing as
compared to the alternative visit
through electronic exchange. A few
commenters, including the Medicare
Payment Advisory Commission,
recommended CMS ensure access to inperson services is not made
prohibitively expensive by differential
cost sharing as it could be
discriminatory if undue financial
burden is imposed on enrollees who
choose in-person services instead of
accessing services through electronic
exchange. Further, commenters
requested that CMS actively monitor
differential cost sharing amounts to
ensure they fairly reflect actual cost
differentials and are not used to steer
enrollees away from preferred methods
of care. Commenters stated that
enrollees lacking internet access should
be able to get in-person services without
facing an increase in out-of-pocket costs.
Some commenters also requested that
CMS clarify that a Qualified Medicare
Beneficiary (QMB) would be protected
from billing for cost sharing for all Part
A/B services delivered via telehealth.
Response: As discussed in the
proposed rule, section 1852(m)(5) of the
Act mandates that MA additional
telehealth benefits shall be treated as if
they were benefits under the original
Medicare fee-for-service program
option. We acknowledged in the
proposed rule that CMS has
traditionally interpreted section
1852(a)(1)(B)(i) and (iii)–(v) of the Act to
mean that, subject to certain exceptions,
MA plans must cover basic benefits
using cost sharing that is actuarially
equivalent to the Part A and B cost
sharing from a plan-level (not enrolleelevel) perspective. MA plans are not
required, in most cases, to have the
exact same cost sharing as in original
Medicare. Subject to certain beneficiary
protections and limits on cost sharing
for certain specific services,6 MA plans
have great flexibility in setting the cost
sharing for specific benefits. Further, for
in-network services, CMS has limited
authority to set the payment structure,
including the payment amount, an MA
6 See
E:\FR\FM\16APR2.SGM
42 CFR 422.100(f), (j) and (k).
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
plan uses to pay its contracted
providers; to some extent, the amount
the MA plan has negotiated to pay its
contracted providers may influence the
cost sharing amount that the MA plan
sets for the associated services. In
addition, MA plans must have uniform
cost sharing per § 422.100(d)(2). CMS
has taken a broad and flexible approach
to the uniformity requirement,
including permitting MA plans to set up
‘‘preferred’’ networks that carry lower
cost sharing for specific services.7 In
response to comments on this topic, we
are clarifying the rationale for
§ 422.135(f).
In the context of original Medicare
Part B, services furnished in an inperson encounter between a clinician
and a patient are subject to different
rules than those delivered through
electronic exchange; in effect, the
statutory provisions governing payment
for original Medicare telehealth services
treat services furnished through
electronic exchange as different services
than the in-person services, rather than
as the same services delivered through
different modalities. Section 1834(m) of
the Act limits Part B payment for
services furnished through electronic
exchange to only certain healthcare
services delivered through certain
technology by specified types of
clinicians to beneficiaries located in
originating sites that meet specific
conditions. Under the statutory scheme
of section 1834(m) of the Act, services
furnished through electronic exchange,
where the physician or practitioner is
not in the same location as the patient,
are distinct and different services from
those furnished in-person and in the
same location.
We interpret the current law
regulating the cost sharing in the MA
context to mean that MA plans must
charge enrollees the same cost sharing
for the same item or service delivered by
the same provider, and we view a
service delivered in-person versus a
service delivered via electronic
exchange as different services because
they are delivered differently. In order
words, delivering a Part B service via
electronic exchange is inherently
different (for example, in modality and
required infrastructure) than delivering
the Part B service in-person under
Medicare coverage rules; therefore, we
consider these to be sufficiently
different services for purposes of the
MA requirement that cost sharing be
uniform, and thus the services can be
7 See Announcement of Calendar Year 2019
Medicare Advantage Capitation Rates and Medicare
Advantage and Part D Payment Policies and Final
Call Letter.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
treated differently from a cost sharing
perspective. Further, the cost of
providing the service via electronic
exchange might be lower, so having
lower cost sharing is acceptable. For
example, an MA plan may offer a
dermatology exam using store-andforward technology as an MA additional
telehealth benefit, and the cost of this
electronic exchange would likely be
lower than the cost of an in-person
dermatology exam. Thus, differential
cost sharing for the electronic exchange
versus the in-person visit would be
appropriate in this scenario. This
overall reasoning is consistent with our
traditional interpretation of the
Medicare statute and the applicable
provisions in Part C, therefore we are
finalizing the regulation text at
§ 422.135(f) as proposed.
We understand commenters’
apprehensions about enrollee
discrimination and enrollee access to
MA additional telehealth benefits. The
anti-discrimination requirements in
current CMS regulations at
§ 422.100(f)(2) and § 422.110(a) are
traditionally related to discrimination
based on health status. Other federal
non-discrimination laws, such as Title
VI of the Civil Rights Act of 1964, focus
on specific protected classes (such as
race and age). Economic status or
geographic location (rural/urban) are not
protected classes under those laws, nor
under current CMS regulations.
Consequently, we do not have clear
authority to enforce anti-discrimination
rules based solely on an enrollee’s
economic status or geographic location.
However, the statutory requirement
(section 1852(m)(4) of the Act) and our
corresponding regulatory requirement in
this final rule (§ 422.135(c)(1))
protecting the enrollee’s choice to
receive covered services in-person
control how an MA plan offers MA
additional telehealth benefits. An MA
plan offering MA additional telehealth
benefits must preserve the enrollee’s
right to choose whether to access the
service in-person or, if offered by the
MA plan, through electronic exchange.
MA plans may not circumvent or limit
enrollee choice by using differential cost
sharing to steer beneficiaries or inhibit
access to services. We view such
steering and inhibiting access as
violations of § 422.100(f)(2) because of
how those activities would inhibit an
enrollee from exercising his or her rights
under section 1852(m)(4) of the Act and
§ 422.135(c). If an MA plan chooses to
maintain differential cost sharing for
MA additional telehealth benefits, we
expect the primary purpose would be to
parallel the actual cost of administering
the service and not to steer beneficiaries
PO 00000
Frm 00013
Fmt 4701
Sfmt 4700
15691
or inhibit access. We will actively
monitor complaints regarding
differential cost sharing for MA
additional telehealth benefits. If we
identify a problem with enrollee access
or steering, we may take compliance or
enforcement actions, as necessary, and
we may modify our policy to address
the issue.
As discussed previously, MA plans
have great flexibility in setting cost
sharing for specific benefits. We believe
that restricting this flexibility for certain
plans that offer MA additional
telehealth benefits, for example in cases
where an MA plan operates in a rural or
underserved area, could result in MA
plans choosing not to offer MA
additional telehealth benefits in rural
service areas. Given this, and given the
existing beneficiary cost sharing
protections described previously, we do
not believe it is appropriate to limit MA
plans’ existing flexibility to set cost
sharing for MA additional telehealth
benefits. However, we encourage MA
plans to take issues like this into
consideration in establishing cost
sharing for MA additional telehealth
benefits.
Finally, we appreciate the comments
regarding QMB cost sharing protections.
However, we believe that the current
requirements at § 422.504(g)(1)(iii)
requiring MA plans to take steps to
ensure that QMBs are protected from
providers billing cost sharing are
adequate. This regulation prohibits MA
plans from imposing cost sharing on
dual eligible individuals when the state
is responsible for paying for the cost
sharing and from imposing cost sharing
on such enrollees that is higher than the
cost sharing permitted by the state
Medicaid plan. For more information on
cost sharing protections provided under
the Act for QMBs and other dual eligible
individuals, we refer readers to the CMS
website for the QMB program at: https://
www.cms.gov/Medicare-MedicaidCoordination/Medicare-and-MedicaidCoordination/Medicare-MedicaidCoordination-Office/QMB.html.
Comment: In accordance with section
1852(m)(4) of the Act, if an MA plan
covers a Part B service as an MA
additional telehealth benefit, then the
MA plan must also provide access to
such service through an in-person visit
and not only through electronic
exchange. We proposed § 422.135(c)(2)
to require MA plans to use their EOC (at
a minimum) to advise enrollees that
they may receive the specified Part B
service(s) either through an in-person
visit or through electronic exchange. We
also proposed, at § 422.135(c)(3), that
MA plans would have to use their
provider directory to identify any
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15692
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
providers offering services for MA
additional telehealth benefits and inperson visits or offering services
exclusively for MA additional telehealth
benefits. While we received some
support for our proposed disclosure
(that is, EOC and provider directory)
requirements for MA additional
telehealth benefits, other commenters
believed that these requirements would
be overly restrictive, burdensome, and/
or time consuming.
Several commenters recommended
that CMS provide more flexibility in
how MA plans can disclose information
about MA additional telehealth benefits
to enrollees. For example, commenters
suggested that CMS allow plans to use
more general terminology instead of
explicitly listing each service in the
EOC, and allow plans to describe in the
EOC how enrollees can obtain
information on telehealth services. In
terms of the provider directory, a
commenter believed CMS should let
plans make the determination regarding
inclusion of telehealth providers in a
way the plan believes optimizes clarity
for enrollees, especially since the
common industry approach is for
telehealth vendors to contract with
licensed providers, and the list of
providers is not static. Another
commenter requested that CMS require
only an indication of which providers
are exclusively available via telehealth
in directories, and allow sufficient leadtime for plans to implement any new
directory requirements. A commenter
suggested CMS work with plans on
alternative ways to responsibly share
information on MA additional
telehealth benefits with enrollees. A few
commenters requested clear guidance
(for example, model language) on the
proposed disclosure requirements and
clarification, such as whether provider
directory updates would need to be
made for all providers or only a specific
subset.
Response: We appreciate commenters’
concerns about the proposed disclosure
requirements being too restrictive and
onerous on plans, and we thank those
who offered alternative solutions and
ideas for more flexibility. As discussed
in the proposed rule, we believe that
choice, transparency, and clarity are
vital when it comes to disclosing MA
additional telehealth benefits to
enrollees. However, we also recognize
that there are various ways to effectively
communicate with enrollees consistent
with the mandatory disclosure and
information requirements in § 422.111.
CMS has traditionally discussed specific
required elements for mandatory
disclosures (for example, the provider
directory and EOC) and marketing
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
materials in sub-regulatory guidance to
explain and interpret the applicable
regulations as well as describe best
practices for MA plans and Part D
sponsors.
We agree with commenters that more
flexibility may be needed, and subregulatory guidance provides an
opportunity for flexibility in applying
the applicable regulations where
possible and for regular updates as
necessary to account for changes in
technology or evolving methods of
compliance. Therefore, we are not
finalizing our proposed regulation text
for the provider directory requirement at
proposed § 422.135(c)(3). Instead, we
will address any provider directory
elements pertaining to plans offering
MA additional telehealth benefits in
future sub-regulatory guidance. We note
that the provider directory requirements
in § 422.111 are not being amended and
continue to apply. Therefore, provider
directories must be complete, accurate,
and updated timely to identify the
healthcare providers currently under
contract with the MA plan to furnish
covered services to enrollees. In
response to comments claiming that the
common industry approach is for
telehealth vendors to contract with
licensed providers and that the list of
providers is not static, we remind MA
plans of the requirement to issue
provider directories and notify enrollees
of network changes per § 422.111. As
the providers of MA additional
telehealth services must be contracted
providers, we expect that they will be
identified as contracted providers in
provider directories.
We intend to be as clear as possible
in our sub-regulatory guidance to assist
plans with their enrollee
communications and to address how the
existing provider directory requirements
apply in the context of MA plan
obligations in connection with
furnishing MA additional telehealth
benefits. We note that, as discussed in
more detail below, we are finalizing our
proposal that only contracted (that is,
in-network) providers may be used by
an MA plan to furnish MA additional
telehealth benefits.
For similar reasons, we are also not
finalizing our reference to the EOC at
proposed regulation text § 422.135(c)(2).
The regulation at § 422.111 establishing
what information must be provided to
enrollees (and when) regarding benefits
covered by the MA plan is sufficient.
We have historically used subregulatory guidance to address the
specific level of detail required by that
regulation and will issue guidance
specific to how MA additional
telehealth benefits must be addressed in
PO 00000
Frm 00014
Fmt 4701
Sfmt 4700
mandatory communication materials
such as the EOC and the Annual Notice
of Change. None of our other regulations
about specific benefits require specific
content in the EOC. We believe that it
is appropriate to follow that practice for
addressing how information about MA
additional telehealth benefits must be
disclosed and provided to enrollees.
However, we are finalizing the
remaining text at (c)(2), which requires
an MA plan furnishing MA additional
telehealth benefits to advise enrollees
that they may receive the specified Part
B service(s) either through an in-person
visit or through electronic exchange. We
have decided to maintain this general
enrollee disclosure requirement
(without reference to the EOC) because
of the statutory requirement at section
1852(m)(4)(B) of the Act that the
enrollee must have that choice. We
believe the MA plan must disclose this
right of choice to enrollees in a
transparent manner in order to ensure
that the right is meaningfully provided.
We plan to issue sub-regulatory
guidance specifically for § 422.135(c)(2)
regarding the requirement that an MA
plan advise enrollees that they may
receive the specified Part B service(s)
through an in-person visit or through
electronic exchange; we will also issue
guidance on disclosure requirements of
MA plans, including model language for
both the EOC and the provider
directory, in the context of MA
additional telehealth benefits.
Comment: In the proposed rule, we
sought comment on what impact, if any,
MA additional telehealth benefits
should have on MA network adequacy
policies, and the comments we received
were mixed. Commenters who were
supportive of a change to network
adequacy policies for MA additional
telehealth benefits stated that CMS
should allow telehealth providers to be
considered in the network adequacy
assessment, either in the network
criteria itself or through the exceptions
process. Some suggested CMS update
the network criteria to account for how
MA plans may offer MA additional
telehealth benefits (for example, allow
telehealth providers to count in the
network review or comprise a certain
percentage of a plan’s providers per
specialty) or eliminate the time and
distance standard and maintain just the
minimum number per enrollee standard
for telehealth providers. Others believed
the current exceptions process was
sufficient, that is, commenters
expressed that through the current
exceptions process, CMS could
potentially allow plans to substitute
telehealth providers for in-person
providers only where there is a shortage
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
of specialty providers. A commenter
suggested CMS consider telehealth
exceptions for network adequacy when
a plan can demonstrate that access to
certain specialties would otherwise be
problematic without permitting the MA
plan to use telehealth providers to meet
the network adequacy requirements; the
commenter believed such policy would
allow for more competition and more
attractive MA plan options. Some
commenters indicated that
incorporating telehealth into network
adequacy would improve enrollee
choice and access in MA, particularly in
rural/underserved areas, for certain
specialties like behavioral health, and
through an increase in after-hours and
weekend care. A few commenters
further encouraged CMS to provide
flexibility regarding time and distance
standards and allow telehealth to fill in
network gaps, which might in turn
streamline the network review process.
Other commenters asserted that a
telehealth provider should not carry the
same weight as an in-person provider
and should only be used as a
supplement, not a replacement, for inperson services. A few commenters
suggested CMS continue basing network
adequacy only on in-person services
given the disparity in internet access.
Still others suggested CMS do a
complete study to assess data in light of
increased telehealth utilization, which
could inform future changes to network
adequacy policies and measurement
options. A commenter recommended
that, minimally, CMS should wait to
reevaluate network criteria until there is
a higher market saturation of telehealth
providers for Part B services. Another
commenter believed CMS should collect
specific feedback on current planprovider telehealth arrangements and
current enrollee experience and
satisfaction with telehealth providers,
both within and outside MA.
Response: We thank the commenters
for their feedback on MA additional
telehealth benefits’ potential impact on
network adequacy. We will consider
these comments as we perform further
research on the issue and update subregulatory guidance to reflect any
applicable changes in policy. We are not
using this final rule to announce or
adopt changes in current policies for
evaluating MA network adequacy under
§ 422.112 because CMS interprets the
requirements at § 422.112 through the
MA network adequacy criteria, which
have traditionally been addressed in
sub-regulatory guidance.
Comment: Many commenters
supported CMS’s proposal to require
MA plans to ensure through their
provider contracts that providers meet
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
and comply with applicable state
licensing requirements and other
applicable laws for the state in which
the enrollee is located and receiving the
service. Specifically, the commenters
suggested CMS allow plan providers to
utilize state-based credentialing
standards for telehealth services as
opposed to federal standards for MA
provider participants authorized in
§ 422.204(b). A commenter believed that
plans should be allowed to apply
additional provider requirements.
Response: We support requiring the
MA plan to ensure through its contract
with the provider that the provider meet
and comply with applicable state
licensing requirements and other
applicable laws for the state in which
the enrollee is located and receiving the
service. This standard is codified in the
final rule at § 422.135(c)(3). We believe
creating additional provider licensing
requirements is unnecessary, but we
acknowledge that states may have
specific provisions regarding the
practice of medicine using electronic
exchange. We remind readers and MA
plans that existing provider
credentialing and network participation
requirements, specifically in §§ 422.200
through 422.224, continue to apply. As
this final rule requires MA plans to use
only contracted (that is, in-network)
physicians and practitioners to furnish
MA additional telehealth benefits, those
existing regulations will apply.
Comment: Several commenters
expressed an openness to CMS
occasionally collecting data on MA
additional telehealth benefits, per the
proposal to require MA plans to make
information about coverage of MA
additional telehealth benefits available
to CMS upon request. However, these
commenters were leery of the potential
for administrative burden on MA plans.
Some voiced concern about CMS
collecting confidential or sensitive
information and specifically requested
that CMS exclude information that
could be held under contractual
consideration. For example, a
commenter stated that specific
information on use or cost of MA
additional telehealth benefits is
proprietary and commercially sensitive,
and revealing contract-specific details
would be anti-competitive. Another
commenter concurred with CMS
collecting data on the costs and benefits
of MA plans’ MA additional telehealth
benefits as long as it was not overly
onerous on plans.
Response: We understand
commenters’ concerns about burden and
confidentiality when it comes to CMS
data collection. However, we note that
the regulation text at proposed
PO 00000
Frm 00015
Fmt 4701
Sfmt 4700
15693
§ 422.135(c)(5)—finalized at
§ 422.135(c)(4)—includes the language
‘‘upon request,’’ which implies that
CMS does not intend to establish
uniform data collection at this time, but
instead reserves the right to ask for this
information from MA plans. We
encourage readers to refer to section
III.B.1. of this final rule, which provides
additional detail and explicitly states
that the information collection
provision at § 422.135(c)(4) is exempt
from the requirements of the Paperwork
Reduction Act (PRA) since we estimate
fewer than 10 respondents. Thus, we do
not anticipate a significant increase in
plan burden due to § 422.135(c)(4). We
also remind readers that any uniform
request to more than nine MA plans
would require further review and would
be subject to public comment under the
PRA requirements.
Comment: A few commenters
questioned whether CMS will allow MA
plans (including PPO plans) to use only
contracted providers for MA additional
telehealth benefits. Some commenters
believed that the contracted providers’
restriction should apply to all MA plan
types. Some commenters rejected CMS’s
proposal that all plan types be required
to use only contracted providers. A few
commenters recommended CMS limit
this requirement to HMOs, thus
allowing PPOs to use both contracted
and non-contracted providers for MA
additional telehealth benefits. Other
commenters recommended that CMS
extend the allowable providers beyond
just contracted, in-network providers,
stating that the issue of no oversight of
out-of-network providers exists whether
or not telehealth is involved.
Response: We are finalizing the
proposal at § 422.135(d) to require that
all MA plan types, including PPO plans,
use only contracted providers to provide
MA additional telehealth benefits. We
are clarifying that if a PPO plan
furnishes MA additional telehealth
benefits consistent with the
requirements at § 422.135, then the PPO
plan requirement at § 422.4(a)(1)(v) (that
the PPO must furnish all services both
in-network and out-of-network) will not
apply to the MA additional telehealth
benefits; all other benefits covered by
the PPO must be covered on both an innetwork and out-of-network basis. In
other words, a PPO plan is not required
to furnish its MA additional telehealth
benefits out-of-network, as is the case
for all other plan-covered services.
However, if a PPO plan would like to
cover a service delivered through
electronic exchange on an out-ofnetwork basis, then the PPO plan has
that option but may only cover the
service as an MA supplemental
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15694
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
telehealth benefit, consistent with the
regulation text at § 422.135(d).
In response to comments that
recommended CMS extend the
allowable providers beyond contracted
providers because the issue of no
oversight for non-contracted providers
exists whether or not telehealth is
involved, we note that MA plans must
be able to review and pre-certify the
qualifications and compliance of
contracted providers to ensure that
telehealth services are furnished
consistent with clinically appropriate
standards of care for the MA additional
telehealth benefits offered by the MA
plan and that all state licensure and
credentialing requirements are met. We
are therefore finalizing the proposed
regulation text at paragraph (d), that an
MA plan must furnish MA additional
telehealth benefits only using contracted
providers. Therefore the regulation will
require that all MA plans, including
PPOs that cover benefits provided by
non-contracted providers, use only
contracted providers for MA additional
telehealth benefits.
Comment: Commenters recommended
that CMS remain flexible in the ultimate
determination of what will be
considered capital and infrastructure
costs and investments to be excluded
from their bid submissions relative to
MA additional telehealth benefits. Some
commenters offered ideas to
operationalize the exclusions. One
suggestion was for CMS to stipulate a
percentage that represents the industry
average of allowed fees as representative
of the capital and infrastructure costs,
which could be trended over time.
Another commenter suggested that CMS
align the definition of capital and
infrastructure costs and investments
with a traditional understanding, such
that those items that would add
permanent or depreciable value to the
plan or enrollee would be excluded,
thus allowing the cost of necessary
support items or services for telehealth
delivery. A few commenters mentioned
the 15 percent used in the Regulatory
Impact Analysis of the proposed rule as
a proxy for these costs. A commenter
stated that the percentage was too high
while another stressed that it was too
low.
Commenters also raised concerns
about the difficulty of identifying with
specificity (for bid purposes) the capital
and infrastructure components of MA
additional telehealth benefits for
services offered directly by the plan or
through downstream entities such as
providers and third party vendors.
Specifically, a few commenters were
concerned with the difficulty in
excluding these costs from their claims
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
capture and data reporting and in
obtaining this information from
contracted providers and vendors absent
an additional contractual provision.
Commenters also stated that capital and
infrastructure costs would vary
significantly from provider to provider.
These commenters pointed out that
currently there is no incentive for
providers or vendors to accurately
identify these costs, and plans would
not be able to verify if the costs were
reasonably stated. Consequently,
commenters expressed, this lack of
standardization and reliability could
lead to challenges of plans’ actuarial
attestations and potential inequitable
reporting in the bid. Another
commenter also opposed the exclusion
of capital and infrastructure costs from
MA plans’ basic benefit bid.
Response: We appreciate the
comments concerning the exclusion of
capital and infrastructure costs relating
to MA additional telehealth benefits
from the basic benefit bid submission.
Section 1852(m)(2)(A)(ii) of the Act
excludes from MA additional telehealth
benefits capital and infrastructure costs
and investments related to MA
additional telehealth benefits. We are
codifying this requirement in
§ 422.254(b)(3)(i) as a restriction on how
MA plans include MA additional
telehealth benefits in their bid
submission. We believe the statutory
limit is tied only to the cost to the
government, which is tied to how MA
additional telehealth benefits may be
included in the bid as basic benefits.
Therefore, our proposal was to eliminate
from the basic benefit bid those capital
and infrastructure costs and investments
that are required or used to enable the
provision of MA additional telehealth
benefits.
We appreciate the concerns raised by
commenters about broad interpretations
of the statutory exclusion of capital and
infrastructure costs and investments. In
recognition of these challenges, we are
clarifying in regulation text that the
exclusion from the bid of capital and
infrastructure costs and investments
relating to MA additional telehealth
benefits, codified at § 422.254(b)(3)(i),
applies to capital and infrastructure
costs and investments ‘‘directly
incurred or paid by the MA plan.’’ The
bid for basic benefits submitted by an
MA plan cannot include such capital
and infrastructure costs or investments
for MA additional telehealth benefits.
We do not propose a specific
definition of capital and infrastructure
costs or investments related to such
benefits here because the costs and
investments needed and used to provide
MA additional telehealth benefits would
PO 00000
Frm 00016
Fmt 4701
Sfmt 4700
vary based on the individual MA plan’s
approach to furnishing the benefits.
We also thank the commenters for
providing lists of capital and
infrastructure examples. Although we
stated in the proposed rule that we
would provide a more detailed list of
examples in this final rule based on
stakeholder feedback, after further
consideration we have chosen not to do
so. We made this decision in
acknowledgment of the variety of
potential capital and infrastructure
models, for which a given MA plan
could incur or pay costs, related to MA
additional telehealth benefits.
Comment: Many commenters
requested clarification on how the
annual bid submission process will
work for MA additional telehealth
benefits. Specifically, commenters
questioned how plans will be expected
to file MA additional telehealth benefits
in the PBP.
Response: We appreciate this request
for greater clarity concerning how the
annual bid submission process will be
impacted by MA additional telehealth
benefits. We will take these comments
into consideration when developing the
annual bid guidance, which we consider
to be a more appropriate place to
provide instruction for completing the
bid.
Comment: Several commenters
supported CMS’s proposal to allow MA
plans to provide MA additional
telehealth benefits because the proposal
does not include geographic and
originating site limitations. A few
commenters believed CMS should
extend authority for MA additional
telehealth benefits to original Medicare,
specifically to eliminate geographic and
originating site limitations applicable in
original Medicare. Some commenters
requested that CMS make efforts to
ensure parity for original Medicare
beneficiaries, claiming they would be
disadvantaged since they cannot access
MA additional telehealth benefits as MA
enrollees can. Some commenters urged
CMS to reference and ensure alignment
with the Part B definition of
telecommunications systems and note
that the section 1834(m) originating site
and geographic restrictions do not apply
to MA additional telehealth benefits.
Response: This final rule will allow
MA plans the ability to offer—as part of
the basic benefit package—MA
additional telehealth benefits beyond
what is currently allowable under
Medicare telehealth services; this is
authorized by section 1852(m) of the
Act, which was added by section 50323
of the Bipartisan Budget Act of 2018.
Neither the statute nor this final rule
includes geographic or originating site
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
limitations as part of defining or
authorizing MA additional telehealth
benefits. With regard to comments
regarding coverage and payment under
the original Medicare program, we note
that we are constrained by the statutory
requirements and that the original
Medicare program is not within the
scope of this final rule.
Comment: A commenter requested
that CMS provide permissible MA
additional telehealth benefit designs to
ensure MA plan compliance with CMS’s
final rule.
Response: We appreciate the
commenter’s request for permissible MA
additional telehealth benefit designs.
However, we do not provide any
specific MA additional telehealth
benefit designs in the final rule in order
to provide MA plans with the discretion
to develop their plan benefit offerings.
Comment: A commenter requested
information regarding whether MA
additional telehealth benefits can be
used to furnish the Medicare Diabetes
Prevention Program (MDPP) services. A
few commenters referenced CMS
previously declining to test online
MDPP diabetes self-management
training.
Response: As discussed above, we are
finalizing this rule to define ‘‘additional
telehealth benefits’’ as services that: (1)
Are furnished by an MA plan for which
benefits are available under Medicare
Part B but which are not payable under
section 1834(m) of the Act; and (2) have
been identified by the MA plan for the
applicable year as clinically appropriate
to furnish through electronic exchange
when the physician (as defined in
section 1861(r) of the Act) or
practitioner (described in section
1842(b)(18)(C) of the Act) providing the
service is not in the same location as the
enrollee. Because this definition
requires MA additional telehealth
benefits to be services provided by a
physician or practitioner, and MDPP
services, pursuant to § 410.79, must be
provided by an MDPP supplier, MDPP
services cannot be offered as MA
additional telehealth benefits. Existing
guidance about how MDPP services may
be provided on a virtual basis or
through electronic exchange still applies
and can be covered as a supplemental
benefit.
Comment: Some commenters
requested that CMS include in the
definition of a telehealth provider
specific specialty types such as
pharmacists, audiologists, speechlanguage pathologists, home health care
aides, and telerehabilitation providers.
Response: We appreciate comments
requesting additional specificity in
identifying permissible telehealth
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
provider types. However, we did not
define a telehealth provider in the
proposed rule and will not finalize such
a definition here. Section
1852(m)(2)(A)(i)(2) uses the term
‘‘physician’’ as defined in section
1861(r) of the Act and the term
‘‘practitioner’’ described in section
1842(b)(18)(C) of the Act. We have
codified these statutory requirements in
our final definition of ‘‘additional
telehealth benefits’’ at § 422.135(a)(2),
described previously. Both the statute
and this final rule limit MA additional
telehealth benefits to services furnished
by physicians and practitioners as so
defined. Further, the statute and
regulation require that the service be
clinically appropriate to furnish through
electronic exchange, which in some
cases may prohibit certain services from
being covered as MA additional
telehealth benefits. Finally, in
§ 422.135(d), we are codifying the
requirement that MA plans furnishing
MA additional telehealth benefits only
do so using contracted providers.
Comment: A few commenters
questioned how MA additional
telehealth benefits will interact with
encounter data and risk adjustment. For
example, commenters recommended
CMS establish rules or clarify the
criteria under which diagnoses obtained
through telehealth encounters can be
considered and submitted for risk
adjustment purposes. A commenter
specifically requested that CMS allow
telehealth encounters to be included for
MA risk adjustment, while other
requestors requested future guidance on
telehealth encounter data submissions.
Response: We appreciate commenters
raising this particular issue. This
regulation does not change the existing
obligation to submit encounters.
Consistent with the requirements under
§ 422.310, MA plans must submit risk
adjustment data that characterize the
context and purpose of each item and
service provided to an MA enrollee, and
must also conform to CMS’s
requirements for submitting these data.
We will be releasing guidance regarding
MA additional telehealth benefits and
encounter data and risk adjustment in
the future.
Summary of Regulatory Changes
We received a range of comments
pertaining to this proposal, the majority
of which reflected support for the
regulations. After careful consideration
of all comments received, and for the
reasons set forth in the proposed rule
and in our responses to the related
comments summarized earlier, we are
finalizing the proposed changes to
§§ 422.100, 422.252, 422.254, and
PO 00000
Frm 00017
Fmt 4701
Sfmt 4700
15695
422.264 and new regulation at
§ 422.135, with the following
modifications:
• In proposed regulation text
§ 422.135(a), we are removing the
phrase ‘‘that meet the following.’’ Thus,
we are revising § 422.135(a) to read as
follows: ‘‘Definitions. For purposes of
this section, the following definitions
apply: Additional telehealth benefits
means services:’’
• In proposed regulation text
§ 422.135(a)(1), we are removing the
phrase ‘‘are furnished by an MA plan’’
but finalizing the remaining text in
(a)(1). Thus, we are revising (a)(1) to
read as follows: ‘‘For which benefits are
available under Medicare Part B but
which are not payable under section
1834(m) of the Act; and’’
• In proposed regulation text
§ 422.135(a)(2), we are adding the word
‘‘That’’ and adding the phrase ‘‘when
the physician (as defined in section
1861(r) of the Act) or practitioner
(described in section 1842(b)(18)(C)) of
the Act) providing the service is not in
the same location as the enrollee.’’
Thus, we are revising (a)(2) to read as
follows: ‘‘That have been identified by
the MA plan for the applicable year as
clinically appropriate to furnish through
electronic exchange when the physician
(as defined in section 1861(r) of the Act)
or practitioner (described in section
1842(b)(18)(C)) of the Act) providing the
service is not in the same location as the
enrollee.’’
• In proposed regulation text
§ 422.135(c)(2), we are removing the
phrase ‘‘at a minimum in the MA plan’s
Evidence of Coverage required at
§ 422.111(b)’’ but finalizing the
remaining text in (c)(2). Thus, we are
revising (c)(2) to read as follows:
‘‘Advise each enrollee that the enrollee
may receive the specified Part B
service(s) through an in-person visit or
through electronic exchange.’’
• We are not finalizing our proposed
regulation text for the provider directory
requirement at proposed § 422.135(c)(3).
Thus, we are removing proposed (c)(3)
in its entirety, redesignating proposed
(c)(4) as (c)(3), and redesignating
proposed (c)(5) as (c)(4).
• In proposed regulation text
§ 422.254(b)(3)(i), we are adding the
phrases ‘‘directly incurred or paid by
the MA plan’’ and ‘‘for the unadjusted
MA statutory non-drug monthly bid
amount.’’ Thus, we are revising (b)(3)(i)
to read as follows: ‘‘MA plans offering
additional telehealth benefits as defined
in § 422.135(a) must exclude any capital
and infrastructure costs and investments
directly incurred or paid by the MA
plan relating to such benefits from their
bid submission for the unadjusted MA
E:\FR\FM\16APR2.SGM
16APR2
15696
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
statutory non-drug monthly bid
amount.’’
khammond on DSKBBV9HB2PROD with RULES2
2. Dual Eligible Special Needs Plans
Special needs plans (SNPs) are MA
plans created by the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108–
173) that are specifically designed to
provide targeted care and limit
enrollment to special needs individuals.
Under the law, SNPs are able to restrict
enrollment to: (1) Institutionalized
individuals, who are defined in § 422.2
as those residing or expecting to reside
for 90 days or longer in a long term care
facility; (2) individuals entitled to
medical assistance under a state plan
under Title XIX; or (3) other individuals
with certain severe or disabling chronic
conditions who would benefit from
enrollment in a SNP. As of June 2018,
the CMS website listed 297 SNP
contracts with 641 SNP plans that have
at least 11 members.8 These figures
included 190 Dual Eligible SNP
contracts (D–SNPs) with 412 D–SNP
plans with at least 11 members, 49
Institutional SNP contracts (I–SNPs)
with 97 I–SNP plans with at least 11
members, and 58 Chronic or Disabling
Condition SNP contracts (C–SNPs) with
132 C–SNP plans with at least 11
members. This final rule implements
the provisions of the Bipartisan Budget
Act of 2018 that establish new
requirements for D–SNPs for the
integration of Medicare and Medicaid
benefits and unification of Medicare and
Medicaid grievance and appeals
procedures that are effective in 2021.
This final rule also clarifies definitions
and operating requirements for D–SNPs
that will be applicable to D–SNPs
starting January 1, 2020, as specified
earlier in this final rule.
a. Integration Requirements for Dual
Eligible Special Needs Plans (§§ 422.2,
422.60, 422.102, 422.107, 422.111, and
422.752)
Beneficiaries who are dually eligible
for both Medicare and Medicaid can
face significant challenges in navigating
the two programs, which include
separate or overlapping benefits and
administrative processes. Fragmentation
between the two programs can result in
a lack of coordination for care delivery,
potentially resulting in: (1) Missed
opportunities to provide appropriate,
high-quality care and improve health
outcomes, and (2) ineffective care, such
8 Centers for Medicare & Medicaid Services (2018,
June). SNP Comprehensive Report. Retrieved from
https://www.cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-and-Reports/
MCRAdvPartDEnrolData/Special-Needs-Plan-SNPData.html.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
as avoidable hospitalizations and a poor
beneficiary experience of care.
Advancing policies and programs that
integrate care for dual eligible
individuals is one way in which we
seek to address such fragmentation.
Under plans that offer integrated care,
dual eligible individuals can receive the
full array of Medicaid and Medicare
benefits through a single delivery
system, thereby improving care
coordination, quality of care, beneficiary
satisfaction, and reducing
administrative burden. Some studies
have shown that highly integrated
managed care programs perform well on
quality of care indicators and enrollee
satisfaction.9
D–SNPs are a type of MA plan that is
intended to integrate or coordinate care
for this population more effectively than
standard MA plans or original Medicare
by focusing enrollment and care
management on dual eligible
individuals. As of June 2018,
approximately 2.3 million dual eligible
individuals (1 out of every 6 dual
eligible individuals) were enrolled in
412 D–SNPs. About 170,000 dual
eligible individuals are enrolled in fully
integrated dual eligible special needs
plans, or FIDE SNPs (that is, where the
same organization receives capitation to
cover both Medicare and Medicaid
services).10 A number of states,
including Arizona, Idaho, Hawaii,
Massachusetts, Minnesota, New Jersey,
New Mexico, New York, Pennsylvania,
Tennessee, Texas, Virginia, and
Wisconsin, operate Medicaid managed
care programs for dual eligible
individuals in which the state requires
9 See: Kim, H., Charlesworth, C.J., McConnell,
K.J., Valentine, J.B., and Grabowski, D.C. (2017,
November 15). Comparing Care for Dual-Eligibles
Across Coverage Models: Empirical Evidence From
Oregon. Retrieved from https://
journals.sagepub.com/doi/abs/10.1177/
1077558717740206; Anderson, W.L., Feng, Z., &
Long, S.K. (2016, March 31). Minnesota Managed
Care Longitudinal Data Analysis, prepared for the
U.S. Department of Health and Human Services
Assistant Secretary for Planning and Evaluation
(ASPE). Retrieved from https://aspe.hhs.gov/report/
minnesota-managed-care-longitudinal-dataanalysis; Health Management Associates (2015, July
21). Value Assessment of the Senior Care Options
(SCO) Program. Retrieved from https://
www.mahp.com/wp-content/uploads/2017/04/SCOWhite-Paper-HMA-2015_07_20-Final.pdf; and
Medicare Payment Advisory Committee (2012, June
16). ‘‘Care coordination programs for dual-eligible
beneficiaries.’’ In June 2012 Report to Congress:
Medicare and Health Care Delivery System.
Retrieved from https://www.medpac.gov/docs/
default-source/reports/chapter-3-appendixes-carecoordination-programs-for-dual-eligiblebeneficiaries-june-2012-report-.pdf?sfvrsn=0.
10 Centers for Medicare & Medicaid Services
(2018, June). SNP Comprehensive Report. Retrieved
from https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-and-Reports/
MCRAdvPartDEnrolData/Special-Needs-Plan-SNPData.html.
PO 00000
Frm 00018
Fmt 4701
Sfmt 4700
that the Medicaid managed care
organizations serving dual eligible
individuals offer a companion D–SNP
product.
As summarized in our proposed rule,
since the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) first authorized D–SNPs’
creation, subsequent legislation has
been enacted that has extended their
authority to operate and set forth
additional programmatic requirements,
including sections 164 and 165 of the
Medicare Improvements for Patients and
Providers Act (MIPPA) (Pub. L. 110–
275), which amended sections 1859(f)
and 1852(a) of the Act, and section 3205
of the Patient Protection and Affordable
Care Act (Pub. L. 111–148), which
revised section 1853(a)(1)(B) of the Act.
Regulations promulgated following the
enactment of these laws implemented
these statutory provisions.
Using the contract that D–SNPs are
required to have with states under
section 1859(f)(3)(D) of the Act,
implemented in the regulation at
§ 422.107, state Medicaid agencies are
able to establish requirements that
surpass the minimum standards set in
federal regulations for D–SNPs with
regard to integration and coordination of
Medicare and Medicaid benefits. To that
end, we have seen states leverage their
contracts with D–SNPs to limit D–SNP
enrollment to individuals who also
receive Medicaid benefits through the
same organization, collect certain data
from the D–SNP, and integrate
beneficiary communication materials
and care management processes to
provide D–SNP enrollees a more
seamless, coordinated experience of
care.11 CMS supports states that have an
interest in pursuing integrated care
models for dual eligible individuals,
including through the use of their
contracts with MA organizations
offering D–SNPs, and provides technical
assistance to states seeking to develop
solutions tailored to their local market
conditions, beneficiary characteristics,
and policy environment.
Through this final rule, we are
adopting new requirements in
accordance with section 50311(b) of the
Bipartisan Budget Act of 2018, which
amended section 1859 of the Act to
require that all D–SNPs meet certain
new minimum criteria for Medicare and
Medicaid integration for 2021 and
subsequent years. Beyond the newly
enacted amendments to the Act, we are
11 Verdier, J, Kruse, A., Sweetland Lester, R.,
Philip, A.M., & Chelminsky, D. (2016, November).
‘‘State Contracting with Medicare Advantage Dual
Eligible Special Needs Plans: Issues and Options.’’
Retrieved from https://www.integratedcareresource
center.com/PDFs/ICRC_DSNP_Issues__Options.pdf.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
also using this final rule to add
requirements and clarifications to
existing regulations to codify guidance
and policy since D–SNPs were
established nearly 15 years ago and to
update certain aspects of the
regulations. Under the newly enacted
section 1859(f)(8)(D)(i) of the Act, the
statute calls for D–SNPs, for 2021 and
subsequent years, to meet one or more
of three specified requirements, to the
extent permitted under state law, for
integration of benefits:
• A D–SNP must, in addition to
meeting the existing requirement of
contracting with the state Medicaid
agency under section 1859(f)(3)(D) of
the Act, coordinate long-term services
and supports (LTSS), behavioral health
services, or both, by meeting an
additional minimum set of requirements
for integration established by the
Secretary based on input from
stakeholders. Such requirements for
integration could include: (1) Notifying
the state in a timely manner of
hospitalizations, emergency room visits,
and hospital or nursing home discharges
of enrollees; (2) assigning one primary
care provider for each enrollee; or (3)
data sharing that benefits the
coordination of items and services
under Medicare and Medicaid.
• A D–SNP must either: (1) Meet the
requirements of a fully integrated dual
eligible special needs plan described in
section 1853(a)(1)(B)(iv)(II) of the Act
(other than the requirement that the
plan have similar average levels of
frailty as the PACE program); or (2)
enter into a capitated contract with the
state Medicaid agency to provide LTSS,
behavioral health services, or both.
• The parent organization of a D–SNP
that is also the parent organization of a
Medicaid managed care organization
providing LTSS or behavioral services
must assume ‘‘clinical and financial
responsibility’’ for benefits provided to
beneficiaries enrolled in both the D–
SNP and Medicaid managed care
organization.
Section 50311(b) of the Bipartisan
Budget Act of 2018 also authorizes the
Secretary, in section 1859(f)(8)(D)(ii) of
the Act, to impose an enrollment
sanction on an MA organization offering
a D–SNP that has failed to meet at least
one of these integration standards in
plan years 2021 through 2025. In the
event that the Secretary imposes such a
sanction, the MA organization must
submit to the Secretary a plan
describing how it will come into
compliance with the integration
standards.
We received a number of comments
on our proposals to implement these
new integration requirements, both in
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
general and with regard to specific
proposals. We summarize and respond
to the comments below.
Comment: We received numerous
comments in support of our integration
proposal, with many commenters citing
the proposal’s fulfillment of statutory
intent and expressing appreciation for
the flexibility afforded to states to define
what integrated care looks like in their
state. For example, some of these
commenters noted the diversity of state
policies, which impact what the D–SNP
market looks like in each state, and
cautioned against any proposal that
upon implementation would disrupt
existing integrated care models and
beneficiaries’ coverage. A subset of
commenters, while supportive of our
proposal, also encouraged CMS to raise
the bar of integration even further. One
commenter encouraged CMS to help
states move toward integration and not
penalize plans and states that are not yet
able to integrate further, advising that
focus should also remain on minimizing
administrative burden and reducing
complexity for beneficiaries. The
Medicare Payment Advisory
Commission (MedPAC) stated its belief
that the proposed rule will do little to
promote greater integration, citing in
particular the first of the proposed new
standards for integration—requiring D–
SNPs to share information on inpatient
and SNF admissions—as having a very
limited impact on improving care
coordination, as discussed in more
detail in the comments we received on
proposed § 422.107(d). Another
commenter objected to our integration
proposal and recommended that CMS
leave all decision-making to the states,
including granting them the ability to
opt out of any of the D–SNP integration
requirements.
Response: We appreciate the
widespread support we received for our
proposal. We believe that the
requirements we are finalizing in this
rule strike an appropriate balance
between increasing integrated care in D–
SNPs for dual eligible individuals and
preserving state flexibility, within the
framework established by the
amendments to section 1859(f)(8) of the
Act made by section 50311(b) of the
Bipartisan Budget Act of 2018. While
our aim is to support states that are
operating successful programs and assist
those seeking to establish more
integrated programs, we also recognize
that our proposal must account for the
current state of integrated care and the
need to meet states where they are by
setting reasonable and achievable
integration benchmarks. As the D–SNP
landscape evolves, we will continue to
consider ways to advance integrated
PO 00000
Frm 00019
Fmt 4701
Sfmt 4700
15697
care, including further rulemaking.
Finally, we note that the statute does
not authorize CMS or states to disregard
a D–SNP’s obligation to meet one or
more of the integration requirements,
and imposes consequences for noncompliance, as discussed in response to
comments on proposed § 422.752(d).
Comment: One commenter expressed
concern about D–SNPs’ ability to meet
the integration requirements by 2021
due to the potential for delayed
decision-making on the part of states.
Another commenter requested a oneyear delay in the effective date in
consideration of the time required to
negotiate and execute contracts between
states and D–SNPs and to develop new
processes, which will vary depending
on each state’s capabilities. Conversely,
another commenter stated that 2021 is
an achievable date for meeting one of
the three integration requirements.
Response: The statute requires that D–
SNPs comply with the integration
requirements by 2021. As discussed
throughout this preamble, the MedicareMedicaid Coordination Office provides
technical assistance to states on
integration issues, and we expect to
continue to engage states, plans, and
other stakeholders as we implement the
requirements in this final rule.
Comment: One commenter observed
that CMS does not make any additional
funding available for the coordination
activities that D–SNPs perform today
and that adding to these requirements
could create burdens on plans and CMS
or cause D–SNPs to exit the market.
Another commenter urged CMS to
establish nationwide standards to
ensure plans can scale best practices
and that beneficiaries receive the same
high quality service no matter where
they live.
Response: While we believe that
states are well positioned to drive
innovation in care delivery for dual
eligible individuals, we also recognize
that the Bipartisan Budget Act of 2018
set forth a minimum level of integration
for all D–SNPs to meet. We believe that
the proposal we set forth is a reasonable
one that preserves state flexibility while
fulfilling our statutory obligation. While
we recognize the desirability of having
national standards, particularly for MA
organizations that operate D–SNPs in
multiple markets across the country, we
have to balance this desire with the
differences that exist in states’
capabilities, ranging from states where
some or all dual eligible individuals
may be precluded from enrolling in any
capitated plan for their Medicaid
services to states with highly integrated
D–SNP models. Notwithstanding our
reluctance to mandate the use of
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15698
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
national standards, we are committed to
cataloguing and disseminating best
practice information as part of the final
rule’s implementation and our ongoing
administrative alignment efforts,
discussed later in the preamble to this
final rule.
Comment: Several commenters
supported our D–SNP integration
proposals but considered them only a
starting point for ensuring better
alignment and encouraged CMS to build
upon these requirements in the future.
Several commenters also recommended
that CMS provide strong oversight to
ensure that integration requirements are
being met and that dual eligible
individuals enrolled in D–SNPs are
actually benefiting from increased
integration. One commenter urged CMS
to go further in recognizing states’
authority and options to implement
even more robustly integrated programs.
Response: We appreciate these
commenters’ perspectives on our
proposal. We acknowledge the
importance of working in close
partnership with states to advance
integration within each state-specific
context. CMS will monitor the
implementation of these provisions to
determine market and beneficiary
impacts and assess the need for
additional rulemaking to modify or
expand upon the integration standards
we are finalizing in this rule.
Comment: One commenter
recommended that CMS conduct a
comprehensive review of basic
operational processes to determine
where Medicare and Medicaid could be
further aligned to enhance care delivery
and quality and to reduce burdens on
plans, providers, and beneficiaries and
to facilitate plans’ moving along the
integration continuum toward a FIDE
SNP or HIDE SNP status. This
commenter further suggested that CMS
advance integration using all available
statutory authorities, including seeking
clarification from Congress regarding its
intent in enacting provisions in the
Bipartisan Budget Act of 2018 related to
the Medicare-Medicaid Coordination
Office.
Several commenters recommended
that CMS extend to D–SNPs processes
and flexibilities developed under the
Financial Alignment Initiative for
MMPs and under the Minnesota
Demonstration to Align Administrative
Functions for Improvements in
Medicare-Medicaid Beneficiary
Experience, including use of the
contract management team structure for
joint oversight of plans, integrated
beneficiary communications materials,
joint CMS-state marketing reviews,
coordinated enrollment processes and
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
timelines, integrated MOCs, dual
eligible-specific network adequacy
requirements, and streamlined and
plan-level reporting processes. Several
commenters suggested other areas in
which CMS could create additional
administrative and policy incentives to
reward states for moving toward further
Medicare-Medicaid alignment,
including year-round marketing to dual
eligible individuals; expansion of
current passive enrollment and default
enrollment authorities; establishment of
a Special Election Period for enrollment
in integrated plans; plan payment
reforms, including changes to the frailty
adjustment for FIDE SNPs; an increase
of the enhanced Medicaid match for
care coordination and IT activities; and
alignment of state and federal
contracting cycles. A commenter
recommended that CMS improve its
messaging about D–SNPs in its
beneficiary-centered materials and tools.
Response: We thank commenters for
their robust feedback about additional
alignment opportunities for D–SNPs.
Since 2013, the Financial Alignment
Initiative and Minnesota demonstration
have provided us with opportunities to
test a number of programmatic and
administrative flexibilities for MMPs
and some D–SNPs, and many of these
flexibilities have been positively
received by beneficiaries, states, and
health plans. We will continue to
consider additional ways to promote
better outcomes and experiences for
dual eligible individuals.
As we have indicated in the CY 2016
Draft and Final Call Letters, the CY 2019
Draft and Final Call Letters, and the CY
2020 Draft Call Letter,12 CMS remains
committed to providing administrative
flexibility that facilitates efforts by state
Medicaid agencies and MA
organizations to use D–SNPs to integrate
coverage of Medicare and Medicaid
benefits, including in the areas of
integrated beneficiary communications,
D–SNP models of care, and enrollment
processes. That commitment is also
evidenced by our recent CY 2019 final
rule (CMS–4182–F, Policy and
Technical Changes to the Medicare
Advantage, Medicare Cost Plan,
Medicare Fee-for-Service, the Medicare
Prescription Drug Benefit Programs, and
the PACE Program) codifying our
authority to permit default enrollment
of newly Medicare-eligible individuals
into integrated D–SNPs at § 422.66(c)(2)
and, at § 422.60(g)(1)(iii), to allow
passive enrollment to preserve
continuity of care and integrated care
12 https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/
Advance2020Part2.pdf.
PO 00000
Frm 00020
Fmt 4701
Sfmt 4700
related to D–SNP non-renewals or state
Medicaid managed care organization
procurements. We have also worked
with states and integrated D–SNPs to
develop integrated beneficiary
communications materials, integrate
model of care requirements and reviews
with states, and provide state Medicaid
agencies with technical assistance and
information on plan performance and
audit results of their contracted D–SNPs
so that the quality of Medicare services
delivered by those D–SNPs can inform
state contracting strategies. We look
forward to continuing our work in this
area with additional states and plans.
Comment: A number of commenters
recommended CMS consideration of
additional regulatory and operational
policies on a number of issues related to
dual eligible individuals that were not
related to the D–SNP integration
requirements in the proposed rule. One
commenter urged CMS to make funds
available for ombudsman programs to
serve dual eligible individuals in
integrated D–SNPs. Several commenters
recommended that CMS continue to
work with plans on identifying a longterm solution impacting dual eligibility
status and socioeconomic factors in
Medicare Advantage Star Ratings. One
commenter reiterated the need for CMS
to develop a risk adjustment model that
adequately accounts for the costs of
serving beneficiaries with functional
limitations. Another commenter urged
CMS to consider how D–SNPs should be
designed to minimize cost-sharing
obligations that are ultimately unpaid
and to consider a more holistic
approach to coverage for dual eligible
individuals that does not simply
transfer cost-sharing liability to
providers. Another commenter noted
the critical importance of home and
community-based service (HCBS)
eligibility barriers when determining
how the D–SNP-to-Medicaid transition
should occur and recommended that the
federal government ease this transition
through reform of the Medicaid HCBS
eligibility requirements. One commenter
requested that CMS consider
recognizing Part B premium buy-downs
in Puerto Rico D–SNPs as part of plans’
bids to provide Parts A and B benefits,
rather than requiring plans to use rebate
dollars to buy down the Part B premium
as a supplemental benefit. Another
commenter recommended cost-sharing
integration processes for dual eligible
individuals at the pharmacy counter or,
in the shorter-term, implementation of
real time beneficiary eligibility solutions
for use within the NCPDP
Telecommunication standard.
Response: These recommendations
are not within the scope of our final rule
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
provisions establishing integration
criteria for D–SNPs effective in 2021,
and some of them are beyond our
programmatic authority. We do,
however, appreciate the many
comments and suggestions related to
programmatic improvements for dual
eligible individuals, including those
enrolled in D–SNPs.
Comment: A range of commenters,
including the Medicaid and CHIP
Payment and Access Commission
(MACPAC), expressed concern that the
market entry of non-D–SNP MA plans
designed and marketed exclusively to
dual eligible individuals—so-called ‘‘D–
SNP look-alike plans’’—threatens to
undermine efforts by CMS, states, and
D–SNPs to increase integration and
coordination of Medicare and Medicaid
services. Some of these commenters
recommended that CMS address this
issue including by requiring MA plans
with a minimum percentage of dual
eligible members to meet all D–SNP
requirements, including the obligation
to contract with the states in which the
plans operate.
Response: Although the issue of D–
SNP look-alike plans is beyond the
scope of this rule, we share the
commenters’ concern with the impact of
such plans on our efforts to increase
Medicare-Medicaid integration. We call
attention to the CY 2020 Draft Call
Letter 13 in which we sought comment
on the impact of D–SNP look-alike plans
in order to inform future policy
development.
Comment: A commenter
recommended that CMS continue and
expand efforts to help states adopt
policies and incentives that assist D–
SNPs in moving toward higher levels of
integration (including FIDE SNP or
HIDE SNP status with better aligned
enrollments) for dual eligible
individuals.
Response: States and CMS both play
important roles in implementing more
integrated care delivery systems for dual
eligible individuals. The MedicareMedicaid Coordination Office facilitates
this technical assistance and dialogue
with states, including through its
Integrated Care Resource Center (see
https://
www.integratedcareresourcecenter.com/
). We are committed to continuing our
work with states based on their specific
policy priorities following the
implementation of this final rule.
Comment: One commenter reaffirmed
their support for Medicare-Medicaid
Plans (MMPs) offered under the
Financial Alignment Initiative and
urged CMS to make them permanent.
The same commenter urged CMS to
develop a common statutory and
regulatory framework for all forms of
integrated plans, including MMPs,
PACE organizations, and FIDE SNPs,
that would include uniform rules on
marketing, enrollment processes, claims
reporting, rate-setting, and risk
adjustment.
Response: We appreciate the
commenter’s support for our work with
states and MMPs in the Financial
Alignment Initiative. CMS will continue
to explore ways within our
programmatic authority to improve the
current regulatory framework for
integrated care as we gain experience
and gather data about the impacts of the
FAI capitated model and other
demonstrations, our administrative
alignment efforts, streamlining of the
PACE program, and the implementation
of new D–SNP integration requirements
finalized in this rule.
Comment: We received comments
from one organization expressing
concerns about CMS’ sole reliance on
the D–SNP delivery model and urging
us to consider other plan types
(including Institutional SNPs (I–SNPs)
and fee-for-service Medicare) that can
help achieve integrated care goals. This
commenter expressed concern that sole
reliance on D–SNPs would result in
unnecessary disruptions to care.
Response: We support beneficiary
choice in selecting the health care
delivery system that best meets each
individual’s needs. The final rule
focuses on the specific requirements
added to section 1859(f) of the Act for
D–SNPs by section 50311 of the
Bipartisan Budget Act. Comments
related to fee-for-service Medicare and
I–SNPs are therefore outside the scope
of this final rule.
Comment: A few commenters
requested that CMS consider providing
guidance on how the integration
requirements will affect the operations
of MMPs.
Response: We clarify that there is no
direct impact on MMPs as a result of
this final rule. The D–SNP requirements
in this final rule are not applicable to
MMPs, and MMP policy and operations
will continue to be established in threeway contract agreements among CMS,
health plans, and states.
13 https://www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/Downloads/
Advance2020Part2.pdf.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
PO 00000
Frm 00021
Fmt 4701
Sfmt 4700
15699
(1) Definitions of a ‘‘Dual Eligible
Special Needs Plan’’, ‘‘Fully Integrated
Dual Eligible Special Needs Plan’’,
‘‘Highly Integrated Dual Eligible Special
Needs Plan’’, and ‘‘Aligned Enrollment’’
(§ 422.2)
D–SNPs are described in various
sections of 42 CFR part 422, including
provisions governing the definition of
specialized MA plans for special needs
individuals in § 422.2, the supplemental
benefit authority for D–SNPs that meet
a high standard of integration and
minimum performance and qualitybased standards in § 422.102(e), state
Medicaid agency contracting
requirements in § 422.107, and specific
benefit disclosure requirements in
§ 422.111(b)(2)(iii). In the proposed rule,
we proposed to consolidate statutory
and regulatory references to D–SNPs; we
also proposed to establish a definition
for such a plan in § 422.2. In addition
to proposing a new definition for the
term ‘‘dual eligible special needs plan,’’
we also proposed a revised definition of
the term ‘‘fully integrated dual eligible
special needs plan,’’ and new
definitions of the terms ‘‘highly
integrated dual eligible special needs
plan’’ and ‘‘aligned enrollment,’’ for
purposes of part 422 (that is, the rules
applicable to the MA program) and the
proposed rule.
In our proposed definition at § 422.2,
we described a dual eligible special
needs plan as a type of specialized MA
plan for individuals who are eligible for
Medicaid under Title XIX of the Act that
provides, as applicable, and coordinates
the delivery of Medicare and Medicaid
services, including LTSS and behavioral
health services, for individuals who are
eligible for such services; has a contract
with the state Medicaid agency
consistent with § 422.107 that meets the
minimum requirements in paragraph (c)
of such section; and satisfies at least one
of following integration requirements:
• It meets the additional state
Medicaid agency contracting
requirement we proposed at
§ 422.107(d) (described in section
II.A.2.a.(2) of the proposed rule) that
surpasses the minimum requirements in
current regulations at § 422.107(c);
• It is a highly integrated dual eligible
special needs plan (HIDE SNP), as
described in further detail later in this
section; or
• It is FIDE SNP.
In addition, we proposed additional
performance requirements for D–SNPs
that we did not incorporate into the
definition; for example, a D–SNP would
provide assistance to individuals filing
a grievance or appeal for a Medicaid
services in accordance with proposed
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15700
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
§ 422.562(a)(5) (described in section
II.A.2.b.(1) of the proposed rule). As
discussed in the proposed rule, we
believed this proposed definition
identified the minimum requirements
for an MA plan to be a D–SNP under
section 1859 of the Act as amended by
the Bipartisan Budget Act of 2018. We
also explained that the proposed
definition would clarify the
applicability of the separate regulatory
provisions that establish the minimum
standards for D–SNPs. We solicited
comment on whether our proposed
definition met these goals or should be
revised to include other regulatory
provisions that establish requirements
for D–SNPs.
We discussed in the proposed rule
and reiterate here that it is important to
clarify through this final rule the
meaning of the requirement in section
1859(f)(3)(D) of the Act, which is
currently codified at § 422.107(b), that
the MA organization have responsibility
under the contract for providing benefits
or arranging for benefits to be provided
for individuals entitled to Medicaid.
Prior to our proposed rule, we had not
adopted a specific interpretation of this
statutory language, ‘‘arranging for
benefits,’’ in previous rulemaking or in
subregulatory guidance. We proposed to
interpret ‘‘arranging for benefits’’ as
requiring a D–SNP, at a minimum, to
coordinate the delivery of Medicare and
Medicaid benefits. We proposed to
relocate this requirement to our
proposed D–SNP definition. As stated in
the proposed rule, while our
interpretation is consistent with the new
statutory integration standards, the
proposed clarification was based on
requirements for D–SNPs that existed
prior to the enactment of the Bipartisan
Budget Act of 2018 that we believe
should be strengthened. We believe
coordination would encompass a wide
range of activities that a D–SNP may
engage in for their dual eligible
members and provided some examples
of such coordination in the preamble to
the proposed rule. If a D–SNP identifies
through an enrollee’s health risk
assessment and/or individualized care
plan, as required by § 422.101(f),
functional limitations or mental health
needs, the D–SNP could: (1) Verify the
enrollee’s eligibility for LTSS and/or
behavioral health services under
Medicaid; (2) determine how the
enrollee receives such services (through
FFS Medicaid or through another
Medicaid managed care product); or (3)
make arrangements with the applicable
Medicaid program (state Medicaid
agency or managed care plan) for the
provision of such services by the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
appropriate payer or provider. We
solicited comment on whether our
proposed definition should be more
prescriptive in identifying which plan
activities constitute coordination or
whether it should remain broadly
defined as proposed.
We proposed revising the definition
of fully integrated dual eligible special
needs plan (FIDE SNP) at § 422.2 to
align with the proposed definition of a
D–SNP and to codify current policy.
Specifically, we proposed the following:
• Striking the reference to a ‘‘CMS
approved MA–PD’’ plan in the current
FIDE SNP definition and paragraph (1),
which refers to the individuals eligible
for enrollment in a FIDE SNP, because
those provisions duplicate elements of
the new proposed definition of a D–SNP
at § 422.2;
• Replacing the reference to ‘‘dual
eligible beneficiaries’’ with ‘‘dual
eligible individuals’’ in newly
redesignated paragraph (1) to align with
the terminology used in section 1935(c)
of the Act;
• Adding to newly redesignated
paragraph (2) that a FIDE SNP’s
capitated contract with a state Medicaid
agency may include specified
behavioral health services, as well as
replacing the term ‘‘long-term care’’
benefits with ‘‘long-term services and
supports’’ to better describe the range of
such services FIDE SNPs cover in
capitated contracts with states. We also
proposed codifying in paragraph (2) the
current policy that the FIDE SNP’s
capitated contract with the state provide
coverage of nursing facility services for
at least 180 days during the plan year; 14
• Striking references to coordination
of covered Medicare and Medicaid
‘‘health and long-term care’’ and
referring more broadly to Medicare and
Medicaid services in in newly
redesignated paragraph (3); and
• Replacing the reference to
‘‘member’’ materials with ‘‘beneficiary
communication materials,’’ consistent
with the definition of ‘‘communication
materials’’ at § 422.2260.
We proposed to codify a definition of
highly integrated dual eligible special
needs plan (HIDE SNP) at § 422.2.
Under the proposed definition, a HIDE
SNP would be a type of D–SNP offered
by an MA organization that has—or
whose parent organization or another
entity that is owned and controlled by
its parent organization has—a capitated
contract with the Medicaid agency in
14 Following the April 2, 2012 issuance of the
‘‘Announcement of Calendar Year (CY) 2013
Medicare Advantage Capitation Rates and Medicare
Advantage and Part D Payment Policies and Final
Call Letter,’’ Chapter 16b of the Medicare Managed
Care Manual was revised to include this policy.
PO 00000
Frm 00022
Fmt 4701
Sfmt 4700
the state in which the D–SNP operates
that includes coverage of LTSS,
behavioral health services, or both,
consistent with state policy. We
solicited comment on this proposed
definition, including on whether
additional requirements for HIDE SNPs
should be addressed in the definition.
We also proposed to establish at
§ 422.2 a definition for the term aligned
enrollment, as many of the other D–SNP
proposals in the proposed rule were
based on this concept. Under our
proposal, aligned enrollment is when a
full-benefit dual eligible individual is a
member of a D–SNP and receives
coverage of Medicaid benefits from the
D–SNP or from a Medicaid managed
care organization, as defined in section
1903(m) of the Act, that is: (1) The same
organization as the MA organization
offering the D–SNP; (2) its parent
organization; or (3) another entity that is
owned and controlled by the D–SNP’s
parent organization. Aligned
enrollment, as we proposed to define it,
would not arise where the MA
organization or its parent organization
solely has a contract with the applicable
state to offer a prepaid inpatient health
plan (PIHP) or prepaid ambulatory
health plan (PAHP) in the state’s
Medicaid program. Unlike a Medicaid
MCO, these other Medicaid managed
care plans cover only a specific and
non-comprehensive set of services. In
the event that it is the policy of the state
Medicaid agency to limit a D–SNP’s
membership to individuals with aligned
enrollment, we proposed describing this
practice as ‘‘exclusively aligned
enrollment,’’ which was embedded in
the proposed definition of ‘‘aligned
enrollment.’’ As noted in the proposed
rule, some states limit D–SNP
enrollment to full-benefit dual eligible
individuals who also choose to receive
Medicaid benefits through the D–SNP or
a Medicaid MCO operated by the same
entity (that is, by the MA organization)
or by the MA organization’s parent
organization. Such a limitation would
be included in the state Medicaid
agency contract with the D–SNP.
Exclusively aligned enrollment is
relevant to how we proposed to apply
the integrated grievance and appeals
requirements described in section
II.A.2.b. of the proposed rule. We
solicited comment on our proposed
definition of aligned enrollment given
its relevance to the category of D–SNPs
to which the integrated grievance and
appeals procedures apply. We also
solicited comment on whether we
should consider other types of Medicaid
managed care arrangements beyond
companion Medicaid MCOs, as defined
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
in section 1903(m) of the Act and
codified at § 438.2, operated by a HIDE
SNP’s parent organization.
Finally, we proposed in our definition
of a D–SNP at § 422.2 to codify that an
MA organization seeking to offer a D–
SNP must satisfy any one (or more) of
the three integration requirements in
section 1859(f)(3)(D)(i) of the Act. We
noted that the statutory language
requires that plans meet one or more
statutorily identified integration
requirements to the extent permitted
under state law. We explained in the
proposed rule how we interpreted the
integration standard in section
1859(f)(8)(D)(i)(II) of the Act (that the D–
SNP be a FIDE SNP or have a capitated
contract with the state Medicaid agency
to provide LTSS or behavioral health
services, or both) to mean that the D–
SNP is a FIDE SNP or HIDE SNP; we
also explained how we interpreted the
integration standard in section
1859(f)(8)(D)(i)(III) of the Act (that
clinical and financial responsibility for
Medicare and Medicaid benefits for
enrollees of the D–SNP be borne by an
entity that is both the parent
organization of the D–SNP and of the
Medicaid managed care organization
providing LTSS or behavioral health
services under a contract under section
1903(m) of the Act) means that the D–
SNP is a HIDE SNP or FIDE SNP with
exclusively aligned enrollment. We
interpreted the phrase ‘‘to the extent
permitted under state law’’ as
acknowledging and respecting the
flexibility provided to states under the
Medicaid program while imposing on
D–SNPs integration requirements that
Congress has deemed necessary. Given
this flexibility, we proposed to interpret
this statutory provision in a way that
provides multiple avenues for a MA
plan to qualify as a D–SNP. However,
we considered other interpretations of
this particular provision. For example,
we considered whether ‘‘to the extent
permitted under state law’’ should mean
that in states that have Medicaid
managed care programs for dual eligible
individuals, all MA organizations
seeking to offer a D–SNP could do so
only if they were under contract with
the state to offer a companion Medicaid
managed care plan in that state, on the
grounds that such an opportunity is
permitted under state law. We solicited
comments on our proposed
interpretation as well as alternatives.
We also requested comment on whether
and how our proposed definition could
or should be revised consistent with our
statutory interpretation.
As discussed in the proposed rule,
our intent was for the proposed
definitions to describe different types of
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
D–SNPs based on the degree to which
they integrate Medicaid benefits at the
plan level. Under section 1859(f)(8)(D)(i)
of the Act, those D–SNPs that are
neither FIDE SNPs nor HIDE SNPs must
meet an additional state Medicaid
contracting requirement beginning in
2021. Our proposed definition of a D–
SNP addressed this in paragraph (1),
cross-referencing the new requirement
proposed to be codified in paragraph (d)
of § 422.107. This proposed new
requirement, which involves the
provision of notice when an individual
who belongs to a group of high-risk dual
eligible individuals has a hospital and
skilled nursing facility admission, is
discussed in section II.A.2.a.(2) of this
final rule in greater detail. We solicited
comments on this proposal and, in
particular, on alternative approaches to
classifying D–SNPs consistent with
requirements of section 1859(f)(8)(D)(i)
of the Act.
We received the following comments
on these proposed definitions and
respond to them below:
Comment: Many commenters
expressed support for CMS’ proposed
regulatory framework for defining D–
SNPs, whereby a D–SNP could satisfy
any one or more of three integration
requirements: (1) As a D–SNP subject to
the hospital and skilled nursing facility
admission notification requirement in
proposed § 422.107(d); (2) as a HIDE
SNP; or (3) as a FIDE SNP. In justifying
their support, several of these
commenters cited one or more of the
following:
• The benefits that accrue to
beneficiaries and taxpayers when there
is a market that permits an array of D–
SNPs to compete with each other, rather
than one that limits the types of D–SNPs
that can compete in that market;
• The need for state flexibility in
promoting integration in a manner that
is incremental and minimizes market
disruption;
• The importance of preserving a
pathway for D–SNPs that do not hold a
Medicaid managed care contract in the
state or operate in states where no such
Medicaid managed care market exists;
or
• The opportunity for D–SNPs to
make the transition on a gradual basis
to greater, and eventually full,
integration. Another commenter
indicated that this proposal would
create a spectrum of integration and give
states and plans clear starting points
from which to better define their goals
and objectives.
Response: We appreciate the
commenters’ support of our proposal to
create multiple pathways for an MA
plan to qualify as a D–SNP, which—as
PO 00000
Frm 00023
Fmt 4701
Sfmt 4700
15701
discussed later in this preamble—we are
finalizing in this final rule.
Comment: Several commenters raised
objections to the alternative we
discussed in the proposed rule to
require, in states that have Medicaid
managed care programs for dual eligible
individuals, all MA organizations
seeking to offer a D–SNP to be under
contract as a Medicaid managed care
plan. One commenter did not believe
that the statute granted CMS authority
to implement this restriction, while
others noted that it would constrain
state decision-making on integration,
unnecessarily limit plan choice and
reduce competition, lead D–SNPs to
cease operating, or create a disincentive
for D–SNPs to invest in care models and
infrastructure. Another commenter
advised that CMS should recognize that
integration is contingent on state
decision-making and incent the states to
move state Medicaid policy toward
more integrated models. Conversely,
other commenters supported this
alternative interpretation and
encouraged CMS to reconsider its
rejection of it. According to one
commenter, without a policy that
requires the parent organization of a D–
SNP to contract with the state Medicaid
agency, a beneficiary in a non-aligned
D–SNP has no option other than
enrolling in a Medicaid managed care
plan operated by another sponsor (or, if
permitted, receiving fee-for-service
Medicaid services); where there is no
alignment of Medicare and Medicaid
coverage, the opportunity for effective
care coordination is reduced.
Commenters also noted the potential of
such a policy to promote aligned
enrollment and coordinate the full
spectrum of needs for this population as
well as the greater familiarity with
Medicaid of organizations that operate
in both Medicare and Medicaid markets
in states, which is helpful in assisting
beneficiaries.
Response: We appreciate the feedback
on this alternative on which we
requested comment and acknowledge
that without such a policy there may be
a missed opportunity to support the
integration of Medicare and Medicaid
services in states that adopt managed
care delivery systems for their dual
eligible population. We also recognize
the concerns raised by commenters
relative to the potential for adverse
impacts on beneficiaries. We will take
all of these comments into consideration
should we decide to address this issue
in future rulemaking. However, we are
not moving forward with the alternative
in this final rule.
Comment: We received significant
comment on our proposed D–SNP, HIDE
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15702
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
SNP, and FIDE SNP definitions. Several
commenters expressed appreciation for
CMS’ effort to create regulatory
definitions for the different types of D–
SNPs that exist in the marketplace
today. A commenter supported our
proposal under the HIDE SNP definition
to permit arrangements in which the
MA organization offering the D–SNP or
its parent organization has a contract to
offer a PIHP or PAHP in the state’s
Medicaid program. Many commenters
expressed appreciation for the ability of
D–SNPs to be defined as HIDE SNPs.
One commenter noted that the proposed
modifications provide far greater clarity
for states and D–SNPs and offer the
appropriate amount of detail to inform
agreements between MAOs and state
Medicaid agencies. Another commenter
noted that the proposed D–SNP
definition is a good first step but that it
alone is insufficient, as truly meaningful
integration for dual eligible individuals
whose enrollment is not aligned
requires a whole host of additional
requirements and activities in key areas,
including, but not limited to, integrated
administrative, information technology,
communications, reporting, and
financial systems; integrated assessment
and care coordination processes and
data sharing; and integrated transition
activities.
Response: We appreciate the support
of our proposal, which, as we explained
earlier in this preamble, reflects our
desire to create a framework in which
we are able to distinguish among the
types of D–SNPs based on the way they
integrate Medicaid services and, as
applicable, align enrollment across
Medicare and Medicaid, while also
accounting for variation in how states
cover these Medicaid services.
Comment: Several commenters
supported our proposal to interpret the
meaning of the statutory language in
section 1859(f)(3)(D) of the Act,
‘‘arranging for benefits,’’ as requiring a
D–SNP to coordinate the delivery of
Medicare and Medicaid benefits and to
relocate this requirement within our
proposed D–SNP definition. One
commenter commended CMS for the
example of coordination included in the
preamble to the proposed rule that
interpreted such activities to include
verifying dual eligible individuals’
eligibility for LTSS or behavioral health
services, determining how the
individual receives such services, and
making arrangements with the LTSS or
behavioral health payer for the
provision of services. A few commenters
supported CMS’ example of D–SNPs
playing an active role in helping
beneficiaries access Medicaid services
as necessary.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Response: We thank the commenters
for their support of our proposed
interpretation and coordination
examples.
Comment: One commenter opposed
any requirement that D–SNPs
extensively coordinate Medicaid
benefits, citing the lack of additional
compensation or clear expectations, and
recommended that CMS instead work
with states to address barriers to
accessing Medicaid benefits. This
commenter opposed any requirement
that D–SNPs assist enrollees with such
activities as completing paperwork or
securing financial, medical, or other
documentation needed to access
Medicaid benefits or any other benefits
not covered by the plan (housing, food
stamps, utility assistance), instead
recommending that plans undertake
these activities at their discretion.
Response: While we agree that
reducing barriers to access in Medicaid
is important, we believe that for all
enrollees who are eligible for Medicaid
services, the D–SNP must fulfill its
statutory responsibility to arrange for
the provision of Medicaid benefits by
facilitating a beneficiary’s meaningful
access to such benefits. As we discussed
in the proposed rule, we believe it
would be insufficient for a D–SNP to
limit its coordination activity simply to
telling a beneficiary to call or write their
Medicaid managed care plan or state
agency without giving specific contact
information, giving specific coaching on
the roles of the Medicaid program (that
is, the state agency or Medicaid
managed care plan versus the D–SNP),
and offering additional support if
needed. As discussed in section
II.A.2.b.(1) of this final rule, we believe
that an important aspect of D–SNPs’
statutory responsibilities includes
providing assistance to dual eligible
individuals with Medicaid-related
coverage issues and grievances. We also
note that our proposed coordination
requirement in the definition of a D–
SNP is specific to Medicaid benefits and
did not extend to some of the services
and programs referenced by this
commenter.
Comment: One commenter expressed
overall support for our inclusion of a
coordination requirement in the
definition of a D–SNP, but noted that
states, unaffiliated Medicaid managed
care organizations, and non-contracted
providers may present barriers to
information-sharing that is necessary to
make such coordination work. A few
commenters endorsed the development
of a system or process for collecting
information about D–SNP enrollee
Medicaid coverage and enrollment
(when enrollment is not aligned) in
PO 00000
Frm 00024
Fmt 4701
Sfmt 4700
order to meaningfully implement this
provision. One of these commenters
recommended that CMS establish a
process by which states must provide
individual-level data on the D–SNP’s
enrollees, including the enrollee’s
Medicaid coverage and plan name (if
applicable) and specific contacts within
each organization (names, phone
numbers, emails, leadership contact
information), in order to facilitate this
coordination across Medicare and
Medicaid.
Response: We appreciate the
commenters’ concern about access to
information about their enrollees’
Medicaid coverage. Establishing a
standardized system or process such as
the one suggested by these commenters
is an option for states and CMS to
consider. However, as discussed in
section II.A.2.b.(1) of this final rule,
there are other ways in which plans can
endeavor to obtain information or
connect enrollees with the appropriate
resources to facilitate coordination of
their Medicare and Medicaid benefits.
Comment: Several commenters
supported the proposed rule’s approach
of broadly requiring D–SNPs to
coordinate the delivery of Medicare and
Medicaid benefits without specifying
particular types of coordination
activities in the regulatory definition of
a D–SNP, citing the need for flexibility
to accommodate differences in plans
and state policies. One commenter
appreciated the broad requirement as a
way of ensuring that D–SNPs have
ownership in coordinating the points
where the D–SNP’s services end and
those provided under Medicaid begin
and are not simply acting as an
additional layer in the process.
However, more commenters requested
that CMS be more specific in identifying
specific plan activities that constitute
coordination, including several
commenters who requested additional
specificity within the regulation text.
One commenter suggested that, without
additional specificity in the definition
about the types of activities that
constitute coordination, plans might
misinterpret or misunderstand the
requirements. Another commenter
anticipated that plans could face
barriers in arranging Medicaid benefits
for enrollees, especially if such benefits
are managed by other health plans, and
cited Tennessee’s requirements that D–
SNPs use the TennCare Online System
to coordinate benefits for enrollees who
are eligible for Medicaid.
A few commenters requested that
CMS incorporate elements of personcentered care as part of the D–SNP care
coordination requirements. One of these
commenters stated that D–SNPs should
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
be held accountable for actively
coordinating benefits and linking plan
members to services (including those
services that are not provided by the D–
SNP). The other commenter encouraged
CMS to emphasize that coordination for
D–SNPs with aligned members that
require LTSS or behavioral health
services includes assessment and care
planning processes that are: (1) At a
minimum, compliant with the personcentered requirements of sections
1915(c), 1915(i), and 1915(k) of the Act,
which were added in two January 16,
2014 final rules (CMS–2249–F and
CMS–2296–F),15 and (2) incorporate the
provision of needed LTSS and/or
behavioral health either directly or in
close coordination with the entity
owned or controlled by the D–SNP’s
parent organization that has contractual
responsibility for LTSS and behavioral
health benefits. Another commenter
stated that in order for coordination to
be effective, D–SNP personnel must
have sufficient training related to the
suite of services available under
Medicaid and through the D–SNP and a
thorough understanding of how to assist
a beneficiary in navigating the delivery
system to access services. One
commenter recommended that CMS
include in the D–SNP definition the
following activities: Staffing plans with
care coordinators who meet specific
criteria; providing comprehensive
information about Medicare, Medicaid,
and plan benefits through plan
materials, customer service, and care
coordinators; ensuring that members
have a primary care physician and that
their providers are actively
communicating through models such as
interdisciplinary care teams; sharing
information about claims, service
authorizations, and care plans with the
state, providers, beneficiaries, and
beneficiaries’ appointed representatives;
and providing assistance with filing
grievances and appeals and
comprehensive explanations of the
appeals process. Another commenter
suggested that further clarification
would be helpful around the role of the
D–SNP related to transitions of care, the
responsibilities of the D–SNP regarding
arrangements for follow up care, and
coordination with the discharging
entity. Another commenter encouraged
CMS to work with plans and states to
15 Medicaid Program; State Plan Home and
Community-Based Services, 5-Year Period for
Waivers, Provider Payment Reassignment, and
Home and Community-Based Setting Requirements
for Community First Choice and Home and
Community-Based Services (HCBS) Waivers (79 FR
3029, January 16, 2014). Accessible at: https://
www.govinfo.gov/content/pkg/FR–2014–01–16/pdf/
2014–00487.pdf.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
ensure that provisions related to
improved care transitions are effective
and consequential for individuals with
dementia.
Response: We appreciate the
comments about additional activities
CMS should consider to be essential for
D–SNPs in coordinating their members’
Medicare and Medicaid benefits. We do
not agree at this time with the
commenters who recommended
including additional detail regarding
those coordination activities in our
regulatory definition of a D–SNP. Wide
variation in the level of integration of
Medicaid benefits across D–SNPs, local
market conditions, and state initiatives
to integrate care for dual eligible
individuals leads us to believe that it is
not prudent to add specific coordination
responsibilities and requirements in this
regulatory definition at this time.
Further, some of the specific
recommendations raise issues related to
compliance with privacy rules
protecting beneficiary information or
other regulations governing D–SNPs
(such as mandatory disclosure
requirements), which are more
appropriately addressed in other
regulations. Our goal in this final rule is
to establish an explicit requirement of
coordination in regulation for the first
time since D–SNPs were established in
2006 and to implement a flexible
approach to coordination that allows
plans to test approaches that best work
for them and in their specific state
context. We are therefore finalizing a
coordination requirement in the
definition of a D–SNP.
Comment: A number of commenters
requested additional clarification of the
role of D–SNPs in coordinating
Medicare and Medicaid benefits,
including in subregulatory guidance,
guiding principles, and additional
examples, to inform states and their
contracted D–SNPs as they collaborate
to identify specific plan activities that
might differ by program or type of
service. One commenter specifically
requested that any list of coordination
activities promulgated by CMS be
considered a set of minimum
requirements. Another commenter
suggested that CMS provide a set of
standardized approaches or acceptable
frameworks that would assist states and
plans in developing aligned approaches
to this requirement, including best
practices for data transfers and tips on
overcoming administrative hurdles.
Another commenter urged CMS to
provide more clarity, citing concerns
about burden on providers.
Response: We appreciate the
commenters’ request for clarification
and anticipate issuing subregulatory
PO 00000
Frm 00025
Fmt 4701
Sfmt 4700
15703
guidance to further clarify the
requirement that D–SNPs coordinate
Medicare and Medicaid benefits for the
dual eligible individuals enrolled in
their plans.
Comment: A commenter suggested
that CMS provide ongoing support to
states in the implementation of our
coordination requirements. Another
commenter suggested that CMS consider
whether further guidance regarding D–
SNP coordination could serve as a
means of persuading states to
standardize their approaches to the
alignment of their Medicaid programs
with the MA program. This commenter
suggested that CMS could, for example,
issue further guidance on how states can
work to establish viable health
information exchanges as a means of
facilitating communication and data
exchange between plans and state
Medicaid agencies, as such actions
could qualify as ‘‘coordinating the
delivery of’’ these services.
Response: CMS supports states that
have an interest in pursuing integrated
care models for dual eligible
individuals, including through the use
of their contracts with MA organizations
offering D–SNPs, and provides technical
assistance to states seeking to develop
solutions tailored to their local market
conditions, beneficiary characteristics,
and policy environment. We are
committed to continuing our work with
states based on their specific policy
priorities following the implementation
of this final rule.
Comment: A few commenters stated
that D–SNPs should be held accountable
for actively coordinating benefits and
linking plan members with services,
both when those services are provided
by the D–SNP or its affiliate and when
they are provided by an unaffiliated
third party. One of these commenters
suggested that CMS look into the extent
to which D–SNPs without Medicaid
contracts may primarily serve partialbenefit dual eligible individuals 16 for
whom there is no need or opportunity
to coordinate Medicaid benefits.
16 Partial-benefit dual eligible programs are
commonly referred to collectively as the ‘‘Medicare
Savings Program’’ (MSP). The MSP includes 4
eligibility groups: Qualified Medicare Beneficiary
Program without other Medicaid (QMB Only) for
whom Medicaid pays their Medicare Part A
premiums, if any, Medicare Part B premiums, and
to the extent consistent with the Medicaid State
plan, Medicare Part A and B deductibles,
coinsurance and copays for Medicare services
provided by Medicare providers; Specified LowIncome Medicare Beneficiary Program without
other Medicaid (SLMB Only) and Qualifying
Individual (QI) Program for whom Medicaid pays
the Part B premiums; Qualified Disabled and
Working Individual (QDWI) Program for whom
Medicaid pays the Part A premiums.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15704
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Response: As we stated in the
preamble to the proposed rule, we
recognize that not all D–SNP
membership will be eligible for the full
complement of Medicaid services,
particularly those who are partialbenefit dual eligible individuals whose
Medicaid eligibility is limited to
payment of their Medicare premiums,
and, if applicable, deductibles and costsharing. Coordination approaches for
partial-benefit dual eligible individuals
will, of necessity, be different than those
for members will full Medicaid benefits.
However, for all enrollees who are
eligible for Medicaid services, the D–
SNP must fulfill its statutory
responsibility to arrange for the
provision of Medicaid benefits by
facilitating a beneficiary’s meaningful
access to such benefits, regardless of
their source or scope of Medicaid
coverage. We discuss the issue of D–
SNPs assisting their members with
Medicaid benefit issues in more detail
in section II.a.2.b.(1) of this final rule.
Comment: Several commenters
emphasized the need for CMS to
monitor D–SNPs’ efforts at coordination
and gauge their effectiveness.
Response: We agree that CMS
oversight and monitoring of D–SNPs’
coordination responsibilities are
important. As we implement the
provisions of this final rule, we will
identify ways in which we can leverage
current tools, including audits, model of
care requirements, and reporting
requirements, to ensure that D–SNPs
assist dual eligible individuals in
connecting with the Medicaid benefits
to which they are entitled.
Comment: A few commenters
expressed concern about the
construction of the proposed D–SNP
definition insofar that it could be
misread or misinterpreted to require all
D–SNPs to provide LTSS and behavioral
health services.
Response: We did not intend our
proposed definition to impose a new
obligation on D–SNPs to provide
coverage of Medicaid services.
Therefore, we are finalizing the
proposed definition of a D–SNP with
modifications to the text to clarify this
point and otherwise make grammatical
and organizational changes to improve
the regulation text. Specifically, a D–
SNP is a plan offered by an MA
organization for dual eligible
individuals that, as provided in new
paragraph (1), coordinates the delivery
of Medicare and Medicaid services for
individuals eligible for such Medicaid
services; as provided in new paragraph
(2), may provide coverage of Medicaid
services, including LTSS and behavioral
health services (for individuals eligible
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
for such services); as provided in new
paragraph (3), has a contract with the
state Medicaid agency consistent with
the requirements of § 422.107 that meets
the minimum requirements detailed in
§ 422.107(c); and (4) beginning January
1, 2021, satisfies one of the three criteria
for integration of Medicare and
Medicaid benefits detailed in the
proposed rule (and now designated as
paragraphs (4)(i) through (iii)). We
intend through these revisions to clarify
that, regardless of whether a D–SNP
provides coverage of Medicaid services
under a capitated or other arrangement
with the state Medicaid agency, it at
minimum must coordinate the
enrollee’s Medicare and Medicaid
services.
As discussed in section II.A.2.a.(2) of
this final rule, to better align with our
proposed definition of a D–SNP, we
proposed a change to § 422.107(c)(1) to
specify that the contract between a state
Medicaid agency and a D–SNP must
document the MA organization’s
responsibility to provide, as applicable,
and coordinate the delivery of Medicaid
benefits, including LTSS and behavioral
health services, for individuals who are
eligible for such services. In response to
the concerns raised by these
commenters, we are finalizing
§ 422.107(c)(1) with minor changes that
express our intent more clearly and
parallel the revisions we are finalizing
in the D–SNP definition described
earlier. Specifically, we are
restructuring paragraph (c)(1) to avoid
any misinterpretation that D–SNPs must
cover LTSS and behavioral health
services. We clarify in paragraph
(c)(1)(i) that the D–SNP must document
its responsibility to coordinate the
delivery of Medicaid services for
individuals who are eligible for such
services, and in paragraph (c)(1)(ii) that,
to the extent a D–SNP provides coverage
of Medicaid benefits—including LTSS
and behavioral health services (for
individuals eligible for such services)—
it must also document in the state
Medicaid agency contract its
responsibility to do so. We believe this
revision clarifies that, in some cases, the
D–SNP may cover (that is, provide
directly or pay health care providers for
providing) Medicaid benefits under a
capitated contract with the state
Medicaid agency; however in all cases
it must coordinate the delivery of
Medicaid benefits.
Comment: A few commenters were
concerned about the introduction of a
new term, HIDE SNP, which did not
exist in regulations previously. Two of
these commenters noted that it is
already difficult for consumers and
advocates to determine which plans are
PO 00000
Frm 00026
Fmt 4701
Sfmt 4700
D–SNPs and what type of D–SNP they
are. They noted that clear, consistent
regulatory definitions can make
important differences between the plan
types and beneficiary options more
understandable.
Response: While we sympathize with
commenters’ reluctance to create
another regulatory definition, we
believe that the definition of HIDE SNP
is meaningful, as it correlates directly
with our interpretation of the D–SNP
integration standard that appears in
section 1859(f)(8)(D)(i)(II) of the Act (D–
SNPs that enter into a capitated contract
with the state Medicaid agency to
provide LTSS or behavioral health
services, or both). We agree with the
commenters that making these terms
understandable to stakeholders,
especially beneficiaries, is an important
aim.
Comment: A commenter
recommended that the proposed
definition of HIDE SNP be redrafted to
allow for risk-sharing arrangements
other than capitation. This commenter
noted that the state or D–SNP may wish
to contract initially on a shared savings/
shared risk or performance-based model
as opposed to a full capitation model.
Another commenter recommended that
CMS consider creating another
regulatory standard of integration other
than a HIDE SNP that would describe
D–SNPs that are at risk for a set of
Medicaid services other than LTSS or
behavioral health services, which can
serve as stepping stones to further
alignment.
Response: We appreciate that there
are varying levels of integration,
including, for example, arrangements in
which a state Medicaid agency may
capitate payment for Medicaid costsharing or a subset of services. However,
the statute is clear that D–SNPs seeking
to meet the integration standard at
section 1859(f)(8)(D)(i)(II) of the Act
must either be a FIDE SNP or enter into
a capitated contract with the state
Medicaid agency for the provision of
LTSS, behavioral health services, or
both. We proposed the definition of
HIDE SNP to align with this statutory
standard of integration, and therefore
we are not making revisions to the HIDE
SNP definition based on these specific
recommendations. As discussed in the
proposed rule (83 FR 54994), a D–SNP
could satisfy the requirements of a HIDE
SNP if its parent organization offered a
companion Medicaid product that
covered only LTSS, behavioral health
services, or both, under a capitated
contract. We believe that this definition
is appropriate for purposes of
addressing and aligning with the
statutory integration standards and for
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
establishing which D–SNPs are eligible,
pursuant to §§ 422.60(g)(2)(i) and
422.102(e), to receive passive
enrollments or offer supplemental
benefits, respectively.
We may consider for future
rulemaking the merits of having a more
detailed classification system that
identifies variations of D–SNPs other
than FIDE SNPs and HIDE SNPs relative
to the extent to which they coordinate
Medicare and Medicaid benefits. We
note that technical assistance resources
are available through the Integrated Care
Resource Center that provide
information about the varied approaches
states have taken to coordinate with D–
SNPs operating in their states.
Comment: A commenter suggested
that CMS consider a HIDE SNP as a
temporary model that could be utilized
as part of a state’s longer term strategy
toward integration of Medicaid benefits
in which all HIDE SNPs transition to a
FIDE SNP model once full integration is
achieved.
Response: We are supportive of states
and plans that wish to pursue a FIDE
SNP model; however, as stated earlier in
this preamble, section 1859(f)(8)(D)(i) of
the Act recognizes a level of integration
that does not meet the requirements of
a FIDE SNP with respect to the breadth
of services provided under a Medicaid
capitated contract with the state (that is,
D–SNPs that cover LTSS, behavioral
health services, or both, under a
capitated contract) as meeting one of the
three required integration standards. We
therefore believe it is useful to codify a
term that encompasses this statutory
standard.
Comment: A commenter requested
that CMS clarify that enrollment in a
HIDE SNP be open to all dual eligible
individuals, including those not yet
eligible for LTSS and/or behavioral
health services, on the grounds that
their needs may change over the course
a year such that they attain eligibility for
these services. According to the
commenter, a plan can play a role in
helping the individual navigate their
options.
Response: The proposed HIDE SNP
definition stated that the MA
organization offering the D–SNP, or the
MA organization’s parent organization
or another entity that is owned or
controlled by its parent organization,
must have a capitated contract with the
Medicaid agency that includes coverage
of LTSS, behavioral health services, or
both, consistent with state policy. The
HIDE SNP definition, as proposed and
finalized in this rule, does not itself
require that the plan limit its MA
enrollment to dual eligible individuals
who qualify for LTSS, behavioral health
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
services, or both. However, it is
important to note that these plans are
financially responsible under a
capitated contract for covering these
services for individuals who are eligible
for them, and a state Medicaid agency
may elect to impose enrollment
restrictions on the D–SNP consistent
with its contracting authority in
§ 422.107.
Comment: A commenter observed that
the proposed definition of HIDE SNP
appears to exclude a plan offered by an
organization that subcontracts on a
capitated basis with an organization or
county agency to which the state
Medicaid agency has ‘‘delegated
Medicaid financial and administrative
responsibility.’’ According to the
commenter, this type of arrangement is
common in California where counties
use different Medicaid managed care
models and recommended that CMS
amend the HIDE SNP definition to
encompass such an arrangement. The
commenter further noted that while the
organization that does not have a direct,
capitated contract with the state, even
though it is providing LTSS, behavioral
health services, or both, under the
Medicaid program, it can provide highly
integrated benefits and should be
considered a HIDE SNP. Relatedly, this
commenter recommended that the
definition of aligned enrollment be
expanded to accommodate this
arrangement, noting that aligned
enrollment could occur for D–SNP
enrollees who receive their Medicaid
benefits from the D–SNP’s parent
organization via this subcontract.
Response: We believe that the
commenter is referring to situations
where the county or another entity has
a contract with the state Medicaid
agency to furnish Medicaid benefits to
eligible individuals on a risk basis; we
disagree that such a contract amounts to
a delegation of financial or
administrative responsibility for the
Medicaid program. A county or entity
with a managed care contract with the
state Medicaid agency may
subsequently subcontract certain
aspects of the managed care contract to
another entity under § 438.230. In such
situations where that subcontractor also
is a D–SNP, we recognize that there may
be a level of integration for enrollees
that is greater than that of a D–SNP that
has no contract—directly or indirectly—
with a state to provide LTSS, behavioral
health services, or both. However, we do
not believe that the subcontractor in that
situation should be treated as a HIDE
SNP. Our proposed definition of a HIDE
SNP at § 422.2 requires a contract
between the state and the D–SNP, its
parent organization, or another
PO 00000
Frm 00027
Fmt 4701
Sfmt 4700
15705
subsidiary of its parent organization and
is more consistent with the statutory
language at section 1859(f)(8)(D)(i)(II) of
the Act, which requires that a D–SNP
enter into a capitated contract with a
state to provide LTSS, behavioral health
services, or both. The relationship
between a D–SNP and its parent
organization (or another plan owned
and operated by the same parent
organization) is one where we believe it
is appropriate to attribute those other
contract arrangements to the D–SNP
itself for purposes of evaluating
integration in the management,
provision, and coordination of benefits
for enrollees. That statutory provision is
the basis for our codification of this
definition. We therefore decline the
commenter’s recommendations that the
definitions of a HIDE SNP and aligned
enrollment be modified to accommodate
this particular contracting arrangement.
Comment: A commenter requested
more information about the eligibility
for each type of D–SNP for passive
enrollment, seamless conversion, and
the frailty adjuster. Several commenters
inquired about how CMS would
designate each type of D–SNP.
Response: We intend to release
guidance prior to the effective date of
these provisions that explains how D–
SNPs will be designated as FIDE SNPs
and HIDE SNPs consistent with the
terms of this final rule. As noted later
in this final rule, we are amending
§ 422.60(g)(2)(i) to clarify that HIDE
SNPs are eligible to receive passive
enrollments; this is not a change in
policy, per se, but a technical update to
use the newly defined term where we
previously used different language.
Chapter 2 of the Medicare Managed Care
Manual provides additional information
for MA organizations about passive and
default enrollment.17 Eligibility for the
frailty adjustment is governed by section
1853(a)(1)(B)(iv) of the Act and
§ 422.308(c)(4), which limit the payment
adjustment to FIDE SNPs that have a
similar average level of frailty, as
determined by the Secretary, as the
PACE program; the eligibility of plans
for the frailty adjustment is not
impacted by this rulemaking.
Comment: Commenters were
generally supportive of our proposal to
account for differences in how states
cover Medicaid services, including
states’ decisions to carve out particular
Medicaid services and deliver them
through a separate arrangement.
However, a number of these
17 Chapter 2 of the Medicare Managed Care
Manual can be accessed here: https://www.cms.gov/
Medicare/Eligibility-and-Enrollment/MedicareMang
CareEligEnrol/.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15706
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
commenters also urged us to clarify our
use of the phrase ‘‘consistent with State
policy,’’ which appears in the proposed
definitions of HIDE SNP and FIDE SNP.
In particular, they wanted to understand
how this phrase impacts D–SNPs that
are seeking to be defined as a HIDE SNP
or FIDE SNP and how HIDE SNPs were
different from FIDE SNPs in relation to
carve-outs. A commenter questioned
whether a state’s carve-out of LTSS
services from its Medicaid managed care
program would that mean that no D–
SNP in that state can qualify as a FIDE
SNP, since FIDE SNPs must cover some
element of LTSS. A commenter
requested clarification about the
obligation of FIDE SNPs to provide
comprehensive Medicaid services and
whether that same obligation applied to
HIDE SNPs, while other commenters
requested clarification about whether a
D–SNP would still be considered a
HIDE SNP if the state were to carve out
behavioral health services or offered a
limited scope of behavioral health
services for dual eligible individuals,
assuming all other HIDE SNP
requirements were met. Yet another
commenter cited its experience using
Medicaid benefit carve-outs and the
potential for the misalignment of
incentives, which may result in
inappropriate utilization or gaps in care.
Response: We proposed to interpret
the phrase ‘‘consistent with State
policy’’ as allowing CMS to permit
certain carve-outs where consistent with
or necessary to accommodate state
policy, except for where specifically
prohibited (such as the minimum of 180
days of coverage of nursing facility
services during the plan year in the
FIDE SNP definition). For A FIDE SNP,
a carve-out by the state of a minimal
scope of services is permissible so long
as the applicable services, as described
in the FIDE SNP definition, are covered
under a Medicaid managed care
organization contract under section
1903(m)(2) of the Act. This means that
if a state opted to carve out LTSS
entirely from capitation, in that state no
D–SNP could qualify as a FIDE SNP.
Similarly for a HIDE SNP, a carve-out by
the state of a minimal scope of services
is permissible so long as the applicable
services, as described in the HIDE SNP
definition, are covered under a capitated
Medicaid contract with the D–SNP or
the affiliated Medicaid managed care
plan. For example, if a state were to
carve out certain targeted case
management services for full-benefit
dual eligible individuals receiving
behavioral health services, a D–SNP
could still satisfy the FIDE SNP or HIDE
SNP definition, provided that: (1) LTSS
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
were covered under the capitated
contract; or (2) behavioral health
services, other than the carved-out case
management, were covered under the
capitated contract.
Our intent is to apply the phrase
‘‘consistent with State policy,’’ to HIDE
SNPs as we have done historically for
D–SNPs seeking FIDE SNP status. In the
case of FIDE SNPs, our policy for
determining whether a D–SNP meets the
FIDE SNP definition at 42 CFR 422.2
was first addressed in the April 2, 2012,
‘‘Announcement of Calendar Year (CY)
2013 Medicare Advantage Capitation
Rates and Medicare Advantage and Part
D Payment Policies and Final Call
Letter’’ and later memorialized in
section 20.2.5 of Chapter 16b of the
Medicare Managed Care Manual.18
Under this policy, CMS permits longterm care benefit carve-outs or
exclusions only if the plan can
demonstrate that it—
• Is At risk for substantially all of the
services under the capitated rate;
• Is at risk for nursing facility services
for at least six months (180 days) of the
plan year;
• Does not disenroll an individual
from the plan as a result of exhausting
the service covered under the capitated
rate; and
• Remains responsible for managing
all benefits including any carved-out
service benefits, notwithstanding the
method of payment (for example, feefor-service, separate capitated rate)
received by the plan (we note that we
interpret ‘‘managing all benefits’’ to be
equivalent to coordinating the delivery
of Medicare and Medicaid services,
consistent with changes made elsewhere
in this final rule, including in the
definition of a D–SNP).
Also under this policy, FIDE SNPs are
not required to cover behavioral health
services in cases where the state decides
to carve out or exclude behavioral
health services from the capitated rate.
We believe that the phrase ‘‘consistent
with State policy’’ in the FIDE SNP and
HIDE SNP definitions serves as an
important acknowledgement of
variation in how states elect to cover
Medicaid services under their capitated
contracts with D–SNPs and Medicaid
managed care plans. As such, among the
states that have capitated contracts with
D–SNPs or the D–SNPs’ parent
organizations, CMS has the ability to
determine that D–SNPs operating in
such states meet the FIDE SNP or HIDE
SNP definition notwithstanding this
18 See https://www.cms.gov/Medicare/HealthPlans/MedicareAdvtgSpecRateStats/Downloads/
Advance2020Part2.pdf and https://www.cms.gov/
Regulations-and-Guidance/Guidance/Manuals/
Downloads/mc86c16b.pdf.
PO 00000
Frm 00028
Fmt 4701
Sfmt 4700
variation. However, in consideration of
the request for clarification, we are
making a minor modification to the
HIDE SNP and FIDE SNP definitions in
§ 422.2 to change the placement of the
phrase ‘‘consistent with State policy,’’
so that it appears prior to the categories
of services to which it applies, as
opposed to placement after them.
Comment: A commenter
recommended that CMS clarify that
HIDE SNPs are not required to cover
under a capitated contract both LTSS
and behavioral health services. Another
commenter recommended that CMS
remove the requirement that the
contract with the state Medicaid agency
include coverage of LTSS, behavioral
health services, or both, and consider
instead the existence of a contract with
the Medicaid agency to cover an
overlapping or potentially overlapping
Medicaid population as the D–SNP, on
the basis that such a plan already
understands the Medicaid market in
which it operates and is well situated to
serve as a platform as states move to
advance integrated care models for dual
eligible individuals.
Response: HIDE SNPs are not required
to cover both LTSS and behavioral
health services but must cover at least
one of those categories of services. We
are finalizing the HIDE SNP definition
at § 422.2 to require that a HIDE SNP
cover LTSS, behavioral health services,
or both, consistent with state policy.
While we recognize that there is a
variety of ways in which D–SNPs
coordinate with Medicaid agencies,
including coverage of Medicare costsharing and Medicaid services other
than LTSS or behavioral health, we
disagree with the comment that HIDE
SNP status should be met without
coverage of either LTSS or behavioral
health services. Our intent in
establishing a definition for HIDE SNPs
is to describe one of the two types of D–
SNPs that satisfies the integration
requirement at section
1859(f)(8)(D)(i)(II) of the Act. Under this
provision, the integration requirement is
satisfied if the D–SNP meets the
requirements of a FIDE SNP (other than
the requirement that it has a similar
level of frailty as the PACE program) or
enters into a capitated contract with the
state Medicaid agency to provide LTSS
or behavioral health services, or both.
We note that we are electing to make a
non-material change to how we refer to
the coverage of LTSS, behavioral health
services, or both, in our HIDE SNP
definition. We are finalizing the
regulation with the phrase ‘‘provides
coverage’’ instead of ‘‘includes
coverage.’’
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Comment: A commenter urged CMS
to work with states that have carve-outs
to ensure that states are committed to
coordinating carved-out services with
D–SNPs. This commenter believed that
state carve-outs, although conceptually
a barrier to integration, are in some
cases well-established and provide
quality services. Though longer term
integration is a goal, a hurried
dismantling of those systems would be
unwise and could cause beneficiary
harm.
Response: We agree that it is an
essential element of any D–SNP to
coordinate the delivery of all Medicaid
services, irrespective of how they are
covered by the state Medicaid agency.
Therefore, as discussed elsewhere in
this final rule, we have made such
coordination a requirement in § 422.2
for any plan that operates as a D–SNP.
Comment: A few commenters
requested that CMS clarify the
differences between HIDE SNPs and
FIDE SNPs, and raised questions about
any notable differences in types of
contracting arrangements that are
permitted (or not) and categories of
services that the plan must cover,
including the requirement that FIDE
SNPs cover behavioral health services.
Response: Conceptually, we proposed
to distinguish D–SNPs based on the
degree to which they integrate Medicaid
benefits at the plan level. FIDE SNPs
that limit enrollment to full-benefit dual
eligible individuals and require (or
have) exclusively aligned enrollment
across Medicare and Medicaid
constitute the most extensive level of
integration, with the greatest potential
for holistic and person-centered care
coordination, integrated appeals and
grievances, comprehensive beneficiary
communication materials, and quality
improvement. HIDE SNPs with
exclusively aligned enrollment are plans
that share much of this potential but
may integrate a narrower set of
Medicaid benefits than FIDE SNPs. FIDE
SNPs and HIDE SNPs where aligned
enrollment is possible—but not
required—under the state contract with
the D–SNP and the state’s
administration of its Medicaid managed
care program would constitute another
form of integration, albeit to a lesser
degree. The table below highlights some
of the key differences between HIDE
SNPs and FIDE SNPs. First, from a
contracting perspective, a FIDE SNP’s
Medicare and Medicaid benefits are
covered under a single legal entity that
contracts (1) with CMS to operate as an
MA plan; and (2) with the state to
operate as a Medicaid MCO. This latter
15707
requirement means that the FIDE SNP
has a contract under section 1903(m) of
the Act to provide a comprehensive set
of services. In the case of a HIDE SNP,
however, there is no stipulation that a
single legal entity must hold the
Medicare and Medicaid contracts, only
that the parties to the capitated contract
are the state Medicaid agency (or state
Medicaid agency’s contractor) and one
of the following: (1) The MA
organization itself; (2) the MA
organization’s parent organization; or (3)
another entity that is owned and
controlled by the MA organization’s
parent organization. Additionally, with
respect to a HIDE SNP, the entity or
entities holding the MA contract and the
Medicaid contract may provide coverage
of Medicaid services as a PIHP, PAHP,
or Medicaid MCO. Second, as noted in
an earlier response to a comment, the
breadth of coverage provided by FIDE
SNPs and HIDE SNPs is different. For
example, FIDE SNPs must provide at
least 180 days of nursing facility
coverage; as reflected in the definitions
of the terms in § 438.2, PIHPs and
PAHPs cover less comprehensive sets of
services than MCOs and are
distinguished from each other based on
whether inpatient or ambulatory
services are covered.
TABLE 1—ATTRIBUTES OF FIDE SNPS AND HIDE SNPS
khammond on DSKBBV9HB2PROD with RULES2
FIDE SNP
HIDE SNP
Must have a contract with the state Medicaid agency that meets the requirements of a managed
care organization as defined in section 1903(m)
of the Social Security Act.
May provide coverage of Medicaid services via a
PIHP or a PAHP.
Must provide coverage of applicable Medicaid benefits through the same entity that contracts with
CMS to operate as an MA plan.
Yes ........................................................
No.
No ..........................................................
Yes.
Yes ........................................................
Must have a capitated contract with the state Medicaid agency to provide coverage of long-term
services and supports (LTSS), consistent with
state policy.
Must have a capitated contract with the state Medicaid agency to provide coverage of behavioral
health services, consistent with state policy.
Must have a capitated contract with the state Medicaid agency to provide coverage of a minimum
of 180 days of nursing facility services during the
plan year.
Yes ........................................................
No. The state Medicaid contract may be with: (1)
The MA organization offering the D–SNP; (2)
the MA organization’s parent organization; or
(3) another entity owned and controlled by the
MA organization’s parent organization.
No, if it otherwise covers behavioral health services.
In consideration of these comments,
we are electing to make one additional
change to our FIDE SNP definition to
mirror language that appears in the
HIDE SNP definition. Specifically, in
paragraph (2) of the FIDE SNP
definition, we are finalizing the
regulation with the phrase ‘‘provides
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
No. Complete carve-out of behavioral
health coverage by the state Medicaid agency is permitted.
Yes ........................................................
coverage’’ instead of ‘‘includes
coverage,’’ which will make references
to the provision of coverage consistent
between the HIDE SNP and FIDE SNP
definition.
Comment: A commenter
recommended that CMS replace in its
definition of FIDE SNP ‘‘aligned’’ care
PO 00000
Frm 00029
Fmt 4701
Sfmt 4700
No, if it otherwise covers LTSS.
No.
management processes with ‘‘fully
integrated’’ care management processes,
with the expectation that either a single
person is responsible for coordination of
the full continuum of Medicare and
Medicaid benefits, or the health plan
uses an integrated team approach, with
clear lines of communication and
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15708
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
accountability, and with integrated care
management data systems that facilitate
timely access to information needed to
facilitate integrated care management
processes.
Response: While we support the
approaches to care identified by this
commenter, we do not believe that such
a change to the FIDE SNP definition is
necessary. Our use of the phrase
‘‘aligned care management processes’’ in
paragraph (3) of the FIDE SNP definition
at § 422.2 is intended to encompass the
variety of ways in which FIDE SNPs
seek to coordinate care for full-benefit
dual eligible individuals.
Comment: We received several
comments concerning the requirement
that FIDE SNPs cover nursing facility
services for at least 180 days during the
plan year and whether this signified a
change in existing FIDE SNP coverage
policy or an expansion of the Medicare
skilled nursing facility benefit.
Response: As noted in a prior
response to a comment, it has been
longstanding CMS policy for a FIDE
SNP to be at risk for providing coverage
of at least 180 days of nursing facility
services, and this rulemaking codifies
rather than revises or reinterprets this
policy. If a state were to carve out
institutionally-based LTSS from its
capitated contract, it would not be
possible for an MA plan to operate as a
FIDE SNP in that state, although it may
be possible to qualify as a HIDE SNP,
assuming all applicable requirements
were met. Similarly, if a state were to
carve out community-based LTSS from
its contract because the state opted to
provide coverage of these services under
a separate arrangement, it would not be
possible for such a plan to qualify as a
FIDE SNP because section
1853(a)(1)(B)(iv) of the Act establishes
that FIDE SNPs must cover long-term
care under a capitated contract with the
state for Medicaid benefits. Communitybased LTSS are long-term care services
and essential to the coverage model
offered by a FIDE SNP.
Comment: A few commenters
supported our proposed definition of
aligned enrollment and its applicability
to particular types of plans. MedPAC
and another commenter agreed with our
proposal to limit the definition of
aligned enrollment to Medicaid
coverage provided by a comprehensive
Medicaid MCO instead of including
plans that provide more limited
Medicaid services as PIHPs or PAHPs. A
few commenters agreed with our
proposal to account for not only D–
SNPs whose Medicaid benefits are
covered by the plan directly but also by
a Medicaid MCO operated by the same
organization, its parent organization, or
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
another entity that is owned and
controlled by its parent organization.
One commenter recommended that we
explicitly incorporate in the definition
the concept from the statute that such
plans have clinical and financial
responsibility for any individual
enrolled in both programs and
expressed concern that a parent
company could sponsor Medicaid plans
and D–SNP products that might be
operated quite separately with little or
no coordination while still accepting
‘‘clinical and financial responsibility
with respect to any individual
enrollee.’’
Response: We thank commenters for
their support of how we defined aligned
enrollment. We disagree, however, with
the commenter about the necessity of
including the phrase ‘‘clinical and
financial responsibility for any
individual enrolled in both programs’’
in the definition of aligned enrollment.
Under our proposed definition, we
stated that aligned enrollment refers to
full-benefit dual eligible D–SNP
enrollees whose Medicaid benefits are
covered by that D–SNP or by a Medicaid
MCO that is the same organization, its
parent organization, or another entity
that is owned and controlled by its
parent organization. When a full-benefit
dual eligible individual is enrolled in
aligned plans, one entity (or entities that
share a parent organization) provides
coverage of Medicare benefits and
Medicaid benefits such as LTSS,
behavioral health services, or both. By
virtue of the provision of coverage
under these types of contractual
relationships, the relevant entity
intrinsically has clinical and financial
responsibility for the covered Medicare
and Medicaid services provided to
enrollees. We believe that explicitly
using the phrase ‘‘clinical and financial
responsibility for benefits’’ in the
definition of aligned enrollment might
imply otherwise and suggest that a
contractual obligation to cover benefits
does not mean financial and clinical
responsibility for those benefits.
We are finalizing the proposed
definition of the term ‘‘aligned
enrollment’’ with some modifications to
clarify this relationship. Rather than
referring to the enrollee’s Medicaid
benefits as being covered by the D–SNP
or by a Medicaid MCO, the final
regulation text refers to the enrollee’s
Medicaid benefits as being covered by
the D–SNP under a Medicaid MCO
contract between the state and: (1) The
MA organization offering the D–SNP; (2)
the D–SNP’s parent organization; or (3)
another entity that is owned and
controlled by the D–SNP’s parent
organization. We believe this regulation
PO 00000
Frm 00030
Fmt 4701
Sfmt 4700
text change clarifies the meaning and
adequately addresses that financial and
clinical responsibility for the enrollees
is held by the MA organization or its
parent organization.
Comment: One commenter, while
supportive of how we intended to
incorporate exclusively aligned
enrollment relative to unifying Medicare
and Medicaid grievance and appeal
procedures, encouraged us to consider
developing additional incentives and
tools for states and plans to move
toward increased alignment. This
commenter expressed interest in the
creation of a combination of rewards,
incentives, new tools, and pathways to
facilitate improvement in enrollment
alignment, which is not a pervasive
practice among states.
Response: The commenter’s point is
well taken. We intend to exercise the
administrative authority we have under
current law to support states that wish
to pursue this particular integrated care
strategy and will consider the necessity
of future rulemaking consistent with our
programmatic authority. We will also
continue to make technical assistance
resources available to states through the
Integrated Care Resource Center.
Comment: A commenter expressed
concern that the definition of
exclusively aligned enrollment may
limit state flexibility insofar that it
would be difficult for one-hundred
percent of a D–SNP’s membership to be
aligned. According to the commenter, a
D–SNP that failed to meet this threshold
wouldn’t be able to benefit from unified
appeals and grievance processes. This
commenter would be opposed to a
policy of having to disenroll members
anytime misalignment occurred.
Another commenter requested that CMS
confirm that HIDE SNPs and exclusively
aligned HIDE SNPs are different types of
plans.
Response: We clarify that through this
rulemaking, the concept of exclusively
aligned enrollment is only relevant to
how we define an applicable integrated
plan, which must unify its Medicare
and Medicaid grievance and appeals
procedures consistent with rules
described in §§ 422.629 through
422.634. Unifying grievance and appeals
procedures is most feasible when
everyone in the plan is receiving
Medicare and Medicaid services from
the same organization (or through a
companion product offered by the
parent organization or through a
common ownership relationship with
the parent organization). In the absence
of aligned enrollment, D–SNP enrollees
may be enrolled in and receiving
coverage from two or more plans
simultaneously, complicating
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
coordination of care and the beneficiary
experience. For FIDE SNPs and HIDE
SNPs, this situation of receiving
coverage from two or more plans may be
true for only some enrollees. Even if this
lack of alignment exists for some and
not all of the D–SNP’s enrollees, there
would be at least two (if not more) sets
of grievance and appeals rules applying
to the D–SNP’s members. State
Medicaid agencies have the ability to
take other steps to integrate grievance
and appeals procedures through their
contracts with D–SNPs. We welcome
the opportunity to partner with states in
developing and implementing these
strategies.
Comment: MedPAC advised that
aligned enrollment should be a
requirement for D–SNPs that provide
significant Medicaid services and meet
both the second and third integration
standards at sections 1859(f)(8)(D)(i)(II)
and (III) of the Act, respectively, where
our proposal only contemplated
applying a requirement of exclusively
aligned enrollment to the third
integration standard (where the parent
organization of the enrollee’s D–SNP is
also the parent organization of the
enrollee’s Medicaid MCO). MedPAC
further stated that the second
integration standard in the statute
should apply to plans where states have
capitated Medicaid contracts directly
with D–SNPs and the D–SNPs provide
Medicaid services, and the third
standard should apply to situations
where states have capitated Medicaid
contracts with another legal entity (a
Medicaid managed care plan) that is
part of the same parent organization as
the D–SNP.
Response: We agree with MedPAC
insofar that alignment of Medicare and
Medicaid coverage, which occurs when
a full-benefit dual eligible individual is
receiving Medicare and all or
substantially all Medicaid services from
one organization, constitutes the most
extensive level of integration. As we
noted in the preamble of the proposed
rule, this arrangement offers the greatest
potential for holistic and personcentered care coordination, integrated
appeals and grievances, comprehensive
beneficiary communication materials,
and quality improvement. However, we
remain concerned about imposing such
a requirement at this time, as states that
have contracts with Medicaid MCOs
and D–SNPs currently have the
authority to require aligned enrollment
but for policy or other reasons, do not
impose one. Finally, we believe that the
most salient differentiator between the
second and third integration standards
at sections 1859(f)(8)(D)(i)(II) and (III) of
the Act is exclusively enrolled
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
alignment, rather than whether the state
contract is with the D–SNP directly or
a related entity. We are therefore not
adopting this recommendation.
Comment: A commenter
recommended that CMS codify the third
integration requirement, which appears
in section 1859(f)(8)(D)(i)(III) of the Act,
and stipulates that a D–SNP’s parent
organization assumes clinical and
financial responsibility for the provision
of Medicare and Medicaid benefits.
While this commenter was supportive of
our interpretation that such clinical and
financial responsibility was only
possible in FIDE SNPs and HIDE SNPs
where there was exclusively aligned
enrollment, the commenter was
concerned that our interpretation only
existed in preamble and not the
regulation text itself.
Response: As noted by the
commenter, in the proposed rule, we
did not explicitly cite or summarize the
integration requirement at section
1859(f)(8)(D)(i)(III) of the Act in our
definition of a D–SNP. Instead, we
interpreted the statutory language on
assuming clinical and financial
responsibility for benefits to mean that
an entity can only truly hold ‘‘clinical
and financial responsibility’’ for the
provision of Medicare and Medicaid
benefits, as described at section
1859(f)(8)(D)(i)(III) of the Act, in the
scenarios of exclusively aligned
enrollment. Therefore, the D–SNPs that
meet this integration standard would be
FIDE SNPs and HIDE SNPs that have
exclusively aligned enrollment. As
implemented in our definitions, section
1859(f)(8)(D)(i)(II) of the Act also
establishes being a FIDE SNP or a HIDE
SNP as a means to satisfy the new,
minimum integration requirements for
D–SNPs. We believe that our proposed
definitions and requirements are clearer
without adding the statutory
terminology from section
1859(f)(8)(D)(i)(III) of the Act. As we
interpreted the statute and proposed the
new rules, any plan that meets the
requirement for clinical and financial
responsibility for the provision of
Medicare and Medicaid benefits would
already meet the second integration
requirement because it would be a FIDE
SNP or HIDE SNP. As discussed in
section II.A.2.b.(2) of this final rule, the
combination of terms that we proposed
is relevant to how we define an
applicable integrated plan that must
unify grievance and appeals procedures
for Medicare and Medicaid services.
Therefore, we believe that adding the
statutory terminology would complicate
the definitions and requirements
relative to any benefits.
PO 00000
Frm 00031
Fmt 4701
Sfmt 4700
15709
After considering the comments we
received, we are finalizing the
provisions related to D–SNP definitions
as proposed with the following
modifications:
• In the definition of aligned
enrollment at § 422.2, we are finalizing
the regulatory text with some
modifications to clarify our intended
meaning regarding financial and clinical
responsibility for enrollees. The final
regulation text refers to the enrollee’s
Medicaid benefits as being covered by
the D–SNP under a Medicaid MCO
contract between the state and: (1) The
MA organization offering the D–SNP; (2)
the D–SNP’s parent organization or (3)
another entity that is owned and
controlled by the D–SNP’s parent
organization.
• In the definition of a D–SNP at
§ 422.2, we are finalizing the substance
of our proposed definition with
modifications that are primarily
organizational. In the final regulation
text, we are inserting ‘‘title’’ prior to
‘‘XIX of the Act,’’ which was
inadvertently excluded in the proposed
rule. We are also using a new paragraph
(1) to clarify that a D–SNP coordinates
the delivery of Medicare and Medicaid
services for individuals eligible for such
Medicaid services, and a new paragraph
(2) to clarify that a D–SNP may provide
coverage of Medicaid services,
including LTSS and behavioral health
services. The requirement that a D–SNP
have a contract with the state Medicaid
agency consistent with the requirements
of § 422.107 and that meets the
minimum requirements detailed in
§ 422.107(c) is now contained in new
paragraph (3), and the requirement that
the D–SNP satisfy, beginning January 1,
2021, one of the three criteria for
integration of Medicare and Medicaid
benefits detailed in the proposed rule is
now contained in new paragraph (4),
with the specific integration
requirements redesignated as
paragraphs (4)(i) through (iii)).
• In paragraph (2) of the definition of
a FIDE SNP at § 422.2, we are finalizing
the definition with a change in the
placement of the phrase ‘‘consistent
with State policy’’ so that it modifies the
verb phrase ‘‘provides coverage’’ and
appears prior to the categories of
services to which it applies. Also in
paragraph (2), we are using ‘‘provides’’
in place of ‘‘includes’’ prior to the
phrase ‘‘coverage, consistent with State
policy.’’
• In the definition of a HIDE SNP at
§ 422.2, we are finalizing the proposal
with non-substantive modifications.
First, we are changing the placement of
the phrase ‘‘consistent with State
policy’’ so that it modifies the verb
E:\FR\FM\16APR2.SGM
16APR2
15710
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
phrase ‘‘provides coverage’’ and appears
prior to the categories of services to
which it applies. Second, we are
reorganizing the text to use new
paragraphs (1) and (2) to identify the
options for the capitated contract to
provide Medicaid services. A HIDE
SNP’s capitated contract to cover LTSS,
behavioral services, or both, must be
between: (1) The MA organization and
the Medicaid agency; or (2) the MA
organization’s parent organization (or
another entity that is owned and
controlled by its parent organization)
and the Medicaid agency. Third, we are
using ‘‘provides’’ in place of ‘‘includes’’
prior to the phrase, ‘‘consistent with
State policy, of long-term services and
supports, behavioral health services, or
both. . .’’
(2) Dual Eligible Special Needs Plans
and Contracts With States (§ 422.107)
We proposed changes in § 422.107 to
more clearly articulate the requirements
of the contract between the D–SNP and
the state Medicaid agency, while also
incorporating the changes required by
the Bipartisan Budget Act of 2018. In
summary, we proposed to make the
following specific changes:
• Delete language in paragraph (b)
that is extraneous and duplicative of the
proposed definition of a D–SNP in
§ 422.2;
• Make clarifying edits in paragraphs
(c)(1) through (c)(3), which govern the
minimum requirements of the contract
between the D–SNP and the state
Medicaid agency;
• Redesignate paragraph (d) as
paragraph (e), which relates to
compliance dates; and
• Establish a revised paragraph (d)
that describes the new minimum
contracting requirement under the
Bipartisan Budget Act of 2018 that the
newly designated paragraph (e)(2)
would make effective January 1, 2021.
Section 50311(b) of the Bipartisan
Budget Act of 2018 amended section
1859(f) of the Act by creating a new
paragraph (8)(D)(i)(I) to require that the
Secretary establish additional
requirements for D–SNPs’ contracts
with state Medicaid agencies. In the
proposed rule preamble, we discussed
how this provision requires a D–SNP to
have a state Medicaid agency contract
that includes additional coordination
requirements (subsection (f)(8)(D)(i)(I) of
the Act); be a FIDE SNP or HIDE SNP
(subsection (f)(8)(D)(i)(II) of the Act); or
have exclusively aligned enrollment and
have its parent organization accept full
clinical and financial responsibility for
all Medicare and Medicaid covered
services (subsection (f)(8)(D)(i)(III) of the
Act), depending on the state’s election.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
We proposed to implement subsection
(f)(8)(D)(i)(I) of the Act by establishing at
§ 422.107(d) that any D–SNP that is not
a FIDE SNP or HIDE SNP is subject to
an additional contracting requirement.
Under this proposed new contract
requirement, the D–SNP would be
required to notify the state Medicaid
agency, or individuals or entities
designated by the state Medicaid
agency, of hospital and skilled nursing
facility (SNF) admissions for at least one
group of high-risk full-benefit dual
eligible individuals, as determined by
the state Medicaid agency. We clarified
in the proposed rule that this proposal
would also permit the D–SNP to
authorize another entity or entities
(such as a D–SNP’s network providers)
to notify the state Medicaid agency and/
or individuals or entities designated by
the state Medicaid agency on its behalf,
with the understanding that the D–SNP
ultimately would retain responsibility
for complying with this requirement.
We direct readers to the proposed rule,
83 FR 54996, for a more detailed
explanation of our intent and rationale
for this approach.
As discussed in the proposed rule, we
believe that our proposal to establish a
notification requirement for D–SNPs for
high-risk individuals’ hospital and SNF
admissions is consistent with the
criteria we used to evaluate various
options for the minimum contracting
requirements. We considered whether a
proposal would:
• Meaningfully improve care
coordination and care transitions,
thereby improving health outcomes for
dual eligible individuals;
• Minimize burden on plans and
states relative to the improvements in
care coordination and transitions;
• Provide flexibility to state Medicaid
agencies;
• Enable CMS to assess compliance
with minimal burden on CMS, plans,
and providers; and
• Be consistent with the statutory
amendments made by the Bipartisan
Budget Act of 2018.
We solicited comment on whether our
proposal satisfied these criteria to a
greater extent than the more prescriptive
or alternative proposals we described in
the proposed rule; 19 whether our
reasoning for why our proposal was
preferable to the more prescriptive or
alternative proposals was sound;
whether there were other minimum
contacting requirements that we did not
consider that were superior to our
proposal; and whether our proposal
19 We direct readers to the proposed rule, 83 FR
54997–98, for a more detailed discussion of these
alternatives.
PO 00000
Frm 00032
Fmt 4701
Sfmt 4700
provided sufficient incentives for plans
and states to pursue greater levels of
integration. Specifically, we considered
and sought comment on the following
alternatives:
• Proposing that notice requirements
apply for all full-benefit dual eligible
individuals’ hospital and SNF
admissions.
• Proposing a minimum size for the
state-selected high-risk population.
• Requiring a notification for every
emergency department visit, as
mentioned in section 1859(f)(8)(D)(i)(I)
of the Act.
• Proposing that the notification
occur not later than 48 hours after the
D–SNP learns of the admission or
discharge.
• Requiring each D–SNP to take
affirmative steps to schedule its
individual health risk assessments at the
same time as similar outreach is
conducted by the Medicaid managed
care plan, to use a combined or aligned
assessment instrument, or take other
steps that would minimize the burden
on enrollees or providers. As we noted
in the proposed rule, we continue to
hear of scenarios where a D–SNP
enrollee is assessed separately by the D–
SNP and then again by their Medicaid
MCO, even though there may be a high
degree of overlap in what each
organization is assessing and ultimately
what each organization is requesting of
the enrollee. We solicited comment on
how pervasive this issue is and the
extent of overlap in the assessment
instruments and degree of burden on
providers and beneficiaries, including a
specific request for feedback on the
extent to which the requirements that
we proposed do not accomplish enough
or should be modified to address this
issue.
• Requiring D–SNPs to identify any
enrollees who are in need of LTSS and
behavioral health services and
transmitting such information to the
state Medicaid agency.
• Requiring D–SNPs to train plan staff
and their network providers on the
availability of LTSS and behavioral
health services covered by Medicaid.
• Requiring D–SNPs to solicit state
input on the plan’s model of care
(which is currently required and
submitted to CMS pursuant to
§ 422.101(f)), health risk assessment
instrument, and beneficiary
communication materials. We sought
comment regarding state burden and on
compelling reasons why additional
contracting requirements in this area
may be necessary.
• The merits of requiring D–SNPs to
share data with state Medicaid agencies
or entities designated by state Medicaid
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
agencies that would benefit the
coordination of Medicare and Medicaid
items and services, as described in
section 1859(f)(8)(D)(i)(I) of the Act as
an example for implementing that
provision. We solicited comment on
whether there should be additional
regulatory requirements around data
sharing.
We requested feedback on our
notification proposal at § 422.107(d),
including the ways that state Medicaid
agencies and plans would fulfill this
requirement, and the additional
contracting requirements we considered
in the proposed rule preamble.
In addition to the new requirement for
contracts between the state and MA
organization at proposed § 422.107(d)
for D–SNPs that are not FIDE SNPs or
HIDE SNPs, we proposed to include
additional specifications in the
regulations governing D–SNP contracts
with state Medicaid agencies at
§ 422.107 by amending paragraph (b)
and several provisions in paragraph (c).
As stated in the preamble to the
proposed rule, we do not believe that
these specifications materially alter
these agreements; however, we
proposed them in response to questions
raised since the state Medicaid agency
contracting requirements were
promulgated in the September 2008
interim final rule (73 FR 54226). We
also believed that these changes aligned
with the integration requirements for D–
SNPs in the Bipartisan Budget Act of
2018.
We proposed modifying the general
rule for contracts with D–SNPs at
§ 422.107(b) to strike ‘‘The MA
organization retains responsibility
under the contract for providing
benefits, or arranging for benefits to be
provided, for individuals entitled to
receive medical assistance under Title
XIX. Such benefits may include longterm care services consistent with State
policy, . . .’’ As discussed in the
proposed rule, we believed this
proposed change would be consistent
with the coordination requirements in
our proposed definition at § 422.2 of
‘‘D–SNP.’’
We proposed to revise the contracting
requirement at § 422.107(c)(1), which
currently requires the contract to
document the MA organization’s
responsibility, including financial
obligations, to provide or arrange for
Medicaid benefits, to specify instead
that the contract must document the MA
organization’s responsibility to provide,
as applicable, and coordinate the
delivery of Medicaid benefits, including
LTSS and behavioral health services, for
individuals who are eligible for such
services. We solicited comment on
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
whether our proposed amendments to
this section fully communicated what
we intend to require of D–SNPs or
whether there were additional revisions
we ought to consider to express our
intent more clearly for D–SNPs, state
Medicaid agencies, and other
stakeholders.
In § 422.107(c)(2), we proposed to
revise the current requirement that the
contract between the D–SNP and the
state Medicaid agency document the
categories of dual eligible individuals
who are eligible to enroll in the D–SNP.
We proposed to revise this requirement
to specify not only the categories of
eligibility but also any additional
criteria of eligibility to account for such
conditions of eligibility under Medicaid
as nursing home level of care and age.
We clarified that these criteria could
also include a requirement for D–SNP
enrollees to enroll in a companion
Medicaid plan to receive their Medicaid
services.
Finally, at § 422.107(c)(3), we
proposed that the contract between the
D–SNP and the state Medicaid agency
document the Medicaid services the D–
SNP is responsible for covering in
accordance with a capitated contract
with the D–SNP directly or through a
risk contract, defined at § 438.2, with
the companion Medicaid managed care
organization operated by the D–SNP’s
parent organization. As discussed in the
proposed rule, we believe this proposed
change would reduce burden on D–
SNPs and would enable us to identify
the particular Medicaid services that are
covered under a capitated contract for
FIDE SNPs and HIDE SNPs but would
not limit or contravene other
requirements for D–SNPs to approach
their obligations to coordinate the
delivery of all Medicare and Medicaid
benefits. We sought comment on
whether the regulatory change fully
communicates what we wish to require.
We received the following comments
on these proposed definitions:
Comment: We received a number of
comments in support of our proposal to
establish a notification requirement for
any D–SNP that is not a FIDE SNP or
HIDE SNP. One commenter believed the
proposed requirement is consistent with
the intent and language of the Bipartisan
Budget Act of 2018. Several commenters
supported the flexibility to allow state
Medicaid agencies to build on
notification processes already in place.
A commenter noted that minimum
contract requirements are more practical
to implement than more prescriptive
requirements due to variation in state
capabilities and current data-sharing
methods. Another commenter
appreciated the flexibility states have to
PO 00000
Frm 00033
Fmt 4701
Sfmt 4700
15711
implement the requirement based on
their needs and readiness. Another
commenter believed that the
notification requirement will facilitate
care transitions for dual eligible
individuals in instances where they are
not enrolled in an aligned D–SNP and
provides a framework upon which states
can advance Medicare and Medicaid
benefit integration in the future.
Response: We thank commenters for
their support of our proposed
notification requirement. We agree that
the requirement is consistent with the
statutory amendments made by the
Bipartisan Budget Act of 2018. We
intend for this notification requirement
to be a catalyst for increasing care
coordination during transitions of care,
while minimizing plan and state burden
and preserving state flexibility to
develop solutions that build upon
current integration efforts.
Comment: Several commenters
supported our proposed notification
requirement but believed that it
represents a transitional step and that
our integration efforts should be scaled
up over time, with one commenter
requesting that CMS establish timelines
and benchmarks for states and plans.
One commenter believed that the new
statutory amendments to the Act made
by the Bipartisan Budget Act of 2018 not
only permit, but require, the notification
requirement to be scaled up over time.
A few commenters recommended that
the notification requirement be
broadened to include more enrollees.
Response: As we discussed in the
proposed rule, our intent in establishing
this notification requirement is for states
and D–SNPs to begin on the path toward
greater integration on a smaller scale.
Not every state is similarly positioned to
move towards greater integration. We
note that, as processes and
infrastructure mature, a state Medicaid
agency may choose through its contracts
with D–SNPs to scale up this
notification to include additional
subpopulations of full-benefit dual
eligible individuals. As we gain
experience with implementing the
integration requirements in this final
rule, we will evaluate whether further
rulemaking is necessary to build on the
notification requirement.
Comment: Some commenters
expressed concern that CMS’s proposed
notification requirement will not meet
the goal of promoting greater integration
of Medicare and Medicaid benefits,
creates unnecessary burden, or may not
be the most appropriate requirement in
all states. MedPAC noted that states are
currently able to require D–SNPs to
provide this information through their
state Medicaid agency contracts, but
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15712
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
since few states do, states were unlikely
to use this information to improve care
coordination. Several commenters
believed that many states may lack the
capability to implement the contracting
requirement and use the data in a
meaningful way. Several commenters
expressed concern that the requirement
was too burdensome for states and
would discourage states from pursuing
or continuing to contract with D–SNPs.
A few commenters noted that
notifications of hospital or SNF
admissions may not be the most useful
or best way to incentivize coordinated
transitions of care in every state and
emphasized that states are in the best
position to determine what
requirements best fit their delivery
system. One commenter noted that
limiting the notification requirement to
only one group of high-risk full-benefit
dual eligible individuals would not
meaningfully advance coordination
efforts. Another commenter believed
that the proposed requirement does not
ensure both the state and D–SNP will be
engaged in discharge planning in a way
that ensures timely access to the most
appropriate and cost effective benefits.
One commenter expressed a belief that
this requirement puts the state in the
middle of communication between the
D–SNP and enrollee’s care team.
Another commenter questioned whether
states would utilize the information
provided in the notifications. Several
commenters also questioned what
would happen to D–SNPs if a state was
not interested in participating in the
notification requirement.
Response: These commenters raise
important points about our proposed
notification requirement. However, we
believe the requirement strikes an
appropriate balance among
incentivizing further integration for
states and D–SNPs, limiting the
administrative burdens for states and
MA organizations, and ensuring
flexibility in implementation to fit the
needs of each state’s policy
environment. In addition to the
notification requirement, we note that—
as discussed in sections II.A.2.a.(1) and
II.A.2.b.(1) of this final rule—we are also
establishing through this rulemaking an
explicit requirement at § 422.2 that D–
SNPs coordinate dual eligible
individuals’ Medicare and Medicaid
benefits, as well as a requirement that
D–SNPs provide assistance with
Medicaid appeals and grievances at
§ 422.562(a)(5). In implementing the
statute by establishing the notification
requirement, we incentivize not only D–
SNPs, but also the states with which
they must contract, to make incremental
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
progress in coordinating care for dual
eligible individuals. By design, the
notification requirement gives the state
Medicaid agency broad latitude to
establish notification procedures and
protocols that are within the state’s
capacity and consistent with the state’s
needs and integration goals. We believe
this requirement is scalable for D–SNPs
and states where no coordination
activity is currently taking place. We
also point to the flexibility within the
notification requirement for the state to
designate another individual or entity to
receive the notification, therefore
allowing for the timeliest action
following a care transition or other
significant event.
Comment: Several commenters
supported the flexibility in the proposed
notification requirement for the state to
designate other individuals or entities to
receive notification of an admission.
These commenters believed that
collection of this information at the state
level may not be the most appropriate
or useful approach. One commenter
noted that Tennessee’s approach, which
requires D–SNPs to notify a Medicaid
provider of hospitalizations and
emergency department visits, better
achieves the goal of improved
coordination of services than a
notification to the state. Another
commenter requested that CMS modify
the notification proposal by requiring
that the beneficiary’s unaligned
Medicaid MCO also be notified of any
admissions for beneficiaries that receive
LTSS or behavioral health services.
Response: We appreciate the
commenters’ support for the flexibility
afforded to states to designate other
individuals or entities to receive
notification of an admission in our
proposal. We agree that in some
markets, providers and other entities,
such as a Medicaid MCO, may be better
able to use admissions information to
timely coordinate care for a beneficiary.
We do not agree that CMS should
finalize the regulation to require D–
SNPs to notify MCOs specifically of
inpatient admissions, however, but note
that such delegation is already
permissible under § 422.107(d). We
defer to states to establish when and to
whom the notification is appropriate to
best achieve integration and improve
outcomes for dual eligible individuals,
based on how the state operates its
Medicaid program.
Comment: Several commenters
expressed concern that our proposed
language allowing a D–SNP to authorize
another entity or entities, such as the D–
SNP’s network providers, to notify the
state Medicaid agency of inpatient
admissions would create significant
PO 00000
Frm 00034
Fmt 4701
Sfmt 4700
burden for providers. However, one
commenter also acknowledged that
notifications would be timelier if
originated by providers. One commenter
recommended removing this language
from the regulatory text, while a few
other commenters recommended that
CMS provide guidance and provider
education about the requirement.
Another commenter noted that states
and D–SNPs are dependent on prompt
and complete claims submissions from
hospitals and SNFs to achieve better
care coordination and emphasized the
importance of provider education about
these requirements to ensure the flow of
this information.
Response: In our proposed
notification requirement, we provided
flexibility to allow for transmission of
information about hospital and SNF
admissions in multiple ways because
we believe the most efficient and
effective processes may vary by state
and evolve over time. In some cases,
this might include reporting by
providers and providing information to
specific providers to aid in care
coordination. However, our proposed
requirement places the ultimate
responsibility on D–SNPs and does not
directly require actions by providers.
When developing notification processes
to meet our regulatory requirements, we
expect that states and D–SNPs will
consider any potential impacts on
providers.
Comment: Several commenters
requested that CMS provide states with
technical assistance and disseminate
best practices related to the notification
requirement both to facilitate the
contracting process and to ensure that a
sufficient degree of coordination is
achieved to promote successful
transitions of care. These commenters’
requests particularly focused on the
need to develop data exchange
technology, systems, and processes to
achieve successful transitions of care.
One commenter recommended CMS
provide states with parameters for
implementing the state contracting
requirements to mitigate operational
burden on D–SNPs while supporting
implementation. Another commenter
recommended CMS seek assistance from
a group of plan and state stakeholders
in developing this guidance and best
practice models.
Response: We agree with these
commenters that support for states will
improve the implementation of the
requirements of this final rule. As stated
earlier in this final rule, the MedicareMedicaid Coordination Office provides
technical assistance to states on
integration issues, including through the
Integrated Care Resource Center (see
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
https://www.integratedcareresource
center.com/). We are committed to
continuing our work with states to
gather and disseminate best practice
information and to engage stakeholders
to ensure a successful implementation.
Comment: Several commenters
requested that CMS establish clear
guidelines and standardized formats for
the proposed notification requirement,
including methods, content, and
timeframes for notification. One
commenter requested clarification with
respect to how high-risk populations
should be defined. Another commenter
recommended requiring that states
include functional ability in their
definitions of high-risk populations. A
few commenters expressed concern that
variation in how this requirement is
implemented across states will be costly
and time consuming, leading to
potential problems in implementing the
requirement effectively. Some
commenters expressed interest in
uniform requirements in order to reduce
administrative burden for plans that
operate in multiple states. One
commenter noted that standardization
of data exchange will contribute to the
value of the data for benchmarking and
quality improvement activities.
Response: As discussed earlier in this
preamble, we intend that the proposed
notification requirement provide states
with discretion to develop solutions
consistent with their particular policy
and operational environments. We
believe that a more prescriptive
notification requirement would
ultimately be counterproductive for
both states and D–SNPs by limiting the
development of solutions appropriate to
each market. Regardless of the approach
a state chooses to take under this final
rule, our aim is to have actionable
information that enables providers and
payers to facilitate seamless care
transitions for high-risk populations,
that is, those full-benefit dual eligible
individuals who are most likely to
benefit from effective interventions
(such as through the provision of LTSS
and behavioral health services) that
enable them to live independently in
the setting of their choice and in a way
that values their own needs and
preferences. As we gain more
experience with the implementation of
the notification requirement in this final
rule, we will share best practices and
continue to provide technical assistance
and guidance to states and D–SNPs.
Comment: Several commenters
requested that CMS do more to establish
a data-sharing system to facilitate the
proposed notification requirement,
citing limited ability for some states to
implement data sharing mechanisms.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Some commenters noted that a unified
system to share data should be used by
states, D–SNPs, providers, and
beneficiaries. One commenter expressed
support for the proposed notification
requirement serving as a starting point
for a robust two-way health information
exchange system between D–SNPs and
states to share data on dual eligible
individuals’ utilization of Medicare and
Medicaid services. Another commenter
recommended that CMS encourage
states to build on current data collection
and sharing efforts, such as health
information exchanges (HIEs). Some
commenters recommended specific data
exchange solutions, such as building on
the Blue Button 2.0 Framework or
modifying the Transformed Medicaid
Statistical Information System (T–
MSIS).
Response: We believe it is most
appropriate at this time to defer to state
Medicaid agencies on the manner in
which notification occurs and how data
be exchanged. For example, in markets
where there is existing infrastructure to
leverage, such as a state HIE, a state may
elect an approach that requires data
sharing across a common platform using
industry standards, including those
adopted by the Office of the National
Coordinator for Health IT in accordance
with 45 CFR part 170, subpart B.
Regardless of process, we expect that
notifications occur timely in order to
ensure prompt care coordination and
effective care transitions. To that end,
we encourage states and D–SNPs to use
the most efficient notification
mechanisms available, which may
include the state’s HIE. However, we
appreciate that not every state is
similarly positioned, and, therefore, if a
state elected to implement this
requirement on a smaller scale, targeting
a small subset of high-risk beneficiaries,
a solution that does not initially require
automation may be more appropriate
and pragmatic. We reiterate that the
notification requirement we are
finalizing in this rule is a first step
towards improved data exchange and
integration. As health information
technology advances and industry
standards for data exchange are
established, it may be feasible to
establish or leverage a standardized
data-sharing system.
Comment: One commenter requested
direction on how to implement the
proposed notification requirement in
states like Washington where high-risk
dual eligible individuals are enrolled in
a health home under demonstration
authority.
Response: As noted previously, our
final requirement at § 422.107(d)
provides broad latitude to each state to
PO 00000
Frm 00035
Fmt 4701
Sfmt 4700
15713
determine the subset of high-risk D–SNP
enrollees subject to the notification
requirement. The regulation, as
proposed and finalized, requires that the
enrollees for which the notification
must be made must be at least one group
of full-benefit dual eligible and highrisk. The state is not required to specify
all high-risk dual eligible individuals for
this group so long as the identification
of the group is consistent with the
regulation’s requirements.
Comment: Several commenters
questioned the impact the proposed
notification requirement will have on
notification systems and the robust
reporting requirements already in place
in several states. One commenter noted
that the proposed requirement would
duplicate the software program
currently used by Washington in which
hospitals enter admissions and
emergency department visit information
for other providers and case managers to
view. Another commenter expressed
concern that the language requiring a D–
SNP to notify or authorize another
entity to notify a state agency may not
accommodate the current Oregon Health
Information Technology System, which
creates a notification of admission
without the D–SNP’s action. This
commenter recommended changing our
proposed regulatory language to ensure
this type of notification system meets
our notification requirement such that
D–SNPs would not be required to repeat
a duplicate notification.
Response: We appreciate that states
have different and evolving
infrastructure and policies, including
mandatory data sharing requirements.
The notification requirement we are
finalizing in this rule is not intended to
impact such existing requirements, and
states may continue to require
additional notifications or other data
sharing consistent with their state
Medicaid agency contracts. We thank
the commenters that raised specific
operational scenarios where HIEs or
other notification systems are currently
in place and could be leveraged for
purposes of satisfying our notification
requirement. In this final rule, we are
modifying the verbs used to describe the
D–SNP’s obligations in § 422.107(d) to
clarify those responsibilities; as
finalized, the D–SNP notifies or arranges
for another entity to notify (instead of
‘‘will notify or authorize another entity’’
as proposed) the state Medicaid agency
of hospital and SNF admissions for at
least one group of high-risk full-benefit
dual eligible individuals, as identified
by the state Medicaid agency. We
believe the phrase ‘‘arrange for’’
provides more flexibility to encompass
arrangements such as those described by
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15714
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
the commenters. Thus, for example, a
D–SNP could meet the notification
requirement by arranging for another
entity—for example, a hospital—to
notify the state Medicaid agency or its
designee when the various parties
participate in an HIE or other
notification system.
Comment: Several commenters raised
concerns about D–SNPs’ ability to fully
comply with our proposed revision to
§ 422.107(c)(1), which codifies a
requirement for D–SNPs to document
their responsibility to coordinate the
delivery of Medicaid benefits for their
enrollees, as well as our proposed
notification requirement at 422.107(d),
citing potential barriers imposed by the
Health Insurance Portability and
Accountability Act of 1996 and 42 CFR
part 2, with respect to sharing
information that would allow D–SNPs
to effectively coordinate and share
information about behavioral health
services. One commenter cited 42 CFR
part 2 as preventing covered entities
from effectively coordinating behavioral
health services when the need for such
services involves substance abuse
treatment and the D–SNP cannot obtain
member consent, and urged CMS to
consider ways to address this issue and
allow for coordinating and sharing of
data without the need for written
consent. Another commenter suggested
that CMS work with the Office for Civil
Rights and the Substance Abuse and
Mental Health Services Administration
on this issue.
Response: These commenters have
raised important issues with respect to
care coordination for individuals with
substance use disorder. This final rule
does not change or eliminate current
requirements for D–SNPs to comply
with HIPAA and 42 CFR part 2. We
clarify that the requirements finalized in
this rule, including the requirement
codified at § 422.2 that a D–SNP
coordinate Medicare and Medicaid
benefits and the requirement at
§ 422.107(d) requiring notification of
high-risk enrollee inpatient and SNF
admissions, must be implemented in a
way that complies with all applicable
laws. As a result, we acknowledge there
are limitations to D–SNPs’ ability to
notify states of certain inpatient
admissions for high-risk enrollees with
substance use disorder, as well as to
their ability to coordinate these
individuals’ care, absent member
consent for the disclosure of such
information. When establishing the
notification requirement in the state
Medicaid agency contract, we encourage
states to collaborate with D–SNPs to
identify and address concerns regarding
compliance with other statutes and
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
regulations, including HIPAA and 42
CFR part 2.
Comment: Some commenters
requested additional requirements for
state Medicaid agency contracts
between states and D–SNPs. One
commenter stated that the proposed
contracting requirements at § 422.107
would better meet CMS’s stated goals if
they were more prescriptive. Several
commenters recommended additional
contracting requirements to those in the
proposed rule, while one commenter
requested that CMS refrain from adding
more contract requirements until after
the implementation of the notification
requirement finalized in this
rulemaking. Some commenters
recommended that CMS require states
and D–SNPs to develop a process for
coordinating Medicaid-funded services,
such as LTSS and behavioral health
services. One commenter recommended
requiring D–SNPs to annually submit a
plan for coordinating Medicaid LTSS
and behavioral health services for
approval by the state. A few
commenters suggested requiring
improved information sharing regarding
Medicaid provider participation and
enrollees’ Medicaid and Medicare
eligibility. One commenter noted that
additional contracting requirements
may ease administrative burdens and
promote further integration and
recommended that CMS clearly define
minimum coordination requirements
and establish uniform language and
definitions.
Response: We appreciate the
suggestions for modifications or
additions to the state Medicaid agency
contract requirements for D–SNPs
currently codified at § 422.107. We are
not finalizing any additional substantive
changes to § 422.107 in this final rule
beyond those discussed in our proposed
rule. However, we will continue to
evaluate D–SNPs’ progress toward
achieving a minimum level of
integration as intended under the
Bipartisan Budget Act of 2018 to
determine whether additional
contracting requirements might be
necessary in the future. As discussed in
various places in this final rule, states
retain the ability to add more stringent
contracting requirements in their state
Medicaid agency contracts with D–SNPs
in order to best achieve their specific
policy goals and meet the needs of their
population of dual eligible individuals.
Comments: Several commenters
recommended that CMS consider new
incentives that would enhance
integration, such as an increase to the
Federal Medical Assistance Percentage
(FMAP) rate for activities related to
Medicare-Medicaid integration,
PO 00000
Frm 00036
Fmt 4701
Sfmt 4700
including for investments in state datasharing systems and infrastructure. One
commenter noted that requiring or
incentivizing states to assist D–SNPs in
the development of such administrative
processes to assist with integration
efforts would prevent states from
shifting this responsibility to D–SNPs.
Response: We agree that state
investments in additional data-sharing
or other administrative processes may
facilitate D–SNP efforts to implement
the notification requirement, but also
more broadly to better coordinate
Medicare and Medicaid coverage. As
discussed in the Collection of
Information section of this final rule, we
estimate that half of the cost of
developing infrastructure and processes
to implement the proposed notification
requirement would be offset by federal
financial participation for Medicaid
administrative activities. However,
increases to FMAP rates are beyond the
scope of this rulemaking.
Comment: A few commenters
supported the alternative we noted for
consideration that would apply the
notification requirement to all fullbenefit dual eligible individuals
enrolled in the D–SNP, and not just a
subgroup of high-risk individuals. These
commenters cited improved access to
Medicaid benefits that promote care in
the least restrictive environment as the
reason to support the broader
requirement. Another commenter
requested that we establish a minimum
size for the state-selected high-risk
population, another alternative CMS
noted for consideration in the proposed
rule. This commenter noted that factors
such as minimum population size
impact the feasibility of implementation
of this provision and would mitigate
operational burden for health plans.
Response: We appreciate the
commenters’ requests for a broader
notification requirement, but we believe
that limiting the notification
requirement to high-risk individuals in
this final rule is preferable. Research
suggests that targeting high-risk
individuals is critically important to
cost-effective interventions.20 In
addition, all states have some care
management infrastructure for high-risk
individuals in their Medicaid programs,
such as through Medicaid 1915(c) HCBS
waivers.21 The notification provision at
20 Brown, R.S., Peikes, D., Peterson, G., Schore, J.
& Razafindrakoto, C.M., (2012). ‘‘Six Features of
Medicare Coordinated Care Demonstration
Programs That Cut Hospital Admissions of Highrisk Patients.’’ Health Affairs, 31(6).
21 See: https://www.medicaid.gov/medicaid/ltss/
health-homes/; https://
www.medicaid.gov/medicaid/section-1115-demo/
demonstration-and-waiver-list/; and Care
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
§ 422.107(d) gives state Medicaid
agencies the discretion to decide which
group of beneficiaries is at high risk and
how large or small the group(s) may be.
Providing states with such flexibility to
define their population of high-risk
individuals will allow them to tailor the
D–SNP notification requirement to align
with existing infrastructure for
coordinating and managing care for
high-risk individuals. Such targeting
will not only limit notifications to those
which are most meaningful and
actionable for the state, but will also
reduce administrative burden and
implementation costs.
Comment: One commenter
encouraged CMS to require D–SNPs to
provide notification of emergency
department visits for unaligned D–SNP
enrollees receiving LTSS and behavioral
health services from fee-for-service
Medicaid or an MCO.
Response: We acknowledge the
potential benefits of a real-time
notification of emergency department
visits, but we decline to finalize a
broader requirement including
notification of emergency department
visits at this time. We believe the
greatest opportunity to target
interventions and improve outcomes is
after a hospital or SNF admission where
there is more time to initiate discharge
planning. However, as noted in the
proposed rule, so long as the
requirements of § 422.107(d) are met, a
state Medicaid agency could choose to
require a notification for full-benefit
dual eligible individuals enrolled in a
D–SNP who are high utilizers of
emergency departments, where there
may be opportunities to address barriers
to accessing primary care and unmet
health care needs.
Comment: One commenter
recommended that CMS improve
person-centered decision making during
care transitions by using protocols for
communication and coordination
similar to interdisciplinary team models
or California’s guidance for MMPs on
hospital discharge planning.
Response: We appreciate the
commenter’s suggestion and will
consider this input as we develop
technical assistance and identify best
practices following the implementation
of this final rule.
Comment: One commenter expressed
support for state flexibility in
determining the timeline for the
notification, while several commenters
Coordination in Managed Long-Term Services and
Supports (2015, July), prepared for AARP by
Truven Health Analytics. Retrieved from: https://
www.aarp.org/content/dam/aarp/ppi/2015/carecoordination-in-managed-long-term-services-andsupports-report.pdf.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
expressed concerns about the lack of a
specific timeliness requirement. Several
commenters requested that CMS require
a specific timeframe for reporting. A few
commenters believed that the 48-hour
requirement discussed in our proposed
rule preamble as an alternative for
consideration was reasonable and
synchronized well with requirements
for discharge notices. One commenter
suggested that CMS ensure that any
timeframes imposed by states begin after
the health plan has received the
admissions data. A few commenters
expressed concern that the notifications
would not be timely and therefore
would not be helpful in care
coordination. One commenter requested
that CMS clarify its intent for requiring
states to collect this admissions
information.
Response: We appreciate comments
on the timing and timeliness of the
notification requirement. We believe
that states may choose to use the
notification for a variety of purposes,
including coordination of care at the
point of hospital or SNF discharge.
When establishing a timeframe, we
encourage the states to consider the
current process for how D–SNPs in their
markets receive admissions information
to reduce burden on D–SNPs and their
provider networks. Because these
processes vary by state, we are not
inclined to specify timing requirements
for these notifications at this time.
However, we may consider a timeliness
standard in future rulemaking based on
our experience implementing the
provisions of this final rule.
Comment: Several commenters
expressed support for the alternative we
noted for consideration in the proposed
rule that would establish requirements
for coordination of individual health
needs or risk assessments between D–
SNPs and Medicaid MCOs. These
commenters generally recommended
that CMS encourage, but not require, D–
SNPs to make every effort to coordinate
the assessment due to concerns about
feasibility. A few commenters noted that
coordination could result in delays in
administering the assessment. One
commenter noted that guidelines for the
coordination of assessments would be
more appropriate in subregulatory
guidance or state contracts, rather than
as a regulatory requirement. Another
commenter requested that CMS consider
requiring D–SNPs to share assessment
findings with coordinating plans. One
commenter noted this could be an area
for future integrated requirements for
exclusively aligned plans.
Response: We agree with commenters’
concerns regarding the feasibility of
coordinating individual health needs or
PO 00000
Frm 00037
Fmt 4701
Sfmt 4700
15715
risk assessments. We believe the
pervasiveness of this issue and the
extent of overlap in assessment
instruments varies across state lines and
requires further study. We are therefore
declining to add this requirement to D–
SNP state Medicaid agency contract
requirements at § 422.107 at this time.
Comment: One commenter supported
requiring that D–SNPs identify and
notify states of enrollees in need of
LTSS or behavioral health services to
promote care coordination and improve
outcomes.
Response: We thank the commenter.
Although we considered this alternative
in the proposed rule, we note that D–
SNPs are already required, at
§ 422.101(f), to develop individualized
care plans and perform health risk
assessments that identify the physical,
psychosocial, and functional needs of
each SNP enrollee. Additionally, D–
SNPs have the responsibility to
coordinate the delivery of Medicare and
Medicaid services consistent with the
D–SNP definition at § 422.2 finalized in
this rule. We do not believe the burden
associated with an additional
requirement to proactively identify for
the state enrollees in need of LTSS or
behavioral health services is advisable
given the potential overlap with these
existing requirements. We are therefore
not modifying our proposed notification
requirement to include notification of
enrollees in need of LTSS or behavioral
health services.
Comment: A few commenters
supported the alternative CMS
considered in the proposed rule that
states provide input on the plan’s model
of care, health risk assessment
instrument, and beneficiary
communication materials. One
commenter noted this requirement
would ensure that states stay active in
their role as health insurance regulators
and that beneficiary materials have
correct state-specific information.
Response: We thank commenters for
their input, but we remain disinclined
to impose such a requirement on D–
SNPs that do not have exclusively
aligned enrollment. We believe this
requirement would create additional
burden for states without capitated
arrangements with D–SNPs for the
provision of Medicaid services, as
Medicaid agencies may not see a role for
themselves in reviewing such
documents. We note that state Medicaid
agencies can choose to require that a D–
SNP provide such documents for state
input through their contracts with D–
SNPs, and that—as discussed earlier in
this preamble—CMS has worked with
several states with integrated D–SNPs to
develop more streamlined and
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15716
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
integrated beneficiary communications
materials.
Comment: A few commenters
supported additional or alternative datasharing requirements for D–SNPs to
comply with the statutory requirements
for integration. One commenter
requested that CMS provide any existing
analysis on whether the notification of
an admission to a hospital or SNF is
more beneficial than sharing other
information, such as enrollment
information and care coordination
contacts.
Response: While there may be
additional or different requirements that
would facilitate D–SNPs’ integration of
Medicare and Medicaid benefits, we are
choosing to initially focus on a
notification requirement for hospital
and SNF admissions, which we believe
will lead to more immediate
improvements in the care transition
process, while preserving state and plan
flexibility and minimizing burden. After
we gain sufficient experience in
implementing the notification
requirement we are finalizing in this
rule, we will assess whether changes are
necessary to achieve additional
integration.
Comment: A few commenters
supported inclusion of a requirement,
consistent with the example included in
section 1859(f)(8)(D)(i)(I) of the Act that
a D–SNP demonstrate its integration of
Medicare and Medicaid benefits by
assigning one primary care provider for
each enrollee. One commenter
requested clarification as to why this
specific requirement was not included
in the proposed rule, noting that the
primary care provider is the coordinator
of the beneficiary’s entire spectrum of
care and a critical liaison between the
beneficiary and the plan.
Response: We agree with the
commenter’s statement about the
importance of a primary care provider,
but we decline to require D–SNPs to
assign a primary care provider for each
enrollee as a minimum standard for
integration. We considered the value of
such a requirement but were unable to
determine how meaningfully it would
advance integration. We also note that,
consistent with § 422.112(a)(2), all MA
organizations offering an MA
coordinated care plan, including those
offering D–SNPs, must establish a panel
from which an enrollee may select a
primary care provider and are permitted
to assign a primary care provider in
limited circumstances. We are
concerned that establishing a primary
care provider assignment requirement
may conflict with enrollee choice
provisions at § 422.112(a)(2).
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Comment: One commenter supported
a requirement that D–SNPs submit to
the state Medicaid agency the name and
contact information for their designated
care coordinators.
Response: We appreciate this
suggestion but decline to make this
change to our regulatory requirements at
this time due to the burden on D–SNPs
provide and update this information
and on states to meaningfully use this
information. We will consider this
suggestion for future rulemaking.
Comment: One commenter
recommend that CMS establish data
reporting requirements that address
integrated care and incorporate LTSS,
such as requiring reporting of quarterly
care coordination and LTSS referral
data.
Response: We thank the commenter
and will consider this suggestion for
future rulemaking.
Comment: One commenter requested
clarification on whether CMS intended
for the notification requirement to
include discharges as well as
admissions.
Response: We chose to focus on
notification of admissions to allow
states to initiate care coordination
activities prior to discharge. Our
proposal deliberately did not address
discharges due to concerns that care
coordination activities would not be
timely if they begin after a discharge
takes place. However, we note that
states are not precluded from adding a
notification requirement for discharges
through the state Medicaid agency
contracts with D–SNPs under § 422.107.
Comment: One commenter
recommended that CMS stop new
enrollment into D–SNPs that are not
contracted by the state to provide
Medicaid benefits, and that CMS also
require these D–SNPs to establish
meaningful and timely data exchange
and coordination processes with the
state or MCOs for existing beneficiaries
to ensure timely access to Medicaid
benefits.
Response: We believe that the
commenter’s recommendation goes
beyond section 1859(f)(8)(D)(i)(I) of the
Act, which envisions a pathway for D–
SNPs to remain an option in states that
do not pursue a selective contracting
model, subject to additional integration
requirements established by CMS in this
final rule. We will, however, continue to
assess opportunities to promote greater
levels of aligned enrollment. We note
that states may establish additional
requirements for data exchange and
coordination in their state Medicaid
agency contracts with D–SNPs.
Comment: A few commenters
requested exceptions to the notification
PO 00000
Frm 00038
Fmt 4701
Sfmt 4700
requirement. One commenter requested
clarifications on possible exemptions for
some non-integrated D–SNPs. Another
commenter recommended that D–SNPs
providing some Medicaid services, but
not providing LTSS or behavioral health
services, be recognized as more
integrated than plans that do not
provide any Medicaid services and
therefore be allowed additional
flexibility on the data elements D–SNPs
are required to share with the state.
Response: Section 1859(f)(8)(D)(i)(I) of
the Act is clear that D–SNPs that do not
(i) meet the requirements of a FIDE SNP
nor (ii) enter into a capitated contract
with the state Medicaid agency to
provide LTSS, behavioral health
services, or both, must meet additional
criteria for integration; CMS is
establishing those criteria in this final
rule. We are therefore unable to exempt
D–SNPs that do not meet the definitions
of either a FIDE SNP or a HIDE SNP
established in this final rule from the
notification requirement. We will
consider the utility of establishing
additional granularity with respect to
D–SNP integration levels but note that
such additional granularity is not
relevant to D–SNPs’ compliance with
the statutory provisions regarding D–
SNP integration.
Comment: One commenter requested
that CMS extend the proposed D–SNP
notification requirements to FIDE SNPs
and HIDE SNPs when the affected
member is not receiving all Medicaid
services through the SNP.
Response: We appreciate the
commenter’s suggestion to hold FIDE
SNPs and HIDE SNPs to the same
standard as other D–SNPs required to
comply with the notification
requirement for their unaligned
members. However, we believe that
most FIDE SNPs and HIDE SNPs already
demonstrate a level of MedicareMedicaid integration through the
provision of Medicaid benefits through
a capitated arrangement with the state
Medicaid agency, such that exchanging
admission data about specified high-risk
dual eligible enrollees would have less
impact relative to the costs of
compliance. We decline to accept the
commenter’s recommendation, as we
believe it would be burdensome for
plans that already provide a higher level
of integration than plans that provide
few or no Medicaid benefits to their
enrollees. As discussed in section
II.A.2.a.(1) of this preamble, we note
that FIDE SNPs and HIDE SNPs are also
required to coordinate their coverage
with their members’ Medicaid benefits.
Comment: Several commenters
supported our proposal at
§ 422.107(c)(2) that the contract between
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
the D–SNP and the state Medicaid
agency document not only the
categories of dual eligible individuals
who may enroll in the D–SNP but also
any additional criteria of eligibility.
Response: We appreciate the
commenters’ support and are finalizing
this provision without modification.
Comment: Several commenters
supported our proposed change to
§ 422.107(c)(3) that would require the
contract between the D–SNP and the
state Medicaid agency to document the
Medicaid services the D–SNP is
responsible for covering in accordance
with a capitated contract with the D–
SNP either directly or through a
companion Medicaid managed care
organization operated by the D–SNP’s
parent organization. One of these
commenters specifically noted that the
revised contract requirement may help
CMS achieve greater consistency in
determining whether a D–SNP is a FIDE
SNP or a HIDE SNP. A few commenters
recommended that the D–SNP’s state
Medicaid agency contract also include a
list of all Medicaid covered services, but
specifically identify those covered by
the D–SNP. One commenter
recommended that in cases where the
state Medicaid agency contract
encompasses all the requirements in
§ 422.107 as amended and already
clearly distinguishes between plan
covered and non-covered Medicaid
benefits, a separate document
duplicating this information should not
be required. Another commenter
requested clarification regarding the
intent of this provision, citing concerns
that CMS’ intent could be misconstrued
as requiring D–SNPs to offer Medicaid
benefits under a capitated contract with
the state.
Response: We thank commenters for
their support of this revised contracting
requirement for D–SNPs. We decline to
accept the recommendation that the
state Medicaid agency contract also
include a list of all Medicaid-covered
services, including those not covered by
the D–SNP or an affiliated MCO. We
believe this change to the current
contracting requirement will reduce
burden on D–SNPs to identify and
document in the contract every
Medicaid-covered service. D–SNPs often
submit to CMS a list of all Medicaid
services in their state Medicaid agency
contracts, even those for which the D–
SNP is not under a capitated contract
and for which the D–SNP bears no risk.
We clarify that our modified
requirement does not impact current
processes for state Medicaid agency
contract submission and approval. We
also clarify that this provision in no way
precludes a D–SNP that does not
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
provide any Medicaid services—and
otherwise meets all relevant regulatory
requirements—from continuing to
contract with CMS to operate as a D–
SNP. We are also simplifying the
language at § 422.107(c)(3) to ensure all
potential variations of D–SNP
contracting arrangements to cover
Medicaid services are documented in
the state Medicaid agency contract.
Specifically, we are revising the
requirement such that the D–SNP must
document any Medicaid benefits
covered by the MA organization offering
the D–SNP, whether under a capitated
contract with the state Medicaid agency,
by the D–SNP’s parent organization, or
by another entity that is owned and
controlled by its parent organization.
After consideration of the comments
we received, we are finalizing our
proposed amendments to § 422.107(b) as
proposed. We are finalizing our
proposed amendments to
§ 422.107(c)(1), (c)(2), (c)(3), (d) and
(e)(2) substantively as proposed but
with some minor modifications from the
proposal.
• We are making a technical, nonsubstantive change to replace the term
‘‘dual-eligible’’ with the term ‘‘dual
eligible’’ in paragraph (a), which is
consistent with the revision to the
section heading for § 422.107 in the
proposed and final rules.
• As discussed in section II.A.2.a.(1)
of this final rule, to better align with our
final definition of a D–SNP, we are
finalizing the regulation with a new
paragraph (c)(1)(i) to clarify that the D–
SNP must document its responsibility to
coordinate the delivery of Medicaid
benefits for individuals who are eligible
for such services, and a new paragraph
(c)(1)(ii) to clarify that, to the extent a
D–SNP provides coverage of Medicaid
benefits—including LTSS and
behavioral health services—for
individuals eligible for such services, it
must also document in the state
Medicaid agency contract its
responsibility to do so.
• As proposed with minor
grammatical corrections, we are
finalizing paragraph (c)(2) to require the
contract to document the categories and
criteria for eligibility for dual eligible
individuals to be enrolled under the
SNP, including as described in sections
1902(a), 1902(f), 1902(p) and 1905 of the
Act.
• We are finalizing paragraph (c)(3)
with revisions to clarify the requirement
of the contract such that the D–SNP
must document any Medicaid benefits
covered under a capitated contract
between the state Medicaid agency and
either: (1) The MA organization offering
the D–SNP; (2) the D–SNP’s parent
PO 00000
Frm 00039
Fmt 4701
Sfmt 4700
15717
organization; or (3) the another entity
that is owned and controlled by the D–
SNP’s parent organization.
In addition, as discussed in section
II.A.2.b.(2) of this final rule, we are
finalizing new text in a new paragraph
(c)(9) to address the requirement under
section 1859(f)(8)(C) of the Act that
contracts between D–SNPs that are
applicable integrated plans, defined in
§ 422.561, and the state Medicaid
agency require the use of unified
grievance and appeals procedures.
• We are finalizing paragraph (d) with
modifications to the regulatory text
clarifying the responsibility of a D–SNP
with the phrase ‘‘the SNP notifies or
arranges for another entity or entities to
notify . . .’’ in place of the proposed
text ‘‘the SNP will notify or authorize
for another entity or entities to notify
. . .’’ and making edits to clarify that
states can require D–SNPs to send
notification of an admission to the state,
individuals or entities designated by the
state, or both.
• Lastly, we are finalizing paragraph
(e)(2) as proposed and with a citation to
paragraph (c)(9) as well as paragraph (d)
to clarify that this state Medicaid agency
contracting requirement is applicable
beginning January 1, 2021.
(3) Conforming and Technical Changes
(§§ 422.60(g), 422.102(e), 422.107(b),
and 422.111(b)(2)(iii))
In the proposed rule, we also
proposed to make the following
conforming changes to several sections
of Part 422 that address D–SNPs by
adopting consistent terminology with
respect to dual eligible individuals and
creating cross-references to the newly
proposed definitions.
• First, at § 422.60(g), which
addresses CMS authority to implement
passive enrollment, we proposed to use
the term ‘‘highly integrated dual eligible
special needs plan’’ in place of text
referring to D–SNPs that meet a high
level of integration, consistent with our
proposed definition in § 422.2. As
discussed in the proposed rule, this
technical change would not materially
change the plan types that are eligible
for passive enrollment; the existing rule
simply refers to them as D–SNPs that
meet a high standard of integration
under the supplemental benefits
authority at § 422.102(e).
• Second, we proposed clarifying at
§ 422.102(e) that not only HIDE SNPs
meeting minimum quality and
performance standards are eligible to
offer supplemental benefits, but FIDE
SNPs that similarly meet minimum
quality and performance standards may
do so as well.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15718
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
• Third, in the general rule at
§ 422.107(b), we proposed to substitute
a ‘‘special needs plan serving
beneficiaries eligible for both Medicare
and Medicaid (dual-eligible)’’ with
‘‘dual eligible special needs plan.’’
• Finally, at § 422.111(b)(2)(iii),
which requires D–SNPs to provide
written information to dual eligible
enrollees about their eligibility for costsharing protections and Medicaid
benefits, we proposed to use the term
‘‘dual eligible special needs plan’’
consistent with the proposed definition.
We received the following comments
and our responses follow.
Comment: One commenter noted their
appreciation of our proposed
clarification at § 422.102(e) that both
FIDE SNPs and HIDE SNPs meeting
minimum quality and performance
standards are eligible to offer
supplemental benefits. Another
commenter requested that we clarify
that current flexibilities with respect to
supplemental benefits will continue for
all FIDE SNPs and HIDE SNPs. Several
commenters requested that CMS
provide additional guidance about the
supplemental benefits HIDE SNPs and
FIDE SNPs may offer, noting recent
regulatory changes that provide
flexibility in the Medicare Advantage
uniformity requirements and expand the
definition of ‘‘primarily health related’’
benefits, as well as new requirements in
the Bipartisan Budget Act of 2018 that
provide additional benefit flexibility for
chronically ill enrollees.
Response: We appreciate the
commenters’ support for the technical
change we proposed at § 422.102(e), and
we clarify that this conforming change
does not impact current policy related
to supplemental benefits for HIDE SNPs
and FIDE SNPs. While we appreciate
the complexities of recent legislative
and regulatory changes related to
permissible Medicare Advantage
supplemental benefits and the need for
clear guidance that several commenters
raised, those comments are outside the
scope of this regulation. For more
information regarding newly expanded
supplemental benefit offerings and
flexibilities for all MA plan types,
please refer to the CY 2019 and CY 2020
Call Letters.22 We are therefore
finalizing our changes to § 422.102(e) as
proposed.
After consideration of the comments
we received, we are finalizing
§ 422.102(e) without modification. We
received no comments on our proposed
conforming changes to § 422.60(g), the
22 See https://www.cms.gov/Medicare/HealthPlans/MedicareAdvtgSpecRateStats/
Announcements-and-Documents.html.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
general rule at § 422.107(b), and
§ 422.111(b)(2)(iii) and are also
finalizing those provisions without
modification.
(4) Eligibility of Partial-Benefit Dual
Eligible Individuals for Dual Eligible
Special Needs Plans
The preamble to our proposed rule
included discussion about an alternative
we considered to propose limits on the
enrollment of partial-benefit dual
eligible individuals in D–SNPs, since
there are no Medicaid services that the
D–SNP is integrating or coordinating on
their behalf. While we ultimately
decided against proposing any such
limits on enrollment in the proposed
rule, we invited comments on this topic.
We received the following comments,
and our responses follow.
Comment: Several commenters
suggested that CMS establish
prohibitions on the enrollment of
partial-benefit dual eligible individuals
in D–SNPs. A few commenters
suggested establishing separate D–SNPs
exclusively for partial-benefit dual
eligible individuals whose primary
focus would not be on integrating
Medicare and Medicaid benefits but
rather on caring for a more complex
population than a traditional MA plan.
MedPAC opined that D–SNPs can do
little to promote greater integration for
partial-benefit dual eligible individuals
and noted that, based on their analysis
of person-level quality data from HEDIS,
D–SNPs perform about the same as
regular MA plans for this population.
MedPAC noted the greater likelihood of
D–SNPs offering supplemental benefits
attractive to partial-benefit dual eligible
individuals than other MA plans.
Consistent with its June 2018 report to
the Congress and at its November 2018
meeting, the Commission described two
potential ways of pursuing greater levels
of integration: (1) Limiting enrollment
in D–SNPs to dual eligible individuals
who qualify for full Medicaid benefits or
(2) requiring MA plan sponsors to have
separate D–SNPs (distinct plan benefit
packages) for full-benefit and partialbenefit dual eligible individuals.
A number of commenters opposed
any limits on the enrollment of partialbenefit dual eligible individuals in D–
SNPs, however. These commenters cited
various rationales for the value of these
beneficiaries’ enrollment in D–SNPs,
including the relative medical
complexity of partial-benefit dual
eligible individuals compared to nondual eligible individuals; the value of
the D–SNP care model, including
additional care coordination, Medicare
benefits, navigation assistance,
individual health risk assessments, care
PO 00000
Frm 00040
Fmt 4701
Sfmt 4700
plans, and interdisciplinary care teams;
the propensity for churn between
various dual eligibility categories and
the value of D–SNPs in facilitating
movement to full benefit dual eligibility
status; and the potential for additional
value for this population through new
supplemental benefits flexibilities
implemented by CMS that might
prevent the need for medical spenddown to full benefit dual eligibility
status. Several commenters
recommended that CMS defer to states
on defining eligibility requirements for
D–SNPs. Another commenter noted that
Congress did not explicitly instruct
CMS to prevent partial-benefit dual
eligible individuals from accessing D–
SNPs. One commenter noted the
variance in eligibility requirements for
partial-benefit dual eligibility across
states. One commenter recommended
that CMS consider administrative
changes to resolve the complexities
related to integration presented by this
population—for example for member
materials and appeals and grievances.
A few commenters requested that, to
the extent CMS continues to permit the
enrollment of partial-benefit dual
eligible individuals in D–SNPs, D–SNPs
should be required to show how they
will meet the needs of these enrollees a
way that is distinct from the benefits
that a non-D–SNP MA plan would offer,
and that CMS measure and evaluate
these additional benefits. These
commenters also recommended that
CMS place marketing restrictions on D–
SNPs so they cannot primarily target
partial-benefit dual eligible individuals,
who may have lower acuity and less
significant health care needs than fullbenefit dual eligible individuals, and to
carefully monitor enrollment patterns.
Response: We thank the commenters
for the feedback on this issue. As we
stated in the proposed rule, we continue
to question the benefit that partialbenefit dual eligible individuals derive
from their enrollment in a D–SNP
relative to the challenges associated
with allowing such enrollment.
Although we did not propose, and
therefore are not finalizing, any changes
to how partial-benefit dual eligible
individuals may enroll in D–SNPs, we
share many of the concerns articulated
by some comments, including those of
MedPAC. CMS may consider future
rulemaking in this area.
Comment: A commenter pointed to
the definition of a D–SNP in the statute
as limiting enrollment to only those
‘‘special needs individuals who are
entitled to medical assistance under a
State plan under XIX of the Act’’ and
requested confirmation from CMS that
we discontinue enrollment of partial-
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
benefit dual eligible individuals in D–
SNPs when there is no Medicaid benefit
they can coordinate for those enrollees.
Response: We note that neither the
MA statute nor current MA regulations
prohibit the enrollment of partialbenefit dual eligible individuals in D–
SNPs, although states may choose to do
so through their contracts with D–SNPs.
We are not finalizing any change in that
policy in this final rule.
Comment: A commenter
recommended that CMS consider
granting eligibility for Qualified
Medicare Beneficiaries to enroll in MAonly D–SNPs and requested that
reimbursement rates for such enrollees
be structured to accurately reflect the
resources needed to adequately provide
care to such complex populations.
Response: We note that these
comments are somewhat outside the
scope of our proposed rule. Further, D–
SNPs must provide Part D prescription
drug coverage, pursuant to § 422.2, as
part of a comprehensive Medicare
benefit package; therefore, D–SNPs may
not offer MA-only coverage. In response
to concerns about the accuracy of the
CMS-Hierarchical Condition Category
(HCC) risk adjustment model for
predicting costs of dual eligible
individuals, CMS analyzed how well
the model performs for various types of
beneficiaries. As a result of this
analysis, CMS implemented significant
changes to the HCC model in CY 2017.
(5) Suspension of Enrollment for NonCompliance with D–SNP Integration
Standards (§ 422.752)
Section 50311(b) of the Bipartisan
Budget Act of 2018 amended section
1859(f) of the Act by creating a new
paragraph (8)(D)(ii) to permit the
Secretary, for plan years 2021 through
2025, to impose an intermediate
sanction of stopping all new enrollment
into a D–SNP if the Secretary
determines that the D–SNP is failing to
comply with the integration
requirements set forth in section
1859(f)(8)(D)(i) of the Act. We proposed
to amend § 422.752 by adding a new
paragraph (d) to require CMS to impose
an enrollment suspension when CMS
finds that the plan is non-compliant
with the integration requirements
during plan years 2021 through 2025,
rather than initiating outright
termination. We stressed in the
proposed rule that we interpreted this
proposal as leaving discretion for CMS,
if the D–SNP does not submit an
acceptable corrective action plan or fails
to abide by the correction action plan,
to determine that contract termination
or other enforcement action or sanction
could also be imposed. In addition, in
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
the event that any harm to enrollees is
imminent, we explained how we would
retain authority to immediately
terminate the contract. We also
proposed in § 422.752(d) that the
suspension of enrollment would
continue in effect until CMS is satisfied
that the deficiencies that are the basis
for the sanction determination have
been corrected and are not likely to
recur. We stated that the procedures,
remedies, and appeal rights available to
plans subject to intermediate sanctions
provided in § 422.756 apply to D–SNPs
that are sanctioned under this new
authority.
Comment: Several commenters
supported CMS’ interpretation of the
statute to impose an intermediate
sanction to suspend enrollment instead
of an immediate contract termination for
D–SNPs that fail to meet the integration
standards by contract year 2021. A few
commenters requested that CMS
consider not penalizing D–SNPs when
state decisions impede integration or the
state does not have the interest and
capacity to facilitate D–SNP compliance
with the integration requirements. Some
commenters recommended that CMS
evaluate the implementation of these
sanctions in order to make
recommendations on how CMS should
sanction D–SNPs that do not meet the
integration standards beyond 2025.
Another commenter provided
recommendations, summarized
elsewhere in final rule, on how CMS
can support and incentivize states to
move toward integration.
One commenter agreed with CMS’
position that non-compliance with the
integration standards should not lead
directly to contract termination but
noted that the enrollment sanction is at
the discretion of CMS. The commenter
recommended that CMS not
immediately impose an enrollment
sanction for minor compliance issues
around the integration requirements
and, rather, only impose an enrollment
sanction for non-compliance that is a
serious threat to the health and safety of
Medicare beneficiaries and let lesser
violations be handled through other
compliance actions (notices of noncompliance, corrective action plans, and
civil monetary penalties).
Response: We appreciate the overall
support for our proposal to require CMS
to impose an enrollment suspension
when we find a D–SNP to be out of
compliance with the integration
requirements in the final rule during
plan years 2021 through 2025. We
disagree with the commenter urging us
adopt a standard for imposing an
intermediate sanction based only on
whether a D–SNP’s integration approach
PO 00000
Frm 00041
Fmt 4701
Sfmt 4700
15719
is a serious threat to the health and
safety of its enrollees. As we discussed
in the preamble to the proposed rule, by
establishing statutory requirements that
established a minimum level of
integration of D–SNPs in section 50311
of the Bipartisan Budget Act of 2018, we
believe the goal was for beneficiaries
enrolled in D–SNPs to receive a greater
level of integration of Medicare and
Medicaid benefits than is the case under
current regulations. Because the
Bipartisan Budget Act of 2018 limited
the applicability of the Secretary’s
authority to impose an intermediate
sanction on plans that do not comply
with the integration requirements to
plan years 2021 through 2025, we
believe that the intent of this provision
is to offer an alternative to outright
contract or plan termination for D–SNPs
that fail to meet the new integration
requirements during the period of 2021
through 2025. With respect to
commenters’ concerns about penalizing
plans, we note that since the authority
to impose the intermediate sanction is
specific to a D–SNP’s non-compliance
with the Medicare and Medicaid
integration standards finalized in this
rule, we intend to consider whether
imposition of intermediate sanctions
would be most appropriate at the plan,
rather than contract, level for each
affected Medicare Advantage
organization. We expect such
determinations to be tied to the facts of
each specific situation.
In addition to authorizing this lesser
sanction, the statute requires a
corrective action plan, which we believe
strengthens our interpretation, as it
illustrates a preference for ultimate
compliance by D–SNPs with the
integration requirements. The statute
authorizes this lesser sanction but does
not require that it be used, leaving it to
our discretion whether an enrollment
sanction combined with a corrective
action plan is sufficient to achieve the
goals of the statute. We believe that
imposing an intermediate sanction to
suspend enrollment establishes
predictability for states, beneficiaries,
and MA organizations by requiring its
imposition for non-compliant plans in
lieu of termination or other actions.
CMS retains discretion—for example, if
the D–SNP does not submit an
acceptable corrective action plan or fails
to abide by the corrective action plan—
to determine that contract termination
or other enforcement action or sanction
is still possible. In addition, in the event
circumstances warrant—for example,
when any harm to beneficiaries is
imminent—we retain authority to
immediately terminate the contract. We
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15720
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
are therefore finalizing our proposal on
intermediate sanctions without
modification.
As discussed elsewhere in this final
rule, CMS is committed to working with
stakeholders and providing technical
assistance and additional guidance to
states and D–SNPs to facilitate
compliance with the integration
requirements in this final rule. We will
evaluate application of our sanction
authority and consider any additional
changes or clarifications, including with
respect to sanctions for those D–SNPs
that fail to meet the integration
requirements for plan years after 2025.
Comment: One commenter
recommended that CMS’ imposition of
sanctions be delayed until 2023 to
accommodate necessary contracting and
systems changes. This commenter also
recommended that CMS impose
sanctions only in states where the state
Medicaid agency has successfully
integrated with other D–SNPs using the
specific integration standards the state
has selected. Another commenter urged
CMS to consider the integration
standards to be met, and an enrollment
sanction not required, if the notification
language requirement discussed in
section II.A.2.a.(2) of this final rule is in
the state Medicaid agency contract in
2021, even if not implemented until
2022.
Response: The Bipartisan Budget Act
of 2018 specifically allows for the
imposition of any enrollment sanctions
related to non-compliance with the D–
SNP integration standards established in
this final rule be applied with respect to
plan years 2021 through 2025. In
addition, we note that the Bipartisan
Budget Act of 2018 requires all D–SNP
integration criteria established by CMS
to be effective starting for the 2021 plan
year. The timing for the publication of
the provisions set forth in this final rule
in the allows D–SNPs ample
opportunity to negotiate with states and
address issues requiring changes in the
state Medicaid agency contracts prior to
the start of the 2021 plan year.
Therefore, solely including the
notification requirement language in a
D–SNP’s state Medicaid agency contract
without implementing the process as
required by that state would render a D–
SNP out of compliance with
§ 422.107(d).
After consideration of the comments
we received, we are finalizing our
proposal regarding CMS’ imposition of
intermediate sanctions for noncompliance with D–SNP integration
standards without modification.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
b. Unified Grievance and Appeals
Procedures for Dual Eligible Special
Needs Plans and Medicaid Managed
Care Plans at the Plan Level
(§§ 422.560–562, 422.566, 422.629–634,
438.210, 438.400, and 438.402)
Section 1859(f)(8)(B) of the Act, as
added by the Bipartisan Budget Act of
2018, directs the Secretary to establish
new procedures that unify, to the extent
feasible, Medicare and Medicaid
grievance and appeals procedures for D–
SNPs. This new authority provides an
important opportunity to address an
area of longstanding misalignment
between the Medicare and Medicaid
programs. Medicare and Medicaid
grievance and appeal processes have
developed independently and operate
entirely separately. Medicare’s fee-forservice appeals processes (authorized
primarily under section 1869 of the Act
for Part A and B claims appeals), and
MA’s processes (authorized under
sections 1852(f) and 1852(g) of the Act
for grievance and appeal processes) are
subject only to federal regulation and
oversight as part of the federallyadministered Medicare program.
Medicaid grievances and appeals are
authorized under sections 1902(a)(3)
and 1902(a)(5) of the Act for Medicaid
programs more generally and section
1932(b)(4) of the Act for Medicaid
managed care plans. Unlike Medicare
and MA, Medicaid appeals and
grievance procedures are subject to both
federal and state regulation and are
primarily subject to state oversight and
administration as part of a joint federalstate financed program. Medicare Part D
grievances and appeals are authorized
under sections 1860D–4(f) and (g) of the
Act and are outside the scope of our
authority to unify grievances and
appeals under new section 1859(f)(8)(B)
of the Act; we note, however, that D–
SNPs are all required to provide Part D
prescription drug coverage pursuant to
§ 422.2 (in the definition of a
specialized MA plan for special needs
individuals), and are therefore subject to
the Part D appeals requirements in
connection with Part D benefits.
Both the Medicare and Medicaid
grievance and appeals systems include
regulations establishing procedures for
the fee-for-service programs as well as
regulations governing managed care
plans, including processes at the plan
and post-plan levels for adjudicating
appeals. Medicare rules are found at 42
CFR part 405 subpart I (general) and
part 422 subpart M (Medicare
Advantage); Medicaid rules are at 42
CFR part 431 subpart E (general) and
part 438 subpart F (managed care).
Regulations for the Medicare and
PO 00000
Frm 00042
Fmt 4701
Sfmt 4700
Medicaid programs take broadly similar
approaches to managed care appeals in
that both programs establish a process
for resolving a dispute at the plan level
initially, followed by an opportunity for
post-plan review. However, these
appeals systems operate independently
with sometimes subtle but important
differences related to notices,
adjudication timeframes, availability of
benefits continuing while the appeal is
pending, and levels of review. Similarly,
regulations for the Medicare and
Medicaid programs take different
approaches with respect to some
processes for grievances, including
filing and adjudication timeframes and
the availability of an expedited
grievance process.
Although comparatively few
beneficiaries file grievances or
appeals,23 these processes are vital
safeguards to ensure that beneficiaries’
concerns and needs are met promptly.
Because of Medicare and Medicaid’s
misalignments in this area, beneficiaries
who are dually eligible for Medicare and
Medicaid can face a confusing array of
choices when they seek to file a
grievance or appeal. They may not know
whether their complaint is tied to
Medicare or Medicaid, and thus may not
know where to direct their grievance.
They may be uncertain if the item or
service they seek is covered by
Medicare, by Medicaid, or potentially
by both programs, and thus may not
know when or where to file an appeal
following the denial of a service. The
issue is particularly complicated for
items and services such as home health
and certain durable medical equipment
that are sometimes covered by both
programs but under different
circumstances.
This confusion for beneficiaries and
for those assisting them can result in
costly and inefficient duplication of
effort, as beneficiaries may file
grievances and appeals under both
programs when only one was necessary.
Health plans and federal and state
agencies may incur additional burdens
and costs from having to administer
parallel appeals systems. Finally, these
misalignments may lead to unintended
harms in the form of delayed or denied
access to needed services as
beneficiaries expend time and energy
pursuing ultimately fruitless appeals in
23 For example, in 2016, Medicare Part C plans
reported 2.93 complaints (grievances) per 1,000
enrollees per month and 19.3 reconsideration
requests (appeals) per 1,000 enrollees per month.
See Analysis of Calendar Year 2016 Medicare Part
C Reporting Requirements Data, available at https://
www.cms.gov/Medicare/Prescription-DrugCoverage/PrescriptionDrugCovContra/
PartCDDataValidation.html.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
one program when they should have
been pursuing them in the other.
As summarized in our proposed rule,
we have made previous efforts to better
align Medicare and Medicaid grievances
and appeals for dual eligible
individuals, including the integrated
initial level of appeal in the Programs of
All-inclusive Care for the Elderly
(PACE). The operation of MedicareMedicaid Plans (MMPs) in the CMS’
Financial Alignment Initiative capitated
model demonstrations has provided us
with the most extensive experience
integrating grievances and appeals for
dual eligible individuals in the managed
care setting. Our experience with MMPs
suggests that, although implementing a
new system can be challenging, once in
operation, integrated grievance and
appeals systems can be simpler for
beneficiaries to navigate than separate
systems for Medicare and Medicaid.
Under the newly enacted
amendments to section 1859(f)(8)(B) of
the Act, the Secretary is required to
establish, not later than April 2020 and
for inclusion in contracts for D–SNPs for
2021 and subsequent years, procedures
unifying grievances and appeals
procedures consistent with several
principles:
• Under paragraph (8)(B)(ii), the new
unified procedures must include
provisions that are most protective for
the enrollee and, to the extent feasible
as determined by the Secretary, are
compatible with unified timeframes and
consolidated access to external review.
The statute requires that the procedures
take into account differences under state
Medicaid plans, and be easily navigable
by enrollees.
• Additionally, under paragraph
(8)(B)(iii), the integrated processes
implemented are required to include a
single written notice that includes all
relevant grievance and appeal rights; a
single pathway for resolution of covered
items and services; notices written in
plain English and available in languages
and formats that are accessible to
enrollees (including in non-English
languages that are prevalent in the
service area of the specialized MA plan);
unified timelines for processes such as
filing, acknowledging, and resolving the
appeal or grievance; and requirements
for plans to process, track, and resolve
the grievances and appeals to ensure
enrollees are notified timely of
decisions and can track the status of
their grievance or appeal.
• Finally, under paragraph (8)(B)(iv),
new grievance and appeals procedures
must, with respect to all benefits under
Medicare Parts A and B and Medicaid
subject to appeal under such
procedures, incorporate provisions
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
under current law and implementing
regulations that provide continuation of
benefits pending appeal under Title
XVIII and Title XIX. We address this
statutory provision in section
II.A.2.b.(7).
Using this statutory framework, we
developed the following goals to guide
development of the unified grievance
and appeals provisions:
• Adopt provisions that are most
protective of the enrollee;
• Reduce burden on beneficiaries
(and those assisting them), plans, states,
and providers; and
• Maintain state flexibility and
minimize disruption by building on
existing rules and policies.
These policy goals also reflect our
belief that timely, efficient, accessible,
and well-functioning grievance and
appeals systems are critical to ensuring
that beneficiaries have access to needed
items and services. Such systems are
especially vital for dual eligible
individuals who typically lack financial
resources that might enable other
beneficiaries to pay out-of-pocket for
needed items or services while a dispute
is pending. We requested comments
regarding these policy goals and the
extent to which the proposed
regulations are consistent with them.
Our policy goal of minimizing
disruption was also informed by
statutory language directing the
Secretary to establish unified provisions
to the extent feasible (section
1859(f)(8)(B)(i) of the Act). Consistent
with this statutory standard, we
primarily proposed incremental changes
that are currently feasible, conform to
other current law, and build upon
existing systems.
Our proposals under the notice of
proposed rulemaking were divided into
three substantively different types:
• First, we proposed to establish
requirements for all D–SNPs, relative to
the role they play in assisting fullbenefit dual eligible individuals, to
assist with Medicaid-related coverage
issues and grievances (§ 422.562(a)).
• Second, we proposed new
requirements in accordance with section
1859(f)(8)(B) of the Act to create
integrated grievance and appeals
systems for a limited subset of D–SNPs
(‘‘applicable integrated plans’’),
identified using terms and concepts we
propose to define in amendments to
§ 422.561, with the integrated processes
established by proposed new
regulations (§§ 422.629–422.634).
• Finally, we proposed a number of
changes of a technical and conforming
nature to existing provisions in parts
422 and 438 (§§ 422.560, 422.562,
PO 00000
Frm 00043
Fmt 4701
Sfmt 4700
15721
422.566, 438.210, 438.400, and
438.402).
Section 1859(f)(8)(B)(i) of the Act
requires the Secretary to establish
unified grievance and appeals
procedures for D–SNPs not later than
April 2020, and section 1859(f)(8)(C) of
the Act requires the use of these unified
procedures in D–SNP contracts for 2021
and subsequent years. The statute does
not, however, explicitly rule out the
possibility of implementing such
unified processes prior to 2021. As
discussed in the proposed rule, we
interpret the statute as permitting a state
to adopt unified grievance and appeals
processes for integrated D–SNPs and
Medicaid plans in that state consistent
with our final regulations on this topic
starting as soon as the regulations
establishing such procedures are final.
Such a state could require establishment
of unified appeals and grievance
procedures consistent with CMS’
regulations in its Medicaid agency
contract required under § 422.107. We
solicited comments on this
interpretation of the statutory
implementation date requirements and
our proposal to make unified
procedures available to states in this
way before 2021.
In this final rule preamble, we
summarize at a high level our specific
proposals for the unified appeals and
grievance processes; we direct readers to
the proposed rule, 83 FR 55003 through
55013, for more detailed discussion of
the proposals and our rationale for
them. We received a number of
comments on our proposals to
implement these unified appeals and
grievance procedures, both in general
and with regard to specific proposals,
and summarize the general comments as
follows:
Comment: We received numerous
comments in support of our proposal for
unified plan-level appeals and grievance
processes. Many commenters supported
our stated policy goals and agreed that
the proposed regulations were
consistent with those goals. Several
commenters expressed support for our
policy principle of choosing the most
beneficiary-friendly appeals processes
and protections where there is a
discrepancy between Medicare and
Medicaid rules. Many commenters
noted the current misalignment of
administrative and operational process
for beneficiaries and plans in the
Medicare and Medicaid appeals
processes, which confuses enrollees and
reduces access to benefits, and
appreciated that our proposed appeals
and grievance processes begin to
address some of these misalignments
through a unified system that is clearer
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15722
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
and easier to navigate for enrollees. One
commenter expressed concern that
requiring D–SNPs, which typically also
offer other non-D–SNP MA–PD plans, to
administer two separate grievance and
appeal procedures is overly
burdensome. One commenter noted that
it may not be possible to implement the
unified appeals and grievance processes
in states with consent decrees that limit
plan-level appeals.
Response: We appreciate the broad
support both for unified appeals and
grievance processes and for the policy
goals underlying our proposed process.
We agree with those commenters who
stated that the unified processes will be
clearer and easier to navigate for
enrollees. We expect the unified
processes to apply to a relatively small
subset of D–SNPs and states. We note
that, with respect to the concern about
the burden of D–SNPs administering
separate grievance and appeals
processes, D–SNPs that contract to
provide Medicaid benefits, including
applicable integrated plans that must
comply with the unified appeal
processes addressed in this rule,
currently administer two separate
processes—one for Medicare and one for
Medicaid—in addition to complying
with specific appeal requirements for
Part D benefits. Under the unified
approach we are finalizing, integrated
applicable plans will only administer
one process for all non-Part D benefits.
Thus, while we understand that there
may be some administrative burden in
setting up the new system, we believe
that once the system is set up, it should
be more efficient for applicable
integrated plans to administer than the
current system. We note that drugs
covered by Medicare Part D will
continue to be processed under the
separate Part D appeals system in 42
CFR part 423. Appeals related to nonPart D drugs covered by Medicaid for
dual eligible individuals will go through
the unified appeals process as outlined
in this final rule for applicable
integrated plans, described later in this
final rule. We therefore do not believe
there will be additional burden for
applicable integrated plans. We also
note that we will accommodate state
circumstances, as needed and possible,
including where a state currently
operates under a consent decree.
Comment: A number of commenters
noted the need for CMS to work closely
with states and other stakeholders
where these unified processes will be
implemented to ensure a smooth
implementation and transition for
enrollees and set clear expectations for
applicable integrated plans. Some
commenters also noted the need for
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
CMS to release additional guidance
prior to the implementation date and to
communicate the process clearly to
enrollees. Several commenters
requested that we issue subregulatory
guidance specifically addressing the
following topics: Allowing enrollees to
raise secondary impact on health based
on the financial hardship of paying for
services that were not initially covered
in post-service payment cases, repeat
grievances, and processing prescription
drug appeals in the unified processes. A
commenter requested additional
information on state regulations that
may need to change in order for the
unified processes to be implemented.
Several commenters also recommended
that CMS review best practices and
lessons learned in the Financial
Alignment Initiative to inform
implementation of unified processes for
D–SNPs. One commenter questioned
how states will react to implementing
these requirements. Another commenter
noted that any new process will
produce new confusion among
beneficiaries.
Response: We appreciate the
commenters’ concerns and anticipate
issuing subregulatory guidance to
further clarify the unified processes. As
discussed throughout this preamble, we
expect to continue to engage states,
plans, and other stakeholders as we
implement the requirements in this final
rule, including providing technical
assistance to states, disseminating best
practices (including from MMPs
participating in the Financial Alignment
Initiative), and issuing additional
subregulatory guidance and model
enrollee communications to ensure a
smooth implementation and to reduce
any potential enrollee confusion. We
also note that, for most states that will
be implementing this new unified
process, this final rule allows CMS 18
months prior to the January 1, 2021,
implementation date to work with
states, plans, and other stakeholders to
ensure a smooth implementation.
Comment: One comment noted the
importance of provider-neutral language
in the proposed rule, which is
consistent with the statutory language
and recognizes the important variety of
providers that serve enrollees in
Medicare and Medicaid.
Response: We appreciate the
commenter’s support of our use of the
term ‘‘provider’’ in the proposed rule
and note that we are maintaining the
use of this term in the final rule.
Comment: One commenter observed
that there is no mention of the grievance
and appeals processes for network
providers, noting the lack of a process
for network providers under existing
PO 00000
Frm 00044
Fmt 4701
Sfmt 4700
contract terms with managed care plans
and expressing concerns about potential
retaliation from managed care plans for
filing appeals or complaints. The
commenter urged us to develop a
process for network providers to file
appeals and grievances and ensure that
network provider concerns are heard by
states and CMS.
Response: The unified process
addressed in this final rule is for
coverage decisions made by the D–SNPs
and the affiliated Medicaid managed
care plans with exclusively aligned
enrollment. As is the case under MA
rules, disputes between network
providers and the applicable integrated
plans are governed by their contracts
with plans. Some states do provide
external processes for Medicaid network
providers, and these processes will
remain available for Medicaid-related
plan-provider disputes. In addition,
providers can file complaints with CMS
through the Complaint Tracking Module
to raise issues and concerns to CMS’
attention.
Comment: One commenter requested
that we include supplemental benefits
and long-term services and supports
(LTSS) in the unified grievance and
appeals processes, similar to the current
process in the Cal MediConnect
Financial Alignment Initiative
demonstration.
Response: We clarify that any LTSS or
supplemental benefits covered by
applicable integrated plans will subject
to the unified grievance and appeals
processes we are finalizing in this rule,
with the exception that MA
supplemental benefits are not subject to
the continuation of benefits pending
appeal process finalized at § 422.632 in
this rule. Continuation of benefits
pending appeal under § 422.632(b) is
available only for ‘‘benefits under Parts
A and B of title XVIII and title XIX.’’
Please see section II.A.2.b.(7) of the
proposed and final rules for more
discussion of this issue.
Comment: Several commenters
requested clarification on the impact of
the unified grievance and appeals
processes on applicable integrated
plans’ Star Ratings. A commenter
recommended a grace period to mitigate
this impact, and another recommended
that we move the measures to the
display page during the transition to the
new processes. Another commenter
requested more information on appeals
and grievance reporting processes. One
commenter requested that we make
timely plan-specific grievance and
appeals data available to the public.
Response: These comments are not
strictly within the scope of our final rule
provisions establishing unified
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
grievances and appeals processes. We
note, however, that we do not expect
Star Ratings to be negatively impacted
by the unified grievance and appeals
processes. The Star Ratings measures
focus on how timely the MA plan sends
the case to the IRE when the plan
upholds its initial adverse organization
determination and whether the plan’s
decision was upheld at the IRE. Under
§§ 422.590(d)(4) and 422.592, if, upon
reconsideration, an MA plan upholds its
initial adverse organization
determination, it must submit the case
file and its decision to the IRE for
automatic review. Under the unified
appeals process, rules governing
submission of case files to the IRE when
a plan upholds its initial adverse
organization determination are
unchanged (see § 422.634(b)). We expect
that an applicable integrated plan could
in fact see a reduction in cases where
the IRE reverses the applicable
integrated plan’s integrated
reconsideration determination for cases
where Medicare and Medicaid benefits
overlap, since the applicable integrated
plan may approve the service or item
under Medicaid coverage and not have
to issue a denial under Medicare. The
applicable integrated plans should then
have fewer cases to auto-forward to the
IRE, and thus fewer cases that that the
IRE could overturn and negatively
impact the plan’s Star Ratings.
Comment: One commenter urged
CMS to reconcile and align
requirements across multiple proposals
aimed at reducing administrative
burdens on plans and beneficiaries,
including those that appeared in the
proposed rule and in other proposals
related to MA and step therapy for Part
B drugs.
Response: We appreciate this
feedback and agree that internal
consistency is an important
consideration in reducing
administrative burden and has been a
priority throughout this rulemaking
process.
Comment: A commenter
recommended that we extend our
enrollee communications requirements
to integrate all member-facing materials.
Response: We appreciate the
suggestion. However, the requirements
of section 1859(f)(8)(B)(iii) of the Act
apply only to notices required under the
unified appeals and grievance
processes. We are therefore not
implementing requirements for other
notices in this final rule. However, as
discussed elsewhere in this final rule,
the Medicare-Medicaid Coordination
Office is working to improve and
consumer test a variety of beneficiary
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
communications materials geared
toward D–SNP and MMP enrollees.
(1) Assisting With Medicaid Coverage
Issues and Grievances (§ 422.562(a)(5))
As an incremental step towards
improving all D–SNP enrollees’
experiences with accessing Medicaid
benefits, and pursuing grievances and
appeals, we proposed new regulation
text to require all D–SNPs to assist
beneficiaries with Medicaid coverage
issues and grievances, including
authorizations for or appeals related to
Medicaid-related services at § 422.562
by adding a new paragraph (a)(5). As
discussed in the proposed rule, these
new requirements are consistent with
our existing guidance and expectations
for D–SNPs, but we proposed
regulations to define their scope and set
mandatory standards to which we can
hold D–SNPs accountable. We believe
that all D–SNPs should assist enrollees
with resolving Medicaid coverage
problems, including assistance with
filing grievances, requesting coverage,
and requesting appeals. Such assistance
is consistent with the standard we
proposed as part of the definition of a
D–SNP at § 422.2. As noted in section
II.A.2.a.(1) of the proposed rule and this
final rule, we are codifying the statutory
requirement at section 1859(f)(3)(D) of
the Act that D–SNPs arrange for their
enrollee’s Medicaid benefits as an
explicit requirement that D–SNPs
coordinate the delivery of Medicare and
Medicaid services for individuals who
are eligible for such services, whether or
not the D–SNP itself contracts with the
state to provide Medicaid services. We
clarified in the proposed rule that the
requirements at § 422.562(a)(5) were
additional requirements for D–SNPs,
specifically related to assisting with
access to benefits, appeals, and
grievances. At § 422.562(a)(5), we
proposed to supplement the obligation
to provide, as applicable, and
coordinate Medicaid benefits by adding
a requirement that when a D–SNP
receives an enrollee’s request for
services, appeal, or grievance related to
Medicaid-covered services (regardless of
whether such coverage is in Medicaid
fee-for-service or a Medicaid managed
care plan, such as a Medicaid MCO,
PIHP, or PAHP as defined in § 438.2),
the D–SNP must provide a certain level
of assistance to the enrollee.
In new paragraph (a)(5)(i), we
proposed to describe the types of
assistance we would require all D–SNPs
to provide to their enrollees regarding
Medicaid-related coverage issues and
grievances, including authorization of
services and appeals. We proposed in
paragraph (a)(5)(i) to include assistance
PO 00000
Frm 00045
Fmt 4701
Sfmt 4700
15723
for all D–SNP enrollees, regardless of
the type of Medicaid coverage in which
they are enrolled.
Our proposed regulation at
§ 422.562(a)(5)(i) included a list of
illustrative examples, at paragraphs
(5)(i)(A) through (5)(i)(C), which we did
not intend to be an exhaustive list of
how a D–SNP would be required to
comply with the assistance obligation in
§ 422.562(a)(5)(i).
• In paragraph (a)(5)(i)(A), we
addressed explaining to a D–SNP
enrollee how to request Medicaid
authorization and file an appeal. Our
proposed regulation text included
examples of the type of assistance we
expect D–SNPs to provide to their
enrollees when the enrollees need
information and explanations about
obtaining Medicaid services. We
proposed, in paragraphs (5)(i)(A)(1)
through (5)(i)(A)(3), examples of the
types of assistance that a D–SNP must
offer, and upon acceptance or request,
provide its enrollees, such as specific
instructions on how to contact the entity
that may cover the service (for example,
the Medicaid managed care plan or a
contact in the fee-for-service system),
and assistance in obtaining and filling
out forms necessary for the next steps in
the process.
• In paragraph (a)(5)(i)(B), we
proposed that D–SNPs provide
assistance in the actual filing of
grievances and appeals. We requested
comments regarding this proposal; in
particular, we requested comments
regarding how D–SNPs that do not have
aligned enrollment would comply with
this requirement when such entities
might have financial and clinical
responsibility for the disputed services,
potentially presenting a conflict of
interest.
• In paragraph (a)(5)(i)(C), we
proposed that the D–SNP assist the
enrollee in obtaining documentation in
support of a request for authorization or
appeal.
We explained how the examples
listed in proposed paragraphs
(a)(5)(i)(A) through (C) were not
intended to be an exhaustive list, but
rather were meant to provide some
leading examples of the assistance we
believe any D–SNP should provide. We
invited comments on this proposal,
specifically whether the regulation text
was clear enough that the examples are
not an exhaustive list of methods of
assistance that the D–SNP must offer its
enrollees, as well as suggestions for
other examples of assistance that we
should include in regulation or address
in subsequent subregulatory guidance.
We also solicited suggestions for
additional examples of assistance, as
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15724
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
well as comments on challenges D–
SNPs and others envision in
implementing the provisions of
proposed paragraph (a)(5). In addition,
we acknowledged potential challenges
D–SNPs may face because Medicaid
systems vary by state.
We also proposed language related to
enrollees accepting the offer of
assistance in proposed paragraph
(a)(5)(i). In our proposal, the only
obligation on D–SNPs is to offer
assistance and, when a request is made
or an offer of assistance is accepted, to
provide it. We requested comments on
whether the regulation text, as we
proposed it, was the best way to achieve
this goal.
In paragraph (a)(5)(ii), we proposed to
specify that the D–SNP’s obligation to
offer assistance arises whenever the D–
SNP becomes aware of an enrollee’s
need for a Medicaid-covered service.
Our proposal included text explicitly
clarifying that enrollees do not need to
make a specific request to their D–SNP
for assistance. As we stated in the
preamble to the proposed rule, if the
issue comes to the attention of the D–
SNP, we would expect the plan to offer
to assist the enrollee in resolving the
coverage issue(s) or grievance given the
D–SNP’s responsibility, consistent with
our proposed definition of a D–SNP at
§ 422.2, that such a D–SNP provide, as
applicable, and coordinate the delivery
of Medicare and Medicaid services for
its enrollees. We requested comments
on whether we should include such
explicit direction to D–SNPs in the
regulation to identify issues that an
enrollee is having, or whether our
proposed regulation text was
sufficiently clear that D–SNPs will
understand and meet our goal of
providing assistance to an enrollee such
that the enrollee can access benefits
regardless of whether the benefit is
covered by Medicare or Medicaid. We
clarified that we were not proposing any
new requirements related to assistance
with Medicare covered services or
services for partial-benefit dual eligible
enrollees. We requested comments
regarding the provisions at proposed
§ 422.562(a)(5)(ii) and the need for any
further clarification limiting the scope
of § 422.562(a)(5) to full-benefit dual
eligible individuals.
In paragraph (a)(5)(iii), we proposed
to provide further detail on the methods
of assistance required by proposed
paragraph (a)(5)(i). The methods we
proposed in the regulation were
intended to be examples of what a D–
SNP will be required to offer and
provide to enrollees and will depend, to
some extent, on the needs and
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
preferences of the enrollee. Specifically,
we proposed:
• In paragraph (a)(5)(iii)(A), that a D–
SNP may provide coaching to the
enrollee to promote self-advocacy. We
requested comments on the methods of
assistance and whether further detail is
needed.
• In paragraph (a)(5)(iii)(B), an
explicit requirement that a D–SNP
provide whatever reasonable assistance
an enrollee needs in navigating the
Medicaid grievance and appeals
systems, such as assistance completing
forms. As discussed in the proposed
rule preamble, existing MA and
Medicaid managed care regulations (for
example, §§ 422.111(h)(1)(iii) and
438.406(a)) address the provision of
interpretation services and auxiliary
aids and services for enrollees who have
limited English proficiency or
disabilities that require accommodation.
We opted not to specify the preferred
technical forms of assistance that would
be required under this proposal, as the
evolution of technology and the
increases in integration over time may
change the analysis of what methods of
assistance are reasonable for a D–SNP to
be required to provide to its enrollees.
However, because D–SNPs are already
required to provide similar assistance to
their enrollees in other circumstances,
we stated in the proposed rule that we
did not anticipate that compliance with
this provision should be burdensome to
plans. We requested comments on this
matter, including whether and how our
goals might be met with more specific
regulation text.
• In paragraph (a)(5)(iv), we proposed
to require that a D–SNP provide
documentation to CMS upon request
that demonstrates how the D–SNP is
providing the assistance proposed under
paragraph (a)(5)(i).
• In paragraph (a)(5)(v), we proposed
to clarify that D–SNPs are not required
to represent enrollees in Medicaid
appeals. We requested comments
regarding whether any further
clarification was needed on this issue.
We received the following comments,
and our responses follow.
Comment: We received a significant
number of comments in support of the
proposed requirement in § 422.562(a)(5)
to require all D–SNPs to provide
assistance to D–SNP enrollees with
Medicaid coverage issues and
grievances. Many commenters were
supportive of our efforts to improve D–
SNP enrollees’ experience and require
all D–SNPs to provide a minimum level
of assistance to their enrollees while
granting D–SNPs flexibility in
complying with the proposed
requirements. A subset of commenters,
PO 00000
Frm 00046
Fmt 4701
Sfmt 4700
while supportive of our proposal,
recommended that CMS provide more
specificity regarding what D–SNP
assistance looks like and additional
guidance on how plans can work with
Medicaid agencies to obtain information
on the Medicaid coverage of their
enrollees.
Response: We appreciate the support
we received for our proposed
requirement that D–SNPs provide
assistance to enrollees with Medicaid
coverage issues and grievances. We
believe these requirements constitute an
incremental, but important, step in
improving all D–SNP enrollees’ access
to the benefits under the Medicare and
Medicaid programs. We address
commenters’ specific requests for
clarification and guidance in subsequent
responses in this section.
Comment: Several commenters
expressed concerns that D–SNPs do not
always have sufficient insight into
whether certain Medicaid benefits are
covered under the state’s Medicaid
program if the D–SNP does not provide
those benefits directly. Many
commenters noted that data sharing
with states is essential for D–SNPs to
access information regarding enrollees’
Medicaid enrollment status—for
example, whether they are enrolled in
Medicaid fee-for-service or a Medicaid
managed care organization (MCO), and
the specific MCO they are enrolled in—
in order to be fully informed about
enrollees’ coverage. A number of
commenters recommended CMS
consider issuing additional guidance to
facilitate state sharing of Medicaid
provider and enrollment information.
One commenter suggested that CMS
should create a centralized enrollment
database that D–SNPs can query for
Medicaid plan information regarding
unaligned D–SNP enrollees. Another
commenter suggested that in order to
streamline the process and facilitate its
implementation, CMS consider
partnering with states to develop
standardized resource lists with critical
information on key Medicaid contacts
that can be shared with enrollees and
D–SNPs to streamline the navigation
process and mitigate operational
burden.
Response: We agree with commenters
that information on how D–SNP
enrollees receive their Medicaid
coverage is essential for effectively
fulfilling both the requirement to assist
with Medicaid coverage and grievance
issues and the requirement we finalized
in the definition of a D–SNP at § 422.2
to coordinate Medicare and Medicaid
coverage that these plans do not provide
directly. We also recognize that,
especially for states that do not contract
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
with D–SNPs to deliver Medicaid
benefits, providing such information
may be an operational challenge that is
not among these states’ priorities. We
agree that it would be useful to provide
states with technical assistance that
would facilitate the exchange of
information and help D–SNPs
effectively coordinate their enrollees’
Medicaid coverage.
At the same time, we do not believe
that the absence of such information
sharing relieves D–SNPs of their
responsibility to coordinate Medicaid
benefits they do not directly provide,
nor prevents them from providing the
types of assistance with Medicaid
coverage issues and grievances that we
outlined in the proposed rule. While we
do not intend to penalize D–SNPs for
not having in place a real-time data
exchange with states on D–SNP
enrollees’ Medicaid coverage, we
emphasize that the obligation for
Medicaid coordination rests on the D–
SNPs, and it is therefore incumbent on
D–SNPs to develop mechanisms to
coordinate Medicaid coverage and assist
with Medicaid appeals and grievance
issues. There are other methods that D–
SNP staff can use to obtain information
to better assist their members with
Medicaid coverage issues, appeals, and
grievances. For example, many states
have data systems that providers use to
obtain information on patients’
Medicaid coverage; D–SNP personnel
may be able to similarly access
information in order to better assist
enrollees. In some circumstances, a plan
can assist a member simply by
questioning the enrollee about their
Medicaid coverage, or by jointly calling
Medicaid customer service to obtain
coverage information. As D–SNPs
implement these provisions, we will
gather and share best practices to help
ensure robust implementation of these
requirements.
Comment: A commenter indicated
that, in certain circumstances, the state
Medicaid agency is the only source that
can clarify or have up-to-date
information for the member. The
commenter stated that D–SNPs should
have the ability to direct members to
state Medicaid agencies as needed.
Response: We wish to clarify that our
proposal would not prevent D–SNPs
from directing enrollees to state
Medicaid agencies. Instead, our
proposal requires that the D–SNP
provide reasonable assistance in
identifying the specific contacts within
the state Medicaid agency, and helping
the enrollee find the correct contact
information, when referral of an
enrollee to Medicaid resources is
appropriate.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Comment: A few commenters
recommended that CMS modify its
proposal so that D–SNPs would be
responsible for assisting members with
appeals and grievances and other
matters related only to services available
through the D–SNP and that are clearly
within the purview of the plan.
Response: We disagree with these
commenters. Despite the valid datasharing challenges, we believe it is
reasonable to require that D–SNPs, as
plans focused on serving dual eligible
individuals, take steps to assist
enrollees with obtaining Medicaid
covered services and resolving Medicaid
grievances, consistent with the
requirement codified in this final rule in
§ 422.2 that D–SNPs coordinate the
delivery of Medicare and Medicaid
services for individuals eligible for such
services. This would necessarily mean
that the D–SNP take steps to gain access
to information about the Medicaid
benefits available to the D–SNP’s
enrollees. Moreover, providing such
assistance is often in a D–SNP’s
financial interest, such as when an
enrollee’s access to Medicaid-covered
services like personal care services and
other home and community based
services (HCBS) could prevent a
hospitalization or address an enrollee’s
condition before it escalates into a need
for medical services.
Comment: Several commenters
requested clarification of whether the
proposed regulation would require a
FIDE SNP to offer to assist a dual
eligible individual in appealing its own
reduction of Medicaid LTSS services.
The commenter believed this would be
burdensome and could present a
conflict for the plan.
Response: We clarify that a FIDE SNP
that covers the Medicaid service
through a capitated contract with a state
also has an obligation to assist a dual
eligible individual in appealing its own
reduction or denial of Medicaid
services, including LTSS, under its
Medicaid MCO contract. The definition
at § 422.2 finalized elsewhere in this
rule requires that FIDE SNPs have
Medicaid MCO contracts. As a Medicaid
MCO, the FIDE SNP has an obligation
under § 438.406(a) to provide reasonable
assistance to its members in completing
forms and taking other procedural steps
related to a grievance or appeal.
Therefore, FIDE SNPs already have an
obligation to assist with Medicaid
appeals. We do not agree that there is
any undue burden or conflict under
either the D–SNP or Medicaid MCO
requirements to assist with appeals
when that assistance results in a FIDE
SNP providing coverage upon
adjudication of the appeal. These
PO 00000
Frm 00047
Fmt 4701
Sfmt 4700
15725
requirements are, in the first instance, a
component of the Medicaid MCO
requirements to implement an appeals
process, and, in the second instance,
consistent with the requirement
codified elsewhere in this final rule that
D–SNPs coordinate Medicaid benefits.
The new requirements we are finalizing
at § 422.562(a)(5) of this final rule are
applicable to all D–SNPs and to all D–
SNP enrollees, whether or not they are
enrolled in the Medicaid MCO offered
by the D–SNP, and thereby effectively
extend and complement the existing
MCO requirements under § 438.406(a).
Further, we note that § 422.562(a)(5)(v)
expressly provides that the D–SNP does
not have any obligation to represent an
enrollee in a Medicaid appeal.
Comment: Several commenters
emphasized that other entities have an
important role in providing enrollees
assistance with Medicaid coverage
issues and grievances. Several of the
commenters stressed the important role
of the state ombudsman. One
commenter proposed that CMS add
language to the regulation text stating
that the D–SNP must make available to
their enrollees specific contact
information for organizations providing
free legal services and for any applicable
ombudsman programs. Another
commenter suggested that D–SNPs be
required to make a written referral for
the enrollee to the state’s Medicaid
managed care ombudsman, particularly
when the D–SNP has a financial and/or
clinical responsibility for the disputed
services. One commenter highlighted
the fact that the ombudsman offices are
specifically funded to assist
beneficiaries in filing grievances and
appeals, and frequently coordinate with
State Health Insurance Assistance
Programs (SHIPs). The same commenter
stated that many community-based
organizations already receive federal
funding to provide coaching to promote
self-advocacy, and D–SNPs should not
duplicate these services.
Response: We agree with commenters
that ombudsman programs, SHIPs, legal
services organizations, and other
community organizations have an
important role in providing assistance
with Medicaid coverage and grievances
and believe that referrals to such
organizations can be an appropriate
method for D–SNPs to provide the
required assistance in certain
circumstances. We recognize that such
organizations often have limited
capacity and encourage D–SNP
partnerships with such organizations to
help ensure the referrals are to
organizations with the capacity to help.
Comment: Several commenters
proposed requiring D–SNPs to provide
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15726
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
assistance in a language and format
needed to effectively assist enrollees
and in compliance with all language
and disability access provisions.
Response: The language suggested by
the commenter is very similar to
obligations already required of Medicaid
managed care organizations at
§ 438.406(a), which includes obligations
to provide interpreter services and
auxiliary aids to assist enrollees with
grievances and appeals. MA plans also
have existing obligations under Title VI
of the Civil Rights Act of 1964 to take
reasonable steps to ensure meaningful
access by individuals with limited
English proficiency and under section
504 of the Rehabilitation Act of 1973 to
take appropriate steps to ensure
effective communication with
individuals with disabilities, including
the provision of auxiliary aids and
services. Section 1557 of the Affordable
Care Act places similar civil rights
obligations on covered entities.
Comment: Several commenters
requested that CMS be mindful of dual
eligible individuals’ choices and
recommended that CMS not penalize
plans for not providing assistance when
enrollees decline such assistance.
Response: If an enrollee does not want
the D–SNP’s help in resolving an issue,
then the D–SNP would not be obligated
under our proposal to provide
assistance.
Comment: A few commenters
recommended expanding the proposal
to include providing assistance with
Medicaid eligibility, and one
commenter noted that case managers are
in a good position to help enrollees with
these issues. One commenter suggested
CMS should explicitly require
assistance in resolving issues related to
Medicaid eligibility as a fourth
requirement at § 422.562(a)(5)(i).
Response: We believe this
recommendation is beyond the scope of
our proposed requirement, which
focuses on assistance with grievance
and coverage appeals and not Medicaid
eligibility. However, states may choose
to require assistance with eligibility
issues in their state Medicaid agency
contracts with D–SNPs.
Comment: Several commenters
recommended that CMS provide states
and D–SNPs with technical assistance
on implementing these provisions. One
commenter stated that CMS should
consider establishing a technical expert
panel to make recommendations to CMS
on appropriate practices and then
develop guidance that establishes
guiding principles for enrollee
assistance, provides examples, and
identifies related issues for states and
Medicaid plans to consider. Another
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
commenter suggested that CMS consult
with states and D–SNPs in developing
additional guidance to help evaluate
recommended pathways for specific
situations. Another commenter
recommended states provide clear
guidance to D–SNPs operating in the
state to define the level of assistance
they should provide, including
applicable examples.
Response: We are committed to
providing technical assistance to states
and to sharing best practices with D–
SNPs to implement these requirements
based on consultations with
stakeholders and evolving practice in
this area. We expect that the best
approaches will be specific to the
Medicaid coverage in specific states and
how these states use D–SNPs to
integrate coverage.
Comment: Several commenters were
supportive of our proposal at
§ 422.562(a)(5)(i)(A) that D–SNPs
provide reasonable assistance to an
enrollee and explain to an enrollee how
to make a request and how to file an
appeal following an adverse benefit
determination. Several commenters also
appreciated that the D–SNP’s only
obligation would be to offer assistance
with filing an appeal and, upon
acceptance of the request, provide its
enrollees such assistance in obtaining
and filling out forms as necessary for the
next steps in the process. Many
commenters appreciated that the
proposed rule recognizes that some
enrollees will wish to self-advocate and
can receive support from the plan for
their efforts. A few commenters believed
plans must empower their staff to act in
the best interests of the enrollee and that
D–SNPs should establish appropriate
staff training and procedures to ensure
that those staff provide the same
reasonable assistance that the dual
eligible individual might receive from a
similarly charged independent assister
(which enrollees could continue to work
with should they choose).
Response: We appreciate the
commenters’ support of CMS’s approach
to broadly requiring D–SNPs to provide
assistance to dual eligible individuals
with Medicaid grievances and appeals.
D–SNPs can provide assistance in many
ways, including advising enrollees to
call providers and the questions to ask,
assisting enrollees with medical
documentation requests, identifying
necessary forms to file, and referring
enrollees to an organization with more
expertise (such as a state ombudsman
and other relevant assistance programs).
We do not seek to be overly prescriptive
in the types of assistance a D–SNP must
provide, and our examples are not
intended to be exhaustive. Further, we
PO 00000
Frm 00048
Fmt 4701
Sfmt 4700
note that the regulation, as proposed
and as finalized in this rule at
§ 422.560(a)(5)(v), does not require the
D–SNP to represent its enrollees in
Medicaid matters.
Comment: Many commenters
recommended that CMS clarify what
constitutes ‘‘reasonable assistance.’’ A
few commenters requested additional
guidance on ‘‘coaching the enrollee to
promote self-advocacy.’’ Some
commenters noted that it is ultimately
the enrollee’s responsibility to ensure
that they take all procedural steps and
provide and submit documentation as
part of the appeals process. Other
commenters requested more guidance
on the expectations and extent of
assistance D–SNPs must offer and give
their enrollees.
Response: We emphasize that our
requirements describe the D–SNP’s
responsibility to provide assistance and
do not include a requirement to resolve
the coverage issue or to represent the
enrollee. Not all enrollees would need
significant assistance; for many
enrollees, simply receiving information
under paragraph (a)(5)(i) would be
sufficient. Some dual eligible
individuals are highly adept at
advocating for themselves, and may
require only modest assistance—for
example, a phone number or direction
to an appropriate website—or help with
technical terms in explaining why they
need a specific piece of equipment.
Other enrollees may need
encouragement and coaching to
advocate for themselves, such as talking
through the steps the enrollee will take
to seek resolution of the issue, or role
playing to practice how to talk to a
representative of the Medicaid agency or
a Medicaid managed care plan. We
encourage D–SNPs to provide such
coaching to empower dual eligible
individuals to advocate for themselves
when appropriate. When a D–SNP
enrollee needs a higher level of
assistance with the act of filing a
Medicaid grievance or appeal, the D–
SNP should provide that help. However,
the D–SNP is not obligated to represent
the enrollee in Medicaid appeals nor
advocate for coverage, as stated in
paragraph (a)(5)(v). Plans can provide
specific contact information, explain to
enrollees the roles of the Medicaid
program, and generally offer different
levels of assistance based on the
individual’s needs.
Comment: Another comment sought
an explanation of the phrase, ‘‘becomes
aware of an enrollee’s need for a
Medicaid-covered service.’’
Response: There are a number of ways
in which a D–SNP could become aware
of the need for assistance. A non-
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
exhaustive list includes: During a health
risk assessment when an enrollee shows
a need for more LTSS than she currently
receives through Medicaid; during a
request for coverage of a Medicaidcovered service made to the D–SNP; and
during a call to the D–SNP’s customer
service line. As the above list illustrates,
the offer of assistance from the D–SNP
is not dependent on an enrollee’s
specific request for assistance.
Comment: Many commenters agreed
with the proposed provision at
§ 422.562(a)(5)(i)(C) requiring plans to
assist an enrollee in obtaining
documentation to support a request for
authorization of Medicaid services or a
Medicaid appeal, such as medical
records. One commenter requested
additional clarification from CMS on the
extent of responsibility that D–SNPs
will assume when obtaining
documentation, including the specific
types of documentation that D–SNPs
might be able to provide. Several
commenters questioned whether CMS
was imposing a requirement on D–SNPs
that duplicates the existing regulations
that require Medicaid MCOs to assist
enrollees with grievances and appeals.
Response: CMS believes the
assistance requirement for D–SNPs is
commensurate with the assistance a
Medicaid MCO is required to provide
for appeals and grievances at
§ 438.406(a), which includes reasonable
assistance in completing forms and
taking other procedural steps related to
a grievance or appeal; however, while
there may be some areas of overlap, the
new MA requirement at § 422.562(a)(5)
is not inappropriately duplicative. Not
all D–SNPs are Medicaid MCOs, PIHPs,
or PAHPs subject to the requirements
under § 438.406(a). Even some D–SNPs,
such as FIDE SNPs, that are also
Medicaid MCOs may have some
members who are not also enrolled in
the Medicaid MCO, or there may be
Medicaid services that are carved out of
the Medicaid MCO’s benefits and
delivered through Medicaid FFS or a
separate Medicaid plan. The assistance
requirement for D–SNPs that we are
finalizing here is an implementation of
the overriding requirement on D–SNPs
under section 1859(f)(3)(D) of the Act to
coordinate Medicaid benefits. To the
extent the assistance in grievances
actually provided by a Medicaid MCO
obviates the need for any additional
assistance by the D–SNP in a grievance
or appeal, such assistance would no
longer be required to be provided by the
D–SNP. To the extent the D–SNP
enrollee requires additional advice or
assistance with completing forms, or
seeking documentation from relevant
providers, the D–SNP should offer to
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
provide such assistance and provide it
when the enrollee agrees.
Comment: Several commenters were
concerned with how D–SNPs should
document and report to CMS that
assistance was offered and whether or
not an offer of assistance was accepted.
A few commenters requested additional
information on the documentation and
reporting requirements that CMS will
establish and whether such
documentation will be reviewed as part
of the audit protocols for D–SNPs. One
commenter requested CMS remove the
requirement at § 422.562(a)(5)(iv) that
requires a D–SNP to provide
documentation to CMS that
demonstrates how the D–SNP is
providing the assistance, citing concerns
with administrative burden on plans.
Response: We agree that
documentation of the assistance D–
SNPs provide their enrollees with
Medicaid coverage and grievances
should not be overly burdensome to
plans. The documentation requirement
(including any potential reporting to
CMS) in § 422.562(a)(5)(iv) does not
prescribe certain types of assistance in
all cases. Particularly in the initial years
of implementation, when plans are
developing processes to best implement
these requirements, our goal is to
provide plans with flexibility on the
type of assistance they provide in
individual cases and to monitor
compliance with this requirement at a
high level. We would not, for example,
require proof that a beneficiary had
declined an offer of assistance. We plan
to detail the scope and content of the
documentation requirements in
subregulatory guidance, and it is likely
that the subregulatory guidance will be
made available for stakeholder comment
before it is finalized.
Comment: Several commenters
suggested that CMS take steps to ensure
that D–SNPs that provide assistance
with Medicaid coverage issues are not
penalized in CMS audits or in the MA
Star Ratings measure that is based on
beneficiary complaints (‘‘Complaints
About the Health Plan’’) when the final
result—the coverage decision made by a
party other than the D–SNP—is not to
the beneficiary’s satisfaction. Another
commenter recommended that CMS
protect D–SNPs from ‘‘liability’’ for
providing assistance with Medicaid
coverage and grievances.
Response: In general, we do not
believe that D–SNPs providing their
enrollees with assistance navigating
their Medicaid coverage will trigger an
increase in beneficiary complaints.
Rather, we expect D–SNP enrollees will
appreciate the assistance that their D–
SNP provides. Nonetheless, we will
PO 00000
Frm 00049
Fmt 4701
Sfmt 4700
15727
review our criteria to ensure we are
capturing complaints appropriately and
will consider any future changes to
these criteria that may be necessary.
Outside of these areas, we are unclear
how providing such assistance would
increase D–SNPs’ ‘‘liability.’’
After considering the comments we
received and for the reasons provided in
the proposed rule and our responses to
those comments, we are finalizing the
text proposed for codification at
§ 422.562(a)(5) with one technical
modification. At paragraph (5)(iii)(B),
we are modifying the regulatory text to
clarify that the requirement that D–SNPs
provide reasonable assistance in
completing forms and procedural steps
applies specifically to Medicaid appeals
and grievances. We believe the
additional clarification provided by our
responses to the comments in this final
rule should give D–SNPs a clearer
understanding of the scope of their
responsibilities under the regulation
and the various methods and resources
D–SNPs can use to fulfill the
requirements. We recognize that there
will be a joint learning process with
states, MA organizations, dual eligible
individuals, and their advocates on the
processes that can facilitate effective
implementation of these requirements.
We expect to provide technical
assistance to states and D–SNPs to help
with implementation. In addition we
plan to provide subregulatory guidance
as necessary, including regarding CMS
oversight of D–SNP performance in this
area. We note that, unlike the remainder
of the appeals and grievances provisions
finalized in section II.A.2.b of this final
rule, the requirements at § 422.562(a)(5)
will be applicable to all D–SNPs and
will be applicable beginning January 1,
2020.
(2) Statutory Basis and Scope for
Unifying Grievances and Appeals
(§ 422.560)
In § 422.560, we proposed to add new
paragraphs (a)(4) and (b)(5) to address
the statutory basis and scope of our
proposal to establish unified grievance
and appeals processes for a subset of D–
SNPs. Specifically, we proposed a new
paragraph (a)(4) to cite section 1859(f)(8)
of the Act and provide that the
procedures under that section apply in
place of otherwise applicable grievance
and appeals procedures with respect to
items and services provided by certain
D–SNPs. We also proposed to add new
paragraph (b)(5) to identify the scope of
the new proposed regulations—that is,
requirements for applicable integrated
plans with regard to unified appeals and
grievance procedures. The substance of
these proposals is addressed in sections
E:\FR\FM\16APR2.SGM
16APR2
15728
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
II.A.2.b.(3) through (11) of the proposed
and final rules.
We received no comments on our
proposed changes to § 422.560 and are
finalizing the regulation text at
paragraph (b)(5) as proposed. However,
we are making a non-substantive
technical change to paragraph (a)(4) to
clarify that the unified appeals and
grievance procedures finalized in this
rule are applicable beginning January 1,
2021. We are also making a technical
change to correct an inadvertent
omission in the proposed rule. Section
1859(f)(8)(C) of the Act states that,
effective in 2021, contracts between D–
SNPs and state Medicaid agencies must
require the use of the unified grievance
and appeals process. In order to reflect
this requirement in regulation, as noted
in section II.A.2.a.(2) of this final rule,
we are finalizing a new paragraph at
§ 422.107(c)(9) that requires that
contracts between D–SNPs that are
applicable integrated plans, defined in
§ 422.561, and the state Medicaid
agency require the use of unified
grievance and appeals procedures.
(3) Definitions of ‘‘Applicable Integrated
Plan’’, ‘‘Integrated Appeal’’, ‘‘Integrated
Grievance’’, ‘‘Integrated Organization
Determination’’, and ‘‘Integrated
Reconsideration,’’ and General
Requirements for Applicable Integrated
Plans (§§ 422.561 and 422.629(a)–(k))
A central challenge to implementing
unified grievance and appeals systems
for D–SNPs and the Medicaid managed
care organization operated by such
plan’s parent organization is the variety
of enrollment scenarios across states.
There are only a limited number of D–
SNPs in which aligned enrollment, as
defined in § 422.2 of this final rule, is
possible—that is, a situation when a
full-benefit dual eligible individual is
enrolled in a D–SNP and receives
coverage of Medicaid benefits from the
D–SNP’s MA organization or from a
Medicaid managed care organization, as
defined in section 1903(m) of the Act,
operated by the D–SNP’s parent
organization or by another entity that is
owned and controlled by the D–SNP’s
parent organization. Even fewer D–SNPs
operate in states where that state
Medicaid agency mandates such aligned
enrollment. With exclusively aligned
enrollment, all of the enrollees of the D–
SNP also receive Medicaid services
through the D–SNP or an affiliated
Medicaid managed care organization
operated by the D–SNP’s parent
organization.
The bulk of D–SNP enrollment,
however, is not exclusively aligned. In
most states, the majority of D–SNP
enrollees have Medicaid coverage either
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
through a different organization’s
Medicaid MCO, in a prepaid ambulatory
or inpatient health plan (PAHP or
PIHP), or through a state’s Medicaid feefor-service system. In these
circumstances, the D–SNP has no
control over the Medicaid grievance and
appeals processes. Even a D–SNP that
has a Medicaid managed care
organization operated by such plan’s
parent organization available to its
enrollees, but whose members may
instead enroll in other Medicaid plans,
can only unify the procedures for
Medicaid appeals and grievances of
those enrollees who are also
simultaneously enrolled in the
Medicaid managed care organization
operated by such plan’s parent
organization.
We proposed to add definitions for
new terms to govern the integrated
grievance and appeals processes. In
§ 422.561 we proposed a new definition
for ‘‘applicable integrated plan,’’ which
is the specific type of D–SNP and
affiliated Medicaid plan that would be
governed by the new integrated
grievance and appeals regulations. In
our definition of applicable integrated
plan, we proposed to include only a
subset of D–SNPs, that is, only FIDE
SNPs and HIDE SNPs with exclusively
aligned enrollment, terms that were also
proposed (see section II.A.2.a.(1) of the
proposed rule) and are finalized with
limited modifications elsewhere in this
rule (see section II.A.2.a.(1) of this final
rule). We proposed that the affiliated
Medicaid plan be a Medicaid managed
care organization, as defined in section
1903(m) of the Act, that is offered by: (1)
The D–SNP with exclusively aligned
enrollment; (2) the parent organization
of such D–SNP; or (3) another entity that
is owned and controlled by the parent
organization of such D–SNP. Thus, as
we stated in the proposed rule, our
proposed unified grievance and appeals
procedures would apply only to the
enrollees of the subset of D–SNPs that
are FIDE SNPs or HIDE SNPs with
exclusively aligned enrollment and the
affiliated Medicaid managed care
organizations through which such
enrollees receive their Medicaid
services. As we noted in our discussion
of the proposed definition of aligned
enrollment in section II.A.2.a.(1) of the
proposed rule, we would not consider a
D–SNP’s companion Medicaid plan to
be an applicable integrated plan where
it is a PIHP or PAHP in the state’s
Medicaid program. We solicited
comments on our proposed definition of
an applicable integrated plan and how
it reflects which plans and entities
would have to use the proposed unified
PO 00000
Frm 00050
Fmt 4701
Sfmt 4700
grievance and appeals procedures. We
sought comment on whether limiting
our proposed policies to MCOs, rather
than including PIHPs and PAHPs, was
appropriate in light of the statute and
our policy goals. We also clarified
which proposed appeal and grievance
procedure requirements for D–SNPs
would not apply to applicable
integrated plans; D–SNPs that are not
applicable integrated plans would
continue to establish and administer
appeal and grievance systems that
comply with the existing requirements
for MA plans.
For the purpose of differentiating the
terminology and procedures within this
framework, we proposed to establish
definitions for ‘‘integrated organization
determination,’’ ‘‘integrated appeal,’’
‘‘integrated reconsideration,’’ and
‘‘integrated grievance’’ and apply them
exclusively to applicable integrated
plans and the unified appeal and
grievance procedures.
Under our proposal, integrated
organization determinations would
encompass both Medicare organization
determinations, as described in
§ 422.566, and adverse benefit
determinations, as defined in
§ 438.400(b); however, these
determinations would be made by
applicable integrated plans and would
therefore be subject to the integrated
organization determination procedures
in proposed §§ 422.629, 422.631, and
422.634. These would be the first
decisions made by the applicable
integrated plan regarding coverage,
approval, or payment for a covered
service.
Similarly, we proposed that integrated
reconsiderations would be the appeal of
the applicable integrated plan’s adverse
integrated organization determination
with respect to the health care services
the enrollee believes he or she is
entitled to receive. Under our proposal,
an integrated reconsideration would be
the same as an MA plan’s
reconsideration (in § 422.580) of an
organization determination (defined in
§ 422.566) and the appeal (defined in
§ 438.400(b)) of an adverse benefit
determination made by a Medicaid
managed care plan. Integrated
reconsiderations would encompass both
Medicare reconsiderations, as described
in §§ 422.578, 422.580, 422.582, and
422.584, and appeals, as defined for the
Medicaid managed care context in
§ 438.400(b). However, these
determinations would be made by
applicable integrated plans and
therefore subject to the integrated
reconsideration procedures in proposed
§ 422.629 and §§ 422.632 through
422.634.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
We proposed defining integrated
appeals to encompass integrated
reconsiderations and any additional
post-plan level unified appeal processes
that may be implemented in the future.
Additionally, we proposed to define
an integrated grievance as a dispute or
complaint that would be defined and
covered, for grievances filed by an
enrollee in non-applicable integrated
plans, under § 422.564 or §§ 438.400
through 438.416. Integrated grievances
would not include appeals procedures
or QIO complaints, as described in
§ 422.564(b) and (c), respectively. An
integrated grievance made by an
enrollee in an applicable integrated plan
would be subject to the integrated
grievance procedures in §§ 422.629 and
422.630.
Our proposed definitions for
integrated grievance, integrated
organization determination, and
integrated reconsideration were
intended to replicate the scope and
meaning of the parallel terms in parts
422 subpart M and part 438 subpart E
regarding the appeals and grievance
procedures required of, respectively,
MA organizations and Medicaid
managed care plans because we were
proposing that these regulations and
procedures would take the place of
those part 422 and part 438 procedures
for applicable integrated plans. We
solicited comment on whether our
proposal adequately accomplished this.
We proposed at § 422.629 to establish
general requirements for applicable
integrated plans, as defined in
§ 422.561. In the proposed rule, we
generally explained how we balanced
existing Medicare and Medicaid
requirements, including existing state
Medicaid flexibilities. In paragraphs (a)
and (b), we proposed language that sets
forth the scope of the requirements and
general process that applicable
integrated plans must implement. In
paragraph (a)(1), we proposed to specify
that the proposed rules apply in lieu of
the general requirements for MA
organizations at §§ 422.564, 422.566(c)
and (d), and 422.568 through 422.596,
and Medicaid managed care plans at
§§ 438.404–438.424, and encompass
integrated grievances, integrated
organization determinations, and
integrated reconsiderations. In
paragraph (b), we set forth the general
requirement that applicable integrated
plans create integrated processes to
administer these grievance and appeals
requirements.
In proposed paragraph (c), we
addressed an overarching question
about whether a state may establish
requirements that are different for the
applicable integrated plan(s) using the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
state Medicaid agency contract with the
D–SNP required under § 422.107.
Specifically, we proposed to apply the
flexibility offered to states under
Medicaid regulations, which establish a
floor for enrollee protections while
offering states flexibility to impose more
stringent requirements for timeframes
and notices so long as they are more
protective of beneficiaries. By
preserving state flexibility in adopting
more stringent, beneficiary-protective
requirements, we believe that we were
adhering to the direction set forth in
sections 1859(f)(8)(B)(ii)(I) and (II) of the
Act for us to take into account
differences in state plans under Title
XIX. Finally, in paragraph (c), we
proposed to codify the opportunity for
states to establish standards that differ
from the standards set forth in these
regulations in its state Medicaid agency
contract, per § 422.107, with the
applicable integrated plans. We
solicited comments on our proposed
approach, and specifically how we
proposed to allow state flexibilities to be
incorporated into the unified
procedures for an applicable integrated
plan.
In paragraph (d), we proposed that the
applicable integrated plan provide the
enrollee who is requesting the
integrated reconsideration a reasonable
opportunity, in writing and in person, to
present evidence and testimony and
make legal and factual arguments in
support of their appeal. We also
proposed to require that applicable
integrated plans inform enrollees of the
limited time available for these
opportunities in cases were the
timeframe is expedited, similar to
§ 422.586 and § 438.406(b)(4).
In paragraph (e), we proposed to
require applicable integrated plans to
provide reasonable assistance to the
enrollee with respect to completing and
submitting their integrated appeals and
integrated grievances, as well as on
navigating this process. This proposal
would impose on applicable integrated
plans a similar standard as applies to
Medicaid managed care plans pursuant
to § 438.406(a).
We proposed at paragraph (f) a
general rule, using cross-references to
the requirements in §§ 422.560, 422.561,
422.562, 422.566, and 422.592 through
422.626, to specify the regulations that
apply to the applicable integrated plan
for grievance and appeals processes
unless otherwise noted.
We proposed at paragraph (g) to
require applicable integrated plans to
send the enrollee an acknowledgement
of receipt in writing for all integrated
grievances and integrated
reconsiderations. We proposed to adopt
PO 00000
Frm 00051
Fmt 4701
Sfmt 4700
15729
the standard currently in § 438.406(b)
for applicable integrated plans and to
clarify that the acknowledgement
should be in written form.
In paragraph (h), we proposed to
adopt Medicaid’s grievance and appeals
recordkeeping requirements, as required
for Medicaid managed care plans at
§ 438.416, to require applicable
integrated plans to maintain records of
integrated appeals and grievances and
review them as part of their ongoing
monitoring procedures.
We proposed in paragraphs (i) and (j)
to incorporate similar provisions as are
imposed on Medicaid managed care
plans pursuant to §§ 438.410(b) and
438.414 regarding relationships between
the plan and its contracted network
providers. Specifically, in paragraph (i),
we proposed to prohibit an applicable
integrated plan from taking any punitive
action against a provider for requesting
an integrated organization
determination or integrated
reconsideration, similar to the
provisions in §§ 422.570(f) and
438.410(b). We also proposed requiring,
in paragraph (j), such a plan to disclose
information about its appeals and
grievances procedures at the time it
enters into a contract with a provider or
subcontractor. We proposed to include
specific topics which must be covered
in this information to providers, and
these specific topics are the same as in
existing Medicaid regulations (see
§ 438.414, which cites to
§ 438.10(g)(2)(xi) for this purpose).
In paragraph (k), we proposed
regulatory standards controlling who
must review an integrated organization
determination. In developing our
proposal, we sought to combine the MA
and Medicaid managed care
requirements for who must review an
organization determination. In
paragraph (k)(1), we proposed to
include the requirement from Medicaid
(§ 438.406(2)(iii)) that any individual
who reviews an integrated appeal or
grievance must consider all information
submitted by the enrollee, regardless of
whether the information was previously
made available to the plan. In paragraph
(k)(2), we proposed to include the
requirements for reviews of Medicaid
grievances (from § 438.406(b)(2)) for
who can review a grievance to
integrated grievances.
In paragraph (k)(3), we proposed to
include the existing requirements from
MA (§ 422.566) for who can review an
organization determination. We also
proposed language that, in accordance
with current MA regulations
(§ 422.566(d)), requires that physicians
or other health care professionals who
review integrated organization
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15730
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
determinations have an unrestricted
license and be acting within the scope
of that license.
In paragraph (k)(4) we proposed to
combine existing MA and Medicaid
requirements for who can review a
reconsideration or adverse benefit
determination since both sets of existing
regulations have relevant requirements.
We explained in the proposed rule (83
FR 55003 through 55006) how we
applied the direction in section
1859(f)(8)(B)(ii)(I) of the Act to adopt the
existing procedures that were more
protective of enrollees and explained
the rationale for our specific proposals
in paragraphs (a) through (k) of
proposed § 422.629. Where MA and
Medicaid managed care rules are
similar, our proposals tracked closely to
existing MA and Medicaid managed
care rules. Where MA and Medicaid
managed care rules differ, we
considered which rule was more
protective of enrollees and proposed
rules that would follow the more
protective approach.
We summarize the comments we
received on proposed § 422.629(a)
through (k) and respond to them as
follows:
Comment: Many commenters agreed
with our approach to limit the unified
appeals and grievance processes to
applicable integrated plans. A subset of
commenters, while supportive of our
proposal, encouraged CMS to extend the
unified processes to all D–SNPs, or at
least to all FIDE SNPs and HIDE SNPs
that are not exclusively aligned, to cover
more dual eligible individuals. Several
of these commenters recommended that,
if CMS is unable to extend the unified
process beyond what was proposed, we
should continue to review lessons
learned and best practices from our
implementation of the unified processes
and potentially extend the processes in
the future as overall integration efforts
advance. A commenter recommended
that, if we are not able to extend the
unified processes beyond applicable
integrated plans at this time, we
encourage states to facilitate cooperation
between D–SNPs and other entities
covering benefits for the D–SNPs
enrollees. A commenter suggested that,
if we did not extend the unified
processes to additional plans, we at
least make it optional for states and
plans other than applicable integrated
plans. Another commenter
recommended that we restrict the
unified processes to exclude HIDE SNP
enrollees, due to lower level of benefits
integration. A few commenters
requested that CMS clarify the impact of
this unified process on MMPs in the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Financial Alignment Initiative
demonstrations.
Response: We appreciate the broad
support for the unified appeals and
grievance processes we proposed. While
we appreciate the support for extending
these requirements to additional D–
SNPs and dual eligible individuals, we
do not believe it is feasible at this time
to implement fully unified grievance
and appeals systems for D–SNPs and
Medicaid managed care plans that do
not have the same enrollees or where
the organizations offering the D–SNPs
and Medicaid plans are unaffiliated or
even competitors. We note that states
may include additional integration
requirements in their state Medicaid
agency contracts with D–SNPs. We
disagree with the commenter that
suggests excluding HIDE SNPs with
exclusively aligned enrollment from the
definition of an applicable integrated
plan, because when a HIDE SNP meets
the definition of exclusively aligned
enrollment, as defined in § 422.2, the
plan covers Medicare and Medicaid
benefits (including at least some LTSS
or behavioral health services) for their
dual eligible enrollees. We also clarify
that this rule will not impact the
appeals or grievance processes for
MMPs, which will continue to be
governed by the demonstration threeway contracts and demonstrationspecific guidance. MMPs will continue
to operate within existing waivers of
part 422, as outlined in the memoranda
of understanding for each
demonstration.
Comment: A commenter requested
that CMS clarify the relationship
between the terms ‘‘aligned
enrollment,’’ ‘‘exclusively aligned
enrollment,’’ and ‘‘applicable integrated
plan,’’ specifically, the relationship
between the plan-specific nature of
‘‘aligned enrollment,’’ the state policyspecific nature of ‘‘exclusively aligned
enrollment,’’ and whether it is actually
CMS’ intent that the term ‘‘applicable
integrated plans’’ be a function of state
policy and not of individual plan
structure. The commenter further
requested clarification as to whether it
is CMS’ intent to use this concept of
‘‘exclusively aligned enrollment’’ as a
policy benchmark for states to meet,
and, if so, whether CMS intends to
somehow influence states toward that
goal. A commenter also recommended
that CMS clarify whether a HIDE SNP or
FIDE SNP operating in a state without
exclusively aligned enrollment cannot
or should not unify their appeals and
grievances in the fashion outlined in
this section.
Response: We acknowledge that
exclusively aligned enrollment is
PO 00000
Frm 00052
Fmt 4701
Sfmt 4700
directly related to state policy choices to
require such alignment. Exclusively
aligned enrollment, as defined in
§ 422.2 in this final rule, occurs when
the state requires a D–SNP operating in
the state to enroll only dual eligible
individuals who are also enrolled in an
MCO (that has an MCO contract under
section 1903(m)(2) of the Act) that is
offered by the D–SNP’s MA
organization, the D–SNP’s parent
organization, or by another entity that is
owned and controlled by the D–SNP’s
parent organization. In effect,
exclusively aligned enrollment means
that Medicare benefits, MA
supplemental benefits, and
comprehensive Medicaid benefits
(which are the benefits that an MCO
contract covers) are provided by one
entity (the D–SNP) or closely affiliated
entities that share a parent organization
for all members. Applicable integrated
plans are the D–SNP and MCO in this
exclusively aligned enrollment
arrangement. Aligned enrollment—in
contrast to exclusively aligned
enrollment—occurs when some, but not
all, of the D–SNP’s enrollees are covered
under this arrangement.
While CMS intends to continue to
provide technical assistance to states on
the value of integration and exclusively
aligned enrollment, we believe that it is
most feasible at this time to impose the
unified processes only on those plans
that have the ability to unify such
processes for all of their members.
Therefore, only applicable integrated
plans are required to comply with the
regulations we proposed and are
finalizing, with some modifications, in
this final rule. D–SNPs, including HIDE
SNPs and FIDE SNPs, that do not meet
the definition of an applicable
integrated plan must comply with the
MA appeal and grievance system
requirements in §§ 422.560 through
422.626. We also note that a state may
establish additional integration
requirements through its state Medicaid
agency contract with D–SNPs.
Comment: We received several
comments supporting our proposed
definitions at § 422.561, as well as a few
requests for additional clarification,
including whether the definition of an
integrated organization determination
includes prior authorizations. One
commenter expressed concern that, if
integrated organization determinations
do include prior authorizations, the 72hour resolution timeframes for an
expedited integrated organization
determination may not be a fast enough
resolution timeframe in all cases.
Response: Integrated organization
determinations include prior
authorizations because prior
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
authorizations are included in the
definitions of organization
determinations under § 422.566, adverse
benefit determinations under
§ 438.400(b), and actions in § 431.201.
We also note that, for resolution of an
expedited integrated organization
determination, the timeframe
requirement is that resolution must be
as expeditiously as the enrollee’s health
condition requires, but not to exceed 72
hours; thus, 72 hours is only a
maximum timeframe, and an applicable
integrated plan must take each
enrollee’s unique circumstances into
consideration in processing and
deciding an integrated organization
determination. This is consistent with
the requirement timeframes under both
MA and Medicaid (see §§ 422.572(b)
and 438.210(d)(2)).
Comment: We received a number of
comments on our proposed requirement
at § 422.629(c) allowing states flexibility
in implementing standards for
timeframes or notice requirements that
are more protective for the enrollee. A
number of commenters supported our
proposal as a way to extend enrollee
protections currently available under
Medicaid in some states. Some
commenters opposed or expressed
concerns related to allowing state
flexibility. One commenter requested
clarification on whether the proposed
procedures would supersede or override
any conflicting current Medicaid state
law or rules and federal statutes and
rules related to D–SNPs and under what
process any of those potential conflicts
could be addressed. A few commenters
noted that allowing states to shorten
timeframes for resolving appeals can be
detrimental to a plan’s ability to collect
necessary information and make fully
informed decisions. A few commenters
expressed concern about the burden and
complexity associated with requiring
applicable integrated plans to
implement different timeframes for
entities that operate in many states. A
commenter questioned how CMS would
make decisions about which state
flexibilities to allow and which not to
allow. One commenter expressed
concern that states would not be able to
implement the intent of Congress and
CMS without additional guidance, or
that CMS would not be able to
accommodate state variations without
impacting or delaying the intent of the
overall process to provide simplification
and clarity for beneficiaries. A few
commenters encouraged CMS to work
with states and stakeholders, including
through a stakeholder panel, to
implement this requirement.
Response: We appreciate commenters’
varied perspectives on this issue. As
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
discussed earlier in this preamble, the
statute requires that we take into
account differences in state plans and
that we implement standards most
protective of enrollees (see sections
1859(f)(8)(B)(ii)(I) and (II) of the Act).
Medicaid regulations governing
managed care plans currently allow
variation from federal regulations as
long as the state policy complies with
federal standards, and thus we are
designing the unified process for
applicable integrated plans to include
similar state flexibilities. In effect, the
federal regulations we proposed and are
finalizing operate as the minimum
requirements on unified grievance and
appeals procedures; states may use the
contract they have with the D–SNP
under § 422.107 and the state Medicaid
contract with the Medicaid managed
care plan to require timeframes that are
more protective of the enrollees in the
applicable integrated plans. We also
note that the unified process will impact
a relatively small universe of states and
plans. The proposed unified process
will apply for enrollees in applicable
integrated plans in lieu of current
federal Medicare and Medicaid
regulations. With respect to the burden
and complexity of administering these
unified processes, D–SNPs that contract
to provide Medicaid benefits, including
applicable integrated plans that must
comply with the unified appeal
processes addressed in this rule,
currently administer two separate
processes—one for Medicare and one for
Medicaid—in addition to complying
with specific appeal requirements for
Part D benefits. Under the unified
approach, they will only administer one
process for all non-Part D benefits.
Thus, though there may be some initial
burden in implementing the new
unified processes, in the long term we
expect the administrative burden on
applicable integrated plans to be
reduced.
With respect to when the state
flexibility will be allowed, to the extent
that a state statute or rule sets a standard
that is more protective of enrollees with
respect to timeframes or notices than the
unified rules we are establishing in this
final rule, which is the standard set by
Congress in the statute, then that state
standard will apply under the flexibility
we are finalizing at § 422.629(c) in the
unified processes, as it would currently
in the state’s Medicaid program. With
respect to how CMS will accommodate
such flexibilities, the flexibilities will
need to be stated in the state’s contracts
with the applicable integrated plan
(meaning both the contract with the D–
SNP under § 422.107 and the state
PO 00000
Frm 00053
Fmt 4701
Sfmt 4700
15731
contract with the Medicaid MCO).
States will then need to ensure
compliance with state-specific
requirements. We expect that any state
requirements that differ from the
requirements as written in this rule will
reflect state-specific Medicaid
requirements, and will therefore ensure
the same degree of protection as that
afforded to all Medicaid beneficiaries in
the state. CMS is committed to
continuing our work with states based
on their specific policy priorities
following the implementation of this
final rule, including any necessary
changes to state regulations or
processes, and we will work to ensure
changes and updates are communicated
to the public.
Comment: One commenter stated that
our proposed requirement, at
§ 422.629(g), to send written
acknowledgements of all integrated
reconsiderations was likely to cause
confusion for enrollees and increase
administrative burden for applicable
integrated plans.
Response: Sections
1859(f)(8)(B)(iii)(IV) and (V) of the Act,
as added by section 50311(b) of the
Bipartisan Budget Act of 2018,
specifically call for unified timelines
and procedures for acknowledgement of
appeals and grievances, and procedures
to ensure enrollees are notified of and
can easily determine the status of the
grievance or appeal. We believe that that
written acknowledgement best meets
these requirements and therefore
decline to make any changes to the
requirement that applicable integrated
plans send written acknowledgment of
each integrated reconsideration. We
note that applicable integrated plans
have flexibility to tailor the
acknowledgement to the enrollee’s case
to improve clarity and help avoid
confusion. This requirement parallels
the Medicaid regulation at § 438.406(b),
and we note that MA guidance also
addresses written acknowledgement of
oral requests for reconsideration (see
Parts C & D Enrollee Grievances,
Organization/Coverage Determination,
and Appeals Guidance § 50.2.1).24
Comment: A commenter suggested
that we consider ways to ensure that
plans are consistently and uniformly
capturing and logging beneficiary
requests for appeals and grievances and
that applicable integrated plans are, at a
minimum, required to provide oral
notification of resolutions.
24 See https://www.cms.gov/Medicare/Appealsand-Grievances/MMCAG/Downloads/Parts-C-andD-Enrollee-Grievances-Organization-CoverageDeterminations-and-Appeals-Guidance.pdf.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15732
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Response: We are finalizing
recordkeeping requirements at
§ 422.629(h) to help ensure consistency
in recordkeeping and documentation of
integrated grievances and appeals,
including the date that the applicable
integrated plan notified the enrollee of
the resolution at § 422.629(h)(vii), as
well as other minimum data elements.
We also note that applicable integrated
plans are required to provide the
resolution of each integrated grievance
to the enrollee, per § 422.630(e), which
we address in detail in section
II.A.2.b.(5) of this final rule. We will
monitor the need for additional
guidance on this issue during and after
implementation of the unified appeals
and grievance processes required by this
final rule.
Comment: We received several
comments supporting the proposed
prohibition, at § 422.629(i), on
applicable integrated plans taking
punitive action against providers for
supporting enrollees’ integrated
organization determinations or
integrated reconsiderations. One
commenter recommended that we
clarify that this prohibition extends to
an applicable integrated plans’
contracted and delegated entities.
Response: We appreciate commenters’
support for this requirement and note
that it is our expectation that applicable
integrated plans will ensure that
contracted and delegated entities follow
this requirement, since the managed
care plan must ensure that requirements
are met completely by its delegated or
subcontracted entity and/or individual
under current Medicaid rules
(§ 438.230(b)) and current MA rules
(§ 422.504(i)).
Comment: One commenter noted
support for our proposed requirement,
at § 422.629(j), for applicable integrated
plans to provide information about the
integrated grievance and appeals
systems to all providers and
subcontractors at the time they enter
into a contract, and requested that we
extend the provision to require annual
refresher trainings.
Response: We appreciate the
commenter’s support. Both Medicaid
and MA have general requirements
about providing information, but no
specific requirements with respect to
frequency (see §§ 438.414, and
422.202(b)). We decline to incorporate
the commenter’s suggested requirement
at this time because annual refresher
training is beyond what current
Medicaid or MA regulations require in
connection with training on appeals and
grievances processes. We believe such a
requirement would be unduly
prescriptive and constrain plans’
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
flexibility in informing and training
their providers and subcontractors.
However, we do expect that applicable
integrated plans will provide
information and training to providers
and subcontractors as often as is
necessary to ensure requirements are
well understood and met by all
delegated entities.
Comment: One commenter supported
the proposed requirement at
§ 422.629(k)(3) related to the specific
individuals who can review an
organization determination. A
commenter recommended that we strike
‘‘nor a subordinate of any such
individual’’ in the requirement at
§ 422.629(k)(4) related to who, at the
applicable integrated plan, can review
integrated reconsiderations.
Response: We appreciate the
commenter’s support for this
requirement, but we decline to make
this change, since our proposed rule
applied the requirement in the Medicaid
managed care regulations and we do not
see a reason to set a new, different
standard for review under the unified
appeals process. We believe that
prohibiting subordinates of someone
who had already made a decision in a
case is appropriate, since the goal of the
requirement is to help ensure a new,
objective review of the case, and a
subordinate may believe a conflict of
interest in this respect.
After review of the comments and for
the reasons set forth in the proposed
rule and our responses to the related
comments, we are finalizing the
definitions at § 422.561 of applicable
integrated plan, integrated appeal,
integrated grievance, integrated
organization determination, and
integrated reconsideration substantively
as proposed with minor technical and
grammatical modifications to the
definition of an integrated organization
determination to improve readability.
We are finalizing the general provisions
at § 422.629(a) through (k) requiring use
of unified appeals and grievance
processes by applicable integrated plans
substantively as proposed with a minor
modifications in paragraph (a) to make
a non-substantive technical change to
clarify that the unified appeals and
grievance procedures finalized in this
rule are applicable beginning January 1,
2021, and to clarify that § 422.618(a)
does not apply to applicable integrated
plans and to remove the designation of
the single paragraph as (a)(1).
(4) Parties and Authorization for Filing
Appeals (§ 422.629(l))
In proposed at § 422.629(l), we
addressed who is able to request
integrated grievances, integrated
PO 00000
Frm 00054
Fmt 4701
Sfmt 4700
organization determinations, and
integrated reconsiderations. Proposed
§ 422.629(1) used the heading ‘‘Parties.’’
Although not explicitly stated in the
preamble of the proposed rule, we
intended the heading to signal that such
individuals would be parties to the
resulting integrated grievance,
integrated organization determination,
and integrated reconsideration.
We also proposed in § 422.629(l)(1)(ii)
to combine the MA and Medicaid
requirements, such that a treating
provider or authorized representative
can file an appeal on behalf of an
enrollee. Our proposal primarily
adopted the MA rules at § 422.566(c)
and § 422.582(a) that allow a treating
provider to file a request for an
organization determination or standard
reconsideration on behalf of an enrollee
without written authorization from the
enrollee, but also require that the
provider notify the beneficiary. In order
to mitigate the risk that a provider
would file an appeal against an
enrollee’s interest and without an
enrollee’s consent, particularly to take
advantage of the provisions that allow a
benefit to continue while the appeal is
pending, we proposed that the
appealing provider obtain the enrollee’s
written consent before requesting an
integrated reconsideration if
continuation of benefits is requested
under § 422.632. Our proposed
regulation text at § 422.629(l)(1)(ii) also
incorporated the MA provision at
§ 422.574(b) that allows a provider to
become an assignee of the enrollee and
thereby become a party to the
organization determination and
redetermination if the provider waives
any right to payment from the enrollee
for the service that is the subject of the
appeal.
We summarize the comments we
received on proposed § 422.629(l) and
respond to them as follows:
Comment: We received broad support
for our approach to authorization for
filing grievances, integrated
organizations, and integrated
reconsiderations. Most commenters
agreed that our proposal presented a
workable compromise between MA and
Medicaid rules that should protect
enrollees’ rights and minimize the
potential for inappropriate appeals. A
few commenters expressed concern that
allowing providers to pursue appeals
without first obtaining enrollees’ written
consent would create a risk of conflicts
of interest and potentially be used to
manipulate negotiated rates.
Response: We thank commenters for
their broad support of our approach.
Because we are adopting existing MA
rules for circumstances where written
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
consent is not required when requesting
integrated reconsiderations, we believe
the potential for conflicts of interest
under our proposal are no greater than
they are under MA. Moreover, because
we believe the most significant potential
for inappropriate provider-filed appeals
exists when aid (that is, coverage and
payment) pending integrated
reconsideration is requested, requiring
enrollees’ written consent in these cases
should mitigate these risks. Our
proposal reflected this concern by
limiting a provider’s ability to seek
benefit continuation pursuant to
§ 422.632 to only when the provider had
received the written request of the
enrollee in proposed § 422.629(l)(1)(ii);
we are finalizing this specific provision
in a new paragraph (l)(1)(iv).
Comment: One commenter expressed
concern that requiring enrollees’ written
consent for provider-filed appeals
requesting continuation of Medicare
services would confuse enrollees and
providers and raise the risk that
enrollees would miss out on the
opportunity to request continuation of
benefits for Medicare-related appeals.
Instead, the commenter recommended
allowing providers to file requests for
integrated reconsiderations on behalf of
enrollees without enrollees’ written
authorization in these cases.
Response: We appreciate this concern
but disagree with the recommendation.
We believe the provision requiring
enrollee authorization for provider-filed
appeals requesting benefits pending
appeal is necessary to mitigate against
potential conflicts of interest. Although
it may be theoretically possible to
exclude Medicare-related appeals from
the requirement for written enrollee
consent in integrated reconsiderations,
implementing such an exception would
likely be more confusing for providers
and enrollees in an integrated appeals
system. We are therefore not adopting
this suggestion, but we encourage plans,
enrollees and their advocates, and
providers to advise us regarding any
difficulties implementing this provision.
Comment: One commenter requested
that we clarify who is a party to the
integrated reconsideration, similar to
what currently exists in § 422.582.
Response: Proposed § 422.629(1) used
the heading ‘‘Parties’’ and identified
who could request an integrated
grievance, integrated organization
determination, and integrated
reconsideration. Although not explicitly
stated in the preamble, we intended the
heading to be clear that such
individuals would be parties to the
resulting integrated grievance,
integrated organization determination,
and integrated reconsideration. We are
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
finalizing the proposal with additional
language clarifying, at § 422.629(l)(1),
that all of the individuals listed in that
paragraph are parties to the integrated
grievance, integrated organization
determination, and integrated
reconsideration.
In addition, we are deleting the
language proposed at § 422.629(l)(3)
regarding which parties can request an
expedited integrated organization
determination and expedited integrated
reconsideration. The same provisions
are also at § 422.631(c)(1) for expedited
integrated organization determinations
and at § 422.633(e)(1) for expedited
integrated reconsiderations, and
including duplicative provisions at
§ 422.629(l)(3) created the potential for
confusion.
Comment: Several commenters
requested clarification regarding
whether non-treating providers would
be authorized to file appeals without an
enrollee’s written consent.
Response: Under § 422.578, only
treating providers are permitted to file
reconsideration requests on behalf of
enrollees without obtaining the
enrollees’ written consent. We did not
intend to broaden the ability of
providers to file appeals on behalf of
enrollees beyond what is permitted in
MA or change the right of assignees of
an enrollee to be parties to an appeal.
We are therefore finalizing regulatory
text in paragraph (l)(1)(ii) that an
assignee of an enrollee includes a
physician or provider that has furnished
or intends to furnish a service to the
enrollee and has waived the right to
payment from the enrollee for the
service. However, we are moving the
provision regarding the need for
physicians and providers to provide
notice to the enrollee when filing a
request for an integrated reconsideration
on behalf on an enrollee to a new
paragraph (l)(3) along with additional
clarifying language. In this new
paragraph (l)(3), we clarify that only
treating providers may request an
integrated pre-service reconsideration
on behalf of enrollees without obtaining
the enrollees’ written consent, but must
also provide notice to the enrollee of
that request. Finally, for additional
clarity, we are also finalizing a new
paragraph (l)(1)(iv) in this final rule that
explicitly states that any providers that
furnish or intend to furnish a service to
the enrollee may request an integrated
organization determination or, subject to
the requirements of paragraph (l)(3), an
integrated reconsideration. This
provision is similar to the MA provision
at § 422.566(c)(1)(ii), and upon
consideration of comments requesting
clarity on the role of treating and non-
PO 00000
Frm 00055
Fmt 4701
Sfmt 4700
15733
treating providers, we believe it will be
helpful to include this provision
explicitly in this final rule. We are also
moving the requirement that a provider
requesting continuation of benefits on
behalf of an enrollee must obtain the
enrollee’s written consent from
proposed paragraph (l)(1)(ii) to the new
paragraph (l)(1)(iv), as this new
paragraph explicitly addresses the rights
of treating providers in connection with
integrated appeals. We are not finalizing
in this new paragraph (l)(1)(iv) the
requirement that was proposed at
(l)(1)(ii) in the proposed rule that an
authorized representative also needs to
obtain written consent when requesting
continuation of benefits because
authorized representatives have—by
definition—obtained authority to act on
enrollees’ behalf.
Comment: Several commenters
requested clarification regarding
whether our proposal for provider
authorization applies both to pre-service
and post-service appeals.
Response: MA rules at § 422.578
specify that the procedures permitting
treating providers to request
reconsiderations on an enrollee’s behalf
without the enrollee’s consent apply
only to pre-service appeals. As with the
limitation to treating providers, we did
not intend to broaden providers’ appeal
rights in this area beyond existing MA
rules. We are therefore removing the
regulatory text at § 422.629(l)(1)(ii) and
adding to the new paragraph (l)(3) in
this final rule regulatory text clarifying
that the ability of providers to file for an
integrated reconsideration without
obtaining the enrollee’s written consent
applies only to pre-service integrated
reconsiderations.
Comment: One commenter supported
our proposal but suggested adding an
explicit requirement that providers
obtain enrollees’ consent and provide
enrollees with status updates during the
appeal process. Another commenter
made a related suggestion that providers
requesting integrated reconsiderations
on behalf of enrollees be required to
sign and document that they have
informed the enrollees of the filing of
the appeal.
Response: We disagree that more
explicit restrictions and obligations
need to be part of the regulation. The
final regulation at § 422.629(l)(3) states
that, as under the MA regulation at
§ 422.578, only treating providers may
request an integrated reconsideration on
behalf on an enrollee without the
enrollee’s written consent upon
providing notice to the enrollee.
Pursuant to § 422.578, a treating
provider may, upon providing notice to
the enrollee, request a pre-service,
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15734
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
standard reconsideration on the
enrollee’s behalf; any provider acting on
behalf of an enrollee may request that
the standard reconsideration be
expedited, and § 422.584 does not
require notice to the enrollee of the
request that the reconsideration be
expedited. MA rules at § 422.578 do not
impose additional explicit obligations
on plans requiring specific
documentation or monitoring of
communications between providers and
enrollees to establish that notice to the
enrollee has been provided in these
situations. Instead, MA policy provides
plans with flexibility in how to
ascertain whether a provider has
adequately informed an enrollee of the
request for reconsideration (see Parts C
& D Enrollee Grievances, Organization/
Coverage Determination, and Appeals
Guidance, § 50.1).25 We believe similar
flexibilities should apply to integrated
reconsiderations. For example, if there
are no records indicating contact
between the provider and enrollee, the
plan should take reasonable steps to
confirm that the provider has informed
the enrollee. Such steps could include
asking the provider either directly or on
the form used to request the
reconsideration, or looking to see that
the enrollee is copied on
correspondence. The plan may also
contact the enrollee to confirm.
Comment: One commenter requested
clarification regarding whether the
provider authorization rules in this
section will also apply to expedited
integrated reconsideration requests.
Response: As under MA rule at
§ 422.578, the rules regarding a provider
requesting a reconsideration on an
enrollee’s behalf apply both to standard
and expedited integrated
reconsideration requests. The new
paragraph § 422.629(l)(3) we are
finalizing in this rule states explicitly
that the rule applies to both standard
and expedited integrated
reconsideration requests. We note that if
there is a request for benefits pending
appeal, then the enrollee’s written
consent is required under the provision
we are finalizing at § 422.629(l)(1)(iv). In
such a circumstance, the provider may
file the expedited request without a
request for aid pending appeal in order
to get the reconsideration request filed
as soon as possible. The provider may
then follow up with written
authorization to request continuing
benefits on the enrollee’s behalf after
securing the enrollee’s consent to that
25 See https://www.cms.gov/Medicare/Appealsand-Grievances/MMCAG/Downloads/Parts-C-andD-Enrollee-Grievances-Organization-CoverageDeterminations-and-Appeals-Guidance.pdf.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
request so long as the time period for
requesting continuing benefits has not
expired.
After consideration of the comments
and for the reasons provided in the
proposed rule and our responses to the
comments, we are finalizing § 422.629(l)
with some modifications. Specifically—
• We have revised paragraph (l)(1) to
more clearly state that that the
individuals and entities identified in
that section are parties to the case;
We moved the provisions addressing
the ability of providers to file appeals on
behalf of enrollees that were proposed at
paragraph (l)(1)(ii) to a new paragraph
(l)(3), and we have deleted references to
authorized representatives in that
paragraph.
• We have added a new paragraph
(l)(1)(iv) to expressly permit any treating
provider to request an integrated
organization determination and
integrated reconsideration. We have also
moved the provisions addressing the
obligation of providers to obtain written
consent of enrollees when requesting
continuation of benefits that were
proposed at paragraph (l)(1)(ii) to the
new paragraph (l)(1)(iv);
• In paragraph (l)(2), which addresses
the use of the term ‘‘enrollee,’’ we have
replaced the words ‘‘this section’ in the
proposed rule with ‘‘§§ 422.629 through
422.634’’ because our intent is that the
use of the term enrollee as described in
this paragraph apply to the entire
integrated grievance and appeal process.
As proposed, we are concerned the
reference to ‘‘this section’’ was
ambiguous and therefore are clarifying
it; and
• We have deleted the proposed
paragraph (l)(3) because that language
was redundant with provisions codified
in §§ 422.631 and 422.633.
(5) Integrated Grievances (§ 422.630)
At § 422.630, we proposed to largely
parallel Medicare and Medicaid
requirements where these requirements
are the same with regard to the
treatment of integrated grievances.
Where MA includes a requirement that
Medicaid does not, or vice versa, or
where the MA and Medicaid regulations
conflict, we proposed applying the
requirement that best aligns with the
principles and statutory requirements
discussed in section II.A.2.b. of the
proposed rule. For integrated
grievances, we specifically proposed:
• At paragraph (a), to establish the
general purpose of the regulation,
similar to § 438.402(a) and § 422.564(a),
by requiring that an applicable
integrated plan provide meaningful
procedures for timely hearing and
resolving integrated grievances filed by
PO 00000
Frm 00056
Fmt 4701
Sfmt 4700
an enrollee. We proposed to define the
scope of the required procedures as
being applicable to any grievances
between the enrollee and the plan or
any entity or individual through which
the applicable integrated plan covers
health care services. We proposed this
requirement for the applicable
integrated plan to be responsible for
ensuring timely and appropriate
resolution of a grievance even if the
grievance pertains to an act or decision
by one of the applicable integrated
plan’s providers of health care services.
In the regulation text, we proposed that
the integrated grievance procedures
applied to ‘‘grievances between
enrollees and the applicable integrated
plan or any other entity or individual
through which the applicable integrated
plan provides health care services.’’
• At paragraph (b), to provide that an
enrollee may file a grievance at any
time, paralleling the current Medicaid
regulation at § 438.402(c)(2).
• At paragraph (c), to allow
grievances to be filed with the
applicable integrated plan orally or in
writing, in alignment with MA and
Medicaid requirements; we also
proposed to allow integrated grievances
related to Medicaid benefits to also be
filed with the state in states that have
processes in place for that in accordance
with § 438.402(c)(3).
• At paragraph (d), we proposed to
largely parallel the MA requirements (at
§ 422.564(f)) to authorize an enrollee to
file an expedited grievance when the
complaint involves the applicable
integrated plan’s decision to extend the
deadline for certain appeals or refusal to
grant a request for an expedited
integrated organization determination or
expedited integrated reconsideration.
• At paragraph (e)(1), to parallel MA’s
maximum 30-day timeframe for
resolving the grievance and MA’s
requirements, at § 422.564(e)(1), for how
the applicable integrated plan must
respond to grievances, depending on
how the grievance is received and the
basis upon which the enrollee filed the
grievance. Although not discussed in
the preamble to the proposed rule, the
proposed regulation text would require
the applicable integrated plan to resolve
an integrated grievance as expeditiously
as the case requires based on the
enrollee’s health status and within 30
days, which is the current requirement
under Medicare (see § 422.564(e)(1)).
• At paragraph (e)(2), to include a
provision, paralleling provisions in MA
(§ 422.564(e)(2)) and Medicaid managed
care (§ 438.408(c)(1)), permitting the
applicable integrated plan to extend the
time period in which a determination
on an integrated grievance must be
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
issued to the enrollee by up to 14 days.
We proposed combining MA and
Medicaid requirements, such that
applicable integrated plans must notify
enrollees immediately, but no later than
within 2 calendar days, which we
believe to be in line with the principles
identified in section 1859(f)(8)(B)(iii) of
the Act for timely, clear notification to
enrollees.
We invited comments on these topics,
specifically whether the proposed
regulation text accurately incorporated
the standards from the underlying part
422 or part 438 regulation that are more
beneficial to the enrollee. We also
solicited comment on whether we
adequately captured all relevant
enrollee protections currently available
under MA and Medicaid. We
summarize and respond to the
comments on these specific proposals as
follows:
Comment: Many commenters
supported our proposed integrated
grievance process, including provisions
for an expedited grievance process, the
14-day extension period for resolving
integrated grievances, the clarification
that applicable integrated plans must
resolve grievances involving any entity
or individual through which the
applicable integrated plan provides
health care services, requiring responses
to grievances within 30 days, and
allowing enrollees to file at any time. A
few commenters opposed the proposal
to allow enrollees to file integrated
grievances at any time, and
recommending that CMS instead limit
enrollees to filing integrated grievances
within 60 days, to be consistent with the
current MA requirement.
Response: We appreciate the support
for our proposed integrated grievance
requirements. We decline to establish in
this final rule a timeframe for enrollees
to file a grievance. While we understand
the commenters’ desire to be consistent
with such limits in the MA program, our
proposed requirements were developed
consistent with the statutory
requirement that we implement
standards most protective of enrollees
(see section 1859(f)(8)(B)(ii)(I) of the
Act). The relevant Medicaid regulation
(§ 438.402(c)(2)(i)) allows a grievance to
be filed at any time, while the MA
regulation (§ 422.564(d)(a)) limits
grievance filing to within 60 days of the
event at issue. Not having a time limit
for enrollees to file grievances is most
protective for enrollees by eliminating
barriers to filing.
In addition, we note that the language
as we proposed in § 422.630(a) with
respect to the types of benefits for which
the applicable integrated plans is
responsible for resolving integrated
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
grievances was limited to disputes
involving entities that provide ‘‘health
care services,’’ which is the MA rule at
§ 422.564(a). Our intent was that an
applicable integrated plan be
responsible for resolving grievances
pertaining to all its contracted
providers, including those that provide
items and services that might not be
strictly considered health care services,
such as Medicaid non-emergency
transportation. Using a broader term
will ensure that the right to file an
integrated grievance with an applicable
integrated plan includes grievances that
could be filed for all Medicare and
Medicaid covered benefits. Therefore,
we are revising § 422.630(a) to state that
the applicable integrated plan is
responsible for resolving grievances
between enrollees and entities through
which the plan provides ‘‘covered items
and services.’’ We are adopting the
provision as set forth in the proposed
rule with this minor revision as noted.
Comment: Several commenters
supported the proposal to allow
enrollees to file Medicaid-related
grievances with the state. A few
commenters requested clarification on
which integrated grievances could be
filed with the state. Another commenter
suggested that CMS go further and allow
integrated grievances to be filed with
providers and 1–800–Medicare, and a
few commenters recommended that
CMS ensure that there is a ‘‘no wrong
door’’ policy such that if an enrollee
files a grievance with the wrong entity,
it is not just dismissed.
Response: We appreciate commenters’
broad support for this provision. We
appreciate the importance of a ‘‘no
wrong door’’ policy, and we intend to
work closely with states that permit
enrollees to file Medicaid grievances
with the state to ensure that applicable
integrated plans have the guidance they
need regarding policies and procedures
for these instances. Further, we will
consider comments about establishment
of ‘‘no wrong door’’ processes for all
enrollees in applicable integrated plans;
we note that CMS has established an
online system for Medicare beneficiaries
to submit complaints and concerns
about the Medicare program, including
MA plans. Additionally, 1–800–
Medicare currently accepts complaints
related to Medicare, and CMS ensures
resolution of them.
With regard to the ability to file
grievances with providers, we do not
believe additional regulatory provisions
are needed. We expect that, as currently
is the case, most enrollees will submit
grievances directly to the applicable
integrated plan. Under § 422.629(j),
applicable integrated plans will be
PO 00000
Frm 00057
Fmt 4701
Sfmt 4700
15735
required to provide information about
the integrated grievance and appeals
system to all contracted providers (as
noted in the proposed rule, this
requirement already exists for Medicaid
MCOs). This information should enable
contracted providers to direct enrollee
grievances properly to the applicable
integrated plan when necessary. In
addition, plans may delegate
responsibility for handling grievances to
provider groups consistent with existing
Medicare policy (see § 422.504(i) and
the Parts C & D Enrollee Grievances,
Organization/Coverage Determinations,
and Appeals Guidance, § 10.4.3 26). In
those circumstances, the plan remains
ultimately responsible for ensuring that
contracted entities comply with all rules
governing responding to grievances.
With regard to comments about filing
grievances with the state, we clarify that
the regulation is designed to provide a
means for the state to address Medicaid
grievances. If a grievance contains
aspects related to both Medicare and
Medicaid benefits, the state can review
the Medicaid benefit portions, but
should ensure that the Medicare benefit
portions are appropriately transferred to
the applicable integrated plan for
review. If a grievance related to
Medicaid benefits is filed with both the
state and the applicable integrated plan,
we expect the two entities to be in
communication to ensure the grievance
is resolved, as would occur now for
Medicaid managed care grievances.
Comment: One commenter requested
that we require all responses to
grievances to be in writing. Several
other commenters suggested that we not
require written acknowledgement of all
grievances.
Response: We do not believe that a
written response to all integrated
grievances is necessary; such a standard
is not imposed under current
requirements for MA plans or for
Medicaid managed care plans. As
proposed and finalized in this rule, the
regulation (§ 422.630(e)(1)) requires
applicable integrated plans to respond
in writing to integrated grievances
when: (1) The integrated grievance was
filed in writing; (2) the enrollee requests
a written response to an integrated
grievance that was orally submitted; and
(3) the integrated grievance was related
to quality of care. The regulation
permits applicable integrated plans to
respond in writing or orally to
integrated grievances that are filed
orally, unless the enrollee requests a
26 See https://www.cms.gov/Medicare/Appealsand-Grievances/MMCAG/Downloads/Parts-C-andD-Enrollee-Grievances-Organization-CoverageDeterminations-and-Appeals-Guidance.pdf.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15736
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
written response. Additionally, the
applicable integrated plan must send
the enrollee a written notice when it
extends the timeframe for responding to
the integrated grievance (consistent with
§ 422.630(e)(2)(ii), it may extend the
timeframe by up to 14 calendar days).
Consistent with § 422.629(c) as
finalized, there is flexibility for states to
set standards that are more protective of
enrollees in connection with timeframes
and notices; a state could, at its
discretion, require that applicable
integrated plans provide the disposition
of all grievances in writing. Such a
requirement would need to be specified
in the state Medicaid agency contract
with the D–SNP. We note that an
applicable integrated plan, consistent
with § 422.629(g), must send a written
notice acknowledging receipt of the
grievance; in this notice, a plan could
also note that the grievance is
considered resolved if the applicable
integrated plan has previously provided
the enrollee an oral resolution to clarify
the status of the grievance for the
enrollee. Accordingly, we are adopting
without change the provision as set
forth in the proposed rule.
Comment: Several commenters
requested clarification on the
requirement that applicable integrated
plans notify enrollees within 2 calendar
days when an extension is being taken.
Response: We clarify that the
applicable integrated plan must notify
the enrollee that an extension is being
taken within two calendar days of when
the applicable integrated plan, after
justifying the need for the extension and
documenting how the delay is in the
enrollee’s interest, makes the decision to
extend the timeframe. We are finalizing
the regulation text at § 422.630(e)(2)(ii)
with additional text to clarify this
timing.
Comment: A commenter suggested
that we implement integrated reporting
in the Complaint Tracking Module
(CTM) for grievances in the CMS Health
Plan Management System (HPMS) and
give states access to track all grievances
and resolutions for transparency and
monitoring.
Response: We appreciate the
comment and will consider it as we
move forward with implementation. If
such a step is operationally feasible, we
do not believe it would require
additional regulatory language.
For the reasons provided in the
proposed rule and our responses to the
comments, we are finalizing the
requirements at § 422.630 substantively
as proposed with some minor
modifications as follows:
• We are revising the regulatory text
at paragraph (a) by replacing ‘‘health
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
care services’’ with ‘‘covered items and
services’’ in order to ensure that
grievances pertaining all Medicare and
Medicaid covered benefits are included
in the requirement;
• We are finalizing the regulatory text
in paragraph (d) with revisions to
streamline the regulation text and, at
paragraph (d)(2), to clarify the terms
used; and
• We are revising paragraph (e)(2)(ii)
to clarify how long the plan has to
notify the enrollee when it extends the
time the resolve a grievance.
(6) Integrated Organization
Determinations (§ 422.631)
In proposed § 422.631, we specified
the procedures applicable integrated
plans would follow in making
integrated organization determinations.
In paragraph (a), we proposed that, as
part of a unified process, all requests for
benefits covered by applicable
integrated plans must be subject to the
same integrated organization
determination process.
In paragraph (b), we proposed to
adopt the MA provisions at § 422.568(a)
allowing an enrollee to request an
integrated organization determination
either orally in writing, but requiring
requests for payment to be made in
writing.
In paragraph (c), we proposed to
articulate the standard for making an
expedited organization determination.
Both MA (at § 422.570(c)) and Medicaid
(at § 438.210(d)(2)) have similar
standards for an expedited organization
determination, including who can file it
(proposed in § 422.631(c)(1)) and how it
should be decided (proposed in
§ 422.631(c)(3)). At paragraph (c)(2), we
proposed that the request to expedite
the appeal can be made orally or in
writing.
In paragraph (d), we proposed rules
regarding timeframes and notices when
resolving integrated coverage
determinations. In paragraph (d)(1), we
proposed to require that an applicable
integrated plan send a written integrated
notice when the organization
determination (standard or expedited) is
adverse to the enrollee. We proposed to
include text specifically identifying as
adverse determinations requiring a
notice any decision to authorize a
service or item in an amount, duration,
or scope that is less than the amount
requested or previously requested or
authorized for an ongoing course of
treatment. We also proposed to include
text specifying, consistent with
Medicaid managed care requirements
(§ 438.404(c)(5)), that the applicable
integrated plan must send an integrated
determination notice when the plan
PO 00000
Frm 00058
Fmt 4701
Sfmt 4700
fails to make a timely decision because
failure to make a decision within the
required timeframe is a denial (and thus
an adverse determination). The
proposed notice would include
information about the determination, as
well as information about the enrollee’s
appeal rights under both Medicare and
Medicaid. We also proposed that the
notice be written in plain language and
available in a language and format that
is accessible to the enrollee; this
proposed requirement is consistent with
section 1859(f)((8)(B)(iii)(III) of the Act.
In paragraph (d)(2), we proposed
timelines for sending this notice that
largely align with both existing
Medicare and Medicaid requirements.
We proposed, in paragraph (d)(2)(i)(A),
to require that applicable integrated
plans send a notice of an integrated
organization determination at least 10
days before the date of action if a
previously authorized benefit is being
reduced, suspended, or terminated, with
some exceptions in accordance with
§§ 431.213 and 431.214; we briefly
explained the exceptions available in
accordance with §§ 431.213 and 431.214
in the proposed rule (83 FR 55008). We
proposed, in paragraph (d)(2)(i)(B), to
require that applicable integrated plans
send the notice as expeditiously as the
enrollee’s health condition requires but
no later than 14 calendar days from
receipt of the request for a standard
integrated organization determination.
We further proposed to permit
extensions, in paragraph (d)(2)(ii), in
circumstances that largely parallel those
that exist in Medicare and Medicaid
currently. In paragraph (d)(2)(iii), we
proposed requirements for notice to be
provided to the enrollee in cases of
extension; these proposed requirements
also largely parallel current MA and
Medicaid requirements at
§ 422.572(b)(2) and § 438.404(c)(4)(i),
respectively. Proposed
§ 422.631(d)(2)(iii)(A) largely parallels
§ 422.572(b)(2), which provides more
specific direction on timing of the
notice. We also proposed in paragraph
(d)(2)(iii)(B) regulatory text controlling
when the notice of the integrated
organization determination must be sent
in cases where the applicable integrated
plan makes the decision to extend the
timeframe.
In paragraph (d)(2)(iv)(A), we
proposed the deadline for issuing notice
of expedited integrated organization
determinations. Both MA and Medicaid
require expedited organization
determinations (or adverse actions) as
expeditiously as the enrollee’s health
condition requires but not later than
within 72 hours of the request, with the
possibility of extending that timeframe
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
by 14 calendar days. We proposed, at
paragraph (d)(2)(iv)(B), to mirror the MA
requirements (§ 422.570(d)), with
required procedures when an applicable
integrated plan denies a request for
expediting an organization
determination. In paragraph
(d)(2)(iv)(C), we proposed to include
requirements, which parallel MA
requirements (§ 422.572(d)), for
applicable integrated plans when
obtaining necessary information from
noncontract providers.
We received the following comments
on the proposals at § 422.631 and our
responses follow.
Comment: We received many
comments related to the notice
requirement in proposed
§ 422.631(d)(1). Several commenters
supported the notice of the integrated
organization determination, the required
content we proposed, and the
requirement that it be written in plain
language and available in the language
and format that is accessible to the
beneficiary. Several commenters
requested clarification regarding
whether the existing Integrated Denial
Notice used by MA plans (Form CMS–
10003–NDMCP) would be used to
satisfy the requirement for notice of the
integrated organization determination.
Several other commenters also
suggested that CMS develop a model
notice to serve as the integrated
organization determination notice for
applicable integrated plans to use. A
commenter recommended that the
notice only be required to be sent when
there is a denial of the service or item
by all coverage sources (that is,
Medicare and Medicaid).
Response: We intend to develop a
separate model notice that will be used
exclusively for integrated organization
determinations and that will be
specifically tailored to contain
information relevant to the unified
appeals process we are finalizing in this
rule. As finalized in § 422.631(d)(1), the
new integrated notice will be sent in
cases where a service or item is being
denied under Medicare and Medicaid.
In addition, as is the case with the
current MA Integrated Denial Notice
(Form CMS–10003–NDMCP), we will
develop instructions for appropriate use
of the new model notice. The
instructions will also explain how plans
should tailor the model notice to
explain the outcome to the enrollee in
situations where a notice is required. As
we note in the Collection of Information
section in this final rule, this model
notice, and its associated requirements
and burden, will be submitted to OMB
for approval separately from this final
rule once we develop the model and
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
accompanying analyses. The OMB
approval process will include a public
comment period.
Comment: A commenter
recommended that we also make the
integrated organization determination
notice available for use by plans other
than applicable integrated plans.
Response: We decline to accept the
commenter’s suggestion. We intend to
tailor the model notice specifically to
the unified appeals process, and
information and procedures relevant to
that process, we are finalizing in this
rule. We do not believe the model notice
will be appropriate for enrollees outside
the unified process and, as such, the
model notice for integrated organization
determinations will be specifically
tailored for use by applicable integrated
plans.
After consideration of the comments
and for the reasons set forth in the
proposed rule and our responses to the
related comments, we are finalizing
§ 422.631 substantively as proposed, but
with minor modifications to streamline
the regulatory text at paragraph (d) as
follows:
• We are finalizing proposed
paragraph (d)(1) as three new
paragraphs, paragraphs (d)(1)(i) through
(iii) and making minor grammatical
changes.
• We are renumbering proposed
paragraphs (d)(1)(i) through (viii) in the
final rule as paragraphs (d)(1)(iii)(A)
through (H).
(7) Continuation of Benefits Pending
Appeal (§ 422.632)
At § 422.632, we proposed rules to
implement the provisions added to
section 1859(f) of the Act by section
50311 of the Bipartisan Budget Act of
2018 pertaining to continuation of
benefits pending appeal under Titles
XVIII and XIX, specifically the new
provision at section 1859(f)(8)(B)(iv) of
the Act. We explained in detail in the
proposed rule (83 FR 55008 through
55009) how we interpret this provision
as requiring CMS to apply continuation
of benefits to all Medicare Parts A and
B and Medicaid benefits under our
proposed unified appeals processes.
Based on that interpretation, we
proposed that the existing Medicaid
standards applicable to Medicaid
managed care plans for continuation of
benefits at § 438.420 apply to applicable
integrated plans for Medicare benefits
under Parts A and B and Medicaid
benefits in our proposed integrated
appeals requirements at § 422.632.
Under our proposal, if an applicable
integrated plan decides to stop (as a
termination or suspension) or reduce a
benefit that the enrollee is currently
PO 00000
Frm 00059
Fmt 4701
Sfmt 4700
15737
authorized to receive, the enrollee could
request that the benefit continue to be
provided at the currently authorized
level while the enrollee’s appeal is
pending through the integrated
reconsideration. The enrollee would be
required to make a timely request for the
continuation. We proposed, at
paragraph (a), a definition for ‘‘timely
files.’’ This proposed definition
mirrored the definition at § 438.420(a),
with minor revisions to make the text
applicable to applicable integrated plans
instead of Medicaid managed care
plans.
We proposed, at paragraph (b), to
require a previously authorized service
covered under Medicaid or Medicare
Part A or Part B, excluding
supplemental benefits as defined at
§ 422.102, to be continued pending an
appeal of a termination of those
services. We proposed to require that
the continuation of these services as a
covered benefit would be conditioned
on meeting the same five criteria listed
in § 438.420:
(1) The enrollee files the request for
an integrated appeal timely in
accordance with § 422.633(e);
(2) The integrated appeal involves the
termination, suspension, or reduction of
previously authorized services;
(3) The services were ordered by an
authorized provider;
(4) The period covered by the original
authorization has not expired; and
(5) The enrollee timely files for
continuation of benefits.
Because proposed paragraph (b)
repeated that language at section
1859(f)(8)(B)(iv) of the Act that limits
the continuation of benefits to only
benefits under Parts A and B of title
XVIII and title XIX of the Act, we noted
in the preamble to the proposed rule
that MA supplemental benefits would
not be subject to the proposed rule (83
FR 55009).
We proposed, at paragraph (c), to
require that an applicable integrated
plan continue such services pending
issuance of the integrated
reconsideration. We noted in the
proposed rule that for Medicaid
managed care plans that are not
applicable integrated plans,
continuation of these services after the
integrated reconsideration and pending
resolution of the state fair hearing is
controlled by § 438.420(c). Proposed
§ 422.632(c)(2) provided that
continuation of services would end
when the applicable integrated plan
issues an adverse integrated
reconsideration. If the applicable
integrated plan finds in favor of the
enrollee, benefits would continue in
accordance with the favorable integrated
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15738
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
reconsideration. In proposed
§ 422.632(c)(3), we proposed
requirements for Medicaid-covered
benefits to continue after the applicable
integrated plan issues an adverse
integrated reconsideration, mirroring
the requirements currently in Medicaid
managed care regulations (see
§ 438.420(c)(2)). The enrollee must make
the request and file for a state fair
hearing within 10 calendar days after
the applicable integrated plan sends the
notice of the integrated reconsideration.
We also proposed to mirror
requirements from § 438.420 for how
long Medicaid-covered benefits must
continue by requiring that the benefits
continue until the enrollee withdraws
the request for the state fair hearing or
until the state fair hearing decision is
issued.
In proposed paragraph (d), we
addressed whether an applicable
integrated plan can seek recovery for the
costs of services provided while an
appeal is pending. We proposed not to
follow Medicaid’s regulations that allow
states to determine whether or not a
plan, or the state, can seek recovery for
the costs of services provided pending
appeal. We noted there is no analogous
process in Medicare, as continuation of
benefits pending appeal is very limited
in Medicare and generally only
available in cases involving QIO review
of inpatient discharges. Instead, drawing
in part on the experience of a number
of Financial Alignment Initiative
demonstrations, we proposed to
prohibit recovery of the costs of services
provided pending the integrated
reconsideration and, for Medicaidcovered benefits, any state fair hearing,
to the extent that services were
continued solely under § 422.632, for all
applicable integrated plans and state
agencies.
We solicited comment generally on
our proposal regarding continuation of
benefits and also requested comments
on alternatives, including regarding the
feasibility of treating Medicare and
Medicaid benefits differently for the
purpose of recovery of costs. We
summarize the comments on this topic
and respond to them as follows:
Comment: Most commenters
supported our overall interpretation of
the statute extending Medicaid’s
approach of providing aid pending
appeal to items and services covered
under Medicare Part A and Part B. One
commenter, in supporting our overall
approach, urged us to monitor for any
unexpected cost consequences to D–
SNPs resulting from the rule and
encouraged us to ensure that any
additional costs resulting from the
policy are allowable for bid purposes.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Another commenter objected to the
entire approach based on concerns
about potential cost implications to the
integrated D–SNPs subject to the
provision. One commenter disagreed
with our approach, stating that we
should make no changes to Medicare’s
coverage of items and services pending
appeal, although this commenter
provided no statutory basis for their
perspective.
Response: We appreciate the strong
support for our overall approach. As we
discussed in the preamble to the
proposed rule, we believe the most
logical reading of the statutory language
directs us to extend Medicaid’s aid
pending appeal procedure to Medicare
Part A and B services covered by
applicable integrated plans. Regarding
costs, MMPs in the Financial Alignment
Initiative have operated under similar
rules and have not reported any
significant resulting adverse impact on
cost. The Regulatory Impact Analysis for
our proposed rule, on which we
received no comments related to this
specific proposal, projected a minimal
cost to plans from extending the
Medicaid aid pending appeal procedure
to Medicare Parts A and B services. We
will provide further guidance on this
topic for plans as part of the bid
submission process.
Comment: We received many
comments regarding our approach to
recovery of the costs of services
provided pending appeal. Many
commenters supported our proposal as
consistent with the statute, clearer to
administer than alternatives, and most
protective of beneficiaries. A significant
number of other commenters, however,
expressed concern that our approach
could increase costs and recommended
instead that states retain the flexibility
to pursue recovery of costs at their
discretion.
Response: We thank the commenters
for their comments on this issue. After
careful consideration of the
commenters’ perspectives, we are
finalizing our proposal with some
modifications to § 422.632(d) regarding
recovery of the costs. We are finalizing
the proposed regulation regarding
recovery of costs at the integrated
reconsideration level, which is now
codified at § 422.632(d)(1). We believe it
is highly desirable to have one single
rule regarding recovery of costs apply to
all services provided pending the
issuance of the integrated
reconsideration decision pursuant to
section 1859(f)(8)(B)(iv) of the Act,
rather than to treat Medicare-related and
Medicaid-related services differently.
We believe that it is simpler and more
protective of beneficiaries to prohibit
PO 00000
Frm 00060
Fmt 4701
Sfmt 4700
the recovery of the costs of all services
provided by an applicable integrated
plan pending an integrated
reconsideration pursuant to a request
filed under § 422.632. All services, both
Medicare-related and Medicaid-related,
provided by applicable integrated plans
through the end of the integrated
reconsideration process are considered
to be furnished under the requirements
of § 422.632 and are therefore not
subject to recovery of costs.
However, we find it persuasive that,
for cases where a plan’s denial is
ultimately affirmed, eliminating the
ability of states to recover the costs of
Medicaid services provided by the
applicable integrated plan after the
integrated reconsideration is final and
pending a state fair hearing could create
significant inconsistencies for state
Medicaid appeal processes and
potentially discourage states from
pursuing exclusively aligned enrollment
and thereby adopting integrated
appeals. Moreover, because our entire
integrated process extends only to the
integrated reconsideration stage and not
to the state fair hearing process, this rule
limiting recovery of costs is also limited
to costs incurred for continuation of
services pending the integrated
reconsideration stage. We are therefore
designating the text in proposed
paragraph (d) as (d)(1) in this final rule
with revised text limiting that rule to
recovery of costs for services continued
pending the integrated reconsideration.
We are also finalizing a new provision
at paragraph (d)(2) to provide states
with the flexibility to recover the costs
of services continued pending the state
fair hearing phase of an appeal (that is,
after the date of the integrated
reconsideration decision and until the
decision is issued on the state fair
hearing), consistent with state rules and
with § 438.420(d). We believe this
addition should mitigate concerns about
costs to states. We also note a number
of Financial Alignment Initiative
demonstrations do not allow
recoupment of costs and MMPs have not
reported any adverse financial impact,
suggesting a minimal impact on costs
from limiting recovery of costs. In
summary, under § 422.632(d)(1) and
(d)(2), recovery of costs is not permitted
for services provided pending the
integrated reconsideration. If an enrollee
requests a state fair hearing after an
adverse integrated reconsideration, then
state Medicaid procedures regarding
continuation of benefits and recovery of
costs will apply. We will work with
states and plans to ensure that enrollees
are fully informed of these rules.
Finally, we note that this provision is
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
unrelated to the requirement at
§ 422.634(e) requiring a plan or state to
pay the costs of benefits provided in the
event a plan’s initial decision is
reversed at the integrated
reconsideration or fair hearing stage.
The obligations at § 422.634(e) are
similar to those under Medicaid at
§ 438.424(b) governing effectuation of a
decision, and apply to any services the
enrollee receives while the appeal is
pending, whether or not continuation of
benefits was requested under § 422.632.
Comment: A commenter requested
that CMS clarify whether services were
required to continue pending IRE
review. We received a number of
comments recommending that we
should require coverage of aid pending
appeal for Medicare Parts A and B
services to extend through the IRE level
(and in some comments, through the
administrative law judge (ALJ) or higher
appeal levels as well), rather than
stopping after the integrated
reconsideration level. One commenter
expressed concern that stopping before
the IRE level would discourage appeals.
Others encouraged continuation through
the IRE level to ensure external review
of all appeals before services ended.
Response: The regulation, as proposed
and finalized at § 422.632(c)(2), requires
integrated applicable plans to continue
Medicare Part A and Part B and
Medicaid benefits through the issuance
of an integrated reconsideration
decision under § 422.633(f)(4). If the
applicable integrated plan affirms its
decision at the integrated
reconsideration level and the case
involves Medicaid benefits, an enrollee
may request a state fair hearing as
described in § 422.634(b)(2). From that
point forward, existing Medicaid rules
apply, including § 438.420 that requires
Medicaid managed care plans—
regardless whether they are applicable
integrated plans—to continue provision
of Medicaid benefits on certain terms
through the state fair hearing process.
We decline at this time to require
continuation of Medicare services
through the IRE level, and will retain
our rule as proposed that requires
continuation of Medicare Parts A and B
services only through the integrated
reconsideration level. Section
1859(f)(8)(B)(iv) of the Act provides
authority to extend benefits pending
appeal in the context of the unified
appeal procedures we are adopting in
this rule. We are not at this time
integrating IRE review into a unified
appeal process; therefore, we believe we
lack statutory authority to extend
benefits pending to the IRE level review
under the unified appeal process. In
addition, most of the Financial
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Alignment Initiative demonstrations
have not included aid pending appeal
through the IRE level. As a result, we
have little experience with either the
operational complexities or the financial
impact of such a policy. Finally,
because IRE review is automatic for all
adverse Medicare plan reconsiderations
under § 422.592, there is not a risk that
enrollees will end their appeal prior to
the IRE review. We believe the more
prudent course is to implement aid
pending appeal for services through the
integrated reconsideration level as we
have proposed. We may consider the
feasibility of broadening the unified
appeal process to include IRE review
and continuation of benefits through
additional appeal levels in future
rulemaking.
Comment: A few commenters
recommended that continuation of
benefits pending appeal also apply to
supplemental benefits provided by
applicable integrated plans.
Response: We decline to adopt this
recommendation and believe that it is
not consistent with the statute. Section
1859(f)(8)(B)(iv) of the Act, added by the
Bipartisan Budget Act of 2018,
authorizes continuation of benefits for
integrated appeals is limited to benefits
under Medicare Parts A and B as well
as Medicaid, but does not include MA
supplemental benefits, which are
offered under Part C of the Act
(specifically section 1852(a)(3) of the
Act). We therefore do not have the
authority to require continuation of
supplemental benefits pending appeal.
Plans may continue such benefits
voluntarily, however, and states may
include conditions affecting coverage of
such benefits in their contracts with D–
SNPs, so long as enrollees are made
aware of any potential risk of financial
liability.
Comment: A few commenters
suggested that we establish an expedited
process for integrated reconsiderations
when continuation of benefits pending
appeal is requested in order to minimize
the risk of payment discrepancies.
Response: We decline to adopt this
suggestion. We note that continuation of
services pending appeal has long been
part of Medicaid appeals and no special
expedited process exists for such cases.
We do not see a reason for treating
integrated reconsiderations differently
in this regard. In addition, applicable
integrated plans may prioritize
resolution of integrated reconsiderations
where services are continuing, so long
as these plans follow all procedural
rules and ensure that enrollees have a
full opportunity to present their case.
Further, the requirement to expedite
certain integrated reconsiderations
PO 00000
Frm 00061
Fmt 4701
Sfmt 4700
15739
based on the enrollee’s health status
(discussed in section II.A.2.b.(8) of this
final rule) applies regardless whether
benefits are continued under § 422.632.
Comment: A few commenters
requested that we add language that
would allow plans to dismiss an
integrated reconsideration request if an
enrollee becomes eligible for a service
while the integrated reconsideration is
pending.
Response: We decline to make this
addition. There are no regulations in the
MA program or Medicaid managed care
program that address dismissals of
reconsiderations or appeals in these
circumstances, and we do not believe
that we should create a new procedure
unique to integrated reconsiderations
here. We note that the Parts C & D
Enrollee Grievances, Organization/
Coverage Determinations, and Appeals
Guidance, § 50.8, does include guidance
regarding dismissal of pre-service
reconsideration requests when a service
has been provided before the
reconsideration is completed. We will
consider if additional guidance is
needed in this area for integrated
reconsiderations when continuation of
services is requested.
After considering the comments and
for the reasons set forth in the proposed
rule and our responses to the comments,
we are finalizing § 422.632 as proposed
with modifications to paragraph (d). In
newly designated paragraph (d)(1), we
are making technical changes to the
proposed regulation text to clarify that
an applicable integrated plan or a state
agency may not pursue recovery of costs
for services continued pending the
integrated reconsideration. In new
paragraph (d)(2), we are finalizing a
provision that authorizes states to
recover the costs of Medicaid services
provided during the state fair hearing
phase of an appeal (that is, after the date
of the integrated reconsideration
decision and until the decision is issued
on the Medicaid state fair hearing),
consistent with state rules and with
§ 438.420(d).
(8) Integrated Reconsiderations
(§ 422.633)
In proposed § 422.633, we laid out our
proposed provisions for an integrated
reconsideration process for applicable
integrated plans. As with other
provisions, we compared relevant
Medicare and Medicaid provisions, and
where they differ, we chose to adopt the
policy that is most protective of the
beneficiary.
In paragraph (a), consistent with
current MA and Medicaid regulations
(§§ 422.590 and 438.402(b),
respectively), we proposed that
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15740
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
applicable integrated plans may only
have one plan level of appeal beyond
the initial decision (the integrated
organization determination).
In paragraph (b), we proposed to
adopt a rule similar to
§ 438.402(c)(1)(i)(B) regarding the
permissibility of external medical
reviews: Medicaid managed care plan
enrollees may be offered an opportunity
to elect external medical review under
a state external review process. Under
our proposal, the ability to elect external
medical review would apply only to
Medicaid covered services that are the
subject of an adverse integrated
reconsideration issued by an applicable
integrated plan because D–SNPs, like all
MA plans, are not subject to state
external review procedures.27
In paragraph (c), we proposed a right
for each enrollee, and their
representatives, to receive a copy of the
enrollee’s case file (including medical
records and evidence considered,
generated, or relied on by the integrated
applicable plan in making the integrated
organization determination) free of
charge, consistent with the protection
for Medicaid enrollees under
§ 438.406(b)(5).
In paragraph (d)(1), we proposed
timelines for filing for a standard
integrated reconsideration that,
consistent with both MA (at
§ 422.582(b)) and Medicaid managed
care (at § 438.402(c)(2)(ii)) regulations,
would require that an integrated
reconsideration be filed within 60 days
of the date of the denial notice. We
proposed, in paragraph (d)(2), that oral
inquiries seeking to make an integrated
reconsideration be treated as integrated
reconsiderations; this is generally
consistent with § 438.406(b)(3). We did
not propose to include the language in
§ 438.406(b)(3) requiring beneficiaries to
provide written confirmation of oral
requests because such a requirement
would be inconsistent with MA policy
that directs plans that do accept oral
requests for reconsideration to provide
written confirmation to the beneficiary
(see Parts C & D Enrollee Grievances,
Organization/Coverage Determination,
and Appeals Guidance, § 50.2.1). We
proposed, in paragraph (d)(3), to include
current requirements from MA (at
§ 422.582(c)) that allow for extending
the timeframe for an enrollee, or a
physician acting on behalf of an
enrollee, to file a late reconsideration.
In paragraph (e), we proposed to
address procedures for filing expedited
integrated reconsiderations, consistent
with current MA and Medicaid rules.
27 Section 1856(b)(3) of the Act preempts state
regulation of MA plans.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
The proposed language in paragraphs
(e)(1) and (e)(2) aligns with § 422.584 in
permitting the enrollee or health care
provider to file a written or oral request
for an expedited reconsideration. The
proposed language in paragraph (e)(3)
aligns with § 422.584 in setting the
standard that the applicable integrated
plan must use in deciding whether to
expedite the integrated reconsideration.
In paragraph (e)(4), we proposed
notice requirements related to requests
for expedited integrated
reconsiderations. We proposed
requirements that parallel Medicaid
managed care requirements for notice to
the enrollee when the request for an
expedited integrated reconsideration is
denied (§ 438.410(c)(2))—specifically,
that the plan must give prompt oral
notice and written notice within 2
calendar days and transfer the matter to
the standard timeframe for making an
integrated reconsideration (that is, the
timeframe specified in paragraph (f)(1)).
We proposed to apply the MA
requirements for what applicable
integrated plans must include in the
written notice to enrollees when the
request to expedite the integrated
reconsideration is denied
(§ 422.584(d)(2)).
In paragraph (e)(5) we proposed to
include requirements, which mirror MA
requirements (§ 422.590(d)(3)), for
applicable integrated plans when
obtaining necessary information from
noncontract providers. These
requirements specify that the applicable
integrated plan must reach out to a
noncontract provider within 24 hours of
the initial request for an expedited
integrated reconsideration.
In paragraph (f), we proposed
timelines and procedures for resolving
an integrated reconsideration request.
We proposed specific requirements for
applicable integrated plans. Both MA (at
§ 422.590(a)) and Medicaid (at
§ 438.408(b)(2)) require resolution of
pre-service standard appeal requests
within 30 calendar days. We proposed
the rules in paragraph (f)(1), that
parallel MA (at § 422.590(a)) and
Medicaid (at § 438.408(b)(2)) with the
addition of a provision mirroring
§ 422.590(a)(2), that the integrated
reconsideration decision be issued as
expeditiously as the enrollee’s health
requires but no later than 30 calendar
days from the date the applicable
integrated plan receives the request for
the integrated reconsideration.
In § 422.633(f)(1), we proposed to
require that all integrated
reconsiderations—pre-service and postservice—be resolved as expeditiously as
the enrollee’s health requires and within
30 calendar days from the date the
PO 00000
Frm 00062
Fmt 4701
Sfmt 4700
applicable integrated plan receives the
request for the integrated
reconsideration. We noted that this
timeframe is consistent with Medicaid
managed care requirements for both preand post-service requests at
§ 438.408(b)(2) and with pre-service
requests under MA at § 422.590(a). We
deviated from the MA requirements for
post-service cases involving denial of
payment, as current MA requirements
provide 60 calendar days for MA plans
to resolve these cases.
In paragraph (f)(2), we proposed to
establish the timeframes for expedited
reconsiderations, which parallel both
MA (at § 422.590(d)(1)) and Medicaid (at
§ 438.408(b)(3)) regulations for managed
care plans in requiring the applicable
integrated plan to resolve the expedited
reconsideration as expeditiously as the
enrollee’s health requires and within 72
hours from the date the applicable
integrated plan receives the request for
the integrated reconsideration. We also
proposed to apply the Medicaid
managed care requirement (at
§ 438.408(d)(2)(ii)) by requiring that
applicable integrated plans make
reasonable efforts to give enrollees oral
notice of the resolution in expedited
cases, in addition to sending the written
notice within 72 hours of receipt of the
request.
In paragraph (f)(3)(i), we proposed
criteria for an applicable integrated plan
to extend the timeframe for resolving
either a standard or expedited
reconsideration. We proposed to adopt
a standard similar to current MA and
Medicaid rules, allowing 14-day
extensions upon request of the enrollee
(or the enrollee’s representative) and
generally using the standard in
§ 438.408(c) that the plan must show
that the extension is in the enrollee’s
interest and that the information is
necessary. We also proposed to use the
MA standard that the timeframe may be
extended if there is a need for additional
information and there is a reasonable
likelihood that receipt of such
information would lead to approval of
the request. We clarified in the
preamble of the proposed rule that an
applicable integrated plan could not
extend the timeframe for making an
integrated reconsideration in order to
develop or find information to justify a
denial of coverage.
In paragraph (f)(3)(ii), we proposed
requirements for the notice that
applicable integrated plans must send to
enrollees when the plan extends the
timeframe for making its determination,
in accordance with the requirements in
this paragraph. We proposed to require
that the applicable integrated plan make
reasonable efforts to give the enrollee
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
prompt oral notice and give the enrollee
written notice within 2 calendar days.
These requirements align with current
Medicaid managed care regulations at
§ 438.408(c)(2). We also proposed that
the notice of the extension include the
reason for the delay and inform the
enrollee of the right to file an expedited
grievance if the enrollee disagrees with
the decision to extend the timeframe.
In paragraph (f)(4), we proposed
requirements for providing appellants
with notices regarding the resolution of
reconsiderations. We proposed to
require that applicable integrated plans
send notices within the resolution
timeframes established in this section
for all integrated reconsideration
determinations, paralleling the current
Medicaid managed care regulations
which require notices of all
determinations. We also proposed to
include language requiring that the
notice be written in plain language and
available in a language and format that
is accessible to the enrollee consistent
with section 1859(8)(B)(iii)(III) of the
Act. We also proposed, in paragraphs
(f)(4)(i) and (ii), to adopt the standards
similar to those governing the content of
a notice found in § 438.408(e)—namely,
that the plan must provide to the
enrollee a notice of the integrated
reconsideration for an adverse decision
that includes the reason for the decision
and the date of completion. We
proposed in paragraph (f)(4)(ii)(A) that,
for integrated notices not resolved
wholly in the enrollee’s favor, the notice
include an explanation of the next level
of appeal under both Medicare and
Medicaid, and the steps the enrollee
must take to further pursue the appeal.
We explained our expectation that the
integrated notice will enable the
enrollee to understand which program
covers the benefit at issue. We also
proposed in paragraph (f)(4)(ii)(B) that
the notice include specific information
about the ability to request continuation
of Medicaid-covered benefits pending
appeal.
We summarize and respond to the
comments on proposed § 422.633 as
follows:
Comment: Many commenters
supported our proposed requirements
related to integrated reconsiderations,
including the timeframes for applicable
integrated plans to resolve integrated
reconsiderations. One commenter
specifically supported the inclusion of
post-service appeals in the expedited
integrated reconsiderations process, at
§ 422.633(e), noting significant financial
need that may be present for dual
eligible individuals. Another
commenter supported the requirement
at § 422.633(f)(1) to use the same
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
timeframes and processes for pre-service
and post-service appeals to simplify the
process for enrollees. One commenter
opposed requiring post-service appeals
to follow the same decision timing as
pre-service appeals, requesting that
CMS instead apply the MA rules, which
allow 60 days for decision in postservice appeals cases to allow
applicable integrated plans more time to
gather necessary information, including
from enrollees, and potentially leading
to fewer plan denials of integrated
reconsiderations.
Response: We appreciate the support
for our proposed integrated
reconsideration requirements. We
clarify that the post-service appeals
timing applies to appeals from
noncontracted providers as well as to
enrollees. We understand the concern
related to obtaining all necessary
information to make a determination for
post-service integrated reconsiderations;
however, we decline to make a change
to our proposed requirements. As we
noted in the proposed rule (83 FR
55010–55011), Medicaid regulations at
§ 438.408(b)(2) do not distinguish
between pre-service and post-service
appeals—all appeals must be resolved
within 30 calendar days. We do not
believe the volume of post-service
appeals, which would generally be only
for payment, is high for dual eligible
individuals, and we believe it is more
protective of enrollees to have all
integrated reconsiderations resolved in
30 calendar days, particularly given
what may be significant financial needs
for these individuals.
Comment: Several commenters
expressed support for our proposed
requirement, at § 422.633(c), that
applicable integrated plans provide the
enrollee or the enrollee’s representative
with a copy of the enrollee’s case file for
free, to help eliminate barriers to
enrollees in obtaining this information.
A few commenters suggested we
establish specific timeframes for when
the case file should be provided to
ensure that it is provided timely, and a
commenter suggested that we require
the case file be sent automatically
whenever an appeal is filed, arguing
that such a requirement would be
consistent with Medicaid rules.
Response: We decline to modify the
regulation text at § 422.633(c) to
establish specific timeframes for
provision of the case file, since we are
adopting the existing requirements
related to case files for Medicaid
managed care plans at § 438.406(b)(5);
that Medicaid managed care regulation
does not include timeframes for sending
the case file but requires instead that the
records and information be provided
PO 00000
Frm 00063
Fmt 4701
Sfmt 4700
15741
sufficiently in advance of the resolution
timeframe for appeals. As proposed and
finalized, § 422.633(c) uses the same
standard. We believe this is sufficient
and decline to establish a specific
deadline for provision of these records
and information. We also decline to
specify that a plan send a case file for
every appeal filed. Rather, we believe
that making it clear to appellants that
they may request the case file at no
charge (for example, as part of the
denial notice) will be less burdensome
for all parties.
Comment: Several commenters
supported the requirement at
§ 422.633(d)(2) for applicable integrated
plans to accept oral requests without
requiring written follow up from the
enrollee, noting that this requirement
helps eliminate barriers for enrollees in
filing appeals. One commenter opposed
this requirement. One commenter
requested that applicable integrated
plans have discretion, as MA plans
currently do under guidance in the Parts
& D Enrollee Grievances, Organization/
Coverage Determination, and Appeals
Guidance § 50.2.1, to require written
follow-up when enrollees file oral
appeals because oral appeals can be
difficult to define, track, and
standardize.
Response: We thank the commenters
for their support of this requirement,
and decline to make any changes to it
at this time. We assume the comment
related to the guidance interpreting
§ 422.568(a)(1) and providing discretion
to MA plans on whether to allow oral
reconsiderations referred to the previous
version of the CMS Medicare Managed
Care Manual, Chapter 13, § 70.2, which
stated that an MA plan may choose to
accept an oral reconsideration. Similar
guidance was published more recently
(February 22, 2019) in an updated
version of the Parts C & D Enrollee
Grievances, Organization/Coverage
Determination, and Appeals Guidance,
§ 50.2.1. We agree that this requirement
is an important way to remove barriers
to filing appeals for enrollees related to
language, literacy, housing, and
behavioral health concerns. We believe
that requiring applicable integrated
plans to allow oral appeals from
enrollees without requiring the enrollee
to follow up in writing is most
consistent with the provision in section
1859(f)(8)(B)(ii)(I) of the Act requiring
us to adopt provisions that are most
protective for enrollees. In addition, we
have recently proposed making a similar
change for similar reasons to the
Medicaid managed care rule at
§ 438.402(c)(3)(ii) (see Medicaid and
Children’s Health Insurance Program
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15742
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
(CHIP) Managed Care (CMS–2408–P), 83
FR 57264, 57283 (November 14, 2018)).
Comment: One commenter requested
that, for expedited integrated
reconsiderations, we clarify our
regulations to align with current MA
guidance and explicitly state that
applicable integrated plans have three
calendar days to mail written
notification when verbal outreach to a
member is successful.
Response: We decline to adopt this
suggestion. Under § 422.633(f)(4), as
proposed and finalized in this rule, the
applicable integrated plan must send a
written determination notice within the
resolution timeframes regulations. For
expedited integrated reconsiderations,
these requirements are located at
§ 422.633(f)(2). In order to clarify the
regulation text and conform it to the
preamble of the proposed rule, we are
finalizing paragraph (f)(2) with revised
text stating that the applicable
integrated plan must resolve the
expedited integrated reconsideration as
expeditiously as the enrollee’s health
condition requires but no later than 72
hours from the receipt of the request.
Pursuant to paragraph (f)(4), this
timeframe will also apply to the
required written notice to the enrollee.
We are also revising the language in the
final rule regarding expedited integrated
reconsiderations under § 422.633(f)(2) to
clarify that the applicable integrated
plan must make reasonable efforts to
provide prompt oral notice of the
determination in addition to providing
the written notice, which aligns with
Medicaid rules that require oral
notification as a separate requirement
that is not tied to the timing of the
written notification (see
§ 438.408(d)(2)(ii)).
Comment: One commenter requested
that we clarify when the timeline begins
for the applicable integrated plan to
notify an enrollee of the decision to
extend the timeframe for deciding the
integrated reconsideration.
Response: We clarify that the
applicable integrated plan must notify
the enrollee that an extension is being
taken within two calendar days of when
the applicable integrated plan, after
considering the factors outlined in
§ 422.633(f)(3)(i), makes the decision to
take an extension. We are finalizing
revised regulation text at
§ 422.633(f)(3)(ii) to clarify this timing.
Comment: A few commenters
supported the requirement at
§ 422.633(f)(4) that applicable integrated
plans send a written determination in
all cases when an integrated
reconsideration is filed. They also
supported the content requirements for
the written determination notice. One
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
commenter noted that this notice should
include information on how to get
assistance with the next level of appeal.
Response: We thank the commenters
for their support of this requirement,
and we agree that information on how
to get assistance with the next step in
the appeal process is important and
useful information for the enrollee and
would be beneficial to include in the
notice. We are adding this content
requirement to the regulation at
§ 422.633(f)(4)(ii)(A). This information
may include the name and contact
information of, for example, the State
Health Insurance Assistance Program
(SHIP), a state ombudsman program if
one exists, or a legal aid office. State
Medicaid agencies may also have
appropriate local referrals.
For the reasons set forth in the
proposed rule and our responses to the
related comments, we are finalizing
§ 422.633 substantively as proposed, but
with some minor modifications from
proposed text as follows:
• At paragraph (c), we are revising the
last sentence to clarify that the records
must be provided sufficiently in
advance of the resolution timeframe for
the integrated reconsideration, or
subsequent appeal;
• At paragraphs (d)(1) and (d)(2), we
are including headings to aid the reader;
• At paragraph (f)(1), we have
modified the regulatory text to clarify
that an applicable integrated plan has a
maximum of 30 calendar days to resolve
the integrated reconsideration, but must
resolve it more quickly if the enrollee’s
health requires faster resolution. As
finalized, this language exactly parallels
the language from the MA requirement
at § 422.590(a);
• At paragraph (f)(2), we have
modified the regulatory text to clarify
that an applicable integrated plan has a
maximum of 72 hours to resolve the
expedited integrated reconsideration,
but must resolve it more quickly if the
enrollee’s health requires faster
resolution. As finalized, this language
exactly parallels the language from the
MA requirement at § 422.590(d)(1). We
also clarify in paragraph (f)(2) that an
applicable integrated plan must make
reasonable efforts attempt to provide
prompt oral notice of the determination
in addition to providing the written
notice;
• At paragraph(f)(3)(ii) we clarify the
timeframe for the applicable integrated
plan to notify the enrollee that an
extension is being taken; and
• At paragraph (f)(4), we are
finalizing regulatory text as proposed
with a modification to clarify that the
notice of resolution the applicable
integrated plan sends must be a written
PO 00000
Frm 00064
Fmt 4701
Sfmt 4700
notice, and to add, at paragraph
(f)(4)(ii)(A), a requirement that the
notice of resolution contain information
on how the enrollee can obtain
assistance in pursuing the next level of
appeal under each program.
(9) Effect (§ 422.634)
We proposed, at § 422.634(a), to use
the same standard as in existing MA and
Medicaid regulations related to a plan’s
failure to made a timely determination.
If an applicable integrated plan fails to
make a timely determination at any
point in the appeals process (for an
integrated organization determination or
an integrated reconsideration), that
failure would constitute an adverse
determination, such that the enrollee
could move forward with the next level
of appeal procedures (see
§§ 438.400(b)((b), 438.402(c)(1)(i)(A),
438.408(c)(3), 422.568(f), and
422.572(f)).
We proposed, at § 422.634(b), to
establish the next steps in the appeals
process if the enrollee receives an
adverse decision from the applicable
integrated plan on the integrated
reconsideration. For cases involving
Medicare benefits, we proposed, for
applicable integrated plans at
§ 422.634(b)(1)(i), to codify the
requirement that adverse
reconsiderations be reviewed and
resolved by an IRE, consistent with
section 1852(g)(4) of the Act and
existing § 422.592. In § 422.634(b)(1)(ii)
and (iii), we proposed to mirror existing
MA regulations (§ 422.590(a)(2) and
(d)(4)) 28 with requirements for
applicable integrated plans to forward
the case file to the independent entity
within set timeframes for both standard
and expedited integrated
reconsiderations.
At § 422.634(b)(2), we proposed that
for cases involving Medicaid benefits,
the enrollee may initiate a state fair
hearing no later than 120 calendar days
from the date of the applicable
integrated plan’s notice of resolution.
We also proposed to include the
requirement that a provider who has not
already obtained the written consent of
an enrollee must do so before filing a
request for a state fair hearing. We
explained in the proposed rule how we
intended the timeframe to mirror the
appeal right and requirement in the
Medicaid managed care regulation at
§ 438.408(f)(2) and (3).
We proposed, at § 422.634(c),
language providing that determinations
are binding on all parties unless the case
28 In the proposed rule (83 FR 55010), we
erroneously cited to § 422.590(d)(3) instead of (d)(4)
and use the correct reference here.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
is appealed to the next applicable level
of appeal. We also proposed to specify
that this means that, in the event that an
enrollee pursues an appeal in multiple
forums simultaneously (for example,
files for an external state medical review
and an integrated reconsideration with
the applicable integrated plan, and the
integrated reconsideration decision is
not in the enrollee’s favor but the
external state medical review decision
is), an applicable integrated plan would
be bound by, and must implement,
decisions favorable to the enrollee from
state fair hearings, external medical
reviews, and independent review
entities (IRE). As we explained in the
proposed rule, for Medicare benefits, the
adverse integrated reconsideration
would be automatically forwarded to
the IRE, pursuant to § 422.634(b)(1), and
thus the IRE’s determination in those
cases would ultimately be binding.
We proposed, at § 422.634(d),
requirements for how quickly services
must be put in to place for an enrollee
after he or she receives a favorable
decision on an integrated
reconsideration or state fair hearing. In
the first sentence of paragraph (d), we
proposed that if an applicable integrated
plan, or a state fair hearing with regard
to a Medicaid benefit, reverses a
decision to deny, limit, or delay services
that were not furnished while the
appeal was pending, the applicable
integrated plan must authorize or
provide the disputed services as
expeditiously as the enrollee’s condition
requires but not later than 72 hours. We
intended this to mean that when an
integrated organization determination or
integrated reconsideration decision is
favorable to the enrollee for any covered
services, and, for Medicaid benefits,
when a state fair hearing reverses an
applicable reconsideration (that is,
makes a decision that is favorable to the
enrollee with regard to Medicaid
benefits), the same timeframe for the
applicable integrated plan to provide
the benefits would apply. We also
proposed to cross-reference the existing
MA regulations at §§ 422.618 and
422.619 that provide how and when
disputed Medicare benefits must be
provided when an integrated
reconsideration denying benefits is
reversed at the post-plan level of appeal.
Finally, we also proposed in this
paragraph to maintain the same
effectuation timelines for reversals by
the Medicare independent review
entity, an administrative law judge or
attorney adjudicator at the Office of
Medicare Hearings and Appeals, or the
Medicare Appeals Council as apply to
other MA plans.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
We proposed, at § 422.634(e), for
Medicaid-covered benefits, to parallel
Medicaid requirements from
§ 438.424(b) governing how services that
were continued during the appeal must
be paid for, if the final determination in
the case is a decision to deny
authorization of the services. For
Medicare-covered services, we proposed
that the applicable integrated plan will
cover the cost of the benefit.
We received the following comments
regarding our proposed provisions at
§ 422.634, and our responses follow.
Comment: A commener supported the
proposed requirements at § 422.634.
Another commenter requested that we
align our requirement at § 422.634(b)(2)
with the proposed Medicaid managed
care rule to allow states to give enrollees
between 90 and 120 days to file for a
state fair hearing.
Response: We thank the commenter
for their support. Our intent in proposed
§ 422.634(b)(2) was to follow the
timeframes in the existing Medicaid
managed care requirements. Because we
have proposed a revision to the
Medicaid managed care rules (see
Medicaid and Children’s Health
Insurance Program (CHIP) Managed
Care (CMS–2408–P), 83 FR 57264
(November 14, 2018)), we are revising
the requirement at § 422.634(b)(2) to
refer to the timeline requirements in
§ 438.408(f)(2) rather than stipulating
those timelines in our final regulations.
By finalizing this cross-reference, the
timeframe for an enrollee to request a
state fair hearing will be the same
regardless of whether the enrollee is
appealing a decision by an applicable
integrated plan or a Medicaid managed
care plan.
After considering the comments and
for the reasons set forth in the proposed
rule and our responses to the related
comments, we are finalizing § 422.634
substantively as proposed, but with
some clarifying modifications at
paragraphs (a), (b), and (d). In paragraph
(a)(2), we are adding a citation to the
parallel Medicaid managed care rule at
§ 438.408(f) for the timeframe for an
enrollee to request a state fair hearing.
In paragraph (b)(2), we have revised the
text to cite to the state fair hearing in the
timeframe specified in § 438.408(f)(2),
rather than cite a specific timeframe, to
ensure alignment with Medicaid
managed care rules as described above.
In paragraph (d), we are finalizing the
first sentence with revisions to clarify
that the applicable integrated plan’s
reversals—of integrated organization
determinations and integrated
reconsiderations, as well as of state fair
hearing reversals—must be effectuated
by the applicable integrated plan within
PO 00000
Frm 00065
Fmt 4701
Sfmt 4700
15743
72 hours rather than the MA timeframe
in § 422.618(a). The regulation text
specifies that state fair hearing decisions
are only with regard to Medicaid
benefits. Post-plan level appeal decision
on Medicare benefits (that is, by the Part
C independent review entity, an
administrative law judge or attorney
adjudicator at the Office of Medicare
Hearings and Appeals, or the Medicare
Appeals Council) must be effectuated in
accordance with §§ 422.618, and
422.619.
(10) Unifying Medicare and Medicaid
Appeals Subsequent to Integrated
Reconsideration
The new section 1859(f)(8)(B)(ii) of
the Act directs us to include, to the
extent we determine feasible,
consolidated access to external review
under an integrated process. We
interpret ‘‘external review’’ in this
statutory provision as meaning review
outside the plan, including by a
government agency or its designee. For
MA, this includes the independent
review entity (IRE) and ALJ review
described in §§ 422.592 through
422.602. For Medicaid, this includes the
state fair hearing process described in
Part 431 Subpart E, as well as any
additional external review offered under
state law.
We believe that such a process could
offer benefits to beneficiaries, plans,
states, and the federal government.
Currently, once a D–SNP or Medicaid
managed care plan makes a final
decision on an appeal, the federallyadministered Medicare and stateadministered Medicaid appeals
processes are entirely separate.
Although they have some common
principles, such as ensuring access to an
independent administrative hearing,
they differ in many respects. In the
proposed rule (83 FR 55012 through
55015), we detailed the considerable
challenges of unifying D–SNP and
Medicaid appeals subsequent to the
reconsideration level.
Based on these complexities, we
stated in the proposed rule our belief
that it is not feasible to propose a
unified post-plan appeals process (that
is, adjudication of appeal subsequent to
an applicable integrated plan’s
integrated reconsideration of an initial
adverse determination) at this time.
Instead, we solicited comments on
viable paths forward given the
constraints presented by the statutory
mandates for the MA and Medicaid
appeals processes and our experience
gained through demonstrations. We
received comments from six
commenters. Overall, the commenters
expressed support for continued efforts
E:\FR\FM\16APR2.SGM
16APR2
15744
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
to move forward in this area in the
future. We thank these commenters for
the time and effort expended on
providing us with comments on the
establishment of a unified post-plan
appeals process in potential future
rulemaking. We will take the comments
into consideration as we continue work
on this issue.
(11) Conforming Changes to Medicare
Managed Care Regulations and
Medicaid Fair Hearing Regulations
(§ 422.562, § 422.566, § 438.210,
§ 438.400, and § 438.402)
We proposed a number of changes to
Medicaid managed care, Medicaid fair
hearing, and Medicaid single state
agency regulations to conform with our
proposed unified grievance and appeals
provisions. Following is a summary of
these proposed changes.
• In § 422.562(a)(1)(i) and (b), we
proposed to add cross references to the
proposed integrated grievance and
appeals regulations along with new text
describing how the provisions proposed
in this rule for applicable integrated
plans would apply in place of existing
regulations.
• In § 422.566, we proposed to add
additional language to paragraph (a) to
establish that the procedures we
proposed in this rule governing
integrated organization determinations
and integrated reconsiderations at
proposed § 422.629 through § 422.634
apply to applicable integrated plans in
lieu of the procedures at §§ 422.568,
422.570, and 422.572.
• In § 438.210(c) and (d)(4), we
proposed to add cross references to the
proposed integrated grievance and
appeals regulations along with new text
describing how the provisions proposed
in this rule for applicable integrated
plans would apply in place of existing
regulations to determinations affecting
dual eligible individuals who are also
enrolled in a D–SNP with exclusively
aligned enrollment, as those terms are
defined in § 422.2. In § 438.210(f), we
proposed to make these Medicaid
changes applicable to applicable
integrated plans no later than January 1,
2021, but, consistent with our
discussion earlier on the effective dates
of our proposed unified appeals and
grievance procedures overall, we would
not preclude states from applying them
sooner.
• In § 438.400, we proposed adding a
new paragraph (a)(4) to include the
statutory basis for the proposed
integration regulations (section
1859(f)(8) of the Act). We also proposed
to amend § 438.400(c) to clarify that
these Medicaid changes apply to
applicable integrated plans no later than
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
January 1, 2021, but, consistent with our
discussion elsewhere in this final rule,
we would not preclude states from
applying them sooner.
• In § 438.402, we proposed
amending paragraph (a) to allow a
Medicaid managed care plan operating
as part of an applicable integrated plan
to the grievance and appeal
requirements laid out in §§ 422.629
through 422.634 in lieu of the normally
applicable Medicaid managed care
requirements.
We received the following comments,
and our responses follow.
Comment: We received several
comments related to the effective date
for the unified grievance and appeals
procedures, including our statement in
the proposed rule that states could
require applicable integrated plans to
implement such procedures prior to
January 1, 2021, using the state
Medicaid managed care contract and the
contract with the D–SNP required under
§ 422.107. Some commenters objected to
earlier implementation, noting the many
processes that applicable integrated
plans will need to complete, such as
systems changes, staff training, policy
and procedure development and
implementation, and developing
enrollee communication materials, as
well as the need for CMS to release
further guidance prior to the effective
date. One commenter noted that
applicable integrated plans need all
final guidance from CMS one year prior
to implementation. Another commenter
supported early implementation,
provided such early implementation
would be on a trial basis only, and plans
would not be subject to intermediate
sanctions, penalties, or audits.
Response: We understand the
commenters’ concerns about the need
for sufficient time to implement the
unified grievance and appeals processes
we are finalizing in this rule. As we
stated in the proposed rule, these
processes will apply to a relatively
small subset of states and plans, and
while early implementation at state
option is possible, we do not anticipate
many states implementing the processes
earlier than required (that is, beginning
January 1, 2021) for many of the reasons
cited by these commenters. However,
CMS will work closely with any state
interested in early implementation to
ensure that impacted applicable
integrated plans have the guidance they
need.
For the reasons explained in the
proposed rule and our responses to
comments, we are finalizing
substantively as proposed the
conforming changes to §§ 422.562,
422.566, 438.210, 438.400, and 438.402.
PO 00000
Frm 00066
Fmt 4701
Sfmt 4700
We are making the following additional
non-substantive changes to the noted
regulations:
• We are modifying the regulatory
text at § 422.562(a)(1)(i), (b)(1), (b)(2),
(b)(3), (b)(4)(i), and (b)(4)(ii), and at
§ 422.566(a), to clarify that the effective
date of the unified appeals and
grievance processes finalized in this
rule is January 1, 2021. We are also
making a minor grammatical change to
§ 422.566(a) to make the language
addressing applicable integrated plans a
separate sentence.
• We are changing ‘‘MA plans’’ to
‘‘Medicare Advantage plans’’ in
§ 438.400(a)(4) because the term ‘‘MA
plans’’ is not defined Part 438.
• We are finalizing § 438.402
substantively as proposed, but with
some modifications to clarify that, for
post-plan appeals of Medicaid benefits,
state fair hearing processes and requests
are subject to § 438.408(f).
• We are changing ‘‘section’’ to ‘‘part’’
in § 438.400(c)(2) to clarify that the
provisions affecting applicable
integrated plans throughout Part 438 are
applicable no later than January 1, 2021.
3. Prescription Drug Plan Sponsors’
Access to Medicare Parts A and B
Claims Data Extracts (§ 423.153)
a. Background
This final rule sets forth the manner
in which CMS will implement section
50354 of the Bipartisan Budget Act of
2018 (BBA), Public Law 115–123,
enacted on February 9, 2018. Section
50354 amends section 1860D–4(c) of the
Social Security Act by adding a new
paragraph (6) entitled ‘‘Providing
Prescription Drug Plans with Parts A
and B Claims Data to Promote the
Appropriate Use of Medications and
Improve Health Outcomes’’.
Specifically, section 1860D–4(c)(6)(A),
as added by section 50354 of the BBA,
provides that the Secretary shall
establish a process under which the
sponsor of a Prescription Drug Plan
(PDP) that provides prescription drug
benefits under Medicare Part D may
request, beginning in plan year 2020,
that the Secretary provide on a periodic
basis and in an electronic format
standardized extracts of Medicare
claims data about its plan enrollees.
Such extracts would contain a subset of
Medicare Parts A and B claims data as
determined by the Secretary. In defining
the specific data elements and time
frames for the Parts A and B claims data
included in such extracts, hereinafter
referred to as ‘‘Medicare claims data,’’
the Secretary is instructed, at section
1860D–4(c)(6)(D) of the Social Security
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Act, to include data ‘‘as current as
practicable.’’
Section 1860D–4(c)(6)(B) of the Act,
as added by section 50354 of the BBA,
further specifies that PDP sponsors
receiving such Medicare claims data for
their corresponding PDP plan enrollees
may use the data for: (i) Optimizing
therapeutic outcomes through improved
medication use; (ii) improving care
coordination so as to prevent adverse
healthcare outcomes, such as
preventable emergency department
visits and hospital readmissions; and
(iii) for any other purposes determined
appropriate by the Secretary. Finally,
section 1860D–4(c)(6)(C) states that the
PDP sponsor may not use the data: (i) To
inform coverage determinations under
Part D; (ii) to conduct retroactive
reviews of medically accepted
conditions; (iii) to facilitate enrollment
changes to a different PDP or a MA–PD
plan offered by the same parent
organization; (iv) to inform marketing of
benefits; or (v) for any other purpose the
Secretary determines is necessary to
include in order to protect the identity
of individuals entitled to or enrolled in
Medicare, and to protect the security of
personal health information.
khammond on DSKBBV9HB2PROD with RULES2
b. Provisions of the Proposed Rule
To implement the new statutory
provision at section 1860D–4(c)(6) of the
Act, as added by section 50354 of the
BBA, we proposed to add a new
paragraph (g) at § 423.153. We
summarize our proposals and comments
received and provide our responses and
final decisions.
c. Purposes and Limitations on the Use
of Data
In accordance with section 1860D–
4(c)(6)(B) of the Act we proposed to
limit the purposes for which PDP
sponsors are permitted to use the
Medicare claims data. Consistent with
the statute, we proposed at
§ 423.153(g)(3) that PDP sponsors would
be permitted to use Medicare claims
data to optimize therapeutic outcomes
through improved medication use, and
to improve care coordination so as to
prevent adverse health outcomes. In
addition, we proposed to permit PDP
sponsors to use Medicare claims data for
the purposes described in the first or
second paragraph of ‘‘health care
operations’’ under 45 CFR 164.501, or
that qualify as ‘‘fraud and abuse
detection or compliance activities’’
under 45 CFR 164.506(c)(4). We also
proposed to permit disclosures that
qualify as a ‘‘required by law’’
disclosure as defined at 45 CFR 164.103.
In accordance with section 1860D–
4(c)(6)(C) of the Act, we proposed
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
specific limitations on how Medicare
claims data provided to the PDP
sponsors may be used. Consistent with
statutory limitations, we proposed that
PDP sponsors must not use Medicare
claims data provided by CMS under this
subsection for any of the following
purposes: (1) To inform coverage
determinations under Part D; (2) to
conduct retroactive reviews of
medically accepted indications
determinations; (3) to facilitate
enrollment changes to a different
prescription drug plan or an MA–PD
plan offered by the same parent
organization; or (4) to inform marketing
of benefits.
Section 1860D–4(c)(6)(C)(v) of the Act
provides that the Secretary may place
additional limitations on the use of
Medicare claims data as necessary to
protect the identity of individuals
entitled to, or enrolled in, benefits
under Part D, and to protect the security
of personal health information.
Therefore, we also proposed to require
that the PDP sponsor contractually bind
its Contractors that will be given access
to Medicare claims data, and to require
those contractors to contractually bind
any further downstream data recipients,
to the terms and conditions imposed on
the PDP Sponsor. In addition, we
proposed to allow CMS to refuse future
releases of Medicare claims data if it
determines or has a reasonable belief
that the PDP sponsor has made
unauthorized uses, reuses, or
disclosures of prior data received under
this provision. We also proposed that a
PDP sponsor would have to complete a
data attestation as part of the data
request process to ensure an
understanding of the purposes for
which the Medicare claims data may be
used and the limitations on its reuse,
and redisclosure.
Comment: A commenter
recommended CMS explore ways to
share the same Parts A and B claims
data with Medicare Advantage (MA)
plans and Cost plans.
Response: We appreciate the
suggestion that CMS explore ways to
share the same Medicare data with MA
plans and Cost plans. While we
understand that this data may be helpful
to MA and Cost plans, section 1860D–
4(c)(6)(A) only provides that the
Secretary shall establish a process for
the sponsor of a Prescription Drug Plan
(PDP) sponsor. We are continuing to
evaluate additional pathways for data
sharing and may consider data sharing
with MA plans and Cost plans in the
future.
Comment: A commenter requested
additional clarification on how the data
could be used for fraud and abuse
PO 00000
Frm 00067
Fmt 4701
Sfmt 4700
15745
detection purposes. Specifically, the
commenter requested that CMS clarify
that while PDP sponsors may not use
the Parts A and B data to change
individual coverage determinations
decisions alone, they may review this
data as part of an effective fraud and
abuse detection program.
Response: We appreciate the request
to clarify the relationship between the
prohibition that PDP sponsors must not
use the Medicare claims data provided
under this provision to change
individual coverage determination
decisions with the permissible use of
the Medicare claims for fraud and abuse
detection or compliance activities. As
stated earlier, the statutory language
prohibits the use of the Medicare claims
data to inform coverage determinations
under Part D and to conduct retroactive
reviews of medically accepted
determinations. There are a number of
fraud and abuse detection or
compliance activities that the Medicare
claims data can be used for that would
not impact an individual Medicare
enrollee’s coverage determination under
Part D. For instance, the PDP sponsor
could use the Medicare claims data to
create algorithms that detect fraud and
abuse and this information could be
used to inform future policies or
procedures. PDP sponsors also could
use the Medicare claims data for
internal and external audits or to
identify fraud and abuse activities by
providers and suppliers. We also
encourage the PDP sponsors to refer to
the current compliance and fraud,
waste, and abuse programs that are in
place under the Part D Sponsor
compliance program and the suggested
elements that CMS has provided to Part
D sponsors to consider when developing
these programs.
Comment: Most commenters
supported CMS’s proposal for the
permitted uses of the data. A few
commenters suggested additional
permissible uses of the data. A
commenter suggested that CMS allow
the use of Medicare claims data for
value-based contracting. Another
commenter encouraged CMS to include,
as a permissible use, use of the data to
make favorable coverage determination
decisions. Finally, a commenter
suggested that CMS permit plan
sponsors to use the data for any other
purpose for which protected health
information can be used under HIPAA,
including as de-identified data.
Response: We thank commenters for
their support of the proposal. When we
considered expanding the permitted
uses of the data provided to the PDP
sponsors beyond the statutory uses, we
took into account a number of factors.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15746
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
First, we examined the purpose for
which Medicare claims data is
provided, namely to promote the
appropriate use of medications and
improve health outcomes. Second, we
considered the statutory limitations
imposed on the use of the data,
specifically that the data not be used to
inform coverage determinations or to
conduct retroactive review of medically
accepted indications. Finally, we took
into account that this is a new data
disclosure. Therefore, we decided to
make the additional permitted uses
narrow. While we will not expand the
permitted uses as suggested at this time,
we will continue to assess whether
additional permissible uses of the data
should be proposed in future
rulemaking.
Comment: A commenter requested
CMS release more specific guidance on
how the data could potentially be used
and provide for additional comment
opportunities so feedback can be shared
with CMS.
Response: We thank the commenter
and believe that the rule provides
adequate information on the limits and
permissible uses of the data under this
section. We will continue to assess the
program to determine if additional
guidance is needed and welcome
stakeholders to provide additional
feedback or seek clarification on
program requirements. If CMS makes
future changes to the regulatory
requirements of this program, then
stakeholders will be able to provide
feedback during that rulemaking
process.
Comment: A few commenters
recommended that CMS not expand the
permissible uses beyond what was
explicitly provided for in statute. These
commenters were concerned that the
expanded uses conflict, or have the
potential to conflict, with the directive
in the statute that PDPs may not use this
information ‘‘to inform coverage
determinations under Part D’’ or to
conduct retroactive reviews of
medically accepted indications. In
particular, they were concerned about
the use of the data for fraud and abuse
detection and compliance activities.
They encouraged CMS to limit
disclosures under this authority to those
expressly allowed by statute, to monitor
plan’s use of the data, and only consider
expansion after the Secretary has
evaluated plans’ actual use of this data
as well as the agency’s audit and review
capacity.
Response: We thank commenters for
this feedback. Section 1860D–
4(c)(6)(B)(iii) of the Act states that the
Secretary can determine if there are
other appropriate purposes for which
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
the data can be used. Therefore,
consistent with this statutory authority,
we proposed to narrowly expand on the
permitted uses of the Medicare claims
data based on the factors discussed
earlier. In terms of concerns about the
use of the data for fraud and abuse
detection and compliance activities, we
clarified previously that the use of the
claims data would still need to comply
with the statutory limitations on the use
of the data at § 423.153(g)(4). These
fraud and abuse activities would not
focus on an individual Medicare
enrollee’s Part D coverage, but rather,
these fraud and abuse detection and
compliance activities would be aimed at
plans and providers/suppliers. In
addition, as discussed in the proposed
rule, we believe that PDP sponsors are
required to comply with the applicable
HIPAA rules, so they would have
extensive experience ensuring that data
is only used and disclosed as permitted
or required by applicable laws. We
believe that PDP sponsors understand
and will abide by their obligations
regarding the permitted uses and
limitations on the use of Medicare data
provided under this provision.
Comment: A few commenters
disagreed with the limitations on using
these data for coverage determinations
and to conduct retroactive reviews of
medically accepted indications
determinations. A commenter stated
that with access to claims data, PDP
sponsors would be better positioned to
identify appropriate interventions
related to medication adherence, opioid
overutilization, risk adjustment and
other medication management related
requirements of PDP sponsors. Another
commenter stated that because plan
sponsors that offer standalone Part D
benefits (PDP sponsors) have no
contracts with prescribing providers,
they currently have no mechanism for
ensuring that medications are
appropriate. They further asserted that
access to claims data would allow PDP
sponsors to validate whether
prescriptions are medically supported,
as well as to identify other interventions
related to opioid overutilization,
medication adherence, risk adjustment
and other functions related to
requirements for Part D sponsors.
Response: We appreciate the feedback
on the limitations on the use of the data;
however, the statutory language at
section 1860D–4(c)(6)(C) of the Act
states that PDP sponsors must not use
Medicare claims data provided by CMS
under this subsection for any of the
following purposes: (1) To inform
coverage determinations under Part D;
(2) to conduct retroactive reviews of
medically accepted indications
PO 00000
Frm 00068
Fmt 4701
Sfmt 4700
determinations; (3) to facilitate
enrollment changes to a different
prescription drug plan or an MA–PD
plan offered by the same parent
organization; or (4) to inform marketing
of benefits.
Comment: A number of commenters
requested clarification that the
permissible uses and limitations
provided in this rule only apply to the
Medicare data received under this
provision and not to Medicare data that
is obtained through other data
disclosure pathways. For instance, a
commenter requested that CMS clarify
that Medicare data obtained through
different sources may still be used for
coverage determinations and to
determine medically accepted
indications. Another commenter
requested clarification on how the
permissible and impermissible use of
this claims data will be taken into
account for purposes of audits and other
reviews—specifically, they requested
confirmation that PDP sponsors will not
be penalized for failing to implement
Medically Accepted Indications (MAI)
and other restrictions, even if the plan
sponsor has Medicare claims data on
hand since PDP sponsors are explicitly
prohibited from using the Medicare
claims data provided under this
provision to conduct retroactive reviews
of medically accepted indications
determinations.
Response: We appreciate the request
for clarification. The limitations and
permissible uses of the Medicare claims
data at § 423.513(g)(3) and (4) only
apply to the data received under the
authority of section 1860D–4(c)(6) of the
Act. Medicare claims data provided to
PDP sponsors under another program or
pathway are subject to those program
requirements. PDP sponsors are not
permitted to use the Medicare claims
data provided under this provision for
any of the impermissible purposes
specified by the statute at section
1860D–4(c)(6)(C). Therefore, we do not
see how a PDP sponsor would be held
accountable for not using that Medicare
claims data in a manner that conflicts
with the statutory requirements.
Comment: We received several
comments on the requirement that PDP
sponsors complete a data attestation as
part of the data request process. A few
commenters questioned whether an
attestation is sufficient to ensure
compliance and urged CMS to monitor
Part D plan sponsors’ use of the data to
ensure restrictions are enforced. A
commenter expressed concern that PDP
sponsors do not need to show with any
specificity how they intend to use the
data or the results that they expect.
Another commenter recommended CMS
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
not adopt an attestation requirement
given the statutory obligations on plans
relating to their use of the Medicare
data. Another commenter mentioned
that they would provide comments on
the data attestation as part of the PRA
process.
Response: Section 1860D–4(c)(6)(C)(v)
of the Act provides that the Secretary
may place additional limitations on the
use of Medicare claims data as
necessary to protect the identity of
individuals entitled to, or enrolled for,
benefits under Part D, and to protect the
security of personal health information.
In proposing additional limitations on
the use of the Medicare data, we sought
to balance the burden on PDP plans
with CMS’ commitment to ensuring
beneficiary-level data is protected by
strict privacy and security requirements.
We believe that the data attestation
requirement is a means of ensuring an
understanding of, and compliance with,
the terms and conditions of data access
and seeks an appropriate balance. In
terms of monitoring, we will pursue any
complaints regarding a PDP sponsor’s
violation of program requirements. We
would emphasize that CMS may refuse
to make future releases of Medicare
claims data to a PDP sponsor if the
Agency makes a determination or has a
reasonable belief that unauthorized
uses, reuses, or disclosures have taken
place. We believe this approach to
monitoring is sufficient since we believe
that PDP sponsors are required to
comply with the HIPAA rules.
Therefore, they have experience
ensuring that data can only be used and
disclosed for specific purposes. We
believe that PDP sponsors understand
and will abide by their obligations
regarding the permitted uses and
limitations on the Medicare data under
this provision. However, as this program
is implemented, we will continue to
monitor and assess our program
compliance policies to determine if
additional oversight or guidance
materials are needed on the use of the
data.
In terms of the PRA process, we
published a stand-alone 60-day Federal
Register notice that set out the
requirements and burden associated
with the request and attestation
(November 30, 2018; 83 FR 61638). We
are also realigning the provision with
this rulemaking by setting out such
requirements and burden in section
III.B.4 of this final rule. In this regard
we will not be publishing a stand-alone
30-day Federal Register notice.
Comment: A commenter requested
clarification as to PDP sponsors’ access
to the data (for example, single point
person or multiple individuals within
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
the PDP permitted to access the data
extract).
Response: As discussed earlier, we
believe that PDP sponsors are required
to comply with the HIPAA Rules,
including Privacy, Security and Breach
Notification requirements. They are
accustomed to dealing with limitations
on the use and disclosure of data. We
expect that they will designate a data
custodian as the recipient, and establish
policies and procedures as to use and
disclosure that will comply with all
applicable law, including this program’s
data usage limitations, and the limits on
use and disclosure under the HIPAA
regulations, including the minimum
necessary concept.
We are finalizing the policy as
proposed.
d. Data Request
Section 1860D–4(c)(6)(A) of the Act
provides that the Secretary shall
establish a process under which a PDP
sponsor of a prescription drug plan may
submit a request for the Secretary to
provide the sponsor with standardized
extracts of Medicare claims data for its
enrollees. Therefore, we proposed at
§ 423.153(g)(1) to establish a process by
which a PDP sponsor may submit a
request to CMS to receive standardized
extracts of Medicare claims data for its
enrollees. We proposed to accept data
requests on an ongoing basis beginning
January 1, 2020. We proposed to require
that such data requests be submitted in
a form and manner specified by CMS.
Consistent with the discretion accorded
to the Secretary under section 1860D–
4(c) (6)(D) of the Act, we proposed not
to allow PDP sponsors to request data
for subsets of their enrolled beneficiary
populations. We proposed allowing
requests to be submitted without an end
date, such that the request, once
reviewed for completeness and
approved, would remain in effect until
one or more of the following occur: the
PDP sponsor notifies CMS that it no
longer wants to receive Medicare claims
data, CMS cancels access to Medicare
claims data when a PDP sponsor leaves
the Part D program, or CMS concludes
or has a reasonable belief, at its sole
discretion, that the PDP sponsor has
used, reused or disclosed the Medicare
claims data in a manner that violates the
requirements of section 1860D–4(c)(6) of
the Act and § 425.153(g). Upon receipt
of the request from the PDP sponsor and
the PDP’s execution of an attestation
discussed earlier, and review for
completeness and approval of the
application by CMS or its contractor, we
proposed that the PDP sponsor would
be provided access to Medicare claims
data. We note that access to Medicare
PO 00000
Frm 00069
Fmt 4701
Sfmt 4700
15747
claims data will be further subject to all
other applicable laws, including, but not
limited to, the part 2 regulations
governing access to certain substance
abuse records (42 CFR part 2).
Comment: One commenter expressed
concern about providing information on
the entire membership on a continuous
basis regardless of whether the Part D
plan needs the complete data set or
membership.
Response: We believe that in order to
accomplish the purposes of the statute
to promote the appropriate use of
medications and improve health
outcomes that the PDP sponsor will
need Medicare claims data for all of its
enrollees. We also believe that this
approach is consistent with the
discretion afforded to the Secretary
under section 1860D–4(c)(6)(D) of the
Act.
Comment: A commenter requested
that CMS clarify how this will comply
with the regulations governing the
disclosure of substance use disorder
data and address whether PDP sponsors
will be required to scrub the substance
use disorder data from the extract.
Response: In compliance with the part
2 regulations governing access to certain
substance abuse records (42 CFR part 2),
we do not anticipate providing
substance use disorder data to PDP
sponsor under this program.
We are finalizing the policy as
proposed.
e. Data Extract Content
Section 1860D–4(c)(6)(D) of the Act
provides the Secretary with the
discretion to determine the time frame
and claims data under Parts A and B to
be included in the standardized extracts
provide to PDP sponsors. To develop a
proposed data set to include in the
standardized extracts of Medicare
claims data, we first considered what
Medicare claims data PDP sponsors
might require if they were to undertake
the activities expressly permitted by
section 1860D- 4(c)(6)(B) of the Act. In
doing so, we attempted to limit the data
set to the minimum data that we believe
PDP sponsors would need to carry out
those statutory activities and the
additional activities we proposed to
permit under § 423.153(g)(3). That is, we
sought to establish data access limits
that would comport with the HIPAA
Privacy Rule’s minimum necessary
concept at 45 CFR 164.502(b) and
164.514(d), and CMS’ policy-driven data
release policies.
We proposed that data from all seven
claim types, including inpatient,
outpatient, carrier, durable medical
equipment, hospice, home health, and
skilled nursing facility data, would be
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15748
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
required to carry out the permitted uses
of the data under section 1860D–
4(c)(6)(B) of the Act and the proposed
provision at § 423.153(g)(3). Because
section 1860D–4(c)(6) of the Act focuses
on providing Medicare claims data to
promote the appropriate use of
medications and improve health
outcomes, we proposed to initially
include the following Medicare Parts A
and B claims data elements (fields) in
the standardized extract: An enrollee
identifier, diagnosis and procedure
codes (for example, ICD–10 diagnosis
and Healthcare Common Procedure
Coding System (HCPCS) codes); dates of
service; place of service; provider
numbers (for example, NPI); and claim
processing and linking identifiers/codes
(for example, claim ID, and claim type
code). We proposed that CMS would
continue to evaluate the data elements
provided to PDP sponsors to determine
if data elements should be added or
removed based on the information
needed to carry out the permitted uses
of the data. Any proposed changes
would be established through
rulemaking.
We next considered the beneficiary
population for which we should draw
the identified data elements, and what
time span of data would best serve PDP
sponsors while honoring the
requirement at section 1860D–4(c)(6)(D)
of the Act that the data should be as
current as practicable. Therefore,
because only the most timely data is
needed for care coordination purposes,
we proposed at § 423.153(g)(2) to draw
the standardized extracts of Medicare
claims data for items and services
furnished under Medicare Parts A and
B to beneficiaries who are enrolled in a
Part D plan offered by the Part D
sponsor at the time of the disclosure.
We proposed to make standardized data
extracts available to eligible PDP
sponsors at least quarterly, as described
earlier, but only on a specified release
date that would be applicable to all
eligible PDP sponsors. We also
anticipate that Medicare claims data
would be provided at least quarterly
with approximately a 3-month lag from
the last day of the last month of the
prior quarter. In addition, given the
permitted uses of the data, we proposed
to use a standard format to deliver the
resulting data to each PDP sponsor with
standard format extracts, meaning that
CMS would not customize the extracts
for a PDP sponsor. We believe that these
standardized data extracts would
provide PDP sponsors with the
minimum data necessary to carry out
the permitted uses specified in section
1860D–4(c)(6)(B) of the Act and as
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
proposed at § 423.153 (g)(3). We
solicited comments about the proposed
frequency and contents of the
standardized data extracts.
Comment: We received a few
comments seeking clarification on the
standardized data extract. A commenter
requested clarification about the
inclusion of Part A and B data furnished
by MA plans. Another commenter
requested clarification that the data feed
includes enrollees who may not be new
to Medicare coverage, but are new to the
health or PDP sponsor. A commenter
requested the inclusion of Part D claims
data for lives enrolled in or attributed to
MA Plans and ENHANCED Track ACOs.
Response: We appreciate commenters’
request for clarification. We proposed at
§ 423.153(g)(2) to draw the standardized
extracts of Medicare claims data for
items and services furnished under
Medicare Parts A and B to beneficiaries
who are enrolled in a Part D plan
offered by the Part D sponsor at the time
of the disclosure. The standardized data
extract only includes Parts A and B
claims data furnished under Medicare
as there are no Part A and B data for MA
plans. The standardized extract also
does not include Part D data. We would
also clarify that the standardized data
extract will include all enrollees for a
PDP sponsor at the time of the
disclosure. Therefore, if an enrollee is
new to the PDP sponsor, but not to
Medicare, that enrollee will be included
in the standardized extract.
Comment: A commenter
recommended that CMS provide itself
flexibility to not have to amend the
rules every time it changes the data
elements included in the data extract.
Response: We appreciate the
commenter’s suggestion, however, CMS
believes that it is necessary to provide
stakeholders with the opportunity to
comment on any proposed data
variables to ensure they are necessary to
carry out the statutory activities and the
additional activities that are proposed to
be permitted under § 423.153(g)(3).
Comment: Several commenters were
supportive of the data elements that
were proposed. However, a commenter
suggested that Hierarchical Condition
Category (HCC) and Prescription Drug
Hierarchical Condition Category
(RxHCC), which are risk adjustment
scores, would also be beneficial as they
could be used to assess the degree of
morbidity and potential morality
associated with a beneficiary to
determine whether there is a need for
outreach or interventions, which would
improve medication outcomes, and for
identifying potential fraud and abuse.
Another commenter suggested the
inclusion of national drug codes (NDC),
PO 00000
Frm 00070
Fmt 4701
Sfmt 4700
lab results, and patient reported
outcomes to support the evaluation of
effectiveness of value-based contracts.
Response: We appreciate the
suggested additions to the data
variables. We do not believe that the
HCC and RxHCC risk scores that are
used to set payment rates are
consistently informative for the
purposes for which data is made
available under this regulation, namely
to provide PDPs with information that
allows them to optimize therapeutic
outcomes through improved medication
use, and to improve care coordination
so as to prevent adverse health
outcomes. The claims data that will be
provided under this regulation will
provide a comprehensive clinical
picture of each member, including
utilization, cost, and diagnostic
information. We do not believe that risk
scores would provide significant
information above and beyond what the
claims data will provide. Further, risk
scores for a year are not finalized until
after that year is complete, and
therefore, to the extent they
theoretically could be pertinent for
some aspect of care coordination, would
not be complete until after treatment
decisions have been made. We also note
that if a PDP sponsor were to want the
risk score of their members, they receive
their Part D risk scores monthly, along
with a report of the specific HCCs that
contribute to those scores. If they
believe that Part C risk scores would be
helpful—that is, risk scores that
predicted relative expected
expenditures for Part A and B services—
they would have the data available to
them to calculate these risk scores with
the claims data. With respect to the
NDC, Part A claims data do not include
NDC, and only very rarely is the NDC
included on the Part B claims data. The
statute instructs the Secretary to provide
claims data, in which NCDs are
generally not available. Therefore, we
do not have the authority under this
program to supplement the claims data
made available under this provision.
Finally, CMS also does not have access
to lab results or patient reported
outcomes in parts A and B claims data,
and therefore would be unable to
provide that information.
Comment: One commenter suggested
adopting an existing standard format for
Parts A and B data after soliciting and
considering stakeholder feedback.
Response: We anticipate that the data
will be provided in standard data
format. CMS will publish the standard
format publicly once it is finalized. As
this provision is implemented, we will
continue to seek feedback on the data
format.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Comment: A number of commenters
urged CMS to make data available as
real-time and with as short of a lag time
as possible, for instance on a monthly
basis.
Response: We recognize that more
timely data with a shorter lag time
would be helpful to PDP sponsors in
achieving the goals of this program.
Currently, our infrastructure only
supports delivery of quarterly data
extracts that have roughly a five-month
lag time. Our goal is to provide the
Medicare data as timely and with as
little of a lag in the claims data as
possible and are striving to meet this
goal.
Comment: A few commenters
suggested providing historical data for
enrollees. A commenter suggested
providing historical data as it is critical
to support the execution of value-based
contracts and suggested a look back
period of at least a year, similar to the
Enhanced Medication Therapy
Management (EMTM) program. Another
commenter suggested providing
historical data for the creation of valuebased care tools to avoid counter
indications. Another commenter
recommended a 14-month look back
similar to the Bundled Payment for Care
Improvement Initiative (BPCI).
Response: Section 1860D–4(c)(6)(D) of
the Act provides that the Secretary shall
make standardized extracts available to
PDP sponsors with data that is the most
current as practicable. While we
understand that historical data may
assist PDP sponsors, we must adhere to
the statutory language. As this program
matures, PDP sponsors will amass
historical data.
Comment: A commenter suggested the
use of an Application Programming
Interface (API) given the volume of
Medicare claims data that will be
provided to PDP sponsors. This
commenter also suggested leveraging
the process established through Blue
Button 2.0 to allow beneficiaries to
release Parts A and B claims directly to
PDP plan sponsors.
Response: We appreciate this
comment and will explore leveraging an
API to enhance data releases to PDP
sponsors.
Comment: Another commenter
requested clarification on the term
‘‘process and ship the data extracts.’’
Response: Under the current data
fulfillment process, CMS receives the
approved request for data. A CMS
contractor then extracts the data based
on the cohort criteria, validates and
performs a quality check on the data
extract, and ships the data on an
encrypted external hard drive to PBP
sponsors.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Comment: A commenter believed that
the CMS Health Plan Management
System (HPMS) would be an adequate
delivery system for the data extracts.
Response: We would clarify that the
Medicare claims data extracts will be
shipped to PDP sponsors, however, we
are exploring the use of the CMS HPMS
for submission of the data request by
PDP sponsors.
We are finalizing the policies as
proposed.
B. Improving Program Quality and
Accessibility
1. Medicare Advantage and Part D
Prescription Drug Plan Quality Rating
System (§§ 422.162(a) and 423.182(a),
§§ 422.166(a) and 423.186(a), §§ 422.164
and 423.184, and §§ 422.166(i) and
423.186(i))
a. Introduction
Last year, in the April 2018 final rule,
CMS codified at §§ 422.160, 422.162,
422.164, and 422.166 (83 FR 16725
through 83 FR 16731) and §§ 423.180,
423.182, 423.184, and 423.186 (83 FR
16743 through 83 FR 16749) the
methodology for the Star Ratings system
for the MA and Part D programs,
respectively. This was part of the
Administration’s effort to increase
transparency and advance notice
regarding enhancements to the Part C
and D Star Ratings program. Going
forward CMS must propose through
rulemaking any changes to the
methodology for calculating the ratings,
the addition of new measures, and
substantive measure changes. The April
2018 final rule included mechanisms for
the removal of measures for specific
reasons (low statistical reliability and
when the clinical guidelines associated
with the specifications of measures
change such that the specifications are
no longer believed to align with positive
health outcomes) but, generally,
removal of a measure for other reasons
would occur through rulemaking.
Commenters to the November 2017
proposed rule (82 FR 56336) expressed
overall support for the use of the
hierarchical clustering algorithm which
is the methodology used for determining
the non-Consumer Assessment of
Healthcare Providers and Systems
(CAHPS) measure-specific cut points.
The cut points are used to separate a
measure-specific distribution of scores
into distinct, non-overlapping groups, or
star categories. The cut points are
determined using the hierarchical
clustering algorithm based on the given
year’s performance data. Performance
data changes from year to year based on
industry performance. Therefore, the cut
points can also change from year to
PO 00000
Frm 00071
Fmt 4701
Sfmt 4700
15749
year. While there was overall support
for the use of the hierarchical clustering
algorithm, the majority of commenters
also recommended some enhancements
be made to the proposed clustering
methodology to capture the attributes
that they consider important.
Commenters expressed a strong
preference for cut points that are stable,
predictable, and free from undue
influence of outliers. Further, some
commenters expressed a preference for
caps to limit the amount of movement
in cut points from year to year. CMS did
not finalize any changes in last year’s
rule to the clustering algorithm for the
determination of the non-CAHPS cut
points for the conversion of measure
scores to measure-level Star Ratings, in
order to allow the necessary time to
simulate and examine the feasibility and
impact of the suggestions provided in
response to the proposed rule. In
addition, CMS evaluated the degree to
which the simulations captured the
desired attributes identified by the
commenters.
In the November 2018 proposed rule,
we proposed enhancements to the cut
point methodology for non-CAHPS
measures. We also proposed substantive
updates to the specifications for 2
measures for the 2022 Star Ratings and
substantive updates to the specifications
for 1 measure for the 2023 Star Ratings.
We also proposed rules for calculating
Star Ratings in the case of extreme and
uncontrollable circumstances. Unless
otherwise stated, data would be
collected and performance would be
measured as described in these
proposed rules and regulations for the
2020 measurement period; the
associated quality Star Ratings would be
released prior to the annual election
period held in late 2021 for the 2022
contract year and would be used to
assign Quality Bonus Payment ratings
for the 2023 payment year. Because of
the timing of the release and use in
conjunction with the annual
coordinated election period, these
would be the ‘‘2022 Star Ratings.’’
CMS appreciates the feedback we
received on our proposals. In the
sections that follow, which are arranged
by topic area, we summarize the
comments we received on each proposal
and provide our responses. Below we
summarize some comments we received
related to the Star Ratings program that
are not about any of the proposals
outlined in the November 2018
proposed rule.
Comment: A commenter suggested
that quality incentive programs should
use a small set of outcomes, patient
experience, and resource use measures
that are not unduly burdensome to
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15750
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
report. Because adjusting measure
results for social risk factors can mask
disparities in clinical performance,
Medicare should account for social risk
factors by directly adjusting payment
through peer grouping. Another
commenter supports CMS efforts to
modernize the CMS Quality Rating
System by relying more heavily upon
measurable improvement in patient
clinical outcomes.
Response: We appreciate these
comments and have been working
towards using more outcome measures
and increasing the weight of patient
experience of care measures in the Star
Ratings system. Currently, to account for
social risk factors we do not directly
adjust the measure scores (or resulting
stars) but add the Categorical
Adjustment Index to address the average
within-contract disparity in
performance among beneficiaries who
receive a low income subsidy, are dual
eligible individuals, and/or are disabled.
CMS is continuing to monitor ongoing
work related to socio-economic status of
measure developers such as National
Committee for Quality Assurance
(NCQA) and the Pharmacy Quality
Alliance (PQA) and the work of the
Office of the Assistant Secretary for
Planning and Evaluation (ASPE) as it
works to complete its second Report to
Congress as required by the Improving
Medicare Post-Acute Care
Transformation Act of 2014 or the
IMPACT Act (Pub. L. 113–185). Changes
to how CMS determines Quality Bonus
Payments and the methodology for
payment to MA organizations generally
are out of scope for this rule.
Comment: A commenter urged CMS
to develop a strategic plan that includes
defined goals for the Quality Star
Ratings program and creates a
framework for the inclusion and
retirement of measures. The commenter
stated that CMS should ensure that the
Quality Star Ratings are simplified,
accurately reflect plan performance, and
place the most emphasis on measures
plans can influence and that improve
beneficiaries’ health. The commenter
also noted that CMS should focus on
data-driven measures with objective
clinical relevance, rather than surveybased measures.
Response: We laid out the framework
for the Star Ratings in the April 2018
final rule. We will take these comments
into consideration as that framework is
revised over time. As part of our efforts
to put patients first, obtaining direct
feedback from beneficiaries is vital in
understanding the quality of care
provided by plans and is an important
component of the Part C and D Star
Ratings program.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Comment: A commenter supported
CMS’s position that all substantive
measure changes be proposed through
rulemaking. However, this commenter
requested more information about what
is considered ‘‘substantive’’.
Response: The April 2018 final rule
provided specific examples of
substantive updates to measures. We
direct readers to pages 83 FR 16534
through 16535 of the April 2018 final
rule.
Comment: Several commenters
offered suggestions related to adjusting
for socioeconomic status (SES). A
commenter suggested CMS adjust for
social risk factors. Another commenter
requested that Categorical Adjustment
Index (CAI) adjustments be made to
individual measures instead of to the
overall Star Ratings, to increase the
measure accuracy. A commenter made
suggestions, including that CMS:
Enhance the CAI by expanding the
range of included measures, letting a 2
percent or greater absolute performance
difference between low income subsidy/
dual eligible and non-low income
subsidy/dual eligible individuals be
sufficient for measure inclusion;
consider other methods for measuring
and rewarding quality for plans with
complex members; and engage with
both NCQA and PQA to drive the
development of adjustments for
socioeconomic factors for their
respective measures; and accelerate the
inclusion of such adjusted measures in
the Star Ratings program.
Another commenter recommended
that to address D–SNPs, CMS compare
D–SNPs to D–SNPs, use appropriate
measures for dual eligible individuals,
evaluate adjusting individual measures
for social risk factors, and make
improvements to the CAI to make the
adjustment more effective, including
additional measures and other adjusters.
A commenter suggested HOS-derived
measures should be included in the
CAI, so that the complexities of each
plan’s enrollee population would be
taken into account. The commenter also
requested CMS use HOS samples that
are larger when the plan enrollment is
larger, to provide a truer representation
of the member population. Another
commenter expressed support for
continued use of the CAI in the Star
Ratings program while CMS develops a
long-term solution to address disparities
in plan performance associated with
socio-economic status and other risk
factors.
Response: CMS appreciates these
comments although changes to how
CMS addresses socioeconomic status
(SES) are out of scope for this
regulation. There continues to be
PO 00000
Frm 00072
Fmt 4701
Sfmt 4700
additional work in the research
community on both identifying the
impact of social risk factors on health
outcomes and how to best address the
impact on clinical quality measurement
such that comparisons across contracts
yield accurate representations of true
differences in quality as opposed to
reflections of changes in the
composition of beneficiaries in
contracts. CMS is following the related
work of the National Quality Forum
(NQF) since it will have a widespread
impact on quality measurement across
multiple settings. The NQF has a
longstanding policy prohibiting risk
adjustment for SES and other
demographic factors. NQF released a
final report in July 2017 29 on the
findings of the 2-year trial period that
temporarily lifted that prohibition. In
the report, NQF recommended a 3-year
initiative to further examine and
consider social risk adjustment to allow
evidence as to whether a change in that
longstanding policy should be revised.
In addition, CMS has engaged the
NCQA and PQA to review and
determine if any measures are sensitive
to the composition of the enrollees in a
plan and whether any modifications to
the specification would be appropriate.
As part of this engagement by the
agency, the PQA examined their
medication adherence measures, which
are currently used in the Star Ratings
Program, for potential risk adjustment
(that is, adjustment for SES and
demographic factors).30 Based on the
results of this analysis, beginning in
2018, the PQA included in the 2018
PQA Measure Manual draft
recommendations on risk adjustment of
the three medication adherence
measures: Medication Adherence for
Diabetes Medications, Medication
Adherence for Hypertension, and
Medication Adherence for Cholesterol.
As part of PQA’s draft
recommendations, they suggest that the
three adherence measures be stratified
by the beneficiary-level
sociodemographic status characteristics
listed earlier to allow health plans to
identify disparities and understand how
their patient population mix is affecting
their measure rates.
The PQA indicated that the riskadjusted adherence measures will be
submitted through the NQF consensus
29 NQF’s Final Report can be assessed using the
following link: https://www.qualityforum.org/
Publications/2017/07/Social_Risk_Trial_Final_
Report.aspx.
30 The PQA summary can be accessed at: SDS
Risk Adjustment PQA PDC CMS Part D Stars or
https://files.constantcontact.com/e9a15233201/
96107f74-f6df-46f9-91e9-4a79d7e1bf0a.pdf?ver
=1515729061000.
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
development process for maintenance of
the measures (NQF Endorsed #0541). If
endorsed by NQF, CMS will consider
how to implement the PQA
recommendations in the future for these
Star Ratings measures.
NCQA’s 2019 HEDIS Volume 2
includes the additional specifications of
4 measures used in the MA Star Ratings.
As discussed in the 2018 Call Letter, the
additional specifications for Breast
Cancer Screening, Colorectal Cancer
Screening, Comprehensive Diabetes
Care—Eye Exam Performed, and Plan
All-Cause Readmissions 31 break out the
rates by SES. While CMS continues to
use specifications for the overall
measure rates not broken out by SES,
which are the same rates as contracts
have submitted in past years, CMS is
considering if and how to best
incorporate the information provided by
the stratified reporting in future years of
the Star Ratings. In particular, CMS is
considering to what extent stratified
reporting helps address in a more
permanent way the same issues
addressed by the Categorical
Adjustment Index (CAI).
The Office of the Assistant Secretary
for Planning and Evaluation (ASPE), as
required in the Improving Medicare
Post-Acute Care Transformation Act of
2014 (IMPACT Act, Pub. L. 113–185),
released the first in a two-part series of
Reports to Congress (RTC) in December
2016.32 ASPE’s second report is due in
the fall of 2019. In the meantime, CMS
continues to be in dialogue with ASPE
to discuss potential options for future
MA Star Ratings.
Based on stakeholders’ feedback, the
April 2018 final rule expanded the
adjusted measure set for the
determination of the CAI beginning with
the 2021 Star Ratings to all measures
identified as a candidate measure. A
measure will be adjusted if it remains
after applying the following four bases
for exclusions as follows: The measure
is already case-mix adjusted for SES (for
example, CAHPS and HOS outcome
measures); the focus of the measurement
is not a beneficiary-level issue but rather
a plan or provider-level issue (for
example, appeals, call center, Part D
price accuracy measures); the measure
is scheduled to be retired or revised
during the Star Rating year in which the
31 A summary of the NCQA analysis and
recommendations can be accessed using the link
that follows: https://www.ncqa.org/hedis-qualitymeasurement/research/hedis-and-the-impact-act.
32 ASPE’s first Report to Congress: Social Risk
Factors and Performance under Medicare’s ValueBased Purchasing Programs can be accessed using
the link that follows: https://aspe.hhs.gov/pdfreport/report-congress-social-risk-factors-andperformance-under-medicares-value-basedpurchasing-programs.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
CAI is being applied; or the measure is
applicable to only Special Needs Plans
(SNPs) (for example, SNP Care
Management, Care for Older Adults
measures). HOS-outcome measures are
not included in the measurement set
since they are already adjusted for SES.
Additionally, since HOS samples are
random, increasing their size will not
make them more representative.
Comment: A few commenters
supported the continued prior
adjustments for the lack of low-income
subsidy in Puerto Rico which is part of
the current CAI calculations with a
commenter recommending formalizing
the rules for determining the percent
LIS for Puerto Rico contracts.
Response: CMS appreciates these
comments. The rules for determining
the percent LIS for Puerto Rico contracts
were codified in the April 2018 final
rule at §§ 422.166(f)(2)(vi) and (vii) and
§§ 423.186(f)(2)(vi) and (vii).
Comment: A commenter suggested
that CMS apply a hold harmless to both
the CAI and the Reward Factor going
forward. This commenter urged CMS to
employ a hold harmless calculation for
plan sponsors that are negatively
impacted by the CAI value if it lowers
a contract’s Summary Ratings or Overall
Ratings and to remove any negative
consequences for high performing
contracts related to the Reward Factor
since high performing contracts are not
able to achieve low variance as easily as
low performing contracts.
Response: We note that this comment
raises an issue that is outside of the
scope of the proposals but we are
explaining the current policy and
regulations. The CAI values address the
average within-contract disparity in
performance revealed through the Star
Ratings data each year among
beneficiaries who receive a low income
subsidy, are dual eligible individuals,
and/or are disabled. The adjustment
factor varies by a contract’s
categorization into a final adjustment
category that is determined by a
contract’s proportion of low income
subsidy/dual eligible individuals and
beneficiaries with disability status. By
design, the CAI values are monotonic
and, thus, contracts with larger
percentages of enrollees that are low
income subsidy/dual eligible and/or
have disability status realize larger
positive adjustments. Contracts with
few beneficiaries that fall in the low
income subsidy/dual eligible and/or
disability status categories have small
negative adjustments since achieving
higher ratings is easier for these
contracts relative to ones with more
significant percentages of vulnerable
beneficiaries. Thus, CMS disagrees that
PO 00000
Frm 00073
Fmt 4701
Sfmt 4700
15751
contracts with low percentages of these
vulnerable beneficiaries should receive
a hold harmless provision. It is not clear
how the commenter suggests to remove
negative consequences of the Reward
Factor since all of the factors are 0 or
positive adjustments.
Comment: Another commenter
supported both the Star Ratings
methodology and past improvements
that CMS has made to increase
accuracy. The commenter also
supported enhancements that aim to
signal CMS’s willingness to reward MA
organizations that demonstrate excellent
outcomes and enrollee experiences.
Another commenter requested CMS
acknowledge that outcome based
measures are more challenging for plans
serving complex populations.
Response: CMS appreciates these
comments. The Star Ratings
methodology weights the experience of
enrollees and outcome measures
heavily, but also includes other metrics
of plan performance, as additional
dimensions for holding MA and Part D
plans accountable for their performance.
Outcome measures such as Improving or
Maintaining Physical Health and
Improving or Maintaining Mental
Health are adjusted for the
characteristics of the enrollees,
including more complex enrollees.
Comment: A commenter expressed
support for retiring measures when
there are 1 percentage point differences
in the same direction year-over-year (for
example, for 3 years).
Response: The April 2018 final rule
codified rules for the retirement of
measures, at §§ 422.164(e)(1) and
423.184(e)(1), which provide for
retirement when a measure has low
reliability and/or the clinical guidelines
change such that the measure
specifications are no longer believed to
align with positive health outcomes. We
appreciate this comment and will take
it into consideration as we contemplate
future enhancements to these rules.
b. Definitions
We proposed to add the following
definitions for the respective subparts in
part 422 and part 423, in paragraph (a)
of §§ 422.162 and 423.182, respectively.
• Absolute percentage cap is a cap
applied to non-CAHPS measures that
are on a 0 to 100 scale that restricts
movement of the current year’s
measure-threshold-specific cut point to
no more than the stated percentage as
compared to the prior year’s cut point.
• Cut point cap is a restriction on the
change in the amount of movement a
measure-threshold-specific cut point
can make as compared to the prior
year’s measure-threshold-specific cut
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15752
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
point. A cut point cap can restrict
upward movement, downward
movement, or both.
• Guardrail is a bidirectional cap that
restricts both upward and downward
movement of a measure-thresholdspecific cut point for the current year’s
measure-level Star Ratings as compared
to the prior year’s measure-thresholdspecific cut point.
• Mean resampling refers to a
technique where measure-specific
scores for the current year’s Star Ratings
are randomly separated into 10 equalsized groups. The hierarchical
clustering algorithm is done 10 times,
each time leaving one of the 10 groups
out. By leaving out one of the 10 groups
for each run, 9 of the 10 groups, which
is 90 percent of the applicable measure
scores, are used for each run of the
clustering algorithm. The method
results in 10 sets of measure-specific cut
points. The mean cut point for each
threshold per measure is calculated
using the 10 values.
• Restricted range is the difference
between the maximum and minimum
measure score values using the prior
year measure scores excluding outerfence outliers (first quartile ¥
3*Interquartile Range (IQR) and third
quartile + 3*IQR).33
We proposed to specify in the
definition the criteria used to identify
the values that correspond to the outer
fences which are used to identify
extreme outliers in the data. Outer-fence
outliers use established statistical
criteria for the determination of the
boundary values that correspond to the
outer fences. The outer fences are the
boundary values for an outer-fence
outlier such that any measure score that
either exceeds the value of the upper
outer fence (third quartile + 3*IQR) or
that is less than the lower outer fence
(first quartile¥3*IQR) is classified as an
outer fence outlier and excluded from
the determination of the value of the
restricted range cap.
• Restricted range cap is a cap
applied to non-CAHPS measures that
restricts movement of the current year’s
measure-threshold-specific cut point to
no more than the stated percentage of
the restricted range of a measure
calculated using the prior year’s
measure score distribution.
We received no comments on these
proposed definitions in paragraph (a) of
§§ 422.162 and 423.182 and are
finalizing them with one nonsubstantive change to the mean
33 The first quartile is median of the lower half
of the data; in other words, the value in the data
once arranged in numerical order that divides the
lower half into two equal parts. The third quartile
is the median of the upper half of the data.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
resampling definition; we have finalized
the definition with an additional
sentence to clarify that by leaving out
one of the 10 groups for each run, 90
percent of the measure scores are used
for each run of the clustering algorithm.
c. Measure-Level Star Ratings
(§§ 422.166(a), 423.186(a))
At §§ 422.166(a) and 423.186(a), we
previously codified the methodology for
calculating Star Ratings at the measure
level in the April 2018 final rule. The
methodology for non-CAHPS measures
employs a hierarchical clustering
algorithm to identify the gaps that exist
within the distribution of the measurespecific scores to create groups
(clusters) that are then used to identify
the cut points. The Star Ratings
categories are designed such that the
scores in the same Star Ratings category
are as similar as possible and the scores
in different Star Ratings categories are as
different as possible. The current
methodology uses only data that
correspond to the measurement period
of the data used for the current Star
Ratings program. The cut points, as
implemented now, are responsive to
changes in performances from one year
to the next. Changes in the measurelevel specific cut points across a Star
Ratings year reflect lower or higher
measure performance than the prior
year, as well as shifts in the distribution
of the scores.
In the April 2018 final rule, CMS
detailed the goals of the Star Ratings
program. The overarching goals of the
Star Ratings program and the specific
sub-goals of setting cut points serve as
the rationale for any proposed changes.
The Star Ratings display quality
information on Medicare Plan Finder to
help beneficiaries, families, and
caregivers make informed choices by
being able to consider a plan’s quality,
cost, and coverage; to provide
information for public accountability; to
incentivize quality improvement; to
provide information to oversee and
monitor quality; and to accurately
measure and calculate scores and stars
to reflect true performance. In addition,
pursuant to section 1853(o) of the Act
and the Medicare Program; Changes to
the Medicare Advantage and the
Medicare Prescription Drug Benefit
Programs for Contract Year 2012 and
Other Changes Final Rule (76 FR 21485
through 21489), the Star Ratings are also
used to assign Quality Bonus Payments
as provided in § 422.558(d).
To separate a distribution of measure
scores into distinct groups or star
categories, a set of values must be
identified to separate one group from
another group. The set of values that
PO 00000
Frm 00074
Fmt 4701
Sfmt 4700
break the distribution of the scores into
non-overlapping groups is referred to as
a set of cut points. The primary goal of
any cut point methodology is to
disaggregate the distribution of scores
into discrete categories such that each
grouping accurately reflects true
performance.
The current MA Star Ratings
methodology converts measure-specific
scores to measure-level Star Ratings so
as to categorize the most similar scores
within the same measure-level Star
Rating while maximizing the differences
across measure-level Star Ratings. To
best serve their purpose, the Star
Ratings categories must capture
meaningful differences in quality across
the Star Ratings scale and minimize the
risk of misclassification. For example, it
would be considered a misclassification
if a ‘‘true’’ 4-star contract were scored as
a 3-star contract, or vice versa, or if
nearly-identical contracts in different
measure-level star categories were
mistakenly identified. CMS currently
employs hierarchical clustering to
identify the cut points for non-CAHPS
measures to ensure that the measurelevel Star Ratings accurately reflect true
performance and provide a signal of
quality and performance on Medicare
Plan Finder to empower beneficiaries,
families, and caregivers to make
informed choices about plans that
would best align with their priorities.
We solicited comments in the 2017
proposed rule regarding the approach to
convert non-CAHPS measure scores to
measure-level Star Ratings (82 FR 56397
through 56399). We requested
stakeholders to provide input on the
desirable attributes of cut points and
recommendations to achieve the
suggested characteristics. In addition,
we requested that commenters either
suggest alternative cut point
methodologies or provide feedback on
several options detailed in the proposed
rule, such as setting the cut points by
using a moving average, using the mean
of the 2 or 3 most recent years of data,
or restricting the size of the change in
the cut points from 1 year to the next.
The commenters identified several
desirable attributes for the cut points
that included stability, predictability,
attenuation of the influence of outliers;
restricted movement of the cut points
from 1 year to the next; and either preannounced cut points before the plan
preview period or pre-determined cut
points before the start of the
measurement period. In the April 2018
final rule (83 FR 16567), we expressed
appreciation for our stakeholders’
feedback and stated our intent to use it
to guide the development of an
enhanced methodology. So as not to
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
implement a methodology that may
inordinately increase the risk of
misclassification, CMS analyzed and
simulated alternative options to assess
the impact of any enhancements on the
Star Ratings program and assess the
degree to which a new methodology
captures the desirable attributes that
were identified by stakeholders. While
CMS looked to balance the request of
stakeholders to increase predictability
and stability of the cut points from year
to year in developing its proposal for
this rulemaking, the goals of the Star
Ratings program, the integrity of the
methodology, and the intent of the cut
point methodology remain the same.
The intent of the cut point methodology
is to accurately measure true
performance.
A Technical Expert Panel (TEP),
comprised of representatives across
various stakeholder groups, convened
on May 31, 2018 to provide feedback to
CMS’s Star Ratings contractor (currently
RAND Corporation) on the Star Ratings
framework, topic areas, methodology,
and operational measures, including
possible enhancements to the clustering
methodology used to convert nonCAHPS measure scores to measure-level
Star Ratings. Information about the TEP
and their feedback can be found at
https://www.rand.org/star-ratingsanalyses.
In developing the proposal for
modifying how cut points are set for
non-CAHPS measures, CMS examined
numerous alternative methodologies to
minimize the influence of outliers, to
restrict the upward or downward
movement of cut points from one year
to the next, and to simulate prediction
models to allow either limited advance
notice or full advance notice of cut
points prior to the measurement period.
As part of our analyses, we analyzed
trends in performance across the Star
Ratings measures. The ability to
announce cut points before (full
advance notice) or during (partial
advance notice) the measurement period
requires the use of modeling and older
data to project the cut points, as well as
the need for an alternative methodology
for new measures introduced to the Star
Ratings program. We explained in the
proposed rule that modeling is
challenging given differences in the
performance trends over time across the
Star Ratings measures; thus, a single
approach for predicting all future
performance does not accurately reflect
performance for all measures.
We also discussed how using
prediction models to establish future cut
points may have unintended
consequences and misalign with the
underlying goals of the Star Ratings
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
program and sub-goals of setting cut
points. Predicting future cut points
using older data can lead to both over
or under-estimations of performance
which results in a distorted signal of the
Star Ratings. Over projections in the cut
points will result in higher cut points
and lower measure-level Star Ratings.
Conversely, under projections can lead
to lower cut points and higher measurelevel Star Ratings. The risk of
misclassification is heightened when
the accuracy of the projected cut points
is diminished. The use of older data for
setting cut points does not allow the
Star Ratings to be responsive to changes
in performance in the current year.
Furthermore, setting cut points in
advance of the measurement year may
lead to MA organizations and Part D
sponsors not focusing on certain areas
once they achieve a set threshold,
eliminating incentives for improvement.
For example, CMS provided
incentives for eligible providers to adopt
certified Electronic Health Records
(EHRs) and report quality measures
under the Meaningful Use (MU)
initiative. Consequently, there were
large gains in performance for a subset
of Star Ratings measures that were
enabled through the EHR, which
reflected a structural change among
health care providers in the delivery of
care. Further, an examination of
performance over time of EHR-enabled
measures indicates a decrease in
variability of measure scores with
contract performance converging toward
greater uniformity. Modeling future
performance using past performance
from before this leveling out of
performance would fail to capture the
large gains in performance in the EHRenabled measures, which would have
resulted in cut points that were
artificially low and measure-level Star
Ratings that were higher than true
performance.
We discussed in the proposed rule
how pre-announced cut points for other
subsets of measures in the Star Ratings
would present different challenges as
compared to EHR-enabled measures.
Performance on new measures typically
has more room to improve, and large
year to year gains are possible and
desirable from a quality improvement
perspective. Projecting cut points using
older data from periods of rapid
improvement would artificially inflate
future cut points which would cause
artificially low measure-level Star
Ratings. Measures that demonstrate very
slow, consistent growth over time could
have projected cut points that are
artificially high. The further the
projection is in advance of the
measurement period, the larger the
PO 00000
Frm 00075
Fmt 4701
Sfmt 4700
15753
potential for unintended consequences.
In addition, there exists the possibility
of external factors, other than structural,
that are unanticipated and unforeseen
that could impact the distribution of
scores for which modeling would not
capture.
We listed in the proposed rule some
of the challenges of full or partial
advance notice:
• Older data often do not accurately
reflect current performance.
• The trend in average performance is
not always linear.
• External or structural factors may
occur that can lead to substantial
changes from period to period rather
than steady, slow year-over-year
improvement.
• Larger gains in performance year to
year exist for relatively new measures,
compared to more established measures.
• The rate of change is less likely to
be linear at lower threshold levels
where contracts have greater
opportunities for improvement.
• Decreasing variation in measure
scores reflects greater improvements in
performance for lower versus higherperforming contracts—contract
performance is converging over time
toward greater uniformity.
These challenges are critical to
consider because if we modify the
current methodology to predict (or set)
cut points using older data and a single
model across all measures, we risk
causing unintended consequences such
as significantly diminishing incentives
for improvement or having the Star
Ratings misaligned with changes in
performance that may be due to external
or structural factors.
Based on stakeholder feedback and
analyses of the data, we proposed two
enhancements to the current
hierarchical clustering methodology that
is used to set cut points for non-CAHPS
measure stars in §§ 422.166(a)(2)(i) and
423.186(a)(2)(i). The first proposed
enhancement was the use of mean
resampling. With mean resampling,
measure-specific scores for the current
year’s Star Ratings are randomly
separated into 10 equal-sized groups.
The hierarchical clustering algorithm is
done 10 times, each time leaving one of
the 10 groups out. The method results
in 10 sets of measure-specific cut points.
The mean cut point for each threshold
per measure is calculated using the 10
values. We explained in the proposed
rule that mean resampling reduces the
sensitivity of the clustering algorithm to
outliers and reduces the random
variation that contributes to fluctuations
in cut points and, therefore, improves
the stability of the cut points over time.
Mean resampling uses the most recent
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15754
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
year’s data for the determination of the
cut points; thus, it does not require
assumptions for predicting cut points
over time and it continues to provide
incentives for improvement in measure
scores. The drawback of mean
resampling alone is that it does not
restrict the movement of the cut points,
so the attribute of predictability is not
fully captured with this methodology.
To increase the predictability of the
cut points, we also proposed a second
enhancement to the clustering
algorithm: A guardrail for measures that
have been in the Part C and D Star
Ratings program for more than 3 years.
We proposed a guardrail of 5 percent to
be a bi-directional cap that restricts
movement both above and below the
prior year’s cut points. A 5 percent cap
restricts the movement of a cut point by
imposing a rule for the maximum
allowable movement per measure
threshold; thus, it allows a degree of
predictability. The trade-off for the
predictability provided by bi-directional
caps is the inability to fully keep pace
with changes in performance across the
industry. While cut points that change
less than the cap would be unbiased and
keep pace with changes in the measure
score trends, changes in overall
performance that are greater than the
cap would not be reflected in the new
cut points. A cap on upward movement
may inflate the measure-level Star
Ratings if true gains in performance
improvements cannot be fully
incorporated in the current year’s
ratings. Conversely, a cap on downward
movement may decrease the measurelevel Star Ratings since the ratings
would not be adjusted fully for
downward shifts in performance.
We discussed in the proposed rule
that a measure-threshold-specific cap
can be set multiple ways and the
methodology may differ based on
whether the measure is scored on a 0 to
100 scale or an alternative scale. For
measures on a 0 to 100 scale, the cap
can restrict the movement of the
measure cut points from one year to the
next by a fixed percentage, such as an
absolute 5 percentage point cap. For
measures not on a 0 to 100 scale, the cap
can be determined for each measure by
using a percentage of the measure’s
score distribution or a subset of the
distribution, such as 5 percent of the
range of the prior year scores without
outer fence outliers, referred to as a
restricted range cap. Alternatively, a
restricted range cap can be used for all
measures, regardless of scale, using a
cap based on the range of the prior year
scores without outliers. We proposed an
absolute 5 percentage point cap for all
measures scored on a 0 to 100 scale and
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
5 percent of the restricted range for all
measures not on a 0 to 100 scale, but we
explained that we were also considering
alternatives to the 5 percent cap, such
as using 3 percent. We noted in the
proposed rule our belief that any cap
larger than 5 percent would not provide
the predictability requested by
stakeholders that our proposal was
designed to incorporate. While smaller
caps provide more predictability, it is
more likely that the cut points will not
keep pace with changes in measure
scores in the industry as the cap size
gets smaller, and may require future
larger one-time adjustments to reset the
measure cut points. Therefore, we
explained in the proposed rule that we
were not sure that a smaller cap, even
at a 3 percent threshold, would meet our
programmatic needs and goals of
providing accurate pictures of the
underlying performance of each contract
and its comparison to other contracts.
We therefore proposed using a 5 percent
cap because the use of the cap allows
predictability of the cut points from year
to year, but also balances the desire to
continue to create incentives for
contracts to focus on the quality of care
of their enrollees and strive to improve
performance. If the cut points are not
keeping pace with the changes in the
scores over time, CMS may need to
propose in the future how to
periodically adjust the cut points to
account for significant changes in
industry performance.
In summary, we proposed to amend
§§ 422.166(a)(2)(i) and 423.186(a)(2)(i)
to add mean resampling of the current
year’s data to the current clustering
algorithm to attenuate the effect of
outliers, and measure-specific caps in
both directions to provide guardrails so
that the measure-threshold-specific cut
points do not increase or decrease more
than the cap from one year to the next.
We proposed a 5 percentage point
absolute cap for measures on a 0 to 100
scale and a 5 percent restricted range
cap ((0.05) * (maximum value ¥
minimum value), where the maximum
and minimum values are calculated
using the prior year’s measure score
distributions excluding outer fence
outliers). For any new measures that
have been in the Part C and D Star
Rating program for 3 years or less, we
proposed to use the hierarchal
clustering methodology with mean
resampling for the first 3 years in the
program in order to not cap the initial
increases in performance that are seen
for new measures. Under our proposal,
existing provisions governing cases
where multiple clusters have the same
measure score value range
PO 00000
Frm 00076
Fmt 4701
Sfmt 4700
(§§ 422.166(a)(2)(ii) and
423.186(a)(2)(ii)) and how the clustering
algorithm would apply for setting cut
points for the improvement score
(§§ 422.166(a)(2)(iii) and 423.186(2)(iii))
remain the same. We solicited
comments on this proposal, including
comments on the percentage used for
the cap, whether the cap should be an
absolute percentage difference for
measures on a 0 to 100 scale, whether
the cap should be a percent of the range
of prior year scores without outliers for
all measures or for the subset of
measures not on a 0 to 100 scale,
whether the cap should be in both the
upward and downward directions, and
alternative methods to account for
outliers.
Below we summarize the comments
we received and provide our responses
and final decisions.
Comment: Commenters
overwhelmingly supported increasing
the stability and predictability of cut
points and attenuating the influence of
outliers.
Response: CMS appreciates the
support for increasing the stability and
predictability of cut points and
attenuating the influence of outliers.
CMS has examined numerous
alternative methodologies for setting cut
points and the methodology changes we
finalize in this rule are intended to
make cut points more stable and
predictable.
Comment: Several commenters
supported implementing cut point
methodology changes for contract year
2020 or as soon as possible and opposed
delaying such methodology changes
until 2022 Ratings.
Response: CMS appreciates the
commenters’ requests to implement
these changes sooner but, as established
in the 2018 final rule, changes to the
methodology for Star Ratings go through
rulemaking and are finalized prior to the
relevant measurement year unless we
are applying a standard in the regulation
text in making the change. We proposed
and are finalizing this change to how
cut points for non-CAHPS measures are
set for the 2020 measurement year,
which is associated with the 2022 Star
Ratings.
Comment: Many commenters
requested more detail on the resampling
methodology, including simulations of
the impact of resampling and guardrails,
and a couple of commenters requested
an additional comment period after
CMS provided more detail on the
resampling methodology, but before
making any changes to the cut point
methodology.
Response: The reason for using the
resampling approach is to increase
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
stability and predictability of cut points.
The approach is implemented as
follows. First, the current year’s contract
scores for a given measure are randomly
divided into 10 groups or subsamples.
(The current year’s data means the data
from the applicable performance year
for the given year of Star Ratings being
calculated. For example, the 2022 Star
Ratings use data from the 2020
performance year.) The process can be
replicated when the random number
generator is given the same seed prior to
each run. Then, for each of the 10
subsamples, the following steps are
taken:
• Omit one subsample from the data.
• Calculate thresholds using the
clustering approach on the data that
combines the remaining 9 subsamples.
After those two steps are completed for
each of the 10 subsamples, the resulting
10 sets of cut points are averaged.
There are two advantages of
resampling. It contributes to stabilizing
the cut points, which is its primary
advantage over using clustering without
mean resampling, and it partially
addresses the sensitivity of the
clustering approach to the ordering of
the observations in the data set. First,
each observation is included in only 90
percent of the cut point estimates that
are averaged. This reduces the
contribution of each observation,
including outliers, to the final cut
points. Second, pulling out a random 10
percent of the data prior to cut point
calculation alters the order of the data.
It partially accounts for the sensitivity of
the clustering approach to the ordering
of observations, as the tie-breaking
approach of the clustering algorithm
depends on the ordering of the data.
Allowing for altered orders of the data
reduces the effect of the tie-breaking on
the final cut points. Resampling is
computationally more feasible than
reordering a large (for example, 1,000)
number of times to search for multiple
cut point combinations, given the
timeline of the Star Ratings calculations.
HCAHPS uses an approach that is
conceptually similar. HCAHPS cut
points are the average of cut points
based on four segments of the data,
divided by quarters, where each
segment contains 25 percent of the data.
Whereas this proposal is to average the
cut points calculated from each of 10
segments where each segment contains
90 percent of the data.
In response to the commenters’
requests, we simulated the impact of the
proposed changes to the cut point
methodology including mean
resampling and a 5 percent guardrail on
the 2018 Star Ratings. However, we note
that some commenters stated that they
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
simulated the proposed changes
themselves prior to commenting on the
proposed rule. All commenters could
have simulated the proposed changes
themselves prior to commenting on the
proposed rule based on the measure
data from 2018 or 2019 Star Ratings
(available at https://go.cms.gov/
partcanddstarratings). While these data
do not contain contracts that terminated
from the Medicare program, the
available data are sufficient to simulate
these methodological changes. Since the
guardrail could have an effect not only
on the current Star Ratings year but also
on subsequent years, we accounted for
this by starting our simulation of the
combined mean resampling and
guardrail approach with the 2016 Star
Ratings data. The resulting cut points
served as the reference point for
applying the guardrail to the cut points
obtained through applying both mean
resampling and guardrails to the 2017
Star Ratings data. Finally, we simulated
the 2018 Star Ratings thresholds with
mean resampling and a 5 percent
guardrail that referenced the simulated
2017 Star Ratings thresholds from the
prior step. Overall the changes in 2018
Star Ratings under this approach were
relatively modest. Six percent of MA–
PD contracts would have seen their
overall rating increase by half a star and
five percent would have decreased by
half a star. For PDP contracts, 5 percent
would have increased by half a star and
7 percent would have decreased by half
a star. In our simulations, there was not
a disproportionally negative impact on
contracts with more LIS/DE enrollees.
For MA–PD contracts with LIS/DE
beneficiaries of up to 50 percent, 6
percent of contracts moved up a halfstar on the overall Star Ratings and 6
percent moved down by half-star. For
contracts with greater than 50 percent
LIS/DE beneficiaries, 7 percent moved
up half-star and 2 percent moved down
half-star. With regard to the request for
an additional comment period, many
other commenters requested CMS
implement the changes as soon as
possible. Further, as explained
previously, some commenters
conducted simulations of the proposed
methodological changes themselves
prior to commenting on the proposed
rule. Overall, we received 47 comments
on the proposed changes to the cut
point methodology from the 60 day
comment period. We believe the public
understood the proposal and were able
to submit comments effectively.
Therefore, we are finalizing the proposal
to implement mean resampling, because
resampling will provide increased
stability and predictability of cut points.
PO 00000
Frm 00077
Fmt 4701
Sfmt 4700
15755
Comment: A couple commenters
expressed concern that mean
resampling can provide varying results
depending on the number of samples
used and questioned why 10 samples
were chosen, and a couple commenters
believed mean resampling would make
the cut point methodology more
complicated.
Response: We proposed and are
finalizing the use of 10 samples because,
as a common choice in related
applications, such as cross-validation, it
has proven advantages. Using 10
samples is less computationally
intensive than using more samples,
which is a significant advantage in light
of the limited time between the
availability of the measure data and the
publication of Star Ratings each year. By
using the ‘‘leave-one-out approach,’’ we
expect improved stability in the cut
point thresholds, as each data point
(including outliers) will be omitted from
10 percent of the cut points that are
estimated and then averaged across the
ten 90 percent samples following
resampling. We appreciate the
commenter’s concern about the
complexity of mean resampling,
however, we find that mean resampling
is not overly complex because it is
replicable, as long as the contract
groupings are pre-specified.
Comment: A commenter suggested
CMS provide Statistical Analysis
System (SAS) programming code to run
the cut points analyses.
Response: CMS provides details about
how the cut points are determined,
including SAS code, in the Technical
Notes CMS provides for each Star
Ratings year (see the Attachment
regarding Individual Measure Star
Assignment Process). The changes to the
cut point methodology finalized in this
rule will be documented in the
Technical Notes for the 2022 Star
Ratings. The Technical Notes can be
found here: https://go.cms.gov/
partcanddstarratings.
Comment: Several commenters
supported mean resampling to address
outliers.
Response: CMS appreciates the
support for mean resampling. We are
finalizing mean resampling as proposed.
Comment: Some commenters believed
resampling would not be sufficient to
address outliers or believed resampling
does not directly address year to year
changes in cut points. A couple
commenters supported removing
outliers before clustering.
Response: CMS appreciates the
commenters concerns and based on
these comments evaluated two options
to address direct removal of outliers—
trimming and Tukey outer fence outlier
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15756
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
deletion. We conducted simulations of
the impact of each outlier deletion
method combined with a cumulative 5
percent guardrail on the 2018 Star
Ratings. In general, there tend to be
more outliers on the lower end of
measure scores. As a result, the one to
two star threshold often increased in the
simulations when outliers were
removed compared to the thresholds
when outliers were not removed, while
other thresholds were not as impacted.
The simulations of trimming and Tukey
outlier deletion also account for the
removal of the two Part D appeals
measures (Appeals Auto-Forward and
Appeals Upheld) and the Part C
measure Adult BMI Assessment,
because these measures will be removed
starting with the 2022 Star Ratings, as
announced in the 2020 Call Letter.
Under trimming, all contracts with
scores below the 1st percentile or above
the 99th percentile are removed prior to
clustering. Although trimming is a
simple way to remove extreme values, it
removes scores below the 1st percentile
or above the 99th percentile regardless
of whether the scores are true outliers.
In some cases, true outliers may be
between the 1st and 99th percentile, and
trimming will not remove these outliers,
and in other cases, trimming will
remove scores that are not true outliers,
especially when the distribution of
scores is skewed. If trimming and a 5
percent cumulative guardrail had been
implemented for the 2018 Star Ratings,
2 percent of MA–PD contracts would
have seen their overall Star Rating
increase by half a star and 17 percent
would have had it decreased by half a
star. For PDP contracts, 4 percent would
have increased their Part D summary
Star Rating by half a star and none
would have decreased.
Tukey outer fence outlier deletion is
a standard statistical method for
removing outliers. Under this
methodology, outliers are defined as
values below a certain point (first
quartile¥3.0 × (third quartile¥first
quartile)) or above a certain point (third
quartile + 3.0 × (third quartile¥first
quartile)). The Tukey outer fence outlier
deletion will remove all outliers based
on the previous definition and will not
remove any cases that are not identified
as outliers. As with trimming, the values
identified by Tukey outer fence outlier
deletion are removed prior to clustering.
If Tukey outer fence outlier deletion and
a 5 percent cumulative guardrail had
been implemented for the 2018 Star
Ratings, 2 percent of MA–PD contracts
would have seen their Star Rating
increase by half a star and 16 percent
would have decreased by half a star. For
PDP contracts, 2 percent would have
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
increased by half a star and 18 percent
would have decreased by half a star.
At this time, CMS is not finalizing a
method to directly remove outliers prior
to clustering. The methods to directly
remove outliers resulted in some
shifting of Star Ratings in the
simulations, as explained previously.
Further, as these methods were not
included in the proposed rule, the
public has not had an opportunity to
comment on them specifically. CMS
will continue to evaluate these and
possibly other methods to directly
address outliers and will consider
proposing outlier deletion in future
rulemaking.
Comment: A commenter opposed
resampling because based on the
commenter’s simulations it would have
little impact on cut points and could
lead to cut points being raised more
often than lowered.
Response: CMS appreciates the
commenter’s concerns that the mean
resampling will not have a significant
impact on cut points. However, we
believe that mean resampling in
conjunction with the use of the
guardrails adequately addresses
concerns about outliers and stability
from year to year. We are finalizing
mean resampling because it will lead to
increased stability and predictability of
cut points and will address the
sensitivity of clustering to the order of
the data.
Comment: A couple commenters
requested CMS consider whether
resampling could increase the influence
of outliers on cut points.
Response: Mean resampling decreases
the influence of outliers on cut points
because each measure score (regardless
of whether the score is an outlier) is
omitted from 10 percent of the cut point
estimates, which are then averaged as
part of mean resampling. Based on this,
any given outlier is omitted from the cut
point estimates in one of the 10 runs of
the clustering algorithm. When the 10
sets of cut point estimates are averaged,
the influence of an outlier is less than
what it would have been if resampling
had not been done. Therefore,
resampling will not increase the
influence of outliers as a function of the
methodology.
Comment: A commenter supported
resampling but would like individual
contract scores to be weighted by
enrollment to reduce the impact of
small contracts that may experience
large changes in scoring from one year
to the next due to small numbers.
Response: CMS appreciates the
commenter’s support for resampling.
Giving contracts very different weights
would decrease the stability of
PO 00000
Frm 00078
Fmt 4701
Sfmt 4700
clustering and increase the role of noise
in setting thresholds. The measures
used in the Star Ratings program have
minimum denominator criteria that
must be met for a contract to be scored
on a measure. As part of our usual
administration of the Star Ratings
system, CMS has examined changes in
scores from year to year when there
have been larger shifts in cut points.
However, based on this comment, we
again examined the data for large
changes in measure scores year-overyear and found that such changes occur
even for contracts with moderate or
large denominators. We therefore
disagree with these commenters and
will not change the methodology as
recommended.
Comment: A commenter opposed
resampling because it does not address
social disparity issues faced by some
plans and outlier removal would
disadvantage plans serving underserved
communities by normalizing metrics
towards the median. Another
commenter requested CMS to consider
how methodological changes may
necessitate adjustments for socioeconomic status (SES) factors.
Response: The purpose of resampling
is to create more stability in the cut
points over time. Separately, CMS in the
April 2018 final rule and the 2020 Call
Letter finalized a policy to expand the
adjusted measures included in the
Categorical Adjustment Index (CAI).
Starting with the 2020 Star Ratings the
CAI values will be determined using all
measures in the candidate measure set
for adjustment. A measure will be
adjusted if it remains after applying the
exclusions as follows: The measure is
already case-mix adjusted for SES, the
measure is a plan or provider issue, the
measure is being retired or revised
during the relevant Star Ratings year, or
the measure only applies to Special
Needs Plans. Further, the CAI for a
given ratings year is developed using
the same cut point methodology that
will be applied in that ratings year. We
believe that the CAI adequately
addresses the impact of SES on the Part
C and D Quality Star Ratings pending
the conclusion of ASPE’s second report
on this issue (scheduled to be released
in the fall of 2019) and steps taken by
the measure stewards to further address
it.
Comment: A commenter supported
reordering in place of resampling,
because the commenter believes
resampling may not result in more
stable cut points and reordering would
address the sensitivity of the
hierarchical clustering algorithm to the
order of the data.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Response: We appreciate the
commenter’s concerns, but we are
finalizing mean resampling as proposed.
The hierarchical clustering algorithm is
sensitive to the order of the data when
ties occur in identifying the clusters.
This means the cut points generated by
the clustering algorithm can sometimes
be slightly different depending on the
order of the data. Mean resampling
helps to address this issue, and we
believe mean resampling combined with
guardrails adequately addresses
concerns about outliers and stability
from year to year. Additionally,
conducting a full-scale reordering is too
computationally intensive given the
time constraints of the Star Ratings
calculations. Under mean resampling,
each time 10 percent of the measure
scores are randomly selected and
removed prior to clustering the
remaining 90 percent, the order of the
data will be altered. We will continue to
evaluate the impact of resampling on
the issue identified by the commenter
and consider additional enhancements
to the methodology if needed.
Comment: Most commenters
supported the implementation of
guardrails. While about half of
commenters supported setting the
guardrails at 5 percent as proposed,
other commenters were mixed in
supporting various other options for
setting guardrails, such as a 2 percent
guardrail, a 3 percent guardrail, and a 5
percent restricted range guardrail for all
measures.
Response: We thank commenters for
their support for implementing
guardrails. While we appreciate
commenters’ suggestions for alternatives
to setting guardrails at 5 percent, we are
finalizing the guardrails at 5 percent as
proposed. Guardrails at 5 percent
provide a balance between providing
predictability in cut points while also
allowing cut points to keep pace with
changes in measure scores in the
industry. Smaller guardrails may
prevent the cut points from keeping
pace with changes in measure scores in
the industry, and may limit the
incentive to improvement. Five percent
guardrails will also allow for less
frequent or possibly no future
adjustments to reset the measure
thresholds to keep pace with industry
changes in measure scores as compared
to smaller guardrails. If cut points are
not keeping pace with the changes in
scores over time, CMS may propose in
the future how to adjust the cut points
to account for significant changes in
industry performance.
Comment: Some commenters
requested additional information about
the guardrails including simulations of
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
the impact. Some commenters requested
simulation data prior to implementation
whereas other commenters requested
simulations of the impact but also
supported the proposed changes.
Response: We appreciate the
commenters request for simulations of
the impact of guardrails. We refer
readers to the earlier response to
comments where we provide the results
of the simulations combining mean
resampling and a 5 percent guardrail.
Commenters could also compare cut
points from prior years to see where the
guardrail would go into effect to
determine which cut points would be
affected. Additionally, data are available
to conduct a full simulation, as
discussed previously.
Comment: A commenter requested
CMS delay finalizing the application of
a guardrail until a final cut point
methodology is finalized, because
guardrails should be assessed only after
the final cut point methodology is
determined.
Response: CMS appreciates the
commenter’s request but does not
believe a delay is necessary or
appropriate as the guardrails are a key
component of how we intend the cut
point methodology to provide stability
and predictability from year to year, in
balance with reflecting true
performance. In addition, many other
commenters requested CMS implement
the changes as soon as possible. CMS
has assessed a number of different
approaches for modifying the cut point
methodology and simulated the impact
of the proposed modifications;
therefore, we understand the impact of
such changes. We discussed the results
of these simulations in response to other
comments earlier in this preamble. We
are finalizing the guardrails as
proposed, because this will lead to
increased stability and predictability of
cut points.
Comment: A commenter supported
guardrails only above the prior year’s
cut points combined with not allowing
cut points to decline from year to year,
because the commenter believes cut
points should not be allowed to
decrease compared to the following
year. Another commenter noted a
concern for cut points getting lower
from year to year since downward
movement could discourage plans from
making improvements to attain higher
ratings.
Response: We thank the commenters
for these suggestions and while we
share the underlying concern about
incentivizing continued improvement in
performance, we do not believe
restricting downward movement in cut
points from year to year is appropriate.
PO 00000
Frm 00079
Fmt 4701
Sfmt 4700
15757
There may be instances in which
industry performance declines from
year to year as a result of factors that are
outside of plans’ control and cut points
should be able to move to account for
this. This is in line with our intent for
the Quality Star Ratings to provide
comparative information about MA and
Part D plan performance.
Comment: A couple commenters were
concerned about the implementation of
guardrails, because it could limit the
ability of the Star Ratings to respond to
industry changes and make the Star
Ratings a less effective comparative tool,
and these commenters also suggested
that guardrails would diminish
incentives for improvement. A
commenter was concerned about the
need to rebase cut points if they did not
keep up with changes in industry
performance.
Response: We appreciate the
commenters concern and agree the Star
Ratings should be able to respond to
industry changes and to reflect true
performance as accurately as possible.
To address this issue, we are finalizing
the guardrails at 5 percent as proposed
rather than a narrower guardrail.
Guardrails at 5 percent provide a
balance between providing
predictability in cut points while also
allowing cut points to keep pace with
changes in measure scores in the
industry. If cut points are not keeping
pace with the changes in scores over
time, CMS may propose in the future
how to adjust the cut points to account
for significant changes in industry
performance.
Comment: Some commenters also
supported setting guardrails for new
measures.
Response: While CMS appreciates the
desire for predictability of cut points,
we believe setting guardrails on new
measures would not allow cut points to
keep pace with initial increases in
performance that are typically seen for
new measures and would diminish
incentives for improvement. We have
seen that for new measures, plans and
their providers work closely to
implement processes to improve
performance. There is typically more
room to improve for new measures and,
consequently, we see large year-to-year
gains in measure scores in particular for
the first three or more years.
Comment: A couple commenters
questioned how measures moved to
display as a result of specification
changes would be treated when they
were returned to the Star Ratings.
Response: Measures returning to the
Star Ratings after being on display as a
result of substantive specification
changes would be treated as new
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15758
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
measures. For these measures, we will
use the hierarchal clustering
methodology with mean resampling for
the first 3 years after returning to the
Star Ratings and add application of the
guardrail only after that point.
Comment: A handful of commenters
requested that CMS continue to work
with stakeholders and other experts to
improve guardrails over time and to
identify alternative methodologies to
increase the predictability and stability
of cut points from year to year,
including how to address the impact of
outliers.
Response: We appreciate the
commenters’ suggestions to continue to
obtain feedback on ways to improve the
methodology over time. We will
continue to solicit feedback from
stakeholders on this issue, and our Star
Ratings contractor will continue to
obtain input from the Part C and D Star
Ratings Technical Expert Panel. We are
committed to continuing to analyze the
impact of outliers in the data and may
propose additional enhancements to
specifically address this issue. We
intend to consider all of this
information as we develop future
policies and regulations for the Part C
and Part D Quality Star Ratings
program.
Comment: A couple commenters
supported guardrails for CAHPS
measures, such as a guardrail of 0.5 to
1.00.
Response: Because cut points for
CAHPS measures have relatively stable
trends over time, CMS did not propose
any guardrails for CAHPS measures. We
will not finalize any such guardrails in
this rule. The proposed narrow
guardrails of 0.5 to 1.0 are below typical
levels of improvement for CAHPS
measures.
Comment: A commenter requested
consideration of the base cut points that
the guardrails are initially applied to.
The commenter stated a recalculation of
base cut points using new or improved
methodology may be more appropriate
prior to application of guardrails.
Response: We agree with the
commenter. When guardrails and mean
resampling are implemented for the
2022 Star Ratings, CMS will rerun the
2021 Star Ratings thresholds with mean
resampling. The 2022 Star Ratings
thresholds that include mean
resampling will then be compared to the
rerun 2021 Star Ratings thresholds in
order to apply the 5 percent guardrail.
Because our proposal occurred after the
start of the 2019 performance period for
the 2021 Star Ratings, the use of mean
resampling for setting cut points is
limited to setting the actual cut points
for 2022 and subsequent Star Ratings.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
We will use the 2021 Star Ratings cut
points as the starting point for applying
the guardrail aspect of the new
methodology, in order to allow for an
apples-to-apples comparison when
applying the guardrails for the 2022 Star
Ratings.
Comment: A commenter believed the
proposed methodology changes
addressed some of the concerns raised
by stakeholders and the TEP and are
broadly defensible. However, the
commenter believed CMS is moving
further away from a standardized,
uniform approach to assigning Star
Ratings for the various care settings/
institutions for which it issues report
cards, including the Part C and D Star
Ratings program and the multiple feefor-service (FFS) Star Ratings programs
for hospitals, dialysis facilities, and
skilled nursing facilities. The
commenter also stated the proposed
methodology changes make an already
complex methodology even more
complex and CMS should consider the
trade-offs between refining setting- or
institution-specific methodologies with
the pressing need for simplicity and
clarity for health care consumers.
Response: CMS understands the
desire to balance customization of the
Star Ratings methodology for each of the
different CMS programs comparing the
quality of care for various types of
healthcare providers, while also
enhancing stability and predictability of
cut points for the MA and Part D Star
Ratings programs. While CMS has an
overall interest and goal in aligning the
various Star Ratings systems across the
agency to the extent feasible, our
proposal was limited to the Part C and
D Star Ratings program and the needs
and purposes of that program. Under
section 1853(o), the Part C and D Star
Ratings are used to identify MA
organizations that are eligible for quality
bonus payments as well as a means to
provide comparative information about
plan quality to Medicare beneficiaries.
In other programs comparing the quality
of care for healthcare providers, such as
Hospital Compare for hospitals,
Medicare FFS payment is not directly
related to the overall Star Rating that is
publicly reported. We believe the
relationship between the Part C and D
Star Ratings system and plan Quality
Bonus Payments means that providing a
measure of stability and predictability
for the rated entities (in this case, MA
and Part D contracts and plans), even if
it means moving further away from a
standardized, uniform approach to
assigning Star Ratings across agency
programs, is appropriate to ensure
predictability and stability. Requiring
the various Star Ratings systems to have
PO 00000
Frm 00080
Fmt 4701
Sfmt 4700
a uniform methodology for setting cut
points would not be consistent with the
goals and uses of the separate programs
and we decline to make uniformity a
goal in and of itself where we see
significant policy reasons to modify the
cut point methodology for the Part C
and D non-CAHPS measures. Simplicity
and clarity for healthcare consumers
would not be sacrificed by differences
between methodologies between various
CMS Star Ratings Systems because
consumers are less likely than other
stakeholders to be interested in
understanding the underlying
methodologies. For those who want
access to more details on the
methodology, the Technical Notes can
be found here: https://go.cms.gov/
partcanddstarratings. However, taking
into account these differences, CMS
works to ensure that the MA and Part D
Star Ratings system is as closely aligned
with other CMS rating systems as
necessary and possible to serve the
programmatic needs of each Star Rating
system.
Comment: A few commenters
supported distributing Quality Bonus
Payments on a continuous scale.
Response: We understand the
commenters’ interest in alternative
methods of distributing Quality Bonus
Payments, however, the distribution of
Quality Bonus Payments is defined in
statute to be based on a Five-Star Rating
system. Changes to the how Quality
Bonus Payments are distributed are out
of scope for this regulation.
Comment: Some commenters
supported using prospectively set
thresholds to create more predictability
and stability, while others were opposed
to setting thresholds prospectively. A
commenter supported setting a
predetermined cut point of 95 percent
for 5 stars and stated predetermined
thresholds have the ability to limit the
impact of outliers and reduce the
additional steps required by the cut
point methodology. Another commenter
supported setting fixed 5-star cut-points
for measures that have stable
performance among the top 25th
percentile of plans over time.
Response: We understand the desire
of some commenters to have pre-set
thresholds. CMS had implemented predetermined 4-star thresholds for some
measures in the 2011 Star Ratings to
increase transparency for organizations/
sponsors and set a priori expectations
for high performance. However, we
found that pre-set thresholds created
more ‘‘noise’’ or measurement error in
the system and disincentivized
contracts from improving once they hit
the 4-star threshold. Further, while we
agree that operational considerations are
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
important in selecting and adopting the
cut point methodology, particularly as
we have a limited amount of time to
process the performance data and issue
Star Ratings each year, CMS does not
believe that those considerations should
be the sole driving factor; the ease
achieved by using a pre-determined cut
point needs to be weighed against the
drawbacks with that methodology and
our overall policy goals for the Star
Ratings program.
Comment: A commenter raised
concerns that plans must often set
unrealistic targets for physicians in
order for the plan to earn incentives
from CMS and supported finalizing cut
point methodologies that do not impede
clinical judgment.
Response: CMS does not set targets
that Part C and D plans must achieve to
do well in the Star Ratings program; as
discussed in the prior response, CMS
has moved away from the use of predetermined cut points for Part C and D
Star Ratings. Plans should not be
impeding clinical judgment; physicians
should be using their clinical expertise
to determine how to appropriately
deliver care to their patients. Further,
the non-interference provision in
section 1854(a)(6)(B)(iii) prohibits CMS
from requiring MA organizations from
having a particular price structure for
payments to network providers; the
Quality Star Rating system does not
itself incentivize plans to compromise
the delivery of medically necessary care
to enrollees.
Comment: A few commenters
suggested CMS use alternative
clustering methodologies to address
outliers, including K-means clustering
with outlier removal (KMOR) and
clustering with outlier removal (COR).
Response: CMS appreciates the
commenters’ suggestions and will
consider these comments and
alternatives as one of the agency’s goals
in administering the Quality Star
Ratings program is continual
improvement. CMS is exploring
standard outlier removal techniques,
such as Tukey outer fence outlier
deletion prior to clustering, that are
similar to alternatives that the
commenter suggests. These approaches
are available in SAS software and thus
have the benefit of being accessible and
transparent to stakeholders. CMS will
continue to evaluate these and possibly
other methods to directly address
outliers and will consider proposing
outlier deletion in future rulemaking.
Comment: A commenter stated cut
points need to reflect meaningful
differences in plan performance.
Response: CMS agrees that the cut
points should provide a meaningful way
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
to distinguish true performance. CMS
believes hierarchical clustering
combined with mean resampling and
guardrails will result in cut points that
meaningfully distinguish performance
while also creating more stability and
predictability. Further, CMS monitors
the performance distribution for each
measure in the Star Ratings program to
determine if scores are tightly
compressed and differences are not
practically meaningful. Even small
differences in scores can be meaningful.
For example, Quigley, Elliott et al.
(2018) established that even one point
differences in CAHPS scores are
meaningful. Further, CMS evaluates
measures for retirement when scores are
compressed and topped out such that
the measure has low reliability.
Comment: A commenter supported
the proposed changes as an interim step,
but offered a number of suggestions for
CMS to model, in particular to see the
impact on plans with a high proportion
of LIS/DE/disabled enrollees. The
commenter’s suggestions included:
Stratifying cohort/peer group quintiles
based on percent LIS/DE/disabled prior
to applying cut point thresholds, using
state as unit of analysis rather than
contract, analyzing whether measures
are sensitive to provider actions,
assessing measures to see whether
performance differs across plan benefit
packages in a contract, addressing
topped out measure performance by
assigning thresholds for higher stars
based on clinical or public health
guidelines, and considering beneficiary
characteristics when examining measure
results.
Response: CMS appreciates the
feedback and will take these suggestions
into consideration as CMS makes future
changes to the Star Ratings
methodology. CMS continually
monitors cut points and will evaluate
the impact of the changes to the cut
point methodology. CMS will propose
additional enhancements to the cut
point methodology as necessary to
further the goals of providing ratings
that are a true reflection of plan quality
and enrollee experience, minimize the
risk of misclassification, treat contracts
fairly and equally, and minimize
unintended consequences.
Comment: A commenter supported
rounding measures scores to the next
decimal place (tenths of a percent).
Response: Measure scores are already
rounded to the precision indicated next
to the label ‘‘Data display’’ within the
detailed description of each measure in
the Part C and D Star Ratings Technical
Notes found at https://www.cms.gov/
Medicare/Prescription-Drug-Coverage/
PrescriptionDrugCovGenIn/Performance
PO 00000
Frm 00081
Fmt 4701
Sfmt 4700
15759
Data.html. Most measures are rounded
to whole numbers so small differences
in performance do not drive the cut
points.
Comment: A couple of commenters
requested additional data to validate
calculations during the second plan
preview and to simulate proposed
enhancements.
Response: CMS will post example
measure data for one Part C and one Part
D measure in HPMS at the beginning of
the second plan preview for contracts to
check the CMS programming.
Additionally, all HEDIS data from 1997
on are available at https://www.cms.gov/
Research-Statistics-Data-and-Systems/
Statistics-Trends-and-Reports/
MCRAdvPartDEnrolData/MA-HEDISPublic-Use-Files.html. These data are
available in September of each year and
can be used to simulate and validate
Ratings calculations.
Comment: A commenter questioned
whether CMS has considered if
measures that have shifts in cut points
of 5 points should be included in the
Star Ratings due to their volatility.
Response: In general, CMS believes
such measures should be included in
the Star Ratings. Some measures may
have occasional large shifts in the
performance distribution, but this does
not suggest that the measure is not a
reliable measure of performance. Shifts
in 5 percentage points can happen
occasionally since the clustering
algorithm not only looks at changes in
the levels of performance, but also takes
into account changes in the distribution
of scores across the industry. When
there are more significant shifts in
performance, there may be larger shifts
in cut points. As finalized in this rule,
the mean resampling and guardrails will
prevent any very large cut point shifts.
Comment: A commenter raised
concerns that the current clustering
methodology is flawed since small plans
with more volatility can have an
outsized impact on thresholds, resulting
in misclassification. Another
commenter believed the proposed
changes would not adequately address
misclassifying nearly identical contracts
into different Star Ratings levels.
Response: We appreciate the
commenters’ concerns about volatility
and misclassification. The clustering
algorithm is set up to maximize
differences across star categories and
minimize differences within star
categories so to avoid misclassifying
nearly identical contracts into different
Star Ratings levels. All measures have
minimum denominators to ensure that
the scores included in the Star Ratings
are reliable. Outliers are seen not just for
small plans that may have smaller
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15760
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
denominators, but with larger plans
with moderate or large denominators.
Reducing the impact of outliers on the
cut points will help to address any
potential volatility. CMS is finalizing
mean resampling to help address
outliers. Along with guardrails, mean
resampling will increase the stability
and predictability of cut points. In an
earlier response, CMS also presented
results from simulations that looked at
two ways of directly addressing outliers.
CMS will continue to evaluate these and
possibly other methods to directly
address outliers and will consider
proposing outlier deletion in future
rulemaking.
Comment: A couple of commenters
noted that currently plans may have a
score that improves but a star that
declines or a score that declines but a
star that improves.
Response: Since the hierarchical
clustering algorithm not only looks at
changes in the levels of performance but
also takes into account changes in the
distribution of scores across the rated
Part C and Part D contracts, scores can
decline from the prior year and have a
higher Star Rating and similarly scores
can increase and have a lower Star
Rating. The Star Ratings provide
information about comparative
performance and how the contracts
performed compared to the other
contracts. CMS is also looking into
methods that directly address outliers
and will consider proposing outlier
deletion in future rulemaking.
Comment: A commenter requested
CMS consider that more beneficiaries
are enrolling in the MA program and
future enhancements may be warranted
to accurately reflect plan performance
and not the prior care these
beneficiaries received before they joined
an MA plan, because quality
improvement often takes longer than a
year.
Response: CMS appreciates this
feedback and will continue to monitor
scores across the industry.
Comment: A commenter stated if
methodologies are in place to restrict
extreme movement of cut points, then
contracts should be able to use the prior
year’s data to set goals and focus on
improvement and reaching specific
benchmarks.
Response: CMS agrees that by
increasing the stability and
predictability of the cut points, this
methodology will assist Part C and Part
D organizations in setting specific goals
for improvement on Quality Star
Ratings.
Comment: A commenter requested
CMS reconsider the model for
developing CAHPS thresholds to create
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
meaningful differences in plan quality,
because the CAHPS measure scores are
clustered tightly.
Response: CMS believes that even one
point differences in CAHPS scores are
meaningful. See Quigley, Elliott et al.
(2018). Further, the methodology for
setting cut points for CAHPS measures
is outside the scope of the proposal and
this rulemaking.
Comment: A commenter supported a
three-year rolling average of cut points
to increase stability for measures that
have not topped out; for topped out
measures the commenter supported
fixed cut points based on the most
recent year when performance is
categorized as topped out, and
providing advance notice of thresholds
for new measures for the first three Star
Ratings years then move to the threeyear rolling average. Additionally, the
commenter stated that topped out
measures should not be removed from
Star Ratings if high quality is still
important to maintain.
Response: Using a three-year rolling
average of cut points would increase the
lag used to determine cut points, which
is problematic because it does not
account for real improvement trends in
measure performance over time.
Providing an accurate reflection of the
performance on measures for the
applicable measurement year is a key
goal of the Quality Star Ratings system.
The methodology CMS proposed and is
finalizing in this rule will increase
stability in cut points without this
limitation. As a measure is becoming
topped out, the cut points already do
not change much from year to year so
we disagree that there would be a need
to set fixed cut points. If there is no or
very little variation across contracts in
a measure, the measure would have low
reliability and, pursuant to §§ 422.164(e)
and 423.184(e), would be removed from
the Star Ratings program. We will take
these comments into consideration as
we consider any changes for our
policies regarding measures with low
reliability.
Comment: A commenter recommends
addressing data reliability by having
measure developers review outliers and
measure methodology, and set more
appropriate specifications, such as
increasing the minimum denominator
and excluding members for which the
measure may not be clinically
appropriate. The commenter believes
this will stabilize cut points.
Response: CMS agrees that measures
used in the Part C and Part D Quality
Star Rating System should be based on
reliable data and provide useful
information about plan performance. As
discussed in the April 2018 final rule
PO 00000
Frm 00082
Fmt 4701
Sfmt 4700
(83 FR 16521) and November 2017
proposed rule (82 FR 56336), one of the
goals of the Star Ratings system is for
ratings to be a true reflection of plan
performance and enrollee experience
and be based on data that are accurate,
complete, and reliable. Measure
developers have been reviewing their
specifications to enhance them and
CMS will encourage them to continue to
review the specifications to improve
their measure specifications. For
example, NCQA has increased the
denominator for the Plan-All Cause
Readmission measure to a minimum of
150. NCQA has also been reviewing the
HEDIS measures for the additional
exclusion for patients with advanced
illness.
Comment: A commenter suggested we
consider input from the Pharmacy
Quality Alliance (PQA).
Response: CMS welcomes input from
all stakeholders, and considered the
comments submitted by the PQA when
finalizing this rule.
Comment: A commenter suggested
setting a minimum number of contracts
per cluster in order to address the
concern that a single contract could
influence a change in cut points even
with guardrails.
Response: CMS believes setting a
minimum number of contracts per
cluster would require making a priori
assumptions about the distribution of
measure scores. The proposed
enhancements to the cut point
methodology address the commenter’s
concerns by moving in the direction of
increasing stability and predictability of
the ratings without having to make a
priori assumptions. Additional outlier
deletion methods may be proposed
through future rulemaking will further
address the commenter’s concern. In an
earlier response, CMS presented results
from simulations that looked at two
ways of directly addressing outliers.
CMS will continue to evaluate these and
possibly other methods to directly
address outliers and will consider
proposing outlier deletion in future
rulemaking.
Comment: A commenter suggested
that CMS communicate on Medicare
Plan Finder that the decrease in stars for
PDPs for the 2019 Star Ratings was due
to differing cut points for PDPs versus
MA–PDs and the impact of outliers on
PDPs.
Response: This comment is outside
the scope of our proposal for setting cut
points for the 2022 and subsequent Star
Ratings. The cut points for MA–PDs and
PDPs have historically been set
separately since performance across MA
organizations that offer Part D and
stand-alone PDPs may differ given the
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
integration of health and drug benefits
under an MA–PD is very different than
how a stand-alone PDP operates. CMS
appreciates the comment, but the
notices on Medicare Plan Finder are not
designed or intended to address the
intricacies of the methodology for the
Star Ratings program; however, the
Technical Notes for each year’s Star
Ratings are available publicly for those
who are interested in that information
and are found at https://www.cms.gov/
Medicare/Prescription-Drug-Coverage/
PrescriptionDrugCovGenIn/
PerformanceData.html. CMS is
concerned that too much
methodological detail can be
overwhelming for those who use the
Medicare Plan Finder website and
believes that most consumers want just
to see the Star Ratings, especially the
overall ratings. As discussed in this
final rule and responses to comments in
this section, the proposed resampling
and guardrails will help mitigate
significant changes in the cut points
from year to year.
khammond on DSKBBV9HB2PROD with RULES2
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
related comments summarized earlier in
this final rule, we are finalizing the
methodology to determine cut points as
proposed at §§ 422.166(a)(2)(i) and
423.186(a)(2)(i). CMS is committed to
incorporating feedback received from
commenters about the direct removal of
outliers from the calculations and will
continue to evaluate the methodologies
described earlier for outlier removal and
possibly other methodologies. We will
consider proposing outlier deletion in
future rulemaking to allow all
stakeholders the opportunity to
comment on potential methodologies.
d. Updating Measures (§§ 422.164,
423.184)
In the April 2018 final rule (83 FR
16537), CMS stated that due to the
regular updates and revisions made to
measures, CMS would not codify a list
of measures and specifications in
regulation text; CMS adopted a final list
of measures for the contract year 2019
measurement period (83 FR 16537–
16546) and indicated how changes to
that list—additions, updates,
removals—would be done in the future,
using the Advance Notice and Rate
Announcement under section 1853(b) of
the Act or rulemaking. The regulations
at §§ 422.164 and 423.184 specify the
criteria and procedure for adding,
updating, and removing measures for
the Star Ratings program. CMS lists the
measures used for the Star Ratings each
year in the Technical Notes or similar
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
guidance document with publication of
the Star Ratings. We proposed measure
changes to the Star Ratings program for
performance periods beginning on or
after January 1, 2020 and performance
periods beginning on or after January 1,
2021. For new measures and substantive
updates to existing measures, as
described at §§ 422.164(c) and (d)(2),
and §§ 423.184(c) and (d)(2), CMS will
initially announce and solicit comment
through the Call Letter attachment to the
announcements issued for changes in
and adoption of payment and risk
adjustment policies in section 1853(b) of
the Act and will subsequently propose
these measures to be added to the Star
Ratings program through rulemaking.
Proposals for substantive updates have
been discussed in prior Call Letters
(contract years 2018 and 2019). We will
continue the process of announcing our
intent with regard to measure updates in
future Call Letters. Any measures with
substantive updates must be on the
display page for at least 2 years before
use in the Star Ratings program. For
new measures and measures with
substantive updates, as described at
§§ 422.166(e)(2), 423.186(e)(2) and
§§ 422.164(d)(2), 423.184(d)(2), the
measure will receive a weight of 1 for
the first year in the Star Ratings
program. In the subsequent years, the
measure will be assigned the weight
associated with its category.
(1) Proposed Measure Updates
(a) Controlling High Blood Pressure
(Part C)
Due to the release of new
hypertension treatment guidelines from
the American College of Cardiology and
American Heart Association,34 NCQA
implemented updates to the Controlling
High Blood Pressure measure for HEDIS
2019. NCQA revised the blood pressure
target to <140/90 mmHg. NCQA also
made some structural changes to the
measure that included allowing two
outpatient encounters to identify the
denominator and removing the medical
record confirmation for hypertension,
allowing the use of telehealth services
for one of the outpatient encounters in
the denominator, adding an
administrative approach that utilizes
CPT category II codes for the numerator,
34 See Whelton P.K., Carey R.M., Aronow W.S., et
al. (2018). Guideline for the prevention, detection,
evaluation, and management of high blood pressure
in adults: A report of the American College of
Cardiology/American Heart Association Task Force
on Clinical Practice Guidelines. Journal of the
American College of Cardiology. 71(19): e127–e248.
Available at https://www.onlinejacc.org/content/71/
19/e127?_
ga=2.143510773.1362500146.1536262802126396490.1536262802.
PO 00000
Frm 00083
Fmt 4701
Sfmt 4700
15761
and allowing remote monitoring device
readings for the numerator. Given the
change to the blood pressure target and
our rules for moving measures with
substantive changes to the display page,
this measure will be moved to the
display page for the 2020 and 2021 Star
Ratings. We proposed to return this
measure as a measure with substantive
updates by the measure steward (NCQA)
to the 2022 Star Ratings using data from
the 2020 measurement year with, as
required by §§ 422.164(d)(2) and
422.166 (e)(2), a weight of 1 for the first
year and a weight of 3 thereafter.
Below we summarize the comments
we received and provide our responses
and final decisions.
Comment: The majority of
commenters supported our proposal.
Response: CMS appreciates receiving
the support for this proposal.
Comment: A few commenters
expressed support, but offered
additional measure specification change
suggestions. These commenters
questioned whether the new standards
are suitable for all populations (that is,
for those with special needs, the aged,
and those with multiple co-morbidities
and advanced cognitive impairment
populations as well as for the generally
healthy elderly population). These
commenters suggested adding some
additional exclusions. A commenter
disagreed with the new clinical
standards as specified in the updated
measure.
Response: NCQA is the measure
steward for the Controlling High Blood
Pressure measure. As codified at
§ 422.164(c)(1) CMS tries to include in
the Star Ratings, to the extent possible,
measures that are nationally endorsed
and in alignment with the private sector
such as the Plan All-Cause
Readmissions measure developed by
NCQA. Although a few commenters
offered suggestions for additional
changes to the measure, CMS is moving
ahead to include the revised measure in
the 2022 Star Ratings since we believe
that this measure has been sufficiently
validated by the measure steward and
most commenters supported the
measure updates to align with the new
clinical guidelines for blood pressure
control. CMS will share all suggestions,
including concerns about additional
exclusions and clinical disagreements
with the specified updates with NCQA
for their consideration as they make
future enhancements to the measure.
Comment: A few commenters believe
the current measure is too important to
remove from the Star Ratings. Rather,
they suggested keeping the legacy
measure in the Star Ratings while the
E:\FR\FM\16APR2.SGM
16APR2
15762
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
updated measure is shown on the
display pages.
Response: CMS agrees that the
Controlling High Blood Pressure
measure is an important measure.
However, CMS believes that keeping the
legacy measure in the Star Ratings while
presenting the updated measure on the
display pages, would create significant
data collection burden on plans given
the data collection complexities of the
Controlling High Blood Pressure
measure. Although § 422.164(d)(2)
permits continued use of legacy
measures when there has been a
substantive update, the regulation does
not require CMS to do so in all cases.
Here, CMS believes that it is not
appropriate.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
related comments summarized earlier,
we are finalizing our proposal to return
the Controlling High Blood Pressure
measure, as updated by the measure
steward, to the 2022 Star Ratings using
data from the 2020 measurement year
with a weight of 1 for the first year and
a weight of 3 thereafter, as required by
§§ 422.164(d)(2) and 422.166 (e)(2).
khammond on DSKBBV9HB2PROD with RULES2
(b) MPF Price Accuracy (Part D)
Continued transparency and accuracy
of sponsors’ pricing data used by
beneficiaries is important; therefore, we
proposed to make enhancements to the
MPF Price Accuracy measure to better
measure the reliability of a contract’s
MPF advertised prices. In accordance
with § 423.184(d)(2), the substantively
updated measure would be a display
measure for 2020 and 2021 and we
proposed to use it in the 2022 Star
Ratings in place of the existing MPF
Price Accuracy measure, which will
remain in the Star Ratings until that
replacement under § 423.184(d)(2). The
proposed update would measure the
magnitude of difference, as well as the
frequency of price differences. We
proposed to implement the following
changes for this measure:
• Factor both how much and how
often prescription drug event (PDE)
prices exceeded the prices reflected on
the MPF by calculating a contract’s
measure score as the mean of the
contract’s Price Accuracy and Claim
Percentage scores, based on the indexes
in this rule:
++ The Price Accuracy index
compares point-of-sale PDE prices to
plan-reported MPF prices and
determines the magnitude of differences
found. Using each PDE’s date of service,
the price displayed on MPF is compared
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
to the PDE price. The Price Accuracy
index is computed as:
(Total amount that PDE is higher than
MPF + Total PDE cost)/(Total PDE cost)
++ The Claim Percentage index
measures the percentage of all PDEs that
meet the inclusion criteria with a total
PDE cost higher than total MPF cost to
determine the frequency of differences
found. The Claim Percentage index is
computed as:
(Total number of claims where PDE is
higher than MPF)/(Total number of
claims)
++ The best possible Price Accuracy
index is 1 and the best possible Claim
Percentage index is 0. This indicates
that a plan did not have PDE prices
greater than MPF prices.
++ A contract’s measure score is
computed as:
—Price Accuracy Score = 100¥((Price
Accuracy Index¥1) * 100)
—Claim Percentage Score = (1¥Claim
Percentage Index) * 100
—Measure Score = (0.5 * Price
Accuracy Score) + (0.5 * Claim
Percentage Score)
• Increase the claims included in the
measure:
++ Expand the days’ supply of claims
included from 30 days to include claims
with fills of 28–34, 60–62, or 90–100
days.
++ Identify additional retail claims
using the PDE-reported Pharmacy
Service Type code. Claims for
pharmacies that are listed as retail in the
MPF Pharmacy Cost file and also have
a pharmacy service type on the PDE of
either Community/Retail or Managed
Care Organization (MCO) will be
included.
• Round a drug’s MPF cost to 2
decimal places for comparison to its
PDE cost. Post-rounding, the PDE cost
must exceed the MPF cost by at least
one cent ($0.01) in order to be counted
towards the accuracy score (previously,
a PDE cost which exceeded the MPF
cost by $0.005 was counted). A contract
may submit an MPF unit cost up to 5
digits, but PDE cost is always specified
to 2 decimal places.
Under our proposed update, PDEs
priced lower than the MPF display
pricing will continue to be ignored and
will not have an impact on the measure
score or rating. Only price increases are
counted in the numerator for this
measure. We proposed to add this
updated measure to the 2022 Star
Ratings based on the 2020 measurement
year with a weight of 1.
Below we summarize the comments
we received and provide our responses
and final decisions.
Comment: The majority of
commenters supported the measure’s
PO 00000
Frm 00084
Fmt 4701
Sfmt 4700
proposed changes, citing it is critical to
provide enrollees with information they
have confidence is reliable and accurate.
There was strong support for price
transparency, and making sure contract
performance is measured in a
meaningful and useful manner.
Response: CMS appreciates these
commenters’ support of this measure
and the proposed changes, and more
broadly the confirmation that
beneficiaries rely on the MPF’s accuracy
to make critical enrollment choices. We
agree that it is essential to continue this
measure so that enrollees can remain
confident that the data displayed on the
MPF are reliable and accurate. Our Star
Ratings contractor will also continue to
obtain feedback on price transparency
and related measure concepts as part of
their TEP. CMS always values feedback
on display and Star Ratings measures
and will continue to identify future
ideas in the 2021 Call Letter.
Comment: Several commenters
opposed the addition of frequency of
price differences to the measure, stating
this would not be a concern to
beneficiaries, or that the current Star
Rating measure already includes this.
They also state the frequency of pricing
differences between the data available
on the MPF and the price reflected in
the PDE data is not due to a contract’s
performance, but due to established
CMS timelines for MPF updates.
Response: We disagree with these
commenters, and believe both the
magnitude and frequency of price
inaccuracies are important. A one-time
discrepancy illustrates different
performance by a Part D plan on this
issue than multiple occasions where the
price is higher than posted on the
Medicare Plan Finder website; we
believe both that beneficiaries
appreciate such differences in
performance and need to be aware of
them. With the current methodology (as
of the 2019 Star Ratings), a sponsor who
frequently submits small inaccuracies
may receive a similar score to a sponsor
who submits MPF prices with very large
price differences only a few times.
Comment: Some commenters
criticized the overall measure because
MPF files are prepared and submitted
by a Part D plan according to the CMSissued calendar and guidelines, which
do not allow submissions outside the
specified bi-weekly schedule. Because
CMS posts files two weeks after
submission which are then displayed on
MPF for two weeks, the commenters
state the data are typically between 19
to 31 days old.
Response: CMS understands that
pricing may change much more
frequently than MPF submission
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
windows. We have instituted a biweekly
submission window to allow for a
correction period (to avoid suppression
of plans on MPF). This submission
schedule does not dictate the schedule
or frequency by which a sponsor
chooses to update their own price files
prior to submission to CMS. Sponsors
who perform well in this measure
typically update their pricing files at
least every other week and typically
closer to the submission dates.
Comment: A few commenters were
opposed to the measure because MPF
pricing data are based on a single
reference/proxy NDC and are compared
to an expanded list of NDCs on the
PDEs. They state this is a flaw since
drug costs vary by NDC, even those with
the same strength or dosage form. This
variability leads to unavoidable
inconsistencies between a Part D plan’s
submitted price and the price on the
claim or PDE record.
Response: For the Star Rating
measure, prices that are higher on MPF
as opposed to the PDE do not harm the
plans’ scores. CMS had expanded the
list of NDCs to be compared to the MPF
prices beginning with the 2011 Star
Ratings in response to sponsors’
requests to expand the claims studied.
Previously, sponsors were only
evaluated with PDEs with the same
reference NDC, which limited claims,
and sponsors stated, unfairly portrayed
their accuracy, especially if they did not
support the pricing NDC selected on the
FRF. To ensure that the measure is
sensitive to the accuracy of claims of
NDCs beyond those on the FRF, claims
for non-reference NDCs that can be
linked to a reference NDC with the same
brand name, generic name, strength, and
dosage form are included in the
measure. The inclusion of these
additional claims allows for a more
robust method of measuring price
accuracy. We remind commenters that
the average score in this measure ranged
from 98–99 for PDPs and MA–PDs in
the 2019 Star Ratings.
Comment: A few commenters stated a
meaningful price difference to
beneficiaries would be greater, and in
the range $0.50–$1.00, and that the de
minimis amount of $0.01 also does not
account for all rounding errors.
Response: The measure’s current
price threshold of $0.005 was based on
data analyses, and sponsor performance
has been high for many years. We are
raising to $0.01 to account for rounding,
and thus allowing a larger variation in
prices that are not counted as price
increases for purposes of the measure
than previously allowed. Raising the
threshold level for counting a price
increase to $0.50 or higher would
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
significantly lower the usefulness of the
measure as a whole, given that plans’
scores have been typically clustered in
the high 90s.
Comment: Some commenters were
overall against CMS using the MPF
Price Accuracy measure in the Star
Ratings program. They state that a 100
rating in this measure does not reflect
truly accurate pricing, but instead is
driven primarily by the timing of the
files and subsequent measure auditing
of pricing. While they agree it is an
important measure to ensure MAOs and
PDPs are accurately representing drug
pricing to plan members; the cut points
require near perfection. They propose
the measure instead be moved to the
display page for monitoring, and that
plans not be penalized by timing issues
outside of plan control.
Response: CMS disagrees. The cut
points are based on the clustering
algorithm and reflects actual
performance. CMS does not modify the
cut points to require near perfection, it
is that Part D sponsors generally do a
good job of posting prices that are at
least as high as the actual charged
prices. CMS sees sponsors’ frequent
auditing of MPF and price adjudication
files to be a beneficial result from the
measure. Beneficiaries and other public
stakeholders are interested in this
measure as well. Knowing that they can
expect accurate pricing on the MPF is
extremely helpful to beneficiaries using
the tool to choose their prescription
drug plans.
Comment: A commenter
recommended that CMS assess the
additional value to beneficiaries of the
MPF measure based on usage patterns
for price data, etc., and weigh that
against the costs to the program
(through higher plan bids) that will arise
from additional investments that may be
required for Part D plans to comply with
the revised methodology for this
measure.
Response: The regulation at
§§ 423.184 (c)(3) and (d)(2) requires new
measures and substantively updated
measures to be on the display page for
at least two years prior to using the
updated measure to calculate and assign
Star Ratings; for the revised Part D price
accuracy measure finalized here, this
two year display period will be the 2020
and 2021 display page. During that
period, CMS will be using the legacy
measure in the Star Ratings. Additional
feedback on this revised measure may
be submitted during the annual Call
Letter process based on experience with
the revised measure on the display page.
CMS does not agree that the measure’s
revised methodology imposes additional
plan burden. Part D sponsors are
PO 00000
Frm 00085
Fmt 4701
Sfmt 4700
15763
required to submit accurate pricing for
MPF, and adjudicate claims accurately
at the point of sale.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to
related comments, we are finalizing the
provisions related to updating the MPF
Price Accuracy measure. As proposed,
we will first display the updated
measure for 2020 and 2021 and then use
it to replace the existing measure in the
2022 Star Ratings. Publishing the
display measure for at least two years
will allow Part D sponsors additional
experience with contract-specific results
using the new specifications.
(c) Plan All-Cause Readmissions (Part C)
NCQA is modifying the Plan AllCause Readmissions measure for HEDIS
2020 (measurement year 2019).35 The
measure assesses the percentage of
hospital discharges resulting in
unplanned readmissions within 30 days
of discharge. The changes made by
NCQA to the measure are: Adding
observation stays as hospital discharges
and readmissions in the denominator
and the numerator; and removing
individuals with high frequency
hospitalizations. These changes were
implemented by the measure steward
(NCQA) based on the rise in observation
stays to ensure the measure better
reflects patient discharge and
readmission volumes. Removing
individuals with high frequency
hospitalizations from the measure
calculation allows the readmissions
rates not to be skewed by this
population. To date, CMS has only
included the 65+ age group in the Plan
All-Cause Readmissions measure. In
addition to the updates made by the
measure steward, CMS proposed to
combine the 18–64 and 65+ age groups
as the updated measure specifications
are adopted and to use NCQA’s new
recommendation of 150 as the minimum
denominator. Given the substantive
nature of the proposed updates for this
measure, it would be moved to display
for the 2021 and 2022 Star Ratings
under our proposal and § 422.164(d)(2).
We proposed to return this measure as
a measure with substantive updates by
the measure steward (NCQA) to the
2023 Star Ratings using data from the
2021 measurement year with, as
required by §§ 422.164(d)(2) and
422.166(e)(2), a weight of 1 for the first
year and a weight of 3 thereafter.
35 HEDIS 2019, Volume2, Technical Update,
Attachment C. https://www.ncqa.org/wp-content/
uploads/2018/10/HEDIS-2019-Volume-2-TechnicalUpdate.pdf.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15764
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Below we summarize the comments
we received and provide our responses
and final decisions.
Comment: The majority of
commenters supported our proposal.
Response: CMS appreciates receiving
the support for this proposal.
Comment: Some commenters
questioned specific aspects of the
measure specification, including the
inclusion of observation stays in the
measure’s numerator and denominator
and whether the measure is appropriate
for high risk populations. A commenter
suggested that by focusing on decreasing
readmissions, mortality rates could
increase. The commenter cited a 2018
JAMA Cardiology article 36 which
presented data showing that the
implementation of the Hospital
Readmissions Reduction Program
(HRRP) was temporally associated with
a reduction in 30-day and 1-year
readmissions but an increase in 30-day
and 1-year mortality for patients
discharged after heart failure among feefor-service Medicare beneficiaries. The
authors of this article suggested that this
may be just a temporary association and
requested additional research to confirm
these results.
Response: NCQA is the measure
steward for the Plan All-Cause
Readmission measure. As codified at
§ 422.164(c)(1) CMS tries to include in
the Star Ratings, to the extent possible,
measures that are nationally endorsed
and in alignment with the private sector
such as the Plan All-Cause
Readmissions measure developed by
NCQA. Despite some commenters
questioning specific aspects of the
measures, most commenters provided
support for the readmissions measure.
CMS believes that this is an important
outcome measure for MA contracts
since the basis of the MA program is for
MA contracts to coordinate the care of
their enrollees. MA contracts are
responsible for coordinating care
following a hospitalization to ensure
that their enrollees are receiving
appropriate care following a
hospitalization, including whether they
need to be rehospitalized due to further
declines in health. CMS will share all
comments concerning appropriate
enrollees eligible for the measure, the
inclusion of observations stays, and the
belief that decreasing readmissions
might increase mortality with NCQA for
consideration as they make future
updates to the measure. Following our
rules for moving measures with
substantive changes to the display page,
36 Gupta A et al, JAMA Cardiol. 2018; 3(1): 44–
53. https://jamanetwork.com/journals/
jamacardiology/fullarticle/2663213.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
this measure will be moved to the
display page for the 2021 and 2022 Star
Ratings for contracts to acclimate to the
new measure specifications.
Comment: A commenter suggested
that when the measure is returned to the
Star Ratings, the measure should have a
weight of 1 for two years, not only for
the first year.
Response: Using a weight of 1 for the
first year of a new or newly revised MA
measure is required by the regulations at
§§ 422.164(d)(2) and 422.166(e)(2).
Measures with substantive specification
changes are treated as new measures.
Changes to that policy are out of scope
for this regulation. We direct readers to
83 FR 16534 for a discussion of that
particular policy.
Comment: A few commenters
expressed the belief that the current
measure is too important to remove
from the Star Ratings. Rather they
suggested keeping the legacy measure in
the Star Ratings, while the updated
measure is on the display page for two
years.
Response: CMS considered keeping
the legacy measure in the Star Ratings
while displaying the updated measure
on the display pages, but believes that
it would create a significant data
collection burden for plans to submit
two different sets of data that follow
different specifications. This measure is
relatively complex and we believe that
the value gained by reporting both the
legacy and updated measure would not
be justified by the additional
administrative burden. Although
§ 422.164(d)(2) permits continued uses
of legacy measures when there has been
a substantive update, the regulation
does not require CMS to do so in all
cases. Here, CMS believes that it is not
appropriate.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
related comments summarized earlier,
we are finalizing our proposal to return
the Plan All-Cause Readmissions
measure, as updated by the measure
steward, to the 2023 Star Ratings with
a weight of 1 for the first year and a
weight of 3 thereafter, as required by
§§ 422.164(d)(2) and 422.166(e)(2).
Pursuant to § 422.164(d)(2), the revised
measure will be collected for display
only for the measurement periods of
2020 and 2021.
(d) Improvement Measures (Parts C and
D)
The process for identifying eligible
measures to be included in the
improvement measure scores is
specified as a series of steps at
PO 00000
Frm 00086
Fmt 4701
Sfmt 4700
§§ 422.164(f)(1) and 423.184(f)(1). As
part of the first step, the measures
eligible to be included in the Part C and
D improvement measures are identified.
Only measures that have a numeric
score for each of the 2 years examined
are included. We proposed to add an
additional rule at §§ 422.164(f)(1)(iv)
and 423.184(f)(1)(iv) that would exclude
any measure that receives a measurelevel Star Rating reduction for data
integrity concerns for either the current
or prior year from the improvement
measure(s) used for the applicable
contract. The proposed new standard
would ensure that the numeric scores
for each of the 2 years are unbiased. If
a measure’s measure-level Star Rating
receives a reduction for data integrity
concerns in either of the 2 years, the
measure would not be eligible to be
included in the improvement
measure(s) for that contract.
Below we summarize the comments
we received and provide our responses
and final decisions.
Comment: The vast majority of
commenters supported our proposal.
Response: CMS appreciates receiving
the support for this proposal.
Comment: A few commenters
suggested different ideas for how the
improvement measures should be
calculated: (1) Use a logarithmic scale
rather than a linear scale; (2) calculate
improvement measures for the display
measures and count them in the Star
Ratings improvement measures; (3)
modify the hold harmless policy; and
(4) weight the improvement change
taking into account how well the
contract performed in the prior year and
the increased difficulty to improve at
the higher star levels. A commenter
suggested that the improvement
measures be entirely dropped from the
Star Ratings, stating they are
unnecessary.
Response: CMS appreciates the
additional feedback related to potential
enhancements to the improvement
measures. However, these suggestions
are outside the scope of the proposed
rule. CMS will consider these
suggestions as we contemplate future
enhancements.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
related comments summarized earlier,
we are finalizing the amendment to how
improvement measures are identified
and used as proposed for performance
periods beginning on or after January 1,
2020.
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Table 2—Additions and Updates to
Individual Star Rating Measures
The measure descriptions listed in the
tables are high-level summaries. The
Star Ratings measure specifications
supporting document, Medicare Part C
& D Star Ratings Technical Notes,
provides detailed specifications for each
measure. Detailed specifications
include, where appropriate, the
identification of a measure’s: (1)
Numerator; (2) denominator; (3)
calculation; (4) timeframe; (5) case-mix
adjustment; and (6) exclusions. The
Technical Notes document is updated
annually. In addition, where
appropriate, the Data Source
descriptions listed in this table
reference the technical manuals of the
measure stewards. The annual Star
Ratings are produced in the fall of the
prior year to assist beneficiaries in
choosing their health and drug plan
during the annual open enrollment. For
example, Star Ratings for the year 2022
are produced in the fall of 2021.
15765
1. If a measurement period is listed as
‘the calendar year 2 years prior to the
Star Ratings year’ and the Star Ratings
year is 2022, the measurement period is
referencing the January 1, 2020 to
December 31, 2020 period.
2. For CAHPS, HOS, and HEDIS/HOS
measures, the measurement period is
listed as ‘most recent data submitted for
the survey of enrollees.’ See measure
stewards’ technical manuals, as
referenced in Data Source column, for
the specific measurement periods of the
most recent data submitted.
TABLE 2A—UPDATES TO INDIVIDUAL STAR RATING MEASURES FOR PERFORMANCE PERIODS BEGINNING ON OR AFTER
JANUARY 1, 2020
Measure
Measure description
Measure
category and
weight
Domain
Data source
NQF
endorsement
Statistical
method for
assigning
star ratings
The calendar
year 2
years prior
to the Star
Ratings
year.
#0018 ............
Clustering ......
MA-PD and
MA-only.
The calendar
year 2
years prior
to the Star
Ratings
year.
Not Applicable
Clustering ......
MA-PD and
PDP.
Measurement
period
Reporting
requirements
(contract type)
Part C Measure
Controlling
Blood Pressure (CBP).
Percent of plan members
18–85 years of age who
had a diagnosis of hypertension (HTN) and whose
blood pressure was adequately controlled (<140/
90).
Managing
Chronic
(Long Term)
Conditions.
Intermediate
Outcome
Measure
Weight of 3.
HEDIS * .........
Part D Measure
MPF Price Accuracy.
A score comparing the
prices members actually
pay for their drugs to the
drug prices the plan provided for the Medicare
Plan Finder website.
Drug Safety
and Accuracy of Drug
Pricing.
Process
Measure
Weight of 1.
PDE data,
MPF Pricing
Files.
* NCQA HEDIS Technical Specifications, Volume 2.
TABLE 2B—UPDATES TO INDIVIDUAL STAR RATING MEASURES FOR PERFORMANCE PERIODS BEGINNING ON OR AFTER
JANUARY 1, 2021
Measure
Measure description
Measure
category and
weight
Domain
Data source
Measurement
period
NQF
endorsement
Statistical
method for
assigning
star ratings
#1768 ............
Clustering ......
Reporting
requirements
(contract type)
Part C Measure
Plan All-Cause
Readmissions (PCR).
Percent of acute inpatient
stays that were followed
by an unplanned acute readmission or an observation stay for any diagnosis
within 30 days, for members ages 18 and over.
Rates are risk-adjusted.
Managing
Chronic
(Long Term)
Conditions.
Intermediate
Outcome
Measure
Weight of 3.
HEDIS * .........
The calendar
year 2
years prior
to the Star
Ratings
year.
MA-PD and
MA-only,
except for
1876 Cost
Plans.
khammond on DSKBBV9HB2PROD with RULES2
* NCQA HEDIS Technical Specifications, Volume 2.
Below we summarize additional
comments CMS received on measures
that were not part of the proposed rule
and provide our responses. CMS
appreciates the additional feedback
related to potential enhancements to
measures and will take this feedback
into consideration as we make future
measure enhancements.
Comment: Commenters requested
measure updates for and possible
removal of the following measures:
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Annual Flu Vaccine, Osteoporosis
Management in Women who had a
Fracture, and Rheumatoid Arthritis
Management. CMS also received
requests for updates to the following
measures: Getting Needed Care, Getting
Appointments and Care Quickly, and
Members Choosing to Leave the Plan.
Some of the comments indicated these
measures need additional specifications
and exclusions, especially for the Puerto
Rican population. Another commenter
PO 00000
Frm 00087
Fmt 4701
Sfmt 4700
further suggested the need for measures
specifically designed for the advanced
illness populations.
Response: These comments are
outside of the scope of the proposed and
final rules. Where appropriate CMS will
share all measure specification
suggestions, including concerns about
additional measure exclusions and the
design of measures specifically for the
advanced illness populations, with the
appropriate measure stewards.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15766
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Comment: A commenter suggested
that for the Part D Appeals AutoForward measure the minimum
enrollment size for a plan to be eligible
for this measure be raised or that plans
having fewer than two auto-forwards be
exempted from reporting. Another
commenter suggested that CMS combine
the call center sampling for the Part C
and Part D Call Center Foreign Language
Interpreter and TTY Availability
measures.
Response: These suggestions are
outside the scope of the proposed and
final rules; however, we will take them
into consideration as we contemplate
future enhancements.
Comment: For the measures
Complaints about Health/Drug Plans, a
commenter stated these measures
should be modified due to complaints
arising from restricting beneficiaries’
access to opioids.
Response: This suggestion is outside
the scope of the proposed and final
rules; however, we will take it into
consideration as we contemplate future
enhancements. In addition, prior to use
in the Star Ratings, complaints are
reviewed for resolution by plans’ and
CMS Regional caseworkers. If necessary,
a complaint may be labeled as a CMS
issue, and thus excluded from the
Complaints Star Rating measure. Please
note however that not all opioid related
complaints should be considered to be
‘‘CMS issues’’; for example, a complaint
that a plan did not properly implement
opioid safety edits, or did not follow
Part D requirements for coverage
determinations/appeals would remain
included in a plan’s complaints measure
data.
Comment: A few commenters
suggested the measure weights for both
the CAHPS and HOS measures should
be reduced.
Response: In the April 2018 final rule,
CMS codified, at §§ 422.166(e)(1) and
423.186(e)(1), the general rules for
assigning measures the weight
associated with their category. Changes
to that policy are out of scope for the
proposed and final rules.
Comment: A few commenters
suggested electronic survey
administration and electronic
submission of hybrid measures to
reduce provider burden and paperwork.
Response: These comments are
outside of the scope of the proposed and
final rules. CMS also supports the move
to more electronic modes of data
collection. CMS will be soliciting
comment in an OMB Paperwork
Reduction Act (PRA) package as CMS
plans to test the web mode of survey
administration across various CMS
surveys. NCQA has also developed
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
HEDIS Electronic Clinical Data Systems
(ECDS) to support obtaining information
that is currently available in electronic
clinical datasets for HEDIS quality
measures.
Comment: A commenter suggested
that given the changes with the
implementation of section 17006 of the
Cures Act, CMS should begin to
consider one or more ESRD quality
measures specific to ESRD beneficiaries,
home dialysis, and/or education about
home dialysis.
Response: These comments are
outside of the scope of the proposed and
final rules. CMS has begun to consider
what measures will potentially be
relevant for ESRD beneficiaries. We are
following the work NCQA will be doing
with the National Kidney Foundation to
develop a provider-level measure
focused on screening for nephropathy in
patients with diabetes. This work may
inform potential updates/changes for
the plan-level measure in HEDIS. We
are also following the quality
measurement work in the
Comprehensive ESRD Care (CEC) Model
test to see if any of those measures will
be relevant. We are open to suggestions
for additional measures.
Comment: A commenter suggested
developing measures that reflect care for
under-65 populations who are
Medicare-eligible due to disability and
that, while also being consistent with
the Medicare Star Ratings methodology,
the measures also reflect complex
medical conditions that these
individuals have. To bolster the ability
of states and others to analyze data
across various factors and programs, the
commenter also requested CMS provide
access to data at levels below the
contract and disaggregated.
Response: These comments are
outside of the scope of the proposed and
final rules. CMS appreciates the
importance of measuring plan
performance in serving the under-65
population and the comment explaining
why. To allow comparisons below the
level of the contract and/or
disaggregated in other ways may be
challenging, since valid and reliable
comparisons at those levels could be
very burdensome to plans or may not be
possible. However, CMS has and will
continue to explore ways to address the
needs of states and others to assess care
for subpopulations.
Comment: A commenter suggested
CMS focus more on outcome measures
than on process measures.
Response: These comments are
outside of the scope of the proposed and
final rules. CMS agrees with the
importance of focusing on outcome
measures and welcomes all suggestions
PO 00000
Frm 00088
Fmt 4701
Sfmt 4700
for potential outcome measures as
additions to the Star Ratings.
Comment: CMS received a request for
additional discussions of how MA and
FFS/ACO regulations can be similarly
constructed to streamline provider
compliance and beneficiary
understanding. CMS received a request
to publicly post measure guides (for
example, Patient Safety Report User
Guides) in addition to the Star Ratings
Technical Notes. The commenter
referenced as an example CMS’s use of
member months in the Statin Use in
Persons with Diabetes (SUPD) measure
which differs from the PQA measure
specifications, and that additional
information would help improve
consistency in sponsors’ quality
improvement efforts. Currently, more
detailed information is included in the
Patient Safety Report User Guides
compared to the Star Ratings Technical
Notes.
Response: CMS appreciates
suggestions for standardizing measures
and regulations across programs. CMS is
currently working to ensure consistency
of measure specifications across
programs where applicable. CMS will
consider these suggestions as we
contemplate future enhancements.
CMS also agrees about the importance
of transparency in CMS’s calculation of
Star Ratings. Sponsors and their
authorized users may access the Patient
Safety User Guides through the Patient
Safety Analysis website set up by CMS
for Part D sponsors to have access to
monthly Patient Safety Reports to
compare their performance to overall
averages and monitor their progress in
improving the prescription drug patient
safety measures. We will consider
options to either publicly post the
Patient Safety Report User Guides or
incorporate additional details in the Star
Ratings Technical Notes. The
commenter’s reference of CMS using
member months in the SUPD measure is
an example of a modification necessary
to fairly evaluate performance of Part D
sponsors. The member-years of
enrollment adjustment is used to
account for beneficiaries who are
enrolled for only part of the contract
year. The measure is weighted based on
enrollment since beneficiaries with
longer enrollment episodes account for
more member-years and therefore have
a larger impact on a contract’s rates.
Each episode of enrollment is
considered separately.
Comment: A commenter suggested
CMS use the Net Promoter Score (NPS)
rather than CAHPS measures.
Response: These comments are
outside of the scope of the proposed and
final rules. CMS disagrees that the NPS
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
should replace the CAHPS measures.
NPS was developed to measure
customer loyalty and does not provide
information about why a customer may
recommend a brand or product. Unless
an organization is collecting
supplemental information, NPS scores
will not help drive quality
improvement. Among proponents of the
NPS score, there is agreement that
additional feedback needs to be
collected from customers.37 This score
alone is not sufficient. MA and Part D
contracts can collect for their own
purposes a limited number of
supplemental survey items on the
CAHPS surveys if they add them to the
end of the survey. Some contracts do
add similar questions to the NPS item
to the current CAHPS surveys for their
own internal purposes. There are
multiple concerns about using the NPS
score instead of CAHPS, including that
the score may mask important
differences in performance between
organizations and the score is more
volatile and less reliable than a
composite measure that includes
multiple survey questions.
khammond on DSKBBV9HB2PROD with RULES2
Summary of Regulatory Changes
No changes are being finalized based
on these comments that are out of scope
of the proposed rule.
(5) Data Integrity (§§ 422.164(g),
423.184(g))
In the April 2018 final rule (83 FR
16562), CMS codified, at
§§ 422.164(g)(1)(iii) and
423.184(g)(1)(ii), a policy to make scaled
reductions to the Star Ratings for a
contract’s Part C or Part D appeals
measures because the relevant
Independent Review Entity (IRE) data
are not complete based on the
Timeliness Monitoring Project (TMP) or
audit information. The reduction is
applied to the measure-level Star
Ratings for the applicable appeals
measures. We proposed to add a
provision at §§ 422.164(g)(1)(iii)(O) and
423.184(g)(1)(ii)(M) that would assign a
1-star rating to the applicable appeals
measure(s) if a contract fails to submit
TMP data for CMS’s review to ensure
the completeness of their IRE data. We
explained in the proposed rule that we
believe it is appropriate to assume that
there is an issue related to performance
when the MA organization or Part D
plan sponsor has refused to provide
information for the purposes of our
oversight of the compliance with the
appeals requirements. We also
37 https://aishealth.com/medicare-and-medicaid/
nps-is-viewed-as-useful-but-not-best-as-solesatisfaction-measure-for-ma-plans/.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
explained how our proposal to modify
measure-specific ratings due to data
integrity issues is separate from any
CMS compliance or enforcement actions
related to a sponsor’s deficiencies; these
rating reductions are necessary to avoid
falsely assigning a high star to a
contract, especially when the MA
organization or Part D sponsor has
refused to submit data for us to evaluate
performance in this area and to ensure
that the data submitted to the IRE are
complete.
Below we summarize the comments
we received and provide our responses
and final decisions.
Comment: Most commenters
supported the downgrade to one star if
a contract fails to submit TMP data for
CMS’s review to ensure the
completeness of the IRE data. A
commenter suggested that a reduction
should only occur when there is a
complete failure to submit TMP data for
CMS review.
Response: CMS appreciates the
support of the data integrity policies. To
fully assess the completeness of the
appeals data, the TMP data need to be
complete and submitted in a timely
manner. The data integrity policies align
with our commitment to data quality
and preserve the integrity of the Star
Ratings. CMS designed the data integrity
policies to distinguish between
occasional errors and systematic issues.
This policy and these rating reductions
are necessary to avoid falsely assigning
a high Star Rating to a contract,
especially when deficiencies have been
identified that show CMS cannot
objectively evaluate a sponsoring
organization’s performance in an area.
Comment: A commenter questioned
whether the proposal is only referring to
the Appeals Auto-Forward measure as
the Part D appeals measure.
Response: The data assignment of one
star is for both the appeals timeliness
and upheld measures for Part C and Part
D. If a contract does not submit the TMP
data for the Part C measures, Plan Makes
Timely Decision about Appeals (Part C)
and the Reviewing Appeals Decisions
(Part C), both will receive reductions.
The same policy applies to the two Part
D appeals measures, Appeals AutoForward (Part D) and Appeals Upheld
(Part D).
Comment: Many commenters
generally opposed scaled reductions,
characterizing them as ‘‘data integrity
penalties’’ using TMP and audit data,
and a commenter supported use of
audits and TMP data for scaled
reductions. The commenters that were
opposed stated these data integrity
findings are not a reflection of the plan’s
quality. Others stated that the TMP is
PO 00000
Frm 00089
Fmt 4701
Sfmt 4700
15767
burdensome due to an additional
requirement that they need to budget for
and manage. A commenter opposed use
of audits because they believe there
could be auditor subjectivity (varying
interpretation of the same issue) and
changes in the audit process. Many
commenters gave recommendations for
the TMP or requested clarifications on
the process of scaled reductions. A
couple of commenters recommend
consolidating auditing and/or TMP
efforts with other requirements and
offered suggestions such as eliminating
the TMP and modifying the Part D
reporting requirements and Technical
Specifications for Coverage
Determinations and Redeterminations
reports to collect the same or similar
data to confirm the accuracy of IRE data.
A commenter recommended applying
the requirements of Executive Order
13771 on Reducing Regulation and
Controlling Regulatory Costs to fulfill
the Star Ratings integrity goal, be
operationally less burdensome for plan
sponsors, and also save CMS and the
Part D program the amount it paid for
the TMP audit in 2017 and 2018. A
commenter requested that CMS provide
its methodology for determining which
cases are in scope for scaled reductions.
Another commenter requested CMS
wait a minimum of 2 calendar years to
use the findings in a ‘‘punitive’’ manner
to allow the plans to adapt to the
process. And a commenter suggested
CMS examine methods to simplify
appeals administration language and
address areas of subjectivity identified
within the guidelines that result in
differing interpretations.
Response: As explained in the
proposed rule, the use of the data
downgrade is not a penalty or punitive
but a necessary measure to reflect how
the data underlying the measure are not
reliable and to avoid false high ratings
on these measures where the sponsoring
organization has failed to provide the
data necessary to ensure that
performance is accurately reflected on
these measures. As we explained in the
April 2018 final rule at 83 FR 16562, all
measures and the associated data for the
Star Ratings have multiple levels of
quality assurance checks. Our
longstanding policy has been to reduce
a contract’s measure rating if we
determine that a contract’s data are
incomplete, inaccurate, or biased. If
there are data issues, we cannot
accurately measure quality and
performance. The data downgrade
policy was adopted not as a penalty but
to address instances when the data that
will be used for specific measures are
not reliable for measuring performance
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15768
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
due to their incompleteness or biased/
erroneous nature. For instances where
the integrity of the data is compromised
because of the action or inaction of the
sponsoring organization (or its
subcontractors or agents), this policy
reflects the underlying fault of the
sponsor and without it sponsoring
organizations could ‘‘game’’ the Star
Ratings and merely fail to submit data
that illustrate poor performance. Not
only is accepting biased data from a
sponsor not fair to other organizations
that follow rules and have procedures in
place to properly handle appeals, but it
is also not fair to beneficiaries, as they
would receive inaccurate information
on the plan’s performance regarding its
handling of appeals. The use of TMP
data for scaled reductions of the appeals
measures was finalized in the April
2018 final rule. In this CY2020
rulemaking, CMS only proposed a
reduction to one star for the applicable
appeals measures for the contracts that
do not submit any TMP data but did not
reopen for comment the entire provision
regarding use of TMP data or scaled
reductions as a whole. Therefore, while
CMS appreciates this feedback related to
the TMP and scaled reductions in
general, these comments are outside the
scope of the proposed rule; CMS will
consider these suggestions as we make
future enhancements.
Comment: A commenter stated the
additional change modifies the appeals
measures from a timeliness measure to
a timeliness and data integrity measure.
Response: CMS disagrees with this
assertion. The proposed addition to the
scaled reductions for not submitting
TMP data is not a modification to the
appeals measures but a mechanism to
ensure that the data used for evaluating
performance on a measure are accurate,
complete, and unbiased. If a contract
does not submit TMP data, CMS does
not have information to assess the
completeness of the data used for these
measures. The data used for CMS’s Star
Ratings must be reliable, meaning that
they are accurate, complete, and
without bias. CMS has historically
identified issues with some contracts’
data and has taken steps to protect the
integrity of the data and the Star
Ratings; publishing Star Ratings that are
not an accurate reflection of plan
performance would not be consistent
with CMS’s statutory obligation to
provide comparative information to
beneficiaries under section 1851(d) of
the Act or with the goals of the Quality
Payment Bonus under section 1853(o) of
the Act. Our longstanding policy has
been to reduce a contract’s measure
rating if we determine that a contract’s
measure data are incomplete,
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
inaccurate, or biased. Determinations
that data are inaccurate or biased may
result from the mishandling of data,
inappropriate processing, or
implementation of incorrect practices.
Comment: A few commenters noted
that there is a short window for the
plans to submit TMP data and that
results are not shared until 9 months
later. A few commenters requested that
plans be provided with TMP results in
advance of the first plan preview period.
A commenter requested that if CMS
chooses to continue the TMP process,
CMS should hold the auditor
accountable for providing at least a draft
audit report within 30 days.
Response: CMS appreciates this
feedback. As described in the December
21, 2018 HPMS memo entitled 2019
Timeliness Monitoring Project (TMP),
the data collection is done in three
waves beginning in January 2019. CMS
receives initial TMP results at the end
of Spring 2019, and then analyzes each
contract’s data to apply the scale
reductions as required by
§§ 422.164(g)(1)(iii) and
423.184(g)(1)(ii); where the applicable
regulation does not require a reduction,
no reduction is taken. There are no draft
TMP reports. CMS will again provide
TMP results and scaled reduction
information in the first plan preview
and sponsoring organizations may
submit any questions or comments if
they believe they should not have
received a reduction. CMS will consider
if it is operationally feasible to make
these data available any earlier in future
years. CMS strongly recommends
sponsoring organizations being
proactive in adopting policies to ensure
that data are accurate, complete, and
unbiased, and that the data integrity
downgrades are not applicable to them.
Comment: A commenter did not
support the proposal to reduce to one
star for not producing the TMP data
citing that CMS should ensure that the
Star Ratings system is focused on
improving quality of care received by
beneficiaries instead of incorporating
‘‘penalties’’ on plans for compliance
purposes. Another commenter
supported the proposal to reduce to one
star if a contract fails to submit TMP
data but stated that reducing the Star
Ratings for data integrity errors confuses
quality measurement with compliance
and audit activities. The commenter
stated that a plan that is ‘‘penalized’’
through compliance audits should not
be ‘‘penalized’’ a second time through
the Star Ratings, which should be
focused on clinical quality and
beneficiary satisfaction.
Response: CMS agrees that the Star
Ratings should be focused on improving
PO 00000
Frm 00090
Fmt 4701
Sfmt 4700
the quality of care provided by health
and drug plans, but in order to ensure
that the Star Ratings can focus on that,
the data used to measure performance in
CMS’s Star Ratings program must be
accurate, complete, and unbiased. We
reiterate that (1) the reductions required
by §§ 422.164(g) and 423.184(g) are not
a penalty but a means to reflect how the
sponsoring organization has not
produced accurate, complete, and
unbiased data for purposes of
performance measurement and (2) that
our proposal was on the narrow issue of
addressing the failure of a sponsoring
organization to submit TMP data so that
CMS could evaluate if the data integrity
provision would require a scaled
reduction in certain appeals measures.
Our longstanding policy has been to
reduce a contract’s measure rating if we
determine that a contract’s data are
inaccurate, incomplete, or biased. If
there are data issues, we cannot
accurately measure quality and
performance. Public postings of the Star
Ratings data use a notice that CMS has
identified issues with a plan’s data in
lieu of the actual rating for a measure;
this notice is used when CMS has
determined that inaccurate, incomplete,
or biased data (such as resulting from
the mishandling of data, inappropriate
processing, or implementation of
incorrect practices) has had an impact
on the measure score. The number of
stars applied to the measure will be
governed by §§ 422.164(g) and
423.184(g), which address scaled
reductions to appeals measures based
on an analysis of TMP or audit data and
to one star for HEDIS measures and
other measures based on NCQA audits,
lack of compliance with CMS data
validation policies, and other means to
identify data integrity issues. The data
integrity policies align with our
commitment to data quality and
preserve the integrity of the Star
Ratings. CMS designed and finalized
these data integrity policies in the April
2018 final rule to distinguish between
occasional errors and systematic issues.
Comment: A commenter suggested
that if the TMP is used to measure
completeness of data, it should be
limited to the data for just one measure,
the Part D Appeals Auto-Forward
measure.
Response: The TMP assess the
completeness of the IRE data for all
applicable appeals measures which
include two Part C and two Part D
appeals measures. The assignment to
one star when no TMP data are
submitted is also applied to the
applicable appeals measures since data
completeness issues impact the data
used for both the timeliness and upheld
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
measures for Part C and Part D. If cases
are missing for the timeliness measure
for either Part C or Part D, it would also
result in missing cases for the applicable
upheld measure.
Comment: A commenter requested
that CMS provide more information on
the impact of cut points if a plan fails
to submit their TMP audit results and
the proposal to reduce the plan’s rating
on the appeals measures is
implemented.
Response: If a contract fails to submit
TMP data for CMS’s review to ensure
the completeness of their IRE data, the
contract receives one star for the
applicable appeals measure(s) under the
new regulation provision we proposed
and are finalizing at
§§ 422.164(g)(1)(iii)(O) and
423.184(g)(1)(ii)(M). Because CMS
would have determined that the data
reported as performance under the
applicable appeals measure(s) was
inaccurate, incomplete or biased, that
data are not included in the creation of
cut points. We base cut points on an
analysis of performance data believed to
be accurate, complete, and unbiased.
Comment: A commenter questioned
what happens if a sponsor submits TMP
data late. Their understanding is that
currently, because there is no late
submission deadline for submitting
TMP data, the result is a reduction to
one star. They sought to understand the
impact of submitting data late under
this new provision, and how this
provision differs from the existing one.
Response: Failure to submit data by
the deadline or an extension granted by
CMS is failure to submit the TMP data.
Under the new regulation provision we
proposed and are finalizing here at
§§ 422.164(g)(1)(iii)(O) and
423.184(g)(1)(ii)(M), the assignment of
one star for the applicable appeals
measures will happen if a contract fails
to submit any TMP data. The December
21, 2018 HPMS memo entitled 2019
Timeliness Monitoring Project (TMP)
provides details about data submission,
including the deadlines. Under the
current practice, a sponsor can let CMS
know if there is an issue meeting the
submission deadline for the TMP data
and CMS can work with the sponsor to
determine if an alternative deadline is
feasible. CMS needs adequate time to
analyze the TMP data once submitted to
be able to determine the completeness
of the appeals data. If the data are
submitted beyond the deadline or an
extension granted by CMS, it is treated
as a failure to submit the TMP data.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
related comments summarized earlier,
we are finalizing at
§§ 422.164(g)(1)(iii)(O) and
423.184(g)(1)(ii)(M) the assignment of a
1-star rating to the applicable appeals
measure(s) if a contract fails to submit
TMP data for CMS’s review to ensure
the completeness of the contract’s IRE
data.
(6) Review of Sponsors’ Data
(§§ 422.166(h), 423.186(h))
At §§ 422.164(h)(1) and 423.184(h)(1),
CMS proposed to codify a policy
regarding the deadlines for an MA
organization or Part D plan sponsor to
request the IRE or CMS to review a
contract’s appeals data or CMS to
review a contract’s Complaints Tracking
Module (CTM) data. For example,
information regarding the Part C and
Part D appeals process is available to
MA organizations and is updated daily
on the IRE website. Additionally,
sponsors can access the Part D Appeals
Reports under the Performance Metrics
pages in HPMS. To allow enough time
for the IRE to make any necessary
changes to ensure the accuracy of a
contract’s measure score, we proposed
that requests for CMS or the IRE to
review contract data must be received
no later than June 30 of the following
year in order to have time to use
accurate information in the Star Ratings
calculations (for example, changes to
contract year 2018 appeals data must be
made by June 30, 2019 for the 2020 Star
Ratings). Reopenings are not taken into
account under this proposed deadline
for corrections to the IRE data. For
purposes of the appeals measures, if a
reopening occurs and is decided prior to
May 1, the revised determination is
used in place of the original
reconsidered determination. If the
revised determination occurs on or after
May 1, the original reconsidered
determination is used.
Similarly, we proposed that any
requests for adjustments following
CMS’s CTM Standard Operating
Procedures for the complaints measures
be made by June 30 of the following
year in order for the changes to be
reflected in a contract’s Star Ratings
data (for example, changes to contract
year 2018 complaints data must be
made by June 30, 2019 for the 2020 Star
Ratings).
Below we summarize the comments
we received and provide our responses
and final decisions.
Comment: Many of the commenters
supported a deadline for an MA
organization or Part D plan sponsor to
request the IRE or CMS to review a
contract’s appeals or CMS to review a
contract’s CTM data, but they did not
PO 00000
Frm 00091
Fmt 4701
Sfmt 4700
15769
support the proposal of the June 30th
date. They all recommended that the
date should be following the first plan
preview stating that the later date would
allow plans to fully respond to all
appeals and complaints.
Response: CMS appreciates the
feedback and is finalizing our proposal
with a modification that will permit
CMS to set the date annually to allow
flexibility each year to determine the
date based on the availability of data for
plans to review.
Comment: A commenter noted that
the timeframes/deadlines CMS is
proposing do not appear to align with
the allotted timeframes CMS allows for
plans and the IRE to re-open decisions.
The commenter proposed CMS review
the IRE reopening process and
timeframes to ensure all cases submitted
to the IRE, in the measurement plan
year, are fully resolved by the first plan
preview period. Additionally, the
commenter recommended that if the IRE
does not meet the IRE reconsideration
timeframes, which are outlined in the
MAXIMUS Federal Medicare Health
Plan Reconsideration Process Manual,
then plans would still be held
accountable for the outcome of the
reconsideration but those cases should
not be included in the plan’s
performance scores since they were not
fully resolved.
Response: Because CMS does not
want to implement policies that
promote reopenings, CMS will not
adopt the policy the commenter
recommends. Excluding cases that were
reopened but do not yet have a decision
would encourage organizations to
reopen more cases and possibly
manipulate their ratings. Therefore, if
the reopening is not decided by May 1st,
the original reconsideration decision is
used in the measure. Reopenings are
supposed to be rare. CMS appreciates
the feedback about the data timeframe
for reopenings and will consider this
comment in the future.
Comment: A commenter did not
support the data review deadline,
because CMS (and its contractor,
MAXIMUS) does not provide full
visibility into the fields that are required
to calculate compliance on an ongoing
basis. For example, the commenter
pointed out that there is no timeliness
indicator on MAXIMUS’ website and as
a result, some of the data cannot be
monitored on an ongoing basis for
accuracy. Instead, MA plans must
develop a workaround, such as
monitoring case dates for accuracy.
Something as simple—and
predictable—as a national holiday
where mail is not delivered can result
in an incorrect timeliness measure.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15770
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Response: Although there are enough
data provided on the MAXIMUS
website for contracts to determine if a
case is late, CMS has worked with
MAXIMUS, the IRE, to add a late
indicator on the website for Part C
Appeals data to make it easier for plans
to monitor the timeliness of their cases.
This update will further allow plans to
request adjustments to their Part C
appeals, if necessary, in a timely
manner before Star Ratings calculations.
Comment: A commenter supported
the proposal, but requested a
clarification of the application of the
deadline related to CTM data, because
CMS often changes the CTM case status
so that cases are no longer visible and
cannot be monitored for accuracy.
Response: We appreciate the support
and the opportunity to clarify which
CTM data are used for Star Ratings
purposes. For CTM, the quarterly
reports only contain CTM complaints
that are used to calculate the Star Rating
CTM measure. If a CTM is not in the
report, the complaint is not considered
a plan issue and it would not be
included in the Star Ratings measure.
Therefore, sponsoring organizations
may wish to focus their requests for
CMS review of CTM data on the data
that are part of the quarterly reports.
Comment: A few commenters
supported the proposal but noted that
CMS should publish a schedule of the
timing of all related reports, while a
commenter did not support the proposal
and requested similarly a schedule of
reports. Additionally, a commenter
stated the Part C MAXIMUS IRE reports
are not published and are only made
available upon request to the CMS
account manager each quarter.
Response: We appreciate the support
and the opportunity to clarify the timing
and availability of the reports which
contain data used for the Star Ratings.
Part D appeals and CTM reports are
posted in HPMS quarterly;
approximately 2 months following the
close of the quarter. Information
regarding the Part C reconsideration
process is available to Medicare
Advantage (MA) organizations on the
www.medicareappeal.com website. The
data available on this website are
updated daily; therefore, MA
organizations that notice discrepancies
or have questions about the data should
bring these issues to the attention of the
IRE as they arise. On the website, MA
organizations are able to see all the
cases related to a particular plan for the
date range they chose and they are also
able to search by case number.
MAXIMUS has added a late indicator to
their website to help in the review;
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
therefore, plans should be able to fully
monitor their data throughout the year.
Comment: A commenter supported
the codification of deadlines for
requests by an MA organization or Part
D plan sponsor to review contract
appeals or Complaints Tracking Module
data.
Response: CMS appreciates the
support.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to
related comments summarized earlier,
we are finalizing the provisions at
§§ 422.164(h)(1) and 423.184(h)(1)
related to the policy regarding the
deadlines for an MA organization or
Part D plan sponsor to request CMS or
the IRE to review its’ appeals data or
CMS to review its’ Complaints Tracking
Module (CTM) data with a substantive
modification. We are not finalizing the
June 30th deadline in regulation. To
provide more flexibility to set the
deadline contingent on the timing of the
availability of data for plans to review,
we are finalizing in this regulation that
an MA organization or Part D plan
sponsor may request that CMS or the
IRE review its’ data, provided that the
request is received by the annual
deadline set forth by CMS for the
applicable Star Ratings year. We intend
to use the annual Call Letter or an
HPMS memo to set the annual deadline.
e. Extreme and Uncontrollable
Circumstances (§§ 422.166(i),
423.186(i))
We proposed a policy to address how
extreme and uncontrollable
circumstances may have a negative
impact on the Quality Star Ratings of an
MA or Part D plan. Extreme and
uncontrollable circumstances such as
natural disasters can directly affect
Medicare beneficiaries and providers, as
well as the Parts C and D organizations
that provide them with important
medical care and prescription drug
coverage. These circumstances may
negatively affect the underlying
operational and clinical systems that
CMS relies on for accurate performance
measurement in the Star Ratings
program, all without fault on the part of
the MA organization or Part D plan
sponsor. We proposed to adjust the Star
Ratings to take into account the effects
of extreme and uncontrollable
circumstances that occurred during the
performance or measurement period in
a manner that would generally hold the
affected contract harmless from
reductions in Star Ratings. We proposed
to codify a series of special rules for
calculation of the Star Ratings of certain
PO 00000
Frm 00092
Fmt 4701
Sfmt 4700
contracts in certain extreme and
uncontrollable circumstances in
paragraph (i) of §§ 422.166 and 423.186.
We proposed that the adjustments be
tailored to the specific areas
experiencing the extreme and
uncontrollable circumstance in order to
avoid over-adjustment or adjustments
that are unnecessary. Health and drug
plans can serve enrollees across large
geographic areas, and thus they may not
be impacted in the same manner as
healthcare providers such as hospitals
or medical centers in specific physical
locations. To ensure that the Star
Ratings adjustments focus on the
specific geographic areas that
experienced the greatest adverse effects
from the extreme and uncontrollable
circumstance and are not applied to
areas sustaining little or no adverse
effects, our proposal targeted the
adjustments to specific contracts and
further specified and limited the
adjustments.
Below we summarize the comments
we received on the disaster adjustments
in general.
Comment: Most commenters
supported our proposals to adjust Star
Ratings in the event of an extreme and
uncontrollable circumstance.
Response: We thank the commenters
for their support of the proposal, which
we are finalizing with some substantive
modifications in this final rule as
described below.
Comment: A few commenters
requested that CMS delay codifying the
extreme and uncontrollable
circumstances policy and continue to
assess and develop the methodology in
case additional modifications are
needed. A commenter requested that
CMS implement the policy for
measurement year 2018 in order to
avoid a temporary lapse in the
application of the proposed policy.
Response: The policy being adopted
in this final rule will apply to the 2022
Star Ratings and beyond, for extreme
and uncontrollable circumstances that
begin on or after January 1, 2020. If
adjustments are needed to the policy,
CMS will propose them through a future
rulemaking or sub regulatory guidance.
The 2020 Call Letter includes CMS’s
policy for the 2020 Star Ratings for
extreme and uncontrollable
circumstances that occurred in 2018.
We decline to delay adoption of this
policy for a future period, because
similar procedures were successfully
applied to the 2019 Star Ratings as a
result of the multiple 2017 disasters.
(1) Identification of Affected Contracts
In paragraph (i)(1) of §§ 422.166 and
423.186, we proposed to identify MA
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
and Part D contracts affected by extreme
and uncontrollable circumstances
during the performance or measurement
period that may have affected their
performance on Star Ratings measures
or their ability to collect the necessary
measure-level data. Under our proposal,
these ‘‘affected contracts’’ are the
contracts eligible for the specified
adjustments that take into account the
effects of the extreme and
uncontrollable circumstances. For an
MA or Part D contract to be considered
an affected contract under our proposal,
the contract would need to meet all of
the following criteria:
• The contract’s service area is within
an ‘‘emergency area’’ during an
‘‘emergency period’’ as defined in
section 1135(g) of the Act.
• The contract’s service area is within
a county, parish, U.S. territory or tribal
area designated in a major disaster
declaration under the Stafford Act and
the Secretary exercised authority under
section 1135 of the Act based on the
same triggering event(s).
• A certain minimum percentage (25
percent for measure star adjustments or
60 percent for exclusion from cut point
and Reward Factor calculations) of the
enrollees under the contract must reside
in a Federal Emergency Management
Agency (FEMA)-designated Individual
Assistance area at the time of the
extreme and uncontrollable
circumstance.
We proposed to identify an area as
having experienced extreme and
uncontrollable circumstances if it is
within an ‘‘emergency area’’ and
‘‘emergency period’’ as defined in
section 1135(g) of the Act, and also is
within a county, parish, U.S. territory or
tribal government designated in a major
disaster declaration under the Stafford
Act, and the Secretary exercised
authority under section 1135 of the Act
based on the same triggering event(s)
(https://www.phe.gov/emergency/news/
healthactions/section1135/Pages/
default.aspx). Major disaster areas are
identified and can be located on
FEMA’s website at https://
www.fema.gov/disasters. To ensure the
policy is applied to those contracts most
likely to have experienced the greatest
adverse effects, we proposed to narrow
it to apply to contracts with a certain
minimum percentage of enrollees
residing in an area declared as an
Individual Assistance area because of
the disaster declaration. Individual
Assistance includes assistance to
individuals and households, crisis
counseling, disaster case management,
disaster unemployment assistance,
disaster legal services, and the disaster
Supplemental Nutrition Assistance
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Program. We explained that our focus
on enrollees residing in counties eligible
for Individual Assistance because of a
major disaster was because most Star
Ratings measures are based on services
provided directly to beneficiaries in
their local area. Health and drug plans
can serve enrollees across large
geographic areas, and thus they may not
be impacted in the same manner as
healthcare providers such as hospitals
or medical centers in specific physical
locations. Therefore, we proposed to
target the adjustments based on extreme
and uncontrollable circumstances to
contracts serving beneficiaries who were
eligible for individual and household
assistance because of the disaster
declaration.
We further proposed that at least 25
percent or 60 percent of the enrollees
under the contract must reside in
Individual Assistance areas identified
because of the extreme and
uncontrollable circumstances in order
for the contract to be an affected
contract eligible for adjustments. We
explained that this limitation would
ensure that the adjustments are limited
to contracts that we believe may have
experienced a real impact from the
extreme and uncontrollable
circumstance in terms of operations or
ability to serve enrollees. In calculations
for the 2019 Star Ratings, we observed
that contracts tend to have either very
few enrollees impacted or most of their
enrollees impacted due to the nature of
contracts either covering a broad region
or a localized area; if 1 out of 4 enrollees
were impacted during the period of the
year when the disaster hit, we stated our
belief that there would be a small
chance that scores may have been
impacted. We proposed to exclude the
numeric measure scores from contracts
with 60 percent or more enrollees
impacted by the extreme and
uncontrollable circumstances from the
determination of the cut points and
explained it as a conservative rule that
would apply only in cases where a clear
majority or all of the enrollees are
impacted. We also explained that using
the Individual Assistance major disaster
declaration as a requirement to identify
contracts that would be eligible for
adjustments ensures that the policy
applies only when the event is extreme,
meriting the use of special adjustments
to the Star Ratings.
We proposed that contracts that do
not meet the definition of an ‘‘affected
contract’’ would not be eligible for any
adjustments based on the occurrence of
the extreme and uncontrollable
circumstances but also noted that the
criteria to be an affected contract would
PO 00000
Frm 00093
Fmt 4701
Sfmt 4700
15771
not be sufficient to receive all the
adjustments we proposed.
Below we summarize the comments
we received on the identification of
affected contracts and provide our
responses and final decisions.
Comment: Several commenters
suggested that CMS commit to being
transparent in how it has applied the
regulations, such as which contracts
received adjustments and the impact on
the Star Ratings program. A few stated
this would allow sponsors a better
understanding of marketplace
performance and reduce inquiries to
CMS. A commenter recommended that
CMS announce areas designated as
disasters for the purposes of Star Ratings
on a quarterly basis, and another
requested greater specificity on how a
plan within a given county would
qualify for the exemption rules. Another
commenter requested that data and
analysis on affected contracts be shared
with state Medicaid agencies as this
information is relevant to the states, and
data sharing reduces burden on the
plans.
Response: Information about which
areas are designated in a major disaster
declaration under the Stafford Act and
when the Secretary exercised authority
under section 1135 of the Act based on
the same triggering event(s) are all
public information we are extracting
from the relevant websites. CMS
published the list of relevant 2017
disasters and affected counties in the
2019 Call Letter, and state, county, and
contract enrollment data are publicly
available, so information about affected
contracts is already available. We agree
that providing additional information
when the adjustments authorized under
§§ 422.166(i) and 423.186(i) may be
possible. To that end, CMS plans to
provide information identifying
contracts that meet the definition of
affected contracts in §§ 422.166(i)(1) and
423.186(i)(1). We note that the
definition of ‘‘affected contract’’ in these
regulations is substantially similar to
the definition and standards CMS used
to make similar adjustments in the 2019
Star Ratings based on disasters that
occurred in 2017. For the 2019 Star
Ratings, which were adjusted for the
disasters (Hurricanes Harvey, Irma, and
Maria, and the wildfires in California)
that occurred during the 2017
performance period, 77 contracts met
the 25 percent threshold of beneficiaries
in FEMA-designated Individual
Assistance areas at the time of the
disaster. Based on a similar policy to
that we are now codifying in
§§ 422.166(i) and 423.186(i), affected
contracts reverted to the prior year’s
rating an average of five times for Part
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15772
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
C measures and three times for Part D
measures. For the 2019 Star Ratings, 57
contracts met the 60 percent threshold
of beneficiaries in FEMA-designated
Individual Assistance areas and had
their numeric values excluded from the
clustering algorithm so they did not
influence cut points. CMS will continue
to release the list of relevant disasters
and FEMA-designated Individual
Assistance counties in the Call Letter
each year after the performance period
so contracts know in advance of the Star
Ratings preview periods whether they
might be considered an affected contract
based on their service area.38
Comment: A commenter questioned
whether requiring affected contracts to
meet all three criteria in §§ 422.166(i)(1)
and 423.186(i)(1) was too restrictive if it
requires a state-level declaration of
emergency and suggested that the third
criteria (that is, §§ 422.166(i)(1)(iii) and
423.186(i)(1)(iii)) was most applicable.
Response: Stafford Act disaster
declarations are made by state but
designate specific counties that are
affected. Our policy addresses contracts
with service areas in FEMA-designated
Individual Assistance counties. We
proposed that for a contract to be
considered an affected contract it would
need to meet all three criteria in
§§ 422.166(i)(1) and 423.186(i)(1). This
ensures the extreme and uncontrollable
circumstances policy is limited to
contracts that may have experienced a
real impact from the disaster in terms of
operations or ability to serve enrollees.
It also ensures that it applies only when
the event is extreme, meriting the use of
special adjustments to the Star Ratings.
Comment: A commenter was
concerned that contracts may
deliberately combine contracts with
enrollment from a non-disaster area
with enrollment in a disaster area in
order to meet the 25 percent threshold
for Star Ratings adjustments and
encouraged CMS to implement
safeguards to prevent abuse of the
extreme and uncontrollable
circumstances policy.
Response: CMS appreciates this
comment and notes that the April 2018
final rule addresses contract
consolidations. In particular, for
consolidations approved on or after
January 1, 2019 we assign Star Ratings
based on the enrollment-weighted mean
of the measure scores of the surviving
and consumed contract(s) so that the
38 Tables 14 and 15 in the 2020 Call Letter contain
a list of the section 1135 waivers that could affect
the 2020 Star Ratings and Individual Assistance
counties from all of the 2018 FEMA major disaster
declarations. https://www.cms.gov/medicare/
health-plans/medicareadvtgspecratestats/
announcements-and-documents.html.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
ratings reflect the performance of all
contracts (surviving and consumed)
involved in the consolidation. Further,
the scenario described by the
commenter is unlikely to occur as
contract consolidations are generally
approved in advance; a sponsoring
organization would not be able to take
advantage of an extreme and
uncontrollable circumstance by
subsequently consolidating contracts.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
related comments summarized earlier,
we are finalizing the definition of an
affected contract in paragraph (i)(1) of
§§ 422.166 and 423.186. We are also
finalizing the introductory sentence in
paragraph (i) substantially as proposed
to establish a rule that in the event of
certain extreme and uncontrollable
circumstances, CMS calculates Star
Ratings for affected contracts using the
rules specified in paragraphs (i)(2)
through (i)(10). Those specific rules and
the text in paragraphs (i)(2) through
(i)(10) are addressed in sections
II.B.1.e.(2) through (10). In finalizing the
first sentence of paragraph (i), we are
making a grammatical change to use
‘‘calculates’’ in place of ‘‘will calculate.’’
We address additional text we are also
finalizing as a new last sentence in the
introductory text of paragraph (i) in
section II.B.1.e.(6).
(2) CAHPS Adjustments
For CAHPS, we proposed two
different types of special rules for
affected contracts: Exemption from
having to administer the CAHPS survey
or adjustments to the Star Ratings on the
CAHPS measures if the affected contract
must administer the CAHPS survey.
CAHPS measures are based on a survey
conducted early in the year in which the
Star Ratings are released, that is, the
year before the year to which the Star
Ratings are applicable. For example, the
CAHPS survey in early 2019 will be
used for the 2020 Star Ratings, which
are released in late 2019, before the
annual coordinated election period for
2020.
We proposed at §§ 422.166(i)(2)(i) and
423.186(i)(2)(i), that an MA and
Prescription Drug Plan contract, even if
it is an affected contract, must
administer the CAHPS survey unless the
contract demonstrates to CMS that the
required sample for the CAHPS survey
cannot be contacted because a
substantial number of the contract’s
enrollees are displaced due to a FEMAdesignated disaster in the prior calendar
year and requests and receives a CMS
approved exemption. We explained in
PO 00000
Frm 00094
Fmt 4701
Sfmt 4700
the proposed rule our belief that
displacement of a substantial number of
the contract’s enrollees would make it
practically impossible to contact the
required sample for the CAHPS survey.
For an affected contract that receives the
exemption from administering the
CAHPS survey, we proposed at
§§ 422.166(i)(2)(iii) and 423.186(i)(2)(iii)
that the affected contract would receive
the prior year’s CAHPS measure stars
(and corresponding measure scores).
We proposed that affected contracts
with at least 25 percent of enrollees in
FEMA-designated Individual Assistance
areas at the time of the extreme and
uncontrollable circumstance would
receive the higher of the previous year’s
Star Rating or the current year’s Star
Rating (and corresponding measure
score) for each CAHPS measure
(including the annual flu vaccine
measure). For example, for the 2022 Star
Ratings for affected contracts, we would
take the higher of the 2021 Star Ratings
or the 2022 Star Ratings for each CAHPS
measure. The affected contract would
receive the CAHPS measure score for
the corresponding Star Rating year
chosen. We proposed the 25 percent
threshold to avoid including contracts
with very few enrollees impacted and
explained our belief that the measurelevel scores should not be adjusted for
contracts with very few enrollees
impacted by the extreme and
uncontrollable circumstances. We stated
that if a small percentage of enrollees
were impacted by an extreme and
uncontrollable circumstance, there
should not be a significant impact on
measure scores. Comments received on
this specific proposal in §§ 422.166(i)(2)
and 423.186(i)(2) are discussed in
section II.B.1.e.(6) of this final rule.
(3) HOS Adjustments
For the HOS survey, we proposed to
follow similar procedures as CAHPS but
due to the follow-up component of
HOS, we proposed that the adjustment
be to the Star Ratings for the year after
the completion of the follow-up HOS
survey (that is administered 2 years after
the baseline HOS survey). For example,
the 2022 Star Ratings are based on data
collected from April through June 2020
and reflect experiences over the past 12
months. The data collected in 2021 will
be used for the 2023 Star Ratings, so
responses may reflect the impact of
2020 extreme and uncontrollable
circumstances and thus, those
circumstances may have an impact on
the 2023 Star Ratings.
We proposed at § 422.166(i)(3)(i) that
an MA contract, even if it is an affected
contract, must administer the HOS
surveys the year after the extreme and
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
uncontrollable circumstance unless the
contract demonstrates to CMS that the
required sample cannot be contacted
because a substantial number of the
contract’s enrollees are displaced due to
a FEMA-designated disaster during the
measurement period and requests and
receives a CMS approved exemption.
For an affected contract that receives the
exemption from administering the HOS
survey, we proposed at paragraph
(i)(3)(iii) that the affected contract
would receive the prior year’s HOS and
HEDIS–HOS measure stars (and
corresponding measure scores).
We proposed at § 422.166(i)(3)(iv) that
affected contracts with at least 25
percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance would
receive the higher of the previous year’s
Star Rating or current year’s Star Rating
for each HOS and HEDIS–HOS measure
(and corresponding measure score) for
the Star Ratings 3 years after the eligible
extreme and uncontrollable
circumstance. As an example, we
explained that for the 2023 Star Ratings
for contracts affected by an extreme and
uncontrollable circumstance in 2020,
we would take the higher of the 2022 or
2023 Star Rating (and corresponding
measure score) for each HOS and
HEDIS–HOS measure in applying the
proposal. Comments received on this
specific proposal in § 422.166(i)(3) are
discussed in section II.B.1.e.(6).
(4) HEDIS Adjustments
For HEDIS, we proposed that an MA
contract, even if an affected contract,
would be required to report HEDIS data
to CMS unless the contract
demonstrates to CMS an inability to
obtain both administrative and medical
record data required for HEDIS
measures due to a FEMA-designated
disaster in the prior calendar year and
requests and receives a CMS approved
exemption. We stated in the preamble of
the proposed rule that all contracts in
FEMA-designated disaster areas can
work with NCQA to request
modifications to the samples for
measures that require medical record
review; however, in our proposed
regulation text codifying this ability, we
proposed only that ‘‘affected contracts’’
without an exemption from reporting
HEDIS data would be able to seek that
kind of modification from NCQA. For
affected contracts that have service areas
with at least 25 percent of enrollees in
a FEMA-designated Individual
Assistance area at the time of the
extreme and uncontrollable
circumstance, we proposed to take the
higher of the previous year’s Star Rating
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
or current year’s Star Rating (and
corresponding measure score) for each
HEDIS measure. For example, for the
2022 Star Ratings for affected contracts
we would take the higher of the 2021 or
2022 Star Ratings for each HEDIS
measure. Comments received on this
specific proposal in § 422.166(i)(4) are
discussed in section II.B.1.e.(6). of this
final rule.
(5) New Measure Adjustments
At proposed §§ 422.166(i)(5) and
423.186(i)(3), we proposed to
implement a hold harmless provision
for new Star Ratings measures if the
inclusion of all applicable new
measure(s) brings down the summary
and/or overall rating. That is, for
affected contracts with at least 25
percent of enrollees in a FEMAdesignated Individual Assistance area at
the time of the extreme and
uncontrollable circumstance, all the
new measures would be excluded from
the calculation of the summary and/or
overall rating if their inclusion brings a
contract’s summary (or in the case of
MA–PD contracts, the overall) rating
down. Comments received on this
specific proposal in §§ 422.166(i)(5) and
423.186(i)(3) are discussed in section
II.B.1.e.(6). of this final rule.
(6) Other Star Ratings Measure
Adjustments
For all other measures for affected
contracts with at least 25 percent of
enrollees in a FEMA-designated
Individual Assistance area at the time of
the extreme and uncontrollable
circumstance (that occurs during the
measurement or performance period),
we proposed to take the higher of the
previous or current year’s measure Star
Rating (and then use the corresponding
measure score), as described at
proposed §§ 422.166(i)(6)(i) and
423.186(i)(4)(i). For example, for the
2022 Star Ratings for affected contracts,
we would take the higher of the 2021 or
2022 Star Ratings. We also proposed to
exclude from this adjustment policy the
Part C Call Center—Foreign Language
Interpreter and TTY Availability and
Part D Call Center—Foreign Language
Interpreter and TTY Availability
measures, except for extreme and
uncontrollable circumstances where
there are continuing communications
issues related to loss of electricity and
damage to infrastructure during the call
center study. We explained the
proposed exclusion by noting that these
measures and the underlying
performance are completely in the
plan’s control and we believed therefore
that there should generally be no impact
from the declaration of an extreme and
PO 00000
Frm 00095
Fmt 4701
Sfmt 4700
15773
uncontrollable circumstance on plan
performance in these areas.
Below we summarize the comments
we received on the proposed rules at
§§ 422.166(i)(2) through (6) and
423.186(i)(2) through (4) for adjustments
to CAHPS, HOS, HEDIS, new, and other
measures and provide our responses
and final decisions.
Comment: A few commenters
requested that we clarify whether our
extreme and uncontrollable
circumstances policy is ‘‘best of’’ the
Star Rating or measure score. A
commenter proposed that we take the
higher of the previous and current year’s
measure score if the Star Rating is the
same in both years to ensure the higher
score is used in the improvement
calculation.
Response: We proposed, for affected
contracts as described specifically in the
applicable regulation text, to select the
higher of the current or previous year’s
measure-level Star Rating and then use
the measure score that corresponds with
the year selected with the higher rating.
We proposed this use of the ‘‘higher Star
Rating’’ rule for CAHPS, new, and other
measures for MA and Part D ratings, and
for HOS and HEDIS measures for MA
ratings. We use the Star Rating for the
measure-level comparison because the
measure stars are used to calculate the
overall Star Rating and the measurelevel cut points can change each year.
We use the corresponding measure
scores for improvement calculations in
order to maintain consistency in the
years being compared. Where the higher
score does not correspond to the higher
rating, we use the score from the year
with the higher Star Rating for the
measure nonetheless. If the Star Rating
for a measure is the same in both years
we use the current year’s data (that is,
Star Rating and score). We only revert
to the previous year’s measure Star
Rating if it is higher. The regulation text
reflects this rule by referring to the
higher of the previous or current year’s
Star Rating (and corresponding measure
score) in §§ 422.166(i)(2)(iv),
422.166(i)(3)(iv), 422.166(i)(4)(v),
422.166(i)(6)(i), 423.186(i)(2)(iv), and
423.186(i)(4)(i).
Comment: A few commenters were
concerned that the 25 percent cutoff for
measure-level adjustments may be
inadequate, or that the policy is biased
against larger contracts serving
populations spread across multiple
regions.
Response: CMS chose the 25 percent
cutoff for measure-level adjustments
because this cutoff avoids including
contracts with very few enrollees
impacted by extreme and uncontrollable
circumstances. As explained in the
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15774
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
proposed rule, we do not believe it
would be appropriate to provide an
adjustment to the ratings when fewer
than a quarter of the enrollees covered
under the contract are affected by the
extreme and uncontrollable
circumstance. If only a small percentage
of enrollees is impacted by a disaster,
there should not be a significant impact
on measure scores (and therefore not on
Ratings). We disagree that the policy is
biased against larger contracts, since it
is applied the same to all contracts.
Further, for contracts with smaller
service areas, the declaration of an
emergency and designation of a FEMAdesignated Individual Assistance area in
one county might be sufficient to result
in 25 percent or more of the contract’s
enrollees being in the FEMA-designated
Individual Assistance area whereas a
larger contract covering the same county
might only have a small portion of its
overall enrollment in the FEMAdesignated Individual Assistance area.
Comment: A few commenters
suggested that we instead remove
beneficiaries who live within impacted
geographic areas from measurement
calculations. Commenters stated this
would ensure that all affected contracts
receive an adjustment that is
proportionate with the level of impact to
plan performance, be consistent with
other exclusion criteria used in Star
Ratings measures, and ensure that Star
Ratings performance is representative of
performance during the measurement
period.
Response: We decline to revise our
policy to include this type of
adjustment, either instead or in addition
to the adjustments we proposed and are
finalizing in §§ 422.166(i)(2) through (6)
and 423.186(i)(2) through (4). For many
measures, this is not operationally
feasible. For example, this would
require modifications to CAHPS and
HOS sampling, as well as to HEDIS
reporting requirements. Other measures
do not have beneficiary-level data that
could be adjusted.
Comment: Several commenters
questioned how CMS will apply the
policy for contracts impacted by
disasters in consecutive years. A few
suggested that CMS use the ‘‘higher of’’
the current year’s Star Rating and prior
year’s adjusted Star Rating, or link back
to the most recent year’s data not
affected by disasters. Another suggested
using best of ratings from periods or
sources: Current measurement year
performance, prior year performance,
parent organization average
performance, or industry average
performance. Other commenters were
concerned about old data being pulled
forward each year. A commenter stated
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
a ‘‘higher of’’ policy would be
inappropriate for consecutive disasters,
and that CMS should treat multiple
year-disaster contracts as new contracts,
rate them on a very small set of
measures, or base their rating on a small
portion of their service area. A
commenter suggested that that CMS
drop the threshold for relief below 25
percent and 60 percent for contracts that
have had two consecutive years of
disaster impact. Several commenters
requested that CMS extend the disaster
adjustment multiple years for select
regions continuing to recover from a
disaster (for example, Puerto Rico that is
still recovering from 2017 hurricanes).
Response: CMS appreciates these
comments and acknowledges that our
proposal did not address year-over-year
disasters. Given the number of
comments on this topic, we believe it is
appropriate to address by adopting
additional provisions specific to this
topic. We agree with commenters that
are concerned about looking back too
many years for contracts affected by
disasters multiple years in a row, as
well as about including too many
measurement periods in 1 year of Star
Ratings. We also must consider
operational feasibility, and using
different thresholds for contracts
affected by disasters in different ways
would be very complicated for
administration and for providing the
necessary transparency to MA
organizations, Part D plan sponsors, and
beneficiaries who use and rely on the
Star Ratings.
We must balance these concerns
about using older data with concerns
about using data based on performance
that has been impacted by consecutive
disasters. In striking a balance of these
concerns, we are finalizing a policy for
setting the Star Ratings for contracts
with at least 25 percent of enrollees in
FEMA-designated Individual Assistance
areas that were affected by disasters that
began in one year that were also affected
by disasters that began in the previous
year. Under the regulations we are
adopting in this final rule, such
multiple year-affected contracts receive
the higher of the current year’s Star
Rating or what the previous year’s Star
Rating would have been in the absence
of any adjustments that took into
account the effects of the previous year’s
disaster for each measure. For example,
if a multiple year-affected contract
reverted back to the 2021 Star Rating on
a given measure in the 2022 Star
Ratings, the 2021 Star Rating is not used
in determining the 2023 Star Rating;
rather, the 2023 Star Rating is compared
to what the 2022 Star Rating would have
been absent any disaster adjustments.
PO 00000
Frm 00096
Fmt 4701
Sfmt 4700
The rule for treatment of multiple yearaffected contracts then does not carry
very old data forward into the Star
Ratings for many years. Under this final
rule, we will use the measure score
associated with the year with the higher
measure Star Rating regardless of
whether the score is higher or lower that
year. We are finalizing this policy to
address when contracts are affected by
separate extreme and uncontrollable
circumstances that occur in successive
years for the adjustments to CAHPS,
HOS, HEDIS, and other measures. This
rule would apply for CAHPS, HOS,
HEDIS, new, and other measures.
Therefore, we are adopting new
provisions at §§ 422.166(i)(2)(v),
422.166(i)(3)(v), 422.166(i)(4)(vi),
422.166(i)(6)(iv), 423.186(i)(2)(v), and
423.186(i)(4)(iv) to include this rule for
how ratings for these measures will be
adjusted in these circumstances.
The issue about whether and how to
take into account extreme and
uncontrollable circumstances that occur
in successive years also raises the
question of how to address a specific
extreme and uncontrollable
circumstance that spans two years. For
example, we note that while Hurricane
Maria happened in 2017 and the
associated declarations of emergency
under section 1135 of the Act initially
happened in 2017, those declarations
extended for some areas into 2018. We
did not propose a specific policy for
addressing such situations. We are
finalizing new text at the end of the
introductory language of paragraph (i) of
both §§ 422.166 and 423.186 to clarify
that the incident start date will be used
to determine which year of Star Ratings
could be affected. We believe this
clarification is necessary because, in
some cases, the incident period end date
may change, which would make it
difficult operationally to determine
which Star Ratings year is impacted. For
example, the major disaster declaration
(DR–4353) for the California wildfires
was declared January 2, 2018. The
incident period was originally only in
December 2017, but it was subsequently
extended by FEMA through January
2018. Limiting adjustments for a single
extreme and uncontrollable
circumstance to one year is appropriate
to avoid adversely impacting
operational timelines, to limit impacts
on contracts not impacted by disasters,
and to preserve transparency of the Star
Ratings for consumers by not using data
from many different measurement years.
Further, as we finalized several years
ago, at §§ 422.504(o) and 423.505(p),
MA organizations and Part D sponsors
must develop, maintain, and implement
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
a business continuity plan containing
policies and procedures to ensure the
restoration of business operations
following disruptions to business
operations which would include natural
or man-made disasters, system failures,
emergencies, and other similar
circumstances and the threat of such
occurrences. We expect that these
business continuity plans will address
many of the issues that would result in
an impact on the performance of an
affected contract where there are
extreme and uncontrollable
circumstances that occur in successive
years or over more than one
performance period.
We note that the proposed rule
establishing the exemption for
administering CAHPS
(§§ 422.166(i)(2)(ii) and
423.186(i)(2)(ii)), administering HOS
(§ 422.166(i)(3)(ii)), and reporting HEDIS
(§ 422.166(i)(4)(ii)) did not specify
which type of affected contract could
apply for the exemption. This lack of
clarity also affected the proposed rules
in §§ 422.166(i)(2)(iii), 422.166(i)(3)(iii),
422.166(i)(4)(iii), and 423.186(i)(2)(iii)
that address how a contract with the
exemption would receive the prior
year’s CAHPS, HOS, or HEDIS measure
Star Rating (and corresponding measure
scores). We clarify here that we
intended these specific rules to apply to
affected contracts with at least 25
percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance. In
finalizing this policy, we are using the
lowest threshold identified in the
definition of affected contract in
paragraph (i)(1)(iii). As a result, the
most generous interpretation of the
potential ambiguity of our proposal is
being finalized.
Finally, comments about disasters
that began in 2017 are out of scope of
this rule as our proposal and final
regulations apply to adjustments to Star
Ratings to take into account extreme and
uncontrollable circumstances that begin
on or after January 1, 2020.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
related comments summarized earlier,
we are finalizing the methodology for
adjustments to CAHPS measures
(§§ 422.166(i)(2) and 423.186(i)(2)), HOS
and HEDIS measures (§§ 422.166(i)(3)
and (i)(4)), new measures
(§§ 422.166(i)(5) and 423.186(i)(3)), and
other Star Ratings measures
(§§ 422.166(i)(6) and 423.186(i)(4)) with
substantive and non-substantive
revisions. The final regulation text
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
includes the following substantive
changes on measure adjustments:
• In §§ 422.166(i)(2)(ii) and
423.186(i)(2)(ii) for CAHPS measures,
422.166(i)(3)(ii) for HOS measures, and
422.166(i)(4)(ii) for HEDIS measures, we
are finalizing additional text to clarify
the section applies to affected contracts
with at least 25 percent of enrollees in
FEMA-designated Individual Assistance
areas at the time of the extreme and
uncontrollable circumstance.
• In § 422.166(i)(4)(iv), the final
regulation text clarifies that all contracts
required to report HEDIS data can work
with NCQA to request modifications to
the samples for measures that require
medical record review. While we did
not receive comments on this, CMS
realized that the preamble and proposed
regulation inadvertently limited which
contracts are eligible to request
modifications to samples from NCQA.
We are finalizing corrected regulation
text to eliminate this inadvertent
limitation.
• In §§ 422.166(i)(2)(v) and
423.186(i)(2)(v) for CAHPS measures,
422.166(i)(3)(v) for HOS measures,
422.166(i)(4)(vi) for HEDIS measures,
and 422.166(i)(6)(iv) and 423.186(4)(iv)
for other Star Ratings measures, we are
finalizing regulation text to identify
multiple year-affected contracts as
contracts that have at least 25 percent of
enrollees in FEMA-designated
Individual Assistance areas at the time
of the extreme and uncontrollable
circumstance with regard to separate
extreme and uncontrollable
circumstances that begin in successive
years. We are finalizing regulation text
that a multiple year-affected contract
receives the higher of the current year’s
Star Rating or what the previous year’s
Star Rating would have been in the
absence of any adjustments that took
into account the effects of the previous
year’s disaster for each measure (using
the corresponding measure score for the
Star Ratings year selected).
• We noted that the regulation text
did not address how this policy would
be applied in the event an extreme and
uncontrollable circumstance occurred
during two performance periods.
Because in some cases the incident
period end date may change, which
would make it difficult operationally to
determine which Star Ratings year is
impacted, we are finalizing regulation
text in the introductory paragraph of (i)
of §§ 422.166 and 423.186 to clarify that
the start date of the incident period will
be used to determine which year of Star
Ratings could be affected, regardless of
whether the incident period lasts until
another calendar year.
PO 00000
Frm 00097
Fmt 4701
Sfmt 4700
15775
In addition to these substantive
changes, we are finalizing nonsubstantive changes in paragraphs (ii)(B)
and (iii) of §§ 422.166(i)(2),
422.166(i)(3), 422.166(i)(4), and
423.186(i)(2) to replace ‘‘exception’’
with ‘‘exemption’’ and refer to the
exemption ‘‘described’’ elsewhere
instead of ‘‘defined’’ elsewhere. We are
also making technical revisions to verb
tense, and in §§ 422.166(6)(i) and
423.186(4)(i) we changed ‘‘then use the
corresponding measure score’’ to ‘‘(and
corresponding measure score).’’ In
§ 422.166(i)(3)(ii)(A) we added the word
‘‘paragraph,’’ and we simplified the
description of §§ 422.166(5) and
423.186(3) for clarity.
(7) Exclusion From Improvement
Measures
Contracts must have data for at least
half of the measures 39 used to calculate
the Part C or Part D improvement
measures to be eligible to receive a
rating in each improvement measure.
For affected contracts that revert back to
the data underlying the previous year’s
Star Rating for a particular measure, we
proposed that measure would be
excluded from both the count of
measures (for the determination of
whether the contract has at least half of
the measures needed to calculate the
relevant improvement measure) and the
applicable improvement measures for
the current and next year’s Star Ratings
as stated at proposed §§ 422.166(i)(7)
and 423.186(i)(5). That is, we proposed
to codify the application of our usual
rule in these special circumstances: To
receive a Star Rating in the
improvement measures, a contract must
have measure scores for both years in at
least half of the required measures used
to calculate the Part C improvement or
Part D improvement measures; our
proposal to use the data from the
previous year’s Star Ratings means that
there is no measure score from the
current year’s Star Ratings, so the usual
rule would eliminate the measure from
consideration. As an example, for
affected contracts that revert back to the
2021 Star Ratings data for a particular
measure for the 2022 Star Ratings, we
would exclude that measure from the
count of measures and applicable
improvement measures for the 2022 and
2023 Star Ratings.
Below we summarize the comments
we received on the exclusion from
improvement measures and provide our
responses and final decisions.
39 See §§ 422.164(f) and 423.184(f) for more
information on Part C and Part D improvement
measures.
E:\FR\FM\16APR2.SGM
16APR2
15776
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
Comment: A commenter was
concerned that CMS’s policy would
permit quality improvement measures
to be excluded continually when there
are repeated disasters, which they stated
would undermine the goals of the Star
Ratings program. A couple of
commenters noted that CMS’s proposed
policy of using prior year’s measure
stars (and corresponding measure
scores) could influence its use in the
improvement calculation.
Response: We proposed in
§§ 422.166(i)(7) and 423.186(i)(5) that
any measure that reverts back to the
data underlying the previous year’s Star
Rating under the rules in paragraph (i)
of §§ 422.166 or 423.186 is excluded
from the improvement calculation. This
would apply to multiple year-affected
contracts as well. Most affected
contracts should still receive
improvement measure scores since
contracts only need data in half of the
measures used to calculate
improvement to receive an
improvement measure score. We also
clarify in the final regulations at
§§ 422.166(i)(7) and 423.186(i)(5) that
contracts affected by extreme and
uncontrollable circumstances do not
have the option of reverting to the prior
year’s improvement rating. This
clarification is necessary because of the
new multiple year-affected contract
policy. The improvement rating is based
on other measure data included in the
Star Ratings program, so taking the
higher of the two improvement ratings
would nullify the calculations and the
application of the disaster policy for the
other measures. The improvement
measure calculates how much of the
plan’s performance improved or
declined from the previous year to the
current year. Allowing affected
contracts to revert to the prior year’s
improvement measure rating could
result in different years of data being
used for the improvement scores and for
the measure scores, or different time
periods used for improvement
calculations for different contracts. This
would be difficult to operationalize and
confusing to consumers. Therefore, we
decline to adopt such an adjustment in
this final rule.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
related comments summarized earlier,
we are finalizing the rule for calculating
the improvement score for affected
contracts at §§ 422.166(i)(7) and
423.186(i)(5) as proposed with
substantive and non-substantive
revisions. We are finalizing a
substantive change to clarify that
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
contracts affected by extreme and
uncontrollable circumstances do not
have the option of reverting to the prior
year’s improvement rating. We are also
making a technical revision to verb
tense.
(8) Missing Data
Except in cases where an exemption
was granted as described earlier, we
proposed that for all measures eligible
for the extreme and uncontrollable
circumstance adjustment, if an affected
contract has missing data in either the
current or previous year (for example,
because of a biased rate or the contract
is too new or too small), the final
measure rating would come from the
current year. We proposed to codify this
rule at §§ 422.166(i)(8) and
423.186(i)(6). For example, if a contract
affected by an eligible 2020 extreme and
uncontrollable circumstance was not
granted an exemption for data collection
and does not have sufficient data to
receive a measure-level 2022 Star
Rating, it would not receive a numeric
rating for that measure for the 2022 Star
Ratings regardless of whether it received
a numeric rating in the previous year.
Similarly, if an affected contract has
missing measure data in the previous
year but received a numeric rating in the
current year, it would receive the
current year’s rating for its final measure
rating. In both cases, the measure would
be excluded from the contract’s
improvement score(s) following our
usual rules.
Below we summarize the comments
we received on missing data and
provide our responses and final
decisions.
Comment: A commenter questioned
how CMS will rate contracts affected by
disasters that are too new to be
measured.
Response: The missing data policy
proposed and codified in this final rule
at §§ 422.166(i)(8) and 423.186(i)(6)
applies to contracts that are too new to
be measured. As proposed and
finalized, the regulation does not
exclude new contracts from its
application. We proposed that except in
cases where an exemption was granted
as described earlier, for all measures
eligible for the extreme and
uncontrollable circumstance
adjustment, if an affected contract has
missing data in either the current or
previous year (for example, because of
a biased rate or the contract is too new
or too small), the final measure rating
would come from the current year.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
PO 00000
Frm 00098
Fmt 4701
Sfmt 4700
related comments summarized earlier,
we are finalizing the methodology for
missing data as proposed at
§§ 422.166(i)(8) and 423.186(i)(6) as
proposed with non-substantive
revisions to replace ‘‘will come’’ with
‘‘comes’’ and ‘‘exceptions’’ with
‘‘exemptions.’’
(9) Cut Points for Non-CAHPS Measures
Currently, the Star Rating for each
non-CAHPS measure is determined by
applying a clustering algorithm to the
measures’ numeric value scores from all
contracts required to submit the
measure. The cut points are derived
from this clustering algorithm. At
proposed §§ 422.166(i)(9) and
423.186(i)(7), we proposed to exclude
from this clustering algorithm the
numeric values for affected contracts
with 60 percent or more of their
enrollees in the FEMA-designated
Individual Assistance area at the time of
the extreme and uncontrollable
circumstance. We explained that the
exclusion would ensure that any impact
of the extreme and uncontrollable
circumstance on an affected contract’s
measure-level scores would not have an
impact on the cut points for other
contracts. We also explained that, under
our proposal, these cut points calculated
for all other non-affected contracts
would be used to assess these affected
contracts’ measure Star Ratings. We
would compare the affected contract’s
previous year’s measure Star Ratings to
the current year’s measure Star Ratings
to determine which is higher, and
therefore used for the affected contract’s
Star Ratings calculations, as previously
discussed. For example, for the 2022
Star Ratings we would compare the
2021 and 2022 measure Star Ratings for
affected contracts.
Below we summarize the comments
we received on cut points for nonCAHPS measures and provide our
responses and final decisions.
Comment: Several commenters were
concerned that removing affected
contracts from cut point calculations
may skew the clustering methodology or
adversely impact plans not affected by
disasters, or that contracts in disaster
areas may make less of an effort to
improve on measures. A commenter
requested a simulation of what the Star
Ratings would be using this
methodology and 2019 data. A
commenter encouraged ongoing
evaluation of cut points to ensure they
are not unduly impacted by adjustments
for disaster-stricken areas year-overyear.
Response: We proposed to exclude
the performance data of affected
contracts that meet the 60 percent
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
threshold (that is, 60 percent or more of
the contract’s enrollees reside in a
FEMA-designated Individual Assistance
area at the time of the extreme and
uncontrollable circumstance) from the
data used to set cut points for nonCAHPS measures. We proposed to limit
this rule to non-CAHPS measures
because CAHPS measures use relative
distribution and significance testing
rather than clustering to determine Star
Ratings cut points. This rule, codified at
§§ 422.166(i)(9) and 423.186(i)(7),
ensures that any impact of the disaster
on their measure-level scores does not
impact the cut points for other
contracts. In our analysis, when affected
contracts were removed from the
distribution of measure-level scores, the
distribution of the remaining contracts
looked very similar, suggesting that the
affected contracts are randomly
distributed among the rating levels.
CMS will continue to review the impact
of the extreme and uncontrollable
circumstances policy on the Star Ratings
of affected and unaffected contracts to
determine whether any enhancements
need to be proposed to these regulations
in the future. Finally, the extreme and
uncontrollable circumstances policy
applied in the 2019 Star Ratings was
very similar so existing contracts have
access to data on how their contracts
were affected.
khammond on DSKBBV9HB2PROD with RULES2
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
related comments summarized earlier,
we are finalizing the methodology for
cut points for non-CAHPS measures as
proposed at §§ 422.166(i)(9) and
423.186(i)(7) with technical revisions to
the verb tense.
(10) Reward Factor
Similarly, at §§ 422.166(i)(10) and
423.186(i)(8), we proposed that affected
contracts with 60 percent or more of
their enrollees impacted would also be
excluded from the determination of the
performance summary and variance
thresholds for the Reward Factor.
However, these contracts would still be
eligible for the Reward Factor based on
the mean and variance calculations of
other contracts.
Below we summarize the comments
we received on the Reward Factor and
provide our responses and final
decisions.
Comment: A commenter supported
the 60 percent cutoff for Reward Factor
calculations but was concerned that the
number of contracts excluded from
Reward Factor calculations could
become significant if disasters become
more frequent.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Response: CMS appreciates the
concern about frequency of extreme and
uncontrollable circumstances and will
continue to monitor application of the
policy to determine if enhancements are
needed.
Summary of Regulatory Changes
For the reasons set forth in the
proposed rule and our responses to the
related comments summarized earlier,
we are finalizing the methodology for
the Reward Factor as proposed at
§§ 422.166(i)(10) and 423.186(i)(8) with
technical revisions to the verb tense.
2. Improving Clarity of the Exceptions
Timeframes for Part D Drugs
(§§ 423.568, 423.570, and 423.572)
In the proposed rule we proposed a
change to Part D adjudication
timeframes related to exceptions
requests in cases where a prescribing
physician’s or other prescriber’s
supporting statement has not been
received by the plan sponsor. We
proposed to limit the amount of time an
exceptions request can be held open in
a pending status while the Part D plan
sponsor attempts to obtain the
prescribing physician’s or other
prescriber’s supporting statement. Due
to the importance of the prescriber’s
supporting statement in the exceptions
process, the adjudication timeframes for
a coverage determination that involves
an exceptions request do not begin until
the prescribing physician’s or other
prescriber’s supporting statement is
received by the Part D plan. As we
noted in the preamble to the proposed
rule, we are seeking to balance the
importance of the plan receiving the
prescriber’s supporting statement so that
a thorough decision may be made on the
request and having a standard
maximum time for notifying an enrollee
of an exceptions request decision. We
believe greater certainty in the
exceptions process will be beneficial to
enrollees and plans.
We proposed to amend §§ 423.568(b),
423.570(d)(1) and 423.572(a) to state
that, for an exceptions request, the plan
must notify the enrollee (and the
prescribing physician or other
prescriber involved, as appropriate) of
its decision no later than 72 hours (or
24 hours in the case of an expedited
decision) after receipt of the prescriber’s
supporting statement or 14 calendar
days after receipt of the request,
whichever occurs first. We invited
comments on this proposal and received
the following comments discussed
below.
Comment: Several commenters
expressed support for the proposed
changes to the Part D exceptions
PO 00000
Frm 00099
Fmt 4701
Sfmt 4700
15777
timeframes, citing increased clarity in
the exceptions process, and questioned
that CMS finalize the rule as proposed.
Response: We thank the commenters
for their support of our proposal to add
clarity to the exceptions process. We
believe the timeframes we are finalizing
in this rule establish clear timeframes
for exceptions requests and strike a
balance between timely notification of
decisions to enrollees and affording
plan sponsors sufficient time to obtain
and review prescriber supporting
statements. As explained more fully
below, we are modifying the proposal
based on comments we received
requesting that the process clearly
account for circumstances where a
prescriber’s supporting statement is
received late in the 14 calendar day
timeframe. Under this final rule, if a
supporting statement is received by the
end of 14 calendar days from receipt of
the exceptions request, the Part D plan
sponsor must notify the enrollee (and
the prescribing physician or other
prescriber involved, as appropriate) of
its determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours (24 hours for an
expedited request) from the date the
supporting statement was received. If a
supporting statement is not received by
the end of 14 calendar days from receipt
of the exceptions request, the Part D
plan sponsor must notify the enrollee
(and the prescribing physician or other
prescriber involved, as appropriate) of
its determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours (24 hours for an
expedited request) from the end of 14
calendar days from receipt of the
exceptions request. In addition to
achieving the goal of greater certainty in
the exceptions process, we believe this
modified approach balances protection
for beneficiaries with affording plan
sponsors sufficient time to obtain and
review prescriber supporting
statements.
Comment: Several commenters
supported the enhanced clarity of the
proposed rule in establishing a
maximum timeframe of 14 days for a
plan sponsor to notify an enrollee of a
decision on an exceptions request, but
also believe there is some ambiguity on
how to handle cases where a
prescriber’s supporting statement is
received late in the 14 day period and
questioned whether the plan sponsor
would have 72 hours (24 hours for
expedited) from the end of the 14 days
period in which to notify an enrollee of
a decision.
Response: We thank commenters for
their support for more certainty in the
process and for requesting additional
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15778
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
clarity on how to handle situations
where a prescriber’s supporting
statement is received late in the
proposed 14 calendar day period. We
agree that if a prescriber’s supporting
statement is received late in this 14
calendar day period, the plan sponsor
should have adequate time to review the
clinical documentation to determine
whether it is appropriate to approve the
exceptions request. After consideration
of these comments, we are establishing
the 14 calendar day time period as the
outer limit for receipt of a prescriber’s
supporting statement. In all cases, the
plan sponsor must notify the enrollee
(and prescriber, as appropriate) of its
decision no later than 72 hours (24
hours for expedited cases) of the date of
receipt of the supporting statement. If
the supporting statement is not received
by the end of the 14 calendar days, then
the plan sponsor must notify the
enrollee (and prescriber, as appropriate)
of its decision no later than 72 hours (24
for expedited cases) from the end of the
14 calendar days from receipt of the
exception request. Plan sponsors are
responsible for making reasonable and
diligent efforts to promptly obtain a
prescriber’s supporting statement if the
supporting statement is not included
with the request for an exception, so as
to avoid the need for an exceptions
request to remain in a pending status for
any longer than necessary. We are
finalizing this rule to reflect the policy
stated previously.
Comment: A few commenters stated
that they believe the proposed rule is
inconsistent with recently released draft
manual guidance, which recommends a
14-day timeframe to receive a
supporting statement. Commenters
expressed support for this approach and
suggested that the final rule clearly align
with the manual guidance. Commenters
also requested that CMS phase-in the
effective dates of the manual guidance
and final rule to allow plans time to
implement new procedures. Three
commenters requested a January 1, 2020
compliance effective date.
Response: We agree that plan
sponsors should have up to 14 calendar
days in which to attempt to obtain a
prescriber’s supporting statement. The
prescriber’s supporting statement is a
key component of the exceptions
process. We believe that allowing up to
14 calendar days for a plan sponsor to
attempt to obtain a supporting statement
appropriately balances the interests of
enrollees receiving a timely decision
based on a thorough clinical review of
the request and of plan sponsors having
adequate time to review the exceptions
request. In all cases, the enrollee must
be notified of the decision as
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
expeditiously as his or her health
condition requires. We emphasize that it
is not our expectation that plan
sponsors routinely have exceptions
requests in a pending status for 14
calendar days. When an exceptions
request is received, the plan sponsor is
responsible for promptly requesting any
documentation needed to support the
request. When a prescriber’s supporting
statement is received, the plan must
notify the enrollee of its decision within
72 hours (24 hours for expedited cases)
of receipt of the supporting statement.
In response to the commenters’
request that there be alignment between
the approach to Part D exceptions
request timeframes taken in this final
rule and the combined Part C & Part D
appeals manual guidance, we agree and
believe the modified approach taken in
this final rule aligns with the guidance;
however, if additional clarity is
necessary, revisions will be made to the
manual guidance. We also agree with
commenters who requested an effective
date of January 1, 2020. The
requirements of the final rule are
applicable January 1, 2020, and we
believe this applicability date provides
plan sponsors adequate time to
implement this regulatory requirement.
We expect plans are already making and
notifying enrollees of decisions on
exceptions requests under a similar
reasonable timeframe and that changes
to plan sponsor operations will be
minimal.
Comment: A commenter
recommended CMS work with
prescribers to emphasize the need to
submit supporting statements as
expeditiously as possible.
Response: We thank the commenter
for the suggestion. We do not have a
direct contractual relationship with
prescribers by which we could
influence timely submission of
supporting statements, but we will
review our provider tip sheets and other
provider communications to ensure
relevant CMS publications convey the
importance of a prescriber’s supporting
statement in the Part D exceptions
process. We also encourage MA–PDs to
communicate the importance of timely
submission of supporting statements in
their provider communication materials.
Comment: We received one comment
suggesting we specify that in addition to
notifying enrollees of appeal rights, the
MA plan be required to notify enrollees
that they are also entitled to submit a
new exceptions request. The commenter
states it would not be appropriate for an
enrollee to be denied a medically
necessary and appropriate exception
because an arbitrary deadline has been
missed.
PO 00000
Frm 00100
Fmt 4701
Sfmt 4700
Response: Under existing regulations,
if a plan sponsor denies the request
because it does not receive timely
supporting clinical documentation, the
enrollee (or the prescriber on the
enrollee’s behalf) has the opportunity to
address the exceptions request on
appeal by submitting documentation
that demonstrates the medical necessity
of an exception. The right of an enrollee
to request a coverage determination
(which includes an exceptions request)
is not extinguished by a plan sponsor
issuing a denial; however, if an
exceptions request is denied, then the
appropriate next step is an appeal, and
the plan can review and approve the
request for a formulary or tiering
exception on appeal.
Comment: A commenter requested
confirmation that this requirement does
not impose an obligation on the plan to
do outreach and obtain the prescriber’s
supporting documentation within the
14-day timeframe. The commenter
noted that compliance with such a
requirement within that timeframe
would be operationally difficult.
Response: We thank the commenter
for feedback on the operational
challenges of outreach for the purposes
of obtaining the prescriber’s supporting
statement within the 14 calendar day
timeframe. Under existing regulatory
requirements at § 423.566(a), Part D
plans must have a procedure in place
for making coverage decisions. This
includes soliciting necessary clinical
documentation. This rule does not
change plan sponsors’ obligation for
doing outreach for necessary clinical
documentation but, instead, establishes
a time limit for a plan sponsor’s
attempts to obtain the information.
When a Part D sponsor does not have all
of the information it needs to make a
coverage decision, the plan must make
reasonable and diligent efforts to obtain
all necessary information, including
medical records and other pertinent
documentation, from the enrollee’s
prescriber within the applicable
adjudication timeframe. For guidance
on best practices related to outreach,
please see the February 22, 2017 HPMS
memorandum titled ‘‘Updated Guidance
on Outreach for Information to Support
Coverage.’’ The memorandum can be
found under ‘‘Downloads’’ at: https://
www.cms.gov/Medicare/Appeals-andGrievances/MedPrescript
DrugApplGriev/?redirect=/
MedPrescriptDrugApplGriev/.
We believe that plans will have ample
time to modify, as needed, their
operations related to adjudication
timeframes for exceptions in order to
comply with this final rule. We expect
plans are already making and notifying
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
enrollees of decisions on exceptions
requests under a similar reasonable
timeframe and that changes to plan
sponsor operations will be minimal.
Comment: A commenter suggested
that CMS standardize the policy for 14day tolling followed by the 72 and 24
hour(s) adjudication timelines across all
exceptions requests; including
exceptions related to formulary, tiering,
quantity limits, and utilization
management. The commenter also
suggested that CMS apply tolling to
other types of coverage determinations.
Response: Based on the comment,
there may be some confusion regarding
what types of decisions are covered by
this rule. This rule covers all types of
exceptions requests, including tiering
and formulary exceptions (that is,
requests for off-formulary drugs and
exceptions to utilization management
requirements applicable to formulary
drugs). We appreciate the suggestion,
but this rule does not apply to other
types of coverage determinations that do
not involve an exceptions request; for
example, a coverage determination
where the enrollee is seeking to satisfy
a utilization management requirement,
such as prior authorization.
Comment: A commenter expressed
support for our efforts to expedite the
decision making process for
beneficiaries, but noted concern about
the potential for denials because
providers missed a deadline, or because
the plan lacked the time to review the
documentation, causing beneficiaries to
rely on the appeals process. The
commenter suggested CMS require
plans read and incorporate
documentation as long as it comes
within the deadline.
Response: We appreciate the
commenter’s concerns about the
potential for denials due to an
adjudication deadline. However, we
believe it is important for there to be
certainty in the timeframe in which a
plan has to notify an enrollee of its
decision. We acknowledge that there
may be circumstances where the plan
has to issue a denial because supporting
documentation has not been received in
a timely manner, but we believe this is
offset by enhancing certainty in the
process by having clear adjudication
timeframes. With respect to the
commenter’s suggestion, § 423.566(a)
requires Part D plan sponsors to have
procedures for making timely coverage
decisions. This includes soliciting
necessary clinical documentation. If a
Part D plan sponsor does not have all of
the information it needs to make a
coverage decision, the plan must make
reasonable and diligent efforts to obtain
all necessary information, including
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
medical records and other pertinent
documentation, from the enrollee’s
provider.
Comment: A few commenters stated
they support CMS providing additional
clarity, stating the previous
‘‘reasonableness’’ standard may have
resulted in longer wait times. However,
these commenters encourage a shorter
timeframe, citing a risk of significant
delays in enrollees getting access to
needed medication.
Response: We thank the commenters
for expressing support for the proposal
to provide additional clarity. While we
understand the commenters’ concern
about the length of the timeframe for
adjudicating exceptions requests, we are
attempting to balance the need to
provide a timely decision with affording
plan sponsors sufficient time to attempt
to obtain the prescriber supporting
statement and perform the clinical
review necessary to determine if an
exception should be granted. Plans are
responsible for attempting to obtain any
necessary supporting documentation
and for notifying an enrollee of its
decision no later than 72 hours of
receipt of the prescriber’s supporting
statement (24 hours for an expedited
request). Again, it is not our intent in
establishing this timeframe that all
exceptions requests be in a pending
status for 14 calendar days but, instead,
to establish an outer limit on the time
a case can be pending for receipt of the
prescriber’s supporting statement. We
agree with the commenters who urged
us to account for circumstances where
the supporting statement is not received
promptly following a plan’s request for
such information from the prescriber
and to allow sufficient time for review
of the supporting clinical
documentation. Accordingly, we are
modifying our proposal to account for
circumstances where the prescriber’s
supporting statement is received late in
the 14 calendar day period.
Comment: A commenter suggested
CMS consider replacing tolling
altogether in favor of fixed processing
timeframes.
Response: Under this final rule, we
are retaining the current regulatory
requirement of the plan sponsor
notifying the enrollee (and the
prescribing physician or other
prescriber involved, as appropriate) of
its determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours (24 hours for an
expedited request) after receipt of the
physician’s or other prescriber’s
supporting statement. As explained
earlier, the prescriber’s supporting
statement is a critical aspect of the
exceptions process. Therefore, we are
PO 00000
Frm 00101
Fmt 4701
Sfmt 4700
15779
retaining the existing standard of tying
the start of the adjudication timeframe
to receipt of the supporting statement. A
plan sponsor cannot adequately assess
the merits of an exceptions request in
the absence of the prescriber’s
supporting statement. However, we are
establishing a maximum timeframe
under which an exceptions request can
be held open pending receipt of the
prescriber’s supporting statement. If a
supporting statement is not received by
the end of 14 calendar days from receipt
of the exceptions request, the Part D
plan sponsor must notify the enrollee
(and the prescribing physician or other
prescriber involved, as appropriate) of
its determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours (24 hours for an
expedited request) from the end of 14
calendar days from receipt of the
exceptions request. We believe this
approach achieves the goals of allowing
adequate time to obtain the prescriber
statement that supports the exceptions
request and establishing greater
certainty in the process by establishing
a maximum period of time a request can
be held open.
Based on several comments received,
we are finalizing this provision with
modification to account for
circumstances where the prescriber’s
supporting statement is received late in
the 14 calendar day period. Under this
final rule, a Part D plan sponsor must
notify the enrollee (and the prescribing
physician or other prescriber involved,
as appropriate) of its determination on
an exceptions request as expeditiously
as the enrollee’s health condition
requires, but no later than 72 hours (24
hours for an expedited request) after
receipt of the physician’s or other
prescriber’s supporting statement. If a
supporting statement is not received by
the end of 14 calendar days from receipt
of the exceptions request, the Part D
plan sponsor must notify the enrollee
(and the prescribing physician or other
prescriber involved, as appropriate) of
its determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours (24 hours for an
expedited request) from the end of 14
calendar days from receipt of the
exceptions request. We believe this
approach achieves the goal of balancing
the importance of the plan receiving the
prescriber’s supporting statement so that
a thorough review of the request can be
performed and having a maximum time
for notifying an enrollee of a decision so
that exceptions requests are not held in
a pending status for an indefinite or
unreasonable period of time.
E:\FR\FM\16APR2.SGM
16APR2
15780
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
C. Clarifying Program Integrity Policies
1. Preclusion List Requirements for
Prescribers in Part D and Individuals
and Entities in MA, Cost Plans, and
PACE
khammond on DSKBBV9HB2PROD with RULES2
a. Background
In the April 2018 final rule, we
removed several provider enrollment
requirements pertaining to the MA and
Part D programs. One requirement,
outlined in § 423.120(c)(6), stated that
for a prescription to be eligible for
coverage under the Part D program, the
prescriber must have: (1) An approved
enrollment record in the Medicare feefor-service program; or (2) a valid optout affidavit on file with a Part A/Part
B Medicare Administrative Contractor
(A/B MAC). A second requirement,
outlined in § 422.222, stated that
providers furnishing health care items
or services to a Medicare enrollee who
receives his or her Medicare benefit
through an MA organization must be
enrolled in Medicare and be in an
approved status no later than January 1,
2019. (The removal of these
requirements had been proposed in a
proposed rule published in the Federal
Register on November 28, 2017, titled
‘‘Medicare Program; Contract Year 2019
Policy and Technical Changes to the
Medicare Advantage, Medicare Cost
Plan, Medicare Fee-for-Service, the
Medicare Prescription Drug Benefit
Programs, and the PACE Program’’ (82
FR 56336) (hereafter referred to as the
November 2017 proposed rule).
The overall purpose of Medicare
provider enrollment is to prevent fraud,
waste, and abuse, and to protect
Medicare beneficiaries, by allowing
CMS to carefully screen all providers
and suppliers (especially those that
potentially pose an elevated risk to
Medicare) to confirm that they are
qualified to furnish, order, certify, refer,
or prescribe Medicare items, services, or
drugs.
During our preparations to implement
the Part D and MA enrollment
provisions by the January 1, 2019
effective date, several provider
organizations expressed concerns about
our forthcoming requirements. The
principal concern was that the burden
of the enrollment process on the
provider community would outweigh
the program integrity benefits to the MA
and Part D programs.
Given this, we stated in the April
2018 final rule our belief that the best
means of reducing the burden of the
Part D and MA enrollment requirements
without compromising our payment
safeguard objectives would be to focus
on prescribers and providers that pose
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
an elevated risk to Medicare
beneficiaries and the Trust Funds. We
accordingly established in the April
2018 final rule an overall policy under
which: (1) Such problematic parties
would be placed on a ‘‘preclusion list’’;
and (2) payment for Part D drugs and
MA services and items prescribed or
furnished by these individuals and
entities would be rejected or denied, as
applicable. Among the policies we
finalized in the April 2018 final rule
were the following:
• In § 423.100 (for Part D) and § 422.2
(for MA), we stated that the term
‘‘preclusion list’’ means a CMScompiled list of, as applicable,
prescribers and providers that:
++ Meet all of the following
requirements:
++ The individual or entity is
currently revoked from the Medicare
program under § 424.535.
++ The individual or entity is
currently under a reenrollment bar
under § 424.535(c).
++ CMS determines that the
underlying conduct that led to the
revocation is detrimental to the best
interests of the Medicare program. In
making this determination under this
paragraph, CMS considers the following
factors:
—The seriousness of the conduct
underlying the individual’s or entity’s
revocation.
—The degree to which the
individual’s or entity’s conduct could
affect the integrity of the Part D or MA
program.
—Any other evidence that CMS
deems relevant to its determination; or
++ Meet both of the following
requirements:
++ The individual or entity has
engaged in behavior for which CMS
could have revoked the individual or
entity to the extent applicable if they
had been enrolled in Medicare.
++ CMS determines that the
underlying conduct that would have led
to the revocation is detrimental to the
best interests of the Medicare program.
In making this determination under this
paragraph, CMS considers the following
factors:
—The seriousness of the conduct
underlying the individual’s or entity’s
revocation.
—The degree to which the
individual’s or entity’s conduct could
affect the integrity of the Part D or MA
program.
—Any other evidence that CMS
deems relevant to its determination.
• We revised and added various
provisions in 42 CFR part 498, subpart
A that permitted individuals and
PO 00000
Frm 00102
Fmt 4701
Sfmt 4700
entities to appeal their inclusion on the
preclusion list. Specifically:
++ We added a new paragraph (20) to
§ 498.3(b) stating that a CMS
determination to include an individual
or entity on the preclusion list
constitutes an initial determination.
++ In § 498.5, we added a new
paragraph (n) containing the following
provisions:
—In paragraph (n)(1), we stated that
any individual or entity dissatisfied
with an initial determination or revised
initial determination that they are to be
included on the preclusion list may
request a reconsideration in accordance
with § 498.22(a).
—In paragraph (n)(2), we stated that if
CMS or the individual or entity under
paragraph (n)(1) is dissatisfied with a
reconsidered determination under
paragraph (n)(1), or a revised
reconsidered determination under
§ 498.30, CMS or the individual or
entity is entitled to a hearing before an
administrative law judge (ALJ).
—In paragraph (n)(3), we stated that if
CMS or the individual or entity under
paragraph (n)(2) is dissatisfied with a
hearing decision as described in
paragraph (n)(2), CMS or the individual
or entity may request review by the
Departmental Appeals Board (DAB) and
the individual or entity may seek
judicial review of the DAB’s decision.
• In § 423.120(c)(6)(v) (for Part D) and
§ 422.222(a)(2) (for MA), we stated that
CMS would send written notice to the
individual or entity via letter of their
inclusion on the preclusion list. The
notice would contain the reason for this
inclusion and would inform the
individual or entity of their appeal
rights. We further stated that the
affected party could appeal their
inclusion on the preclusion list in
accordance with Part 498.
• We stated in § 423.120(c)(6)(iv)(A)
that a Part D sponsor or its Pharmacy
Benefit Manager (PBM) must not reject
a pharmacy claim or request for
reimbursement for a Part D drug unless
the sponsor has provided the written
notice to the beneficiary described in
§ 423.120(c)(6)(iv)(B). Under paragraph
(iv)(B), the Part D sponsor or its PBM
must:
++ Provide an advance written notice
to any beneficiary who has received a
prescription from a prescriber on the
preclusion list as soon as possible but to
ensure that the beneficiary receives the
notice no later than 30 days after the
posting of the most recent preclusion
list; and
++ Ensure that reasonable efforts are
made to notify the prescriber of a
beneficiary who was sent a notice under
paragraph (iv)(B).
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
• We stated in the preamble to the
April 2018 final rule that individuals
and entities would only be placed on
the preclusion list upon exhausting
their first level of appeal.
• In the preamble to the November
2017 proposed rule (82 FR 56446), we
stated that if a beneficiary’s access to a
service, item, or drug is denied because
of the application of the preclusion list
to his or her prescriber or provider, the
beneficiary would be permitted to
appeal alleged errors in applying the
preclusion list. In the preamble to the
April 2018 final rule (83 FR 16660),
however, we stated that if payment is
denied because the prescriber or
provider is on the preclusion list, the
beneficiary would not have the right to
appeal as denials due to preclusion are
not coverage determinations
accompanied by appeal rights.
• We stated in the preamble to the
April 2018 final rule (83 FR 16642) that
an unenrolled individual or entity
would remain on the preclusion list for
the same length of time as the
reenrollment bar that we could have
imposed on the individual or entity had
they been enrolled in Medicare and then
revoked.
We also stated in that preamble that
the preclusion list provisions in the
April 2018 final rule (83 FR 16440) were
to become effective on January 1, 2019.
khammond on DSKBBV9HB2PROD with RULES2
b. Proposed Changes
In CMS–4185–P, we proposed several
changes to our existing preclusion list
policies. These changes, for the most
part, stemmed from further CMS
consideration of, and stakeholder
feedback on, some of the provisions we
finalized in the April 2018 final rule
and the need for modifications thereto.
These proposed provisions, and brief
explanations of the rationale for them,
are summarized in this section of this
final rule.
(1) Appeals Process for Individuals and
Entities on the Preclusion List
As already mentioned, we stated in
the preamble to the April 2018 final rule
(83 FR 16662) that individuals and
entities would only be placed on the
preclusion list upon exhausting their
first level of appeal. Upon further
analysis, we became concerned that
there could be a very lengthy delay
before the individual or entity is
actually placed on the list. This is
because the individual or entity, under
existing regulations, would be able to
first appeal their Medicare revocation
and, if unsuccessful, could then appeal
their placement on the preclusion list
(due to the revocation). This is
inconsistent with the principal goal of
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
the preclusion list, which is to prevent
payment for Part D drugs or MA services
or items prescribed or furnished, as
applicable, by problematic parties. So as
to shorten the timeframe before a
provider is placed on the preclusion list,
we proposed the following regulatory
revisions:
• In § 423.120(c)(6)(v), we proposed
to:
++ Consolidate the existing version of
paragraph (v) into a revised
§ 423.120(c)(6)(v)(A).
++ Establish a new
§ 423.120(c)(6)(v)(B) stating that in
situations where the prescriber’s
inclusion on the preclusion list is based
on a contemporaneous Medicare
revocation under § 424.535:
—The notice described in paragraph
(c)(6)(v)(A) must also include notice of
the revocation, the reason(s) for the
revocation, and a description of the
prescriber’s appeal rights concerning the
revocation.
—The appeals of the prescriber’s
inclusion on the preclusion list and the
prescriber’s revocation shall be filed
jointly by the prescriber and, as
applicable, considered jointly by CMS
under 42 CFR part 498.
• In § 422.222(a)(2), we proposed to
do the following:
++ Move the existing version of this
paragraph into a new § 422.222(a)(2)(i).
++ Establish a new § 422.222(a)(2)(ii)
stating that in situations where the
individual’s or entity’s inclusion on the
preclusion list is based on a
contemporaneous Medicare revocation
under § 424.535:
—The notice described in paragraph
(a)(2)(i) must also include notice of the
revocation, the reason(s) for the
revocation, and a description of the
individual’s or entity’s appeal rights
concerning the revocation.
—The appeals of the individual’s or
entity’s inclusion on the preclusion list
and the individual’s or entity’s
revocation shall be filed jointly by the
individual or entity and, as applicable,
considered jointly by CMS under 42
CFR part 498.
• In § 498.5(n)(1), we proposed to:
++ Move the existing version of this
paragraph to a new § 498.5(n)(1)(i).
++ Establish a new
§ 498.5(n)(1)(ii)(A) stating that in
situations where the individual’s or
entity’s inclusion on the preclusion list
is based on a Medicare revocation under
§ 424.535 and the individual or entity
receives contemporaneous notice of
both actions, the individual or entity
may request a joint reconsideration of
both the preclusion list inclusion and
the revocation in accordance with
§ 498.22(a).
PO 00000
Frm 00103
Fmt 4701
Sfmt 4700
15781
++ Establish a new § 498.5(n)(1)(ii)(B)
stating that the individual or entity may
not submit separate reconsideration
requests under paragraph (ii)(A) for
inclusion on the preclusion list or a
revocation if the individual or entity
received contemporaneous notice of
both actions.
We believed that these changes would
clarify our expectations and the program
procedures concerning the filing of
appeals when a party’s placement on
the preclusion list is based on a
Medicare revocation. We also stressed
that our proposed appeals consolidation
would not affect appeals of OIG
exclusions, which are handled through
a separate process outlined in the
applicable OIG regulations.
(2) Timing of Addition to the Preclusion
List
While, again, we stated in the
preamble to the April 2018 final rule (83
FR 16662) that prescribers and
providers would only be placed on the
preclusion list upon exhausting their
first level of appeal, we did not include
this language in the regulatory text. We
therefore proposed to do so in CMS–
4185–P. Specifically, we proposed in
new § 423.120(c)(6)(v)(C)(1) (for Part D)
and new § 422.222(a)(3)(i) (for MA) that,
respectively, a prescriber or provider
would only be included on the
preclusion list after the expiration of
either of the following:
• If the prescriber or provider does
not file a reconsideration request under
§ 498.5(n)(1), the prescriber or provider
will be added to the preclusion list
upon the expiration of the 60-day period
in which the prescriber or provider may
request a reconsideration.
• If the prescriber or provider files a
reconsideration request under
§ 498.5(n)(1), the prescriber or provider
will be added to the preclusion list
effective on the date on which CMS, if
applicable, denies the prescriber’s or
provider’s reconsideration.40
Notwithstanding the above, we noted
that section 1862(e) of the Act (42 U.S.C.
1395y(e)) states that no federal health
care program payment may be made for
any items or services furnished by an
excluded individual or entity, or
directed or prescribed by an excluded
physician. We believed that a failure to
add an excluded provider or prescriber
40 In the April 2018 final rule, we adopted crossreferences in 42 CFR parts 417 and 460 to part 422
so that our MA preclusion list provisions in that
rule would also apply to, respectively, cost plans
(Part 417) and PACE organizations (Part 460).
Consistent with said cross-references, we proposed
that our MA preclusion list provisions in the
proposed rule would similarly apply to cost plans
and PACE organizations.
E:\FR\FM\16APR2.SGM
16APR2
15782
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
to the preclusion list until the
expiration of the applicable time
periods in § 423.120(c)(6)(v)(C)(1) (for
Part D) and § 422.222(a)(3)(i) (for MA)
would be inconsistent with section
1862(e) of the Act. Accordingly, we
proposed in new § 423.120(c)(6)(v)(C)(2)
(for Part D) and § 422.222(a)(3)(ii) (for
MA) that an excluded prescriber or
provider would be added to the
preclusion list effective on the date of
the exclusion.
khammond on DSKBBV9HB2PROD with RULES2
(3) Effective Date
We generally proposed that the
preclusion list regulatory revisions and
additions addressed in CMS–4185–P
would become applicable to MA
organizations (and cost plans and PACE
organizations by virtue of crossreferences in parts 417 and 460 to the
MA part 422 regulation) and Part D
plans on January 1, 2020, which we
believed would give stakeholders
adequate time to prepare for our
proposed changes. We did, however,
propose one exception to this, in that
the effective date of our previously
mentioned consolidated appeals
provisions in §§ 423.120(c)(6)(v),
422.222(a)(2), and § 498.5(n)(1) would
be 60 days after their publication in a
final rule. This was to ensure that
problematic providers and prescribers
were placed on the preclusion list as
soon as possible. We also solicited
public comments on whether some or
all of our other proposed preclusion list
provisions discussed in section III.C. of
the proposed rule should become
effective and applicable beginning 60
days after the publication date of a final
rule.
We noted that the January 1, 2019
preclusion list effective date identified
in the April 2018 final rule for the
provisions finalized in that rule would
remain in place.
(4) Claim Denials and Beneficiary
Notification
We stated in the preamble to the April
2018 final rule (83 FR 16440) that, upon
CMS’ publication of the first preclusion
list, once a prescriber or provider is
added to such initial list after the
completion of their first level of appeal,
claims would not be impacted for up to
a 90-day period thereafter (82 FR
16667). We explained that this 90-day
period would include—(1) a 30-day
period for the plans and MA
organizations to intake the preclusion
list data; and (2) a 60-day period in
which the plan or MA organization
would—(a) notify the beneficiary of the
prescriber’s or provider’s preclusion;
and (b) allow time for the beneficiary to
transition to a new prescriber or
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
provider. Once this 90-day period
expires, claim denials and rejections
would commence. Yet for all
subsequent updates (that is, all updates
after the release of the initial preclusion
list), we would not require the
expiration of a 90-day period before
claims were denied.
After additional review, we became
concerned that beneficiaries whose
prescribers and providers were added to
subsequent updates to the preclusion
list would not receive any notice of
those additions nor of the consequences
of placement of such providers and
prescribers on the preclusion list.
Consequently, we proposed in CMS–
4185–P that claim denials for preclusion
list updates, beginning in 2020, would
occur consistent with the following
timeframes:
• Upon the posting of the updated
preclusion list, the Part D sponsor or
MA organization would be required to
send notice to the beneficiary that his or
her prescriber or provider has been
added to preclusion list within 30 days
of the posting of the updated preclusion
list.
• Beginning 60 days after sending the
beneficiary notice(s) described in the
previous paragraph, the plan sponsor or
MA organization would deny the
prescriber’s or provider’s prescriptions
or claims. This 60-day period would
give beneficiaries time to locate another
prescriber or provider from whom they
can receive Part D prescriptions or MA
services and items.
We recognized in the proposed rule
that applying this 60 to 90-day period to
subsequent updates (rather than
exclusively to the initially published
list) could result in a precluded
prescriber or provider being permitted
to continue treating Part D and MA
beneficiaries for up to 3 months without
their Part D prescriptions or MA claims
being denied. However, we believed
that the prevention of potentially
serious dangers to the health and safety
of Medicare beneficiaries that could
ensue if they are without crucial
medications for an extended period
must take precedence.
Although we discussed the delayed
claim denial period in the preamble to
the April 2018 final rule, we did not
incorporate this policy into the
regulatory text. In addition, while
§ 423.120(c)(6) contained certain
provisions regarding beneficiary
notification about the preclusion list,
there were no such concomitant
provisions for MA in § 422.222. Thus,
we proposed to make the following
revisions and additions, as applicable,
to § 423.120(c)(6) and § 422.222 in the
April 2018 final rule:
PO 00000
Frm 00104
Fmt 4701
Sfmt 4700
• Section 422.222 would be revised
as follows:
++ Existing paragraph (a)(1) would be
moved to a new paragraph (a)(1)(i) that
would state: ‘‘Except as provided in
paragraph (a)(1)(ii) of this section, an
MA organization must not make
payment for a health care item or
service furnished by an individual or
entity that is included on the preclusion
list, defined in § 422.2.’’
++ New paragraph (a)(1)(ii) would
state: ‘‘With respect to MA providers
that have been added to an updated
preclusion list, the MA organization
must do all of the following:’’
++ New paragraph (a)(1)(ii)(A) would
state: ‘‘No later than 30 days after the
posting of this updated preclusion list,
must provide an advance written notice
to any beneficiary who has received an
MA service or item from the individual
or entity added to the preclusion list in
this update.’’
++ New paragraph (a)(1)(ii)(B) would
state: ‘‘Must ensure that reasonable
efforts are made to notify the individual
or entity described in paragraph
(a)(1)(ii) of this section of a beneficiary
who was sent a notice under paragraph
(a)(1)(ii)(A) of this section; and’’
++ New paragraph (a)(1)(ii)(C) would
state: ‘‘Must not deny payment for a
service or item furnished by the newly
added individual or entity, solely on the
ground that they have been included in
the updated preclusion list, in the 60day period after the date it sent the
notice described in paragraph
(a)(1)(ii)(A) of this section.’’
We noted that, consistent with
§ 422.224, the prohibition against
paying precluded individuals and
entities would include contracted and
non-contracted parties for purposes of
the provisions in § 422.222(a)(1).
Consistent with our proposed changes
to § 422.222(a)(1), we proposed to delete
the existing structure of
§ 423.120(c)(6)(iv), which we cited
previously, and replace it with the
following:
++ A new opening paragraph of
(c)(6)(iv) would state: ‘‘With respect to
Part D prescribers that have been added
to an updated preclusion list, the Part D
plan sponsor must do all of the
following:’’
++ Revised paragraph (c)(6)(iv)(A)
would state: ‘‘Subject to all other Part D
rules and plan coverage requirements,
and no later than 30 days after the
posting of this updated preclusion list,
must provide an advance written notice
to any beneficiary who has received a
Part D drug prescribed by a prescriber
added to the preclusion list in this
update.’’
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
++ Revised paragraph (c)(6)(iv)(B)
would state: ‘‘Must ensure that
reasonable efforts are made to notify the
prescriber described in paragraph
(c)(6)(iv) of this section of a beneficiary
who was sent a notice under paragraph
(c)(6)(iv)(A) of this section; and’’
++ New paragraph (c)(6)(iv)(C) would
state: ‘‘Must not reject a pharmacy claim
or deny beneficiary request for
reimbursement for a Part D drug
prescribed by the prescriber, solely on
the ground that they have been included
in the updated preclusion list, in the 60day period after the date it sent the
notice described in paragraph
(c)(6)(iv)(A) of this section.’’
We mentioned that for providers and
prescribers that are both on the
preclusion list and excluded by the OIG,
the aforementioned beneficiary
notification process would not be
intended to replace or supplant any
existing OIG processes for notifying
beneficiaries of excluded providers or
prescribers.
khammond on DSKBBV9HB2PROD with RULES2
(5) Beneficiary Appeals
We noted earlier that in the preamble
to the April 2018 final rule, we stated
that if payment is denied because the
prescriber or provider is on the
preclusion list, the affected beneficiary
would not have the right to appeal that
denial as denials due to preclusion are
not coverage determinations
accompanied by appeal rights. As we
did not include accompanying
regulatory text in the April 2018 final
rule, we proposed in CMS–4185–P to
add new § 423.120(c)(6)(viii) and
§ 422.222(a)(4) stating that payment
denials based upon, respectively, a
prescriber’s or provider’s inclusion on
the preclusion list are not appealable by
beneficiaries.
(6) Felony Convictions
We proposed in the November 2017
proposed rule to keep unenrolled
prescribers and providers on the
preclusion list for the same length of
time as the reenrollment bar that we
could have imposed on the prescriber or
provider had they been enrolled and
then revoked. While this policy was
finalized in the April 2018 final rule, it
was not included in the regulatory text.
Given this, we proposed several
regulatory revisions.
First, we proposed to revise the
definitions of ‘‘preclusion list’’ in
§§ 423.100 and 422.2. The current
definitions contain two general
categories of parties that could be
included on the preclusion list—(1)
prescribers and providers that are
currently revoked from Medicare and
are under a reenrollment bar; and (2)
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
prescribers and providers that have
engaged in behavior for which CMS
could have revoked the prescriber or
provider to the extent applicable had
they been enrolled in Medicare. While
these two categories encompass felony
convictions, we stated in CMS–4185–P
that the severity of felonious behavior
warranted the establishment of a third
category that is specific to felony
convictions. We therefore proposed to
remove felony convictions from the
scope of the first two categories, with
the new third category covering
prescribers and providers—regardless of
whether they are or were enrolled in
Medicare—that have been convicted of
a felony under federal or state law
within the previous 10 years that CMS
deems detrimental to the best interests
of the Medicare program. Recognizing
that the facts of each case are different
and must be judged on their own merits,
we proposed that CMS would first
consider the following factors before
determining whether a prescriber’s or
provider’s inclusion on the preclusion
list is warranted under our new
proposed third category for felony
convictions: (1) The severity of the
offense; (2) when the offense occurred;
and (3) any other information that CMS
deems relevant to its determination. In
conformity with this change, we also
proposed to add an ‘‘or’’ to the
regulatory text immediately after the
second category in the preclusion list
definitions; this would clarify that a
prescriber or provider need only come
within the purview of one of the three
categories to be included on the
preclusion list.
Second, we proposed to establish new
§§ 423.120(c)(6)(vii) and 422.222(a)(5)
that would codify, clarify, and expand
upon the previously mentioned policy
concerning the length of a prescriber’s
or provider’s inclusion on the
preclusion list:
• In §§ 423.120(c)(6)(vii)(A) and
422.222(a)(5)(i), we proposed that,
except as provided in
§§ 423.120(c)(6)(vii)(C) and (D) and
422.222(a)(5)(iii) and (iv), revoked
prescribers and providers, respectively,
would be included on the preclusion
list for the same length of time as the
prescriber’s or provider’s reenrollment
bar.
• In §§ 423.120(c)(6)(vii)(B) and
422.222(a)(5)(ii), we proposed that,
except as provided in
§§ 423.120(c)(6)(vii)(C) and (D) and
422.222(a)(5)(iii) and (iv), unenrolled
prescribers and providers, respectively,
would be included on the preclusion
list for the same length of time as the
reenrollment bar that we could have
imposed on the prescriber or provider
PO 00000
Frm 00105
Fmt 4701
Sfmt 4700
15783
had they been enrolled and then
revoked.
• In §§ 423.120(c)(6)(vii)(C) and
422.222(a)(5)(iii), we proposed that,
except as provided in
§§ 423.120(c)(6)(vii)(D) and
422.222(a)(5)(iv), prescribers and
providers—regardless of whether they
are or were enrolled in Medicare—that
are included on the preclusion list
because of a felony conviction would
remain on the preclusion list for a 10year period, beginning on the date of the
felony conviction, unless CMS
determines that a shorter time length of
time is warranted. Factors that we
would consider in making such a
determination would be: (1) The
severity of the offense; (2) when the
offense occurred; and (3) any other
information that CMS deems relevant to
its determination.
We mentioned in CMS–4185–P that
because our proposed preclusion list
period for felonious prescribers and
providers would begin on the date of the
conviction, such parties may actually be
included on the preclusion list for less
than 10 years even if CMS imposes the
full 10-year period.
We also explained in CMS–4185–P
that the OIG in many cases excludes
providers and prescribers for a period
that is longer than the period permitted
for a reenrollment bar under
§ 424.535(c). We believed that CMS
should keep an excluded provider or
prescriber on the preclusion list at least
until the provider or prescriber has been
reinstated by the OIG in order to be
consistent with section 1862(e) of the
Act. We thus proposed in new
§ 423.120(c)(6)(vii)(D) and
422.222(a)(5)(iv) that in cases where a
prescriber or provider is excluded by
the OIG, the prescriber or provider
remains on the preclusion list until the
expiration of the CMS-imposed
preclusion list period or reinstatement
by the OIG, whichever occurs later.
(7) Beneficiary Liability
Consistent with our existing authority
under section 1857(e)(1) of the Act, we
proposed to add a new paragraph
(g)(1)(iv) to § 422.504 under which the
MA organization is required to agree
that the enrollee must not have any
financial liability for services or items
furnished to the enrollee by an MA
contracted individual or entity on the
preclusion list, as defined in § 422.2 and
as described in § 422.222. This
provision would be limited to providers
under contract with the MA
organization, for we believed this is
consistent with the general applicability
and scope of § 422.504 and the ability of
the MA organization to control or
E:\FR\FM\16APR2.SGM
16APR2
15784
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
impose requirements on the health care
providers that furnish covered services
and items to enrollees. We stated our
belief that proposed paragraph (g)(1)(iv)
would help financially protect
beneficiaries from problematic
providers. It would also formally codify
this position, which we expressed in the
preamble to the April 2018 final rule but
did not address in the regulatory text.
(8) Technical Correction Concerning the
Term ‘‘Individual’’ in § 423.120(c)(6)
We also proposed to make technical
changes to § 423.120(c)(6)(i), (ii), (iii),
and (vi). These paragraphs stated as
follows, respectively:
• Except as provided in paragraph
(c)(6)(iv) of this section, a Part D
sponsor must reject, or must require its
PBM to reject, a pharmacy claim for a
Part D drug if the individual who
prescribed the drug is included on the
preclusion list, defined in § 423.100.
• Except as provided in paragraph
(c)(6)(iv) of this section, a Part D
sponsor must deny, or must require its
PBM to deny, a request for
reimbursement from a Medicare
beneficiary if the request pertains to a
Part D drug that was prescribed by an
individual who is identified by name in
the request and who is included on the
preclusion list, defined in § 423.100.
• A Part D plan sponsor may not
submit a prescription drug event (PDE)
record to CMS unless it includes on the
PDE record the active and valid
individual NPI of the prescriber of the
drug, and the prescriber is not included
on the preclusion list, defined in
§ 423.100, for the date of service.
• CMS has the discretion not to
include a particular individual on (or if
warranted, remove the individual from)
the preclusion list should it determine
that exceptional circumstances exist
regarding beneficiary access to
prescriptions.
Because some states permit
pharmacies to prescribe medications
under very specific circumstances, we
believed that the use of the term
‘‘individual’’ in paragraphs (i), (ii), (iii),
and (vi) was too restrictive. We therefore
proposed in paragraphs (i), (ii), and (vi)
to change this term to ‘‘prescriber’’ so as
to clarify that the prescriber need not be
an individual when these specific
circumstances are met. In a similar vein,
we proposed:
• In § 423.120(c)(6)(iii) to change the
phrase ‘‘individual NPI of the
prescriber’’ to ‘‘NPI of the prescriber’’,
and
• In paragraph (2)(i) of the definition
of ‘‘Preclusion list’’ in § 423.100 (and as
reflected in our previously discussed
proposal to revise this paragraph (see
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
section (C)(1)(b)(6) above)) to change the
phrase ‘‘he or she’’ to ‘‘prescriber.’’
c. Comments Received
We received comments concerning
our proposed changes from
approximately 25 commenters. The
comments are summarized below,
followed respectively by our responses
thereto. They are organized into general
categories, though we note that some
comments and responses involve
multiple policy areas.
(1) Claim Denials
Comment: With respect to claim
denials, a commenter questioned: (1)
Whether plans should deny all claim
types (regardless of origin) when the
claim date of service is equal to or
greater than the ‘‘claim reject date’’ (for
example, point of service claims; batch
claims; paper claims); and (2) whether
the ‘‘claim reject date’’ is the date that
CMS will use to edit the PDE. In a
similar vein, another comment
questioned whether: (1) Part D plan
sponsors should utilize the ‘‘claim reject
date’’ (rather than the ‘‘effective date’’
field) as the relevant field for the date
when claim rejections begin; and (2) the
‘‘claim reject date’’ is the relevant date
for when CMS validates the PDE.
Response: We will be addressing
operational issues in guidance as
necessary and appropriate. We note,
though, that PDE editing will use the
‘‘claim reject date.’’ (See HPMS
memorandum, ‘‘February 2019 Updates
to the Drug Data Processing System
(‘‘DDPS’’),’’ dated January 8, 2019 and
released January 9, 2019.)
Comment: A commenter stated that if
CMS intends for each Part D plan to
separately track a 60-day period after
beneficiary notices have been sent
before claim denials can occur, this
could create non-standardized effective
dates for claim denials across the
industry. The commenter cited the
example of one plan sponsor sending
the beneficiary notice on day 10 and
another sending the notice on day 20.
The commenter recommended that CMS
standardize the timing of the effective
claim denial date so as to ensure (1)
consistency within the industry and (2)
that claim rejects start on the same day
for precluded prescribers.
Response: We respectfully decline to
adopt the commenter’s suggestion as a
regulatory requirement. Given that Part
D plans may have different internal
procedures, different numbers of
beneficiaries to contact, and different
operational mechanisms, we believe it is
best to afford them the maximum
feasible flexibility in sending out
beneficiary notices. We believe this
PO 00000
Frm 00106
Fmt 4701
Sfmt 4700
ensures that all beneficiaries are
provided equal notice and time to find
a new provider or prescriber. However,
we do understand the commenter’s
concerns, and have indicated a claims
denial/reject date on the preclusion file
shared with both Part C and D plans.
This date indicates the close of the 90day period and the latest point at which
claims must deny or reject. We will
diligently monitor the preclusion list’s
implementation; should we determine
that more uniformity may be necessary,
we will consider addressing the matter
in future rulemaking as appropriate.
Comment: Once a provider or
prescriber has been added to the
preclusion list and claims from the
precluded provider or prescriber start to
be denied, a commenter questioned how
CMS expects a Part C organization
determination or Part D coverage
determination (submitted by either a
provider on the preclusion list or an
enrollee whose provider or prescriber is
on the preclusion list) to be reviewed.
Response: We respectfully believe
that this comment may reflect a
misunderstanding of how a point-of-sale
rejection is treated in the Part D
program. A rejection of a pharmacy
claim at point-of-sale does not
constitute a coverage determination. If a
claim is rejected because the prescriber
is on the preclusion list, the appropriate
action is for the enrollee to find another
prescriber to prescribe the drug. Further,
as finalized in § 422.222(a)(4), a
beneficiary enrolled in an MA plan (or
a cost plan or PACE organization under
the incorporation of the MA regulation
into those programs at §§ 417.478 and
460.86) will not be able to appeal a
payment denial that is based on an
individual or entity’s placement on the
preclusion list. The appeal rights
available to an enrollee under 42 CFR
part 422, subpart M are tied to whether
a decision by the MA plan is an
organization determination; because
there will be no appeal rights for these
denials, we do not believe it is
appropriate to characterize denials that
occur solely because of the preclusion
list requirements as organization
determinations. We believe that this
policy appropriately balances the need
to provide an appeal process to ensure
protection of Medicare beneficiaries and
their ability to challenge denials issued
by an MA plan; an MA plan will not
have any discretion to pay a precluded
provider where this final rule prohibits
payment and an appeal by an enrollee
of a denial of payment to the precluded
provider could never be resolved in the
enrollee’s favor. Therefore, this is not an
issue that can be resolved through the
benefit appeals process set forth at part
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
422, subpart M, under the regulation we
are finalizing.
(2) Provider Reinstatement
Comment: Several commenters stated
that CMS should explain the process
and timing that will be used when a
provider is no longer on the preclusion
list. A commenter sought clarification as
to what a provider record looks like
when the provider is reinstated on the
file and how this compares to the
original provider record.
Response: The preclusion list file will
include a reinstatement date indicating
when a provider or prescriber is no
longer precluded. The reinstatement
date will be published upon the
provider or prescriber being reinstated.
Records of a provider’s or prescriber’s
preclusion will not be removed from the
file. We will clarify additional
operational details pertaining to these
issues in sub-regulatory guidance.
Comment: A commenter requested
confirmation as to whether reinstated
providers will: (1) Be removed from the
preclusion list; or (2) remain in the
preclusion list database with a date
indicating the end of their preclusion
period.
Response: As already mentioned,
records of a provider’s or prescriber’s
preclusion will not be removed from the
preclusion list file. In such instances,
the reinstated provider or prescriber
will remain in the preclusion list
database. Upon the prescriber or
provider being reinstated, the
reinstatement date will be indicated.
Comment: A commenter questioned
whether reinstatement dates will be
provided for each preclusion effective
date and, if so, how far in advance of a
provider being reinstated will the date
be provided in the file.
Response: CMS will not provide
advance notice regarding a
reinstatement. However, once the
provider is reinstated, CMS will
populate a reinstatement date on the
file.
Comment: A commenter
recommended that CMS clarify: (1) That
the removal of a provider who
successfully appeals his or her addition
to the preclusion list would not be
retroactive to the date of the provider’s
original preclusion; (2) that the MA plan
would not be required to retroactively
pay claims for such a provider; and (3)
how MA plans should implement such
a provider’s removal from the
preclusion list. These suggestions
stemmed from several concerns the
commenter raised. First, requiring plans
to pay such claims retroactively could
create confusion among members, who
may be urged by their precluded
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
providers to continue to see the
precluded provider during the appeals.
Second, members may be liable for cost
sharing associated with the re-submitted
claims. Third, plans would face
uncertainty in determining how to pay
such claims (for example, at what
payment rate), for the provider contract
will likely have been terminated.
Response: We respectfully disagree
with the commenter’s apparent request
that CMS not reinstate a provider or
prescriber back to the original
preclusion date. Providers or prescribers
who are successful upon appeal will be
reinstated back to the preclusion
effective date. Once reinstated, the
provider would have the option of
resubmitting claims that had been
denied during the preclusion period,
which would be eligible for payment by
an MA plan under this final rule, using
the plan’s rules for claims processing;
we are not finalizing a requirement that
an MA plan must waive any claims
filing deadlines that may have elapsed
in the time between the date of service
and the decision to reinstate the
provider. If a provider is reinstated
retroactively, plans should pay claims
that were rejected or denied due to the
preclusion using, again, the MA plan’s
usual claims processing procedures; it
is, however, the provider’s
responsibility to resubmit any rejected
or denied claims. If a beneficiary paid
out of pocket for a Part D drug that was
rejected based on the prescriber’s
preclusion, the beneficiary would have
to submit a request for reimbursement.
We will clarify the process for reinstated
providers and prescribers to resubmit
claims in sub-regulatory guidance.
Comment: A commenter sought
clarification as to how a beneficiary
would know to resubmit a previously
rejected claim for reimbursement if a
precluded provider is reinstated
retroactively.
Response: We intend to address this
issue in sub-regulatory guidance. While
this final rule does not require the Part
D or MA plan to issue additional notices
to enrollees about individuals or entities
that have been reinstated after a
successful appeal of placement on the
preclusion list, we encourage plans to
do so, especially in cases where
placement on the preclusion list was in
error.
(3) ‘‘Reasonable Efforts’’/Notification
Comment: Several commenters
requested clarification as to what the
term ‘‘reasonable efforts’’ means in the
context of furnishing the notification to
the prescriber as described in
§ 423.120(c)(6)(iv)(B). A commenter
added that various parts of CMS’ sub-
PO 00000
Frm 00107
Fmt 4701
Sfmt 4700
15785
regulatory guidance indicate that the
‘‘reasonable efforts’’ notification is
required but elsewhere state that it is
optional; the commenter recommended
that CMS explain the circumstances
under which it is, or may be, required.
Response: The term ‘‘reasonable
efforts’’ in both § 423.120(c)(6)(iv)(B)
and § 422.222(a)(1)(ii)(B) involves the
plan using available contact information
it has for a prescriber or provider to
copy them on the notice mailed to the
beneficiary. We expect that MA
organizations would always have
contact information for their MAcontracted providers. We acknowledge,
however, that they may not have this
data for non-contracted providers
(unless the non-contracted provider
submits a claim) and that Part D plan
sponsors may not have this information
concerning prescribers of drugs. Given
this dilemma, and to ensure that a
proper balance is attained between the
importance of notification and the fact
that contact data may be unavailable in
certain circumstances, we are changing
the timing and scope of this notification
requirement. We are finalizing
§ 422.222(a)(1)(ii)(B) and
§ 423.120(c)(6)(iv)(B) with the following
modifications:
++ The existing versions of these
paragraphs will be incorporated into,
respectively, new paragraphs
§§ 422.222(a)(1)(ii)(B)(1) and
423.120(c)(6)(iv)(B)(1). The beginning of
these respective new paragraphs,
moreover, will state, ‘‘Subject to
paragraph (a)(1)(ii)(B)(2) of this section’’
and ‘‘Subject to paragraph
(c)(6)(iv)(B)(2) of this section’’.
++ In new paragraphs
§§ 422.222(a)(1)(ii)(B)(2) and
423.120(c)(6)(iv)(B)(2), we will state that
paragraph (B)(1) only applies upon
receipt of a claim from, respectively, a
precluded MA provider (contracted or
non-contracted) or upon a prescriber
writing a Part D prescription when: (i)
Sufficient contact information is
available; and (ii) the claim is received
after the claim denial or reject date in
the preclusion file.
Paragraph (B)(2), in effect, means that
the ‘‘reasonable efforts’’ requirement in
paragraph (B)(1) will apply only if both
of the following conditions are met: (1)
The MA organization or plan sponsor
has enough information on file to either
copy the provider or prescriber on the
notification previously sent to the
beneficiary or send a new notice
informing the provider or prescriber that
they may not see plan beneficiaries due
to their preclusion status; and (2) the
claim is received after the claim denial
or reject date in the preclusion file. We
believe this second criterion is
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15786
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
necessary to help clarify the timing of
the notification requirement; it will also
help to mitigate instances where a
beneficiary mistakenly receives care
from a precluded prescriber.
Comment: A number of commenters
opposed the requirement under
§ 422.222(a)(1)(ii)(B) or
§ 423.120(c)(6)(iv)(B) that MA
organizations and Part D sponsors
ensure that ‘‘reasonable efforts’’ are
made regarding provider and prescriber
notification. Some stated that this
activity should not be the responsibility
of MA plans or Part D plan sponsors;
this is because CMS already adequately
notifies providers and prescribers of
their placement on the preclusion list
and remains, in the commenters’ view,
in the best position to continue doing
so. The commenters believed that
imposing the requirements of
§ 422.222(a)(1)(ii)(B) or
§ 423.120(c)(6)(iv)(B) on MA plans and
Part D sponsors would thus: (1) Be both
duplicative and a further administrative
burden on MA plans and Part D
sponsors, involving thousands of
additional letters and unnecessary costs;
(2) be inconsistent with the Patients
over Paperwork initiative; and (3) lead
to provider frustration and confusion
because the provider would be receiving
multiple notices regarding the same
matter. A commenter added that
precluded providers and prescribers are
able to identify their impacted patients
and need not receive this information
from MA plans and Part D sponsors; the
latter should not bear additional cost
and burden in order to assist
problematic providers and prescribers
with managing impacted patients within
their practices. Another commenter
stated that with respect to MA noncontracted providers, it is possible that
the services they provided were on an
emergency/urgent basis, rather than for
ongoing, routine care; there is,
consequently, little value in MA plans
furnishing additional notification under
§ 422.222(a)(1)(ii)(B) given the limited
impact on a ‘‘go-forward’’ basis. An
additional commenter stated that these
notification requirements have not been
imposed with respect to OIG-excluded
providers.
Response: We appreciate the concerns
these commenters expressed regarding
the aforementioned requirement.
Considering, however, the plans’ role in
the daily operational and logistical
facilitation of the Medicare Part C and
D programs and their close
administrative relationship with
prescribers and providers, we believe
that the plans are best-positioned to
communicate with prescribers and
providers regarding their relationships
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
with specific beneficiaries. We mention
also that we have attempted to reduce
to burden of this requirement with our
aforementioned revisions to
§ 422.222(a)(1)(ii)(B) or
§ 423.120(c)(6)(iv)(B).
With respect to the final comment, we
note that the OIG exclusion list and the
administrative requirements pertaining
thereto are separate from and nonbinding on those regarding the
preclusion list. Merely because the OIG
regulations lack a requirement
concomitant with § 422.222(a)(1)(ii)(B)
or § 423.120(c)(6)(iv)(B) does not
mandate that CMS eliminate these two
provisions.
(4) Notification to Provider of
Preclusion
Comment: A commenter
recommended that CMS notify the
prescriber of their inclusion on the
preclusion list because having
individual plan sponsors perform
simultaneous outreach to providers
would be inefficient and confusing.
Response: We believe that the
commenter is referring to the CMS
requirement that was finalized in the
April 2018 final rule and codified in
§ 423.120(c)(6)(v). Assuming this is so,
we agree with the commenter and stress
that we did not propose to change this
requirement in the November 1, 2018
proposed rule.
Comment: A commenter urged that
the written notice to the individual or
entity via letter of their inclusion on the
preclusion list be sent via certified mail
and that the letter be standardized
across the MA and Part D programs.
This, the commenter explained, would
prevent instances where an individual
or entity is not properly notified, the
letter is lost in transit, or the letter goes
to an incorrect office or staff member; it
will also help ensure a proper chain of
custody. The commenter also stated that
standard language and uniformity in the
letter’s format will assist individuals
and entities in distinguishing the notice
and its purposes from other
communications.
Response: We appreciate this
comment and wish to clarify that CMS
is indeed mailing these notices via
certified mail. Additionally, the same
letter template, including similar format
and language, is used for notification to
both Part C and D providers and
prescribers.
(5) Relation to OIG Exclusion List
Comment: Several commenters urged
CMS to treat the OIG exclusion list and
the preclusion list consistently to avoid
provider, beneficiary, and plan
confusion. A commenter requested
PO 00000
Frm 00108
Fmt 4701
Sfmt 4700
clarification regarding CMS’ rationale
for treating precluded providers
differently than those on the OIG
exclusion list, particularly with respect
to the timing for the denial of claims.
The commenter noted that, in contrast
to the OIG exclusion process, claims
denials will be delayed for the initial
preclusion list and subsequent lists.
Response: We appreciate these
comments. As explained in subregulatory guidance we have issued
(https://www.cms.gov/Medicare/
Provider-Enrollment-and-Certification/
MedicareProviderSupEnroll/
PreclusionList.html), we have attempted
to conform the preclusion list policies to
those concerning the OIG exclusion list
as much as possible. We emphasize,
however, that complete uniformity and/
or full integration of the two lists is
impracticable at this time for several
reasons. First, the OIG exclusion list is
governed by statute, consistent with the
provisions of section 1128 of the Act.
The OIG exclusion list (and the policies
and procedures associated therewith) is
operated under an entirely different set
of laws and regulations. Second, the
requirements for inclusion on the
preclusion list and for inclusion on the
OIG exclusion list are very different. For
instance, revocation of Medicare
enrollment (which can be based on any
of the reasons identified in § 424.535(a))
and a non-health care related felony can
serve as bases for adding a provider to
the preclusion list, whereas these
grounds are not, in and of themselves,
bases for inclusion on the OIG exclusion
list. The revocation reasons in
§ 424.535(a), moreover, are quite
distinct from the reasons for imposing
an OIG exclusion under section 1128 of
the Act. The Medicare enrollment/
revocation and OIG exclusion processes,
in short, are operated by different
agencies under different rules with
different requirements, which prevents
these lists from being uniform.
We also believe that the preclusion
list will apply to a much larger provider
population than that included on the
OIG exclusion list. We remind
commenters that the intent of the
preclusion list was to create an effective
alternative to enrollment. We thus
concluded that it was necessary to
establish criteria for a provider to be
precluded that were broader than those
for exclusion, such as being revoked
from Medicare; otherwise, it was
possible that certain problematic
providers and prescribers could
continue to furnish MA services and
items or prescribe Part D drugs. By the
same token, we have certain safeguards
for the preclusion list, such as the claim
denial timing, to prevent access to care
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
issues. We believe this properly
balances the need for strong program
integrity measures (as evidenced by our
above-referenced, broader preclusion
list criteria) and the importance of
ensuring that beneficiaries receive
needed health care.
Notwithstanding the above, we
emphasize that the OIG list should take
precedence over the preclusion list;
consequently, no OIG-excluded
provider shall receive payment or the
60-day period addressed in this rule.
Once a provider is no longer excluded
and a plan must review the preclusion
list, there will be instances (based on
Medicare reenrollment bars) where a
provider is precluded after their
reinstatement from an exclusion.
Comment: A commenter stated that
administering the preclusion list
differently than the OIG exclusion list
increases administrative burden for
plans while adding little value. The
commenter instead supported
terminating providers and denying
claims in a timeframe consistent with
the OIG exclusion process, rather than
waiting for at least 60 days after release
of the preclusion list, as CMS proposed.
The commenter stated that there should
not be a 60-day period before claim
denials, for a provider would know that
they are precluded and should thus not
be seeing Medicare beneficiaries or
prescribing drugs. The commenter
added that having separate notices to
the beneficiary and different claims
denial timeframes could lead to
beneficiary confusion. Accordingly, the
commenter recommended that CMS: (1)
Use one list that combines exclusions
and preclusions; or (2) revise the
preclusion list requirements to apply in
the same manner as the OIG list,
allowing plans to deny claims upon
release of the preclusion list.
Response: As already explained, the
differing requirements for inclusion on
each list, the different legal and
statutory requirements, and the different
operational aspects involved do not
permit us to establish any greater
uniformity than that already described
in the above-mentioned sub-regulatory
guidance. With respect to claim denials,
we recognize the validity of the
commenter’s concern. Considering,
however, that (1) the preclusion list is
a new concept, (2) plans need time to
accustom themselves to the preclusion
list process, and (3) some beneficiaries
will need time to find new prescribers
or providers, we are not in a position at
this stage to require immediate claim
denials upon release of the preclusion
list. In time, should stakeholders
(including the plan and beneficiary
communities) become fully acclimated
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
to the preclusion list process such that
a period as long as 90 days is not
realistically needed, CMS may revisit
this issue in future rulemaking.
Regarding the commenter’s concerns
about plan and beneficiary burden and
confusion, we will continue our
educational and outreach efforts to
stakeholders so as to minimize these
effects.
Comment: A commenter
recommended that CMS only include
non-OIG excluded prescribers on the
preclusion list in order to keep the
preclusion and OIG exclusion lists
separate. The commenter was concerned
that with both programs releasing a
monthly file at different times during
the month, the potential exists for
timing problems and confusion.
Response: We appreciate this
suggestion. However, because (1) an OIG
exclusion constitutes grounds for
revocation under § 424.535(a) and (2)
the revocation policies in § 424.535 (for
example, application of a reenrollment
bar) would apply in such cases, we
believe it is important to include all
revocation grounds and policies within
the scope of the preclusion list. We will
continue to work with stakeholders to
minimize confusion regarding the
interaction between the two lists. We
are confident that, with time, affected
parties will become acclimated to the
different processes.
Comment: A commenter contended
that including preclusion list standards
on top of the existing OIG exclusion
statutory requirements is unnecessary,
creates numerous inconsistencies, and
imposes operational complexities. For
example, the commenter stated, once a
provider is added to the OIG exclusion
list, there is no grace period during
which plans can continue to make
payment. The proposed rule, however,
contains such a period for the
preclusion list under §§ 422.222(a)(1)
and 423.120(c)(6)(iv). The commenter
stated that: (1) Simultaneous
compliance with both of these standards
is impossible; and (2) CMS cannot
create a rule that directly conflicts with
the OIG exclusion provisions in the
Social Security Act. The commenter
added that while CMS could create
exceptions to the preclusion list
requirements for excluded providers or
revise the preclusion list requirements
to be consistent with those applicable to
excluded providers, it would be
administratively cleaner to simply
extract excluded providers from the
preclusion list.
Response: For reasons already stated,
we are not in a position to separate the
two lists or to make the preclusion list
processes entirely consistent with those
PO 00000
Frm 00109
Fmt 4701
Sfmt 4700
15787
of the OIG exclusion list. We are also
unable to remove OIG excluded
prescribers and providers from the
preclusion list, for CMS takes revocation
action that is separate and apart from
whatever exclusion action the OIG
might take. A revocation action warrants
the addition of the prescriber or
provider to the preclusion list and is
accompanied by a reenrollment bar,
which determines the length of the
preclusion. The reenrollment bar length
may exceed the period for which the
prescriber or provider is OIG excluded,
which further prohibits the affected
prescriber or provider from furnishing
items and services to Medicare
beneficiaries.
Notwithstanding the above, however,
we have already clarified via subregulatory guidance that the OIG
exclusion list takes precedence over the
preclusion list. Thus, if a plan locates a
provider on the OIG exclusion list, it
need not consult the preclusion list with
respect to that provider. The plan would
simply follow its processes for OIG
excluded providers as described at 42
CFR 422.204(b)(4), 422.224(a), and
422.752(a)(8). We mention further that
providers and prescribers who are
precluded due to an exclusion are not
afforded the 60-day grace period, for the
plan would reject the claim or deny the
provider’s requests for reimbursement
based on the exclusion prior to
determining if the provider or prescriber
is precluded.
To codify the above policy in
regulation, we will clarify the opening
paragraphs of §§ 423.120(c)(6)(iv) and
422.222(a)(1)(ii) to state that
§§ 423.120(c)(6)(iv) and 422.222(a)(1)(ii)
do not apply if the prescriber or
provider is currently excluded by the
OIG. This means, in effect, that if a
provider or prescriber is on both the
OIG exclusion list and the preclusion
list, the MA organization or Part D plan
sponsor need not (with respect to that
prescriber or provider) carry out the
requirements of §§ 423.120(c)(6)(iv) and
422.222(a)(1)(ii) (for example, provide
advance written notice to the
beneficiary; delay payment denials). We
believe this will help reduce duplicative
administrative functions (such as letters
to beneficiaries) and ensure compliance
with the statutory payment prohibitions
concerning OIG exclusions (that is, no
grace period).
Comment: A commenter
recommended that CMS limit the
preclusion list to providers who are not
on the OIG exclusion list so as to avoid
conflicts between the exclusion and
preclusion requirements. If CMS
declines this suggestion, the commenter
stated that giving plans up to 90 days to
E:\FR\FM\16APR2.SGM
16APR2
15788
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
begin denying payment would allow
them to meet their obligation (under
both OIG and CMS regulations) to deny
claims for items and services provided
by an excluded provider, while also
allowing time—where permitted—for
members to be notified and transition to
a new provider. The commenter
contended that this would be more
consistent with MAOs’ current
obligations to provide members with 30
days’ advance notice of a provider’s
contract termination; the commenter
questioned why a provider placed on
the preclusion list should continue to be
paid for a longer period of time than a
provider whose contract terminates for
another reason.
Response: We previously outlined our
rationale for declining to extract OIGexcluded parties from the preclusion list
and the reasons for the 90-day delay in
claim denials. As we indicated
regarding the latter, though, we may in
the future consider shortening this time
period via rulemaking should
circumstances warrant and operational
considerations permit. We note that
currently, pursuant to § 422.202(d)(4), if
an MA plan terminates a contracted
provider from the provider network for
‘‘no cause’’, the plan is required to
furnish the provider with 60 days’
advance notice; if an MA plan
terminates a provider for cause, the
provider is entitled to appeal rights
under § 422.202(d)(1) through (3). Based
on this, we believe that the timeframe of
60–90 days before an MA plan can deny
payment to a precluded provider is
similar to what is required when a
provider is terminated by the plan
under § 422.202(d)(4) without cause.
(6) Relationship to Medicaid
Comment: In cases where Medicaid is
the primary payer for a drug for a dualeligible individual, a commenter
questioned whether the pharmacy must
fill a prescription for a drug prescribed
by a precluded prescriber. The
commenter stated that CMS must
address how the preclusion list applies
to Medicaid-Medicare Plans (MMPs)
with a three-way contract. Specifically,
in an MMP the enrollee has one
insurance card; he or she may thus be
confused if the MMP rejects his or her
Part D drugs (because the prescriber is
precluded) but then pays for the
Medicaid drug from the same prescriber.
Response: A Part D drug that is not
covered because the prescriber is on the
preclusion list—but is otherwise
coverable by Part D—is not coverable
under Medicaid, including under an
MMP as the claim would not cross over
once rejected by the Part D plan. In the
rare circumstance that Medicaid is the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
primary payer for a prescription drug
furnished to a Part D eligible individual,
the preclusion list does not apply as the
drug would be adjudicated through the
Medicaid claims system.
Comment: A commenter requested
that CMS collaborate with states if
future consideration is given to the
preclusion list’s potential application to
(and implementation by) state Medicaid
agencies in unison with private sector
health plan partners.
Response: We appreciate this
comment and will make certain to
collaborate with the states should the
contingency the commenter mentions
arises.
(7) Timeframe for Denying Claims
Comment: Noting the proposed
commencement of claim denials 61–90
days following preclusion list
publication, a commenter recommended
a hard timeline of 90 days from file
release to claim denial. The commenter
believed that this would foster industrywide consistency. Another commenter
stated that if CMS intends to require
plans to terminate precluded providers
from their networks, CMS should: (1)
Promulgate this requirement through
rulemaking, not via sub-regulatory
guidance; and (2) permit plans to
terminate providers at any time prior to
when plans must begin denying
payments.
Response: We appreciate these
comments. However, we do not wish to
delay claim denials any longer than
absolutely necessary, which is why we
respectfully decline to mandate the
expiration of a full 90-day period. Under
§ 422.222(a)(1), as amended in this final
rule, an MA organization is prohibited
from paying a provider who is on the
preclusion list; this prohibition applies
to claims with dates of service that fall
60 days or more after the MA
organization has notified the enrollee
that the provider has been placed on the
preclusion list and that claims for
services furnished by that provider will
be denied. Section 422.222 does not
itself require termination of any contract
between the MA organization and the
precluded provider. We anticipate,
though, that many MA plans will take
steps to terminate their contracts with
precluded providers, at least for
purposes of the MA plan, because of the
prohibition on payments to precluded
providers in connection with items and
services provided to Medicare
beneficiaries. Further, we do not believe
that rulemaking is required regarding
language in CMS’ sub-regulatory
guidance, which only suggests and does
not require the removal of precluded
providers from plan networks.
PO 00000
Frm 00110
Fmt 4701
Sfmt 4700
We believe that compliance with
§ 422.222(a)(1) by an MA plan will take
slightly different forms depending on
whether the precluded individual or
entity has a contract with the MA plan
to participate in its network. In
managing their contracted networks,
MA plans: (1) Must provide advance
written notice to any beneficiary who
received an item or service from an
individual or entity added to the
preclusion list no later than 30 days
after the posting of the updated
preclusion list; and (2) may pay the
precluded provider for 60–90 days,
depending on when the enrollee was
notified. When an enrollee has received
services from a non-network precluded
provider, MA plans should notify the
enrollee that the non-contract provider
is precluded and the plan will not pay
any claims from the precluded provider
with a date of service after the
expiration of the allowable payment
period for that precluded provider.
Comment: A commenter agreed that
the previously mentioned 60–90 day
claim denial period will assist
beneficiaries in transitioning to new
providers.
Response: We appreciate the
commenter’s support.
Comment: Several commenters
expressed support for the proposed
application of the 90-day period before
a claim is denied to all releases of the
preclusion list (not merely the initial
preclusion list).
Response: We appreciate the
commenters’ support.
Comment: A commenter stated that
payment denials should be allowed to
begin at any point up to 90 days after
the provider is placed on the preclusion
list. Any member notice requirement,
the commenter contended, should be
independent of the time frame for
denying payments.
Response: Under
§ 422.222(a)(1)(ii)(C), the prohibition on
payment to a precluded individual or
entity is tied to expiration of a period
of 60 days from issuance of the advance
written notice to the enrollee. However,
the MA plan may terminate a network
provider under its contract, thereby
removing the provider from its network
of providers available to its enrollees in
accordance with other procedures and
requirements. The MA regulation at
§ 422.202(d) permits for-cause and
without-cause terminations of provider
participation agreements; § 422.111(e)
specifies that an MA organization
terminating a provider must make a
good-faith effort to notify enrollees at
least 30 calendar days before the
provider termination date. If an enrollee
is left without a primary care provider
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
and one is necessary in order to access
coverage and benefits under the MA
plan, § 422.112(a)(2) permits the MA
organization to assign a primary care
provider to the enrollee; further,
§ 422.122(b) imposes coordination of
care responsibilities on MA
organizations, which CMS generally
believes means that an MA organization
should offer to assist enrollees in
locating a suitable provider and in
ensuring that ongoing treatment is
properly transitioned to a new health
care provider. Section
422.222(a)(1)(ii)(A) requires that MA
organizations notify enrollees within 30
days from when the MA plan receives
notification from CMS that a provider
has been placed on the preclusion list,
which will start the 60-day period for
when denials of payment based solely
on the provider’s inclusion on the
preclusion must occur.
The enrollee notification of a
terminated provider should inform the
enrollee that the terminated precluded
provider is no longer available to
furnish plan services and offer to assist
the enrollees in transitioning to a new
network provider. For services received
from a non-contracting precluded
provider, the MA plan must also notify
the enrollee that the non-network
provider is precluded and include in
that notification the date on which the
plan will not pay any further claims
from that precluded provider. This gives
the enrollee time to transition to an
alternative non-network provider if he
or she chooses to do so.
While we believe it is clear that
§ 422.222 is equally applicable to
network and non-network precluded
providers, we wish to eliminate any
confusion on this matter. As such, we
are changing the title of § 422.222 from
‘‘Preclusion list’’ to ‘‘Preclusion list for
contracted and non-contracted
individuals and entities.’’ We believe
this will help clarify the applicability of
§ 422.222,
Comment: A commenter urged CMS
to allow plans up to 90 days to
commence denying payments, meaning
that plans would be permitted to: (1)
Immediately stop paying claims (as
required with OIG excluded providers);
and (2) begin denials at any point
within 90 days if there is no other legal
requirement to act immediately. The
commenter stated that requiring plans to
pay claims for a period of time after the
provider is placed on the preclusion list
conflicts with other requirements that
plans must follow and introduces
multiple challenges. The commenter
added that because the applicable
statute prohibits plans from making
payment for items and services
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
furnished or prescribed by an excluded
provider, CMS cannot impose a separate
requirement that plans continue to pay
claims for precluded providers (some of
whom will also be on the exclusion list)
for a particular period of time.
Response: As previously explained,
we believe that beneficiaries should be
afforded a sufficient opportunity to
locate a new prescriber or provider
should their current prescriber or
provider be included on the preclusion
list. We note also that nothing in the
provisions we finalized in the April
2018 final rule or are finalizing in the
present rule prohibit plans from
immediately denying claims based on
an OIG exclusion pursuant to the longstanding requirement to do so under the
Social Security Act. Indeed, we refer the
commenter to our previously mentioned
changes to §§ 423.120(c)(6)(iv) and
422.222(a)(1)(ii), under which these
provisions would not apply if the
prescriber or provider is currently
excluded by the OIG.
Comment: A commenter stated that
the April 2018 final rule prohibits
MAOs from paying claims from
precluded providers and contains no
requirement that the MAO notify the
member or otherwise delay the denial of
payment. The commenter also pointed
out, however, that the previously
mentioned HPMS Memo ‘‘recommends’’
that MAOs wait 90 days before denying
payment. The commenter stated it will
be impossible for MAOs to comply with
both the immediate payment
prohibition and the 90-day
recommendation for claim denials.
Response: CMS acknowledges, in the
previously mentioned HPMS memo, the
failure to include in the regulatory text
of the April 2018 final rule certain
policies outlined in our responses to the
comments therein. Due to the language
in the April 2018 final rule preamble
summarized above and our guidance in
the HPMS memo, we believe that the
90-day approach is permissible for plans
pending the applicability date of this
final rule and our amendments to
§ 422.222(a). We clarify here that the
HPMS memo simply requests that plans
follow the 90-day approach and that this
approach is being codified in the
regulatory text of this final rule. We
mention, however, with the finalization
of this rule, that the above-referenced
60-day period and beneficiary
notification will be required upon the
final rule’s effective date.
(8) Beneficiary Notification
Comment: A commenter sought
clarification on how a plan should
proceed (assuming a January 1, 2019
release of the initial preclusion list) if,
PO 00000
Frm 00111
Fmt 4701
Sfmt 4700
15789
on day 89 following the publication of
the preclusion list, a beneficiary
receives a service from a precluded
provider for which no pharmacy claims
history exists. The commenter
questioned whether: (1) This beneficiary
would receive notification from the plan
about the provider’s preclusion; (2) the
90-day clock will begin to run again for
this beneficiary; and (3) a provider or
prescriber identified on January 1, 2019
as meeting the requirements for
preclusion could provide services to a
Medicare beneficiary for close to 6
months following its preclusion. The
commenter believed that if CMS
releases the preclusion list on January 1,
2019, plans would have until February
1 to notify beneficiaries, at which time
claims begin to be denied on April 1; if,
however, a beneficiary sees a provider
placed on the initial preclusion list on
March 28, a new 90-day clock would
begin to run, under which the plan
would be given 30 days to contact the
beneficiary (April 28) and claims would
not be denied until June 28.
Response: First, we note that the
commenter’s example appears to be
about the preclusion list regulation
adopted in the April 2018 final rule that
became applicable beginning January 1,
2019, and not about our proposed rule.
CMS has addressed this topic via subregulatory guidance at the following
link: https://www.cms.gov/Medicare/
Provider-Enrollment-and-Certification/
MedicareProviderSupEnroll/
PreclusionList.html. That guidance
clarifies that if no claims history exists
for the previous 12-month period, the
plan is not required to notify
beneficiaries. If no notification is made,
the 60–90 day period is not required,
although plans may choose to wait to
deny claims until the claim denial/reject
date included on the preclusion list file.
Second, under the amended
regulations we are finalizing here and in
regard to the commenter’s specific
scenario, if a beneficiary received a
service from a precluded provider on
the 89th day following publication of
the list, the plan would pay the claim.
The provider would not receive an
additional 60–90 day period and after
the 89th day would thus be unable to
continue furnishing MA items and
services or prescribing Part D drugs for
Medicare beneficiaries. If the service
was provided on the 90th day, the plan
would (upon receiving the claim) deny
or reject the claim and notify the
provider or prescriber that he/she is
precluded, as we have finalized at
§ 422.222(a)(1)(ii)(B) and
§ 423.120(c)(6)(iv)(B). In this specific
scenario, we are assuming the provider
is granted the 60–90 day period as there
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15790
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
may be a claims history with at least one
beneficiary. To further clarify, in
situations where there is no claims
history concerning the specific provider
and any beneficiaries, the 60–90 day
period is not required.
Comment: Citing CMS’ Patients over
Paperwork initiative, a commenter
requested clarification of the rationale
for requiring the mailing of beneficiary
notices instead of permitting email. The
commenter cited the situation where a
beneficiary indicates that electronic
communication is his or her preferred
method of communication.
Response: Per the December 14, 2018
HPMS memo, CMS will not allow
different modes of communication
regardless of the beneficiary’s
preference. We recognize that some
beneficiaries may prefer email.
However, we believe that using mail is
the surest means of making certain that
the beneficiary receives the notice, a
critical consideration given the
importance of the information furnished
therein.
Comment: Several commenters urged
CMS to add language to the sample
beneficiary notification letter stating
that appeal rights will not apply when
a claim is denied due to a precluded
prescriber. Failure to do so, a
commenter contended, could lead to
beneficiary confusion.
Response: In the sample notification
letter, we refer the beneficiary to our
sub-regulatory guidance (https://
www.cms.gov/Medicare/ProviderEnrollment-and-Certification/
MedicareProviderSupEnroll/
PreclusionList.html), in which we
outline the lack of beneficiary appeals
in the situation the commenter
describes. We believe this furnishes
sufficient notification to beneficiaries on
the issue of appeals.
Comment: A commenter stated that
the sample notification letter informs
stand-alone Part D plans to insert the 1–
800–Medicare number but then leaves
the ‘‘hours of operation’’ configurable.
The commenter questioned: (1) Whether
the hours should be the standard hours
for 1–800–Medicare; (2) whether the
stand-alone Part D enrollees should call
only if they need assistance in finding
another prescriber but should call plans
at the plan number for further questions
regarding the status of their
prescriptions; (3) whether, based on the
sample notice, there should be two
numbers for stand-alone Part D plans;
(4) whether the 1–800-Medicare number
should only be furnished if assistance is
needed in finding another provider; and
(5) whether plans should list their
customer care phone number if there are
further questions regarding the status of
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
their prescription with the plan’s
customer care hours of operations.
Response: We will address these
operational issues via sub-regulatory
guidance.
Comment: Regarding an enrollee who
did not receive a notification letter (and
given the previously mentioned 90-day
period), a commenter sought
clarification as to: (1) The requirements
concerning PDE edits; (2) whether CMS
will pay for the PDE; and (3) whether a
new PDE edit will be created to reject
PDEs submitted for precluded
providers.
Response: We assume the commenter
is referring to situations, per the
regulations finalized in the April 2018
rule, where the beneficiary did not
receive notification that his or her
provider or prescriber is precluded. PDE
editing will be based on the ‘‘claim
reject date,’’ regardless of beneficiary
notification receipt status as the timing
for claim denials and/or rejections
begins upon the notice being sent by the
plan. (See HPMS memorandum,
‘‘February 2019 Updates to the Drug
Data Processing System (‘‘DDPS’’),’’
dated January 8, 2019 and released
January 9, 2019.)
Comment: A commenter expressed
concern that beneficiaries will not have
had adequate experience with the
preclusion list initiative before receiving
the mandated 60-day notification.
Response: We understand the
commenter’s concern. We will work
with beneficiary groups to help educate
potentially affected Medicare patients
about the preclusion list process.
Comment: A commenter urged that
the beneficiary notification letter should
state that: (1) The beneficiary cannot
request any review of CMS’ preclusion
determination; and (2) he or she must
seek a non-precluded prescriber for
future prescriptions.
Response: With respect to the first
part of the comment, we do not believe
it is helpful for the notification letter to
state what the beneficiary cannot do
under these circumstances. Instead,
consistent with the second part of the
comment, we believe it is more helpful
for the notification letter to clearly
explain the actions the beneficiary can
and should take to ensure future
payments and coverage of benefits; that
is, to find another non-precluded
provider to furnish similar items or
services.
(9) Pharmacies and Part B Drugs
Comment: A commenter stated that
Part B pharmacy claims are included in
Part C reporting. The commenter sought
guidance regarding—if a plan offers
both Part D and Part B pharmacy
PO 00000
Frm 00112
Fmt 4701
Sfmt 4700
benefits to its members—the Part B
pharmacy drug claims process if the
provider is on the preclusion list.
Specifically, the commenter questioned
whether the Part D processed claims
will reject but Part B drug claims will
be allowed to process. The commenter
stated that beneficiaries may be
confused if some of their claims
involving a precluded provider are
denied while others are processed.
Another commenter, too, sought
clarification as to whether MA or MA–
PD plans should deny payment of Part
B pharmacy prescriptions written by a
precluded provider. This commenter
cited the example of a beneficiary who
presents a pharmacy with two
prescriptions from a precluded
prescriber—one for a Part D drug and
one for a Part B drug; the commenter
questioned whether the pharmacy
should reject one prescription (Part D)
and fill the other prescription (Part B).
Response: We believe this situation is
likely to be rare, provided that plans are
applying the preclusion list to all claims
submitted by both contracted and noncontracted providers. However, we
acknowledge that such a situation could
arise and, if it did, would cause
confusion for beneficiaries and
pharmacies. To reduce confusion,
therefore,, if the prescriber or provider
is precluded, the plan will be prohibited
from making payment regardless of
whether the drug is a Part B or D drug.
After consideration of these comments,
we will modify the language in
§ 422.222(a)(1)(i) that reads ‘‘health care
item or service furnished’’ to instead
state ‘‘health care item, service, or drug
that is furnished, ordered, or
prescribed’’. To ensure consistency with
this revision, we will make similar edits
to § 422.222(a)(1)(ii)(A) and (C) and to
422.504(g)(1)(iv); specifically, we will
include therein, as applicable,
references to ‘‘ordered,’’ ‘‘prescribed,’’
and ‘‘drugs.’’
Comment: A commenter requested
that CMS clarify whether the proposed
replacement of the term ‘‘individual’’
with ‘‘prescriber’’ in § 423.120(c)(6)
means that: (1) Type 2 NPIs—when
submitted on the PDE—can be accepted
as a valid submission on claims; and (2)
any valid NPI—whether Individual or
Organizational—can be used to
adjudicate claims.
Response: Based on comments we
received regarding this proposed
change, we are concerned that such a
revision will cause confusion that will
outweigh the proposal’s objective.
Indeed, we note that the policy that Part
D plans submit PDEs with Type I NPIs
is a long-standing one that supports an
important program integrity goal. For
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
these reasons, we are not finalizing this
proposal.
Comment: Several commenters
recommended that CMS explain the
scope of the Part D preclusion list,
indicate whether and how it applies to
pharmacies, and make any necessary
regulatory revisions. A commenter
requested that the regulatory text clarify
whether CMS intends to add to the
preclusion list those pharmacies that do
not prescribe drugs to Part D members
but do fill member prescriptions. The
commenter contended that the
applicable preclusion list regulations
require the denial of payments to
precluded prescribers but do not extend
to pharmacies that fill member
prescriptions. The commenter also
requested that CMS limit the preclusion
list to those pharmacies that are
prescribers until the regulations are
modified. The commenter stated that
the inclusion of non-prescribing
pharmacies on the preclusion list risks
exposing plan sponsors that deny
payments to such pharmacies to legal
claims in light of, the commenter
contended, the lack of regulatory
authority for those denials.
Response: Although pharmacies are
indeed on the preclusion list, the
regulations at 422.222 only apply to
pharmacy claims for Part A or B drugs
covered under Part C and supplemental
items or services furnished by the
pharmacy (that is, they will not affect
the pharmacy’s ability to dispense Part
D drugs so long as the prescription is
not from a precluded prescriber).
Coverage of Part D drugs, whether by an
MA–PD or stand-alone Part D plan, are
addressed in 423.120. As such, we
decline to add this requirement to
regulatory text. We note that the
application of these requirements to
pharmacies in Part C and not Part D is
due to the supplemental pharmacy
benefits offered by some Part C plans.
We also clarify that Part A and B drugs
are typically not dispensed by the
pharmacy under Part C but are
furnished by the Part C provider.
Comment: A commenter stated that in
its December 14 FAQ, CMS mentions
that Part D plans are expected to remove
precluded pharmacies from their
network. However, the commenter
contended, the FAQ did not furnish
additional information (including the
necessary rulemaking) for such a
decision to be made; the FAQ, the
commenter stated, merely references
‘‘future rulemaking’’ and does not
contain legal authority for such
terminations.
Response: The November 2, 2018
CMS-issued HPMS memo entitled
‘‘Preclusion List Requirements’’ (https://
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
www.cms.gov/Medicare/ProviderEnrollment-and-Certification/Medicare
ProviderSupEnroll/PreclusionList.html.)
suggests that Part D plan sponsors
remove precluded pharmacies from
their network as soon as possible. Thus,
there is no formal requirement that Part
D plan sponsors do so.
(10) Implementation Timeframe
Comment: A number of commenters
urged CMS to delay implementation of
all of the preclusion list requirements in
their entirety (including those in the
April 2018 final rule) until January 1,
2020. A commenter stated that the
preclusion list policies place an extreme
strain on plans’ resources, especially
given the end-of-year testing. Other
commenters stated that CMS has not
furnished sufficient responses to
stakeholders’ questions and has not
provided adequate guidance. This, they
contended, leaves numerous issues
open to interpretation, which will result
in beneficiary and plan confusion. To
efficiently implement these rules, these
commenters added, a delay until
January 1, 2020 is essential. Another
commenter stated that while CMS has
issued guidance regarding the
preclusion list, a significant number of
outstanding matters remain; these must
be resolved before the preclusion list
can be implemented. An additional
commenter expressed concern that the
varying effective dates (and
contradictory requirements) concerning
preclusion list implementation will
confuse beneficiaries, providers,
prescribers, and plans. This commenter
and others added that such confusion,
combined with a hasty implementation,
could also harm beneficiaries who are
unable to access medications or needed
services. Other commenters suggested
an effective date for all preclusion list
requirements that is: (1) At least 18
months after CMS publishes the
necessary technical guidance and
confirmed file layouts; (2) at least 18
months after the publication date of this
final rule; (3) at least 1 year after the
consolidation of the issues covered in
multiple CMS guidance documents; or
(4) sometime after CMS engages with
stakeholders to address outstanding
operational and logistical challenges.
Response: We appreciate these
comments and understand the
sentiments raised. We must, however,
respectfully decline to delay the
implementation of the preclusion list as
the commenters suggest. It is imperative
that the preclusion list process
commence as soon as possible so as to
protect the Medicare program and
beneficiaries from fraud, waste, and
abuse. We believe that a delay until
PO 00000
Frm 00113
Fmt 4701
Sfmt 4700
15791
January 1, 2020 or later would be
inconsistent with our obligations to
safeguard the Trust Funds and to ensure
that payments are made correctly.
Nonetheless, we will closely monitor
the preclusion list’s progress throughout
2019 and continue engaging regularly
with all stakeholders to facilitate as
smooth an implementation as possible.
Comment: While recommending a
January 1, 2020 implementation date for
all of the preclusion list requirements,
several commenters suggested that CMS
could instead exercise enforcement
discretion in 2019 against Medicare
plans for good-faith efforts they make to
implement the preclusion list rules
finalized in the April 2018 rule. A
commenter added that CMS could
refrain from sanctioning plans that fall
short of implementing the preclusion
list requirements until CY 2020. In a
similar vein, a commenter stated that
CMS should not enforce the preclusion
list requirements (1) before January 1,
2020 and (2) until CMS has released
guidance that clarifies the outstanding
operational issues.
Response: As stated, we respectfully
decline to establish a January 1, 2020
effective date for all of the preclusion
list provisions. We continue to believe
it is imperative to implement the
preclusion list requirements as soon as
possible in order to protect Medicare
beneficiaries and the Trust Funds.
Comment: A commenter urged CMS
not to implement the provisions in the
proposed rule.
Response: As explained previously,
we believe that the provisions outlined
in the proposed rule are necessary to
ensure that the preclusion list process
satisfies our program integrity objectives
without unnecessarily burdening
stakeholders.
Comment: Several commenters
supported the January 1, 2020 effective
date for the provisions in the proposed
rule.
Response: We appreciate the
commenters’ support, though we note
that our consolidated appeals provisions
will become effective 60 days after the
publication of this rule.
Comment: A commenter supported
having all of the proposed preclusion
list provisions become effective and
applicable beginning 60 days after their
publication in a final rule.
Response: While we appreciate this
comment, we would prefer to give
stakeholders until January 1, 2020 to
prepare for the provisions we are
finalizing in the rule (excluding the
consolidated appeals policy).
E:\FR\FM\16APR2.SGM
16APR2
15792
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
(11) Beneficiary Liability
Comment: A commenter expressed
concern about the potential financial
liability of beneficiaries for precluded
out-of-network providers. While
supporting the proposed requirement
that an MA contract with CMS state that
a MA enrollee must not have any
financial liability for items or services
furnished to the beneficiary by a
precluded MA-contracted individual,
the commenter noted that this would
not extend to out-of-network providers.
In addition, the commenter stated that
the proposed rule does not allow a
beneficiary to appeal a payment denial
based upon a provider’s inclusion on
the preclusion list. Coupled together,
the commenter stated, a beneficiary may
have financial liability but no
administrative recourse. Regarding
beneficiary appeals and liability,
another commenter recommended that
CMS either: (1) Allow a beneficiary to
appeal a payment denial for precluded
out-of-network providers; or (2) require
language in the proposed advance
written notice to the beneficiary of his
or her financial liability if he or she
continues to receive services from the
out-of-network provider.
Response: We thank the commenter
for the support for our proposal to
minimize enrollee liability for payments
to network providers. We are finalizing
this requirement in § 422.504(g)(1)(iv)
with several grammatical revisions; we
are adding the language ‘‘Ensure that’’ to
the beginning of the paragraph to ensure
that it properly and grammatically flows
from the closing wording of the opening
paragraph of § 422.504(g). In addition,
as previously explained, we are adding
references to ‘‘ordered,’’ ‘‘prescribed,’’
and ‘‘drugs’’ to this new paragraph in
the regulation.
In addition to the protection
described in § 422.504(g)(1)(iv), we also
proposed and are finalizing that the
prohibition on payment to a precluded
provider under § 422.222(a) must begin
only after advance written notice to
enrollees that a provider from whom the
enrollee has previously received
services is on the preclusion list. As
finalized at § 422.222(a)(1)(ii)(A), plans
are required to provide at least 60 days’
notice to enrollees within 30 days of the
posting of an updated list. We believe
this timeframe will allow enrollees
sufficient time to locate a new provider
and avoid seeking further services from
a precluded provider and any potential
financial liability that may result. We
believe that this advance written notice
and delay as to when an MA plan is
prohibited from paying a precluded
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
provider will ensure appropriate
protection of the beneficiary.
CMS believes most plans will remove
precluded providers and prescribers
from their networks upon identifying
them. Therefore, as required by
§ 422.222(a)(1)(ii)(A) and consistent
with § 422.111(e), MA plans that choose
to terminate a precluded provider must
make a good-faith effort to furnish
enrollees with at least 30 days’ advance
notice of the termination of a network
provider. Further, upon the expiration
of the 60-day period (at which point
both the provider and beneficiary have
been notified of the preclusion), if the
provider is terminated from the plan’s
network but seeks payment from the
Medicare beneficiary, the provider
would be in violation of section
1848(g)(4)(A) of the Act. If the provider
remains in the plan’s network, however,
the provider is bound to the contractual
requirements within the provider’s
contract, with the plan prohibiting the
provider from seeking payment from the
beneficiary in cases where the plan
denies requests for reimbursement due
to the provider’s precluded status.
Because the beneficiary’s liability would
be dependent on what action the plan
takes in regard to the provider’s MA
contract (for they are not required to
terminate the MA contract in order to
operationalize the payment prohibition),
we believe it would be inaccurate to add
language to the notice regarding the
beneficiary’s potential liability and
therefore decline to do so.
In addition, with respect to services
received from a non-contracting
precluded provider, the MA plan must
notify the enrollee that the provider is
precluded and include in that
notification the date on which the plan
will not pay any further claims from
that precluded provider.
Comment: A commenter stated that
CMS should clarify the point at which
MA plans should terminate providers.
The commenter explained that MA
plans may need or prefer to remain
contracted with a provider for a short
period of time for various reasons. The
commenter stated that: (1) A
requirement to terminate a contract
while payments are still being made
would unnecessarily complicate
delivery of the plan benefit; and (2)
plans should be able to retain
contractual protections for themselves
(including contractual obligations
imposed on providers and agreed-upon
pricing terms) while they are still
making payments. Moreover, the
commenter stated that allowing
termination up until denial of the
claims would conform to: (1) CMS’
requirement to notify members that a
PO 00000
Frm 00114
Fmt 4701
Sfmt 4700
plan is terminating a network provider;
and (2) similar state laws.
Response: Our final rule at § 422.222
does not require an MA plan to
terminate a provider from its network if
or when the provider is placed on the
preclusion list. Provider termination is
a decision for the MA plan. MA plans
may, however, not pay a precluded
provider for services rendered to plan
enrollees after the 60–90 day beneficiary
notification period has expired.
Comment: A commenter expressed
concern regarding the proposal that an
MAO’s contract with CMS provide that
a member shall not have any financial
liability for services or items furnished
by a contracted provider on the
preclusion list. The commenter
explained that this provision would
confront plans with inconsistent
requirements—specifically, that plans
must not pay providers’ claims while
also requiring that they hold members
harmless if the provider bills the
member. If the provider indeed does the
latter, the commenter continued, plans
might have to pay the provider (so as to
hold the member harmless); this would
conflict with the requirement not to pay
a claim. Alternatively, plans might have
to reimburse a member who has paid
the provider, effectively allowing the
provider to circumvent the preclusion
list. The commenter recommended that,
in lieu of the ‘‘hold harmless’’
provision, CMS should either: (1)
Prohibit the precluded provider from
billing or otherwise seeking payment
from the member; or (2) make the ‘‘hold
harmless’’ obligation inapplicable (i) to
services and items furnished by
precluded providers after their contracts
have been terminated or (ii) to claims
the MAO must deny under
§ 422.222(a)(1).
Response: Under § 422.222(a)(1)(ii)(C),
the MA plan may pay precluded
providers for up to 60 days after the MA
plan has notified enrollees that the
provider has been precluded. We
anticipate that MA organizations will
also use this period to assist affected
enrollees in transitioning to new
providers or, if a new primary care
provider is necessary for the enrollee to
access plan covered services, to assign
a new primary care provider to each
affected enrollee. The plan’s ability to
pay a provider for up to 60–90 days after
preclusion will not violate the MAO’s
contract with CMS and is an important
beneficiary protection. At the
conclusion of the 60-day period, the
provider will no longer be eligible for
payment from the plan and will be
prohibited from pursuing payment from
the beneficiary as stipulated by the
terms of the contract between CMS and
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
the plan per 422.504(g)(1)(iv). Therefore,
the provider would hold financial
liability for furnished, ordered, or
prescribed services and items after the
close of the 60 day period, at which
point the provider and the beneficiary
would have already received
notification of the preclusion. To
formally incorporate this policy in
regulatory text, we are also finalizing a
new paragraph (g)(1)(v) in § 422.504;
this paragraph requires that the MA
plan’s provider agreements contain a
provision acknowledging the preclusion
list requirements, prohibiting the
precluded network provider from
seeking payment from the enrollee, and
providing that the provider will hold
financial liability for any items,
services, or drugs the provider
furnishes, orders, or prescribes after the
prohibition on payment begins (i.e.,
after expiration of the 60–90 day
period). This will make clear that the
MA organization must agree to this
requirement.
If the MA organization’s participation
agreement with the precluded provider
is terminated, we recognize that the MA
organization will not have a contractual
means to prohibit the precluded
provider from seeking payment directly
from the enrollee. We encourage MA
organizations to provide sufficient
information and assistance to enrollees
so that they look for new providers from
whom to receive covered services. We
further clarify that once the 60-day
period ends and the provider’s network
contract has been terminated (at which
point both the provider and beneficiary
have been notified of the preclusion),
there is no legal mechanism to apply the
hold harmless provision nor would
CMS or the plan be able to prohibit the
provider from seeking payment from the
beneficiary.
Comment: A commenter concurred
with the proposal that the beneficiary be
held harmless for financial liability if
his or her provider is included on the
preclusion list. Noting that the policy
only applied to contracted providers,
however, the commenter stated that
members who use non-contracted
providers that are included on the
preclusion list are vulnerable to
inappropriate demands for payments
sent directly to them by unscrupulous
providers. The commenter added that
further communication and
transparency concerning all providers
on the preclusion list would help
minimize inappropriate billing.
Response: We concur with the
commenter and will work with
stakeholders, including the plans and
beneficiary groups, to consider effective
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
means of preventing the situations that
the commenter describes.
Comment: While supporting the
limitation on beneficiary liability, a
commenter encouraged CMS to expand
this protection to non-contracted
entities in the following two
circumstances: (1) When the provider
was a contracted individual or entity
prior to their preclusion but whose
contract was terminated as a result of
the preclusion; and (2) when the MA is
a PPO and offers out-of-network
coverage.
Response: As noted in the previous
response, we will work with
stakeholders regarding effective
methods to protect beneficiaries who,
through no fault of their own, receive
services from a precluded provider. We
continue to believe, however, that the
notification of enrollees and the period
available to pay precluded providers
will ensure that most MA patients of a
precluded provider will have sufficient
time to transition to a new qualified
provider who can be paid by their MA
plan. In regard to the commenter’s
suggestion of expanding the limitation
on beneficiary liability, we note that
once a provider’s network contract is
terminated, there is no legal mechanism
to apply the hold harmless provision
nor would CMS or the plan be able to
prohibit the provider from seeking
payment from the beneficiary.
(12) Appeals
Comment: Several commenters
expressed support for the proposals to:
(1) Shorten the preclusion list appeal
timeframe from 9 months to 5 months;
and (2) place providers and prescribers
on the preclusion list after their first
level of appeal. In both of these cases,
a commenter stated, CMS has taken
common sense steps to reduce
administrative burden on MAOs and
Part D plans, to ensure that precluded
providers and prescribers do not
continue to provide care and/or
prescribe medications, and to consider
the best interests of beneficiaries.
Response: We appreciate the
commenters’ support.
Comment: A commenter stated that
notwithstanding the proposal that
beneficiaries may not appeal a payment
denial based on their provider’s or
prescriber’s preclusion, CMS recently
issued different guidance. Specifically,
the commenter stated that in a
December 14 FAQ, CMS declined to
inform beneficiaries of their lack of
appeal rights but stated that an enrollee
may seek a coverage decision from the
plan if there is a question regarding
coverage for an item, service, or drug.
PO 00000
Frm 00115
Fmt 4701
Sfmt 4700
15793
The commenter accordingly sought
clarification on a number of issues: (1)
Whether enrollees will be permitted to
appeal the denial of a claim (due to a
provider’s preclusion) during CY 2019
given that beneficiary appeals were not
addressed in the April 2018 final rule
applicable to CY 2019; (2) if the answer
to the prior issue is yes, how CMS
intends to notify beneficiaries of the
change in policy for CY 2020; (3)
whether, based on the language in the
December 14 FAQ, the determination of
a provider’s preclusion constitutes a
coverage decision that is subject to
standard appeal rights; and (4) whether
a beneficiary who did not receive notice
that his or her provider was excluded
and accordingly continued to use that
provider could appeal the denial of the
claim. Another commenter also raised
the first, second, and fourth issues,
while questioning whether the
beneficiary can at least appeal the
denial of the claim (given that he or she
cannot appeal the provider’s preclusion
status).
Response: We clarify that the cited
guidance was issued based on the April
2018 final rule. Therefore, that guidance
is not fully applicable to this final rule
and the amendments we are making to
§§ 422.222 and 423.120.
A Part D claim that is rejected at the
point-of-sale does not constitute a
coverage determination; thus, there are
no Part D appeal rights. As with claims
from prescribers on the OIG exclusion
list, a claim rejected at point-of-sale
because the prescriber is on the
preclusion list does not return the 569
reject code. In other words, the network
pharmacy does not deliver the
pharmacy notice that instructs an
enrollee how to request a coverage
determination. As previously noted in
this preamble, a claim rejection at pointof-sale due to preclusion is not a Part D
coverage determination, so the enrollee
would not have appeal rights. This
having always been the case, nothing
has changed between CY 2019 and CY
2020. As previously stated in this
preamble, we are finalizing
§ 422.222(a)(4) to state that a beneficiary
enrolled in an MA plan (or a cost plan
or PACE organization under the
incorporation of the MA regulation into
those programs at §§ 417.478 and
460.86) will not be able to appeal a
payment denial that is based on an
individual or entity’s placement on the
preclusion list.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15794
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
Finally, we note that
§ 422.222(a)(1)(ii)(A), as amended by
this final rule, requires an MA plan to
issue a notice to affected enrollees when
a provider is placed on the preclusion
list. The prohibition on payment will
begin the earlier of 60 days after this
notice or 90 days after the provider was
placed in the preclusion list. An MA
plan that fails to provide the notices
required by this regulation will be in
violation of its responsibilities such that
CMS may take necessary enforcement
action.
Comment: A commenter supported
making the proposed appeals process
effective 60 days after publication of
this final rule.
Response: We appreciate the
commenter’s support.
Comment: A commenter urged CMS
to permit limited beneficiary appeals of
denials of claims based upon a provider
or prescriber’s preclusion. The
commenter stated that if the beneficiary
notice required at § 422.222(a)(1)(ii)(A)
described previously was incomplete or
ineffective, the beneficiary should not
be responsible for payment. The
commenter added that CMS should
consider mechanisms to protect
beneficiaries from liability in such
circumstances.
Response: Under the regulation we
are finalizing at § 422.222(a)(4), denials
of payment based on a provider’s or
prescriber’s preclusion cannot be
resolved through the beneficiary appeals
process as outlined in Subpart M of 42
CFR part 423. If payment is denied
because of the prescriber’s or provider’s
preclusion, the enrollee should find
another provider in the area to furnish
these services and to contact the plan if
assistance is needed. (This is explained
in the beneficiary notice.) Further, a
request for payment by a contract
provider where an enrollee is held
harmless does not constitute an
organization determination.
Concerning an incomplete or
ineffective notice, the provider or
prescriber would still have been made
aware of the preclusion. Indeed, this
further supports our rationale for
allowing claims to be paid without
penalty for 60 days following the
issuance of the notice to the beneficiary.
In regard to Part C, following the 60day period and once a provider’s
network contract is terminated, there is
no legal mechanism to apply the hold
harmless provision nor would CMS or
the plan be able to prohibit the provider
from seeking payment from the
beneficiary if the provider is terminated
from the plan’s network. However, if the
provider remains in the plan’s network,
the provider must comply with
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
contractual requirements prohibiting the
provider from seeking payment from the
beneficiary in cases where the plan
denies requests for reimbursement due
to the provider’s precluded status.
We are finalizing our proposed
changes concerning appeals with one
exception. We are deleting the phrase
‘‘by CMS’’ in proposed
§ 422.222(a)(2)(ii)(B) and
§ 423.120(c)(6)(v)(B)(2). This is to clarify
that Administrative Law Judges and the
Department of Appeals Board, which, as
applicable, consider the appeals in
question, are not part of CMS.
(13) Miscellaneous Comments
Comment: A commenter suggested
that the relevant notice provisions and
payment preclusions in § 422.222(a)(1)
be referenced in the PACE regulation by
including an explicit cross reference in
§ 460.86. This would, the commenter
stated, ensure that PACE organizations
know where in the CFR to find more
detailed requirements related to the
preclusion list.
Response: We appreciate this
comment and may consider it for future
rulemaking. At this time, we believe
that the PACE regulation is sufficient.
We explained in the April 2018 final
rule, in our proposed rule, and in this
final rule how the requirements in
§ 422.222 are incorporated into the
requirements for the PACE program.
Comment: A commenter supported
the discretion given to plans to not
include a particular prescriber on the
preclusion list when CMS determines
that exceptional circumstances exist
regarding beneficiary access to
prescriptions. The commenter
recommended that CMS also provide
similar discretion to MA plans when
CMS determines the previously
referenced exceptional circumstances
exist.
Response: We clarify that only CMS
has the discretion not to place a
provider on the preclusion list due to
access to care concerns. Plans can notify
CMS if they believe there will be access
to care issues by removing a particular
provider from their network, and CMS
will notify the plan of its determination
regarding the preclusion. Nonetheless,
we agree with the commenters’ general
rationale that an exception should be
made for MA regarding access to care
concerns. We are therefore adding a new
paragraph (a)(6) to § 422.222 that
mirrors the access to care exception
provided at § 423.120(c)(6)(vi);
specifically, CMS will have the
discretion not to include a particular
individual or entity on (or, if warranted,
remove the individual from) the
preclusion list should it determine that
PO 00000
Frm 00116
Fmt 4701
Sfmt 4700
exceptional circumstances exist
regarding beneficiary access to MA
items, services, or drugs. In making a
determination as to whether such
circumstances exist, CMS takes into
account: (i) The degree to which
beneficiary access to MA services,
items, or drugs would be impaired; and
(ii) any other evidence that CMS deems
relevant to its determination.
Comment: Concerning the 10-year
period for the preclusion list, a
commenter recommended that CMS set
a lower default preclusion period of 3
years and use aggravating or mitigating
factors to adjust the period as
applicable. The commenter was
concerned that under the proposed rule,
any felony conviction automatically
defaults to a 10-year preclusion period.
Consistent with the March 1, 2016
proposed rule published in the Federal
Register titled ‘‘Medicare, Medicaid,
and Children’s Health Insurance
Programs; Program Integrity
Enhancements to the Provider
Enrollment Process’’ (CMS–6058–P), the
commenter stated that the 10-year
period should be maximum, not
mandatory, unless the party in question
is excluded by the OIG for a longer
period. The commenter stated that the
10-year default period is greater than the
OIG mandatory exclusion of 5 years and
the general default of 3 years of
permissive exclusions. Moreover, the
commenter stated, OIG mandatory
exclusions only cover specific conduct
and not all felonies. The commenter
added that CMS should provide
parameters regarding what types of
felonies fall under this section; the
commenter stated that this would be
consistent with felony determinations
under § 424.535(a)(3).
Response: We note that our proposed
provisions do not automatically require
a 10-year preclusion list period for every
felony conviction. Under proposed
§ 423.120(c)(6)(vii), for instance, a 10year period will be used unless CMS
determines that a shorter timeframe is
warranted based upon CMS’
consideration of several factors. In each
case, CMS will examine whether a
period of less than 10 years is justified.
Insofar as the types of felonies that may
come within the purview of these
provisions, we will consider further
clarification via sub-regulatory
guidance.
Comment: Several commenters stated
that, according to their understanding,
CMS would undertake a three-step
process for implementing the preclusion
list: (1) Beginning on January 1, 2019,
the preclusion list will go into effect
without the proposals outlined in the
proposed rule; (2) 60 days following
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
publication of CMS–4185–F, Medicare
plans will be required to implement the
new consolidated appeals provisions;
and (3) any other changes in the
proposed rule that are eventually
finalized will not become effective until
January 1, 2020. The commenters
expressed several concerns about this
process. First, they believed that it
saddles Medicare plans with managing
multiple deadlines and effective dates
despite long-term planning already
underway. Second, the process involves
changing and uncertain rules, which
could confuse stakeholders (including
beneficiaries) as to which policies apply
at which time (for example, a
beneficiary may be uncertain as to
whether or when he or she has appeal
rights); this, the commenters believed,
could interrupt beneficiary care and
cause beneficiary frustration with their
Medicare plans and providers.
Response: While we appreciate the
commenters’ concerns, we stress that we
have worked very closely with the plans
and other stakeholders to: (1) Prepare
them for the preclusion list’s
implementation; and (2) develop subregulatory guidance to address their
questions. We are closely and diligently
monitoring the progress of the
implementation. We will continue
regular communication with
stakeholders and expeditiously address
issues if or as they develop.
Comment: A commenter stated that
the previously mentioned HPMS memo
sought to impose requirements that go
beyond the provisions of the April 2018
final rule. The commenter contended
that: (1) These additional requirements
must be promulgated through noticeand-comment rulemaking; and (2) CMS
should withdraw the HPMS memo and/
or clarify that it does not create binding
requirements.
Response: We respectfully disagree.
The HPMS memo focuses on
operational details that are most
appropriately developed and
disseminated through sub-regulatory
guidance.
Comment: Several commenters
supported CMS’ elimination of the
provider enrollment requirements for
MA providers and Part D prescribers.
Response: We appreciate the
commenters’ support.
Comment: A number of commenters
supported the implementation of the
preclusion list requirements as a whole.
Response: We appreciate the
commenters’ support.
Comment: Numerous commenters
stated that CMS must work with the
industry and other stakeholders to help
ensure smooth execution of the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
preclusion list with as little disruption
in beneficiary care as possible.
Response: We agree with the
commenters. We have worked closely
with stakeholders to ensure an effective
implementation of the preclusion list
and will continue to do so.
Comment: Several commenters stated
that CMS must make certain that the
preclusion list: (1) Is updated frequently
to minimize the time between when a
provider is precluded and the time that
information is available to plans and
providers; and (2) contains information
needed to properly identify a precluded
prescriber (for example, an NPI).
Response: We agree with the
commenters. We are striving to ensure
that preclusion list updates are
appropriately made and that the
preclusion list file contains sufficient
identifying data.
Comment: A commenter questioned
whether Medicare plans will be limited
in the number of users granted access to
the preclusion list. The commenter
stated that PBMs that process and pay
claims and others need access to this
file. Although the commenter contended
that CMS indicated in its December 14
sub-regulatory guidance that it will not
grant access to the preclusion list to
PBMs, the commenter urged CMS to
reconsider this position, perhaps by
making the preclusion list public.
Response: We state respectfully that
CMS will not make the preclusion list
public. The list contains sensitive data
(such as revoked provider information),
and CMS historically has not shared this
information publicly. Nonetheless, CMS
is exploring secure means (other than
public release) to make the data
available to PBMs and other plan
subcontracted entities.
Comment: A commenter
recommended that CMS work with
plans to develop an automated process
so that preclusion list requirements can
be better implemented and
operationalized.
Response: We are always receptive to
plan feedback regarding file delivery
and format. We are available to work
with plans to implement enhancements
that would make the process more
efficient. We believe, however, that such
enhancements are best considered once
a baseline has been implemented by the
applicable deadline.
Comment: A commenter urged CMS
to encourage plans to educate
beneficiaries about the preclusion list so
that the latter understand the concept
before they perhaps encounter it.
Response: We agree and have indeed
suggested that plans educate their
enrollees regarding the preclusion list
for the reason the commenter states.
PO 00000
Frm 00117
Fmt 4701
Sfmt 4700
15795
Comment: A commenter questioned
whether there will be a link to the
preclusion list or whether CMS will
transmit the list to plans and MA
organizations.
Response: Plans are granted access to
the list via a secure website and file
transfer process.
Comment: A commenter encouraged
CMS to be flexible in overseeing and
enforcing the preclusion list, for
stakeholders have been using their best
efforts to comply with the changing
requirements and need time to
acclimate to the new processes.
Response: We appreciate this
comment and recognize that
stakeholders have been making efforts to
prepare for the preclusion list’s
implementation. We will closely
monitor the progress of this
implementation.
Comment: A commenter contended
that the proposed changes (especially
the reduced timeline for the mandatory
denial of claims) will cause several
difficulties without enhancing program
integrity. First, they will significantly
increase plan administrative costs.
Second, beneficiaries could be harmed
due to disruptions in their medication.
Third, beneficiaries could become
dissatisfied with the timeframes in
which they must seek a new provider.
Fourth, the proposed rule contains no
protections that could mitigate the
above-referenced problems. The
commenter accordingly recommended
that CMS retain the standards
established in the April 2018 final rule
and engage MAOs (and other
stakeholders) in developing means of
aligning preclusion list processes with
those for the OIG exclusion list.
Response: While we appreciate the
commenter’s concerns, we believe the
changes in this rule facilitate a more
patient-minded approach. We reiterate
that enrollees will have 60–90 days’
prior notification that their provider is
precluded. During that period, claims
and prescriptions associated with the
precluded provider can be paid by the
Part C or D plan. This will give the
enrollee time to transfer to a new, nonprecluded provider. Indeed, we note
that Part C and D plans are currently
prohibited from paying for claims and
prescriptions associated with excluded
providers. The additional administrative
burden for a plan to check the
preclusion list is not, in our view, a
significant new requirement. While this
rule establishes a beneficiary notice
timeframe, we have simultaneously
streamlined the date that a plan is to
reject/deny claims for each version of
the monthly preclusion list, rather than
require plans to track timeframes for
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15796
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
rejections/denials on a beneficiary basis.
If plans were required to implement the
preclusion list in the manner that the
OIG exclusion list is operationalized,
there may be no beneficiary notification
period. For these reasons, we
respectfully decline to adopt the
commenter’s suggestion.
Comment: A commenter stated that
there is insufficient technical guidance
for dual-eligible special needs plans (D–
SNPs), their PBMs, and other delegated
entities to sufficiently test and
implement the preclusion list process
by January 1, 2019. The commenter
urged CMS to extend the first review
period for D–SNPs to at least 180 days;
this would enable D–SNPs and CMS to
ensure that systems are appropriately
configured and operational policies
established prior to any payment
denials.
Response: We believe that the
commenter is suggesting a minimum
180-day delay in the implementation of
the preclusion list as a whole. As stated
previously, we respectfully decline to
do so. However, we will work closely
with D–SNPs concerning this
implementation and will issue subregulatory guidance to assist D–SNPs in
this regard.
Comment: A commenter questioned
whether any of the fields are
conditionally required (for example,
whether a date of birth for businesses or
an EIN is required).
Response: CMS will issue subregulatory guidance on this issue as
soon as feasible.
Comment: A commenter questioned
whether there is a communication
process for questionable data records
(for example, for missing required fields
such as an NPI or a missing effective
date).
Response: CMS has issued subregulatory guidance that clarifies the
process for communicating questionable
data records. It can be accessed at the
following link: https://www.cms.gov/
Medicare/Provider-Enrollment-andCertification/MedicareProvider
SupEnroll/PreclusionList.html.
Comment: A commenter sought
clarification as to when PDE guidance
will be available.
Response: We refer the commenter to
the PDE guidance issued in the
previously referenced HPMS
memorandum, ‘‘February 2019 Updates
to the Drug Data Processing System
(‘‘DDPS’’),’’ dated January 8, 2019 and
released January 9, 2019.
Comment: A commenter stated that
the proposed rule lacks a ‘‘look-back’’
period indicating which plan members
must be notified of a precluded
provider. The commenter recommended
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
that CMS revise proposed
§§ 422.222(a)(1)(ii)(A) and
423.120(c)(6)(iv)(A) to clarify that plans
need only notify a member who has
received services from a precluded
provider in the 12 months prior to the
date the provider was added to the
preclusion list. Codifying a ‘‘look back’’
period in regulation, rather than merely
via sub-regulatory guidance, will
provide clarity to plans.
Response: While we appreciate this
suggestion, we respectfully decline to
establish a formal look-back period in
this rule. We must retain the flexibility
(especially during the early stages of the
preclusion list’s implementation) to
carefully monitor the program and to
make any revisions (such as a look-back
period) only after a careful deliberation.
Comment: Several commenters stated
that CMS should clarify each of the
provider types and specialties that will
be on the list.
Response: We appreciate this
comment and may consider furnishing
such clarification, as needed, in
subregulatory guidance.
Comment: Several commenters
recommended that CMS detail the data
sources used to place dentists who have
never enrolled in Medicare on the
preclusion list.
Response: Using CMS’ internal data
and systems (which includes, but is not
limited to, the Provider Enrollment,
Chain, and Ownership System and the
National Plan and Provider
Enumeration System), we will screen
any prescriber or provider that could
potentially prescribe Part D drugs or
furnish MA services or items to a
Medicare beneficiary through an MA
plan.
Comment: Several commenters
recommended that when CMS notifies
providers that they are precluded, CMS
should require those providers to inform
patients that they do not accept
Medicare beneficiaries and that their
claims will not be processed. A
commenter believed that this approach
would be particularly appropriate if
there is no claim history (for example,
new patient or referral) and thus no
ability for plans to notify beneficiaries.
Response: We appreciate this
comment and may consider it for future
rulemaking as appropriate.
Comment: Several commenters urged
CMS to clarify whether urgent and
emergency services are exempt from the
requirement that MA plans and
delegated entities deny claims for
services furnished by precluded
providers.
Response: Urgent and emergency
services are not exempt from the claim
denial requirements of § 422.222.
PO 00000
Frm 00118
Fmt 4701
Sfmt 4700
Comment: A commenter expressed
support for the proposals to add
language to the regulatory text
concerning the following policies: (1)
Beneficiaries may not appeal payment
denials based on a provider’s
preclusion; and (2) unenrolled
prescribers and providers should remain
precluded for the same length of time as
the reenrollment bar that CMS could
have imposed had that prescriber or
provider been enrolled and then
revoked.
Response: We appreciate the
commenter’s support.
Comment: A commenter contended
that CMS’ proposed changes to its
preclusion list policies would create
additional complexities and be of
limited value. The commenter added
that the separately required beneficiary
notices (and the claims denial deadlines
triggered thereby) are inconsistent with
CMS’ goal of operationalizing the
preclusion list in the same manner as
the OIG exclusion list. Under the
exclusion list process, the commenter
stated, CMS makes the exclusion list
public, updates it monthly, posts it 15
days prior to the exclusion effective
date, and expects plans to deny claims
as of the effective date. The commenter
suggested that CMS make the preclusion
list public and implement it similar to
the exclusion list. This approach, the
commenter believed, would alleviate
inconsistencies and stakeholders’
concerns.
Response: For reasons stated
previously, CMS is unable to make the
preclusion list public. Moreover, we do
not believe it is possible to implement
the preclusion list in a fashion that
mirrors the OIG exclusion list. We
believe that the preclusion list, upon
full implementation, will impact a
much larger provider population than
the OIG exclusion list, for the intent of
the preclusion list was to create an
effective alternative to enrollment. The
criteria for a provider to become
precluded are therefore different and
broader than those for exclusion. For
this reason, we believe the beneficiary
notice period is essential to protect
beneficiaries from major disruptions of
care. We note also that CMS has added
data fields to the file to increase
consistency between the notification
period and the claims rejection/denial
date.
Comment: A commenter questioned
whether a provider must inform
beneficiaries if they learn that another
provider has been excluded. The
commenter cited the example of a
beneficiary who attempts to fill a
prescription at a pharmacy retail
location and the prescription is denied
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
due to the provider being excluded. The
commenter sought clarification
concerning the pharmacy’s
responsibility (if any) to notify the
beneficiary of the excluded provider.
Response: We appreciate this
comment but believe it is outside the
scope of this rule.
Comment: Several commenters noted
that in an FAQ issued December 14,
2018 (see (https://www.cms.gov/
Medicare/Provider-Enrollment-andCertification/MedicareProvider
SupEnroll/PreclusionList.html.), CMS
stated that subcontractors will not be
granted access to the preclusion list and
that MAOs will have to share the list
with subcontractors as needed. Some
subcontractors, the commenters noted,
process all claims and credentialing
activities, which makes direct access to
the preclusion list imperative. Without
such access, the commenters stated,
downstream entities will have to work
through MA organizations, which could
delay enrollee notification. In sum, the
commenters requested that: (1)
Subcontractors and delegated entities be
provided access to the preclusion list;
and (2) the enforcement date for
subcontractors to use the preclusion list
be delayed until subcontractors have
access to it.
Response: As explained earlier, CMS
is unable to publicize preclusion data.
However, CMS is exploring other secure
means of making the data available to
PBMs and other plan subcontracted
entities. We must, however, respectfully
decline to delay the implementation of
the preclusion list as the commenter
suggests.
d. Final Provisions
Given the foregoing, we are finalizing
all of our proposed preclusion list
provisions as proposed except as
follows:
• Our proposed revisions to
§ 423.120(c)(6)(i), (ii), and (vi) that
would change the term ‘‘individual’’ to
‘‘prescriber’’ will not be finalized.
• Our proposed change of the phrase
‘‘individual NPI of the prescriber’’ to
‘‘NPI of the prescriber’’ in
§ 423.120(c)(6)(iii) will not be finalized.
• In § 422.222(a)(1)(i), we are
changing the language ‘‘health care item
or service furnished’’ to ‘‘health care
item, service, or drug that is furnished,
ordered, or prescribed’’. We are making
similar edits to § 422.222(a)(1)(ii)(A) and
(C) and to § 422.504(g)(1)(iv);
specifically, we will include therein, as
applicable, references to ‘‘ordered,’’
‘‘prescribed,’’ and ‘‘drugs.’’
• We are deleting the phrase ‘‘by
CMS’’ in proposed § 422.222(a)(2)(ii)(B)
and § 423.120(c)(6)(v)(B)(2). This is to
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
clarify that Administrative Law Judges
and the Department of Appeals Board
(which would, applicable, consider the
appeals in question jointly) are not part
of CMS.
• We are clarifying the opening
paragraphs of §§ 423.120(c)(6)(iv) and
422.222(a)(1)(ii) to state that
§§ 423.120(c)(6)(iv) and 422.222(a)(1)(ii)
do not apply if the prescriber or
provider is currently excluded by the
OIG.
• We are revising
§§ 423.120(c)(6)(iv)(B) and
422.222(a)(1)(ii)(B) as follows:
++ The existing versions of these
paragraphs will be incorporated into
new paragraphs
§§ 423.120(c)(6)(iv)(B)(1) and
422.222(a)(1)(ii)(B)(1), respectively.
Also, we are inserting the following
language at the beginning of these
respective new paragraphs: ‘‘Subject to
paragraph (c)(6)(iv)(B)(2) of this section’’
and ‘‘Subject to paragraph (a)(1)(ii)(B)(2)
of this section’’.
++ In new paragraphs
§§ 423.120(c)(6)(iv)(B)(2) and
422.222(a)(1)(ii)(B)(2), we will state that
paragraph (B)(1) will apply only upon
receipt of a claim from, respectively, a
precluded provider (either contracted or
non-contracted) in Medicare Part C or
upon a prescriber writing a prescription
in Medicare Part D when: (i) The MA
organization or plan sponsor has enough
information on file to either copy the
provider or prescriber on the
notification previously sent to the
beneficiary or send a new notice
informing the provider or prescriber that
they may not see plan beneficiaries due
to their preclusion status; and (ii) the
claim is received after the claim denial
or reject date in the preclusion file.
• To clarify the applicability of
§ 422.222, we are changing the title of
this section from ‘‘Preclusion list’’ to
‘‘Preclusion list for contracted and noncontracted individuals and entities.’’
• We are adding a new paragraph
(a)(6) to § 422.222 that would mirror the
existing version of § 423.120(c)(6)(vi)
and state as follows:
++ The opening paragraph will read:
‘‘CMS has the discretion not to include
a particular individual or entity on (or,
if warranted, remove the individual or
entity from) the preclusion list should it
determine that exceptional
circumstances exist regarding
beneficiary access to MA items,
services, or drugs. In making a
determination as to whether such
circumstances exist, CMS takes into
account’’
++ Paragraph (a)(6)(i) will read: ‘‘The
degree to which beneficiary access to
PO 00000
Frm 00119
Fmt 4701
Sfmt 4700
15797
MA items, services, or drugs would be
impaired; and
++ Paragraph (a)(6)(ii) will read: ‘‘Any
other evidence that CMS deems relevant
to its determination.’’
++ We are adding the language
‘‘Ensure that’’ to the beginning of
§ 422.504(g)(1)(iv).
++ We are adding a new
§ 422.504(g)(1)(v) that would state as
follows: ‘‘Ensure that the plan’s
provider agreement contains a provision
stating that after the expiration of the
60-day period specified in § 422.222:
—The provider will no longer be
eligible for payment from the plan
and will be prohibited from pursuing
payment from the beneficiary as
stipulated by the terms of the contract
between CMS and the plan per
§ 422.504(g)(1)(iv); and
—The provider will hold financial
liability for services, items, and drugs
that are furnished, ordered, or
prescribed after this 60-day period, at
which point the provider and the
beneficiary will have already received
notification of the preclusion.’’
D. Implementing Other Changes
1. Clarification Regarding Accreditation
for Quality Improvement Programs
Section 1852(e)(4) of the Act requires
the Secretary to deem that an MA
organization has met all of the
requirements for any one out of the six
program areas listed in section
1852(e)(4)(B) of the Act if the MA
organization is accredited in that area by
an accrediting organization that has
been approved by CMS and that uses
the same (or stricter) standards than
CMS uses to evaluate compliance with
the applicable requirements. An
amendment to the Act to revise
subsection (e) made by section 722(a) of
the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 appears not to have been fully
incorporated into the provisions
governing the authority to deem
compliance with section 1852(e)(3) of
the Act by an MA organization based on
accreditation by an approved
accreditation entity. We direct readers
to the proposed rule for additional
discussion (83 FR 55041). In the
proposed rule, we clarified that an MA
organization may be deemed to have
satisfied the requirements of section
1852(e)(3) of the Act and the paragraphs
of § 422.152 related to section 1852(e)(3)
of the Act based on the review of an
approved accreditation organization. We
received one comment thanking us for
the clarification. We will implement the
clarified scope of the regulation going
forward.
E:\FR\FM\16APR2.SGM
16APR2
15798
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
2. Delete the Reference to Quality
Improvement Projects in § 422.156(b)(1)
Section 1852(e) of the Act requires
each MA organization to have an
ongoing Quality Improvement (QI)
Program for the purpose of improving
the quality of care provided to its
enrollees. Our regulations at § 422.152
outline the QI Program requirements
MA organizations. Section 422.152(a)(3)
requires each MA organization to
conduct quality improvement projects
(QIPs) for its enrollees, and § 422.152(d)
establishes the requirements for the
QIPs. Effective January 1, 2019, CMS
eliminated the requirements for QIPs in
§§ 422.152(a)(3) and 422.152(d) in the
April 2018 final rule (83 FR 16440).
However, the reference to QIPs was not
deleted in § 422.156(b)(1), which says
QIPs are exempt from the process for
deeming compliance based on
accreditation.
We proposed a technical correction
that would delete the phrase ‘‘the
quality improvement projects (QIPs)
and’’ from § 422.156(b)(1). We did not
receive any comments on the proposal.
We are finalizing the technical
correction without modification in this
final rule. We direct readers to the
proposed rule for additional discussion
(83 FR 55041).
III. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. 3501 et seq.),
we are required to provide 30-day notice
in the Federal Register and solicit
public comment before a ‘‘collection of
information,’’ as defined under 5 CFR
1320.3(c) of the PRA’s implementing
regulations, is submitted to the Office of
Management and Budget (OMB) for
review and approval. In order to fairly
evaluate whether an information
collection requirement (ICR) should be
approved by OMB, section 3506(c)(2)(A)
of the PRA requires that we solicit
comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
In the November 1, 2018 (83 FR
54982) proposed rule, we solicited
public comment on our proposed
information collection requirements,
burden, and assumptions. As discussed
in section III.B.1. of this final rule, we
received comments pertaining to
Evidence of Coverage (EOC)
notifications and provider directory
requirements. Based on internal review,
we have revised several cost estimates
(see Wage Data). As explained in section
III.B.4. of this final rule, we have also
added burden related to Medicare Parts
A and B claims data extracts.
A. Wage Data
To derive average costs, we used data
from the U.S. Bureau of Labor Statistics’
(BLS’s) May 2017 National
Occupational Employment and Wage
Estimates for all salary estimates (https://
www.bls.gov/oes/current/oes_nat.htm).
In this regard, Table 2 presents the mean
hourly wage, the cost of fringe benefits
and overhead (calculated at 100 percent
of salary), and the adjusted hourly wage.
The adjusted wages are used to derive
our cost estimates.
TABLE 3—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES
Occupation
code
khammond on DSKBBV9HB2PROD with RULES2
Business Operation Specialist .........................................................................
Lawyer .............................................................................................................
Software Developers and Programmers .........................................................
As indicated, we are adjusting our
employee hourly wage estimates by a
factor of 100 percent. This is a necessary
rough adjustment, both because fringe
benefits and overhead costs vary
significantly from employer to employer
and because methods of estimating
these costs vary widely from study to
study. We believe that doubling the
hourly wage to estimate total cost is a
reasonably accurate estimation method.
While we did not receive any public
comments pertaining to our proposed
wage estimates, based on internal
review we have changed our proposed
Programmer respondent type (BLS
occupation code 15–1311 at $40.95/hr)
to Software Developers and
Programmers (BLS occupation code 15–
1130 at $49.27/hr). The change adds
$8.32/hr (mean) to our proposed
Programmer-specific cost estimates and
$16.64/hr (adjusted). The change affects
sections III.B.2.a.(2), III.B.2.b.(2), and
III.B.3.a.(2) of this final rule.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
13–1199
23–1011
15–1130
We have also corrected the
occupation code for Business
Operations Specialists from 13–000 to
13–1199. This correction adds $1.88/hr
(mean) to our proposed Business
Operations Specialist-specific cost
estimates and $3.76/hr (adjusted). The
change affects sections III.B.2.a.(2),
III.B.2.b.(2), III.B.3.a.(1), and III.B.4. of
this final rule.
We are not making any changes to the
proposed Lawyer respondent type (BLS
occupation code 23–1011 at $68.22/hr
(mean) and $136.44/hr (adjusted)).
B. Information Collection Requirements
(ICRs)
The following ICRs are listed in the
order of appearance in section II. of this
final rule.
PO 00000
Frm 00120
Fmt 4701
Sfmt 4700
Mean hourly
wage
($/hr)
$36.42
68.22
49.27
Fringe
benefits and
overhead
($/hr)
$36.42
68.22
49.27
Adjusted
hourly wage
($/hr)
$72.84
136.44
98.54
1. ICRs Regarding the Requirements for
Medicare Advantage Plans Offering
Additional Telehealth Benefits
(§ 422.135)
As described in section II.A.1. of this
final rule, section 50323 of the
Bipartisan Budget Act of 2018 allows
MA plans the ability to provide MA
additional telehealth benefits to
enrollees starting in plan year 2020 and
treat them as basic benefits. In this rule,
we are finalizing—with slight
modifications—most proposed
requirements at § 422.135, which will
authorize and set standards for MA
plans to offer MA additional telehealth
benefits. More specifically, we are
finalizing our requirement that MA
plans must advise enrollees that they
may receive the specified Part B
service(s) either through an in-person
visit or through electronic exchange
(§ 422.135(c)(2)). As discussed in
section II.A.1. of this final rule, based on
public comments we are not finalizing
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
the portion of proposed § 422.135(c)(2)
that referenced the EOC document as
the required vehicle for this notification.
Instead, we intend to address the EOC
in future sub-regulatory guidance.
MA plans will be required to make
information about the coverage of
additional telehealth benefits available
to CMS upon request (finalized at
§ 422.135(c)(4)). We do not anticipate
requesting this information from more
than nine MA plans in a given year
because historically we have not
received a large number of complaints
about coverage of benefits that might
warrant our request for information
from many plans. However, we reserve
the right to ask for this information.
Since we estimate fewer than 10
respondents, the information collection
requirement is exempt (5 CFR 1320.3(c))
from the requirements of the PRA.
As discussed in section II.A.1. of this
final rule, based on public comments we
are not finalizing our proposed provider
directory requirements under proposed
§ 422.135(c)(3). We have therefore
modified our discussion of potential
information collection requirements and
assumptions related to provider
directories, as it is no longer necessary
to address them in the context of this
final rule. Similar to the EOC, we intend
to address the provider directory in
future sub-regulatory guidance.
This final rule is consistent with our
proposed rule in that neither set out any
burden related to MA plans offering MA
additional telehealth benefits.
2. ICRs Regarding Integration
Requirements for Dual Eligible Special
Needs Plans (§ 422.107)
The following requirements and
burden will be submitted to OMB for
approval under control number 0938–
0753 (CMS–R–267).
As described in section II.A.2.a. of
this final rule, we are establishing new
requirements in accordance with
amendments to section 1859(f)(8) of the
Act (made by section 50311(b) of the
Bipartisan Budget Act of 2018), which
stipulates that all dual eligible special
needs plans (D–SNPs) meet certain new
minimum criteria for Medicare and
Medicaid integration for 2021 and
subsequent years. We are also codifying
the various forms of integrated care
provided by D–SNPs that have evolved
since their establishment nearly 15
years ago.
In § 422.107(d), any D–SNP that is not
a fully integrated dual eligible special
needs plan (FIDE SNP) or a highly
integrated dual eligible special needs
plan (HIDE SNP), as defined in § 422.2,
will be subject to an additional
contracting requirement. Under the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
additional contracting requirement, the
D–SNP must notify the state Medicaid
agency and/or individuals or entities
designated by the state Medicaid agency
of hospital and skilled nursing facility
(SNF) admissions for at least one group
of high-risk full-benefit dual eligible
individuals, as determined by the state
Medicaid agency.
In addition, we are modifying existing
requirements for the contract between
states and D–SNPs at § 422.107(c). The
modifications will include requirements
that the contract between the D–SNP
and the state: (1) Document the D–SNP’s
responsibility to coordinate the delivery
of Medicaid benefits for individuals
who are eligible for such services and,
if applicable, to provide coverage of
Medicaid services for those eligible; (2)
specify the categories and criteria for
eligibility for dual eligible individuals
to be enrolled in the plan; and (3)
specify the Medicaid benefits covered
by the MA organization offering the D–
SNP under a capitated contract with the
State Medicaid agency or by the D–
SNP’s parent organization or another
entity that is owned and controlled by
its parent organization. We are also
finalizing a new requirement that the
contract between a D–SNP that is an
applicable integrated plan, as defined in
§ 422.561, and the state document the
D–SNP’s use of the unified appeals and
grievance procedures required under
§§ 422.629 and 422.630, 438.210,
438.400, and 438.402, as finalized in
this rule.
The primary burden arising from the
modifications to the contracting
provisions between states and D–SNPs
will consist of the following:
• Burden to states to—
++ Execute D–SNP contract
modifications regarding new and
modified requirements under
§ 422.107(c) and the notification
requirement at § 422.107(d), as detailed
in section II.A.2.a.(2). of this final rule;
and
++ Establish the terms of the
notification at § 422.107(d), including
its method, timing, and scope, and
receive such notification from D–SNPs
about high-risk enrollees’ hospital and
SNF admissions (if the state contracts
with D–SNPs that are not FIDE SNPs or
HIDE SNPs, as those terms are defined
in § 422.2).
• Burden to D–SNPs to—
++ Execute a contract modification
with the state Medicaid agency
regarding new and modified
requirements under § 422.107(c) and the
notification requirement at § 422.107(d),
as detailed in section II.A.2.a.(2). of this
final rule; and
PO 00000
Frm 00121
Fmt 4701
Sfmt 4700
15799
++ Notify the state Medicaid agency
or its designee(s) about the hospital and
SNF admissions for the state-identified
population of high-risk enrollees (if the
D–SNP is not a FIDE SNP or HIDE SNP,
as those terms are defined in § 422.2).
a. Burden to States
(1) Contract Modifications With D–SNPs
(§ 422.107)
For the initial year, we expect it will
take 24 hours at $136.44/hr for a lawyer
to update the state Medicaid agency’s
contract with every D–SNP in its market
to address the changes to § 422.107
made by this final rule. Since half of the
cost will be offset by federal financial
participation for Medicaid
administrative activities, we have
adjusted our estimates for state agencies
by 50 percent. Given the market
penetration of D–SNPs in certain states
relative to others, we recognize that this
estimate reflects an average cost across
all states and territories with D–SNPs.
We expect that the state Medicaid
agency will establish uniform
contracting requirements for all D–SNPs
operating in their market. As of June
2018, there were 42 states, plus the
District of Columbia and Puerto Rico, in
which D–SNPs were available to MA
enrollees.41 In aggregate, we estimate a
one-time burden of 1,056 hours (44
respondents × 24 hr/response) at an
adjusted cost of $72,040 (1,056 hr ×
$136.44/hr × 0.50). Over the course of
OMB’s anticipated 3-year approval
period, we estimate an annual burden of
352 hours (1,056 hr × 1⁄3) at a cost of
$24,013 ($72,040 × 1⁄3). We are
annualizing the one-time estimate since
we do not anticipate any additional
burden after the 3-year approval period
expires.
In future years, we anticipate minimal
burden associated with modifications to
contract terms consistent with the
changes we are finalizing to
§ 422.107(c)(1) through (3). While it is
possible more states will move toward
increased integration by contracting
with applicable integrated plans and
would therefore need to modify their
state Medicaid agency contracts with D–
SNPs consistent with the changes we
are finalizing to § 422.107(c)(9), we are
unable to reliably estimate the
additional burden in subsequent years.
In addition, while we recognize that,
over time, states could modify the
newly required contract term at
41 Centers for Medicare & Medicaid Services
(2018, June). SNP Comprehensive Report. Retrieved
from https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-and-Reports/
MCRAdvPartDEnrolData/Special-Needs-Plan-SNPData.html.
E:\FR\FM\16APR2.SGM
16APR2
15800
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
§ 422.107(d) to require notification
about admissions for certain high-risk
enrollees (for example, by expanding
the population of high-risk full-benefit
dual eligible individuals to whom this
notification applies), we do not believe
that such a contract change will have a
material impact on time and effort and,
therefore, will already be accounted for
in the burden estimate for the overall
contract that the state Medicaid agency
has with each D–SNP.
Given the lack of material impact and
the uncertainty involved in estimating
state behavior, we are estimating a
minimum of zero burden in subsequent
years on plans. The maximum burden
will be the estimated first year cost.
However, we believe the maximum
estimate is unlikely to be accurate since
we expect any changes to contracting
requirements to be iterative compared to
the first year update.
We solicited public comment on our
assumptions in the proposed rule and
whether there are reasonable ways of
modeling state behavior. We received no
comments on our information collection
requirements, burden estimates, and
assumptions and are finalizing them
without modification.
(2) Notification (§ 422.107(d))
To address differences among the
states in available infrastructure,
population sizes, and mix of enrollees,
this rule provides broad flexibility to
identify the groups for which the state
Medicaid agency wishes to be notified
and how the notification should take
place. These flexibilities include: (1)
Consideration of certain groups who
experience hospital and SNF
admissions; (2) protocols and
timeframes for the notification; (3) data
sharing and automated or manual
notifications; and (4) use of a stratified
approach over several years starting at a
small scale and increasing to a larger
scale. This final rule also allows states
to determine whether to receive
notifications directly from D–SNPs or to
require that D–SNPs notify a state
designee such as a Medicaid managed
care organization, section 1915(c)
waiver case management entity, area
agency on aging, or some other
organization.
Some states, using a rich
infrastructure and a well-developed
automated system, may fulfill this
notification requirement with minimal
burden, while states with less
developed or no infrastructure or
automated systems may incur greater
burden. Furthermore, the burden,
especially to those states starting on a
small scale, may differ significantly
from year to year. Because of the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
flexibilities provided in this final rule,
we expect that states will choose
strategies that are within their budget
and best fit their existing or alreadyplanned capabilities. We expect any
state choosing to receive notification
itself of such admissions to claim
federal financial participation under
Medicaid for that administrative
activity.
As of June 2018, there were 42 states,
plus the District of Columbia and Puerto
Rico, in which D–SNPs were available
to MA enrollees. We estimate that there
are nine (9) states and territories with
D–SNPs that are all expected to qualify
as either FIDE SNPs or HIDE SNPs—
Arizona, Florida, Hawaii, Idaho,
Massachusetts, Minnesota, New Jersey,
New Mexico, and Puerto Rico. We do
not expect these states to establish a
notification system under this final rule
because none of their D–SNPs will be
subject to the state notification
requirement at § 422.107(d). We
estimate that nine additional states that
primarily use managed care for longterm services and supports (LTSS)
(Michigan, New York, North Carolina,
Ohio, Oregon, Pennsylvania, Tennessee,
Texas, and Virginia) will delegate
receipt of this information to their
Medicaid managed care organizations.
We also estimate that approximately
half of the remaining 26 states (42
states—16 states, excluding the District
of Columbia and Puerto Rico) or 13
states will build an automated system
for receiving notification of hospital and
SNF admissions consistent with this
final rule.
We estimate that, on average, this
work could be accomplished in a month
with one software developer/
programmer to build an automated
system and one business operations
specialist to define requirements. We
estimate a one-time burden of 4,160
hours (13 states × 40 hr/week × 4 weeks
× 2 FTEs). Since half of the cost will be
offset by 50 percent federal financial
participation for Medicaid
administrative activities, we estimate an
adjusted cost of $178,235 [((2,080 hr ×
$98.54/hr) + (2,080 hr × $72.84/hr)) ×
0.50]. Over the course of OMB’s
anticipated 3-year approval period, we
estimate an annual burden of 1,386.667
hours (4,160 hr × 1⁄3) at a cost of $59,412
($178,235 × 1⁄3). We are annualizing the
one-time estimate since we do not
anticipate any additional burden after
the 3-year approval period expires.
Because of the possible wide
variability in states’ approaches in
implementing this requirement, we
solicited comment in the proposed rule
and requested suggestions for modeling
state approaches and costs related to
PO 00000
Frm 00122
Fmt 4701
Sfmt 4700
this provision. Given the uncertainty
involved in estimating state behavior,
we estimated a minimum of zero burden
in subsequent years on plans and a
maximum burden that is the estimated
first-year cost. We received no
comments and are finalizing our time
estimates without change. Our proposed
cost estimates have been revised to
account for the changes discussed in
section III.A. of this final rule.
b. Burden on Plans
(1) Contract Modifications With State
Medicaid Agencies (§ 422.107)
For the initial year, we expect it will
take 8 hours at $136.44/hr for a lawyer
to update their plan’s contract with the
state Medicaid agency to reflect the
revised and new provisions finalized in
this rule at § 422.107(c)(1)–(3), (c)(9),
and (d). We are unable to differentiate
how these provisions impact individual
D–SNP contracts due to the ways
contracts are structured. For example,
some contracts will include FIDE SNPs,
HIDE SNPs, and other D–SNPs, while
others may include only a subset of
these D–SNP types. The specific
requirements for the content of and
scope of changes to the contract vary
somewhat based on the type of D–SNP
the plan is. However, it is reasonable to
project that every D–SNP contract will
require contract modifications with the
state Medicaid agency.
There are 190 D–SNP contracts as of
June 2018.42 In aggregate, we estimate a
one-time burden of 1,520 hours (190 D–
SNPs × 8 hr/modification) at a cost of
$207,389 (1,520 hr × $136.44/hr). Over
the course of OMB’s anticipated 3-year
approval period, we estimate an annual
burden of 507 hours (1,520 hr × 1⁄3) at
a cost of $69,130 ($207,389/3). We are
annualizing the one-time estimate since
we do not anticipate any additional
burden after the 3-year approval period
expires.
We believe that we have no
reasonable way of estimating or
illustrating burden in later years. The
expected behavior among states is
unknown relative to how often they will
modify their contracts with D–SNPs on
this particular matter. For example, state
Medicaid agencies may remain satisfied
with the initial year selection of highrisk groups and see no reason to modify
their contracts in later years. In contrast,
other state Medicaid agencies may seek
to expand the notification requirement
42 Centers for Medicare & Medicaid Services
(2018, June). SNP Comprehensive Report. Retrieved
from https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-and-Reports/
MCRAdvPartDEnrolData/Special-Needs-Plan-SNPData.html.
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
evaluate financial and marketing
activities, the furnishing of services, the
quality improvement program, and the
administrative and management aspects
of their organization (§ 422.503(b)(4)(ii)).
Independent of the state Medicaid
agency’s selection of high-risk
populations, protocols, and notification
schedules, an MA organization’s most
likely method of sharing this
notification will be through the use of
an automated system that could identify
enrollees with criteria stipulated by the
states and issue electronic alerts to
specified entities. We do not believe
that this work is very complex.
Therefore, we estimate it could be
accomplished in a month with one
software developer/programmer to
update systems and one business
operations specialist to define
requirements. The burden will be at the
contract, not the plan, level for a subset
of D–SNP contracts that are not FIDE
SNPs or HIDE SNPs and to which the
notification requirements are applicable.
As noted previously, there are 190 D–
SNP contracts as of June 2018, of which
37 contracts, or 12.7 percent (about one-
eighth), are FIDE SNPs.43 While we do
not have a precise count of D–SNPs that
will likely meet the definition of a HIDE
SNP, we estimate that another 12.7
percent of the 190 D–SNP contracts will
be HIDE SNP contracts. Therefore, we
expect that the number of contracts
needing modification is 190 D–SNP
contracts, less 37 FIDE SNP contracts,
less 37 HIDE SNP contracts, or 116 D–
SNP contracts. Accordingly, we estimate
a one-time burden of 37,120 hours (116
contracts × 40 hr × 4 weeks × 2 FTEs)
at a cost of $3,180,813 [(18,560 hr ×
$98.54/hr) + (18,560 hr × $72.84/hr)].
Over the course of OMB’s anticipated 3year approval period, we estimate an
annual burden of 12,373 hours (37,120
hr × 1⁄3) at a cost of $1,060,271
($3,180,813 × 1⁄3). We are annualizing
the one-time estimate since we do not
anticipate any additional burden after
the 3-year approval period expires.
As described in section II.A.2.b. of
this final rule, we are establishing for
inclusion in contracts for applicable
integrated plans, as defined in
§ 422.561, no later than 2021,
procedures unifying Medicare and
Medicaid grievances and appeals
procedures in accordance with the
newly enacted amendments to section
1859(f)(8)(B) and (C) of the Act. In this
final rule, § 422.562(a)(5) requires that
all dual eligible special needs plans (D–
SNPs) provide assistance to
beneficiaries with Medicaid coverage
issues, appeals and grievances. When
ready, the requirements and burden
associated with these requirements will
be submitted to OMB for approval under
control number 0938–0753 (CMS–R–
267).
As of June 2018, our Special Needs
Plan Comprehensive Report lists 190 D–
SNP contracts with 412 D–SNP plans
that have at least 11 members.44 The
universe of D–SNPs to which our
unified grievance and appeals
procedures will apply is comprised of
D–SNPs that are either fully integrated
dual eligible special needs plans (FIDE
SNPs) or highly integrated dual eligible
special needs plans (HIDE SNPs) with
exclusively aligned enrollment—that is,
where all of the plan’s membership
receives Medicare and Medicaid
benefits from the same organization.
Currently, exclusively aligned
enrollment occurs in only eight states:
Florida, Idaho, Massachusetts,
Minnesota, New Jersey, New York,
Tennessee, and Wisconsin. Currently,
there are only 37 D–SNPs operating
under 34 contracts with 150,000
enrollees that could be classified as
FIDE SNPs or HIDE SNPs which operate
43 Centers for Medicare & Medicaid Services
(2018, June). SNP Comprehensive Report. Retrieved
from https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-and-Reports/
MCRAdvPartDEnrolData/Special-Needs-Plan-SNPData.html.
44 See https://www.cms.gov/Research-StatisticsData-and-Systems/Statistics-Trends-and-Reports/
MCRAdvPartDEnrolData/Special-Needs-Plan-SNPData-Items/SNP-Comprehensive-Report-201806.html?DLPage=1&DLEntries=10&DLSort=1&
DLSortDir=descending.
(2) Notifications to State Medicaid
Agencies or Their Designees
(§ 422.107(d))
We have noted previously in section
II.A.2.a. of this final rule the broad
flexibility in notification options for
states. We also note that MA
organizations are already required to
have systems that are sufficient to
organize, implement, control, and
3. ICRs Regarding Unified Grievance
and Appeals Procedures for Dual
Eligible Special Needs Plans and
Medicaid Managed Care Plans at the
Plan Level (§§ 422.560 through 422.562,
422.566, 422.629 Through 422.634,
438.210, 438.400, and 438.402)
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
PO 00000
Frm 00123
Fmt 4701
Sfmt 4700
c. Summary of Burden Related to
Integration Provisions for Dual Eligible
Special Needs Plans
Table 4 summarizes the burden for
the aforementioned provisions.
E:\FR\FM\16APR2.SGM
16APR2
ER16AP19.000</GPH>
to encompass additional groups of highrisk dual eligible individuals and may
therefore modify their contracts on this
basis. Given the uncertainty involved in
estimating state behavior, we are
estimating a minimum of zero burden in
subsequent years on plans. The
maximum burden will be the first year
costs.
We received no comments on our
assumptions in the proposed rule or on
ways to reasonably model state behavior
and are finalizing our proposed
estimates without modification.
However, we are finalizing our burden
estimates to reflect the omission of the
burden associated with §§ 422.107(c)(1)
through (3) and 422.107(c)(9) in the
proposed rule.
khammond on DSKBBV9HB2PROD with RULES2
15801
khammond on DSKBBV9HB2PROD with RULES2
15802
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
in states with exclusively aligned
enrollment. The 150,000 enrollment
figure for contract year 2018 is projected
to grow to 172,000 (150,000 x 1.145)
enrollees by 2021, the first year that
compliance with these provisions will
be required.45 While unifying grievance
and appeals provisions will necessitate
states with exclusively aligned
enrollment policies to modify their
Medicaid managed care plan contracts
to incorporate the new requirements, it
will impose this burden on fewer than
10 states, thereby falling below the
threshold for PRA purposes.
We believe that our requirements at
§§ 422.629, 422.630, and 422.631 related
to integrated organization
determinations and integrated
grievances should not be altogether
unfamiliar to applicable integrated
plans because, in general terms, we are
adopting whichever of the current MA
D–SNP or Medicaid managed care plan
contract requirements under part 422
subpart M (Medicare Advantage) and
part 438 subpart F (Managed Care),
respectively, is more protective of the
rights of the beneficiary or provides the
most state flexibility, consistent with
the statutory requirements of section
1859(f)(8) of the Act. Furthermore, we
believe that by unifying Medicare and
Medicaid integrated organization
determination and grievance
requirements for applicable integrated
plans (that is, FIDE SNPs and HIDE
SNPs with exclusively aligned
enrollment), we are reducing
duplicative reviews and notices, thereby
ultimately reducing the level of burden
on these organizations. We detail the
following:
• In section III.B.3.a. of this final rule,
the burden associated with the
implementation of our integrated
organization determination and
integrated grievance procedures
(§§ 422.629, 422.630, and 422.631).
• In section III.B.3.b. of this final rule,
that the information collection activities
undertaken to administer our unified
appeals procedures (§§ 422.629,
422.633, and 422.634) are exempt from
the PRA.
• In section III.B.3.c. of this final rule,
that the requirement for all D–SNPs to
assist enrollees with Medicaid coverage
issues and grievances in § 422.562(a)(5)
is also exempt from the PRA.
45 Table IV.C1, ‘‘Private Health Enrollment’’ in
2018 Trustee Report, accessible at https://
www.cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-and-Reports/
ReportsTrustFunds/Downloads/TR2018.pdf.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
a. Integrated Organization
Determinations and Integrated
Grievances (§§ 422.629, 422.630, and
422.631)
Section 422.631 requires that each
applicable integrated plan issue one
integrated organization determination,
so that all requests for benefits from and
appeals of denials of coverage by
applicable integrated plans will be
subject to the same integrated
organization determination process.
Section 422.631(d)(1) requires that an
applicable integrated plan send an
integrated notice when the integrated
organization determination is adverse to
the enrollee. The notice must include
information about the determination, as
well as information about the enrollee’s
appeal rights for both Medicare and
Medicaid covered benefits. Though
integrating information on Medicare and
Medicaid appeal rights will be a new
requirement, we note that the
requirement for a notice and the content
of the notice largely align with current
requirements in Medicaid (§ 438.404(b))
and MA (§ 422.572(e)). We believe that
the provision will have minimal impact
on plans based on our understanding of
how plans that will meet the definition
of an applicable integrated plan under
this final rule currently handle coverage
determinations for full-benefit dual
eligible individuals receiving Medicare
and Medicaid services through the plan.
Currently, if such a plan were to deny
or only partially cover a Medicaid
service never covered by Medicare (like
a personal care attendant or a clear
request for Medicaid coverage), it will
only issue a Medicaid denial (one
notice). Under this final rule, it will do
the same (that is, issue one notice). On
the other hand, if the plan denied a
service that is covered under either
Medicare or Medicaid, such as home
health services, we believe that the plan
covering both Medicare and Medicaid
benefits in most, if not all, states will
issue an integrated determination notice
that includes information about the
application of Medicare and Medicaid
coverage criteria to the requested service
and how to appeal under both Medicare
and Medicaid (one notice). This final
rule codifies this practice for applicable
integrated plans.
Also under § 422.568(d), if the plan
covers a service such as durable medical
equipment or home health services
under Medicaid, but denies the same
service under Medicare’s rules, it must
issue a Medicare denial even though the
service was actually covered by the plan
based on its Medicaid contract. Under
this final rule, a plan covering both
Medicare and Medicaid benefits will no
PO 00000
Frm 00124
Fmt 4701
Sfmt 4700
longer need to issue a notice in this
situation. We do not have data to
estimate the number of instances in
which D–SNPs currently issue denial
notices related to overlap services;
therefore, we are unable to reliably
estimate the reduction in plan burden
resulting from our unified appeals
requirements. We solicited feedback on
the burden imposed on integrated plans
by having to send such a Medicare
denial notice when the service is
covered by the plan under Medicaid
rules in the proposed rule. We did not
receive any comment.
We are developing a model integrated
denial notice form for use by applicable
integrated plans. When ready, the model
form and its associated requirements
and burden will be submitted to OMB
for approval. It will also be made
available to the public for review/
comment under the standard PRA
process which includes the publication
of 60- and 30-day Federal Register
notices and the posting of the collection
of information documents on our PRA
website. Additionally, changes to the
procedures for applicable integrated
plans will be reflected in the current
Notice of Denial of Medical Coverage
form and instructions (OMB control
number 0938–0892; CMS–10003), but
will not impact this rule’s burden
estimates. As we did not finalize the
necessary revisions for this notice at the
time of the proposed rule’s publication
date, we did not set out such burden or
solicit such comments. We are in the
process of publishing a stand-alone 60day Federal Register notice that set outs
the revised form and form instructions.
Under § 422.629(g), applicable
integrated plans must send a notice of
acknowledgment for all integrated
grievances and integrated
reconsiderations. Medicaid managed
care organizations are currently required
to send this notice under
§ 438.406(b)(1), whereas MA plans are
not currently required to send this
notice. Under this final rule, applicable
integrated plans must now send this
notice for all grievances and appeals,
not only those pertaining to Medicaid
issues. Section 422.630(e) requires that
applicable integrated plans issue a
notice upon resolution of the integrated
grievance, unless the integrated
grievance was made orally and it did
not concern quality of care, and the
enrollee did not request a written
response. A beneficiary’s integrated
grievance and the subsequent
information collection activities
necessitated by that grievance are
exempt from the requirements of the
PRA since the grievance would be
submitted in response to an
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
administrative action against a specific
individual (5 CFR 1320.4). However, the
impact related to these requirements is
estimated in section IV.B.3. of this final
rule.
We believe this final rule will result
in a reduction in the number of
grievance reviews conducted by
applicable integrated plans detailed
under § 422.629(k)(2) due to the
elimination of duplicative grievance
reviews for Medicare and Medicaid
overlap issues. We do not estimate this
burden reduction as this information
collection activity is exempt under 5
CFR 1320.4 from the requirements of the
PRA since it occurs as part of an
administrative action. However, the
impact from changes to these activities
are estimated in section IV.B.3. of this
final rule.
We estimate negligible impacts on
information collection activities
involved in unifying grievances
associated with our provisions at
§ 422.630. Under § 422.630(b),
applicable integrated plans will be
required to accept grievances filed at
any time consistent with the Medicaid
standard at § 438.402(c)(2)(i). This
change will have the net effect of
permitting enrollees to file a grievance
for a Medicare-covered service outside
of the current 60-day timely filing
standard, as measured from the date of
the event or incident that precipitated
the grievance. The provision will
effectively eliminate the timely filing
period for Medicare-related grievances.
We do not expect this requirement to
increase the volume of grievances that
an applicable integrated plan will be
responsible for handling since we
believe that the timeframes for filing
Medicare grievances were designed to
be consistent with current practice and
were set in place only to eliminate
complaint outliers.
Under § 422.630(c), enrollees of
applicable integrated plans may file
integrated grievances with the plan
orally or in writing, in alignment with
current Medicare and Medicaid
requirements, or with the state, in states
that have existing processes for
accepting Medicaid grievances in place
in accordance with § 438.402(c)(3).
Because this provision simply extends
an existing avenue for filing grievances,
in states where it exists, for enrollees to
file Medicaid benefits grievances with
the state, we do not expect an increase
in the volume of grievances that either
states or applicable plans will be
responsible for handling.
Section 422.630(d) will permit an
enrollee to file an expedited grievance,
which is available under current law for
Medicare-covered, but not Medicaid-
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
covered, benefits. We estimate that the
availability of an expedited grievance
for Medicaid benefits will have a
negligible impact on information
collection activities because applicable
integrated plans will already have
procedures in place to handle expedited
grievances for Medicare-covered
services, which could be leveraged for
Medicaid-covered services.
Furthermore, the availability of the
expedited resolution pathway (where
under current law there is only one
resolution pathway for Medicaidcovered services) will have no impact
on the volume of grievances.
Section 422.630(e)(1) will require that
an applicable integrated plan resolve a
standard (non-expedited) grievance
within 30 days consistent with the MA
standard (§ 422.564(e)); under Medicaid
(§ 438.408(b)), the timeframe is
established by the state but may not
exceed 90 calendar days from day the
plan receives the grievance. We estimate
that this change in timeframe will have
a negligible impact on information
collection activities because applicable
integrated plans already have business
processes in place to comply with a 30day timeframe under MA.
Section 422.630(e)(2) requires an
applicable integrated plan, when
extending the grievance resolution
timeframe, to make reasonable efforts to
notify the enrollee orally and send
written notice of the reasons for the
delay within 2 calendar days. We do not
believe that this provision will have
more than a negligible impact on plans
since it adopts existing MA
requirements for how an applicable
integrated plan must notify an enrollee
of an extension and the existing
Medicaid managed care requirement for
the timeliness standard. Thus,
applicable integrated plans will already
have business processes in place to
comply with these requirements.
Although we do not estimate burden
for applicable integrated plans related to
information collection activities
involved in unifying grievances
associated with our provisions at
§§ 422.629 and 422.630, some of the
individual provisions in §§ 422.629
(general requirements), 422.630
(integrated grievances), and 422.631
(integrated organization determinations)
will necessitate operational and systems
changes on the part of applicable
integrated plans. The following sections
set out our burden estimates related to
updates to policies and procedures and
recordkeeping and storage.
(1) Updates to Policies and Procedures
We estimate a one-time burden for
each applicable integrated plan to
PO 00000
Frm 00125
Fmt 4701
Sfmt 4700
15803
update its policies and procedures to
reflect the new integrated organization
determination and grievance procedures
under §§ 422.629, 422.630 and 422.631.
We anticipate this task will take a
business operation specialist 8 hours at
$72.84/hr. In aggregate, we estimate a
one-time burden of 272 hours (8 hr × 34
contracts) at a cost of $19,812 (272 hr ×
$72.84/hr). Over the course of OMB’s
anticipated 3-year approval period, we
estimate an annual burden of 91 hours
(272 hr × 1⁄3) at a cost of $6,604 ($19,812
× 1⁄3). We are annualizing the one-time
estimate since we do not anticipate any
additional burden after the 3-year
approval period expires.
(2) Recordkeeping and Storage
D–SNPs, like other MA plans, are
currently required to maintain records
for grievances (§ 422.504(d)). However,
§ 422.629(h) will require the
maintenance of specific data elements
consisting of: A general description of
the reason for the integrated grievance;
the date of receipt; the date of each
review or, if applicable, the review
meeting; the resolution at each level of
the integrated grievance, if applicable;
the date of resolution at each level, if
applicable; and the name of the enrollee
for whom the integrated grievance was
filed.
We estimate a one-time burden for
applicable integrated plans to revise
their systems for recordkeeping related
to integrated grievances. We anticipate
this task will take a software developer/
programmer 3 hours at $98.54/hr. Three
hours is consistent with the perresponse time estimated in the May
2016 Medicaid Managed Care final rule
(81 FR 27498). In aggregate, we estimate
a one-time burden of 102 hours (3 hr ×
34 contracts) at a cost of $10,051 (102
hr × $98.54/hr). Over the course of
OMB’s anticipated 3-year approval
period, we estimate an annual burden of
34 hours (102 hr × 1⁄3) at a cost of $3,350
($10,051 × 1⁄3). We are annualizing the
one-time estimate since we do not
anticipate any additional burden after
the 3-year approval period expires.
We do not expect the cost of storage
to change under § 422.629(h)(3) since
D–SNPs are currently required to store
records under § 422.504(d), and the
provision will not impose any new or
revised storage requirements or burden.
We received no comments on our
assumptions for estimating the burden
associated with the operational and
systems changes necessitated by
§§ 422.629, 422.630, and 422.631.
However, we are updating our
proposed burden estimates to reflect
several omissions and minor
modifications to two occupational codes
E:\FR\FM\16APR2.SGM
16APR2
15804
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
and corresponding adjusted hourly
wages. Table 5 summarizes the burden
resulting from these provisions.
b. Unified Appeals Procedures
(§§ 422.629, 422.633, and 422.634)
A beneficiary’s appeal of an adverse
integrated coverage determination and
the subsequent information collection
activities necessitated by that appeal are
exempt from the requirements of the
PRA since the appeal would be
submitted in response to an
administrative action against a specific
individual (5 CFR 1320.4). In the case of
this final rule, the exemption covers any
information collection activities
undertaken after the adverse integrated
organization determination by an
applicable integrated plan, including:
acknowledgement of integrated
reconsiderations under § 422.629(g),
recordkeeping related to integrated
appeals at § 422.629(h), and notification
of the applicable integrated plan’s
integrated reconsideration
determination at § 422.633(f)(4).
filing of their grievance or appeal as
required in § 422.562(a)(5). Since the
provision of such assistance is a usual
and customary business practice it is
exempt from the PRA under 5 CFR
1320.3(b)(2). We believe that this
function would be performed in the
absence of federal regulation.
d. Summary
The burden associated with the
individual components of our
provisions for unified grievance and
appeals procedures for applicable
integrated plans are summarized in
Table 5.
c. Assisting With Medicaid Coverage
Issues and Grievances (§ 422.562(a)(5))
We have not calculated the burden for
all D–SNPs to assist enrollees with the
TABLE 5—SUMMARY OF D–SNP UNIFIED GRIEVANCE AND APPEALS PROCEDURES BURDEN
[OMB Control Number 0938–0753, CMS–R–267]
Item
Regulation
khammond on DSKBBV9HB2PROD with RULES2
Updates to Policies and Procedures
Number of
respondents
Hours per
respondent
Total hours 1
Hourly wage
Total cost
($)
34
8
91
72.84
6,604
Recordkeeping ...................................
422.629, 422.630,
and 422.631.
422.629(g) ...........
34
3
34
98.54
3,350
Total ............................................
..............................
34
Varies
125
Varies
9,954
4. ICRs Regarding Prescription Drug
Plan Sponsors’ Access to Medicare Parts
A and B Claims Data Extracts
(§ 423.153(g))
The following requirements and
burden will be submitted to OMB for
approval under control number 0938–
TBD 46 (CMS–10691).
As described in section II.A.3. of this
final rule, section 50354 of the
Bipartisan Budget Act of 2018 requires
the establishment of a process under
which the sponsor of a PDP that
provides prescription drug benefits
under Medicare Part D may request,
beginning in plan year 2020, that the
Secretary provide on a periodic basis
and in an electronic format standardized
extracts of Medicare Parts A and B
claims data about its plan enrollees. In
this final rule we add a new § 423.153(g)
to implement the process for requesting
this data. The provision will allow the
PDP sponsor to submit a request to CMS
for claims data for its enrollees and to
attest that it will adhere to the permitted
uses and limitations on the use of the
Medicare claims data that are listed in
§ 423.153.
At the time of the proposed rule’s
publication date, we did not finalize the
operational aspects of this provision.
Therefore, we did not set out such
46 Currently, the control number is to be
determined (TBD). OMB will assign the control
number upon their approval of this new
information collection request. Approval can be
monitored at reginfo.gov without any login or
password.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
burden or request comment in the
Collection of Information section of that
rule. However, since that time, we have
finalized the operational aspects and
published a stand-alone 60-day Federal
Register notice that set out the
requirements and burden associated
with the request and attestation
(November 30, 2018; 83 FR 61638).
Comments were received and are
responded to below. We are also
realigning the proposed provision with
this final rulemaking by setting out such
requirements and burden below. In this
regard we will not be publishing a
stand-alone 30-day Federal Register
notice.
Section 423.153(g)(1)(i) states that
beginning in plan year 2020, a PDP
sponsor may submit a request to CMS
for claims data on enrollees in its
prescription drug plans. In addition,
§ 423.153(g)(5) provides that as a
condition of receiving the requested
data, the PDP sponsor must attest that
it will adhere to the permitted uses and
limitations on the use of the Medicare
claims data. In the stand-alone notice
we anticipated that the data request and
attestation will be combined into a
single submission. We continue to
estimate it will take a business
operations specialist 1 minute at $72.84/
hr to complete the request for data and
the attestation. As mentioned in section
III.A. of this rule, we are updating the
hourly wage associated with the
business operations specialist.
PO 00000
Frm 00126
Fmt 4701
Sfmt 4700
Currently, there are 63 PDP sponsors
and we estimate that all PDP sponsors
would initially submit a request and
attestation. We also estimate that each
year approximately 1 to 5 PDP sponsors
would start requesting CMS claims data
for its enrollees. For purposes of impact
estimates we assume the maximum, 5
PDP sponsors per year. We estimate it
will take a business operations
specialist 1 minute to complete the
request for data and the attestation. We
also estimate that each year
approximately 1 to 5 PDP sponsors will
request that CMS stop sending claims
data for its enrollees. For purposes of
impact estimates we assume the
maximum, 5 sponsors, will request
discontinuation. We estimate it will take
a business operations specialist 1
minute (1/60 hr) to submit a request to
CMS to stop sending claims data for its
enrollees.
For first year sponsor requests we
estimate a burden of 63/60 hours (1
hour and 3 minutes) (63 sponsors × 1/
60 hr/response) at an aggregate cost of
$76.48 (63 sponsors × 1/60 hr × $72.84/
hr).
In subsequent years we estimate a
burden of 10/60 hours (1/60/hr × (5
requests for data + 5 requests for
discontinuation) at an aggregate cost of
$12.14 (10/60 × 72.84).
The aggregate impact over 3 years is
83/60 hour (63/60 for the first year + 10/
60 × 2 for the next 2 years) at a cost
$100.76 ($76.48 for the first year +
$12.14 × 2 for the next 2 years). When
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
annualized over 3 years, the annual
impact is 28/60 hr (83/60 divided by 3)
at a cost of $33.59.
While we received a few comments,
none of them were related to the PRA
or any of our collection of information
requirements or burden estimates.
Nonetheless, we considered the
comments since they were rule-related
and have responded to them under the
appropriate sections of this preamble,
namely section II.A.3. of this final rule.
5. ICRs Regarding Medicare Advantage
and Part D Prescription Drug Plan
Quality Rating System (§§ 422.162(a)
and 423.182(a), 422.166(a) and
423.186(a), 422.164 and 423.184, and
422.166(i)(1) and 423.186(i)(1))
khammond on DSKBBV9HB2PROD with RULES2
As described in section II.B.1. of this
final rule, we are finalizing: Measure
updates for the 2022 and 2023 Star
Ratings, enhancements to the cut point
methodology for non-CAHPS measures,
and a policy for calculating the Part C
and D Star Ratings when extreme and
uncontrollable circumstances occur.
The provisions will not change any
respondent requirements or burden
pertaining to any of CMS’s Star Ratingsrelated PRA packages, including: OMB
control number 0938–0732 for CAHPS
(CMS–R–246), OMB control number
0938–0701 for HOS (CMS–10203), OMB
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
control number 0938–1028 for HEDIS
(CMS–10219), OMB control number
0938–1054 for Part C Reporting
Requirements (CMS–10261), and OMB
control number 0938–0992 for Part D
Reporting Requirements (CMS–10185).
Since the provisions will not impose
any new or revised information
collection requirements or burden, we
are not making changes under any of the
aforementioned control numbers.
6. ICRs Regarding Improving Clarity of
the Exceptions Timeframes for Part D
Drugs (§§ 423.568, 423.570, and
423.572)
To establish greater certainty in the
Part D exceptions process, we limited
the amount of time an exception request
can be held in a pending status while
the Part D plan sponsor attempts to
obtain the prescriber’s supporting
statement; specifically, that a plan must
notify the enrollee (and the prescriber
involved, as appropriate) of its decision
on an exceptions request no later than
72 hours (24 hours for expedited) of
receipt of the prescriber’s supporting
statement or 14 calendar days after
receipt of the request, whichever occurs
first.
These provisions will not impose any
new or revised information collection
requirements or burden. Consequently,
PO 00000
Frm 00127
Fmt 4701
Sfmt 4700
15805
the provisions are not subject to the
PRA. We did not receive any comments
pertaining to our position that the
proposed provisions are not subject to
the PRA. Consequently, we are
finalizing our position without change.
7. ICRs Regarding Preclusion List
Requirements for Prescribers in Part D
and Individuals and Entities in MA,
Cost Plans, and PACE (§§ 422.222 and
423.120(c)(6))
As described in section II.C.1. of this
final rule, the provisions in §§ 422.222
and 423.120(c)(6) will not involve
activities for plan sponsors and MA
organizations outside of those described
in the previously referenced April 2018
final rule (83 FR 16440). The provisions
are, generally speaking, clarifications of
intended policy and will not impose
any new or revised information
collection requirements or burden.
Consequently, the provisions are not
subject to the PRA.
We did not receive any comments
pertaining to our position that the
proposed provisions are not subject to
the PRA. Consequently, we are
finalizing our position without change.
C. Summary of Information Collection
Requirements and Burden
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15806
VerDate Sep<11>2014
Jkt 247001
PO 00000
Regulatory Reference
Frm 00128
§ 422.107 (Initial update of States of their Contracts with D SNPs)
OMB Control
Number
(CMSID
Number)
0938-0753
(CMS-R-267)
0938-0753
(CMS-R-267)
0938-0753
(CMS-R-267)
Total
Number
of
Responses
Hours Per
Response
Total
Hours2
Wages
($/hr)
Total Cost
($)1
Fmt 4701
Sfmt 4725
E:\FR\FM\16APR2.SGM
16APR2
44
1
24
352
136.44
24,013
13
44
1
1
160
Varies
1387
1,739
85.69 3•
Varies
59,412
83,425
190
1
8
507
136.44
69,130
116
1
160
12,373
85.69 3•
1,060,271
34
1
8
91
72.84
6,604
34
1
3
34
98.54
3,350
§§ 423.153(g)(1)(i) and (g)(5) (Data requests and attestation)
28
1
1 min (1/60 hr)
Subtotal (Private Sector)
190
1
Varies
Varies
1
Varies
Total
NOTES:
I. For state burdens, reflects 50 percent reduction to Federal Matching program.
2· Reflects division by 3 to annualize a one-time update over 3 years.
3 · Average of $72.84 and $98.54, the wages of a business operations specialist and programmer working simultaneously on this task.
28/60
13,005
14,744
72.84
Varies
Varies
34
1,139,389
1,222,814
§ 422.107 (Initial notification systems for State Medicaid Agencies)
Subtotal (State Burden)
§ 422.107 (Initial updates ofD-SNPs of their Contracts with the State)
§ 422.107 (Initial notification ofD-SNPs to Medicaid Agencies)
§§ 422.629, 422.630, and 422.631 (Updates to D-SNP policies and procedures)
§ 422.629(g) (Recordkeeping)
0938-0753
(CMS-R-267)
0938-0753
(CMS-R-267)
0938-0753
(CMS-R-267)
0938-0753
(CMS-R-267
0938-TBD
(CMS-10691)
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
18:09 Apr 15, 2019
ER16AP19.001</GPH>
fABLE 6: ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
IV. Regulatory Impact Analysis
khammond on DSKBBV9HB2PROD with RULES2
A. Statement of Need
This final rule implements specific
provisions of the Bipartisan Budget Act
of 2018 related to MA additional
telehealth benefits, MA dual eligible
special needs plans (D–SNPs), and Part
D sponsors’ access to Medicare claims
data. The rule will also improve quality
and accessibility; clarify certain
program integrity policies; reduce
burden on providers, MA organizations,
and Part D sponsors through providing
additional policy clarification; and
implement other technical changes
regarding quality improvement.
Although satisfaction with the MA and
Part D programs remains high, these
changes are necessary to implement
certain provisions of the Bipartisan
Budget Act of 2018 and are responsive
to input we received from stakeholders
while administering the programs, as
well as through our requests for
comment. We decided to modify the
MA and Part D Prescription Drug Plan
Quality Rating System in response to
comments from the proposed rule
entitled Medicare Program; Contract
Year 2019 Policy and Technical
Changes to the Medicare Advantage,
Medicare Cost Plan, Medicare Fee-forService, The Medicare Prescription Drug
Benefit Programs, and the PACE
program (November 28, 2017, 82 FR
56336).
In this final rule, our policies
continue to drive affordable private plan
options for Medicare beneficiaries that
meet their unique healthcare needs,
such as supporting innovation in
telehealth among MA plans to provide
more options and additional benefits for
MA enrollees. These provisions align
with the Administration’s focus on the
interests and needs of beneficiaries,
providers, MA plans, and Part D
sponsors.
B. Overall Impact
We examined the impact of this final
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), Executive Order 13272 on Proper
Consideration of Small Entities in
Agency Rulemaking (August 13, 2002),
section 1102(b) of the Act, section 202
of the Unfunded Mandates Reform Act
of 1995 (UMRA) (March 22, 1995; Pub.
L. 104–4), Executive Order 13132 on
Federalism (August 4, 1999), the
Congressional Review Act (5 U.S.C.
804(2)), and Executive Order 13771 on
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Reducing Regulation and Controlling
Regulatory Costs (January 30, 2017).
The RFA, as amended, requires
agencies to analyze options for
regulatory relief of small businesses, if
a rule has a significant impact on a
substantial number of small entities. For
purposes of the RFA, small entities
include small businesses, nonprofit
organizations, and small governmental
jurisdictions.
This final rule affects MA plans and
Part D sponsors (North American
Industry Classification System (NAICS)
category 524114) with a minimum
threshold for small business size of
$38.5 million (https://www.sba.gov/
content/small-business-size-standards).
This final rule additionally affects
hospitals (NAICS subsector 622) and a
variety of provider categories, including
physicians and specialists (NAICS
subsector 621).
To clarify the flow of payments
between these entities and the federal
government, note that MA organizations
submit bids (that is, proposed plan
designs and projections of the revenue
needed to provide those benefits,
divided into three categories—basic
benefits, supplemental benefits, and
Part D drug benefits) in June 2019 for
operation in contract year 2020. These
bids project payments to hospitals,
providers, and staff as well as the cost
of administration and profits. These
bids in turn determine the payments
from the Medicare Trust Fund to the
MA organizations that pay providers
and other stakeholders for their
provision of covered benefits to
enrollees. Consequently, our analysis
will focus on MA organizations.
There are various types of Medicare
health plans, including MA plans, Part
D sponsors, demonstrations, section
1876 cost plans, PDPs, and PACE plans.
Forty-three percent of all Medicare
health plan organizations are not-forprofit, and 31 percent of all MA plans
and Part D sponsors are not-for-profit.
(These figures were determined by
examining records from the most recent
year for which we have complete data,
2016.)
There are varieties of ways to assess
whether MA organizations meet the
$38.5 million threshold for small
businesses. The assessment can be done
by examining net worth, net income,
cash flow from operations, and
projected claims as indicated in their
bids. Using projected monetary
requirements and projected enrollment
for 2018 from submitted bids, 32
percent of the MA organizations fell
below the $38.5 million threshold for
small businesses. Additionally, an
analysis of 2016 data—the most recent
PO 00000
Frm 00129
Fmt 4701
Sfmt 4700
15807
year for which we have actual data on
MA organization net worth—shows that
32 percent of all MA organizations fall
below the minimum threshold for small
businesses.
Executive Order 13272 requires that
the Department of Health and Human
Services (HHS) thoroughly review rules
to assess and take appropriate account
of their potential impact on small
business, small governmental
jurisdictions, and small organizations
(as mandated by the RFA).
If a final rule may have a significant
economic impact on a substantial
number of small entities, then the final
rule must discuss steps taken, including
alternatives, to minimize burden on
small entities. The RFA does not define
the terms ‘‘significant economic impact’’
or ‘‘substantial number.’’ The Small
Business Administration (SBA) 47
advises that this absence of statutory
specificity allows what is ‘‘significant’’
or ‘‘substantial’’ to vary, depending on
the problem that is to be addressed in
the rulemaking, the rule’s requirements,
and the preliminary assessment of the
rule’s impact. To ensure that a broad
range of impacts are fully considered in
the analysis, we consider ‘‘substantial
number’’ to mean 5 percent or more of
the affected small entities within an
identified industry.
The 1984 HHS Handbook, On
Developing Low Burden and Low Cost
Regulatory Proposals, set forth the
following definitional narrative for the
term ‘‘significant economic impact’’ and
is still applicable: A rule has a
significant economic impact on the
small entities it affects, if it significantly
affects their total costs or revenues. If
the economic impact is expected to be
similar for all affected small entities and
those entities have similar costs and
revenues, then an average impact can be
calculated. If the average annual impact
on small entities is 3 to 5 percent or
more, then we consider the rule has a
significant economic impact on small
entities.
While a significant number (more
than 5 percent) of not-for-profit
organizations and small businesses are
affected by this final rule, the impact is
not significant. To assess impact, we use
the data in Table 17, which show that
the raw (not discounted) net cost of this
final rule over 10 years is $24.1 million.
Comparing this number to the total
monetary amounts projected to be
needed just for 2020, based on plan
submitted bids, we find that the impact
47 The Regulatory Flexibility Act An
Implementation Guide for Federal Agencies, pages
17–19. Issued by SBA’s Office of Advocacy, and
accessible at www.sba.gov/advo.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15808
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
of this rule is significantly below the 3
to 5 percent threshold for significant
impact. Had we compared the 2020
impact of the rule to projected 2020
monetary need, the impact would still
be less.
Consequently, the Secretary has
determined that this final rule will not
have a significant economic impact on
a substantial number of small entities,
and we have met the requirements of
Executive Order 13272 and the RFA. In
addition, section 1102(b) of the Act
requires us to prepare a regulatory
analysis for any final rule under title
XVIII, title XIX, or Part B of Title XI of
the Act that may have significant impact
on the operations of a substantial
number of small rural hospitals. We are
not preparing an analysis for section
1102(b) of the Act because the Secretary
certifies that this final rule will not have
a significant impact on the operations of
a substantial number of small rural
hospitals.
Section 202 of UMRA also requires
that agencies assess anticipated costs
and benefits before issuing any final
rule whose mandates require spending
in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2019, that threshold is approximately
$154 million. This final rule is not
anticipated to have an effect on state,
local, or tribal governments, in the
aggregate, or on the private sector of
$154 million or more.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a final
rule that imposes substantial direct
requirement costs on state and local
governments, preempts state law, or
otherwise has federalism implications.
Since this final rule does not impose
any substantial costs on state or local
governments, the requirements of
Executive Order 13132 are not
applicable.
If regulations impose administrative
costs on reviewers, such as the time
needed to read and interpret this final
rule, then we should estimate the cost
associated with regulatory review. There
are currently 750 MA contracts (which
also includes PDPs), 50 state Medicaid
agencies, and 200 Medicaid managed
care organizations (1,000 reviewers
total). We assume each entity will have
one designated staff member who will
review the entire rule. Other
assumptions are possible.
Using the wage information from the
Bureau of Labor Statistics (BLS) for
medical and health service managers
(code 11–9111), we estimate that the
cost of reviewing this final rule is
$107.38 per hour, including fringe
benefits and overhead costs (https://
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
www.bls.gov/oes/current/oes_nat.htm).
Assuming an average reading speed, we
estimate that it will take approximately
12.5 hours for each person to review
this final rule. For each entity that
reviews the rule, the estimated cost is
$1,342 (12.5 hours * $107.38).
Therefore, we estimate that the total cost
of reviewing this final rule is $1,342,000
($1,342 * 1,000 reviewers).
Note that this analysis assumed one
reader per contract. Some alternatives
include assuming one reader per parent
organization. Using parent organizations
instead of contracts will reduce the
number of reviewers to approximately
500 (assuming approximately 250
parent organizations), and this will cut
the total cost of reviewing in half.
However, we believe it is likely that
reviewing will be performed by
contract. The argument for this is that a
parent organization may have local
reviewers assessing potential regionspecific effects from this final rule.
In accordance with the provisions of
Executive Order 12866, this final rule
was reviewed by the Office of
Management and Budget (OMB).
We received no comments on our
estimates of impact on small businesses
and other items mentioned in the
Overall Impact section. Therefore, we
are finalizing this section as without
modification.
C. Anticipated Effects
1. Requirements for Medicare
Advantage Plans Offering Additional
Telehealth Benefits (§§ 422.100,
422.135, 422.252, 422.254, and 422.264)
As described in section II.A.1. of this
final rule, section 50323 of the
Bipartisan Budget Act of 2018 allows
MA plans the ability to provide MA
additional telehealth benefits to
enrollees starting in plan year 2020 and
treat them as basic benefits. In this rule,
we are finalizing—with slight
modifications—most proposed
requirements at § 422.135, which will
authorize and set standards for MA
plans to offer MA additional telehealth
benefits. Section 422.135(a) defines
these benefits as Part B services that
have been identified by the MA plan for
the applicable year as clinically
appropriate to furnish through
electronic exchange when the physician
(as defined in section 1861(r) of the Act)
or practitioner (described in section
1842(b)(18)(C) of the Act) providing the
service is not in the same location as the
enrollee. We are revising our proposed
impact estimates based on stakeholder
feedback. In the proposed rule, we set
forth the following impacts.
PO 00000
Frm 00130
Fmt 4701
Sfmt 4700
There are two primary aspects of the
MA additional telehealth benefits
provision that could affect the cost and
utilization of MA basic benefits, with a
corresponding impact on Medicare
program expenditures. The most direct
effect is the reclassification of certain
telehealth services covered by MA plans
pre-Bipartisan Budget Act of 2018 from
MA supplemental telehealth benefits to
basic benefits. This change will lead to
higher basic benefit bids, as the cost of
MA additional telehealth benefits will
be included in the basic benefit bid. The
impact on the basic benefit bid may be
muted due to the exclusion from the bid
of capital and infrastructure costs
related to MA additional telehealth
benefits.
Prior to estimating the impact on the
bid, we point out several other sources
of impact. Many studies have argued
that telehealth will increase utilization
of medical services by making them
more accessible. However, the increased
utilization could lead to increased
savings or cost. The increased
utilization could lead to significant
savings due to prevention of future
illness. Alternatively, the increased
utilization could lead to increased costs
if enrollees start seeing doctors for
complaints on which they did not
traditionally seek medical advice. We
cite studies for each possibility.
Additionally, if there are more
telehealth visits, providers may request
more in-person visits to protect
themselves from liability.
Consequently, there are four potential
impacts of this provision, which we
discuss in more detail later in this
section. The four areas are as follows:
• Impact on the Medicare Trust Fund
• Savings for Enrollees due to
Decreased Travel Time to Providers
• Savings from Illness Prevention due
to Increased Access to Services
• Increased Costs if Unnecessary
Medical Visits Increase
The final rule allows for differential
cost sharing. We expect that enrollees
would incur lower cost sharing from
telehealth services than they would
from in-person visits. This would result
in enrollee savings. However, we have
no way of estimating this savings
because we lack any data experience
with this differential cost sharing.
Therefore, we are scoring this as a
qualitative savings.
Because of the wide variability in
potential impact, in the proposed rule
we solicited comments on best practices
in telehealth and the resulting savings.
In the following sections, we summarize
and respond to these comments.
E:\FR\FM\16APR2.SGM
16APR2
15809
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
a. Impact on the Medicare Trust Fund
Superficially, there appears to be no
program change since the provision
simply reclassifies certain benefits as
basic instead of MA supplemental.
Thus, the same benefits are provided.
However, a closer look at the language
and assumptions of the provision show
that, while collectively MA additional
telehealth benefits will yield a
negligible change in program spending,
there is a small transfer of costs
(estimated to be 0.002 percent of the MA
baseline) from enrollees to the Medicare
Trust Fund, associated with
reclassifying these benefits from MA
supplemental benefits to basic benefits.
MA supplemental benefits are generally
paid with rebates while basic benefits
are paid by a capitation rate, calculated
with reference to the bid. For MA plans
to provide benefits using rebates
requires additional funding since the
amount of rebates provided by the
Medicare Trust Fund averages only
$0.66 on the dollar. Thus, the effect of
the rebate aspect is that the enrollee
either pays a lower supplemental
premium or receives richer MA
supplemental benefits. In either case,
whether the enrollee saves or receives
richer MA supplemental benefits, the
Medicare Trust Fund incurs a cost. It
follows that this provision creates a cost
transfer from the Medicare Trust Fund
to enrollees. The direction of the cost is
classified by whether the Medicare
Trust Fund loses or gains. In this case,
since the Medicare Trust Fund loses
money, we classify the transfer as a cost.
However, the transfer results in a
savings to enrollees. After accounting
for the exclusion of capital and
infrastructure costs, and backing out the
Part B premium, the extra cost to the
Medicare Trust Fund is projected to be
$80 million over 10 years. The
calculations for these 10 years are
presented in Table 7 and discussed in
the narrative.
In order to estimate the 10-year
impact (2020 through 2029) of the MA
additional telehealth benefits provision
on the Medicare Trust Fund, we
considered the following six factors.
• First, we estimated the costs of MA
additional telehealth benefits that are to
be transferred from MA supplemental
telehealth benefits to basic benefits.
Using the 2019 submitted bid
information, we estimated that $0.09 per
member per month (PMPM) will be
transferred. We computed $0.09 by
examining and averaging the largest
organizations’ MA supplemental
telehealth benefits, particularly under
the category ‘‘Web and Phone Based
Technology.’’ The reason for basing
estimates on the largest organizations is
that in past years, only the largest
organizations included the category
‘‘Web and Phone Based Technology’’ as
a separate line item in their bids; by
contrast, the other organizations
combined multiple, non-telehealth
benefits in the same line as the MA
supplemental telehealth benefits, and so
we were not able to distinguish the costs
between telehealth and non-telehealth
for the smaller organizations.
Information from the 2018 Medicare
Trustees Report 48 shows that the
applicable medical-inflation trend that
should be applied to the $0.09 PMPM is
5.2 percent per year; the average trend
can be derived from information in
Table IV.C3 of this report.
• We applied the PMPM amounts to
the projected MA enrollment for the
years 2020 through 2029. The source of
the projected MA enrollment is Table
IV.C1 of the 2018 Medicare Trustees
Report.
• We assumed that 15 percent of the
MA additional telehealth benefits will
be considered capital and infrastructure
costs. As discussed in section II.A.1. of
this final rule, these costs are excluded
from the Medicare Trust Fund payments
for MA additional telehealth benefits.
We obtained the 15 percent assumption
by subtracting the 85 percent required
medical loss ratio (MLR) from 100
percent. We used the MLR as a proxy for
the medical share of provider payments.
• We applied the average rebate
percentage of 66 percent, which is based
on the expected submitted bid
information, including expected
enrollment and expected average Star
Ratings.
• We applied a factor of 86 percent to
the calculation, which represents the
exclusion or the backing out of the Part
B premium.
• However, per OMB guidance,
ordinary inflation should be carved out
of estimates, while medical inflation,
which outpaces ordinary inflation (as
well as enrollment growth), may be
retained. The source of the ordinary
inflation is Table IV.D1 of the 2018
Medicare Trustees Report. It is 2.6
percent per year for each of the years
2020 through 2029.
TABLE 7—CALCULATIONS OF NET COSTS PER YEAR TO THE MEDICARE TRUST FUND FOR MA ADDITIONAL TELEHEALTH
BENEFITS
Year
khammond on DSKBBV9HB2PROD with RULES2
2020
2021
2022
2023
2024
2025
2026
2027
2028
2029
MA enrollment
(in thousands)
PMPM cost
Number of
months per
year
Gross amount
($ in millions)
Capital and
infrastructure
costs
(%)
Average
rebate
percentage
(%)
Backing out
of Part B
premium
(%)
(A)
(B)
(C)
(D)
Net cost
($ in millions)
Ordinary
inflation
(%)
Net costs
($ in millions)
(A * (1 – B) *
(1 – C) * (D))
(E)
(F)
(E)/(1 + (F)) ∧
(year-2019)
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
21,995
22,873
23,739
24,584
25,395
26,198
26,986
27,737
28,455
29,101
0.09
0.10
0.10
0.11
0.12
0.12
0.13
0.14
0.14
0.15
12
12
12
12
12
12
12
12
12
12
25.0
27.3
29.8
32.5
35.3
38.4
41.6
44.9
48.5
52.2
15
15
15
15
15
15
15
15
15
15
66
66
66
66
66
66
66
66
66
66
86
86
86
86
86
86
85
85
85
85
6.2
6.8
7.4
8.1
8.8
9.5
10.2
11.0
11.9
12.8
2.6
2.6
2.6
2.6
2.6
2.6
2.6
2.6
2.6
2.6
6.1
6.5
6.9
7.3
7.7
8.2
8.5
9.0
9.5
9.9
Raw Total .......
........................
........................
........................
........................
........................
........................
........................
........................
........................
79.6
Combining these six factors, we
calculated the net costs to the Medicare
Trust Fund to be $6.1 million in 2020,
$6.5 million in 2021, $6.9 million in
2022, $7.3 million in 2023, and $7.7
million in 2024. We calculated the net
costs to the Medicare Trust Fund for
years 2025 through 2029 to be $8.2
million, $8.5 million, $9.0 million, $9.5
48 https://www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-and-Reports/
ReportsTrustFunds/Downloads/TR2018.pdf.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
PO 00000
Frm 00131
Fmt 4701
Sfmt 4700
E:\FR\FM\16APR2.SGM
16APR2
15810
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
million, and $9.9 million, respectively.
The calculations of impact for years
2020 through 2029 are summarized in
Table 7. The total cost for all 10 years
is found in the right-most column of
Table 7, titled ‘‘Net Costs.’’
b. Savings for Enrollees Due to
Decreased Travel Time to Providers
MA additional telehealth benefits will
save enrollees the cost of traveling to
and from providers. Currently, Medicare
telehealth services are used to bring
healthcare services to MA enrollees,
including those in rural locations. In
their comments on the proposed rule, as
well as in response to specific inquiries
we made in the proposed rule related to
telehealth, stakeholders have informed
CMS that MA enrollees benefit from the
use of telehealth services to reduce
travel times and have greater access to
providers that may not otherwise be
available. Several commenters provided
specific details from their own
experiences on the nature of these
savings.
khammond on DSKBBV9HB2PROD with RULES2
(1) Assumptions
Prior to our actual estimation of the
savings for enrollees due to decreased
travel time to providers, we discuss
seven assumptions underlying our
calculations.
(a) Current MA Supplemental
Telehealth Benefits’ Usage
Under the current MA program, MA
plans may offer MA supplemental
telehealth benefits in the form of
telemonitoring and remote access
technologies (including nursing
hotlines).49 However, the plan benefit
package software does not have
sufficient granularity to identify which
types of MA supplemental telehealth
benefits are being offered. Analyzing
supporting documentation for the plan
bids, the Office of the Actuary (OACT)
has found an average spending of $0.09
PMPM for MA supplemental telehealth
benefits among the large MA plans
(smaller plans do not provide this data).
OACT estimates that in 2019 there will
be an average rebate of $110 PMPM. Of
this $110, on average, 44 percent is
applied to reduction in cost sharing
(compared to cost sharing in original
Medicare for Part A and B benefits), and
32 percent is applied to buying down
the Part B and Part D premiums, leaving
24 percent or $27 PMPM with which to
fund additional services. It follows that
large MA plans use only 0.33 percent
($0.09/$27) of available rebate resources
49 Chapter 4 of the Managed Care Manual, Section
30.3 https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/Downloads/
mc86c04.pdf.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
to fund MA supplemental telehealth
benefits. It is reasonable that the $0.09
PMPM average for large MA plans is
even less for smaller plans who may not
have the resources to be as aggressive in
their MA supplemental telehealth
benefit designs.
These considerations—coupled with a
discussion of how CMS and
stakeholders expect telehealth to be
used—suggest that while current MA
policy theoretically allows MA
supplemental telehealth benefits, they
are not being significantly offered. The
arguments for this are as follows:
• Telehealth Specialties and
Telemonitoring: In response to our
discussion and request for comments in
the proposed rule, commenters
enthusiastically supported the MA
additional telehealth benefits proposal
as a saver precisely because both
telemonitoring and certain specialties—
especially dermatology, cardiology, and
psychiatry—will be used significantly
more often under these new benefits.
Commenters pointed out that there are
not enough dermatologists,
cardiologists, and psychiatrists to
provide all needed services in rural
areas. The availability of MA additional
telehealth benefits will remedy a lack of
access based on this lack of resources.
Some commenters related their personal
experience and the savings they
expected to accrue. No commenter
dissented whether this provision would
significantly save. The tone of the
comments seem to imply that these
commenters believed that the final rule
would allow these MA additional
telehealth benefits or greatly facilitate
their offering.
• Current Allowed MA Supplemental
Telehealth Benefits: As discussed
previously in the estimates of impact on
the Medicare Trust Fund, we found that
approximately $0.09 PMPM was being
used for current MA supplemental
telehealth benefits (telemonitoring and
remote access technologies). Telehealth
services are not low-cost (though they
cost less than in-person visits). This
$0.09 must pay for the provider review
and assessment. Hence, this $0.09
reflects a significantly low utilization.
The following simple hypothetical
example illustrates this. Suppose in a
plan, once a month, 30 enrollees in a
plan with 8,300 total enrollees are using
MA supplemental telehealth benefits,
which costs $100/hr and takes 15
minutes to review. Then the cost to the
plan is 30 enrollees × $100/hr × 0.25 hr
= $750. However, the cost per enrollee
is $750/8,300 = $0.09. This illustrative
example with hypothetical numbers
clarifies why we are inferring from the
PO 00000
Frm 00132
Fmt 4701
Sfmt 4700
$0.09 that plan utilization is extremely
low.
Although this $0.09 reflects the cost
to the plan, it is legitimate to use this
to estimate savings to enrollees. The
logic behind this is as follows. The low
cost of $0.09 indicates low utilization,
and it is the low utilization which
drives our assumption that few
enrollees are spending travel time
currently. For example, in our simple
hypothetical example above, without
MA additional telehealth benefits, only
30 enrollees would have to travel back
and forth to a provider once a month.
We are estimating that, under this final
rule, there would be more usage of
telehealth; we expect more than 30
enrollees to use this and we expect it to
be used more than once a month.
Without MA additional telehealth
benefits, this would necessitate the cost
of travel, while with MA additional
telehealth benefits, there is no travel;
hence, the estimate of savings is
justified. Tables 8 and 9 indicate the
frequency of utilization we expect over
the next 10 years.
Despite the previous arguments, we
must concede that currently some
telehealth benefits are being offered as
MA supplemental telehealth benefits. In
the absence of further data, we are
making an assumption that less than 50
percent of the telehealth services that
will be furnished under this final rule
are currently available. This assumption
has intuitive appeal. If only $0.09 out of
$27 is being used for MA supplemental
telehealth benefits, while the remaining
$26.91 is being used to fund nontelehealth benefits, it is very reasonable
to assume that current utilization is less
than 50 percent of what it is expected
to become under the final rule when
plans can fund these benefits from the
Medicare Trust Fund without using
their rebate dollars.
(b) Possible Overutilization
In the proposed rule, although we did
estimate the potential savings to
enrollees from reduced travel time to
and from providers arising from MA
additional telehealth benefits, we did
not include this estimate in the
summary and accounting tables (Tables
16 and 17) because there was a concern
that telehealth would possibly lead to
overutilization of provider visits, thus
offsetting the savings. We address this
concern in the following points:
• Only one article raised this concern,
and the article itself listed several
drawbacks to its conclusion.50 More
specifically, the article—
50 J. Ashwood, A. Mehrotra, D. Cowling, and L.
Uscher-Pines, ‘‘Direct to Consumer Telehealth May
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
++ Used data from only one
telehealth company;
++ Used data on only specific
medical conditions;
++ Referenced a population study
that had a ‘‘low uptake of telehealth;’’
and
++ Was from an early period in
telehealth.
Despite low uptake of telehealth in
2013, we have seen a significant
increase in telehealth usage over the
past few years. Furthermore, one article
on telehealth points to the importance
of patient buy-in, which is more
common today.51
• To better understand the concern
regarding overutilization, we solicited
comments in the proposed rule on
whether MA additional telehealth
benefits would save enrollees due to
reduced travel time. We received
numerous comments from several
sources, and the commenters were
overwhelmingly supportive. The
comments were not subjective but
evidence-based, reflecting MA plans’
first-hand experience with telehealth in
some of their existing products. Some
commenters specifically addressed the
travel time issue. For example, a
commenter indicated that virtual visits
can not only reduce patient travel time,
but can also potentially supplant
nursing and in-home visits. In addition,
the commenter referenced a virtual care
experience in one particular plan which
spoke to both clinician and patient timein-transit savings. Other commenters
simply echoed the travel time estimates
in the proposed rule. However, many
commenters discussed increased usage
of telehealth services particularly in
specialties such as cardiology,
psychiatry, and dermatology, and
especially in rural areas where there is
a shortage of specialists.
Based on the previous discussion, we
are including our estimates of travel
savings in the summary and accounting
tables (Tables 16 and 17). In making
these estimates, we are assuming that
the number of visits will remain the
same overall but that a certain
percentage of the in-person visits will be
replaced by visits through electronic
Increase Access to Care but Does not Decrease
Spending,’’ Health Affairs 36(3), 2017, accessible at
https://www.healthaffairs.org/doi/10.1377/
hlthaff.2016.1130.
51 Harry Wang, Director Health and Mobile
Product Research, Parks Associates ‘‘Virtual Health
Care will revolutionize the Industry If we let it’’,
Forbes, 2014, accessible at https://www.forbes.com/
sites/ciocentral/2014/04/03/virtual-health-carevisits-will-revolutionize-the-industry-if-we-let-it/
#4ee9a9e97c25; https://www.forbes.com/sites/
ciocentral/2014/04/03/virtual-health-care-visitswill-revolutionize-the-industry-if-we-let-it/
#4ee9a9e97c25.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
exchange from MA additional telehealth
benefits.
(c) Telehealth Provider Utilization by
Age
The available statistics discuss
telehealth without adequate distinction
based on age. It is very likely that a
breakout by age would give more
precise estimates, but unfortunately we
do not have such data.
(d) Avoiding Overestimation of
Telehealth Growth
In creating a 10-year estimate, there
are several conflicting sources with the
growth of telehealth visits. To avoid
problems of overestimation, we adopted
the lower growth rate estimates. We
present numerical details of this
approach in the section containing the
actual estimates.
(e) Enrollee Savings Versus Medicare
Trust Fund Impact
We explicitly clarify that the $80
million cost over 10 years, estimated in
Table 7, is a cost incurred by the
Medicare Trust Fund and represents a
transfer from the government to
enrollees, because the rebate dollars that
formerly paid for MA supplemental
telehealth benefits are now being freed,
possibly, for additional benefits to
enrollees either in the form of MA
supplemental benefits or reduced cost
sharing. However, the savings described
are savings to enrollees.
(f) Internet Access in the 65+ Population
Our estimates of impact include a
trend factor for increased general use of
telehealth over the next few years. This
trend factor is for the entire population.
We therefore clarify that we do not
believe that access to telehealth will be
lower in the 65+ population because of
the following:
• Telehealth does not exclusively
require broadband internet capability;
for example, telehealth access may also
be provided through cell phones
providing internet access.
• Many seniors have children or other
members of their social support group
who regularly visit them and could
provide internet access through laptops,
tablets, cell phones, or other internetcapable devices during their visits.
• There is now a large market for
internet access, possibly without
computers, offered by major
manufacturers and targeted specifically
for seniors. Current products include
smart televisions allowing access
without a computer, laptops specifically
designed for seniors, and free or lowcost laptops provided by a number of
national and local organizations in an
PO 00000
Frm 00133
Fmt 4701
Sfmt 4700
15811
effort to specifically encourage senior
computer use.
• There are a variety of free online
courses specifically targeted to seniors
to facilitate familiarity with internet
usage.
Therefore, we believe that the
uniformity of trend for telehealth access
is not an issue.
(g) Healthcare Savings
Although we are including in our
impact analysis the savings to enrollees
arising from reduced travel time, we are
not including a quantification of
healthcare savings. The commenters
overwhelmingly supported the idea that
telehealth would reduce healthcare
spending due to increased preventive
measures, consequent reduced
readmissions and reduced initial
hospitalizations, and greater access to
certain specialties where access is
currently low, such as cardiology,
psychiatry, and dermatology.
Furthermore, in the proposed rule, we
had provided references, estimating in
specific (typically one-time) settings,
and the healthcare savings per inpatient
enrollee. We have omitted mention of
these studies in this final rule because
MA additional telehealth benefits only
apply to Part B services, not to inpatient
services. However, commenters merged
comments about savings from both
inpatient telehealth and specialty
telehealth such as tele-cardiology, teledermatology, and tele-psychiatry. In
general, the commenters were
enthusiastic about all aspects of
telehealth saving money for both Part B
and Part A services. Many of the
commenters cited similar studies or
their own experience. These articles and
comments point to a quantitative
savings in health care. Although, as
mentioned previously, in the early years
of telehealth there was concern for
overutilization which would raise costs,
this does not seem to be major issue
today.
However, we are not quantifying the
healthcare savings since each dollar of
healthcare savings does not
automatically become a dollar reduction
in Medicare Trust Fund expenditures
paying for plan bid estimates. As a
simple example, some savings may
translate to higher administrative
margins (increased profits). Similarly, a
portion of the healthcare savings may be
allocated to increased benefits, for
example, preventive benefits. We do not
have a basis for quantifying these
factors. Therefore, we are leaving the
healthcare savings as a qualitative
impact without further quantification.
E:\FR\FM\16APR2.SGM
16APR2
15812
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
(2) Actual Estimation
Having completed our discussion of
assumptions, we next turn to the actual
estimation. We require four component
estimates to estimate aggregate savings
for enrollees due to decreased travel
time to providers. We provide these four
component estimates as follows:
(a) Average Travel Time and Average
Travel Distance per Visit
khammond on DSKBBV9HB2PROD with RULES2
While it is difficult to estimate the
savings in reduced travel time
quantitatively, since distances from
enrollees to providers vary significantly,
to estimate the travel time to providers
we use a former CMS standard that
providers should be located within 30
minutes or 30 miles of each enrollee.
While this standard has since been
replaced by a more sophisticated
measurement of access, we can use it as
a proxy. The former CMS standard was
used because it is formulated simply in
terms of time (30 minutes) and mileage
(30 miles) and does not differentiate
among provider types. The current
standards for access involve
sophisticated algorithms, which involve
more than two parameters (time and
mileage) and additionally differ by
geographic location and provider types.
Therefore, the current standards were
not suitable due to their complexity. We
therefore assume that the midpoint, 15
minutes or 0.25 hour, represents the
typical travel time to providers per
enrollee visit. We note that our estimate
of 30 minutes round-trip is close to the
37-minute estimate used in one
article.52 Similarly, we believe that 15
miles (one-half of 30 miles) is the
average travel distance per provider
visit.
In estimating the savings in wages due
to reduced travel time, we first note that
the group of individual respondents
varies widely by respondent age,
location, years of employment,
educational attainment, and working
status with many people over 65 retired.
To deal with this variability, we follow
the OMB guidance for estimating hourly
wages for enrollees using the
52 J. Ashwood, A. Mehrotra, D. Cowling, and L.
Uscher-Pines, ‘‘Direct to Consumer Telehealth May
Increase Access to Care but Does not Decrease
Spending,’’ Health Affairs 36(3), 2017, accessible at
https://www.healthaffairs.org/doi/10.1377/
hlthaff.2016.1130.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
occupational title ‘‘All Occupations’’
(occupation code 00–0000 on the BLS
website), with a mean wage of $24.34/
hour. This guidance reflects the OMB
approach that all time should have a
dollar value. However, since we believe
most MA enrollees are not working, we
are not adding 100 percent for overtime
and fringe benefits. In other words, we
are scoring the wages as $24.34/hour.
Thus, the net impact per enrollee per
telehealth visit to providers would be
$18.17 (15 miles * 2 (round trip) * $0.20
per mile (cost of gasoline for medical
transportation 53) + 0.25 hours travel
time * 2 (round trip) * $24.34/hr). The
$0.20 per mile for cost of gasoline for
medical transportation reflects updated
numbers by the Internal Revenue
Service (IRS) for 2019. As discussed
previously, we assume that at most 50
percent of expected telehealth visits are
currently being offered. Therefore, we
save at most $9.09 (0.5 × $18.17) per
enrollee per telehealth visit. The actual
percentage saved may be significantly
more than 50 percent. This is
summarized in Table 8.
(b) Average Number of Visits per
Enrollee
In 2014, the Centers for Disease
Control and Prevention (CDC) estimated
that persons 65 years of age and older
average 5.89 visits per person per year.54
(c) Number of MA Enrollees
Table IV.C1 of the 2018 Medicare
Trustees Report provides the projected
MA enrollment.
(d) Percent, per Year, of Provider Visits
That Are Telehealth
Ideally, we would like an estimate on
the number of total visits and telehealth
visits for 65-year-olds. However, these
data are not available. Therefore, we use
the best available proportions. We
proceed as follows.
The CDC website cited earlier
estimates 885 million provider visits in
2014. This is an aggregate number over
all age groups; the 885 million was not
broken out further by age group.
Absent information on the proportion
of telehealth visits among total visits by
53 https://www.irs.gov/newsroom/irs-issuesstandard-mileage-rates-for-2019.
54 https://www.cdc.gov/nchs/products/databriefs/
db292.htm; https://www.cdc.gov/nchs/products/
databriefs/db292.htm.
PO 00000
Frm 00134
Fmt 4701
Sfmt 4700
65-year-olds to providers, we use
general averages (across all age groups)
with the understanding that some
accuracy is lost. The Statista website
suggests 22 million telehealth visits in
2014.55 This implies that 2.49 percent
(22/885) of all physician visits were
telehealth visits.
Inferring growth rates from the
numbers on the Statista website, the
projected low and high growth rates for
telehealth services are 8.9 percent and
22 percent respectively. Other websites
give similar ranges. For example, Becker
gives three estimates for telehealth
growth rates of 14.3 percent, 16.5
percent, and 27.5 percent.56 Because of
this variability, we use the lower
estimate for projected telehealth growth,
which is about 8.9 percent. These
numbers can be used to estimate the
proportion of provider visits that will be
telehealth in future years. For example,
in 2015, we assume 1.089 (growth rate)
* 2.49 percent (proportion of provider
visits that are telehealth in 2014) = 2.71
percent of provider visits will be
telehealth visits.
Multiplying these four component
estimates together—average savings per
visit ($9.09) * visits per enrollee (5.89)
* number of MA enrollees * percent of
provider visits that are telehealth (2.49
percent * 1.089 per year)—we arrive at
a conservative aggregate savings
estimate of $30 million, growing to $50
million in 2024, and $88 million in
2029. Had we used the higher projected
visits, we would have obtained $30
million, growing to $280 million. The
aggregate savings over 10 years is $557
million. The results are summarized in
Table 9.
55 https://www.statista.com/statistics/820756/
number-of-telehealth-visits-in-us/; https://
www.statista.com/statistics/820756/number-oftelehealth-visits-in-us/.
56 See https://www.beckershospitalreview.com/
healthcare-information-technology/telemedicine-toattract-7m-patient-users-by-2018-12-statistics-onthe-thriving-market.html; https://
www.beckershospitalreview.com/telehealth/globaltelemedicine-market-to-experience-16-5-annualgrowth-rate-through-2023.html; https://
www.beckershospitalreview.com/healthcareinformation-technology/the-growth-of-telehealth20-things-to-know.html; https://
www.beckershospitalreview.com/telehealth/globaltelemedicine-market-to-experience-16-5-annualgrowth-rate-through-2023.html.
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
15813
TABLE 8—TRAVEL SAVINGS PER PROVIDER VISIT, TELEHEALTH
Label
Item
Amount
Source
(A) ...........
One way travel to provider .................................
0.25 hours ......
Prior CMS standard of provider availability within 30 minutes or
30 miles. We use the midpoint of 30 and 0 minutes, or 15
minutes/0.25 hours. An alternative approach uses the Health
Affairs article of 37 minutes total.
(B) ...........
(C) ...........
Travel to and from provider ................................
Wages for enrollee per hour ...............................
2
$24.34 ............
(D) ...........
(E) ...........
Mileage cost per mile for medical travel .............
Mileage ...............................................................
$0.20 ..............
15 miles .........
(F) ...........
(G) ...........
(H) ...........
Wage savings per provider visit .........................
Mileage savings per provider visit ......................
Factor to be applied for current telehealth
usage.
$12.17 ............
$6.00 ..............
0.50 ................
Total savings per visit ..................................
$9.09 ..............
OMB guidance, use of occupational code 00–0000 on BLS
website. OMB provided further guidance that, although it supports the idea of dollar value of time, since many enrollees
are retirees, the wage estimate should not be doubled to reflect overhead and benefits.
IRS website.
Prior CMS standard of provider availability within 30 minutes or
30 miles. We use the midpoint of 30 and 0 miles, or 15 miles.
(A) * (B) * (C).
(E) * (B ) * (D).
Currently, only 0.3% of rebate dollars available for supplemental
benefits are spent on telehealth services. This small percentage suggests that, at most, half of all expected telehealth
services are currently being offered.
0.5 × [(F) + (G)]
Notes: This table reflects savings based on the following two assumptions: The value of enrollee time is $24.34/hr and at most 50% of expected telehealth is being offered.
TABLE 9—TRAVEL SAVINGS PER YEAR, TELEHEALTH
Total travel
savings ($ in
thousands) to
enrollees from
telehealth
Year
2020
2021
2022
2023
2024
2025
2026
2027
2028
2029
Provider
visits per
enrollee
Percent of
provider
visits that
use
telehealth
(percent)
.............................................................................
.............................................................................
.............................................................................
.............................................................................
.............................................................................
.............................................................................
.............................................................................
.............................................................................
.............................................................................
.............................................................................
$30,903.7
34,912.4
39,441.6
44,440.5
50,048.2
56,218.7
63,057.8
70,572.1
78,981.9
88,393.9
23,181
24,062
24,972
25,858
26,708
27,549
28,375
29,161
29,969
30,799
$9.09
9.09
9.09
9.09
9.09
9.09
9.09
9.09
9.09
9.09
5.89
5.89
5.89
5.89
5.89
5.89
5.89
5.89
5.89
5.89
2.49
2.71
2.95
3.21
3.50
3.81
4.15
4.52
4.92
5.36
Raw Total ..............................................................
556,970.9
............................
........................
........................
........................
c. Savings From Illness Prevention Due
to Increased Access to Services
khammond on DSKBBV9HB2PROD with RULES2
MA enrollment
(in thousands)
Savings per
telehealth
visit
Telehealth savings due to preventive
telemonitoring may arise from easier or
increased access to Part B services. The
MA additional telehealth benefits to be
included in the MA basic benefit bid
stem from the Bipartisan Budget Act of
2018 amendment of section 1852 of the
Act, and will likely represent a mix of
replacement of pre-Bipartisan Budget
Act of 2018 in-person visits and
additional Part B services. We believe
that increased coverage of the MA
additional telehealth benefits will
generally result in an aggregate
reduction in use of emergency room
visits and inpatient admissions because
the relative increased ease of receiving
healthcare services should improve
health outcomes and reduce avoidable
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
utilization that results from untreated
conditions that exacerbate illness.
Several studies predict that telehealth
can significantly reduce illness through
prevention. We mention two situations
where Part B services could be provided
by a physician or practitioner via MA
additional telehealth benefits: (1)
Comprehensive medication reviews and
(2) post-discharge transitional care
programs.
(1) Comprehensive Medication
Reviews 57
Telehealth can help significantly with
patients who need multiple
medications. Remote medication
57 Our
current MA program allows
telemonitoring, hospital readmission prevention
programs, and post-discharge in home medication
reconciliation.
PO 00000
Frm 00135
Fmt 4701
Sfmt 4700
management can reduce the multiple
patient visits that are often necessary to
get the appropriate mix of medications.
One recent meta-study on medication
reviews summarizes seven studies,
showing that using comprehensive
medication reviews reduced
hospitalizations, readmissions, drugs,
and mortality.58
(2) Post-Discharge Transitional Care
Programs
Telehealth has been used to provide
transitional care for discharged hospital
patients. One study found a savings of
$1,333 per beneficiary, half of which
58 Evan A. DeZeeuw, PharmD; Ashley M.
Coleman, PharmD; and Milap C. Nahata, PharmD,
MS, ‘‘Impact of Telephonic Comprehensive
Medication Reviews on Patient Outcomes’’, Am J
Manag Care. 2018;24(2):e54–e58.
E:\FR\FM\16APR2.SGM
16APR2
15814
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
was due to reduced inpatient follow-up
care.59
In the proposed rule, we solicited
comments on potential savings.
Numerous commenters were
overwhelmingly supportive of CMS’s
projected savings. Furthermore, they
backed their support with quantifiable
details from their own experiences in
their various products. Commenters
particularly emphasized healthcare
savings due to increased preventive
care, significantly reduced hospital
admissions, and increased access to
specialties with insufficient providers to
meet current demands (for example,
tele-cardiology, tele-psychiatry, and
tele-dermatology).
khammond on DSKBBV9HB2PROD with RULES2
d. Increased Costs if Unnecessary
Medical Visits Increase
We have moved the content in this
section of the proposed rule to the
previous section ‘‘Possible
Overutilization.’’ We noted that we
received overwhelming support from
commenters that there should be no
concern about overutilization, and the
one article citing this concern is an old
article in a very specific setting (the
article itself cast doubt on its own
findings).
We are finalizing our requirement that
MA plans must advise enrollees that
they may receive the specified Part B
service(s) either through an in-person
visit or through electronic exchange
(§ 422.135(c)(2)). As discussed in
section II.A.1. of this final rule, based on
public comments, we are not finalizing
the portion of proposed § 422.135(c)(2)
that referenced the Evidence of
Coverage (EOC) document as the
required vehicle for this notification.
Instead, we intend to address the EOC
in future subregulatory guidance.
We received the following comments,
and our responses follow.
Comment: In response to CMS’s
request for comments in the proposed
rule on whether there would be savings
to enrollees arising from reduced travel
time to and from providers, several
commenters expressed overwhelming
support. More specifically, there were
no dissenting comments that
overutilization of services would reduce
these enrollee savings.
Response: We appreciate the
commenters’ support. Although there
will be no change in policy, based on
59 Keith Kranker, Ph.D.; Linda M. Barterian, MPP;
Rumin Sarwar, MS; G. Greg Peterson, Ph.D.; Boyd
Gilman, Ph.D.; Laura Blue, Ph.D.; Kate Allison
Stewart, Ph.D.; Sheila D. Hoag, MA; Timothy J. Day,
MSHP; and Lorenzo Moreno, Ph.D. ‘‘Rural Hospital
Transitional Care Program Reduces Medicare
Spending’’, Am J Manag Care. 2018;24(5):256–260.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
these comments, we are confident in
including the savings due to reduced
enrollee travel time to and from
providers in the summary and
accounting tables (Tables 16 and 17).
This will result in a $557 million
savings over 10 years, making this final
rule economically significant.
Comment: In response to CMS’s
request for comments in the proposed
rule on whether telehealth would
significantly reduce medical spending, a
variety of commenters also expressed
overwhelming support. Commenters
pointed out that savings would arise
from increased prevention, reduced
hospital readmissions, and increased
access in such areas as tele-dermatology
and tele-psychiatry. Commenters
frequently provided statistics based on
their own experience.
Response: We thank the commenters
for their support. Although it is clear
that telehealth will result in healthcare
savings, we do not have enough
information to estimate the impact on
reductions of Medicare Trust Fund
payments. Consequently, we are scoring
this as a qualitative savings in this final
rule.
We received several comments on our
estimated impacts for MA additional
telehealth benefits. The comments were
overwhelmingly supportive with no one
dissenting to our impact estimates. After
careful consideration of all comments
received, and for the reasons set forth in
our responses to the related comments
summarized earlier, we are finalizing
our impact analysis for this provision
with the following modification. We are
revising our proposed impact of this
rule. The final rule is now expected to
be an economically significant rule that
will save enrollees $557 million over 10
years. The savings to enrollees are due
to the MA additional telehealth benefits
provision, which will reduce enrollee
travel time to and from providers.
SNPs other than FIDE SNPs and HIDE
SNPs, which are also defined at § 422.2.
As noted in the preamble of the
proposed rule and at section II.A.2.a. of
this final rule, many of the changes we
proposed would unify and streamline
existing requirements, which should
reduce burden and are therefore not
expected to have impact. For example—
• Passive enrollment: The reference
to the definition of a HIDE SNP at
§ 422.2 will not materially change the
plan types that are eligible for passive
enrollment; rather, the existing rule
simply refers to them as the D–SNPs
that meet a high standard of integration
under the supplemental benefit
authority at § 422.102(e); and
• Enhanced Supplemental Benefits:
We are also clarifying at § 422.102(e)
that not only are HIDE SNPs that meet
minimum quality and performance
standards eligible to offer supplemental
benefits, but FIDE SNPs that similarly
meet minimum quality and performance
standards may do so as well. While this
amendment does not change what has
occurred in practice, we believe it
clarifies the types of plans that are
eligible to offer enhanced supplemental
benefits.
2. Integration Requirements for Dual
Eligible Special Needs Plans (§§ 422.2,
422.60, 422.102, 422.107, 422.111, and
422.752)
The impacts were presented in
section III.B.2. of this final rule.
However, the COI reduced the cost to
state Medicaid agencies by 50 percent,
reflecting a 50 percent Federal Financial
Participation (FFP) rate; consequently,
the RIA must include this 50 percent
FFP rate as a cost to the federal
government. Table 10 repeats the
analysis summarized in Table 4 and
includes transfers to the federal
government. The narrative
accompanying Table 4 presents our
assumptions in reaching this impact as
well as our assumption that there are no
costs in subsequent years. As noted in
section III.B.2. of this final rule, wage
estimates and occupational titles were
updated to reflect greater specificity as
well as the latest BLS wage data.
As stated in the earlier in the
preamble of this final rule, starting in
2021, section 50311(b) of the Bipartisan
Budget Act of 2018 establishes new
Medicare and Medicaid integration
standards for MA organizations seeking
to offer D–SNPs and enrollment
sanctions for those MA organizations
that fail to comply with the new
standards. We proposed to add a revised
definition for ‘‘D–SNP’’ at § 422.2 and
establish at § 422.107 revisions to the
existing minimum state Medicaid
agency contracting requirement for D–
As detailed in this section, the total
first year cost is $3.9 million ($3.4
million to plans + $0.25 million to State
Medicaid Agencies and $0.25 million to
the federal government). The $3.9
million represents a true cost since it
pays for the services of lawyers,
software developers and programmers,
and business operation specialists. Of
this $3.9 million, $3.4 million is a cost
to plans, while $0.5 million is a cost to
the state Medicaid agencies which
transfers $0.25 million to the federal
government.
PO 00000
Frm 00136
Fmt 4701
Sfmt 4700
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
15815
TABLE 10—FIRST YEAR COSTS OF D–SNP INTEGRATION REQUIREMENTS
44 (states) ............
24
1,056
136.44
......................
72,040
72,040
13 .........................
13 .........................
160
160
2,080
2,080
98.54
72.84
......................
102,482
75,754
102,482
75,754
190 (D–SNPs) ......
8
1,520
136.44
207,389
......................
......................
116 .......................
116 .......................
160
160
18,560
18,560
98.54
72.84
1,828,902
111,351,910
......................
......................
Total by Stakeholder ...................................
...............................
......................
......................
......................
3,388,201
250,276
250,276
3. Unified Grievance and Appeals
Procedures for Dual Eligible Special
Needs Plans and Medicaid Managed
Care Plans at the Plan Level (§§ 422.560
Through 422.562, 422.566, 422.629
Through 422.634, 438.210, 438.400, and
438.402)
khammond on DSKBBV9HB2PROD with RULES2
Transfers to
federal
government
($)
Initial update by state Medicaid agency of its
contracts with D–SNPs.
Initial establishment of system for notification of
hospital and SNF admissions by state Medicaid agency.
Initial update by D–SNPs of their contracts with
state Medicaid agency.
Initial notification of hospital and SNF admissions by D–SNPs to state Medicaid agency.
The addition of the appeals and
grievances provisions at §§ 422.629
through 422.634 focus on creating MA
and Medicaid appeal and grievances
processes that are unified for D–SNPs
that also have comprehensive Medicaid
managed care contracts (or are the
subsidiary of a parent organization or
share a parent organization with the
entity with a comprehensive Medicaid
managed care contract) and have
exclusively aligned enrollment. The
final rule addresses appeals at the plan
level. Currently, Medicaid and MA
appeals and grievance processes differ
in several key ways. These differences
hinder a streamlined grievance and
appeals process across Medicare and
Medicaid managed care sectors and
create unnecessary administrative
complexity for plans that cover dual
eligible individuals for both Medicare
and Medicaid services. These new
regulations will allow enrollees in a D–
SNP that is also a Medicaid managed
care plan through which the enrollees
get Medicaid coverage to better
understand the grievance and appeals
processes and generally receive a
resolution of their grievances and
appeals more quickly.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Total hours
Cost per hour
($)
Cost to state
Medicaid
agencies
($)
Number of
respondents
We received no comments on our
impact estimates related to these
provisions and therefore are finalizing
our estimates as proposed, with
modifications to reflect the omission of
estimates for the impact of the contract
modification at §§ 422.107(c)(1) through
(3) and 422.107(c)(9) in the proposed
rule, minor modifications to the
occupational codes, and the
corresponding adjusted hourly wages
previously mentioned in this section.
Hours per
respondent
Cost to
D–SNPs
($)
Item
There are four areas where this
provision will have an impact, listed
here and discussed in further detail later
in this section.
• Furnishing Medicare Parts A and B
Services during the pendency of appeals
(that is, through the integrated
reconsideration);
• Updating plan grievance policies
and procedures and consolidation of
plan grievance notifications and
reviews;
• Updating applicable integrated plan
appeals policies and procedures; and
• Sending appeal files to enrollees
who request them.
Following are details on these four
areas of impact.
a. Furnishing Medicare Parts A and B
Services During the Pendency of
Appeals
One of the provisions related to
appeals integration may marginally
impact the ways MA sponsors bid for
their D–SNPs, which could impact
Medicare spending. We are finalizing as
proposed that the existing standards for
continuation of benefits at § 438.420
apply to applicable integrated plans for
Medicare benefits under Parts A and B
and Medicaid benefits in the new
integrated appeals requirements at
§ 422.632. Under our final rule, and as
is applicable to Medicaid managed care
plans currently, if an applicable
integrated plan decides to stop or
reduce a benefit that the enrollee is
currently authorized to receive, the
enrollee could request that the benefit
continue to be provided at the currently
authorized level while the enrollee’s
appeal is pending through the integrated
reconsideration. Currently, MA plans
generally are not required to provide
benefits pending appeal, whereas in
Medicaid it has been a long-standing
feature.
We expect that the new integrated
appeals provisions will result in an
increase in expenditures by applicable
integrated plans for Medicare Parts A
PO 00000
Frm 00137
Fmt 4701
Sfmt 4700
and Part B covered services because
they will be required to continue
coverage for services during the
pendency of the reconsideration
request, or first-level appeal under our
final rule.
The estimate of impact of this
continuation is based on calendar year
2016 appeal metrics, which are then
trended to calendar year 2021. The
assumptions, sources and calculations
are summarized in Tables 11 and 12 in
this rule and further clarified as follows.
The first step in this estimation is to
determine the number of integrated
reconsiderations per 1,000 beneficiaries
enrolled in applicable integrated plans
affected by this provision. Given the
similarity of population characteristics,
the reconsideration experience for the
Medicare-Medicaid Plans (MMPs)
participating in the Financial Alignment
Initiative was used as a proxy for the
applicable integrated plans. In 2016,
MMP enrollees were impacted by 1,232
reconsiderations for services which
were resolved adversely or partially
favorably to the beneficiary. The
corresponding MMP enrollment in 2016
was 368,841, which implies a rate of 3.3
reconsiderations per 1,000 in 2016.
We projected D–SNP enrollment
impacted by the unified procedures to
grow from 150,000 in 2018 to 172,000
(150,000 * 1.145) in 2021 based on the
estimated enrollment growth for all D–
SNPs during the period of 14.5 percent.
Applying the MMP reconsideration rate
of 3.3 per 1,000 to the projected 2021
enrollment in applicable integrated
plans of 172,000 results in an estimated
568 (172,000 * 3.3/1,000) service
reconsiderations for applicable
integrated plans in 2020.
The next step is to determine the
average level of benefit subject to the
appeals. Table 1 in the report Medicare
Part C QIC Reconsideration Data for
E:\FR\FM\16APR2.SGM
16APR2
15816
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
2016 60 contains data on the number and
benefit amounts by service category for
the second level appeals filed in 2016.
Analysis of these data resulted in an
estimated per-appeal benefit value of
$737 for 2016. The determination of this
value took into account that some
services would not be subject to the
regulatory extension of coverage due to
the existence of immediate review rights
(inpatient hospital, skilled nursing
facility, and home health), other benefits
would likely have been rendered
already (emergency room, and
ambulance), and other services are not
covered as a D–SNP basic benefit
(hospice and non-Medicare benefits).
Accounting for 19.5 percent inflation in
per-capita Medicare spending between
2016 and 2021, and carving out the
13.38 percent consumer price index
inflation in years 2016–2020 inclusive,
results in an estimated per-appeal
benefit value of $774 (that is, $737 *
1.195/1.1338) for 2021.
khammond on DSKBBV9HB2PROD with RULES2
60 https://www.cms.gov/Medicare/Appeals-andGrievances/MMCAG/IRE.html.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
Taking the product of the number of
applicable integrated plan service
reconsiderations in 2021 (568) and
average benefit value in 2021 ($774)
yields an estimated cost in 2021 of
$439,632 (that is, 568 * $774) due to an
increase in Medicare expenditures
stemming from the unified appeals
procedures for applicable integrated
plans. We believe that this figure
represents an upper bound of the cost
given that not all applicable services
will be rendered during the extended
period of benefit continuation in this
regulation. These calculations are
summarized in Table 11.
Using the 2021 estimates as a basis,
estimates for 2021 through 2029 are
presented in Table 12. The following
assumptions were used in creating
Table 12:
• As described earlier in this section,
the numbers in the row for 2021 come
from Table 11.
• The projected FIDE SNP enrollment
for 2022 through 2029 was obtained by
multiplying the estimated 2021 FIDE
SNP enrollment of 172,000, using SNP
PO 00000
Frm 00138
Fmt 4701
Sfmt 4700
enrollment growth factors inferred from
Table IV.C1 in the 2018 Medicare
Trustees Report.
• The projected cost per appeal for
2022 through 2029 was obtained by first
multiplying the estimated 2021 cost per
appeal of $774 by FFS per capita growth
rates obtained from internal
documentation for the Table of FFS
USPCC, non-ESRD estimates in
attachment II of the 2019 Rate
Announcement and Call Letter (https://
www.cms.gov/Medicare/Health-Plans/
MedicareAdvtgSpecRateStats/
Downloads/Announcement2019.pdf).
As summarized in Table 12, there is
an estimated true cost (reflecting
purchase of goods and services) of $0.4
million in 2021 and $0.5 million in
2022 through 2025, modestly increasing
to $0.6 and $0.7 million in 2026 through
2029. Eighty-six percent of this cost is
transferred from the plans to the
Medicare Trust Fund; the remainder of
this cost is born by beneficiary cost
sharing.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
VerDate Sep<11>2014
Row
ID
Item Description
Number
Data Source
MMP Appeals: 2016
Jkt 247001
Appeals
(B)
Enrollment
(C)
(D)
MMP appeals per 1000
FIDE SNP Appeals 2021
Enrollment 2018
(E)
D-SNP enrollment growth: '18-'21
(F)
(G)
(H)
(I)
Enrollment 2021
MMP Appeals per 1000 in 2016
FIDE SNP appeals 2021
Cost of FIDE SNP Appeals: 2021
Average benefit per appeal (20 16)
(J)
Inflation: 20 16 - 2021
(K)
Carving out Ordinary Inflation 2016-2021
(L)
(M)
Average benefit per appeal (2021)
Aggregate amount of appeal (2021)
1,232
PO 00000
(A)
Frm 00139
368,841
3.3
Fmt 4701
150,000
Sfmt 4725
14.5%
E:\FR\FM\16APR2.SGM
172,000
3.3
568
$737
19.5%
16APR2
13.80%
$774
$440,000
2016 Parts C and D Reporting Requirements PUF (not incl. Part D MTM
data) from h!IDs://www .cms.gov/Medicare/Prescriytion-DrugCoverage/PrescriytionDrugCovContra!PartCDDataValidation .html. Sum of
service reconsiderations partially favorable and adverse for organization type
"Demo"
2016 Parts C and D Reporting Requirements PUF (not incl. Part D MTM
data) from httQs://www.cms.gov/Medicare/Prescriytion-DrugCoverage/PrescriytionDrugCovContra!PartCDDataValidation.html. Sum of
enrollment for organization type "Demo"
( C ) =(A) I (B) * 1000
Internal CMS enrollment extract in HPMS data system for July 2018
Table IV.C1, "Private Health Enrollment" in 2018 Medicare Trustees Report,
accessible at: h!IDs://www .cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-andReoorts/ReoortsTmstFunds/Down loads/TR20 18. odf
(F) = (D)*(1 +(E))
Row (C)
(H)= (F)/1000 * (G)
Data obtained from CMS Appeal & Grievance Contractor
Ratio of2021 and 2016 entries in table "Comparison of Current and Previous
Estimates of the FFS USPCC- Non ESRD" in the 2019 Rate Announcement
and Call letter accessible at: httys://www.cms.gov/Medicare/HealthPlans/MedicareAdvtgSpecRateStats/Downloads/Announcement20 19.pdf
Product of the urban consumer price index (CPI-U) increase factors for 20162020 inclusive. Data were obtained from Table V.B2 in the 2017 Medicare
Trustees Report accessible at: httQs://www.cms.gov/Research-StatisticsData-and-Systems/Statistics-Trends-andReports/ReportsTmstFunds/Downloads/TR20 17.pdf
(L) =G) * (1 + (J)) I (1+( K ))
(M) = (L) * (H)
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
18:09 Apr 15, 2019
TABLE 11: IMPACT OF INTEGRATED APPEALS PROVISION OF FIDE SNPS
15817
ER16AP19.002</GPH>
15818
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
TABLE 12—NET COST PER YEAR TO THE MEDICARE TRUST FUND FOR INTEGRATED PLAN APPEALS
Contract year
2021
2022
2023
2024
2025
2026
2027
2028
2029
Affected
FIDE SNP
enrollment
Appeals per
1,000 affected
enrollees
Number of
affected
appeals
per year
Cost per
appeal
Gross cost of
appeals
($ in millions)
Share of cost
funded by
medicare
trust fund
(%)
Net cost of
appeals to
medicare
trust fund
($ in millions)
Net cost of
appeals to
beneficiaries
($ in millions)
(A)
(B)
(C) = (A)/
1000 * (B)
(D)
(E) = (D) * (C)/
1,000,000
(F)
(F) * ( E )
(1–F) * (E)
............................
............................
............................
............................
............................
............................
............................
............................
............................
172,000
179,000
185,000
191,000
197,000
203,000
209,000
215,000
220,000
3.3
3.3
3.3
3.3
3.3
3.3
3.3
3.3
3.3
b. Updating Plan Grievance Policies and
Procedures and Consolidation of Plan
Grievance Notifications and Reviews
As detailed in section III.B.3. of this
final rule, there are only 34 contracts
representing 37 D–SNPs that we
currently believe will be classified as a
HIDE SNP or FIDE SNP and operate in
states that have policies requiring
exclusively aligned enrollment across
MA and Medicaid managed care plans.
In addition to the costs estimated in
section III.B.3. of this final rule, we
estimate the following impacts: (1)
Sending a notice of acknowledgement;
(2) sending a notice of resolution; and
(3) review of integrated grievances.
khammond on DSKBBV9HB2PROD with RULES2
(1) Sending a Notice of
Acknowledgement
Under § 422.629(g), applicable
integrated plans must send a notice of
acknowledgment for all grievances, both
those submitted orally and in writing.
Medicaid managed care organizations
are currently required to send this
notice under § 438.406(b)(1), whereas
MA plans are not currently required to
send this notice. Under this final rule,
applicable integrated plans must now
send this notice for all grievances, not
only those pertaining to Medicaid
issues. In the absence of data on the
types of grievances submitted, we
assume half the grievances currently
made to an applicable integrated plan
are related to Medicare issues and half
are related to Medicaid issues.
Estimates of impacts for this notice
take into account overlapping Medicare
and Medicaid benefits. As we do not
have data on grievances for overlapping
Medicare and Medicaid benefits, we
assume 25 percent of all grievances are
related to overlapping Medicare and
Medicaid benefits. This 25 percent
estimate reflects our belief that there is
some (more than 0 percent) overlap, but
that the majority of grievances (more
than 50 percent) do not overlap. The
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
568
591
611
630
650
670
690
710
726
$774
791
808
828
842
861
883
903
920
0.4
0.5
0.5
0.5
0.5
0.6
0.6
0.6
0.7
average of 0 percent and 50 percent
results in the 25 percent assumption we
have made. We use the following 6
estimates to estimate the costs
associated with this provision:
• As detailed in section IV.B.3.a of
this final rule, we estimate that the
aggregate number of enrollees in
applicable integrated plans in Contract
Year 2021 is 172,000. We used an
average of the following two estimates
for the percentage of enrollees expected
to file a grievance:
++ The May 2016 Medicaid Managed
Care final rule estimate of a 2 percent
filing rate; and
++ The currently approved burden
under OMB control number 0938–0753
(CMS–R–267) estimate of a 6.8 percent
filing rate.
Thus we estimate that 4.4 percent (1⁄2
× (6.8 percent + 2 percent) of all
enrollees file a grievance.
• As indicated previously, we
estimate that 50 percent of all
grievances are related to Medicare
coverage issues and half are related to
Medicaid coverage issues.
• As indicated previously, we
estimate 25 percent of all grievances for
applicable integrated plans are
regarding overlapping Medicare and
Medicaid benefits issues.
• We estimate that the time for
mailing an acknowledgment notice
using a standard form is 1 minute, or
1/60th of an hour.
• A business operations specialist
would perform this task at an hourly
wage of $72.84/hr.
• Therefore, we estimate there are
7,568 grievances (172,000 enrollees ×
4.4 percent who file a grievance), of
which 3,784 (7,568 grievances × 50
percent) are related to enrollees’
Medicare coverage and 3,784 are related
to their Medicaid coverage. We estimate
that 1,892 grievances (7,568 grievances
× 25 percent of grievances for
overlapping benefits) are made with
respect to overlapping Medicare and
PO 00000
Frm 00140
Fmt 4701
Sfmt 4700
86%
86
86
86
86
85
85
85
85
0.4
0.4
0.4
0.4
0.5
0.5
0.5
0.5
0.6
........................
0.1
0.1
0.1
0.1
0.1
0.1
0.1
0.1
Medicaid issues and currently only
require acknowledgment notices under
Medicaid rules. It follows that the new
burden arising from this provision
applies to 1,892 grievances (3,784
grievances related to Medicare coverage
minus the 1,892 grievances that would
have resulted in notices of
acknowledgement because they related
to Medicaid coverage).
Thus the aggregate annual burden
across all plans from this provision is 32
hours (1,892 grievances × 1/60 hr) at a
cost of $2,297 (1,892 grievances × 1/60
hr × $72.84/hr).
(2) Sending a Notice of Resolution
Section 422.630(e) requires that
applicable integrated plans issue a
notice upon resolution of the integrated
grievance, unless the grievance was
made orally and: (1) Was not regarding
quality of care; and (2) the enrollee did
not request a written response. To
estimate the savings from the reduction
in the number of grievance resolution
notices due to unification of grievance
processes for applicable integrated
plans, we first estimate the total cost of
issuing such notices and then multiply
by 25 percent (the estimated number of
grievances that are regarding
overlapping Medicare and Medicaid
benefits). The resulting amount is the
cost of the eliminated duplicative
grievance notices under the unified
procedures. We used the following 7
estimates in our calculation:
• As previously discussed regarding
sending the notice of acknowledgement,
we estimate that the aggregate number
of enrollees in applicable integrated
plans in Contract Year 2021 is 172,000.
• As previously discussed regarding
sending the notice of acknowledgement,
we estimate that 4.4 percent of all
enrollees file a grievance.
• The currently approved burden
under OMB control number 0938–0753
(CMS–R–267) estimates that 60 percent
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
of all those who file a grievance will file
orally.
• We estimate that of those who file
orally, 10 percent will request a follow
up written response.
• We estimate 9.5 percent of those
who file a grievance, file on quality
matters.61
• We estimate that it will take onequarter of an hour to prepare a written
response to a grievance, reflecting the
current time estimate under OMB
control number 0938–0753 (CMS–R–
267).
• A business operations specialist
would perform this task at an hourly
wage of $72.84/hr.
We use these 7 estimates to derive the
following:
• We estimate there will be 7,568
grievances (172,000 enrollees × 4.4
percent who file a grievance)
• 51.13 percent of those who file a
grievance require written responses,
either because the grievance was on a
quality issue, was submitted in writing,
or was orally submitted (but not on
quality issues) and the enrollee
requested a written response. The 51.13
percent estimate is based on the
following assumptions:
++ 9.5 percent of all grievances are
on quality matters, all of which require
written response;
++ 36.2 percent of all grievances are
submitted in writing and not on quality
issues (90.5 percent of grievances that
are not on quality issues × 40 percent
(100 percent¥60 percent of grievances
submitted orally));
++ 5.43 percent of all grievances are
orally submitted (but not on quality
issues), and the enrollee requested a
written response (90.5 percent of
grievances that are not on quality issues
× 60 percent of grievances are filed
orally × 10 percent of all oral grievances
request a written response).
It therefore follows that 51.13 percent
of grievances (9.5 percent + 36.20
percent + 5.43 percent) require written
response.
Thus, the aggregate burden associated
with responding in writing to grievances
is 967 hours (7,568 grievances × 51.13
percent of grievances requiring a written
response × 0.25 hr to write a response)
at a cost of $70,436 (967 hours × $72.84/
hour wage of a business operations
specialist). It follows that the savings
due to reduction of duplicative notices
is 242 hours (967 hours × 0.25
grievances involving an overlap of
Medicare and Medicaid benefits) at an
61 This percent estimate comes from the total
percent of grievances relating to quality of care as
reported by MA plans for calendar Year 2017
Medicare Part C Reporting Requirements Data.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
annual savings of $17,616 (172,000
enrollees × 4.4 percent of enrollees who
file grievances × 51.13 percent of
grievances requiring a written response
× one quarter of grievances eliminated
due to overlap of Medicare and
Medicaid × one quarter hour × $72.84/
hour).
(3) Review of Grievances
We estimate a burden adjustment
from grievance reviews detailed under
§ 422.629(k)(2) in a manner similar to
the estimates for sending notices of
acknowledgement and resolution. We
first estimate total cost and then
estimate the savings as 25 percent of
that total cost due to the elimination of
duplicative grievance reviews for
Medicare and Medicaid overlap issues.
We assume that the review of each
grievance will be done by a business
operations specialist working at $72.84/
hr. Based on the May 2016 Medicaid
Managed Care final rule (81 FR 21498),
we assume the average grievance takes
30 minutes for a business operations
specialist to resolve. We estimate the
aggregate annual cost for grievance
review is 3,784 hours (172,000 enrollees
× 0.044 × 0.5 hr) at a cost of $275,627
(3,784 hr × $72.84/hr). Therefore, the
reduction in grievance reviews is 946
hours (3,784 hr × 25 percent), at an
annual savings of $68,907 (3,784/h4 ×
$72.84).
Thus, the total annual savings
associated with consolidation of
applicable integrated plans’ grievance
notifications and reviews is $84,226 per
year [($17,616 (notice of resolution) +
$68,907 (grievance review)¥$2,297
(notice of acknowledgement).]
Section III.B.3. of this final rule
estimates a one-time cost of $29,864
($19,812 for updating policies and
procedures + $10,051 for
recordkeeping). Thus, the total impact
arising from updating policies and
procedures and consolidation of
grievance notices and reviews is a
savings of $54,362 ($88,820¥$29,864)
in the first year and savings of $84,226
in subsequent years.
c. Updating Applicable Integrated Plan
Appeals Policies and Procedures
Applicable integrated plans’ internal
appeals policies and procedures must be
updated to comply with the unified
appeals requirements. In terms of
updates, we see no reason to
differentiate between the work required
for grievances and appeals. Therefore, as
indicated in section IV.B.3.b. of this
final rule, we estimated a one-time cost
of $29,864 for updating applicable
integrated plans’ appeals policies and
procedures.
PO 00000
Frm 00141
Fmt 4701
Sfmt 4700
15819
d. Sending Appeal Files to Enrollees
Who Request Them
Medicaid managed care regulations
under § 438.406(b)(5) currently require
plans to send, for free, appeal case files
to enrollees who appeal while, in
contrast, the Parts C & D Enrollee
Grievance, Organization/Coverage
Determinations, and Appeals Guidance,
§ 50.5.2, requires MA plans to send such
files at a reasonable cost.62 Our final
rule requires the applicable integrated
plans to send such files for free. To
estimate this cost, we must first estimate
the cost of sending such a file.
Livanta, a Quality Improvement
Organization, estimates the cost per case
file as $40–$100.63 This can be justified
independently with a stricter range as
follows: Assuming a typical case file has
100 pages, it would weigh about 1
pound at 6 pages per ounce. The cost of
mailing a 1-pound case file by FedEx (to
assure security) is $10. The cost of
photocopying 100 pages at a minimum
rate of $0.05 per page is $5. The $0.05
per page is likely to be an overestimate
for plans that own their own
photocopying equipment. Thus, the
total cost of photocopying and mailing
would be about $15. We assume a
correspondence clerk, BLS occupation
code 43–4021,64 would take 1 hour of
work, at $36.64 per hour (including 100
percent for overtime and fringe benefits)
to retrieve the file, photocopy it, and
prepare it for mailing. Thus we estimate
the total cost at $36.64 + $10 + $5 =
$51.64.
We need further estimates to complete
the calculation. We assume 43.5 total
appeals (favorable and unfavorable) per
1,000.65 Based on our experience, we
assume that 10 percent of all appeals
would require a file sent. Finally, as
indicated in section III.B.3. of this final
rule, there are 37 applicable integrated
plans in 34 contracts with 150,000
enrollees in 2018 projected to grow to
172,000 enrollees in 2021. Thus we
estimate the total annual cost of mailing
files to enrollees as $38,637 (that is,
172,000 enrollees * 4.35 percent appeals
* 10 percent requesting files * $51.64
cost).
The various impacts of unified
grievances and appeals are summarized
in Table 13. The aggregate impact is a
cost $0.4 to $0.6 million per year for the
62 See https://www.cms.gov/Medicare/Appealsand-Grievances/MMCAG/Downloads/Parts-C-andD-Enrollee-Grievances-Organization-CoverageDeterminations-and-Appeals-Guidance.pdf.
63 See https://bfccqioareal.com/
recordrequests.html.
64 https://www.bls.gov/oes/current/oes_nat.htm.
65 https://www.cms.gov/Medicare/PrescriptionDrug-Coverage/PrescriptionDrugCovContra/
PartCDDataValidation.html.
E:\FR\FM\16APR2.SGM
16APR2
15820
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
next 10 years. This impact reflects both
costs to the Medicare Trust Fund, costs
to enrollees, costs related to first-year
updates to policies and procedures, and
savings due to consolidation of
notifications to enrollees as a result of
unified grievance procedures.
TABLE 13—SUMMARY OF COSTS FOR GRIEVANCE INTEGRATION PROVISION ($ IN MILLIONS)
[Negative numbers indicate savings]
Item
Cost to
Medicare
Trust Fund
Cost sharing
for MA
enrollees
Updating
policies and
procedures and
consolidation
of grievance
notices and
reviews
(a)
(a)
(b)
Subsection in this Unified Grievance
Section ..............................................
2020 .....................................................
2021 .....................................................
2022 .....................................................
2023 .....................................................
2024 .....................................................
2025 .....................................................
2026 .....................................................
2027 .....................................................
2028 .....................................................
2029 .....................................................
n/a
0.38
0.4
0.42
0.45
0.47
0.49
0.52
0.54
0.57
We note that these costs and savings
are true costs and savings since they
reflect payment for additional or fewer
economic resources (reduced
notifications and increased cost of
appeals). The increased appeals costs
are a cost to MA plans, which transfer
this cost to enrollees and the Medicare
Trust Fund (the government).
We received no comments on our
estimates and therefore are finalizing
them with modifications to reflect the
omission of the impact associated with
sending the notice of acknowledgement
and to the occupational codes and
corresponding adjusted hourly wages as
previously mentioned in this section.
4. Proposal for Prescription Drug Plan
Sponsors’ Access to Medicare Parts A
and B Claims Data Extracts (§ 423.153)
As described in section II.A.3. of this
final rule, section 50354 of the
Bipartisan Budget Act of 2018 requires
the establishment of a process under
which the sponsor of a PDP that
provides prescription drug benefits
under Medicare Part D may request,
beginning in plan year 2020, that the
Secretary provide on a periodic basis
and in an electronic format standardized
n/a
0.06
0.07
0.07
0.07
0.08
0.09
0.09
0.1
0.1
Updating
appeal
policies and
procedures
Sending files
to enrollees
who request
them
(c)
(d)
n/a
(0.05)
(0.08)
(0.08)
(0.08)
(0.08)
(0.08)
(0.08)
(0.08)
(0.08)
extracts of Medicare claims data about
its plan enrollees. In the proposed rule,
we proposed to add a new § 423.153(g)
to implement the process for requesting
these data.
To estimate the impact we required a
model of operationalizing this
provision, without however committing
to a particular operationalizing process.
We outlined a process which—
• Meets all regulatory requirements;
and
• Requires as little burden as possible
to make and grant requests.
We solicited comments from
stakeholders on this proposed
operationalization.
Electronic request and transfers are
superior (have less burden) than paper
processes. We could therefore add
functionalities to the CMS HPMS
system (or other CMS systems) which
would allow the following functions:
• Request of claims data for the
current and future quarters for enrollees
of the PDP requesting the data.
• Request to no longer receive data.
• Attestation that all regulatory
requirements will be complied with.
The attestation would be in the form of
a screen listing all regulatory
requirements; the authorized PDP
n/a
0.03
0
0
0
0
0
0
0
0
n/a
0.038
0.038
0.038
0.038
0.038
0.038
0.038
0.038
0.038
Total impact
n/a
0.5
0.4
0.4
0.5
0.5
0.5
0.6
0.6
0.6
HPMS user would have to electronically
attest by clicking a button.
Such a process would combine
request and attestation. The receipt of
the submission would verify
completeness of request. Furthermore,
there would be no burden in request
(under 1 minute of work).
The HPMS contractors estimated that
there would be a one-time update
costing approximately $200,000.
Besides requesting the data, data must
be transmitted to the requesting
sponsor. Ideally, data would be
transmitted electronically but we do not
yet have such an API. Instead, we would
treat requested data like data requested
for research. Typically, such data is
downloaded onto encrypted external
hard drives and mailed to requestors.
The data could come from the
Chronic Condition Warehouse (CCW).
We asked our contractors the cost of
downloading quarterly such data and
sending it out. The cost varies by
sponsor size. Currently, based on CMS
public data, there are 63 PDP sponsors.
Their size and the quarterly cost per
sponsor of providing them with data,
should they request it, is summarized in
Table 14.
khammond on DSKBBV9HB2PROD with RULES2
TABLE 14—COST PER PDP SPONSOR PER QUARTER FOR TRANSMITTING CLAIMS DATA
Above 5 million ................................................................................................................................
1 million–5 million ............................................................................................................................
100,000–1 million .............................................................................................................................
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
PO 00000
Frm 00142
Cost per quarter
per sponsor for
transmission of
claims data
Number of
sponsors
PDP size in enrollees
Fmt 4701
Sfmt 4700
E:\FR\FM\16APR2.SGM
1
6
11
16APR2
$26,500
17,500
10,500
15821
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
TABLE 14—COST PER PDP SPONSOR PER QUARTER FOR TRANSMITTING CLAIMS DATA—Continued
Under 100,000 .................................................................................................................................
To complete the annual impact
analysis we needed an estimate of
proportions for each plan size that
would request data. For example, we are
certain that the 1 PDP sponsor with over
5 million enrollees will request data.
Thus the annual burden for that plan
size is 1 * 4 quarters × $26,500 per
quarter = $106,000. Similarly, if we
assume that all six PDP sponsors with
enrollments between 1 and 5 million
would request data then the annual
burden is 6 sponsors * 4 quarters *
$17,500 per quarter per sponsor =
$420,000. If we assume that only three-
Cost per quarter
per sponsor for
transmission of
claims data
Number of
sponsors
PDP size in enrollees
quarters of these six sponsors request
data then the annual burden would be
0.75 * $420,000 = $315,000. In the
absence of any other basis for the
decision, it is reasonable to assume that
the proportion goes down as the size
goes down. In the absence of data, we
could use a descent of simple fractions
(1, three-fourths, one-half, one-fourth).
Note, that 50 percent of plans with
under 100,000 enrollees have under
10,000 enrollees. It is very unlikely that
such plans would have the resources to
use the data. Thus an assumption that
only 50 percent of plans under 100,000
45
10,500
request data is reasonable. However, we
considered multiple scenarios. Table 15
presents for a variety of scenarios of
proportions and their total impact. The
average of the five scenarios is $1.5
million while the median is $1.3
million. The range of impacts is $0.8
million to $2.9 million. For purposes of
Executive Order 13771 accounting we
listed the impact as $1.5 million
annually, with a $0.2 million one-time
cost in the first year. We did not trend
this estimate by year since the number
of PDP sponsors has remained at 63
since 2015.
TABLE 15—ANNUAL BURDEN OF PROVIDING CLAIMS DATA TO PDP SPONSORS
Scenario label
A
B
C
D
E
Proportion of
sponsors with
1–5 million
enrollees
requesting data
(%)
Proportion of
sponsors with
100,000 to
1 million
enrollees
requesting data
(%)
Proportion of
sponsors with
less than
100,000
enrollees
requesting data
(%)
Aggregate
annual burden
based on costs
provided in
Table 14
($ in millions)
100
100
100
100
100
75
100
50
100
100
50
75
33
100
50
33
50
25
100
0
1.3
1.8
0.9
2.9
0.8
.................................................................................
.................................................................................
.................................................................................
.................................................................................
.................................................................................
We did not anticipate any further
burden. It is most likely that the PDP
sponsor would exclusively use the data.
In the event that downstream entities
are shared any data they are already
bound in their contracts by all Medicare
regulations including the regulations of
this provision.
We received no comments on this
proposal and therefore are finalizing
this provision without modification.
khammond on DSKBBV9HB2PROD with RULES2
Proportion of
sponsors with
over 5 million
enrollees
requesting data
(%)
5. Medicare Advantage and Part D
Prescription Drug Plan Quality Rating
System (§§ 422.162(a) and 423.182(a),
§§ 422.166(a) and 423.186(a), §§ 422.164
and 423.184, and §§ 422.166(i)(1) and
423.186(i)(1))
We proposed some measure
specification updates. These type of
changes are routine and do not have an
impact on the highest ratings of
contracts (that is, overall rating for MA–
PDs, Part C summary rating for MA-only
contracts, and Part D summary rating for
stand-alone prescription drug plans).
Hence, there will be no, or negligible,
impact on the Medicare Trust Fund.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
We also proposed some adjustments
to MA and Part D Star Ratings for
extreme and uncontrollable
circumstances. The proposed policy
will make adjustments to take into
account the potential impact on
contracts when there are extreme and
uncontrollable circumstances affecting
them. This policy is in response to the
multiple disasters in 2017 and 2018,
including several hurricanes and
wildfires. We proposed a policy to
permit an adjustment to Star Ratings
when extreme and uncontrollable
circumstances occur during the
performance period or measurement
period for MA and Part D plans.
We also proposed enhancements to
the current methodology to set Star
Ratings cut points. The intent of the
changes is to increase the stability and
predictability of cut points from year to
year. This proposal is consistent with
the CMS goal to increase transparency.
We believe this provision would also
have minimal impact on the highest
ratings of contracts. Specifically,
simulations of the proposed changes to
PO 00000
Frm 00143
Fmt 4701
Sfmt 4700
the Star Ratings methodology using the
2018 Star Ratings data show that the
impact on the MA Quality Bonus
Payment (QBP) ratings is minimal with
the QBP ratings overall increasing for
less than 1 percent of MA enrollees.
We received no comments on our
proposed RIA statement and, therefore,
are finalizing this provision without
modification.
6. Improving Clarity of the Exceptions
Timeframes for Part D Drugs
(§§ 423.568, 423.570, and 423.572)
We proposed to limit the amount of
time an exceptions request can be held
open to 14 calendar days, meaning that
there will be an outside limit to how
long the request is in a pending status
while the Part D plan sponsor attempts
to obtain the prescribing physician’s or
other prescriber’s supporting statement.
Under current manual guidance, plan
sponsors are instructed that an
exceptions request should only be held
open for a reasonable period of time if
a supporting statement is needed. We
believe that no more than 14 calendar
E:\FR\FM\16APR2.SGM
16APR2
15822
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
days is a reasonable period of time to
have an exceptions request open and
this rule seeks to codify that standard.
Based on comments received, we are
modifying the proposed approach to
clearly account for circumstances where
a prescriber’s supporting statement is
received late or not received at all
within the 14 calendar day timeframe.
Under this final rule, if a supporting
statement is not received by the end of
14 calendar days from receipt of the
exceptions request, the Part D plan
sponsor must notify the enrollee (and
the prescribing physician or other
prescriber involved, as appropriate) of
its determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours (24 hours for an
expedited request) from the end of 14
calendar days from receipt of the
exceptions request. We do not expect
this to have any new impact on the
number of pending appeals or pose a
potential burden to plan sponsors, as we
expect plans are already making and
notifying enrollees of decisions on
exceptions requests under a similar
reasonable timeframe. Based on findings
from plan sponsor audits, this approach
is generally consistent with how plans
sponsors have operationalized the
current guidance that cases only be held
open for a reasonable period of time
pending receipt of a prescriber’s
supporting statement. Therefore, we do
not expect that plan sponsors would
need to hire more staff or adjust their
operations in a manner that would affect
costs. Consequently, we expect the
impact of this final rule to be negligible.
We received no comments on our
proposed RIA statement and therefore
are finalizing this provision of the RIA
statement without modification.
khammond on DSKBBV9HB2PROD with RULES2
7. Preclusion List Requirements for
Prescribers in Part D and Individuals
and Entities in MA, Cost Plans, and
PACE (§§ 422.222 and 423.120(c)(6))
We do not anticipate any additional
cost or savings associated with our
preclusion list provisions. As we
indicated in section II.C.1 of this final
rule, said provisions will not involve
activities for plan sponsors and MA
organizations outside of those described
in the previously mentioned April 2018
final rule. The provisions are, generally
speaking, clarifications of our intended
policy and do not constitute new
requirements. Hence, the expected
impact is negligible.
We received no comments on our
proposed RIA statement and are
therefore finalizing it without
modification.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
D. Alternatives Considered
1. Requirements for Medicare
Advantage Plans Offering Additional
Telehealth Benefits (§§ 422.100,
422.135, 422.252, 422.254, and 422.264)
Section 1852(m)(2)(A)(i) of the Act, as
added by the Bipartisan Budget Act of
2018, defines MA additional telehealth
benefits as services that are identified
for the applicable year as clinically
appropriate to furnish using electronic
information and telecommunications
technology when a physician (as
defined in section 1861(r) of the Act) or
practitioner (described in section
1842(b)(18)(C) of the Act) providing the
service is not at the same location as the
plan enrollee (which we refer to as
‘‘through electronic exchange’’). We
considered various alternative
definitions of ‘‘clinically appropriate’’
but decided not to finalize specific
regulation text defining the term. We are
finalizing our proposal to implement the
statutory requirement for MA additional
telehealth benefits to be provided only
when ‘‘clinically appropriate’’ to align
with existing CMS rules for contract
provisions at § 422.504(a)(3)(iii), which
requires each MA organization to agree
to provide all benefits covered by
Medicare ‘‘in a manner consistent with
professionally recognized standards of
health care.’’
The statute does not specify who or
what entity identifies the services for
the year. We considered various
alternatives, including retaining the
authority as an agency to specify what
services are clinically appropriate to
furnish each year. MA plans could have
been required to comply with an annual
list of clinically appropriate services
identified by CMS. However, we
rejected this alternative as too
restrictive; we believe MA plans are in
the best position and it is in their own
interest to stay abreast of professional
standards necessary to determine which
services are clinically appropriate. MA
plans have a vested interest in staying
abreast of the current professionally
recognized standards of health care.
Healthcare standards and technology
continuously develop as a result of new
advancements in modern medicine. As
healthcare standards change over time
and differ from practice area to practice
area, we believe our approach is flexible
enough to allow plans to take those
changes and differences into account.
We believe that failing to allow this
flexibility will result in the need for
another regulation that addresses future
technological changes in health care.
We do not want to unduly burden MA
plans with an unnecessary regulation or
restrict their efforts to provide
PO 00000
Frm 00144
Fmt 4701
Sfmt 4700
healthcare services. Thus, we are
finalizing our proposal to interpret this
provision broadly by not specifying the
Part B services that an MA plan may
offer as MA additional telehealth
benefits for the applicable year, but
instead allowing MA plans to
independently determine which
services each year are clinically
appropriate to furnish in this manner.
Our final definition of additional
telehealth benefits at § 422.135(a)(2)
provides that it is the MA plan (not
CMS) that identifies the appropriate
services for the applicable year.
We also considered alternatives to
implement how telehealth benefits are
provided through ‘‘electronic
exchange.’’ CMS considered defining
the specific means of ‘‘electronic
exchange.’’ However, we decided to
define ‘‘electronic exchange’’ at
§ 422.135(a) as ‘‘electronic information
and telecommunications technology,’’
as the former is a concise term for the
latter, which is the statutory description
of the means used to provide the MA
additional telehealth benefits. We did
not propose specific regulation text that
defines or provides examples of
electronic information and
telecommunications technology. We
considered providing a complete list of
means of providing electronic
information and telecommunications
technology. Although we provided
examples of electronic information and
telecommunications technology in the
proposed rule, we did not provide a
comprehensive list because the
technology needed and used to provide
MA additional telehealth benefits will
vary based on the service being offered.
CMS appreciates that health care is
evolving. CMS’s purpose in not
providing specific regulation text that
defines or provides examples of
electronic information and
telecommunications technology is to
promote flexibility that allows plans to
continue to develop methods of
healthcare delivery. CMS cannot
contemplate the various technological
methods plans will use to deliver
healthcare services. We do not believe
plans will misuse this flexibility
because it is in their best interest to
provide healthcare services that meet
the changing needs of enrollees. We also
believe the more narrow approach of
defining or providing examples of
electronic information and
telecommunications technology will
cause the added burden of requiring
another CMS rule.
We believe this broad approach will
avoid tying the authority in the final
rule to specific information formats or
technologies that permit non-face-to-
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
face interactions for furnishing
clinically appropriate services. This
approach will also result in savings due
to increased disease prevention among
enrollees because plans will be able to
develop technology that is less
expensive, more predictive, and more
accurate. We received no comments on
our alternatives considered for this
provision and are therefore finalizing
our explanation of them without
modification.
would impact a larger number of D–SNP
enrollees and require additional state
data-sharing infrastructure than the
notification requirement we are
finalizing in this rule, which we believe
would result in increased administrative
burden and implementation costs. We
received no comments on this
discussion of alternatives to the
proposed rule and therefore are
finalizing our discussion without
modification.
2. Integration Requirements for Dual
Eligible Special Needs Plans (§§ 422.2,
422.60, 422.102, 422.107, 422.111, and
422.752)
3. Unified Grievance and Appeals
Procedures for Dual Eligible Special
Needs Plans and Medicaid Managed
Care Plans at the Plan Level (§§ 422.560,
422.562, 422.566, 422.629 Through
422.634, 438.210, 438.400, and 438.402)
khammond on DSKBBV9HB2PROD with RULES2
This final rule requires D–SNPs that—
(1) do not meet the HIDE SNP or FIDE
SNP integration standard; and (2) do not
have a parent organization assuming
clinical and financial responsibility for
Medicare and Medicaid benefits to
notify the state Medicaid agency or its
designee when a high-risk full-benefit
dual eligible individual has a hospital or
skilled nursing facility admission. We
considered several alternatives to this
proposal, as explained in section
II.A.2.a.(2). of the proposed rule,
including examples provided in the
Bipartisan Budget Act of 2018: Notifying
the state in a timely manner of
enrollees’ emergency room visits and
hospital or nursing home discharges;
assigning each enrollee a primary care
provider; and data sharing that benefits
the coordination of items and services
under Medicare and Medicaid.
However, we believe our final rule is
preferable to the alternatives when
considering the degree to which it meets
our criteria for establishing minimum
contract criteria discussed in section
II.A.2.a.(2) of the proposed and final
rules. While we lack experience and
data to quantify cost, these alternatives
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
We are creating unified grievance and
appeals procedures for certain D–SNPs
(FIDE SNPs and HIDE SNPs) with
exclusively aligned enrollment, which
we define as occurring when such a D–
SNP limits enrollment to full-benefit
dual eligible individuals whose
Medicaid benefits are covered by the D–
SNP itself, or by a Medicaid managed
care organization that is the same
organization, the D–SNP’s parent
organization, or another entity that is
owned and controlled by the D–SNP’s
parent organization. Because most D–
SNP enrollees are not enrolled in D–
SNPs with exclusively aligned
enrollment, we considered the
feasibility of broadening the scope of
these unified procedures to apply to
more D–SNPs—that is, to D–SNPs
without exclusively aligned enrollment.
However, in most states, the majority of
D–SNP enrollees have Medicaid
coverage either through a different
organization’s Medicaid MCO, in a
prepaid ambulatory or inpatient health
plan (PAHP or PIHP), or through a
state’s Medicaid fee-for-service system.
PO 00000
Frm 00145
Fmt 4701
Sfmt 4700
15823
In these circumstances, the D–SNP has
no control over the Medicaid grievance
and appeals process. Even a D–SNP that
has a Medicaid managed care
organization operated by such plan’s
parent organization available to its
enrollees, but whose members may
instead enroll in other Medicaid plans,
can only unify the procedures for
Medicaid appeals and grievances of
those enrollees who are also
simultaneously enrolled in the
Medicaid managed care organization
controlled by such plan’s parent
organization. We lack experience and
data to quantify the cost of this
alternative due to the uncertainty
involved in calculating the additional
levels of administrative burden and cost
associated with unifying grievance and
appeals processes when D–SNPs and
Medicaid managed care plans that do
not have the same enrollees, or where
the organizations offering the D–SNPs
and Medicaid plans are unaffiliated or
even competitors. We received no
comments on this proposal and
therefore are finalizing our discussion
here without modification.
E. Accounting Statement and Table
The following table summarizes costs,
savings, and transfers by provision.
As required by OMB Circular A–4
(available at https://
obamawhitehouse.archives.gov/omb/
circulars_a004_a-4/), in Table 16, we
have prepared an accounting statement
showing the savings, costs, and transfers
associated with the provisions of this
final rule for calendar years 2020
through 2029. Table 16 is based on
Tables 17A, B, and C which lists
savings, costs, and transfers by
provision.
BILLING CODE 4120–01–P
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15824
Jkt 247001
Transfers Per Year
2.51
2.45
2020-2029
(7.73)
(7.86)
2020-2029
Costs Per Year
PO 00000
Frm 00146
Fmt 4701
Sfmt 4700
16APR2
transfers. The transfer numbers are
expressed as negative numbers to reflect
the fact that the Medicare Trust Fund
incurs a cost while enrollees experience
a cost savings. All numbers are in
millions. Tables 17A, 17B, and 17C form
the basis for Table 16 and for the
E:\FR\FM\16APR2.SGM
totals). In these tables, all numbers are
positive; positive numbers in the
savings columns indicate actual dollars
saved while positive numbers in the
cost columns indicate actual dollars
spent; and the aggregate row indicates
savings less costs and does not include
For Calendar Years 2020 To 2029
($ in millions)
Net Savings Per Year
Savings Per Year
Savin2s
Discount Rate
7%
3%
49.76
51.75
52.27
54.21
Period
Covered
2020-2029
2020-2029
Whom is Saving, Spending, or Transferring
See itemization in rows below.
MA enrollees save from reduced travel times to and from providers.
MA enrollees (cost sharing) and MA plans (that pass costs to the Medicare
Trust Fund), Contractors (for claims processing), State Medicaid Agencies that
transfer 50% of costs to the federal government.
Medicare Trust Fund and MA enrollees (enrollees save while Medicare Trust
Fund incurs cost of telehealth as a basic vs. supplemental benefit; hence the
amount is listed as negative, reflecting Medicare Trust Fund cost)
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
18:09 Apr 15, 2019
The following Table 17 summarizes
savings, costs, and transfers by
provision and forms a basis for the
accounting table. For reasons of space,
Table 17 is broken into Table 17A (2020
through 2023), Table 17B (2024 through
2027), and Table 17C (2028, 2029, and
VerDate Sep<11>2014
ER16AP19.003</GPH>
TABLE 16: ACCOUNTING STATEMENT- CLASSIFICATIONS OF ESTIMATED SAVINGS,
COSTS, AND TRANSFERS
khammond on DSKBBV9HB2PROD with RULES2
Jkt 247001
2020
Costs
2020
Transfers
2021
Savinl!s
35.0
5.6
2021
Costs
2021
Transfers
2022
Savinl!s
39.5
33.0
2023
Costs
2023
Transfers
42.5
(7.3)
(6.9)
39.4
44.4
(6.5)
(7.3)
(6.9)
Frm 00147
3.4
0.5
0.1
0.1
0.1
0.4
1.5
0.0
0.0
1.7
0.1
0.1
0.4
1.5
Fmt 4701
0.0
0.0
0.1
0.4
1.5
0.0
0.0
0.0
0.0
Sfmt 4725
TABLE 17B: AGGREGATE SAVINGS, COSTS, AND TRANSFERS IN MILLIONS BY PROVISION AND YEAR
FROM 2024 TO 2027
E:\FR\FM\16APR2.SGM
16APR2
Total Savings
Total Costs
Aggregate Total
Total Transfers
Telehealth Enrollees
Telehealth Government
D-SNP Integration, MA Plans
D-SNP Integration, State Medicaid Agencies
D-SNP Grievance & Appeals, Paperwork Reduction
D-SNP Grievance & Appeals, Enrollees
D-SNP Grievance & Appeals, Medicare Trust Fund
Claims Data
Star Ratings
Preclusion
2024
Savings
50.1
2024
Costs
2024
Transfers
2025
Savings
56.3
2.0
2025
Costs
70.6
(8.5)
0.1
0.1
0.5
1.5
0.0
0.0
(9.0)
0.1
0.1
0.5
1.5
0.0
0.0
2027
Transfers
(9.0)
(8.5)
(8.2)
0.1
2027
Costs
2.1
63.1
(7 7)
2027
Savini!S
70.7
68.5
(8.2)
56.2
0.1
0.5
1.5
2026
Transfers
61.1
(7.7)
50.0
2026
Costs
2.1
54.3
0.1
2026
Savings
63.1
2.1
48.1
0.0
0.0
2025
Transfers
0.1
0.5
1.5
0.0
0.0
discounted to 2016, mentioned in the
conclusion.
PO 00000
(6.5)
34.9
(6 I)
2023
Savinl!s
44.5
2.0
37.6
(6.1)
30.9
2022
Transfers
2.0
1.9
25.3
2022
Costs
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
18:09 Apr 15, 2019
Total Savings
Total Costs
Aggregate Total
Total Transfers
Telehealth Enrollees
Telehealth Government
D-SNP Integration, MA Plans
D-SNP Integration, State Medicaid Agencies
D-SNP Grievance & Appeals, Paperwork Reduction
D-SNP Grievance & Appeals Enrollees
D-SNP Grievance & Appeals, Medicare Trust Fund
Claims Data
Star Ratings
Preclusion
2020 Savinl!s
30.9
calculation to the infinite horizon
VerDate Sep<11>2014
TABLE 17A: AGGREGATE SAVINGS, COSTS, AND TRANSFERS IN MILLIONS BY PROVISION AND YEAR
FROM 2020 TO 2023
15825
ER16AP19.004</GPH>
khammond on DSKBBV9HB2PROD with RULES2
15826
Jkt 247001
Frm 00148
through 2029. The raw total net savings
over 10 years is $534 million.
PO 00000
Fmt 4701
Sfmt 4700
G. Reducing Regulation and Controlling
Regulatory Costs
16APR2
Executive Order 13771 requires that
the costs associated with significant
new regulations ‘‘shall, to the extent
permitted by law, be offset by the
E:\FR\FM\16APR2.SGM
Total Savings
Total Costs
Aggregate Total
Total Transfers
Telehealth Enrollees
Telehealth Government
D-SNP Integration, MA Plans
D-SNP Integration, State Medicaid Agencies
D-SNP Grievance & Appeals, Paperwork Reduction
D-SNP Grievance & Appeals, Enrollees
D-SNP Grievance & Appeals, Medicare Trust Fund
Claims Data
Star Ratings
Preclusion
2028
Savings
79.1
2028 Costs
2028
Transfers
2029
Savings
88.5
2.1
2029
Costs
2029
Transfers
Raw
Totals
Savings
557.7
2.2
76.9
533.6
(9.5)
(9.9)
88.4
(79.6)
557.0
(9.5)
(9.9)
3.4
0.5
0.1
0.1
0.1
0.5
1.5
0.0
0.7
0.1
0.6
1.5
0.0
Raw Totals,
Transfers, Costs
to Medicare
Trust Fund
24.1
86.3
79.0
Raw
Totals
Costs
0.7
4.2
15.2
0.0
0.0
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
BILLING CODE 4120–01–C
18:09 Apr 15, 2019
F. Conclusion
As indicated in Tables 17A through C,
we estimate that this final rule generates
annual cost savings of approximately
$25 to $86 million per year over 2020
VerDate Sep<11>2014
ER16AP19.005</GPH>
TABLE 17C: AGGREGATE SAVINGS, COSTS, AND TRANSFERS IN MILLIONS BY PROVISION AND YEAR
FROM 2028 TO 2029, AND TOTALS COLUMNS
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
elimination of existing costs associated
with at least two prior regulations.’’ In
line with Executive Order 13771, in
Table 18 we estimate present and
annualized values of costs and cost
savings over an infinite time horizon.
Both costs and savings are presented as
positive numbers; net savings equals
savings minus costs and is positive. As
shown, this final rule generates level
annual cost savings of $55.80 million in
2016 dollars over an infinite time
horizon, discounted at 7 percent. Based
on these cost savings, this final rule
would be considered a deregulatory
action under Executive Order 13771.
Details on estimated savings is found in
the preceding analyses.
TABLE 18—EXECUTIVE ORDER 13771
SUMMARY TABLE IN 2016 DOLLARS
OVER AN INFINITE TIME HORIZON
[$ In millions]
Primary
(7%)
Item
Present Value of Costs .......
Present Value of Cost Savings ..................................
Present Value of Net Costs
Annualized Costs ................
Annualized Cost Savings ....
Annualized Net Savings ......
Primary
(3%)
27.27
68.39
824.36
797.09
1.91
57.71
55.80
2,431.69
2,363.30
2.05
72.95
70.90
List of Subjects
42 CFR Part 422
Administrative practice and
procedure, Health facilities, Health
maintenance organizations (HMO),
Medicare, Penalties, Privacy, and
Reporting and recordkeeping
requirements.
42 CFR Part 423
Administrative practice and
procedure, Emergency medical services,
Health facilities, Health maintenance
organizations (HMO), Health
professionals, Medicare, Penalties,
Privacy, and Reporting and
recordkeeping requirements.
42 CFR Part 438
Grant programs-health, Medicaid,
Reporting and recordkeeping
requirements.
khammond on DSKBBV9HB2PROD with RULES2
42 CFR Part 498
Administrative practice and
procedure, Health facilities, Health
professions, Medicare, and Reporting
and recordkeeping requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
PART 422—MEDICARE ADVANTAGE
PROGRAM
1. The authority citation for part 422
is revised to read as follows:
■
Authority: 42 U.S.C. 1302 and 1395hh.
2. Section 422.2 is amended—
a. By adding definitions of ‘‘Aligned
enrollment’’ and ‘‘Dual eligible special
needs plan’’ in alphabetical order;
■ b. By revising the definition of ‘‘Fully
integrated dual eligible special needs
plan’’;
■ c. By adding the definition of ‘‘Highly
integrated dual eligible special needs
plan’’ in alphabetical order; and
■ d. In the definition of ‘‘Preclusion
list’’ by revising the introductory text
and paragraphs (1)(i), (2)(i), (2)(ii)(C)
and adding paragraph (3).
The additions and revisions read as
follows:
■
■
§ 422.2
Definitions.
*
*
*
*
*
Aligned enrollment refers to the
enrollment in a dual eligible special
needs plan of full-benefit dual eligible
individuals whose Medicaid benefits are
covered under a Medicaid managed care
organization contract under section
1903(m) of the Act between the
applicable State and: the dual eligible
special needs plan’s (D–SNP’s) MA
organization, the D–SNP’s parent
organization, or another entity that is
owned and controlled by the D–SNP’s
parent organization. When State policy
limits a D–SNP’s membership to
individuals with aligned enrollment,
this condition is referred to as
exclusively aligned enrollment.
*
*
*
*
*
Dual eligible special needs plan or D–
SNP means a specialized MA plan for
special needs individuals who are
entitled to medical assistance under a
State plan under title XIX of the Act
that—
(1) Coordinates the delivery of
Medicare and Medicaid services for
individuals who are eligible for such
services;
(2) May provide coverage of Medicaid
services, including long-term services
and supports and behavioral health
services for individuals eligible for such
services;
(3) Has a contract with the State
Medicaid agency consistent with
§ 422.107 that meets the minimum
requirements in paragraph (c) of such
section; and
(4) Beginning January 1, 2021,
satisfies one or more of the following
criteria for the integration of Medicare
and Medicaid benefits:
PO 00000
Frm 00149
Fmt 4701
Sfmt 4700
15827
(i) Meets the additional requirement
specified in § 422.107(d) in its contract
with the State Medicaid agency.
(ii) Is a highly integrated dual eligible
special needs plan.
(iii) Is a fully integrated dual eligible
special needs plan.
*
*
*
*
*
Fully integrated dual eligible special
needs plan means a dual eligible special
needs plan—
(1) That provides dual eligible
individuals access to Medicare and
Medicaid benefits under a single entity
that holds both an MA contract with
CMS and a Medicaid managed care
organization contract under section
1903(m) of the Act with the applicable
State;
(2) Whose capitated contract with the
State Medicaid agency provides
coverage, consistent with State policy,
of specified primary care, acute care,
behavioral health, and long-term
services and supports, and provides
coverage of nursing facility services for
a period of at least 180 days during the
plan year;
(3) That coordinates the delivery of
covered Medicare and Medicaid
services using aligned care management
and specialty care network methods for
high-risk beneficiaries; and
(4) That employs policies and
procedures approved by CMS and the
State to coordinate or integrate
beneficiary communication materials,
enrollment, communications, grievance
and appeals, and quality improvement.
*
*
*
*
*
Highly integrated dual eligible special
needs plan means a dual eligible special
needs plan offered by an MA
organization that provides coverage,
consistent with State policy, of longterm services and supports, behavioral
health services, or both, under a
capitated contract that meets one of the
following arrangements—
(1) The capitated contract is between
the MA organization and the Medicaid
agency; or
(2) The capitated contract is between
the MA organization’s parent
organization (or another entity that is
owned and controlled by its parent
organization) and the Medicaid agency.
*
*
*
*
*
Preclusion list means a CMS compiled
list of individuals and entities that—
(1) * * *
(i) The individual or entity is
currently revoked from Medicare for a
reason other than that stated in
§ 424.535(a)(3) of this chapter.
*
*
*
*
*
(2) * * *
(i) The individual or entity has
engaged in behavior, other than that
E:\FR\FM\16APR2.SGM
16APR2
15828
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
described in § 424.535(a)(3) of this
chapter, for which CMS could have
revoked the individual or entity to the
extent applicable had they been
enrolled in Medicare.
(ii) * * *
(C) Any other evidence that CMS
deems relevant to its determination; or
(3) The individual or entity,
regardless of whether they are or were
enrolled in Medicare, has been
convicted of a felony under Federal or
State law within the previous 10 years
that CMS deems detrimental to the best
interests of the Medicare program.
Factors that CMS considers in making
such a determination under this
paragraph (3) are—
(i) The severity of the offense;
(ii) When the offense occurred; and
(iii) Any other information that CMS
deems relevant to its determination.
*
*
*
*
*
■ 3. Section 422.60 is amended by
revising paragraph (g)(2)(i) to read as
follows:
§ 422.60
Election process.
*
*
*
*
*
(g) * * *
(2) * * *
(i) Operate as a fully integrated dual
eligible special needs plan or highly
integrated dual eligible special needs
plan.
*
*
*
*
*
■ 4. Section 422.100 is amended by
revising paragraphs (a) and (c)(1) to read
as follows:
khammond on DSKBBV9HB2PROD with RULES2
§ 422.100
General requirements.
(a) Basic rule. Subject to the
conditions and limitations set forth in
this subpart, an MA organization
offering an MA plan must provide
enrollees in that plan with coverage of
the basic benefits described in
paragraph (c)(1) of this section (except
that additional telehealth benefits may
be, but are not required to be, offered by
the MA plan) and, to the extent
applicable, supplemental benefits as
described in paragraph (c)(2) of this
section, by furnishing the benefits
directly or through arrangements, or by
paying for the benefits. CMS reviews
these benefits subject to the
requirements of this section and the
requirements in subpart G of this part.
*
*
*
*
*
(c) * * *
(1) Basic benefits are all items and
services (other than hospice care or
coverage for organ acquisitions for
kidney transplants) for which benefits
are available under parts A and B of
Medicare, including additional
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
telehealth benefits offered consistent
with the requirements at § 422.135.
*
*
*
*
*
■ 5. Section 422.102 is amended by
revising paragraph (e) introductory text
to read as follows:
§ 422.102
Supplemental benefits.
*
*
*
*
*
(e) Supplemental benefits for certain
dual eligible special needs plans.
Subject to CMS approval, fully
integrated dual eligible special needs
plans and highly integrated dual eligible
special needs plans that meet minimum
performance and quality-based
standards may offer additional
supplemental benefits, consistent with
the requirements of this part, where
CMS finds that the offering of such
benefits could better integrate care for
the dual eligible population provided
that the special needs plan—
*
*
*
*
*
■ 6. Section 422.107 is amended by—
■ a. Revising the section heading;
■ b. By revising paragraphs (a), (b),
(c)(1), (c)(2), and (c)(3);
■ c. By redesignating paragraph (d) as
paragraph (e); and
■ d. Reserving paragraph (d).
The revisions and additions read as
follows:
§ 422.107 Special needs plans and dual
eligibles: Contract with State Medicaid
Agency.
(a) Definition. For the purpose of this
section, a contract with a State Medicaid
agency means a formal written
agreement between an MA organization
and the State Medicaid agency
documenting each entity’s roles and
responsibilities with regard to dual
eligible individuals.
(b) General rule. MA organizations
seeking to offer a dual eligible special
needs plan must have a contract
consistent with this section with the
State Medicaid agency.
(c) * * *
(1) The MA organization’s
responsibility to—
(i) Coordinate the delivery of
Medicaid benefits for individuals who
are eligible for such services; and
(ii) If applicable, provide coverage of
Medicaid services, including long-term
services and supports and behavioral
health services, for individuals eligible
for such services.
(2) The category(ies) and criteria for
eligibility for dual eligible individuals
to be enrolled under the SNP, including
as described in sections 1902(a), 1902(f),
1902(p), and 1905 of the Act.
(3) The Medicaid benefits covered
under a capitated contract between the
PO 00000
Frm 00150
Fmt 4701
Sfmt 4700
State Medicaid agency and the MA
organization offering the SNP, the SNP’s
parent organization, or another entity
that is owned and controlled by the
SNP’s parent organization.
*
*
*
*
*
(d) [Reserved]
■ 7. Effective January 1, 2021, § 422.107
is further amended by adding
paragraphs (c)(9), (d), and (e)(2) to read
as follows:
§ 422.107 Special needs plans and dual
eligibles: Contract with State Medicaid
Agency.
(c) * * *
*
*
*
*
(9) For each dual eligible special
needs plan that is an applicable
integrated plan as defined in § 422.561,
a requirement for the use of the unified
appeals and grievance procedures under
§§ 422.629 through 422.634, 438.210,
438.400, and 438.402.
*
*
*
*
*
(d) Additional minimum contract
requirement. For any dual eligible
special needs plan that is not a fully
integrated or highly integrated dual
eligible special needs plan, the contract
must also stipulate that, for the purpose
of coordinating Medicare and Medicaidcovered services between settings of
care, the SNP notifies, or arrange for
another entity or entities to notify, the
State Medicaid agency, individuals or
entities designated by the State
Medicaid agency, or both, of hospital
and skilled nursing facility admissions
for at least one group of high-risk fullbenefit dual eligible individuals,
identified by the State Medicaid agency.
The State Medicaid agency must
establish the timeframe(s) and
method(s) by which notice is provided.
In the event that a SNP authorizes
another entity or entities to perform this
notification, the SNP must retain
responsibility for complying with this
requirement.
(e) * * *
(2) MA organizations offering a dual
eligible SNP must comply with
paragraphs (c)(9) and (d) of this section
beginning January 1, 2021.
*
*
*
*
*
■ 8. Section 422.111 is amended by
revising paragraph (b)(2)(iii) to read as
follows:
*
§ 422.111
Disclosure requirements.
*
*
*
*
*
(b) * * *
(2) * * *
(iii) By a dual eligible special needs
plan, prior to enrollment, for each
prospective enrollee, a comprehensive
written statement describing cost
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
sharing protections and benefits that the
individual is entitled to under title
XVIII and the State Medicaid program
under title XIX.
*
*
*
*
*
■ 9. Section 422.135 is added to subpart
C to read as follows:
khammond on DSKBBV9HB2PROD with RULES2
§ 422.135
Additional telehealth benefits.
(a) Definitions. For purposes of this
section, the following definitions apply:
Additional telehealth benefits means
services:
(1) For which benefits are available
under Medicare Part B but which are
not payable under section 1834(m) of
the Act; and
(2) That have been identified by the
MA plan for the applicable year as
clinically appropriate to furnish through
electronic exchange when the physician
(as defined in section 1861(r) of the Act)
or practitioner (described in section
1842(b)(18)(C) of the Act) providing the
service is not in the same location as the
enrollee.
Electronic exchange means electronic
information and telecommunications
technology.
(b) General rule. An MA plan may
treat additional telehealth benefits as
basic benefits covered under the original
Medicare fee-for-service program for
purposes of this part 422 provided that
the requirements of this section are met.
If the MA plan fails to comply with the
requirements of this section, then the
MA plan may not treat the benefits
provided through electronic exchange as
additional telehealth benefits, but may
treat them as supplemental benefits as
described in § 422.102, subject to CMS
approval.
(c) Requirements. An MA plan
furnishing additional telehealth benefits
must:
(1) Furnish in-person access to the
specified Part B service(s) at the election
of the enrollee.
(2) Advise each enrollee that the
enrollee may receive the specified Part
B service(s) through an in-person visit
or through electronic exchange.
(3) Comply with the provider
selection and credentialing
requirements provided in § 422.204,
and, when providing additional
telehealth benefits, ensure through its
contract with the provider that the
provider meet and comply with
applicable State licensing requirements
and other applicable laws for the State
in which the enrollee is located and
receiving the service.
(4) Make information about coverage
of additional telehealth benefits
available to CMS upon request.
Information may include, but is not
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
limited to, statistics on use or cost,
manner(s) or method of electronic
exchange, evaluations of effectiveness,
and demonstration of compliance with
the requirements of this section.
(d) Requirement to use contracted
providers. An MA plan furnishing
additional telehealth benefits may only
do so using contracted providers.
Coverage of benefits furnished by a noncontracted provider through electronic
exchange may only be covered as a
supplemental benefit.
(e) Bidding. An MA plan that fully
complies with this section may include
additional telehealth benefits in its bid
for basic benefits in accordance with
§ 422.254.
(f) Cost sharing. MA plans offering
additional telehealth benefits may
maintain different cost sharing for the
specified Part B service(s) furnished
through an in-person visit and the
specified Part B service(s) furnished
through electronic exchange.
§ 422.156
[Amended]
10. Section 422.156 is amended in
paragraph (b)(1) by removing the phrase
‘‘the quality improvement projects
(QIPs) and’’.
■ 11. Section 422.162 (a) is amended by
adding the definitions ‘‘Absolute
percentage cap’’, ‘‘Cut point cap’’,
‘‘Guardrail’’, ‘‘Mean resampling’’,
‘‘Restricted range’’, and ‘‘Restricted
range cap’’ in alphabetical order to read
as follows:
■
§ 422.162 Medicare Advantage Quality
Rating System.
(a) * * *
Absolute percentage cap is a cap
applied to non-CAHPS measures that
are on a 0 to 100 scale that restricts
movement of the current year’s
measure-threshold-specific cut point to
no more than the stated percentage as
compared to the prior year’s cut point.
*
*
*
*
*
Cut point cap is a restriction on the
change in the amount of movement a
measure-threshold-specific cut point
can make as compared to the prior
year’s measure-threshold-specific cut
point. A cut point cap can restrict
upward movement, downward
movement, or both.
*
*
*
*
*
Guardrail is a bidirectional cap that
restricts both upward and downward
movement of a measure-thresholdspecific cut point for the current year’s
measure-level Star Ratings as compared
to the prior year’s measure-thresholdspecific cut point.
*
*
*
*
*
Mean resampling refers to a technique
where measure-specific scores for the
PO 00000
Frm 00151
Fmt 4701
Sfmt 4700
15829
current year’s Star Ratings are randomly
separated into 10 equal-sized groups.
The hierarchal clustering algorithm is
done 10 times, each time leaving one of
the 10 groups out. By leaving out one of
the 10 groups for each run, 9 of the 10
groups, which is 90 percent of the
applicable measure scores, are used for
each run of the clustering algorithm.
The method results in 10 sets of
measure-specific cut points. The mean
cut point for each threshold per measure
is calculated using the 10 values.
*
*
*
*
*
Restricted range is the difference
between the maximum and minimum
measure score values using the prior
year measure scores excluding outer
fence outliers (first quartile
¥3*Interquartile Range (IQR) and third
quartile + 3*IQR).
Restricted range cap is a cap applied
to non-CAHPS measures that restricts
movement of the current year’s
measure-threshold-specific cut point to
no more than the stated percentage of
the restricted range of a measure
calculated using the prior year’s
measure score distribution.
*
*
*
*
*
■ 12. Section 422.164 is amended by
adding paragraphs (f)(1)(v), (g)(1)(iii)(O),
and (h) to read as follows:
§ 422.164 Adding, updating, and removing
measures.
*
*
*
*
*
(f) * * *
(1) * * *
(v) CMS excludes any measure that
receives a measure-level Star Rating
reduction for data integrity concerns for
either the current or prior year from the
improvement measure(s).
*
*
*
*
*
(g) * * *
(1) * * *
(iii) * * *
(O) CMS reduces the measure rating
to 1 star for the applicable appeals
measure(s) if a contract fails to submit
Timeliness Monitoring Project data for
CMS’s review to ensure the
completeness of the contract’s IRE data.
*
*
*
*
*
(h) Review of sponsors’ data. (1) An
MA organization may request that CMS
or the IRE review its’ contract’s appeals
data provided that the request is
received by the annual deadline set by
CMS.
(2) An MA organization may request
that CMS review its’ contract’s
Complaints Tracking Module (CTM)
data provided that the request is
received by the annual deadline set by
CMS for the applicable Star Ratings
year.
E:\FR\FM\16APR2.SGM
16APR2
15830
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
13. Section 422.166 is amended by
revising paragraph (a)(2)(i) and adding
paragraph (i) to read as follows:
■
khammond on DSKBBV9HB2PROD with RULES2
§ 422.166
Calculation of Star Ratings.
(a) * * *
(2) * * *
(i) The method maximizes differences
across the star categories and minimizes
the differences within star categories
using mean resampling with the
hierarchal clustering of the current
year’s data, and a guardrail so that the
measure-threshold-specific cut points
for non-CAHPS measures do not
increase or decrease more than the value
of the cap from one year to the next. The
cap is equal to 5 percentage points for
measures having a 0 to 100 scale
(absolute percentage cap) or 5 percent of
the restricted range for measures not
having a 0 to 100 scale (restricted range
cap). New measures that have been in
the Part C and D Star Rating program for
three years or less use the hierarchal
clustering methodology with mean
resampling with no guardrail for the
first three years in the program.
*
*
*
*
*
(i) Extreme and uncontrollable
circumstances. In the event of extreme
and uncontrollable circumstances that
may negatively impact operational and
clinical systems and contracts’ abilities
to conduct surveys needed for accurate
performance measurement, CMS
calculates the Star Ratings as specified
in paragraphs (i)(2) through (10) of this
section for each contract that is an
affected contract during the
performance period for the applicable
measures. We use the start date of the
incident period to determine which year
of Star Ratings could be affected,
regardless of whether the incident
period lasts until another calendar year.
(1) Identification of affected contracts.
A contract that meets all of the
following criteria is an affected contract:
(i) The contract’s service area is
within an ‘‘emergency area’’ during an
‘‘emergency period’’ as defined in
section 1135(g) of the Act.
(ii) The contract’s service area is
within a county, parish, U.S. territory or
tribal area designated in a major disaster
declaration under the Stafford Act and
the Secretary exercised authority under
section 1135 of the Act based on the
same triggering event(s).
(iii) As specified in paragraphs (i)(2)
through (10) of this section, a certain
minimum percentage (25 percent or 60
percent) of the enrollees under the
contract must reside in a Federal
Emergency Management Agency
(FEMA)-designated Individual
Assistance area at the time of the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
extreme and uncontrollable
circumstance.
(2) CAHPS adjustments. (i) A
contract, even if an affected contract,
must administer the CAHPS survey
unless exempt under paragraph (i)(2)(ii)
of this section.
(ii) An affected contract with at least
25 percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance is exempt
from administering the CAHPS survey if
the contract completes both of the
following:
(A) Demonstrates to CMS that the
required sample for the survey cannot
be contacted because a substantial
number of the contract’s enrollees are
displaced due to the FEMA-designated
disaster identified in paragraph (i)(1)(iii)
of this section in the prior calendar year.
(B) Requests and receives a CMS
approved exemption.
(iii) An affected contract with an
exemption described in paragraph
(i)(2)(ii) of this section receives the
contract’s CAHPS measure stars and
corresponding measure scores from the
prior year.
(iv) For an affected contract with at
least 25 percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance, the
contract receives the higher of the
previous year’s Star Rating or the
current year’s Star Rating (and
corresponding measure score) for each
CAHPS measure.
(v) When a contract is an affected
contract with at least 25 percent of
enrollees in FEMA-designated
Individual Assistance areas at the time
of the extreme and uncontrollable
circumstance with regard to separate
extreme and uncontrollable
circumstances that begin in successive
years, it is a multiple year-affected
contract. A multiple year-affected
contract receives the higher of the
current year’s Star Rating or what the
previous year’s Star Rating would have
been in the absence of any adjustments
that took into account the effects of the
previous year’s disaster for each
measure (using the corresponding
measure score for the Star Ratings year
selected).
(3) HOS adjustments. (i) An affected
contract must administer the HOS
survey unless exempt under paragraph
(i)(3)(ii) of this section.
(ii) An affected contract with at least
25 percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance is exempt
PO 00000
Frm 00152
Fmt 4701
Sfmt 4700
from administering the HOS survey if
the contract completes the following:
(A) Demonstrates to CMS that the
required sample for the survey cannot
be contacted because a substantial
number of the contract’s enrollees are
displaced due to the FEMA-designated
disaster identified in paragraph (i)(1)(iii)
of this section during the measurement
period.
(B) Requests and receives a CMS
approved exemption.
(iii) Affected contracts with an
exemption described in paragraph
(i)(3)(ii) of this section receive the prior
year’s HOS and Healthcare Effectiveness
Data and Information Set (HEDIS)-HOS
measure stars and corresponding
measure scores.
(iv) For an affected contract with at
least 25 percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance, the
affected contract receives the higher of
the previous year’s Star Rating or the
current year’s Star Rating (and
corresponding measure score) for each
HOS and HEDIS–HOS measure.
(v) When a contract is an affected
contract with at least 25 percent of
enrollees in FEMA-designated
Individual Assistance areas at the time
of the extreme and uncontrollable
circumstance with regard to separate
extreme and uncontrollable
circumstances that begin in successive
years, it is a multiple year-affected
contract. A multiple year-affected
contract receives the higher of the
current year’s Star Rating or what the
previous year’s Star Rating would have
been in the absence of any adjustments
that took into account the effects of the
previous year’s disaster for each
measure (using the corresponding
measure score for the Star Ratings year
selected).
(4) HEDIS adjustments. (i) An affected
contract must report HEDIS data unless
exempted under paragraph (i)(4)(ii) of
this section.
(ii) An affected contract with at least
25 percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance is exempt
from reporting HEDIS data if the
contract completes the following:
(A) Demonstrates an inability to
obtain both administrative and medical
record data that are required for
reporting HEDIS measures due to a
FEMA-designated disaster in the prior
calendar year.
(B) Requests and receives a CMS
approved exemption.
(iii) Affected contracts with an
exemption described in paragraph
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
(i)(4)(ii) of this section receive the prior
year’s HEDIS measure stars and
corresponding measure scores.
(iv) Contracts that do not have an
exemption defined in paragraph (i)(4)(ii)
of this section may contact National
Committee for Quality Assurance
(NCQA) to request modifications to the
samples for measures that require
medical record review.
(v) For an affected contract with at
least 25 percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance, the
affected contract receives the higher of
the previous year’s Star Rating or the
current year’s Star Rating (and
corresponding measure score) for each
HEDIS measure.
(vi) When a contract is an affected
contract with at least 25 percent of
enrollees in FEMA-designated
Individual Assistance areas at the time
of the extreme and uncontrollable
circumstance with regard to separate
extreme and uncontrollable
circumstances that begin in successive
years, it is a multiple year-affected
contract. A multiple year-affected
contract receives the higher of the
current year’s Star Rating or what the
previous year’s Star Rating would have
been in the absence of any adjustments
that took into account the effects of the
previous year’s disaster for each
measure (using the corresponding
measure score for the Star Ratings year
selected).
(5) New measure adjustments. For
affected contracts with at least 25
percent of enrollees in a FEMAdesignated Individual Assistance area at
the time of the extreme and
uncontrollable circumstance, CMS
holds the affected contract harmless by
using the higher of the contract’s
summary or overall rating or both with
and without including all of the
applicable new measures.
(6) Other Star Ratings measure
adjustments. (i) For all other measures
except those measures identified in this
paragraph (i)(6)(ii) of this section,
affected contracts with at least 25
percent of enrollees in a FEMAdesignated Individual Assistance area at
the time of the extreme and
uncontrollable circumstance receive the
higher of the previous or current year’s
measure Star Rating (and corresponding
measure score).
(ii) CMS does not adjust the scores or
Star Ratings for the following measures,
unless the exemption in paragraph
(i)(6)(iii) of this section applies.
(A) Part C Call Center—Foreign
Language Interpreter and TTY
Availability.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
(B) Part D Call Center—Foreign
Language Interpreter and TTY
Availability.
(iii) CMS adjusts the measures listed
in paragraph (i)(6)(ii) of this section
using the adjustments listed in
paragraph (i)(6)(i) of this section for
contracts affected by extreme and
uncontrollable circumstances where
there are continuing communications
issues related to loss of electricity and
damage to infrastructure during the call
center study.
(iv) When a contract is an affected
contract with at least 25 percent of
enrollees in FEMA-designated
Individual Assistance areas at the time
of the extreme and uncontrollable
circumstance with regard to separate
extreme and uncontrollable
circumstances that begin in successive
years, it is a multiple year-affected
contract. A multiple year-affected
contract receives the higher of the
current year’s Star Rating or what the
previous year’s Star Rating would have
been in the absence of any adjustments
that took into account the effects of the
previous year’s disaster for each
measure (using the corresponding
measure score for the Star Ratings year
selected).
(7) Exclusion from improvement
measures. Any measure that reverts
back to the data underlying the previous
year’s Star Rating due to the
adjustments made in paragraph (i) of
this section is excluded from both the
count of measures and the applicable
improvement measures for the current
and next year’s Star Ratings for the
affected contract. Contracts affected by
extreme and uncontrollable
circumstances do not have the option of
reverting to the prior year’s
improvement rating.
(8) Missing data. For an affected
contract that has missing data in the
current or previous year, the final
measure rating comes from the current
year unless any of the exemptions
described in paragraphs (i)(2)(ii),
(i)(3)(ii), and (i)(4)(ii) of this section
apply.
(9) Cut points for non-CAHPS
measures. (i) CMS excludes the numeric
values for affected contracts with 60
percent or more of their enrollees in the
FEMA-designated Individual Assistance
area at the time of the extreme and
uncontrollable circumstance from the
clustering algorithms described in
paragraph (a)(2) of this section.
(ii) The cut points calculated as
described in paragraph (i)(9)(i) of this
section are used to assess all affected
contracts’ measure Star Ratings.
(10) Reward Factor. (i) CMS excludes
the numeric values for affected contracts
PO 00000
Frm 00153
Fmt 4701
Sfmt 4700
15831
with 60 percent or more of their
enrollees in the FEMA-designated
Individual Assistance area at the time of
the extreme and uncontrollable
circumstance from the determination of
the performance summary and variance
thresholds for the Reward Factor
described in paragraph (f)(1) of this
section.
(ii) All affected contracts are eligible
for the Reward Factor based on the
calculations described in paragraph
(i)(10)(i) of this section.
■ 14. Effective June 17, 2019, § 422.222
is amended by revising paragraph (a)(2)
to read as follows:
§ 422.222
Preclusion list.
(a) * * *
(2)(i) CMS sends written notice to the
individual or entity via letter of their
inclusion on the preclusion list. The
notice must contain the reason for the
inclusion and inform the individual or
entity of their appeal rights. An
individual or entity may appeal their
inclusion on the preclusion list, defined
in § 422.2, in accordance with part 498
of this chapter.
(ii) If the individual’s or entity’s
inclusion on the preclusion list is based
on a contemporaneous Medicare
revocation under § 424.535 of this
chapter:
(A) The notice described in paragraph
(a)(2)(i) of this section must also include
notice of the revocation, the reason(s)
for the revocation, and a description of
the individual’s or entity’s appeal rights
concerning the revocation.
(B) The appeals of the individual’s or
entity’s inclusion on the preclusion list
and the individual’s or entity’s
revocation must be filed jointly by the
individual or entity and, as applicable,
considered jointly under part 498 of this
chapter.
■ 15. Section 422.222 is amended by
revising the section heading and
paragraph (a) to read as follows:
§ 422.222 Preclusion list for contracted
and non-contracted individuals and entities.
(a)(1)(i) Except as provided in
paragraph (a)(1)(ii) of this section, an
MA organization must not make
payment for a health care item, service,
or drug that is furnished, ordered, or
prescribed by an individual or entity
that is included on the preclusion list,
defined in § 422.2.
(ii) With respect to MA providers that
have been added to an updated
preclusion list but are not currently
excluded by the OIG, the MA
organization must do all of the
following:
(A) No later than 30 days after the
posting of this updated preclusion list,
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15832
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
must provide an advance written notice
to any beneficiary who has received or
been prescribed an MA service, item, or
drug from or by the individual or entity
added to the preclusion list in this
update.
(B)(1) Subject to paragraph
(a)(1)(ii)(B)(2) of this section, must
ensure that reasonable efforts are made
to notify the individual or entity
described in paragraph (a)(1)(ii) of this
section of a beneficiary who was sent a
notice under paragraph (a)(1)(ii)(A) of
this section.
(2) Paragraph (a)(1)(ii)(B)(1) of this
section applies only upon receipt of a
claim from a precluded provider in
Medicare Part C when—
(i) The MA organization has enough
information on file to either copy the
provider on the notification previously
sent to the beneficiary or send a new
notice informing the provider that they
may not see plan beneficiaries due to
their preclusion status; and
(ii) The claim is received after the
claim denial or reject date in the
preclusion file.
(C) Must not deny payment for a
service, item, or drug furnished,
ordered, or prescribed by the newly
added individual or entity, solely on the
ground that they have been included in
the updated preclusion list, in the 60day period after the date it sent the
notice described in paragraph
(a)(1)(ii)(A) of this section.
(2)(i) CMS sends written notice to the
individual or entity via letter of their
inclusion on the preclusion list. The
notice must contain the reason for the
inclusion and inform the individual or
entity of their appeal rights. An
individual or entity may appeal their
inclusion on the preclusion list, defined
in § 422.2, in accordance with part 498
of this chapter.
(ii) If the individual’s or entity’s
inclusion on the preclusion list is based
on a contemporaneous Medicare
revocation under § 424.535 of this
chapter:
(A) The notice described in paragraph
(a)(2)(i) of this section must also include
notice of the revocation, the reason(s)
for the revocation, and a description of
the individual’s or entity’s appeal rights
concerning the revocation.
(B) The appeals of the individual’s or
entity’s inclusion on the preclusion list
and the individual’s or entity’s
revocation must be filed jointly by the
individual or entity and, as applicable,
considered jointly under part 498 of this
chapter.
(3)(i) Except as provided in paragraph
(a)(3)(ii) of this section, an individual or
entity will only be included on the
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
preclusion list after the expiration of
either of the following:
(A) If the individual or entity does not
file a reconsideration request under
§ 498.5(n)(1) of this chapter, the
individual or entity will be added to the
preclusion list upon the expiration of
the 60-day period in which the
individual or entity may request a
reconsideration; or
(B) If the individual or entity files a
reconsideration request under
§ 498.5(n)(1) of this chapter, the
individual or entity will be added to the
preclusion list effective on the date on
which CMS, if applicable, denies the
individual’s or entity’s reconsideration.
(ii) An OIG excluded individual or
entity is added to the preclusion list
effective on the date of the exclusion.
(4) Payment denials based upon an
individual’s or entity’s inclusion on the
preclusion list are not appealable by
beneficiaries.
(5)(i) Except as provided in
paragraphs (a)(5)(iii) and (iv) of this
section, an individual or entity that is
revoked under § 424.535 of this chapter
will be included on the preclusion list
for the same length of time as the
individual’s or entity’s reenrollment bar.
(ii) Except as provided in paragraphs
(a)(5)(iii) and (iv) of this section, an
individual or entity that is not enrolled
in Medicare will be included on the
preclusion list for the same length of
time as the reenrollment bar that CMS
could have imposed on the individual
or entity had they been enrolled and
then revoked.
(iii) Except as provided in paragraph
(a)(5)(iv) of this section, an individual or
entity, regardless of whether they are or
were enrolled in Medicare, that is
included on the preclusion list because
of a felony conviction will remain on
the preclusion list for a 10-year period,
beginning on the date of the felony
conviction, unless CMS determines that
a shorter length of time is warranted.
Factors that CMS considers in making
such a determination are as follows:—
(A) The severity of the offense.
(B) When the offense occurred.
(C) Any other information that CMS
deems relevant to its determination.
(iv) In cases where an individual or
entity is excluded by the OIG, the
individual or entity must remain on the
preclusion list until the expiration of
the CMS-imposed preclusion list period
or reinstatement by the OIG, whichever
occurs later.
(6) CMS has the discretion not to
include a particular individual or entity
on (or if warranted, remove the
individual or entity from) the preclusion
list should it determine that exceptional
circumstances exist regarding
PO 00000
Frm 00154
Fmt 4701
Sfmt 4700
beneficiary access to MA items,
services, or drugs. In making a
determination as to whether such
circumstances exist, CMS takes into
account:
(i) The degree to which beneficiary
access to MA items, services, or drugs
would be impaired; and
(ii) Any other evidence that CMS
deems relevant to its determination.
*
*
*
*
*
16. Section 422.252 is amended by
revising the definition of ‘‘MA monthly
basic beneficiary premium’’, ‘‘MA
monthly MSA premium’’, ‘‘Monthly
aggregate bid amount’’, ‘‘Plan basic cost
sharing’’, and ‘‘Unadjusted MA statutory
non-drug monthly bid amount’’ to read
as follows:
■
§ 422.252
Terminology.
*
*
*
*
*
MA monthly basic beneficiary
premium means the premium amount
(if any) an MA plan (except an MSA
plan) charges an enrollee for basic
benefits as defined in § 422.100(c)(1),
and is calculated as described at
§ 422.262.
MA monthly MSA premium means
the amount of the plan premium for
coverage of basic benefits as defined in
§ 422.100(c)(1) through an MSA plan, as
set forth at § 422.254(e).
*
*
*
*
*
Monthly aggregate bid amount means
the total monthly plan bid amount for
coverage of an MA eligible beneficiary
with a nationally average risk profile for
the factors described in § 422.308(c),
and this amount is comprised of the
following:
(1) The unadjusted MA statutory nondrug monthly bid amount for coverage
of basic benefits as defined in
§ 422.100(c)(1).
(2) The amount for coverage of basic
prescription drug benefits under Part D
(if any).
(3) The amount for provision of
supplemental health care benefits (if
any).
*
*
*
*
*
Plan basic cost sharing means cost
sharing that would be charged by a plan
for basic benefits as defined in
§ 422.100(c)(1) before any reductions
resulting from mandatory supplemental
benefits.
*
*
*
*
*
Unadjusted MA statutory non-drug
monthly bid amount means a plan’s
estimate of its average monthly required
revenue to provide coverage of basic
benefits as defined in § 422.100(c)(1) to
an MA eligible beneficiary with a
nationally average risk profile for the
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
risk factors CMS applies to payment
calculations as set forth at § 422.308(c).
17. Section 422.254 is amended by—
a. Revising paragraph (b)(1)(i);
b. Adding paragraph (b)(3)(i);
c. Reserving paragraph (b)(3)(ii); and
d. Revising paragraphs (b)(4), (c)(3)(i),
and (e)(2).
The revisions and addition read as
follows:
■
■
■
■
■
§ 422.254
Submission of bids.
khammond on DSKBBV9HB2PROD with RULES2
*
*
*
*
*
(b) * * *
(1) * * *
(i) The unadjusted MA statutory nondrug monthly bid amount, which is the
MA plan’s estimated average monthly
required revenue for providing basic
benefits as defined in § 422.100(c)(1).
*
*
*
*
*
(3) * * *
(i) MA plans offering additional
telehealth benefits as defined in
§ 422.135(a) must exclude any capital
and infrastructure costs and investments
directly incurred or paid by the MA
plan relating to such benefits from their
bid submission for the unadjusted MA
statutory non-drug monthly bid amount.
(ii) [Reserved]
(4) The bid amount is for plan
payments only but must be based on
plan assumptions about the amount of
revenue required from enrollee costsharing. The estimate of plan costsharing for the unadjusted MA statutory
non-drug monthly bid amount for
coverage of basic benefits as defined in
§ 422.100(c)(1) must reflect the
requirement that the level of cost
sharing MA plans charge to enrollees
must be actuarially equivalent to the
level of cost sharing (deductible,
copayments, or coinsurance) charged to
beneficiaries under the original
Medicare fee-for-service program
option. The actuarially equivalent level
of cost sharing reflected in a regional
plan’s unadjusted MA statutory nondrug monthly bid amount does not
include cost sharing for out-of-network
Medicare benefits, as described at
§ 422.101(d).
*
*
*
*
*
(c) * * *
(3) * * *
(i) The provision of basic benefits as
defined in § 422.100(c)(1);
*
*
*
*
*
(e) * * *
(2) The amount of the MA monthly
MSA premium for basic benefits (as
defined in § 422.252);
*
*
*
*
*
■ 18. Section 422.264 is amended by
revising paragraph (a) to read as follows:
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
§ 422.264
Calculation of savings.
(a) Computation of risk adjusted bids
and benchmarks—(1) The risk adjusted
MA statutory non-drug monthly bid
amount is the unadjusted MA statutory
non-drug monthly bid amount (defined
at § 422.254(b)(1)(i)), adjusted using the
factors described in paragraph (c) of this
section for local plans and paragraph (e)
of this section for regional plans.
(2) The risk adjusted MA area-specific
non-drug monthly benchmark amount is
the unadjusted benchmark amount for
coverage of basic benefits defined in
§ 422.100(c)(1) by a local MA plan,
adjusted using the factors described in
paragraph (c) of this section.
(3) The risk adjusted MA regionspecific non-drug monthly benchmark
amount is the unadjusted benchmark
amount for coverage of basic benefits
defined in § 422.100(c)(1) by a regional
MA plan, adjusted using the factors
described in paragraph (e) of this
section.
*
*
*
*
*
■ 19. Section 422.504 is amended by
adding paragraphs (g)(1)(iv) and (v) to
read as follows:
§ 422.504
Contract provisions.
*
*
*
*
*
(g) * * *
(1) * * *
(iv) Ensure that the enrollee does not
have any financial liability for services,
items, or drugs furnished, ordered, or
prescribed to the enrollee by an MA
contracted individual or entity on the
preclusion list, as defined in § 422.2 and
as described in § 422.222.
(v) Ensure that the plan’s provider
agreement contains a provision stating
that after the expiration of the 60-day
period specified in § 422.222:
(A) The provider will no longer be
eligible for payment from the plan and
will be prohibited from pursuing
payment from the beneficiary as
stipulated by the terms of the contract
between CMS and the plan per
§ 422.504(g)(1)(iv); and
(B) The provider will hold financial
liability for services, items, and drugs
that are furnished, ordered, or
prescribed after this 60-day period, at
which point the provider and the
beneficiary will have already received
notification of the preclusion.
*
*
*
*
*
■ 20. Effective January 1, 2021,
§ 422.560 is amended by adding
paragraphs (a)(4) and (b)(5) to read as
follows:
§ 422.560
Basis and scope.
(a) * * *
(4) Section 1859(f)(8) of the Act
provides for, to the extent feasible,
PO 00000
Frm 00155
Fmt 4701
Sfmt 4700
15833
unifying grievances and appeals
procedures under sections 1852(f),
1852(g), 1902(a)(3), 1902(a)(5), and
1932(b)(4) of the Act for Medicare and
Medicaid covered items and services
provided by specialized MA plans for
special needs individuals described in
subsection 1859(b)(6)(B)(ii) of the Act
for individuals who are eligible under
titles XVIII and XIX of the Act.
Beginning January 1, 2021, procedures
established under section 1859(f)(8) of
the Act apply in place of otherwise
applicable grievances and appeals
procedures with respect to Medicare
and Medicaid covered items and
services provided by applicable
integrated plans.
(b) * * *
(5) Requirements for applicable
integrated plans with respect to
procedures for integrated grievances,
integrated organization determinations,
and integrated reconsiderations.
*
*
*
*
*
■ 21. Section 422.561 is amended by
adding the definitions ‘‘Applicable
integrated plans’’, ‘‘Integrated appeal’’,
‘‘Integrated grievance’’, ‘‘Integrated
organization determination’’, and
‘‘Integrated reconsideration’’ in
alphabetical order to read as follows:
§ 422.561
Definitions.
*
*
*
*
*
Applicable integrated plan means:
(1) A fully integrated dual eligible
special needs plan with exclusively
aligned enrollment or a highly
integrated dual eligible special needs
plan with exclusively aligned
enrollment, and
(2) The Medicaid managed care
organization, as defined in section
1903(m) of the Act, through which such
dual eligible special needs plan, its
parent organization, or another entity
that is owned and controlled by its
parent organization covers Medicaid
services for dually eligible individuals
enrolled in such dual eligible special
needs plan and such Medicaid managed
care organization.
*
*
*
*
*
Integrated appeal means any of the
procedures that deal with, or result
from, adverse integrated organization
determinations by an applicable
integrated plan on the health care
services the enrollee believes he or she
is entitled to receive, including delay in
providing, arranging for, or approving
the health care services (such that a
delay would adversely affect the health
of the enrollee), or on any amounts the
enrollee must pay for a service.
Integrated appeals cover procedures that
would otherwise be defined and
E:\FR\FM\16APR2.SGM
16APR2
15834
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
covered, for non-applicable integrated
plans, as an appeal defined in § 422.561
or the procedures required for appeals
in accordance with §§ 438.400 through
438.424 of this chapter. Such
procedures include integrated
reconsiderations.
Integrated grievance means a dispute
or compliant that would be defined and
covered, for grievances filed by an
enrollee in non-applicable integrated
plans, under § 422.564 or §§ 438.400
through 438.416 of this chapter.
Integrated grievances do not include
appeals procedures and QIO
complaints, as described in § 422.564(b)
and (c). An integrated grievance made
by an enrollee in an applicable
integrated plan is subject to the
integrated grievance procedures in
§§ 422.629 and 422.630.
Integrated organization determination
means an organization determination
that would otherwise be defined and
covered, for a non-applicable integrated
plan, as an organization determination
under § 422.566, an adverse benefit
determination under § 438.400(b), or an
action under § 431.201 of this chapter.
An integrated organization
determination is made by an applicable
integrated plan and is subject to the
integrated organization determination
procedures in §§ 422.629, 422.631, and
422.634.
Integrated reconsideration means a
reconsideration that would otherwise be
defined and covered, for a nonapplicable integrated plan, as a
reconsideration under § 422.580 and
appeal under § 438.400(b) of this
chapter. An integrated reconsideration
is made by an applicable integrated plan
and is subject to the integrated
reconsideration procedures in
§§ 422.629 and 422.632 through
422.634.
*
*
*
*
*
22. Section 422.562 is amended by—
a. Revising paragraph (a)(1)(i);
b. By adding paragraph (a)(5); and
c. By revising paragraphs (b)(1), (b)(2),
(b)(3), (b)(4)(i), and (b)(4)(ii).
The revisions and addition read as
follows:
■
■
■
■
khammond on DSKBBV9HB2PROD with RULES2
§ 422.562
General provisions.
(a) * * *
(1) * * *
(i) A grievance procedure as described
in § 422.564 or, beginning January 1,
2021, § 422.630 as applicable, for
addressing issues that do not involve
organization determinations;
*
*
*
*
*
(5) An MA organization that offers a
dual eligible special needs plan has the
following additional responsibilities:
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
(i) The dual eligible special needs
plan must offer to assist an enrollee in
that dual eligible special needs plan
with obtaining Medicaid covered
services and resolving grievances,
including requesting authorization of
Medicaid services, as applicable, and
navigating Medicaid appeals and
grievances in connection with the
enrollee’s own Medicaid coverage,
regardless of whether such coverage is
in Medicaid fee-for-service or a
Medicaid managed care plan, such as a
Medicaid MCO, PIHP, or PAHP as
defined in § 438.2 of this chapter. If the
enrollee accepts the offer of assistance,
the plan must provide the assistance.
Examples of such assistance include the
following:
(A) Explaining to an enrollee how to
make a request for Medicaid
authorization of a service and how to
file appeal following an adverse benefit
determination, such as—
(1) Assisting the enrollee in
identifying the enrollee’s specific
Medicaid managed care plan or fee-forservice point of contact;
(2) Providing specific instructions for
contacting the appropriate agency in a
fee-for-service setting or for contacting
the enrollee’s Medicaid managed care
plan, regardless of whether the
Medicaid managed care plan is affiliated
with the enrollee’s dual eligible special
needs plan; and
(3) Assisting the enrollee in making
contact with the enrollee’s fee-forservice contact or Medicaid managed
care plan.
(B) Assisting a beneficiary in filing a
Medicaid grievance or a Medicaid
appeal.
(C) Assisting an enrollee in obtaining
documentation to support a request for
authorization of Medicaid services or a
Medicaid appeal.
(ii) The dual eligible special needs
plan must offer to provide the assistance
described in paragraph (a)(5)(i) of this
section whenever it becomes aware of
an enrollee’s need for a Medicaidcovered service. Offering such
assistance is not dependent on an
enrollee’s specific request.
(iii) The dual eligible special needs
plan must offer to provide and actually
provide assistance as required by
paragraph (a)(5)(i) of this section using
multiple methods.
(A) When an enrollee accepts the offer
of assistance described in paragraph
(a)(5)(i) of this section, the dual eligible
special needs plan may coach the
enrollee on how to self-advocate.
(B) The dual eligible special needs
plan must also provide an enrollee
reasonable assistance in completing
forms and taking procedural steps
PO 00000
Frm 00156
Fmt 4701
Sfmt 4700
related to Medicaid grievances and
appeals.
(iv) The dual eligible special needs
plan must, upon request from CMS,
provide documentation demonstrating
its compliance with this paragraph
(a)(5).
(v) The obligation to provide
assistance under paragraph (a)(5)(i) of
this section does not create an
obligation for a dual eligible special
needs plan to represent an enrollee in a
Medicaid appeal.
(b) * * *
(1) The right to have grievances
between the enrollee and the MA
organization heard and resolved, as
described in § 422.564 or, beginning
January 1, 2021, § 422.630, as
applicable.
(2) The right to a timely organization
determination, as provided under
§ 422.566 or, beginning January 1, 2021,
§ 422.631, as applicable.
(3) The right to request an expedited
organization determination, as provided
under §§ 422.570 or, beginning January
1, 2021, § 422.631(e), as applicable.
(4) * * *
(i) The right to a reconsideration of
the adverse organization determination
by the MA organization, as provided
under § 422.578 or, beginning January 1,
2021, § 422.633, as applicable.
(ii) The right to request an expedited
reconsideration, as provided under
§ 422.584 or, beginning January 1, 2021,
§ 422.633(f), as applicable.
*
*
*
*
*
■ 23. Effective January 1, 2021,
§ 422.566 is amended by revising
paragraph (a) to read as follows:
§ 422.566
Organization determinations.
(a) Responsibilities of the MA
organization. Each MA organization
must have a procedure for making
timely organization determinations (in
accordance with the requirements of
this subpart) regarding the benefits an
enrollee is entitled to receive under an
MA plan, including basic benefits as
described under § 422.100(c)(1) and
mandatory and optional supplemental
benefits as described under § 422.102,
and the amount, if any, that the enrollee
is required to pay for a health service.
The MA organization must have a
standard procedure for making
determinations, in accordance with
§ 422.568, and an expedited procedure
for situations in which applying the
standard procedure could seriously
jeopardize the enrollee’s life, health, or
ability to regain maximum function, in
accordance with §§ 422.570 and
422.572. For an applicable integrated
plan, beginning January 1, 2021, the MA
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
organization must comply with
§§ 422.629 through 422.634 in lieu of
§§ 422.566(c) and (d), 422.568, 422.570
and 422.572 with regard to the
procedures for making determinations,
including integrated organization
determinations and integrated
reconsiderations, on a standard and
expedited basis.
*
*
*
*
*
■ 24. Effective January 1, 2021, add an
undesignated center heading and
§§ 422.629 through 422.634 to Subpart
M to read as follows:
Subpart M—Grievances, Organization
Determinations and Appeals
*
*
*
*
*
Requirements Applicable to Certain
Integrated Dual Eligible Special Needs
Plans
Sec.
422.629 General requirements for
applicable integrated plans.
422.630 Integrated grievances.
422.631 Integrated organization
determinations.
422.632 Continuation of benefits while the
applicable integrated plan
reconsideration is pending.
422.633 Integrated reconsideration.
422.634 Effect.
Requirements Applicable to Certain
Integrated Dual Eligible Special Needs
Plans
khammond on DSKBBV9HB2PROD with RULES2
§ 422.629 General requirements for
applicable integrated plans.
(a) Scope. The provisions in this
section and in §§ 422.630 through
422.634 set forth requirements for
unified appeals and grievance processes
with which applicable integrated plans
must comply. Beginning January 1,
2021, these provisions apply to an
applicable integrated plan in lieu of
§§ 422.564, 422.566(c) and (d), and
422.568 through 422.590, and
422.618(a) and §§ 438.404 through
438.424 of this chapter.
(b) General process. An applicable
integrated plan must create integrated
processes for enrollees for integrated
grievances, integrated organization
determinations, and integrated
reconsiderations.
(c) State flexibilities. A State may, at
its discretion, implement standards for
timeframes or notice requirements that
are more protective for the enrollee than
required by this section and §§ 422.630
through 422.634. The contract under
§ 422.107 must include any standards
that differ from the standards set forth
in this section.
(d) Evidence. The applicable
integrated plan must provide the
enrollee a reasonable opportunity, in
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
person and in writing, to present
evidence and testimony and make legal
and factual arguments for integrated
grievances, and integrated
reconsiderations. The applicable
integrated plan must inform the enrollee
of the limited time available for
presenting evidence sufficiently in
advance of the resolution timeframe for
appeals as specified in this section if the
case is being considered under an
expedited timeframe for the integrated
grievance or integrated reconsideration.
(e) Assistance. In addition to the
requirements in § 422.562(a)(5), the
applicable integrated plan must provide
an enrollee reasonable assistance in
completing forms and taking other
procedural steps related to integrated
grievances and integrated appeals.
(f) Applicable requirements. The
requirements in §§ 422.560, 422.561,
422.562, 422.566, and 422.592 through
422.626 apply to an applicable
integrated plan unless otherwise
provided in this section or in §§ 422.630
through 422.634.
(g) Acknowledgement. The applicable
integrated plan must send to the
enrollee written acknowledgement of
integrated grievances and integrated
reconsiderations upon receiving the
request.
(h) Recordkeeping. (1) The applicable
integrated plan must maintain records
of integrated grievances and integrated
appeals. Each applicable integrated plan
that is a Medicaid managed care
organization must review the Medicaidrelated information as part of its
ongoing monitoring procedures, as well
as for updates and revisions to the State
quality strategy.
(2) The record of each integrated
grievance or integrated appeal must
contain, at a minimum:
(i) A general description of the reason
for the integrated appeal or integrated
grievance.
(ii) The date of receipt.
(iii) The date of each review or, if
applicable, review meeting.
(iv) Resolution at each level of the
integrated appeal or integrated
grievance, if applicable.
(v) Date of resolution at each level, if
applicable.
(vi) Name of the enrollee for whom
the integrated appeal or integrated
grievance was filed.
(vii) Date the applicable integrated
plan notified the enrollee of the
resolution.
(3) The record of each integrated
grievance or integrated appeal must be
accurately maintained in a manner
accessible to the State and available
upon request to CMS.
PO 00000
Frm 00157
Fmt 4701
Sfmt 4700
15835
(i) Prohibition on punitive action.
Each applicable integrated plan must
ensure that no punitive action is taken
against a provider that requests an
integrated organization determination or
integrated reconsideration, or supports
an enrollee’s request for these actions.
(j) Information to providers and
subcontractors. The applicable
integrated plan must provide
information about the integrated
grievance and integrated appeal system
to all providers and subcontractors at
the time they enter into a contract
including, at minimum, information on
integrated grievance, integrated
reconsideration, and fair hearing
procedures and timeframes as
applicable. Such information must
include the following:
(1) The right to file an integrated
grievance and integrated
reconsideration.
(2) The requirements and timeframes
for filing an integrated grievance or
integrated reconsideration.
(3) The availability of assistance in
the filing process.
(k) Review decision-making
requirements—(1) General rules.
Individuals making decisions on
integrated appeals and grievances must
take into account all comments,
documents, records, and other
information submitted by the enrollee or
their representative without regard to
whether such information was
submitted or considered in the initial
adverse integrated organization
determination.
(2) Integrated grievances. Individuals
making decisions on integrated
grievances must be individuals who—
(i) Were neither involved in any
previous level of review or decisionmaking nor a subordinate of any such
individual; and
(ii) If deciding any of the following,
have the appropriate clinical expertise
in treating the enrollee’s condition or
disease:
(A) A grievance regarding denial of
expedited resolution of an appeal.
(B) A grievance that involves clinical
issues.
(3) Integrated organization
determinations. If the applicable
integrated plan expects to issue a
partially or fully adverse medical
necessity (or any substantively
equivalent term used to describe the
concept of medical necessity) decision
based on the initial review of the
request, the integrated organization
determination must be reviewed by a
physician or other appropriate health
care professional with sufficient
medical and other expertise, including
knowledge of Medicare and Medicaid
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
15836
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
coverage criteria, before the applicable
integrated plan issues the integrated
organization determination. Any
physician or other health care
professional who reviews an integrated
organization determination must have a
current and unrestricted license to
practice within the scope of his or her
profession.
(4) Integrated reconsideration
determinations. Individuals making an
integrated reconsideration
determination must be individuals
who—
(i) Were neither involved in any
previous level of review or decisionmaking nor a subordinate of any such
individual; and
(ii) If deciding an appeal of a denial
that is based on lack of medical
necessity (or any substantively
equivalent term used to describe the
concept of medical necessity), are a
physician or other appropriate health
care professional who have the
appropriate clinical expertise, in
treating the enrollee’s condition or
disease, and knowledge of Medicare
coverage criteria, before the MA
organization issues the organization
determination decision.
(l) Parties. (1) The following
individuals or entities can request an
integrated grievance, integrated
organization determination, and
integrated reconsideration, and are
parties to the case:
(i) The enrollee or his or her
representative;
(ii) An assignee of the enrollee (that
is, a physician or other provider who
has furnished or intends to furnish a
service to the enrollee and formally
agrees to waive any right to payment
from the enrollee for that service), or
any other provider or entity (other than
the applicable integrated plan) who has
an appealable interest in the proceeding;
(iii) The legal representative of a
deceased enrollee’s estate; or
(iv) Subject to paragraph (l)(3) of this
section, any provider that furnishes, or
intends to furnish, services to the
enrollee. If the provider requests that
the benefits continue while the appeal
is pending, pursuant to § 422.632 and
consistent with State law, the provider
must obtain the written consent of the
enrollee to request the appeal on behalf
of the enrollee.
(2) When the term ‘‘enrollee’’ is used
throughout §§ 422.629 through 422.634,
it includes providers that file a request
and authorized representatives
consistent with this paragraph, unless
otherwise specified.
(3) A provider who is providing
treatment to the enrollee may, upon
providing notice to the enrollee, request
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
a standard or expedited pre-service
integrated reconsideration on behalf of
an enrollee.
§ 422.630
Integrated grievances.
(a) General rule. In lieu of complying
with § 422.564, and the grievance
requirements of §§ 438.402, 438.406,
438.408, 438.414, and 438.416 of this
chapter, each applicable integrated plan
must comply with this section. Each
applicable integrated plan must provide
meaningful procedures for timely
hearing and resolving integrated
grievances between enrollees and the
applicable integrated plan or any other
entity or individual through which the
applicable integrated plan provides
covered items and services.
(b) Timing. An enrollee may file an
integrated grievance at any time with
the applicable integrated plan.
(c) Filing. An enrollee may file an
integrated grievance orally or in writing
with the applicable integrated plan, or
with the State for an integrated
grievance related to a Medicaid benefit,
if the State has a process for accepting
Medicaid grievances.
(d) Expedited grievances. An
applicable integrated plan must respond
to an enrollee’s grievance within 24
hours if the complaint involves the
applicable integrated plan’s—
(1) Decision to invoke an extension
relating to an integrated organization
determination or integrated
reconsideration; or
(2) Refusal to grant an enrollee’s
request for an expedited integrated
organization determination under
§ 422.631 or expedited integrated
reconsideration under § 422.633.
(e) Resolution and notice. (1) The
applicable integrated plan must resolve
standard integrated grievances as
expeditiously as the case requires, based
on the enrollee’s health status, but no
later than 30 calendar days from the
date it receives the integrated grievance.
(i) All integrated grievances submitted
in writing must be responded to in
writing.
(ii) Integrated grievances submitted
orally may be responded to either orally
or in writing, unless the enrollee
requests a written response.
(iii) All integrated grievances related
to quality of care, regardless of how the
integrated grievance is filed, must be
responded to in writing. The response
must include a description of the
enrollee’s right to file a written
complaint with the QIO with regard to
Medicare covered services. For any
complaint submitted to a QIO, the
applicable integrated plan must
cooperate with the QIO in resolving the
complaint.
PO 00000
Frm 00158
Fmt 4701
Sfmt 4700
(2) The timeframe for resolving the
integrated grievance may be extended
by 14 calendar days if the enrollee
requests an extension or if the
applicable integrated plan justifies the
need for additional information and
documents how the delay is in the
interest of the enrollee. When the
applicable integrated plan extends the
timeframe, it must—
(i) Make reasonable efforts to
promptly notify the enrollee orally of
the reasons for the delay; and
(ii) Send written notice to the enrollee
of the reasons for the delay
immediately, but no later than within 2
calendar days of making the decision to
extend the timeframe to resolve the
integrated grievance. This notice must
explain the right to file an integrated
grievance if the enrollee disagrees with
the decision to delay.
§ 422.631 Integrated organization
determinations.
(a) General rule. An applicable
integrated plan must adopt and
implement a process for enrollees to
request that the plan make an integrated
organization determination. The process
for requesting that the applicable
integrated plan make an integrated
organization determination must be the
same for all covered benefits.
(b) Requests. The enrollee, or a
provider on behalf of an enrollee, may
request an integrated organization
determination orally or in writing,
except for requests for payment, which
must be in writing (unless the
applicable integrated plan or entity
responsible for making the
determination has implemented a
voluntary policy of accepting verbal
payment requests).
(c) Expedited integrated organization
determinations. (1) An enrollee, or a
provider on behalf of an enrollee, may
request an expedited integrated
organization determination.
(2) The request can be oral or in
writing.
(3) The applicable integrated plan
must complete an expedited integrated
organization determination when the
applicable integrated plan determines
(based on a request from the enrollee or
on its own) or the provider indicates (in
making the request on the enrollee’s
behalf or supporting the enrollee’s
request) that taking the time for a
standard resolution could seriously
jeopardize the enrollee’s life, physical or
mental health, or ability to attain,
maintain, or regain maximum function.
(d) Timeframes and notice—(1)
Integrated organization determination
notice. (i) The applicable integrated
plan must send an enrollee a written
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
notice of any adverse decision on an
integrated organization determination
(including a determination to authorize
a service or item in an amount,
duration, or scope that is less than the
amount previously requested or
authorized for an ongoing course of
treatment) within the timeframes set
forth in this section.
(ii) For an integrated organization
determination not reached within the
timeframes specified in this section
(which constitutes a denial and is thus
an adverse decision), the applicable
integrated plan must send a notice on
the date that the timeframes expire.
Such notice must describe all applicable
Medicare and Medicaid appeal rights.
(iii) Integrated organization
determination notices must be written
in plain language, be available in a
language and format that is accessible to
the enrollee, and explain the following:
(A) The applicable integrated plan’s
determination.
(B) The date the determination was
made.
(C) The date the determination will
take effect.
(D) The reasons for the determination.
(E) The enrollee’s right to file an
integrated reconsideration and the
ability for someone else to file an appeal
on the enrollee’s behalf.
(F) Procedures for exercising
enrollee’s rights to an integrated
reconsideration.
(G) Circumstances under which
expedited resolution is available and
how to request it.
(H) If applicable, the enrollee’s rights
to have benefits continue pending the
resolution of the integrated appeal
process.
(2) Timing of notice—(i) Standard
integrated organization determinations.
(A) The applicable integrated plan must
send a notice of its integrated
organization determination at least 10
days before the date of action (that is,
before the date on which a termination,
suspension, or reduction becomes
effective), in cases where a previously
approved service is being reduced,
suspended, or terminated, except in
circumstances where an exception is
permitted under §§ 431.213 and 431.214
of this chapter.
(B) For other integrated organization
determinations that are not expedited
integrated organization determinations,
the applicable integrated plan must
send a notice of its integrated
organization determination as
expeditiously as the enrollee’s health
condition requires, but no later than 14
calendar days from when it receives the
request for the integrated organization
determination.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
(ii) Extensions. The applicable
integrated plan may extend the
timeframe for a standard or expedited
integrated organization determination
by up to 14 calendar days if—
(A) The enrollee or provider requests
the extension; or
(B) The applicable integrated plan can
show that—
(1) The extension is in the enrollee’s
interest; and
(2) There is need for additional
information and there is a reasonable
likelihood that receipt of such
information would lead to approval of
the request, if received.
(iii) Notices in cases of extension. (A)
When the applicable integrated plan
extends the timeframe, it must notify
the enrollee in writing of the reasons for
the delay as expeditiously as the
enrollee’s health condition requires but
no later than upon expiration of the
extension, and inform the enrollee of
the right to file an expedited integrated
grievance if he or she disagrees with the
applicable integrated plan’s decision to
grant an extension.
(B) If the applicable integrated plan
extends the timeframe for making its
integrated organization determination, it
must send the notice of its
determination as expeditiously as the
enrollee’s health condition requires and
no later than the date the extension
expires.
(iv) Expedited integrated organization
determinations. (A) The applicable
integrated plan must provide notice of
its expedited integrated organization
determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours after receiving the
request.
(B) If the applicable integrated plan
denies the request for an expedited
integrated organization determination, it
must:
(1) Automatically transfer a request to
the standard timeframe and make the
determination within the 14-day
timeframe established in this paragraph
for a standard integrated organization
determination. The 14-day period
begins with the day the applicable
integrated plan receives the request for
expedited integrated organization
determination.
(2) Give the enrollee prompt oral
notice of the denial and transfer and
subsequently deliver, within 3 calendar
days, a written letter that—
(i) Explains that the applicable
integrated plan will process the request
using the 14-day timeframe for standard
integrated organization determinations;
(ii) Informs the enrollee of the right to
file an expedited integrated grievance if
he or she disagrees with the applicable
PO 00000
Frm 00159
Fmt 4701
Sfmt 4700
15837
integrated plan’s decision not to
expedite;
(iii) Informs the enrollee of the right
to resubmit a request for an expedited
integrated organization determination
with any physician’s support; and
(iv) Provides instructions about the
integrated grievance process and its
timeframes.
(C) If the applicable integrated plan
must receive medical information from
noncontract providers, the applicable
integrated plan must request the
necessary information from the
noncontract provider within 24 hours of
the initial request for an expedited
integrated organization determination.
Noncontract providers must make
reasonable and diligent efforts to
expeditiously gather and forward all
necessary information to assist the
applicable integrated plan in meeting
the required timeframe. Regardless of
whether the applicable integrated plan
must request information from
noncontract providers, the applicable
integrated plan is responsible for
meeting the timeframe and notice
requirements of this section.
§ 422.632 Continuation of benefits while
the applicable integrated plan
reconsideration is pending.
(a) Definition. As used in this section,
timely files means files for continuation
of benefits on or before the later of the
following:
(1) Within 10 calendar days of the
applicable integrated plan sending the
notice of adverse integrated organization
determination.
(2) The intended effective date of the
applicable integrated plan’s proposed
adverse integrated organization
determination.
(b) Continuation of benefits. The
applicable integrated plan must
continue the enrollee’s benefits under
Parts A and B of title XVIII and title XIX
if all of the following occur:
(1) The enrollee files the request for
an integrated appeal timely in
accordance with § 422.633(e);
(2) The integrated appeal involves the
termination, suspension, or reduction of
previously authorized services;
(3) The services were ordered by an
authorized provider;
(4) The period covered by the original
authorization has not expired; and
(5) The enrollee timely files for
continuation of benefits.
(c) Duration of continued or
reinstated benefits. If, at the enrollee’s
request, the applicable integrated plan
continues or reinstates the enrollee’s
benefits, as described in paragraph (b) of
this section, while the integrated
reconsideration is pending, the benefits
must be continued until—
E:\FR\FM\16APR2.SGM
16APR2
15838
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
(1) The enrollee withdraws the
request for an integrated
reconsideration;
(2) The applicable integrated plan
issues an integrated reconsideration that
is unfavorable to the enrollee related to
the benefit that has been continued;
(3) For an appeal involving Medicaid
benefits—
(i) The enrollee fails to file a request
for a State fair hearing and continuation
of benefits, within 10 calendar days
after the applicable integrated plan
sends the notice of the integrated
reconsideration;
(ii) The enrollee withdraws the appeal
or request for a State fair hearing; or
(iii) A State fair hearing office issues
a hearing decision adverse to the
enrollee.
(d) Recovery of costs. In the event the
appeal or State fair hearing is adverse to
the enrollee—
(1) The applicable integrated plan or
State agency may not pursue recovery
for costs of services furnished by the
applicable integrated plan pending the
integrated reconsideration, to the extent
that the services were furnished solely
under of the requirements of this
section.
(2) If, after the integrated
reconsideration decision is final, an
enrollee requests that Medicaid services
continue through a State fair hearing,
state rules on recovery of costs, in
accordance with the requirements of
§ 438.420(d) of this chapter, apply for
costs incurred for services furnished
pending appeal subsequent to the date
of the integrated reconsideration
decision.
khammond on DSKBBV9HB2PROD with RULES2
§ 422.633
Integrated reconsideration.
(a) General rule. An applicable
integrated plan may only have one level
of integrated reconsideration for an
enrollee.
(b) External medical reviews. If a State
has established an external medical
review process, the requirements of
§ 438.402(c)(1)(i)(B) of this chapter
apply to each applicable integrated plan
that is a Medicaid managed care
organization, as defined in section 1903
of the Act.
(c) Case file. Upon request of the
enrollee or his or her representative, the
applicable integrated plan must provide
the enrollee and his or her
representative the enrollee’s case file,
including medical records, other
documents and records, and any new or
additional evidence considered, relied
upon, or generated by the applicable
integrated plan (or at the direction of the
applicable integrated plan) in
connection with the appeal of the
integrated organization determination.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
This information must be provided free
of charge and sufficiently in advance of
the resolution timeframe for the
integrated reconsideration, or
subsequent appeal, as specified in this
section.
(d) Timing. (1) Timeframe for filing—
An enrollee has 60 calendar days from
the date on the adverse organization
determination notice to file a request for
an integrated reconsideration with the
applicable integrated plan.
(2) Oral inquires—Oral inquires
seeking to appeal an adverse integrated
organization determination must be
treated as a request for an integrated
reconsideration (to establish the earliest
possible filing date for the appeal).
(3) Extending the time for filing a
request—(i) General rule. If a party or
physician acting on behalf of an enrollee
shows good cause, the applicable
integrated plan may extend the
timeframe for filing a request for an
integrated reconsideration.
(ii) How to request an extension of
timeframe. If the 60-day period in which
to file a request for an integrated
reconsideration has expired, a party to
the integrated organization
determination or a physician acting on
behalf of an enrollee may file a request
for integrated reconsideration with the
applicable integrated plan. The request
for integrated reconsideration and to
extend the timeframe must—
(A) Be in writing; and
(B) State why the request for
integrated reconsideration was not filed
on time.
(e) Expedited integrated
reconsiderations. (1) An enrollee may
request, or a provider may request on
behalf of an enrollee, an expedited
review of the integrated reconsideration.
(2) The request can be oral or in
writing.
(3) The applicable integrated plan
must grant the request to expedite the
integrated reconsideration when it
determines (for a request from the
enrollee), or the provider indicates (in
making the request on the enrollee’s
behalf or supporting the enrollee’s
request), that taking the time for a
standard resolution could seriously
jeopardize the enrollee’s life, physical or
mental health, or ability to attain,
maintain, or regain maximum function.
(4) If an applicable integrated plan
denies an enrollee’s request for an
expedited integrated reconsideration, it
must automatically transfer a request to
the standard timeframe and make the
determination within the 30-day
timeframe established in paragraph
(f)(1) of this section for a standard
integrated reconsideration. The 30-day
period begins with the day the
PO 00000
Frm 00160
Fmt 4701
Sfmt 4700
applicable integrated plan receives the
request for expedited integrated
reconsideration. The applicable
integrated plan must give the enrollee
prompt oral notice of the decision, and
give the enrollee written notice within
2 calendar days. The written notice
must do all of the following:
(i) Include the reason for the denial.
(ii) Inform the enrollee of the right to
file a grievance if the enrollee disagrees
with the decision not to expedite,
including timeframes and procedures
for filing a grievance.
(iii) Inform the enrollee of the right to
resubmit a request for an expedited
determination with any physician’s
support.
(5) If the applicable integrated plan
must receive medical information from
noncontract providers, the applicable
integrated plan must request the
necessary information from the
noncontract provider within 24 hours of
the initial request for an expedited
integrated reconsideration. Noncontract
providers must make reasonable and
diligent efforts to expeditiously gather
and forward all necessary information to
assist the applicable integrated plan in
meeting the required timeframe.
Regardless of whether the applicable
integrated plan must request
information from noncontract providers,
the applicable integrated plan is
responsible for meeting the timeframe
and notice requirements of this section.
(f) Resolution and notification. The
applicable integrated plan must make
integrated reconsidered determinations
as expeditiously as the enrollee’s health
condition requires but no later than the
timeframes established in this section.
(1) Standard integrated
reconsiderations. The applicable
integrated plan must resolve integrated
reconsiderations as expeditiously as the
enrollee’s health condition requires but
no longer than 30 calendar days from
the date of receipt of the request for the
integrated reconsideration. This
timeframe may be extended as described
in paragraph (f)(3) of this section.
(2) Expedited integrated
reconsiderations. The applicable
integrated plan must resolve expedited
integrated reconsiderations as
expeditiously as the enrollee’s health
condition requires but no later than
within 72 hours of receipt for the
integrated reconsideration. This
timeframe may be extended as described
in paragraph (f)(3) of this section. In
addition to the written notice required
under paragraph (f)(4) of this section,
the applicable integrated plan must
make reasonable efforts to provide
prompt oral notice of the expedited
resolution to the enrollee.
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
khammond on DSKBBV9HB2PROD with RULES2
(3) Extensions. (i) The applicable
integrated plan may extend the
timeframe for resolving integrated
reconsiderations by 14 calendar days
if—
(A) The enrollee requests the
extension; or
(B) The applicable integrated plan can
show that—
(1) The extension is in the enrollee’s
interest; and
(2) There is need for additional
information and there is a reasonable
likelihood that receipt of such
information would lead to approval of
the request, if received.
(ii) If the applicable integrated plan
extends the timeframe for resolving the
integrated reconsideration, it must make
reasonable efforts to give the enrollee
prompt oral notice of the delay, and give
the enrollee written notice within 2
calendar days of making the decision to
extend the timeframe to resolve the
integrated reconsideration. The notice
must include the reason for the delay
and inform the enrollee of the right to
file an expedited grievance if he or she
disagrees with the decision to grant an
extension.
(4) Notice of resolution. The
applicable integrated plan must send a
written notice to enrollees that includes
the integrated reconsidered
determination, within the resolution
timeframes set forth in this section. The
notice of determination must be written
in plain language and available in a
language and format that is accessible to
the enrollee and must explain the
following:
(i) The resolution of and basis for the
integrated reconsideration and the date
it was completed.
(ii) For integrated reconsiderations
not resolved wholly in favor of the
enrollee:
(A) An explanation of the next level
of appeal available under the Medicare
and Medicaid programs, and what steps
the enrollee must take to pursue the
next level of appeal under each
program, and how the enrollee can
obtain assistance in pursuing the next
level of appeal under each program; and
(B) The right to request and receive
Medicaid-covered benefits while the
next level of appeal is pending, if
applicable.
§ 422.634
Effect.
(a) Failure of the applicable integrated
plan to send timely notice of a
determination. If the applicable
integrated plan fails to adhere to the
notice and timing for an integrated
organization determination or integrated
reconsideration, this failure constitutes
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
an adverse determination for the
enrollee.
(1) For an integrated organization
determination, this means that the
enrollee may request an integrated
reconsideration.
(2) For integrated reconsiderations of
Medicare benefits, this means the
applicable integrated plan must forward
the case to the independent review
entity, in accordance with the
timeframes under paragraph (b) of this
section and § 422.592. For integrated
reconsiderations of Medicaid benefits,
this means that an enrollee or other
party may file for a State fair hearing in
accordance with § 438.408(f) of this
chapter, or if applicable, a State external
medical review in accordance with
§ 438.402(c) of this chapter.
(b) Adverse integrated
reconsiderations. (1) Subject to
paragraph (b)(2) of this section, when
the applicable integrated plan affirms,
in whole or in part, its adverse
integrated organization determination
involving a Medicare benefit—
(i) The issues that remain in dispute
must be reviewed and resolved by an
independent, outside entity that
contracts with CMS, in accordance with
§§ 422.592 and 422.594 through
422.619;
(ii) For standard integrated
reconsiderations, the applicable
integrated plan must prepare a written
explanation and send the case file to the
independent review entity contracted by
CMS, as expeditiously as the enrollee’s
health condition requires, but no later
than 30 calendar days from the date it
receives the request (or no later than the
expiration of an extension described in
§ 422.633(f)(3)). The applicable
integrated plan must make reasonable
and diligent efforts to assist in gathering
and forwarding information to the
independent entity; and
(iii) For expedited integrated
reconsiderations, the applicable
integrated plan must prepare a written
explanation and send the case file to the
independent review entity contracted by
CMS as expeditiously as the enrollee’s
health condition requires, but no later
than within 24 hours of its affirmation
(or no later than the expiration of an
extension described in § 422.633(f)(3)).
The applicable integrated plan must
make reasonable and diligent efforts to
assist in gathering and forwarding
information to the independent entity.
(2) When the applicable integrated
plan affirms, in whole or in part, its
adverse integrated organization
determination involving a Medicaid
benefit, the enrollee or other party (that
is not the applicable integrated plan)
may initiate a State fair hearing in the
PO 00000
Frm 00161
Fmt 4701
Sfmt 4700
15839
timeframe specified in § 438.408(f)(2)
following the integrated plan’s notice of
resolution. If a provider is filing for a
State fair hearing on behalf of the
enrollee as permitted by State law, the
provider needs the written consent of
the enrollee, if he or she has not already
obtained such consent.
(c) Final determination. The
reconsidered determination of the
applicable integrated plan is binding on
all parties unless it is appealed to the
next applicable level. In the event that
the enrollee pursues the appeal in
multiple forums and receives conflicting
decisions, the applicable integrated plan
is bound by, and must act in accordance
with, decisions favorable to the enrollee.
(d) Services not furnished while the
appeal is pending. If an applicable
integrated plan reverses its decision, or,
for a Medicaid benefit, a State fair
hearing reverses an applicable plan’s
integrated reconsideration decision, to
deny, limit, or delay services that were
not furnished while the appeal was
pending, the applicable integrated plan
must authorize or provide the disputed
services promptly and as expeditiously
as the enrollee’s health condition
requires but no later than 72 hours from
the date it receives notice reversing the
determination in lieu of the timeframes
described in § 422.618(a). Reversals by
the Part C independent review entity, an
administrative law judge or attorney
adjudicator at the Office of Medicare
Hearings and Appeals, or the Medicare
Appeals Council must be effectuated
under same timelines applicable to
other MA plans as specified in
§§ 422.618 and 422.619.
(e) Services furnished while the
appeal is pending. If the applicable
integrated plan or the State fair hearing
officer reverses a decision to deny, limit,
or delay Medicaid-covered benefits, and
the enrollee received the disputed
services while the integrated
reconsideration was pending, the
applicable integrated plan or the State
must pay for those services, in
accordance with State policy and
regulations. If the applicable integrated
plan reverses a decision to deny, limit,
or delay Medicare-covered benefits, and
the enrollee received the disputed
services while the integrated
reconsideration was pending, the
applicable integrated plan must pay for
those services.
■ 25. Effective January 1, 2021,
§ 422.752 is amended by adding
paragraph (d) to read as follows:
§ 422.752 Basis for imposing intermediate
sanctions and civil money penalties.
*
E:\FR\FM\16APR2.SGM
*
*
16APR2
*
*
15840
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
(d) Special rule for non-compliant
dual eligible special needs plans.
Notwithstanding any other provision of
this section, CMS must impose during
plan years 2021 through 2025
intermediate sanctions specified at
§ 422.750(a) on an MA organization
with a contract to operate a dual eligible
special needs plan if CMS determines
that the dual eligible special needs plan
fails to comply with at least one of the
criteria for the integration of Medicare
and Medicaid benefits provided in the
definition of a dual eligible special
needs plan at § 422.2. If CMS imposes
such an intermediate sanction, the MA
organization must submit to CMS a
corrective action plan in a form,
manner, and timeframe established by
CMS. The procedures outlined in
§ 422.756 apply to the imposition of the
intermediate sanction under this
provision.
PART 423—VOLUNTARY MEDICARE
PRESCRIPTION DRUG BENEFIT
26. The authority citation for part 423
is revised to read as follows:
■
Authority: 42 U.S.C. 1302, 1395w–101
through 1395w–152, and 1395hh.
27. In 423.100, in the definition of
‘‘Preclusion list’’, revise paragraphs
(1)(i), (2)(i), (2)(ii)(C) and add paragraph
(3) to read as follows:
■
§ 423.100
Definitions.
khammond on DSKBBV9HB2PROD with RULES2
*
*
*
*
*
Preclusion list * * *
(1) * * *
(i) The prescriber is currently revoked
from Medicare for a reason other than
that stated in § 424.535(a)(3) of this
chapter.
*
*
*
*
*
(2) * * *
(i) The prescriber has engaged in
behavior, other than that described in
§ 424.535(a)(3) of this chapter, for which
CMS could have revoked the individual
to the extent applicable had he or she
been enrolled in Medicare.
(ii) * * *
(C) Any other evidence that CMS
deems relevant to its determination; or
(3) The prescriber, regardless of
whether he or she is or was enrolled in
Medicare, has been convicted of a
felony under Federal or State law within
the previous 10 years that CMS deems
detrimental to the best interests of the
Medicare program. Factors that CMS
considers in making such a
determination under this paragraph are
as follows:
(i) The severity of the offense.
(ii) When the offense occurred.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
(iii) Any other information that CMS
deems relevant to its determination.
*
*
*
*
*
■ 28. Effective June 17, 2019, § 423.120
is amended by revising paragraphs
(c)(6)(iv) to read as follows:
§ 423.120
Access to covered Part D drugs.
*
*
*
*
*
(c) * * *
(6) * * *
(iv) With respect to Part D prescribers
who have been added to an updated
preclusion list but are not currently
excluded by the OIG, the Part D plan
sponsor must do all of the following:
(A) Subject to all other Part D rules
and plan coverage requirements, and no
later than 30 days after the posting of
this updated preclusion list, must
provide an advance written notice to
any beneficiary who has received a Part
D drug prescribed by an individual
added to the preclusion list in this
update and whom the plan sponsor has
identified during the applicable 30-day
period.
(B)(1) Subject to paragraph
(c)(6)(iv)(B)(2) of this section, must
ensure that reasonable efforts are made
to notify the individual described in
paragraph (c)(6)(iv) of this section of a
beneficiary who was sent a notice under
paragraph (c)(6)(iv)(A) of this section.
(2) Paragraph (c)(6)(iv)(B)(1) of this
section applies only upon a prescriber
writing a prescription in Medicare Part
D when:
(i) The plan sponsor has enough
information on file to either copy the
prescriber on the notification previously
sent to the beneficiary or send a new
notice informing the prescriber that they
may not see plan beneficiaries due to
their preclusion status; and
(ii) The claim is received after the
claim denial or reject date in the
preclusion file.
(C) Must not reject a pharmacy claim
or deny a beneficiary request for
reimbursement for a Part D drug
prescribed by the prescriber, solely on
the ground that they have been included
in the updated preclusion list, in the 60day period after the date it sent the
notice described in paragraph
(c)(6)(iv)(A) of this section.
■ 29. Section 423.120 is further
amended by—
■ a. Revising paragraphs (c)(6)(v); and
■ b. Adding paragraphs (c)(6)(vii) and
(viii).
The revision and additions read as
follows:
§ 423.120
*
PO 00000
Access to covered Part D drugs.
*
*
(c) * * *
Frm 00162
*
Fmt 4701
*
Sfmt 4700
(6) * * *
(v)(A) CMS sends written notice to the
prescriber via letter of his or her
inclusion on the preclusion list. The
notice must contain the reason for the
inclusion on the preclusion list and
inform the prescriber of his or her
appeal rights. A prescriber may appeal
his or her inclusion on the preclusion
list under this section in accordance
with part 498 of this chapter.
(B) If the prescriber’s inclusion on the
preclusion list is based on a
contemporaneous Medicare revocation
under § 424.535 of this chapter:
(1) The notice described in paragraph
(c)(6)(v)(A) of this section must also
include notice of the revocation, the
reason(s) for the revocation, and a
description of the prescriber’s appeal
rights concerning the revocation.
(2) The appeals of the prescriber’s
inclusion on the preclusion list and the
prescriber’s revocation must be filed
jointly by the prescriber and, as
applicable, considered jointly under
part 498 of this chapter.
(C)(1) Except as provided in
paragraph (c)(6)(v)(C)(2) of this section,
a prescriber will only be included on
the preclusion list after the expiration of
either of the following:
(i) If the prescriber does not file a
reconsideration request under
§ 498.5(n)(1) of this chapter, the
prescriber will be added to the
preclusion list upon the expiration of
the 60-day period in which the
prescriber may request a
reconsideration.
(ii) If the prescriber files a
reconsideration request under
§ 498.5(n)(1) of this chapter, the
prescriber will be added to the
preclusion list effective on the date on
which CMS, if applicable, denies the
prescriber’s reconsideration.
(2) An OIG excluded prescriber is
added to the preclusion list effective on
the date of the exclusion.
*
*
*
*
*
(vii)(A) Except as provided in
paragraphs (c)(6)(vii)(C) and (D) of this
section, a prescriber who is revoked
under § 424.535 of this chapter will be
included on the preclusion list for the
same length of time as the prescriber’s
reenrollment bar.
(B) Except as provided in paragraphs
(c)(6)(vii)(C) and (D) of this section, a
prescriber who is not enrolled in
Medicare will be included on the
preclusion list for the same length of
time as the reenrollment bar that CMS
could have imposed on the prescriber
had the prescriber been enrolled and
then revoked.
(C) Except as provided in paragraph
(c)(6)(vii)(D) of this section, an
E:\FR\FM\16APR2.SGM
16APR2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
individual, regardless of whether the
individual is or was enrolled in
Medicare, that is included on the
preclusion list because of a felony
conviction will remain on the
preclusion list for a 10-year period,
beginning on the date of the felony
conviction, unless CMS determines that
a shorter length of time is warranted.
Factors that CMS considers in making
such a determination are—
(1) The severity of the offense;
(2) When the offense occurred; and
(3) Any other information that CMS
deems relevant to its determination.
(D) In cases where an individual is
excluded by the OIG, the individual
must remain on the preclusion list until
the expiration of the CMS-imposed
preclusion list period or reinstatement
by the OIG, whichever occurs later.
(viii) Payment denials under
paragraph (c)(6) of this section that are
based upon the prescriber’s inclusion on
the preclusion list are not appealable by
beneficiaries.
*
*
*
*
*
■ 30. Section 423.153 is amended by
revising the section heading and adding
paragraph (g) to read as follows:
§ 423.153 Prescription drug plan
sponsors’ access to Medicare Parts A and
B claims data extracts.
khammond on DSKBBV9HB2PROD with RULES2
*
*
*
*
*
(g) Parts A and B claims data
extracts—(1) General rule. (i) Beginning
in plan year 2020, a PDP sponsor may
submit a request to CMS for the data
described in paragraph (g)(2) of this
section about enrollees in its
prescription drug plans.
(ii) CMS makes the data requested in
paragraph (g)(1)(i) of this section
available to eligible PDP sponsors, in
accordance with all applicable laws.
The data is provided at least quarterly
on a specified release date, and in an
electronic format to be determined by
CMS.
(iii) If CMS determines or has a
reasonable belief that the PDP sponsor
has violated the requirements of this
paragraph (g) or that unauthorized uses,
reuses, or disclosures of the Medicare
claims data have taken place, at CMS’
sole discretion, the PDP sponsor may be
denied further access to the data
described in paragraph (g)(2) of this
section.
(2) Data described. The data that may
be requested under paragraph (g)(1) of
this section are standardized extracts of
claims data under Medicare parts A and
B for items and services furnished under
such parts to beneficiaries who are
enrolled in a plan offered by the PDP
sponsor at the time of the disclosure.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
(3) Purposes. A PDP sponsor must
comply with all laws that may be
applicable to data received under this
provision, including State and Federal
privacy and security laws, and,
furthermore subject to the limitations in
paragraph (g)(4) of this section may only
use or disclose the data provided by
CMS under paragraph (g)(1) of this
section for the following purposes:
(i) To optimize therapeutic outcomes
through improved medication use, as
such phrase is used in paragraph
(d)(1)(i) of this section.
(ii) To improve care coordination so
as to prevent adverse health outcomes,
such as preventable emergency
department visits and hospital
readmissions.
(iii) For activities falling under
paragraph (1) of the definition of
‘‘health care operations’’ under 45 CFR
164.501.
(iv) For activities falling under
paragraph (2) of the definition of
‘‘health care operations’’ under 45 CFR
164.501.
(v) For ‘‘fraud and abuse detection or
compliance activities’’ under 45 CFR
164.506(c)(4)(ii).
(vi) For disclosures that qualify as
‘‘required by law’’ disclosures at 45 CFR
164.103.
(4) Limitations. A PDP sponsor must
comply with the following requirements
regarding the data provided by CMS
under this paragraph (g):
(i) The PDP sponsor will not use the
data to inform coverage determinations
under Part D.
(ii) The PDP sponsor will not use the
data to conduct retroactive reviews of
medically accepted indications
determinations.
(iii) The PDP sponsor will not use the
data to facilitate enrollment changes to
a different prescription drug plan or an
MA–PD plan offered by the same parent
organization.
(iv) The PDP sponsor will not use the
data to inform marketing of benefits.
(v) The PDP sponsor will
contractually bind its contractors that
have access to the Medicare claims data,
and require their contractors to
contractually bind any other potential
downstream data recipients, to the
terms and conditions imposed on the
PDP sponsor under this paragraph (g).
(5) Ensuring the privacy and security
of data. As a condition of receiving the
requested data, the PDP sponsor must
attest that it will adhere to the permitted
uses and limitations on the use of the
Medicare claims data listed in
paragraphs (g)(3) and (4) of this section.
■ 31. Section 423.182(a) is amended by
adding the definitions ‘‘Absolute
PO 00000
Frm 00163
Fmt 4701
Sfmt 4700
15841
percentage cap’’, ‘‘Cut point cap’’,
‘‘Guardrail’’, ‘‘Mean resampling’’,
‘‘Restricted range’’, and ‘‘Restricted
range cap’’ in alphabetical order to read
as follows:
§ 423.182 Part D Prescription Drug Plan
Quality Rating System.
(a) * * *
Absolute percentage cap is a cap
applied to non-CAHPS measures that
are on a 0 to 100 scale that restricts
movement of the current year’s
measure-threshold-specific cut point to
no more than the stated percentage as
compared to the prior year’s cut point.
*
*
*
*
*
Cut point cap is a restriction on the
change in the amount of movement a
measure-threshold-specific cut point
can make as compared to the prior
year’s measure-threshold-specific cut
point. A cut point cap can restrict
upward movement, downward
movement, or both.
*
*
*
*
*
Guardrail is a bidirectional cap that
restricts both upward and downward
movement of a measure-thresholdspecific cut point for the current year’s
measure-level Star Ratings as compared
to the prior year’s measure-thresholdspecific cut point.
*
*
*
*
*
Mean resampling refers to a technique
where measure-specific scores for the
current year’s Star Ratings are randomly
separated into 10 equal-sized groups.
The hierarchal clustering algorithm is
done 10 times, each time leaving one of
the 10 groups out. By leaving out one of
the 10 groups for each run, 9 of the 10
groups, which is 90 percent of the
applicable measure scores, are used for
each run of the clustering algorithm.
The method results in 10 sets of
measure-specific cut points. The mean
cut point for each threshold per measure
is calculated using the 10 values.
*
*
*
*
*
Restricted range is the difference
between the maximum and minimum
measure score values using the prior
year measure scores excluding outer
fence outliers (first quartile
¥3*Interquartile Range (IQR) and third
quartile + 3*IQR).
Restricted range cap is a cap applied
to non-CAHPS measures that restricts
movement of the current year’s
measure-threshold-specific cut point to
no more than the stated percentage of
the restricted range of a measure
calculated using the prior year’s
measure score distribution.
*
*
*
*
*
E:\FR\FM\16APR2.SGM
16APR2
15842
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
32. Section 423.184 is amended by
adding paragraphs (f)(1)(iv),
(g)(1)(ii)(M), and (h) to read as follows:
■
§ 423.184 Adding, updating, and removing
measures.
*
*
*
*
*
(f) * * *
(1) * * *
(iv) CMS excludes any measure that
receives a measure-level Star Rating
reduction for data integrity concerns for
either the current or prior year from the
improvement measure(s).
*
*
*
*
*
(g) * * *
(1) * * *
(ii) * * *
(M) CMS reduces the measure rating
to 1 star for the applicable appeals
measure(s) if a contract fails to submit
Timeliness Monitoring Project data for
CMS’s review to ensure the
completeness of the contract’s IRE data.
*
*
*
*
*
(h) Review of sponsors’ data. (1) A
Part D plan sponsor may request that
CMS or the IRE review its’ contract’s
appeals data provided that the request is
received by the annual deadline set by
CMS for the applicable Star Ratings
year.
(2) A Part D plan sponsor may request
that CMS review its’ contract’s
Complaints Tracking Module (CTM)
data provided that the request is
received by the annual deadline set by
CMS for the applicable Star Ratings
year.
■ 33. Section 423.186 is amended by
revising paragraph (a)(2)(i) and adding
paragraph (i) to read as follows:
khammond on DSKBBV9HB2PROD with RULES2
§ 423.186
Calculation of Star Ratings.
(a) * * *
(2) * * *
(i) The method maximizes differences
across the star categories and minimizes
the differences within star categories
using mean resampling with the
hierarchal clustering of the current
year’s data, and a guardrail so that the
measure-threshold-specific cut points
for non-CAHPS measures do not
increase or decrease more than the value
of the cap from one year to the next. The
cap is equal to 5 percentage points for
measures having a 0 to 100 scale
(absolute percentage cap) or 5 percent of
the restricted range for measures not
having a 0 to 100 scale (restricted range
cap). New measures that have been in
the Part C and D Star Rating program for
three years or less use the hierarchal
clustering methodology with mean
resampling with no guardrail for the
first 3 years in the program.
*
*
*
*
*
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
(i) Extreme and uncontrollable
circumstances. In the event of extreme
and uncontrollable circumstances that
may negatively impact operational and
clinical systems and contracts’ abilities
to conduct surveys needed for accurate
performance measurement, CMS
calculates the Star Ratings as specified
in paragraphs (i)(2) through (8) of this
section for each contract that is an
affected contract during the
performance period for the applicable
measures. We use the start date of the
incident period to determine which year
of Star Ratings could be affected,
regardless of whether the incident
period lasts until another calendar year.
(1) Identification of affected contracts.
A contract that meets all of the
following criteria is an affected contract:
(i) The contract’s service area is
within an ‘‘emergency area’’ during an
‘‘emergency period’’ as defined in
section 1135(g) of the Act.
(ii) The contract’s service area is
within a county, parish, U.S. territory or
tribal area designated in a major disaster
declaration under the Stafford Act and
the Secretary exercised authority under
section 1135 of the Act based on the
same triggering event(s).
(iii) As specified in paragraphs (i)(2)
through (8) of this section, a certain
minimum percentage (25 percent or 60
percent) of the enrollees under the
contract must reside in a Federal
Emergency Management Agency
(FEMA)-designated Individual
Assistance area at the time of the
extreme and uncontrollable
circumstance.
(2) CAHPS adjustments. (i) A
contract, even if an affected contract,
must administer the CAHPS survey
unless exempt under paragraph (i)(2)(ii)
of this section.
(ii) An affected contract with at least
25 percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance is exempt
from administering the CAHPS survey if
the contract completes both of the
following:
(A) Demonstrates to CMS that the
required sample for the survey cannot
be contacted because a substantial
number of the contract’s enrollees are
displaced due to the FEMA-designated
disaster identified in paragraph (i)(1)(iii)
of this section in the prior calendar year.
(B) Requests and receives a CMS
approved exemption.
(iii) An affected contract with an
exemption described in paragraph
(i)(2)(ii) of this section receives the
contract’s CAHPS measure stars and
corresponding measure scores from the
prior year.
PO 00000
Frm 00164
Fmt 4701
Sfmt 4700
(iv) For an affected contract with at
least 25 percent of enrollees in FEMAdesignated Individual Assistance areas
at the time of the extreme and
uncontrollable circumstance, the
contract receives the higher of the
previous year’s Star Rating or the
current year’s Star Rating (and
corresponding measure score) for each
CAHPS measure.
(v) When a contract is an affected
contract with at least 25 percent of
enrollees in FEMA-designated
Individual Assistance areas at the time
of the extreme and uncontrollable
circumstance with regard to separate
extreme and uncontrollable
circumstances that begin in successive
years, it is a multiple year-affected
contract. A multiple year-affected
contract receives the higher of the
current year’s Star Rating or what the
previous year’s Star Rating would have
been in the absence of any adjustments
that took into account the effects of the
previous year’s disaster for each
measure (using the corresponding
measure score for the Star Ratings year
selected).
(3) New measure adjustments. For
affected contracts with at least 25
percent of enrollees in a FEMAdesignated Individual Assistance area at
the time of the extreme and
uncontrollable circumstance, CMS
holds the affected contract harmless by
using the higher of the contract’s
summary or overall rating or both with
and without including all of the
applicable new measures.
(4) Other Star Ratings measure
adjustments. (i) For all other Part D
measures except those measures
identified in this paragraph (i)(4)(ii) of
this section, affected contracts with at
least 25 percent of enrollees in a FEMAdesignated Individual Assistance area at
the time of the extreme and
uncontrollable circumstance receive the
higher of the previous or current year’s
measure Star Rating (and corresponding
measure score).
(ii) CMS does not adjust the scores of
the Star Ratings for the Part D Call
Center—Foreign Language Interpreter
and TTY Availability measure, unless
the exemption listed in paragraph
(i)(4)(iii) of this section applies.
(iii) CMS adjusts the measure listed in
paragraph (i)(4)(ii) of this section using
the adjustments listed in paragraph
(i)(4)(i) of this section for contracts
affected by extreme and uncontrollable
circumstances where there are
continuing communications issues
related to loss of electricity and damage
to infrastructure during the call center
study.
E:\FR\FM\16APR2.SGM
16APR2
khammond on DSKBBV9HB2PROD with RULES2
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
(iv) When a contract is an affected
contract with at least 25 percent of
enrollees in FEMA-designated
Individual Assistance areas at the time
of the extreme and uncontrollable
circumstance with regard to separate
extreme and uncontrollable
circumstances that begin in successive
years, it is a multiple year-affected
contract. A multiple year-affected
contract receives the higher of the
current year’s Star Rating or what the
previous year’s Star Rating would have
been in the absence of any adjustments
that took into account the effects of the
previous year’s disaster for each
measure (using the corresponding
measure score for the Star Ratings year
selected).
(5) Exclusion from improvement
measures. Any measure that reverts
back to the data underlying the previous
year’s Star Rating due to the
adjustments made in paragraph (i) of
this section is excluded from both the
count of measures and the applicable
improvement measures for the current
and next year’s Star Ratings for the
affected contract. Contracts affected by
extreme and uncontrollable
circumstances do not have the option of
reverting to the prior year’s
improvement rating.
(6) Missing data. For an affected
contract that has missing data in the
current or previous year, the final
measure rating comes from the current
year unless an exemption described in
paragraph (i)(2)(ii) of this section
applies.
(7) Cut points for non-CAHPS
measures. (i) CMS excludes the numeric
values for affected contracts with 60
percent or more of their enrollees in the
FEMA-designated Individual Assistance
area at the time of the extreme and
uncontrollable circumstance from the
clustering algorithms described in
paragraph (a)(2) of this section.
(ii) The cut points calculated as
described in paragraph (i)(7)(i) of this
section are used to assess all affected
contracts’ measure Star Ratings.
(8) Reward factor. (i) CMS excludes
the numeric values for affected contracts
with 60 percent or more of their
enrollees in the FEMA-designated
Individual Assistance area at the time of
the extreme and uncontrollable
circumstance from the determination of
the performance summary and variance
thresholds for the Reward Factor
described in paragraph (f)(1) of this
section.
(ii) All affected contracts are eligible
for the Reward Factor based on the
calculations described in paragraph
(i)(8)(i) of this section.
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
34. Section 423.568 is amended by
revising paragraph (b) to read as follows:
■
§ 423.568 Standard timeframe and notice
requirements for coverage determinations.
*
*
*
*
*
(b) Timeframe for requests for drug
benefits. When a party makes a request
for a drug benefit, the Part D plan
sponsor must notify the enrollee (and
the prescribing physician or other
prescriber involved, as appropriate) of
its determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours after receipt of
the request. For an exceptions request,
the Part D plan sponsor must notify the
enrollee (and the prescribing physician
or other prescriber involved, as
appropriate) of its determination as
expeditiously as the enrollee’s health
condition requires, but no later than 72
hours after receipt of the physician’s or
other prescriber’s supporting statement.
If a supporting statement is not received
by the end of 14 calendar days from
receipt of the exceptions request, the
Part D plan sponsor must notify the
enrollee (and the prescribing physician
or other prescriber involved, as
appropriate) of its determination as
expeditiously as the enrollee’s health
condition requires, but no later than 72
hours from the end of 14 calendar days
from receipt of the exceptions request.
*
*
*
*
*
■ 35. Section 423.570 is amended by
revising paragraph (d)(1) to read as
follows:
§ 423.570 Expediting certain coverage
determinations.
*
*
*
*
*
(d) * * *
(1) Make the determination within the
72-hour timeframe established in
§ 423.568(b) for a standard
determination. The 72-hour period
begins on the day the Part D plan
sponsor receives the request for
expedited determination. For an
exceptions request, the Part D plan
sponsor must notify the enrollee (and
the prescribing physician or other
prescriber involved, as appropriate) of
its determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours after receipt of
the physician’s or other prescriber’s
supporting statement. If a supporting
statement is not received by the end of
14 calendar days from receipt of the
exceptions request, the Part D plan
sponsor must notify the enrollee (and
the prescribing physician or other
prescriber involved, as appropriate) of
its determination as expeditiously as the
enrollee’s health condition requires, but
no later than 72 hours from the end of
PO 00000
Frm 00165
Fmt 4701
Sfmt 4700
15843
14 calendar days from receipt of the
exceptions request.
*
*
*
*
*
■ 36. Section 423.572 is amended by
revising paragraph (a) to read as follows:
§ 423.572 Timeframes and notice
requirements for expedited coverage
determinations.
(a) Timeframe for determination and
notification. Except as provided in
paragraph (b) of this section, a Part D
plan sponsor that approves a request for
expedited determination must make its
determination and notify the enrollee
(and the prescribing physician or other
prescriber involved, as appropriate) of
its decision, whether adverse or
favorable, as expeditiously as the
enrollee’s health condition requires, but
no later than 24 hours after receiving the
request. For an exceptions request, the
Part D plan sponsor must notify the
enrollee (and the prescribing physician
or other prescriber involved, as
appropriate) of its determination as
expeditiously as the enrollee’s health
condition requires, but no later than 24
hours after receipt of the physician’s or
other prescriber’s supporting statement.
If a supporting statement is not received
by the end of 14 calendar days from
receipt of the exceptions request, the
Part D plan sponsor must notify the
enrollee (and the prescribing physician
or other prescriber involved, as
appropriate) of its determination as
expeditiously as the enrollee’s health
condition requires, but no later than 24
hours from the end of 14 calendar days
from receipt of the exceptions request.
*
*
*
*
*
PART 438—MANAGED CARE
37. The authority for part 438 is
revised to read as follows:
■
Authority: 42 U.S.C. 1302.
38. Effective January 1, 2021,
§ 438.210 is amended by—
■ a. Revising paragraph (c);
■ b. Adding paragraph (d)(4); and
■ c. Revising paragraph (f).
The addition and revisions read as
follows:
■
§ 438.210
services.
Coverage and authorization of
*
*
*
*
*
(c) Notice of adverse benefit
determination. Each contract must
provide for the MCO, PIHP, or PAHP to
notify the requesting provider, and give
the enrollee written notice of any
decision by the MCO, PIHP, or PAHP to
deny a service authorization request, or
to authorize a service in an amount,
duration, or scope that is less than
E:\FR\FM\16APR2.SGM
16APR2
15844
Federal Register / Vol. 84, No. 73 / Tuesday, April 16, 2019 / Rules and Regulations
requested. For MCOs, PIHPs, and
PAHPs, the enrollee’s notice must meet
the requirements of § 438.404. For
Medicaid contracts with an applicable
integrated plan, as defined in § 422.561
of this chapter, in lieu of the provisions
in this paragraph governing notices of
adverse benefit determinations, the
provisions set forth in §§ 422.629
through 422.634 of this chapter apply to
determinations affecting dually eligible
individuals who are also enrolled in a
dual eligible special needs plan with
exclusively aligned enrollment, as
defined in § 422.2 of this chapter.
(d) * * *
*
*
*
*
*
(4) For Medicaid contracts with an
applicable integrated plan, as defined in
§ 422.561 of this chapter, timelines for
decisions and notices must be
compliant with the provisions set forth
in §§ 422.629 through 422.634 of this
chapter in lieu of §§ 438.404 through
438.424.
*
*
*
*
*
(f) Applicability date. (1) Subject to
paragraph (f)(2) of this section, this
section applies to the rating period for
contracts with MCOs, PIHPs, and
PAHPs beginning on or after July 1,
2017. Until that applicability date,
States are required to continue to
comply with § 438.210 contained in the
42 CFR parts 430 to 481, edition revised
as of October 1, 2015.
(2) Provisions in this section affecting
applicable integrated plans, as defined
in § 422.561 of this chapter, are
applicable no later than January 1, 2021.
■ 39. Effective January 1, 20121,
§ 438.400 is amendedby adding
paragraph (a)(4) and revising paragraph
(c) to read as follows:
§ 438.400 Statutory basis, definitions, and
applicability.
khammond on DSKBBV9HB2PROD with RULES2
(a) * * *
(4) Section 1859(f)(8)(B) of the Act
requires that the Secretary, to the extent
feasible, establish procedures unifying
grievances and appeals procedures
under sections 1852(f), 1852(g),
1902(a)(3), 1902(a)(5), and 1932(b)(4) of
VerDate Sep<11>2014
18:09 Apr 15, 2019
Jkt 247001
the Act for items and services provided,
by specialized Medicare Advantage
plans for special needs individuals
described in section 1859(b)(6)(B)(ii),
under Titles XVIII and XIX of the Act.
*
*
*
*
*
(c) Applicability. (1) Subject to
paragraph (c)(2) of this section, this
subpart applies to the rating period for
contracts with MCOs, PIHPs, and
PAHPs beginning on or after July 1,
2017. Until that applicability date,
States, MCOs, PIHPs, and PAHPs are
required to continue to comply with
subpart F contained in the 42 CFR parts
430 to 481, edition revised as of October
1, 2015.
(2) Provisions in this part affecting
applicable integrated plans, as defined
in § 422.561 of this chapter, are
applicable no later than January 1, 2021.
■ 40. Effective January 1, 2021,
§ 438.402 is amended by revising
paragraph (a) to read as follows:
§ 438.402
General requirements.
(a) The grievance and appeal system.
Each MCO, PIHP, and PAHP must have
a grievance and appeal system in place
for enrollees. Non-emergency medical
transportation PAHPs, as defined in
§ 438.9, are not subject to this subpart F.
For grievances and appeals at the plan
level, an applicable integrated plan as
defined in § 422.561 of this chapter is
not subject to this subpart F, and is
instead subject to the requirements of
§§ 422.629 through 422.634 of this
chapter. For appeals of integrated
reconsiderations, applicable integrated
plans are subject to § 438.408(f).
*
*
*
*
*
PART 498—APPEALS PROCEDURES
FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE
PROGRAM AND FOR
DETERMINATIONS THAT AFFECT THE
PARTICIPATION OF ICFs/IID AND
CERTAIN NFs IN THE MEDICAID
PROGRAM
Authority: 42 U.S.C. 1302, 1320a–7j, and
1395hh.
42. Effective June 17, 2019, § 498.5 is
amended by revising paragraph (n)(1) to
read as follows:
■
§ 498.5
Appeal rights.
*
*
*
*
*
(n) * * *
(1)(i) Any individual or entity that is
dissatisfied with an initial
determination or revised initial
determination that they are to be
included on the preclusion list (as
defined in § 422.2 or § 423.100 of this
chapter) may request a reconsideration
in accordance with § 498.22(a).
(ii)(A) If the individual’s or entity’s
inclusion on the preclusion list is based
on a Medicare revocation under
§ 424.535 of this chapter and the
individual or entity receives
contemporaneous notice of both actions,
the individual or entity may request a
joint reconsideration of both the
preclusion list inclusion and the
revocation in accordance with
§ 498.22(a).
(B) The individual or entity may not
submit separate reconsideration
requests under paragraph (n)(1)(ii)(A) of
this section for inclusion on the
preclusion list or a revocation if the
individual or entity received
contemporaneous notice of both actions.
*
*
*
*
*
Dated: March 27, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: March 28, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2019–06822 Filed 4–5–19; 4:15 pm]
BILLING CODE 4120–01–P
41. The authority for part 498 is
revised to read as follows:
■
PO 00000
Frm 00166
Fmt 4701
Sfmt 9990
E:\FR\FM\16APR2.SGM
16APR2
]]>Agencies
[Federal Register Volume 84, Number 73 (Tuesday, April 16, 2019)]
[Rules and Regulations]
[Pages 15680-15844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06822]
[[Page 15679]]
Vol. 84
Tuesday,
No. 73
April 16, 2019
Part II
Department of Health and Human Services
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
42 CFR Parts 422, 423, 438, et al.
Medicare and Medicaid Programs; Policy and Technical Changes to the
Medicare Advantage, Medicare Prescription Drug Benefit, Programs of
All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service,
and Medicaid Managed Care Programs for Years 2020 and 2021; Final Rule
Federal Register / Vol. 84 , No. 73 / Tuesday, April 16, 2019 / Rules
and Regulations
[[Page 15680]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 422, 423, 438, and 498
[CMS-4185-F]
RIN 0938-AT59
Medicare and Medicaid Programs; Policy and Technical Changes to
the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of
All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service,
and Medicaid Managed Care Programs for Years 2020 and 2021
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule will revise the Medicare Advantage (MA)
program (Part C) regulations and Prescription Drug Benefit program
(Part D) regulations to implement certain provisions of the Bipartisan
Budget Act of 2018; improve quality and accessibility; clarify certain
program integrity policies for MA, Part D, and cost plans and PACE
organizations; reduce burden on providers, MA plans, and Part D
sponsors through providing additional policy clarification; and
implement other technical changes regarding quality improvement. This
final rule will also revise the appeals and grievances requirements for
certain Medicaid managed care and MA special needs plans for dual
eligible individuals to implement certain provisions of the Bipartisan
Budget Act of 2018.
DATES: Effective Dates: These regulations are effective on January 1,
2020, except for the amendments to Sec. Sec. 422.107(c)(9), (d),
(e)(2), 422.560(a)(4) and (b)(5), 422.566(a), 422.629 through 422.634,
422.752(d), 438.210, 438.400, and 438.402, which are effective January
1, 2021, and for the amendments to Sec. Sec. 422.222(a)(2),
423.120(c)(6)(iv), and 498.5(n)(1), which are effective June 17, 2019.
FOR FURTHER INFORMATION CONTACT: Theresa Wachter, (410) 786-1157, or
Cali Diehl, (410) 786-4053, MA/Part C Issues. Elizabeth Goldstein,
(410) 786-6665, Parts C and D Quality Ratings Issues. Kari Gaare, (410)
786-8612, Prescription Drug Plan Access to Parts A and B Data Issues.
Vanessa Duran, (410) 786-8697, D-SNP Issues. Frank Whelan, (410) 786-
1302, Preclusion List Issues.
SUPPLEMENTARY INFORMATION:
I. Executive Summary and Background
A. Executive Summary
1. Purpose
The primary purpose of this final rule is to revise the Medicare
Advantage (MA) program (Part C) and Prescription Drug Benefit Program
(Part D) regulations based on our continued experience in the
administration of the Part C and Part D programs and to implement
certain provisions of the Bipartisan Budget Act of 2018. The changes
are necessary to--
Implement the Bipartisan Budget Act of 2018 provisions;
Improve program quality and accessibility;
Clarify program integrity policies; and
Implement other changes.
This final rule will meet the Administration's priorities to reduce
burden across the Medicare program by reducing unnecessary regulatory
complexity, and improve the regulatory framework to facilitate
development of Part C and Part D products that better meet the
individual beneficiary's healthcare needs. Because the Bipartisan
Budget Act of 2018 requires the Secretary to establish procedures, to
the extent feasible, for integration and unification of the appeals and
grievance processes for dual eligible individuals who are enrolled in
Medicaid and in MA special needs plans for dual eligible individuals
(D-SNPs), this final rule also includes provisions to revise the
appeals and grievances requirements for Medicaid managed care and MA D-
SNPs. While the Part C and Part D programs have high satisfaction among
beneficiaries, we continually evaluate program policies and regulations
to remain responsive to current trends and newer technologies, and
provide increased flexibility to serve patients. Specifically, this
final rule meets the Secretary's priorities to: (1) Reform health
insurance by increasing access to personalized health care, (2)
transform our healthcare system to be value-based and innovative by
promoting health information technology, and (3) support boosting
transparency around price and quality. These changes being finalized
will promote more convenient, cost-effective access to care within Part
C and D plans, improve accountability and bolster program integrity,
allow plans to innovate in response to patients' needs, and promote
coordination within MA D-SNPs.
2. Summary of the Major Provisions
a. Requirements for Medicare Advantage Plans Offering Additional
Telehealth Benefits (Sec. Sec. 422.100, 422.135, 422.252, 422.254, and
422.264)
Section 50323 of the Bipartisan Budget Act of 2018 (Pub. L. 115-
123) created a new section 1852(m) of the Social Security Act (the
Act), which allows MA plans the ability to provide ``additional
telehealth benefits'' (referred to as ``MA additional telehealth
benefits'' in this rule) to enrollees starting in plan year 2020 and
treat them as basic benefits. The statute limits these authorized MA
additional telehealth benefits to services for which benefits are
available under Medicare Part B, but that are not payable under section
1834(m) of the Act and have been identified for the applicable year as
clinically appropriate to furnish through electronic information and
telecommunications technology (referred to as ``electronic exchange''
in this rule). Under this final rule, MA plans will be permitted to
offer--as part of the basic benefit package--MA additional telehealth
benefits beyond what is currently allowable under the original Medicare
telehealth benefit (referred to as ``Medicare telehealth services'' in
this rule). In addition, MA plans will continue to be able to offer MA
supplemental benefits (that is, benefits not covered by original
Medicare) via remote access technologies and/or telemonitoring
(referred to as ``MA supplemental telehealth benefits'' in this rule)
for those services that do not meet the requirements for coverage under
original Medicare or the requirements for MA additional telehealth
benefits.
Section 1852(m)(4) of the Act mandates that enrollee choice is a
priority. If an MA plan covers a Part B service as an MA additional
telehealth benefit, then the MA plan must also provide access to such
service through an in-person visit and not only through electronic
exchange. The enrollee must have the option whether to receive such
service through an in-person visit or, if offered by the MA plan,
through electronic exchange. In addition, section 1852(m)(2)(A)(ii) of
the Act excludes from MA additional telehealth benefits capital and
infrastructure costs and investments relating to such benefits. These
statutory provisions have guided our rule.
In this final rule, we establish regulatory requirements that will
allow MA plans to cover Part B benefits furnished through electronic
exchange but not payable under section 1834(m) of the Act as MA
additional telehealth
[[Page 15681]]
benefits--and as part of the basic benefits defined in Sec. 422.101
instead of separate MA supplemental benefits. We believe MA additional
telehealth benefits will increase access to patient-centered care by
giving enrollees more control to determine when, where, and how they
access benefits. We solicited comments from stakeholders on various
aspects of our proposal, which informed how we are implementing the MA
additional telehealth benefits in this final rule.
b. Dual Eligible Special Needs Plans Provisions (Sec. Sec. 422.2,
422.60, 422.102, 422.107, 422.111, 422.560 Through 422.562, 422.566,
422.629 Through 422.634, 422.752, 438.210, 438.400, and 438.402)
Section 50311(b) of the Bipartisan Budget Act of 2018 amends
section 1859 of the Act to require integration of the Medicare and
Medicaid benefits provided to enrollees in Dual Eligible Special Needs
Plans (D-SNPs). In particular, the statute requires: (1) Development of
unified grievance and appeals processes for D-SNPs; and (2)
establishment of new standards for integration of Medicare and Medicaid
benefits for D-SNPs.
The statute specifies a number of key elements for unified D-SNP
grievance and appeals processes and grants the Secretary discretion to
determine the extent to which unification of these processes is
feasible. In particular, the unified processes must adopt the
provisions from section 1852(f) and (g) of the Act (MA grievances and
appeals) and sections 1902(a)(3) and (5), and 1932(b)(4) of the Act
(Medicaid grievances and appeals, including managed care) that are most
protective to the enrollee, take into account differences in state
Medicaid plans to the extent necessary, easily navigable by an
enrollee, include a single written notification of all applicable
grievance and appeal rights, provide a single pathway for resolution of
a grievance or appeal, provide clear notices, employ unified timeframes
for grievances and appeals, establish requirements for how the plan
must process, track, and resolve grievances and appeals, and with
respect to benefits covered under Medicare Parts A and B and Medicaid,
incorporate existing law that provides continuation of benefits pending
appeal for items and services covered under Medicare and Medicaid. The
statute requires the Secretary to establish unified grievance and
appeals procedures by April 1, 2020 and requires D-SNP contracts with
state Medicaid agencies to use the unified procedures for 2021 and
subsequent years.
Regarding the establishment of new standards for integration of
Medicare and Medicaid benefits, the statute requires that all D-SNPs
meet certain new minimum criteria for such integration for 2021 and
subsequent years, either by covering Medicaid benefits through a
capitated payment from a state Medicaid agency or meeting a minimum set
of requirements as determined by the Secretary. The law also stipulates
that for the years 2021 through 2025, if the Secretary determines that
a D-SNP failed to meet one of these integration standards, the
Secretary may impose an enrollment sanction, which would prevent the D-
SNP from enrolling new members. In describing the ``additional minimum
set of requirements'' established by the Secretary, the statute directs
the Federally Coordinated Health Care Office in CMS to base such
standards on input from stakeholders. We implement these new statutory
provisions and clarify definitions and operating requirements for D-
SNPs in this final rule.
c. Medicare Advantage and Part D Prescription Drug Plan Quality Rating
System (Sec. Sec. 422.162(a) and 423.182(a), Sec. Sec. 422.166(a) and
423.186(a), Sec. Sec. 422.164 and 423.184, and Sec. Sec. 422.166(i)
and 423.186(i))
In the Medicare Program; Contract Year 2019 Policy and Technical
Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-
for-Service, the Medicare Prescription Drug Benefit Programs, and the
PACE Program Final Rule (hereafter referred to as the April 2018 final
rule), CMS codified at Sec. Sec. 422.160, 422.162, 422.164, and
422.166 (83 FR 16725 through 16731) and Sec. Sec. 423.180, 423.182,
423.184, and 423.186 (83 FR 16743 through 16749) the methodology for
the Star Ratings system for the MA and Part D programs, respectively.
This was part of the Administration's effort to increase transparency
and advance notice regarding enhancements to the Part C and D Star
Ratings program.
At this time, we are finalizing enhancements to the cut point
methodology for non-Consumer Assessment of Healthcare Providers and
Systems (CAHPS) measures. We are also making substantive updates to the
specifications for a few measures for the 2022 and 2023 Star Ratings,
and finalizing rules for calculating Star Ratings in the case of
extreme and uncontrollable circumstances. Data would be collected and
performance measured using these final rules and regulations for the
2020 measurement period and the 2022 Star Ratings, except for the Plan
All-Cause Readmission measure where the applicability date is the 2021
measurement period as described in section II.B.1.d.(1).(c) of this
final rule.
d. Preclusion List Requirements for Prescribers in Part D and
Individuals and Entities in MA, Cost Plans, and PACE (Sec. Sec.
422.222 and 423.120(c)(6))
In the April 2018 final rule, CMS removed several requirements
pertaining to MA and Part D provider and prescriber enrollment that
were to become effective on January 1, 2019. We stated in that final
rule our belief that the best means of reducing the burden of the MA
and Part D provider and prescriber enrollment requirements without
compromising our payment safeguard objectives would be to focus on
providers and prescribers that pose an elevated risk to Medicare
beneficiaries and the Trust Funds. That is, rather than require the
enrollment of MA providers and Part D prescribers regardless of the
level of risk they might pose, we would prevent payment for MA items or
services and Part D drugs that are, as applicable, furnished or
prescribed by demonstrably problematic providers and prescribers. We
therefore established in the April 2018 final rule a policy under
which: (1) Such problematic parties would be placed on a ``preclusion
list''; and (2) payment for MA services and items and Part D drugs
furnished or prescribed by these individuals and entities would be
rejected or denied, as applicable. The MA and Part D enrollment
requirements, in short, were replaced with the payment-oriented
approach of the preclusion list.
This final rule will make several revisions and additions to the
preclusion list provisions we finalized in the April 2018 final rule.
We believe these changes will help clarify for stakeholders CMS'
expectations regarding the preclusion list.
3. Summary of Costs and Benefits
[[Page 15682]]
----------------------------------------------------------------------------------------------------------------
Provision Description Impact
----------------------------------------------------------------------------------------------------------------
Requirements for Medicare Consistent with section 50323 of the MA additional telehealth benefits are
Advantage Plans Offering Bipartisan Budget Act of 2018, MA expected to produce $557 million in
Additional Telehealth Benefits plans have the ability to provide savings for enrollees over 10 years
(Sec. Sec. 422.100, 422.135, ``additional telehealth benefits'' to from reduced travel time to and from
422.252, 422.254, and 422.264). enrollees starting in plan year 2020 providers. The impact of paying for
and treat them as basic benefits. MA additional telehealth benefits
out of the Medicare Trust Fund (as
basic benefits) versus out of the
rebates (as supplemental benefits)
results in a transfer of $80 million
from the Medicare Trust Fund to
enrollees over 10 years.
Integration Requirements for Dual Consistent with section 50311(b) of For the initial year of
Eligible Special Needs Plans the Bipartisan Budget Act of 2018, we implementation, we estimate a $3.4
(Sec. Sec. 422.2, 422.60, are establishing, effective 2021, million cost to MA plans and a $0.5
422.102, 422.107, 422.111, and Medicare and Medicaid integration million cost to state Medicaid
422.752). standards D-SNPs. Effective 2021 agencies, half of which is
through 2025, we will require the transferred to the federal
imposition of an intermediate government, in order to transition
sanction of prohibiting new to the new requirements. After that,
enrollment into a D-SNP if CMS we estimate that impact will be
determines that the D-SNP is failing negligible.
to comply with these integration
standards. Finally, we are creating
new and modifying existing regulatory
definitions that relate to D-SNPs.
Unified Grievances and Appeals Consistent with section 50311(b) of The provision gives rise to both
Procedures for Dual Eligible the Bipartisan Budget Act of 2018, we savings, from the increased
Special Needs Plans and Medicaid are unifying Medicare and Medicaid efficiency of a unified process, and
Managed Care Plans at the Plan grievance and appeals procedures for costs from the requirement to
Level (Sec. Sec. 422.560-562, certain D-SNPs that enroll provide benefits while appeals are
422.566, 422.629-422.634, individuals who receive Medicare and pending. Over 10 years there are
438.210, 438.400, and 438.402). Medicaid benefits from the D-SNP and three anticipated effects: (1) Plans
a Medicaid managed care organization will save $0.7 million from the
offered by the D-SNP's MA increased efficiency of unified
organization, the parent appeals and grievance processes;
organization, or subsidiary owned by this savings is passed to the
the parent organization. Medicare and Medicare Trust Fund; (2) the
Medicaid grievance and appeals Medicare Trust Fund will incur a
processes differ in several key ways, $4.2 million expense for providing
which in effect creates unnecessary benefits while appeals are pending;
administrative complexity for health and (3) enrollees will incur an
issuers participating across product extra $0.7 million in cost sharing
lines. This will allow enrollees to for benefits while appeals are
follow one resolution pathway at the pending.
plan level when filing a complaint or
contesting an adverse coverage
determination with their plan
regardless of whether the matter
involves a Medicare or Medicaid
covered service.
MA and Part D Prescription Drug We are finalizing several measure Negligible impact.
Plan Quality Rating System (Sec. specification updates, adjustments
Sec. 422.162(a) and due to extreme and uncontrollable
423.182(a), 422.166(a) and circumstances, and an enhanced cut
423.186(a), 422.164 and 423.184, point methodology. The measure
and 422.166(i)(1) and changes are routine and do not have a
423.186(i)(1)). significant impact on the ratings of
contracts. The policy for disasters
will hold contracts harmless from
decreases in ratings from the prior
year when there are extreme and
uncontrollable circumstances
affecting them. The methodology to
set Star Ratings cut points will help
increase the stability and
predictability of cut points from
year to year.
Preclusion List Requirements for We are making several revisions to the Negligible impact.
Prescribers in Part D and MA and Part D preclusion list
Individuals and Entities in MA, policies that we finalized in the
Cost Plans, and PACE (Sec. Sec. April 2018 final rule.
422.222 and 423.120(c)(6)).
----------------------------------------------------------------------------------------------------------------
B. Background
We received approximately 180 timely pieces of correspondence
containing multiple comments on the proposed rule titled ``Medicare and
Medicaid Programs; Policy and Technical Changes to the Medicare
Advantage, Medicare Prescription Drug Benefit, Program of All-Inclusive
Care for the Elderly (PACE), Medicaid Fee-for-Service, and Medicaid
Managed Care Programs for Years 2020 and 2021'' which published
November 1, 2018, in the Federal Register (83 FR 54982). While we
intend to address the Risk Adjustment Data Validation (RADV) proposals
in subsequent rulemaking (due to an extended comment period for these
proposals until April 30, 2019, per 83 FR 66661), we are finalizing all
other provisions with changes varying from minor clarifications to more
significant modifications based on comments received. We also note that
some of the public comments received were outside of the scope of the
proposed rule. These
[[Page 15683]]
out-of-scope public comments are not addressed in this final rule.
Summaries of the public comments that are within the scope of the
proposed rule and our responses to those public comments are set forth
in the various sections of this final rule under the appropriate
headings. However, we note that in this final rule we are not
addressing comments received with respect to the RADV provision of the
proposed rule that we are not finalizing at this time. Rather, we will
address these comments in subsequent rulemaking, as appropriate.
II. Provisions of the Proposed Rule and Analysis of and Responses to
Public Comments
A. Implementing the Bipartisan Budget Act of 2018 Provisions
1. Requirements for Medicare Advantage Plans Offering Additional
Telehealth Benefits (Sec. Sec. 422.100, 422.135, 422.252, 422.254, and
422.264)
Technologies that enable healthcare providers to deliver care to
patients in locations remote from the providers (hereinafter referred
to as ``telehealth'') are increasingly being used to complement face-
to-face patient-provider encounters. Telehealth visits among rural
Medicare beneficiaries participating in original Medicare have
increased more than 25 percent a year from 2004 to 2013.\1\ In Medicare
Advantage (MA), about 81 percent of MA plans offered supplemental
telehealth benefits in the form of remote access technologies in 2018,
an increase from 77 percent in 2017.\2\ This shows that the healthcare
industry has made significant advances in technology that enable
secure, reliable, real-time, interactive communication and data
transfer that were not possible in the past. Moreover, the use of
telehealth as a care delivery option for MA enrollees may improve
access to and timeliness of needed care, increase convenience for
patients, increase communication between providers and patients,
enhance care coordination, improve quality, and reduce costs related to
in-person care.\3\
---------------------------------------------------------------------------
\1\ Mehrotra, A., Jena, A., Busch, A., Souza, J., Uscher-Pines,
L., Landon, B. (2016). ``Utilization of Telemedicine Among Rural
Medicare Beneficiaries.'' JAMA, 315(18): 2015-2016.
\2\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/
\3\ Medicare Payment Advisory Commission (MedPAC), Report to the
Congress: Medicare Payment Policy, March 2018.
---------------------------------------------------------------------------
MA basic benefits are structured and financed based on what is
covered under Medicare Parts A and B (paid through the capitation rate
by the government) with coverage of additional items and services and
more generous cost sharing provisions financed as MA supplemental
benefits (paid using rebate dollars or supplemental premiums paid by
enrollees). Traditionally, MA plans have been limited in how they may
deliver telehealth services outside of the original Medicare telehealth
benefit under section 1834(m) of the Act (hereinafter referred to as
``Medicare telehealth services'') because of this financing structure;
only services covered by original Medicare under Parts A and B, with
actuarially equivalent cost sharing, are in the basic benefit bid paid
by the capitation rate. Section 1834(m) of the Act and Sec. 410.78
generally limit payment for Medicare telehealth services by authorizing
payment only for specified services provided using an interactive audio
and video telecommunications system that permits real-time
communication between a Medicare beneficiary and either a physician or
specified other type of practitioner, and by specifying where the
beneficiary may receive telehealth services (eligible originating
sites). Eligible originating sites are limited as to the type of
geographic location (generally rural) and the type of care setting. The
statute grants the Secretary the authority to add to the list of
Medicare telehealth services based on an established annual process but
does not allow for exceptions to the restrictions on types of
practitioners that can furnish those services or on the eligible
originating sites. Because sections 1852(a), 1853, and 1854 of the Act
limit the basic benefits covered by the government's capitation payment
to only Parts A and B services covered under original Medicare with
actuarially equivalent cost sharing, telehealth benefits offered by MA
plans in addition to those covered by original Medicare are currently
offered as MA supplemental benefits and funded through the use of
rebate dollars or supplemental premiums paid by enrollees.
On February 9, 2018, President Trump signed the Bipartisan Budget
Act of 2018 (Pub. L. 115-123) into law. Section 50323 of the Bipartisan
Budget Act of 2018 created a new section 1852(m) of the Act, which
allows MA plans the ability to provide ``additional telehealth
benefits'' (hereinafter referred to as ``MA additional telehealth
benefits'') to enrollees starting in plan year 2020 and treat them as
basic benefits (also known as ``original Medicare benefits'' or
``benefits under the original Medicare fee-for-service program
option''). The statute limits these authorized MA additional telehealth
benefits to services for which benefits are available under Medicare
Part B but that are not payable under section 1834(m) of the Act and
have been identified for the applicable year as clinically appropriate
to furnish through electronic information and telecommunications
technology (hereinafter referred to as ``electronic exchange''). While
MA plans have always been able to offer more telehealth services than
are currently payable under original Medicare through MA supplemental
benefits, this change in how such MA additional telehealth benefits are
financed (that is, accounted for in the capitated payment) makes it
more likely that MA plans would offer them and that more enrollees
would use the benefit.
We are adding a new regulation at Sec. 422.135 to implement the
new section 1852(m) of the Act and amending existing regulations at
Sec. Sec. 422.100, 422.252, 422.254, and 422.264. Specifically, we are
codifying a new regulation at Sec. 422.135 to allow MA plans to offer
MA additional telehealth benefits, to establish definitions applicable
to this new classification of benefits, and to enact requirements and
limitations on them. Further, we are amending Sec. 422.100(a) and
(c)(1) to include MA additional telehealth benefits in the definition
of basic benefits and adding a cross-reference to new Sec. 422.135 to
reflect how these benefits may be provided as part of basic benefits.
Finally, we are amending the bidding regulations at Sec. Sec. 422.252,
422.254, and 422.264 to account for MA additional telehealth benefits
in the basic benefit bid.
We proposed that, beginning in contract year 2020, MA plans will be
permitted to offer--as part of the basic benefit package--MA additional
telehealth benefits beyond what is currently allowable under Medicare
telehealth services. Pursuant to section 1852 of the Act and the
regulation at Sec. 422.100(a), MA plans are able to offer Medicare
telehealth services including those described in existing authority at
section 1834(m) of the Act and Sec. Sec. 410.78 and 414.65 of the
regulations. We proposed that in addition to Medicare telehealth
services, MA plans will be able (but not required) to offer MA
additional telehealth benefits described in this final rule and at
section 1852(m) of the Act. In addition, we proposed to continue
authority for MA plans to offer MA supplemental benefits (that is,
benefits not covered by original Medicare) via remote access
technologies and telemonitoring (as
[[Page 15684]]
currently named in the plan benefit package (PBP) software; hereinafter
referred to as ``MA supplemental telehealth benefits'') for those
services that do not meet the requirements for coverage under original
Medicare (for example, for Medicare telehealth services under section
1834(m)) or the requirements for MA additional telehealth benefits,
such as the requirement of being covered by Part B when provided in-
person. For instance, an MA plan may offer, as an MA supplemental
telehealth benefit, a videoconference dental visit to assess dental
needs because services primarily provided for the care, treatment,
removal, or replacement of teeth or structures directly supporting
teeth are not currently covered Part B benefits and thus would not be
allowable as MA additional telehealth benefits.
We proposed to establish regulatory requirements that will allow MA
plans to cover Part B benefits furnished through electronic exchange
but not payable under section 1834(m) of the Act as MA additional
telehealth benefits--and as part of the basic benefits defined in Sec.
422.101 instead of separate MA supplemental benefits. We believe MA
additional telehealth benefits will increase access to patient-centered
care by giving enrollees more control to determine when, where, and how
they access benefits.
Section 1852(m)(2)(A)(i) of the Act, as added by the Bipartisan
Budget Act of 2018, defines ``additional telehealth benefits'' as
services--(1) for which benefits are available under Part B, including
services for which payment is not made under section 1834(m) of the Act
due to the conditions for payment under such section; and (2) that are
identified for the applicable year as clinically appropriate to furnish
using electronic information and telecommunications technology (which
we refer to as ``through electronic exchange'') when a physician (as
defined in section 1861(r) of the Act) or practitioner (described in
section 1842(b)(18)(C) of the Act) providing the service is not at the
same location as the plan enrollee. In addition, section
1852(m)(2)(A)(ii) of the Act excludes from ``additional telehealth
benefits'' capital and infrastructure costs and investments relating to
such benefits. This statutory definition of ``additional telehealth
benefits'' guided our proposal.
We proposed a new regulation at Sec. 422.135 to authorize and
govern the provision of MA additional telehealth benefits by MA plans,
consistent with our interpretation of the new statutory provision.
First, we proposed definitions for the terms ``additional telehealth
benefits'' and ``electronic exchange'' in Sec. 422.135(a). We proposed
to define ``additional telehealth benefits'' as services that meet the
following: (1) Are furnished by an MA plan for which benefits are
available under Medicare Part B but which are not payable under section
1834(m) of the Act; and (2) have been identified by the MA plan for the
applicable year as clinically appropriate to furnish through electronic
exchange. For purposes of this specific regulation and addressing the
requirements and limitations on MA additional telehealth benefits, we
proposed to define ``electronic exchange'' as ``electronic information
and telecommunications technology'' as this is a concise term for the
statutory description of the means used to provide the MA additional
telehealth benefits. We did not propose specific regulation text that
defines or provides examples of electronic information and
telecommunications technology because the technology needed and used to
provide MA additional telehealth benefits would vary based on the
service being offered. Examples of electronic information and
telecommunications technology (or ``electronic exchange'') may include,
but are not limited to, the following: Secure messaging, store and
forward technologies, telephone, videoconferencing, other internet-
enabled technologies, and other evolving technologies as appropriate
for non-face-to-face communication. We believe this broad and
encompassing approach will allow for technological advances that may
develop in the future and avoid tying the authority in the regulation
to specific information formats or technologies that permit non-face-
to-face interactions for furnishing clinically appropriate services.
We did not propose specific regulation text defining ``clinically
appropriate;'' rather, we proposed to implement the statutory
requirement for MA additional telehealth benefits to be provided only
when ``clinically appropriate'' to align with our existing regulations
for contract provisions at Sec. 422.504(a)(3)(iii), which requires
each MA organization to agree to provide all benefits covered by
Medicare ``in a manner consistent with professionally recognized
standards of health care.'' We proposed to apply the same principle to
MA additional telehealth benefits, as MA additional telehealth benefits
must be treated as if they were benefits under original Medicare per
section 1852(m)(5) of the Act.
The statute limits MA additional telehealth benefits to those
services that are identified for the applicable year as clinically
appropriate to furnish through electronic exchange. The statute does
not specify who or what entity identifies the services for the year.
Therefore, we proposed to interpret this provision broadly by not
specifying the Part B services that an MA plan may offer as MA
additional telehealth benefits for the applicable year, but instead
allowing MA plans to independently determine each year which services
are clinically appropriate to furnish in this manner. Thus, our
definition of MA additional telehealth benefits at Sec. 422.135(a)
provides that it is the MA plan (not CMS) that identifies the
appropriate services for the applicable year. We believe that MA plans
are in the best position to identify each year whether MA additional
telehealth benefits are clinically appropriate to furnish through
electronic exchange. MA plans have a vested interest in and
responsibility for staying abreast of the current professionally
recognized standards of health care, as these standards are
continuously developing with new advancements in modern medicine. As
professionally recognized standards of health care change over time and
differ from practice area to practice area, our approach is flexible
enough to take those changes and differences into account.
Furthermore, Sec. 422.111(b)(2) requires the MA plan to annually
disclose the benefits offered under a plan, including applicable
conditions and limitations, premiums and cost sharing (such as
copayments, deductibles, and coinsurance) and any other conditions
associated with receipt or use of benefits. MA plans satisfy this
requirement through the Evidence of Coverage, or EOC, document provided
to all enrollees. This disclosure requirement would have to include
applicable MA additional telehealth benefit limitations. That is, any
MA plan offering MA additional telehealth benefits must identify the
services that can be covered as MA additional telehealth benefits when
provided through electronic exchange. We believe that it is through
this mechanism (the EOC) that the MA plan would identify each year
which services are clinically appropriate to furnish through electronic
exchange as MA additional telehealth benefits.
We solicited comment on this proposed implementation of the statute
and our reasoning. We noted in the proposed rule how we had considered
whether CMS should use the list of Medicare telehealth services payable
by original Medicare under section 1834(m) of the Act as the list of
services that are clinically appropriate to be
[[Page 15685]]
provided through electronic exchange for MA additional telehealth
benefits. In that circumstance, services on the list could be
considered as clinically appropriate to be provided through electronic
exchange for MA additional telehealth benefits without application of
the location limitations of section 1834(m) of the Act. However, we do
not believe that is the best means to take full advantage of the
flexibility that Congress has authorized for the MA program. The list
of Medicare telehealth services for which payment can be made under
section 1834(m) of the Act under the original Medicare program includes
services specifically identified by section 1834(m) of the Act as well
as other services added to the Medicare telehealth list using criteria
and an annual process established by CMS. We stated in the proposed
rule that we believe these limitations and criteria should not apply to
MA additional telehealth benefits under new section 1852(m) of the Act
for MA plans.
The statute requires the Secretary to solicit comment on what types
of items and services should be considered to be MA additional
telehealth benefits. Therefore, we also solicited comments on whether
we should place any limitations on what types of Part B items and
services (for example, primary care visits, routine and/or specialty
consultations, dermatological examinations, behavior health counseling,
etc.) can be MA additional telehealth benefits provided under this
authority.
An enrollee has the right to request MA additional telehealth
benefits through the organization determination process. If an enrollee
is dissatisfied with the organization determination, then the enrollee
has the right to appeal the decision. We believe these rights help
ensure access to medically necessary services, including MA additional
telehealth benefits offered by an MA plan as described in this rule. In
addition, CMS audits plan performance with respect to timeliness and
clinical appropriateness of organization determinations and appeals.
While the MA plan would make the ``clinically appropriate''
decision in terms of coverage of an MA additional telehealth benefit,
we note that each healthcare provider must also provide services that
are clinically appropriate. We acknowledge that not all Part B items
and services would be suitable for MA additional telehealth benefits
because a provider must be physically present in order to properly
deliver care in some cases (for example, hands-on examination,
administering certain medications). As stated earlier, we proposed that
MA plans would independently determine each year which services are
clinically appropriate to furnish in this manner. Behavioral health, in
particular, is a prime example of a service that could be provided
remotely through MA plans' offering of MA additional telehealth
benefits under this rule. The President's Commission on Combating Drug
Addiction and the Opioid Crisis recommends telehealth as useful in the
effort to combat the opioid crisis when clinically appropriate,
especially in geographically isolated regions and underserved areas
where people with opioid use disorders and other substance use
disorders may benefit from remote access to needed treatment.\4\
---------------------------------------------------------------------------
\4\ Retrieved at: https://www.whitehouse.gov/sites/whitehouse.gov/files/images/Meeting%20Draft%20of%20Final%20Report%20-%20November%201%2C%202017.pdf.
---------------------------------------------------------------------------
We proposed in paragraph (b) the general rule to govern how an MA
plan may offer MA additional telehealth benefits. Specifically, we
proposed that if an MA plan chooses to furnish MA additional telehealth
benefits, the MA plan may treat these benefits as basic benefits
covered under the original Medicare fee-for-service program as long as
the requirements of proposed Sec. 422.135 are met. We also proposed in
Sec. 422.135(b) that if the MA plan fails to comply with the
requirements of Sec. 422.135, then the MA plan may not treat the
benefits provided through electronic exchange as MA additional
telehealth benefits, but may treat them as MA supplemental telehealth
benefits, subject to CMS approval of the MA supplemental telehealth
benefits. For example, a non-Medicare covered service provided through
electronic exchange cannot be offered as an MA additional telehealth
benefit because it does not comply with Sec. 422.135, which is limited
to furnishing through electronic exchange otherwise covered Part B
covered services, but it may be offered it as an MA supplemental
telehealth benefit.
Section 1852(m)(4) of the Act mandates that enrollee choice is a
priority. If an MA plan covers a Part B service as an MA additional
telehealth benefit, then the MA plan must also provide access to such
service through an in-person visit and not only through electronic
exchange. We proposed to codify this statutory mandate preserving
enrollee choice in regulation text at Sec. 422.135(c)(1), which
requires that the enrollee must have the option to receive a service
that the MA plan covers as an MA additional telehealth benefit either
through an in-person visit or through electronic exchange. Section
1852(m)(5) of the Act mandates that MA additional telehealth benefits
shall be treated as if they were benefits under the original Medicare
fee-for-service program option. In proposed regulation text at Sec.
422.135(f), we proposed to allow MA plans to maintain different cost
sharing for the specified Part B service(s) furnished through an in-
person visit and the specified Part B service(s) furnished through
electronic exchange.
We proposed Sec. 422.135(c)(2) to require MA plans to use their
EOC (at a minimum) to advise enrollees that they may receive the
specified Part B service(s) either through an in-person visit or
through electronic exchange. We proposed, at Sec. 422.135(c)(3), that
MA plans would have to use their provider directory to identify any
providers offering services for MA additional telehealth benefits and
in-person visits or offering services exclusively for MA additional
telehealth benefits. We stated in the proposed rule that these
notifications in the EOC and the provider directory are important to
ensure choice, transparency, and clarity for enrollees who might be
interested in taking advantage of MA additional telehealth benefits. We
requested comments on what impact, if any, MA additional telehealth
benefits should have on MA network adequacy policies. Specifically, we
were looking for the degree to which MA additional telehealth benefit
providers should be considered in the assessment of network adequacy
(including for certain provider types and/or services in areas with
access concerns) and any potential impact on rural MA plans, providers,
and/or enrollees.
Section 1852(m)(3) of the Act requires the Secretary to specify
limitations or additional requirements for the provision or furnishing
of MA additional telehealth benefits, including requirements with
respect to physician or practitioner qualifications, factors necessary
for the coordination of MA additional telehealth benefits with other
items and services (including those furnished in-person), and other
areas identified by the Secretary. We recognize the potential for MA
additional telehealth benefits to support coordinated health care and
increase access to care in both rural and urban areas. We stated in the
proposed rule how we expect MA plans would use these types of benefits
to support an effective, ongoing doctor-patient relationship and the
efficient delivery of needed care.
We proposed in regulation text at Sec. 422.135(c)(4) to require an
MA plan
[[Page 15686]]
offering MA additional telehealth benefits to comply with the provider
selection and credentialing requirements provided in Sec. 422.204. An
MA plan must have written policies and procedures for the selection and
evaluation of providers and must follow a documented process with
respect to providers and suppliers, as described in Sec. 422.204.
Further, we proposed that the MA plan, when providing MA additional
telehealth benefits, must ensure through its contract with the provider
that the provider meet and comply with applicable state licensing
requirements and other applicable laws for the state in which the
enrollee is located and receiving the service. We recognize, however,
that it is possible for a state to have specific provisions regarding
the practice of medicine using electronic exchange; our proposal
reflected our intent to ensure that MA network providers comply with
these laws and that MA plans ensure compliance with such laws and only
cover MA additional telehealth benefits provided in compliance with
such laws. We solicited comment on whether to impose additional
requirements for qualifications of providers of MA additional
telehealth benefits, and if so, what those requirements should be.
In order to monitor the impact of the MA additional telehealth
benefits on MA plans, providers, enrollees, and the MA program as a
whole, we also proposed to require MA plans to make information about
coverage of MA additional telehealth benefits available to CMS upon
request, per proposed Sec. 422.135(c)(5). We proposed that this
information may include, but is not limited to, statistics on use or
cost of MA additional telehealth benefits, manner(s) or method(s) of
electronic exchange, evaluations of effectiveness, and demonstration of
compliance with the requirements in Sec. 422.135. We explained in our
proposed rule that the purpose of requiring MA plans to make such
information available to CMS upon request would be to determine whether
CMS should make improvements to the regulation and/or guidance
regarding MA additional telehealth benefits.
In Sec. 422.135(d), we proposed to require that MA plans
furnishing MA additional telehealth benefits may only do so using
contracted (that is, network) providers. We believe limiting service
delivery of MA additional telehealth benefits to contracted providers
offers MA enrollees access to these covered services in a manner more
consistent with the statute because plans would have more control over
how and when such services are furnished. The regulation at Sec.
422.204 requires MA plans to have written policies and procedures for
the selection and evaluation of providers and that such policies
conform with MA specific credentialing requirements outlined in Sec.
422.204. We explained in the proposed rule that these policies would
also be a means to ensure additional oversight of providers'
performance, thereby increasing plans' ability to provide covered
services such as MA additional telehealth benefits. We also proposed to
specify that if an MA plan covers benefits furnished by a non-
contracted provider through electronic exchange, then those benefits
may only be covered as MA supplemental telehealth benefits. These
benefits are not MA additional telehealth or basic benefits if
furnished by a non-contracted provider through electronic exchange. We
requested comment on whether the contracted providers' restriction
should be placed on all MA plan types or limited only to certain plan
types, such as local/regional preferred provider organization (PPO)
plans, medical savings account (MSA) plans, and/or private fee-for-
service (PFFS) plans. Currently, pursuant to Sec. 422.4(a)(1)(v), PPO
plans must provide reimbursement for all plan-covered medically
necessary services received from non-contracted providers without prior
authorization requirements. We explained in the proposed rule our view
that without an opportunity to review the qualifications of the non-
contracted provider and to impose limits on how only clinically
appropriate services are provided as MA additional telehealth benefits,
PPO plans would not be able to meet the proposed requirements.
Therefore, we solicited comment on whether to require just PPOs (or MSA
plans, PFFS plans, etc.), instead of all MA plan types, to use only
contracted providers for MA additional telehealth benefits.
Per section 1852(m)(2)(A)(ii) of the Act, the term ``additional
telehealth benefits'' does not include capital and infrastructure costs
and investments relating to such benefits. We proposed to codify this
requirement in Sec. 422.254(b)(3)(i) as a restriction on how MA plans
include MA additional telehealth benefits in their bid submission. We
stated that we believe that the statutory limit is tied only to the
cost to the government, which is tied to how MA additional telehealth
benefits may be included in the bid as basic benefits. Therefore, our
proposal was to eliminate from the basic benefit bid those capital and
infrastructure costs and investments that are required or used to
enable the provision of MA additional telehealth benefits. We did not
propose specific definitions of capital and infrastructure costs or
investments related to such benefits because the costs and investments
needed and used to provide MA additional telehealth benefits would vary
based on the individual MA plan's approach to furnishing the benefits.
In the proposed rule, we provided some examples of capital and
infrastructure costs, including, but not limited to, high-speed
internet installation and service, communication platforms and
software, and video conferencing equipment. We also solicited comment
on what other types of capital and infrastructure costs and investments
should be excluded from the bid and how CMS should operationalize this
statutory requirement in the annual bid process. We proposed to provide
a more detailed list of examples in this final rule, based on feedback
received from stakeholders.
We explained in the proposed rule that our proposal at Sec.
422.254(b)(3)(i) meant that MA plans must exclude any capital and
infrastructure costs and investments specifically relating to MA
additional telehealth benefits from their bid submission for MA
additional telehealth services offered directly by the plan sponsor and
by a third party provider. Accordingly, we explained our proposal meant
that the projected expenditures in the MA bid for services provided via
MA additional telehealth benefits must not include the corresponding
capital and infrastructure costs and that any items provided to the
enrollee in the administration of MA additional telehealth benefits
must be directly related to the care and treatment of the enrollee for
the Part B benefit. In the proposed rule, we provided an example of
this provision, noting that MA plans would not be able to provide
enrollees with internet service or permanently install
telecommunication systems in an enrollee's home as part of
administration of MA additional telehealth benefits.
In addition to our proposal at Sec. 422.135, we also proposed to
amend paragraphs (a) and (c)(1) of Sec. 422.100 to explicitly address
how MA additional telehealth benefits may be offered by an MA plan.
Section 1852(a)(1)(A) of the Act requires that each MA plan shall
provide enrollees benefits under the original Medicare fee-for-service
program option. As amended by the Bipartisan Budget Act of 2018,
section 1852(a)(1)(B) of the Act defines ``benefits under the original
Medicare fee-for-service program option'' to mean--subject to
subsection (m) (regarding provision of MA additional
[[Page 15687]]
telehealth benefits)--those items and services (other than hospice care
or coverage for organ acquisitions for kidney transplants) for which
benefits are available under Parts A and B to individuals entitled to
benefits under Part A and enrolled under Part B. Since this definition
is subject to the statutory provision for MA additional telehealth
benefits, this means that all of the same coverage and access
requirements that apply with respect to basic benefits also apply to
any MA additional telehealth benefits an MA plan may choose to offer.
Therefore, we proposed to amend Sec. 422.100(c)(1) to include MA
additional telehealth benefits in the definition of basic benefits and
to cross-reference Sec. 422.135, which provides the rules governing MA
additional telehealth benefits. We proposed to further clarify the
regulation text in Sec. 422.100(c)(1) to track the statutory language
described earlier more closely in addressing both kidney acquisition
and hospice in the definition of basic benefits. Finally, we proposed
to make corresponding technical revisions to Sec. 422.100(a) to
reference the new paragraph (c)(1) for basic benefits (clarifying that
MA additional telehealth benefits are voluntary benefits for MA plans
to offer but are not required) and paragraph (c)(2) for MA supplemental
benefits (instead of Sec. 422.102 because MA supplemental benefits are
listed as a benefit type in (c)(2)). We also proposed a small technical
correction in the last sentence of Sec. 422.100(a) to replace the
reference to Sec. 422.100(g) with ``this section'' because there are a
number of provisions in Sec. 422.100--not just paragraph (g)--that are
applicable to the benefits CMS reviews.
Additionally, we proposed amendments to the bidding regulations at
Sec. Sec. 422.252, 422.254, and 422.264 to account for MA additional
telehealth benefits and to correct the inconsistent phrasing of
references to basic benefits (for example, these regulations variously
use the terms ``original Medicare benefits,'' ``benefits under the
original Medicare program,'' ``benefits under the original Medicare FFS
program option,'' etc.). In order to make the MA additional telehealth
benefits part of the basic benefit bid and included in the ``monthly
aggregate bid amount'' as part of the original Medicare benefits that
are the scope of the basic benefit bid, we proposed to update these
various phrases to consistently use the phrase ``basic benefits as
defined in Sec. 422.100(c)(1).'' We also proposed a few minor
technical corrections to the bidding regulations. Finally, we proposed
a paragraph (e) in new Sec. 422.135 to state that an MA plan that
fully complies with Sec. 422.135 may include MA additional telehealth
benefits in its bid for basic benefits in accordance with Sec.
422.254. This provision means that inclusion in the bid is subject to
the bidding regulations we proposed to amend.
In offering MA additional telehealth benefits, MA plans must comply
with existing MA rules, including, but not limited to: Access to
services at Sec. 422.112; recordkeeping requirements at Sec. 422.118
(for example, confidentiality, accuracy, timeliness); standards for
communications and marketing at Sec. 422.2268 (for example, inducement
prohibition); and non-discrimination at Sec. Sec. 422.100(f)(2) and
422.110(a). Further, in addition to Sec. Sec. 422.112, 422.118,
422.2268, 422.100(f)(2), and 422.110(a), MA plans must also ensure
compliance with other federal non-discrimination laws, such as Title VI
of the Civil Rights Act of 1964, section 504 of the Rehabilitation Act
of 1973, and section 1557 of the Affordable Care Act. We did not
propose specific reference to these existing requirements in new Sec.
422.135 because we do not believe that to be necessary. Compliance with
these existing laws is already required; we merely note, as an aid to
MA plans, how provision of MA additional telehealth benefits must be
consistent with these regulations. We solicited comment on this policy
choice, specifically whether there were other existing regulations that
CMS should revise to address their application in the context of MA
additional telehealth benefits.
Finally, section 1852(m)(2)(B) of the Act instructed the Secretary
to solicit comments on the implementation of these MA additional
telehealth benefits by November 30, 2018; in addition to the proposed
regulations to implement section 1852(m) of the Act, we used the
proposed rule and the associated comment period to satisfy this
statutory requirement. We thank commenters for their input to help
inform CMS's next steps related to implementing the MA additional
telehealth benefits. We received the following comments on this
proposal, and our response follows:
Comment: Many commenters suggested that CMS's approach to MA
additional telehealth benefits align with CMS's existing approaches to
what is currently available via telehealth under original Medicare.
These commenters referenced the ``Medicare telehealth services''
definition in section 1834(m) of the Act, payment for remote patient
monitoring (RPM) services outside of section 1834(m) of the Act, as
well as the new communication technology-based services not subject to
section 1834(m) restrictions, described in the Medicare Program;
Revisions to Payment Policies Under the Physician Fee Schedule and
Other Revisions to Part B for CY 2019 (83 FR 59452, Nov. 23, 2018;
hereinafter referred to as the Calendar Year 2019 Physician Fee
Schedule final rule). Commenters also requested that CMS clarify the
distinction between MA additional telehealth benefits and the various
services in original Medicare that use communications technology
(including Medicare telehealth services under section 1834(m) of the
Act). Specifically, some commenters recommended that CMS state in the
final rule that MA additional telehealth benefits are subject to the
technological specifications for Medicare telehealth services furnished
under section 1834(m) of the Act, that is, two-way audio and visual
real-time and interactive services. Further, commenters requested that
CMS explicitly state that under current original Medicare rules, MA
plans may already include other clinically appropriate virtual services
that are not subject to the location limitations of section 1834(m) of
the Act--such as RPM technology--as part of basic benefits because such
services are payable under Part B for original Medicare.
Response: We understand commenters' concerns that differences
between telehealth services under original Medicare and MA additional
telehealth benefits be clearly distinguished and explained. We
appreciate the input offered by commenters and provide a thorough and
clear discussion here.
First, we must emphasize that the term ``additional telehealth
benefits'' is a term of art with a specific meaning in the MA program;
it is defined in section 1852(m)(A) of the Act and in the regulation we
finalize here at Sec. 422.135(a). We are finalizing the regulatory
definition with changes from the proposed rule to delete ``are
furnished by an MA plan'' and to include the statutory provisions that
MA additional telehealth benefits are services for which benefits are
available under Part B and are provided when specific healthcare
providers and enrollees are in different locations. As finalized, the
definition reads that additional telehealth benefits means services:
(1) For which benefits are available under Medicare Part B but
which are not payable under section 1834(m) of the Act; and
[[Page 15688]]
(2) That have been identified by the MA plan for the applicable
year as clinically appropriate to furnish through electronic exchange
when the physician (as defined in section 1861(r) of the Act) or
practitioner (described in section 1842(b)(18)(C) of the Act) providing
the service is not in the same location as the enrollee. We are focused
here on the first part of this definition.
Second, determining whether a service may be offered by an MA plan
as part of basic benefits requires addressing two questions: (1) Is the
service covered and payable under Part A or Part B?; and (2) if not, is
the reason it is not payable under Part B solely because of the limits
in section 1834(m) of the Act? If the answer to the first question is
yes, then the service is already a benefit under the original Medicare
fee-for-service program option and, unless it is hospice care or
coverage for organ acquisitions for kidney transplants, must be
provided under current law at section 1852(a) of the Act and the MA
regulations in 42 CFR part 422. If the answer to the second question is
yes, then provision of the service through electronic exchange may be
covered as an MA basic benefit under section 1852(m) of the Act, as
added by the Bipartisan Budget Act of 2018, and the regulations (at
Sec. Sec. 422.100, 422.135, 422.252, 422.254, and 422.264) we are
finalizing in this rule. We note that these regulations include other
conditions that must also be satisfied in order for the service to be
MA additional telehealth benefits that may be included as basic
benefits, but our focus for this specific discussion is on the
relationship to Part B coverage. We turn now to Part B coverage of
telehealth services.
Under original Medicare, Part B provides for coverage and payment
of services (and items, which are not relevant for purposes of this
discussion), including services furnished in an in-person encounter
between a physician or other practitioner, services furnished as
Medicare telehealth services as specified under section 1834(m) of the
Act, and certain other services that can be furnished in full without
the patient being present. ``Medicare telehealth services,'' as defined
in section 1834(m) of the Act and the implementing regulations at
Sec. Sec. 410.78 and 414.65 include professional consultations, office
visits, office psychiatry services, and other similar services that
must ordinarily be furnished in-person but instead may be furnished
using interactive, real-time telecommunication technology subject to
the restrictions on Medicare telehealth services specified under
section 1834(m) of the Act. Also under section 1834 of the Act,
synchronous ``store and forward'' telehealth services may be furnished
as part of federal telemedicine demonstration projects in Alaska and
Hawaii. Medicare telehealth services under section 1834(m) of the Act
are limited in that they must only be furnished by physicians and other
specified types of practitioners, and can be furnished and paid only
when the beneficiary is located at an eligible originating site.
As we explained in the Calendar Year 2019 Physician Fee Schedule
final rule, we have generally regarded the Medicare telehealth services
for which payment can be made under section 1834(m) of the Act as being
limited to services that must ordinarily be furnished in-person during
an encounter between a clinician and the patient, but are instead
furnished using telecommunication technology as a substitute for that
in-person encounter (83 FR 59482-59483). There are other services under
original Medicare that use telecommunication technology, but are not
considered Medicare telehealth services as defined under section
1834(m) of the Act, for example, RPM and remote interpretation of
diagnostic tests, chronic care management services, transitional care
management services (other than the included evaluation and management
service), and behavioral health integration services.
Additionally, as established in the Calendar Year 2019 Physician
Fee Schedule final rule, effective January 1, 2019, original Medicare
now makes separate payment for new ``communication technology-based
services.'' These services are not subject to the limitations of
section 1834(m) of the Act because they are not a substitute for an in-
person, face-to-face encounter between a clinician and a patient. As
such, these services are inherently non-face-to-face, are paid under
the Physician Fee Schedule like other physicians' services, and are not
subject to the restrictions on Medicare telehealth services specified
under section 1834(m) of the Act. The communication technology-based
services include brief communication technology-based service (virtual
check-in), remote evaluation of pre-recorded patient information, and
interprofessional internet consultation. These three services and their
corresponding Healthcare Common Procedure Coding System (HCPCS) codes
are described in detail in the Calendar Year 2019 Physician Fee
Schedule final rule at 83 FR 59482 through 59491. That rule also
finalized separate payment under the Physician Fee Schedule for chronic
care remote physiologic monitoring services.
In the Calendar Year 2019 Physician Fee Schedule final rule, CMS
also implemented sections 50302 and 50325 of the Bipartisan Budget Act
of 2018 to remove certain section 1834(m) limitations on geography and
originating site (patient setting) for certain services. Specifically,
the policies under section 50302 of the Bipartisan Budget Act of 2018
added renal dialysis facilities and the homes of beneficiaries as
allowable originating sites and removed the geographic restrictions for
hospital-based or critical access hospital-based renal dialysis
centers, renal dialysis facilities, and beneficiary homes, for purposes
of monthly ESRD-related clinical assessments for patients receiving
home dialysis. The policies under section 50325 of the Bipartisan
Budget Act of 2018 added mobile stroke units as allowable originating
sites and removed the originating site type and geographic
restrictions, for acute stroke-related telehealth services. Both are
effective January 1, 2019.
Additionally, CMS revised the Medicare telehealth regulations to
reflect the amendments made to section 1834(m) of the Act by section
2001(a) of the Substance Use-Disorder Prevention that Promotes Opioid
Recovery and Treatment for Patients and Communities Act (SUPPORT Act)
(Pub. L. 115-271) to remove the originating site geographic
requirements for all originating sites described in section
1834(m)(4)(C)(ii) of the Act, except for renal dialysis facilities that
are only permissible originating sites for purposes of monthly ESRD-
related clinical assessments for patients receiving home dialysis, and
to add the home of an individual as a permissible originating site,
with respect to telehealth services furnished for purposes of the
treatment of an individual with a substance use disorder diagnosis or
co-occurring mental health disorder, effective July 1, 2019 (83 FR
59494 through 59496).
All of the telehealth services and other non-face-to-face services
furnished via communication technology described earlier are covered
and paid under original Medicare. Therefore, MA plans must cover these
services because they are required basic benefits. Any services falling
outside the scope of these services that an MA plan wishes to offer may
potentially be covered as MA additional telehealth benefits, effective
January 1, 2020, assuming they meet the requirements under section
1852(m) of the Act. In other words, MA additional telehealth benefits
can
[[Page 15689]]
include an even broader range of telehealth services for enrollees in
an MA plan offering MA additional telehealth benefits, beyond original
Medicare benefits. An examination conducted using videoconferencing
and/or other telecommunications systems to relay information (such as
images and vital signs) may be covered as a primary care visit when the
physician (as defined in section 1861(r) of the Act) or practitioner
(described in section 1842(b)(18)(C) of the Act) and enrollee are in
different locations that do not meet the requirements under section
1834(m) of the Act. As a practical matter, we do not expect MA plans to
find implementation and compliance difficult because, if a service
provided by the physician or practitioner is a Part B covered service
for which payment could be made, but for the limitations in section
1834(m) of the Act, it may be an MA additional telehealth benefit if
the MA plan complies with Sec. 422.135 as finalized. If a service or
item provided by a physician or practitioner is covered under Part B by
the original Medicare program and payment is not prohibited based on
the limitations in section 1834(m) of the Act, then the service or item
is a basic benefit without consideration of whether Sec. 422.135 could
apply. Finally, if a service is not covered under Part B, even if the
limitations in section 1834(m) of the Act are taken into account, then
the service may only be covered by an MA plan as an MA supplemental
telehealth benefit, and not offered as an MA additional telehealth
benefit. In addition, we clarify in this final rule that if a service
is covered under Part B and provided through electronic exchange but
otherwise does not comply with Sec. 422.135 (for example, if it is
provided by an out-of-network healthcare provider), then the service
may be covered only as an MA supplemental telehealth benefit per Sec.
422.135(b). For example, a nursing hotline staffed by nurses, that are
not practitioners specified in section 1842(b)(18)(C) \5\ of the Act,
that provides assistance in identifying when to seek additional medical
help would not be covered under Part B even if the assistance were
provided in person. We discuss these issues in more detail in our
responses to comments below.
---------------------------------------------------------------------------
\5\ Such practitioners include: (i) A physician assistant, nurse
practitioner, or clinical nurse specialist (as defined in section
1861(aa)(5)) of the Act; (ii) A certified registered nurse
anesthetist (as defined in section 1861(bb)(2)); (iii) A certified
nurse-midwife (as defined in section 1861(gg)(2)); (iv) A clinical
social worker (as defined in section 1861(hh)(1)); (v) A clinical
psychologist (as defined by the Secretary for purposes of section
1861(ii)) and (vi) A registered dietitian or nutrition professional.
---------------------------------------------------------------------------
We thank commenters for their feedback on how to reconcile the
telehealth differences between MA and original Medicare, and we hope
our response provides adequate clarification and removes any
misinterpretation. Please note, CMS intends to release more detailed
sub-regulatory guidance relating to telehealth for both the original
Medicare and MA programs.
Comment: Several commenters supported CMS's explicit recognition
that MA plans may continue to offer other telehealth services through
MA supplemental telehealth benefits. A commenter questioned whether
non-contracted providers will be allowed to provide MA additional
telehealth benefits as supplemental benefits.
Response: We thank commenters for their support for continuing to
allow MA plans to offer MA supplemental telehealth benefits for those
services that do not meet the requirements for coverage under original
Medicare or as MA additional telehealth benefits. We are finalizing our
proposal, at Sec. 422.135(d), to require that MA additional telehealth
benefits only be furnished using contracted providers. As discussed in
the preamble of the proposed rule, an MA plan may still cover out-of-
network services that would be considered MA additional telehealth
benefits (and thus offered as MA basic benefits) when provided by a
contracted provider, but these out-of-network services may only be
covered as MA supplemental telehealth benefits because the MA plan has
not complied with Sec. 422.135(d). These services are not MA
additional telehealth benefits if furnished by a non-contracted
provider through electronic exchange.
Comment: Many commenters supported CMS's proposed definition for
the term ``electronic exchange'' in proposed regulation text at Sec.
422.135(a). The commenters stated that CMS's broad definition, which
defines electronic exchange as ``electronic information and
telecommunications technology,'' is reasonable as it allows MA plans to
use evolving technology to provide MA additional telehealth benefits.
Further, some commenters strongly urged CMS to rescind the electronic
exchange examples listed in the proposed rule preamble, but finalize as
proposed the definition of ``electronic exchange'' in the regulation
text at Sec. 422.135(a). Commenters stated CMS could not provide a
list of electronic exchange examples that adequately takes in to
account future technological innovation. Commenters also explained that
a limited list of electronic exchange examples would cause confusion in
the marketplace because plans and providers would be uncertain about
permissible forms of electronic exchange technology.
Response: We appreciate all of the comments received on the
proposed definition for the term ``electronic exchange.'' Our
definition is based on how section 1852(m)(2) of the Act uses the
phrase ``electronic information and telecommunications technology'' to
describe how the services are provided when the physician or
practitioner and the patient are not in the same location. In Sec.
422.135(a) as finalized, we define ``electronic exchange'' as
``electronic information and telecommunications technology.'' We agree
that this definition of ``electronic exchange'' allows MA plans the use
of various forms of technology to provide MA additional telehealth
benefits to enrollees. Our purpose in defining ``electronic exchange''
in this manner is to allow modernization in the MA program and the
provision of evidence-based, effective health care. As noted in the
proposed rule, we did not propose specific regulation text that defines
or provides examples of electronic information and telecommunications
technology. We stated that we believe this broad and encompassing
approach will allow for technological advances that may develop in the
future.
While our list of electronic exchange examples in the proposed rule
preamble was not intended to be a comprehensive list for purposes of
the final rule, we acknowledge that the list of electronic exchange
examples does not take into account future technological innovation,
and we seek to allow plans the flexibility to develop forms of
electronic exchange without unnecessary burden. We are finalizing as
proposed the definition of ``electronic exchange'' in the regulation
text at Sec. 422.135(a). We believe this more general approach allows
for MA plan flexibility and innovation, does not inadvertently restrict
MA plans to certain forms of electronic exchange, and avoids the
possibility of overlap with original Medicare telehealth coverage. We
explicitly clarify here that future technology that is within the scope
of the phrase ``electronic information and telecommunications
technology'' as used in the statute may be used for purposes of
providing MA additional telehealth benefits.
Comment: Many commenters supported CMS's decision not to propose
specific regulation text that defines or provides examples of
electronic information and telecommunications technology because
[[Page 15690]]
the technology needed and used to provide MA additional telehealth
benefits will vary based on the service being offered. A commenter
suggested there be a governing body to review and certify the
telehealth technology used and to ensure proper telehealth provider
training.
Response: We agree with commenters' position that specific
regulation text that defines or provides examples of electronic
information and telecommunications technology should not be included in
the final rule. We do not include this specific regulation text in the
final rule because technology will vary based on user and over time. As
discussed earlier, we believe this broad and encompassing approach will
allow for technological advances that may develop in the future and
avoid tying the authority in the new regulation to specific information
formats or technologies.
We appreciate the commenter's suggestion that there be a governing
body to review and certify the telehealth technology used and to ensure
proper telehealth provider training. We are not requiring a governing
body to conduct oversight of telehealth technology and providers at
this time, but we will use authority codified in this final rule at
Sec. 422.135(c)(4) to review information about coverage of MA
additional telehealth benefits, which may include, but is not limited
to, statistics on use or cost, manner(s) or method of electronic
exchange, evaluations of effectiveness, and demonstration of compliance
with the requirements of this final rule.
Comment: Many commenters supported CMS allowing MA plans to
independently determine each year which services are clinically
appropriate to furnish through electronic exchange as MA additional
telehealth benefits. These commenters stated that MA plans should have
authority to make these determinations because plans and healthcare
providers work directly with enrollees and are more aware of evolving
methods of delivering care. A few commenters recommended that CMS
authorize healthcare providers, rather than or in addition to MA plans,
to make the annual determination of which services are clinically
appropriate to furnish through MA additional telehealth benefits.
Response: We are finalizing our proposal that MA plans have the
discretion to determine which Part B services are clinically
appropriate to provide through electronic exchange and to make that
determination for each applicable plan year. Such services, when the
other requirements in Sec. 422.135 are met, would be permissible MA
additional telehealth benefits. As professionally recognized standards
of health care change over time, we believe MA plans have an interest
in working with providers to develop and use the methods of modern
medicine necessary to provide MA additional telehealth benefits to
enrollees who choose to have their health benefits delivered in this
manner. MA plans are required, per Sec. 422.202(b), to consult with
their contracted network providers regarding the MA plan's medical
policy; this would include any applicable MA additional telehealth
benefits policy, and we believe that is sufficient for establishing the
required involvement of healthcare providers. We encourage MA plans to
involve their contracted providers when making determinations about
which services are clinically appropriate to furnish through MA
additional telehealth benefits beyond the consultation required under
that regulation, but we are not adopting such a requirement in this
final rule.
Furthermore, we note that in accordance with Sec. 422.112(b)(3),
all MA coordinated care plans are required to coordinate MA benefits
with community and social services generally available in the plan
service area. Therefore, we expect MA coordinated care plans offering
MA additional telehealth benefits to coordinate care for enrollees
receiving the specified Part B service(s) through electronic exchange
in the same manner as for enrollees receiving the service in-person.
Comment: Many commenters opposed CMS placing limitations on the
types of Part B items and services that can be MA additional telehealth
benefits. Specifically, commenters urged CMS to use only the MA plan
annual determination and medical review to define the types of items
and services to be included as MA additional telehealth benefits. They
explained that any definition of items or services will lock CMS into
an approach supported by today's evidence, which will hinder CMS's
ability to update its policies for future evidence-based innovation.
Response: We agree with the commenters that adopting a specific
list of services that could be MA additional telehealth benefits when
provided through electronic exchange creates a risk of not being
sufficiently flexible in the future. We proposed and are finalizing
regulation text that allows MA plans flexibility to determine which
services are clinically appropriate to furnish through MA additional
telehealth benefits on an annual basis consistent with the limits in
the statute and Sec. 422.135.
Comment: Some commenters supported CMS's proposal to allow MA plans
offering MA additional telehealth benefits to maintain different cost
sharing for in-person visits and visits through electronic exchange,
while several commenters opposed differential cost sharing. Commenters
expressed concerns that low-income enrollees living in rural,
underserved areas without internet access may be disadvantaged because
they would have to choose the in-person option, which may have higher
cost sharing as compared to the alternative visit through electronic
exchange. A few commenters, including the Medicare Payment Advisory
Commission, recommended CMS ensure access to in-person services is not
made prohibitively expensive by differential cost sharing as it could
be discriminatory if undue financial burden is imposed on enrollees who
choose in-person services instead of accessing services through
electronic exchange. Further, commenters requested that CMS actively
monitor differential cost sharing amounts to ensure they fairly reflect
actual cost differentials and are not used to steer enrollees away from
preferred methods of care. Commenters stated that enrollees lacking
internet access should be able to get in-person services without facing
an increase in out-of-pocket costs. Some commenters also requested that
CMS clarify that a Qualified Medicare Beneficiary (QMB) would be
protected from billing for cost sharing for all Part A/B services
delivered via telehealth.
Response: As discussed in the proposed rule, section 1852(m)(5) of
the Act mandates that MA additional telehealth benefits shall be
treated as if they were benefits under the original Medicare fee-for-
service program option. We acknowledged in the proposed rule that CMS
has traditionally interpreted section 1852(a)(1)(B)(i) and (iii)-(v) of
the Act to mean that, subject to certain exceptions, MA plans must
cover basic benefits using cost sharing that is actuarially equivalent
to the Part A and B cost sharing from a plan-level (not enrollee-level)
perspective. MA plans are not required, in most cases, to have the
exact same cost sharing as in original Medicare. Subject to certain
beneficiary protections and limits on cost sharing for certain specific
services,\6\ MA plans have great flexibility in setting the cost
sharing for specific benefits. Further, for in-network services, CMS
has limited authority to set the payment structure, including the
payment amount, an MA
[[Page 15691]]
plan uses to pay its contracted providers; to some extent, the amount
the MA plan has negotiated to pay its contracted providers may
influence the cost sharing amount that the MA plan sets for the
associated services. In addition, MA plans must have uniform cost
sharing per Sec. 422.100(d)(2). CMS has taken a broad and flexible
approach to the uniformity requirement, including permitting MA plans
to set up ``preferred'' networks that carry lower cost sharing for
specific services.\7\ In response to comments on this topic, we are
clarifying the rationale for Sec. 422.135(f).
---------------------------------------------------------------------------
\6\ See 42 CFR 422.100(f), (j) and (k).
\7\ See Announcement of Calendar Year 2019 Medicare Advantage
Capitation Rates and Medicare Advantage and Part D Payment Policies
and Final Call Letter.
---------------------------------------------------------------------------
In the context of original Medicare Part B, services furnished in
an in-person encounter between a clinician and a patient are subject to
different rules than those delivered through electronic exchange; in
effect, the statutory provisions governing payment for original
Medicare telehealth services treat services furnished through
electronic exchange as different services than the in-person services,
rather than as the same services delivered through different
modalities. Section 1834(m) of the Act limits Part B payment for
services furnished through electronic exchange to only certain
healthcare services delivered through certain technology by specified
types of clinicians to beneficiaries located in originating sites that
meet specific conditions. Under the statutory scheme of section 1834(m)
of the Act, services furnished through electronic exchange, where the
physician or practitioner is not in the same location as the patient,
are distinct and different services from those furnished in-person and
in the same location.
We interpret the current law regulating the cost sharing in the MA
context to mean that MA plans must charge enrollees the same cost
sharing for the same item or service delivered by the same provider,
and we view a service delivered in-person versus a service delivered
via electronic exchange as different services because they are
delivered differently. In order words, delivering a Part B service via
electronic exchange is inherently different (for example, in modality
and required infrastructure) than delivering the Part B service in-
person under Medicare coverage rules; therefore, we consider these to
be sufficiently different services for purposes of the MA requirement
that cost sharing be uniform, and thus the services can be treated
differently from a cost sharing perspective. Further, the cost of
providing the service via electronic exchange might be lower, so having
lower cost sharing is acceptable. For example, an MA plan may offer a
dermatology exam using store-and-forward technology as an MA additional
telehealth benefit, and the cost of this electronic exchange would
likely be lower than the cost of an in-person dermatology exam. Thus,
differential cost sharing for the electronic exchange versus the in-
person visit would be appropriate in this scenario. This overall
reasoning is consistent with our traditional interpretation of the
Medicare statute and the applicable provisions in Part C, therefore we
are finalizing the regulation text at Sec. 422.135(f) as proposed.
We understand commenters' apprehensions about enrollee
discrimination and enrollee access to MA additional telehealth
benefits. The anti-discrimination requirements in current CMS
regulations at Sec. 422.100(f)(2) and Sec. 422.110(a) are
traditionally related to discrimination based on health status. Other
federal non-discrimination laws, such as Title VI of the Civil Rights
Act of 1964, focus on specific protected classes (such as race and
age). Economic status or geographic location (rural/urban) are not
protected classes under those laws, nor under current CMS regulations.
Consequently, we do not have clear authority to enforce anti-
discrimination rules based solely on an enrollee's economic status or
geographic location.
However, the statutory requirement (section 1852(m)(4) of the Act)
and our corresponding regulatory requirement in this final rule (Sec.
422.135(c)(1)) protecting the enrollee's choice to receive covered
services in-person control how an MA plan offers MA additional
telehealth benefits. An MA plan offering MA additional telehealth
benefits must preserve the enrollee's right to choose whether to access
the service in-person or, if offered by the MA plan, through electronic
exchange. MA plans may not circumvent or limit enrollee choice by using
differential cost sharing to steer beneficiaries or inhibit access to
services. We view such steering and inhibiting access as violations of
Sec. 422.100(f)(2) because of how those activities would inhibit an
enrollee from exercising his or her rights under section 1852(m)(4) of
the Act and Sec. 422.135(c). If an MA plan chooses to maintain
differential cost sharing for MA additional telehealth benefits, we
expect the primary purpose would be to parallel the actual cost of
administering the service and not to steer beneficiaries or inhibit
access. We will actively monitor complaints regarding differential cost
sharing for MA additional telehealth benefits. If we identify a problem
with enrollee access or steering, we may take compliance or enforcement
actions, as necessary, and we may modify our policy to address the
issue.
As discussed previously, MA plans have great flexibility in setting
cost sharing for specific benefits. We believe that restricting this
flexibility for certain plans that offer MA additional telehealth
benefits, for example in cases where an MA plan operates in a rural or
underserved area, could result in MA plans choosing not to offer MA
additional telehealth benefits in rural service areas. Given this, and
given the existing beneficiary cost sharing protections described
previously, we do not believe it is appropriate to limit MA plans'
existing flexibility to set cost sharing for MA additional telehealth
benefits. However, we encourage MA plans to take issues like this into
consideration in establishing cost sharing for MA additional telehealth
benefits.
Finally, we appreciate the comments regarding QMB cost sharing
protections. However, we believe that the current requirements at Sec.
422.504(g)(1)(iii) requiring MA plans to take steps to ensure that QMBs
are protected from providers billing cost sharing are adequate. This
regulation prohibits MA plans from imposing cost sharing on dual
eligible individuals when the state is responsible for paying for the
cost sharing and from imposing cost sharing on such enrollees that is
higher than the cost sharing permitted by the state Medicaid plan. For
more information on cost sharing protections provided under the Act for
QMBs and other dual eligible individuals, we refer readers to the CMS
website for the QMB program at: https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/QMB.html.
Comment: In accordance with section 1852(m)(4) of the Act, if an MA
plan covers a Part B service as an MA additional telehealth benefit,
then the MA plan must also provide access to such service through an
in-person visit and not only through electronic exchange. We proposed
Sec. 422.135(c)(2) to require MA plans to use their EOC (at a minimum)
to advise enrollees that they may receive the specified Part B
service(s) either through an in-person visit or through electronic
exchange. We also proposed, at Sec. 422.135(c)(3), that MA plans would
have to use their provider directory to identify any
[[Page 15692]]
providers offering services for MA additional telehealth benefits and
in-person visits or offering services exclusively for MA additional
telehealth benefits. While we received some support for our proposed
disclosure (that is, EOC and provider directory) requirements for MA
additional telehealth benefits, other commenters believed that these
requirements would be overly restrictive, burdensome, and/or time
consuming.
Several commenters recommended that CMS provide more flexibility in
how MA plans can disclose information about MA additional telehealth
benefits to enrollees. For example, commenters suggested that CMS allow
plans to use more general terminology instead of explicitly listing
each service in the EOC, and allow plans to describe in the EOC how
enrollees can obtain information on telehealth services. In terms of
the provider directory, a commenter believed CMS should let plans make
the determination regarding inclusion of telehealth providers in a way
the plan believes optimizes clarity for enrollees, especially since the
common industry approach is for telehealth vendors to contract with
licensed providers, and the list of providers is not static. Another
commenter requested that CMS require only an indication of which
providers are exclusively available via telehealth in directories, and
allow sufficient lead-time for plans to implement any new directory
requirements. A commenter suggested CMS work with plans on alternative
ways to responsibly share information on MA additional telehealth
benefits with enrollees. A few commenters requested clear guidance (for
example, model language) on the proposed disclosure requirements and
clarification, such as whether provider directory updates would need to
be made for all providers or only a specific subset.
Response: We appreciate commenters' concerns about the proposed
disclosure requirements being too restrictive and onerous on plans, and
we thank those who offered alternative solutions and ideas for more
flexibility. As discussed in the proposed rule, we believe that choice,
transparency, and clarity are vital when it comes to disclosing MA
additional telehealth benefits to enrollees. However, we also recognize
that there are various ways to effectively communicate with enrollees
consistent with the mandatory disclosure and information requirements
in Sec. 422.111. CMS has traditionally discussed specific required
elements for mandatory disclosures (for example, the provider directory
and EOC) and marketing materials in sub-regulatory guidance to explain
and interpret the applicable regulations as well as describe best
practices for MA plans and Part D sponsors.
We agree with commenters that more flexibility may be needed, and
sub-regulatory guidance provides an opportunity for flexibility in
applying the applicable regulations where possible and for regular
updates as necessary to account for changes in technology or evolving
methods of compliance. Therefore, we are not finalizing our proposed
regulation text for the provider directory requirement at proposed
Sec. 422.135(c)(3). Instead, we will address any provider directory
elements pertaining to plans offering MA additional telehealth benefits
in future sub-regulatory guidance. We note that the provider directory
requirements in Sec. 422.111 are not being amended and continue to
apply. Therefore, provider directories must be complete, accurate, and
updated timely to identify the healthcare providers currently under
contract with the MA plan to furnish covered services to enrollees. In
response to comments claiming that the common industry approach is for
telehealth vendors to contract with licensed providers and that the
list of providers is not static, we remind MA plans of the requirement
to issue provider directories and notify enrollees of network changes
per Sec. 422.111. As the providers of MA additional telehealth
services must be contracted providers, we expect that they will be
identified as contracted providers in provider directories.
We intend to be as clear as possible in our sub-regulatory guidance
to assist plans with their enrollee communications and to address how
the existing provider directory requirements apply in the context of MA
plan obligations in connection with furnishing MA additional telehealth
benefits. We note that, as discussed in more detail below, we are
finalizing our proposal that only contracted (that is, in-network)
providers may be used by an MA plan to furnish MA additional telehealth
benefits.
For similar reasons, we are also not finalizing our reference to
the EOC at proposed regulation text Sec. 422.135(c)(2). The regulation
at Sec. 422.111 establishing what information must be provided to
enrollees (and when) regarding benefits covered by the MA plan is
sufficient. We have historically used sub-regulatory guidance to
address the specific level of detail required by that regulation and
will issue guidance specific to how MA additional telehealth benefits
must be addressed in mandatory communication materials such as the EOC
and the Annual Notice of Change. None of our other regulations about
specific benefits require specific content in the EOC. We believe that
it is appropriate to follow that practice for addressing how
information about MA additional telehealth benefits must be disclosed
and provided to enrollees.
However, we are finalizing the remaining text at (c)(2), which
requires an MA plan furnishing MA additional telehealth benefits to
advise enrollees that they may receive the specified Part B service(s)
either through an in-person visit or through electronic exchange. We
have decided to maintain this general enrollee disclosure requirement
(without reference to the EOC) because of the statutory requirement at
section 1852(m)(4)(B) of the Act that the enrollee must have that
choice. We believe the MA plan must disclose this right of choice to
enrollees in a transparent manner in order to ensure that the right is
meaningfully provided. We plan to issue sub-regulatory guidance
specifically for Sec. 422.135(c)(2) regarding the requirement that an
MA plan advise enrollees that they may receive the specified Part B
service(s) through an in-person visit or through electronic exchange;
we will also issue guidance on disclosure requirements of MA plans,
including model language for both the EOC and the provider directory,
in the context of MA additional telehealth benefits.
Comment: In the proposed rule, we sought comment on what impact, if
any, MA additional telehealth benefits should have on MA network
adequacy policies, and the comments we received were mixed. Commenters
who were supportive of a change to network adequacy policies for MA
additional telehealth benefits stated that CMS should allow telehealth
providers to be considered in the network adequacy assessment, either
in the network criteria itself or through the exceptions process. Some
suggested CMS update the network criteria to account for how MA plans
may offer MA additional telehealth benefits (for example, allow
telehealth providers to count in the network review or comprise a
certain percentage of a plan's providers per specialty) or eliminate
the time and distance standard and maintain just the minimum number per
enrollee standard for telehealth providers. Others believed the current
exceptions process was sufficient, that is, commenters expressed that
through the current exceptions process, CMS could potentially allow
plans to substitute telehealth providers for in-person providers only
where there is a shortage
[[Page 15693]]
of specialty providers. A commenter suggested CMS consider telehealth
exceptions for network adequacy when a plan can demonstrate that access
to certain specialties would otherwise be problematic without
permitting the MA plan to use telehealth providers to meet the network
adequacy requirements; the commenter believed such policy would allow
for more competition and more attractive MA plan options. Some
commenters indicated that incorporating telehealth into network
adequacy would improve enrollee choice and access in MA, particularly
in rural/underserved areas, for certain specialties like behavioral
health, and through an increase in after-hours and weekend care. A few
commenters further encouraged CMS to provide flexibility regarding time
and distance standards and allow telehealth to fill in network gaps,
which might in turn streamline the network review process.
Other commenters asserted that a telehealth provider should not
carry the same weight as an in-person provider and should only be used
as a supplement, not a replacement, for in-person services. A few
commenters suggested CMS continue basing network adequacy only on in-
person services given the disparity in internet access.
Still others suggested CMS do a complete study to assess data in
light of increased telehealth utilization, which could inform future
changes to network adequacy policies and measurement options. A
commenter recommended that, minimally, CMS should wait to reevaluate
network criteria until there is a higher market saturation of
telehealth providers for Part B services. Another commenter believed
CMS should collect specific feedback on current plan-provider
telehealth arrangements and current enrollee experience and
satisfaction with telehealth providers, both within and outside MA.
Response: We thank the commenters for their feedback on MA
additional telehealth benefits' potential impact on network adequacy.
We will consider these comments as we perform further research on the
issue and update sub-regulatory guidance to reflect any applicable
changes in policy. We are not using this final rule to announce or
adopt changes in current policies for evaluating MA network adequacy
under Sec. 422.112 because CMS interprets the requirements at Sec.
422.112 through the MA network adequacy criteria, which have
traditionally been addressed in sub-regulatory guidance.
Comment: Many commenters supported CMS's proposal to require MA
plans to ensure through their provider contracts that providers meet
and comply with applicable state licensing requirements and other
applicable laws for the state in which the enrollee is located and
receiving the service. Specifically, the commenters suggested CMS allow
plan providers to utilize state-based credentialing standards for
telehealth services as opposed to federal standards for MA provider
participants authorized in Sec. 422.204(b). A commenter believed that
plans should be allowed to apply additional provider requirements.
Response: We support requiring the MA plan to ensure through its
contract with the provider that the provider meet and comply with
applicable state licensing requirements and other applicable laws for
the state in which the enrollee is located and receiving the service.
This standard is codified in the final rule at Sec. 422.135(c)(3). We
believe creating additional provider licensing requirements is
unnecessary, but we acknowledge that states may have specific
provisions regarding the practice of medicine using electronic
exchange. We remind readers and MA plans that existing provider
credentialing and network participation requirements, specifically in
Sec. Sec. 422.200 through 422.224, continue to apply. As this final
rule requires MA plans to use only contracted (that is, in-network)
physicians and practitioners to furnish MA additional telehealth
benefits, those existing regulations will apply.
Comment: Several commenters expressed an openness to CMS
occasionally collecting data on MA additional telehealth benefits, per
the proposal to require MA plans to make information about coverage of
MA additional telehealth benefits available to CMS upon request.
However, these commenters were leery of the potential for
administrative burden on MA plans. Some voiced concern about CMS
collecting confidential or sensitive information and specifically
requested that CMS exclude information that could be held under
contractual consideration. For example, a commenter stated that
specific information on use or cost of MA additional telehealth
benefits is proprietary and commercially sensitive, and revealing
contract-specific details would be anti-competitive. Another commenter
concurred with CMS collecting data on the costs and benefits of MA
plans' MA additional telehealth benefits as long as it was not overly
onerous on plans.
Response: We understand commenters' concerns about burden and
confidentiality when it comes to CMS data collection. However, we note
that the regulation text at proposed Sec. 422.135(c)(5)--finalized at
Sec. 422.135(c)(4)--includes the language ``upon request,'' which
implies that CMS does not intend to establish uniform data collection
at this time, but instead reserves the right to ask for this
information from MA plans. We encourage readers to refer to section
III.B.1. of this final rule, which provides additional detail and
explicitly states that the information collection provision at Sec.
422.135(c)(4) is exempt from the requirements of the Paperwork
Reduction Act (PRA) since we estimate fewer than 10 respondents. Thus,
we do not anticipate a significant increase in plan burden due to Sec.
422.135(c)(4). We also remind readers that any uniform request to more
than nine MA plans would require further review and would be subject to
public comment under the PRA requirements.
Comment: A few commenters questioned whether CMS will allow MA
plans (including PPO plans) to use only contracted providers for MA
additional telehealth benefits. Some commenters believed that the
contracted providers' restriction should apply to all MA plan types.
Some commenters rejected CMS's proposal that all plan types be required
to use only contracted providers. A few commenters recommended CMS
limit this requirement to HMOs, thus allowing PPOs to use both
contracted and non-contracted providers for MA additional telehealth
benefits. Other commenters recommended that CMS extend the allowable
providers beyond just contracted, in-network providers, stating that
the issue of no oversight of out-of-network providers exists whether or
not telehealth is involved.
Response: We are finalizing the proposal at Sec. 422.135(d) to
require that all MA plan types, including PPO plans, use only
contracted providers to provide MA additional telehealth benefits. We
are clarifying that if a PPO plan furnishes MA additional telehealth
benefits consistent with the requirements at Sec. 422.135, then the
PPO plan requirement at Sec. 422.4(a)(1)(v) (that the PPO must furnish
all services both in-network and out-of-network) will not apply to the
MA additional telehealth benefits; all other benefits covered by the
PPO must be covered on both an in-network and out-of-network basis. In
other words, a PPO plan is not required to furnish its MA additional
telehealth benefits out-of-network, as is the case for all other plan-
covered services. However, if a PPO plan would like to cover a service
delivered through electronic exchange on an out-of-network basis, then
the PPO plan has that option but may only cover the service as an MA
supplemental
[[Page 15694]]
telehealth benefit, consistent with the regulation text at Sec.
422.135(d).
In response to comments that recommended CMS extend the allowable
providers beyond contracted providers because the issue of no oversight
for non-contracted providers exists whether or not telehealth is
involved, we note that MA plans must be able to review and pre-certify
the qualifications and compliance of contracted providers to ensure
that telehealth services are furnished consistent with clinically
appropriate standards of care for the MA additional telehealth benefits
offered by the MA plan and that all state licensure and credentialing
requirements are met. We are therefore finalizing the proposed
regulation text at paragraph (d), that an MA plan must furnish MA
additional telehealth benefits only using contracted providers.
Therefore the regulation will require that all MA plans, including PPOs
that cover benefits provided by non-contracted providers, use only
contracted providers for MA additional telehealth benefits.
Comment: Commenters recommended that CMS remain flexible in the
ultimate determination of what will be considered capital and
infrastructure costs and investments to be excluded from their bid
submissions relative to MA additional telehealth benefits. Some
commenters offered ideas to operationalize the exclusions. One
suggestion was for CMS to stipulate a percentage that represents the
industry average of allowed fees as representative of the capital and
infrastructure costs, which could be trended over time. Another
commenter suggested that CMS align the definition of capital and
infrastructure costs and investments with a traditional understanding,
such that those items that would add permanent or depreciable value to
the plan or enrollee would be excluded, thus allowing the cost of
necessary support items or services for telehealth delivery. A few
commenters mentioned the 15 percent used in the Regulatory Impact
Analysis of the proposed rule as a proxy for these costs. A commenter
stated that the percentage was too high while another stressed that it
was too low.
Commenters also raised concerns about the difficulty of identifying
with specificity (for bid purposes) the capital and infrastructure
components of MA additional telehealth benefits for services offered
directly by the plan or through downstream entities such as providers
and third party vendors. Specifically, a few commenters were concerned
with the difficulty in excluding these costs from their claims capture
and data reporting and in obtaining this information from contracted
providers and vendors absent an additional contractual provision.
Commenters also stated that capital and infrastructure costs would vary
significantly from provider to provider. These commenters pointed out
that currently there is no incentive for providers or vendors to
accurately identify these costs, and plans would not be able to verify
if the costs were reasonably stated. Consequently, commenters
expressed, this lack of standardization and reliability could lead to
challenges of plans' actuarial attestations and potential inequitable
reporting in the bid. Another commenter also opposed the exclusion of
capital and infrastructure costs from MA plans' basic benefit bid.
Response: We appreciate the comments concerning the exclusion of
capital and infrastructure costs relating to MA additional telehealth
benefits from the basic benefit bid submission. Section
1852(m)(2)(A)(ii) of the Act excludes from MA additional telehealth
benefits capital and infrastructure costs and investments related to MA
additional telehealth benefits. We are codifying this requirement in
Sec. 422.254(b)(3)(i) as a restriction on how MA plans include MA
additional telehealth benefits in their bid submission. We believe the
statutory limit is tied only to the cost to the government, which is
tied to how MA additional telehealth benefits may be included in the
bid as basic benefits. Therefore, our proposal was to eliminate from
the basic benefit bid those capital and infrastructure costs and
investments that are required or used to enable the provision of MA
additional telehealth benefits.
We appreciate the concerns raised by commenters about broad
interpretations of the statutory exclusion of capital and
infrastructure costs and investments. In recognition of these
challenges, we are clarifying in regulation text that the exclusion
from the bid of capital and infrastructure costs and investments
relating to MA additional telehealth benefits, codified at Sec.
422.254(b)(3)(i), applies to capital and infrastructure costs and
investments ``directly incurred or paid by the MA plan.'' The bid for
basic benefits submitted by an MA plan cannot include such capital and
infrastructure costs or investments for MA additional telehealth
benefits.
We do not propose a specific definition of capital and
infrastructure costs or investments related to such benefits here
because the costs and investments needed and used to provide MA
additional telehealth benefits would vary based on the individual MA
plan's approach to furnishing the benefits.
We also thank the commenters for providing lists of capital and
infrastructure examples. Although we stated in the proposed rule that
we would provide a more detailed list of examples in this final rule
based on stakeholder feedback, after further consideration we have
chosen not to do so. We made this decision in acknowledgment of the
variety of potential capital and infrastructure models, for which a
given MA plan could incur or pay costs, related to MA additional
telehealth benefits.
Comment: Many commenters requested clarification on how the annual
bid submission process will work for MA additional telehealth benefits.
Specifically, commenters questioned how plans will be expected to file
MA additional telehealth benefits in the PBP.
Response: We appreciate this request for greater clarity concerning
how the annual bid submission process will be impacted by MA additional
telehealth benefits. We will take these comments into consideration
when developing the annual bid guidance, which we consider to be a more
appropriate place to provide instruction for completing the bid.
Comment: Several commenters supported CMS's proposal to allow MA
plans to provide MA additional telehealth benefits because the proposal
does not include geographic and originating site limitations. A few
commenters believed CMS should extend authority for MA additional
telehealth benefits to original Medicare, specifically to eliminate
geographic and originating site limitations applicable in original
Medicare. Some commenters requested that CMS make efforts to ensure
parity for original Medicare beneficiaries, claiming they would be
disadvantaged since they cannot access MA additional telehealth
benefits as MA enrollees can. Some commenters urged CMS to reference
and ensure alignment with the Part B definition of telecommunications
systems and note that the section 1834(m) originating site and
geographic restrictions do not apply to MA additional telehealth
benefits.
Response: This final rule will allow MA plans the ability to
offer--as part of the basic benefit package--MA additional telehealth
benefits beyond what is currently allowable under Medicare telehealth
services; this is authorized by section 1852(m) of the Act, which was
added by section 50323 of the Bipartisan Budget Act of 2018. Neither
the statute nor this final rule includes geographic or originating site
[[Page 15695]]
limitations as part of defining or authorizing MA additional telehealth
benefits. With regard to comments regarding coverage and payment under
the original Medicare program, we note that we are constrained by the
statutory requirements and that the original Medicare program is not
within the scope of this final rule.
Comment: A commenter requested that CMS provide permissible MA
additional telehealth benefit designs to ensure MA plan compliance with
CMS's final rule.
Response: We appreciate the commenter's request for permissible MA
additional telehealth benefit designs. However, we do not provide any
specific MA additional telehealth benefit designs in the final rule in
order to provide MA plans with the discretion to develop their plan
benefit offerings.
Comment: A commenter requested information regarding whether MA
additional telehealth benefits can be used to furnish the Medicare
Diabetes Prevention Program (MDPP) services. A few commenters
referenced CMS previously declining to test online MDPP diabetes self-
management training.
Response: As discussed above, we are finalizing this rule to define
``additional telehealth benefits'' as services that: (1) Are furnished
by an MA plan for which benefits are available under Medicare Part B
but which are not payable under section 1834(m) of the Act; and (2)
have been identified by the MA plan for the applicable year as
clinically appropriate to furnish through electronic exchange when the
physician (as defined in section 1861(r) of the Act) or practitioner
(described in section 1842(b)(18)(C) of the Act) providing the service
is not in the same location as the enrollee. Because this definition
requires MA additional telehealth benefits to be services provided by a
physician or practitioner, and MDPP services, pursuant to Sec. 410.79,
must be provided by an MDPP supplier, MDPP services cannot be offered
as MA additional telehealth benefits. Existing guidance about how MDPP
services may be provided on a virtual basis or through electronic
exchange still applies and can be covered as a supplemental benefit.
Comment: Some commenters requested that CMS include in the
definition of a telehealth provider specific specialty types such as
pharmacists, audiologists, speech-language pathologists, home health
care aides, and telerehabilitation providers.
Response: We appreciate comments requesting additional specificity
in identifying permissible telehealth provider types. However, we did
not define a telehealth provider in the proposed rule and will not
finalize such a definition here. Section 1852(m)(2)(A)(i)(2) uses the
term ``physician'' as defined in section 1861(r) of the Act and the
term ``practitioner'' described in section 1842(b)(18)(C) of the Act.
We have codified these statutory requirements in our final definition
of ``additional telehealth benefits'' at Sec. 422.135(a)(2), described
previously. Both the statute and this final rule limit MA additional
telehealth benefits to services furnished by physicians and
practitioners as so defined. Further, the statute and regulation
require that the service be clinically appropriate to furnish through
electronic exchange, which in some cases may prohibit certain services
from being covered as MA additional telehealth benefits. Finally, in
Sec. 422.135(d), we are codifying the requirement that MA plans
furnishing MA additional telehealth benefits only do so using
contracted providers.
Comment: A few commenters questioned how MA additional telehealth
benefits will interact with encounter data and risk adjustment. For
example, commenters recommended CMS establish rules or clarify the
criteria under which diagnoses obtained through telehealth encounters
can be considered and submitted for risk adjustment purposes. A
commenter specifically requested that CMS allow telehealth encounters
to be included for MA risk adjustment, while other requestors requested
future guidance on telehealth encounter data submissions.
Response: We appreciate commenters raising this particular issue.
This regulation does not change the existing obligation to submit
encounters. Consistent with the requirements under Sec. 422.310, MA
plans must submit risk adjustment data that characterize the context
and purpose of each item and service provided to an MA enrollee, and
must also conform to CMS's requirements for submitting these data. We
will be releasing guidance regarding MA additional telehealth benefits
and encounter data and risk adjustment in the future.
Summary of Regulatory Changes
We received a range of comments pertaining to this proposal, the
majority of which reflected support for the regulations. After careful
consideration of all comments received, and for the reasons set forth
in the proposed rule and in our responses to the related comments
summarized earlier, we are finalizing the proposed changes to
Sec. Sec. 422.100, 422.252, 422.254, and 422.264 and new regulation at
Sec. 422.135, with the following modifications:
In proposed regulation text Sec. 422.135(a), we are
removing the phrase ``that meet the following.'' Thus, we are revising
Sec. 422.135(a) to read as follows: ``Definitions. For purposes of
this section, the following definitions apply: Additional telehealth
benefits means services:''
In proposed regulation text Sec. 422.135(a)(1), we are
removing the phrase ``are furnished by an MA plan'' but finalizing the
remaining text in (a)(1). Thus, we are revising (a)(1) to read as
follows: ``For which benefits are available under Medicare Part B but
which are not payable under section 1834(m) of the Act; and''
In proposed regulation text Sec. 422.135(a)(2), we are
adding the word ``That'' and adding the phrase ``when the physician (as
defined in section 1861(r) of the Act) or practitioner (described in
section 1842(b)(18)(C)) of the Act) providing the service is not in the
same location as the enrollee.'' Thus, we are revising (a)(2) to read
as follows: ``That have been identified by the MA plan for the
applicable year as clinically appropriate to furnish through electronic
exchange when the physician (as defined in section 1861(r) of the Act)
or practitioner (described in section 1842(b)(18)(C)) of the Act)
providing the service is not in the same location as the enrollee.''
In proposed regulation text Sec. 422.135(c)(2), we are
removing the phrase ``at a minimum in the MA plan's Evidence of
Coverage required at Sec. 422.111(b)'' but finalizing the remaining
text in (c)(2). Thus, we are revising (c)(2) to read as follows:
``Advise each enrollee that the enrollee may receive the specified Part
B service(s) through an in-person visit or through electronic
exchange.''
We are not finalizing our proposed regulation text for the
provider directory requirement at proposed Sec. 422.135(c)(3). Thus,
we are removing proposed (c)(3) in its entirety, redesignating proposed
(c)(4) as (c)(3), and redesignating proposed (c)(5) as (c)(4).
In proposed regulation text Sec. 422.254(b)(3)(i), we are
adding the phrases ``directly incurred or paid by the MA plan'' and
``for the unadjusted MA statutory non-drug monthly bid amount.'' Thus,
we are revising (b)(3)(i) to read as follows: ``MA plans offering
additional telehealth benefits as defined in Sec. 422.135(a) must
exclude any capital and infrastructure costs and investments directly
incurred or paid by the MA plan relating to such benefits from their
bid submission for the unadjusted MA
[[Page 15696]]
statutory non-drug monthly bid amount.''
2. Dual Eligible Special Needs Plans
Special needs plans (SNPs) are MA plans created by the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L.
108-173) that are specifically designed to provide targeted care and
limit enrollment to special needs individuals. Under the law, SNPs are
able to restrict enrollment to: (1) Institutionalized individuals, who
are defined in Sec. 422.2 as those residing or expecting to reside for
90 days or longer in a long term care facility; (2) individuals
entitled to medical assistance under a state plan under Title XIX; or
(3) other individuals with certain severe or disabling chronic
conditions who would benefit from enrollment in a SNP. As of June 2018,
the CMS website listed 297 SNP contracts with 641 SNP plans that have
at least 11 members.\8\ These figures included 190 Dual Eligible SNP
contracts (D-SNPs) with 412 D-SNP plans with at least 11 members, 49
Institutional SNP contracts (I-SNPs) with 97 I-SNP plans with at least
11 members, and 58 Chronic or Disabling Condition SNP contracts (C-
SNPs) with 132 C-SNP plans with at least 11 members. This final rule
implements the provisions of the Bipartisan Budget Act of 2018 that
establish new requirements for D-SNPs for the integration of Medicare
and Medicaid benefits and unification of Medicare and Medicaid
grievance and appeals procedures that are effective in 2021. This final
rule also clarifies definitions and operating requirements for D-SNPs
that will be applicable to D-SNPs starting January 1, 2020, as
specified earlier in this final rule.
---------------------------------------------------------------------------
\8\ Centers for Medicare & Medicaid Services (2018, June). SNP
Comprehensive Report. Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html.
---------------------------------------------------------------------------
a. Integration Requirements for Dual Eligible Special Needs Plans
(Sec. Sec. 422.2, 422.60, 422.102, 422.107, 422.111, and 422.752)
Beneficiaries who are dually eligible for both Medicare and
Medicaid can face significant challenges in navigating the two
programs, which include separate or overlapping benefits and
administrative processes. Fragmentation between the two programs can
result in a lack of coordination for care delivery, potentially
resulting in: (1) Missed opportunities to provide appropriate, high-
quality care and improve health outcomes, and (2) ineffective care,
such as avoidable hospitalizations and a poor beneficiary experience of
care. Advancing policies and programs that integrate care for dual
eligible individuals is one way in which we seek to address such
fragmentation. Under plans that offer integrated care, dual eligible
individuals can receive the full array of Medicaid and Medicare
benefits through a single delivery system, thereby improving care
coordination, quality of care, beneficiary satisfaction, and reducing
administrative burden. Some studies have shown that highly integrated
managed care programs perform well on quality of care indicators and
enrollee satisfaction.\9\
---------------------------------------------------------------------------
\9\ See: Kim, H., Charlesworth, C.J., McConnell, K.J.,
Valentine, J.B., and Grabowski, D.C. (2017, November 15). Comparing
Care for Dual-Eligibles Across Coverage Models: Empirical Evidence
From Oregon. Retrieved from https://journals.sagepub.com/doi/abs/10.1177/1077558717740206; Anderson, W.L., Feng, Z., & Long, S.K.
(2016, March 31). Minnesota Managed Care Longitudinal Data Analysis,
prepared for the U.S. Department of Health and Human Services
Assistant Secretary for Planning and Evaluation (ASPE). Retrieved
from https://aspe.hhs.gov/report/minnesota-managed-care-longitudinal-data-analysis; Health Management Associates (2015, July
21). Value Assessment of the Senior Care Options (SCO) Program.
Retrieved from https://www.mahp.com/wp-content/uploads/2017/04/SCO-White-Paper-HMA-2015_07_20-Final.pdf; and Medicare Payment Advisory
Committee (2012, June 16). ``Care coordination programs for dual-
eligible beneficiaries.'' In June 2012 Report to Congress: Medicare
and Health Care Delivery System. Retrieved from https://www.medpac.gov/docs/default-source/reports/chapter-3-appendixes-care-coordination-programs-for-dual-eligible-beneficiaries-june-2012-report-.pdf?sfvrsn=0.
---------------------------------------------------------------------------
D-SNPs are a type of MA plan that is intended to integrate or
coordinate care for this population more effectively than standard MA
plans or original Medicare by focusing enrollment and care management
on dual eligible individuals. As of June 2018, approximately 2.3
million dual eligible individuals (1 out of every 6 dual eligible
individuals) were enrolled in 412 D-SNPs. About 170,000 dual eligible
individuals are enrolled in fully integrated dual eligible special
needs plans, or FIDE SNPs (that is, where the same organization
receives capitation to cover both Medicare and Medicaid services).\10\
A number of states, including Arizona, Idaho, Hawaii, Massachusetts,
Minnesota, New Jersey, New Mexico, New York, Pennsylvania, Tennessee,
Texas, Virginia, and Wisconsin, operate Medicaid managed care programs
for dual eligible individuals in which the state requires that the
Medicaid managed care organizations serving dual eligible individuals
offer a companion D-SNP product.
---------------------------------------------------------------------------
\10\ Centers for Medicare & Medicaid Services (2018, June). SNP
Comprehensive Report. Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html.
---------------------------------------------------------------------------
As summarized in our proposed rule, since the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003 (MMA) first authorized
D-SNPs' creation, subsequent legislation has been enacted that has
extended their authority to operate and set forth additional
programmatic requirements, including sections 164 and 165 of the
Medicare Improvements for Patients and Providers Act (MIPPA) (Pub. L.
110-275), which amended sections 1859(f) and 1852(a) of the Act, and
section 3205 of the Patient Protection and Affordable Care Act (Pub. L.
111-148), which revised section 1853(a)(1)(B) of the Act. Regulations
promulgated following the enactment of these laws implemented these
statutory provisions.
Using the contract that D-SNPs are required to have with states
under section 1859(f)(3)(D) of the Act, implemented in the regulation
at Sec. 422.107, state Medicaid agencies are able to establish
requirements that surpass the minimum standards set in federal
regulations for D-SNPs with regard to integration and coordination of
Medicare and Medicaid benefits. To that end, we have seen states
leverage their contracts with D-SNPs to limit D-SNP enrollment to
individuals who also receive Medicaid benefits through the same
organization, collect certain data from the D-SNP, and integrate
beneficiary communication materials and care management processes to
provide D-SNP enrollees a more seamless, coordinated experience of
care.\11\ CMS supports states that have an interest in pursuing
integrated care models for dual eligible individuals, including through
the use of their contracts with MA organizations offering D-SNPs, and
provides technical assistance to states seeking to develop solutions
tailored to their local market conditions, beneficiary characteristics,
and policy environment.
---------------------------------------------------------------------------
\11\ Verdier, J, Kruse, A., Sweetland Lester, R., Philip, A.M.,
& Chelminsky, D. (2016, November). ``State Contracting with Medicare
Advantage Dual Eligible Special Needs Plans: Issues and Options.''
Retrieved from https://www.integratedcareresourcecenter.com/PDFs/ICRC_DSNP_Issues__Options.pdf.
---------------------------------------------------------------------------
Through this final rule, we are adopting new requirements in
accordance with section 50311(b) of the Bipartisan Budget Act of 2018,
which amended section 1859 of the Act to require that all D-SNPs meet
certain new minimum criteria for Medicare and Medicaid integration for
2021 and subsequent years. Beyond the newly enacted amendments to the
Act, we are
[[Page 15697]]
also using this final rule to add requirements and clarifications to
existing regulations to codify guidance and policy since D-SNPs were
established nearly 15 years ago and to update certain aspects of the
regulations. Under the newly enacted section 1859(f)(8)(D)(i) of the
Act, the statute calls for D-SNPs, for 2021 and subsequent years, to
meet one or more of three specified requirements, to the extent
permitted under state law, for integration of benefits:
A D-SNP must, in addition to meeting the existing
requirement of contracting with the state Medicaid agency under section
1859(f)(3)(D) of the Act, coordinate long-term services and supports
(LTSS), behavioral health services, or both, by meeting an additional
minimum set of requirements for integration established by the
Secretary based on input from stakeholders. Such requirements for
integration could include: (1) Notifying the state in a timely manner
of hospitalizations, emergency room visits, and hospital or nursing
home discharges of enrollees; (2) assigning one primary care provider
for each enrollee; or (3) data sharing that benefits the coordination
of items and services under Medicare and Medicaid.
A D-SNP must either: (1) Meet the requirements of a fully
integrated dual eligible special needs plan described in section
1853(a)(1)(B)(iv)(II) of the Act (other than the requirement that the
plan have similar average levels of frailty as the PACE program); or
(2) enter into a capitated contract with the state Medicaid agency to
provide LTSS, behavioral health services, or both.
The parent organization of a D-SNP that is also the parent
organization of a Medicaid managed care organization providing LTSS or
behavioral services must assume ``clinical and financial
responsibility'' for benefits provided to beneficiaries enrolled in
both the D-SNP and Medicaid managed care organization.
Section 50311(b) of the Bipartisan Budget Act of 2018 also
authorizes the Secretary, in section 1859(f)(8)(D)(ii) of the Act, to
impose an enrollment sanction on an MA organization offering a D-SNP
that has failed to meet at least one of these integration standards in
plan years 2021 through 2025. In the event that the Secretary imposes
such a sanction, the MA organization must submit to the Secretary a
plan describing how it will come into compliance with the integration
standards.
We received a number of comments on our proposals to implement
these new integration requirements, both in general and with regard to
specific proposals. We summarize and respond to the comments below.
Comment: We received numerous comments in support of our
integration proposal, with many commenters citing the proposal's
fulfillment of statutory intent and expressing appreciation for the
flexibility afforded to states to define what integrated care looks
like in their state. For example, some of these commenters noted the
diversity of state policies, which impact what the D-SNP market looks
like in each state, and cautioned against any proposal that upon
implementation would disrupt existing integrated care models and
beneficiaries' coverage. A subset of commenters, while supportive of
our proposal, also encouraged CMS to raise the bar of integration even
further. One commenter encouraged CMS to help states move toward
integration and not penalize plans and states that are not yet able to
integrate further, advising that focus should also remain on minimizing
administrative burden and reducing complexity for beneficiaries. The
Medicare Payment Advisory Commission (MedPAC) stated its belief that
the proposed rule will do little to promote greater integration, citing
in particular the first of the proposed new standards for integration--
requiring D-SNPs to share information on inpatient and SNF admissions--
as having a very limited impact on improving care coordination, as
discussed in more detail in the comments we received on proposed Sec.
422.107(d). Another commenter objected to our integration proposal and
recommended that CMS leave all decision-making to the states, including
granting them the ability to opt out of any of the D-SNP integration
requirements.
Response: We appreciate the widespread support we received for our
proposal. We believe that the requirements we are finalizing in this
rule strike an appropriate balance between increasing integrated care
in D-SNPs for dual eligible individuals and preserving state
flexibility, within the framework established by the amendments to
section 1859(f)(8) of the Act made by section 50311(b) of the
Bipartisan Budget Act of 2018. While our aim is to support states that
are operating successful programs and assist those seeking to establish
more integrated programs, we also recognize that our proposal must
account for the current state of integrated care and the need to meet
states where they are by setting reasonable and achievable integration
benchmarks. As the D-SNP landscape evolves, we will continue to
consider ways to advance integrated care, including further rulemaking.
Finally, we note that the statute does not authorize CMS or states to
disregard a D-SNP's obligation to meet one or more of the integration
requirements, and imposes consequences for non-compliance, as discussed
in response to comments on proposed Sec. 422.752(d).
Comment: One commenter expressed concern about D-SNPs' ability to
meet the integration requirements by 2021 due to the potential for
delayed decision-making on the part of states. Another commenter
requested a one-year delay in the effective date in consideration of
the time required to negotiate and execute contracts between states and
D-SNPs and to develop new processes, which will vary depending on each
state's capabilities. Conversely, another commenter stated that 2021 is
an achievable date for meeting one of the three integration
requirements.
Response: The statute requires that D-SNPs comply with the
integration requirements by 2021. As discussed throughout this
preamble, the Medicare-Medicaid Coordination Office provides technical
assistance to states on integration issues, and we expect to continue
to engage states, plans, and other stakeholders as we implement the
requirements in this final rule.
Comment: One commenter observed that CMS does not make any
additional funding available for the coordination activities that D-
SNPs perform today and that adding to these requirements could create
burdens on plans and CMS or cause D-SNPs to exit the market. Another
commenter urged CMS to establish nationwide standards to ensure plans
can scale best practices and that beneficiaries receive the same high
quality service no matter where they live.
Response: While we believe that states are well positioned to drive
innovation in care delivery for dual eligible individuals, we also
recognize that the Bipartisan Budget Act of 2018 set forth a minimum
level of integration for all D-SNPs to meet. We believe that the
proposal we set forth is a reasonable one that preserves state
flexibility while fulfilling our statutory obligation. While we
recognize the desirability of having national standards, particularly
for MA organizations that operate D-SNPs in multiple markets across the
country, we have to balance this desire with the differences that exist
in states' capabilities, ranging from states where some or all dual
eligible individuals may be precluded from enrolling in any capitated
plan for their Medicaid services to states with highly integrated D-SNP
models. Notwithstanding our reluctance to mandate the use of
[[Page 15698]]
national standards, we are committed to cataloguing and disseminating
best practice information as part of the final rule's implementation
and our ongoing administrative alignment efforts, discussed later in
the preamble to this final rule.
Comment: Several commenters supported our D-SNP integration
proposals but considered them only a starting point for ensuring better
alignment and encouraged CMS to build upon these requirements in the
future. Several commenters also recommended that CMS provide strong
oversight to ensure that integration requirements are being met and
that dual eligible individuals enrolled in D-SNPs are actually
benefiting from increased integration. One commenter urged CMS to go
further in recognizing states' authority and options to implement even
more robustly integrated programs.
Response: We appreciate these commenters' perspectives on our
proposal. We acknowledge the importance of working in close partnership
with states to advance integration within each state-specific context.
CMS will monitor the implementation of these provisions to determine
market and beneficiary impacts and assess the need for additional
rulemaking to modify or expand upon the integration standards we are
finalizing in this rule.
Comment: One commenter recommended that CMS conduct a comprehensive
review of basic operational processes to determine where Medicare and
Medicaid could be further aligned to enhance care delivery and quality
and to reduce burdens on plans, providers, and beneficiaries and to
facilitate plans' moving along the integration continuum toward a FIDE
SNP or HIDE SNP status. This commenter further suggested that CMS
advance integration using all available statutory authorities,
including seeking clarification from Congress regarding its intent in
enacting provisions in the Bipartisan Budget Act of 2018 related to the
Medicare-Medicaid Coordination Office.
Several commenters recommended that CMS extend to D-SNPs processes
and flexibilities developed under the Financial Alignment Initiative
for MMPs and under the Minnesota Demonstration to Align Administrative
Functions for Improvements in Medicare-Medicaid Beneficiary Experience,
including use of the contract management team structure for joint
oversight of plans, integrated beneficiary communications materials,
joint CMS-state marketing reviews, coordinated enrollment processes and
timelines, integrated MOCs, dual eligible-specific network adequacy
requirements, and streamlined and plan-level reporting processes.
Several commenters suggested other areas in which CMS could create
additional administrative and policy incentives to reward states for
moving toward further Medicare-Medicaid alignment, including year-round
marketing to dual eligible individuals; expansion of current passive
enrollment and default enrollment authorities; establishment of a
Special Election Period for enrollment in integrated plans; plan
payment reforms, including changes to the frailty adjustment for FIDE
SNPs; an increase of the enhanced Medicaid match for care coordination
and IT activities; and alignment of state and federal contracting
cycles. A commenter recommended that CMS improve its messaging about D-
SNPs in its beneficiary-centered materials and tools.
Response: We thank commenters for their robust feedback about
additional alignment opportunities for D-SNPs. Since 2013, the
Financial Alignment Initiative and Minnesota demonstration have
provided us with opportunities to test a number of programmatic and
administrative flexibilities for MMPs and some D-SNPs, and many of
these flexibilities have been positively received by beneficiaries,
states, and health plans. We will continue to consider additional ways
to promote better outcomes and experiences for dual eligible
individuals.
As we have indicated in the CY 2016 Draft and Final Call Letters,
the CY 2019 Draft and Final Call Letters, and the CY 2020 Draft Call
Letter,\12\ CMS remains committed to providing administrative
flexibility that facilitates efforts by state Medicaid agencies and MA
organizations to use D-SNPs to integrate coverage of Medicare and
Medicaid benefits, including in the areas of integrated beneficiary
communications, D-SNP models of care, and enrollment processes. That
commitment is also evidenced by our recent CY 2019 final rule (CMS-
4182-F, Policy and Technical Changes to the Medicare Advantage,
Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription
Drug Benefit Programs, and the PACE Program) codifying our authority to
permit default enrollment of newly Medicare-eligible individuals into
integrated D-SNPs at Sec. 422.66(c)(2) and, at Sec.
422.60(g)(1)(iii), to allow passive enrollment to preserve continuity
of care and integrated care related to D-SNP non-renewals or state
Medicaid managed care organization procurements. We have also worked
with states and integrated D-SNPs to develop integrated beneficiary
communications materials, integrate model of care requirements and
reviews with states, and provide state Medicaid agencies with technical
assistance and information on plan performance and audit results of
their contracted D-SNPs so that the quality of Medicare services
delivered by those D-SNPs can inform state contracting strategies. We
look forward to continuing our work in this area with additional states
and plans.
---------------------------------------------------------------------------
\12\ https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2020Part2.pdf.
---------------------------------------------------------------------------
Comment: A number of commenters recommended CMS consideration of
additional regulatory and operational policies on a number of issues
related to dual eligible individuals that were not related to the D-SNP
integration requirements in the proposed rule. One commenter urged CMS
to make funds available for ombudsman programs to serve dual eligible
individuals in integrated D-SNPs. Several commenters recommended that
CMS continue to work with plans on identifying a long-term solution
impacting dual eligibility status and socioeconomic factors in Medicare
Advantage Star Ratings. One commenter reiterated the need for CMS to
develop a risk adjustment model that adequately accounts for the costs
of serving beneficiaries with functional limitations. Another commenter
urged CMS to consider how D-SNPs should be designed to minimize cost-
sharing obligations that are ultimately unpaid and to consider a more
holistic approach to coverage for dual eligible individuals that does
not simply transfer cost-sharing liability to providers. Another
commenter noted the critical importance of home and community-based
service (HCBS) eligibility barriers when determining how the D-SNP-to-
Medicaid transition should occur and recommended that the federal
government ease this transition through reform of the Medicaid HCBS
eligibility requirements. One commenter requested that CMS consider
recognizing Part B premium buy-downs in Puerto Rico D-SNPs as part of
plans' bids to provide Parts A and B benefits, rather than requiring
plans to use rebate dollars to buy down the Part B premium as a
supplemental benefit. Another commenter recommended cost-sharing
integration processes for dual eligible individuals at the pharmacy
counter or, in the shorter-term, implementation of real time
beneficiary eligibility solutions for use within the NCPDP
Telecommunication standard.
Response: These recommendations are not within the scope of our
final rule
[[Page 15699]]
provisions establishing integration criteria for D-SNPs effective in
2021, and some of them are beyond our programmatic authority. We do,
however, appreciate the many comments and suggestions related to
programmatic improvements for dual eligible individuals, including
those enrolled in D-SNPs.
Comment: A range of commenters, including the Medicaid and CHIP
Payment and Access Commission (MACPAC), expressed concern that the
market entry of non-D-SNP MA plans designed and marketed exclusively to
dual eligible individuals--so-called ``D-SNP look-alike plans''--
threatens to undermine efforts by CMS, states, and D-SNPs to increase
integration and coordination of Medicare and Medicaid services. Some of
these commenters recommended that CMS address this issue including by
requiring MA plans with a minimum percentage of dual eligible members
to meet all D-SNP requirements, including the obligation to contract
with the states in which the plans operate.
Response: Although the issue of D-SNP look-alike plans is beyond
the scope of this rule, we share the commenters' concern with the
impact of such plans on our efforts to increase Medicare-Medicaid
integration. We call attention to the CY 2020 Draft Call Letter \13\ in
which we sought comment on the impact of D-SNP look-alike plans in
order to inform future policy development.
---------------------------------------------------------------------------
\13\ https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2020Part2.pdf.
---------------------------------------------------------------------------
Comment: A commenter recommended that CMS continue and expand
efforts to help states adopt policies and incentives that assist D-SNPs
in moving toward higher levels of integration (including FIDE SNP or
HIDE SNP status with better aligned enrollments) for dual eligible
individuals.
Response: States and CMS both play important roles in implementing
more integrated care delivery systems for dual eligible individuals.
The Medicare-Medicaid Coordination Office facilitates this technical
assistance and dialogue with states, including through its Integrated
Care Resource Center (see https://www.integratedcareresourcecenter.com/
). We are committed to continuing our work with states based on their
specific policy priorities following the implementation of this final
rule.
Comment: One commenter reaffirmed their support for Medicare-
Medicaid Plans (MMPs) offered under the Financial Alignment Initiative
and urged CMS to make them permanent. The same commenter urged CMS to
develop a common statutory and regulatory framework for all forms of
integrated plans, including MMPs, PACE organizations, and FIDE SNPs,
that would include uniform rules on marketing, enrollment processes,
claims reporting, rate-setting, and risk adjustment.
Response: We appreciate the commenter's support for our work with
states and MMPs in the Financial Alignment Initiative. CMS will
continue to explore ways within our programmatic authority to improve
the current regulatory framework for integrated care as we gain
experience and gather data about the impacts of the FAI capitated model
and other demonstrations, our administrative alignment efforts,
streamlining of the PACE program, and the implementation of new D-SNP
integration requirements finalized in this rule.
Comment: We received comments from one organization expressing
concerns about CMS' sole reliance on the D-SNP delivery model and
urging us to consider other plan types (including Institutional SNPs
(I-SNPs) and fee-for-service Medicare) that can help achieve integrated
care goals. This commenter expressed concern that sole reliance on D-
SNPs would result in unnecessary disruptions to care.
Response: We support beneficiary choice in selecting the health
care delivery system that best meets each individual's needs. The final
rule focuses on the specific requirements added to section 1859(f) of
the Act for D-SNPs by section 50311 of the Bipartisan Budget Act.
Comments related to fee-for-service Medicare and I-SNPs are therefore
outside the scope of this final rule.
Comment: A few commenters requested that CMS consider providing
guidance on how the integration requirements will affect the operations
of MMPs.
Response: We clarify that there is no direct impact on MMPs as a
result of this final rule. The D-SNP requirements in this final rule
are not applicable to MMPs, and MMP policy and operations will continue
to be established in three-way contract agreements among CMS, health
plans, and states.
(1) Definitions of a ``Dual Eligible Special Needs Plan'', ``Fully
Integrated Dual Eligible Special Needs Plan'', ``Highly Integrated Dual
Eligible Special Needs Plan'', and ``Aligned Enrollment'' (Sec. 422.2)
D-SNPs are described in various sections of 42 CFR part 422,
including provisions governing the definition of specialized MA plans
for special needs individuals in Sec. 422.2, the supplemental benefit
authority for D-SNPs that meet a high standard of integration and
minimum performance and quality-based standards in Sec. 422.102(e),
state Medicaid agency contracting requirements in Sec. 422.107, and
specific benefit disclosure requirements in Sec. 422.111(b)(2)(iii).
In the proposed rule, we proposed to consolidate statutory and
regulatory references to D-SNPs; we also proposed to establish a
definition for such a plan in Sec. 422.2. In addition to proposing a
new definition for the term ``dual eligible special needs plan,'' we
also proposed a revised definition of the term ``fully integrated dual
eligible special needs plan,'' and new definitions of the terms
``highly integrated dual eligible special needs plan'' and ``aligned
enrollment,'' for purposes of part 422 (that is, the rules applicable
to the MA program) and the proposed rule.
In our proposed definition at Sec. 422.2, we described a dual
eligible special needs plan as a type of specialized MA plan for
individuals who are eligible for Medicaid under Title XIX of the Act
that provides, as applicable, and coordinates the delivery of Medicare
and Medicaid services, including LTSS and behavioral health services,
for individuals who are eligible for such services; has a contract with
the state Medicaid agency consistent with Sec. 422.107 that meets the
minimum requirements in paragraph (c) of such section; and satisfies at
least one of following integration requirements:
It meets the additional state Medicaid agency contracting
requirement we proposed at Sec. 422.107(d) (described in section
II.A.2.a.(2) of the proposed rule) that surpasses the minimum
requirements in current regulations at Sec. 422.107(c);
It is a highly integrated dual eligible special needs plan
(HIDE SNP), as described in further detail later in this section; or
It is FIDE SNP.
In addition, we proposed additional performance requirements for D-
SNPs that we did not incorporate into the definition; for example, a D-
SNP would provide assistance to individuals filing a grievance or
appeal for a Medicaid services in accordance with proposed
[[Page 15700]]
Sec. 422.562(a)(5) (described in section II.A.2.b.(1) of the proposed
rule). As discussed in the proposed rule, we believed this proposed
definition identified the minimum requirements for an MA plan to be a
D-SNP under section 1859 of the Act as amended by the Bipartisan Budget
Act of 2018. We also explained that the proposed definition would
clarify the applicability of the separate regulatory provisions that
establish the minimum standards for D-SNPs. We solicited comment on
whether our proposed definition met these goals or should be revised to
include other regulatory provisions that establish requirements for D-
SNPs.
We discussed in the proposed rule and reiterate here that it is
important to clarify through this final rule the meaning of the
requirement in section 1859(f)(3)(D) of the Act, which is currently
codified at Sec. 422.107(b), that the MA organization have
responsibility under the contract for providing benefits or arranging
for benefits to be provided for individuals entitled to Medicaid. Prior
to our proposed rule, we had not adopted a specific interpretation of
this statutory language, ``arranging for benefits,'' in previous
rulemaking or in subregulatory guidance. We proposed to interpret
``arranging for benefits'' as requiring a D-SNP, at a minimum, to
coordinate the delivery of Medicare and Medicaid benefits. We proposed
to relocate this requirement to our proposed D-SNP definition. As
stated in the proposed rule, while our interpretation is consistent
with the new statutory integration standards, the proposed
clarification was based on requirements for D-SNPs that existed prior
to the enactment of the Bipartisan Budget Act of 2018 that we believe
should be strengthened. We believe coordination would encompass a wide
range of activities that a D-SNP may engage in for their dual eligible
members and provided some examples of such coordination in the preamble
to the proposed rule. If a D-SNP identifies through an enrollee's
health risk assessment and/or individualized care plan, as required by
Sec. 422.101(f), functional limitations or mental health needs, the D-
SNP could: (1) Verify the enrollee's eligibility for LTSS and/or
behavioral health services under Medicaid; (2) determine how the
enrollee receives such services (through FFS Medicaid or through
another Medicaid managed care product); or (3) make arrangements with
the applicable Medicaid program (state Medicaid agency or managed care
plan) for the provision of such services by the appropriate payer or
provider. We solicited comment on whether our proposed definition
should be more prescriptive in identifying which plan activities
constitute coordination or whether it should remain broadly defined as
proposed.
We proposed revising the definition of fully integrated dual
eligible special needs plan (FIDE SNP) at Sec. 422.2 to align with the
proposed definition of a D-SNP and to codify current policy.
Specifically, we proposed the following:
Striking the reference to a ``CMS approved MA-PD'' plan in
the current FIDE SNP definition and paragraph (1), which refers to the
individuals eligible for enrollment in a FIDE SNP, because those
provisions duplicate elements of the new proposed definition of a D-SNP
at Sec. 422.2;
Replacing the reference to ``dual eligible beneficiaries''
with ``dual eligible individuals'' in newly redesignated paragraph (1)
to align with the terminology used in section 1935(c) of the Act;
Adding to newly redesignated paragraph (2) that a FIDE
SNP's capitated contract with a state Medicaid agency may include
specified behavioral health services, as well as replacing the term
``long-term care'' benefits with ``long-term services and supports'' to
better describe the range of such services FIDE SNPs cover in capitated
contracts with states. We also proposed codifying in paragraph (2) the
current policy that the FIDE SNP's capitated contract with the state
provide coverage of nursing facility services for at least 180 days
during the plan year; \14\
---------------------------------------------------------------------------
\14\ Following the April 2, 2012 issuance of the ``Announcement
of Calendar Year (CY) 2013 Medicare Advantage Capitation Rates and
Medicare Advantage and Part D Payment Policies and Final Call
Letter,'' Chapter 16b of the Medicare Managed Care Manual was
revised to include this policy.
---------------------------------------------------------------------------
Striking references to coordination of covered Medicare
and Medicaid ``health and long-term care'' and referring more broadly
to Medicare and Medicaid services in in newly redesignated paragraph
(3); and
Replacing the reference to ``member'' materials with
``beneficiary communication materials,'' consistent with the definition
of ``communication materials'' at Sec. 422.2260.
We proposed to codify a definition of highly integrated dual
eligible special needs plan (HIDE SNP) at Sec. 422.2. Under the
proposed definition, a HIDE SNP would be a type of D-SNP offered by an
MA organization that has--or whose parent organization or another
entity that is owned and controlled by its parent organization has--a
capitated contract with the Medicaid agency in the state in which the
D-SNP operates that includes coverage of LTSS, behavioral health
services, or both, consistent with state policy. We solicited comment
on this proposed definition, including on whether additional
requirements for HIDE SNPs should be addressed in the definition.
We also proposed to establish at Sec. 422.2 a definition for the
term aligned enrollment, as many of the other D-SNP proposals in the
proposed rule were based on this concept. Under our proposal, aligned
enrollment is when a full-benefit dual eligible individual is a member
of a D-SNP and receives coverage of Medicaid benefits from the D-SNP or
from a Medicaid managed care organization, as defined in section
1903(m) of the Act, that is: (1) The same organization as the MA
organization offering the D-SNP; (2) its parent organization; or (3)
another entity that is owned and controlled by the D-SNP's parent
organization. Aligned enrollment, as we proposed to define it, would
not arise where the MA organization or its parent organization solely
has a contract with the applicable state to offer a prepaid inpatient
health plan (PIHP) or prepaid ambulatory health plan (PAHP) in the
state's Medicaid program. Unlike a Medicaid MCO, these other Medicaid
managed care plans cover only a specific and non-comprehensive set of
services. In the event that it is the policy of the state Medicaid
agency to limit a D-SNP's membership to individuals with aligned
enrollment, we proposed describing this practice as ``exclusively
aligned enrollment,'' which was embedded in the proposed definition of
``aligned enrollment.'' As noted in the proposed rule, some states
limit D-SNP enrollment to full-benefit dual eligible individuals who
also choose to receive Medicaid benefits through the D-SNP or a
Medicaid MCO operated by the same entity (that is, by the MA
organization) or by the MA organization's parent organization. Such a
limitation would be included in the state Medicaid agency contract with
the D-SNP. Exclusively aligned enrollment is relevant to how we
proposed to apply the integrated grievance and appeals requirements
described in section II.A.2.b. of the proposed rule. We solicited
comment on our proposed definition of aligned enrollment given its
relevance to the category of D-SNPs to which the integrated grievance
and appeals procedures apply. We also solicited comment on whether we
should consider other types of Medicaid managed care arrangements
beyond companion Medicaid MCOs, as defined
[[Page 15701]]
in section 1903(m) of the Act and codified at Sec. 438.2, operated by
a HIDE SNP's parent organization.
Finally, we proposed in our definition of a D-SNP at Sec. 422.2 to
codify that an MA organization seeking to offer a D-SNP must satisfy
any one (or more) of the three integration requirements in section
1859(f)(3)(D)(i) of the Act. We noted that the statutory language
requires that plans meet one or more statutorily identified integration
requirements to the extent permitted under state law. We explained in
the proposed rule how we interpreted the integration standard in
section 1859(f)(8)(D)(i)(II) of the Act (that the D-SNP be a FIDE SNP
or have a capitated contract with the state Medicaid agency to provide
LTSS or behavioral health services, or both) to mean that the D-SNP is
a FIDE SNP or HIDE SNP; we also explained how we interpreted the
integration standard in section 1859(f)(8)(D)(i)(III) of the Act (that
clinical and financial responsibility for Medicare and Medicaid
benefits for enrollees of the D-SNP be borne by an entity that is both
the parent organization of the D-SNP and of the Medicaid managed care
organization providing LTSS or behavioral health services under a
contract under section 1903(m) of the Act) means that the D-SNP is a
HIDE SNP or FIDE SNP with exclusively aligned enrollment. We
interpreted the phrase ``to the extent permitted under state law'' as
acknowledging and respecting the flexibility provided to states under
the Medicaid program while imposing on D-SNPs integration requirements
that Congress has deemed necessary. Given this flexibility, we proposed
to interpret this statutory provision in a way that provides multiple
avenues for a MA plan to qualify as a D-SNP. However, we considered
other interpretations of this particular provision. For example, we
considered whether ``to the extent permitted under state law'' should
mean that in states that have Medicaid managed care programs for dual
eligible individuals, all MA organizations seeking to offer a D-SNP
could do so only if they were under contract with the state to offer a
companion Medicaid managed care plan in that state, on the grounds that
such an opportunity is permitted under state law. We solicited comments
on our proposed interpretation as well as alternatives. We also
requested comment on whether and how our proposed definition could or
should be revised consistent with our statutory interpretation.
As discussed in the proposed rule, our intent was for the proposed
definitions to describe different types of D-SNPs based on the degree
to which they integrate Medicaid benefits at the plan level. Under
section 1859(f)(8)(D)(i) of the Act, those D-SNPs that are neither FIDE
SNPs nor HIDE SNPs must meet an additional state Medicaid contracting
requirement beginning in 2021. Our proposed definition of a D-SNP
addressed this in paragraph (1), cross-referencing the new requirement
proposed to be codified in paragraph (d) of Sec. 422.107. This
proposed new requirement, which involves the provision of notice when
an individual who belongs to a group of high-risk dual eligible
individuals has a hospital and skilled nursing facility admission, is
discussed in section II.A.2.a.(2) of this final rule in greater detail.
We solicited comments on this proposal and, in particular, on
alternative approaches to classifying D-SNPs consistent with
requirements of section 1859(f)(8)(D)(i) of the Act.
We received the following comments on these proposed definitions
and respond to them below:
Comment: Many commenters expressed support for CMS' proposed
regulatory framework for defining D-SNPs, whereby a D-SNP could satisfy
any one or more of three integration requirements: (1) As a D-SNP
subject to the hospital and skilled nursing facility admission
notification requirement in proposed Sec. 422.107(d); (2) as a HIDE
SNP; or (3) as a FIDE SNP. In justifying their support, several of
these commenters cited one or more of the following:
The benefits that accrue to beneficiaries and taxpayers
when there is a market that permits an array of D-SNPs to compete with
each other, rather than one that limits the types of D-SNPs that can
compete in that market;
The need for state flexibility in promoting integration in
a manner that is incremental and minimizes market disruption;
The importance of preserving a pathway for D-SNPs that do
not hold a Medicaid managed care contract in the state or operate in
states where no such Medicaid managed care market exists; or
The opportunity for D-SNPs to make the transition on a
gradual basis to greater, and eventually full, integration. Another
commenter indicated that this proposal would create a spectrum of
integration and give states and plans clear starting points from which
to better define their goals and objectives.
Response: We appreciate the commenters' support of our proposal to
create multiple pathways for an MA plan to qualify as a D-SNP, which--
as discussed later in this preamble--we are finalizing in this final
rule.
Comment: Several commenters raised objections to the alternative we
discussed in the proposed rule to require, in states that have Medicaid
managed care programs for dual eligible individuals, all MA
organizations seeking to offer a D-SNP to be under contract as a
Medicaid managed care plan. One commenter did not believe that the
statute granted CMS authority to implement this restriction, while
others noted that it would constrain state decision-making on
integration, unnecessarily limit plan choice and reduce competition,
lead D-SNPs to cease operating, or create a disincentive for D-SNPs to
invest in care models and infrastructure. Another commenter advised
that CMS should recognize that integration is contingent on state
decision-making and incent the states to move state Medicaid policy
toward more integrated models. Conversely, other commenters supported
this alternative interpretation and encouraged CMS to reconsider its
rejection of it. According to one commenter, without a policy that
requires the parent organization of a D-SNP to contract with the state
Medicaid agency, a beneficiary in a non-aligned D-SNP has no option
other than enrolling in a Medicaid managed care plan operated by
another sponsor (or, if permitted, receiving fee-for-service Medicaid
services); where there is no alignment of Medicare and Medicaid
coverage, the opportunity for effective care coordination is reduced.
Commenters also noted the potential of such a policy to promote aligned
enrollment and coordinate the full spectrum of needs for this
population as well as the greater familiarity with Medicaid of
organizations that operate in both Medicare and Medicaid markets in
states, which is helpful in assisting beneficiaries.
Response: We appreciate the feedback on this alternative on which
we requested comment and acknowledge that without such a policy there
may be a missed opportunity to support the integration of Medicare and
Medicaid services in states that adopt managed care delivery systems
for their dual eligible population. We also recognize the concerns
raised by commenters relative to the potential for adverse impacts on
beneficiaries. We will take all of these comments into consideration
should we decide to address this issue in future rulemaking. However,
we are not moving forward with the alternative in this final rule.
Comment: We received significant comment on our proposed D-SNP,
HIDE
[[Page 15702]]
SNP, and FIDE SNP definitions. Several commenters expressed
appreciation for CMS' effort to create regulatory definitions for the
different types of D-SNPs that exist in the marketplace today. A
commenter supported our proposal under the HIDE SNP definition to
permit arrangements in which the MA organization offering the D-SNP or
its parent organization has a contract to offer a PIHP or PAHP in the
state's Medicaid program. Many commenters expressed appreciation for
the ability of D-SNPs to be defined as HIDE SNPs. One commenter noted
that the proposed modifications provide far greater clarity for states
and D-SNPs and offer the appropriate amount of detail to inform
agreements between MAOs and state Medicaid agencies. Another commenter
noted that the proposed D-SNP definition is a good first step but that
it alone is insufficient, as truly meaningful integration for dual
eligible individuals whose enrollment is not aligned requires a whole
host of additional requirements and activities in key areas, including,
but not limited to, integrated administrative, information technology,
communications, reporting, and financial systems; integrated assessment
and care coordination processes and data sharing; and integrated
transition activities.
Response: We appreciate the support of our proposal, which, as we
explained earlier in this preamble, reflects our desire to create a
framework in which we are able to distinguish among the types of D-SNPs
based on the way they integrate Medicaid services and, as applicable,
align enrollment across Medicare and Medicaid, while also accounting
for variation in how states cover these Medicaid services.
Comment: Several commenters supported our proposal to interpret the
meaning of the statutory language in section 1859(f)(3)(D) of the Act,
``arranging for benefits,'' as requiring a D-SNP to coordinate the
delivery of Medicare and Medicaid benefits and to relocate this
requirement within our proposed D-SNP definition. One commenter
commended CMS for the example of coordination included in the preamble
to the proposed rule that interpreted such activities to include
verifying dual eligible individuals' eligibility for LTSS or behavioral
health services, determining how the individual receives such services,
and making arrangements with the LTSS or behavioral health payer for
the provision of services. A few commenters supported CMS' example of
D-SNPs playing an active role in helping beneficiaries access Medicaid
services as necessary.
Response: We thank the commenters for their support of our proposed
interpretation and coordination examples.
Comment: One commenter opposed any requirement that D-SNPs
extensively coordinate Medicaid benefits, citing the lack of additional
compensation or clear expectations, and recommended that CMS instead
work with states to address barriers to accessing Medicaid benefits.
This commenter opposed any requirement that D-SNPs assist enrollees
with such activities as completing paperwork or securing financial,
medical, or other documentation needed to access Medicaid benefits or
any other benefits not covered by the plan (housing, food stamps,
utility assistance), instead recommending that plans undertake these
activities at their discretion.
Response: While we agree that reducing barriers to access in
Medicaid is important, we believe that for all enrollees who are
eligible for Medicaid services, the D-SNP must fulfill its statutory
responsibility to arrange for the provision of Medicaid benefits by
facilitating a beneficiary's meaningful access to such benefits. As we
discussed in the proposed rule, we believe it would be insufficient for
a D-SNP to limit its coordination activity simply to telling a
beneficiary to call or write their Medicaid managed care plan or state
agency without giving specific contact information, giving specific
coaching on the roles of the Medicaid program (that is, the state
agency or Medicaid managed care plan versus the D-SNP), and offering
additional support if needed. As discussed in section II.A.2.b.(1) of
this final rule, we believe that an important aspect of D-SNPs'
statutory responsibilities includes providing assistance to dual
eligible individuals with Medicaid-related coverage issues and
grievances. We also note that our proposed coordination requirement in
the definition of a D-SNP is specific to Medicaid benefits and did not
extend to some of the services and programs referenced by this
commenter.
Comment: One commenter expressed overall support for our inclusion
of a coordination requirement in the definition of a D-SNP, but noted
that states, unaffiliated Medicaid managed care organizations, and non-
contracted providers may present barriers to information-sharing that
is necessary to make such coordination work. A few commenters endorsed
the development of a system or process for collecting information about
D-SNP enrollee Medicaid coverage and enrollment (when enrollment is not
aligned) in order to meaningfully implement this provision. One of
these commenters recommended that CMS establish a process by which
states must provide individual-level data on the D-SNP's enrollees,
including the enrollee's Medicaid coverage and plan name (if
applicable) and specific contacts within each organization (names,
phone numbers, emails, leadership contact information), in order to
facilitate this coordination across Medicare and Medicaid.
Response: We appreciate the commenters' concern about access to
information about their enrollees' Medicaid coverage. Establishing a
standardized system or process such as the one suggested by these
commenters is an option for states and CMS to consider. However, as
discussed in section II.A.2.b.(1) of this final rule, there are other
ways in which plans can endeavor to obtain information or connect
enrollees with the appropriate resources to facilitate coordination of
their Medicare and Medicaid benefits.
Comment: Several commenters supported the proposed rule's approach
of broadly requiring D-SNPs to coordinate the delivery of Medicare and
Medicaid benefits without specifying particular types of coordination
activities in the regulatory definition of a D-SNP, citing the need for
flexibility to accommodate differences in plans and state policies. One
commenter appreciated the broad requirement as a way of ensuring that
D-SNPs have ownership in coordinating the points where the D-SNP's
services end and those provided under Medicaid begin and are not simply
acting as an additional layer in the process. However, more commenters
requested that CMS be more specific in identifying specific plan
activities that constitute coordination, including several commenters
who requested additional specificity within the regulation text. One
commenter suggested that, without additional specificity in the
definition about the types of activities that constitute coordination,
plans might misinterpret or misunderstand the requirements. Another
commenter anticipated that plans could face barriers in arranging
Medicaid benefits for enrollees, especially if such benefits are
managed by other health plans, and cited Tennessee's requirements that
D-SNPs use the TennCare Online System to coordinate benefits for
enrollees who are eligible for Medicaid.
A few commenters requested that CMS incorporate elements of person-
centered care as part of the D-SNP care coordination requirements. One
of these commenters stated that D-SNPs should
[[Page 15703]]
be held accountable for actively coordinating benefits and linking plan
members to services (including those services that are not provided by
the D-SNP). The other commenter encouraged CMS to emphasize that
coordination for D-SNPs with aligned members that require LTSS or
behavioral health services includes assessment and care planning
processes that are: (1) At a minimum, compliant with the person-
centered requirements of sections 1915(c), 1915(i), and 1915(k) of the
Act, which were added in two January 16, 2014 final rules (CMS-2249-F
and CMS-2296-F),\15\ and (2) incorporate the provision of needed LTSS
and/or behavioral health either directly or in close coordination with
the entity owned or controlled by the D-SNP's parent organization that
has contractual responsibility for LTSS and behavioral health benefits.
Another commenter stated that in order for coordination to be
effective, D-SNP personnel must have sufficient training related to the
suite of services available under Medicaid and through the D-SNP and a
thorough understanding of how to assist a beneficiary in navigating the
delivery system to access services. One commenter recommended that CMS
include in the D-SNP definition the following activities: Staffing
plans with care coordinators who meet specific criteria; providing
comprehensive information about Medicare, Medicaid, and plan benefits
through plan materials, customer service, and care coordinators;
ensuring that members have a primary care physician and that their
providers are actively communicating through models such as
interdisciplinary care teams; sharing information about claims, service
authorizations, and care plans with the state, providers,
beneficiaries, and beneficiaries' appointed representatives; and
providing assistance with filing grievances and appeals and
comprehensive explanations of the appeals process. Another commenter
suggested that further clarification would be helpful around the role
of the D-SNP related to transitions of care, the responsibilities of
the D-SNP regarding arrangements for follow up care, and coordination
with the discharging entity. Another commenter encouraged CMS to work
with plans and states to ensure that provisions related to improved
care transitions are effective and consequential for individuals with
dementia.
---------------------------------------------------------------------------
\15\ Medicaid Program; State Plan Home and Community-Based
Services, 5-Year Period for Waivers, Provider Payment Reassignment,
and Home and Community-Based Setting Requirements for Community
First Choice and Home and Community-Based Services (HCBS) Waivers
(79 FR 3029, January 16, 2014). Accessible at: https://www.govinfo.gov/content/pkg/FR-2014-01-16/pdf/2014-00487.pdf.
---------------------------------------------------------------------------
Response: We appreciate the comments about additional activities
CMS should consider to be essential for D-SNPs in coordinating their
members' Medicare and Medicaid benefits. We do not agree at this time
with the commenters who recommended including additional detail
regarding those coordination activities in our regulatory definition of
a D-SNP. Wide variation in the level of integration of Medicaid
benefits across D-SNPs, local market conditions, and state initiatives
to integrate care for dual eligible individuals leads us to believe
that it is not prudent to add specific coordination responsibilities
and requirements in this regulatory definition at this time. Further,
some of the specific recommendations raise issues related to compliance
with privacy rules protecting beneficiary information or other
regulations governing D-SNPs (such as mandatory disclosure
requirements), which are more appropriately addressed in other
regulations. Our goal in this final rule is to establish an explicit
requirement of coordination in regulation for the first time since D-
SNPs were established in 2006 and to implement a flexible approach to
coordination that allows plans to test approaches that best work for
them and in their specific state context. We are therefore finalizing a
coordination requirement in the definition of a D-SNP.
Comment: A number of commenters requested additional clarification
of the role of D-SNPs in coordinating Medicare and Medicaid benefits,
including in subregulatory guidance, guiding principles, and additional
examples, to inform states and their contracted D-SNPs as they
collaborate to identify specific plan activities that might differ by
program or type of service. One commenter specifically requested that
any list of coordination activities promulgated by CMS be considered a
set of minimum requirements. Another commenter suggested that CMS
provide a set of standardized approaches or acceptable frameworks that
would assist states and plans in developing aligned approaches to this
requirement, including best practices for data transfers and tips on
overcoming administrative hurdles. Another commenter urged CMS to
provide more clarity, citing concerns about burden on providers.
Response: We appreciate the commenters' request for clarification
and anticipate issuing subregulatory guidance to further clarify the
requirement that D-SNPs coordinate Medicare and Medicaid benefits for
the dual eligible individuals enrolled in their plans.
Comment: A commenter suggested that CMS provide ongoing support to
states in the implementation of our coordination requirements. Another
commenter suggested that CMS consider whether further guidance
regarding D-SNP coordination could serve as a means of persuading
states to standardize their approaches to the alignment of their
Medicaid programs with the MA program. This commenter suggested that
CMS could, for example, issue further guidance on how states can work
to establish viable health information exchanges as a means of
facilitating communication and data exchange between plans and state
Medicaid agencies, as such actions could qualify as ``coordinating the
delivery of'' these services.
Response: CMS supports states that have an interest in pursuing
integrated care models for dual eligible individuals, including through
the use of their contracts with MA organizations offering D-SNPs, and
provides technical assistance to states seeking to develop solutions
tailored to their local market conditions, beneficiary characteristics,
and policy environment. We are committed to continuing our work with
states based on their specific policy priorities following the
implementation of this final rule.
Comment: A few commenters stated that D-SNPs should be held
accountable for actively coordinating benefits and linking plan members
with services, both when those services are provided by the D-SNP or
its affiliate and when they are provided by an unaffiliated third
party. One of these commenters suggested that CMS look into the extent
to which D-SNPs without Medicaid contracts may primarily serve partial-
benefit dual eligible individuals \16\ for whom there is no need or
opportunity to coordinate Medicaid benefits.
---------------------------------------------------------------------------
\16\ Partial-benefit dual eligible programs are commonly
referred to collectively as the ``Medicare Savings Program'' (MSP).
The MSP includes 4 eligibility groups: Qualified Medicare
Beneficiary Program without other Medicaid (QMB Only) for whom
Medicaid pays their Medicare Part A premiums, if any, Medicare Part
B premiums, and to the extent consistent with the Medicaid State
plan, Medicare Part A and B deductibles, coinsurance and copays for
Medicare services provided by Medicare providers; Specified Low-
Income Medicare Beneficiary Program without other Medicaid (SLMB
Only) and Qualifying Individual (QI) Program for whom Medicaid pays
the Part B premiums; Qualified Disabled and Working Individual
(QDWI) Program for whom Medicaid pays the Part A premiums.
---------------------------------------------------------------------------
[[Page 15704]]
Response: As we stated in the preamble to the proposed rule, we
recognize that not all D-SNP membership will be eligible for the full
complement of Medicaid services, particularly those who are partial-
benefit dual eligible individuals whose Medicaid eligibility is limited
to payment of their Medicare premiums, and, if applicable, deductibles
and cost-sharing. Coordination approaches for partial-benefit dual
eligible individuals will, of necessity, be different than those for
members will full Medicaid benefits. However, for all enrollees who are
eligible for Medicaid services, the D-SNP must fulfill its statutory
responsibility to arrange for the provision of Medicaid benefits by
facilitating a beneficiary's meaningful access to such benefits,
regardless of their source or scope of Medicaid coverage. We discuss
the issue of D-SNPs assisting their members with Medicaid benefit
issues in more detail in section II.a.2.b.(1) of this final rule.
Comment: Several commenters emphasized the need for CMS to monitor
D-SNPs' efforts at coordination and gauge their effectiveness.
Response: We agree that CMS oversight and monitoring of D-SNPs'
coordination responsibilities are important. As we implement the
provisions of this final rule, we will identify ways in which we can
leverage current tools, including audits, model of care requirements,
and reporting requirements, to ensure that D-SNPs assist dual eligible
individuals in connecting with the Medicaid benefits to which they are
entitled.
Comment: A few commenters expressed concern about the construction
of the proposed D-SNP definition insofar that it could be misread or
misinterpreted to require all D-SNPs to provide LTSS and behavioral
health services.
Response: We did not intend our proposed definition to impose a new
obligation on D-SNPs to provide coverage of Medicaid services.
Therefore, we are finalizing the proposed definition of a D-SNP with
modifications to the text to clarify this point and otherwise make
grammatical and organizational changes to improve the regulation text.
Specifically, a D-SNP is a plan offered by an MA organization for dual
eligible individuals that, as provided in new paragraph (1),
coordinates the delivery of Medicare and Medicaid services for
individuals eligible for such Medicaid services; as provided in new
paragraph (2), may provide coverage of Medicaid services, including
LTSS and behavioral health services (for individuals eligible for such
services); as provided in new paragraph (3), has a contract with the
state Medicaid agency consistent with the requirements of Sec. 422.107
that meets the minimum requirements detailed in Sec. 422.107(c); and
(4) beginning January 1, 2021, satisfies one of the three criteria for
integration of Medicare and Medicaid benefits detailed in the proposed
rule (and now designated as paragraphs (4)(i) through (iii)). We intend
through these revisions to clarify that, regardless of whether a D-SNP
provides coverage of Medicaid services under a capitated or other
arrangement with the state Medicaid agency, it at minimum must
coordinate the enrollee's Medicare and Medicaid services.
As discussed in section II.A.2.a.(2) of this final rule, to better
align with our proposed definition of a D-SNP, we proposed a change to
Sec. 422.107(c)(1) to specify that the contract between a state
Medicaid agency and a D-SNP must document the MA organization's
responsibility to provide, as applicable, and coordinate the delivery
of Medicaid benefits, including LTSS and behavioral health services,
for individuals who are eligible for such services. In response to the
concerns raised by these commenters, we are finalizing Sec.
422.107(c)(1) with minor changes that express our intent more clearly
and parallel the revisions we are finalizing in the D-SNP definition
described earlier. Specifically, we are restructuring paragraph (c)(1)
to avoid any misinterpretation that D-SNPs must cover LTSS and
behavioral health services. We clarify in paragraph (c)(1)(i) that the
D-SNP must document its responsibility to coordinate the delivery of
Medicaid services for individuals who are eligible for such services,
and in paragraph (c)(1)(ii) that, to the extent a D-SNP provides
coverage of Medicaid benefits--including LTSS and behavioral health
services (for individuals eligible for such services)--it must also
document in the state Medicaid agency contract its responsibility to do
so. We believe this revision clarifies that, in some cases, the D-SNP
may cover (that is, provide directly or pay health care providers for
providing) Medicaid benefits under a capitated contract with the state
Medicaid agency; however in all cases it must coordinate the delivery
of Medicaid benefits.
Comment: A few commenters were concerned about the introduction of
a new term, HIDE SNP, which did not exist in regulations previously.
Two of these commenters noted that it is already difficult for
consumers and advocates to determine which plans are D-SNPs and what
type of D-SNP they are. They noted that clear, consistent regulatory
definitions can make important differences between the plan types and
beneficiary options more understandable.
Response: While we sympathize with commenters' reluctance to create
another regulatory definition, we believe that the definition of HIDE
SNP is meaningful, as it correlates directly with our interpretation of
the D-SNP integration standard that appears in section
1859(f)(8)(D)(i)(II) of the Act (D-SNPs that enter into a capitated
contract with the state Medicaid agency to provide LTSS or behavioral
health services, or both). We agree with the commenters that making
these terms understandable to stakeholders, especially beneficiaries,
is an important aim.
Comment: A commenter recommended that the proposed definition of
HIDE SNP be redrafted to allow for risk-sharing arrangements other than
capitation. This commenter noted that the state or D-SNP may wish to
contract initially on a shared savings/shared risk or performance-based
model as opposed to a full capitation model. Another commenter
recommended that CMS consider creating another regulatory standard of
integration other than a HIDE SNP that would describe D-SNPs that are
at risk for a set of Medicaid services other than LTSS or behavioral
health services, which can serve as stepping stones to further
alignment.
Response: We appreciate that there are varying levels of
integration, including, for example, arrangements in which a state
Medicaid agency may capitate payment for Medicaid cost-sharing or a
subset of services. However, the statute is clear that D-SNPs seeking
to meet the integration standard at section 1859(f)(8)(D)(i)(II) of the
Act must either be a FIDE SNP or enter into a capitated contract with
the state Medicaid agency for the provision of LTSS, behavioral health
services, or both. We proposed the definition of HIDE SNP to align with
this statutory standard of integration, and therefore we are not making
revisions to the HIDE SNP definition based on these specific
recommendations. As discussed in the proposed rule (83 FR 54994), a D-
SNP could satisfy the requirements of a HIDE SNP if its parent
organization offered a companion Medicaid product that covered only
LTSS, behavioral health services, or both, under a capitated contract.
We believe that this definition is appropriate for purposes of
addressing and aligning with the statutory integration standards and
for
[[Page 15705]]
establishing which D-SNPs are eligible, pursuant to Sec. Sec.
422.60(g)(2)(i) and 422.102(e), to receive passive enrollments or offer
supplemental benefits, respectively.
We may consider for future rulemaking the merits of having a more
detailed classification system that identifies variations of D-SNPs
other than FIDE SNPs and HIDE SNPs relative to the extent to which they
coordinate Medicare and Medicaid benefits. We note that technical
assistance resources are available through the Integrated Care Resource
Center that provide information about the varied approaches states have
taken to coordinate with D-SNPs operating in their states.
Comment: A commenter suggested that CMS consider a HIDE SNP as a
temporary model that could be utilized as part of a state's longer term
strategy toward integration of Medicaid benefits in which all HIDE SNPs
transition to a FIDE SNP model once full integration is achieved.
Response: We are supportive of states and plans that wish to pursue
a FIDE SNP model; however, as stated earlier in this preamble, section
1859(f)(8)(D)(i) of the Act recognizes a level of integration that does
not meet the requirements of a FIDE SNP with respect to the breadth of
services provided under a Medicaid capitated contract with the state
(that is, D-SNPs that cover LTSS, behavioral health services, or both,
under a capitated contract) as meeting one of the three required
integration standards. We therefore believe it is useful to codify a
term that encompasses this statutory standard.
Comment: A commenter requested that CMS clarify that enrollment in
a HIDE SNP be open to all dual eligible individuals, including those
not yet eligible for LTSS and/or behavioral health services, on the
grounds that their needs may change over the course a year such that
they attain eligibility for these services. According to the commenter,
a plan can play a role in helping the individual navigate their
options.
Response: The proposed HIDE SNP definition stated that the MA
organization offering the D-SNP, or the MA organization's parent
organization or another entity that is owned or controlled by its
parent organization, must have a capitated contract with the Medicaid
agency that includes coverage of LTSS, behavioral health services, or
both, consistent with state policy. The HIDE SNP definition, as
proposed and finalized in this rule, does not itself require that the
plan limit its MA enrollment to dual eligible individuals who qualify
for LTSS, behavioral health services, or both. However, it is important
to note that these plans are financially responsible under a capitated
contract for covering these services for individuals who are eligible
for them, and a state Medicaid agency may elect to impose enrollment
restrictions on the D-SNP consistent with its contracting authority in
Sec. 422.107.
Comment: A commenter observed that the proposed definition of HIDE
SNP appears to exclude a plan offered by an organization that
subcontracts on a capitated basis with an organization or county agency
to which the state Medicaid agency has ``delegated Medicaid financial
and administrative responsibility.'' According to the commenter, this
type of arrangement is common in California where counties use
different Medicaid managed care models and recommended that CMS amend
the HIDE SNP definition to encompass such an arrangement. The commenter
further noted that while the organization that does not have a direct,
capitated contract with the state, even though it is providing LTSS,
behavioral health services, or both, under the Medicaid program, it can
provide highly integrated benefits and should be considered a HIDE SNP.
Relatedly, this commenter recommended that the definition of aligned
enrollment be expanded to accommodate this arrangement, noting that
aligned enrollment could occur for D-SNP enrollees who receive their
Medicaid benefits from the D-SNP's parent organization via this
subcontract.
Response: We believe that the commenter is referring to situations
where the county or another entity has a contract with the state
Medicaid agency to furnish Medicaid benefits to eligible individuals on
a risk basis; we disagree that such a contract amounts to a delegation
of financial or administrative responsibility for the Medicaid program.
A county or entity with a managed care contract with the state Medicaid
agency may subsequently subcontract certain aspects of the managed care
contract to another entity under Sec. 438.230. In such situations
where that subcontractor also is a D-SNP, we recognize that there may
be a level of integration for enrollees that is greater than that of a
D-SNP that has no contract--directly or indirectly--with a state to
provide LTSS, behavioral health services, or both. However, we do not
believe that the subcontractor in that situation should be treated as a
HIDE SNP. Our proposed definition of a HIDE SNP at Sec. 422.2 requires
a contract between the state and the D-SNP, its parent organization, or
another subsidiary of its parent organization and is more consistent
with the statutory language at section 1859(f)(8)(D)(i)(II) of the Act,
which requires that a D-SNP enter into a capitated contract with a
state to provide LTSS, behavioral health services, or both. The
relationship between a D-SNP and its parent organization (or another
plan owned and operated by the same parent organization) is one where
we believe it is appropriate to attribute those other contract
arrangements to the D-SNP itself for purposes of evaluating integration
in the management, provision, and coordination of benefits for
enrollees. That statutory provision is the basis for our codification
of this definition. We therefore decline the commenter's
recommendations that the definitions of a HIDE SNP and aligned
enrollment be modified to accommodate this particular contracting
arrangement.
Comment: A commenter requested more information about the
eligibility for each type of D-SNP for passive enrollment, seamless
conversion, and the frailty adjuster. Several commenters inquired about
how CMS would designate each type of D-SNP.
Response: We intend to release guidance prior to the effective date
of these provisions that explains how D-SNPs will be designated as FIDE
SNPs and HIDE SNPs consistent with the terms of this final rule. As
noted later in this final rule, we are amending Sec. 422.60(g)(2)(i)
to clarify that HIDE SNPs are eligible to receive passive enrollments;
this is not a change in policy, per se, but a technical update to use
the newly defined term where we previously used different language.
Chapter 2 of the Medicare Managed Care Manual provides additional
information for MA organizations about passive and default
enrollment.\17\ Eligibility for the frailty adjustment is governed by
section 1853(a)(1)(B)(iv) of the Act and Sec. 422.308(c)(4), which
limit the payment adjustment to FIDE SNPs that have a similar average
level of frailty, as determined by the Secretary, as the PACE program;
the eligibility of plans for the frailty adjustment is not impacted by
this rulemaking.
---------------------------------------------------------------------------
\17\ Chapter 2 of the Medicare Managed Care Manual can be
accessed here: https://www.cms.gov/Medicare/Eligibility-and-Enrollment/MedicareMangCareEligEnrol/.
---------------------------------------------------------------------------
Comment: Commenters were generally supportive of our proposal to
account for differences in how states cover Medicaid services,
including states' decisions to carve out particular Medicaid services
and deliver them through a separate arrangement. However, a number of
these
[[Page 15706]]
commenters also urged us to clarify our use of the phrase ``consistent
with State policy,'' which appears in the proposed definitions of HIDE
SNP and FIDE SNP. In particular, they wanted to understand how this
phrase impacts D-SNPs that are seeking to be defined as a HIDE SNP or
FIDE SNP and how HIDE SNPs were different from FIDE SNPs in relation to
carve-outs. A commenter questioned whether a state's carve-out of LTSS
services from its Medicaid managed care program would that mean that no
D-SNP in that state can qualify as a FIDE SNP, since FIDE SNPs must
cover some element of LTSS. A commenter requested clarification about
the obligation of FIDE SNPs to provide comprehensive Medicaid services
and whether that same obligation applied to HIDE SNPs, while other
commenters requested clarification about whether a D-SNP would still be
considered a HIDE SNP if the state were to carve out behavioral health
services or offered a limited scope of behavioral health services for
dual eligible individuals, assuming all other HIDE SNP requirements
were met. Yet another commenter cited its experience using Medicaid
benefit carve-outs and the potential for the misalignment of
incentives, which may result in inappropriate utilization or gaps in
care.
Response: We proposed to interpret the phrase ``consistent with
State policy'' as allowing CMS to permit certain carve-outs where
consistent with or necessary to accommodate state policy, except for
where specifically prohibited (such as the minimum of 180 days of
coverage of nursing facility services during the plan year in the FIDE
SNP definition). For A FIDE SNP, a carve-out by the state of a minimal
scope of services is permissible so long as the applicable services, as
described in the FIDE SNP definition, are covered under a Medicaid
managed care organization contract under section 1903(m)(2) of the Act.
This means that if a state opted to carve out LTSS entirely from
capitation, in that state no D-SNP could qualify as a FIDE SNP.
Similarly for a HIDE SNP, a carve-out by the state of a minimal scope
of services is permissible so long as the applicable services, as
described in the HIDE SNP definition, are covered under a capitated
Medicaid contract with the D-SNP or the affiliated Medicaid managed
care plan. For example, if a state were to carve out certain targeted
case management services for full-benefit dual eligible individuals
receiving behavioral health services, a D-SNP could still satisfy the
FIDE SNP or HIDE SNP definition, provided that: (1) LTSS were covered
under the capitated contract; or (2) behavioral health services, other
than the carved-out case management, were covered under the capitated
contract.
Our intent is to apply the phrase ``consistent with State policy,''
to HIDE SNPs as we have done historically for D-SNPs seeking FIDE SNP
status. In the case of FIDE SNPs, our policy for determining whether a
D-SNP meets the FIDE SNP definition at 42 CFR 422.2 was first addressed
in the April 2, 2012, ``Announcement of Calendar Year (CY) 2013
Medicare Advantage Capitation Rates and Medicare Advantage and Part D
Payment Policies and Final Call Letter'' and later memorialized in
section 20.2.5 of Chapter 16b of the Medicare Managed Care Manual.\18\
Under this policy, CMS permits long-term care benefit carve-outs or
exclusions only if the plan can demonstrate that it--
---------------------------------------------------------------------------
\18\ See https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Advance2020Part2.pdf and
https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c16b.pdf.
---------------------------------------------------------------------------
Is At risk for substantially all of the services under the
capitated rate;
Is at risk for nursing facility services for at least six
months (180 days) of the plan year;
Does not disenroll an individual from the plan as a result
of exhausting the service covered under the capitated rate; and
Remains responsible for managing all benefits including
any carved-out service benefits, notwithstanding the method of payment
(for example, fee-for-service, separate capitated rate) received by the
plan (we note that we interpret ``managing all benefits'' to be
equivalent to coordinating the delivery of Medicare and Medicaid
services, consistent with changes made elsewhere in this final rule,
including in the definition of a D-SNP).
Also under this policy, FIDE SNPs are not required to cover
behavioral health services in cases where the state decides to carve
out or exclude behavioral health services from the capitated rate. We
believe that the phrase ``consistent with State policy'' in the FIDE
SNP and HIDE SNP definitions serves as an important acknowledgement of
variation in how states elect to cover Medicaid services under their
capitated contracts with D-SNPs and Medicaid managed care plans. As
such, among the states that have capitated contracts with D-SNPs or the
D-SNPs' parent organizations, CMS has the ability to determine that D-
SNPs operating in such states meet the FIDE SNP or HIDE SNP definition
notwithstanding this variation. However, in consideration of the
request for clarification, we are making a minor modification to the
HIDE SNP and FIDE SNP definitions in Sec. 422.2 to change the
placement of the phrase ``consistent with State policy,'' so that it
appears prior to the categories of services to which it applies, as
opposed to placement after them.
Comment: A commenter recommended that CMS clarify that HIDE SNPs
are not required to cover under a capitated contract both LTSS and
behavioral health services. Another commenter recommended that CMS
remove the requirement that the contract with the state Medicaid agency
include coverage of LTSS, behavioral health services, or both, and
consider instead the existence of a contract with the Medicaid agency
to cover an overlapping or potentially overlapping Medicaid population
as the D-SNP, on the basis that such a plan already understands the
Medicaid market in which it operates and is well situated to serve as a
platform as states move to advance integrated care models for dual
eligible individuals.
Response: HIDE SNPs are not required to cover both LTSS and
behavioral health services but must cover at least one of those
categories of services. We are finalizing the HIDE SNP definition at
Sec. 422.2 to require that a HIDE SNP cover LTSS, behavioral health
services, or both, consistent with state policy. While we recognize
that there is a variety of ways in which D-SNPs coordinate with
Medicaid agencies, including coverage of Medicare cost-sharing and
Medicaid services other than LTSS or behavioral health, we disagree
with the comment that HIDE SNP status should be met without coverage of
either LTSS or behavioral health services. Our intent in establishing a
definition for HIDE SNPs is to describe one of the two types of D-SNPs
that satisfies the integration requirement at section
1859(f)(8)(D)(i)(II) of the Act. Under this provision, the integration
requirement is satisfied if the D-SNP meets the requirements of a FIDE
SNP (other than the requirement that it has a similar level of frailty
as the PACE program) or enters into a capitated contract with the state
Medicaid agency to provide LTSS or behavioral health services, or both.
We note that we are electing to make a non-material change to how we
refer to the coverage of LTSS, behavioral health services, or both, in
our HIDE SNP definition. We are finalizing the regulation with the
phrase ``provides coverage'' instead of ``includes coverage.''
[[Page 15707]]
Comment: A commenter urged CMS to work with states that have carve-
outs to ensure that states are committed to coordinating carved-out
services with D-SNPs. This commenter believed that state carve-outs,
although conceptually a barrier to integration, are in some cases well-
established and provide quality services. Though longer term
integration is a goal, a hurried dismantling of those systems would be
unwise and could cause beneficiary harm.
Response: We agree that it is an essential element of any D-SNP to
coordinate the delivery of all Medicaid services, irrespective of how
they are covered by the state Medicaid agency. Therefore, as discussed
elsewhere in this final rule, we have made such coordination a
requirement in Sec. 422.2 for any plan that operates as a D-SNP.
Comment: A few commenters requested that CMS clarify the
differences between HIDE SNPs and FIDE SNPs, and raised questions about
any notable differences in types of contracting arrangements that are
permitted (or not) and categories of services that the plan must cover,
including the requirement that FIDE SNPs cover behavioral health
services.
Response: Conceptually, we proposed to distinguish D-SNPs based on
the degree to which they integrate Medicaid benefits at the plan level.
FIDE SNPs that limit enrollment to full-benefit dual eligible
individuals and require (or have) exclusively aligned enrollment across
Medicare and Medicaid constitute the most extensive level of
integration, with the greatest potential for holistic and person-
centered care coordination, integrated appeals and grievances,
comprehensive beneficiary communication materials, and quality
improvement. HIDE SNPs with exclusively aligned enrollment are plans
that share much of this potential but may integrate a narrower set of
Medicaid benefits than FIDE SNPs. FIDE SNPs and HIDE SNPs where aligned
enrollment is possible--but not required--under the state contract with
the D-SNP and the state's administration of its Medicaid managed care
program would constitute another form of integration, albeit to a
lesser degree. The table below highlights some of the key differences
between HIDE SNPs and FIDE SNPs. First, from a contracting perspective,
a FIDE SNP's Medicare and Medicaid benefits are covered under a single
legal entity that contracts (1) with CMS to operate as an MA plan; and
(2) with the state to operate as a Medicaid MCO. This latter
requirement means that the FIDE SNP has a contract under section
1903(m) of the Act to provide a comprehensive set of services. In the
case of a HIDE SNP, however, there is no stipulation that a single
legal entity must hold the Medicare and Medicaid contracts, only that
the parties to the capitated contract are the state Medicaid agency (or
state Medicaid agency's contractor) and one of the following: (1) The
MA organization itself; (2) the MA organization's parent organization;
or (3) another entity that is owned and controlled by the MA
organization's parent organization. Additionally, with respect to a
HIDE SNP, the entity or entities holding the MA contract and the
Medicaid contract may provide coverage of Medicaid services as a PIHP,
PAHP, or Medicaid MCO. Second, as noted in an earlier response to a
comment, the breadth of coverage provided by FIDE SNPs and HIDE SNPs is
different. For example, FIDE SNPs must provide at least 180 days of
nursing facility coverage; as reflected in the definitions of the terms
in Sec. 438.2, PIHPs and PAHPs cover less comprehensive sets of
services than MCOs and are distinguished from each other based on
whether inpatient or ambulatory services are covered.
Table 1--Attributes of FIDE SNPs and HIDE SNPs
----------------------------------------------------------------------------------------------------------------
FIDE SNP HIDE SNP
----------------------------------------------------------------------------------------------------------------
Must have a contract with the state Yes............................. No.
Medicaid agency that meets the
requirements of a managed care
organization as defined in section
1903(m) of the Social Security Act.
May provide coverage of Medicaid No.............................. Yes.
services via a PIHP or a PAHP.
Must provide coverage of applicable Yes............................. No. The state Medicaid contract may
Medicaid benefits through the same be with: (1) The MA organization
entity that contracts with CMS to offering the D-SNP; (2) the MA
operate as an MA plan. organization's parent organization;
or (3) another entity owned and
controlled by the MA organization's
parent organization.
Must have a capitated contract with the Yes............................. No, if it otherwise covers
state Medicaid agency to provide behavioral health services.
coverage of long-term services and
supports (LTSS), consistent with state
policy.
Must have a capitated contract with the No. Complete carve-out of No, if it otherwise covers LTSS.
state Medicaid agency to provide behavioral health coverage by
coverage of behavioral health services, the state Medicaid agency is
consistent with state policy. permitted.
Must have a capitated contract with the Yes............................. No.
state Medicaid agency to provide
coverage of a minimum of 180 days of
nursing facility services during the
plan year.
----------------------------------------------------------------------------------------------------------------
In consideration of these comments, we are electing to make one
additional change to our FIDE SNP definition to mirror language that
appears in the HIDE SNP definition. Specifically, in paragraph (2) of
the FIDE SNP definition, we are finalizing the regulation with the
phrase ``provides coverage'' instead of ``includes coverage,'' which
will make references to the provision of coverage consistent between
the HIDE SNP and FIDE SNP definition.
Comment: A commenter recommended that CMS replace in its definition
of FIDE SNP ``aligned'' care management processes with ``fully
integrated'' care management processes, with the expectation that
either a single person is responsible for coordination of the full
continuum of Medicare and Medicaid benefits, or the health plan uses an
integrated team approach, with clear lines of communication and
[[Page 15708]]
accountability, and with integrated care management data systems that
facilitate timely access to information needed to facilitate integrated
care management processes.
Response: While we support the approaches to care identified by
this commenter, we do not believe that such a change to the FIDE SNP
definition is necessary. Our use of the phrase ``aligned care
management processes'' in paragraph (3) of the FIDE SNP definition at
Sec. 422.2 is intended to encompass the variety of ways in which FIDE
SNPs seek to coordinate care for full-benefit dual eligible
individuals.
Comment: We received several comments concerning the requirement
that FIDE SNPs cover nursing facility services for at least 180 days
during the plan year and whether this signified a change in existing
FIDE SNP coverage policy or an expansion of the Medicare skilled
nursing facility benefit.
Response: As noted in a prior response to a comment, it has been
longstanding CMS policy for a FIDE SNP to be at risk for providing
coverage of at least 180 days of nursing facility services, and this
rulemaking codifies rather than revises or reinterprets this policy. If
a state were to carve out institutionally-based LTSS from its capitated
contract, it would not be possible for an MA plan to operate as a FIDE
SNP in that state, although it may be possible to qualify as a HIDE
SNP, assuming all applicable requirements were met. Similarly, if a
state were to carve out community-based LTSS from its contract because
the state opted to provide coverage of these services under a separate
arrangement, it would not be possible for such a plan to qualify as a
FIDE SNP because section 1853(a)(1)(B)(iv) of the Act establishes that
FIDE SNPs must cover long-term care under a capitated contract with the
state for Medicaid benefits. Community-based LTSS are long-term care
services and essential to the coverage model offered by a FIDE SNP.
Comment: A few commenters supported our proposed definition of
aligned enrollment and its applicability to particular types of plans.
MedPAC and another commenter agreed with our proposal to limit the
definition of aligned enrollment to Medicaid coverage provided by a
comprehensive Medicaid MCO instead of including plans that provide more
limited Medicaid services as PIHPs or PAHPs. A few commenters agreed
with our proposal to account for not only D-SNPs whose Medicaid
benefits are covered by the plan directly but also by a Medicaid MCO
operated by the same organization, its parent organization, or another
entity that is owned and controlled by its parent organization. One
commenter recommended that we explicitly incorporate in the definition
the concept from the statute that such plans have clinical and
financial responsibility for any individual enrolled in both programs
and expressed concern that a parent company could sponsor Medicaid
plans and D-SNP products that might be operated quite separately with
little or no coordination while still accepting ``clinical and
financial responsibility with respect to any individual enrollee.''
Response: We thank commenters for their support of how we defined
aligned enrollment. We disagree, however, with the commenter about the
necessity of including the phrase ``clinical and financial
responsibility for any individual enrolled in both programs'' in the
definition of aligned enrollment.
Under our proposed definition, we stated that aligned enrollment
refers to full-benefit dual eligible D-SNP enrollees whose Medicaid
benefits are covered by that D-SNP or by a Medicaid MCO that is the
same organization, its parent organization, or another entity that is
owned and controlled by its parent organization. When a full-benefit
dual eligible individual is enrolled in aligned plans, one entity (or
entities that share a parent organization) provides coverage of
Medicare benefits and Medicaid benefits such as LTSS, behavioral health
services, or both. By virtue of the provision of coverage under these
types of contractual relationships, the relevant entity intrinsically
has clinical and financial responsibility for the covered Medicare and
Medicaid services provided to enrollees. We believe that explicitly
using the phrase ``clinical and financial responsibility for benefits''
in the definition of aligned enrollment might imply otherwise and
suggest that a contractual obligation to cover benefits does not mean
financial and clinical responsibility for those benefits.
We are finalizing the proposed definition of the term ``aligned
enrollment'' with some modifications to clarify this relationship.
Rather than referring to the enrollee's Medicaid benefits as being
covered by the D-SNP or by a Medicaid MCO, the final regulation text
refers to the enrollee's Medicaid benefits as being covered by the D-
SNP under a Medicaid MCO contract between the state and: (1) The MA
organization offering the D-SNP; (2) the D-SNP's parent organization;
or (3) another entity that is owned and controlled by the D-SNP's
parent organization. We believe this regulation text change clarifies
the meaning and adequately addresses that financial and clinical
responsibility for the enrollees is held by the MA organization or its
parent organization.
Comment: One commenter, while supportive of how we intended to
incorporate exclusively aligned enrollment relative to unifying
Medicare and Medicaid grievance and appeal procedures, encouraged us to
consider developing additional incentives and tools for states and
plans to move toward increased alignment. This commenter expressed
interest in the creation of a combination of rewards, incentives, new
tools, and pathways to facilitate improvement in enrollment alignment,
which is not a pervasive practice among states.
Response: The commenter's point is well taken. We intend to
exercise the administrative authority we have under current law to
support states that wish to pursue this particular integrated care
strategy and will consider the necessity of future rulemaking
consistent with our programmatic authority. We will also continue to
make technical assistance resources available to states through the
Integrated Care Resource Center.
Comment: A commenter expressed concern that the definition of
exclusively aligned enrollment may limit state flexibility insofar that
it would be difficult for one-hundred percent of a D-SNP's membership
to be aligned. According to the commenter, a D-SNP that failed to meet
this threshold wouldn't be able to benefit from unified appeals and
grievance processes. This commenter would be opposed to a policy of
having to disenroll members anytime misalignment occurred. Another
commenter requested that CMS confirm that HIDE SNPs and exclusively
aligned HIDE SNPs are different types of plans.
Response: We clarify that through this rulemaking, the concept of
exclusively aligned enrollment is only relevant to how we define an
applicable integrated plan, which must unify its Medicare and Medicaid
grievance and appeals procedures consistent with rules described in
Sec. Sec. 422.629 through 422.634. Unifying grievance and appeals
procedures is most feasible when everyone in the plan is receiving
Medicare and Medicaid services from the same organization (or through a
companion product offered by the parent organization or through a
common ownership relationship with the parent organization). In the
absence of aligned enrollment, D-SNP enrollees may be enrolled in and
receiving coverage from two or more plans simultaneously, complicating
[[Page 15709]]
coordination of care and the beneficiary experience. For FIDE SNPs and
HIDE SNPs, this situation of receiving coverage from two or more plans
may be true for only some enrollees. Even if this lack of alignment
exists for some and not all of the D-SNP's enrollees, there would be at
least two (if not more) sets of grievance and appeals rules applying to
the D-SNP's members. State Medicaid agencies have the ability to take
other steps to integrate grievance and appeals procedures through their
contracts with D-SNPs. We welcome the opportunity to partner with
states in developing and implementing these strategies.
Comment: MedPAC advised that aligned enrollment should be a
requirement for D-SNPs that provide significant Medicaid services and
meet both the second and third integration standards at sections
1859(f)(8)(D)(i)(II) and (III) of the Act, respectively, where our
proposal only contemplated applying a requirement of exclusively
aligned enrollment to the third integration standard (where the parent
organization of the enrollee's D-SNP is also the parent organization of
the enrollee's Medicaid MCO). MedPAC further stated that the second
integration standard in the statute should apply to plans where states
have capitated Medicaid contracts directly with D-SNPs and the D-SNPs
provide Medicaid services, and the third standard should apply to
situations where states have capitated Medicaid contracts with another
legal entity (a Medicaid managed care plan) that is part of the same
parent organization as the D-SNP.
Response: We agree with MedPAC insofar that alignment of Medicare
and Medicaid coverage, which occurs when a full-benefit dual eligible
individual is receiving Medicare and all or substantially all Medicaid
services from one organization, constitutes the most extensive level of
integration. As we noted in the preamble of the proposed rule, this
arrangement offers the greatest potential for holistic and person-
centered care coordination, integrated appeals and grievances,
comprehensive beneficiary communication materials, and quality
improvement. However, we remain concerned about imposing such a
requirement at this time, as states that have contracts with Medicaid
MCOs and D-SNPs currently have the authority to require aligned
enrollment but for policy or other reasons, do not impose one. Finally,
we believe that the most salient differentiator between the second and
third integration standards at sections 1859(f)(8)(D)(i)(II) and (III)
of the Act is exclusively enrolled alignment, rather than whether the
state contract is with the D-SNP directly or a related entity. We are
therefore not adopting this recommendation.
Comment: A commenter recommended that CMS codify the third
integration requirement, which appears in section 1859(f)(8)(D)(i)(III)
of the Act, and stipulates that a D-SNP's parent organization assumes
clinical and financial responsibility for the provision of Medicare and
Medicaid benefits. While this commenter was supportive of our
interpretation that such clinical and financial responsibility was only
possible in FIDE SNPs and HIDE SNPs where there was exclusively aligned
enrollment, the commenter was concerned that our interpretation only
existed in preamble and not the regulation text itself.
Response: As noted by the commenter, in the proposed rule, we did
not explicitly cite or summarize the integration requirement at section
1859(f)(8)(D)(i)(III) of the Act in our definition of a D-SNP. Instead,
we interpreted the statutory language on assuming clinical and
financial responsibility for benefits to mean that an entity can only
truly hold ``clinical and financial responsibility'' for the provision
of Medicare and Medicaid benefits, as described at section
1859(f)(8)(D)(i)(III) of the Act, in the scenarios of exclusively
aligned enrollment. Therefore, the D-SNPs that meet this integration
standard would be FIDE SNPs and HIDE SNPs that have exclusively aligned
enrollment. As implemented in our definitions, section
1859(f)(8)(D)(i)(II) of the Act also establishes being a FIDE SNP or a
HIDE SNP as a means to satisfy the new, minimum integration
requirements for D-SNPs. We believe that our proposed definitions and
requirements are clearer without adding the statutory terminology from
section 1859(f)(8)(D)(i)(III) of the Act. As we interpreted the statute
and proposed the new rules, any plan that meets the requirement for
clinical and financial responsibility for the provision of Medicare and
Medicaid benefits would already meet the second integration requirement
because it would be a FIDE SNP or HIDE SNP. As discussed in section
II.A.2.b.(2) of this final rule, the combination of terms that we
proposed is relevant to how we define an applicable integrated plan
that must unify grievance and appeals procedures for Medicare and
Medicaid services. Therefore, we believe that adding the statutory
terminology would complicate the definitions and requirements relative
to any benefits.
After considering the comments we received, we are finalizing the
provisions related to D-SNP definitions as proposed with the following
modifications:
In the definition of aligned enrollment at Sec. 422.2, we
are finalizing the regulatory text with some modifications to clarify
our intended meaning regarding financial and clinical responsibility
for enrollees. The final regulation text refers to the enrollee's
Medicaid benefits as being covered by the D-SNP under a Medicaid MCO
contract between the state and: (1) The MA organization offering the D-
SNP; (2) the D-SNP's parent organization or (3) another entity that is
owned and controlled by the D-SNP's parent organization.
In the definition of a D-SNP at Sec. 422.2, we are
finalizing the substance of our proposed definition with modifications
that are primarily organizational. In the final regulation text, we are
inserting ``title'' prior to ``XIX of the Act,'' which was
inadvertently excluded in the proposed rule. We are also using a new
paragraph (1) to clarify that a D-SNP coordinates the delivery of
Medicare and Medicaid services for individuals eligible for such
Medicaid services, and a new paragraph (2) to clarify that a D-SNP may
provide coverage of Medicaid services, including LTSS and behavioral
health services. The requirement that a D-SNP have a contract with the
state Medicaid agency consistent with the requirements of Sec. 422.107
and that meets the minimum requirements detailed in Sec. 422.107(c) is
now contained in new paragraph (3), and the requirement that the D-SNP
satisfy, beginning January 1, 2021, one of the three criteria for
integration of Medicare and Medicaid benefits detailed in the proposed
rule is now contained in new paragraph (4), with the specific
integration requirements redesignated as paragraphs (4)(i) through
(iii)).
In paragraph (2) of the definition of a FIDE SNP at Sec.
422.2, we are finalizing the definition with a change in the placement
of the phrase ``consistent with State policy'' so that it modifies the
verb phrase ``provides coverage'' and appears prior to the categories
of services to which it applies. Also in paragraph (2), we are using
``provides'' in place of ``includes'' prior to the phrase ``coverage,
consistent with State policy.''
In the definition of a HIDE SNP at Sec. 422.2, we are
finalizing the proposal with non-substantive modifications. First, we
are changing the placement of the phrase ``consistent with State
policy'' so that it modifies the verb
[[Page 15710]]
phrase ``provides coverage'' and appears prior to the categories of
services to which it applies. Second, we are reorganizing the text to
use new paragraphs (1) and (2) to identify the options for the
capitated contract to provide Medicaid services. A HIDE SNP's capitated
contract to cover LTSS, behavioral services, or both, must be between:
(1) The MA organization and the Medicaid agency; or (2) the MA
organization's parent organization (or another entity that is owned and
controlled by its parent organization) and the Medicaid agency. Third,
we are using ``provides'' in place of ``includes'' prior to the phrase,
``consistent with State policy, of long-term services and supports,
behavioral health services, or both. . .''
(2) Dual Eligible Special Needs Plans and Contracts With States (Sec.
422.107)
We proposed changes in Sec. 422.107 to more clearly articulate the
requirements of the contract between the D-SNP and the state Medicaid
agency, while also incorporating the changes required by the Bipartisan
Budget Act of 2018. In summary, we proposed to make the following
specific changes:
Delete language in paragraph (b) that is extraneous and
duplicative of the proposed definition of a D-SNP in Sec. 422.2;
Make clarifying edits in paragraphs (c)(1) through (c)(3),
which govern the minimum requirements of the contract between the D-SNP
and the state Medicaid agency;
Redesignate paragraph (d) as paragraph (e), which relates
to compliance dates; and
Establish a revised paragraph (d) that describes the new
minimum contracting requirement under the Bipartisan Budget Act of 2018
that the newly designated paragraph (e)(2) would make effective January
1, 2021.
Section 50311(b) of the Bipartisan Budget Act of 2018 amended
section 1859(f) of the Act by creating a new paragraph (8)(D)(i)(I) to
require that the Secretary establish additional requirements for D-
SNPs' contracts with state Medicaid agencies. In the proposed rule
preamble, we discussed how this provision requires a D-SNP to have a
state Medicaid agency contract that includes additional coordination
requirements (subsection (f)(8)(D)(i)(I) of the Act); be a FIDE SNP or
HIDE SNP (subsection (f)(8)(D)(i)(II) of the Act); or have exclusively
aligned enrollment and have its parent organization accept full
clinical and financial responsibility for all Medicare and Medicaid
covered services (subsection (f)(8)(D)(i)(III) of the Act), depending
on the state's election.
We proposed to implement subsection (f)(8)(D)(i)(I) of the Act by
establishing at Sec. 422.107(d) that any D-SNP that is not a FIDE SNP
or HIDE SNP is subject to an additional contracting requirement. Under
this proposed new contract requirement, the D-SNP would be required to
notify the state Medicaid agency, or individuals or entities designated
by the state Medicaid agency, of hospital and skilled nursing facility
(SNF) admissions for at least one group of high-risk full-benefit dual
eligible individuals, as determined by the state Medicaid agency. We
clarified in the proposed rule that this proposal would also permit the
D-SNP to authorize another entity or entities (such as a D-SNP's
network providers) to notify the state Medicaid agency and/or
individuals or entities designated by the state Medicaid agency on its
behalf, with the understanding that the D-SNP ultimately would retain
responsibility for complying with this requirement. We direct readers
to the proposed rule, 83 FR 54996, for a more detailed explanation of
our intent and rationale for this approach.
As discussed in the proposed rule, we believe that our proposal to
establish a notification requirement for D-SNPs for high-risk
individuals' hospital and SNF admissions is consistent with the
criteria we used to evaluate various options for the minimum
contracting requirements. We considered whether a proposal would:
Meaningfully improve care coordination and care
transitions, thereby improving health outcomes for dual eligible
individuals;
Minimize burden on plans and states relative to the
improvements in care coordination and transitions;
Provide flexibility to state Medicaid agencies;
Enable CMS to assess compliance with minimal burden on
CMS, plans, and providers; and
Be consistent with the statutory amendments made by the
Bipartisan Budget Act of 2018.
We solicited comment on whether our proposal satisfied these
criteria to a greater extent than the more prescriptive or alternative
proposals we described in the proposed rule; \19\ whether our reasoning
for why our proposal was preferable to the more prescriptive or
alternative proposals was sound; whether there were other minimum
contacting requirements that we did not consider that were superior to
our proposal; and whether our proposal provided sufficient incentives
for plans and states to pursue greater levels of integration.
Specifically, we considered and sought comment on the following
alternatives:
---------------------------------------------------------------------------
\19\ We direct readers to the proposed rule, 83 FR 54997-98, for
a more detailed discussion of these alternatives.
---------------------------------------------------------------------------
Proposing that notice requirements apply for all full-
benefit dual eligible individuals' hospital and SNF admissions.
Proposing a minimum size for the state-selected high-risk
population.
Requiring a notification for every emergency department
visit, as mentioned in section 1859(f)(8)(D)(i)(I) of the Act.
Proposing that the notification occur not later than 48
hours after the D-SNP learns of the admission or discharge.
Requiring each D-SNP to take affirmative steps to schedule
its individual health risk assessments at the same time as similar
outreach is conducted by the Medicaid managed care plan, to use a
combined or aligned assessment instrument, or take other steps that
would minimize the burden on enrollees or providers. As we noted in the
proposed rule, we continue to hear of scenarios where a D-SNP enrollee
is assessed separately by the D-SNP and then again by their Medicaid
MCO, even though there may be a high degree of overlap in what each
organization is assessing and ultimately what each organization is
requesting of the enrollee. We solicited comment on how pervasive this
issue is and the extent of overlap in the assessment instruments and
degree of burden on providers and beneficiaries, including a specific
request for feedback on the extent to which the requirements that we
proposed do not accomplish enough or should be modified to address this
issue.
Requiring D-SNPs to identify any enrollees who are in need
of LTSS and behavioral health services and transmitting such
information to the state Medicaid agency.
Requiring D-SNPs to train plan staff and their network
providers on the availability of LTSS and behavioral health services
covered by Medicaid.
Requiring D-SNPs to solicit state input on the plan's
model of care (which is currently required and submitted to CMS
pursuant to Sec. 422.101(f)), health risk assessment instrument, and
beneficiary communication materials. We sought comment regarding state
burden and on compelling reasons why additional contracting
requirements in this area may be necessary.
The merits of requiring D-SNPs to share data with state
Medicaid agencies or entities designated by state Medicaid
[[Page 15711]]
agencies that would benefit the coordination of Medicare and Medicaid
items and services, as described in section 1859(f)(8)(D)(i)(I) of the
Act as an example for implementing that provision. We solicited comment
on whether there should be additional regulatory requirements around
data sharing.
We requested feedback on our notification proposal at Sec.
422.107(d), including the ways that state Medicaid agencies and plans
would fulfill this requirement, and the additional contracting
requirements we considered in the proposed rule preamble.
In addition to the new requirement for contracts between the state
and MA organization at proposed Sec. 422.107(d) for D-SNPs that are
not FIDE SNPs or HIDE SNPs, we proposed to include additional
specifications in the regulations governing D-SNP contracts with state
Medicaid agencies at Sec. 422.107 by amending paragraph (b) and
several provisions in paragraph (c). As stated in the preamble to the
proposed rule, we do not believe that these specifications materially
alter these agreements; however, we proposed them in response to
questions raised since the state Medicaid agency contracting
requirements were promulgated in the September 2008 interim final rule
(73 FR 54226). We also believed that these changes aligned with the
integration requirements for D-SNPs in the Bipartisan Budget Act of
2018.
We proposed modifying the general rule for contracts with D-SNPs at
Sec. 422.107(b) to strike ``The MA organization retains responsibility
under the contract for providing benefits, or arranging for benefits to
be provided, for individuals entitled to receive medical assistance
under Title XIX. Such benefits may include long-term care services
consistent with State policy, . . .'' As discussed in the proposed
rule, we believed this proposed change would be consistent with the
coordination requirements in our proposed definition at Sec. 422.2 of
``D-SNP.''
We proposed to revise the contracting requirement at Sec.
422.107(c)(1), which currently requires the contract to document the MA
organization's responsibility, including financial obligations, to
provide or arrange for Medicaid benefits, to specify instead that the
contract must document the MA organization's responsibility to provide,
as applicable, and coordinate the delivery of Medicaid benefits,
including LTSS and behavioral health services, for individuals who are
eligible for such services. We solicited comment on whether our
proposed amendments to this section fully communicated what we intend
to require of D-SNPs or whether there were additional revisions we
ought to consider to express our intent more clearly for D-SNPs, state
Medicaid agencies, and other stakeholders.
In Sec. 422.107(c)(2), we proposed to revise the current
requirement that the contract between the D-SNP and the state Medicaid
agency document the categories of dual eligible individuals who are
eligible to enroll in the D-SNP. We proposed to revise this requirement
to specify not only the categories of eligibility but also any
additional criteria of eligibility to account for such conditions of
eligibility under Medicaid as nursing home level of care and age. We
clarified that these criteria could also include a requirement for D-
SNP enrollees to enroll in a companion Medicaid plan to receive their
Medicaid services.
Finally, at Sec. 422.107(c)(3), we proposed that the contract
between the D-SNP and the state Medicaid agency document the Medicaid
services the D-SNP is responsible for covering in accordance with a
capitated contract with the D-SNP directly or through a risk contract,
defined at Sec. 438.2, with the companion Medicaid managed care
organization operated by the D-SNP's parent organization. As discussed
in the proposed rule, we believe this proposed change would reduce
burden on D-SNPs and would enable us to identify the particular
Medicaid services that are covered under a capitated contract for FIDE
SNPs and HIDE SNPs but would not limit or contravene other requirements
for D-SNPs to approach their obligations to coordinate the delivery of
all Medicare and Medicaid benefits. We sought comment on whether the
regulatory change fully communicates what we wish to require.
We received the following comments on these proposed definitions:
Comment: We received a number of comments in support of our
proposal to establish a notification requirement for any D-SNP that is
not a FIDE SNP or HIDE SNP. One commenter believed the proposed
requirement is consistent with the intent and language of the
Bipartisan Budget Act of 2018. Several commenters supported the
flexibility to allow state Medicaid agencies to build on notification
processes already in place. A commenter noted that minimum contract
requirements are more practical to implement than more prescriptive
requirements due to variation in state capabilities and current data-
sharing methods. Another commenter appreciated the flexibility states
have to implement the requirement based on their needs and readiness.
Another commenter believed that the notification requirement will
facilitate care transitions for dual eligible individuals in instances
where they are not enrolled in an aligned D-SNP and provides a
framework upon which states can advance Medicare and Medicaid benefit
integration in the future.
Response: We thank commenters for their support of our proposed
notification requirement. We agree that the requirement is consistent
with the statutory amendments made by the Bipartisan Budget Act of
2018. We intend for this notification requirement to be a catalyst for
increasing care coordination during transitions of care, while
minimizing plan and state burden and preserving state flexibility to
develop solutions that build upon current integration efforts.
Comment: Several commenters supported our proposed notification
requirement but believed that it represents a transitional step and
that our integration efforts should be scaled up over time, with one
commenter requesting that CMS establish timelines and benchmarks for
states and plans. One commenter believed that the new statutory
amendments to the Act made by the Bipartisan Budget Act of 2018 not
only permit, but require, the notification requirement to be scaled up
over time. A few commenters recommended that the notification
requirement be broadened to include more enrollees.
Response: As we discussed in the proposed rule, our intent in
establishing this notification requirement is for states and D-SNPs to
begin on the path toward greater integration on a smaller scale. Not
every state is similarly positioned to move towards greater
integration. We note that, as processes and infrastructure mature, a
state Medicaid agency may choose through its contracts with D-SNPs to
scale up this notification to include additional subpopulations of
full-benefit dual eligible individuals. As we gain experience with
implementing the integration requirements in this final rule, we will
evaluate whether further rulemaking is necessary to build on the
notification requirement.
Comment: Some commenters expressed concern that CMS's proposed
notification requirement will not meet the goal of promoting greater
integration of Medicare and Medicaid benefits, creates unnecessary
burden, or may not be the most appropriate requirement in all states.
MedPAC noted that states are currently able to require D-SNPs to
provide this information through their state Medicaid agency contracts,
but
[[Page 15712]]
since few states do, states were unlikely to use this information to
improve care coordination. Several commenters believed that many states
may lack the capability to implement the contracting requirement and
use the data in a meaningful way. Several commenters expressed concern
that the requirement was too burdensome for states and would discourage
states from pursuing or continuing to contract with D-SNPs. A few
commenters noted that notifications of hospital or SNF admissions may
not be the most useful or best way to incentivize coordinated
transitions of care in every state and emphasized that states are in
the best position to determine what requirements best fit their
delivery system. One commenter noted that limiting the notification
requirement to only one group of high-risk full-benefit dual eligible
individuals would not meaningfully advance coordination efforts.
Another commenter believed that the proposed requirement does not
ensure both the state and D-SNP will be engaged in discharge planning
in a way that ensures timely access to the most appropriate and cost
effective benefits. One commenter expressed a belief that this
requirement puts the state in the middle of communication between the
D-SNP and enrollee's care team. Another commenter questioned whether
states would utilize the information provided in the notifications.
Several commenters also questioned what would happen to D-SNPs if a
state was not interested in participating in the notification
requirement.
Response: These commenters raise important points about our
proposed notification requirement. However, we believe the requirement
strikes an appropriate balance among incentivizing further integration
for states and D-SNPs, limiting the administrative burdens for states
and MA organizations, and ensuring flexibility in implementation to fit
the needs of each state's policy environment. In addition to the
notification requirement, we note that--as discussed in sections
II.A.2.a.(1) and II.A.2.b.(1) of this final rule--we are also
establishing through this rulemaking an explicit requirement at Sec.
422.2 that D-SNPs coordinate dual eligible individuals' Medicare and
Medicaid benefits, as well as a requirement that D-SNPs provide
assistance with Medicaid appeals and grievances at Sec. 422.562(a)(5).
In implementing the statute by establishing the notification
requirement, we incentivize not only D-SNPs, but also the states with
which they must contract, to make incremental progress in coordinating
care for dual eligible individuals. By design, the notification
requirement gives the state Medicaid agency broad latitude to establish
notification procedures and protocols that are within the state's
capacity and consistent with the state's needs and integration goals.
We believe this requirement is scalable for D-SNPs and states where no
coordination activity is currently taking place. We also point to the
flexibility within the notification requirement for the state to
designate another individual or entity to receive the notification,
therefore allowing for the timeliest action following a care transition
or other significant event.
Comment: Several commenters supported the flexibility in the
proposed notification requirement for the state to designate other
individuals or entities to receive notification of an admission. These
commenters believed that collection of this information at the state
level may not be the most appropriate or useful approach. One commenter
noted that Tennessee's approach, which requires D-SNPs to notify a
Medicaid provider of hospitalizations and emergency department visits,
better achieves the goal of improved coordination of services than a
notification to the state. Another commenter requested that CMS modify
the notification proposal by requiring that the beneficiary's unaligned
Medicaid MCO also be notified of any admissions for beneficiaries that
receive LTSS or behavioral health services.
Response: We appreciate the commenters' support for the flexibility
afforded to states to designate other individuals or entities to
receive notification of an admission in our proposal. We agree that in
some markets, providers and other entities, such as a Medicaid MCO, may
be better able to use admissions information to timely coordinate care
for a beneficiary. We do not agree that CMS should finalize the
regulation to require D-SNPs to notify MCOs specifically of inpatient
admissions, however, but note that such delegation is already
permissible under Sec. 422.107(d). We defer to states to establish
when and to whom the notification is appropriate to best achieve
integration and improve outcomes for dual eligible individuals, based
on how the state operates its Medicaid program.
Comment: Several commenters expressed concern that our proposed
language allowing a D-SNP to authorize another entity or entities, such
as the D-SNP's network providers, to notify the state Medicaid agency
of inpatient admissions would create significant burden for providers.
However, one commenter also acknowledged that notifications would be
timelier if originated by providers. One commenter recommended removing
this language from the regulatory text, while a few other commenters
recommended that CMS provide guidance and provider education about the
requirement. Another commenter noted that states and D-SNPs are
dependent on prompt and complete claims submissions from hospitals and
SNFs to achieve better care coordination and emphasized the importance
of provider education about these requirements to ensure the flow of
this information.
Response: In our proposed notification requirement, we provided
flexibility to allow for transmission of information about hospital and
SNF admissions in multiple ways because we believe the most efficient
and effective processes may vary by state and evolve over time. In some
cases, this might include reporting by providers and providing
information to specific providers to aid in care coordination. However,
our proposed requirement places the ultimate responsibility on D-SNPs
and does not directly require actions by providers. When developing
notification processes to meet our regulatory requirements, we expect
that states and D-SNPs will consider any potential impacts on
providers.
Comment: Several commenters requested that CMS provide states with
technical assistance and disseminate best practices related to the
notification requirement both to facilitate the contracting process and
to ensure that a sufficient degree of coordination is achieved to
promote successful transitions of care. These commenters' requests
particularly focused on the need to develop data exchange technology,
systems, and processes to achieve successful transitions of care. One
commenter recommended CMS provide states with parameters for
implementing the state contracting requirements to mitigate operational
burden on D-SNPs while supporting implementation. Another commenter
recommended CMS seek assistance from a group of plan and state
stakeholders in developing this guidance and best practice models.
Response: We agree with these commenters that support for states
will improve the implementation of the requirements of this final rule.
As stated earlier in this final rule, the Medicare-Medicaid
Coordination Office provides technical assistance to states on
integration issues, including through the Integrated Care Resource
Center (see
[[Page 15713]]
https://www.integratedcareresourcecenter.com/). We are committed to
continuing our work with states to gather and disseminate best practice
information and to engage stakeholders to ensure a successful
implementation.
Comment: Several commenters requested that CMS establish clear
guidelines and standardized formats for the proposed notification
requirement, including methods, content, and timeframes for
notification. One commenter requested clarification with respect to how
high-risk populations should be defined. Another commenter recommended
requiring that states include functional ability in their definitions
of high-risk populations. A few commenters expressed concern that
variation in how this requirement is implemented across states will be
costly and time consuming, leading to potential problems in
implementing the requirement effectively. Some commenters expressed
interest in uniform requirements in order to reduce administrative
burden for plans that operate in multiple states. One commenter noted
that standardization of data exchange will contribute to the value of
the data for benchmarking and quality improvement activities.
Response: As discussed earlier in this preamble, we intend that the
proposed notification requirement provide states with discretion to
develop solutions consistent with their particular policy and
operational environments. We believe that a more prescriptive
notification requirement would ultimately be counterproductive for both
states and D-SNPs by limiting the development of solutions appropriate
to each market. Regardless of the approach a state chooses to take
under this final rule, our aim is to have actionable information that
enables providers and payers to facilitate seamless care transitions
for high-risk populations, that is, those full-benefit dual eligible
individuals who are most likely to benefit from effective interventions
(such as through the provision of LTSS and behavioral health services)
that enable them to live independently in the setting of their choice
and in a way that values their own needs and preferences. As we gain
more experience with the implementation of the notification requirement
in this final rule, we will share best practices and continue to
provide technical assistance and guidance to states and D-SNPs.
Comment: Several commenters requested that CMS do more to establish
a data-sharing system to facilitate the proposed notification
requirement, citing limited ability for some states to implement data
sharing mechanisms. Some commenters noted that a unified system to
share data should be used by states, D-SNPs, providers, and
beneficiaries. One commenter expressed support for the proposed
notification requirement serving as a starting point for a robust two-
way health information exchange system between D-SNPs and states to
share data on dual eligible individuals' utilization of Medicare and
Medicaid services. Another commenter recommended that CMS encourage
states to build on current data collection and sharing efforts, such as
health information exchanges (HIEs). Some commenters recommended
specific data exchange solutions, such as building on the Blue Button
2.0 Framework or modifying the Transformed Medicaid Statistical
Information System (T-MSIS).
Response: We believe it is most appropriate at this time to defer
to state Medicaid agencies on the manner in which notification occurs
and how data be exchanged. For example, in markets where there is
existing infrastructure to leverage, such as a state HIE, a state may
elect an approach that requires data sharing across a common platform
using industry standards, including those adopted by the Office of the
National Coordinator for Health IT in accordance with 45 CFR part 170,
subpart B. Regardless of process, we expect that notifications occur
timely in order to ensure prompt care coordination and effective care
transitions. To that end, we encourage states and D-SNPs to use the
most efficient notification mechanisms available, which may include the
state's HIE. However, we appreciate that not every state is similarly
positioned, and, therefore, if a state elected to implement this
requirement on a smaller scale, targeting a small subset of high-risk
beneficiaries, a solution that does not initially require automation
may be more appropriate and pragmatic. We reiterate that the
notification requirement we are finalizing in this rule is a first step
towards improved data exchange and integration. As health information
technology advances and industry standards for data exchange are
established, it may be feasible to establish or leverage a standardized
data-sharing system.
Comment: One commenter requested direction on how to implement the
proposed notification requirement in states like Washington where high-
risk dual eligible individuals are enrolled in a health home under
demonstration authority.
Response: As noted previously, our final requirement at Sec.
422.107(d) provides broad latitude to each state to determine the
subset of high-risk D-SNP enrollees subject to the notification
requirement. The regulation, as proposed and finalized, requires that
the enrollees for which the notification must be made must be at least
one group of full-benefit dual eligible and high-risk. The state is not
required to specify all high-risk dual eligible individuals for this
group so long as the identification of the group is consistent with the
regulation's requirements.
Comment: Several commenters questioned the impact the proposed
notification requirement will have on notification systems and the
robust reporting requirements already in place in several states. One
commenter noted that the proposed requirement would duplicate the
software program currently used by Washington in which hospitals enter
admissions and emergency department visit information for other
providers and case managers to view. Another commenter expressed
concern that the language requiring a D-SNP to notify or authorize
another entity to notify a state agency may not accommodate the current
Oregon Health Information Technology System, which creates a
notification of admission without the D-SNP's action. This commenter
recommended changing our proposed regulatory language to ensure this
type of notification system meets our notification requirement such
that D-SNPs would not be required to repeat a duplicate notification.
Response: We appreciate that states have different and evolving
infrastructure and policies, including mandatory data sharing
requirements. The notification requirement we are finalizing in this
rule is not intended to impact such existing requirements, and states
may continue to require additional notifications or other data sharing
consistent with their state Medicaid agency contracts. We thank the
commenters that raised specific operational scenarios where HIEs or
other notification systems are currently in place and could be
leveraged for purposes of satisfying our notification requirement. In
this final rule, we are modifying the verbs used to describe the D-
SNP's obligations in Sec. 422.107(d) to clarify those
responsibilities; as finalized, the D-SNP notifies or arranges for
another entity to notify (instead of ``will notify or authorize another
entity'' as proposed) the state Medicaid agency of hospital and SNF
admissions for at least one group of high-risk full-benefit dual
eligible individuals, as identified by the state Medicaid agency. We
believe the phrase ``arrange for'' provides more flexibility to
encompass arrangements such as those described by
[[Page 15714]]
the commenters. Thus, for example, a D-SNP could meet the notification
requirement by arranging for another entity--for example, a hospital--
to notify the state Medicaid agency or its designee when the various
parties participate in an HIE or other notification system.
Comment: Several commenters raised concerns about D-SNPs' ability
to fully comply with our proposed revision to Sec. 422.107(c)(1),
which codifies a requirement for D-SNPs to document their
responsibility to coordinate the delivery of Medicaid benefits for
their enrollees, as well as our proposed notification requirement at
422.107(d), citing potential barriers imposed by the Health Insurance
Portability and Accountability Act of 1996 and 42 CFR part 2, with
respect to sharing information that would allow D-SNPs to effectively
coordinate and share information about behavioral health services. One
commenter cited 42 CFR part 2 as preventing covered entities from
effectively coordinating behavioral health services when the need for
such services involves substance abuse treatment and the D-SNP cannot
obtain member consent, and urged CMS to consider ways to address this
issue and allow for coordinating and sharing of data without the need
for written consent. Another commenter suggested that CMS work with the
Office for Civil Rights and the Substance Abuse and Mental Health
Services Administration on this issue.
Response: These commenters have raised important issues with
respect to care coordination for individuals with substance use
disorder. This final rule does not change or eliminate current
requirements for D-SNPs to comply with HIPAA and 42 CFR part 2. We
clarify that the requirements finalized in this rule, including the
requirement codified at Sec. 422.2 that a D-SNP coordinate Medicare
and Medicaid benefits and the requirement at Sec. 422.107(d) requiring
notification of high-risk enrollee inpatient and SNF admissions, must
be implemented in a way that complies with all applicable laws. As a
result, we acknowledge there are limitations to D-SNPs' ability to
notify states of certain inpatient admissions for high-risk enrollees
with substance use disorder, as well as to their ability to coordinate
these individuals' care, absent member consent for the disclosure of
such information. When establishing the notification requirement in the
state Medicaid agency contract, we encourage states to collaborate with
D-SNPs to identify and address concerns regarding compliance with other
statutes and regulations, including HIPAA and 42 CFR part 2.
Comment: Some commenters requested additional requirements for
state Medicaid agency contracts between states and D-SNPs. One
commenter stated that the proposed contracting requirements at Sec.
422.107 would better meet CMS's stated goals if they were more
prescriptive. Several commenters recommended additional contracting
requirements to those in the proposed rule, while one commenter
requested that CMS refrain from adding more contract requirements until
after the implementation of the notification requirement finalized in
this rulemaking. Some commenters recommended that CMS require states
and D-SNPs to develop a process for coordinating Medicaid-funded
services, such as LTSS and behavioral health services. One commenter
recommended requiring D-SNPs to annually submit a plan for coordinating
Medicaid LTSS and behavioral health services for approval by the state.
A few commenters suggested requiring improved information sharing
regarding Medicaid provider participation and enrollees' Medicaid and
Medicare eligibility. One commenter noted that additional contracting
requirements may ease administrative burdens and promote further
integration and recommended that CMS clearly define minimum
coordination requirements and establish uniform language and
definitions.
Response: We appreciate the suggestions for modifications or
additions to the state Medicaid agency contract requirements for D-SNPs
currently codified at Sec. 422.107. We are not finalizing any
additional substantive changes to Sec. 422.107 in this final rule
beyond those discussed in our proposed rule. However, we will continue
to evaluate D-SNPs' progress toward achieving a minimum level of
integration as intended under the Bipartisan Budget Act of 2018 to
determine whether additional contracting requirements might be
necessary in the future. As discussed in various places in this final
rule, states retain the ability to add more stringent contracting
requirements in their state Medicaid agency contracts with D-SNPs in
order to best achieve their specific policy goals and meet the needs of
their population of dual eligible individuals.
Comments: Several commenters recommended that CMS consider new
incentives that would enhance integration, such as an increase to the
Federal Medical Assistance Percentage (FMAP) rate for activities
related to Medicare-Medicaid integration, including for investments in
state data-sharing systems and infrastructure. One commenter noted that
requiring or incentivizing states to assist D-SNPs in the development
of such administrative processes to assist with integration efforts
would prevent states from shifting this responsibility to D-SNPs.
Response: We agree that state investments in additional data-
sharing or other administrative processes may facilitate D-SNP efforts
to implement the notification requirement, but also more broadly to
better coordinate Medicare and Medicaid coverage. As discussed in the
Collection of Information section of this final rule, we estimate that
half of the cost of developing infrastructure and processes to
implement the proposed notification requirement would be offset by
federal financial participation for Medicaid administrative activities.
However, increases to FMAP rates are beyond the scope of this
rulemaking.
Comment: A few commenters supported the alternative we noted for
consideration that would apply the notification requirement to all
full-benefit dual eligible individuals enrolled in the D-SNP, and not
just a subgroup of high-risk individuals. These commenters cited
improved access to Medicaid benefits that promote care in the least
restrictive environment as the reason to support the broader
requirement. Another commenter requested that we establish a minimum
size for the state-selected high-risk population, another alternative
CMS noted for consideration in the proposed rule. This commenter noted
that factors such as minimum population size impact the feasibility of
implementation of this provision and would mitigate operational burden
for health plans.
Response: We appreciate the commenters' requests for a broader
notification requirement, but we believe that limiting the notification
requirement to high-risk individuals in this final rule is preferable.
Research suggests that targeting high-risk individuals is critically
important to cost-effective interventions.\20\ In addition, all states
have some care management infrastructure for high-risk individuals in
their Medicaid programs, such as through Medicaid 1915(c) HCBS
waivers.\21\ The notification provision at
[[Page 15715]]
Sec. 422.107(d) gives state Medicaid agencies the discretion to decide
which group of beneficiaries is at high risk and how large or small the
group(s) may be. Providing states with such flexibility to define their
population of high-risk individuals will allow them to tailor the D-SNP
notification requirement to align with existing infrastructure for
coordinating and managing care for high-risk individuals. Such
targeting will not only limit notifications to those which are most
meaningful and actionable for the state, but will also reduce
administrative burden and implementation costs.
---------------------------------------------------------------------------
\20\ Brown, R.S., Peikes, D., Peterson, G., Schore, J. &
Razafindrakoto, C.M., (2012). ``Six Features of Medicare Coordinated
Care Demonstration Programs That Cut Hospital Admissions of High-
risk Patients.'' Health Affairs, 31(6).
\21\ See: https://www.medicaid.gov/medicaid/ltss/health-homes/; https://www.medicaid.gov/medicaid/section-1115-demo/demonstration-and-waiver-list/; and Care Coordination in
Managed Long-Term Services and Supports (2015, July), prepared for
AARP by Truven Health Analytics. Retrieved from: https://www.aarp.org/content/dam/aarp/ppi/2015/care-coordination-in-managed-long-term-services-and-supports-report.pdf.
---------------------------------------------------------------------------
Comment: One commenter encouraged CMS to require D-SNPs to provide
notification of emergency department visits for unaligned D-SNP
enrollees receiving LTSS and behavioral health services from fee-for-
service Medicaid or an MCO.
Response: We acknowledge the potential benefits of a real-time
notification of emergency department visits, but we decline to finalize
a broader requirement including notification of emergency department
visits at this time. We believe the greatest opportunity to target
interventions and improve outcomes is after a hospital or SNF admission
where there is more time to initiate discharge planning. However, as
noted in the proposed rule, so long as the requirements of Sec.
422.107(d) are met, a state Medicaid agency could choose to require a
notification for full-benefit dual eligible individuals enrolled in a
D-SNP who are high utilizers of emergency departments, where there may
be opportunities to address barriers to accessing primary care and
unmet health care needs.
Comment: One commenter recommended that CMS improve person-centered
decision making during care transitions by using protocols for
communication and coordination similar to interdisciplinary team models
or California's guidance for MMPs on hospital discharge planning.
Response: We appreciate the commenter's suggestion and will
consider this input as we develop technical assistance and identify
best practices following the implementation of this final rule.
Comment: One commenter expressed support for state flexibility in
determining the timeline for the notification, while several commenters
expressed concerns about the lack of a specific timeliness requirement.
Several commenters requested that CMS require a specific timeframe for
reporting. A few commenters believed that the 48-hour requirement
discussed in our proposed rule preamble as an alternative for
consideration was reasonable and synchronized well with requirements
for discharge notices. One commenter suggested that CMS ensure that any
timeframes imposed by states begin after the health plan has received
the admissions data. A few commenters expressed concern that the
notifications would not be timely and therefore would not be helpful in
care coordination. One commenter requested that CMS clarify its intent
for requiring states to collect this admissions information.
Response: We appreciate comments on the timing and timeliness of
the notification requirement. We believe that states may choose to use
the notification for a variety of purposes, including coordination of
care at the point of hospital or SNF discharge. When establishing a
timeframe, we encourage the states to consider the current process for
how D-SNPs in their markets receive admissions information to reduce
burden on D-SNPs and their provider networks. Because these processes
vary by state, we are not inclined to specify timing requirements for
these notifications at this time. However, we may consider a timeliness
standard in future rulemaking based on our experience implementing the
provisions of this final rule.
Comment: Several commenters expressed support for the alternative
we noted for consideration in the proposed rule that would establish
requirements for coordination of individual health needs or risk
assessments between D-SNPs and Medicaid MCOs. These commenters
generally recommended that CMS encourage, but not require, D-SNPs to
make every effort to coordinate the assessment due to concerns about
feasibility. A few commenters noted that coordination could result in
delays in administering the assessment. One commenter noted that
guidelines for the coordination of assessments would be more
appropriate in subregulatory guidance or state contracts, rather than
as a regulatory requirement. Another commenter requested that CMS
consider requiring D-SNPs to share assessment findings with
coordinating plans. One commenter noted this could be an area for
future integrated requirements for exclusively aligned plans.
Response: We agree with commenters' concerns regarding the
feasibility of coordinating individual health needs or risk
assessments. We believe the pervasiveness of this issue and the extent
of overlap in assessment instruments varies across state lines and
requires further study. We are therefore declining to add this
requirement to D-SNP state Medicaid agency contract requirements at
Sec. 422.107 at this time.
Comment: One commenter supported requiring that D-SNPs identify and
notify states of enrollees in need of LTSS or behavioral health
services to promote care coordination and improve outcomes.
Response: We thank the commenter. Although we considered this
alternative in the proposed rule, we note that D-SNPs are already
required, at Sec. 422.101(f), to develop individualized care plans and
perform health risk assessments that identify the physical,
psychosocial, and functional needs of each SNP enrollee. Additionally,
D-SNPs have the responsibility to coordinate the delivery of Medicare
and Medicaid services consistent with the D-SNP definition at Sec.
422.2 finalized in this rule. We do not believe the burden associated
with an additional requirement to proactively identify for the state
enrollees in need of LTSS or behavioral health services is advisable
given the potential overlap with these existing requirements. We are
therefore not modifying our proposed notification requirement to
include notification of enrollees in need of LTSS or behavioral health
services.
Comment: A few commenters supported the alternative CMS considered
in the proposed rule that states provide input on the plan's model of
care, health risk assessment instrument, and beneficiary communication
materials. One commenter noted this requirement would ensure that
states stay active in their role as health insurance regulators and
that beneficiary materials have correct state-specific information.
Response: We thank commenters for their input, but we remain
disinclined to impose such a requirement on D-SNPs that do not have
exclusively aligned enrollment. We believe this requirement would
create additional burden for states without capitated arrangements with
D-SNPs for the provision of Medicaid services, as Medicaid agencies may
not see a role for themselves in reviewing such documents. We note that
state Medicaid agencies can choose to require that a D-SNP provide such
documents for state input through their contracts with D-SNPs, and
that--as discussed earlier in this preamble--CMS has worked with
several states with integrated D-SNPs to develop more streamlined and
[[Page 15716]]
integrated beneficiary communications materials.
Comment: A few commenters supported additional or alternative data-
sharing requirements for D-SNPs to comply with the statutory
requirements for integration. One commenter requested that CMS provide
any existing analysis on whether the notification of an admission to a
hospital or SNF is more beneficial than sharing other information, such
as enrollment information and care coordination contacts.
Response: While there may be additional or different requirements
that would facilitate D-SNPs' integration of Medicare and Medicaid
benefits, we are choosing to initially focus on a notification
requirement for hospital and SNF admissions, which we believe will lead
to more immediate improvements in the care transition process, while
preserving state and plan flexibility and minimizing burden. After we
gain sufficient experience in implementing the notification requirement
we are finalizing in this rule, we will assess whether changes are
necessary to achieve additional integration.
Comment: A few commenters supported inclusion of a requirement,
consistent with the example included in section 1859(f)(8)(D)(i)(I) of
the Act that a D-SNP demonstrate its integration of Medicare and
Medicaid benefits by assigning one primary care provider for each
enrollee. One commenter requested clarification as to why this specific
requirement was not included in the proposed rule, noting that the
primary care provider is the coordinator of the beneficiary's entire
spectrum of care and a critical liaison between the beneficiary and the
plan.
Response: We agree with the commenter's statement about the
importance of a primary care provider, but we decline to require D-SNPs
to assign a primary care provider for each enrollee as a minimum
standard for integration. We considered the value of such a requirement
but were unable to determine how meaningfully it would advance
integration. We also note that, consistent with Sec. 422.112(a)(2),
all MA organizations offering an MA coordinated care plan, including
those offering D-SNPs, must establish a panel from which an enrollee
may select a primary care provider and are permitted to assign a
primary care provider in limited circumstances. We are concerned that
establishing a primary care provider assignment requirement may
conflict with enrollee choice provisions at Sec. 422.112(a)(2).
Comment: One commenter supported a requirement that D-SNPs submit
to the state Medicaid agency the name and contact information for their
designated care coordinators.
Response: We appreciate this suggestion but decline to make this
change to our regulatory requirements at this time due to the burden on
D-SNPs provide and update this information and on states to
meaningfully use this information. We will consider this suggestion for
future rulemaking.
Comment: One commenter recommend that CMS establish data reporting
requirements that address integrated care and incorporate LTSS, such as
requiring reporting of quarterly care coordination and LTSS referral
data.
Response: We thank the commenter and will consider this suggestion
for future rulemaking.
Comment: One commenter requested clarification on whether CMS
intended for the notification requirement to include discharges as well
as admissions.
Response: We chose to focus on notification of admissions to allow
states to initiate care coordination activities prior to discharge. Our
proposal deliberately did not address discharges due to concerns that
care coordination activities would not be timely if they begin after a
discharge takes place. However, we note that states are not precluded
from adding a notification requirement for discharges through the state
Medicaid agency contracts with D-SNPs under Sec. 422.107.
Comment: One commenter recommended that CMS stop new enrollment
into D-SNPs that are not contracted by the state to provide Medicaid
benefits, and that CMS also require these D-SNPs to establish
meaningful and timely data exchange and coordination processes with the
state or MCOs for existing beneficiaries to ensure timely access to
Medicaid benefits.
Response: We believe that the commenter's recommendation goes
beyond section 1859(f)(8)(D)(i)(I) of the Act, which envisions a
pathway for D-SNPs to remain an option in states that do not pursue a
selective contracting model, subject to additional integration
requirements established by CMS in this final rule. We will, however,
continue to assess opportunities to promote greater levels of aligned
enrollment. We note that states may establish additional requirements
for data exchange and coordination in their state Medicaid agency
contracts with D-SNPs.
Comment: A few commenters requested exceptions to the notification
requirement. One commenter requested clarifications on possible
exemptions for some non-integrated D-SNPs. Another commenter
recommended that D-SNPs providing some Medicaid services, but not
providing LTSS or behavioral health services, be recognized as more
integrated than plans that do not provide any Medicaid services and
therefore be allowed additional flexibility on the data elements D-SNPs
are required to share with the state.
Response: Section 1859(f)(8)(D)(i)(I) of the Act is clear that D-
SNPs that do not (i) meet the requirements of a FIDE SNP nor (ii) enter
into a capitated contract with the state Medicaid agency to provide
LTSS, behavioral health services, or both, must meet additional
criteria for integration; CMS is establishing those criteria in this
final rule. We are therefore unable to exempt D-SNPs that do not meet
the definitions of either a FIDE SNP or a HIDE SNP established in this
final rule from the notification requirement. We will consider the
utility of establishing additional granularity with respect to D-SNP
integration levels but note that such additional granularity is not
relevant to D-SNPs' compliance with the statutory provisions regarding
D-SNP integration.
Comment: One commenter requested that CMS extend the proposed D-SNP
notification requirements to FIDE SNPs and HIDE SNPs when the affected
member is not receiving all Medicaid services through the SNP.
Response: We appreciate the commenter's suggestion to hold FIDE
SNPs and HIDE SNPs to the same standard as other D-SNPs required to
comply with the notification requirement for their unaligned members.
However, we believe that most FIDE SNPs and HIDE SNPs already
demonstrate a level of Medicare-Medicaid integration through the
provision of Medicaid benefits through a capitated arrangement with the
state Medicaid agency, such that exchanging admission data about
specified high-risk dual eligible enrollees would have less impact
relative to the costs of compliance. We decline to accept the
commenter's recommendation, as we believe it would be burdensome for
plans that already provide a higher level of integration than plans
that provide few or no Medicaid benefits to their enrollees. As
discussed in section II.A.2.a.(1) of this preamble, we note that FIDE
SNPs and HIDE SNPs are also required to coordinate their coverage with
their members' Medicaid benefits.
Comment: Several commenters supported our proposal at Sec.
422.107(c)(2) that the contract between
[[Page 15717]]
the D-SNP and the state Medicaid agency document not only the
categories of dual eligible individuals who may enroll in the D-SNP but
also any additional criteria of eligibility.
Response: We appreciate the commenters' support and are finalizing
this provision without modification.
Comment: Several commenters supported our proposed change to Sec.
422.107(c)(3) that would require the contract between the D-SNP and the
state Medicaid agency to document the Medicaid services the D-SNP is
responsible for covering in accordance with a capitated contract with
the D-SNP either directly or through a companion Medicaid managed care
organization operated by the D-SNP's parent organization. One of these
commenters specifically noted that the revised contract requirement may
help CMS achieve greater consistency in determining whether a D-SNP is
a FIDE SNP or a HIDE SNP. A few commenters recommended that the D-SNP's
state Medicaid agency contract also include a list of all Medicaid
covered services, but specifically identify those covered by the D-SNP.
One commenter recommended that in cases where the state Medicaid agency
contract encompasses all the requirements in Sec. 422.107 as amended
and already clearly distinguishes between plan covered and non-covered
Medicaid benefits, a separate document duplicating this information
should not be required. Another commenter requested clarification
regarding the intent of this provision, citing concerns that CMS'
intent could be misconstrued as requiring D-SNPs to offer Medicaid
benefits under a capitated contract with the state.
Response: We thank commenters for their support of this revised
contracting requirement for D-SNPs. We decline to accept the
recommendation that the state Medicaid agency contract also include a
list of all Medicaid-covered services, including those not covered by
the D-SNP or an affiliated MCO. We believe this change to the current
contracting requirement will reduce burden on D-SNPs to identify and
document in the contract every Medicaid-covered service. D-SNPs often
submit to CMS a list of all Medicaid services in their state Medicaid
agency contracts, even those for which the D-SNP is not under a
capitated contract and for which the D-SNP bears no risk. We clarify
that our modified requirement does not impact current processes for
state Medicaid agency contract submission and approval. We also clarify
that this provision in no way precludes a D-SNP that does not provide
any Medicaid services--and otherwise meets all relevant regulatory
requirements--from continuing to contract with CMS to operate as a D-
SNP. We are also simplifying the language at Sec. 422.107(c)(3) to
ensure all potential variations of D-SNP contracting arrangements to
cover Medicaid services are documented in the state Medicaid agency
contract. Specifically, we are revising the requirement such that the
D-SNP must document any Medicaid benefits covered by the MA
organization offering the D-SNP, whether under a capitated contract
with the state Medicaid agency, by the D-SNP's parent organization, or
by another entity that is owned and controlled by its parent
organization.
After consideration of the comments we received, we are finalizing
our proposed amendments to Sec. 422.107(b) as proposed. We are
finalizing our proposed amendments to Sec. 422.107(c)(1), (c)(2),
(c)(3), (d) and (e)(2) substantively as proposed but with some minor
modifications from the proposal.
We are making a technical, non-substantive change to
replace the term ``dual-eligible'' with the term ``dual eligible'' in
paragraph (a), which is consistent with the revision to the section
heading for Sec. 422.107 in the proposed and final rules.
As discussed in section II.A.2.a.(1) of this final rule,
to better align with our final definition of a D-SNP, we are finalizing
the regulation with a new paragraph (c)(1)(i) to clarify that the D-SNP
must document its responsibility to coordinate the delivery of Medicaid
benefits for individuals who are eligible for such services, and a new
paragraph (c)(1)(ii) to clarify that, to the extent a D-SNP provides
coverage of Medicaid benefits--including LTSS and behavioral health
services--for individuals eligible for such services, it must also
document in the state Medicaid agency contract its responsibility to do
so.
As proposed with minor grammatical corrections, we are
finalizing paragraph (c)(2) to require the contract to document the
categories and criteria for eligibility for dual eligible individuals
to be enrolled under the SNP, including as described in sections
1902(a), 1902(f), 1902(p) and 1905 of the Act.
We are finalizing paragraph (c)(3) with revisions to
clarify the requirement of the contract such that the D-SNP must
document any Medicaid benefits covered under a capitated contract
between the state Medicaid agency and either: (1) The MA organization
offering the D-SNP; (2) the D-SNP's parent organization; or (3) the
another entity that is owned and controlled by the D-SNP's parent
organization.
In addition, as discussed in section II.A.2.b.(2) of this final
rule, we are finalizing new text in a new paragraph (c)(9) to address
the requirement under section 1859(f)(8)(C) of the Act that contracts
between D-SNPs that are applicable integrated plans, defined in Sec.
422.561, and the state Medicaid agency require the use of unified
grievance and appeals procedures.
We are finalizing paragraph (d) with modifications to the
regulatory text clarifying the responsibility of a D-SNP with the
phrase ``the SNP notifies or arranges for another entity or entities to
notify . . .'' in place of the proposed text ``the SNP will notify or
authorize for another entity or entities to notify . . .'' and making
edits to clarify that states can require D-SNPs to send notification of
an admission to the state, individuals or entities designated by the
state, or both.
Lastly, we are finalizing paragraph (e)(2) as proposed and
with a citation to paragraph (c)(9) as well as paragraph (d) to clarify
that this state Medicaid agency contracting requirement is applicable
beginning January 1, 2021.
(3) Conforming and Technical Changes (Sec. Sec. 422.60(g), 422.102(e),
422.107(b), and 422.111(b)(2)(iii))
In the proposed rule, we also proposed to make the following
conforming changes to several sections of Part 422 that address D-SNPs
by adopting consistent terminology with respect to dual eligible
individuals and creating cross-references to the newly proposed
definitions.
First, at Sec. 422.60(g), which addresses CMS authority
to implement passive enrollment, we proposed to use the term ``highly
integrated dual eligible special needs plan'' in place of text
referring to D-SNPs that meet a high level of integration, consistent
with our proposed definition in Sec. 422.2. As discussed in the
proposed rule, this technical change would not materially change the
plan types that are eligible for passive enrollment; the existing rule
simply refers to them as D-SNPs that meet a high standard of
integration under the supplemental benefits authority at Sec.
422.102(e).
Second, we proposed clarifying at Sec. 422.102(e) that
not only HIDE SNPs meeting minimum quality and performance standards
are eligible to offer supplemental benefits, but FIDE SNPs that
similarly meet minimum quality and performance standards may do so as
well.
[[Page 15718]]
Third, in the general rule at Sec. 422.107(b), we
proposed to substitute a ``special needs plan serving beneficiaries
eligible for both Medicare and Medicaid (dual-eligible)'' with ``dual
eligible special needs plan.''
Finally, at Sec. 422.111(b)(2)(iii), which requires D-
SNPs to provide written information to dual eligible enrollees about
their eligibility for cost-sharing protections and Medicaid benefits,
we proposed to use the term ``dual eligible special needs plan''
consistent with the proposed definition.
We received the following comments and our responses follow.
Comment: One commenter noted their appreciation of our proposed
clarification at Sec. 422.102(e) that both FIDE SNPs and HIDE SNPs
meeting minimum quality and performance standards are eligible to offer
supplemental benefits. Another commenter requested that we clarify that
current flexibilities with respect to supplemental benefits will
continue for all FIDE SNPs and HIDE SNPs. Several commenters requested
that CMS provide additional guidance about the supplemental benefits
HIDE SNPs and FIDE SNPs may offer, noting recent regulatory changes
that provide flexibility in the Medicare Advantage uniformity
requirements and expand the definition of ``primarily health related''
benefits, as well as new requirements in the Bipartisan Budget Act of
2018 that provide additional benefit flexibility for chronically ill
enrollees.
Response: We appreciate the commenters' support for the technical
change we proposed at Sec. 422.102(e), and we clarify that this
conforming change does not impact current policy related to
supplemental benefits for HIDE SNPs and FIDE SNPs. While we appreciate
the complexities of recent legislative and regulatory changes related
to permissible Medicare Advantage supplemental benefits and the need
for clear guidance that several commenters raised, those comments are
outside the scope of this regulation. For more information regarding
newly expanded supplemental benefit offerings and flexibilities for all
MA plan types, please refer to the CY 2019 and CY 2020 Call
Letters.\22\ We are therefore finalizing our changes to Sec.
422.102(e) as proposed.
---------------------------------------------------------------------------
\22\ See https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents.html.
---------------------------------------------------------------------------
After consideration of the comments we received, we are finalizing
Sec. 422.102(e) without modification. We received no comments on our
proposed conforming changes to Sec. 422.60(g), the general rule at
Sec. 422.107(b), and Sec. 422.111(b)(2)(iii) and are also finalizing
those provisions without modification.
(4) Eligibility of Partial-Benefit Dual Eligible Individuals for Dual
Eligible Special Needs Plans
The preamble to our proposed rule included discussion about an
alternative we considered to propose limits on the enrollment of
partial-benefit dual eligible individuals in D-SNPs, since there are no
Medicaid services that the D-SNP is integrating or coordinating on
their behalf. While we ultimately decided against proposing any such
limits on enrollment in the proposed rule, we invited comments on this
topic. We received the following comments, and our responses follow.
Comment: Several commenters suggested that CMS establish
prohibitions on the enrollment of partial-benefit dual eligible
individuals in D-SNPs. A few commenters suggested establishing separate
D-SNPs exclusively for partial-benefit dual eligible individuals whose
primary focus would not be on integrating Medicare and Medicaid
benefits but rather on caring for a more complex population than a
traditional MA plan.
MedPAC opined that D-SNPs can do little to promote greater
integration for partial-benefit dual eligible individuals and noted
that, based on their analysis of person-level quality data from HEDIS,
D-SNPs perform about the same as regular MA plans for this population.
MedPAC noted the greater likelihood of D-SNPs offering supplemental
benefits attractive to partial-benefit dual eligible individuals than
other MA plans. Consistent with its June 2018 report to the Congress
and at its November 2018 meeting, the Commission described two
potential ways of pursuing greater levels of integration: (1) Limiting
enrollment in D-SNPs to dual eligible individuals who qualify for full
Medicaid benefits or (2) requiring MA plan sponsors to have separate D-
SNPs (distinct plan benefit packages) for full-benefit and partial-
benefit dual eligible individuals.
A number of commenters opposed any limits on the enrollment of
partial-benefit dual eligible individuals in D-SNPs, however. These
commenters cited various rationales for the value of these
beneficiaries' enrollment in D-SNPs, including the relative medical
complexity of partial-benefit dual eligible individuals compared to
non-dual eligible individuals; the value of the D-SNP care model,
including additional care coordination, Medicare benefits, navigation
assistance, individual health risk assessments, care plans, and
interdisciplinary care teams; the propensity for churn between various
dual eligibility categories and the value of D-SNPs in facilitating
movement to full benefit dual eligibility status; and the potential for
additional value for this population through new supplemental benefits
flexibilities implemented by CMS that might prevent the need for
medical spend-down to full benefit dual eligibility status. Several
commenters recommended that CMS defer to states on defining eligibility
requirements for D-SNPs. Another commenter noted that Congress did not
explicitly instruct CMS to prevent partial-benefit dual eligible
individuals from accessing D-SNPs. One commenter noted the variance in
eligibility requirements for partial-benefit dual eligibility across
states. One commenter recommended that CMS consider administrative
changes to resolve the complexities related to integration presented by
this population--for example for member materials and appeals and
grievances.
A few commenters requested that, to the extent CMS continues to
permit the enrollment of partial-benefit dual eligible individuals in
D-SNPs, D-SNPs should be required to show how they will meet the needs
of these enrollees a way that is distinct from the benefits that a non-
D-SNP MA plan would offer, and that CMS measure and evaluate these
additional benefits. These commenters also recommended that CMS place
marketing restrictions on D-SNPs so they cannot primarily target
partial-benefit dual eligible individuals, who may have lower acuity
and less significant health care needs than full-benefit dual eligible
individuals, and to carefully monitor enrollment patterns.
Response: We thank the commenters for the feedback on this issue.
As we stated in the proposed rule, we continue to question the benefit
that partial-benefit dual eligible individuals derive from their
enrollment in a D-SNP relative to the challenges associated with
allowing such enrollment. Although we did not propose, and therefore
are not finalizing, any changes to how partial-benefit dual eligible
individuals may enroll in D-SNPs, we share many of the concerns
articulated by some comments, including those of MedPAC. CMS may
consider future rulemaking in this area.
Comment: A commenter pointed to the definition of a D-SNP in the
statute as limiting enrollment to only those ``special needs
individuals who are entitled to medical assistance under a State plan
under XIX of the Act'' and requested confirmation from CMS that we
discontinue enrollment of partial-
[[Page 15719]]
benefit dual eligible individuals in D-SNPs when there is no Medicaid
benefit they can coordinate for those enrollees.
Response: We note that neither the MA statute nor current MA
regulations prohibit the enrollment of partial-benefit dual eligible
individuals in D-SNPs, although states may choose to do so through
their contracts with D-SNPs. We are not finalizing any change in that
policy in this final rule.
Comment: A commenter recommended that CMS consider granting
eligibility for Qualified Medicare Beneficiaries to enroll in MA-only
D-SNPs and requested that reimbursement rates for such enrollees be
structured to accurately reflect the resources needed to adequately
provide care to such complex populations.
Response: We note that these comments are somewhat outside the
scope of our proposed rule. Further, D-SNPs must provide Part D
prescription drug coverage, pursuant to Sec. 422.2, as part of a
comprehensive Medicare benefit package; therefore, D-SNPs may not offer
MA-only coverage. In response to concerns about the accuracy of the
CMS-Hierarchical Condition Category (HCC) risk adjustment model for
predicting costs of dual eligible individuals, CMS analyzed how well
the model performs for various types of beneficiaries. As a result of
this analysis, CMS implemented significant changes to the HCC model in
CY 2017.
(5) Suspension of Enrollment for Non-Compliance with D-SNP Integration
Standards (Sec. 422.752)
Section 50311(b) of the Bipartisan Budget Act of 2018 amended
section 1859(f) of the Act by creating a new paragraph (8)(D)(ii) to
permit the Secretary, for plan years 2021 through 2025, to impose an
intermediate sanction of stopping all new enrollment into a D-SNP if
the Secretary determines that the D-SNP is failing to comply with the
integration requirements set forth in section 1859(f)(8)(D)(i) of the
Act. We proposed to amend Sec. 422.752 by adding a new paragraph (d)
to require CMS to impose an enrollment suspension when CMS finds that
the plan is non-compliant with the integration requirements during plan
years 2021 through 2025, rather than initiating outright termination.
We stressed in the proposed rule that we interpreted this proposal as
leaving discretion for CMS, if the D-SNP does not submit an acceptable
corrective action plan or fails to abide by the correction action plan,
to determine that contract termination or other enforcement action or
sanction could also be imposed. In addition, in the event that any harm
to enrollees is imminent, we explained how we would retain authority to
immediately terminate the contract. We also proposed in Sec.
422.752(d) that the suspension of enrollment would continue in effect
until CMS is satisfied that the deficiencies that are the basis for the
sanction determination have been corrected and are not likely to recur.
We stated that the procedures, remedies, and appeal rights available to
plans subject to intermediate sanctions provided in Sec. 422.756 apply
to D-SNPs that are sanctioned under this new authority.
Comment: Several commenters supported CMS' interpretation of the
statute to impose an intermediate sanction to suspend enrollment
instead of an immediate contract termination for D-SNPs that fail to
meet the integration standards by contract year 2021. A few commenters
requested that CMS consider not penalizing D-SNPs when state decisions
impede integration or the state does not have the interest and capacity
to facilitate D-SNP compliance with the integration requirements. Some
commenters recommended that CMS evaluate the implementation of these
sanctions in order to make recommendations on how CMS should sanction
D-SNPs that do not meet the integration standards beyond 2025. Another
commenter provided recommendations, summarized elsewhere in final rule,
on how CMS can support and incentivize states to move toward
integration.
One commenter agreed with CMS' position that non-compliance with
the integration standards should not lead directly to contract
termination but noted that the enrollment sanction is at the discretion
of CMS. The commenter recommended that CMS not immediately impose an
enrollment sanction for minor compliance issues around the integration
requirements and, rather, only impose an enrollment sanction for non-
compliance that is a serious threat to the health and safety of
Medicare beneficiaries and let lesser violations be handled through
other compliance actions (notices of non-compliance, corrective action
plans, and civil monetary penalties).
Response: We appreciate the overall support for our proposal to
require CMS to impose an enrollment suspension when we find a D-SNP to
be out of compliance with the integration requirements in the final
rule during plan years 2021 through 2025. We disagree with the
commenter urging us adopt a standard for imposing an intermediate
sanction based only on whether a D-SNP's integration approach is a
serious threat to the health and safety of its enrollees. As we
discussed in the preamble to the proposed rule, by establishing
statutory requirements that established a minimum level of integration
of D-SNPs in section 50311 of the Bipartisan Budget Act of 2018, we
believe the goal was for beneficiaries enrolled in D-SNPs to receive a
greater level of integration of Medicare and Medicaid benefits than is
the case under current regulations. Because the Bipartisan Budget Act
of 2018 limited the applicability of the Secretary's authority to
impose an intermediate sanction on plans that do not comply with the
integration requirements to plan years 2021 through 2025, we believe
that the intent of this provision is to offer an alternative to
outright contract or plan termination for D-SNPs that fail to meet the
new integration requirements during the period of 2021 through 2025.
With respect to commenters' concerns about penalizing plans, we note
that since the authority to impose the intermediate sanction is
specific to a D-SNP's non-compliance with the Medicare and Medicaid
integration standards finalized in this rule, we intend to consider
whether imposition of intermediate sanctions would be most appropriate
at the plan, rather than contract, level for each affected Medicare
Advantage organization. We expect such determinations to be tied to the
facts of each specific situation.
In addition to authorizing this lesser sanction, the statute
requires a corrective action plan, which we believe strengthens our
interpretation, as it illustrates a preference for ultimate compliance
by D-SNPs with the integration requirements. The statute authorizes
this lesser sanction but does not require that it be used, leaving it
to our discretion whether an enrollment sanction combined with a
corrective action plan is sufficient to achieve the goals of the
statute. We believe that imposing an intermediate sanction to suspend
enrollment establishes predictability for states, beneficiaries, and MA
organizations by requiring its imposition for non-compliant plans in
lieu of termination or other actions. CMS retains discretion--for
example, if the D-SNP does not submit an acceptable corrective action
plan or fails to abide by the corrective action plan--to determine that
contract termination or other enforcement action or sanction is still
possible. In addition, in the event circumstances warrant--for example,
when any harm to beneficiaries is imminent--we retain authority to
immediately terminate the contract. We
[[Page 15720]]
are therefore finalizing our proposal on intermediate sanctions without
modification.
As discussed elsewhere in this final rule, CMS is committed to
working with stakeholders and providing technical assistance and
additional guidance to states and D-SNPs to facilitate compliance with
the integration requirements in this final rule. We will evaluate
application of our sanction authority and consider any additional
changes or clarifications, including with respect to sanctions for
those D-SNPs that fail to meet the integration requirements for plan
years after 2025.
Comment: One commenter recommended that CMS' imposition of
sanctions be delayed until 2023 to accommodate necessary contracting
and systems changes. This commenter also recommended that CMS impose
sanctions only in states where the state Medicaid agency has
successfully integrated with other D-SNPs using the specific
integration standards the state has selected. Another commenter urged
CMS to consider the integration standards to be met, and an enrollment
sanction not required, if the notification language requirement
discussed in section II.A.2.a.(2) of this final rule is in the state
Medicaid agency contract in 2021, even if not implemented until 2022.
Response: The Bipartisan Budget Act of 2018 specifically allows for
the imposition of any enrollment sanctions related to non-compliance
with the D-SNP integration standards established in this final rule be
applied with respect to plan years 2021 through 2025. In addition, we
note that the Bipartisan Budget Act of 2018 requires all D-SNP
integration criteria established by CMS to be effective starting for
the 2021 plan year. The timing for the publication of the provisions
set forth in this final rule in the allows D-SNPs ample opportunity to
negotiate with states and address issues requiring changes in the state
Medicaid agency contracts prior to the start of the 2021 plan year.
Therefore, solely including the notification requirement language in a
D-SNP's state Medicaid agency contract without implementing the process
as required by that state would render a D-SNP out of compliance with
Sec. 422.107(d).
After consideration of the comments we received, we are finalizing
our proposal regarding CMS' imposition of intermediate sanctions for
non-compliance with D-SNP integration standards without modification.
b. Unified Grievance and Appeals Procedures for Dual Eligible Special
Needs Plans and Medicaid Managed Care Plans at the Plan Level
(Sec. Sec. 422.560-562, 422.566, 422.629-634, 438.210, 438.400, and
438.402)
Section 1859(f)(8)(B) of the Act, as added by the Bipartisan Budget
Act of 2018, directs the Secretary to establish new procedures that
unify, to the extent feasible, Medicare and Medicaid grievance and
appeals procedures for D-SNPs. This new authority provides an important
opportunity to address an area of longstanding misalignment between the
Medicare and Medicaid programs. Medicare and Medicaid grievance and
appeal processes have developed independently and operate entirely
separately. Medicare's fee-for-service appeals processes (authorized
primarily under section 1869 of the Act for Part A and B claims
appeals), and MA's processes (authorized under sections 1852(f) and
1852(g) of the Act for grievance and appeal processes) are subject only
to federal regulation and oversight as part of the federally-
administered Medicare program. Medicaid grievances and appeals are
authorized under sections 1902(a)(3) and 1902(a)(5) of the Act for
Medicaid programs more generally and section 1932(b)(4) of the Act for
Medicaid managed care plans. Unlike Medicare and MA, Medicaid appeals
and grievance procedures are subject to both federal and state
regulation and are primarily subject to state oversight and
administration as part of a joint federal-state financed program.
Medicare Part D grievances and appeals are authorized under sections
1860D-4(f) and (g) of the Act and are outside the scope of our
authority to unify grievances and appeals under new section
1859(f)(8)(B) of the Act; we note, however, that D-SNPs are all
required to provide Part D prescription drug coverage pursuant to Sec.
422.2 (in the definition of a specialized MA plan for special needs
individuals), and are therefore subject to the Part D appeals
requirements in connection with Part D benefits.
Both the Medicare and Medicaid grievance and appeals systems
include regulations establishing procedures for the fee-for-service
programs as well as regulations governing managed care plans, including
processes at the plan and post-plan levels for adjudicating appeals.
Medicare rules are found at 42 CFR part 405 subpart I (general) and
part 422 subpart M (Medicare Advantage); Medicaid rules are at 42 CFR
part 431 subpart E (general) and part 438 subpart F (managed care).
Regulations for the Medicare and Medicaid programs take broadly similar
approaches to managed care appeals in that both programs establish a
process for resolving a dispute at the plan level initially, followed
by an opportunity for post-plan review. However, these appeals systems
operate independently with sometimes subtle but important differences
related to notices, adjudication timeframes, availability of benefits
continuing while the appeal is pending, and levels of review.
Similarly, regulations for the Medicare and Medicaid programs take
different approaches with respect to some processes for grievances,
including filing and adjudication timeframes and the availability of an
expedited grievance process.
Although comparatively few beneficiaries file grievances or
appeals,\23\ these processes are vital safeguards to ensure that
beneficiaries' concerns and needs are met promptly. Because of Medicare
and Medicaid's misalignments in this area, beneficiaries who are dually
eligible for Medicare and Medicaid can face a confusing array of
choices when they seek to file a grievance or appeal. They may not know
whether their complaint is tied to Medicare or Medicaid, and thus may
not know where to direct their grievance. They may be uncertain if the
item or service they seek is covered by Medicare, by Medicaid, or
potentially by both programs, and thus may not know when or where to
file an appeal following the denial of a service. The issue is
particularly complicated for items and services such as home health and
certain durable medical equipment that are sometimes covered by both
programs but under different circumstances.
---------------------------------------------------------------------------
\23\ For example, in 2016, Medicare Part C plans reported 2.93
complaints (grievances) per 1,000 enrollees per month and 19.3
reconsideration requests (appeals) per 1,000 enrollees per month.
See Analysis of Calendar Year 2016 Medicare Part C Reporting
Requirements Data, available at https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/PartCDDataValidation.html.
---------------------------------------------------------------------------
This confusion for beneficiaries and for those assisting them can
result in costly and inefficient duplication of effort, as
beneficiaries may file grievances and appeals under both programs when
only one was necessary. Health plans and federal and state agencies may
incur additional burdens and costs from having to administer parallel
appeals systems. Finally, these misalignments may lead to unintended
harms in the form of delayed or denied access to needed services as
beneficiaries expend time and energy pursuing ultimately fruitless
appeals in
[[Page 15721]]
one program when they should have been pursuing them in the other.
As summarized in our proposed rule, we have made previous efforts
to better align Medicare and Medicaid grievances and appeals for dual
eligible individuals, including the integrated initial level of appeal
in the Programs of All-inclusive Care for the Elderly (PACE). The
operation of Medicare-Medicaid Plans (MMPs) in the CMS' Financial
Alignment Initiative capitated model demonstrations has provided us
with the most extensive experience integrating grievances and appeals
for dual eligible individuals in the managed care setting. Our
experience with MMPs suggests that, although implementing a new system
can be challenging, once in operation, integrated grievance and appeals
systems can be simpler for beneficiaries to navigate than separate
systems for Medicare and Medicaid.
Under the newly enacted amendments to section 1859(f)(8)(B) of the
Act, the Secretary is required to establish, not later than April 2020
and for inclusion in contracts for D-SNPs for 2021 and subsequent
years, procedures unifying grievances and appeals procedures consistent
with several principles:
Under paragraph (8)(B)(ii), the new unified procedures
must include provisions that are most protective for the enrollee and,
to the extent feasible as determined by the Secretary, are compatible
with unified timeframes and consolidated access to external review. The
statute requires that the procedures take into account differences
under state Medicaid plans, and be easily navigable by enrollees.
Additionally, under paragraph (8)(B)(iii), the integrated
processes implemented are required to include a single written notice
that includes all relevant grievance and appeal rights; a single
pathway for resolution of covered items and services; notices written
in plain English and available in languages and formats that are
accessible to enrollees (including in non-English languages that are
prevalent in the service area of the specialized MA plan); unified
timelines for processes such as filing, acknowledging, and resolving
the appeal or grievance; and requirements for plans to process, track,
and resolve the grievances and appeals to ensure enrollees are notified
timely of decisions and can track the status of their grievance or
appeal.
Finally, under paragraph (8)(B)(iv), new grievance and
appeals procedures must, with respect to all benefits under Medicare
Parts A and B and Medicaid subject to appeal under such procedures,
incorporate provisions under current law and implementing regulations
that provide continuation of benefits pending appeal under Title XVIII
and Title XIX. We address this statutory provision in section
II.A.2.b.(7).
Using this statutory framework, we developed the following goals to
guide development of the unified grievance and appeals provisions:
Adopt provisions that are most protective of the enrollee;
Reduce burden on beneficiaries (and those assisting them),
plans, states, and providers; and
Maintain state flexibility and minimize disruption by
building on existing rules and policies.
These policy goals also reflect our belief that timely, efficient,
accessible, and well-functioning grievance and appeals systems are
critical to ensuring that beneficiaries have access to needed items and
services. Such systems are especially vital for dual eligible
individuals who typically lack financial resources that might enable
other beneficiaries to pay out-of-pocket for needed items or services
while a dispute is pending. We requested comments regarding these
policy goals and the extent to which the proposed regulations are
consistent with them.
Our policy goal of minimizing disruption was also informed by
statutory language directing the Secretary to establish unified
provisions to the extent feasible (section 1859(f)(8)(B)(i) of the
Act). Consistent with this statutory standard, we primarily proposed
incremental changes that are currently feasible, conform to other
current law, and build upon existing systems.
Our proposals under the notice of proposed rulemaking were divided
into three substantively different types:
First, we proposed to establish requirements for all D-
SNPs, relative to the role they play in assisting full-benefit dual
eligible individuals, to assist with Medicaid-related coverage issues
and grievances (Sec. 422.562(a)).
Second, we proposed new requirements in accordance with
section 1859(f)(8)(B) of the Act to create integrated grievance and
appeals systems for a limited subset of D-SNPs (``applicable integrated
plans''), identified using terms and concepts we propose to define in
amendments to Sec. 422.561, with the integrated processes established
by proposed new regulations (Sec. Sec. 422.629-422.634).
Finally, we proposed a number of changes of a technical
and conforming nature to existing provisions in parts 422 and 438
(Sec. Sec. 422.560, 422.562, 422.566, 438.210, 438.400, and 438.402).
Section 1859(f)(8)(B)(i) of the Act requires the Secretary to
establish unified grievance and appeals procedures for D-SNPs not later
than April 2020, and section 1859(f)(8)(C) of the Act requires the use
of these unified procedures in D-SNP contracts for 2021 and subsequent
years. The statute does not, however, explicitly rule out the
possibility of implementing such unified processes prior to 2021. As
discussed in the proposed rule, we interpret the statute as permitting
a state to adopt unified grievance and appeals processes for integrated
D-SNPs and Medicaid plans in that state consistent with our final
regulations on this topic starting as soon as the regulations
establishing such procedures are final. Such a state could require
establishment of unified appeals and grievance procedures consistent
with CMS' regulations in its Medicaid agency contract required under
Sec. 422.107. We solicited comments on this interpretation of the
statutory implementation date requirements and our proposal to make
unified procedures available to states in this way before 2021.
In this final rule preamble, we summarize at a high level our
specific proposals for the unified appeals and grievance processes; we
direct readers to the proposed rule, 83 FR 55003 through 55013, for
more detailed discussion of the proposals and our rationale for them.
We received a number of comments on our proposals to implement these
unified appeals and grievance procedures, both in general and with
regard to specific proposals, and summarize the general comments as
follows:
Comment: We received numerous comments in support of our proposal
for unified plan-level appeals and grievance processes. Many commenters
supported our stated policy goals and agreed that the proposed
regulations were consistent with those goals. Several commenters
expressed support for our policy principle of choosing the most
beneficiary-friendly appeals processes and protections where there is a
discrepancy between Medicare and Medicaid rules. Many commenters noted
the current misalignment of administrative and operational process for
beneficiaries and plans in the Medicare and Medicaid appeals processes,
which confuses enrollees and reduces access to benefits, and
appreciated that our proposed appeals and grievance processes begin to
address some of these misalignments through a unified system that is
clearer
[[Page 15722]]
and easier to navigate for enrollees. One commenter expressed concern
that requiring D-SNPs, which typically also offer other non-D-SNP MA-PD
plans, to administer two separate grievance and appeal procedures is
overly burdensome. One commenter noted that it may not be possible to
implement the unified appeals and grievance processes in states with
consent decrees that limit plan-level appeals.
Response: We appreciate the broad support both for unified appeals
and grievance processes and for the policy goals underlying our
proposed process. We agree with those commenters who stated that the
unified processes will be clearer and easier to navigate for enrollees.
We expect the unified processes to apply to a relatively small subset
of D-SNPs and states. We note that, with respect to the concern about
the burden of D-SNPs administering separate grievance and appeals
processes, D-SNPs that contract to provide Medicaid benefits, including
applicable integrated plans that must comply with the unified appeal
processes addressed in this rule, currently administer two separate
processes--one for Medicare and one for Medicaid--in addition to
complying with specific appeal requirements for Part D benefits. Under
the unified approach we are finalizing, integrated applicable plans
will only administer one process for all non-Part D benefits. Thus,
while we understand that there may be some administrative burden in
setting up the new system, we believe that once the system is set up,
it should be more efficient for applicable integrated plans to
administer than the current system. We note that drugs covered by
Medicare Part D will continue to be processed under the separate Part D
appeals system in 42 CFR part 423. Appeals related to non-Part D drugs
covered by Medicaid for dual eligible individuals will go through the
unified appeals process as outlined in this final rule for applicable
integrated plans, described later in this final rule. We therefore do
not believe there will be additional burden for applicable integrated
plans. We also note that we will accommodate state circumstances, as
needed and possible, including where a state currently operates under a
consent decree.
Comment: A number of commenters noted the need for CMS to work
closely with states and other stakeholders where these unified
processes will be implemented to ensure a smooth implementation and
transition for enrollees and set clear expectations for applicable
integrated plans. Some commenters also noted the need for CMS to
release additional guidance prior to the implementation date and to
communicate the process clearly to enrollees. Several commenters
requested that we issue subregulatory guidance specifically addressing
the following topics: Allowing enrollees to raise secondary impact on
health based on the financial hardship of paying for services that were
not initially covered in post-service payment cases, repeat grievances,
and processing prescription drug appeals in the unified processes. A
commenter requested additional information on state regulations that
may need to change in order for the unified processes to be
implemented. Several commenters also recommended that CMS review best
practices and lessons learned in the Financial Alignment Initiative to
inform implementation of unified processes for D-SNPs. One commenter
questioned how states will react to implementing these requirements.
Another commenter noted that any new process will produce new confusion
among beneficiaries.
Response: We appreciate the commenters' concerns and anticipate
issuing subregulatory guidance to further clarify the unified
processes. As discussed throughout this preamble, we expect to continue
to engage states, plans, and other stakeholders as we implement the
requirements in this final rule, including providing technical
assistance to states, disseminating best practices (including from MMPs
participating in the Financial Alignment Initiative), and issuing
additional subregulatory guidance and model enrollee communications to
ensure a smooth implementation and to reduce any potential enrollee
confusion. We also note that, for most states that will be implementing
this new unified process, this final rule allows CMS 18 months prior to
the January 1, 2021, implementation date to work with states, plans,
and other stakeholders to ensure a smooth implementation.
Comment: One comment noted the importance of provider-neutral
language in the proposed rule, which is consistent with the statutory
language and recognizes the important variety of providers that serve
enrollees in Medicare and Medicaid.
Response: We appreciate the commenter's support of our use of the
term ``provider'' in the proposed rule and note that we are maintaining
the use of this term in the final rule.
Comment: One commenter observed that there is no mention of the
grievance and appeals processes for network providers, noting the lack
of a process for network providers under existing contract terms with
managed care plans and expressing concerns about potential retaliation
from managed care plans for filing appeals or complaints. The commenter
urged us to develop a process for network providers to file appeals and
grievances and ensure that network provider concerns are heard by
states and CMS.
Response: The unified process addressed in this final rule is for
coverage decisions made by the D-SNPs and the affiliated Medicaid
managed care plans with exclusively aligned enrollment. As is the case
under MA rules, disputes between network providers and the applicable
integrated plans are governed by their contracts with plans. Some
states do provide external processes for Medicaid network providers,
and these processes will remain available for Medicaid-related plan-
provider disputes. In addition, providers can file complaints with CMS
through the Complaint Tracking Module to raise issues and concerns to
CMS' attention.
Comment: One commenter requested that we include supplemental
benefits and long-term services and supports (LTSS) in the unified
grievance and appeals processes, similar to the current process in the
Cal MediConnect Financial Alignment Initiative demonstration.
Response: We clarify that any LTSS or supplemental benefits covered
by applicable integrated plans will subject to the unified grievance
and appeals processes we are finalizing in this rule, with the
exception that MA supplemental benefits are not subject to the
continuation of benefits pending appeal process finalized at Sec.
422.632 in this rule. Continuation of benefits pending appeal under
Sec. 422.632(b) is available only for ``benefits under Parts A and B
of title XVIII and title XIX.'' Please see section II.A.2.b.(7) of the
proposed and final rules for more discussion of this issue.
Comment: Several commenters requested clarification on the impact
of the unified grievance and appeals processes on applicable integrated
plans' Star Ratings. A commenter recommended a grace period to mitigate
this impact, and another recommended that we move the measures to the
display page during the transition to the new processes. Another
commenter requested more information on appeals and grievance reporting
processes. One commenter requested that we make timely plan-specific
grievance and appeals data available to the public.
Response: These comments are not strictly within the scope of our
final rule provisions establishing unified
[[Page 15723]]
grievances and appeals processes. We note, however, that we do not
expect Star Ratings to be negatively impacted by the unified grievance
and appeals processes. The Star Ratings measures focus on how timely
the MA plan sends the case to the IRE when the plan upholds its initial
adverse organization determination and whether the plan's decision was
upheld at the IRE. Under Sec. Sec. 422.590(d)(4) and 422.592, if, upon
reconsideration, an MA plan upholds its initial adverse organization
determination, it must submit the case file and its decision to the IRE
for automatic review. Under the unified appeals process, rules
governing submission of case files to the IRE when a plan upholds its
initial adverse organization determination are unchanged (see Sec.
422.634(b)). We expect that an applicable integrated plan could in fact
see a reduction in cases where the IRE reverses the applicable
integrated plan's integrated reconsideration determination for cases
where Medicare and Medicaid benefits overlap, since the applicable
integrated plan may approve the service or item under Medicaid coverage
and not have to issue a denial under Medicare. The applicable
integrated plans should then have fewer cases to auto-forward to the
IRE, and thus fewer cases that that the IRE could overturn and
negatively impact the plan's Star Ratings.
Comment: One commenter urged CMS to reconcile and align
requirements across multiple proposals aimed at reducing administrative
burdens on plans and beneficiaries, including those that appeared in
the proposed rule and in other proposals related to MA and step therapy
for Part B drugs.
Response: We appreciate this feedback and agree that internal
consistency is an important consideration in reducing administrative
burden and has been a priority throughout this rulemaking process.
Comment: A commenter recommended that we extend our enrollee
communications requirements to integrate all member-facing materials.
Response: We appreciate the suggestion. However, the requirements
of section 1859(f)(8)(B)(iii) of the Act apply only to notices required
under the unified appeals and grievance processes. We are therefore not
implementing requirements for other notices in this final rule.
However, as discussed elsewhere in this final rule, the Medicare-
Medicaid Coordination Office is working to improve and consumer test a
variety of beneficiary communications materials geared toward D-SNP and
MMP enrollees.
(1) Assisting With Medicaid Coverage Issues and Grievances (Sec.
422.562(a)(5))
As an incremental step towards improving all D-SNP enrollees'
experiences with accessing Medicaid benefits, and pursuing grievances
and appeals, we proposed new regulation text to require all D-SNPs to
assist beneficiaries with Medicaid coverage issues and grievances,
including authorizations for or appeals related to Medicaid-related
services at Sec. 422.562 by adding a new paragraph (a)(5). As
discussed in the proposed rule, these new requirements are consistent
with our existing guidance and expectations for D-SNPs, but we proposed
regulations to define their scope and set mandatory standards to which
we can hold D-SNPs accountable. We believe that all D-SNPs should
assist enrollees with resolving Medicaid coverage problems, including
assistance with filing grievances, requesting coverage, and requesting
appeals. Such assistance is consistent with the standard we proposed as
part of the definition of a D-SNP at Sec. 422.2. As noted in section
II.A.2.a.(1) of the proposed rule and this final rule, we are codifying
the statutory requirement at section 1859(f)(3)(D) of the Act that D-
SNPs arrange for their enrollee's Medicaid benefits as an explicit
requirement that D-SNPs coordinate the delivery of Medicare and
Medicaid services for individuals who are eligible for such services,
whether or not the D-SNP itself contracts with the state to provide
Medicaid services. We clarified in the proposed rule that the
requirements at Sec. 422.562(a)(5) were additional requirements for D-
SNPs, specifically related to assisting with access to benefits,
appeals, and grievances. At Sec. 422.562(a)(5), we proposed to
supplement the obligation to provide, as applicable, and coordinate
Medicaid benefits by adding a requirement that when a D-SNP receives an
enrollee's request for services, appeal, or grievance related to
Medicaid-covered services (regardless of whether such coverage is in
Medicaid fee-for-service or a Medicaid managed care plan, such as a
Medicaid MCO, PIHP, or PAHP as defined in Sec. 438.2), the D-SNP must
provide a certain level of assistance to the enrollee.
In new paragraph (a)(5)(i), we proposed to describe the types of
assistance we would require all D-SNPs to provide to their enrollees
regarding Medicaid-related coverage issues and grievances, including
authorization of services and appeals. We proposed in paragraph
(a)(5)(i) to include assistance for all D-SNP enrollees, regardless of
the type of Medicaid coverage in which they are enrolled.
Our proposed regulation at Sec. 422.562(a)(5)(i) included a list
of illustrative examples, at paragraphs (5)(i)(A) through (5)(i)(C),
which we did not intend to be an exhaustive list of how a D-SNP would
be required to comply with the assistance obligation in Sec.
422.562(a)(5)(i).
In paragraph (a)(5)(i)(A), we addressed explaining to a D-
SNP enrollee how to request Medicaid authorization and file an appeal.
Our proposed regulation text included examples of the type of
assistance we expect D-SNPs to provide to their enrollees when the
enrollees need information and explanations about obtaining Medicaid
services. We proposed, in paragraphs (5)(i)(A)(1) through (5)(i)(A)(3),
examples of the types of assistance that a D-SNP must offer, and upon
acceptance or request, provide its enrollees, such as specific
instructions on how to contact the entity that may cover the service
(for example, the Medicaid managed care plan or a contact in the fee-
for-service system), and assistance in obtaining and filling out forms
necessary for the next steps in the process.
In paragraph (a)(5)(i)(B), we proposed that D-SNPs provide
assistance in the actual filing of grievances and appeals. We requested
comments regarding this proposal; in particular, we requested comments
regarding how D-SNPs that do not have aligned enrollment would comply
with this requirement when such entities might have financial and
clinical responsibility for the disputed services, potentially
presenting a conflict of interest.
In paragraph (a)(5)(i)(C), we proposed that the D-SNP
assist the enrollee in obtaining documentation in support of a request
for authorization or appeal.
We explained how the examples listed in proposed paragraphs
(a)(5)(i)(A) through (C) were not intended to be an exhaustive list,
but rather were meant to provide some leading examples of the
assistance we believe any D-SNP should provide. We invited comments on
this proposal, specifically whether the regulation text was clear
enough that the examples are not an exhaustive list of methods of
assistance that the D-SNP must offer its enrollees, as well as
suggestions for other examples of assistance that we should include in
regulation or address in subsequent subregulatory guidance. We also
solicited suggestions for additional examples of assistance, as
[[Page 15724]]
well as comments on challenges D-SNPs and others envision in
implementing the provisions of proposed paragraph (a)(5). In addition,
we acknowledged potential challenges D-SNPs may face because Medicaid
systems vary by state.
We also proposed language related to enrollees accepting the offer
of assistance in proposed paragraph (a)(5)(i). In our proposal, the
only obligation on D-SNPs is to offer assistance and, when a request is
made or an offer of assistance is accepted, to provide it. We requested
comments on whether the regulation text, as we proposed it, was the
best way to achieve this goal.
In paragraph (a)(5)(ii), we proposed to specify that the D-SNP's
obligation to offer assistance arises whenever the D-SNP becomes aware
of an enrollee's need for a Medicaid-covered service. Our proposal
included text explicitly clarifying that enrollees do not need to make
a specific request to their D-SNP for assistance. As we stated in the
preamble to the proposed rule, if the issue comes to the attention of
the D-SNP, we would expect the plan to offer to assist the enrollee in
resolving the coverage issue(s) or grievance given the D-SNP's
responsibility, consistent with our proposed definition of a D-SNP at
Sec. 422.2, that such a D-SNP provide, as applicable, and coordinate
the delivery of Medicare and Medicaid services for its enrollees. We
requested comments on whether we should include such explicit direction
to D-SNPs in the regulation to identify issues that an enrollee is
having, or whether our proposed regulation text was sufficiently clear
that D-SNPs will understand and meet our goal of providing assistance
to an enrollee such that the enrollee can access benefits regardless of
whether the benefit is covered by Medicare or Medicaid. We clarified
that we were not proposing any new requirements related to assistance
with Medicare covered services or services for partial-benefit dual
eligible enrollees. We requested comments regarding the provisions at
proposed Sec. 422.562(a)(5)(ii) and the need for any further
clarification limiting the scope of Sec. 422.562(a)(5) to full-benefit
dual eligible individuals.
In paragraph (a)(5)(iii), we proposed to provide further detail on
the methods of assistance required by proposed paragraph (a)(5)(i). The
methods we proposed in the regulation were intended to be examples of
what a D-SNP will be required to offer and provide to enrollees and
will depend, to some extent, on the needs and preferences of the
enrollee. Specifically, we proposed:
In paragraph (a)(5)(iii)(A), that a D-SNP may provide
coaching to the enrollee to promote self-advocacy. We requested
comments on the methods of assistance and whether further detail is
needed.
In paragraph (a)(5)(iii)(B), an explicit requirement that
a D-SNP provide whatever reasonable assistance an enrollee needs in
navigating the Medicaid grievance and appeals systems, such as
assistance completing forms. As discussed in the proposed rule
preamble, existing MA and Medicaid managed care regulations (for
example, Sec. Sec. 422.111(h)(1)(iii) and 438.406(a)) address the
provision of interpretation services and auxiliary aids and services
for enrollees who have limited English proficiency or disabilities that
require accommodation. We opted not to specify the preferred technical
forms of assistance that would be required under this proposal, as the
evolution of technology and the increases in integration over time may
change the analysis of what methods of assistance are reasonable for a
D-SNP to be required to provide to its enrollees. However, because D-
SNPs are already required to provide similar assistance to their
enrollees in other circumstances, we stated in the proposed rule that
we did not anticipate that compliance with this provision should be
burdensome to plans. We requested comments on this matter, including
whether and how our goals might be met with more specific regulation
text.
In paragraph (a)(5)(iv), we proposed to require that a D-
SNP provide documentation to CMS upon request that demonstrates how the
D-SNP is providing the assistance proposed under paragraph (a)(5)(i).
In paragraph (a)(5)(v), we proposed to clarify that D-SNPs
are not required to represent enrollees in Medicaid appeals. We
requested comments regarding whether any further clarification was
needed on this issue.
We received the following comments, and our responses follow.
Comment: We received a significant number of comments in support of
the proposed requirement in Sec. 422.562(a)(5) to require all D-SNPs
to provide assistance to D-SNP enrollees with Medicaid coverage issues
and grievances. Many commenters were supportive of our efforts to
improve D-SNP enrollees' experience and require all D-SNPs to provide a
minimum level of assistance to their enrollees while granting D-SNPs
flexibility in complying with the proposed requirements. A subset of
commenters, while supportive of our proposal, recommended that CMS
provide more specificity regarding what D-SNP assistance looks like and
additional guidance on how plans can work with Medicaid agencies to
obtain information on the Medicaid coverage of their enrollees.
Response: We appreciate the support we received for our proposed
requirement that D-SNPs provide assistance to enrollees with Medicaid
coverage issues and grievances. We believe these requirements
constitute an incremental, but important, step in improving all D-SNP
enrollees' access to the benefits under the Medicare and Medicaid
programs. We address commenters' specific requests for clarification
and guidance in subsequent responses in this section.
Comment: Several commenters expressed concerns that D-SNPs do not
always have sufficient insight into whether certain Medicaid benefits
are covered under the state's Medicaid program if the D-SNP does not
provide those benefits directly. Many commenters noted that data
sharing with states is essential for D-SNPs to access information
regarding enrollees' Medicaid enrollment status--for example, whether
they are enrolled in Medicaid fee-for-service or a Medicaid managed
care organization (MCO), and the specific MCO they are enrolled in-- in
order to be fully informed about enrollees' coverage. A number of
commenters recommended CMS consider issuing additional guidance to
facilitate state sharing of Medicaid provider and enrollment
information. One commenter suggested that CMS should create a
centralized enrollment database that D-SNPs can query for Medicaid plan
information regarding unaligned D-SNP enrollees. Another commenter
suggested that in order to streamline the process and facilitate its
implementation, CMS consider partnering with states to develop
standardized resource lists with critical information on key Medicaid
contacts that can be shared with enrollees and D-SNPs to streamline the
navigation process and mitigate operational burden.
Response: We agree with commenters that information on how D-SNP
enrollees receive their Medicaid coverage is essential for effectively
fulfilling both the requirement to assist with Medicaid coverage and
grievance issues and the requirement we finalized in the definition of
a D-SNP at Sec. 422.2 to coordinate Medicare and Medicaid coverage
that these plans do not provide directly. We also recognize that,
especially for states that do not contract
[[Page 15725]]
with D-SNPs to deliver Medicaid benefits, providing such information
may be an operational challenge that is not among these states'
priorities. We agree that it would be useful to provide states with
technical assistance that would facilitate the exchange of information
and help D-SNPs effectively coordinate their enrollees' Medicaid
coverage.
At the same time, we do not believe that the absence of such
information sharing relieves D-SNPs of their responsibility to
coordinate Medicaid benefits they do not directly provide, nor prevents
them from providing the types of assistance with Medicaid coverage
issues and grievances that we outlined in the proposed rule. While we
do not intend to penalize D-SNPs for not having in place a real-time
data exchange with states on D-SNP enrollees' Medicaid coverage, we
emphasize that the obligation for Medicaid coordination rests on the D-
SNPs, and it is therefore incumbent on D-SNPs to develop mechanisms to
coordinate Medicaid coverage and assist with Medicaid appeals and
grievance issues. There are other methods that D-SNP staff can use to
obtain information to better assist their members with Medicaid
coverage issues, appeals, and grievances. For example, many states have
data systems that providers use to obtain information on patients'
Medicaid coverage; D-SNP personnel may be able to similarly access
information in order to better assist enrollees. In some circumstances,
a plan can assist a member simply by questioning the enrollee about
their Medicaid coverage, or by jointly calling Medicaid customer
service to obtain coverage information. As D-SNPs implement these
provisions, we will gather and share best practices to help ensure
robust implementation of these requirements.
Comment: A commenter indicated that, in certain circumstances, the
state Medicaid agency is the only source that can clarify or have up-
to-date information for the member. The commenter stated that D-SNPs
should have the ability to direct members to state Medicaid agencies as
needed.
Response: We wish to clarify that our proposal would not prevent D-
SNPs from directing enrollees to state Medicaid agencies. Instead, our
proposal requires that the D-SNP provide reasonable assistance in
identifying the specific contacts within the state Medicaid agency, and
helping the enrollee find the correct contact information, when
referral of an enrollee to Medicaid resources is appropriate.
Comment: A few commenters recommended that CMS modify its proposal
so that D-SNPs would be responsible for assisting members with appeals
and grievances and other matters related only to services available
through the D-SNP and that are clearly within the purview of the plan.
Response: We disagree with these commenters. Despite the valid
data-sharing challenges, we believe it is reasonable to require that D-
SNPs, as plans focused on serving dual eligible individuals, take steps
to assist enrollees with obtaining Medicaid covered services and
resolving Medicaid grievances, consistent with the requirement codified
in this final rule in Sec. 422.2 that D-SNPs coordinate the delivery
of Medicare and Medicaid services for individuals eligible for such
services. This would necessarily mean that the D-SNP take steps to gain
access to information about the Medicaid benefits available to the D-
SNP's enrollees. Moreover, providing such assistance is often in a D-
SNP's financial interest, such as when an enrollee's access to
Medicaid-covered services like personal care services and other home
and community based services (HCBS) could prevent a hospitalization or
address an enrollee's condition before it escalates into a need for
medical services.
Comment: Several commenters requested clarification of whether the
proposed regulation would require a FIDE SNP to offer to assist a dual
eligible individual in appealing its own reduction of Medicaid LTSS
services. The commenter believed this would be burdensome and could
present a conflict for the plan.
Response: We clarify that a FIDE SNP that covers the Medicaid
service through a capitated contract with a state also has an
obligation to assist a dual eligible individual in appealing its own
reduction or denial of Medicaid services, including LTSS, under its
Medicaid MCO contract. The definition at Sec. 422.2 finalized
elsewhere in this rule requires that FIDE SNPs have Medicaid MCO
contracts. As a Medicaid MCO, the FIDE SNP has an obligation under
Sec. 438.406(a) to provide reasonable assistance to its members in
completing forms and taking other procedural steps related to a
grievance or appeal. Therefore, FIDE SNPs already have an obligation to
assist with Medicaid appeals. We do not agree that there is any undue
burden or conflict under either the D-SNP or Medicaid MCO requirements
to assist with appeals when that assistance results in a FIDE SNP
providing coverage upon adjudication of the appeal. These requirements
are, in the first instance, a component of the Medicaid MCO
requirements to implement an appeals process, and, in the second
instance, consistent with the requirement codified elsewhere in this
final rule that D-SNPs coordinate Medicaid benefits. The new
requirements we are finalizing at Sec. 422.562(a)(5) of this final
rule are applicable to all D-SNPs and to all D-SNP enrollees, whether
or not they are enrolled in the Medicaid MCO offered by the D-SNP, and
thereby effectively extend and complement the existing MCO requirements
under Sec. 438.406(a). Further, we note that Sec. 422.562(a)(5)(v)
expressly provides that the D-SNP does not have any obligation to
represent an enrollee in a Medicaid appeal.
Comment: Several commenters emphasized that other entities have an
important role in providing enrollees assistance with Medicaid coverage
issues and grievances. Several of the commenters stressed the important
role of the state ombudsman. One commenter proposed that CMS add
language to the regulation text stating that the D-SNP must make
available to their enrollees specific contact information for
organizations providing free legal services and for any applicable
ombudsman programs. Another commenter suggested that D-SNPs be required
to make a written referral for the enrollee to the state's Medicaid
managed care ombudsman, particularly when the D-SNP has a financial
and/or clinical responsibility for the disputed services. One commenter
highlighted the fact that the ombudsman offices are specifically funded
to assist beneficiaries in filing grievances and appeals, and
frequently coordinate with State Health Insurance Assistance Programs
(SHIPs). The same commenter stated that many community-based
organizations already receive federal funding to provide coaching to
promote self-advocacy, and D-SNPs should not duplicate these services.
Response: We agree with commenters that ombudsman programs, SHIPs,
legal services organizations, and other community organizations have an
important role in providing assistance with Medicaid coverage and
grievances and believe that referrals to such organizations can be an
appropriate method for D-SNPs to provide the required assistance in
certain circumstances. We recognize that such organizations often have
limited capacity and encourage D-SNP partnerships with such
organizations to help ensure the referrals are to organizations with
the capacity to help.
Comment: Several commenters proposed requiring D-SNPs to provide
[[Page 15726]]
assistance in a language and format needed to effectively assist
enrollees and in compliance with all language and disability access
provisions.
Response: The language suggested by the commenter is very similar
to obligations already required of Medicaid managed care organizations
at Sec. 438.406(a), which includes obligations to provide interpreter
services and auxiliary aids to assist enrollees with grievances and
appeals. MA plans also have existing obligations under Title VI of the
Civil Rights Act of 1964 to take reasonable steps to ensure meaningful
access by individuals with limited English proficiency and under
section 504 of the Rehabilitation Act of 1973 to take appropriate steps
to ensure effective communication with individuals with disabilities,
including the provision of auxiliary aids and services. Section 1557 of
the Affordable Care Act places similar civil rights obligations on
covered entities.
Comment: Several commenters requested that CMS be mindful of dual
eligible individuals' choices and recommended that CMS not penalize
plans for not providing assistance when enrollees decline such
assistance.
Response: If an enrollee does not want the D-SNP's help in
resolving an issue, then the D-SNP would not be obligated under our
proposal to provide assistance.
Comment: A few commenters recommended expanding the proposal to
include providing assistance with Medicaid eligibility, and one
commenter noted that case managers are in a good position to help
enrollees with these issues. One commenter suggested CMS should
explicitly require assistance in resolving issues related to Medicaid
eligibility as a fourth requirement at Sec. 422.562(a)(5)(i).
Response: We believe this recommendation is beyond the scope of our
proposed requirement, which focuses on assistance with grievance and
coverage appeals and not Medicaid eligibility. However, states may
choose to require assistance with eligibility issues in their state
Medicaid agency contracts with D-SNPs.
Comment: Several commenters recommended that CMS provide states and
D-SNPs with technical assistance on implementing these provisions. One
commenter stated that CMS should consider establishing a technical
expert panel to make recommendations to CMS on appropriate practices
and then develop guidance that establishes guiding principles for
enrollee assistance, provides examples, and identifies related issues
for states and Medicaid plans to consider. Another commenter suggested
that CMS consult with states and D-SNPs in developing additional
guidance to help evaluate recommended pathways for specific situations.
Another commenter recommended states provide clear guidance to D-SNPs
operating in the state to define the level of assistance they should
provide, including applicable examples.
Response: We are committed to providing technical assistance to
states and to sharing best practices with D-SNPs to implement these
requirements based on consultations with stakeholders and evolving
practice in this area. We expect that the best approaches will be
specific to the Medicaid coverage in specific states and how these
states use D-SNPs to integrate coverage.
Comment: Several commenters were supportive of our proposal at
Sec. 422.562(a)(5)(i)(A) that D-SNPs provide reasonable assistance to
an enrollee and explain to an enrollee how to make a request and how to
file an appeal following an adverse benefit determination. Several
commenters also appreciated that the D-SNP's only obligation would be
to offer assistance with filing an appeal and, upon acceptance of the
request, provide its enrollees such assistance in obtaining and filling
out forms as necessary for the next steps in the process. Many
commenters appreciated that the proposed rule recognizes that some
enrollees will wish to self-advocate and can receive support from the
plan for their efforts. A few commenters believed plans must empower
their staff to act in the best interests of the enrollee and that D-
SNPs should establish appropriate staff training and procedures to
ensure that those staff provide the same reasonable assistance that the
dual eligible individual might receive from a similarly charged
independent assister (which enrollees could continue to work with
should they choose).
Response: We appreciate the commenters' support of CMS's approach
to broadly requiring D-SNPs to provide assistance to dual eligible
individuals with Medicaid grievances and appeals. D-SNPs can provide
assistance in many ways, including advising enrollees to call providers
and the questions to ask, assisting enrollees with medical
documentation requests, identifying necessary forms to file, and
referring enrollees to an organization with more expertise (such as a
state ombudsman and other relevant assistance programs). We do not seek
to be overly prescriptive in the types of assistance a D-SNP must
provide, and our examples are not intended to be exhaustive. Further,
we note that the regulation, as proposed and as finalized in this rule
at Sec. 422.560(a)(5)(v), does not require the D-SNP to represent its
enrollees in Medicaid matters.
Comment: Many commenters recommended that CMS clarify what
constitutes ``reasonable assistance.'' A few commenters requested
additional guidance on ``coaching the enrollee to promote self-
advocacy.'' Some commenters noted that it is ultimately the enrollee's
responsibility to ensure that they take all procedural steps and
provide and submit documentation as part of the appeals process. Other
commenters requested more guidance on the expectations and extent of
assistance D-SNPs must offer and give their enrollees.
Response: We emphasize that our requirements describe the D-SNP's
responsibility to provide assistance and do not include a requirement
to resolve the coverage issue or to represent the enrollee. Not all
enrollees would need significant assistance; for many enrollees, simply
receiving information under paragraph (a)(5)(i) would be sufficient.
Some dual eligible individuals are highly adept at advocating for
themselves, and may require only modest assistance--for example, a
phone number or direction to an appropriate website--or help with
technical terms in explaining why they need a specific piece of
equipment. Other enrollees may need encouragement and coaching to
advocate for themselves, such as talking through the steps the enrollee
will take to seek resolution of the issue, or role playing to practice
how to talk to a representative of the Medicaid agency or a Medicaid
managed care plan. We encourage D-SNPs to provide such coaching to
empower dual eligible individuals to advocate for themselves when
appropriate. When a D-SNP enrollee needs a higher level of assistance
with the act of filing a Medicaid grievance or appeal, the D-SNP should
provide that help. However, the D-SNP is not obligated to represent the
enrollee in Medicaid appeals nor advocate for coverage, as stated in
paragraph (a)(5)(v). Plans can provide specific contact information,
explain to enrollees the roles of the Medicaid program, and generally
offer different levels of assistance based on the individual's needs.
Comment: Another comment sought an explanation of the phrase,
``becomes aware of an enrollee's need for a Medicaid-covered service.''
Response: There are a number of ways in which a D-SNP could become
aware of the need for assistance. A non-
[[Page 15727]]
exhaustive list includes: During a health risk assessment when an
enrollee shows a need for more LTSS than she currently receives through
Medicaid; during a request for coverage of a Medicaid-covered service
made to the D-SNP; and during a call to the D-SNP's customer service
line. As the above list illustrates, the offer of assistance from the
D-SNP is not dependent on an enrollee's specific request for
assistance.
Comment: Many commenters agreed with the proposed provision at
Sec. 422.562(a)(5)(i)(C) requiring plans to assist an enrollee in
obtaining documentation to support a request for authorization of
Medicaid services or a Medicaid appeal, such as medical records. One
commenter requested additional clarification from CMS on the extent of
responsibility that D-SNPs will assume when obtaining documentation,
including the specific types of documentation that D-SNPs might be able
to provide. Several commenters questioned whether CMS was imposing a
requirement on D-SNPs that duplicates the existing regulations that
require Medicaid MCOs to assist enrollees with grievances and appeals.
Response: CMS believes the assistance requirement for D-SNPs is
commensurate with the assistance a Medicaid MCO is required to provide
for appeals and grievances at Sec. 438.406(a), which includes
reasonable assistance in completing forms and taking other procedural
steps related to a grievance or appeal; however, while there may be
some areas of overlap, the new MA requirement at Sec. 422.562(a)(5) is
not inappropriately duplicative. Not all D-SNPs are Medicaid MCOs,
PIHPs, or PAHPs subject to the requirements under Sec. 438.406(a).
Even some D-SNPs, such as FIDE SNPs, that are also Medicaid MCOs may
have some members who are not also enrolled in the Medicaid MCO, or
there may be Medicaid services that are carved out of the Medicaid
MCO's benefits and delivered through Medicaid FFS or a separate
Medicaid plan. The assistance requirement for D-SNPs that we are
finalizing here is an implementation of the overriding requirement on
D-SNPs under section 1859(f)(3)(D) of the Act to coordinate Medicaid
benefits. To the extent the assistance in grievances actually provided
by a Medicaid MCO obviates the need for any additional assistance by
the D-SNP in a grievance or appeal, such assistance would no longer be
required to be provided by the D-SNP. To the extent the D-SNP enrollee
requires additional advice or assistance with completing forms, or
seeking documentation from relevant providers, the D-SNP should offer
to provide such assistance and provide it when the enrollee agrees.
Comment: Several commenters were concerned with how D-SNPs should
document and report to CMS that assistance was offered and whether or
not an offer of assistance was accepted. A few commenters requested
additional information on the documentation and reporting requirements
that CMS will establish and whether such documentation will be reviewed
as part of the audit protocols for D-SNPs. One commenter requested CMS
remove the requirement at Sec. 422.562(a)(5)(iv) that requires a D-SNP
to provide documentation to CMS that demonstrates how the D-SNP is
providing the assistance, citing concerns with administrative burden on
plans.
Response: We agree that documentation of the assistance D-SNPs
provide their enrollees with Medicaid coverage and grievances should
not be overly burdensome to plans. The documentation requirement
(including any potential reporting to CMS) in Sec. 422.562(a)(5)(iv)
does not prescribe certain types of assistance in all cases.
Particularly in the initial years of implementation, when plans are
developing processes to best implement these requirements, our goal is
to provide plans with flexibility on the type of assistance they
provide in individual cases and to monitor compliance with this
requirement at a high level. We would not, for example, require proof
that a beneficiary had declined an offer of assistance. We plan to
detail the scope and content of the documentation requirements in
subregulatory guidance, and it is likely that the subregulatory
guidance will be made available for stakeholder comment before it is
finalized.
Comment: Several commenters suggested that CMS take steps to ensure
that D-SNPs that provide assistance with Medicaid coverage issues are
not penalized in CMS audits or in the MA Star Ratings measure that is
based on beneficiary complaints (``Complaints About the Health Plan'')
when the final result--the coverage decision made by a party other than
the D-SNP--is not to the beneficiary's satisfaction. Another commenter
recommended that CMS protect D-SNPs from ``liability'' for providing
assistance with Medicaid coverage and grievances.
Response: In general, we do not believe that D-SNPs providing their
enrollees with assistance navigating their Medicaid coverage will
trigger an increase in beneficiary complaints. Rather, we expect D-SNP
enrollees will appreciate the assistance that their D-SNP provides.
Nonetheless, we will review our criteria to ensure we are capturing
complaints appropriately and will consider any future changes to these
criteria that may be necessary. Outside of these areas, we are unclear
how providing such assistance would increase D-SNPs' ``liability.''
After considering the comments we received and for the reasons
provided in the proposed rule and our responses to those comments, we
are finalizing the text proposed for codification at Sec.
422.562(a)(5) with one technical modification. At paragraph
(5)(iii)(B), we are modifying the regulatory text to clarify that the
requirement that D-SNPs provide reasonable assistance in completing
forms and procedural steps applies specifically to Medicaid appeals and
grievances. We believe the additional clarification provided by our
responses to the comments in this final rule should give D-SNPs a
clearer understanding of the scope of their responsibilities under the
regulation and the various methods and resources D-SNPs can use to
fulfill the requirements. We recognize that there will be a joint
learning process with states, MA organizations, dual eligible
individuals, and their advocates on the processes that can facilitate
effective implementation of these requirements. We expect to provide
technical assistance to states and D-SNPs to help with implementation.
In addition we plan to provide subregulatory guidance as necessary,
including regarding CMS oversight of D-SNP performance in this area. We
note that, unlike the remainder of the appeals and grievances
provisions finalized in section II.A.2.b of this final rule, the
requirements at Sec. 422.562(a)(5) will be applicable to all D-SNPs
and will be applicable beginning January 1, 2020.
(2) Statutory Basis and Scope for Unifying Grievances and Appeals
(Sec. 422.560)
In Sec. 422.560, we proposed to add new paragraphs (a)(4) and
(b)(5) to address the statutory basis and scope of our proposal to
establish unified grievance and appeals processes for a subset of D-
SNPs. Specifically, we proposed a new paragraph (a)(4) to cite section
1859(f)(8) of the Act and provide that the procedures under that
section apply in place of otherwise applicable grievance and appeals
procedures with respect to items and services provided by certain D-
SNPs. We also proposed to add new paragraph (b)(5) to identify the
scope of the new proposed regulations--that is, requirements for
applicable integrated plans with regard to unified appeals and
grievance procedures. The substance of these proposals is addressed in
sections
[[Page 15728]]
II.A.2.b.(3) through (11) of the proposed and final rules.
We received no comments on our proposed changes to Sec. 422.560
and are finalizing the regulation text at paragraph (b)(5) as proposed.
However, we are making a non-substantive technical change to paragraph
(a)(4) to clarify that the unified appeals and grievance procedures
finalized in this rule are applicable beginning January 1, 2021. We are
also making a technical change to correct an inadvertent omission in
the proposed rule. Section 1859(f)(8)(C) of the Act states that,
effective in 2021, contracts between D-SNPs and state Medicaid agencies
must require the use of the unified grievance and appeals process. In
order to reflect this requirement in regulation, as noted in section
II.A.2.a.(2) of this final rule, we are finalizing a new paragraph at
Sec. 422.107(c)(9) that requires that contracts between D-SNPs that
are applicable integrated plans, defined in Sec. 422.561, and the
state Medicaid agency require the use of unified grievance and appeals
procedures.
(3) Definitions of ``Applicable Integrated Plan'', ``Integrated
Appeal'', ``Integrated Grievance'', ``Integrated Organization
Determination'', and ``Integrated Reconsideration,'' and General
Requirements for Applicable Integrated Plans (Sec. Sec. 422.561 and
422.629(a)-(k))
A central challenge to implementing unified grievance and appeals
systems for D-SNPs and the Medicaid managed care organization operated
by such plan's parent organization is the variety of enrollment
scenarios across states. There are only a limited number of D-SNPs in
which aligned enrollment, as defined in Sec. 422.2 of this final rule,
is possible--that is, a situation when a full-benefit dual eligible
individual is enrolled in a D-SNP and receives coverage of Medicaid
benefits from the D-SNP's MA organization or from a Medicaid managed
care organization, as defined in section 1903(m) of the Act, operated
by the D-SNP's parent organization or by another entity that is owned
and controlled by the D-SNP's parent organization. Even fewer D-SNPs
operate in states where that state Medicaid agency mandates such
aligned enrollment. With exclusively aligned enrollment, all of the
enrollees of the D-SNP also receive Medicaid services through the D-SNP
or an affiliated Medicaid managed care organization operated by the D-
SNP's parent organization.
The bulk of D-SNP enrollment, however, is not exclusively aligned.
In most states, the majority of D-SNP enrollees have Medicaid coverage
either through a different organization's Medicaid MCO, in a prepaid
ambulatory or inpatient health plan (PAHP or PIHP), or through a
state's Medicaid fee-for-service system. In these circumstances, the D-
SNP has no control over the Medicaid grievance and appeals processes.
Even a D-SNP that has a Medicaid managed care organization operated by
such plan's parent organization available to its enrollees, but whose
members may instead enroll in other Medicaid plans, can only unify the
procedures for Medicaid appeals and grievances of those enrollees who
are also simultaneously enrolled in the Medicaid managed care
organization operated by such plan's parent organization.
We proposed to add definitions for new terms to govern the
integrated grievance and appeals processes. In Sec. 422.561 we
proposed a new definition for ``applicable integrated plan,'' which is
the specific type of D-SNP and affiliated Medicaid plan that would be
governed by the new integrated grievance and appeals regulations. In
our definition of applicable integrated plan, we proposed to include
only a subset of D-SNPs, that is, only FIDE SNPs and HIDE SNPs with
exclusively aligned enrollment, terms that were also proposed (see
section II.A.2.a.(1) of the proposed rule) and are finalized with
limited modifications elsewhere in this rule (see section II.A.2.a.(1)
of this final rule). We proposed that the affiliated Medicaid plan be a
Medicaid managed care organization, as defined in section 1903(m) of
the Act, that is offered by: (1) The D-SNP with exclusively aligned
enrollment; (2) the parent organization of such D-SNP; or (3) another
entity that is owned and controlled by the parent organization of such
D-SNP. Thus, as we stated in the proposed rule, our proposed unified
grievance and appeals procedures would apply only to the enrollees of
the subset of D-SNPs that are FIDE SNPs or HIDE SNPs with exclusively
aligned enrollment and the affiliated Medicaid managed care
organizations through which such enrollees receive their Medicaid
services. As we noted in our discussion of the proposed definition of
aligned enrollment in section II.A.2.a.(1) of the proposed rule, we
would not consider a D-SNP's companion Medicaid plan to be an
applicable integrated plan where it is a PIHP or PAHP in the state's
Medicaid program. We solicited comments on our proposed definition of
an applicable integrated plan and how it reflects which plans and
entities would have to use the proposed unified grievance and appeals
procedures. We sought comment on whether limiting our proposed policies
to MCOs, rather than including PIHPs and PAHPs, was appropriate in
light of the statute and our policy goals. We also clarified which
proposed appeal and grievance procedure requirements for D-SNPs would
not apply to applicable integrated plans; D-SNPs that are not
applicable integrated plans would continue to establish and administer
appeal and grievance systems that comply with the existing requirements
for MA plans.
For the purpose of differentiating the terminology and procedures
within this framework, we proposed to establish definitions for
``integrated organization determination,'' ``integrated appeal,''
``integrated reconsideration,'' and ``integrated grievance'' and apply
them exclusively to applicable integrated plans and the unified appeal
and grievance procedures.
Under our proposal, integrated organization determinations would
encompass both Medicare organization determinations, as described in
Sec. 422.566, and adverse benefit determinations, as defined in Sec.
438.400(b); however, these determinations would be made by applicable
integrated plans and would therefore be subject to the integrated
organization determination procedures in proposed Sec. Sec. 422.629,
422.631, and 422.634. These would be the first decisions made by the
applicable integrated plan regarding coverage, approval, or payment for
a covered service.
Similarly, we proposed that integrated reconsiderations would be
the appeal of the applicable integrated plan's adverse integrated
organization determination with respect to the health care services the
enrollee believes he or she is entitled to receive. Under our proposal,
an integrated reconsideration would be the same as an MA plan's
reconsideration (in Sec. 422.580) of an organization determination
(defined in Sec. 422.566) and the appeal (defined in Sec. 438.400(b))
of an adverse benefit determination made by a Medicaid managed care
plan. Integrated reconsiderations would encompass both Medicare
reconsiderations, as described in Sec. Sec. 422.578, 422.580, 422.582,
and 422.584, and appeals, as defined for the Medicaid managed care
context in Sec. 438.400(b). However, these determinations would be
made by applicable integrated plans and therefore subject to the
integrated reconsideration procedures in proposed Sec. 422.629 and
Sec. Sec. 422.632 through 422.634.
[[Page 15729]]
We proposed defining integrated appeals to encompass integrated
reconsiderations and any additional post-plan level unified appeal
processes that may be implemented in the future.
Additionally, we proposed to define an integrated grievance as a
dispute or complaint that would be defined and covered, for grievances
filed by an enrollee in non-applicable integrated plans, under Sec.
422.564 or Sec. Sec. 438.400 through 438.416. Integrated grievances
would not include appeals procedures or QIO complaints, as described in
Sec. 422.564(b) and (c), respectively. An integrated grievance made by
an enrollee in an applicable integrated plan would be subject to the
integrated grievance procedures in Sec. Sec. 422.629 and 422.630.
Our proposed definitions for integrated grievance, integrated
organization determination, and integrated reconsideration were
intended to replicate the scope and meaning of the parallel terms in
parts 422 subpart M and part 438 subpart E regarding the appeals and
grievance procedures required of, respectively, MA organizations and
Medicaid managed care plans because we were proposing that these
regulations and procedures would take the place of those part 422 and
part 438 procedures for applicable integrated plans. We solicited
comment on whether our proposal adequately accomplished this.
We proposed at Sec. 422.629 to establish general requirements for
applicable integrated plans, as defined in Sec. 422.561. In the
proposed rule, we generally explained how we balanced existing Medicare
and Medicaid requirements, including existing state Medicaid
flexibilities. In paragraphs (a) and (b), we proposed language that
sets forth the scope of the requirements and general process that
applicable integrated plans must implement. In paragraph (a)(1), we
proposed to specify that the proposed rules apply in lieu of the
general requirements for MA organizations at Sec. Sec. 422.564,
422.566(c) and (d), and 422.568 through 422.596, and Medicaid managed
care plans at Sec. Sec. 438.404-438.424, and encompass integrated
grievances, integrated organization determinations, and integrated
reconsiderations. In paragraph (b), we set forth the general
requirement that applicable integrated plans create integrated
processes to administer these grievance and appeals requirements.
In proposed paragraph (c), we addressed an overarching question
about whether a state may establish requirements that are different for
the applicable integrated plan(s) using the state Medicaid agency
contract with the D-SNP required under Sec. 422.107. Specifically, we
proposed to apply the flexibility offered to states under Medicaid
regulations, which establish a floor for enrollee protections while
offering states flexibility to impose more stringent requirements for
timeframes and notices so long as they are more protective of
beneficiaries. By preserving state flexibility in adopting more
stringent, beneficiary-protective requirements, we believe that we were
adhering to the direction set forth in sections 1859(f)(8)(B)(ii)(I)
and (II) of the Act for us to take into account differences in state
plans under Title XIX. Finally, in paragraph (c), we proposed to codify
the opportunity for states to establish standards that differ from the
standards set forth in these regulations in its state Medicaid agency
contract, per Sec. 422.107, with the applicable integrated plans. We
solicited comments on our proposed approach, and specifically how we
proposed to allow state flexibilities to be incorporated into the
unified procedures for an applicable integrated plan.
In paragraph (d), we proposed that the applicable integrated plan
provide the enrollee who is requesting the integrated reconsideration a
reasonable opportunity, in writing and in person, to present evidence
and testimony and make legal and factual arguments in support of their
appeal. We also proposed to require that applicable integrated plans
inform enrollees of the limited time available for these opportunities
in cases were the timeframe is expedited, similar to Sec. 422.586 and
Sec. 438.406(b)(4).
In paragraph (e), we proposed to require applicable integrated
plans to provide reasonable assistance to the enrollee with respect to
completing and submitting their integrated appeals and integrated
grievances, as well as on navigating this process. This proposal would
impose on applicable integrated plans a similar standard as applies to
Medicaid managed care plans pursuant to Sec. 438.406(a).
We proposed at paragraph (f) a general rule, using cross-references
to the requirements in Sec. Sec. 422.560, 422.561, 422.562, 422.566,
and 422.592 through 422.626, to specify the regulations that apply to
the applicable integrated plan for grievance and appeals processes
unless otherwise noted.
We proposed at paragraph (g) to require applicable integrated plans
to send the enrollee an acknowledgement of receipt in writing for all
integrated grievances and integrated reconsiderations. We proposed to
adopt the standard currently in Sec. 438.406(b) for applicable
integrated plans and to clarify that the acknowledgement should be in
written form.
In paragraph (h), we proposed to adopt Medicaid's grievance and
appeals recordkeeping requirements, as required for Medicaid managed
care plans at Sec. 438.416, to require applicable integrated plans to
maintain records of integrated appeals and grievances and review them
as part of their ongoing monitoring procedures.
We proposed in paragraphs (i) and (j) to incorporate similar
provisions as are imposed on Medicaid managed care plans pursuant to
Sec. Sec. 438.410(b) and 438.414 regarding relationships between the
plan and its contracted network providers. Specifically, in paragraph
(i), we proposed to prohibit an applicable integrated plan from taking
any punitive action against a provider for requesting an integrated
organization determination or integrated reconsideration, similar to
the provisions in Sec. Sec. 422.570(f) and 438.410(b). We also
proposed requiring, in paragraph (j), such a plan to disclose
information about its appeals and grievances procedures at the time it
enters into a contract with a provider or subcontractor. We proposed to
include specific topics which must be covered in this information to
providers, and these specific topics are the same as in existing
Medicaid regulations (see Sec. 438.414, which cites to Sec.
438.10(g)(2)(xi) for this purpose).
In paragraph (k), we proposed regulatory standards controlling who
must review an integrated organization determination. In developing our
proposal, we sought to combine the MA and Medicaid managed care
requirements for who must review an organization determination. In
paragraph (k)(1), we proposed to include the requirement from Medicaid
(Sec. 438.406(2)(iii)) that any individual who reviews an integrated
appeal or grievance must consider all information submitted by the
enrollee, regardless of whether the information was previously made
available to the plan. In paragraph (k)(2), we proposed to include the
requirements for reviews of Medicaid grievances (from Sec.
438.406(b)(2)) for who can review a grievance to integrated grievances.
In paragraph (k)(3), we proposed to include the existing
requirements from MA (Sec. 422.566) for who can review an organization
determination. We also proposed language that, in accordance with
current MA regulations (Sec. 422.566(d)), requires that physicians or
other health care professionals who review integrated organization
[[Page 15730]]
determinations have an unrestricted license and be acting within the
scope of that license.
In paragraph (k)(4) we proposed to combine existing MA and Medicaid
requirements for who can review a reconsideration or adverse benefit
determination since both sets of existing regulations have relevant
requirements.
We explained in the proposed rule (83 FR 55003 through 55006) how
we applied the direction in section 1859(f)(8)(B)(ii)(I) of the Act to
adopt the existing procedures that were more protective of enrollees
and explained the rationale for our specific proposals in paragraphs
(a) through (k) of proposed Sec. 422.629. Where MA and Medicaid
managed care rules are similar, our proposals tracked closely to
existing MA and Medicaid managed care rules. Where MA and Medicaid
managed care rules differ, we considered which rule was more protective
of enrollees and proposed rules that would follow the more protective
approach.
We summarize the comments we received on proposed Sec. 422.629(a)
through (k) and respond to them as follows:
Comment: Many commenters agreed with our approach to limit the
unified appeals and grievance processes to applicable integrated plans.
A subset of commenters, while supportive of our proposal, encouraged
CMS to extend the unified processes to all D-SNPs, or at least to all
FIDE SNPs and HIDE SNPs that are not exclusively aligned, to cover more
dual eligible individuals. Several of these commenters recommended
that, if CMS is unable to extend the unified process beyond what was
proposed, we should continue to review lessons learned and best
practices from our implementation of the unified processes and
potentially extend the processes in the future as overall integration
efforts advance. A commenter recommended that, if we are not able to
extend the unified processes beyond applicable integrated plans at this
time, we encourage states to facilitate cooperation between D-SNPs and
other entities covering benefits for the D-SNPs enrollees. A commenter
suggested that, if we did not extend the unified processes to
additional plans, we at least make it optional for states and plans
other than applicable integrated plans. Another commenter recommended
that we restrict the unified processes to exclude HIDE SNP enrollees,
due to lower level of benefits integration. A few commenters requested
that CMS clarify the impact of this unified process on MMPs in the
Financial Alignment Initiative demonstrations.
Response: We appreciate the broad support for the unified appeals
and grievance processes we proposed. While we appreciate the support
for extending these requirements to additional D-SNPs and dual eligible
individuals, we do not believe it is feasible at this time to implement
fully unified grievance and appeals systems for D-SNPs and Medicaid
managed care plans that do not have the same enrollees or where the
organizations offering the D-SNPs and Medicaid plans are unaffiliated
or even competitors. We note that states may include additional
integration requirements in their state Medicaid agency contracts with
D-SNPs. We disagree with the commenter that suggests excluding HIDE
SNPs with exclusively aligned enrollment from the definition of an
applicable integrated plan, because when a HIDE SNP meets the
definition of exclusively aligned enrollment, as defined in Sec.
422.2, the plan covers Medicare and Medicaid benefits (including at
least some LTSS or behavioral health services) for their dual eligible
enrollees. We also clarify that this rule will not impact the appeals
or grievance processes for MMPs, which will continue to be governed by
the demonstration three-way contracts and demonstration-specific
guidance. MMPs will continue to operate within existing waivers of part
422, as outlined in the memoranda of understanding for each
demonstration.
Comment: A commenter requested that CMS clarify the relationship
between the terms ``aligned enrollment,'' ``exclusively aligned
enrollment,'' and ``applicable integrated plan,'' specifically, the
relationship between the plan-specific nature of ``aligned
enrollment,'' the state policy-specific nature of ``exclusively aligned
enrollment,'' and whether it is actually CMS' intent that the term
``applicable integrated plans'' be a function of state policy and not
of individual plan structure. The commenter further requested
clarification as to whether it is CMS' intent to use this concept of
``exclusively aligned enrollment'' as a policy benchmark for states to
meet, and, if so, whether CMS intends to somehow influence states
toward that goal. A commenter also recommended that CMS clarify whether
a HIDE SNP or FIDE SNP operating in a state without exclusively aligned
enrollment cannot or should not unify their appeals and grievances in
the fashion outlined in this section.
Response: We acknowledge that exclusively aligned enrollment is
directly related to state policy choices to require such alignment.
Exclusively aligned enrollment, as defined in Sec. 422.2 in this final
rule, occurs when the state requires a D-SNP operating in the state to
enroll only dual eligible individuals who are also enrolled in an MCO
(that has an MCO contract under section 1903(m)(2) of the Act) that is
offered by the D-SNP's MA organization, the D-SNP's parent
organization, or by another entity that is owned and controlled by the
D-SNP's parent organization. In effect, exclusively aligned enrollment
means that Medicare benefits, MA supplemental benefits, and
comprehensive Medicaid benefits (which are the benefits that an MCO
contract covers) are provided by one entity (the D-SNP) or closely
affiliated entities that share a parent organization for all members.
Applicable integrated plans are the D-SNP and MCO in this exclusively
aligned enrollment arrangement. Aligned enrollment--in contrast to
exclusively aligned enrollment--occurs when some, but not all, of the
D-SNP's enrollees are covered under this arrangement.
While CMS intends to continue to provide technical assistance to
states on the value of integration and exclusively aligned enrollment,
we believe that it is most feasible at this time to impose the unified
processes only on those plans that have the ability to unify such
processes for all of their members. Therefore, only applicable
integrated plans are required to comply with the regulations we
proposed and are finalizing, with some modifications, in this final
rule. D-SNPs, including HIDE SNPs and FIDE SNPs, that do not meet the
definition of an applicable integrated plan must comply with the MA
appeal and grievance system requirements in Sec. Sec. 422.560 through
422.626. We also note that a state may establish additional integration
requirements through its state Medicaid agency contract with D-SNPs.
Comment: We received several comments supporting our proposed
definitions at Sec. 422.561, as well as a few requests for additional
clarification, including whether the definition of an integrated
organization determination includes prior authorizations. One commenter
expressed concern that, if integrated organization determinations do
include prior authorizations, the 72-hour resolution timeframes for an
expedited integrated organization determination may not be a fast
enough resolution timeframe in all cases.
Response: Integrated organization determinations include prior
authorizations because prior
[[Page 15731]]
authorizations are included in the definitions of organization
determinations under Sec. 422.566, adverse benefit determinations
under Sec. 438.400(b), and actions in Sec. 431.201. We also note
that, for resolution of an expedited integrated organization
determination, the timeframe requirement is that resolution must be as
expeditiously as the enrollee's health condition requires, but not to
exceed 72 hours; thus, 72 hours is only a maximum timeframe, and an
applicable integrated plan must take each enrollee's unique
circumstances into consideration in processing and deciding an
integrated organization determination. This is consistent with the
requirement timeframes under both MA and Medicaid (see Sec. Sec.
422.572(b) and 438.210(d)(2)).
Comment: We received a number of comments on our proposed
requirement at Sec. 422.629(c) allowing states flexibility in
implementing standards for timeframes or notice requirements that are
more protective for the enrollee. A number of commenters supported our
proposal as a way to extend enrollee protections currently available
under Medicaid in some states. Some commenters opposed or expressed
concerns related to allowing state flexibility. One commenter requested
clarification on whether the proposed procedures would supersede or
override any conflicting current Medicaid state law or rules and
federal statutes and rules related to D-SNPs and under what process any
of those potential conflicts could be addressed. A few commenters noted
that allowing states to shorten timeframes for resolving appeals can be
detrimental to a plan's ability to collect necessary information and
make fully informed decisions. A few commenters expressed concern about
the burden and complexity associated with requiring applicable
integrated plans to implement different timeframes for entities that
operate in many states. A commenter questioned how CMS would make
decisions about which state flexibilities to allow and which not to
allow. One commenter expressed concern that states would not be able to
implement the intent of Congress and CMS without additional guidance,
or that CMS would not be able to accommodate state variations without
impacting or delaying the intent of the overall process to provide
simplification and clarity for beneficiaries. A few commenters
encouraged CMS to work with states and stakeholders, including through
a stakeholder panel, to implement this requirement.
Response: We appreciate commenters' varied perspectives on this
issue. As discussed earlier in this preamble, the statute requires that
we take into account differences in state plans and that we implement
standards most protective of enrollees (see sections
1859(f)(8)(B)(ii)(I) and (II) of the Act). Medicaid regulations
governing managed care plans currently allow variation from federal
regulations as long as the state policy complies with federal
standards, and thus we are designing the unified process for applicable
integrated plans to include similar state flexibilities. In effect, the
federal regulations we proposed and are finalizing operate as the
minimum requirements on unified grievance and appeals procedures;
states may use the contract they have with the D-SNP under Sec.
422.107 and the state Medicaid contract with the Medicaid managed care
plan to require timeframes that are more protective of the enrollees in
the applicable integrated plans. We also note that the unified process
will impact a relatively small universe of states and plans. The
proposed unified process will apply for enrollees in applicable
integrated plans in lieu of current federal Medicare and Medicaid
regulations. With respect to the burden and complexity of administering
these unified processes, D-SNPs that contract to provide Medicaid
benefits, including applicable integrated plans that must comply with
the unified appeal processes addressed in this rule, currently
administer two separate processes--one for Medicare and one for
Medicaid--in addition to complying with specific appeal requirements
for Part D benefits. Under the unified approach, they will only
administer one process for all non-Part D benefits. Thus, though there
may be some initial burden in implementing the new unified processes,
in the long term we expect the administrative burden on applicable
integrated plans to be reduced.
With respect to when the state flexibility will be allowed, to the
extent that a state statute or rule sets a standard that is more
protective of enrollees with respect to timeframes or notices than the
unified rules we are establishing in this final rule, which is the
standard set by Congress in the statute, then that state standard will
apply under the flexibility we are finalizing at Sec. 422.629(c) in
the unified processes, as it would currently in the state's Medicaid
program. With respect to how CMS will accommodate such flexibilities,
the flexibilities will need to be stated in the state's contracts with
the applicable integrated plan (meaning both the contract with the D-
SNP under Sec. 422.107 and the state contract with the Medicaid MCO).
States will then need to ensure compliance with state-specific
requirements. We expect that any state requirements that differ from
the requirements as written in this rule will reflect state-specific
Medicaid requirements, and will therefore ensure the same degree of
protection as that afforded to all Medicaid beneficiaries in the state.
CMS is committed to continuing our work with states based on their
specific policy priorities following the implementation of this final
rule, including any necessary changes to state regulations or
processes, and we will work to ensure changes and updates are
communicated to the public.
Comment: One commenter stated that our proposed requirement, at
Sec. 422.629(g), to send written acknowledgements of all integrated
reconsiderations was likely to cause confusion for enrollees and
increase administrative burden for applicable integrated plans.
Response: Sections 1859(f)(8)(B)(iii)(IV) and (V) of the Act, as
added by section 50311(b) of the Bipartisan Budget Act of 2018,
specifically call for unified timelines and procedures for
acknowledgement of appeals and grievances, and procedures to ensure
enrollees are notified of and can easily determine the status of the
grievance or appeal. We believe that that written acknowledgement best
meets these requirements and therefore decline to make any changes to
the requirement that applicable integrated plans send written
acknowledgment of each integrated reconsideration. We note that
applicable integrated plans have flexibility to tailor the
acknowledgement to the enrollee's case to improve clarity and help
avoid confusion. This requirement parallels the Medicaid regulation at
Sec. 438.406(b), and we note that MA guidance also addresses written
acknowledgement of oral requests for reconsideration (see Parts C & D
Enrollee Grievances, Organization/Coverage Determination, and Appeals
Guidance Sec. 50.2.1).\24\
---------------------------------------------------------------------------
\24\ See https://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/Downloads/Parts-C-and-D-Enrollee-Grievances-Organization-Coverage-Determinations-and-Appeals-Guidance.pdf.
---------------------------------------------------------------------------
Comment: A commenter suggested that we consider ways to ensure that
plans are consistently and uniformly capturing and logging beneficiary
requests for appeals and grievances and that applicable integrated
plans are, at a minimum, required to provide oral notification of
resolutions.
[[Page 15732]]
Response: We are finalizing recordkeeping requirements at Sec.
422.629(h) to help ensure consistency in recordkeeping and
documentation of integrated grievances and appeals, including the date
that the applicable integrated plan notified the enrollee of the
resolution at Sec. 422.629(h)(vii), as well as other minimum data
elements. We also note that applicable integrated plans are required to
provide the resolution of each integrated grievance to the enrollee,
per Sec. 422.630(e), which we address in detail in section
II.A.2.b.(5) of this final rule. We will monitor the need for
additional guidance on this issue during and after implementation of
the unified appeals and grievance processes required by this final
rule.
Comment: We received several comments supporting the proposed
prohibition, at Sec. 422.629(i), on applicable integrated plans taking
punitive action against providers for supporting enrollees' integrated
organization determinations or integrated reconsiderations. One
commenter recommended that we clarify that this prohibition extends to
an applicable integrated plans' contracted and delegated entities.
Response: We appreciate commenters' support for this requirement
and note that it is our expectation that applicable integrated plans
will ensure that contracted and delegated entities follow this
requirement, since the managed care plan must ensure that requirements
are met completely by its delegated or subcontracted entity and/or
individual under current Medicaid rules (Sec. 438.230(b)) and current
MA rules (Sec. 422.504(i)).
Comment: One commenter noted support for our proposed requirement,
at Sec. 422.629(j), for applicable integrated plans to provide
information about the integrated grievance and appeals systems to all
providers and subcontractors at the time they enter into a contract,
and requested that we extend the provision to require annual refresher
trainings.
Response: We appreciate the commenter's support. Both Medicaid and
MA have general requirements about providing information, but no
specific requirements with respect to frequency (see Sec. Sec.
438.414, and 422.202(b)). We decline to incorporate the commenter's
suggested requirement at this time because annual refresher training is
beyond what current Medicaid or MA regulations require in connection
with training on appeals and grievances processes. We believe such a
requirement would be unduly prescriptive and constrain plans'
flexibility in informing and training their providers and
subcontractors. However, we do expect that applicable integrated plans
will provide information and training to providers and subcontractors
as often as is necessary to ensure requirements are well understood and
met by all delegated entities.
Comment: One commenter supported the proposed requirement at Sec.
422.629(k)(3) related to the specific individuals who can review an
organization determination. A commenter recommended that we strike
``nor a subordinate of any such individual'' in the requirement at
Sec. 422.629(k)(4) related to who, at the applicable integrated plan,
can review integrated reconsiderations.
Response: We appreciate the commenter's support for this
requirement, but we decline to make this change, since our proposed
rule applied the requirement in the Medicaid managed care regulations
and we do not see a reason to set a new, different standard for review
under the unified appeals process. We believe that prohibiting
subordinates of someone who had already made a decision in a case is
appropriate, since the goal of the requirement is to help ensure a new,
objective review of the case, and a subordinate may believe a conflict
of interest in this respect.
After review of the comments and for the reasons set forth in the
proposed rule and our responses to the related comments, we are
finalizing the definitions at Sec. 422.561 of applicable integrated
plan, integrated appeal, integrated grievance, integrated organization
determination, and integrated reconsideration substantively as proposed
with minor technical and grammatical modifications to the definition of
an integrated organization determination to improve readability. We are
finalizing the general provisions at Sec. 422.629(a) through (k)
requiring use of unified appeals and grievance processes by applicable
integrated plans substantively as proposed with a minor modifications
in paragraph (a) to make a non-substantive technical change to clarify
that the unified appeals and grievance procedures finalized in this
rule are applicable beginning January 1, 2021, and to clarify that
Sec. 422.618(a) does not apply to applicable integrated plans and to
remove the designation of the single paragraph as (a)(1).
(4) Parties and Authorization for Filing Appeals (Sec. 422.629(l))
In proposed at Sec. 422.629(l), we addressed who is able to
request integrated grievances, integrated organization determinations,
and integrated reconsiderations. Proposed Sec. 422.629(1) used the
heading ``Parties.'' Although not explicitly stated in the preamble of
the proposed rule, we intended the heading to signal that such
individuals would be parties to the resulting integrated grievance,
integrated organization determination, and integrated reconsideration.
We also proposed in Sec. 422.629(l)(1)(ii) to combine the MA and
Medicaid requirements, such that a treating provider or authorized
representative can file an appeal on behalf of an enrollee. Our
proposal primarily adopted the MA rules at Sec. 422.566(c) and Sec.
422.582(a) that allow a treating provider to file a request for an
organization determination or standard reconsideration on behalf of an
enrollee without written authorization from the enrollee, but also
require that the provider notify the beneficiary. In order to mitigate
the risk that a provider would file an appeal against an enrollee's
interest and without an enrollee's consent, particularly to take
advantage of the provisions that allow a benefit to continue while the
appeal is pending, we proposed that the appealing provider obtain the
enrollee's written consent before requesting an integrated
reconsideration if continuation of benefits is requested under Sec.
422.632. Our proposed regulation text at Sec. 422.629(l)(1)(ii) also
incorporated the MA provision at Sec. 422.574(b) that allows a
provider to become an assignee of the enrollee and thereby become a
party to the organization determination and redetermination if the
provider waives any right to payment from the enrollee for the service
that is the subject of the appeal.
We summarize the comments we received on proposed Sec. 422.629(l)
and respond to them as follows:
Comment: We received broad support for our approach to
authorization for filing grievances, integrated organizations, and
integrated reconsiderations. Most commenters agreed that our proposal
presented a workable compromise between MA and Medicaid rules that
should protect enrollees' rights and minimize the potential for
inappropriate appeals. A few commenters expressed concern that allowing
providers to pursue appeals without first obtaining enrollees' written
consent would create a risk of conflicts of interest and potentially be
used to manipulate negotiated rates.
Response: We thank commenters for their broad support of our
approach. Because we are adopting existing MA rules for circumstances
where written
[[Page 15733]]
consent is not required when requesting integrated reconsiderations, we
believe the potential for conflicts of interest under our proposal are
no greater than they are under MA. Moreover, because we believe the
most significant potential for inappropriate provider-filed appeals
exists when aid (that is, coverage and payment) pending integrated
reconsideration is requested, requiring enrollees' written consent in
these cases should mitigate these risks. Our proposal reflected this
concern by limiting a provider's ability to seek benefit continuation
pursuant to Sec. 422.632 to only when the provider had received the
written request of the enrollee in proposed Sec. 422.629(l)(1)(ii); we
are finalizing this specific provision in a new paragraph (l)(1)(iv).
Comment: One commenter expressed concern that requiring enrollees'
written consent for provider-filed appeals requesting continuation of
Medicare services would confuse enrollees and providers and raise the
risk that enrollees would miss out on the opportunity to request
continuation of benefits for Medicare-related appeals. Instead, the
commenter recommended allowing providers to file requests for
integrated reconsiderations on behalf of enrollees without enrollees'
written authorization in these cases.
Response: We appreciate this concern but disagree with the
recommendation. We believe the provision requiring enrollee
authorization for provider-filed appeals requesting benefits pending
appeal is necessary to mitigate against potential conflicts of
interest. Although it may be theoretically possible to exclude
Medicare-related appeals from the requirement for written enrollee
consent in integrated reconsiderations, implementing such an exception
would likely be more confusing for providers and enrollees in an
integrated appeals system. We are therefore not adopting this
suggestion, but we encourage plans, enrollees and their advocates, and
providers to advise us regarding any difficulties implementing this
provision.
Comment: One commenter requested that we clarify who is a party to
the integrated reconsideration, similar to what currently exists in
Sec. 422.582.
Response: Proposed Sec. 422.629(1) used the heading ``Parties''
and identified who could request an integrated grievance, integrated
organization determination, and integrated reconsideration. Although
not explicitly stated in the preamble, we intended the heading to be
clear that such individuals would be parties to the resulting
integrated grievance, integrated organization determination, and
integrated reconsideration. We are finalizing the proposal with
additional language clarifying, at Sec. 422.629(l)(1), that all of the
individuals listed in that paragraph are parties to the integrated
grievance, integrated organization determination, and integrated
reconsideration.
In addition, we are deleting the language proposed at Sec.
422.629(l)(3) regarding which parties can request an expedited
integrated organization determination and expedited integrated
reconsideration. The same provisions are also at Sec. 422.631(c)(1)
for expedited integrated organization determinations and at Sec.
422.633(e)(1) for expedited integrated reconsiderations, and including
duplicative provisions at Sec. 422.629(l)(3) created the potential for
confusion.
Comment: Several commenters requested clarification regarding
whether non-treating providers would be authorized to file appeals
without an enrollee's written consent.
Response: Under Sec. 422.578, only treating providers are
permitted to file reconsideration requests on behalf of enrollees
without obtaining the enrollees' written consent. We did not intend to
broaden the ability of providers to file appeals on behalf of enrollees
beyond what is permitted in MA or change the right of assignees of an
enrollee to be parties to an appeal. We are therefore finalizing
regulatory text in paragraph (l)(1)(ii) that an assignee of an enrollee
includes a physician or provider that has furnished or intends to
furnish a service to the enrollee and has waived the right to payment
from the enrollee for the service. However, we are moving the provision
regarding the need for physicians and providers to provide notice to
the enrollee when filing a request for an integrated reconsideration on
behalf on an enrollee to a new paragraph (l)(3) along with additional
clarifying language. In this new paragraph (l)(3), we clarify that only
treating providers may request an integrated pre-service
reconsideration on behalf of enrollees without obtaining the enrollees'
written consent, but must also provide notice to the enrollee of that
request. Finally, for additional clarity, we are also finalizing a new
paragraph (l)(1)(iv) in this final rule that explicitly states that any
providers that furnish or intend to furnish a service to the enrollee
may request an integrated organization determination or, subject to the
requirements of paragraph (l)(3), an integrated reconsideration. This
provision is similar to the MA provision at Sec. 422.566(c)(1)(ii),
and upon consideration of comments requesting clarity on the role of
treating and non-treating providers, we believe it will be helpful to
include this provision explicitly in this final rule. We are also
moving the requirement that a provider requesting continuation of
benefits on behalf of an enrollee must obtain the enrollee's written
consent from proposed paragraph (l)(1)(ii) to the new paragraph
(l)(1)(iv), as this new paragraph explicitly addresses the rights of
treating providers in connection with integrated appeals. We are not
finalizing in this new paragraph (l)(1)(iv) the requirement that was
proposed at (l)(1)(ii) in the proposed rule that an authorized
representative also needs to obtain written consent when requesting
continuation of benefits because authorized representatives have--by
definition--obtained authority to act on enrollees' behalf.
Comment: Several commenters requested clarification regarding
whether our proposal for provider authorization applies both to pre-
service and post-service appeals.
Response: MA rules at Sec. 422.578 specify that the procedures
permitting treating providers to request reconsiderations on an
enrollee's behalf without the enrollee's consent apply only to pre-
service appeals. As with the limitation to treating providers, we did
not intend to broaden providers' appeal rights in this area beyond
existing MA rules. We are therefore removing the regulatory text at
Sec. 422.629(l)(1)(ii) and adding to the new paragraph (l)(3) in this
final rule regulatory text clarifying that the ability of providers to
file for an integrated reconsideration without obtaining the enrollee's
written consent applies only to pre-service integrated
reconsiderations.
Comment: One commenter supported our proposal but suggested adding
an explicit requirement that providers obtain enrollees' consent and
provide enrollees with status updates during the appeal process.
Another commenter made a related suggestion that providers requesting
integrated reconsiderations on behalf of enrollees be required to sign
and document that they have informed the enrollees of the filing of the
appeal.
Response: We disagree that more explicit restrictions and
obligations need to be part of the regulation. The final regulation at
Sec. 422.629(l)(3) states that, as under the MA regulation at Sec.
422.578, only treating providers may request an integrated
reconsideration on behalf on an enrollee without the enrollee's written
consent upon providing notice to the enrollee. Pursuant to Sec.
422.578, a treating provider may, upon providing notice to the
enrollee, request a pre-service,
[[Page 15734]]
standard reconsideration on the enrollee's behalf; any provider acting
on behalf of an enrollee may request that the standard reconsideration
be expedited, and Sec. 422.584 does not require notice to the enrollee
of the request that the reconsideration be expedited. MA rules at Sec.
422.578 do not impose additional explicit obligations on plans
requiring specific documentation or monitoring of communications
between providers and enrollees to establish that notice to the
enrollee has been provided in these situations. Instead, MA policy
provides plans with flexibility in how to ascertain whether a provider
has adequately informed an enrollee of the request for reconsideration
(see Parts C & D Enrollee Grievances, Organization/Coverage
Determination, and Appeals Guidance, Sec. 50.1).\25\ We believe
similar flexibilities should apply to integrated reconsiderations. For
example, if there are no records indicating contact between the
provider and enrollee, the plan should take reasonable steps to confirm
that the provider has informed the enrollee. Such steps could include
asking the provider either directly or on the form used to request the
reconsideration, or looking to see that the enrollee is copied on
correspondence. The plan may also contact the enrollee to confirm.
---------------------------------------------------------------------------
\25\ See https://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/Downloads/Parts-C-and-D-Enrollee-Grievances-Organization-Coverage-Determinations-and-Appeals-Guidance.pdf.
---------------------------------------------------------------------------
Comment: One commenter requested clarification regarding whether
the provider authorization rules in this section will also apply to
expedited integrated reconsideration requests.
Response: As under MA rule at Sec. 422.578, the rules regarding a
provider requesting a reconsideration on an enrollee's behalf apply
both to standard and expedited integrated reconsideration requests. The
new paragraph Sec. 422.629(l)(3) we are finalizing in this rule states
explicitly that the rule applies to both standard and expedited
integrated reconsideration requests. We note that if there is a request
for benefits pending appeal, then the enrollee's written consent is
required under the provision we are finalizing at Sec.
422.629(l)(1)(iv). In such a circumstance, the provider may file the
expedited request without a request for aid pending appeal in order to
get the reconsideration request filed as soon as possible. The provider
may then follow up with written authorization to request continuing
benefits on the enrollee's behalf after securing the enrollee's consent
to that request so long as the time period for requesting continuing
benefits has not expired.
After consideration of the comments and for the reasons provided in
the proposed rule and our responses to the comments, we are finalizing
Sec. 422.629(l) with some modifications. Specifically--
We have revised paragraph (l)(1) to more clearly state
that that the individuals and entities identified in that section are
parties to the case;
We moved the provisions addressing the ability of providers to file
appeals on behalf of enrollees that were proposed at paragraph
(l)(1)(ii) to a new paragraph (l)(3), and we have deleted references to
authorized representatives in that paragraph.
We have added a new paragraph (l)(1)(iv) to expressly
permit any treating provider to request an integrated organization
determination and integrated reconsideration. We have also moved the
provisions addressing the obligation of providers to obtain written
consent of enrollees when requesting continuation of benefits that were
proposed at paragraph (l)(1)(ii) to the new paragraph (l)(1)(iv);
In paragraph (l)(2), which addresses the use of the term
``enrollee,'' we have replaced the words ``this section' in the
proposed rule with ``Sec. Sec. 422.629 through 422.634'' because our
intent is that the use of the term enrollee as described in this
paragraph apply to the entire integrated grievance and appeal process.
As proposed, we are concerned the reference to ``this section'' was
ambiguous and therefore are clarifying it; and
We have deleted the proposed paragraph (l)(3) because that
language was redundant with provisions codified in Sec. Sec. 422.631
and 422.633.
(5) Integrated Grievances (Sec. 422.630)
At Sec. 422.630, we proposed to largely parallel Medicare and
Medicaid requirements where these requirements are the same with regard
to the treatment of integrated grievances. Where MA includes a
requirement that Medicaid does not, or vice versa, or where the MA and
Medicaid regulations conflict, we proposed applying the requirement
that best aligns with the principles and statutory requirements
discussed in section II.A.2.b. of the proposed rule. For integrated
grievances, we specifically proposed:
At paragraph (a), to establish the general purpose of the
regulation, similar to Sec. 438.402(a) and Sec. 422.564(a), by
requiring that an applicable integrated plan provide meaningful
procedures for timely hearing and resolving integrated grievances filed
by an enrollee. We proposed to define the scope of the required
procedures as being applicable to any grievances between the enrollee
and the plan or any entity or individual through which the applicable
integrated plan covers health care services. We proposed this
requirement for the applicable integrated plan to be responsible for
ensuring timely and appropriate resolution of a grievance even if the
grievance pertains to an act or decision by one of the applicable
integrated plan's providers of health care services. In the regulation
text, we proposed that the integrated grievance procedures applied to
``grievances between enrollees and the applicable integrated plan or
any other entity or individual through which the applicable integrated
plan provides health care services.''
At paragraph (b), to provide that an enrollee may file a
grievance at any time, paralleling the current Medicaid regulation at
Sec. 438.402(c)(2).
At paragraph (c), to allow grievances to be filed with the
applicable integrated plan orally or in writing, in alignment with MA
and Medicaid requirements; we also proposed to allow integrated
grievances related to Medicaid benefits to also be filed with the state
in states that have processes in place for that in accordance with
Sec. 438.402(c)(3).
At paragraph (d), we proposed to largely parallel the MA
requirements (at Sec. 422.564(f)) to authorize an enrollee to file an
expedited grievance when the complaint involves the applicable
integrated plan's decision to extend the deadline for certain appeals
or refusal to grant a request for an expedited integrated organization
determination or expedited integrated reconsideration.
At paragraph (e)(1), to parallel MA's maximum 30-day
timeframe for resolving the grievance and MA's requirements, at Sec.
422.564(e)(1), for how the applicable integrated plan must respond to
grievances, depending on how the grievance is received and the basis
upon which the enrollee filed the grievance. Although not discussed in
the preamble to the proposed rule, the proposed regulation text would
require the applicable integrated plan to resolve an integrated
grievance as expeditiously as the case requires based on the enrollee's
health status and within 30 days, which is the current requirement
under Medicare (see Sec. 422.564(e)(1)).
At paragraph (e)(2), to include a provision, paralleling
provisions in MA (Sec. 422.564(e)(2)) and Medicaid managed care (Sec.
438.408(c)(1)), permitting the applicable integrated plan to extend the
time period in which a determination on an integrated grievance must be
[[Page 15735]]
issued to the enrollee by up to 14 days. We proposed combining MA and
Medicaid requirements, such that applicable integrated plans must
notify enrollees immediately, but no later than within 2 calendar days,
which we believe to be in line with the principles identified in
section 1859(f)(8)(B)(iii) of the Act for timely, clear notification to
enrollees.
We invited comments on these topics, specifically whether the
proposed regulation text accurately incorporated the standards from the
underlying part 422 or part 438 regulation that are more beneficial to
the enrollee. We also solicited comment on whether we adequately
captured all relevant enrollee protections currently available under MA
and Medicaid. We summarize and respond to the comments on these
specific proposals as follows:
Comment: Many commenters supported our proposed integrated
grievance process, including provisions for an expedited grievance
process, the 14-day extension period for resolving integrated
grievances, the clarification that applicable integrated plans must
resolve grievances involving any entity or individual through which the
applicable integrated plan provides health care services, requiring
responses to grievances within 30 days, and allowing enrollees to file
at any time. A few commenters opposed the proposal to allow enrollees
to file integrated grievances at any time, and recommending that CMS
instead limit enrollees to filing integrated grievances within 60 days,
to be consistent with the current MA requirement.
Response: We appreciate the support for our proposed integrated
grievance requirements. We decline to establish in this final rule a
timeframe for enrollees to file a grievance. While we understand the
commenters' desire to be consistent with such limits in the MA program,
our proposed requirements were developed consistent with the statutory
requirement that we implement standards most protective of enrollees
(see section 1859(f)(8)(B)(ii)(I) of the Act). The relevant Medicaid
regulation (Sec. 438.402(c)(2)(i)) allows a grievance to be filed at
any time, while the MA regulation (Sec. 422.564(d)(a)) limits
grievance filing to within 60 days of the event at issue. Not having a
time limit for enrollees to file grievances is most protective for
enrollees by eliminating barriers to filing.
In addition, we note that the language as we proposed in Sec.
422.630(a) with respect to the types of benefits for which the
applicable integrated plans is responsible for resolving integrated
grievances was limited to disputes involving entities that provide
``health care services,'' which is the MA rule at Sec. 422.564(a). Our
intent was that an applicable integrated plan be responsible for
resolving grievances pertaining to all its contracted providers,
including those that provide items and services that might not be
strictly considered health care services, such as Medicaid non-
emergency transportation. Using a broader term will ensure that the
right to file an integrated grievance with an applicable integrated
plan includes grievances that could be filed for all Medicare and
Medicaid covered benefits. Therefore, we are revising Sec. 422.630(a)
to state that the applicable integrated plan is responsible for
resolving grievances between enrollees and entities through which the
plan provides ``covered items and services.'' We are adopting the
provision as set forth in the proposed rule with this minor revision as
noted.
Comment: Several commenters supported the proposal to allow
enrollees to file Medicaid-related grievances with the state. A few
commenters requested clarification on which integrated grievances could
be filed with the state. Another commenter suggested that CMS go
further and allow integrated grievances to be filed with providers and
1-800-Medicare, and a few commenters recommended that CMS ensure that
there is a ``no wrong door'' policy such that if an enrollee files a
grievance with the wrong entity, it is not just dismissed.
Response: We appreciate commenters' broad support for this
provision. We appreciate the importance of a ``no wrong door'' policy,
and we intend to work closely with states that permit enrollees to file
Medicaid grievances with the state to ensure that applicable integrated
plans have the guidance they need regarding policies and procedures for
these instances. Further, we will consider comments about establishment
of ``no wrong door'' processes for all enrollees in applicable
integrated plans; we note that CMS has established an online system for
Medicare beneficiaries to submit complaints and concerns about the
Medicare program, including MA plans. Additionally, 1-800-Medicare
currently accepts complaints related to Medicare, and CMS ensures
resolution of them.
With regard to the ability to file grievances with providers, we do
not believe additional regulatory provisions are needed. We expect
that, as currently is the case, most enrollees will submit grievances
directly to the applicable integrated plan. Under Sec. 422.629(j),
applicable integrated plans will be required to provide information
about the integrated grievance and appeals system to all contracted
providers (as noted in the proposed rule, this requirement already
exists for Medicaid MCOs). This information should enable contracted
providers to direct enrollee grievances properly to the applicable
integrated plan when necessary. In addition, plans may delegate
responsibility for handling grievances to provider groups consistent
with existing Medicare policy (see Sec. 422.504(i) and the Parts C & D
Enrollee Grievances, Organization/Coverage Determinations, and Appeals
Guidance, Sec. 10.4.3 \26\). In those circumstances, the plan remains
ultimately responsible for ensuring that contracted entities comply
with all rules governing responding to grievances.
---------------------------------------------------------------------------
\26\ See https://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/Downloads/Parts-C-and-D-Enrollee-Grievances-Organization-Coverage-Determinations-and-Appeals-Guidance.pdf.
---------------------------------------------------------------------------
With regard to comments about filing grievances with the state, we
clarify that the regulation is designed to provide a means for the
state to address Medicaid grievances. If a grievance contains aspects
related to both Medicare and Medicaid benefits, the state can review
the Medicaid benefit portions, but should ensure that the Medicare
benefit portions are appropriately transferred to the applicable
integrated plan for review. If a grievance related to Medicaid benefits
is filed with both the state and the applicable integrated plan, we
expect the two entities to be in communication to ensure the grievance
is resolved, as would occur now for Medicaid managed care grievances.
Comment: One commenter requested that we require all responses to
grievances to be in writing. Several other commenters suggested that we
not require written acknowledgement of all grievances.
Response: We do not believe that a written response to all
integrated grievances is necessary; such a standard is not imposed
under current requirements for MA plans or for Medicaid managed care
plans. As proposed and finalized in this rule, the regulation (Sec.
422.630(e)(1)) requires applicable integrated plans to respond in
writing to integrated grievances when: (1) The integrated grievance was
filed in writing; (2) the enrollee requests a written response to an
integrated grievance that was orally submitted; and (3) the integrated
grievance was related to quality of care. The regulation permits
applicable integrated plans to respond in writing or orally to
integrated grievances that are filed orally, unless the enrollee
requests a
[[Page 15736]]
written response. Additionally, the applicable integrated plan must
send the enrollee a written notice when it extends the timeframe for
responding to the integrated grievance (consistent with Sec.
422.630(e)(2)(ii), it may extend the timeframe by up to 14 calendar
days). Consistent with Sec. 422.629(c) as finalized, there is
flexibility for states to set standards that are more protective of
enrollees in connection with timeframes and notices; a state could, at
its discretion, require that applicable integrated plans provide the
disposition of all grievances in writing. Such a requirement would need
to be specified in the state Medicaid agency contract with the D-SNP.
We note that an applicable integrated plan, consistent with Sec.
422.629(g), must send a written notice acknowledging receipt of the
grievance; in this notice, a plan could also note that the grievance is
considered resolved if the applicable integrated plan has previously
provided the enrollee an oral resolution to clarify the status of the
grievance for the enrollee. Accordingly, we are adopting without change
the provision as set forth in the proposed rule.
Comment: Several commenters requested clarification on the
requirement that applicable integrated plans notify enrollees within 2
calendar days when an extension is being taken.
Response: We clarify that the applicable integrated plan must
notify the enrollee that an extension is being taken within two
calendar days of when the applicable integrated plan, after justifying
the need for the extension and documenting how the delay is in the
enrollee's interest, makes the decision to extend the timeframe. We are
finalizing the regulation text at Sec. 422.630(e)(2)(ii) with
additional text to clarify this timing.
Comment: A commenter suggested that we implement integrated
reporting in the Complaint Tracking Module (CTM) for grievances in the
CMS Health Plan Management System (HPMS) and give states access to
track all grievances and resolutions for transparency and monitoring.
Response: We appreciate the comment and will consider it as we move
forward with implementation. If such a step is operationally feasible,
we do not believe it would require additional regulatory language.
For the reasons provided in the proposed rule and our responses to
the comments, we are finalizing the requirements at Sec. 422.630
substantively as proposed with some minor modifications as follows:
We are revising the regulatory text at paragraph (a) by
replacing ``health care services'' with ``covered items and services''
in order to ensure that grievances pertaining all Medicare and Medicaid
covered benefits are included in the requirement;
We are finalizing the regulatory text in paragraph (d)
with revisions to streamline the regulation text and, at paragraph
(d)(2), to clarify the terms used; and
We are revising paragraph (e)(2)(ii) to clarify how long
the plan has to notify the enrollee when it extends the time the
resolve a grievance.
(6) Integrated Organization Determinations (Sec. 422.631)
In proposed Sec. 422.631, we specified the procedures applicable
integrated plans would follow in making integrated organization
determinations. In paragraph (a), we proposed that, as part of a
unified process, all requests for benefits covered by applicable
integrated plans must be subject to the same integrated organization
determination process.
In paragraph (b), we proposed to adopt the MA provisions at Sec.
422.568(a) allowing an enrollee to request an integrated organization
determination either orally in writing, but requiring requests for
payment to be made in writing.
In paragraph (c), we proposed to articulate the standard for making
an expedited organization determination. Both MA (at Sec. 422.570(c))
and Medicaid (at Sec. 438.210(d)(2)) have similar standards for an
expedited organization determination, including who can file it
(proposed in Sec. 422.631(c)(1)) and how it should be decided
(proposed in Sec. 422.631(c)(3)). At paragraph (c)(2), we proposed
that the request to expedite the appeal can be made orally or in
writing.
In paragraph (d), we proposed rules regarding timeframes and
notices when resolving integrated coverage determinations. In paragraph
(d)(1), we proposed to require that an applicable integrated plan send
a written integrated notice when the organization determination
(standard or expedited) is adverse to the enrollee. We proposed to
include text specifically identifying as adverse determinations
requiring a notice any decision to authorize a service or item in an
amount, duration, or scope that is less than the amount requested or
previously requested or authorized for an ongoing course of treatment.
We also proposed to include text specifying, consistent with Medicaid
managed care requirements (Sec. 438.404(c)(5)), that the applicable
integrated plan must send an integrated determination notice when the
plan fails to make a timely decision because failure to make a decision
within the required timeframe is a denial (and thus an adverse
determination). The proposed notice would include information about the
determination, as well as information about the enrollee's appeal
rights under both Medicare and Medicaid. We also proposed that the
notice be written in plain language and available in a language and
format that is accessible to the enrollee; this proposed requirement is
consistent with section 1859(f)((8)(B)(iii)(III) of the Act.
In paragraph (d)(2), we proposed timelines for sending this notice
that largely align with both existing Medicare and Medicaid
requirements. We proposed, in paragraph (d)(2)(i)(A), to require that
applicable integrated plans send a notice of an integrated organization
determination at least 10 days before the date of action if a
previously authorized benefit is being reduced, suspended, or
terminated, with some exceptions in accordance with Sec. Sec. 431.213
and 431.214; we briefly explained the exceptions available in
accordance with Sec. Sec. 431.213 and 431.214 in the proposed rule (83
FR 55008). We proposed, in paragraph (d)(2)(i)(B), to require that
applicable integrated plans send the notice as expeditiously as the
enrollee's health condition requires but no later than 14 calendar days
from receipt of the request for a standard integrated organization
determination. We further proposed to permit extensions, in paragraph
(d)(2)(ii), in circumstances that largely parallel those that exist in
Medicare and Medicaid currently. In paragraph (d)(2)(iii), we proposed
requirements for notice to be provided to the enrollee in cases of
extension; these proposed requirements also largely parallel current MA
and Medicaid requirements at Sec. 422.572(b)(2) and Sec.
438.404(c)(4)(i), respectively. Proposed Sec. 422.631(d)(2)(iii)(A)
largely parallels Sec. 422.572(b)(2), which provides more specific
direction on timing of the notice. We also proposed in paragraph
(d)(2)(iii)(B) regulatory text controlling when the notice of the
integrated organization determination must be sent in cases where the
applicable integrated plan makes the decision to extend the timeframe.
In paragraph (d)(2)(iv)(A), we proposed the deadline for issuing
notice of expedited integrated organization determinations. Both MA and
Medicaid require expedited organization determinations (or adverse
actions) as expeditiously as the enrollee's health condition requires
but not later than within 72 hours of the request, with the possibility
of extending that timeframe
[[Page 15737]]
by 14 calendar days. We proposed, at paragraph (d)(2)(iv)(B), to mirror
the MA requirements (Sec. 422.570(d)), with required procedures when
an applicable integrated plan denies a request for expediting an
organization determination. In paragraph (d)(2)(iv)(C), we proposed to
include requirements, which parallel MA requirements (Sec.
422.572(d)), for applicable integrated plans when obtaining necessary
information from noncontract providers.
We received the following comments on the proposals at Sec.
422.631 and our responses follow.
Comment: We received many comments related to the notice
requirement in proposed Sec. 422.631(d)(1). Several commenters
supported the notice of the integrated organization determination, the
required content we proposed, and the requirement that it be written in
plain language and available in the language and format that is
accessible to the beneficiary. Several commenters requested
clarification regarding whether the existing Integrated Denial Notice
used by MA plans (Form CMS-10003-NDMCP) would be used to satisfy the
requirement for notice of the integrated organization determination.
Several other commenters also suggested that CMS develop a model notice
to serve as the integrated organization determination notice for
applicable integrated plans to use. A commenter recommended that the
notice only be required to be sent when there is a denial of the
service or item by all coverage sources (that is, Medicare and
Medicaid).
Response: We intend to develop a separate model notice that will be
used exclusively for integrated organization determinations and that
will be specifically tailored to contain information relevant to the
unified appeals process we are finalizing in this rule. As finalized in
Sec. 422.631(d)(1), the new integrated notice will be sent in cases
where a service or item is being denied under Medicare and Medicaid. In
addition, as is the case with the current MA Integrated Denial Notice
(Form CMS-10003-NDMCP), we will develop instructions for appropriate
use of the new model notice. The instructions will also explain how
plans should tailor the model notice to explain the outcome to the
enrollee in situations where a notice is required. As we note in the
Collection of Information section in this final rule, this model
notice, and its associated requirements and burden, will be submitted
to OMB for approval separately from this final rule once we develop the
model and accompanying analyses. The OMB approval process will include
a public comment period.
Comment: A commenter recommended that we also make the integrated
organization determination notice available for use by plans other than
applicable integrated plans.
Response: We decline to accept the commenter's suggestion. We
intend to tailor the model notice specifically to the unified appeals
process, and information and procedures relevant to that process, we
are finalizing in this rule. We do not believe the model notice will be
appropriate for enrollees outside the unified process and, as such, the
model notice for integrated organization determinations will be
specifically tailored for use by applicable integrated plans.
After consideration of the comments and for the reasons set forth
in the proposed rule and our responses to the related comments, we are
finalizing Sec. 422.631 substantively as proposed, but with minor
modifications to streamline the regulatory text at paragraph (d) as
follows:
We are finalizing proposed paragraph (d)(1) as three new
paragraphs, paragraphs (d)(1)(i) through (iii) and making minor
grammatical changes.
We are renumbering proposed paragraphs (d)(1)(i) through
(viii) in the final rule as paragraphs (d)(1)(iii)(A) through (H).
(7) Continuation of Benefits Pending Appeal (Sec. 422.632)
At Sec. 422.632, we proposed rules to implement the provisions
added to section 1859(f) of the Act by section 50311 of the Bipartisan
Budget Act of 2018 pertaining to continuation of benefits pending
appeal under Titles XVIII and XIX, specifically the new provision at
section 1859(f)(8)(B)(iv) of the Act. We explained in detail in the
proposed rule (83 FR 55008 through 55009) how we interpret this
provision as requiring CMS to apply continuation of benefits to all
Medicare Parts A and B and Medicaid benefits under our proposed unified
appeals processes.
Based on that interpretation, we proposed that the existing
Medicaid standards applicable to Medicaid managed care plans for
continuation of benefits at Sec. 438.420 apply to applicable
integrated plans for Medicare benefits under Parts A and B and Medicaid
benefits in our proposed integrated appeals requirements at Sec.
422.632. Under our proposal, if an applicable integrated plan decides
to stop (as a termination or suspension) or reduce a benefit that the
enrollee is currently authorized to receive, the enrollee could request
that the benefit continue to be provided at the currently authorized
level while the enrollee's appeal is pending through the integrated
reconsideration. The enrollee would be required to make a timely
request for the continuation. We proposed, at paragraph (a), a
definition for ``timely files.'' This proposed definition mirrored the
definition at Sec. 438.420(a), with minor revisions to make the text
applicable to applicable integrated plans instead of Medicaid managed
care plans.
We proposed, at paragraph (b), to require a previously authorized
service covered under Medicaid or Medicare Part A or Part B, excluding
supplemental benefits as defined at Sec. 422.102, to be continued
pending an appeal of a termination of those services. We proposed to
require that the continuation of these services as a covered benefit
would be conditioned on meeting the same five criteria listed in Sec.
438.420:
(1) The enrollee files the request for an integrated appeal timely
in accordance with Sec. 422.633(e);
(2) The integrated appeal involves the termination, suspension, or
reduction of previously authorized services;
(3) The services were ordered by an authorized provider;
(4) The period covered by the original authorization has not
expired; and
(5) The enrollee timely files for continuation of benefits.
Because proposed paragraph (b) repeated that language at section
1859(f)(8)(B)(iv) of the Act that limits the continuation of benefits
to only benefits under Parts A and B of title XVIII and title XIX of
the Act, we noted in the preamble to the proposed rule that MA
supplemental benefits would not be subject to the proposed rule (83 FR
55009).
We proposed, at paragraph (c), to require that an applicable
integrated plan continue such services pending issuance of the
integrated reconsideration. We noted in the proposed rule that for
Medicaid managed care plans that are not applicable integrated plans,
continuation of these services after the integrated reconsideration and
pending resolution of the state fair hearing is controlled by Sec.
438.420(c). Proposed Sec. 422.632(c)(2) provided that continuation of
services would end when the applicable integrated plan issues an
adverse integrated reconsideration. If the applicable integrated plan
finds in favor of the enrollee, benefits would continue in accordance
with the favorable integrated
[[Page 15738]]
reconsideration. In proposed Sec. 422.632(c)(3), we proposed
requirements for Medicaid-covered benefits to continue after the
applicable integrated plan issues an adverse integrated
reconsideration, mirroring the requirements currently in Medicaid
managed care regulations (see Sec. 438.420(c)(2)). The enrollee must
make the request and file for a state fair hearing within 10 calendar
days after the applicable integrated plan sends the notice of the
integrated reconsideration. We also proposed to mirror requirements
from Sec. 438.420 for how long Medicaid-covered benefits must continue
by requiring that the benefits continue until the enrollee withdraws
the request for the state fair hearing or until the state fair hearing
decision is issued.
In proposed paragraph (d), we addressed whether an applicable
integrated plan can seek recovery for the costs of services provided
while an appeal is pending. We proposed not to follow Medicaid's
regulations that allow states to determine whether or not a plan, or
the state, can seek recovery for the costs of services provided pending
appeal. We noted there is no analogous process in Medicare, as
continuation of benefits pending appeal is very limited in Medicare and
generally only available in cases involving QIO review of inpatient
discharges. Instead, drawing in part on the experience of a number of
Financial Alignment Initiative demonstrations, we proposed to prohibit
recovery of the costs of services provided pending the integrated
reconsideration and, for Medicaid-covered benefits, any state fair
hearing, to the extent that services were continued solely under Sec.
422.632, for all applicable integrated plans and state agencies.
We solicited comment generally on our proposal regarding
continuation of benefits and also requested comments on alternatives,
including regarding the feasibility of treating Medicare and Medicaid
benefits differently for the purpose of recovery of costs. We summarize
the comments on this topic and respond to them as follows:
Comment: Most commenters supported our overall interpretation of
the statute extending Medicaid's approach of providing aid pending
appeal to items and services covered under Medicare Part A and Part B.
One commenter, in supporting our overall approach, urged us to monitor
for any unexpected cost consequences to D-SNPs resulting from the rule
and encouraged us to ensure that any additional costs resulting from
the policy are allowable for bid purposes. Another commenter objected
to the entire approach based on concerns about potential cost
implications to the integrated D-SNPs subject to the provision. One
commenter disagreed with our approach, stating that we should make no
changes to Medicare's coverage of items and services pending appeal,
although this commenter provided no statutory basis for their
perspective.
Response: We appreciate the strong support for our overall
approach. As we discussed in the preamble to the proposed rule, we
believe the most logical reading of the statutory language directs us
to extend Medicaid's aid pending appeal procedure to Medicare Part A
and B services covered by applicable integrated plans. Regarding costs,
MMPs in the Financial Alignment Initiative have operated under similar
rules and have not reported any significant resulting adverse impact on
cost. The Regulatory Impact Analysis for our proposed rule, on which we
received no comments related to this specific proposal, projected a
minimal cost to plans from extending the Medicaid aid pending appeal
procedure to Medicare Parts A and B services. We will provide further
guidance on this topic for plans as part of the bid submission process.
Comment: We received many comments regarding our approach to
recovery of the costs of services provided pending appeal. Many
commenters supported our proposal as consistent with the statute,
clearer to administer than alternatives, and most protective of
beneficiaries. A significant number of other commenters, however,
expressed concern that our approach could increase costs and
recommended instead that states retain the flexibility to pursue
recovery of costs at their discretion.
Response: We thank the commenters for their comments on this issue.
After careful consideration of the commenters' perspectives, we are
finalizing our proposal with some modifications to Sec. 422.632(d)
regarding recovery of the costs. We are finalizing the proposed
regulation regarding recovery of costs at the integrated
reconsideration level, which is now codified at Sec. 422.632(d)(1). We
believe it is highly desirable to have one single rule regarding
recovery of costs apply to all services provided pending the issuance
of the integrated reconsideration decision pursuant to section
1859(f)(8)(B)(iv) of the Act, rather than to treat Medicare-related and
Medicaid-related services differently. We believe that it is simpler
and more protective of beneficiaries to prohibit the recovery of the
costs of all services provided by an applicable integrated plan pending
an integrated reconsideration pursuant to a request filed under Sec.
422.632. All services, both Medicare-related and Medicaid-related,
provided by applicable integrated plans through the end of the
integrated reconsideration process are considered to be furnished under
the requirements of Sec. 422.632 and are therefore not subject to
recovery of costs.
However, we find it persuasive that, for cases where a plan's
denial is ultimately affirmed, eliminating the ability of states to
recover the costs of Medicaid services provided by the applicable
integrated plan after the integrated reconsideration is final and
pending a state fair hearing could create significant inconsistencies
for state Medicaid appeal processes and potentially discourage states
from pursuing exclusively aligned enrollment and thereby adopting
integrated appeals. Moreover, because our entire integrated process
extends only to the integrated reconsideration stage and not to the
state fair hearing process, this rule limiting recovery of costs is
also limited to costs incurred for continuation of services pending the
integrated reconsideration stage. We are therefore designating the text
in proposed paragraph (d) as (d)(1) in this final rule with revised
text limiting that rule to recovery of costs for services continued
pending the integrated reconsideration. We are also finalizing a new
provision at paragraph (d)(2) to provide states with the flexibility to
recover the costs of services continued pending the state fair hearing
phase of an appeal (that is, after the date of the integrated
reconsideration decision and until the decision is issued on the state
fair hearing), consistent with state rules and with Sec. 438.420(d).
We believe this addition should mitigate concerns about costs to
states. We also note a number of Financial Alignment Initiative
demonstrations do not allow recoupment of costs and MMPs have not
reported any adverse financial impact, suggesting a minimal impact on
costs from limiting recovery of costs. In summary, under Sec.
422.632(d)(1) and (d)(2), recovery of costs is not permitted for
services provided pending the integrated reconsideration. If an
enrollee requests a state fair hearing after an adverse integrated
reconsideration, then state Medicaid procedures regarding continuation
of benefits and recovery of costs will apply. We will work with states
and plans to ensure that enrollees are fully informed of these rules.
Finally, we note that this provision is
[[Page 15739]]
unrelated to the requirement at Sec. 422.634(e) requiring a plan or
state to pay the costs of benefits provided in the event a plan's
initial decision is reversed at the integrated reconsideration or fair
hearing stage. The obligations at Sec. 422.634(e) are similar to those
under Medicaid at Sec. 438.424(b) governing effectuation of a
decision, and apply to any services the enrollee receives while the
appeal is pending, whether or not continuation of benefits was
requested under Sec. 422.632.
Comment: A commenter requested that CMS clarify whether services
were required to continue pending IRE review. We received a number of
comments recommending that we should require coverage of aid pending
appeal for Medicare Parts A and B services to extend through the IRE
level (and in some comments, through the administrative law judge (ALJ)
or higher appeal levels as well), rather than stopping after the
integrated reconsideration level. One commenter expressed concern that
stopping before the IRE level would discourage appeals. Others
encouraged continuation through the IRE level to ensure external review
of all appeals before services ended.
Response: The regulation, as proposed and finalized at Sec.
422.632(c)(2), requires integrated applicable plans to continue
Medicare Part A and Part B and Medicaid benefits through the issuance
of an integrated reconsideration decision under Sec. 422.633(f)(4). If
the applicable integrated plan affirms its decision at the integrated
reconsideration level and the case involves Medicaid benefits, an
enrollee may request a state fair hearing as described in Sec.
422.634(b)(2). From that point forward, existing Medicaid rules apply,
including Sec. 438.420 that requires Medicaid managed care plans--
regardless whether they are applicable integrated plans--to continue
provision of Medicaid benefits on certain terms through the state fair
hearing process. We decline at this time to require continuation of
Medicare services through the IRE level, and will retain our rule as
proposed that requires continuation of Medicare Parts A and B services
only through the integrated reconsideration level. Section
1859(f)(8)(B)(iv) of the Act provides authority to extend benefits
pending appeal in the context of the unified appeal procedures we are
adopting in this rule. We are not at this time integrating IRE review
into a unified appeal process; therefore, we believe we lack statutory
authority to extend benefits pending to the IRE level review under the
unified appeal process. In addition, most of the Financial Alignment
Initiative demonstrations have not included aid pending appeal through
the IRE level. As a result, we have little experience with either the
operational complexities or the financial impact of such a policy.
Finally, because IRE review is automatic for all adverse Medicare plan
reconsiderations under Sec. 422.592, there is not a risk that
enrollees will end their appeal prior to the IRE review. We believe the
more prudent course is to implement aid pending appeal for services
through the integrated reconsideration level as we have proposed. We
may consider the feasibility of broadening the unified appeal process
to include IRE review and continuation of benefits through additional
appeal levels in future rulemaking.
Comment: A few commenters recommended that continuation of benefits
pending appeal also apply to supplemental benefits provided by
applicable integrated plans.
Response: We decline to adopt this recommendation and believe that
it is not consistent with the statute. Section 1859(f)(8)(B)(iv) of the
Act, added by the Bipartisan Budget Act of 2018, authorizes
continuation of benefits for integrated appeals is limited to benefits
under Medicare Parts A and B as well as Medicaid, but does not include
MA supplemental benefits, which are offered under Part C of the Act
(specifically section 1852(a)(3) of the Act). We therefore do not have
the authority to require continuation of supplemental benefits pending
appeal. Plans may continue such benefits voluntarily, however, and
states may include conditions affecting coverage of such benefits in
their contracts with D-SNPs, so long as enrollees are made aware of any
potential risk of financial liability.
Comment: A few commenters suggested that we establish an expedited
process for integrated reconsiderations when continuation of benefits
pending appeal is requested in order to minimize the risk of payment
discrepancies.
Response: We decline to adopt this suggestion. We note that
continuation of services pending appeal has long been part of Medicaid
appeals and no special expedited process exists for such cases. We do
not see a reason for treating integrated reconsiderations differently
in this regard. In addition, applicable integrated plans may prioritize
resolution of integrated reconsiderations where services are
continuing, so long as these plans follow all procedural rules and
ensure that enrollees have a full opportunity to present their case.
Further, the requirement to expedite certain integrated
reconsiderations based on the enrollee's health status (discussed in
section II.A.2.b.(8) of this final rule) applies regardless whether
benefits are continued under Sec. 422.632.
Comment: A few commenters requested that we add language that would
allow plans to dismiss an integrated reconsideration request if an
enrollee becomes eligible for a service while the integrated
reconsideration is pending.
Response: We decline to make this addition. There are no
regulations in the MA program or Medicaid managed care program that
address dismissals of reconsiderations or appeals in these
circumstances, and we do not believe that we should create a new
procedure unique to integrated reconsiderations here. We note that the
Parts C & D Enrollee Grievances, Organization/Coverage Determinations,
and Appeals Guidance, Sec. 50.8, does include guidance regarding
dismissal of pre-service reconsideration requests when a service has
been provided before the reconsideration is completed. We will consider
if additional guidance is needed in this area for integrated
reconsiderations when continuation of services is requested.
After considering the comments and for the reasons set forth in the
proposed rule and our responses to the comments, we are finalizing
Sec. 422.632 as proposed with modifications to paragraph (d). In newly
designated paragraph (d)(1), we are making technical changes to the
proposed regulation text to clarify that an applicable integrated plan
or a state agency may not pursue recovery of costs for services
continued pending the integrated reconsideration. In new paragraph
(d)(2), we are finalizing a provision that authorizes states to recover
the costs of Medicaid services provided during the state fair hearing
phase of an appeal (that is, after the date of the integrated
reconsideration decision and until the decision is issued on the
Medicaid state fair hearing), consistent with state rules and with
Sec. 438.420(d).
(8) Integrated Reconsiderations (Sec. 422.633)
In proposed Sec. 422.633, we laid out our proposed provisions for
an integrated reconsideration process for applicable integrated plans.
As with other provisions, we compared relevant Medicare and Medicaid
provisions, and where they differ, we chose to adopt the policy that is
most protective of the beneficiary.
In paragraph (a), consistent with current MA and Medicaid
regulations (Sec. Sec. 422.590 and 438.402(b), respectively), we
proposed that
[[Page 15740]]
applicable integrated plans may only have one plan level of appeal
beyond the initial decision (the integrated organization
determination).
In paragraph (b), we proposed to adopt a rule similar to Sec.
438.402(c)(1)(i)(B) regarding the permissibility of external medical
reviews: Medicaid managed care plan enrollees may be offered an
opportunity to elect external medical review under a state external
review process. Under our proposal, the ability to elect external
medical review would apply only to Medicaid covered services that are
the subject of an adverse integrated reconsideration issued by an
applicable integrated plan because D-SNPs, like all MA plans, are not
subject to state external review procedures.\27\
---------------------------------------------------------------------------
\27\ Section 1856(b)(3) of the Act preempts state regulation of
MA plans.
---------------------------------------------------------------------------
In paragraph (c), we proposed a right for each enrollee, and their
representatives, to receive a copy of the enrollee's case file
(including medical records and evidence considered, generated, or
relied on by the integrated applicable plan in making the integrated
organization determination) free of charge, consistent with the
protection for Medicaid enrollees under Sec. 438.406(b)(5).
In paragraph (d)(1), we proposed timelines for filing for a
standard integrated reconsideration that, consistent with both MA (at
Sec. 422.582(b)) and Medicaid managed care (at Sec.
438.402(c)(2)(ii)) regulations, would require that an integrated
reconsideration be filed within 60 days of the date of the denial
notice. We proposed, in paragraph (d)(2), that oral inquiries seeking
to make an integrated reconsideration be treated as integrated
reconsiderations; this is generally consistent with Sec.
438.406(b)(3). We did not propose to include the language in Sec.
438.406(b)(3) requiring beneficiaries to provide written confirmation
of oral requests because such a requirement would be inconsistent with
MA policy that directs plans that do accept oral requests for
reconsideration to provide written confirmation to the beneficiary (see
Parts C & D Enrollee Grievances, Organization/Coverage Determination,
and Appeals Guidance, Sec. 50.2.1). We proposed, in paragraph (d)(3),
to include current requirements from MA (at Sec. 422.582(c)) that
allow for extending the timeframe for an enrollee, or a physician
acting on behalf of an enrollee, to file a late reconsideration.
In paragraph (e), we proposed to address procedures for filing
expedited integrated reconsiderations, consistent with current MA and
Medicaid rules. The proposed language in paragraphs (e)(1) and (e)(2)
aligns with Sec. 422.584 in permitting the enrollee or health care
provider to file a written or oral request for an expedited
reconsideration. The proposed language in paragraph (e)(3) aligns with
Sec. 422.584 in setting the standard that the applicable integrated
plan must use in deciding whether to expedite the integrated
reconsideration.
In paragraph (e)(4), we proposed notice requirements related to
requests for expedited integrated reconsiderations. We proposed
requirements that parallel Medicaid managed care requirements for
notice to the enrollee when the request for an expedited integrated
reconsideration is denied (Sec. 438.410(c)(2))--specifically, that the
plan must give prompt oral notice and written notice within 2 calendar
days and transfer the matter to the standard timeframe for making an
integrated reconsideration (that is, the timeframe specified in
paragraph (f)(1)). We proposed to apply the MA requirements for what
applicable integrated plans must include in the written notice to
enrollees when the request to expedite the integrated reconsideration
is denied (Sec. 422.584(d)(2)).
In paragraph (e)(5) we proposed to include requirements, which
mirror MA requirements (Sec. 422.590(d)(3)), for applicable integrated
plans when obtaining necessary information from noncontract providers.
These requirements specify that the applicable integrated plan must
reach out to a noncontract provider within 24 hours of the initial
request for an expedited integrated reconsideration.
In paragraph (f), we proposed timelines and procedures for
resolving an integrated reconsideration request. We proposed specific
requirements for applicable integrated plans. Both MA (at Sec.
422.590(a)) and Medicaid (at Sec. 438.408(b)(2)) require resolution of
pre-service standard appeal requests within 30 calendar days. We
proposed the rules in paragraph (f)(1), that parallel MA (at Sec.
422.590(a)) and Medicaid (at Sec. 438.408(b)(2)) with the addition of
a provision mirroring Sec. 422.590(a)(2), that the integrated
reconsideration decision be issued as expeditiously as the enrollee's
health requires but no later than 30 calendar days from the date the
applicable integrated plan receives the request for the integrated
reconsideration.
In Sec. 422.633(f)(1), we proposed to require that all integrated
reconsiderations--pre-service and post-service--be resolved as
expeditiously as the enrollee's health requires and within 30 calendar
days from the date the applicable integrated plan receives the request
for the integrated reconsideration. We noted that this timeframe is
consistent with Medicaid managed care requirements for both pre- and
post-service requests at Sec. 438.408(b)(2) and with pre-service
requests under MA at Sec. [thinsp]422.590(a). We deviated from the MA
requirements for post-service cases involving denial of payment, as
current MA requirements provide 60 calendar days for MA plans to
resolve these cases.
In paragraph (f)(2), we proposed to establish the timeframes for
expedited reconsiderations, which parallel both MA (at Sec.
422.590(d)(1)) and Medicaid (at Sec. 438.408(b)(3)) regulations for
managed care plans in requiring the applicable integrated plan to
resolve the expedited reconsideration as expeditiously as the
enrollee's health requires and within 72 hours from the date the
applicable integrated plan receives the request for the integrated
reconsideration. We also proposed to apply the Medicaid managed care
requirement (at Sec. 438.408(d)(2)(ii)) by requiring that applicable
integrated plans make reasonable efforts to give enrollees oral notice
of the resolution in expedited cases, in addition to sending the
written notice within 72 hours of receipt of the request.
In paragraph (f)(3)(i), we proposed criteria for an applicable
integrated plan to extend the timeframe for resolving either a standard
or expedited reconsideration. We proposed to adopt a standard similar
to current MA and Medicaid rules, allowing 14-day extensions upon
request of the enrollee (or the enrollee's representative) and
generally using the standard in Sec. 438.408(c) that the plan must
show that the extension is in the enrollee's interest and that the
information is necessary. We also proposed to use the MA standard that
the timeframe may be extended if there is a need for additional
information and there is a reasonable likelihood that receipt of such
information would lead to approval of the request. We clarified in the
preamble of the proposed rule that an applicable integrated plan could
not extend the timeframe for making an integrated reconsideration in
order to develop or find information to justify a denial of coverage.
In paragraph (f)(3)(ii), we proposed requirements for the notice
that applicable integrated plans must send to enrollees when the plan
extends the timeframe for making its determination, in accordance with
the requirements in this paragraph. We proposed to require that the
applicable integrated plan make reasonable efforts to give the enrollee
[[Page 15741]]
prompt oral notice and give the enrollee written notice within 2
calendar days. These requirements align with current Medicaid managed
care regulations at Sec. 438.408(c)(2). We also proposed that the
notice of the extension include the reason for the delay and inform the
enrollee of the right to file an expedited grievance if the enrollee
disagrees with the decision to extend the timeframe.
In paragraph (f)(4), we proposed requirements for providing
appellants with notices regarding the resolution of reconsiderations.
We proposed to require that applicable integrated plans send notices
within the resolution timeframes established in this section for all
integrated reconsideration determinations, paralleling the current
Medicaid managed care regulations which require notices of all
determinations. We also proposed to include language requiring that the
notice be written in plain language and available in a language and
format that is accessible to the enrollee consistent with section
1859(8)(B)(iii)(III) of the Act. We also proposed, in paragraphs
(f)(4)(i) and (ii), to adopt the standards similar to those governing
the content of a notice found in Sec. 438.408(e)--namely, that the
plan must provide to the enrollee a notice of the integrated
reconsideration for an adverse decision that includes the reason for
the decision and the date of completion. We proposed in paragraph
(f)(4)(ii)(A) that, for integrated notices not resolved wholly in the
enrollee's favor, the notice include an explanation of the next level
of appeal under both Medicare and Medicaid, and the steps the enrollee
must take to further pursue the appeal. We explained our expectation
that the integrated notice will enable the enrollee to understand which
program covers the benefit at issue. We also proposed in paragraph
(f)(4)(ii)(B) that the notice include specific information about the
ability to request continuation of Medicaid-covered benefits pending
appeal.
We summarize and respond to the comments on proposed Sec. 422.633
as follows:
Comment: Many commenters supported our proposed requirements
related to integrated reconsiderations, including the timeframes for
applicable integrated plans to resolve integrated reconsiderations. One
commenter specifically supported the inclusion of post-service appeals
in the expedited integrated reconsiderations process, at Sec.
422.633(e), noting significant financial need that may be present for
dual eligible individuals. Another commenter supported the requirement
at Sec. 422.633(f)(1) to use the same timeframes and processes for
pre-service and post-service appeals to simplify the process for
enrollees. One commenter opposed requiring post-service appeals to
follow the same decision timing as pre-service appeals, requesting that
CMS instead apply the MA rules, which allow 60 days for decision in
post-service appeals cases to allow applicable integrated plans more
time to gather necessary information, including from enrollees, and
potentially leading to fewer plan denials of integrated
reconsiderations.
Response: We appreciate the support for our proposed integrated
reconsideration requirements. We clarify that the post-service appeals
timing applies to appeals from noncontracted providers as well as to
enrollees. We understand the concern related to obtaining all necessary
information to make a determination for post-service integrated
reconsiderations; however, we decline to make a change to our proposed
requirements. As we noted in the proposed rule (83 FR 55010-55011),
Medicaid regulations at Sec. 438.408(b)(2) do not distinguish between
pre-service and post-service appeals--all appeals must be resolved
within 30 calendar days. We do not believe the volume of post-service
appeals, which would generally be only for payment, is high for dual
eligible individuals, and we believe it is more protective of enrollees
to have all integrated reconsiderations resolved in 30 calendar days,
particularly given what may be significant financial needs for these
individuals.
Comment: Several commenters expressed support for our proposed
requirement, at Sec. 422.633(c), that applicable integrated plans
provide the enrollee or the enrollee's representative with a copy of
the enrollee's case file for free, to help eliminate barriers to
enrollees in obtaining this information. A few commenters suggested we
establish specific timeframes for when the case file should be provided
to ensure that it is provided timely, and a commenter suggested that we
require the case file be sent automatically whenever an appeal is
filed, arguing that such a requirement would be consistent with
Medicaid rules.
Response: We decline to modify the regulation text at Sec.
422.633(c) to establish specific timeframes for provision of the case
file, since we are adopting the existing requirements related to case
files for Medicaid managed care plans at Sec. 438.406(b)(5); that
Medicaid managed care regulation does not include timeframes for
sending the case file but requires instead that the records and
information be provided sufficiently in advance of the resolution
timeframe for appeals. As proposed and finalized, Sec. 422.633(c) uses
the same standard. We believe this is sufficient and decline to
establish a specific deadline for provision of these records and
information. We also decline to specify that a plan send a case file
for every appeal filed. Rather, we believe that making it clear to
appellants that they may request the case file at no charge (for
example, as part of the denial notice) will be less burdensome for all
parties.
Comment: Several commenters supported the requirement at Sec.
422.633(d)(2) for applicable integrated plans to accept oral requests
without requiring written follow up from the enrollee, noting that this
requirement helps eliminate barriers for enrollees in filing appeals.
One commenter opposed this requirement. One commenter requested that
applicable integrated plans have discretion, as MA plans currently do
under guidance in the Parts & D Enrollee Grievances, Organization/
Coverage Determination, and Appeals Guidance Sec. 50.2.1, to require
written follow-up when enrollees file oral appeals because oral appeals
can be difficult to define, track, and standardize.
Response: We thank the commenters for their support of this
requirement, and decline to make any changes to it at this time. We
assume the comment related to the guidance interpreting Sec.
422.568(a)(1) and providing discretion to MA plans on whether to allow
oral reconsiderations referred to the previous version of the CMS
Medicare Managed Care Manual, Chapter 13, Sec. 70.2, which stated that
an MA plan may choose to accept an oral reconsideration. Similar
guidance was published more recently (February 22, 2019) in an updated
version of the Parts C & D Enrollee Grievances, Organization/Coverage
Determination, and Appeals Guidance, Sec. 50.2.1. We agree that this
requirement is an important way to remove barriers to filing appeals
for enrollees related to language, literacy, housing, and behavioral
health concerns. We believe that requiring applicable integrated plans
to allow oral appeals from enrollees without requiring the enrollee to
follow up in writing is most consistent with the provision in section
1859(f)(8)(B)(ii)(I) of the Act requiring us to adopt provisions that
are most protective for enrollees. In addition, we have recently
proposed making a similar change for similar reasons to the Medicaid
managed care rule at Sec. 438.402(c)(3)(ii) (see Medicaid and
Children's Health Insurance Program
[[Page 15742]]
(CHIP) Managed Care (CMS-2408-P), 83 FR 57264, 57283 (November 14,
2018)).
Comment: One commenter requested that, for expedited integrated
reconsiderations, we clarify our regulations to align with current MA
guidance and explicitly state that applicable integrated plans have
three calendar days to mail written notification when verbal outreach
to a member is successful.
Response: We decline to adopt this suggestion. Under Sec.
422.633(f)(4), as proposed and finalized in this rule, the applicable
integrated plan must send a written determination notice within the
resolution timeframes regulations. For expedited integrated
reconsiderations, these requirements are located at Sec.
422.633(f)(2). In order to clarify the regulation text and conform it
to the preamble of the proposed rule, we are finalizing paragraph
(f)(2) with revised text stating that the applicable integrated plan
must resolve the expedited integrated reconsideration as expeditiously
as the enrollee's health condition requires but no later than 72 hours
from the receipt of the request. Pursuant to paragraph (f)(4), this
timeframe will also apply to the required written notice to the
enrollee. We are also revising the language in the final rule regarding
expedited integrated reconsiderations under Sec. 422.633(f)(2) to
clarify that the applicable integrated plan must make reasonable
efforts to provide prompt oral notice of the determination in addition
to providing the written notice, which aligns with Medicaid rules that
require oral notification as a separate requirement that is not tied to
the timing of the written notification (see Sec. 438.408(d)(2)(ii)).
Comment: One commenter requested that we clarify when the timeline
begins for the applicable integrated plan to notify an enrollee of the
decision to extend the timeframe for deciding the integrated
reconsideration.
Response: We clarify that the applicable integrated plan must
notify the enrollee that an extension is being taken within two
calendar days of when the applicable integrated plan, after considering
the factors outlined in Sec. 422.633(f)(3)(i), makes the decision to
take an extension. We are finalizing revised regulation text at Sec.
422.633(f)(3)(ii) to clarify this timing.
Comment: A few commenters supported the requirement at Sec.
422.633(f)(4) that applicable integrated plans send a written
determination in all cases when an integrated reconsideration is filed.
They also supported the content requirements for the written
determination notice. One commenter noted that this notice should
include information on how to get assistance with the next level of
appeal.
Response: We thank the commenters for their support of this
requirement, and we agree that information on how to get assistance
with the next step in the appeal process is important and useful
information for the enrollee and would be beneficial to include in the
notice. We are adding this content requirement to the regulation at
Sec. 422.633(f)(4)(ii)(A). This information may include the name and
contact information of, for example, the State Health Insurance
Assistance Program (SHIP), a state ombudsman program if one exists, or
a legal aid office. State Medicaid agencies may also have appropriate
local referrals.
For the reasons set forth in the proposed rule and our responses to
the related comments, we are finalizing Sec. 422.633 substantively as
proposed, but with some minor modifications from proposed text as
follows:
At paragraph (c), we are revising the last sentence to
clarify that the records must be provided sufficiently in advance of
the resolution timeframe for the integrated reconsideration, or
subsequent appeal;
At paragraphs (d)(1) and (d)(2), we are including headings
to aid the reader;
At paragraph (f)(1), we have modified the regulatory text
to clarify that an applicable integrated plan has a maximum of 30
calendar days to resolve the integrated reconsideration, but must
resolve it more quickly if the enrollee's health requires faster
resolution. As finalized, this language exactly parallels the language
from the MA requirement at Sec. [thinsp]422.590(a);
At paragraph (f)(2), we have modified the regulatory text
to clarify that an applicable integrated plan has a maximum of 72 hours
to resolve the expedited integrated reconsideration, but must resolve
it more quickly if the enrollee's health requires faster resolution. As
finalized, this language exactly parallels the language from the MA
requirement at Sec. [thinsp]422.590(d)(1). We also clarify in
paragraph (f)(2) that an applicable integrated plan must make
reasonable efforts attempt to provide prompt oral notice of the
determination in addition to providing the written notice;
At paragraph(f)(3)(ii) we clarify the timeframe for the
applicable integrated plan to notify the enrollee that an extension is
being taken; and
At paragraph (f)(4), we are finalizing regulatory text as
proposed with a modification to clarify that the notice of resolution
the applicable integrated plan sends must be a written notice, and to
add, at paragraph (f)(4)(ii)(A), a requirement that the notice of
resolution contain information on how the enrollee can obtain
assistance in pursuing the next level of appeal under each program.
(9) Effect (Sec. 422.634)
We proposed, at Sec. 422.634(a), to use the same standard as in
existing MA and Medicaid regulations related to a plan's failure to
made a timely determination. If an applicable integrated plan fails to
make a timely determination at any point in the appeals process (for an
integrated organization determination or an integrated
reconsideration), that failure would constitute an adverse
determination, such that the enrollee could move forward with the next
level of appeal procedures (see Sec. Sec. 438.400(b)((b),
438.402(c)(1)(i)(A), 438.408(c)(3), 422.568(f), and 422.572(f)).
We proposed, at Sec. 422.634(b), to establish the next steps in
the appeals process if the enrollee receives an adverse decision from
the applicable integrated plan on the integrated reconsideration. For
cases involving Medicare benefits, we proposed, for applicable
integrated plans at Sec. 422.634(b)(1)(i), to codify the requirement
that adverse reconsiderations be reviewed and resolved by an IRE,
consistent with section 1852(g)(4) of the Act and existing Sec.
422.592. In Sec. 422.634(b)(1)(ii) and (iii), we proposed to mirror
existing MA regulations (Sec. 422.590(a)(2) and (d)(4)) \28\ with
requirements for applicable integrated plans to forward the case file
to the independent entity within set timeframes for both standard and
expedited integrated reconsiderations.
---------------------------------------------------------------------------
\28\ In the proposed rule (83 FR 55010), we erroneously cited to
Sec. 422.590(d)(3) instead of (d)(4) and use the correct reference
here.
---------------------------------------------------------------------------
At Sec. 422.634(b)(2), we proposed that for cases involving
Medicaid benefits, the enrollee may initiate a state fair hearing no
later than 120 calendar days from the date of the applicable integrated
plan's notice of resolution. We also proposed to include the
requirement that a provider who has not already obtained the written
consent of an enrollee must do so before filing a request for a state
fair hearing. We explained in the proposed rule how we intended the
timeframe to mirror the appeal right and requirement in the Medicaid
managed care regulation at Sec. 438.408(f)(2) and (3).
We proposed, at Sec. 422.634(c), language providing that
determinations are binding on all parties unless the case
[[Page 15743]]
is appealed to the next applicable level of appeal. We also proposed to
specify that this means that, in the event that an enrollee pursues an
appeal in multiple forums simultaneously (for example, files for an
external state medical review and an integrated reconsideration with
the applicable integrated plan, and the integrated reconsideration
decision is not in the enrollee's favor but the external state medical
review decision is), an applicable integrated plan would be bound by,
and must implement, decisions favorable to the enrollee from state fair
hearings, external medical reviews, and independent review entities
(IRE). As we explained in the proposed rule, for Medicare benefits, the
adverse integrated reconsideration would be automatically forwarded to
the IRE, pursuant to Sec. 422.634(b)(1), and thus the IRE's
determination in those cases would ultimately be binding.
We proposed, at Sec. 422.634(d), requirements for how quickly
services must be put in to place for an enrollee after he or she
receives a favorable decision on an integrated reconsideration or state
fair hearing. In the first sentence of paragraph (d), we proposed that
if an applicable integrated plan, or a state fair hearing with regard
to a Medicaid benefit, reverses a decision to deny, limit, or delay
services that were not furnished while the appeal was pending, the
applicable integrated plan must authorize or provide the disputed
services as expeditiously as the enrollee's condition requires but not
later than 72 hours. We intended this to mean that when an integrated
organization determination or integrated reconsideration decision is
favorable to the enrollee for any covered services, and, for Medicaid
benefits, when a state fair hearing reverses an applicable
reconsideration (that is, makes a decision that is favorable to the
enrollee with regard to Medicaid benefits), the same timeframe for the
applicable integrated plan to provide the benefits would apply. We also
proposed to cross-reference the existing MA regulations at Sec. Sec.
422.618 and 422.619 that provide how and when disputed Medicare
benefits must be provided when an integrated reconsideration denying
benefits is reversed at the post-plan level of appeal. Finally, we also
proposed in this paragraph to maintain the same effectuation timelines
for reversals by the Medicare independent review entity, an
administrative law judge or attorney adjudicator at the Office of
Medicare Hearings and Appeals, or the Medicare Appeals Council as apply
to other MA plans.
We proposed, at Sec. 422.634(e), for Medicaid-covered benefits, to
parallel Medicaid requirements from Sec. 438.424(b) governing how
services that were continued during the appeal must be paid for, if the
final determination in the case is a decision to deny authorization of
the services. For Medicare-covered services, we proposed that the
applicable integrated plan will cover the cost of the benefit.
We received the following comments regarding our proposed
provisions at Sec. 422.634, and our responses follow.
Comment: A commener supported the proposed requirements at Sec.
422.634. Another commenter requested that we align our requirement at
Sec. 422.634(b)(2) with the proposed Medicaid managed care rule to
allow states to give enrollees between 90 and 120 days to file for a
state fair hearing.
Response: We thank the commenter for their support. Our intent in
proposed Sec. 422.634(b)(2) was to follow the timeframes in the
existing Medicaid managed care requirements. Because we have proposed a
revision to the Medicaid managed care rules (see Medicaid and
Children's Health Insurance Program (CHIP) Managed Care (CMS-2408-P),
83 FR 57264 (November 14, 2018)), we are revising the requirement at
Sec. 422.634(b)(2) to refer to the timeline requirements in Sec.
438.408(f)(2) rather than stipulating those timelines in our final
regulations. By finalizing this cross-reference, the timeframe for an
enrollee to request a state fair hearing will be the same regardless of
whether the enrollee is appealing a decision by an applicable
integrated plan or a Medicaid managed care plan.
After considering the comments and for the reasons set forth in the
proposed rule and our responses to the related comments, we are
finalizing Sec. 422.634 substantively as proposed, but with some
clarifying modifications at paragraphs (a), (b), and (d). In paragraph
(a)(2), we are adding a citation to the parallel Medicaid managed care
rule at Sec. 438.408(f) for the timeframe for an enrollee to request a
state fair hearing. In paragraph (b)(2), we have revised the text to
cite to the state fair hearing in the timeframe specified in Sec.
438.408(f)(2), rather than cite a specific timeframe, to ensure
alignment with Medicaid managed care rules as described above. In
paragraph (d), we are finalizing the first sentence with revisions to
clarify that the applicable integrated plan's reversals--of integrated
organization determinations and integrated reconsiderations, as well as
of state fair hearing reversals--must be effectuated by the applicable
integrated plan within 72 hours rather than the MA timeframe in Sec.
422.618(a). The regulation text specifies that state fair hearing
decisions are only with regard to Medicaid benefits. Post-plan level
appeal decision on Medicare benefits (that is, by the Part C
independent review entity, an administrative law judge or attorney
adjudicator at the Office of Medicare Hearings and Appeals, or the
Medicare Appeals Council) must be effectuated in accordance with
Sec. Sec. 422.618, and 422.619.
(10) Unifying Medicare and Medicaid Appeals Subsequent to Integrated
Reconsideration
The new section 1859(f)(8)(B)(ii) of the Act directs us to include,
to the extent we determine feasible, consolidated access to external
review under an integrated process. We interpret ``external review'' in
this statutory provision as meaning review outside the plan, including
by a government agency or its designee. For MA, this includes the
independent review entity (IRE) and ALJ review described in Sec. Sec.
422.592 through 422.602. For Medicaid, this includes the state fair
hearing process described in Part 431 Subpart E, as well as any
additional external review offered under state law.
We believe that such a process could offer benefits to
beneficiaries, plans, states, and the federal government. Currently,
once a D-SNP or Medicaid managed care plan makes a final decision on an
appeal, the federally-administered Medicare and state-administered
Medicaid appeals processes are entirely separate. Although they have
some common principles, such as ensuring access to an independent
administrative hearing, they differ in many respects. In the proposed
rule (83 FR 55012 through 55015), we detailed the considerable
challenges of unifying D-SNP and Medicaid appeals subsequent to the
reconsideration level.
Based on these complexities, we stated in the proposed rule our
belief that it is not feasible to propose a unified post-plan appeals
process (that is, adjudication of appeal subsequent to an applicable
integrated plan's integrated reconsideration of an initial adverse
determination) at this time. Instead, we solicited comments on viable
paths forward given the constraints presented by the statutory mandates
for the MA and Medicaid appeals processes and our experience gained
through demonstrations. We received comments from six commenters.
Overall, the commenters expressed support for continued efforts
[[Page 15744]]
to move forward in this area in the future. We thank these commenters
for the time and effort expended on providing us with comments on the
establishment of a unified post-plan appeals process in potential
future rulemaking. We will take the comments into consideration as we
continue work on this issue.
(11) Conforming Changes to Medicare Managed Care Regulations and
Medicaid Fair Hearing Regulations (Sec. 422.562, Sec. 422.566, Sec.
438.210, Sec. 438.400, and Sec. 438.402)
We proposed a number of changes to Medicaid managed care, Medicaid
fair hearing, and Medicaid single state agency regulations to conform
with our proposed unified grievance and appeals provisions. Following
is a summary of these proposed changes.
In Sec. 422.562(a)(1)(i) and (b), we proposed to add
cross references to the proposed integrated grievance and appeals
regulations along with new text describing how the provisions proposed
in this rule for applicable integrated plans would apply in place of
existing regulations.
In Sec. 422.566, we proposed to add additional language
to paragraph (a) to establish that the procedures we proposed in this
rule governing integrated organization determinations and integrated
reconsiderations at proposed Sec. 422.629 through Sec. 422.634 apply
to applicable integrated plans in lieu of the procedures at Sec. Sec.
422.568, 422.570, and 422.572.
In Sec. 438.210(c) and (d)(4), we proposed to add cross
references to the proposed integrated grievance and appeals regulations
along with new text describing how the provisions proposed in this rule
for applicable integrated plans would apply in place of existing
regulations to determinations affecting dual eligible individuals who
are also enrolled in a D-SNP with exclusively aligned enrollment, as
those terms are defined in Sec. 422.2. In Sec. 438.210(f), we
proposed to make these Medicaid changes applicable to applicable
integrated plans no later than January 1, 2021, but, consistent with
our discussion earlier on the effective dates of our proposed unified
appeals and grievance procedures overall, we would not preclude states
from applying them sooner.
In Sec. 438.400, we proposed adding a new paragraph
(a)(4) to include the statutory basis for the proposed integration
regulations (section 1859(f)(8) of the Act). We also proposed to amend
Sec. 438.400(c) to clarify that these Medicaid changes apply to
applicable integrated plans no later than January 1, 2021, but,
consistent with our discussion elsewhere in this final rule, we would
not preclude states from applying them sooner.
In Sec. 438.402, we proposed amending paragraph (a) to
allow a Medicaid managed care plan operating as part of an applicable
integrated plan to the grievance and appeal requirements laid out in
Sec. Sec. 422.629 through 422.634 in lieu of the normally applicable
Medicaid managed care requirements.
We received the following comments, and our responses follow.
Comment: We received several comments related to the effective date
for the unified grievance and appeals procedures, including our
statement in the proposed rule that states could require applicable
integrated plans to implement such procedures prior to January 1, 2021,
using the state Medicaid managed care contract and the contract with
the D-SNP required under Sec. 422.107. Some commenters objected to
earlier implementation, noting the many processes that applicable
integrated plans will need to complete, such as systems changes, staff
training, policy and procedure development and implementation, and
developing enrollee communication materials, as well as the need for
CMS to release further guidance prior to the effective date. One
commenter noted that applicable integrated plans need all final
guidance from CMS one year prior to implementation. Another commenter
supported early implementation, provided such early implementation
would be on a trial basis only, and plans would not be subject to
intermediate sanctions, penalties, or audits.
Response: We understand the commenters' concerns about the need for
sufficient time to implement the unified grievance and appeals
processes we are finalizing in this rule. As we stated in the proposed
rule, these processes will apply to a relatively small subset of states
and plans, and while early implementation at state option is possible,
we do not anticipate many states implementing the processes earlier
than required (that is, beginning January 1, 2021) for many of the
reasons cited by these commenters. However, CMS will work closely with
any state interested in early implementation to ensure that impacted
applicable integrated plans have the guidance they need.
For the reasons explained in the proposed rule and our responses to
comments, we are finalizing substantively as proposed the conforming
changes to Sec. Sec. 422.562, 422.566, 438.210, 438.400, and 438.402.
We are making the following additional non-substantive changes to the
noted regulations:
We are modifying the regulatory text at Sec.
422.562(a)(1)(i), (b)(1), (b)(2), (b)(3), (b)(4)(i), and (b)(4)(ii),
and at Sec. 422.566(a), to clarify that the effective date of the
unified appeals and grievance processes finalized in this rule is
January 1, 2021. We are also making a minor grammatical change to Sec.
422.566(a) to make the language addressing applicable integrated plans
a separate sentence.
We are changing ``MA plans'' to ``Medicare Advantage
plans'' in Sec. 438.400(a)(4) because the term ``MA plans'' is not
defined Part 438.
We are finalizing Sec. 438.402 substantively as proposed,
but with some modifications to clarify that, for post-plan appeals of
Medicaid benefits, state fair hearing processes and requests are
subject to Sec. 438.408(f).
We are changing ``section'' to ``part'' in Sec.
438.400(c)(2) to clarify that the provisions affecting applicable
integrated plans throughout Part 438 are applicable no later than
January 1, 2021.
3. Prescription Drug Plan Sponsors' Access to Medicare Parts A and B
Claims Data Extracts (Sec. 423.153)
a. Background
This final rule sets forth the manner in which CMS will implement
section 50354 of the Bipartisan Budget Act of 2018 (BBA), Public Law
115-123, enacted on February 9, 2018. Section 50354 amends section
1860D-4(c) of the Social Security Act by adding a new paragraph (6)
entitled ``Providing Prescription Drug Plans with Parts A and B Claims
Data to Promote the Appropriate Use of Medications and Improve Health
Outcomes''. Specifically, section 1860D-4(c)(6)(A), as added by section
50354 of the BBA, provides that the Secretary shall establish a process
under which the sponsor of a Prescription Drug Plan (PDP) that provides
prescription drug benefits under Medicare Part D may request, beginning
in plan year 2020, that the Secretary provide on a periodic basis and
in an electronic format standardized extracts of Medicare claims data
about its plan enrollees. Such extracts would contain a subset of
Medicare Parts A and B claims data as determined by the Secretary. In
defining the specific data elements and time frames for the Parts A and
B claims data included in such extracts, hereinafter referred to as
``Medicare claims data,'' the Secretary is instructed, at section
1860D-4(c)(6)(D) of the Social Security
[[Page 15745]]
Act, to include data ``as current as practicable.''
Section 1860D-4(c)(6)(B) of the Act, as added by section 50354 of
the BBA, further specifies that PDP sponsors receiving such Medicare
claims data for their corresponding PDP plan enrollees may use the data
for: (i) Optimizing therapeutic outcomes through improved medication
use; (ii) improving care coordination so as to prevent adverse
healthcare outcomes, such as preventable emergency department visits
and hospital readmissions; and (iii) for any other purposes determined
appropriate by the Secretary. Finally, section 1860D-4(c)(6)(C) states
that the PDP sponsor may not use the data: (i) To inform coverage
determinations under Part D; (ii) to conduct retroactive reviews of
medically accepted conditions; (iii) to facilitate enrollment changes
to a different PDP or a MA-PD plan offered by the same parent
organization; (iv) to inform marketing of benefits; or (v) for any
other purpose the Secretary determines is necessary to include in order
to protect the identity of individuals entitled to or enrolled in
Medicare, and to protect the security of personal health information.
b. Provisions of the Proposed Rule
To implement the new statutory provision at section 1860D-4(c)(6)
of the Act, as added by section 50354 of the BBA, we proposed to add a
new paragraph (g) at Sec. 423.153. We summarize our proposals and
comments received and provide our responses and final decisions.
c. Purposes and Limitations on the Use of Data
In accordance with section 1860D-4(c)(6)(B) of the Act we proposed
to limit the purposes for which PDP sponsors are permitted to use the
Medicare claims data. Consistent with the statute, we proposed at Sec.
423.153(g)(3) that PDP sponsors would be permitted to use Medicare
claims data to optimize therapeutic outcomes through improved
medication use, and to improve care coordination so as to prevent
adverse health outcomes. In addition, we proposed to permit PDP
sponsors to use Medicare claims data for the purposes described in the
first or second paragraph of ``health care operations'' under 45 CFR
164.501, or that qualify as ``fraud and abuse detection or compliance
activities'' under 45 CFR 164.506(c)(4). We also proposed to permit
disclosures that qualify as a ``required by law'' disclosure as defined
at 45 CFR 164.103.
In accordance with section 1860D-4(c)(6)(C) of the Act, we proposed
specific limitations on how Medicare claims data provided to the PDP
sponsors may be used. Consistent with statutory limitations, we
proposed that PDP sponsors must not use Medicare claims data provided
by CMS under this subsection for any of the following purposes: (1) To
inform coverage determinations under Part D; (2) to conduct retroactive
reviews of medically accepted indications determinations; (3) to
facilitate enrollment changes to a different prescription drug plan or
an MA-PD plan offered by the same parent organization; or (4) to inform
marketing of benefits.
Section 1860D-4(c)(6)(C)(v) of the Act provides that the Secretary
may place additional limitations on the use of Medicare claims data as
necessary to protect the identity of individuals entitled to, or
enrolled in, benefits under Part D, and to protect the security of
personal health information. Therefore, we also proposed to require
that the PDP sponsor contractually bind its Contractors that will be
given access to Medicare claims data, and to require those contractors
to contractually bind any further downstream data recipients, to the
terms and conditions imposed on the PDP Sponsor. In addition, we
proposed to allow CMS to refuse future releases of Medicare claims data
if it determines or has a reasonable belief that the PDP sponsor has
made unauthorized uses, reuses, or disclosures of prior data received
under this provision. We also proposed that a PDP sponsor would have to
complete a data attestation as part of the data request process to
ensure an understanding of the purposes for which the Medicare claims
data may be used and the limitations on its reuse, and redisclosure.
Comment: A commenter recommended CMS explore ways to share the same
Parts A and B claims data with Medicare Advantage (MA) plans and Cost
plans.
Response: We appreciate the suggestion that CMS explore ways to
share the same Medicare data with MA plans and Cost plans. While we
understand that this data may be helpful to MA and Cost plans, section
1860D-4(c)(6)(A) only provides that the Secretary shall establish a
process for the sponsor of a Prescription Drug Plan (PDP) sponsor. We
are continuing to evaluate additional pathways for data sharing and may
consider data sharing with MA plans and Cost plans in the future.
Comment: A commenter requested additional clarification on how the
data could be used for fraud and abuse detection purposes.
Specifically, the commenter requested that CMS clarify that while PDP
sponsors may not use the Parts A and B data to change individual
coverage determinations decisions alone, they may review this data as
part of an effective fraud and abuse detection program.
Response: We appreciate the request to clarify the relationship
between the prohibition that PDP sponsors must not use the Medicare
claims data provided under this provision to change individual coverage
determination decisions with the permissible use of the Medicare claims
for fraud and abuse detection or compliance activities. As stated
earlier, the statutory language prohibits the use of the Medicare
claims data to inform coverage determinations under Part D and to
conduct retroactive reviews of medically accepted determinations. There
are a number of fraud and abuse detection or compliance activities that
the Medicare claims data can be used for that would not impact an
individual Medicare enrollee's coverage determination under Part D. For
instance, the PDP sponsor could use the Medicare claims data to create
algorithms that detect fraud and abuse and this information could be
used to inform future policies or procedures. PDP sponsors also could
use the Medicare claims data for internal and external audits or to
identify fraud and abuse activities by providers and suppliers. We also
encourage the PDP sponsors to refer to the current compliance and
fraud, waste, and abuse programs that are in place under the Part D
Sponsor compliance program and the suggested elements that CMS has
provided to Part D sponsors to consider when developing these programs.
Comment: Most commenters supported CMS's proposal for the permitted
uses of the data. A few commenters suggested additional permissible
uses of the data. A commenter suggested that CMS allow the use of
Medicare claims data for value-based contracting. Another commenter
encouraged CMS to include, as a permissible use, use of the data to
make favorable coverage determination decisions. Finally, a commenter
suggested that CMS permit plan sponsors to use the data for any other
purpose for which protected health information can be used under HIPAA,
including as de-identified data.
Response: We thank commenters for their support of the proposal.
When we considered expanding the permitted uses of the data provided to
the PDP sponsors beyond the statutory uses, we took into account a
number of factors.
[[Page 15746]]
First, we examined the purpose for which Medicare claims data is
provided, namely to promote the appropriate use of medications and
improve health outcomes. Second, we considered the statutory
limitations imposed on the use of the data, specifically that the data
not be used to inform coverage determinations or to conduct retroactive
review of medically accepted indications. Finally, we took into account
that this is a new data disclosure. Therefore, we decided to make the
additional permitted uses narrow. While we will not expand the
permitted uses as suggested at this time, we will continue to assess
whether additional permissible uses of the data should be proposed in
future rulemaking.
Comment: A commenter requested CMS release more specific guidance
on how the data could potentially be used and provide for additional
comment opportunities so feedback can be shared with CMS.
Response: We thank the commenter and believe that the rule provides
adequate information on the limits and permissible uses of the data
under this section. We will continue to assess the program to determine
if additional guidance is needed and welcome stakeholders to provide
additional feedback or seek clarification on program requirements. If
CMS makes future changes to the regulatory requirements of this
program, then stakeholders will be able to provide feedback during that
rulemaking process.
Comment: A few commenters recommended that CMS not expand the
permissible uses beyond what was explicitly provided for in statute.
These commenters were concerned that the expanded uses conflict, or
have the potential to conflict, with the directive in the statute that
PDPs may not use this information ``to inform coverage determinations
under Part D'' or to conduct retroactive reviews of medically accepted
indications. In particular, they were concerned about the use of the
data for fraud and abuse detection and compliance activities. They
encouraged CMS to limit disclosures under this authority to those
expressly allowed by statute, to monitor plan's use of the data, and
only consider expansion after the Secretary has evaluated plans' actual
use of this data as well as the agency's audit and review capacity.
Response: We thank commenters for this feedback. Section 1860D-
4(c)(6)(B)(iii) of the Act states that the Secretary can determine if
there are other appropriate purposes for which the data can be used.
Therefore, consistent with this statutory authority, we proposed to
narrowly expand on the permitted uses of the Medicare claims data based
on the factors discussed earlier. In terms of concerns about the use of
the data for fraud and abuse detection and compliance activities, we
clarified previously that the use of the claims data would still need
to comply with the statutory limitations on the use of the data at
Sec. 423.153(g)(4). These fraud and abuse activities would not focus
on an individual Medicare enrollee's Part D coverage, but rather, these
fraud and abuse detection and compliance activities would be aimed at
plans and providers/suppliers. In addition, as discussed in the
proposed rule, we believe that PDP sponsors are required to comply with
the applicable HIPAA rules, so they would have extensive experience
ensuring that data is only used and disclosed as permitted or required
by applicable laws. We believe that PDP sponsors understand and will
abide by their obligations regarding the permitted uses and limitations
on the use of Medicare data provided under this provision.
Comment: A few commenters disagreed with the limitations on using
these data for coverage determinations and to conduct retroactive
reviews of medically accepted indications determinations. A commenter
stated that with access to claims data, PDP sponsors would be better
positioned to identify appropriate interventions related to medication
adherence, opioid overutilization, risk adjustment and other medication
management related requirements of PDP sponsors. Another commenter
stated that because plan sponsors that offer standalone Part D benefits
(PDP sponsors) have no contracts with prescribing providers, they
currently have no mechanism for ensuring that medications are
appropriate. They further asserted that access to claims data would
allow PDP sponsors to validate whether prescriptions are medically
supported, as well as to identify other interventions related to opioid
overutilization, medication adherence, risk adjustment and other
functions related to requirements for Part D sponsors.
Response: We appreciate the feedback on the limitations on the use
of the data; however, the statutory language at section 1860D-
4(c)(6)(C) of the Act states that PDP sponsors must not use Medicare
claims data provided by CMS under this subsection for any of the
following purposes: (1) To inform coverage determinations under Part D;
(2) to conduct retroactive reviews of medically accepted indications
determinations; (3) to facilitate enrollment changes to a different
prescription drug plan or an MA-PD plan offered by the same parent
organization; or (4) to inform marketing of benefits.
Comment: A number of commenters requested clarification that the
permissible uses and limitations provided in this rule only apply to
the Medicare data received under this provision and not to Medicare
data that is obtained through other data disclosure pathways. For
instance, a commenter requested that CMS clarify that Medicare data
obtained through different sources may still be used for coverage
determinations and to determine medically accepted indications. Another
commenter requested clarification on how the permissible and
impermissible use of this claims data will be taken into account for
purposes of audits and other reviews--specifically, they requested
confirmation that PDP sponsors will not be penalized for failing to
implement Medically Accepted Indications (MAI) and other restrictions,
even if the plan sponsor has Medicare claims data on hand since PDP
sponsors are explicitly prohibited from using the Medicare claims data
provided under this provision to conduct retroactive reviews of
medically accepted indications determinations.
Response: We appreciate the request for clarification. The
limitations and permissible uses of the Medicare claims data at Sec.
423.513(g)(3) and (4) only apply to the data received under the
authority of section 1860D-4(c)(6) of the Act. Medicare claims data
provided to PDP sponsors under another program or pathway are subject
to those program requirements. PDP sponsors are not permitted to use
the Medicare claims data provided under this provision for any of the
impermissible purposes specified by the statute at section 1860D-
4(c)(6)(C). Therefore, we do not see how a PDP sponsor would be held
accountable for not using that Medicare claims data in a manner that
conflicts with the statutory requirements.
Comment: We received several comments on the requirement that PDP
sponsors complete a data attestation as part of the data request
process. A few commenters questioned whether an attestation is
sufficient to ensure compliance and urged CMS to monitor Part D plan
sponsors' use of the data to ensure restrictions are enforced. A
commenter expressed concern that PDP sponsors do not need to show with
any specificity how they intend to use the data or the results that
they expect. Another commenter recommended CMS
[[Page 15747]]
not adopt an attestation requirement given the statutory obligations on
plans relating to their use of the Medicare data. Another commenter
mentioned that they would provide comments on the data attestation as
part of the PRA process.
Response: Section 1860D-4(c)(6)(C)(v) of the Act provides that the
Secretary may place additional limitations on the use of Medicare
claims data as necessary to protect the identity of individuals
entitled to, or enrolled for, benefits under Part D, and to protect the
security of personal health information. In proposing additional
limitations on the use of the Medicare data, we sought to balance the
burden on PDP plans with CMS' commitment to ensuring beneficiary-level
data is protected by strict privacy and security requirements. We
believe that the data attestation requirement is a means of ensuring an
understanding of, and compliance with, the terms and conditions of data
access and seeks an appropriate balance. In terms of monitoring, we
will pursue any complaints regarding a PDP sponsor's violation of
program requirements. We would emphasize that CMS may refuse to make
future releases of Medicare claims data to a PDP sponsor if the Agency
makes a determination or has a reasonable belief that unauthorized
uses, reuses, or disclosures have taken place. We believe this approach
to monitoring is sufficient since we believe that PDP sponsors are
required to comply with the HIPAA rules. Therefore, they have
experience ensuring that data can only be used and disclosed for
specific purposes. We believe that PDP sponsors understand and will
abide by their obligations regarding the permitted uses and limitations
on the Medicare data under this provision. However, as this program is
implemented, we will continue to monitor and assess our program
compliance policies to determine if additional oversight or guidance
materials are needed on the use of the data.
In terms of the PRA process, we published a stand-alone 60-day
Federal Register notice that set out the requirements and burden
associated with the request and attestation (November 30, 2018; 83 FR
61638). We are also realigning the provision with this rulemaking by
setting out such requirements and burden in section III.B.4 of this
final rule. In this regard we will not be publishing a stand-alone 30-
day Federal Register notice.
Comment: A commenter requested clarification as to PDP sponsors'
access to the data (for example, single point person or multiple
individuals within the PDP permitted to access the data extract).
Response: As discussed earlier, we believe that PDP sponsors are
required to comply with the HIPAA Rules, including Privacy, Security
and Breach Notification requirements. They are accustomed to dealing
with limitations on the use and disclosure of data. We expect that they
will designate a data custodian as the recipient, and establish
policies and procedures as to use and disclosure that will comply with
all applicable law, including this program's data usage limitations,
and the limits on use and disclosure under the HIPAA regulations,
including the minimum necessary concept.
We are finalizing the policy as proposed.
d. Data Request
Section 1860D-4(c)(6)(A) of the Act provides that the Secretary
shall establish a process under which a PDP sponsor of a prescription
drug plan may submit a request for the Secretary to provide the sponsor
with standardized extracts of Medicare claims data for its enrollees.
Therefore, we proposed at Sec. 423.153(g)(1) to establish a process by
which a PDP sponsor may submit a request to CMS to receive standardized
extracts of Medicare claims data for its enrollees. We proposed to
accept data requests on an ongoing basis beginning January 1, 2020. We
proposed to require that such data requests be submitted in a form and
manner specified by CMS. Consistent with the discretion accorded to the
Secretary under section 1860D-4(c) (6)(D) of the Act, we proposed not
to allow PDP sponsors to request data for subsets of their enrolled
beneficiary populations. We proposed allowing requests to be submitted
without an end date, such that the request, once reviewed for
completeness and approved, would remain in effect until one or more of
the following occur: the PDP sponsor notifies CMS that it no longer
wants to receive Medicare claims data, CMS cancels access to Medicare
claims data when a PDP sponsor leaves the Part D program, or CMS
concludes or has a reasonable belief, at its sole discretion, that the
PDP sponsor has used, reused or disclosed the Medicare claims data in a
manner that violates the requirements of section 1860D-4(c)(6) of the
Act and Sec. 425.153(g). Upon receipt of the request from the PDP
sponsor and the PDP's execution of an attestation discussed earlier,
and review for completeness and approval of the application by CMS or
its contractor, we proposed that the PDP sponsor would be provided
access to Medicare claims data. We note that access to Medicare claims
data will be further subject to all other applicable laws, including,
but not limited to, the part 2 regulations governing access to certain
substance abuse records (42 CFR part 2).
Comment: One commenter expressed concern about providing
information on the entire membership on a continuous basis regardless
of whether the Part D plan needs the complete data set or membership.
Response: We believe that in order to accomplish the purposes of
the statute to promote the appropriate use of medications and improve
health outcomes that the PDP sponsor will need Medicare claims data for
all of its enrollees. We also believe that this approach is consistent
with the discretion afforded to the Secretary under section 1860D-
4(c)(6)(D) of the Act.
Comment: A commenter requested that CMS clarify how this will
comply with the regulations governing the disclosure of substance use
disorder data and address whether PDP sponsors will be required to
scrub the substance use disorder data from the extract.
Response: In compliance with the part 2 regulations governing
access to certain substance abuse records (42 CFR part 2), we do not
anticipate providing substance use disorder data to PDP sponsor under
this program.
We are finalizing the policy as proposed.
e. Data Extract Content
Section 1860D-4(c)(6)(D) of the Act provides the Secretary with the
discretion to determine the time frame and claims data under Parts A
and B to be included in the standardized extracts provide to PDP
sponsors. To develop a proposed data set to include in the standardized
extracts of Medicare claims data, we first considered what Medicare
claims data PDP sponsors might require if they were to undertake the
activities expressly permitted by section 1860D- 4(c)(6)(B) of the Act.
In doing so, we attempted to limit the data set to the minimum data
that we believe PDP sponsors would need to carry out those statutory
activities and the additional activities we proposed to permit under
Sec. 423.153(g)(3). That is, we sought to establish data access limits
that would comport with the HIPAA Privacy Rule's minimum necessary
concept at 45 CFR 164.502(b) and 164.514(d), and CMS' policy-driven
data release policies.
We proposed that data from all seven claim types, including
inpatient, outpatient, carrier, durable medical equipment, hospice,
home health, and skilled nursing facility data, would be
[[Page 15748]]
required to carry out the permitted uses of the data under section
1860D-4(c)(6)(B) of the Act and the proposed provision at Sec.
423.153(g)(3). Because section 1860D-4(c)(6) of the Act focuses on
providing Medicare claims data to promote the appropriate use of
medications and improve health outcomes, we proposed to initially
include the following Medicare Parts A and B claims data elements
(fields) in the standardized extract: An enrollee identifier, diagnosis
and procedure codes (for example, ICD-10 diagnosis and Healthcare
Common Procedure Coding System (HCPCS) codes); dates of service; place
of service; provider numbers (for example, NPI); and claim processing
and linking identifiers/codes (for example, claim ID, and claim type
code). We proposed that CMS would continue to evaluate the data
elements provided to PDP sponsors to determine if data elements should
be added or removed based on the information needed to carry out the
permitted uses of the data. Any proposed changes would be established
through rulemaking.
We next considered the beneficiary population for which we should
draw the identified data elements, and what time span of data would
best serve PDP sponsors while honoring the requirement at section
1860D-4(c)(6)(D) of the Act that the data should be as current as
practicable. Therefore, because only the most timely data is needed for
care coordination purposes, we proposed at Sec. 423.153(g)(2) to draw
the standardized extracts of Medicare claims data for items and
services furnished under Medicare Parts A and B to beneficiaries who
are enrolled in a Part D plan offered by the Part D sponsor at the time
of the disclosure. We proposed to make standardized data extracts
available to eligible PDP sponsors at least quarterly, as described
earlier, but only on a specified release date that would be applicable
to all eligible PDP sponsors. We also anticipate that Medicare claims
data would be provided at least quarterly with approximately a 3-month
lag from the last day of the last month of the prior quarter. In
addition, given the permitted uses of the data, we proposed to use a
standard format to deliver the resulting data to each PDP sponsor with
standard format extracts, meaning that CMS would not customize the
extracts for a PDP sponsor. We believe that these standardized data
extracts would provide PDP sponsors with the minimum data necessary to
carry out the permitted uses specified in section 1860D-4(c)(6)(B) of
the Act and as proposed at Sec. 423.153 (g)(3). We solicited comments
about the proposed frequency and contents of the standardized data
extracts.
Comment: We received a few comments seeking clarification on the
standardized data extract. A commenter requested clarification about
the inclusion of Part A and B data furnished by MA plans. Another
commenter requested clarification that the data feed includes enrollees
who may not be new to Medicare coverage, but are new to the health or
PDP sponsor. A commenter requested the inclusion of Part D claims data
for lives enrolled in or attributed to MA Plans and ENHANCED Track
ACOs.
Response: We appreciate commenters' request for clarification. We
proposed at Sec. 423.153(g)(2) to draw the standardized extracts of
Medicare claims data for items and services furnished under Medicare
Parts A and B to beneficiaries who are enrolled in a Part D plan
offered by the Part D sponsor at the time of the disclosure. The
standardized data extract only includes Parts A and B claims data
furnished under Medicare as there are no Part A and B data for MA
plans. The standardized extract also does not include Part D data. We
would also clarify that the standardized data extract will include all
enrollees for a PDP sponsor at the time of the disclosure. Therefore,
if an enrollee is new to the PDP sponsor, but not to Medicare, that
enrollee will be included in the standardized extract.
Comment: A commenter recommended that CMS provide itself
flexibility to not have to amend the rules every time it changes the
data elements included in the data extract.
Response: We appreciate the commenter's suggestion, however, CMS
believes that it is necessary to provide stakeholders with the
opportunity to comment on any proposed data variables to ensure they
are necessary to carry out the statutory activities and the additional
activities that are proposed to be permitted under Sec. 423.153(g)(3).
Comment: Several commenters were supportive of the data elements
that were proposed. However, a commenter suggested that Hierarchical
Condition Category (HCC) and Prescription Drug Hierarchical Condition
Category (RxHCC), which are risk adjustment scores, would also be
beneficial as they could be used to assess the degree of morbidity and
potential morality associated with a beneficiary to determine whether
there is a need for outreach or interventions, which would improve
medication outcomes, and for identifying potential fraud and abuse.
Another commenter suggested the inclusion of national drug codes
(NDC), lab results, and patient reported outcomes to support the
evaluation of effectiveness of value-based contracts.
Response: We appreciate the suggested additions to the data
variables. We do not believe that the HCC and RxHCC risk scores that
are used to set payment rates are consistently informative for the
purposes for which data is made available under this regulation, namely
to provide PDPs with information that allows them to optimize
therapeutic outcomes through improved medication use, and to improve
care coordination so as to prevent adverse health outcomes. The claims
data that will be provided under this regulation will provide a
comprehensive clinical picture of each member, including utilization,
cost, and diagnostic information. We do not believe that risk scores
would provide significant information above and beyond what the claims
data will provide. Further, risk scores for a year are not finalized
until after that year is complete, and therefore, to the extent they
theoretically could be pertinent for some aspect of care coordination,
would not be complete until after treatment decisions have been made.
We also note that if a PDP sponsor were to want the risk score of their
members, they receive their Part D risk scores monthly, along with a
report of the specific HCCs that contribute to those scores. If they
believe that Part C risk scores would be helpful--that is, risk scores
that predicted relative expected expenditures for Part A and B
services--they would have the data available to them to calculate these
risk scores with the claims data. With respect to the NDC, Part A
claims data do not include NDC, and only very rarely is the NDC
included on the Part B claims data. The statute instructs the Secretary
to provide claims data, in which NCDs are generally not available.
Therefore, we do not have the authority under this program to
supplement the claims data made available under this provision.
Finally, CMS also does not have access to lab results or patient
reported outcomes in parts A and B claims data, and therefore would be
unable to provide that information.
Comment: One commenter suggested adopting an existing standard
format for Parts A and B data after soliciting and considering
stakeholder feedback.
Response: We anticipate that the data will be provided in standard
data format. CMS will publish the standard format publicly once it is
finalized. As this provision is implemented, we will continue to seek
feedback on the data format.
[[Page 15749]]
Comment: A number of commenters urged CMS to make data available as
real-time and with as short of a lag time as possible, for instance on
a monthly basis.
Response: We recognize that more timely data with a shorter lag
time would be helpful to PDP sponsors in achieving the goals of this
program. Currently, our infrastructure only supports delivery of
quarterly data extracts that have roughly a five-month lag time. Our
goal is to provide the Medicare data as timely and with as little of a
lag in the claims data as possible and are striving to meet this goal.
Comment: A few commenters suggested providing historical data for
enrollees. A commenter suggested providing historical data as it is
critical to support the execution of value-based contracts and
suggested a look back period of at least a year, similar to the
Enhanced Medication Therapy Management (EMTM) program. Another
commenter suggested providing historical data for the creation of
value-based care tools to avoid counter indications. Another commenter
recommended a 14-month look back similar to the Bundled Payment for
Care Improvement Initiative (BPCI).
Response: Section 1860D-4(c)(6)(D) of the Act provides that the
Secretary shall make standardized extracts available to PDP sponsors
with data that is the most current as practicable. While we understand
that historical data may assist PDP sponsors, we must adhere to the
statutory language. As this program matures, PDP sponsors will amass
historical data.
Comment: A commenter suggested the use of an Application
Programming Interface (API) given the volume of Medicare claims data
that will be provided to PDP sponsors. This commenter also suggested
leveraging the process established through Blue Button 2.0 to allow
beneficiaries to release Parts A and B claims directly to PDP plan
sponsors.
Response: We appreciate this comment and will explore leveraging an
API to enhance data releases to PDP sponsors.
Comment: Another commenter requested clarification on the term
``process and ship the data extracts.''
Response: Under the current data fulfillment process, CMS receives
the approved request for data. A CMS contractor then extracts the data
based on the cohort criteria, validates and performs a quality check on
the data extract, and ships the data on an encrypted external hard
drive to PBP sponsors.
Comment: A commenter believed that the CMS Health Plan Management
System (HPMS) would be an adequate delivery system for the data
extracts.
Response: We would clarify that the Medicare claims data extracts
will be shipped to PDP sponsors, however, we are exploring the use of
the CMS HPMS for submission of the data request by PDP sponsors.
We are finalizing the policies as proposed.
B. Improving Program Quality and Accessibility
1. Medicare Advantage and Part D Prescription Drug Plan Quality Rating
System (Sec. Sec. 422.162(a) and 423.182(a), Sec. Sec. 422.166(a) and
423.186(a), Sec. Sec. 422.164 and 423.184, and Sec. Sec. 422.166(i)
and 423.186(i))
a. Introduction
Last year, in the April 2018 final rule, CMS codified at Sec. Sec.
422.160, 422.162, 422.164, and 422.166 (83 FR 16725 through 83 FR
16731) and Sec. Sec. 423.180, 423.182, 423.184, and 423.186 (83 FR
16743 through 83 FR 16749) the methodology for the Star Ratings system
for the MA and Part D programs, respectively. This was part of the
Administration's effort to increase transparency and advance notice
regarding enhancements to the Part C and D Star Ratings program. Going
forward CMS must propose through rulemaking any changes to the
methodology for calculating the ratings, the addition of new measures,
and substantive measure changes. The April 2018 final rule included
mechanisms for the removal of measures for specific reasons (low
statistical reliability and when the clinical guidelines associated
with the specifications of measures change such that the specifications
are no longer believed to align with positive health outcomes) but,
generally, removal of a measure for other reasons would occur through
rulemaking.
Commenters to the November 2017 proposed rule (82 FR 56336)
expressed overall support for the use of the hierarchical clustering
algorithm which is the methodology used for determining the non-
Consumer Assessment of Healthcare Providers and Systems (CAHPS)
measure-specific cut points. The cut points are used to separate a
measure-specific distribution of scores into distinct, non-overlapping
groups, or star categories. The cut points are determined using the
hierarchical clustering algorithm based on the given year's performance
data. Performance data changes from year to year based on industry
performance. Therefore, the cut points can also change from year to
year. While there was overall support for the use of the hierarchical
clustering algorithm, the majority of commenters also recommended some
enhancements be made to the proposed clustering methodology to capture
the attributes that they consider important. Commenters expressed a
strong preference for cut points that are stable, predictable, and free
from undue influence of outliers. Further, some commenters expressed a
preference for caps to limit the amount of movement in cut points from
year to year. CMS did not finalize any changes in last year's rule to
the clustering algorithm for the determination of the non-CAHPS cut
points for the conversion of measure scores to measure-level Star
Ratings, in order to allow the necessary time to simulate and examine
the feasibility and impact of the suggestions provided in response to
the proposed rule. In addition, CMS evaluated the degree to which the
simulations captured the desired attributes identified by the
commenters.
In the November 2018 proposed rule, we proposed enhancements to the
cut point methodology for non-CAHPS measures. We also proposed
substantive updates to the specifications for 2 measures for the 2022
Star Ratings and substantive updates to the specifications for 1
measure for the 2023 Star Ratings. We also proposed rules for
calculating Star Ratings in the case of extreme and uncontrollable
circumstances. Unless otherwise stated, data would be collected and
performance would be measured as described in these proposed rules and
regulations for the 2020 measurement period; the associated quality
Star Ratings would be released prior to the annual election period held
in late 2021 for the 2022 contract year and would be used to assign
Quality Bonus Payment ratings for the 2023 payment year. Because of the
timing of the release and use in conjunction with the annual
coordinated election period, these would be the ``2022 Star Ratings.''
CMS appreciates the feedback we received on our proposals. In the
sections that follow, which are arranged by topic area, we summarize
the comments we received on each proposal and provide our responses.
Below we summarize some comments we received related to the Star
Ratings program that are not about any of the proposals outlined in the
November 2018 proposed rule.
Comment: A commenter suggested that quality incentive programs
should use a small set of outcomes, patient experience, and resource
use measures that are not unduly burdensome to
[[Page 15750]]
report. Because adjusting measure results for social risk factors can
mask disparities in clinical performance, Medicare should account for
social risk factors by directly adjusting payment through peer
grouping. Another commenter supports CMS efforts to modernize the CMS
Quality Rating System by relying more heavily upon measurable
improvement in patient clinical outcomes.
Response: We appreciate these comments and have been working
towards using more outcome measures and increasing the weight of
patient experience of care measures in the Star Ratings system.
Currently, to account for social risk factors we do not directly adjust
the measure scores (or resulting stars) but add the Categorical
Adjustment Index to address the average within-contract disparity in
performance among beneficiaries who receive a low income subsidy, are
dual eligible individuals, and/or are disabled. CMS is continuing to
monitor ongoing work related to socio-economic status of measure
developers such as National Committee for Quality Assurance (NCQA) and
the Pharmacy Quality Alliance (PQA) and the work of the Office of the
Assistant Secretary for Planning and Evaluation (ASPE) as it works to
complete its second Report to Congress as required by the Improving
Medicare Post-Acute Care Transformation Act of 2014 or the IMPACT Act
(Pub. L. 113-185). Changes to how CMS determines Quality Bonus Payments
and the methodology for payment to MA organizations generally are out
of scope for this rule.
Comment: A commenter urged CMS to develop a strategic plan that
includes defined goals for the Quality Star Ratings program and creates
a framework for the inclusion and retirement of measures. The commenter
stated that CMS should ensure that the Quality Star Ratings are
simplified, accurately reflect plan performance, and place the most
emphasis on measures plans can influence and that improve
beneficiaries' health. The commenter also noted that CMS should focus
on data-driven measures with objective clinical relevance, rather than
survey-based measures.
Response: We laid out the framework for the Star Ratings in the
April 2018 final rule. We will take these comments into consideration
as that framework is revised over time. As part of our efforts to put
patients first, obtaining direct feedback from beneficiaries is vital
in understanding the quality of care provided by plans and is an
important component of the Part C and D Star Ratings program.
Comment: A commenter supported CMS's position that all substantive
measure changes be proposed through rulemaking. However, this commenter
requested more information about what is considered ``substantive''.
Response: The April 2018 final rule provided specific examples of
substantive updates to measures. We direct readers to pages 83 FR 16534
through 16535 of the April 2018 final rule.
Comment: Several commenters offered suggestions related to
adjusting for socioeconomic status (SES). A commenter suggested CMS
adjust for social risk factors. Another commenter requested that
Categorical Adjustment Index (CAI) adjustments be made to individual
measures instead of to the overall Star Ratings, to increase the
measure accuracy. A commenter made suggestions, including that CMS:
Enhance the CAI by expanding the range of included measures, letting a
2 percent or greater absolute performance difference between low income
subsidy/dual eligible and non-low income subsidy/dual eligible
individuals be sufficient for measure inclusion; consider other methods
for measuring and rewarding quality for plans with complex members; and
engage with both NCQA and PQA to drive the development of adjustments
for socioeconomic factors for their respective measures; and accelerate
the inclusion of such adjusted measures in the Star Ratings program.
Another commenter recommended that to address D-SNPs, CMS compare
D-SNPs to D-SNPs, use appropriate measures for dual eligible
individuals, evaluate adjusting individual measures for social risk
factors, and make improvements to the CAI to make the adjustment more
effective, including additional measures and other adjusters. A
commenter suggested HOS-derived measures should be included in the CAI,
so that the complexities of each plan's enrollee population would be
taken into account. The commenter also requested CMS use HOS samples
that are larger when the plan enrollment is larger, to provide a truer
representation of the member population. Another commenter expressed
support for continued use of the CAI in the Star Ratings program while
CMS develops a long-term solution to address disparities in plan
performance associated with socio-economic status and other risk
factors.
Response: CMS appreciates these comments although changes to how
CMS addresses socioeconomic status (SES) are out of scope for this
regulation. There continues to be additional work in the research
community on both identifying the impact of social risk factors on
health outcomes and how to best address the impact on clinical quality
measurement such that comparisons across contracts yield accurate
representations of true differences in quality as opposed to
reflections of changes in the composition of beneficiaries in
contracts. CMS is following the related work of the National Quality
Forum (NQF) since it will have a widespread impact on quality
measurement across multiple settings. The NQF has a longstanding policy
prohibiting risk adjustment for SES and other demographic factors. NQF
released a final report in July 2017 \29\ on the findings of the 2-year
trial period that temporarily lifted that prohibition. In the report,
NQF recommended a 3-year initiative to further examine and consider
social risk adjustment to allow evidence as to whether a change in that
longstanding policy should be revised.
---------------------------------------------------------------------------
\29\ NQF's Final Report can be assessed using the following
link: https://www.qualityforum.org/Publications/2017/07/Social_Risk_Trial_Final_Report.aspx.
---------------------------------------------------------------------------
In addition, CMS has engaged the NCQA and PQA to review and
determine if any measures are sensitive to the composition of the
enrollees in a plan and whether any modifications to the specification
would be appropriate.
As part of this engagement by the agency, the PQA examined their
medication adherence measures, which are currently used in the Star
Ratings Program, for potential risk adjustment (that is, adjustment for
SES and demographic factors).\30\ Based on the results of this
analysis, beginning in 2018, the PQA included in the 2018 PQA Measure
Manual draft recommendations on risk adjustment of the three medication
adherence measures: Medication Adherence for Diabetes Medications,
Medication Adherence for Hypertension, and Medication Adherence for
Cholesterol. As part of PQA's draft recommendations, they suggest that
the three adherence measures be stratified by the beneficiary-level
sociodemographic status characteristics listed earlier to allow health
plans to identify disparities and understand how their patient
population mix is affecting their measure rates.
---------------------------------------------------------------------------
\30\ The PQA summary can be accessed at: SDS Risk Adjustment PQA
PDC CMS Part D Stars or https://files.constantcontact.com/e9a15233201/96107f74-f6df-46f9-91e9-4a79d7e1bf0a.pdf?ver
=1515729061000.
---------------------------------------------------------------------------
The PQA indicated that the risk-adjusted adherence measures will be
submitted through the NQF consensus
[[Page 15751]]
development process for maintenance of the measures (NQF Endorsed
#0541). If endorsed by NQF, CMS will consider how to implement the PQA
recommendations in the future for these Star Ratings measures.
NCQA's 2019 HEDIS Volume 2 includes the additional specifications
of 4 measures used in the MA Star Ratings. As discussed in the 2018
Call Letter, the additional specifications for Breast Cancer Screening,
Colorectal Cancer Screening, Comprehensive Diabetes Care--Eye Exam
Performed, and Plan All-Cause Readmissions \31\ break out the rates by
SES. While CMS continues to use specifications for the overall measure
rates not broken out by SES, which are the same rates as contracts have
submitted in past years, CMS is considering if and how to best
incorporate the information provided by the stratified reporting in
future years of the Star Ratings. In particular, CMS is considering to
what extent stratified reporting helps address in a more permanent way
the same issues addressed by the Categorical Adjustment Index (CAI).
---------------------------------------------------------------------------
\31\ A summary of the NCQA analysis and recommendations can be
accessed using the link that follows: https://www.ncqa.org/hedis-quality-measurement/research/hedis-and-the-impact-act.
---------------------------------------------------------------------------
The Office of the Assistant Secretary for Planning and Evaluation
(ASPE), as required in the Improving Medicare Post-Acute Care
Transformation Act of 2014 (IMPACT Act, Pub. L. 113-185), released the
first in a two-part series of Reports to Congress (RTC) in December
2016.\32\ ASPE's second report is due in the fall of 2019. In the
meantime, CMS continues to be in dialogue with ASPE to discuss
potential options for future MA Star Ratings.
---------------------------------------------------------------------------
\32\ ASPE's first Report to Congress: Social Risk Factors and
Performance under Medicare's Value-Based Purchasing Programs can be
accessed using the link that follows: https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
---------------------------------------------------------------------------
Based on stakeholders' feedback, the April 2018 final rule expanded
the adjusted measure set for the determination of the CAI beginning
with the 2021 Star Ratings to all measures identified as a candidate
measure. A measure will be adjusted if it remains after applying the
following four bases for exclusions as follows: The measure is already
case-mix adjusted for SES (for example, CAHPS and HOS outcome
measures); the focus of the measurement is not a beneficiary-level
issue but rather a plan or provider-level issue (for example, appeals,
call center, Part D price accuracy measures); the measure is scheduled
to be retired or revised during the Star Rating year in which the CAI
is being applied; or the measure is applicable to only Special Needs
Plans (SNPs) (for example, SNP Care Management, Care for Older Adults
measures). HOS-outcome measures are not included in the measurement set
since they are already adjusted for SES. Additionally, since HOS
samples are random, increasing their size will not make them more
representative.
Comment: A few commenters supported the continued prior adjustments
for the lack of low-income subsidy in Puerto Rico which is part of the
current CAI calculations with a commenter recommending formalizing the
rules for determining the percent LIS for Puerto Rico contracts.
Response: CMS appreciates these comments. The rules for determining
the percent LIS for Puerto Rico contracts were codified in the April
2018 final rule at Sec. Sec. 422.166(f)(2)(vi) and (vii) and
Sec. Sec. 423.186(f)(2)(vi) and (vii).
Comment: A commenter suggested that CMS apply a hold harmless to
both the CAI and the Reward Factor going forward. This commenter urged
CMS to employ a hold harmless calculation for plan sponsors that are
negatively impacted by the CAI value if it lowers a contract's Summary
Ratings or Overall Ratings and to remove any negative consequences for
high performing contracts related to the Reward Factor since high
performing contracts are not able to achieve low variance as easily as
low performing contracts.
Response: We note that this comment raises an issue that is outside
of the scope of the proposals but we are explaining the current policy
and regulations. The CAI values address the average within-contract
disparity in performance revealed through the Star Ratings data each
year among beneficiaries who receive a low income subsidy, are dual
eligible individuals, and/or are disabled. The adjustment factor varies
by a contract's categorization into a final adjustment category that is
determined by a contract's proportion of low income subsidy/dual
eligible individuals and beneficiaries with disability status. By
design, the CAI values are monotonic and, thus, contracts with larger
percentages of enrollees that are low income subsidy/dual eligible and/
or have disability status realize larger positive adjustments.
Contracts with few beneficiaries that fall in the low income subsidy/
dual eligible and/or disability status categories have small negative
adjustments since achieving higher ratings is easier for these
contracts relative to ones with more significant percentages of
vulnerable beneficiaries. Thus, CMS disagrees that contracts with low
percentages of these vulnerable beneficiaries should receive a hold
harmless provision. It is not clear how the commenter suggests to
remove negative consequences of the Reward Factor since all of the
factors are 0 or positive adjustments.
Comment: Another commenter supported both the Star Ratings
methodology and past improvements that CMS has made to increase
accuracy. The commenter also supported enhancements that aim to signal
CMS's willingness to reward MA organizations that demonstrate excellent
outcomes and enrollee experiences. Another commenter requested CMS
acknowledge that outcome based measures are more challenging for plans
serving complex populations.
Response: CMS appreciates these comments. The Star Ratings
methodology weights the experience of enrollees and outcome measures
heavily, but also includes other metrics of plan performance, as
additional dimensions for holding MA and Part D plans accountable for
their performance. Outcome measures such as Improving or Maintaining
Physical Health and Improving or Maintaining Mental Health are adjusted
for the characteristics of the enrollees, including more complex
enrollees.
Comment: A commenter expressed support for retiring measures when
there are 1 percentage point differences in the same direction year-
over-year (for example, for 3 years).
Response: The April 2018 final rule codified rules for the
retirement of measures, at Sec. Sec. 422.164(e)(1) and 423.184(e)(1),
which provide for retirement when a measure has low reliability and/or
the clinical guidelines change such that the measure specifications are
no longer believed to align with positive health outcomes. We
appreciate this comment and will take it into consideration as we
contemplate future enhancements to these rules.
b. Definitions
We proposed to add the following definitions for the respective
subparts in part 422 and part 423, in paragraph (a) of Sec. Sec.
422.162 and 423.182, respectively.
Absolute percentage cap is a cap applied to non-CAHPS
measures that are on a 0 to 100 scale that restricts movement of the
current year's measure-threshold-specific cut point to no more than the
stated percentage as compared to the prior year's cut point.
Cut point cap is a restriction on the change in the amount
of movement a measure-threshold-specific cut point can make as compared
to the prior year's measure-threshold-specific cut
[[Page 15752]]
point. A cut point cap can restrict upward movement, downward movement,
or both.
Guardrail is a bidirectional cap that restricts both
upward and downward movement of a measure-threshold-specific cut point
for the current year's measure-level Star Ratings as compared to the
prior year's measure-threshold-specific cut point.
Mean resampling refers to a technique where measure-
specific scores for the current year's Star Ratings are randomly
separated into 10 equal-sized groups. The hierarchical clustering
algorithm is done 10 times, each time leaving one of the 10 groups out.
By leaving out one of the 10 groups for each run, 9 of the 10 groups,
which is 90 percent of the applicable measure scores, are used for each
run of the clustering algorithm. The method results in 10 sets of
measure-specific cut points. The mean cut point for each threshold per
measure is calculated using the 10 values.
Restricted range is the difference between the maximum and
minimum measure score values using the prior year measure scores
excluding outer-fence outliers (first quartile - 3*Interquartile Range
(IQR) and third quartile + 3*IQR).\33\
---------------------------------------------------------------------------
\33\ The first quartile is median of the lower half of the data;
in other words, the value in the data once arranged in numerical
order that divides the lower half into two equal parts. The third
quartile is the median of the upper half of the data.
---------------------------------------------------------------------------
We proposed to specify in the definition the criteria used to
identify the values that correspond to the outer fences which are used
to identify extreme outliers in the data. Outer-fence outliers use
established statistical criteria for the determination of the boundary
values that correspond to the outer fences. The outer fences are the
boundary values for an outer-fence outlier such that any measure score
that either exceeds the value of the upper outer fence (third quartile
+ 3*IQR) or that is less than the lower outer fence (first quartile-
3*IQR) is classified as an outer fence outlier and excluded from the
determination of the value of the restricted range cap.
Restricted range cap is a cap applied to non-CAHPS
measures that restricts movement of the current year's measure-
threshold-specific cut point to no more than the stated percentage of
the restricted range of a measure calculated using the prior year's
measure score distribution.
We received no comments on these proposed definitions in paragraph
(a) of Sec. Sec. 422.162 and 423.182 and are finalizing them with one
non-substantive change to the mean resampling definition; we have
finalized the definition with an additional sentence to clarify that by
leaving out one of the 10 groups for each run, 90 percent of the
measure scores are used for each run of the clustering algorithm.
c. Measure-Level Star Ratings (Sec. Sec. 422.166(a), 423.186(a))
At Sec. Sec. 422.166(a) and 423.186(a), we previously codified the
methodology for calculating Star Ratings at the measure level in the
April 2018 final rule. The methodology for non-CAHPS measures employs a
hierarchical clustering algorithm to identify the gaps that exist
within the distribution of the measure-specific scores to create groups
(clusters) that are then used to identify the cut points. The Star
Ratings categories are designed such that the scores in the same Star
Ratings category are as similar as possible and the scores in different
Star Ratings categories are as different as possible. The current
methodology uses only data that correspond to the measurement period of
the data used for the current Star Ratings program. The cut points, as
implemented now, are responsive to changes in performances from one
year to the next. Changes in the measure-level specific cut points
across a Star Ratings year reflect lower or higher measure performance
than the prior year, as well as shifts in the distribution of the
scores.
In the April 2018 final rule, CMS detailed the goals of the Star
Ratings program. The overarching goals of the Star Ratings program and
the specific sub-goals of setting cut points serve as the rationale for
any proposed changes.
The Star Ratings display quality information on Medicare Plan
Finder to help beneficiaries, families, and caregivers make informed
choices by being able to consider a plan's quality, cost, and coverage;
to provide information for public accountability; to incentivize
quality improvement; to provide information to oversee and monitor
quality; and to accurately measure and calculate scores and stars to
reflect true performance. In addition, pursuant to section 1853(o) of
the Act and the Medicare Program; Changes to the Medicare Advantage and
the Medicare Prescription Drug Benefit Programs for Contract Year 2012
and Other Changes Final Rule (76 FR 21485 through 21489), the Star
Ratings are also used to assign Quality Bonus Payments as provided in
Sec. 422.558(d).
To separate a distribution of measure scores into distinct groups
or star categories, a set of values must be identified to separate one
group from another group. The set of values that break the distribution
of the scores into non-overlapping groups is referred to as a set of
cut points. The primary goal of any cut point methodology is to
disaggregate the distribution of scores into discrete categories such
that each grouping accurately reflects true performance.
The current MA Star Ratings methodology converts measure-specific
scores to measure-level Star Ratings so as to categorize the most
similar scores within the same measure-level Star Rating while
maximizing the differences across measure-level Star Ratings. To best
serve their purpose, the Star Ratings categories must capture
meaningful differences in quality across the Star Ratings scale and
minimize the risk of misclassification. For example, it would be
considered a misclassification if a ``true'' 4-star contract were
scored as a 3-star contract, or vice versa, or if nearly-identical
contracts in different measure-level star categories were mistakenly
identified. CMS currently employs hierarchical clustering to identify
the cut points for non-CAHPS measures to ensure that the measure-level
Star Ratings accurately reflect true performance and provide a signal
of quality and performance on Medicare Plan Finder to empower
beneficiaries, families, and caregivers to make informed choices about
plans that would best align with their priorities.
We solicited comments in the 2017 proposed rule regarding the
approach to convert non-CAHPS measure scores to measure-level Star
Ratings (82 FR 56397 through 56399). We requested stakeholders to
provide input on the desirable attributes of cut points and
recommendations to achieve the suggested characteristics. In addition,
we requested that commenters either suggest alternative cut point
methodologies or provide feedback on several options detailed in the
proposed rule, such as setting the cut points by using a moving
average, using the mean of the 2 or 3 most recent years of data, or
restricting the size of the change in the cut points from 1 year to the
next.
The commenters identified several desirable attributes for the cut
points that included stability, predictability, attenuation of the
influence of outliers; restricted movement of the cut points from 1
year to the next; and either pre-announced cut points before the plan
preview period or pre-determined cut points before the start of the
measurement period. In the April 2018 final rule (83 FR 16567), we
expressed appreciation for our stakeholders' feedback and stated our
intent to use it to guide the development of an enhanced methodology.
So as not to
[[Page 15753]]
implement a methodology that may inordinately increase the risk of
misclassification, CMS analyzed and simulated alternative options to
assess the impact of any enhancements on the Star Ratings program and
assess the degree to which a new methodology captures the desirable
attributes that were identified by stakeholders. While CMS looked to
balance the request of stakeholders to increase predictability and
stability of the cut points from year to year in developing its
proposal for this rulemaking, the goals of the Star Ratings program,
the integrity of the methodology, and the intent of the cut point
methodology remain the same. The intent of the cut point methodology is
to accurately measure true performance.
A Technical Expert Panel (TEP), comprised of representatives across
various stakeholder groups, convened on May 31, 2018 to provide
feedback to CMS's Star Ratings contractor (currently RAND Corporation)
on the Star Ratings framework, topic areas, methodology, and
operational measures, including possible enhancements to the clustering
methodology used to convert non-CAHPS measure scores to measure-level
Star Ratings. Information about the TEP and their feedback can be found
at https://www.rand.org/star-ratings-analyses.
In developing the proposal for modifying how cut points are set for
non-CAHPS measures, CMS examined numerous alternative methodologies to
minimize the influence of outliers, to restrict the upward or downward
movement of cut points from one year to the next, and to simulate
prediction models to allow either limited advance notice or full
advance notice of cut points prior to the measurement period. As part
of our analyses, we analyzed trends in performance across the Star
Ratings measures. The ability to announce cut points before (full
advance notice) or during (partial advance notice) the measurement
period requires the use of modeling and older data to project the cut
points, as well as the need for an alternative methodology for new
measures introduced to the Star Ratings program. We explained in the
proposed rule that modeling is challenging given differences in the
performance trends over time across the Star Ratings measures; thus, a
single approach for predicting all future performance does not
accurately reflect performance for all measures.
We also discussed how using prediction models to establish future
cut points may have unintended consequences and misalign with the
underlying goals of the Star Ratings program and sub-goals of setting
cut points. Predicting future cut points using older data can lead to
both over or under-estimations of performance which results in a
distorted signal of the Star Ratings. Over projections in the cut
points will result in higher cut points and lower measure-level Star
Ratings. Conversely, under projections can lead to lower cut points and
higher measure-level Star Ratings. The risk of misclassification is
heightened when the accuracy of the projected cut points is diminished.
The use of older data for setting cut points does not allow the Star
Ratings to be responsive to changes in performance in the current year.
Furthermore, setting cut points in advance of the measurement year may
lead to MA organizations and Part D sponsors not focusing on certain
areas once they achieve a set threshold, eliminating incentives for
improvement.
For example, CMS provided incentives for eligible providers to
adopt certified Electronic Health Records (EHRs) and report quality
measures under the Meaningful Use (MU) initiative. Consequently, there
were large gains in performance for a subset of Star Ratings measures
that were enabled through the EHR, which reflected a structural change
among health care providers in the delivery of care. Further, an
examination of performance over time of EHR-enabled measures indicates
a decrease in variability of measure scores with contract performance
converging toward greater uniformity. Modeling future performance using
past performance from before this leveling out of performance would
fail to capture the large gains in performance in the EHR-enabled
measures, which would have resulted in cut points that were
artificially low and measure-level Star Ratings that were higher than
true performance.
We discussed in the proposed rule how pre-announced cut points for
other subsets of measures in the Star Ratings would present different
challenges as compared to EHR-enabled measures. Performance on new
measures typically has more room to improve, and large year to year
gains are possible and desirable from a quality improvement
perspective. Projecting cut points using older data from periods of
rapid improvement would artificially inflate future cut points which
would cause artificially low measure-level Star Ratings. Measures that
demonstrate very slow, consistent growth over time could have projected
cut points that are artificially high. The further the projection is in
advance of the measurement period, the larger the potential for
unintended consequences. In addition, there exists the possibility of
external factors, other than structural, that are unanticipated and
unforeseen that could impact the distribution of scores for which
modeling would not capture.
We listed in the proposed rule some of the challenges of full or
partial advance notice:
Older data often do not accurately reflect current
performance.
The trend in average performance is not always linear.
External or structural factors may occur that can lead to
substantial changes from period to period rather than steady, slow
year-over-year improvement.
Larger gains in performance year to year exist for
relatively new measures, compared to more established measures.
The rate of change is less likely to be linear at lower
threshold levels where contracts have greater opportunities for
improvement.
Decreasing variation in measure scores reflects greater
improvements in performance for lower versus higher-performing
contracts--contract performance is converging over time toward greater
uniformity.
These challenges are critical to consider because if we modify the
current methodology to predict (or set) cut points using older data and
a single model across all measures, we risk causing unintended
consequences such as significantly diminishing incentives for
improvement or having the Star Ratings misaligned with changes in
performance that may be due to external or structural factors.
Based on stakeholder feedback and analyses of the data, we proposed
two enhancements to the current hierarchical clustering methodology
that is used to set cut points for non-CAHPS measure stars in
Sec. Sec. 422.166(a)(2)(i) and 423.186(a)(2)(i). The first proposed
enhancement was the use of mean resampling. With mean resampling,
measure-specific scores for the current year's Star Ratings are
randomly separated into 10 equal-sized groups. The hierarchical
clustering algorithm is done 10 times, each time leaving one of the 10
groups out. The method results in 10 sets of measure-specific cut
points. The mean cut point for each threshold per measure is calculated
using the 10 values. We explained in the proposed rule that mean
resampling reduces the sensitivity of the clustering algorithm to
outliers and reduces the random variation that contributes to
fluctuations in cut points and, therefore, improves the stability of
the cut points over time. Mean resampling uses the most recent
[[Page 15754]]
year's data for the determination of the cut points; thus, it does not
require assumptions for predicting cut points over time and it
continues to provide incentives for improvement in measure scores. The
drawback of mean resampling alone is that it does not restrict the
movement of the cut points, so the attribute of predictability is not
fully captured with this methodology.
To increase the predictability of the cut points, we also proposed
a second enhancement to the clustering algorithm: A guardrail for
measures that have been in the Part C and D Star Ratings program for
more than 3 years. We proposed a guardrail of 5 percent to be a bi-
directional cap that restricts movement both above and below the prior
year's cut points. A 5 percent cap restricts the movement of a cut
point by imposing a rule for the maximum allowable movement per measure
threshold; thus, it allows a degree of predictability. The trade-off
for the predictability provided by bi-directional caps is the inability
to fully keep pace with changes in performance across the industry.
While cut points that change less than the cap would be unbiased and
keep pace with changes in the measure score trends, changes in overall
performance that are greater than the cap would not be reflected in the
new cut points. A cap on upward movement may inflate the measure-level
Star Ratings if true gains in performance improvements cannot be fully
incorporated in the current year's ratings. Conversely, a cap on
downward movement may decrease the measure-level Star Ratings since the
ratings would not be adjusted fully for downward shifts in performance.
We discussed in the proposed rule that a measure-threshold-specific
cap can be set multiple ways and the methodology may differ based on
whether the measure is scored on a 0 to 100 scale or an alternative
scale. For measures on a 0 to 100 scale, the cap can restrict the
movement of the measure cut points from one year to the next by a fixed
percentage, such as an absolute 5 percentage point cap. For measures
not on a 0 to 100 scale, the cap can be determined for each measure by
using a percentage of the measure's score distribution or a subset of
the distribution, such as 5 percent of the range of the prior year
scores without outer fence outliers, referred to as a restricted range
cap. Alternatively, a restricted range cap can be used for all
measures, regardless of scale, using a cap based on the range of the
prior year scores without outliers. We proposed an absolute 5
percentage point cap for all measures scored on a 0 to 100 scale and 5
percent of the restricted range for all measures not on a 0 to 100
scale, but we explained that we were also considering alternatives to
the 5 percent cap, such as using 3 percent. We noted in the proposed
rule our belief that any cap larger than 5 percent would not provide
the predictability requested by stakeholders that our proposal was
designed to incorporate. While smaller caps provide more
predictability, it is more likely that the cut points will not keep
pace with changes in measure scores in the industry as the cap size
gets smaller, and may require future larger one-time adjustments to
reset the measure cut points. Therefore, we explained in the proposed
rule that we were not sure that a smaller cap, even at a 3 percent
threshold, would meet our programmatic needs and goals of providing
accurate pictures of the underlying performance of each contract and
its comparison to other contracts. We therefore proposed using a 5
percent cap because the use of the cap allows predictability of the cut
points from year to year, but also balances the desire to continue to
create incentives for contracts to focus on the quality of care of
their enrollees and strive to improve performance. If the cut points
are not keeping pace with the changes in the scores over time, CMS may
need to propose in the future how to periodically adjust the cut points
to account for significant changes in industry performance.
In summary, we proposed to amend Sec. Sec. 422.166(a)(2)(i) and
423.186(a)(2)(i) to add mean resampling of the current year's data to
the current clustering algorithm to attenuate the effect of outliers,
and measure-specific caps in both directions to provide guardrails so
that the measure-threshold-specific cut points do not increase or
decrease more than the cap from one year to the next. We proposed a 5
percentage point absolute cap for measures on a 0 to 100 scale and a 5
percent restricted range cap ((0.05) * (maximum value - minimum value),
where the maximum and minimum values are calculated using the prior
year's measure score distributions excluding outer fence outliers). For
any new measures that have been in the Part C and D Star Rating program
for 3 years or less, we proposed to use the hierarchal clustering
methodology with mean resampling for the first 3 years in the program
in order to not cap the initial increases in performance that are seen
for new measures. Under our proposal, existing provisions governing
cases where multiple clusters have the same measure score value range
(Sec. Sec. 422.166(a)(2)(ii) and 423.186(a)(2)(ii)) and how the
clustering algorithm would apply for setting cut points for the
improvement score (Sec. Sec. 422.166(a)(2)(iii) and 423.186(2)(iii))
remain the same. We solicited comments on this proposal, including
comments on the percentage used for the cap, whether the cap should be
an absolute percentage difference for measures on a 0 to 100 scale,
whether the cap should be a percent of the range of prior year scores
without outliers for all measures or for the subset of measures not on
a 0 to 100 scale, whether the cap should be in both the upward and
downward directions, and alternative methods to account for outliers.
Below we summarize the comments we received and provide our
responses and final decisions.
Comment: Commenters overwhelmingly supported increasing the
stability and predictability of cut points and attenuating the
influence of outliers.
Response: CMS appreciates the support for increasing the stability
and predictability of cut points and attenuating the influence of
outliers. CMS has examined numerous alternative methodologies for
setting cut points and the methodology changes we finalize in this rule
are intended to make cut points more stable and predictable.
Comment: Several commenters supported implementing cut point
methodology changes for contract year 2020 or as soon as possible and
opposed delaying such methodology changes until 2022 Ratings.
Response: CMS appreciates the commenters' requests to implement
these changes sooner but, as established in the 2018 final rule,
changes to the methodology for Star Ratings go through rulemaking and
are finalized prior to the relevant measurement year unless we are
applying a standard in the regulation text in making the change. We
proposed and are finalizing this change to how cut points for non-CAHPS
measures are set for the 2020 measurement year, which is associated
with the 2022 Star Ratings.
Comment: Many commenters requested more detail on the resampling
methodology, including simulations of the impact of resampling and
guardrails, and a couple of commenters requested an additional comment
period after CMS provided more detail on the resampling methodology,
but before making any changes to the cut point methodology.
Response: The reason for using the resampling approach is to
increase
[[Page 15755]]
stability and predictability of cut points. The approach is implemented
as follows. First, the current year's contract scores for a given
measure are randomly divided into 10 groups or subsamples. (The current
year's data means the data from the applicable performance year for the
given year of Star Ratings being calculated. For example, the 2022 Star
Ratings use data from the 2020 performance year.) The process can be
replicated when the random number generator is given the same seed
prior to each run. Then, for each of the 10 subsamples, the following
steps are taken:
Omit one subsample from the data.
Calculate thresholds using the clustering approach on the
data that combines the remaining 9 subsamples.
After those two steps are completed for each of the 10 subsamples, the
resulting 10 sets of cut points are averaged.
There are two advantages of resampling. It contributes to
stabilizing the cut points, which is its primary advantage over using
clustering without mean resampling, and it partially addresses the
sensitivity of the clustering approach to the ordering of the
observations in the data set. First, each observation is included in
only 90 percent of the cut point estimates that are averaged. This
reduces the contribution of each observation, including outliers, to
the final cut points. Second, pulling out a random 10 percent of the
data prior to cut point calculation alters the order of the data. It
partially accounts for the sensitivity of the clustering approach to
the ordering of observations, as the tie-breaking approach of the
clustering algorithm depends on the ordering of the data. Allowing for
altered orders of the data reduces the effect of the tie-breaking on
the final cut points. Resampling is computationally more feasible than
reordering a large (for example, 1,000) number of times to search for
multiple cut point combinations, given the timeline of the Star Ratings
calculations. HCAHPS uses an approach that is conceptually similar.
HCAHPS cut points are the average of cut points based on four segments
of the data, divided by quarters, where each segment contains 25
percent of the data. Whereas this proposal is to average the cut points
calculated from each of 10 segments where each segment contains 90
percent of the data.
In response to the commenters' requests, we simulated the impact of
the proposed changes to the cut point methodology including mean
resampling and a 5 percent guardrail on the 2018 Star Ratings. However,
we note that some commenters stated that they simulated the proposed
changes themselves prior to commenting on the proposed rule. All
commenters could have simulated the proposed changes themselves prior
to commenting on the proposed rule based on the measure data from 2018
or 2019 Star Ratings (available at https://go.cms.gov/partcanddstarratings). While these data do not contain contracts that
terminated from the Medicare program, the available data are sufficient
to simulate these methodological changes. Since the guardrail could
have an effect not only on the current Star Ratings year but also on
subsequent years, we accounted for this by starting our simulation of
the combined mean resampling and guardrail approach with the 2016 Star
Ratings data. The resulting cut points served as the reference point
for applying the guardrail to the cut points obtained through applying
both mean resampling and guardrails to the 2017 Star Ratings data.
Finally, we simulated the 2018 Star Ratings thresholds with mean
resampling and a 5 percent guardrail that referenced the simulated 2017
Star Ratings thresholds from the prior step. Overall the changes in
2018 Star Ratings under this approach were relatively modest. Six
percent of MA-PD contracts would have seen their overall rating
increase by half a star and five percent would have decreased by half a
star. For PDP contracts, 5 percent would have increased by half a star
and 7 percent would have decreased by half a star. In our simulations,
there was not a disproportionally negative impact on contracts with
more LIS/DE enrollees. For MA-PD contracts with LIS/DE beneficiaries of
up to 50 percent, 6 percent of contracts moved up a half-star on the
overall Star Ratings and 6 percent moved down by half-star. For
contracts with greater than 50 percent LIS/DE beneficiaries, 7 percent
moved up half-star and 2 percent moved down half-star. With regard to
the request for an additional comment period, many other commenters
requested CMS implement the changes as soon as possible. Further, as
explained previously, some commenters conducted simulations of the
proposed methodological changes themselves prior to commenting on the
proposed rule. Overall, we received 47 comments on the proposed changes
to the cut point methodology from the 60 day comment period. We believe
the public understood the proposal and were able to submit comments
effectively. Therefore, we are finalizing the proposal to implement
mean resampling, because resampling will provide increased stability
and predictability of cut points.
Comment: A couple commenters expressed concern that mean resampling
can provide varying results depending on the number of samples used and
questioned why 10 samples were chosen, and a couple commenters believed
mean resampling would make the cut point methodology more complicated.
Response: We proposed and are finalizing the use of 10 samples
because, as a common choice in related applications, such as cross-
validation, it has proven advantages. Using 10 samples is less
computationally intensive than using more samples, which is a
significant advantage in light of the limited time between the
availability of the measure data and the publication of Star Ratings
each year. By using the ``leave-one-out approach,'' we expect improved
stability in the cut point thresholds, as each data point (including
outliers) will be omitted from 10 percent of the cut points that are
estimated and then averaged across the ten 90 percent samples following
resampling. We appreciate the commenter's concern about the complexity
of mean resampling, however, we find that mean resampling is not overly
complex because it is replicable, as long as the contract groupings are
pre-specified.
Comment: A commenter suggested CMS provide Statistical Analysis
System (SAS) programming code to run the cut points analyses.
Response: CMS provides details about how the cut points are
determined, including SAS code, in the Technical Notes CMS provides for
each Star Ratings year (see the Attachment regarding Individual Measure
Star Assignment Process). The changes to the cut point methodology
finalized in this rule will be documented in the Technical Notes for
the 2022 Star Ratings. The Technical Notes can be found here: https://go.cms.gov/partcanddstarratings.
Comment: Several commenters supported mean resampling to address
outliers.
Response: CMS appreciates the support for mean resampling. We are
finalizing mean resampling as proposed.
Comment: Some commenters believed resampling would not be
sufficient to address outliers or believed resampling does not directly
address year to year changes in cut points. A couple commenters
supported removing outliers before clustering.
Response: CMS appreciates the commenters concerns and based on
these comments evaluated two options to address direct removal of
outliers--trimming and Tukey outer fence outlier
[[Page 15756]]
deletion. We conducted simulations of the impact of each outlier
deletion method combined with a cumulative 5 percent guardrail on the
2018 Star Ratings. In general, there tend to be more outliers on the
lower end of measure scores. As a result, the one to two star threshold
often increased in the simulations when outliers were removed compared
to the thresholds when outliers were not removed, while other
thresholds were not as impacted. The simulations of trimming and Tukey
outlier deletion also account for the removal of the two Part D appeals
measures (Appeals Auto-Forward and Appeals Upheld) and the Part C
measure Adult BMI Assessment, because these measures will be removed
starting with the 2022 Star Ratings, as announced in the 2020 Call
Letter.
Under trimming, all contracts with scores below the 1st percentile
or above the 99th percentile are removed prior to clustering. Although
trimming is a simple way to remove extreme values, it removes scores
below the 1st percentile or above the 99th percentile regardless of
whether the scores are true outliers. In some cases, true outliers may
be between the 1st and 99th percentile, and trimming will not remove
these outliers, and in other cases, trimming will remove scores that
are not true outliers, especially when the distribution of scores is
skewed. If trimming and a 5 percent cumulative guardrail had been
implemented for the 2018 Star Ratings, 2 percent of MA-PD contracts
would have seen their overall Star Rating increase by half a star and
17 percent would have had it decreased by half a star. For PDP
contracts, 4 percent would have increased their Part D summary Star
Rating by half a star and none would have decreased.
Tukey outer fence outlier deletion is a standard statistical method
for removing outliers. Under this methodology, outliers are defined as
values below a certain point (first quartile-3.0 x (third quartile-
first quartile)) or above a certain point (third quartile + 3.0 x
(third quartile-first quartile)). The Tukey outer fence outlier
deletion will remove all outliers based on the previous definition and
will not remove any cases that are not identified as outliers. As with
trimming, the values identified by Tukey outer fence outlier deletion
are removed prior to clustering. If Tukey outer fence outlier deletion
and a 5 percent cumulative guardrail had been implemented for the 2018
Star Ratings, 2 percent of MA-PD contracts would have seen their Star
Rating increase by half a star and 16 percent would have decreased by
half a star. For PDP contracts, 2 percent would have increased by half
a star and 18 percent would have decreased by half a star.
At this time, CMS is not finalizing a method to directly remove
outliers prior to clustering. The methods to directly remove outliers
resulted in some shifting of Star Ratings in the simulations, as
explained previously. Further, as these methods were not included in
the proposed rule, the public has not had an opportunity to comment on
them specifically. CMS will continue to evaluate these and possibly
other methods to directly address outliers and will consider proposing
outlier deletion in future rulemaking.
Comment: A commenter opposed resampling because based on the
commenter's simulations it would have little impact on cut points and
could lead to cut points being raised more often than lowered.
Response: CMS appreciates the commenter's concerns that the mean
resampling will not have a significant impact on cut points. However,
we believe that mean resampling in conjunction with the use of the
guardrails adequately addresses concerns about outliers and stability
from year to year. We are finalizing mean resampling because it will
lead to increased stability and predictability of cut points and will
address the sensitivity of clustering to the order of the data.
Comment: A couple commenters requested CMS consider whether
resampling could increase the influence of outliers on cut points.
Response: Mean resampling decreases the influence of outliers on
cut points because each measure score (regardless of whether the score
is an outlier) is omitted from 10 percent of the cut point estimates,
which are then averaged as part of mean resampling. Based on this, any
given outlier is omitted from the cut point estimates in one of the 10
runs of the clustering algorithm. When the 10 sets of cut point
estimates are averaged, the influence of an outlier is less than what
it would have been if resampling had not been done. Therefore,
resampling will not increase the influence of outliers as a function of
the methodology.
Comment: A commenter supported resampling but would like individual
contract scores to be weighted by enrollment to reduce the impact of
small contracts that may experience large changes in scoring from one
year to the next due to small numbers.
Response: CMS appreciates the commenter's support for resampling.
Giving contracts very different weights would decrease the stability of
clustering and increase the role of noise in setting thresholds. The
measures used in the Star Ratings program have minimum denominator
criteria that must be met for a contract to be scored on a measure. As
part of our usual administration of the Star Ratings system, CMS has
examined changes in scores from year to year when there have been
larger shifts in cut points. However, based on this comment, we again
examined the data for large changes in measure scores year-over-year
and found that such changes occur even for contracts with moderate or
large denominators. We therefore disagree with these commenters and
will not change the methodology as recommended.
Comment: A commenter opposed resampling because it does not address
social disparity issues faced by some plans and outlier removal would
disadvantage plans serving underserved communities by normalizing
metrics towards the median. Another commenter requested CMS to consider
how methodological changes may necessitate adjustments for socio-
economic status (SES) factors.
Response: The purpose of resampling is to create more stability in
the cut points over time. Separately, CMS in the April 2018 final rule
and the 2020 Call Letter finalized a policy to expand the adjusted
measures included in the Categorical Adjustment Index (CAI). Starting
with the 2020 Star Ratings the CAI values will be determined using all
measures in the candidate measure set for adjustment. A measure will be
adjusted if it remains after applying the exclusions as follows: The
measure is already case-mix adjusted for SES, the measure is a plan or
provider issue, the measure is being retired or revised during the
relevant Star Ratings year, or the measure only applies to Special
Needs Plans. Further, the CAI for a given ratings year is developed
using the same cut point methodology that will be applied in that
ratings year. We believe that the CAI adequately addresses the impact
of SES on the Part C and D Quality Star Ratings pending the conclusion
of ASPE's second report on this issue (scheduled to be released in the
fall of 2019) and steps taken by the measure stewards to further
address it.
Comment: A commenter supported reordering in place of resampling,
because the commenter believes resampling may not result in more stable
cut points and reordering would address the sensitivity of the
hierarchical clustering algorithm to the order of the data.
[[Page 15757]]
Response: We appreciate the commenter's concerns, but we are
finalizing mean resampling as proposed. The hierarchical clustering
algorithm is sensitive to the order of the data when ties occur in
identifying the clusters. This means the cut points generated by the
clustering algorithm can sometimes be slightly different depending on
the order of the data. Mean resampling helps to address this issue, and
we believe mean resampling combined with guardrails adequately
addresses concerns about outliers and stability from year to year.
Additionally, conducting a full-scale reordering is too computationally
intensive given the time constraints of the Star Ratings calculations.
Under mean resampling, each time 10 percent of the measure scores are
randomly selected and removed prior to clustering the remaining 90
percent, the order of the data will be altered. We will continue to
evaluate the impact of resampling on the issue identified by the
commenter and consider additional enhancements to the methodology if
needed.
Comment: Most commenters supported the implementation of
guardrails. While about half of commenters supported setting the
guardrails at 5 percent as proposed, other commenters were mixed in
supporting various other options for setting guardrails, such as a 2
percent guardrail, a 3 percent guardrail, and a 5 percent restricted
range guardrail for all measures.
Response: We thank commenters for their support for implementing
guardrails. While we appreciate commenters' suggestions for
alternatives to setting guardrails at 5 percent, we are finalizing the
guardrails at 5 percent as proposed. Guardrails at 5 percent provide a
balance between providing predictability in cut points while also
allowing cut points to keep pace with changes in measure scores in the
industry. Smaller guardrails may prevent the cut points from keeping
pace with changes in measure scores in the industry, and may limit the
incentive to improvement. Five percent guardrails will also allow for
less frequent or possibly no future adjustments to reset the measure
thresholds to keep pace with industry changes in measure scores as
compared to smaller guardrails. If cut points are not keeping pace with
the changes in scores over time, CMS may propose in the future how to
adjust the cut points to account for significant changes in industry
performance.
Comment: Some commenters requested additional information about the
guardrails including simulations of the impact. Some commenters
requested simulation data prior to implementation whereas other
commenters requested simulations of the impact but also supported the
proposed changes.
Response: We appreciate the commenters request for simulations of
the impact of guardrails. We refer readers to the earlier response to
comments where we provide the results of the simulations combining mean
resampling and a 5 percent guardrail. Commenters could also compare cut
points from prior years to see where the guardrail would go into effect
to determine which cut points would be affected. Additionally, data are
available to conduct a full simulation, as discussed previously.
Comment: A commenter requested CMS delay finalizing the application
of a guardrail until a final cut point methodology is finalized,
because guardrails should be assessed only after the final cut point
methodology is determined.
Response: CMS appreciates the commenter's request but does not
believe a delay is necessary or appropriate as the guardrails are a key
component of how we intend the cut point methodology to provide
stability and predictability from year to year, in balance with
reflecting true performance. In addition, many other commenters
requested CMS implement the changes as soon as possible. CMS has
assessed a number of different approaches for modifying the cut point
methodology and simulated the impact of the proposed modifications;
therefore, we understand the impact of such changes. We discussed the
results of these simulations in response to other comments earlier in
this preamble. We are finalizing the guardrails as proposed, because
this will lead to increased stability and predictability of cut points.
Comment: A commenter supported guardrails only above the prior
year's cut points combined with not allowing cut points to decline from
year to year, because the commenter believes cut points should not be
allowed to decrease compared to the following year. Another commenter
noted a concern for cut points getting lower from year to year since
downward movement could discourage plans from making improvements to
attain higher ratings.
Response: We thank the commenters for these suggestions and while
we share the underlying concern about incentivizing continued
improvement in performance, we do not believe restricting downward
movement in cut points from year to year is appropriate. There may be
instances in which industry performance declines from year to year as a
result of factors that are outside of plans' control and cut points
should be able to move to account for this. This is in line with our
intent for the Quality Star Ratings to provide comparative information
about MA and Part D plan performance.
Comment: A couple commenters were concerned about the
implementation of guardrails, because it could limit the ability of the
Star Ratings to respond to industry changes and make the Star Ratings a
less effective comparative tool, and these commenters also suggested
that guardrails would diminish incentives for improvement. A commenter
was concerned about the need to rebase cut points if they did not keep
up with changes in industry performance.
Response: We appreciate the commenters concern and agree the Star
Ratings should be able to respond to industry changes and to reflect
true performance as accurately as possible. To address this issue, we
are finalizing the guardrails at 5 percent as proposed rather than a
narrower guardrail. Guardrails at 5 percent provide a balance between
providing predictability in cut points while also allowing cut points
to keep pace with changes in measure scores in the industry. If cut
points are not keeping pace with the changes in scores over time, CMS
may propose in the future how to adjust the cut points to account for
significant changes in industry performance.
Comment: Some commenters also supported setting guardrails for new
measures.
Response: While CMS appreciates the desire for predictability of
cut points, we believe setting guardrails on new measures would not
allow cut points to keep pace with initial increases in performance
that are typically seen for new measures and would diminish incentives
for improvement. We have seen that for new measures, plans and their
providers work closely to implement processes to improve performance.
There is typically more room to improve for new measures and,
consequently, we see large year-to-year gains in measure scores in
particular for the first three or more years.
Comment: A couple commenters questioned how measures moved to
display as a result of specification changes would be treated when they
were returned to the Star Ratings.
Response: Measures returning to the Star Ratings after being on
display as a result of substantive specification changes would be
treated as new
[[Page 15758]]
measures. For these measures, we will use the hierarchal clustering
methodology with mean resampling for the first 3 years after returning
to the Star Ratings and add application of the guardrail only after
that point.
Comment: A handful of commenters requested that CMS continue to
work with stakeholders and other experts to improve guardrails over
time and to identify alternative methodologies to increase the
predictability and stability of cut points from year to year, including
how to address the impact of outliers.
Response: We appreciate the commenters' suggestions to continue to
obtain feedback on ways to improve the methodology over time. We will
continue to solicit feedback from stakeholders on this issue, and our
Star Ratings contractor will continue to obtain input from the Part C
and D Star Ratings Technical Expert Panel. We are committed to
continuing to analyze the impact of outliers in the data and may
propose additional enhancements to specifically address this issue. We
intend to consider all of this information as we develop future
policies and regulations for the Part C and Part D Quality Star Ratings
program.
Comment: A couple commenters supported guardrails for CAHPS
measures, such as a guardrail of 0.5 to 1.00.
Response: Because cut points for CAHPS measures have relatively
stable trends over time, CMS did not propose any guardrails for CAHPS
measures. We will not finalize any such guardrails in this rule. The
proposed narrow guardrails of 0.5 to 1.0 are below typical levels of
improvement for CAHPS measures.
Comment: A commenter requested consideration of the base cut points
that the guardrails are initially applied to. The commenter stated a
recalculation of base cut points using new or improved methodology may
be more appropriate prior to application of guardrails.
Response: We agree with the commenter. When guardrails and mean
resampling are implemented for the 2022 Star Ratings, CMS will rerun
the 2021 Star Ratings thresholds with mean resampling. The 2022 Star
Ratings thresholds that include mean resampling will then be compared
to the rerun 2021 Star Ratings thresholds in order to apply the 5
percent guardrail. Because our proposal occurred after the start of the
2019 performance period for the 2021 Star Ratings, the use of mean
resampling for setting cut points is limited to setting the actual cut
points for 2022 and subsequent Star Ratings. We will use the 2021 Star
Ratings cut points as the starting point for applying the guardrail
aspect of the new methodology, in order to allow for an apples-to-
apples comparison when applying the guardrails for the 2022 Star
Ratings.
Comment: A commenter believed the proposed methodology changes
addressed some of the concerns raised by stakeholders and the TEP and
are broadly defensible. However, the commenter believed CMS is moving
further away from a standardized, uniform approach to assigning Star
Ratings for the various care settings/institutions for which it issues
report cards, including the Part C and D Star Ratings program and the
multiple fee-for-service (FFS) Star Ratings programs for hospitals,
dialysis facilities, and skilled nursing facilities. The commenter also
stated the proposed methodology changes make an already complex
methodology even more complex and CMS should consider the trade-offs
between refining setting- or institution-specific methodologies with
the pressing need for simplicity and clarity for health care consumers.
Response: CMS understands the desire to balance customization of
the Star Ratings methodology for each of the different CMS programs
comparing the quality of care for various types of healthcare
providers, while also enhancing stability and predictability of cut
points for the MA and Part D Star Ratings programs. While CMS has an
overall interest and goal in aligning the various Star Ratings systems
across the agency to the extent feasible, our proposal was limited to
the Part C and D Star Ratings program and the needs and purposes of
that program. Under section 1853(o), the Part C and D Star Ratings are
used to identify MA organizations that are eligible for quality bonus
payments as well as a means to provide comparative information about
plan quality to Medicare beneficiaries. In other programs comparing the
quality of care for healthcare providers, such as Hospital Compare for
hospitals, Medicare FFS payment is not directly related to the overall
Star Rating that is publicly reported. We believe the relationship
between the Part C and D Star Ratings system and plan Quality Bonus
Payments means that providing a measure of stability and predictability
for the rated entities (in this case, MA and Part D contracts and
plans), even if it means moving further away from a standardized,
uniform approach to assigning Star Ratings across agency programs, is
appropriate to ensure predictability and stability. Requiring the
various Star Ratings systems to have a uniform methodology for setting
cut points would not be consistent with the goals and uses of the
separate programs and we decline to make uniformity a goal in and of
itself where we see significant policy reasons to modify the cut point
methodology for the Part C and D non-CAHPS measures. Simplicity and
clarity for healthcare consumers would not be sacrificed by differences
between methodologies between various CMS Star Ratings Systems because
consumers are less likely than other stakeholders to be interested in
understanding the underlying methodologies. For those who want access
to more details on the methodology, the Technical Notes can be found
here: https://go.cms.gov/partcanddstarratings. However, taking into
account these differences, CMS works to ensure that the MA and Part D
Star Ratings system is as closely aligned with other CMS rating systems
as necessary and possible to serve the programmatic needs of each Star
Rating system.
Comment: A few commenters supported distributing Quality Bonus
Payments on a continuous scale.
Response: We understand the commenters' interest in alternative
methods of distributing Quality Bonus Payments, however, the
distribution of Quality Bonus Payments is defined in statute to be
based on a Five-Star Rating system. Changes to the how Quality Bonus
Payments are distributed are out of scope for this regulation.
Comment: Some commenters supported using prospectively set
thresholds to create more predictability and stability, while others
were opposed to setting thresholds prospectively. A commenter supported
setting a predetermined cut point of 95 percent for 5 stars and stated
predetermined thresholds have the ability to limit the impact of
outliers and reduce the additional steps required by the cut point
methodology. Another commenter supported setting fixed 5-star cut-
points for measures that have stable performance among the top 25th
percentile of plans over time.
Response: We understand the desire of some commenters to have pre-
set thresholds. CMS had implemented pre-determined 4-star thresholds
for some measures in the 2011 Star Ratings to increase transparency for
organizations/sponsors and set a priori expectations for high
performance. However, we found that pre-set thresholds created more
``noise'' or measurement error in the system and disincentivized
contracts from improving once they hit the 4-star threshold. Further,
while we agree that operational considerations are
[[Page 15759]]
important in selecting and adopting the cut point methodology,
particularly as we have a limited amount of time to process the
performance data and issue Star Ratings each year, CMS does not believe
that those considerations should be the sole driving factor; the ease
achieved by using a pre-determined cut point needs to be weighed
against the drawbacks with that methodology and our overall policy
goals for the Star Ratings program.
Comment: A commenter raised concerns that plans must often set
unrealistic targets for physicians in order for the plan to earn
incentives from CMS and supported finalizing cut point methodologies
that do not impede clinical judgment.
Response: CMS does not set targets that Part C and D plans must
achieve to do well in the Star Ratings program; as discussed in the
prior response, CMS has moved away from the use of pre-determined cut
points for Part C and D Star Ratings. Plans should not be impeding
clinical judgment; physicians should be using their clinical expertise
to determine how to appropriately deliver care to their patients.
Further, the non-interference provision in section 1854(a)(6)(B)(iii)
prohibits CMS from requiring MA organizations from having a particular
price structure for payments to network providers; the Quality Star
Rating system does not itself incentivize plans to compromise the
delivery of medically necessary care to enrollees.
Comment: A few commenters suggested CMS use alternative clustering
methodologies to address outliers, including K-means clustering with
outlier removal (KMOR) and clustering with outlier removal (COR).
Response: CMS appreciates the commenters' suggestions and will
consider these comments and alternatives as one of the agency's goals
in administering the Quality Star Ratings program is continual
improvement. CMS is exploring standard outlier removal techniques, such
as Tukey outer fence outlier deletion prior to clustering, that are
similar to alternatives that the commenter suggests. These approaches
are available in SAS software and thus have the benefit of being
accessible and transparent to stakeholders. CMS will continue to
evaluate these and possibly other methods to directly address outliers
and will consider proposing outlier deletion in future rulemaking.
Comment: A commenter stated cut points need to reflect meaningful
differences in plan performance.
Response: CMS agrees that the cut points should provide a
meaningful way to distinguish true performance. CMS believes
hierarchical clustering combined with mean resampling and guardrails
will result in cut points that meaningfully distinguish performance
while also creating more stability and predictability. Further, CMS
monitors the performance distribution for each measure in the Star
Ratings program to determine if scores are tightly compressed and
differences are not practically meaningful. Even small differences in
scores can be meaningful. For example, Quigley, Elliott et al. (2018)
established that even one point differences in CAHPS scores are
meaningful. Further, CMS evaluates measures for retirement when scores
are compressed and topped out such that the measure has low
reliability.
Comment: A commenter supported the proposed changes as an interim
step, but offered a number of suggestions for CMS to model, in
particular to see the impact on plans with a high proportion of LIS/DE/
disabled enrollees. The commenter's suggestions included: Stratifying
cohort/peer group quintiles based on percent LIS/DE/disabled prior to
applying cut point thresholds, using state as unit of analysis rather
than contract, analyzing whether measures are sensitive to provider
actions, assessing measures to see whether performance differs across
plan benefit packages in a contract, addressing topped out measure
performance by assigning thresholds for higher stars based on clinical
or public health guidelines, and considering beneficiary
characteristics when examining measure results.
Response: CMS appreciates the feedback and will take these
suggestions into consideration as CMS makes future changes to the Star
Ratings methodology. CMS continually monitors cut points and will
evaluate the impact of the changes to the cut point methodology. CMS
will propose additional enhancements to the cut point methodology as
necessary to further the goals of providing ratings that are a true
reflection of plan quality and enrollee experience, minimize the risk
of misclassification, treat contracts fairly and equally, and minimize
unintended consequences.
Comment: A commenter supported rounding measures scores to the next
decimal place (tenths of a percent).
Response: Measure scores are already rounded to the precision
indicated next to the label ``Data display'' within the detailed
description of each measure in the Part C and D Star Ratings Technical
Notes found at https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html. Most measures are
rounded to whole numbers so small differences in performance do not
drive the cut points.
Comment: A couple of commenters requested additional data to
validate calculations during the second plan preview and to simulate
proposed enhancements.
Response: CMS will post example measure data for one Part C and one
Part D measure in HPMS at the beginning of the second plan preview for
contracts to check the CMS programming. Additionally, all HEDIS data
from 1997 on are available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/MA-HEDIS-Public-Use-Files.html. These data are available in September of
each year and can be used to simulate and validate Ratings
calculations.
Comment: A commenter questioned whether CMS has considered if
measures that have shifts in cut points of 5 points should be included
in the Star Ratings due to their volatility.
Response: In general, CMS believes such measures should be included
in the Star Ratings. Some measures may have occasional large shifts in
the performance distribution, but this does not suggest that the
measure is not a reliable measure of performance. Shifts in 5
percentage points can happen occasionally since the clustering
algorithm not only looks at changes in the levels of performance, but
also takes into account changes in the distribution of scores across
the industry. When there are more significant shifts in performance,
there may be larger shifts in cut points. As finalized in this rule,
the mean resampling and guardrails will prevent any very large cut
point shifts.
Comment: A commenter raised concerns that the current clustering
methodology is flawed since small plans with more volatility can have
an outsized impact on thresholds, resulting in misclassification.
Another commenter believed the proposed changes would not adequately
address misclassifying nearly identical contracts into different Star
Ratings levels.
Response: We appreciate the commenters' concerns about volatility
and misclassification. The clustering algorithm is set up to maximize
differences across star categories and minimize differences within star
categories so to avoid misclassifying nearly identical contracts into
different Star Ratings levels. All measures have minimum denominators
to ensure that the scores included in the Star Ratings are reliable.
Outliers are seen not just for small plans that may have smaller
[[Page 15760]]
denominators, but with larger plans with moderate or large
denominators. Reducing the impact of outliers on the cut points will
help to address any potential volatility. CMS is finalizing mean
resampling to help address outliers. Along with guardrails, mean
resampling will increase the stability and predictability of cut
points. In an earlier response, CMS also presented results from
simulations that looked at two ways of directly addressing outliers.
CMS will continue to evaluate these and possibly other methods to
directly address outliers and will consider proposing outlier deletion
in future rulemaking.
Comment: A couple of commenters noted that currently plans may have
a score that improves but a star that declines or a score that declines
but a star that improves.
Response: Since the hierarchical clustering algorithm not only
looks at changes in the levels of performance but also takes into
account changes in the distribution of scores across the rated Part C
and Part D contracts, scores can decline from the prior year and have a
higher Star Rating and similarly scores can increase and have a lower
Star Rating. The Star Ratings provide information about comparative
performance and how the contracts performed compared to the other
contracts. CMS is also looking into methods that directly address
outliers and will consider proposing outlier deletion in future
rulemaking.
Comment: A commenter requested CMS consider that more beneficiaries
are enrolling in the MA program and future enhancements may be
warranted to accurately reflect plan performance and not the prior care
these beneficiaries received before they joined an MA plan, because
quality improvement often takes longer than a year.
Response: CMS appreciates this feedback and will continue to
monitor scores across the industry.
Comment: A commenter stated if methodologies are in place to
restrict extreme movement of cut points, then contracts should be able
to use the prior year's data to set goals and focus on improvement and
reaching specific benchmarks.
Response: CMS agrees that by increasing the stability and
predictability of the cut points, this methodology will assist Part C
and Part D organizations in setting specific goals for improvement on
Quality Star Ratings.
Comment: A commenter requested CMS reconsider the model for
developing CAHPS thresholds to create meaningful differences in plan
quality, because the CAHPS measure scores are clustered tightly.
Response: CMS believes that even one point differences in CAHPS
scores are meaningful. See Quigley, Elliott et al. (2018). Further, the
methodology for setting cut points for CAHPS measures is outside the
scope of the proposal and this rulemaking.
Comment: A commenter supported a three-year rolling average of cut
points to increase stability for measures that have not topped out; for
topped out measures the commenter supported fixed cut points based on
the most recent year when performance is categorized as topped out, and
providing advance notice of thresholds for new measures for the first
three Star Ratings years then move to the three-year rolling average.
Additionally, the commenter stated that topped out measures should not
be removed from Star Ratings if high quality is still important to
maintain.
Response: Using a three-year rolling average of cut points would
increase the lag used to determine cut points, which is problematic
because it does not account for real improvement trends in measure
performance over time. Providing an accurate reflection of the
performance on measures for the applicable measurement year is a key
goal of the Quality Star Ratings system. The methodology CMS proposed
and is finalizing in this rule will increase stability in cut points
without this limitation. As a measure is becoming topped out, the cut
points already do not change much from year to year so we disagree that
there would be a need to set fixed cut points. If there is no or very
little variation across contracts in a measure, the measure would have
low reliability and, pursuant to Sec. Sec. 422.164(e) and 423.184(e),
would be removed from the Star Ratings program. We will take these
comments into consideration as we consider any changes for our policies
regarding measures with low reliability.
Comment: A commenter recommends addressing data reliability by
having measure developers review outliers and measure methodology, and
set more appropriate specifications, such as increasing the minimum
denominator and excluding members for which the measure may not be
clinically appropriate. The commenter believes this will stabilize cut
points.
Response: CMS agrees that measures used in the Part C and Part D
Quality Star Rating System should be based on reliable data and provide
useful information about plan performance. As discussed in the April
2018 final rule (83 FR 16521) and November 2017 proposed rule (82 FR
56336), one of the goals of the Star Ratings system is for ratings to
be a true reflection of plan performance and enrollee experience and be
based on data that are accurate, complete, and reliable. Measure
developers have been reviewing their specifications to enhance them and
CMS will encourage them to continue to review the specifications to
improve their measure specifications. For example, NCQA has increased
the denominator for the Plan-All Cause Readmission measure to a minimum
of 150. NCQA has also been reviewing the HEDIS measures for the
additional exclusion for patients with advanced illness.
Comment: A commenter suggested we consider input from the Pharmacy
Quality Alliance (PQA).
Response: CMS welcomes input from all stakeholders, and considered
the comments submitted by the PQA when finalizing this rule.
Comment: A commenter suggested setting a minimum number of
contracts per cluster in order to address the concern that a single
contract could influence a change in cut points even with guardrails.
Response: CMS believes setting a minimum number of contracts per
cluster would require making a priori assumptions about the
distribution of measure scores. The proposed enhancements to the cut
point methodology address the commenter's concerns by moving in the
direction of increasing stability and predictability of the ratings
without having to make a priori assumptions. Additional outlier
deletion methods may be proposed through future rulemaking will further
address the commenter's concern. In an earlier response, CMS presented
results from simulations that looked at two ways of directly addressing
outliers. CMS will continue to evaluate these and possibly other
methods to directly address outliers and will consider proposing
outlier deletion in future rulemaking.
Comment: A commenter suggested that CMS communicate on Medicare
Plan Finder that the decrease in stars for PDPs for the 2019 Star
Ratings was due to differing cut points for PDPs versus MA-PDs and the
impact of outliers on PDPs.
Response: This comment is outside the scope of our proposal for
setting cut points for the 2022 and subsequent Star Ratings. The cut
points for MA-PDs and PDPs have historically been set separately since
performance across MA organizations that offer Part D and stand-alone
PDPs may differ given the
[[Page 15761]]
integration of health and drug benefits under an MA-PD is very
different than how a stand-alone PDP operates. CMS appreciates the
comment, but the notices on Medicare Plan Finder are not designed or
intended to address the intricacies of the methodology for the Star
Ratings program; however, the Technical Notes for each year's Star
Ratings are available publicly for those who are interested in that
information and are found at https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovGenIn/PerformanceData.html. CMS is
concerned that too much methodological detail can be overwhelming for
those who use the Medicare Plan Finder website and believes that most
consumers want just to see the Star Ratings, especially the overall
ratings. As discussed in this final rule and responses to comments in
this section, the proposed resampling and guardrails will help mitigate
significant changes in the cut points from year to year.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier in this final rule, we are
finalizing the methodology to determine cut points as proposed at
Sec. Sec. 422.166(a)(2)(i) and 423.186(a)(2)(i). CMS is committed to
incorporating feedback received from commenters about the direct
removal of outliers from the calculations and will continue to evaluate
the methodologies described earlier for outlier removal and possibly
other methodologies. We will consider proposing outlier deletion in
future rulemaking to allow all stakeholders the opportunity to comment
on potential methodologies.
d. Updating Measures (Sec. Sec. 422.164, 423.184)
In the April 2018 final rule (83 FR 16537), CMS stated that due to
the regular updates and revisions made to measures, CMS would not
codify a list of measures and specifications in regulation text; CMS
adopted a final list of measures for the contract year 2019 measurement
period (83 FR 16537-16546) and indicated how changes to that list--
additions, updates, removals--would be done in the future, using the
Advance Notice and Rate Announcement under section 1853(b) of the Act
or rulemaking. The regulations at Sec. Sec. 422.164 and 423.184
specify the criteria and procedure for adding, updating, and removing
measures for the Star Ratings program. CMS lists the measures used for
the Star Ratings each year in the Technical Notes or similar guidance
document with publication of the Star Ratings. We proposed measure
changes to the Star Ratings program for performance periods beginning
on or after January 1, 2020 and performance periods beginning on or
after January 1, 2021. For new measures and substantive updates to
existing measures, as described at Sec. Sec. 422.164(c) and (d)(2),
and Sec. Sec. 423.184(c) and (d)(2), CMS will initially announce and
solicit comment through the Call Letter attachment to the announcements
issued for changes in and adoption of payment and risk adjustment
policies in section 1853(b) of the Act and will subsequently propose
these measures to be added to the Star Ratings program through
rulemaking. Proposals for substantive updates have been discussed in
prior Call Letters (contract years 2018 and 2019). We will continue the
process of announcing our intent with regard to measure updates in
future Call Letters. Any measures with substantive updates must be on
the display page for at least 2 years before use in the Star Ratings
program. For new measures and measures with substantive updates, as
described at Sec. Sec. 422.166(e)(2), 423.186(e)(2) and Sec. Sec.
422.164(d)(2), 423.184(d)(2), the measure will receive a weight of 1
for the first year in the Star Ratings program. In the subsequent
years, the measure will be assigned the weight associated with its
category.
(1) Proposed Measure Updates
(a) Controlling High Blood Pressure (Part C)
Due to the release of new hypertension treatment guidelines from
the American College of Cardiology and American Heart Association,\34\
NCQA implemented updates to the Controlling High Blood Pressure measure
for HEDIS 2019. NCQA revised the blood pressure target to <140/90 mmHg.
NCQA also made some structural changes to the measure that included
allowing two outpatient encounters to identify the denominator and
removing the medical record confirmation for hypertension, allowing the
use of telehealth services for one of the outpatient encounters in the
denominator, adding an administrative approach that utilizes CPT
category II codes for the numerator, and allowing remote monitoring
device readings for the numerator. Given the change to the blood
pressure target and our rules for moving measures with substantive
changes to the display page, this measure will be moved to the display
page for the 2020 and 2021 Star Ratings. We proposed to return this
measure as a measure with substantive updates by the measure steward
(NCQA) to the 2022 Star Ratings using data from the 2020 measurement
year with, as required by Sec. Sec. 422.164(d)(2) and 422.166 (e)(2),
a weight of 1 for the first year and a weight of 3 thereafter.
---------------------------------------------------------------------------
\34\ See Whelton P.K., Carey R.M., Aronow W.S., et al. (2018).
Guideline for the prevention, detection, evaluation, and management
of high blood pressure in adults: A report of the American College
of Cardiology/American Heart Association Task Force on Clinical
Practice Guidelines. Journal of the American College of Cardiology.
71(19): e127-e248. Available at https://www.onlinejacc.org/content/71/19/e127?_ga=2.143510773.1362500146.1536262802-126396490.1536262802.
---------------------------------------------------------------------------
Below we summarize the comments we received and provide our
responses and final decisions.
Comment: The majority of commenters supported our proposal.
Response: CMS appreciates receiving the support for this proposal.
Comment: A few commenters expressed support, but offered additional
measure specification change suggestions. These commenters questioned
whether the new standards are suitable for all populations (that is,
for those with special needs, the aged, and those with multiple co-
morbidities and advanced cognitive impairment populations as well as
for the generally healthy elderly population). These commenters
suggested adding some additional exclusions. A commenter disagreed with
the new clinical standards as specified in the updated measure.
Response: NCQA is the measure steward for the Controlling High
Blood Pressure measure. As codified at Sec. 422.164(c)(1) CMS tries to
include in the Star Ratings, to the extent possible, measures that are
nationally endorsed and in alignment with the private sector such as
the Plan All-Cause Readmissions measure developed by NCQA. Although a
few commenters offered suggestions for additional changes to the
measure, CMS is moving ahead to include the revised measure in the 2022
Star Ratings since we believe that this measure has been sufficiently
validated by the measure steward and most commenters supported the
measure updates to align with the new clinical guidelines for blood
pressure control. CMS will share all suggestions, including concerns
about additional exclusions and clinical disagreements with the
specified updates with NCQA for their consideration as they make future
enhancements to the measure.
Comment: A few commenters believe the current measure is too
important to remove from the Star Ratings. Rather, they suggested
keeping the legacy measure in the Star Ratings while the
[[Page 15762]]
updated measure is shown on the display pages.
Response: CMS agrees that the Controlling High Blood Pressure
measure is an important measure. However, CMS believes that keeping the
legacy measure in the Star Ratings while presenting the updated measure
on the display pages, would create significant data collection burden
on plans given the data collection complexities of the Controlling High
Blood Pressure measure. Although Sec. 422.164(d)(2) permits continued
use of legacy measures when there has been a substantive update, the
regulation does not require CMS to do so in all cases. Here, CMS
believes that it is not appropriate.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing our proposal
to return the Controlling High Blood Pressure measure, as updated by
the measure steward, to the 2022 Star Ratings using data from the 2020
measurement year with a weight of 1 for the first year and a weight of
3 thereafter, as required by Sec. Sec. 422.164(d)(2) and 422.166
(e)(2).
(b) MPF Price Accuracy (Part D)
Continued transparency and accuracy of sponsors' pricing data used
by beneficiaries is important; therefore, we proposed to make
enhancements to the MPF Price Accuracy measure to better measure the
reliability of a contract's MPF advertised prices. In accordance with
Sec. 423.184(d)(2), the substantively updated measure would be a
display measure for 2020 and 2021 and we proposed to use it in the 2022
Star Ratings in place of the existing MPF Price Accuracy measure, which
will remain in the Star Ratings until that replacement under Sec.
423.184(d)(2). The proposed update would measure the magnitude of
difference, as well as the frequency of price differences. We proposed
to implement the following changes for this measure:
Factor both how much and how often prescription drug event
(PDE) prices exceeded the prices reflected on the MPF by calculating a
contract's measure score as the mean of the contract's Price Accuracy
and Claim Percentage scores, based on the indexes in this rule:
++ The Price Accuracy index compares point-of-sale PDE prices to
plan-reported MPF prices and determines the magnitude of differences
found. Using each PDE's date of service, the price displayed on MPF is
compared to the PDE price. The Price Accuracy index is computed as:
(Total amount that PDE is higher than MPF + Total PDE cost)/(Total
PDE cost)
++ The Claim Percentage index measures the percentage of all PDEs
that meet the inclusion criteria with a total PDE cost higher than
total MPF cost to determine the frequency of differences found. The
Claim Percentage index is computed as:
(Total number of claims where PDE is higher than MPF)/(Total number
of claims)
++ The best possible Price Accuracy index is 1 and the best
possible Claim Percentage index is 0. This indicates that a plan did
not have PDE prices greater than MPF prices.
++ A contract's measure score is computed as:
--Price Accuracy Score = 100-((Price Accuracy Index-1) * 100)
--Claim Percentage Score = (1-Claim Percentage Index) * 100
--Measure Score = (0.5 * Price Accuracy Score) + (0.5 * Claim
Percentage Score)
Increase the claims included in the measure:
++ Expand the days' supply of claims included from 30 days to
include claims with fills of 28-34, 60-62, or 90-100 days.
++ Identify additional retail claims using the PDE-reported
Pharmacy Service Type code. Claims for pharmacies that are listed as
retail in the MPF Pharmacy Cost file and also have a pharmacy service
type on the PDE of either Community/Retail or Managed Care Organization
(MCO) will be included.
Round a drug's MPF cost to 2 decimal places for comparison
to its PDE cost. Post-rounding, the PDE cost must exceed the MPF cost
by at least one cent ($0.01) in order to be counted towards the
accuracy score (previously, a PDE cost which exceeded the MPF cost by
$0.005 was counted). A contract may submit an MPF unit cost up to 5
digits, but PDE cost is always specified to 2 decimal places.
Under our proposed update, PDEs priced lower than the MPF display
pricing will continue to be ignored and will not have an impact on the
measure score or rating. Only price increases are counted in the
numerator for this measure. We proposed to add this updated measure to
the 2022 Star Ratings based on the 2020 measurement year with a weight
of 1.
Below we summarize the comments we received and provide our
responses and final decisions.
Comment: The majority of commenters supported the measure's
proposed changes, citing it is critical to provide enrollees with
information they have confidence is reliable and accurate. There was
strong support for price transparency, and making sure contract
performance is measured in a meaningful and useful manner.
Response: CMS appreciates these commenters' support of this measure
and the proposed changes, and more broadly the confirmation that
beneficiaries rely on the MPF's accuracy to make critical enrollment
choices. We agree that it is essential to continue this measure so that
enrollees can remain confident that the data displayed on the MPF are
reliable and accurate. Our Star Ratings contractor will also continue
to obtain feedback on price transparency and related measure concepts
as part of their TEP. CMS always values feedback on display and Star
Ratings measures and will continue to identify future ideas in the 2021
Call Letter.
Comment: Several commenters opposed the addition of frequency of
price differences to the measure, stating this would not be a concern
to beneficiaries, or that the current Star Rating measure already
includes this. They also state the frequency of pricing differences
between the data available on the MPF and the price reflected in the
PDE data is not due to a contract's performance, but due to established
CMS timelines for MPF updates.
Response: We disagree with these commenters, and believe both the
magnitude and frequency of price inaccuracies are important. A one-time
discrepancy illustrates different performance by a Part D plan on this
issue than multiple occasions where the price is higher than posted on
the Medicare Plan Finder website; we believe both that beneficiaries
appreciate such differences in performance and need to be aware of
them. With the current methodology (as of the 2019 Star Ratings), a
sponsor who frequently submits small inaccuracies may receive a similar
score to a sponsor who submits MPF prices with very large price
differences only a few times.
Comment: Some commenters criticized the overall measure because MPF
files are prepared and submitted by a Part D plan according to the CMS-
issued calendar and guidelines, which do not allow submissions outside
the specified bi-weekly schedule. Because CMS posts files two weeks
after submission which are then displayed on MPF for two weeks, the
commenters state the data are typically between 19 to 31 days old.
Response: CMS understands that pricing may change much more
frequently than MPF submission
[[Page 15763]]
windows. We have instituted a biweekly submission window to allow for a
correction period (to avoid suppression of plans on MPF). This
submission schedule does not dictate the schedule or frequency by which
a sponsor chooses to update their own price files prior to submission
to CMS. Sponsors who perform well in this measure typically update
their pricing files at least every other week and typically closer to
the submission dates.
Comment: A few commenters were opposed to the measure because MPF
pricing data are based on a single reference/proxy NDC and are compared
to an expanded list of NDCs on the PDEs. They state this is a flaw
since drug costs vary by NDC, even those with the same strength or
dosage form. This variability leads to unavoidable inconsistencies
between a Part D plan's submitted price and the price on the claim or
PDE record.
Response: For the Star Rating measure, prices that are higher on
MPF as opposed to the PDE do not harm the plans' scores. CMS had
expanded the list of NDCs to be compared to the MPF prices beginning
with the 2011 Star Ratings in response to sponsors' requests to expand
the claims studied. Previously, sponsors were only evaluated with PDEs
with the same reference NDC, which limited claims, and sponsors stated,
unfairly portrayed their accuracy, especially if they did not support
the pricing NDC selected on the FRF. To ensure that the measure is
sensitive to the accuracy of claims of NDCs beyond those on the FRF,
claims for non-reference NDCs that can be linked to a reference NDC
with the same brand name, generic name, strength, and dosage form are
included in the measure. The inclusion of these additional claims
allows for a more robust method of measuring price accuracy. We remind
commenters that the average score in this measure ranged from 98-99 for
PDPs and MA-PDs in the 2019 Star Ratings.
Comment: A few commenters stated a meaningful price difference to
beneficiaries would be greater, and in the range $0.50-$1.00, and that
the de minimis amount of $0.01 also does not account for all rounding
errors.
Response: The measure's current price threshold of $0.005 was based
on data analyses, and sponsor performance has been high for many years.
We are raising to $0.01 to account for rounding, and thus allowing a
larger variation in prices that are not counted as price increases for
purposes of the measure than previously allowed. Raising the threshold
level for counting a price increase to $0.50 or higher would
significantly lower the usefulness of the measure as a whole, given
that plans' scores have been typically clustered in the high 90s.
Comment: Some commenters were overall against CMS using the MPF
Price Accuracy measure in the Star Ratings program. They state that a
100 rating in this measure does not reflect truly accurate pricing, but
instead is driven primarily by the timing of the files and subsequent
measure auditing of pricing. While they agree it is an important
measure to ensure MAOs and PDPs are accurately representing drug
pricing to plan members; the cut points require near perfection. They
propose the measure instead be moved to the display page for
monitoring, and that plans not be penalized by timing issues outside of
plan control.
Response: CMS disagrees. The cut points are based on the clustering
algorithm and reflects actual performance. CMS does not modify the cut
points to require near perfection, it is that Part D sponsors generally
do a good job of posting prices that are at least as high as the actual
charged prices. CMS sees sponsors' frequent auditing of MPF and price
adjudication files to be a beneficial result from the measure.
Beneficiaries and other public stakeholders are interested in this
measure as well. Knowing that they can expect accurate pricing on the
MPF is extremely helpful to beneficiaries using the tool to choose
their prescription drug plans.
Comment: A commenter recommended that CMS assess the additional
value to beneficiaries of the MPF measure based on usage patterns for
price data, etc., and weigh that against the costs to the program
(through higher plan bids) that will arise from additional investments
that may be required for Part D plans to comply with the revised
methodology for this measure.
Response: The regulation at Sec. Sec. 423.184 (c)(3) and (d)(2)
requires new measures and substantively updated measures to be on the
display page for at least two years prior to using the updated measure
to calculate and assign Star Ratings; for the revised Part D price
accuracy measure finalized here, this two year display period will be
the 2020 and 2021 display page. During that period, CMS will be using
the legacy measure in the Star Ratings. Additional feedback on this
revised measure may be submitted during the annual Call Letter process
based on experience with the revised measure on the display page. CMS
does not agree that the measure's revised methodology imposes
additional plan burden. Part D sponsors are required to submit accurate
pricing for MPF, and adjudicate claims accurately at the point of sale.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
related comments, we are finalizing the provisions related to updating
the MPF Price Accuracy measure. As proposed, we will first display the
updated measure for 2020 and 2021 and then use it to replace the
existing measure in the 2022 Star Ratings. Publishing the display
measure for at least two years will allow Part D sponsors additional
experience with contract-specific results using the new specifications.
(c) Plan All-Cause Readmissions (Part C)
NCQA is modifying the Plan All-Cause Readmissions measure for HEDIS
2020 (measurement year 2019).\35\ The measure assesses the percentage
of hospital discharges resulting in unplanned readmissions within 30
days of discharge. The changes made by NCQA to the measure are: Adding
observation stays as hospital discharges and readmissions in the
denominator and the numerator; and removing individuals with high
frequency hospitalizations. These changes were implemented by the
measure steward (NCQA) based on the rise in observation stays to ensure
the measure better reflects patient discharge and readmission volumes.
Removing individuals with high frequency hospitalizations from the
measure calculation allows the readmissions rates not to be skewed by
this population. To date, CMS has only included the 65+ age group in
the Plan All-Cause Readmissions measure. In addition to the updates
made by the measure steward, CMS proposed to combine the 18-64 and 65+
age groups as the updated measure specifications are adopted and to use
NCQA's new recommendation of 150 as the minimum denominator. Given the
substantive nature of the proposed updates for this measure, it would
be moved to display for the 2021 and 2022 Star Ratings under our
proposal and Sec. 422.164(d)(2). We proposed to return this measure as
a measure with substantive updates by the measure steward (NCQA) to the
2023 Star Ratings using data from the 2021 measurement year with, as
required by Sec. Sec. 422.164(d)(2) and 422.166(e)(2), a weight of 1
for the first year and a weight of 3 thereafter.
---------------------------------------------------------------------------
\35\ HEDIS 2019, Volume2, Technical Update, Attachment C.
https://www.ncqa.org/wp-content/uploads/2018/10/HEDIS-2019-Volume-2-Technical-Update.pdf.
---------------------------------------------------------------------------
[[Page 15764]]
Below we summarize the comments we received and provide our
responses and final decisions.
Comment: The majority of commenters supported our proposal.
Response: CMS appreciates receiving the support for this proposal.
Comment: Some commenters questioned specific aspects of the measure
specification, including the inclusion of observation stays in the
measure's numerator and denominator and whether the measure is
appropriate for high risk populations. A commenter suggested that by
focusing on decreasing readmissions, mortality rates could increase.
The commenter cited a 2018 JAMA Cardiology article \36\ which presented
data showing that the implementation of the Hospital Readmissions
Reduction Program (HRRP) was temporally associated with a reduction in
30-day and 1-year readmissions but an increase in 30-day and 1-year
mortality for patients discharged after heart failure among fee-for-
service Medicare beneficiaries. The authors of this article suggested
that this may be just a temporary association and requested additional
research to confirm these results.
---------------------------------------------------------------------------
\36\ Gupta A et al, JAMA Cardiol. 2018; 3(1): 44-53. https://jamanetwork.com/journals/jamacardiology/fullarticle/2663213.
---------------------------------------------------------------------------
Response: NCQA is the measure steward for the Plan All-Cause
Readmission measure. As codified at Sec. 422.164(c)(1) CMS tries to
include in the Star Ratings, to the extent possible, measures that are
nationally endorsed and in alignment with the private sector such as
the Plan All-Cause Readmissions measure developed by NCQA. Despite some
commenters questioning specific aspects of the measures, most
commenters provided support for the readmissions measure. CMS believes
that this is an important outcome measure for MA contracts since the
basis of the MA program is for MA contracts to coordinate the care of
their enrollees. MA contracts are responsible for coordinating care
following a hospitalization to ensure that their enrollees are
receiving appropriate care following a hospitalization, including
whether they need to be rehospitalized due to further declines in
health. CMS will share all comments concerning appropriate enrollees
eligible for the measure, the inclusion of observations stays, and the
belief that decreasing readmissions might increase mortality with NCQA
for consideration as they make future updates to the measure. Following
our rules for moving measures with substantive changes to the display
page, this measure will be moved to the display page for the 2021 and
2022 Star Ratings for contracts to acclimate to the new measure
specifications.
Comment: A commenter suggested that when the measure is returned to
the Star Ratings, the measure should have a weight of 1 for two years,
not only for the first year.
Response: Using a weight of 1 for the first year of a new or newly
revised MA measure is required by the regulations at Sec. Sec.
422.164(d)(2) and 422.166(e)(2). Measures with substantive
specification changes are treated as new measures. Changes to that
policy are out of scope for this regulation. We direct readers to 83 FR
16534 for a discussion of that particular policy.
Comment: A few commenters expressed the belief that the current
measure is too important to remove from the Star Ratings. Rather they
suggested keeping the legacy measure in the Star Ratings, while the
updated measure is on the display page for two years.
Response: CMS considered keeping the legacy measure in the Star
Ratings while displaying the updated measure on the display pages, but
believes that it would create a significant data collection burden for
plans to submit two different sets of data that follow different
specifications. This measure is relatively complex and we believe that
the value gained by reporting both the legacy and updated measure would
not be justified by the additional administrative burden. Although
Sec. 422.164(d)(2) permits continued uses of legacy measures when
there has been a substantive update, the regulation does not require
CMS to do so in all cases. Here, CMS believes that it is not
appropriate.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing our proposal
to return the Plan All-Cause Readmissions measure, as updated by the
measure steward, to the 2023 Star Ratings with a weight of 1 for the
first year and a weight of 3 thereafter, as required by Sec. Sec.
422.164(d)(2) and 422.166(e)(2). Pursuant to Sec. 422.164(d)(2), the
revised measure will be collected for display only for the measurement
periods of 2020 and 2021.
(d) Improvement Measures (Parts C and D)
The process for identifying eligible measures to be included in the
improvement measure scores is specified as a series of steps at
Sec. Sec. 422.164(f)(1) and 423.184(f)(1). As part of the first step,
the measures eligible to be included in the Part C and D improvement
measures are identified. Only measures that have a numeric score for
each of the 2 years examined are included. We proposed to add an
additional rule at Sec. Sec. 422.164(f)(1)(iv) and 423.184(f)(1)(iv)
that would exclude any measure that receives a measure-level Star
Rating reduction for data integrity concerns for either the current or
prior year from the improvement measure(s) used for the applicable
contract. The proposed new standard would ensure that the numeric
scores for each of the 2 years are unbiased. If a measure's measure-
level Star Rating receives a reduction for data integrity concerns in
either of the 2 years, the measure would not be eligible to be included
in the improvement measure(s) for that contract.
Below we summarize the comments we received and provide our
responses and final decisions.
Comment: The vast majority of commenters supported our proposal.
Response: CMS appreciates receiving the support for this proposal.
Comment: A few commenters suggested different ideas for how the
improvement measures should be calculated: (1) Use a logarithmic scale
rather than a linear scale; (2) calculate improvement measures for the
display measures and count them in the Star Ratings improvement
measures; (3) modify the hold harmless policy; and (4) weight the
improvement change taking into account how well the contract performed
in the prior year and the increased difficulty to improve at the higher
star levels. A commenter suggested that the improvement measures be
entirely dropped from the Star Ratings, stating they are unnecessary.
Response: CMS appreciates the additional feedback related to
potential enhancements to the improvement measures. However, these
suggestions are outside the scope of the proposed rule. CMS will
consider these suggestions as we contemplate future enhancements.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing the
amendment to how improvement measures are identified and used as
proposed for performance periods beginning on or after January 1, 2020.
[[Page 15765]]
Table 2--Additions and Updates to Individual Star Rating Measures
The measure descriptions listed in the tables are high-level
summaries. The Star Ratings measure specifications supporting document,
Medicare Part C & D Star Ratings Technical Notes, provides detailed
specifications for each measure. Detailed specifications include, where
appropriate, the identification of a measure's: (1) Numerator; (2)
denominator; (3) calculation; (4) timeframe; (5) case-mix adjustment;
and (6) exclusions. The Technical Notes document is updated annually.
In addition, where appropriate, the Data Source descriptions listed in
this table reference the technical manuals of the measure stewards. The
annual Star Ratings are produced in the fall of the prior year to
assist beneficiaries in choosing their health and drug plan during the
annual open enrollment. For example, Star Ratings for the year 2022 are
produced in the fall of 2021.
1. If a measurement period is listed as `the calendar year 2 years
prior to the Star Ratings year' and the Star Ratings year is 2022, the
measurement period is referencing the January 1, 2020 to December 31,
2020 period.
2. For CAHPS, HOS, and HEDIS/HOS measures, the measurement period
is listed as `most recent data submitted for the survey of enrollees.'
See measure stewards' technical manuals, as referenced in Data Source
column, for the specific measurement periods of the most recent data
submitted.
Table 2A--Updates to Individual Star Rating Measures for Performance Periods Beginning on or After January 1, 2020
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical method Reporting
Measure Measure Domain Measure category Data source Measurement period NQF endorsement for assigning star requirements
description and weight ratings (contract type)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Part C Measure
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Controlling Blood Pressure (CBP) Percent of plan Managing Chronic Intermediate HEDIS *........... The calendar year #0018............. Clustering........ MA-PD and MA-only.
members 18-85 (Long Term) Outcome Measure 2 years prior to
years of age who Conditions. Weight of 3. the Star Ratings
had a diagnosis year.
of hypertension
(HTN) and whose
blood pressure
was adequately
controlled (<140/
90).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Part D Measure
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
MPF Price Accuracy.............. A score comparing Drug Safety and Process Measure PDE data, MPF The calendar year Not Applicable.... Clustering........ MA-PD and PDP.
the prices Accuracy of Drug Weight of 1. Pricing Files. 2 years prior to
members actually Pricing. the Star Ratings
pay for their year.
drugs to the drug
prices the plan
provided for the
Medicare Plan
Finder website.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* NCQA HEDIS Technical Specifications, Volume 2.
Table 2B--Updates to Individual Star Rating Measures for Performance Periods Beginning on or After January 1, 2021
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Statistical method Reporting
Measure Measure Domain Measure category Data source Measurement period NQF endorsement for assigning star requirements
description and weight ratings (contract type)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Part C Measure
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Plan All-Cause Readmissions Percent of acute Managing Chronic Intermediate HEDIS *........... The calendar year #1768............. Clustering........ MA-PD and MA-only,
(PCR). inpatient stays (Long Term) Outcome Measure 2 years prior to except for 1876
that were Conditions. Weight of 3. the Star Ratings Cost Plans.
followed by an year.
unplanned acute
readmission or an
observation stay
for any diagnosis
within 30 days,
for members ages
18 and over.
Rates are risk-
adjusted.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* NCQA HEDIS Technical Specifications, Volume 2.
Below we summarize additional comments CMS received on measures
that were not part of the proposed rule and provide our responses. CMS
appreciates the additional feedback related to potential enhancements
to measures and will take this feedback into consideration as we make
future measure enhancements.
Comment: Commenters requested measure updates for and possible
removal of the following measures: Annual Flu Vaccine, Osteoporosis
Management in Women who had a Fracture, and Rheumatoid Arthritis
Management. CMS also received requests for updates to the following
measures: Getting Needed Care, Getting Appointments and Care Quickly,
and Members Choosing to Leave the Plan. Some of the comments indicated
these measures need additional specifications and exclusions,
especially for the Puerto Rican population. Another commenter further
suggested the need for measures specifically designed for the advanced
illness populations.
Response: These comments are outside of the scope of the proposed
and final rules. Where appropriate CMS will share all measure
specification suggestions, including concerns about additional measure
exclusions and the design of measures specifically for the advanced
illness populations, with the appropriate measure stewards.
[[Page 15766]]
Comment: A commenter suggested that for the Part D Appeals Auto-
Forward measure the minimum enrollment size for a plan to be eligible
for this measure be raised or that plans having fewer than two auto-
forwards be exempted from reporting. Another commenter suggested that
CMS combine the call center sampling for the Part C and Part D Call
Center Foreign Language Interpreter and TTY Availability measures.
Response: These suggestions are outside the scope of the proposed
and final rules; however, we will take them into consideration as we
contemplate future enhancements.
Comment: For the measures Complaints about Health/Drug Plans, a
commenter stated these measures should be modified due to complaints
arising from restricting beneficiaries' access to opioids.
Response: This suggestion is outside the scope of the proposed and
final rules; however, we will take it into consideration as we
contemplate future enhancements. In addition, prior to use in the Star
Ratings, complaints are reviewed for resolution by plans' and CMS
Regional caseworkers. If necessary, a complaint may be labeled as a CMS
issue, and thus excluded from the Complaints Star Rating measure.
Please note however that not all opioid related complaints should be
considered to be ``CMS issues''; for example, a complaint that a plan
did not properly implement opioid safety edits, or did not follow Part
D requirements for coverage determinations/appeals would remain
included in a plan's complaints measure data.
Comment: A few commenters suggested the measure weights for both
the CAHPS and HOS measures should be reduced.
Response: In the April 2018 final rule, CMS codified, at Sec. Sec.
422.166(e)(1) and 423.186(e)(1), the general rules for assigning
measures the weight associated with their category. Changes to that
policy are out of scope for the proposed and final rules.
Comment: A few commenters suggested electronic survey
administration and electronic submission of hybrid measures to reduce
provider burden and paperwork.
Response: These comments are outside of the scope of the proposed
and final rules. CMS also supports the move to more electronic modes of
data collection. CMS will be soliciting comment in an OMB Paperwork
Reduction Act (PRA) package as CMS plans to test the web mode of survey
administration across various CMS surveys. NCQA has also developed
HEDIS Electronic Clinical Data Systems (ECDS) to support obtaining
information that is currently available in electronic clinical datasets
for HEDIS quality measures.
Comment: A commenter suggested that given the changes with the
implementation of section 17006 of the Cures Act, CMS should begin to
consider one or more ESRD quality measures specific to ESRD
beneficiaries, home dialysis, and/or education about home dialysis.
Response: These comments are outside of the scope of the proposed
and final rules. CMS has begun to consider what measures will
potentially be relevant for ESRD beneficiaries. We are following the
work NCQA will be doing with the National Kidney Foundation to develop
a provider-level measure focused on screening for nephropathy in
patients with diabetes. This work may inform potential updates/changes
for the plan-level measure in HEDIS. We are also following the quality
measurement work in the Comprehensive ESRD Care (CEC) Model test to see
if any of those measures will be relevant. We are open to suggestions
for additional measures.
Comment: A commenter suggested developing measures that reflect
care for under-65 populations who are Medicare-eligible due to
disability and that, while also being consistent with the Medicare Star
Ratings methodology, the measures also reflect complex medical
conditions that these individuals have. To bolster the ability of
states and others to analyze data across various factors and programs,
the commenter also requested CMS provide access to data at levels below
the contract and disaggregated.
Response: These comments are outside of the scope of the proposed
and final rules. CMS appreciates the importance of measuring plan
performance in serving the under-65 population and the comment
explaining why. To allow comparisons below the level of the contract
and/or disaggregated in other ways may be challenging, since valid and
reliable comparisons at those levels could be very burdensome to plans
or may not be possible. However, CMS has and will continue to explore
ways to address the needs of states and others to assess care for
subpopulations.
Comment: A commenter suggested CMS focus more on outcome measures
than on process measures.
Response: These comments are outside of the scope of the proposed
and final rules. CMS agrees with the importance of focusing on outcome
measures and welcomes all suggestions for potential outcome measures as
additions to the Star Ratings.
Comment: CMS received a request for additional discussions of how
MA and FFS/ACO regulations can be similarly constructed to streamline
provider compliance and beneficiary understanding. CMS received a
request to publicly post measure guides (for example, Patient Safety
Report User Guides) in addition to the Star Ratings Technical Notes.
The commenter referenced as an example CMS's use of member months in
the Statin Use in Persons with Diabetes (SUPD) measure which differs
from the PQA measure specifications, and that additional information
would help improve consistency in sponsors' quality improvement
efforts. Currently, more detailed information is included in the
Patient Safety Report User Guides compared to the Star Ratings
Technical Notes.
Response: CMS appreciates suggestions for standardizing measures
and regulations across programs. CMS is currently working to ensure
consistency of measure specifications across programs where applicable.
CMS will consider these suggestions as we contemplate future
enhancements.
CMS also agrees about the importance of transparency in CMS's
calculation of Star Ratings. Sponsors and their authorized users may
access the Patient Safety User Guides through the Patient Safety
Analysis website set up by CMS for Part D sponsors to have access to
monthly Patient Safety Reports to compare their performance to overall
averages and monitor their progress in improving the prescription drug
patient safety measures. We will consider options to either publicly
post the Patient Safety Report User Guides or incorporate additional
details in the Star Ratings Technical Notes. The commenter's reference
of CMS using member months in the SUPD measure is an example of a
modification necessary to fairly evaluate performance of Part D
sponsors. The member-years of enrollment adjustment is used to account
for beneficiaries who are enrolled for only part of the contract year.
The measure is weighted based on enrollment since beneficiaries with
longer enrollment episodes account for more member-years and therefore
have a larger impact on a contract's rates. Each episode of enrollment
is considered separately.
Comment: A commenter suggested CMS use the Net Promoter Score (NPS)
rather than CAHPS measures.
Response: These comments are outside of the scope of the proposed
and final rules. CMS disagrees that the NPS
[[Page 15767]]
should replace the CAHPS measures. NPS was developed to measure
customer loyalty and does not provide information about why a customer
may recommend a brand or product. Unless an organization is collecting
supplemental information, NPS scores will not help drive quality
improvement. Among proponents of the NPS score, there is agreement that
additional feedback needs to be collected from customers.\37\ This
score alone is not sufficient. MA and Part D contracts can collect for
their own purposes a limited number of supplemental survey items on the
CAHPS surveys if they add them to the end of the survey. Some contracts
do add similar questions to the NPS item to the current CAHPS surveys
for their own internal purposes. There are multiple concerns about
using the NPS score instead of CAHPS, including that the score may mask
important differences in performance between organizations and the
score is more volatile and less reliable than a composite measure that
includes multiple survey questions.
---------------------------------------------------------------------------
\37\ https://aishealth.com/medicare-and-medicaid/nps-is-viewed-as-useful-but-not-best-as-sole-satisfaction-measure-for-ma-plans/.
---------------------------------------------------------------------------
Summary of Regulatory Changes
No changes are being finalized based on these comments that are out
of scope of the proposed rule.
(5) Data Integrity (Sec. Sec. 422.164(g), 423.184(g))
In the April 2018 final rule (83 FR 16562), CMS codified, at
Sec. Sec. 422.164(g)(1)(iii) and 423.184(g)(1)(ii), a policy to make
scaled reductions to the Star Ratings for a contract's Part C or Part D
appeals measures because the relevant Independent Review Entity (IRE)
data are not complete based on the Timeliness Monitoring Project (TMP)
or audit information. The reduction is applied to the measure-level
Star Ratings for the applicable appeals measures. We proposed to add a
provision at Sec. Sec. 422.164(g)(1)(iii)(O) and 423.184(g)(1)(ii)(M)
that would assign a 1-star rating to the applicable appeals measure(s)
if a contract fails to submit TMP data for CMS's review to ensure the
completeness of their IRE data. We explained in the proposed rule that
we believe it is appropriate to assume that there is an issue related
to performance when the MA organization or Part D plan sponsor has
refused to provide information for the purposes of our oversight of the
compliance with the appeals requirements. We also explained how our
proposal to modify measure-specific ratings due to data integrity
issues is separate from any CMS compliance or enforcement actions
related to a sponsor's deficiencies; these rating reductions are
necessary to avoid falsely assigning a high star to a contract,
especially when the MA organization or Part D sponsor has refused to
submit data for us to evaluate performance in this area and to ensure
that the data submitted to the IRE are complete.
Below we summarize the comments we received and provide our
responses and final decisions.
Comment: Most commenters supported the downgrade to one star if a
contract fails to submit TMP data for CMS's review to ensure the
completeness of the IRE data. A commenter suggested that a reduction
should only occur when there is a complete failure to submit TMP data
for CMS review.
Response: CMS appreciates the support of the data integrity
policies. To fully assess the completeness of the appeals data, the TMP
data need to be complete and submitted in a timely manner. The data
integrity policies align with our commitment to data quality and
preserve the integrity of the Star Ratings. CMS designed the data
integrity policies to distinguish between occasional errors and
systematic issues. This policy and these rating reductions are
necessary to avoid falsely assigning a high Star Rating to a contract,
especially when deficiencies have been identified that show CMS cannot
objectively evaluate a sponsoring organization's performance in an
area.
Comment: A commenter questioned whether the proposal is only
referring to the Appeals Auto-Forward measure as the Part D appeals
measure.
Response: The data assignment of one star is for both the appeals
timeliness and upheld measures for Part C and Part D. If a contract
does not submit the TMP data for the Part C measures, Plan Makes Timely
Decision about Appeals (Part C) and the Reviewing Appeals Decisions
(Part C), both will receive reductions. The same policy applies to the
two Part D appeals measures, Appeals Auto-Forward (Part D) and Appeals
Upheld (Part D).
Comment: Many commenters generally opposed scaled reductions,
characterizing them as ``data integrity penalties'' using TMP and audit
data, and a commenter supported use of audits and TMP data for scaled
reductions. The commenters that were opposed stated these data
integrity findings are not a reflection of the plan's quality. Others
stated that the TMP is burdensome due to an additional requirement that
they need to budget for and manage. A commenter opposed use of audits
because they believe there could be auditor subjectivity (varying
interpretation of the same issue) and changes in the audit process.
Many commenters gave recommendations for the TMP or requested
clarifications on the process of scaled reductions. A couple of
commenters recommend consolidating auditing and/or TMP efforts with
other requirements and offered suggestions such as eliminating the TMP
and modifying the Part D reporting requirements and Technical
Specifications for Coverage Determinations and Redeterminations reports
to collect the same or similar data to confirm the accuracy of IRE
data. A commenter recommended applying the requirements of Executive
Order 13771 on Reducing Regulation and Controlling Regulatory Costs to
fulfill the Star Ratings integrity goal, be operationally less
burdensome for plan sponsors, and also save CMS and the Part D program
the amount it paid for the TMP audit in 2017 and 2018. A commenter
requested that CMS provide its methodology for determining which cases
are in scope for scaled reductions. Another commenter requested CMS
wait a minimum of 2 calendar years to use the findings in a
``punitive'' manner to allow the plans to adapt to the process. And a
commenter suggested CMS examine methods to simplify appeals
administration language and address areas of subjectivity identified
within the guidelines that result in differing interpretations.
Response: As explained in the proposed rule, the use of the data
downgrade is not a penalty or punitive but a necessary measure to
reflect how the data underlying the measure are not reliable and to
avoid false high ratings on these measures where the sponsoring
organization has failed to provide the data necessary to ensure that
performance is accurately reflected on these measures. As we explained
in the April 2018 final rule at 83 FR 16562, all measures and the
associated data for the Star Ratings have multiple levels of quality
assurance checks. Our longstanding policy has been to reduce a
contract's measure rating if we determine that a contract's data are
incomplete, inaccurate, or biased. If there are data issues, we cannot
accurately measure quality and performance. The data downgrade policy
was adopted not as a penalty but to address instances when the data
that will be used for specific measures are not reliable for measuring
performance
[[Page 15768]]
due to their incompleteness or biased/erroneous nature. For instances
where the integrity of the data is compromised because of the action or
inaction of the sponsoring organization (or its subcontractors or
agents), this policy reflects the underlying fault of the sponsor and
without it sponsoring organizations could ``game'' the Star Ratings and
merely fail to submit data that illustrate poor performance. Not only
is accepting biased data from a sponsor not fair to other organizations
that follow rules and have procedures in place to properly handle
appeals, but it is also not fair to beneficiaries, as they would
receive inaccurate information on the plan's performance regarding its
handling of appeals. The use of TMP data for scaled reductions of the
appeals measures was finalized in the April 2018 final rule. In this
CY2020 rulemaking, CMS only proposed a reduction to one star for the
applicable appeals measures for the contracts that do not submit any
TMP data but did not reopen for comment the entire provision regarding
use of TMP data or scaled reductions as a whole. Therefore, while CMS
appreciates this feedback related to the TMP and scaled reductions in
general, these comments are outside the scope of the proposed rule; CMS
will consider these suggestions as we make future enhancements.
Comment: A commenter stated the additional change modifies the
appeals measures from a timeliness measure to a timeliness and data
integrity measure.
Response: CMS disagrees with this assertion. The proposed addition
to the scaled reductions for not submitting TMP data is not a
modification to the appeals measures but a mechanism to ensure that the
data used for evaluating performance on a measure are accurate,
complete, and unbiased. If a contract does not submit TMP data, CMS
does not have information to assess the completeness of the data used
for these measures. The data used for CMS's Star Ratings must be
reliable, meaning that they are accurate, complete, and without bias.
CMS has historically identified issues with some contracts' data and
has taken steps to protect the integrity of the data and the Star
Ratings; publishing Star Ratings that are not an accurate reflection of
plan performance would not be consistent with CMS's statutory
obligation to provide comparative information to beneficiaries under
section 1851(d) of the Act or with the goals of the Quality Payment
Bonus under section 1853(o) of the Act. Our longstanding policy has
been to reduce a contract's measure rating if we determine that a
contract's measure data are incomplete, inaccurate, or biased.
Determinations that data are inaccurate or biased may result from the
mishandling of data, inappropriate processing, or implementation of
incorrect practices.
Comment: A few commenters noted that there is a short window for
the plans to submit TMP data and that results are not shared until 9
months later. A few commenters requested that plans be provided with
TMP results in advance of the first plan preview period. A commenter
requested that if CMS chooses to continue the TMP process, CMS should
hold the auditor accountable for providing at least a draft audit
report within 30 days.
Response: CMS appreciates this feedback. As described in the
December 21, 2018 HPMS memo entitled 2019 Timeliness Monitoring Project
(TMP), the data collection is done in three waves beginning in January
2019. CMS receives initial TMP results at the end of Spring 2019, and
then analyzes each contract's data to apply the scale reductions as
required by Sec. Sec. 422.164(g)(1)(iii) and 423.184(g)(1)(ii); where
the applicable regulation does not require a reduction, no reduction is
taken. There are no draft TMP reports. CMS will again provide TMP
results and scaled reduction information in the first plan preview and
sponsoring organizations may submit any questions or comments if they
believe they should not have received a reduction. CMS will consider if
it is operationally feasible to make these data available any earlier
in future years. CMS strongly recommends sponsoring organizations being
proactive in adopting policies to ensure that data are accurate,
complete, and unbiased, and that the data integrity downgrades are not
applicable to them.
Comment: A commenter did not support the proposal to reduce to one
star for not producing the TMP data citing that CMS should ensure that
the Star Ratings system is focused on improving quality of care
received by beneficiaries instead of incorporating ``penalties'' on
plans for compliance purposes. Another commenter supported the proposal
to reduce to one star if a contract fails to submit TMP data but stated
that reducing the Star Ratings for data integrity errors confuses
quality measurement with compliance and audit activities. The commenter
stated that a plan that is ``penalized'' through compliance audits
should not be ``penalized'' a second time through the Star Ratings,
which should be focused on clinical quality and beneficiary
satisfaction.
Response: CMS agrees that the Star Ratings should be focused on
improving the quality of care provided by health and drug plans, but in
order to ensure that the Star Ratings can focus on that, the data used
to measure performance in CMS's Star Ratings program must be accurate,
complete, and unbiased. We reiterate that (1) the reductions required
by Sec. Sec. 422.164(g) and 423.184(g) are not a penalty but a means
to reflect how the sponsoring organization has not produced accurate,
complete, and unbiased data for purposes of performance measurement and
(2) that our proposal was on the narrow issue of addressing the failure
of a sponsoring organization to submit TMP data so that CMS could
evaluate if the data integrity provision would require a scaled
reduction in certain appeals measures. Our longstanding policy has been
to reduce a contract's measure rating if we determine that a contract's
data are inaccurate, incomplete, or biased. If there are data issues,
we cannot accurately measure quality and performance. Public postings
of the Star Ratings data use a notice that CMS has identified issues
with a plan's data in lieu of the actual rating for a measure; this
notice is used when CMS has determined that inaccurate, incomplete, or
biased data (such as resulting from the mishandling of data,
inappropriate processing, or implementation of incorrect practices) has
had an impact on the measure score. The number of stars applied to the
measure will be governed by Sec. Sec. 422.164(g) and 423.184(g), which
address scaled reductions to appeals measures based on an analysis of
TMP or audit data and to one star for HEDIS measures and other measures
based on NCQA audits, lack of compliance with CMS data validation
policies, and other means to identify data integrity issues. The data
integrity policies align with our commitment to data quality and
preserve the integrity of the Star Ratings. CMS designed and finalized
these data integrity policies in the April 2018 final rule to
distinguish between occasional errors and systematic issues.
Comment: A commenter suggested that if the TMP is used to measure
completeness of data, it should be limited to the data for just one
measure, the Part D Appeals Auto-Forward measure.
Response: The TMP assess the completeness of the IRE data for all
applicable appeals measures which include two Part C and two Part D
appeals measures. The assignment to one star when no TMP data are
submitted is also applied to the applicable appeals measures since data
completeness issues impact the data used for both the timeliness and
upheld
[[Page 15769]]
measures for Part C and Part D. If cases are missing for the timeliness
measure for either Part C or Part D, it would also result in missing
cases for the applicable upheld measure.
Comment: A commenter requested that CMS provide more information on
the impact of cut points if a plan fails to submit their TMP audit
results and the proposal to reduce the plan's rating on the appeals
measures is implemented.
Response: If a contract fails to submit TMP data for CMS's review
to ensure the completeness of their IRE data, the contract receives one
star for the applicable appeals measure(s) under the new regulation
provision we proposed and are finalizing at Sec. Sec.
422.164(g)(1)(iii)(O) and 423.184(g)(1)(ii)(M). Because CMS would have
determined that the data reported as performance under the applicable
appeals measure(s) was inaccurate, incomplete or biased, that data are
not included in the creation of cut points. We base cut points on an
analysis of performance data believed to be accurate, complete, and
unbiased.
Comment: A commenter questioned what happens if a sponsor submits
TMP data late. Their understanding is that currently, because there is
no late submission deadline for submitting TMP data, the result is a
reduction to one star. They sought to understand the impact of
submitting data late under this new provision, and how this provision
differs from the existing one.
Response: Failure to submit data by the deadline or an extension
granted by CMS is failure to submit the TMP data. Under the new
regulation provision we proposed and are finalizing here at Sec. Sec.
422.164(g)(1)(iii)(O) and 423.184(g)(1)(ii)(M), the assignment of one
star for the applicable appeals measures will happen if a contract
fails to submit any TMP data. The December 21, 2018 HPMS memo entitled
2019 Timeliness Monitoring Project (TMP) provides details about data
submission, including the deadlines. Under the current practice, a
sponsor can let CMS know if there is an issue meeting the submission
deadline for the TMP data and CMS can work with the sponsor to
determine if an alternative deadline is feasible. CMS needs adequate
time to analyze the TMP data once submitted to be able to determine the
completeness of the appeals data. If the data are submitted beyond the
deadline or an extension granted by CMS, it is treated as a failure to
submit the TMP data.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing at
Sec. Sec. 422.164(g)(1)(iii)(O) and 423.184(g)(1)(ii)(M) the
assignment of a 1-star rating to the applicable appeals measure(s) if a
contract fails to submit TMP data for CMS's review to ensure the
completeness of the contract's IRE data.
(6) Review of Sponsors' Data (Sec. Sec. 422.166(h), 423.186(h))
At Sec. Sec. 422.164(h)(1) and 423.184(h)(1), CMS proposed to
codify a policy regarding the deadlines for an MA organization or Part
D plan sponsor to request the IRE or CMS to review a contract's appeals
data or CMS to review a contract's Complaints Tracking Module (CTM)
data. For example, information regarding the Part C and Part D appeals
process is available to MA organizations and is updated daily on the
IRE website. Additionally, sponsors can access the Part D Appeals
Reports under the Performance Metrics pages in HPMS. To allow enough
time for the IRE to make any necessary changes to ensure the accuracy
of a contract's measure score, we proposed that requests for CMS or the
IRE to review contract data must be received no later than June 30 of
the following year in order to have time to use accurate information in
the Star Ratings calculations (for example, changes to contract year
2018 appeals data must be made by June 30, 2019 for the 2020 Star
Ratings). Reopenings are not taken into account under this proposed
deadline for corrections to the IRE data. For purposes of the appeals
measures, if a reopening occurs and is decided prior to May 1, the
revised determination is used in place of the original reconsidered
determination. If the revised determination occurs on or after May 1,
the original reconsidered determination is used.
Similarly, we proposed that any requests for adjustments following
CMS's CTM Standard Operating Procedures for the complaints measures be
made by June 30 of the following year in order for the changes to be
reflected in a contract's Star Ratings data (for example, changes to
contract year 2018 complaints data must be made by June 30, 2019 for
the 2020 Star Ratings).
Below we summarize the comments we received and provide our
responses and final decisions.
Comment: Many of the commenters supported a deadline for an MA
organization or Part D plan sponsor to request the IRE or CMS to review
a contract's appeals or CMS to review a contract's CTM data, but they
did not support the proposal of the June 30th date. They all
recommended that the date should be following the first plan preview
stating that the later date would allow plans to fully respond to all
appeals and complaints.
Response: CMS appreciates the feedback and is finalizing our
proposal with a modification that will permit CMS to set the date
annually to allow flexibility each year to determine the date based on
the availability of data for plans to review.
Comment: A commenter noted that the timeframes/deadlines CMS is
proposing do not appear to align with the allotted timeframes CMS
allows for plans and the IRE to re-open decisions. The commenter
proposed CMS review the IRE reopening process and timeframes to ensure
all cases submitted to the IRE, in the measurement plan year, are fully
resolved by the first plan preview period. Additionally, the commenter
recommended that if the IRE does not meet the IRE reconsideration
timeframes, which are outlined in the MAXIMUS Federal Medicare Health
Plan Reconsideration Process Manual, then plans would still be held
accountable for the outcome of the reconsideration but those cases
should not be included in the plan's performance scores since they were
not fully resolved.
Response: Because CMS does not want to implement policies that
promote reopenings, CMS will not adopt the policy the commenter
recommends. Excluding cases that were reopened but do not yet have a
decision would encourage organizations to reopen more cases and
possibly manipulate their ratings. Therefore, if the reopening is not
decided by May 1st, the original reconsideration decision is used in
the measure. Reopenings are supposed to be rare. CMS appreciates the
feedback about the data timeframe for reopenings and will consider this
comment in the future.
Comment: A commenter did not support the data review deadline,
because CMS (and its contractor, MAXIMUS) does not provide full
visibility into the fields that are required to calculate compliance on
an ongoing basis. For example, the commenter pointed out that there is
no timeliness indicator on MAXIMUS' website and as a result, some of
the data cannot be monitored on an ongoing basis for accuracy. Instead,
MA plans must develop a workaround, such as monitoring case dates for
accuracy. Something as simple--and predictable--as a national holiday
where mail is not delivered can result in an incorrect timeliness
measure.
[[Page 15770]]
Response: Although there are enough data provided on the MAXIMUS
website for contracts to determine if a case is late, CMS has worked
with MAXIMUS, the IRE, to add a late indicator on the website for Part
C Appeals data to make it easier for plans to monitor the timeliness of
their cases. This update will further allow plans to request
adjustments to their Part C appeals, if necessary, in a timely manner
before Star Ratings calculations.
Comment: A commenter supported the proposal, but requested a
clarification of the application of the deadline related to CTM data,
because CMS often changes the CTM case status so that cases are no
longer visible and cannot be monitored for accuracy.
Response: We appreciate the support and the opportunity to clarify
which CTM data are used for Star Ratings purposes. For CTM, the
quarterly reports only contain CTM complaints that are used to
calculate the Star Rating CTM measure. If a CTM is not in the report,
the complaint is not considered a plan issue and it would not be
included in the Star Ratings measure. Therefore, sponsoring
organizations may wish to focus their requests for CMS review of CTM
data on the data that are part of the quarterly reports.
Comment: A few commenters supported the proposal but noted that CMS
should publish a schedule of the timing of all related reports, while a
commenter did not support the proposal and requested similarly a
schedule of reports. Additionally, a commenter stated the Part C
MAXIMUS IRE reports are not published and are only made available upon
request to the CMS account manager each quarter.
Response: We appreciate the support and the opportunity to clarify
the timing and availability of the reports which contain data used for
the Star Ratings. Part D appeals and CTM reports are posted in HPMS
quarterly; approximately 2 months following the close of the quarter.
Information regarding the Part C reconsideration process is available
to Medicare Advantage (MA) organizations on the www.medicareappeal.com
website. The data available on this website are updated daily;
therefore, MA organizations that notice discrepancies or have questions
about the data should bring these issues to the attention of the IRE as
they arise. On the website, MA organizations are able to see all the
cases related to a particular plan for the date range they chose and
they are also able to search by case number. MAXIMUS has added a late
indicator to their website to help in the review; therefore, plans
should be able to fully monitor their data throughout the year.
Comment: A commenter supported the codification of deadlines for
requests by an MA organization or Part D plan sponsor to review
contract appeals or Complaints Tracking Module data.
Response: CMS appreciates the support.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
related comments summarized earlier, we are finalizing the provisions
at Sec. Sec. 422.164(h)(1) and 423.184(h)(1) related to the policy
regarding the deadlines for an MA organization or Part D plan sponsor
to request CMS or the IRE to review its' appeals data or CMS to review
its' Complaints Tracking Module (CTM) data with a substantive
modification. We are not finalizing the June 30th deadline in
regulation. To provide more flexibility to set the deadline contingent
on the timing of the availability of data for plans to review, we are
finalizing in this regulation that an MA organization or Part D plan
sponsor may request that CMS or the IRE review its' data, provided that
the request is received by the annual deadline set forth by CMS for the
applicable Star Ratings year. We intend to use the annual Call Letter
or an HPMS memo to set the annual deadline.
e. Extreme and Uncontrollable Circumstances (Sec. Sec. 422.166(i),
423.186(i))
We proposed a policy to address how extreme and uncontrollable
circumstances may have a negative impact on the Quality Star Ratings of
an MA or Part D plan. Extreme and uncontrollable circumstances such as
natural disasters can directly affect Medicare beneficiaries and
providers, as well as the Parts C and D organizations that provide them
with important medical care and prescription drug coverage. These
circumstances may negatively affect the underlying operational and
clinical systems that CMS relies on for accurate performance
measurement in the Star Ratings program, all without fault on the part
of the MA organization or Part D plan sponsor. We proposed to adjust
the Star Ratings to take into account the effects of extreme and
uncontrollable circumstances that occurred during the performance or
measurement period in a manner that would generally hold the affected
contract harmless from reductions in Star Ratings. We proposed to
codify a series of special rules for calculation of the Star Ratings of
certain contracts in certain extreme and uncontrollable circumstances
in paragraph (i) of Sec. Sec. 422.166 and 423.186.
We proposed that the adjustments be tailored to the specific areas
experiencing the extreme and uncontrollable circumstance in order to
avoid over-adjustment or adjustments that are unnecessary. Health and
drug plans can serve enrollees across large geographic areas, and thus
they may not be impacted in the same manner as healthcare providers
such as hospitals or medical centers in specific physical locations. To
ensure that the Star Ratings adjustments focus on the specific
geographic areas that experienced the greatest adverse effects from the
extreme and uncontrollable circumstance and are not applied to areas
sustaining little or no adverse effects, our proposal targeted the
adjustments to specific contracts and further specified and limited the
adjustments.
Below we summarize the comments we received on the disaster
adjustments in general.
Comment: Most commenters supported our proposals to adjust Star
Ratings in the event of an extreme and uncontrollable circumstance.
Response: We thank the commenters for their support of the
proposal, which we are finalizing with some substantive modifications
in this final rule as described below.
Comment: A few commenters requested that CMS delay codifying the
extreme and uncontrollable circumstances policy and continue to assess
and develop the methodology in case additional modifications are
needed. A commenter requested that CMS implement the policy for
measurement year 2018 in order to avoid a temporary lapse in the
application of the proposed policy.
Response: The policy being adopted in this final rule will apply to
the 2022 Star Ratings and beyond, for extreme and uncontrollable
circumstances that begin on or after January 1, 2020. If adjustments
are needed to the policy, CMS will propose them through a future
rulemaking or sub regulatory guidance. The 2020 Call Letter includes
CMS's policy for the 2020 Star Ratings for extreme and uncontrollable
circumstances that occurred in 2018. We decline to delay adoption of
this policy for a future period, because similar procedures were
successfully applied to the 2019 Star Ratings as a result of the
multiple 2017 disasters.
(1) Identification of Affected Contracts
In paragraph (i)(1) of Sec. Sec. 422.166 and 423.186, we proposed
to identify MA
[[Page 15771]]
and Part D contracts affected by extreme and uncontrollable
circumstances during the performance or measurement period that may
have affected their performance on Star Ratings measures or their
ability to collect the necessary measure-level data. Under our
proposal, these ``affected contracts'' are the contracts eligible for
the specified adjustments that take into account the effects of the
extreme and uncontrollable circumstances. For an MA or Part D contract
to be considered an affected contract under our proposal, the contract
would need to meet all of the following criteria:
The contract's service area is within an ``emergency
area'' during an ``emergency period'' as defined in section 1135(g) of
the Act.
The contract's service area is within a county, parish,
U.S. territory or tribal area designated in a major disaster
declaration under the Stafford Act and the Secretary exercised
authority under section 1135 of the Act based on the same triggering
event(s).
A certain minimum percentage (25 percent for measure star
adjustments or 60 percent for exclusion from cut point and Reward
Factor calculations) of the enrollees under the contract must reside in
a Federal Emergency Management Agency (FEMA)-designated Individual
Assistance area at the time of the extreme and uncontrollable
circumstance.
We proposed to identify an area as having experienced extreme and
uncontrollable circumstances if it is within an ``emergency area'' and
``emergency period'' as defined in section 1135(g) of the Act, and also
is within a county, parish, U.S. territory or tribal government
designated in a major disaster declaration under the Stafford Act, and
the Secretary exercised authority under section 1135 of the Act based
on the same triggering event(s) (https://www.phe.gov/emergency/news/healthactions/section1135/Pages/default.aspx). Major disaster areas are
identified and can be located on FEMA's website at https://www.fema.gov/disasters. To ensure the policy is applied to those
contracts most likely to have experienced the greatest adverse effects,
we proposed to narrow it to apply to contracts with a certain minimum
percentage of enrollees residing in an area declared as an Individual
Assistance area because of the disaster declaration. Individual
Assistance includes assistance to individuals and households, crisis
counseling, disaster case management, disaster unemployment assistance,
disaster legal services, and the disaster Supplemental Nutrition
Assistance Program. We explained that our focus on enrollees residing
in counties eligible for Individual Assistance because of a major
disaster was because most Star Ratings measures are based on services
provided directly to beneficiaries in their local area. Health and drug
plans can serve enrollees across large geographic areas, and thus they
may not be impacted in the same manner as healthcare providers such as
hospitals or medical centers in specific physical locations. Therefore,
we proposed to target the adjustments based on extreme and
uncontrollable circumstances to contracts serving beneficiaries who
were eligible for individual and household assistance because of the
disaster declaration.
We further proposed that at least 25 percent or 60 percent of the
enrollees under the contract must reside in Individual Assistance areas
identified because of the extreme and uncontrollable circumstances in
order for the contract to be an affected contract eligible for
adjustments. We explained that this limitation would ensure that the
adjustments are limited to contracts that we believe may have
experienced a real impact from the extreme and uncontrollable
circumstance in terms of operations or ability to serve enrollees. In
calculations for the 2019 Star Ratings, we observed that contracts tend
to have either very few enrollees impacted or most of their enrollees
impacted due to the nature of contracts either covering a broad region
or a localized area; if 1 out of 4 enrollees were impacted during the
period of the year when the disaster hit, we stated our belief that
there would be a small chance that scores may have been impacted. We
proposed to exclude the numeric measure scores from contracts with 60
percent or more enrollees impacted by the extreme and uncontrollable
circumstances from the determination of the cut points and explained it
as a conservative rule that would apply only in cases where a clear
majority or all of the enrollees are impacted. We also explained that
using the Individual Assistance major disaster declaration as a
requirement to identify contracts that would be eligible for
adjustments ensures that the policy applies only when the event is
extreme, meriting the use of special adjustments to the Star Ratings.
We proposed that contracts that do not meet the definition of an
``affected contract'' would not be eligible for any adjustments based
on the occurrence of the extreme and uncontrollable circumstances but
also noted that the criteria to be an affected contract would not be
sufficient to receive all the adjustments we proposed.
Below we summarize the comments we received on the identification
of affected contracts and provide our responses and final decisions.
Comment: Several commenters suggested that CMS commit to being
transparent in how it has applied the regulations, such as which
contracts received adjustments and the impact on the Star Ratings
program. A few stated this would allow sponsors a better understanding
of marketplace performance and reduce inquiries to CMS. A commenter
recommended that CMS announce areas designated as disasters for the
purposes of Star Ratings on a quarterly basis, and another requested
greater specificity on how a plan within a given county would qualify
for the exemption rules. Another commenter requested that data and
analysis on affected contracts be shared with state Medicaid agencies
as this information is relevant to the states, and data sharing reduces
burden on the plans.
Response: Information about which areas are designated in a major
disaster declaration under the Stafford Act and when the Secretary
exercised authority under section 1135 of the Act based on the same
triggering event(s) are all public information we are extracting from
the relevant websites. CMS published the list of relevant 2017
disasters and affected counties in the 2019 Call Letter, and state,
county, and contract enrollment data are publicly available, so
information about affected contracts is already available. We agree
that providing additional information when the adjustments authorized
under Sec. Sec. 422.166(i) and 423.186(i) may be possible. To that
end, CMS plans to provide information identifying contracts that meet
the definition of affected contracts in Sec. Sec. 422.166(i)(1) and
423.186(i)(1). We note that the definition of ``affected contract'' in
these regulations is substantially similar to the definition and
standards CMS used to make similar adjustments in the 2019 Star Ratings
based on disasters that occurred in 2017. For the 2019 Star Ratings,
which were adjusted for the disasters (Hurricanes Harvey, Irma, and
Maria, and the wildfires in California) that occurred during the 2017
performance period, 77 contracts met the 25 percent threshold of
beneficiaries in FEMA-designated Individual Assistance areas at the
time of the disaster. Based on a similar policy to that we are now
codifying in Sec. Sec. 422.166(i) and 423.186(i), affected contracts
reverted to the prior year's rating an average of five times for Part
[[Page 15772]]
C measures and three times for Part D measures. For the 2019 Star
Ratings, 57 contracts met the 60 percent threshold of beneficiaries in
FEMA-designated Individual Assistance areas and had their numeric
values excluded from the clustering algorithm so they did not influence
cut points. CMS will continue to release the list of relevant disasters
and FEMA-designated Individual Assistance counties in the Call Letter
each year after the performance period so contracts know in advance of
the Star Ratings preview periods whether they might be considered an
affected contract based on their service area.\38\
---------------------------------------------------------------------------
\38\ Tables 14 and 15 in the 2020 Call Letter contain a list of
the section 1135 waivers that could affect the 2020 Star Ratings and
Individual Assistance counties from all of the 2018 FEMA major
disaster declarations. https://www.cms.gov/medicare/health-plans/
medicareadvtgspecratestats/announcements-and-documents.html.
---------------------------------------------------------------------------
Comment: A commenter questioned whether requiring affected
contracts to meet all three criteria in Sec. Sec. 422.166(i)(1) and
423.186(i)(1) was too restrictive if it requires a state-level
declaration of emergency and suggested that the third criteria (that
is, Sec. Sec. 422.166(i)(1)(iii) and 423.186(i)(1)(iii)) was most
applicable.
Response: Stafford Act disaster declarations are made by state but
designate specific counties that are affected. Our policy addresses
contracts with service areas in FEMA-designated Individual Assistance
counties. We proposed that for a contract to be considered an affected
contract it would need to meet all three criteria in Sec. Sec.
422.166(i)(1) and 423.186(i)(1). This ensures the extreme and
uncontrollable circumstances policy is limited to contracts that may
have experienced a real impact from the disaster in terms of operations
or ability to serve enrollees. It also ensures that it applies only
when the event is extreme, meriting the use of special adjustments to
the Star Ratings.
Comment: A commenter was concerned that contracts may deliberately
combine contracts with enrollment from a non-disaster area with
enrollment in a disaster area in order to meet the 25 percent threshold
for Star Ratings adjustments and encouraged CMS to implement safeguards
to prevent abuse of the extreme and uncontrollable circumstances
policy.
Response: CMS appreciates this comment and notes that the April
2018 final rule addresses contract consolidations. In particular, for
consolidations approved on or after January 1, 2019 we assign Star
Ratings based on the enrollment-weighted mean of the measure scores of
the surviving and consumed contract(s) so that the ratings reflect the
performance of all contracts (surviving and consumed) involved in the
consolidation. Further, the scenario described by the commenter is
unlikely to occur as contract consolidations are generally approved in
advance; a sponsoring organization would not be able to take advantage
of an extreme and uncontrollable circumstance by subsequently
consolidating contracts.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing the
definition of an affected contract in paragraph (i)(1) of Sec. Sec.
422.166 and 423.186. We are also finalizing the introductory sentence
in paragraph (i) substantially as proposed to establish a rule that in
the event of certain extreme and uncontrollable circumstances, CMS
calculates Star Ratings for affected contracts using the rules
specified in paragraphs (i)(2) through (i)(10). Those specific rules
and the text in paragraphs (i)(2) through (i)(10) are addressed in
sections II.B.1.e.(2) through (10). In finalizing the first sentence of
paragraph (i), we are making a grammatical change to use ``calculates''
in place of ``will calculate.'' We address additional text we are also
finalizing as a new last sentence in the introductory text of paragraph
(i) in section II.B.1.e.(6).
(2) CAHPS Adjustments
For CAHPS, we proposed two different types of special rules for
affected contracts: Exemption from having to administer the CAHPS
survey or adjustments to the Star Ratings on the CAHPS measures if the
affected contract must administer the CAHPS survey. CAHPS measures are
based on a survey conducted early in the year in which the Star Ratings
are released, that is, the year before the year to which the Star
Ratings are applicable. For example, the CAHPS survey in early 2019
will be used for the 2020 Star Ratings, which are released in late
2019, before the annual coordinated election period for 2020.
We proposed at Sec. Sec. 422.166(i)(2)(i) and 423.186(i)(2)(i),
that an MA and Prescription Drug Plan contract, even if it is an
affected contract, must administer the CAHPS survey unless the contract
demonstrates to CMS that the required sample for the CAHPS survey
cannot be contacted because a substantial number of the contract's
enrollees are displaced due to a FEMA-designated disaster in the prior
calendar year and requests and receives a CMS approved exemption. We
explained in the proposed rule our belief that displacement of a
substantial number of the contract's enrollees would make it
practically impossible to contact the required sample for the CAHPS
survey. For an affected contract that receives the exemption from
administering the CAHPS survey, we proposed at Sec. Sec.
422.166(i)(2)(iii) and 423.186(i)(2)(iii) that the affected contract
would receive the prior year's CAHPS measure stars (and corresponding
measure scores).
We proposed that affected contracts with at least 25 percent of
enrollees in FEMA-designated Individual Assistance areas at the time of
the extreme and uncontrollable circumstance would receive the higher of
the previous year's Star Rating or the current year's Star Rating (and
corresponding measure score) for each CAHPS measure (including the
annual flu vaccine measure). For example, for the 2022 Star Ratings for
affected contracts, we would take the higher of the 2021 Star Ratings
or the 2022 Star Ratings for each CAHPS measure. The affected contract
would receive the CAHPS measure score for the corresponding Star Rating
year chosen. We proposed the 25 percent threshold to avoid including
contracts with very few enrollees impacted and explained our belief
that the measure-level scores should not be adjusted for contracts with
very few enrollees impacted by the extreme and uncontrollable
circumstances. We stated that if a small percentage of enrollees were
impacted by an extreme and uncontrollable circumstance, there should
not be a significant impact on measure scores. Comments received on
this specific proposal in Sec. Sec. 422.166(i)(2) and 423.186(i)(2)
are discussed in section II.B.1.e.(6) of this final rule.
(3) HOS Adjustments
For the HOS survey, we proposed to follow similar procedures as
CAHPS but due to the follow-up component of HOS, we proposed that the
adjustment be to the Star Ratings for the year after the completion of
the follow-up HOS survey (that is administered 2 years after the
baseline HOS survey). For example, the 2022 Star Ratings are based on
data collected from April through June 2020 and reflect experiences
over the past 12 months. The data collected in 2021 will be used for
the 2023 Star Ratings, so responses may reflect the impact of 2020
extreme and uncontrollable circumstances and thus, those circumstances
may have an impact on the 2023 Star Ratings.
We proposed at Sec. 422.166(i)(3)(i) that an MA contract, even if
it is an affected contract, must administer the HOS surveys the year
after the extreme and
[[Page 15773]]
uncontrollable circumstance unless the contract demonstrates to CMS
that the required sample cannot be contacted because a substantial
number of the contract's enrollees are displaced due to a FEMA-
designated disaster during the measurement period and requests and
receives a CMS approved exemption. For an affected contract that
receives the exemption from administering the HOS survey, we proposed
at paragraph (i)(3)(iii) that the affected contract would receive the
prior year's HOS and HEDIS-HOS measure stars (and corresponding measure
scores).
We proposed at Sec. 422.166(i)(3)(iv) that affected contracts with
at least 25 percent of enrollees in FEMA-designated Individual
Assistance areas at the time of the extreme and uncontrollable
circumstance would receive the higher of the previous year's Star
Rating or current year's Star Rating for each HOS and HEDIS-HOS measure
(and corresponding measure score) for the Star Ratings 3 years after
the eligible extreme and uncontrollable circumstance. As an example, we
explained that for the 2023 Star Ratings for contracts affected by an
extreme and uncontrollable circumstance in 2020, we would take the
higher of the 2022 or 2023 Star Rating (and corresponding measure
score) for each HOS and HEDIS-HOS measure in applying the proposal.
Comments received on this specific proposal in Sec. 422.166(i)(3) are
discussed in section II.B.1.e.(6).
(4) HEDIS Adjustments
For HEDIS, we proposed that an MA contract, even if an affected
contract, would be required to report HEDIS data to CMS unless the
contract demonstrates to CMS an inability to obtain both administrative
and medical record data required for HEDIS measures due to a FEMA-
designated disaster in the prior calendar year and requests and
receives a CMS approved exemption. We stated in the preamble of the
proposed rule that all contracts in FEMA-designated disaster areas can
work with NCQA to request modifications to the samples for measures
that require medical record review; however, in our proposed regulation
text codifying this ability, we proposed only that ``affected
contracts'' without an exemption from reporting HEDIS data would be
able to seek that kind of modification from NCQA. For affected
contracts that have service areas with at least 25 percent of enrollees
in a FEMA-designated Individual Assistance area at the time of the
extreme and uncontrollable circumstance, we proposed to take the higher
of the previous year's Star Rating or current year's Star Rating (and
corresponding measure score) for each HEDIS measure. For example, for
the 2022 Star Ratings for affected contracts we would take the higher
of the 2021 or 2022 Star Ratings for each HEDIS measure. Comments
received on this specific proposal in Sec. 422.166(i)(4) are discussed
in section II.B.1.e.(6). of this final rule.
(5) New Measure Adjustments
At proposed Sec. Sec. 422.166(i)(5) and 423.186(i)(3), we proposed
to implement a hold harmless provision for new Star Ratings measures if
the inclusion of all applicable new measure(s) brings down the summary
and/or overall rating. That is, for affected contracts with at least 25
percent of enrollees in a FEMA-designated Individual Assistance area at
the time of the extreme and uncontrollable circumstance, all the new
measures would be excluded from the calculation of the summary and/or
overall rating if their inclusion brings a contract's summary (or in
the case of MA-PD contracts, the overall) rating down. Comments
received on this specific proposal in Sec. Sec. 422.166(i)(5) and
423.186(i)(3) are discussed in section II.B.1.e.(6). of this final
rule.
(6) Other Star Ratings Measure Adjustments
For all other measures for affected contracts with at least 25
percent of enrollees in a FEMA-designated Individual Assistance area at
the time of the extreme and uncontrollable circumstance (that occurs
during the measurement or performance period), we proposed to take the
higher of the previous or current year's measure Star Rating (and then
use the corresponding measure score), as described at proposed
Sec. Sec. 422.166(i)(6)(i) and 423.186(i)(4)(i). For example, for the
2022 Star Ratings for affected contracts, we would take the higher of
the 2021 or 2022 Star Ratings. We also proposed to exclude from this
adjustment policy the Part C Call Center--Foreign Language Interpreter
and TTY Availability and Part D Call Center--Foreign Language
Interpreter and TTY Availability measures, except for extreme and
uncontrollable circumstances where there are continuing communications
issues related to loss of electricity and damage to infrastructure
during the call center study. We explained the proposed exclusion by
noting that these measures and the underlying performance are
completely in the plan's control and we believed therefore that there
should generally be no impact from the declaration of an extreme and
uncontrollable circumstance on plan performance in these areas.
Below we summarize the comments we received on the proposed rules
at Sec. Sec. 422.166(i)(2) through (6) and 423.186(i)(2) through (4)
for adjustments to CAHPS, HOS, HEDIS, new, and other measures and
provide our responses and final decisions.
Comment: A few commenters requested that we clarify whether our
extreme and uncontrollable circumstances policy is ``best of'' the Star
Rating or measure score. A commenter proposed that we take the higher
of the previous and current year's measure score if the Star Rating is
the same in both years to ensure the higher score is used in the
improvement calculation.
Response: We proposed, for affected contracts as described
specifically in the applicable regulation text, to select the higher of
the current or previous year's measure-level Star Rating and then use
the measure score that corresponds with the year selected with the
higher rating. We proposed this use of the ``higher Star Rating'' rule
for CAHPS, new, and other measures for MA and Part D ratings, and for
HOS and HEDIS measures for MA ratings. We use the Star Rating for the
measure-level comparison because the measure stars are used to
calculate the overall Star Rating and the measure-level cut points can
change each year. We use the corresponding measure scores for
improvement calculations in order to maintain consistency in the years
being compared. Where the higher score does not correspond to the
higher rating, we use the score from the year with the higher Star
Rating for the measure nonetheless. If the Star Rating for a measure is
the same in both years we use the current year's data (that is, Star
Rating and score). We only revert to the previous year's measure Star
Rating if it is higher. The regulation text reflects this rule by
referring to the higher of the previous or current year's Star Rating
(and corresponding measure score) in Sec. Sec. 422.166(i)(2)(iv),
422.166(i)(3)(iv), 422.166(i)(4)(v), 422.166(i)(6)(i),
423.186(i)(2)(iv), and 423.186(i)(4)(i).
Comment: A few commenters were concerned that the 25 percent cutoff
for measure-level adjustments may be inadequate, or that the policy is
biased against larger contracts serving populations spread across
multiple regions.
Response: CMS chose the 25 percent cutoff for measure-level
adjustments because this cutoff avoids including contracts with very
few enrollees impacted by extreme and uncontrollable circumstances. As
explained in the
[[Page 15774]]
proposed rule, we do not believe it would be appropriate to provide an
adjustment to the ratings when fewer than a quarter of the enrollees
covered under the contract are affected by the extreme and
uncontrollable circumstance. If only a small percentage of enrollees is
impacted by a disaster, there should not be a significant impact on
measure scores (and therefore not on Ratings). We disagree that the
policy is biased against larger contracts, since it is applied the same
to all contracts. Further, for contracts with smaller service areas,
the declaration of an emergency and designation of a FEMA-designated
Individual Assistance area in one county might be sufficient to result
in 25 percent or more of the contract's enrollees being in the FEMA-
designated Individual Assistance area whereas a larger contract
covering the same county might only have a small portion of its overall
enrollment in the FEMA-designated Individual Assistance area.
Comment: A few commenters suggested that we instead remove
beneficiaries who live within impacted geographic areas from
measurement calculations. Commenters stated this would ensure that all
affected contracts receive an adjustment that is proportionate with the
level of impact to plan performance, be consistent with other exclusion
criteria used in Star Ratings measures, and ensure that Star Ratings
performance is representative of performance during the measurement
period.
Response: We decline to revise our policy to include this type of
adjustment, either instead or in addition to the adjustments we
proposed and are finalizing in Sec. Sec. 422.166(i)(2) through (6) and
423.186(i)(2) through (4). For many measures, this is not operationally
feasible. For example, this would require modifications to CAHPS and
HOS sampling, as well as to HEDIS reporting requirements. Other
measures do not have beneficiary-level data that could be adjusted.
Comment: Several commenters questioned how CMS will apply the
policy for contracts impacted by disasters in consecutive years. A few
suggested that CMS use the ``higher of'' the current year's Star Rating
and prior year's adjusted Star Rating, or link back to the most recent
year's data not affected by disasters. Another suggested using best of
ratings from periods or sources: Current measurement year performance,
prior year performance, parent organization average performance, or
industry average performance. Other commenters were concerned about old
data being pulled forward each year. A commenter stated a ``higher of''
policy would be inappropriate for consecutive disasters, and that CMS
should treat multiple year-disaster contracts as new contracts, rate
them on a very small set of measures, or base their rating on a small
portion of their service area. A commenter suggested that that CMS drop
the threshold for relief below 25 percent and 60 percent for contracts
that have had two consecutive years of disaster impact. Several
commenters requested that CMS extend the disaster adjustment multiple
years for select regions continuing to recover from a disaster (for
example, Puerto Rico that is still recovering from 2017 hurricanes).
Response: CMS appreciates these comments and acknowledges that our
proposal did not address year-over-year disasters. Given the number of
comments on this topic, we believe it is appropriate to address by
adopting additional provisions specific to this topic. We agree with
commenters that are concerned about looking back too many years for
contracts affected by disasters multiple years in a row, as well as
about including too many measurement periods in 1 year of Star Ratings.
We also must consider operational feasibility, and using different
thresholds for contracts affected by disasters in different ways would
be very complicated for administration and for providing the necessary
transparency to MA organizations, Part D plan sponsors, and
beneficiaries who use and rely on the Star Ratings.
We must balance these concerns about using older data with concerns
about using data based on performance that has been impacted by
consecutive disasters. In striking a balance of these concerns, we are
finalizing a policy for setting the Star Ratings for contracts with at
least 25 percent of enrollees in FEMA-designated Individual Assistance
areas that were affected by disasters that began in one year that were
also affected by disasters that began in the previous year. Under the
regulations we are adopting in this final rule, such multiple year-
affected contracts receive the higher of the current year's Star Rating
or what the previous year's Star Rating would have been in the absence
of any adjustments that took into account the effects of the previous
year's disaster for each measure. For example, if a multiple year-
affected contract reverted back to the 2021 Star Rating on a given
measure in the 2022 Star Ratings, the 2021 Star Rating is not used in
determining the 2023 Star Rating; rather, the 2023 Star Rating is
compared to what the 2022 Star Rating would have been absent any
disaster adjustments. The rule for treatment of multiple year-affected
contracts then does not carry very old data forward into the Star
Ratings for many years. Under this final rule, we will use the measure
score associated with the year with the higher measure Star Rating
regardless of whether the score is higher or lower that year. We are
finalizing this policy to address when contracts are affected by
separate extreme and uncontrollable circumstances that occur in
successive years for the adjustments to CAHPS, HOS, HEDIS, and other
measures. This rule would apply for CAHPS, HOS, HEDIS, new, and other
measures. Therefore, we are adopting new provisions at Sec. Sec.
422.166(i)(2)(v), 422.166(i)(3)(v), 422.166(i)(4)(vi),
422.166(i)(6)(iv), 423.186(i)(2)(v), and 423.186(i)(4)(iv) to include
this rule for how ratings for these measures will be adjusted in these
circumstances.
The issue about whether and how to take into account extreme and
uncontrollable circumstances that occur in successive years also raises
the question of how to address a specific extreme and uncontrollable
circumstance that spans two years. For example, we note that while
Hurricane Maria happened in 2017 and the associated declarations of
emergency under section 1135 of the Act initially happened in 2017,
those declarations extended for some areas into 2018. We did not
propose a specific policy for addressing such situations. We are
finalizing new text at the end of the introductory language of
paragraph (i) of both Sec. Sec. 422.166 and 423.186 to clarify that
the incident start date will be used to determine which year of Star
Ratings could be affected. We believe this clarification is necessary
because, in some cases, the incident period end date may change, which
would make it difficult operationally to determine which Star Ratings
year is impacted. For example, the major disaster declaration (DR-4353)
for the California wildfires was declared January 2, 2018. The incident
period was originally only in December 2017, but it was subsequently
extended by FEMA through January 2018. Limiting adjustments for a
single extreme and uncontrollable circumstance to one year is
appropriate to avoid adversely impacting operational timelines, to
limit impacts on contracts not impacted by disasters, and to preserve
transparency of the Star Ratings for consumers by not using data from
many different measurement years. Further, as we finalized several
years ago, at Sec. Sec. 422.504(o) and 423.505(p), MA organizations
and Part D sponsors must develop, maintain, and implement
[[Page 15775]]
a business continuity plan containing policies and procedures to ensure
the restoration of business operations following disruptions to
business operations which would include natural or man-made disasters,
system failures, emergencies, and other similar circumstances and the
threat of such occurrences. We expect that these business continuity
plans will address many of the issues that would result in an impact on
the performance of an affected contract where there are extreme and
uncontrollable circumstances that occur in successive years or over
more than one performance period.
We note that the proposed rule establishing the exemption for
administering CAHPS (Sec. Sec. 422.166(i)(2)(ii) and
423.186(i)(2)(ii)), administering HOS (Sec. 422.166(i)(3)(ii)), and
reporting HEDIS (Sec. 422.166(i)(4)(ii)) did not specify which type of
affected contract could apply for the exemption. This lack of clarity
also affected the proposed rules in Sec. Sec. 422.166(i)(2)(iii),
422.166(i)(3)(iii), 422.166(i)(4)(iii), and 423.186(i)(2)(iii) that
address how a contract with the exemption would receive the prior
year's CAHPS, HOS, or HEDIS measure Star Rating (and corresponding
measure scores). We clarify here that we intended these specific rules
to apply to affected contracts with at least 25 percent of enrollees in
FEMA-designated Individual Assistance areas at the time of the extreme
and uncontrollable circumstance. In finalizing this policy, we are
using the lowest threshold identified in the definition of affected
contract in paragraph (i)(1)(iii). As a result, the most generous
interpretation of the potential ambiguity of our proposal is being
finalized.
Finally, comments about disasters that began in 2017 are out of
scope of this rule as our proposal and final regulations apply to
adjustments to Star Ratings to take into account extreme and
uncontrollable circumstances that begin on or after January 1, 2020.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing the
methodology for adjustments to CAHPS measures (Sec. Sec. 422.166(i)(2)
and 423.186(i)(2)), HOS and HEDIS measures (Sec. Sec. 422.166(i)(3)
and (i)(4)), new measures (Sec. Sec. 422.166(i)(5) and 423.186(i)(3)),
and other Star Ratings measures (Sec. Sec. 422.166(i)(6) and
423.186(i)(4)) with substantive and non-substantive revisions. The
final regulation text includes the following substantive changes on
measure adjustments:
In Sec. Sec. 422.166(i)(2)(ii) and 423.186(i)(2)(ii) for
CAHPS measures, 422.166(i)(3)(ii) for HOS measures, and
422.166(i)(4)(ii) for HEDIS measures, we are finalizing additional text
to clarify the section applies to affected contracts with at least 25
percent of enrollees in FEMA-designated Individual Assistance areas at
the time of the extreme and uncontrollable circumstance.
In Sec. 422.166(i)(4)(iv), the final regulation text
clarifies that all contracts required to report HEDIS data can work
with NCQA to request modifications to the samples for measures that
require medical record review. While we did not receive comments on
this, CMS realized that the preamble and proposed regulation
inadvertently limited which contracts are eligible to request
modifications to samples from NCQA. We are finalizing corrected
regulation text to eliminate this inadvertent limitation.
In Sec. Sec. 422.166(i)(2)(v) and 423.186(i)(2)(v) for
CAHPS measures, 422.166(i)(3)(v) for HOS measures, 422.166(i)(4)(vi)
for HEDIS measures, and 422.166(i)(6)(iv) and 423.186(4)(iv) for other
Star Ratings measures, we are finalizing regulation text to identify
multiple year-affected contracts as contracts that have at least 25
percent of enrollees in FEMA-designated Individual Assistance areas at
the time of the extreme and uncontrollable circumstance with regard to
separate extreme and uncontrollable circumstances that begin in
successive years. We are finalizing regulation text that a multiple
year-affected contract receives the higher of the current year's Star
Rating or what the previous year's Star Rating would have been in the
absence of any adjustments that took into account the effects of the
previous year's disaster for each measure (using the corresponding
measure score for the Star Ratings year selected).
We noted that the regulation text did not address how this
policy would be applied in the event an extreme and uncontrollable
circumstance occurred during two performance periods. Because in some
cases the incident period end date may change, which would make it
difficult operationally to determine which Star Ratings year is
impacted, we are finalizing regulation text in the introductory
paragraph of (i) of Sec. Sec. 422.166 and 423.186 to clarify that the
start date of the incident period will be used to determine which year
of Star Ratings could be affected, regardless of whether the incident
period lasts until another calendar year.
In addition to these substantive changes, we are finalizing non-
substantive changes in paragraphs (ii)(B) and (iii) of Sec. Sec.
422.166(i)(2), 422.166(i)(3), 422.166(i)(4), and 423.186(i)(2) to
replace ``exception'' with ``exemption'' and refer to the exemption
``described'' elsewhere instead of ``defined'' elsewhere. We are also
making technical revisions to verb tense, and in Sec. Sec.
422.166(6)(i) and 423.186(4)(i) we changed ``then use the corresponding
measure score'' to ``(and corresponding measure score).'' In Sec.
422.166(i)(3)(ii)(A) we added the word ``paragraph,'' and we simplified
the description of Sec. Sec. 422.166(5) and 423.186(3) for clarity.
(7) Exclusion From Improvement Measures
Contracts must have data for at least half of the measures \39\
used to calculate the Part C or Part D improvement measures to be
eligible to receive a rating in each improvement measure. For affected
contracts that revert back to the data underlying the previous year's
Star Rating for a particular measure, we proposed that measure would be
excluded from both the count of measures (for the determination of
whether the contract has at least half of the measures needed to
calculate the relevant improvement measure) and the applicable
improvement measures for the current and next year's Star Ratings as
stated at proposed Sec. Sec. 422.166(i)(7) and 423.186(i)(5). That is,
we proposed to codify the application of our usual rule in these
special circumstances: To receive a Star Rating in the improvement
measures, a contract must have measure scores for both years in at
least half of the required measures used to calculate the Part C
improvement or Part D improvement measures; our proposal to use the
data from the previous year's Star Ratings means that there is no
measure score from the current year's Star Ratings, so the usual rule
would eliminate the measure from consideration. As an example, for
affected contracts that revert back to the 2021 Star Ratings data for a
particular measure for the 2022 Star Ratings, we would exclude that
measure from the count of measures and applicable improvement measures
for the 2022 and 2023 Star Ratings.
---------------------------------------------------------------------------
\39\ See Sec. Sec. 422.164(f) and 423.184(f) for more
information on Part C and Part D improvement measures.
---------------------------------------------------------------------------
Below we summarize the comments we received on the exclusion from
improvement measures and provide our responses and final decisions.
[[Page 15776]]
Comment: A commenter was concerned that CMS's policy would permit
quality improvement measures to be excluded continually when there are
repeated disasters, which they stated would undermine the goals of the
Star Ratings program. A couple of commenters noted that CMS's proposed
policy of using prior year's measure stars (and corresponding measure
scores) could influence its use in the improvement calculation.
Response: We proposed in Sec. Sec. 422.166(i)(7) and 423.186(i)(5)
that any measure that reverts back to the data underlying the previous
year's Star Rating under the rules in paragraph (i) of Sec. Sec.
422.166 or 423.186 is excluded from the improvement calculation. This
would apply to multiple year-affected contracts as well. Most affected
contracts should still receive improvement measure scores since
contracts only need data in half of the measures used to calculate
improvement to receive an improvement measure score. We also clarify in
the final regulations at Sec. Sec. 422.166(i)(7) and 423.186(i)(5)
that contracts affected by extreme and uncontrollable circumstances do
not have the option of reverting to the prior year's improvement
rating. This clarification is necessary because of the new multiple
year-affected contract policy. The improvement rating is based on other
measure data included in the Star Ratings program, so taking the higher
of the two improvement ratings would nullify the calculations and the
application of the disaster policy for the other measures. The
improvement measure calculates how much of the plan's performance
improved or declined from the previous year to the current year.
Allowing affected contracts to revert to the prior year's improvement
measure rating could result in different years of data being used for
the improvement scores and for the measure scores, or different time
periods used for improvement calculations for different contracts. This
would be difficult to operationalize and confusing to consumers.
Therefore, we decline to adopt such an adjustment in this final rule.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing the rule for
calculating the improvement score for affected contracts at Sec. Sec.
422.166(i)(7) and 423.186(i)(5) as proposed with substantive and non-
substantive revisions. We are finalizing a substantive change to
clarify that contracts affected by extreme and uncontrollable
circumstances do not have the option of reverting to the prior year's
improvement rating. We are also making a technical revision to verb
tense.
(8) Missing Data
Except in cases where an exemption was granted as described
earlier, we proposed that for all measures eligible for the extreme and
uncontrollable circumstance adjustment, if an affected contract has
missing data in either the current or previous year (for example,
because of a biased rate or the contract is too new or too small), the
final measure rating would come from the current year. We proposed to
codify this rule at Sec. Sec. 422.166(i)(8) and 423.186(i)(6). For
example, if a contract affected by an eligible 2020 extreme and
uncontrollable circumstance was not granted an exemption for data
collection and does not have sufficient data to receive a measure-level
2022 Star Rating, it would not receive a numeric rating for that
measure for the 2022 Star Ratings regardless of whether it received a
numeric rating in the previous year. Similarly, if an affected contract
has missing measure data in the previous year but received a numeric
rating in the current year, it would receive the current year's rating
for its final measure rating. In both cases, the measure would be
excluded from the contract's improvement score(s) following our usual
rules.
Below we summarize the comments we received on missing data and
provide our responses and final decisions.
Comment: A commenter questioned how CMS will rate contracts
affected by disasters that are too new to be measured.
Response: The missing data policy proposed and codified in this
final rule at Sec. Sec. 422.166(i)(8) and 423.186(i)(6) applies to
contracts that are too new to be measured. As proposed and finalized,
the regulation does not exclude new contracts from its application. We
proposed that except in cases where an exemption was granted as
described earlier, for all measures eligible for the extreme and
uncontrollable circumstance adjustment, if an affected contract has
missing data in either the current or previous year (for example,
because of a biased rate or the contract is too new or too small), the
final measure rating would come from the current year.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing the
methodology for missing data as proposed at Sec. Sec. 422.166(i)(8)
and 423.186(i)(6) as proposed with non-substantive revisions to replace
``will come'' with ``comes'' and ``exceptions'' with ``exemptions.''
(9) Cut Points for Non-CAHPS Measures
Currently, the Star Rating for each non-CAHPS measure is determined
by applying a clustering algorithm to the measures' numeric value
scores from all contracts required to submit the measure. The cut
points are derived from this clustering algorithm. At proposed
Sec. Sec. 422.166(i)(9) and 423.186(i)(7), we proposed to exclude from
this clustering algorithm the numeric values for affected contracts
with 60 percent or more of their enrollees in the FEMA-designated
Individual Assistance area at the time of the extreme and
uncontrollable circumstance. We explained that the exclusion would
ensure that any impact of the extreme and uncontrollable circumstance
on an affected contract's measure-level scores would not have an impact
on the cut points for other contracts. We also explained that, under
our proposal, these cut points calculated for all other non-affected
contracts would be used to assess these affected contracts' measure
Star Ratings. We would compare the affected contract's previous year's
measure Star Ratings to the current year's measure Star Ratings to
determine which is higher, and therefore used for the affected
contract's Star Ratings calculations, as previously discussed. For
example, for the 2022 Star Ratings we would compare the 2021 and 2022
measure Star Ratings for affected contracts.
Below we summarize the comments we received on cut points for non-
CAHPS measures and provide our responses and final decisions.
Comment: Several commenters were concerned that removing affected
contracts from cut point calculations may skew the clustering
methodology or adversely impact plans not affected by disasters, or
that contracts in disaster areas may make less of an effort to improve
on measures. A commenter requested a simulation of what the Star
Ratings would be using this methodology and 2019 data. A commenter
encouraged ongoing evaluation of cut points to ensure they are not
unduly impacted by adjustments for disaster-stricken areas year-over-
year.
Response: We proposed to exclude the performance data of affected
contracts that meet the 60 percent
[[Page 15777]]
threshold (that is, 60 percent or more of the contract's enrollees
reside in a FEMA-designated Individual Assistance area at the time of
the extreme and uncontrollable circumstance) from the data used to set
cut points for non-CAHPS measures. We proposed to limit this rule to
non-CAHPS measures because CAHPS measures use relative distribution and
significance testing rather than clustering to determine Star Ratings
cut points. This rule, codified at Sec. Sec. 422.166(i)(9) and
423.186(i)(7), ensures that any impact of the disaster on their
measure-level scores does not impact the cut points for other
contracts. In our analysis, when affected contracts were removed from
the distribution of measure-level scores, the distribution of the
remaining contracts looked very similar, suggesting that the affected
contracts are randomly distributed among the rating levels. CMS will
continue to review the impact of the extreme and uncontrollable
circumstances policy on the Star Ratings of affected and unaffected
contracts to determine whether any enhancements need to be proposed to
these regulations in the future. Finally, the extreme and
uncontrollable circumstances policy applied in the 2019 Star Ratings
was very similar so existing contracts have access to data on how their
contracts were affected.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing the
methodology for cut points for non-CAHPS measures as proposed at
Sec. Sec. 422.166(i)(9) and 423.186(i)(7) with technical revisions to
the verb tense.
(10) Reward Factor
Similarly, at Sec. Sec. 422.166(i)(10) and 423.186(i)(8), we
proposed that affected contracts with 60 percent or more of their
enrollees impacted would also be excluded from the determination of the
performance summary and variance thresholds for the Reward Factor.
However, these contracts would still be eligible for the Reward Factor
based on the mean and variance calculations of other contracts.
Below we summarize the comments we received on the Reward Factor
and provide our responses and final decisions.
Comment: A commenter supported the 60 percent cutoff for Reward
Factor calculations but was concerned that the number of contracts
excluded from Reward Factor calculations could become significant if
disasters become more frequent.
Response: CMS appreciates the concern about frequency of extreme
and uncontrollable circumstances and will continue to monitor
application of the policy to determine if enhancements are needed.
Summary of Regulatory Changes
For the reasons set forth in the proposed rule and our responses to
the related comments summarized earlier, we are finalizing the
methodology for the Reward Factor as proposed at Sec. Sec.
422.166(i)(10) and 423.186(i)(8) with technical revisions to the verb
tense.
2. Improving Clarity of the Exceptions Timeframes for Part D Drugs
(Sec. Sec. 423.568, 423.570, and 423.572)
In the proposed rule we proposed a change to Part D adjudication
timeframes related to exceptions requests in cases where a prescribing
physician's or other prescriber's supporting statement has not been
received by the plan sponsor. We proposed to limit the amount of time
an exceptions request can be held open in a pending status while the
Part D plan sponsor attempts to obtain the prescribing physician's or
other prescriber's supporting statement. Due to the importance of the
prescriber's supporting statement in the exceptions process, the
adjudication timeframes for a coverage determination that involves an
exceptions request do not begin until the prescribing physician's or
other prescriber's supporting statement is received by the Part D plan.
As we noted in the preamble to the proposed rule, we are seeking to
balance the importance of the plan receiving the prescriber's
supporting statement so that a thorough decision may be made on the
request and having a standard maximum time for notifying an enrollee of
an exceptions request decision. We believe greater certainty in the
exceptions process will be beneficial to enrollees and plans.
We proposed to amend Sec. Sec. 423.568(b), 423.570(d)(1) and
423.572(a) to state that, for an exceptions request, the plan must
notify the enrollee (and the prescribing physician or other prescriber
involved, as appropriate) of its decision no later than 72 hours (or 24
hours in the case of an expedited decision) after receipt of the
prescriber's supporting statement or 14 calendar days after receipt of
the request, whichever occurs first. We invited comments on this
proposal and received the following comments discussed below.
Comment: Several commenters expressed support for the proposed
changes to the Part D exceptions timeframes, citing increased clarity
in the exceptions process, and questioned that CMS finalize the rule as
proposed.
Response: We thank the commenters for their support of our proposal
to add clarity to the exceptions process. We believe the timeframes we
are finalizing in this rule establish clear timeframes for exceptions
requests and strike a balance between timely notification of decisions
to enrollees and affording plan sponsors sufficient time to obtain and
review prescriber supporting statements. As explained more fully below,
we are modifying the proposal based on comments we received requesting
that the process clearly account for circumstances where a prescriber's
supporting statement is received late in the 14 calendar day timeframe.
Under this final rule, if a supporting statement is received by the end
of 14 calendar days from receipt of the exceptions request, the Part D
plan sponsor must notify the enrollee (and the prescribing physician or
other prescriber involved, as appropriate) of its determination as
expeditiously as the enrollee's health condition requires, but no later
than 72 hours (24 hours for an expedited request) from the date the
supporting statement was received. If a supporting statement is not
received by the end of 14 calendar days from receipt of the exceptions
request, the Part D plan sponsor must notify the enrollee (and the
prescribing physician or other prescriber involved, as appropriate) of
its determination as expeditiously as the enrollee's health condition
requires, but no later than 72 hours (24 hours for an expedited
request) from the end of 14 calendar days from receipt of the
exceptions request. In addition to achieving the goal of greater
certainty in the exceptions process, we believe this modified approach
balances protection for beneficiaries with affording plan sponsors
sufficient time to obtain and review prescriber supporting statements.
Comment: Several commenters supported the enhanced clarity of the
proposed rule in establishing a maximum timeframe of 14 days for a plan
sponsor to notify an enrollee of a decision on an exceptions request,
but also believe there is some ambiguity on how to handle cases where a
prescriber's supporting statement is received late in the 14 day period
and questioned whether the plan sponsor would have 72 hours (24 hours
for expedited) from the end of the 14 days period in which to notify an
enrollee of a decision.
Response: We thank commenters for their support for more certainty
in the process and for requesting additional
[[Page 15778]]
clarity on how to handle situations where a prescriber's supporting
statement is received late in the proposed 14 calendar day period. We
agree that if a prescriber's supporting statement is received late in
this 14 calendar day period, the plan sponsor should have adequate time
to review the clinical documentation to determine whether it is
appropriate to approve the exceptions request. After consideration of
these comments, we are establishing the 14 calendar day time period as
the outer limit for receipt of a prescriber's supporting statement. In
all cases, the plan sponsor must notify the enrollee (and prescriber,
as appropriate) of its decision no later than 72 hours (24 hours for
expedited cases) of the date of receipt of the supporting statement. If
the supporting statement is not received by the end of the 14 calendar
days, then the plan sponsor must notify the enrollee (and prescriber,
as appropriate) of its decision no later than 72 hours (24 for
expedited cases) from the end of the 14 calendar days from receipt of
the exception request. Plan sponsors are responsible for making
reasonable and diligent efforts to promptly obtain a prescriber's
supporting statement if the supporting statement is not included with
the request for an exception, so as to avoid the need for an exceptions
request to remain in a pending status for any longer than necessary. We
are finalizing this rule to reflect the policy stated previously.
Comment: A few commenters stated that they believe the proposed
rule is inconsistent with recently released draft manual guidance,
which recommends a 14-day timeframe to receive a supporting statement.
Commenters expressed support for this approach and suggested that the
final rule clearly align with the manual guidance. Commenters also
requested that CMS phase-in the effective dates of the manual guidance
and final rule to allow plans time to implement new procedures. Three
commenters requested a January 1, 2020 compliance effective date.
Response: We agree that plan sponsors should have up to 14 calendar
days in which to attempt to obtain a prescriber's supporting statement.
The prescriber's supporting statement is a key component of the
exceptions process. We believe that allowing up to 14 calendar days for
a plan sponsor to attempt to obtain a supporting statement
appropriately balances the interests of enrollees receiving a timely
decision based on a thorough clinical review of the request and of plan
sponsors having adequate time to review the exceptions request. In all
cases, the enrollee must be notified of the decision as expeditiously
as his or her health condition requires. We emphasize that it is not
our expectation that plan sponsors routinely have exceptions requests
in a pending status for 14 calendar days. When an exceptions request is
received, the plan sponsor is responsible for promptly requesting any
documentation needed to support the request. When a prescriber's
supporting statement is received, the plan must notify the enrollee of
its decision within 72 hours (24 hours for expedited cases) of receipt
of the supporting statement.
In response to the commenters' request that there be alignment
between the approach to Part D exceptions request timeframes taken in
this final rule and the combined Part C & Part D appeals manual
guidance, we agree and believe the modified approach taken in this
final rule aligns with the guidance; however, if additional clarity is
necessary, revisions will be made to the manual guidance. We also agree
with commenters who requested an effective date of January 1, 2020. The
requirements of the final rule are applicable January 1, 2020, and we
believe this applicability date provides plan sponsors adequate time to
implement this regulatory requirement. We expect plans are already
making and notifying enrollees of decisions on exceptions requests
under a similar reasonable timeframe and that changes to plan sponsor
operations will be minimal.
Comment: A commenter recommended CMS work with prescribers to
emphasize the need to submit supporting statements as expeditiously as
possible.
Response: We thank the commenter for the suggestion. We do not have
a direct contractual relationship with prescribers by which we could
influence timely submission of supporting statements, but we will
review our provider tip sheets and other provider communications to
ensure relevant CMS publications convey the importance of a
prescriber's supporting statement in the Part D exceptions process. We
also encourage MA-PDs to communicate the importance of timely
submission of supporting statements in their provider communication
materials.
Comment: We received one comment suggesting we specify that in
addition to notifying enrollees of appeal rights, the MA plan be
required to notify enrollees that they are also entitled to submit a
new exceptions request. The commenter states it would not be
appropriate for an enrollee to be denied a medically necessary and
appropriate exception because an arbitrary deadline has been missed.
Response: Under existing regulations, if a plan sponsor denies the
request because it does not receive timely supporting clinical
documentation, the enrollee (or the prescriber on the enrollee's
behalf) has the opportunity to address the exceptions request on appeal
by submitting documentation that demonstrates the medical necessity of
an exception. The right of an enrollee to request a coverage
determination (which includes an exceptions request) is not
extinguished by a plan sponsor issuing a denial; however, if an
exceptions request is denied, then the appropriate next step is an
appeal, and the plan can review and approve the request for a formulary
or tiering exception on appeal.
Comment: A commenter requested confirmation that this requirement
does not impose an obligation on the plan to do outreach and obtain the
prescriber's supporting documentation within the 14-day timeframe. The
commenter noted that compliance with such a requirement within that
timeframe would be operationally difficult.
Response: We thank the commenter for feedback on the operational
challenges of outreach for the purposes of obtaining the prescriber's
supporting statement within the 14 calendar day timeframe. Under
existing regulatory requirements at Sec. 423.566(a), Part D plans must
have a procedure in place for making coverage decisions. This includes
soliciting necessary clinical documentation. This rule does not change
plan sponsors' obligation for doing outreach for necessary clinical
documentation but, instead, establishes a time limit for a plan
sponsor's attempts to obtain the information. When a Part D sponsor
does not have all of the information it needs to make a coverage
decision, the plan must make reasonable and diligent efforts to obtain
all necessary information, including medical records and other
pertinent documentation, from the enrollee's prescriber within the
applicable adjudication timeframe. For guidance on best practices
related to outreach, please see the February 22, 2017 HPMS memorandum
titled ``Updated Guidance on Outreach for Information to Support
Coverage.'' The memorandum can be found under ``Downloads'' at: https://www.cms.gov/Medicare/Appeals-and-Grievances/MedPrescriptDrugApplGriev/?redirect=/MedPrescriptDrugApplGriev/.
We believe that plans will have ample time to modify, as needed,
their operations related to adjudication timeframes for exceptions in
order to comply with this final rule. We expect plans are already
making and notifying
[[Page 15779]]
enrollees of decisions on exceptions requests under a similar
reasonable timeframe and that changes to plan sponsor operations will
be minimal.
Comment: A commenter suggested that CMS standardize the policy for
14-day tolling followed by the 72 and 24 hour(s) adjudication timelines
across all exceptions requests; including exceptions related to
formulary, tiering, quantity limits, and utilization management. The
commenter also suggested that CMS apply tolling to other types of
coverage determinations.
Response: Based on the comment, there may be some confusion
regarding what types of decisions are covered by this rule. This rule
covers all types of exceptions requests, including tiering and
formulary exceptions (that is, requests for off-formulary drugs and
exceptions to utilization management requirements applicable to
formulary drugs). We appreciate the suggestion, but this rule does not
apply to other types of coverage determinations that do not involve an
exceptions request; for example, a coverage determination where the
enrollee is seeking to satisfy a utilization management requirement,
such as prior authorization.
Comment: A commenter expressed support for our efforts to expedite
the decision making process for beneficiaries, but noted concern about
the potential for denials because providers missed a deadline, or
because the plan lacked the time to review the documentation, causing
beneficiaries to rely on the appeals process. The commenter suggested
CMS require plans read and incorporate documentation as long as it
comes within the deadline.
Response: We appreciate the commenter's concerns about the
potential for denials due to an adjudication deadline. However, we
believe it is important for there to be certainty in the timeframe in
which a plan has to notify an enrollee of its decision. We acknowledge
that there may be circumstances where the plan has to issue a denial
because supporting documentation has not been received in a timely
manner, but we believe this is offset by enhancing certainty in the
process by having clear adjudication timeframes. With respect to the
commenter's suggestion, Sec. 423.566(a) requires Part D plan sponsors
to have procedures for making timely coverage decisions. This includes
soliciting necessary clinical documentation. If a Part D plan sponsor
does not have all of the information it needs to make a coverage
decision, the plan must make reasonable and diligent efforts to obtain
all necessary information, including medical records and other
pertinent documentation, from the enrollee's provider.
Comment: A few commenters stated they support CMS providing
additional clarity, stating the previous ``reasonableness'' standard
may have resulted in longer wait times. However, these commenters
encourage a shorter timeframe, citing a risk of significant delays in
enrollees getting access to needed medication.
Response: We thank the commenters for expressing support for the
proposal to provide additional clarity. While we understand the
commenters' concern about the length of the timeframe for adjudicating
exceptions requests, we are attempting to balance the need to provide a
timely decision with affording plan sponsors sufficient time to attempt
to obtain the prescriber supporting statement and perform the clinical
review necessary to determine if an exception should be granted. Plans
are responsible for attempting to obtain any necessary supporting
documentation and for notifying an enrollee of its decision no later
than 72 hours of receipt of the prescriber's supporting statement (24
hours for an expedited request). Again, it is not our intent in
establishing this timeframe that all exceptions requests be in a
pending status for 14 calendar days but, instead, to establish an outer
limit on the time a case can be pending for receipt of the prescriber's
supporting statement. We agree with the commenters who urged us to
account for circumstances where the supporting statement is not
received promptly following a plan's request for such information from
the prescriber and to allow sufficient time for review of the
supporting clinical documentation. Accordingly, we are modifying our
proposal to account for circumstances where the prescriber's supporting
statement is received late in the 14 calendar day period.
Comment: A commenter suggested CMS consider replacing tolling
altogether in favor of fixed processing timeframes.
Response: Under this final rule, we are retaining the current
regulatory requirement of the plan sponsor notifying the enrollee (and
the prescribing physician or other prescriber involved, as appropriate)
of its determination as expeditiously as the enrollee's health
condition requires, but no later than 72 hours (24 hours for an
expedited request) after receipt of the physician's or other
prescriber's supporting statement. As explained earlier, the
prescriber's supporting statement is a critical aspect of the
exceptions process. Therefore, we are retaining the existing standard
of tying the start of the adjudication timeframe to receipt of the
supporting statement. A plan sponsor cannot adequately assess the
merits of an exceptions request in the absence of the prescriber's
supporting statement. However, we are establishing a maximum timeframe
under which an exceptions request can be held open pending receipt of
the prescriber's supporting statement. If a supporting statement is not
received by the end of 14 calendar days from receipt of the exceptions
request, the Part D plan sponsor must notify the enrollee (and the
prescribing physician or other prescriber involved, as appropriate) of
its determination as expeditiously as the enrollee's health condition
requires, but no later than 72 hours (24 hours for an expedited
request) from the end of 14 calendar days from receipt of the
exceptions request. We believe this approach achieves the goals of
allowing adequate time to obtain the prescriber statement that supports
the exceptions request and establishing greater certainty in the
process by establishing a maximum period of time a request can be held
open.
Based on several comments received, we are finalizing this
provision with modification to account for circumstances where the
prescriber's supporting statement is received late in the 14 calendar
day period. Under this final rule, a Part D plan sponsor must notify
the enrollee (and the prescribing physician or other prescriber
involved, as appropriate) of its determination on an exceptions request
as expeditiously as the enrollee's health condition requires, but no
later than 72 hours (24 hours for an expedited request) after receipt
of the physician's or other prescriber's supporting statement. If a
supporting statement is not received by the end of 14 calendar days
from receipt of the exceptions request, the Part D plan sponsor must
notify the enrollee (and the prescribing physician or other prescriber
involved, as appropriate) of its determination as expeditiously as the
enrollee's health condition requires, but no later than 72 hours (24
hours for an expedited request) from the end of 14 calendar days from
receipt of the exceptions request. We believe this approach achieves
the goal of balancing the importance of the plan receiving the
prescriber's supporting statement so that a thorough review of the
request can be performed and having a maximum time for notifying an
enrollee of a decision so that exceptions requests are not held in a
pending status for an indefinite or unreasonable period of time.
[[Page 15780]]
C. Clarifying Program Integrity Policies
1. Preclusion List Requirements for Prescribers in Part D and
Individuals and Entities in MA, Cost Plans, and PACE
a. Background
In the April 2018 final rule, we removed several provider
enrollment requirements pertaining to the MA and Part D programs. One
requirement, outlined in Sec. 423.120(c)(6), stated that for a
prescription to be eligible for coverage under the Part D program, the
prescriber must have: (1) An approved enrollment record in the Medicare
fee-for-service program; or (2) a valid opt-out affidavit on file with
a Part A/Part B Medicare Administrative Contractor (A/B MAC). A second
requirement, outlined in Sec. 422.222, stated that providers
furnishing health care items or services to a Medicare enrollee who
receives his or her Medicare benefit through an MA organization must be
enrolled in Medicare and be in an approved status no later than January
1, 2019. (The removal of these requirements had been proposed in a
proposed rule published in the Federal Register on November 28, 2017,
titled ``Medicare Program; Contract Year 2019 Policy and Technical
Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-
for-Service, the Medicare Prescription Drug Benefit Programs, and the
PACE Program'' (82 FR 56336) (hereafter referred to as the November
2017 proposed rule).
The overall purpose of Medicare provider enrollment is to prevent
fraud, waste, and abuse, and to protect Medicare beneficiaries, by
allowing CMS to carefully screen all providers and suppliers
(especially those that potentially pose an elevated risk to Medicare)
to confirm that they are qualified to furnish, order, certify, refer,
or prescribe Medicare items, services, or drugs.
During our preparations to implement the Part D and MA enrollment
provisions by the January 1, 2019 effective date, several provider
organizations expressed concerns about our forthcoming requirements.
The principal concern was that the burden of the enrollment process on
the provider community would outweigh the program integrity benefits to
the MA and Part D programs.
Given this, we stated in the April 2018 final rule our belief that
the best means of reducing the burden of the Part D and MA enrollment
requirements without compromising our payment safeguard objectives
would be to focus on prescribers and providers that pose an elevated
risk to Medicare beneficiaries and the Trust Funds. We accordingly
established in the April 2018 final rule an overall policy under which:
(1) Such problematic parties would be placed on a ``preclusion list'';
and (2) payment for Part D drugs and MA services and items prescribed
or furnished by these individuals and entities would be rejected or
denied, as applicable. Among the policies we finalized in the April
2018 final rule were the following:
In Sec. 423.100 (for Part D) and Sec. 422.2 (for MA), we
stated that the term ``preclusion list'' means a CMS-compiled list of,
as applicable, prescribers and providers that:
++ Meet all of the following requirements:
++ The individual or entity is currently revoked from the Medicare
program under Sec. 424.535.
++ The individual or entity is currently under a reenrollment bar
under Sec. 424.535(c).
++ CMS determines that the underlying conduct that led to the
revocation is detrimental to the best interests of the Medicare
program. In making this determination under this paragraph, CMS
considers the following factors:
--The seriousness of the conduct underlying the individual's or
entity's revocation.
--The degree to which the individual's or entity's conduct could
affect the integrity of the Part D or MA program.
--Any other evidence that CMS deems relevant to its determination;
or
++ Meet both of the following requirements:
++ The individual or entity has engaged in behavior for which CMS
could have revoked the individual or entity to the extent applicable if
they had been enrolled in Medicare.
++ CMS determines that the underlying conduct that would have led
to the revocation is detrimental to the best interests of the Medicare
program. In making this determination under this paragraph, CMS
considers the following factors:
--The seriousness of the conduct underlying the individual's or
entity's revocation.
--The degree to which the individual's or entity's conduct could
affect the integrity of the Part D or MA program.
--Any other evidence that CMS deems relevant to its determination.
We revised and added various provisions in 42 CFR part
498, subpart A that permitted individuals and entities to appeal their
inclusion on the preclusion list. Specifically:
++ We added a new paragraph (20) to Sec. 498.3(b) stating that a
CMS determination to include an individual or entity on the preclusion
list constitutes an initial determination.
++ In Sec. 498.5, we added a new paragraph (n) containing the
following provisions:
--In paragraph (n)(1), we stated that any individual or entity
dissatisfied with an initial determination or revised initial
determination that they are to be included on the preclusion list may
request a reconsideration in accordance with Sec. 498.22(a).
--In paragraph (n)(2), we stated that if CMS or the individual or
entity under paragraph (n)(1) is dissatisfied with a reconsidered
determination under paragraph (n)(1), or a revised reconsidered
determination under Sec. 498.30, CMS or the individual or entity is
entitled to a hearing before an administrative law judge (ALJ).
--In paragraph (n)(3), we stated that if CMS or the individual or
entity under paragraph (n)(2) is dissatisfied with a hearing decision
as described in paragraph (n)(2), CMS or the individual or entity may
request review by the Departmental Appeals Board (DAB) and the
individual or entity may seek judicial review of the DAB's decision.
In Sec. 423.120(c)(6)(v) (for Part D) and Sec.
422.222(a)(2) (for MA), we stated that CMS would send written notice to
the individual or entity via letter of their inclusion on the
preclusion list. The notice would contain the reason for this inclusion
and would inform the individual or entity of their appeal rights. We
further stated that the affected party could appeal their inclusion on
the preclusion list in accordance with Part 498.
We stated in Sec. 423.120(c)(6)(iv)(A) that a Part D
sponsor or its Pharmacy Benefit Manager (PBM) must not reject a
pharmacy claim or request for reimbursement for a Part D drug unless
the sponsor has provided the written notice to the beneficiary
described in Sec. 423.120(c)(6)(iv)(B). Under paragraph (iv)(B), the
Part D sponsor or its PBM must:
++ Provide an advance written notice to any beneficiary who has
received a prescription from a prescriber on the preclusion list as
soon as possible but to ensure that the beneficiary receives the notice
no later than 30 days after the posting of the most recent preclusion
list; and
++ Ensure that reasonable efforts are made to notify the prescriber
of a beneficiary who was sent a notice under paragraph (iv)(B).
[[Page 15781]]
We stated in the preamble to the April 2018 final rule
that individuals and entities would only be placed on the preclusion
list upon exhausting their first level of appeal.
In the preamble to the November 2017 proposed rule (82 FR
56446), we stated that if a beneficiary's access to a service, item, or
drug is denied because of the application of the preclusion list to his
or her prescriber or provider, the beneficiary would be permitted to
appeal alleged errors in applying the preclusion list. In the preamble
to the April 2018 final rule (83 FR 16660), however, we stated that if
payment is denied because the prescriber or provider is on the
preclusion list, the beneficiary would not have the right to appeal as
denials due to preclusion are not coverage determinations accompanied
by appeal rights.
We stated in the preamble to the April 2018 final rule (83
FR 16642) that an unenrolled individual or entity would remain on the
preclusion list for the same length of time as the reenrollment bar
that we could have imposed on the individual or entity had they been
enrolled in Medicare and then revoked.
We also stated in that preamble that the preclusion list provisions
in the April 2018 final rule (83 FR 16440) were to become effective on
January 1, 2019.
b. Proposed Changes
In CMS-4185-P, we proposed several changes to our existing
preclusion list policies. These changes, for the most part, stemmed
from further CMS consideration of, and stakeholder feedback on, some of
the provisions we finalized in the April 2018 final rule and the need
for modifications thereto. These proposed provisions, and brief
explanations of the rationale for them, are summarized in this section
of this final rule.
(1) Appeals Process for Individuals and Entities on the Preclusion List
As already mentioned, we stated in the preamble to the April 2018
final rule (83 FR 16662) that individuals and entities would only be
placed on the preclusion list upon exhausting their first level of
appeal. Upon further analysis, we became concerned that there could be
a very lengthy delay before the individual or entity is actually placed
on the list. This is because the individual or entity, under existing
regulations, would be able to first appeal their Medicare revocation
and, if unsuccessful, could then appeal their placement on the
preclusion list (due to the revocation). This is inconsistent with the
principal goal of the preclusion list, which is to prevent payment for
Part D drugs or MA services or items prescribed or furnished, as
applicable, by problematic parties. So as to shorten the timeframe
before a provider is placed on the preclusion list, we proposed the
following regulatory revisions:
In Sec. 423.120(c)(6)(v), we proposed to:
++ Consolidate the existing version of paragraph (v) into a revised
Sec. 423.120(c)(6)(v)(A).
++ Establish a new Sec. 423.120(c)(6)(v)(B) stating that in
situations where the prescriber's inclusion on the preclusion list is
based on a contemporaneous Medicare revocation under Sec. 424.535:
--The notice described in paragraph (c)(6)(v)(A) must also include
notice of the revocation, the reason(s) for the revocation, and a
description of the prescriber's appeal rights concerning the
revocation.
--The appeals of the prescriber's inclusion on the preclusion list
and the prescriber's revocation shall be filed jointly by the
prescriber and, as applicable, considered jointly by CMS under 42 CFR
part 498.
In Sec. 422.222(a)(2), we proposed to do the following:
++ Move the existing version of this paragraph into a new Sec.
422.222(a)(2)(i).
++ Establish a new Sec. 422.222(a)(2)(ii) stating that in
situations where the individual's or entity's inclusion on the
preclusion list is based on a contemporaneous Medicare revocation under
Sec. 424.535:
--The notice described in paragraph (a)(2)(i) must also include
notice of the revocation, the reason(s) for the revocation, and a
description of the individual's or entity's appeal rights concerning
the revocation.
--The appeals of the individual's or entity's inclusion on the
preclusion list and the individual's or entity's revocation shall be
filed jointly by the individual or entity and, as applicable,
considered jointly by CMS under 42 CFR part 498.
In Sec. 498.5(n)(1), we proposed to:
++ Move the existing version of this paragraph to a new Sec.
498.5(n)(1)(i).
++ Establish a new Sec. 498.5(n)(1)(ii)(A) stating that in
situations where the individual's or entity's inclusion on the
preclusion list is based on a Medicare revocation under Sec. 424.535
and the individual or entity receives contemporaneous notice of both
actions, the individual or entity may request a joint reconsideration
of both the preclusion list inclusion and the revocation in accordance
with Sec. 498.22(a).
++ Establish a new Sec. 498.5(n)(1)(ii)(B) stating that the
individual or entity may not submit separate reconsideration requests
under paragraph (ii)(A) for inclusion on the preclusion list or a
revocation if the individual or entity received contemporaneous notice
of both actions.
We believed that these changes would clarify our expectations and
the program procedures concerning the filing of appeals when a party's
placement on the preclusion list is based on a Medicare revocation. We
also stressed that our proposed appeals consolidation would not affect
appeals of OIG exclusions, which are handled through a separate process
outlined in the applicable OIG regulations.
(2) Timing of Addition to the Preclusion List
While, again, we stated in the preamble to the April 2018 final
rule (83 FR 16662) that prescribers and providers would only be placed
on the preclusion list upon exhausting their first level of appeal, we
did not include this language in the regulatory text. We therefore
proposed to do so in CMS-4185-P. Specifically, we proposed in new Sec.
423.120(c)(6)(v)(C)(1) (for Part D) and new Sec. 422.222(a)(3)(i) (for
MA) that, respectively, a prescriber or provider would only be included
on the preclusion list after the expiration of either of the following:
If the prescriber or provider does not file a
reconsideration request under Sec. 498.5(n)(1), the prescriber or
provider will be added to the preclusion list upon the expiration of
the 60-day period in which the prescriber or provider may request a
reconsideration.
If the prescriber or provider files a reconsideration
request under Sec. 498.5(n)(1), the prescriber or provider will be
added to the preclusion list effective on the date on which CMS, if
applicable, denies the prescriber's or provider's reconsideration.\40\
---------------------------------------------------------------------------
\40\ In the April 2018 final rule, we adopted cross-references
in 42 CFR parts 417 and 460 to part 422 so that our MA preclusion
list provisions in that rule would also apply to, respectively, cost
plans (Part 417) and PACE organizations (Part 460). Consistent with
said cross-references, we proposed that our MA preclusion list
provisions in the proposed rule would similarly apply to cost plans
and PACE organizations.
---------------------------------------------------------------------------
Notwithstanding the above, we noted that section 1862(e) of the Act
(42 U.S.C. 1395y(e)) states that no federal health care program payment
may be made for any items or services furnished by an excluded
individual or entity, or directed or prescribed by an excluded
physician. We believed that a failure to add an excluded provider or
prescriber
[[Page 15782]]
to the preclusion list until the expiration of the applicable time
periods in Sec. 423.120(c)(6)(v)(C)(1) (for Part D) and Sec.
422.222(a)(3)(i) (for MA) would be inconsistent with section 1862(e) of
the Act. Accordingly, we proposed in new Sec. 423.120(c)(6)(v)(C)(2)
(for Part D) and Sec. 422.222(a)(3)(ii) (for MA) that an excluded
prescriber or provider would be added to the preclusion list effective
on the date of the exclusion.
(3) Effective Date
We generally proposed that the preclusion list regulatory revisions
and additions addressed in CMS-4185-P would become applicable to MA
organizations (and cost plans and PACE organizations by virtue of
cross-references in parts 417 and 460 to the MA part 422 regulation)
and Part D plans on January 1, 2020, which we believed would give
stakeholders adequate time to prepare for our proposed changes. We did,
however, propose one exception to this, in that the effective date of
our previously mentioned consolidated appeals provisions in Sec. Sec.
423.120(c)(6)(v), 422.222(a)(2), and Sec. 498.5(n)(1) would be 60 days
after their publication in a final rule. This was to ensure that
problematic providers and prescribers were placed on the preclusion
list as soon as possible. We also solicited public comments on whether
some or all of our other proposed preclusion list provisions discussed
in section III.C. of the proposed rule should become effective and
applicable beginning 60 days after the publication date of a final
rule.
We noted that the January 1, 2019 preclusion list effective date
identified in the April 2018 final rule for the provisions finalized in
that rule would remain in place.
(4) Claim Denials and Beneficiary Notification
We stated in the preamble to the April 2018 final rule (83 FR
16440) that, upon CMS' publication of the first preclusion list, once a
prescriber or provider is added to such initial list after the
completion of their first level of appeal, claims would not be impacted
for up to a 90-day period thereafter (82 FR 16667). We explained that
this 90-day period would include--(1) a 30-day period for the plans and
MA organizations to intake the preclusion list data; and (2) a 60-day
period in which the plan or MA organization would--(a) notify the
beneficiary of the prescriber's or provider's preclusion; and (b) allow
time for the beneficiary to transition to a new prescriber or provider.
Once this 90-day period expires, claim denials and rejections would
commence. Yet for all subsequent updates (that is, all updates after
the release of the initial preclusion list), we would not require the
expiration of a 90-day period before claims were denied.
After additional review, we became concerned that beneficiaries
whose prescribers and providers were added to subsequent updates to the
preclusion list would not receive any notice of those additions nor of
the consequences of placement of such providers and prescribers on the
preclusion list. Consequently, we proposed in CMS-4185-P that claim
denials for preclusion list updates, beginning in 2020, would occur
consistent with the following timeframes:
Upon the posting of the updated preclusion list, the Part
D sponsor or MA organization would be required to send notice to the
beneficiary that his or her prescriber or provider has been added to
preclusion list within 30 days of the posting of the updated preclusion
list.
Beginning 60 days after sending the beneficiary notice(s)
described in the previous paragraph, the plan sponsor or MA
organization would deny the prescriber's or provider's prescriptions or
claims. This 60-day period would give beneficiaries time to locate
another prescriber or provider from whom they can receive Part D
prescriptions or MA services and items.
We recognized in the proposed rule that applying this 60 to 90-day
period to subsequent updates (rather than exclusively to the initially
published list) could result in a precluded prescriber or provider
being permitted to continue treating Part D and MA beneficiaries for up
to 3 months without their Part D prescriptions or MA claims being
denied. However, we believed that the prevention of potentially serious
dangers to the health and safety of Medicare beneficiaries that could
ensue if they are without crucial medications for an extended period
must take precedence.
Although we discussed the delayed claim denial period in the
preamble to the April 2018 final rule, we did not incorporate this
policy into the regulatory text. In addition, while Sec. 423.120(c)(6)
contained certain provisions regarding beneficiary notification about
the preclusion list, there were no such concomitant provisions for MA
in Sec. 422.222. Thus, we proposed to make the following revisions and
additions, as applicable, to Sec. 423.120(c)(6) and Sec. 422.222 in
the April 2018 final rule:
Section 422.222 would be revised as follows:
++ Existing paragraph (a)(1) would be moved to a new paragraph
(a)(1)(i) that would state: ``Except as provided in paragraph
(a)(1)(ii) of this section, an MA organization must not make payment
for a health care item or service furnished by an individual or entity
that is included on the preclusion list, defined in Sec. 422.2.''
++ New paragraph (a)(1)(ii) would state: ``With respect to MA
providers that have been added to an updated preclusion list, the MA
organization must do all of the following:''
++ New paragraph (a)(1)(ii)(A) would state: ``No later than 30 days
after the posting of this updated preclusion list, must provide an
advance written notice to any beneficiary who has received an MA
service or item from the individual or entity added to the preclusion
list in this update.''
++ New paragraph (a)(1)(ii)(B) would state: ``Must ensure that
reasonable efforts are made to notify the individual or entity
described in paragraph (a)(1)(ii) of this section of a beneficiary who
was sent a notice under paragraph (a)(1)(ii)(A) of this section; and''
++ New paragraph (a)(1)(ii)(C) would state: ``Must not deny payment
for a service or item furnished by the newly added individual or
entity, solely on the ground that they have been included in the
updated preclusion list, in the 60-day period after the date it sent
the notice described in paragraph (a)(1)(ii)(A) of this section.''
We noted that, consistent with Sec. 422.224, the prohibition
against paying precluded individuals and entities would include
contracted and non-contracted parties for purposes of the provisions in
Sec. 422.222(a)(1).
Consistent with our proposed changes to Sec. 422.222(a)(1), we
proposed to delete the existing structure of Sec. 423.120(c)(6)(iv),
which we cited previously, and replace it with the following:
++ A new opening paragraph of (c)(6)(iv) would state: ``With
respect to Part D prescribers that have been added to an updated
preclusion list, the Part D plan sponsor must do all of the
following:''
++ Revised paragraph (c)(6)(iv)(A) would state: ``Subject to all
other Part D rules and plan coverage requirements, and no later than 30
days after the posting of this updated preclusion list, must provide an
advance written notice to any beneficiary who has received a Part D
drug prescribed by a prescriber added to the preclusion list in this
update.''
[[Page 15783]]
++ Revised paragraph (c)(6)(iv)(B) would state: ``Must ensure that
reasonable efforts are made to notify the prescriber described in
paragraph (c)(6)(iv) of this section of a beneficiary who was sent a
notice under paragraph (c)(6)(iv)(A) of this section; and''
++ New paragraph (c)(6)(iv)(C) would state: ``Must not reject a
pharmacy claim or deny beneficiary request for reimbursement for a Part
D drug prescribed by the prescriber, solely on the ground that they
have been included in the updated preclusion list, in the 60-day period
after the date it sent the notice described in paragraph (c)(6)(iv)(A)
of this section.''
We mentioned that for providers and prescribers that are both on
the preclusion list and excluded by the OIG, the aforementioned
beneficiary notification process would not be intended to replace or
supplant any existing OIG processes for notifying beneficiaries of
excluded providers or prescribers.
(5) Beneficiary Appeals
We noted earlier that in the preamble to the April 2018 final rule,
we stated that if payment is denied because the prescriber or provider
is on the preclusion list, the affected beneficiary would not have the
right to appeal that denial as denials due to preclusion are not
coverage determinations accompanied by appeal rights. As we did not
include accompanying regulatory text in the April 2018 final rule, we
proposed in CMS-4185-P to add new Sec. 423.120(c)(6)(viii) and Sec.
422.222(a)(4) stating that payment denials based upon, respectively, a
prescriber's or provider's inclusion on the preclusion list are not
appealable by beneficiaries.
(6) Felony Convictions
We proposed in the November 2017 proposed rule to keep unenrolled
prescribers and providers on the preclusion list for the same length of
time as the reenrollment bar that we could have imposed on the
prescriber or provider had they been enrolled and then revoked. While
this policy was finalized in the April 2018 final rule, it was not
included in the regulatory text. Given this, we proposed several
regulatory revisions.
First, we proposed to revise the definitions of ``preclusion list''
in Sec. Sec. 423.100 and 422.2. The current definitions contain two
general categories of parties that could be included on the preclusion
list--(1) prescribers and providers that are currently revoked from
Medicare and are under a reenrollment bar; and (2) prescribers and
providers that have engaged in behavior for which CMS could have
revoked the prescriber or provider to the extent applicable had they
been enrolled in Medicare. While these two categories encompass felony
convictions, we stated in CMS-4185-P that the severity of felonious
behavior warranted the establishment of a third category that is
specific to felony convictions. We therefore proposed to remove felony
convictions from the scope of the first two categories, with the new
third category covering prescribers and providers--regardless of
whether they are or were enrolled in Medicare--that have been convicted
of a felony under federal or state law within the previous 10 years
that CMS deems detrimental to the best interests of the Medicare
program. Recognizing that the facts of each case are different and must
be judged on their own merits, we proposed that CMS would first
consider the following factors before determining whether a
prescriber's or provider's inclusion on the preclusion list is
warranted under our new proposed third category for felony convictions:
(1) The severity of the offense; (2) when the offense occurred; and (3)
any other information that CMS deems relevant to its determination. In
conformity with this change, we also proposed to add an ``or'' to the
regulatory text immediately after the second category in the preclusion
list definitions; this would clarify that a prescriber or provider need
only come within the purview of one of the three categories to be
included on the preclusion list.
Second, we proposed to establish new Sec. Sec. 423.120(c)(6)(vii)
and 422.222(a)(5) that would codify, clarify, and expand upon the
previously mentioned policy concerning the length of a prescriber's or
provider's inclusion on the preclusion list:
In Sec. Sec. 423.120(c)(6)(vii)(A) and 422.222(a)(5)(i),
we proposed that, except as provided in Sec. Sec.
423.120(c)(6)(vii)(C) and (D) and 422.222(a)(5)(iii) and (iv), revoked
prescribers and providers, respectively, would be included on the
preclusion list for the same length of time as the prescriber's or
provider's reenrollment bar.
In Sec. Sec. 423.120(c)(6)(vii)(B) and 422.222(a)(5)(ii),
we proposed that, except as provided in Sec. Sec.
423.120(c)(6)(vii)(C) and (D) and 422.222(a)(5)(iii) and (iv),
unenrolled prescribers and providers, respectively, would be included
on the preclusion list for the same length of time as the reenrollment
bar that we could have imposed on the prescriber or provider had they
been enrolled and then revoked.
In Sec. Sec. 423.120(c)(6)(vii)(C) and
422.222(a)(5)(iii), we proposed that, except as provided in Sec. Sec.
423.120(c)(6)(vii)(D) and 422.222(a)(5)(iv), prescribers and
providers--regardless of whether they are or were enrolled in
Medicare--that are included on the preclusion list because of a felony
conviction would remain on the preclusion list for a 10-year period,
beginning on the date of the felony conviction, unless CMS determines
that a shorter time length of time is warranted. Factors that we would
consider in making such a determination would be: (1) The severity of
the offense; (2) when the offense occurred; and (3) any other
information that CMS deems relevant to its determination.
We mentioned in CMS-4185-P that because our proposed preclusion
list period for felonious prescribers and providers would begin on the
date of the conviction, such parties may actually be included on the
preclusion list for less than 10 years even if CMS imposes the full 10-
year period.
We also explained in CMS-4185-P that the OIG in many cases excludes
providers and prescribers for a period that is longer than the period
permitted for a reenrollment bar under Sec. 424.535(c). We believed
that CMS should keep an excluded provider or prescriber on the
preclusion list at least until the provider or prescriber has been
reinstated by the OIG in order to be consistent with section 1862(e) of
the Act. We thus proposed in new Sec. 423.120(c)(6)(vii)(D) and
422.222(a)(5)(iv) that in cases where a prescriber or provider is
excluded by the OIG, the prescriber or provider remains on the
preclusion list until the expiration of the CMS-imposed preclusion list
period or reinstatement by the OIG, whichever occurs later.
(7) Beneficiary Liability
Consistent with our existing authority under section 1857(e)(1) of
the Act, we proposed to add a new paragraph (g)(1)(iv) to Sec. 422.504
under which the MA organization is required to agree that the enrollee
must not have any financial liability for services or items furnished
to the enrollee by an MA contracted individual or entity on the
preclusion list, as defined in Sec. 422.2 and as described in Sec.
422.222. This provision would be limited to providers under contract
with the MA organization, for we believed this is consistent with the
general applicability and scope of Sec. 422.504 and the ability of the
MA organization to control or
[[Page 15784]]
impose requirements on the health care providers that furnish covered
services and items to enrollees. We stated our belief that proposed
paragraph (g)(1)(iv) would help financially protect beneficiaries from
problematic providers. It would also formally codify this position,
which we expressed in the preamble to the April 2018 final rule but did
not address in the regulatory text.
(8) Technical Correction Concerning the Term ``Individual'' in Sec.
423.120(c)(6)
We also proposed to make technical changes to Sec.
423.120(c)(6)(i), (ii), (iii), and (vi). These paragraphs stated as
follows, respectively:
Except as provided in paragraph (c)(6)(iv) of this
section, a Part D sponsor must reject, or must require its PBM to
reject, a pharmacy claim for a Part D drug if the individual who
prescribed the drug is included on the preclusion list, defined in
Sec. 423.100.
Except as provided in paragraph (c)(6)(iv) of this
section, a Part D sponsor must deny, or must require its PBM to deny, a
request for reimbursement from a Medicare beneficiary if the request
pertains to a Part D drug that was prescribed by an individual who is
identified by name in the request and who is included on the preclusion
list, defined in Sec. 423.100.
A Part D plan sponsor may not submit a prescription drug
event (PDE) record to CMS unless it includes on the PDE record the
active and valid individual NPI of the prescriber of the drug, and the
prescriber is not included on the preclusion list, defined in Sec.
423.100, for the date of service.
CMS has the discretion not to include a particular
individual on (or if warranted, remove the individual from) the
preclusion list should it determine that exceptional circumstances
exist regarding beneficiary access to prescriptions.
Because some states permit pharmacies to prescribe medications
under very specific circumstances, we believed that the use of the term
``individual'' in paragraphs (i), (ii), (iii), and (vi) was too
restrictive. We therefore proposed in paragraphs (i), (ii), and (vi) to
change this term to ``prescriber'' so as to clarify that the prescriber
need not be an individual when these specific circumstances are met. In
a similar vein, we proposed:
In Sec. 423.120(c)(6)(iii) to change the phrase
``individual NPI of the prescriber'' to ``NPI of the prescriber'', and
In paragraph (2)(i) of the definition of ``Preclusion
list'' in Sec. 423.100 (and as reflected in our previously discussed
proposal to revise this paragraph (see section (C)(1)(b)(6) above)) to
change the phrase ``he or she'' to ``prescriber.''
c. Comments Received
We received comments concerning our proposed changes from
approximately 25 commenters. The comments are summarized below,
followed respectively by our responses thereto. They are organized into
general categories, though we note that some comments and responses
involve multiple policy areas.
(1) Claim Denials
Comment: With respect to claim denials, a commenter questioned: (1)
Whether plans should deny all claim types (regardless of origin) when
the claim date of service is equal to or greater than the ``claim
reject date'' (for example, point of service claims; batch claims;
paper claims); and (2) whether the ``claim reject date'' is the date
that CMS will use to edit the PDE. In a similar vein, another comment
questioned whether: (1) Part D plan sponsors should utilize the ``claim
reject date'' (rather than the ``effective date'' field) as the
relevant field for the date when claim rejections begin; and (2) the
``claim reject date'' is the relevant date for when CMS validates the
PDE.
Response: We will be addressing operational issues in guidance as
necessary and appropriate. We note, though, that PDE editing will use
the ``claim reject date.'' (See HPMS memorandum, ``February 2019
Updates to the Drug Data Processing System (``DDPS''),'' dated January
8, 2019 and released January 9, 2019.)
Comment: A commenter stated that if CMS intends for each Part D
plan to separately track a 60-day period after beneficiary notices have
been sent before claim denials can occur, this could create non-
standardized effective dates for claim denials across the industry. The
commenter cited the example of one plan sponsor sending the beneficiary
notice on day 10 and another sending the notice on day 20. The
commenter recommended that CMS standardize the timing of the effective
claim denial date so as to ensure (1) consistency within the industry
and (2) that claim rejects start on the same day for precluded
prescribers.
Response: We respectfully decline to adopt the commenter's
suggestion as a regulatory requirement. Given that Part D plans may
have different internal procedures, different numbers of beneficiaries
to contact, and different operational mechanisms, we believe it is best
to afford them the maximum feasible flexibility in sending out
beneficiary notices. We believe this ensures that all beneficiaries are
provided equal notice and time to find a new provider or prescriber.
However, we do understand the commenter's concerns, and have indicated
a claims denial/reject date on the preclusion file shared with both
Part C and D plans. This date indicates the close of the 90-day period
and the latest point at which claims must deny or reject. We will
diligently monitor the preclusion list's implementation; should we
determine that more uniformity may be necessary, we will consider
addressing the matter in future rulemaking as appropriate.
Comment: Once a provider or prescriber has been added to the
preclusion list and claims from the precluded provider or prescriber
start to be denied, a commenter questioned how CMS expects a Part C
organization determination or Part D coverage determination (submitted
by either a provider on the preclusion list or an enrollee whose
provider or prescriber is on the preclusion list) to be reviewed.
Response: We respectfully believe that this comment may reflect a
misunderstanding of how a point-of-sale rejection is treated in the
Part D program. A rejection of a pharmacy claim at point-of-sale does
not constitute a coverage determination. If a claim is rejected because
the prescriber is on the preclusion list, the appropriate action is for
the enrollee to find another prescriber to prescribe the drug. Further,
as finalized in Sec. 422.222(a)(4), a beneficiary enrolled in an MA
plan (or a cost plan or PACE organization under the incorporation of
the MA regulation into those programs at Sec. Sec. 417.478 and 460.86)
will not be able to appeal a payment denial that is based on an
individual or entity's placement on the preclusion list. The appeal
rights available to an enrollee under 42 CFR part 422, subpart M are
tied to whether a decision by the MA plan is an organization
determination; because there will be no appeal rights for these
denials, we do not believe it is appropriate to characterize denials
that occur solely because of the preclusion list requirements as
organization determinations. We believe that this policy appropriately
balances the need to provide an appeal process to ensure protection of
Medicare beneficiaries and their ability to challenge denials issued by
an MA plan; an MA plan will not have any discretion to pay a precluded
provider where this final rule prohibits payment and an appeal by an
enrollee of a denial of payment to the precluded provider could never
be resolved in the enrollee's favor. Therefore, this is not an issue
that can be resolved through the benefit appeals process set forth at
part
[[Page 15785]]
422, subpart M, under the regulation we are finalizing.
(2) Provider Reinstatement
Comment: Several commenters stated that CMS should explain the
process and timing that will be used when a provider is no longer on
the preclusion list. A commenter sought clarification as to what a
provider record looks like when the provider is reinstated on the file
and how this compares to the original provider record.
Response: The preclusion list file will include a reinstatement
date indicating when a provider or prescriber is no longer precluded.
The reinstatement date will be published upon the provider or
prescriber being reinstated. Records of a provider's or prescriber's
preclusion will not be removed from the file. We will clarify
additional operational details pertaining to these issues in sub-
regulatory guidance.
Comment: A commenter requested confirmation as to whether
reinstated providers will: (1) Be removed from the preclusion list; or
(2) remain in the preclusion list database with a date indicating the
end of their preclusion period.
Response: As already mentioned, records of a provider's or
prescriber's preclusion will not be removed from the preclusion list
file. In such instances, the reinstated provider or prescriber will
remain in the preclusion list database. Upon the prescriber or provider
being reinstated, the reinstatement date will be indicated.
Comment: A commenter questioned whether reinstatement dates will be
provided for each preclusion effective date and, if so, how far in
advance of a provider being reinstated will the date be provided in the
file.
Response: CMS will not provide advance notice regarding a
reinstatement. However, once the provider is reinstated, CMS will
populate a reinstatement date on the file.
Comment: A commenter recommended that CMS clarify: (1) That the
removal of a provider who successfully appeals his or her addition to
the preclusion list would not be retroactive to the date of the
provider's original preclusion; (2) that the MA plan would not be
required to retroactively pay claims for such a provider; and (3) how
MA plans should implement such a provider's removal from the preclusion
list. These suggestions stemmed from several concerns the commenter
raised. First, requiring plans to pay such claims retroactively could
create confusion among members, who may be urged by their precluded
providers to continue to see the precluded provider during the appeals.
Second, members may be liable for cost sharing associated with the re-
submitted claims. Third, plans would face uncertainty in determining
how to pay such claims (for example, at what payment rate), for the
provider contract will likely have been terminated.
Response: We respectfully disagree with the commenter's apparent
request that CMS not reinstate a provider or prescriber back to the
original preclusion date. Providers or prescribers who are successful
upon appeal will be reinstated back to the preclusion effective date.
Once reinstated, the provider would have the option of resubmitting
claims that had been denied during the preclusion period, which would
be eligible for payment by an MA plan under this final rule, using the
plan's rules for claims processing; we are not finalizing a requirement
that an MA plan must waive any claims filing deadlines that may have
elapsed in the time between the date of service and the decision to
reinstate the provider. If a provider is reinstated retroactively,
plans should pay claims that were rejected or denied due to the
preclusion using, again, the MA plan's usual claims processing
procedures; it is, however, the provider's responsibility to resubmit
any rejected or denied claims. If a beneficiary paid out of pocket for
a Part D drug that was rejected based on the prescriber's preclusion,
the beneficiary would have to submit a request for reimbursement. We
will clarify the process for reinstated providers and prescribers to
resubmit claims in sub-regulatory guidance.
Comment: A commenter sought clarification as to how a beneficiary
would know to resubmit a previously rejected claim for reimbursement if
a precluded provider is reinstated retroactively.
Response: We intend to address this issue in sub-regulatory
guidance. While this final rule does not require the Part D or MA plan
to issue additional notices to enrollees about individuals or entities
that have been reinstated after a successful appeal of placement on the
preclusion list, we encourage plans to do so, especially in cases where
placement on the preclusion list was in error.
(3) ``Reasonable Efforts''/Notification
Comment: Several commenters requested clarification as to what the
term ``reasonable efforts'' means in the context of furnishing the
notification to the prescriber as described in Sec.
423.120(c)(6)(iv)(B). A commenter added that various parts of CMS' sub-
regulatory guidance indicate that the ``reasonable efforts''
notification is required but elsewhere state that it is optional; the
commenter recommended that CMS explain the circumstances under which it
is, or may be, required.
Response: The term ``reasonable efforts'' in both Sec.
423.120(c)(6)(iv)(B) and Sec. 422.222(a)(1)(ii)(B) involves the plan
using available contact information it has for a prescriber or provider
to copy them on the notice mailed to the beneficiary. We expect that MA
organizations would always have contact information for their MA-
contracted providers. We acknowledge, however, that they may not have
this data for non-contracted providers (unless the non-contracted
provider submits a claim) and that Part D plan sponsors may not have
this information concerning prescribers of drugs. Given this dilemma,
and to ensure that a proper balance is attained between the importance
of notification and the fact that contact data may be unavailable in
certain circumstances, we are changing the timing and scope of this
notification requirement. We are finalizing Sec. 422.222(a)(1)(ii)(B)
and Sec. 423.120(c)(6)(iv)(B) with the following modifications:
++ The existing versions of these paragraphs will be incorporated
into, respectively, new paragraphs Sec. Sec. 422.222(a)(1)(ii)(B)(1)
and 423.120(c)(6)(iv)(B)(1). The beginning of these respective new
paragraphs, moreover, will state, ``Subject to paragraph
(a)(1)(ii)(B)(2) of this section'' and ``Subject to paragraph
(c)(6)(iv)(B)(2) of this section''.
++ In new paragraphs Sec. Sec. 422.222(a)(1)(ii)(B)(2) and
423.120(c)(6)(iv)(B)(2), we will state that paragraph (B)(1) only
applies upon receipt of a claim from, respectively, a precluded MA
provider (contracted or non-contracted) or upon a prescriber writing a
Part D prescription when: (i) Sufficient contact information is
available; and (ii) the claim is received after the claim denial or
reject date in the preclusion file.
Paragraph (B)(2), in effect, means that the ``reasonable efforts''
requirement in paragraph (B)(1) will apply only if both of the
following conditions are met: (1) The MA organization or plan sponsor
has enough information on file to either copy the provider or
prescriber on the notification previously sent to the beneficiary or
send a new notice informing the provider or prescriber that they may
not see plan beneficiaries due to their preclusion status; and (2) the
claim is received after the claim denial or reject date in the
preclusion file. We believe this second criterion is
[[Page 15786]]
necessary to help clarify the timing of the notification requirement;
it will also help to mitigate instances where a beneficiary mistakenly
receives care from a precluded prescriber.
Comment: A number of commenters opposed the requirement under Sec.
422.222(a)(1)(ii)(B) or Sec. 423.120(c)(6)(iv)(B) that MA
organizations and Part D sponsors ensure that ``reasonable efforts''
are made regarding provider and prescriber notification. Some stated
that this activity should not be the responsibility of MA plans or Part
D plan sponsors; this is because CMS already adequately notifies
providers and prescribers of their placement on the preclusion list and
remains, in the commenters' view, in the best position to continue
doing so. The commenters believed that imposing the requirements of
Sec. 422.222(a)(1)(ii)(B) or Sec. 423.120(c)(6)(iv)(B) on MA plans
and Part D sponsors would thus: (1) Be both duplicative and a further
administrative burden on MA plans and Part D sponsors, involving
thousands of additional letters and unnecessary costs; (2) be
inconsistent with the Patients over Paperwork initiative; and (3) lead
to provider frustration and confusion because the provider would be
receiving multiple notices regarding the same matter. A commenter added
that precluded providers and prescribers are able to identify their
impacted patients and need not receive this information from MA plans
and Part D sponsors; the latter should not bear additional cost and
burden in order to assist problematic providers and prescribers with
managing impacted patients within their practices. Another commenter
stated that with respect to MA non-contracted providers, it is possible
that the services they provided were on an emergency/urgent basis,
rather than for ongoing, routine care; there is, consequently, little
value in MA plans furnishing additional notification under Sec.
422.222(a)(1)(ii)(B) given the limited impact on a ``go-forward''
basis. An additional commenter stated that these notification
requirements have not been imposed with respect to OIG-excluded
providers.
Response: We appreciate the concerns these commenters expressed
regarding the aforementioned requirement. Considering, however, the
plans' role in the daily operational and logistical facilitation of the
Medicare Part C and D programs and their close administrative
relationship with prescribers and providers, we believe that the plans
are best-positioned to communicate with prescribers and providers
regarding their relationships with specific beneficiaries. We mention
also that we have attempted to reduce to burden of this requirement
with our aforementioned revisions to Sec. 422.222(a)(1)(ii)(B) or
Sec. 423.120(c)(6)(iv)(B).
With respect to the final comment, we note that the OIG exclusion
list and the administrative requirements pertaining thereto are
separate from and non-binding on those regarding the preclusion list.
Merely because the OIG regulations lack a requirement concomitant with
Sec. 422.222(a)(1)(ii)(B) or Sec. 423.120(c)(6)(iv)(B) does not
mandate that CMS eliminate these two provisions.
(4) Notification to Provider of Preclusion
Comment: A commenter recommended that CMS notify the prescriber of
their inclusion on the preclusion list because having individual plan
sponsors perform simultaneous outreach to providers would be
inefficient and confusing.
Response: We believe that the commenter is referring to the CMS
requirement that was finalized in the April 2018 final rule and
codified in Sec. 423.120(c)(6)(v). Assuming this is so, we agree with
the commenter and stress that we did not propose to change this
requirement in the November 1, 2018 proposed rule.
Comment: A commenter urged that the written notice to the
individual or entity via letter of their inclusion on the preclusion
list be sent via certified mail and that the letter be standardized
across the MA and Part D programs. This, the commenter explained, would
prevent instances where an individual or entity is not properly
notified, the letter is lost in transit, or the letter goes to an
incorrect office or staff member; it will also help ensure a proper
chain of custody. The commenter also stated that standard language and
uniformity in the letter's format will assist individuals and entities
in distinguishing the notice and its purposes from other
communications.
Response: We appreciate this comment and wish to clarify that CMS
is indeed mailing these notices via certified mail. Additionally, the
same letter template, including similar format and language, is used
for notification to both Part C and D providers and prescribers.
(5) Relation to OIG Exclusion List
Comment: Several commenters urged CMS to treat the OIG exclusion
list and the preclusion list consistently to avoid provider,
beneficiary, and plan confusion. A commenter requested clarification
regarding CMS' rationale for treating precluded providers differently
than those on the OIG exclusion list, particularly with respect to the
timing for the denial of claims. The commenter noted that, in contrast
to the OIG exclusion process, claims denials will be delayed for the
initial preclusion list and subsequent lists.
Response: We appreciate these comments. As explained in sub-
regulatory guidance we have issued (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/PreclusionList.html), we have attempted to conform the preclusion list
policies to those concerning the OIG exclusion list as much as
possible. We emphasize, however, that complete uniformity and/or full
integration of the two lists is impracticable at this time for several
reasons. First, the OIG exclusion list is governed by statute,
consistent with the provisions of section 1128 of the Act. The OIG
exclusion list (and the policies and procedures associated therewith)
is operated under an entirely different set of laws and regulations.
Second, the requirements for inclusion on the preclusion list and for
inclusion on the OIG exclusion list are very different. For instance,
revocation of Medicare enrollment (which can be based on any of the
reasons identified in Sec. 424.535(a)) and a non-health care related
felony can serve as bases for adding a provider to the preclusion list,
whereas these grounds are not, in and of themselves, bases for
inclusion on the OIG exclusion list. The revocation reasons in Sec.
424.535(a), moreover, are quite distinct from the reasons for imposing
an OIG exclusion under section 1128 of the Act. The Medicare
enrollment/revocation and OIG exclusion processes, in short, are
operated by different agencies under different rules with different
requirements, which prevents these lists from being uniform.
We also believe that the preclusion list will apply to a much
larger provider population than that included on the OIG exclusion
list. We remind commenters that the intent of the preclusion list was
to create an effective alternative to enrollment. We thus concluded
that it was necessary to establish criteria for a provider to be
precluded that were broader than those for exclusion, such as being
revoked from Medicare; otherwise, it was possible that certain
problematic providers and prescribers could continue to furnish MA
services and items or prescribe Part D drugs. By the same token, we
have certain safeguards for the preclusion list, such as the claim
denial timing, to prevent access to care
[[Page 15787]]
issues. We believe this properly balances the need for strong program
integrity measures (as evidenced by our above-referenced, broader
preclusion list criteria) and the importance of ensuring that
beneficiaries receive needed health care.
Notwithstanding the above, we emphasize that the OIG list should
take precedence over the preclusion list; consequently, no OIG-excluded
provider shall receive payment or the 60-day period addressed in this
rule. Once a provider is no longer excluded and a plan must review the
preclusion list, there will be instances (based on Medicare
reenrollment bars) where a provider is precluded after their
reinstatement from an exclusion.
Comment: A commenter stated that administering the preclusion list
differently than the OIG exclusion list increases administrative burden
for plans while adding little value. The commenter instead supported
terminating providers and denying claims in a timeframe consistent with
the OIG exclusion process, rather than waiting for at least 60 days
after release of the preclusion list, as CMS proposed. The commenter
stated that there should not be a 60-day period before claim denials,
for a provider would know that they are precluded and should thus not
be seeing Medicare beneficiaries or prescribing drugs. The commenter
added that having separate notices to the beneficiary and different
claims denial timeframes could lead to beneficiary confusion.
Accordingly, the commenter recommended that CMS: (1) Use one list that
combines exclusions and preclusions; or (2) revise the preclusion list
requirements to apply in the same manner as the OIG list, allowing
plans to deny claims upon release of the preclusion list.
Response: As already explained, the differing requirements for
inclusion on each list, the different legal and statutory requirements,
and the different operational aspects involved do not permit us to
establish any greater uniformity than that already described in the
above-mentioned sub-regulatory guidance. With respect to claim denials,
we recognize the validity of the commenter's concern. Considering,
however, that (1) the preclusion list is a new concept, (2) plans need
time to accustom themselves to the preclusion list process, and (3)
some beneficiaries will need time to find new prescribers or providers,
we are not in a position at this stage to require immediate claim
denials upon release of the preclusion list. In time, should
stakeholders (including the plan and beneficiary communities) become
fully acclimated to the preclusion list process such that a period as
long as 90 days is not realistically needed, CMS may revisit this issue
in future rulemaking.
Regarding the commenter's concerns about plan and beneficiary
burden and confusion, we will continue our educational and outreach
efforts to stakeholders so as to minimize these effects.
Comment: A commenter recommended that CMS only include non-OIG
excluded prescribers on the preclusion list in order to keep the
preclusion and OIG exclusion lists separate. The commenter was
concerned that with both programs releasing a monthly file at different
times during the month, the potential exists for timing problems and
confusion.
Response: We appreciate this suggestion. However, because (1) an
OIG exclusion constitutes grounds for revocation under Sec. 424.535(a)
and (2) the revocation policies in Sec. 424.535 (for example,
application of a reenrollment bar) would apply in such cases, we
believe it is important to include all revocation grounds and policies
within the scope of the preclusion list. We will continue to work with
stakeholders to minimize confusion regarding the interaction between
the two lists. We are confident that, with time, affected parties will
become acclimated to the different processes.
Comment: A commenter contended that including preclusion list
standards on top of the existing OIG exclusion statutory requirements
is unnecessary, creates numerous inconsistencies, and imposes
operational complexities. For example, the commenter stated, once a
provider is added to the OIG exclusion list, there is no grace period
during which plans can continue to make payment. The proposed rule,
however, contains such a period for the preclusion list under
Sec. Sec. 422.222(a)(1) and 423.120(c)(6)(iv). The commenter stated
that: (1) Simultaneous compliance with both of these standards is
impossible; and (2) CMS cannot create a rule that directly conflicts
with the OIG exclusion provisions in the Social Security Act. The
commenter added that while CMS could create exceptions to the
preclusion list requirements for excluded providers or revise the
preclusion list requirements to be consistent with those applicable to
excluded providers, it would be administratively cleaner to simply
extract excluded providers from the preclusion list.
Response: For reasons already stated, we are not in a position to
separate the two lists or to make the preclusion list processes
entirely consistent with those of the OIG exclusion list. We are also
unable to remove OIG excluded prescribers and providers from the
preclusion list, for CMS takes revocation action that is separate and
apart from whatever exclusion action the OIG might take. A revocation
action warrants the addition of the prescriber or provider to the
preclusion list and is accompanied by a reenrollment bar, which
determines the length of the preclusion. The reenrollment bar length
may exceed the period for which the prescriber or provider is OIG
excluded, which further prohibits the affected prescriber or provider
from furnishing items and services to Medicare beneficiaries.
Notwithstanding the above, however, we have already clarified via
sub-regulatory guidance that the OIG exclusion list takes precedence
over the preclusion list. Thus, if a plan locates a provider on the OIG
exclusion list, it need not consult the preclusion list with respect to
that provider. The plan would simply follow its processes for OIG
excluded providers as described at 42 CFR 422.204(b)(4), 422.224(a),
and 422.752(a)(8). We mention further that providers and prescribers
who are precluded due to an exclusion are not afforded the 60-day grace
period, for the plan would reject the claim or deny the provider's
requests for reimbursement based on the exclusion prior to determining
if the provider or prescriber is precluded.
To codify the above policy in regulation, we will clarify the
opening paragraphs of Sec. Sec. 423.120(c)(6)(iv) and
422.222(a)(1)(ii) to state that Sec. Sec. 423.120(c)(6)(iv) and
422.222(a)(1)(ii) do not apply if the prescriber or provider is
currently excluded by the OIG. This means, in effect, that if a
provider or prescriber is on both the OIG exclusion list and the
preclusion list, the MA organization or Part D plan sponsor need not
(with respect to that prescriber or provider) carry out the
requirements of Sec. Sec. 423.120(c)(6)(iv) and 422.222(a)(1)(ii) (for
example, provide advance written notice to the beneficiary; delay
payment denials). We believe this will help reduce duplicative
administrative functions (such as letters to beneficiaries) and ensure
compliance with the statutory payment prohibitions concerning OIG
exclusions (that is, no grace period).
Comment: A commenter recommended that CMS limit the preclusion list
to providers who are not on the OIG exclusion list so as to avoid
conflicts between the exclusion and preclusion requirements. If CMS
declines this suggestion, the commenter stated that giving plans up to
90 days to
[[Page 15788]]
begin denying payment would allow them to meet their obligation (under
both OIG and CMS regulations) to deny claims for items and services
provided by an excluded provider, while also allowing time--where
permitted--for members to be notified and transition to a new provider.
The commenter contended that this would be more consistent with MAOs'
current obligations to provide members with 30 days' advance notice of
a provider's contract termination; the commenter questioned why a
provider placed on the preclusion list should continue to be paid for a
longer period of time than a provider whose contract terminates for
another reason.
Response: We previously outlined our rationale for declining to
extract OIG-excluded parties from the preclusion list and the reasons
for the 90-day delay in claim denials. As we indicated regarding the
latter, though, we may in the future consider shortening this time
period via rulemaking should circumstances warrant and operational
considerations permit. We note that currently, pursuant to Sec.
422.202(d)(4), if an MA plan terminates a contracted provider from the
provider network for ``no cause'', the plan is required to furnish the
provider with 60 days' advance notice; if an MA plan terminates a
provider for cause, the provider is entitled to appeal rights under
Sec. 422.202(d)(1) through (3). Based on this, we believe that the
timeframe of 60-90 days before an MA plan can deny payment to a
precluded provider is similar to what is required when a provider is
terminated by the plan under Sec. 422.202(d)(4) without cause.
(6) Relationship to Medicaid
Comment: In cases where Medicaid is the primary payer for a drug
for a dual-eligible individual, a commenter questioned whether the
pharmacy must fill a prescription for a drug prescribed by a precluded
prescriber. The commenter stated that CMS must address how the
preclusion list applies to Medicaid-Medicare Plans (MMPs) with a three-
way contract. Specifically, in an MMP the enrollee has one insurance
card; he or she may thus be confused if the MMP rejects his or her Part
D drugs (because the prescriber is precluded) but then pays for the
Medicaid drug from the same prescriber.
Response: A Part D drug that is not covered because the prescriber
is on the preclusion list--but is otherwise coverable by Part D--is not
coverable under Medicaid, including under an MMP as the claim would not
cross over once rejected by the Part D plan. In the rare circumstance
that Medicaid is the primary payer for a prescription drug furnished to
a Part D eligible individual, the preclusion list does not apply as the
drug would be adjudicated through the Medicaid claims system.
Comment: A commenter requested that CMS collaborate with states if
future consideration is given to the preclusion list's potential
application to (and implementation by) state Medicaid agencies in
unison with private sector health plan partners.
Response: We appreciate this comment and will make certain to
collaborate with the states should the contingency the commenter
mentions arises.
(7) Timeframe for Denying Claims
Comment: Noting the proposed commencement of claim denials 61-90
days following preclusion list publication, a commenter recommended a
hard timeline of 90 days from file release to claim denial. The
commenter believed that this would foster industry-wide consistency.
Another commenter stated that if CMS intends to require plans to
terminate precluded providers from their networks, CMS should: (1)
Promulgate this requirement through rulemaking, not via sub-regulatory
guidance; and (2) permit plans to terminate providers at any time prior
to when plans must begin denying payments.
Response: We appreciate these comments. However, we do not wish to
delay claim denials any longer than absolutely necessary, which is why
we respectfully decline to mandate the expiration of a full 90-day
period. Under Sec. 422.222(a)(1), as amended in this final rule, an MA
organization is prohibited from paying a provider who is on the
preclusion list; this prohibition applies to claims with dates of
service that fall 60 days or more after the MA organization has
notified the enrollee that the provider has been placed on the
preclusion list and that claims for services furnished by that provider
will be denied. Section 422.222 does not itself require termination of
any contract between the MA organization and the precluded provider. We
anticipate, though, that many MA plans will take steps to terminate
their contracts with precluded providers, at least for purposes of the
MA plan, because of the prohibition on payments to precluded providers
in connection with items and services provided to Medicare
beneficiaries. Further, we do not believe that rulemaking is required
regarding language in CMS' sub-regulatory guidance, which only suggests
and does not require the removal of precluded providers from plan
networks.
We believe that compliance with Sec. 422.222(a)(1) by an MA plan
will take slightly different forms depending on whether the precluded
individual or entity has a contract with the MA plan to participate in
its network. In managing their contracted networks, MA plans: (1) Must
provide advance written notice to any beneficiary who received an item
or service from an individual or entity added to the preclusion list no
later than 30 days after the posting of the updated preclusion list;
and (2) may pay the precluded provider for 60-90 days, depending on
when the enrollee was notified. When an enrollee has received services
from a non-network precluded provider, MA plans should notify the
enrollee that the non-contract provider is precluded and the plan will
not pay any claims from the precluded provider with a date of service
after the expiration of the allowable payment period for that precluded
provider.
Comment: A commenter agreed that the previously mentioned 60-90 day
claim denial period will assist beneficiaries in transitioning to new
providers.
Response: We appreciate the commenter's support.
Comment: Several commenters expressed support for the proposed
application of the 90-day period before a claim is denied to all
releases of the preclusion list (not merely the initial preclusion
list).
Response: We appreciate the commenters' support.
Comment: A commenter stated that payment denials should be allowed
to begin at any point up to 90 days after the provider is placed on the
preclusion list. Any member notice requirement, the commenter
contended, should be independent of the time frame for denying
payments.
Response: Under Sec. 422.222(a)(1)(ii)(C), the prohibition on
payment to a precluded individual or entity is tied to expiration of a
period of 60 days from issuance of the advance written notice to the
enrollee. However, the MA plan may terminate a network provider under
its contract, thereby removing the provider from its network of
providers available to its enrollees in accordance with other
procedures and requirements. The MA regulation at Sec. 422.202(d)
permits for-cause and without-cause terminations of provider
participation agreements; Sec. 422.111(e) specifies that an MA
organization terminating a provider must make a good-faith effort to
notify enrollees at least 30 calendar days before the provider
termination date. If an enrollee is left without a primary care
provider
[[Page 15789]]
and one is necessary in order to access coverage and benefits under the
MA plan, Sec. 422.112(a)(2) permits the MA organization to assign a
primary care provider to the enrollee; further, Sec. 422.122(b)
imposes coordination of care responsibilities on MA organizations,
which CMS generally believes means that an MA organization should offer
to assist enrollees in locating a suitable provider and in ensuring
that ongoing treatment is properly transitioned to a new health care
provider. Section 422.222(a)(1)(ii)(A) requires that MA organizations
notify enrollees within 30 days from when the MA plan receives
notification from CMS that a provider has been placed on the preclusion
list, which will start the 60-day period for when denials of payment
based solely on the provider's inclusion on the preclusion must occur.
The enrollee notification of a terminated provider should inform
the enrollee that the terminated precluded provider is no longer
available to furnish plan services and offer to assist the enrollees in
transitioning to a new network provider. For services received from a
non-contracting precluded provider, the MA plan must also notify the
enrollee that the non-network provider is precluded and include in that
notification the date on which the plan will not pay any further claims
from that precluded provider. This gives the enrollee time to
transition to an alternative non-network provider if he or she chooses
to do so.
While we believe it is clear that Sec. 422.222 is equally
applicable to network and non-network precluded providers, we wish to
eliminate any confusion on this matter. As such, we are changing the
title of Sec. 422.222 from ``Preclusion list'' to ``Preclusion list
for contracted and non-contracted individuals and entities.'' We
believe this will help clarify the applicability of Sec. 422.222,
Comment: A commenter urged CMS to allow plans up to 90 days to
commence denying payments, meaning that plans would be permitted to:
(1) Immediately stop paying claims (as required with OIG excluded
providers); and (2) begin denials at any point within 90 days if there
is no other legal requirement to act immediately. The commenter stated
that requiring plans to pay claims for a period of time after the
provider is placed on the preclusion list conflicts with other
requirements that plans must follow and introduces multiple challenges.
The commenter added that because the applicable statute prohibits plans
from making payment for items and services furnished or prescribed by
an excluded provider, CMS cannot impose a separate requirement that
plans continue to pay claims for precluded providers (some of whom will
also be on the exclusion list) for a particular period of time.
Response: As previously explained, we believe that beneficiaries
should be afforded a sufficient opportunity to locate a new prescriber
or provider should their current prescriber or provider be included on
the preclusion list. We note also that nothing in the provisions we
finalized in the April 2018 final rule or are finalizing in the present
rule prohibit plans from immediately denying claims based on an OIG
exclusion pursuant to the long-standing requirement to do so under the
Social Security Act. Indeed, we refer the commenter to our previously
mentioned changes to Sec. Sec. 423.120(c)(6)(iv) and
422.222(a)(1)(ii), under which these provisions would not apply if the
prescriber or provider is currently excluded by the OIG.
Comment: A commenter stated that the April 2018 final rule
prohibits MAOs from paying claims from precluded providers and contains
no requirement that the MAO notify the member or otherwise delay the
denial of payment. The commenter also pointed out, however, that the
previously mentioned HPMS Memo ``recommends'' that MAOs wait 90 days
before denying payment. The commenter stated it will be impossible for
MAOs to comply with both the immediate payment prohibition and the 90-
day recommendation for claim denials.
Response: CMS acknowledges, in the previously mentioned HPMS memo,
the failure to include in the regulatory text of the April 2018 final
rule certain policies outlined in our responses to the comments
therein. Due to the language in the April 2018 final rule preamble
summarized above and our guidance in the HPMS memo, we believe that the
90-day approach is permissible for plans pending the applicability date
of this final rule and our amendments to Sec. 422.222(a). We clarify
here that the HPMS memo simply requests that plans follow the 90-day
approach and that this approach is being codified in the regulatory
text of this final rule. We mention, however, with the finalization of
this rule, that the above-referenced 60-day period and beneficiary
notification will be required upon the final rule's effective date.
(8) Beneficiary Notification
Comment: A commenter sought clarification on how a plan should
proceed (assuming a January 1, 2019 release of the initial preclusion
list) if, on day 89 following the publication of the preclusion list, a
beneficiary receives a service from a precluded provider for which no
pharmacy claims history exists. The commenter questioned whether: (1)
This beneficiary would receive notification from the plan about the
provider's preclusion; (2) the 90-day clock will begin to run again for
this beneficiary; and (3) a provider or prescriber identified on
January 1, 2019 as meeting the requirements for preclusion could
provide services to a Medicare beneficiary for close to 6 months
following its preclusion. The commenter believed that if CMS releases
the preclusion list on January 1, 2019, plans would have until February
1 to notify beneficiaries, at which time claims begin to be denied on
April 1; if, however, a beneficiary sees a provider placed on the
initial preclusion list on March 28, a new 90-day clock would begin to
run, under which the plan would be given 30 days to contact the
beneficiary (April 28) and claims would not be denied until June 28.
Response: First, we note that the commenter's example appears to be
about the preclusion list regulation adopted in the April 2018 final
rule that became applicable beginning January 1, 2019, and not about
our proposed rule. CMS has addressed this topic via sub-regulatory
guidance at the following link: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/PreclusionList.html. That guidance clarifies that if no claims history
exists for the previous 12-month period, the plan is not required to
notify beneficiaries. If no notification is made, the 60-90 day period
is not required, although plans may choose to wait to deny claims until
the claim denial/reject date included on the preclusion list file.
Second, under the amended regulations we are finalizing here and in
regard to the commenter's specific scenario, if a beneficiary received
a service from a precluded provider on the 89th day following
publication of the list, the plan would pay the claim. The provider
would not receive an additional 60-90 day period and after the 89th day
would thus be unable to continue furnishing MA items and services or
prescribing Part D drugs for Medicare beneficiaries. If the service was
provided on the 90th day, the plan would (upon receiving the claim)
deny or reject the claim and notify the provider or prescriber that he/
she is precluded, as we have finalized at Sec. 422.222(a)(1)(ii)(B)
and Sec. 423.120(c)(6)(iv)(B). In this specific scenario, we are
assuming the provider is granted the 60-90 day period as there
[[Page 15790]]
may be a claims history with at least one beneficiary. To further
clarify, in situations where there is no claims history concerning the
specific provider and any beneficiaries, the 60-90 day period is not
required.
Comment: Citing CMS' Patients over Paperwork initiative, a
commenter requested clarification of the rationale for requiring the
mailing of beneficiary notices instead of permitting email. The
commenter cited the situation where a beneficiary indicates that
electronic communication is his or her preferred method of
communication.
Response: Per the December 14, 2018 HPMS memo, CMS will not allow
different modes of communication regardless of the beneficiary's
preference. We recognize that some beneficiaries may prefer email.
However, we believe that using mail is the surest means of making
certain that the beneficiary receives the notice, a critical
consideration given the importance of the information furnished
therein.
Comment: Several commenters urged CMS to add language to the sample
beneficiary notification letter stating that appeal rights will not
apply when a claim is denied due to a precluded prescriber. Failure to
do so, a commenter contended, could lead to beneficiary confusion.
Response: In the sample notification letter, we refer the
beneficiary to our sub-regulatory guidance (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/PreclusionList.html), in which we outline the
lack of beneficiary appeals in the situation the commenter describes.
We believe this furnishes sufficient notification to beneficiaries on
the issue of appeals.
Comment: A commenter stated that the sample notification letter
informs stand-alone Part D plans to insert the 1-800-Medicare number
but then leaves the ``hours of operation'' configurable. The commenter
questioned: (1) Whether the hours should be the standard hours for 1-
800-Medicare; (2) whether the stand-alone Part D enrollees should call
only if they need assistance in finding another prescriber but should
call plans at the plan number for further questions regarding the
status of their prescriptions; (3) whether, based on the sample notice,
there should be two numbers for stand-alone Part D plans; (4) whether
the 1-800-Medicare number should only be furnished if assistance is
needed in finding another provider; and (5) whether plans should list
their customer care phone number if there are further questions
regarding the status of their prescription with the plan's customer
care hours of operations.
Response: We will address these operational issues via sub-
regulatory guidance.
Comment: Regarding an enrollee who did not receive a notification
letter (and given the previously mentioned 90-day period), a commenter
sought clarification as to: (1) The requirements concerning PDE edits;
(2) whether CMS will pay for the PDE; and (3) whether a new PDE edit
will be created to reject PDEs submitted for precluded providers.
Response: We assume the commenter is referring to situations, per
the regulations finalized in the April 2018 rule, where the beneficiary
did not receive notification that his or her provider or prescriber is
precluded. PDE editing will be based on the ``claim reject date,''
regardless of beneficiary notification receipt status as the timing for
claim denials and/or rejections begins upon the notice being sent by
the plan. (See HPMS memorandum, ``February 2019 Updates to the Drug
Data Processing System (``DDPS''),'' dated January 8, 2019 and released
January 9, 2019.)
Comment: A commenter expressed concern that beneficiaries will not
have had adequate experience with the preclusion list initiative before
receiving the mandated 60-day notification.
Response: We understand the commenter's concern. We will work with
beneficiary groups to help educate potentially affected Medicare
patients about the preclusion list process.
Comment: A commenter urged that the beneficiary notification letter
should state that: (1) The beneficiary cannot request any review of
CMS' preclusion determination; and (2) he or she must seek a non-
precluded prescriber for future prescriptions.
Response: With respect to the first part of the comment, we do not
believe it is helpful for the notification letter to state what the
beneficiary cannot do under these circumstances. Instead, consistent
with the second part of the comment, we believe it is more helpful for
the notification letter to clearly explain the actions the beneficiary
can and should take to ensure future payments and coverage of benefits;
that is, to find another non-precluded provider to furnish similar
items or services.
(9) Pharmacies and Part B Drugs
Comment: A commenter stated that Part B pharmacy claims are
included in Part C reporting. The commenter sought guidance regarding--
if a plan offers both Part D and Part B pharmacy benefits to its
members--the Part B pharmacy drug claims process if the provider is on
the preclusion list. Specifically, the commenter questioned whether the
Part D processed claims will reject but Part B drug claims will be
allowed to process. The commenter stated that beneficiaries may be
confused if some of their claims involving a precluded provider are
denied while others are processed. Another commenter, too, sought
clarification as to whether MA or MA-PD plans should deny payment of
Part B pharmacy prescriptions written by a precluded provider. This
commenter cited the example of a beneficiary who presents a pharmacy
with two prescriptions from a precluded prescriber--one for a Part D
drug and one for a Part B drug; the commenter questioned whether the
pharmacy should reject one prescription (Part D) and fill the other
prescription (Part B).
Response: We believe this situation is likely to be rare, provided
that plans are applying the preclusion list to all claims submitted by
both contracted and non-contracted providers. However, we acknowledge
that such a situation could arise and, if it did, would cause confusion
for beneficiaries and pharmacies. To reduce confusion, therefore,, if
the prescriber or provider is precluded, the plan will be prohibited
from making payment regardless of whether the drug is a Part B or D
drug. After consideration of these comments, we will modify the
language in Sec. 422.222(a)(1)(i) that reads ``health care item or
service furnished'' to instead state ``health care item, service, or
drug that is furnished, ordered, or prescribed''. To ensure consistency
with this revision, we will make similar edits to Sec.
422.222(a)(1)(ii)(A) and (C) and to 422.504(g)(1)(iv); specifically, we
will include therein, as applicable, references to ``ordered,''
``prescribed,'' and ``drugs.''
Comment: A commenter requested that CMS clarify whether the
proposed replacement of the term ``individual'' with ``prescriber'' in
Sec. 423.120(c)(6) means that: (1) Type 2 NPIs--when submitted on the
PDE--can be accepted as a valid submission on claims; and (2) any valid
NPI--whether Individual or Organizational--can be used to adjudicate
claims.
Response: Based on comments we received regarding this proposed
change, we are concerned that such a revision will cause confusion that
will outweigh the proposal's objective. Indeed, we note that the policy
that Part D plans submit PDEs with Type I NPIs is a long-standing one
that supports an important program integrity goal. For
[[Page 15791]]
these reasons, we are not finalizing this proposal.
Comment: Several commenters recommended that CMS explain the scope
of the Part D preclusion list, indicate whether and how it applies to
pharmacies, and make any necessary regulatory revisions. A commenter
requested that the regulatory text clarify whether CMS intends to add
to the preclusion list those pharmacies that do not prescribe drugs to
Part D members but do fill member prescriptions. The commenter
contended that the applicable preclusion list regulations require the
denial of payments to precluded prescribers but do not extend to
pharmacies that fill member prescriptions. The commenter also requested
that CMS limit the preclusion list to those pharmacies that are
prescribers until the regulations are modified. The commenter stated
that the inclusion of non-prescribing pharmacies on the preclusion list
risks exposing plan sponsors that deny payments to such pharmacies to
legal claims in light of, the commenter contended, the lack of
regulatory authority for those denials.
Response: Although pharmacies are indeed on the preclusion list,
the regulations at 422.222 only apply to pharmacy claims for Part A or
B drugs covered under Part C and supplemental items or services
furnished by the pharmacy (that is, they will not affect the pharmacy's
ability to dispense Part D drugs so long as the prescription is not
from a precluded prescriber). Coverage of Part D drugs, whether by an
MA-PD or stand-alone Part D plan, are addressed in 423.120. As such, we
decline to add this requirement to regulatory text. We note that the
application of these requirements to pharmacies in Part C and not Part
D is due to the supplemental pharmacy benefits offered by some Part C
plans. We also clarify that Part A and B drugs are typically not
dispensed by the pharmacy under Part C but are furnished by the Part C
provider.
Comment: A commenter stated that in its December 14 FAQ, CMS
mentions that Part D plans are expected to remove precluded pharmacies
from their network. However, the commenter contended, the FAQ did not
furnish additional information (including the necessary rulemaking) for
such a decision to be made; the FAQ, the commenter stated, merely
references ``future rulemaking'' and does not contain legal authority
for such terminations.
Response: The November 2, 2018 CMS-issued HPMS memo entitled
``Preclusion List Requirements'' (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/PreclusionList.html.) suggests that Part D plan sponsors remove
precluded pharmacies from their network as soon as possible. Thus,
there is no formal requirement that Part D plan sponsors do so.
(10) Implementation Timeframe
Comment: A number of commenters urged CMS to delay implementation
of all of the preclusion list requirements in their entirety (including
those in the April 2018 final rule) until January 1, 2020. A commenter
stated that the preclusion list policies place an extreme strain on
plans' resources, especially given the end-of-year testing. Other
commenters stated that CMS has not furnished sufficient responses to
stakeholders' questions and has not provided adequate guidance. This,
they contended, leaves numerous issues open to interpretation, which
will result in beneficiary and plan confusion. To efficiently implement
these rules, these commenters added, a delay until January 1, 2020 is
essential. Another commenter stated that while CMS has issued guidance
regarding the preclusion list, a significant number of outstanding
matters remain; these must be resolved before the preclusion list can
be implemented. An additional commenter expressed concern that the
varying effective dates (and contradictory requirements) concerning
preclusion list implementation will confuse beneficiaries, providers,
prescribers, and plans. This commenter and others added that such
confusion, combined with a hasty implementation, could also harm
beneficiaries who are unable to access medications or needed services.
Other commenters suggested an effective date for all preclusion list
requirements that is: (1) At least 18 months after CMS publishes the
necessary technical guidance and confirmed file layouts; (2) at least
18 months after the publication date of this final rule; (3) at least 1
year after the consolidation of the issues covered in multiple CMS
guidance documents; or (4) sometime after CMS engages with stakeholders
to address outstanding operational and logistical challenges.
Response: We appreciate these comments and understand the
sentiments raised. We must, however, respectfully decline to delay the
implementation of the preclusion list as the commenters suggest. It is
imperative that the preclusion list process commence as soon as
possible so as to protect the Medicare program and beneficiaries from
fraud, waste, and abuse. We believe that a delay until January 1, 2020
or later would be inconsistent with our obligations to safeguard the
Trust Funds and to ensure that payments are made correctly.
Nonetheless, we will closely monitor the preclusion list's progress
throughout 2019 and continue engaging regularly with all stakeholders
to facilitate as smooth an implementation as possible.
Comment: While recommending a January 1, 2020 implementation date
for all of the preclusion list requirements, several commenters
suggested that CMS could instead exercise enforcement discretion in
2019 against Medicare plans for good-faith efforts they make to
implement the preclusion list rules finalized in the April 2018 rule. A
commenter added that CMS could refrain from sanctioning plans that fall
short of implementing the preclusion list requirements until CY 2020.
In a similar vein, a commenter stated that CMS should not enforce the
preclusion list requirements (1) before January 1, 2020 and (2) until
CMS has released guidance that clarifies the outstanding operational
issues.
Response: As stated, we respectfully decline to establish a January
1, 2020 effective date for all of the preclusion list provisions. We
continue to believe it is imperative to implement the preclusion list
requirements as soon as possible in order to protect Medicare
beneficiaries and the Trust Funds.
Comment: A commenter urged CMS not to implement the provisions in
the proposed rule.
Response: As explained previously, we believe that the provisions
outlined in the proposed rule are necessary to ensure that the
preclusion list process satisfies our program integrity objectives
without unnecessarily burdening stakeholders.
Comment: Several commenters supported the January 1, 2020 effective
date for the provisions in the proposed rule.
Response: We appreciate the commenters' support, though we note
that our consolidated appeals provisions will become effective 60 days
after the publication of this rule.
Comment: A commenter supported having all of the proposed
preclusion list provisions become effective and applicable beginning 60
days after their publication in a final rule.
Response: While we appreciate this comment, we would prefer to give
stakeholders until January 1, 2020 to prepare for the provisions we are
finalizing in the rule (excluding the consolidated appeals policy).
[[Page 15792]]
(11) Beneficiary Liability
Comment: A commenter expressed concern about the potential
financial liability of beneficiaries for precluded out-of-network
providers. While supporting the proposed requirement that an MA
contract with CMS state that a MA enrollee must not have any financial
liability for items or services furnished to the beneficiary by a
precluded MA-contracted individual, the commenter noted that this would
not extend to out-of-network providers. In addition, the commenter
stated that the proposed rule does not allow a beneficiary to appeal a
payment denial based upon a provider's inclusion on the preclusion
list. Coupled together, the commenter stated, a beneficiary may have
financial liability but no administrative recourse. Regarding
beneficiary appeals and liability, another commenter recommended that
CMS either: (1) Allow a beneficiary to appeal a payment denial for
precluded out-of-network providers; or (2) require language in the
proposed advance written notice to the beneficiary of his or her
financial liability if he or she continues to receive services from the
out-of-network provider.
Response: We thank the commenter for the support for our proposal
to minimize enrollee liability for payments to network providers. We
are finalizing this requirement in Sec. 422.504(g)(1)(iv) with several
grammatical revisions; we are adding the language ``Ensure that'' to
the beginning of the paragraph to ensure that it properly and
grammatically flows from the closing wording of the opening paragraph
of Sec. 422.504(g). In addition, as previously explained, we are
adding references to ``ordered,'' ``prescribed,'' and ``drugs'' to this
new paragraph in the regulation.
In addition to the protection described in Sec. 422.504(g)(1)(iv),
we also proposed and are finalizing that the prohibition on payment to
a precluded provider under Sec. 422.222(a) must begin only after
advance written notice to enrollees that a provider from whom the
enrollee has previously received services is on the preclusion list. As
finalized at Sec. 422.222(a)(1)(ii)(A), plans are required to provide
at least 60 days' notice to enrollees within 30 days of the posting of
an updated list. We believe this timeframe will allow enrollees
sufficient time to locate a new provider and avoid seeking further
services from a precluded provider and any potential financial
liability that may result. We believe that this advance written notice
and delay as to when an MA plan is prohibited from paying a precluded
provider will ensure appropriate protection of the beneficiary.
CMS believes most plans will remove precluded providers and
prescribers from their networks upon identifying them. Therefore, as
required by Sec. 422.222(a)(1)(ii)(A) and consistent with Sec.
422.111(e), MA plans that choose to terminate a precluded provider must
make a good-faith effort to furnish enrollees with at least 30 days'
advance notice of the termination of a network provider. Further, upon
the expiration of the 60-day period (at which point both the provider
and beneficiary have been notified of the preclusion), if the provider
is terminated from the plan's network but seeks payment from the
Medicare beneficiary, the provider would be in violation of section
1848(g)(4)(A) of the Act. If the provider remains in the plan's
network, however, the provider is bound to the contractual requirements
within the provider's contract, with the plan prohibiting the provider
from seeking payment from the beneficiary in cases where the plan
denies requests for reimbursement due to the provider's precluded
status. Because the beneficiary's liability would be dependent on what
action the plan takes in regard to the provider's MA contract (for they
are not required to terminate the MA contract in order to
operationalize the payment prohibition), we believe it would be
inaccurate to add language to the notice regarding the beneficiary's
potential liability and therefore decline to do so.
In addition, with respect to services received from a non-
contracting precluded provider, the MA plan must notify the enrollee
that the provider is precluded and include in that notification the
date on which the plan will not pay any further claims from that
precluded provider.
Comment: A commenter stated that CMS should clarify the point at
which MA plans should terminate providers. The commenter explained that
MA plans may need or prefer to remain contracted with a provider for a
short period of time for various reasons. The commenter stated that:
(1) A requirement to terminate a contract while payments are still
being made would unnecessarily complicate delivery of the plan benefit;
and (2) plans should be able to retain contractual protections for
themselves (including contractual obligations imposed on providers and
agreed-upon pricing terms) while they are still making payments.
Moreover, the commenter stated that allowing termination up until
denial of the claims would conform to: (1) CMS' requirement to notify
members that a plan is terminating a network provider; and (2) similar
state laws.
Response: Our final rule at Sec. 422.222 does not require an MA
plan to terminate a provider from its network if or when the provider
is placed on the preclusion list. Provider termination is a decision
for the MA plan. MA plans may, however, not pay a precluded provider
for services rendered to plan enrollees after the 60-90 day beneficiary
notification period has expired.
Comment: A commenter expressed concern regarding the proposal that
an MAO's contract with CMS provide that a member shall not have any
financial liability for services or items furnished by a contracted
provider on the preclusion list. The commenter explained that this
provision would confront plans with inconsistent requirements--
specifically, that plans must not pay providers' claims while also
requiring that they hold members harmless if the provider bills the
member. If the provider indeed does the latter, the commenter
continued, plans might have to pay the provider (so as to hold the
member harmless); this would conflict with the requirement not to pay a
claim. Alternatively, plans might have to reimburse a member who has
paid the provider, effectively allowing the provider to circumvent the
preclusion list. The commenter recommended that, in lieu of the ``hold
harmless'' provision, CMS should either: (1) Prohibit the precluded
provider from billing or otherwise seeking payment from the member; or
(2) make the ``hold harmless'' obligation inapplicable (i) to services
and items furnished by precluded providers after their contracts have
been terminated or (ii) to claims the MAO must deny under Sec.
422.222(a)(1).
Response: Under Sec. 422.222(a)(1)(ii)(C), the MA plan may pay
precluded providers for up to 60 days after the MA plan has notified
enrollees that the provider has been precluded. We anticipate that MA
organizations will also use this period to assist affected enrollees in
transitioning to new providers or, if a new primary care provider is
necessary for the enrollee to access plan covered services, to assign a
new primary care provider to each affected enrollee. The plan's ability
to pay a provider for up to 60-90 days after preclusion will not
violate the MAO's contract with CMS and is an important beneficiary
protection. At the conclusion of the 60-day period, the provider will
no longer be eligible for payment from the plan and will be prohibited
from pursuing payment from the beneficiary as stipulated by the terms
of the contract between CMS and
[[Page 15793]]
the plan per 422.504(g)(1)(iv). Therefore, the provider would hold
financial liability for furnished, ordered, or prescribed services and
items after the close of the 60 day period, at which point the provider
and the beneficiary would have already received notification of the
preclusion. To formally incorporate this policy in regulatory text, we
are also finalizing a new paragraph (g)(1)(v) in Sec. 422.504; this
paragraph requires that the MA plan's provider agreements contain a
provision acknowledging the preclusion list requirements, prohibiting
the precluded network provider from seeking payment from the enrollee,
and providing that the provider will hold financial liability for any
items, services, or drugs the provider furnishes, orders, or prescribes
after the prohibition on payment begins (i.e., after expiration of the
60-90 day period). This will make clear that the MA organization must
agree to this requirement.
If the MA organization's participation agreement with the precluded
provider is terminated, we recognize that the MA organization will not
have a contractual means to prohibit the precluded provider from
seeking payment directly from the enrollee. We encourage MA
organizations to provide sufficient information and assistance to
enrollees so that they look for new providers from whom to receive
covered services. We further clarify that once the 60-day period ends
and the provider's network contract has been terminated (at which point
both the provider and beneficiary have been notified of the
preclusion), there is no legal mechanism to apply the hold harmless
provision nor would CMS or the plan be able to prohibit the provider
from seeking payment from the beneficiary.
Comment: A commenter concurred with the proposal that the
beneficiary be held harmless for financial liability if his or her
provider is included on the preclusion list. Noting that the policy
only applied to contracted providers, however, the commenter stated
that members who use non-contracted providers that are included on the
preclusion list are vulnerable to inappropriate demands for payments
sent directly to them by unscrupulous providers. The commenter added
that further communication and transparency concerning all providers on
the preclusion list would help minimize inappropriate billing.
Response: We concur with the commenter and will work with
stakeholders, including the plans and beneficiary groups, to consider
effective means of preventing the situations that the commenter
describes.
Comment: While supporting the limitation on beneficiary liability,
a commenter encouraged CMS to expand this protection to non-contracted
entities in the following two circumstances: (1) When the provider was
a contracted individual or entity prior to their preclusion but whose
contract was terminated as a result of the preclusion; and (2) when the
MA is a PPO and offers out-of-network coverage.
Response: As noted in the previous response, we will work with
stakeholders regarding effective methods to protect beneficiaries who,
through no fault of their own, receive services from a precluded
provider. We continue to believe, however, that the notification of
enrollees and the period available to pay precluded providers will
ensure that most MA patients of a precluded provider will have
sufficient time to transition to a new qualified provider who can be
paid by their MA plan. In regard to the commenter's suggestion of
expanding the limitation on beneficiary liability, we note that once a
provider's network contract is terminated, there is no legal mechanism
to apply the hold harmless provision nor would CMS or the plan be able
to prohibit the provider from seeking payment from the beneficiary.
(12) Appeals
Comment: Several commenters expressed support for the proposals to:
(1) Shorten the preclusion list appeal timeframe from 9 months to 5
months; and (2) place providers and prescribers on the preclusion list
after their first level of appeal. In both of these cases, a commenter
stated, CMS has taken common sense steps to reduce administrative
burden on MAOs and Part D plans, to ensure that precluded providers and
prescribers do not continue to provide care and/or prescribe
medications, and to consider the best interests of beneficiaries.
Response: We appreciate the commenters' support.
Comment: A commenter stated that notwithstanding the proposal that
beneficiaries may not appeal a payment denial based on their provider's
or prescriber's preclusion, CMS recently issued different guidance.
Specifically, the commenter stated that in a December 14 FAQ, CMS
declined to inform beneficiaries of their lack of appeal rights but
stated that an enrollee may seek a coverage decision from the plan if
there is a question regarding coverage for an item, service, or drug.
The commenter accordingly sought clarification on a number of issues:
(1) Whether enrollees will be permitted to appeal the denial of a claim
(due to a provider's preclusion) during CY 2019 given that beneficiary
appeals were not addressed in the April 2018 final rule applicable to
CY 2019; (2) if the answer to the prior issue is yes, how CMS intends
to notify beneficiaries of the change in policy for CY 2020; (3)
whether, based on the language in the December 14 FAQ, the
determination of a provider's preclusion constitutes a coverage
decision that is subject to standard appeal rights; and (4) whether a
beneficiary who did not receive notice that his or her provider was
excluded and accordingly continued to use that provider could appeal
the denial of the claim. Another commenter also raised the first,
second, and fourth issues, while questioning whether the beneficiary
can at least appeal the denial of the claim (given that he or she
cannot appeal the provider's preclusion status).
Response: We clarify that the cited guidance was issued based on
the April 2018 final rule. Therefore, that guidance is not fully
applicable to this final rule and the amendments we are making to
Sec. Sec. 422.222 and 423.120.
A Part D claim that is rejected at the point-of-sale does not
constitute a coverage determination; thus, there are no Part D appeal
rights. As with claims from prescribers on the OIG exclusion list, a
claim rejected at point-of-sale because the prescriber is on the
preclusion list does not return the 569 reject code. In other words,
the network pharmacy does not deliver the pharmacy notice that
instructs an enrollee how to request a coverage determination. As
previously noted in this preamble, a claim rejection at point-of-sale
due to preclusion is not a Part D coverage determination, so the
enrollee would not have appeal rights. This having always been the
case, nothing has changed between CY 2019 and CY 2020. As previously
stated in this preamble, we are finalizing Sec. 422.222(a)(4) to state
that a beneficiary enrolled in an MA plan (or a cost plan or PACE
organization under the incorporation of the MA regulation into those
programs at Sec. Sec. 417.478 and 460.86) will not be able to appeal a
payment denial that is based on an individual or entity's placement on
the preclusion list.
[[Page 15794]]
Finally, we note that Sec. 422.222(a)(1)(ii)(A), as amended by
this final rule, requires an MA plan to issue a notice to affected
enrollees when a provider is placed on the preclusion list. The
prohibition on payment will begin the earlier of 60 days after this
notice or 90 days after the provider was placed in the preclusion list.
An MA plan that fails to provide the notices required by this
regulation will be in violation of its responsibilities such that CMS
may take necessary enforcement action.
Comment: A commenter supported making the proposed appeals process
effective 60 days after publication of this final rule.
Response: We appreciate the commenter's support.
Comment: A commenter urged CMS to permit limited beneficiary
appeals of denials of claims based upon a provider or prescriber's
preclusion. The commenter stated that if the beneficiary notice
required at Sec. 422.222(a)(1)(ii)(A) described previously was
incomplete or ineffective, the beneficiary should not be responsible
for payment. The commenter added that CMS should consider mechanisms to
protect beneficiaries from liability in such circumstances.
Response: Under the regulation we are finalizing at Sec.
422.222(a)(4), denials of payment based on a provider's or prescriber's
preclusion cannot be resolved through the beneficiary appeals process
as outlined in Subpart M of 42 CFR part 423. If payment is denied
because of the prescriber's or provider's preclusion, the enrollee
should find another provider in the area to furnish these services and
to contact the plan if assistance is needed. (This is explained in the
beneficiary notice.) Further, a request for payment by a contract
provider where an enrollee is held harmless does not constitute an
organization determination.
Concerning an incomplete or ineffective notice, the provider or
prescriber would still have been made aware of the preclusion. Indeed,
this further supports our rationale for allowing claims to be paid
without penalty for 60 days following the issuance of the notice to the
beneficiary.
In regard to Part C, following the 60-day period and once a
provider's network contract is terminated, there is no legal mechanism
to apply the hold harmless provision nor would CMS or the plan be able
to prohibit the provider from seeking payment from the beneficiary if
the provider is terminated from the plan's network. However, if the
provider remains in the plan's network, the provider must comply with
contractual requirements prohibiting the provider from seeking payment
from the beneficiary in cases where the plan denies requests for
reimbursement due to the provider's precluded status.
We are finalizing our proposed changes concerning appeals with one
exception. We are deleting the phrase ``by CMS'' in proposed Sec.
422.222(a)(2)(ii)(B) and Sec. 423.120(c)(6)(v)(B)(2). This is to
clarify that Administrative Law Judges and the Department of Appeals
Board, which, as applicable, consider the appeals in question, are not
part of CMS.
(13) Miscellaneous Comments
Comment: A commenter suggested that the relevant notice provisions
and payment preclusions in Sec. 422.222(a)(1) be referenced in the
PACE regulation by including an explicit cross reference in Sec.
460.86. This would, the commenter stated, ensure that PACE
organizations know where in the CFR to find more detailed requirements
related to the preclusion list.
Response: We appreciate this comment and may consider it for future
rulemaking. At this time, we believe that the PACE regulation is
sufficient. We explained in the April 2018 final rule, in our proposed
rule, and in this final rule how the requirements in Sec. 422.222 are
incorporated into the requirements for the PACE program.
Comment: A commenter supported the discretion given to plans to not
include a particular prescriber on the preclusion list when CMS
determines that exceptional circumstances exist regarding beneficiary
access to prescriptions. The commenter recommended that CMS also
provide similar discretion to MA plans when CMS determines the
previously referenced exceptional circumstances exist.
Response: We clarify that only CMS has the discretion not to place
a provider on the preclusion list due to access to care concerns. Plans
can notify CMS if they believe there will be access to care issues by
removing a particular provider from their network, and CMS will notify
the plan of its determination regarding the preclusion. Nonetheless, we
agree with the commenters' general rationale that an exception should
be made for MA regarding access to care concerns. We are therefore
adding a new paragraph (a)(6) to Sec. 422.222 that mirrors the access
to care exception provided at Sec. 423.120(c)(6)(vi); specifically,
CMS will have the discretion not to include a particular individual or
entity on (or, if warranted, remove the individual from) the preclusion
list should it determine that exceptional circumstances exist regarding
beneficiary access to MA items, services, or drugs. In making a
determination as to whether such circumstances exist, CMS takes into
account: (i) The degree to which beneficiary access to MA services,
items, or drugs would be impaired; and (ii) any other evidence that CMS
deems relevant to its determination.
Comment: Concerning the 10-year period for the preclusion list, a
commenter recommended that CMS set a lower default preclusion period of
3 years and use aggravating or mitigating factors to adjust the period
as applicable. The commenter was concerned that under the proposed
rule, any felony conviction automatically defaults to a 10-year
preclusion period. Consistent with the March 1, 2016 proposed rule
published in the Federal Register titled ``Medicare, Medicaid, and
Children's Health Insurance Programs; Program Integrity Enhancements to
the Provider Enrollment Process'' (CMS-6058-P), the commenter stated
that the 10-year period should be maximum, not mandatory, unless the
party in question is excluded by the OIG for a longer period. The
commenter stated that the 10-year default period is greater than the
OIG mandatory exclusion of 5 years and the general default of 3 years
of permissive exclusions. Moreover, the commenter stated, OIG mandatory
exclusions only cover specific conduct and not all felonies. The
commenter added that CMS should provide parameters regarding what types
of felonies fall under this section; the commenter stated that this
would be consistent with felony determinations under Sec.
424.535(a)(3).
Response: We note that our proposed provisions do not automatically
require a 10-year preclusion list period for every felony conviction.
Under proposed Sec. 423.120(c)(6)(vii), for instance, a 10-year period
will be used unless CMS determines that a shorter timeframe is
warranted based upon CMS' consideration of several factors. In each
case, CMS will examine whether a period of less than 10 years is
justified. Insofar as the types of felonies that may come within the
purview of these provisions, we will consider further clarification via
sub-regulatory guidance.
Comment: Several commenters stated that, according to their
understanding, CMS would undertake a three-step process for
implementing the preclusion list: (1) Beginning on January 1, 2019, the
preclusion list will go into effect without the proposals outlined in
the proposed rule; (2) 60 days following
[[Page 15795]]
publication of CMS-4185-F, Medicare plans will be required to implement
the new consolidated appeals provisions; and (3) any other changes in
the proposed rule that are eventually finalized will not become
effective until January 1, 2020. The commenters expressed several
concerns about this process. First, they believed that it saddles
Medicare plans with managing multiple deadlines and effective dates
despite long-term planning already underway. Second, the process
involves changing and uncertain rules, which could confuse stakeholders
(including beneficiaries) as to which policies apply at which time (for
example, a beneficiary may be uncertain as to whether or when he or she
has appeal rights); this, the commenters believed, could interrupt
beneficiary care and cause beneficiary frustration with their Medicare
plans and providers.
Response: While we appreciate the commenters' concerns, we stress
that we have worked very closely with the plans and other stakeholders
to: (1) Prepare them for the preclusion list's implementation; and (2)
develop sub-regulatory guidance to address their questions. We are
closely and diligently monitoring the progress of the implementation.
We will continue regular communication with stakeholders and
expeditiously address issues if or as they develop.
Comment: A commenter stated that the previously mentioned HPMS memo
sought to impose requirements that go beyond the provisions of the
April 2018 final rule. The commenter contended that: (1) These
additional requirements must be promulgated through notice-and-comment
rulemaking; and (2) CMS should withdraw the HPMS memo and/or clarify
that it does not create binding requirements.
Response: We respectfully disagree. The HPMS memo focuses on
operational details that are most appropriately developed and
disseminated through sub-regulatory guidance.
Comment: Several commenters supported CMS' elimination of the
provider enrollment requirements for MA providers and Part D
prescribers.
Response: We appreciate the commenters' support.
Comment: A number of commenters supported the implementation of the
preclusion list requirements as a whole.
Response: We appreciate the commenters' support.
Comment: Numerous commenters stated that CMS must work with the
industry and other stakeholders to help ensure smooth execution of the
preclusion list with as little disruption in beneficiary care as
possible.
Response: We agree with the commenters. We have worked closely with
stakeholders to ensure an effective implementation of the preclusion
list and will continue to do so.
Comment: Several commenters stated that CMS must make certain that
the preclusion list: (1) Is updated frequently to minimize the time
between when a provider is precluded and the time that information is
available to plans and providers; and (2) contains information needed
to properly identify a precluded prescriber (for example, an NPI).
Response: We agree with the commenters. We are striving to ensure
that preclusion list updates are appropriately made and that the
preclusion list file contains sufficient identifying data.
Comment: A commenter questioned whether Medicare plans will be
limited in the number of users granted access to the preclusion list.
The commenter stated that PBMs that process and pay claims and others
need access to this file. Although the commenter contended that CMS
indicated in its December 14 sub-regulatory guidance that it will not
grant access to the preclusion list to PBMs, the commenter urged CMS to
reconsider this position, perhaps by making the preclusion list public.
Response: We state respectfully that CMS will not make the
preclusion list public. The list contains sensitive data (such as
revoked provider information), and CMS historically has not shared this
information publicly. Nonetheless, CMS is exploring secure means (other
than public release) to make the data available to PBMs and other plan
subcontracted entities.
Comment: A commenter recommended that CMS work with plans to
develop an automated process so that preclusion list requirements can
be better implemented and operationalized.
Response: We are always receptive to plan feedback regarding file
delivery and format. We are available to work with plans to implement
enhancements that would make the process more efficient. We believe,
however, that such enhancements are best considered once a baseline has
been implemented by the applicable deadline.
Comment: A commenter urged CMS to encourage plans to educate
beneficiaries about the preclusion list so that the latter understand
the concept before they perhaps encounter it.
Response: We agree and have indeed suggested that plans educate
their enrollees regarding the preclusion list for the reason the
commenter states.
Comment: A commenter questioned whether there will be a link to the
preclusion list or whether CMS will transmit the list to plans and MA
organizations.
Response: Plans are granted access to the list via a secure website
and file transfer process.
Comment: A commenter encouraged CMS to be flexible in overseeing
and enforcing the preclusion list, for stakeholders have been using
their best efforts to comply with the changing requirements and need
time to acclimate to the new processes.
Response: We appreciate this comment and recognize that
stakeholders have been making efforts to prepare for the preclusion
list's implementation. We will closely monitor the progress of this
implementation.
Comment: A commenter contended that the proposed changes
(especially the reduced timeline for the mandatory denial of claims)
will cause several difficulties without enhancing program integrity.
First, they will significantly increase plan administrative costs.
Second, beneficiaries could be harmed due to disruptions in their
medication. Third, beneficiaries could become dissatisfied with the
timeframes in which they must seek a new provider. Fourth, the proposed
rule contains no protections that could mitigate the above-referenced
problems. The commenter accordingly recommended that CMS retain the
standards established in the April 2018 final rule and engage MAOs (and
other stakeholders) in developing means of aligning preclusion list
processes with those for the OIG exclusion list.
Response: While we appreciate the commenter's concerns, we believe
the changes in this rule facilitate a more patient-minded approach. We
reiterate that enrollees will have 60-90 days' prior notification that
their provider is precluded. During that period, claims and
prescriptions associated with the precluded provider can be paid by the
Part C or D plan. This will give the enrollee time to transfer to a
new, non-precluded provider. Indeed, we note that Part C and D plans
are currently prohibited from paying for claims and prescriptions
associated with excluded providers. The additional administrative
burden for a plan to check the preclusion list is not, in our view, a
significant new requirement. While this rule establishes a beneficiary
notice timeframe, we have simultaneously streamlined the date that a
plan is to reject/deny claims for each version of the monthly
preclusion list, rather than require plans to track timeframes for
[[Page 15796]]
rejections/denials on a beneficiary basis. If plans were required to
implement the preclusion list in the manner that the OIG exclusion list
is operationalized, there may be no beneficiary notification period.
For these reasons, we respectfully decline to adopt the commenter's
suggestion.
Comment: A commenter stated that there is insufficient technical
guidance for dual-eligible special needs plans (D-SNPs), their PBMs,
and other delegated entities to sufficiently test and implement the
preclusion list process by January 1, 2019. The commenter urged CMS to
extend the first review period for D-SNPs to at least 180 days; this
would enable D-SNPs and CMS to ensure that systems are appropriately
configured and operational policies established prior to any payment
denials.
Response: We believe that the commenter is suggesting a minimum
180-day delay in the implementation of the preclusion list as a whole.
As stated previously, we respectfully decline to do so. However, we
will work closely with D-SNPs concerning this implementation and will
issue sub-regulatory guidance to assist D-SNPs in this regard.
Comment: A commenter questioned whether any of the fields are
conditionally required (for example, whether a date of birth for
businesses or an EIN is required).
Response: CMS will issue sub-regulatory guidance on this issue as
soon as feasible.
Comment: A commenter questioned whether there is a communication
process for questionable data records (for example, for missing
required fields such as an NPI or a missing effective date).
Response: CMS has issued sub-regulatory guidance that clarifies the
process for communicating questionable data records. It can be accessed
at the following link: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/PreclusionList.html.
Comment: A commenter sought clarification as to when PDE guidance
will be available.
Response: We refer the commenter to the PDE guidance issued in the
previously referenced HPMS memorandum, ``February 2019 Updates to the
Drug Data Processing System (``DDPS''),'' dated January 8, 2019 and
released January 9, 2019.
Comment: A commenter stated that the proposed rule lacks a ``look-
back'' period indicating which plan members must be notified of a
precluded provider. The commenter recommended that CMS revise proposed
Sec. Sec. 422.222(a)(1)(ii)(A) and 423.120(c)(6)(iv)(A) to clarify
that plans need only notify a member who has received services from a
precluded provider in the 12 months prior to the date the provider was
added to the preclusion list. Codifying a ``look back'' period in
regulation, rather than merely via sub-regulatory guidance, will
provide clarity to plans.
Response: While we appreciate this suggestion, we respectfully
decline to establish a formal look-back period in this rule. We must
retain the flexibility (especially during the early stages of the
preclusion list's implementation) to carefully monitor the program and
to make any revisions (such as a look-back period) only after a careful
deliberation.
Comment: Several commenters stated that CMS should clarify each of
the provider types and specialties that will be on the list.
Response: We appreciate this comment and may consider furnishing
such clarification, as needed, in subregulatory guidance.
Comment: Several commenters recommended that CMS detail the data
sources used to place dentists who have never enrolled in Medicare on
the preclusion list.
Response: Using CMS' internal data and systems (which includes, but
is not limited to, the Provider Enrollment, Chain, and Ownership System
and the National Plan and Provider Enumeration System), we will screen
any prescriber or provider that could potentially prescribe Part D
drugs or furnish MA services or items to a Medicare beneficiary through
an MA plan.
Comment: Several commenters recommended that when CMS notifies
providers that they are precluded, CMS should require those providers
to inform patients that they do not accept Medicare beneficiaries and
that their claims will not be processed. A commenter believed that this
approach would be particularly appropriate if there is no claim history
(for example, new patient or referral) and thus no ability for plans to
notify beneficiaries.
Response: We appreciate this comment and may consider it for future
rulemaking as appropriate.
Comment: Several commenters urged CMS to clarify whether urgent and
emergency services are exempt from the requirement that MA plans and
delegated entities deny claims for services furnished by precluded
providers.
Response: Urgent and emergency services are not exempt from the
claim denial requirements of Sec. 422.222.
Comment: A commenter expressed support for the proposals to add
language to the regulatory text concerning the following policies: (1)
Beneficiaries may not appeal payment denials based on a provider's
preclusion; and (2) unenrolled prescribers and providers should remain
precluded for the same length of time as the reenrollment bar that CMS
could have imposed had that prescriber or provider been enrolled and
then revoked.
Response: We appreciate the commenter's support.
Comment: A commenter contended that CMS' proposed changes to its
preclusion list policies would create additional complexities and be of
limited value. The commenter added that the separately required
beneficiary notices (and the claims denial deadlines triggered thereby)
are inconsistent with CMS' goal of operationalizing the preclusion list
in the same manner as the OIG exclusion list. Under the exclusion list
process, the commenter stated, CMS makes the exclusion list public,
updates it monthly, posts it 15 days prior to the exclusion effective
date, and expects plans to deny claims as of the effective date. The
commenter suggested that CMS make the preclusion list public and
implement it similar to the exclusion list. This approach, the
commenter believed, would alleviate inconsistencies and stakeholders'
concerns.
Response: For reasons stated previously, CMS is unable to make the
preclusion list public. Moreover, we do not believe it is possible to
implement the preclusion list in a fashion that mirrors the OIG
exclusion list. We believe that the preclusion list, upon full
implementation, will impact a much larger provider population than the
OIG exclusion list, for the intent of the preclusion list was to create
an effective alternative to enrollment. The criteria for a provider to
become precluded are therefore different and broader than those for
exclusion. For this reason, we believe the beneficiary notice period is
essential to protect beneficiaries from major disruptions of care. We
note also that CMS has added data fields to the file to increase
consistency between the notification period and the claims rejection/
denial date.
Comment: A commenter questioned whether a provider must inform
beneficiaries if they learn that another provider has been excluded.
The commenter cited the example of a beneficiary who attempts to fill a
prescription at a pharmacy retail location and the prescription is
denied
[[Page 15797]]
due to the provider being excluded. The commenter sought clarification
concerning the pharmacy's responsibility (if any) to notify the
beneficiary of the excluded provider.
Response: We appreciate this comment but believe it is outside the
scope of this rule.
Comment: Several commenters noted that in an FAQ issued December
14, 2018 (see (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/MedicareProviderSupEnroll/PreclusionList.html.), CMS
stated that subcontractors will not be granted access to the preclusion
list and that MAOs will have to share the list with subcontractors as
needed. Some subcontractors, the commenters noted, process all claims
and credentialing activities, which makes direct access to the
preclusion list imperative. Without such access, the commenters stated,
downstream entities will have to work through MA organizations, which
could delay enrollee notification. In sum, the commenters requested
that: (1) Subcontractors and delegated entities be provided access to
the preclusion list; and (2) the enforcement date for subcontractors to
use the preclusion list be delayed until subcontractors have access to
it.
Response: As explained earlier, CMS is unable to publicize
preclusion data. However, CMS is exploring other secure means of making
the data available to PBMs and other plan subcontracted entities. We
must, however, respectfully decline to delay the implementation of the
preclusion list as the commenter suggests.
d. Final Provisions
Given the foregoing, we are finalizing all of our proposed
preclusion list provisions as proposed except as follows:
Our proposed revisions to Sec. 423.120(c)(6)(i), (ii),
and (vi) that would change the term ``individual'' to ``prescriber''
will not be finalized.
Our proposed change of the phrase ``individual NPI of the
prescriber'' to ``NPI of the prescriber'' in Sec. 423.120(c)(6)(iii)
will not be finalized.
In Sec. 422.222(a)(1)(i), we are changing the language
``health care item or service furnished'' to ``health care item,
service, or drug that is furnished, ordered, or prescribed''. We are
making similar edits to Sec. 422.222(a)(1)(ii)(A) and (C) and to Sec.
422.504(g)(1)(iv); specifically, we will include therein, as
applicable, references to ``ordered,'' ``prescribed,'' and ``drugs.''
We are deleting the phrase ``by CMS'' in proposed Sec.
422.222(a)(2)(ii)(B) and Sec. 423.120(c)(6)(v)(B)(2). This is to
clarify that Administrative Law Judges and the Department of Appeals
Board (which would, applicable, consider the appeals in question
jointly) are not part of CMS.
We are clarifying the opening paragraphs of Sec. Sec.
423.120(c)(6)(iv) and 422.222(a)(1)(ii) to state that Sec. Sec.
423.120(c)(6)(iv) and 422.222(a)(1)(ii) do not apply if the prescriber
or provider is currently excluded by the OIG.
We are revising Sec. Sec. 423.120(c)(6)(iv)(B) and
422.222(a)(1)(ii)(B) as follows:
++ The existing versions of these paragraphs will be incorporated
into new paragraphs Sec. Sec. 423.120(c)(6)(iv)(B)(1) and
422.222(a)(1)(ii)(B)(1), respectively. Also, we are inserting the
following language at the beginning of these respective new paragraphs:
``Subject to paragraph (c)(6)(iv)(B)(2) of this section'' and ``Subject
to paragraph (a)(1)(ii)(B)(2) of this section''.
++ In new paragraphs Sec. Sec. 423.120(c)(6)(iv)(B)(2) and
422.222(a)(1)(ii)(B)(2), we will state that paragraph (B)(1) will apply
only upon receipt of a claim from, respectively, a precluded provider
(either contracted or non-contracted) in Medicare Part C or upon a
prescriber writing a prescription in Medicare Part D when: (i) The MA
organization or plan sponsor has enough information on file to either
copy the provider or prescriber on the notification previously sent to
the beneficiary or send a new notice informing the provider or
prescriber that they may not see plan beneficiaries due to their
preclusion status; and (ii) the claim is received after the claim
denial or reject date in the preclusion file.
To clarify the applicability of Sec. 422.222, we are
changing the title of this section from ``Preclusion list'' to
``Preclusion list for contracted and non-contracted individuals and
entities.''
We are adding a new paragraph (a)(6) to Sec. 422.222 that
would mirror the existing version of Sec. 423.120(c)(6)(vi) and state
as follows:
++ The opening paragraph will read: ``CMS has the discretion not to
include a particular individual or entity on (or, if warranted, remove
the individual or entity from) the preclusion list should it determine
that exceptional circumstances exist regarding beneficiary access to MA
items, services, or drugs. In making a determination as to whether such
circumstances exist, CMS takes into account''
++ Paragraph (a)(6)(i) will read: ``The degree to which beneficiary
access to MA items, services, or drugs would be impaired; and
++ Paragraph (a)(6)(ii) will read: ``Any other evidence that CMS
deems relevant to its determination.''
++ We are adding the language ``Ensure that'' to the beginning of
Sec. 422.504(g)(1)(iv).
++ We are adding a new Sec. 422.504(g)(1)(v) that would state as
follows: ``Ensure that the plan's provider agreement contains a
provision stating that after the expiration of the 60-day period
specified in Sec. 422.222:
--The provider will no longer be eligible for payment from the plan and
will be prohibited from pursuing payment from the beneficiary as
stipulated by the terms of the contract between CMS and the plan per
Sec. 422.504(g)(1)(iv); and
--The provider will hold financial liability for services, items, and
drugs that are furnished, ordered, or prescribed after this 60-day
period, at which point the provider and the beneficiary will have
already received notification of the preclusion.''
D. Implementing Other Changes
1. Clarification Regarding Accreditation for Quality Improvement
Programs
Section 1852(e)(4) of the Act requires the Secretary to deem that
an MA organization has met all of the requirements for any one out of
the six program areas listed in section 1852(e)(4)(B) of the Act if the
MA organization is accredited in that area by an accrediting
organization that has been approved by CMS and that uses the same (or
stricter) standards than CMS uses to evaluate compliance with the
applicable requirements. An amendment to the Act to revise subsection
(e) made by section 722(a) of the Medicare Prescription Drug,
Improvement, and Modernization Act of 2003 appears not to have been
fully incorporated into the provisions governing the authority to deem
compliance with section 1852(e)(3) of the Act by an MA organization
based on accreditation by an approved accreditation entity. We direct
readers to the proposed rule for additional discussion (83 FR 55041).
In the proposed rule, we clarified that an MA organization may be
deemed to have satisfied the requirements of section 1852(e)(3) of the
Act and the paragraphs of Sec. 422.152 related to section 1852(e)(3)
of the Act based on the review of an approved accreditation
organization. We received one comment thanking us for the
clarification. We will implement the clarified scope of the regulation
going forward.
[[Page 15798]]
2. Delete the Reference to Quality Improvement Projects in Sec.
422.156(b)(1)
Section 1852(e) of the Act requires each MA organization to have an
ongoing Quality Improvement (QI) Program for the purpose of improving
the quality of care provided to its enrollees. Our regulations at Sec.
422.152 outline the QI Program requirements MA organizations. Section
422.152(a)(3) requires each MA organization to conduct quality
improvement projects (QIPs) for its enrollees, and Sec. 422.152(d)
establishes the requirements for the QIPs. Effective January 1, 2019,
CMS eliminated the requirements for QIPs in Sec. Sec. 422.152(a)(3)
and 422.152(d) in the April 2018 final rule (83 FR 16440). However, the
reference to QIPs was not deleted in Sec. 422.156(b)(1), which says
QIPs are exempt from the process for deeming compliance based on
accreditation.
We proposed a technical correction that would delete the phrase
``the quality improvement projects (QIPs) and'' from Sec.
422.156(b)(1). We did not receive any comments on the proposal. We are
finalizing the technical correction without modification in this final
rule. We direct readers to the proposed rule for additional discussion
(83 FR 55041).
III. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et
seq.), we are required to provide 30-day notice in the Federal Register
and solicit public comment before a ``collection of information,'' as
defined under 5 CFR 1320.3(c) of the PRA's implementing regulations, is
submitted to the Office of Management and Budget (OMB) for review and
approval. In order to fairly evaluate whether an information collection
requirement (ICR) should be approved by OMB, section 3506(c)(2)(A) of
the PRA requires that we solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
In the November 1, 2018 (83 FR 54982) proposed rule, we solicited
public comment on our proposed information collection requirements,
burden, and assumptions. As discussed in section III.B.1. of this final
rule, we received comments pertaining to Evidence of Coverage (EOC)
notifications and provider directory requirements. Based on internal
review, we have revised several cost estimates (see Wage Data). As
explained in section III.B.4. of this final rule, we have also added
burden related to Medicare Parts A and B claims data extracts.
A. Wage Data
To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' (BLS's) May 2017 National Occupational Employment and Wage
Estimates for all salary estimates (https://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 2 presents the mean hourly wage,
the cost of fringe benefits and overhead (calculated at 100 percent of
salary), and the adjusted hourly wage. The adjusted wages are used to
derive our cost estimates.
Table 3--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
Fringe
Occupation Mean hourly benefits and Adjusted
code wage ($/hr) overhead ($/ hourly wage ($/
hr) hr)
----------------------------------------------------------------------------------------------------------------
Business Operation Specialist................... 13-1199 $36.42 $36.42 $72.84
Lawyer.......................................... 23-1011 68.22 68.22 136.44
Software Developers and Programmers............. 15-1130 49.27 49.27 98.54
----------------------------------------------------------------------------------------------------------------
As indicated, we are adjusting our employee hourly wage estimates
by a factor of 100 percent. This is a necessary rough adjustment, both
because fringe benefits and overhead costs vary significantly from
employer to employer and because methods of estimating these costs vary
widely from study to study. We believe that doubling the hourly wage to
estimate total cost is a reasonably accurate estimation method.
While we did not receive any public comments pertaining to our
proposed wage estimates, based on internal review we have changed our
proposed Programmer respondent type (BLS occupation code 15-1311 at
$40.95/hr) to Software Developers and Programmers (BLS occupation code
15-1130 at $49.27/hr). The change adds $8.32/hr (mean) to our proposed
Programmer-specific cost estimates and $16.64/hr (adjusted). The change
affects sections III.B.2.a.(2), III.B.2.b.(2), and III.B.3.a.(2) of
this final rule.
We have also corrected the occupation code for Business Operations
Specialists from 13-000 to 13-1199. This correction adds $1.88/hr
(mean) to our proposed Business Operations Specialist-specific cost
estimates and $3.76/hr (adjusted). The change affects sections
III.B.2.a.(2), III.B.2.b.(2), III.B.3.a.(1), and III.B.4. of this final
rule.
We are not making any changes to the proposed Lawyer respondent
type (BLS occupation code 23-1011 at $68.22/hr (mean) and $136.44/hr
(adjusted)).
B. Information Collection Requirements (ICRs)
The following ICRs are listed in the order of appearance in section
II. of this final rule.
1. ICRs Regarding the Requirements for Medicare Advantage Plans
Offering Additional Telehealth Benefits (Sec. 422.135)
As described in section II.A.1. of this final rule, section 50323
of the Bipartisan Budget Act of 2018 allows MA plans the ability to
provide MA additional telehealth benefits to enrollees starting in plan
year 2020 and treat them as basic benefits. In this rule, we are
finalizing--with slight modifications--most proposed requirements at
Sec. 422.135, which will authorize and set standards for MA plans to
offer MA additional telehealth benefits. More specifically, we are
finalizing our requirement that MA plans must advise enrollees that
they may receive the specified Part B service(s) either through an in-
person visit or through electronic exchange (Sec. 422.135(c)(2)). As
discussed in section II.A.1. of this final rule, based on public
comments we are not finalizing
[[Page 15799]]
the portion of proposed Sec. 422.135(c)(2) that referenced the EOC
document as the required vehicle for this notification. Instead, we
intend to address the EOC in future sub-regulatory guidance.
MA plans will be required to make information about the coverage of
additional telehealth benefits available to CMS upon request (finalized
at Sec. 422.135(c)(4)). We do not anticipate requesting this
information from more than nine MA plans in a given year because
historically we have not received a large number of complaints about
coverage of benefits that might warrant our request for information
from many plans. However, we reserve the right to ask for this
information. Since we estimate fewer than 10 respondents, the
information collection requirement is exempt (5 CFR 1320.3(c)) from the
requirements of the PRA.
As discussed in section II.A.1. of this final rule, based on public
comments we are not finalizing our proposed provider directory
requirements under proposed Sec. 422.135(c)(3). We have therefore
modified our discussion of potential information collection
requirements and assumptions related to provider directories, as it is
no longer necessary to address them in the context of this final rule.
Similar to the EOC, we intend to address the provider directory in
future sub-regulatory guidance.
This final rule is consistent with our proposed rule in that
neither set out any burden related to MA plans offering MA additional
telehealth benefits.
2. ICRs Regarding Integration Requirements for Dual Eligible Special
Needs Plans (Sec. 422.107)
The following requirements and burden will be submitted to OMB for
approval under control number 0938-0753 (CMS-R-267).
As described in section II.A.2.a. of this final rule, we are
establishing new requirements in accordance with amendments to section
1859(f)(8) of the Act (made by section 50311(b) of the Bipartisan
Budget Act of 2018), which stipulates that all dual eligible special
needs plans (D-SNPs) meet certain new minimum criteria for Medicare and
Medicaid integration for 2021 and subsequent years. We are also
codifying the various forms of integrated care provided by D-SNPs that
have evolved since their establishment nearly 15 years ago.
In Sec. 422.107(d), any D-SNP that is not a fully integrated dual
eligible special needs plan (FIDE SNP) or a highly integrated dual
eligible special needs plan (HIDE SNP), as defined in Sec. 422.2, will
be subject to an additional contracting requirement. Under the
additional contracting requirement, the D-SNP must notify the state
Medicaid agency and/or individuals or entities designated by the state
Medicaid agency of hospital and skilled nursing facility (SNF)
admissions for at least one group of high-risk full-benefit dual
eligible individuals, as determined by the state Medicaid agency.
In addition, we are modifying existing requirements for the
contract between states and D-SNPs at Sec. 422.107(c). The
modifications will include requirements that the contract between the
D-SNP and the state: (1) Document the D-SNP's responsibility to
coordinate the delivery of Medicaid benefits for individuals who are
eligible for such services and, if applicable, to provide coverage of
Medicaid services for those eligible; (2) specify the categories and
criteria for eligibility for dual eligible individuals to be enrolled
in the plan; and (3) specify the Medicaid benefits covered by the MA
organization offering the D-SNP under a capitated contract with the
State Medicaid agency or by the D-SNP's parent organization or another
entity that is owned and controlled by its parent organization. We are
also finalizing a new requirement that the contract between a D-SNP
that is an applicable integrated plan, as defined in Sec. 422.561, and
the state document the D-SNP's use of the unified appeals and grievance
procedures required under Sec. Sec. 422.629 and 422.630, 438.210,
438.400, and 438.402, as finalized in this rule.
The primary burden arising from the modifications to the
contracting provisions between states and D-SNPs will consist of the
following:
Burden to states to--
++ Execute D-SNP contract modifications regarding new and modified
requirements under Sec. 422.107(c) and the notification requirement at
Sec. 422.107(d), as detailed in section II.A.2.a.(2). of this final
rule; and
++ Establish the terms of the notification at Sec. 422.107(d),
including its method, timing, and scope, and receive such notification
from D-SNPs about high-risk enrollees' hospital and SNF admissions (if
the state contracts with D-SNPs that are not FIDE SNPs or HIDE SNPs, as
those terms are defined in Sec. 422.2).
Burden to D-SNPs to--
++ Execute a contract modification with the state Medicaid agency
regarding new and modified requirements under Sec. 422.107(c) and the
notification requirement at Sec. 422.107(d), as detailed in section
II.A.2.a.(2). of this final rule; and
++ Notify the state Medicaid agency or its designee(s) about the
hospital and SNF admissions for the state-identified population of
high-risk enrollees (if the D-SNP is not a FIDE SNP or HIDE SNP, as
those terms are defined in Sec. 422.2).
a. Burden to States
(1) Contract Modifications With D-SNPs (Sec. 422.107)
For the initial year, we expect it will take 24 hours at $136.44/hr
for a lawyer to update the state Medicaid agency's contract with every
D-SNP in its market to address the changes to Sec. 422.107 made by
this final rule. Since half of the cost will be offset by federal
financial participation for Medicaid administrative activities, we have
adjusted our estimates for state agencies by 50 percent. Given the
market penetration of D-SNPs in certain states relative to others, we
recognize that this estimate reflects an average cost across all states
and territories with D-SNPs. We expect that the state Medicaid agency
will establish uniform contracting requirements for all D-SNPs
operating in their market. As of June 2018, there were 42 states, plus
the District of Columbia and Puerto Rico, in which D-SNPs were
available to MA enrollees.\41\ In aggregate, we estimate a one-time
burden of 1,056 hours (44 respondents x 24 hr/response) at an adjusted
cost of $72,040 (1,056 hr x $136.44/hr x 0.50). Over the course of
OMB's anticipated 3-year approval period, we estimate an annual burden
of 352 hours (1,056 hr x \1/3\) at a cost of $24,013 ($72,040 x \1/3\).
We are annualizing the one-time estimate since we do not anticipate any
additional burden after the 3-year approval period expires.
---------------------------------------------------------------------------
\41\ Centers for Medicare & Medicaid Services (2018, June). SNP
Comprehensive Report. Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html.
---------------------------------------------------------------------------
In future years, we anticipate minimal burden associated with
modifications to contract terms consistent with the changes we are
finalizing to Sec. 422.107(c)(1) through (3). While it is possible
more states will move toward increased integration by contracting with
applicable integrated plans and would therefore need to modify their
state Medicaid agency contracts with D-SNPs consistent with the changes
we are finalizing to Sec. 422.107(c)(9), we are unable to reliably
estimate the additional burden in subsequent years. In addition, while
we recognize that, over time, states could modify the newly required
contract term at
[[Page 15800]]
Sec. 422.107(d) to require notification about admissions for certain
high-risk enrollees (for example, by expanding the population of high-
risk full-benefit dual eligible individuals to whom this notification
applies), we do not believe that such a contract change will have a
material impact on time and effort and, therefore, will already be
accounted for in the burden estimate for the overall contract that the
state Medicaid agency has with each D-SNP.
Given the lack of material impact and the uncertainty involved in
estimating state behavior, we are estimating a minimum of zero burden
in subsequent years on plans. The maximum burden will be the estimated
first year cost. However, we believe the maximum estimate is unlikely
to be accurate since we expect any changes to contracting requirements
to be iterative compared to the first year update.
We solicited public comment on our assumptions in the proposed rule
and whether there are reasonable ways of modeling state behavior. We
received no comments on our information collection requirements, burden
estimates, and assumptions and are finalizing them without
modification.
(2) Notification (Sec. 422.107(d))
To address differences among the states in available
infrastructure, population sizes, and mix of enrollees, this rule
provides broad flexibility to identify the groups for which the state
Medicaid agency wishes to be notified and how the notification should
take place. These flexibilities include: (1) Consideration of certain
groups who experience hospital and SNF admissions; (2) protocols and
timeframes for the notification; (3) data sharing and automated or
manual notifications; and (4) use of a stratified approach over several
years starting at a small scale and increasing to a larger scale. This
final rule also allows states to determine whether to receive
notifications directly from D-SNPs or to require that D-SNPs notify a
state designee such as a Medicaid managed care organization, section
1915(c) waiver case management entity, area agency on aging, or some
other organization.
Some states, using a rich infrastructure and a well-developed
automated system, may fulfill this notification requirement with
minimal burden, while states with less developed or no infrastructure
or automated systems may incur greater burden. Furthermore, the burden,
especially to those states starting on a small scale, may differ
significantly from year to year. Because of the flexibilities provided
in this final rule, we expect that states will choose strategies that
are within their budget and best fit their existing or already-planned
capabilities. We expect any state choosing to receive notification
itself of such admissions to claim federal financial participation
under Medicaid for that administrative activity.
As of June 2018, there were 42 states, plus the District of
Columbia and Puerto Rico, in which D-SNPs were available to MA
enrollees. We estimate that there are nine (9) states and territories
with D-SNPs that are all expected to qualify as either FIDE SNPs or
HIDE SNPs--Arizona, Florida, Hawaii, Idaho, Massachusetts, Minnesota,
New Jersey, New Mexico, and Puerto Rico. We do not expect these states
to establish a notification system under this final rule because none
of their D-SNPs will be subject to the state notification requirement
at Sec. 422.107(d). We estimate that nine additional states that
primarily use managed care for long-term services and supports (LTSS)
(Michigan, New York, North Carolina, Ohio, Oregon, Pennsylvania,
Tennessee, Texas, and Virginia) will delegate receipt of this
information to their Medicaid managed care organizations. We also
estimate that approximately half of the remaining 26 states (42
states--16 states, excluding the District of Columbia and Puerto Rico)
or 13 states will build an automated system for receiving notification
of hospital and SNF admissions consistent with this final rule.
We estimate that, on average, this work could be accomplished in a
month with one software developer/programmer to build an automated
system and one business operations specialist to define requirements.
We estimate a one-time burden of 4,160 hours (13 states x 40 hr/week x
4 weeks x 2 FTEs). Since half of the cost will be offset by 50 percent
federal financial participation for Medicaid administrative activities,
we estimate an adjusted cost of $178,235 [((2,080 hr x $98.54/hr) +
(2,080 hr x $72.84/hr)) x 0.50]. Over the course of OMB's anticipated
3-year approval period, we estimate an annual burden of 1,386.667 hours
(4,160 hr x \1/3\) at a cost of $59,412 ($178,235 x \1/3\). We are
annualizing the one-time estimate since we do not anticipate any
additional burden after the 3-year approval period expires.
Because of the possible wide variability in states' approaches in
implementing this requirement, we solicited comment in the proposed
rule and requested suggestions for modeling state approaches and costs
related to this provision. Given the uncertainty involved in estimating
state behavior, we estimated a minimum of zero burden in subsequent
years on plans and a maximum burden that is the estimated first-year
cost. We received no comments and are finalizing our time estimates
without change. Our proposed cost estimates have been revised to
account for the changes discussed in section III.A. of this final rule.
b. Burden on Plans
(1) Contract Modifications With State Medicaid Agencies (Sec. 422.107)
For the initial year, we expect it will take 8 hours at $136.44/hr
for a lawyer to update their plan's contract with the state Medicaid
agency to reflect the revised and new provisions finalized in this rule
at Sec. 422.107(c)(1)-(3), (c)(9), and (d). We are unable to
differentiate how these provisions impact individual D-SNP contracts
due to the ways contracts are structured. For example, some contracts
will include FIDE SNPs, HIDE SNPs, and other D-SNPs, while others may
include only a subset of these D-SNP types. The specific requirements
for the content of and scope of changes to the contract vary somewhat
based on the type of D-SNP the plan is. However, it is reasonable to
project that every D-SNP contract will require contract modifications
with the state Medicaid agency.
There are 190 D-SNP contracts as of June 2018.\42\ In aggregate, we
estimate a one-time burden of 1,520 hours (190 D-SNPs x 8 hr/
modification) at a cost of $207,389 (1,520 hr x $136.44/hr). Over the
course of OMB's anticipated 3-year approval period, we estimate an
annual burden of 507 hours (1,520 hr x \1/3\) at a cost of $69,130
($207,389/3). We are annualizing the one-time estimate since we do not
anticipate any additional burden after the 3-year approval period
expires.
---------------------------------------------------------------------------
\42\ Centers for Medicare & Medicaid Services (2018, June). SNP
Comprehensive Report. Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html.
---------------------------------------------------------------------------
We believe that we have no reasonable way of estimating or
illustrating burden in later years. The expected behavior among states
is unknown relative to how often they will modify their contracts with
D-SNPs on this particular matter. For example, state Medicaid agencies
may remain satisfied with the initial year selection of high-risk
groups and see no reason to modify their contracts in later years. In
contrast, other state Medicaid agencies may seek to expand the
notification requirement
[[Page 15801]]
to encompass additional groups of high-risk dual eligible individuals
and may therefore modify their contracts on this basis. Given the
uncertainty involved in estimating state behavior, we are estimating a
minimum of zero burden in subsequent years on plans. The maximum burden
will be the first year costs.
We received no comments on our assumptions in the proposed rule or
on ways to reasonably model state behavior and are finalizing our
proposed estimates without modification. However, we are finalizing our
burden estimates to reflect the omission of the burden associated with
Sec. Sec. 422.107(c)(1) through (3) and 422.107(c)(9) in the proposed
rule.
(2) Notifications to State Medicaid Agencies or Their Designees (Sec.
422.107(d))
We have noted previously in section II.A.2.a. of this final rule
the broad flexibility in notification options for states. We also note
that MA organizations are already required to have systems that are
sufficient to organize, implement, control, and evaluate financial and
marketing activities, the furnishing of services, the quality
improvement program, and the administrative and management aspects of
their organization (Sec. 422.503(b)(4)(ii)). Independent of the state
Medicaid agency's selection of high-risk populations, protocols, and
notification schedules, an MA organization's most likely method of
sharing this notification will be through the use of an automated
system that could identify enrollees with criteria stipulated by the
states and issue electronic alerts to specified entities. We do not
believe that this work is very complex. Therefore, we estimate it could
be accomplished in a month with one software developer/programmer to
update systems and one business operations specialist to define
requirements. The burden will be at the contract, not the plan, level
for a subset of D-SNP contracts that are not FIDE SNPs or HIDE SNPs and
to which the notification requirements are applicable. As noted
previously, there are 190 D-SNP contracts as of June 2018, of which 37
contracts, or 12.7 percent (about one-eighth), are FIDE SNPs.\43\ While
we do not have a precise count of D-SNPs that will likely meet the
definition of a HIDE SNP, we estimate that another 12.7 percent of the
190 D-SNP contracts will be HIDE SNP contracts. Therefore, we expect
that the number of contracts needing modification is 190 D-SNP
contracts, less 37 FIDE SNP contracts, less 37 HIDE SNP contracts, or
116 D-SNP contracts. Accordingly, we estimate a one-time burden of
37,120 hours (116 contracts x 40 hr x 4 weeks x 2 FTEs) at a cost of
$3,180,813 [(18,560 hr x $98.54/hr) + (18,560 hr x $72.84/hr)]. Over
the course of OMB's anticipated 3-year approval period, we estimate an
annual burden of 12,373 hours (37,120 hr x \1/3\) at a cost of
$1,060,271 ($3,180,813 x \1/3\). We are annualizing the one-time
estimate since we do not anticipate any additional burden after the 3-
year approval period expires.
---------------------------------------------------------------------------
\43\ Centers for Medicare & Medicaid Services (2018, June). SNP
Comprehensive Report. Retrieved from https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data.html.
---------------------------------------------------------------------------
c. Summary of Burden Related to Integration Provisions for Dual
Eligible Special Needs Plans
Table 4 summarizes the burden for the aforementioned provisions.
[GRAPHIC] [TIFF OMITTED] TR16AP19.000
3. ICRs Regarding Unified Grievance and Appeals Procedures for Dual
Eligible Special Needs Plans and Medicaid Managed Care Plans at the
Plan Level (Sec. Sec. 422.560 through 422.562, 422.566, 422.629
Through 422.634, 438.210, 438.400, and 438.402)
As described in section II.A.2.b. of this final rule, we are
establishing for inclusion in contracts for applicable integrated
plans, as defined in Sec. 422.561, no later than 2021, procedures
unifying Medicare and Medicaid grievances and appeals procedures in
accordance with the newly enacted amendments to section 1859(f)(8)(B)
and (C) of the Act. In this final rule, Sec. 422.562(a)(5) requires
that all dual eligible special needs plans (D-SNPs) provide assistance
to beneficiaries with Medicaid coverage issues, appeals and grievances.
When ready, the requirements and burden associated with these
requirements will be submitted to OMB for approval under control number
0938-0753 (CMS-R-267).
As of June 2018, our Special Needs Plan Comprehensive Report lists
190 D-SNP contracts with 412 D-SNP plans that have at least 11
members.\44\ The universe of D-SNPs to which our unified grievance and
appeals procedures will apply is comprised of D-SNPs that are either
fully integrated dual eligible special needs plans (FIDE SNPs) or
highly integrated dual eligible special needs plans (HIDE SNPs) with
exclusively aligned enrollment--that is, where all of the plan's
membership receives Medicare and Medicaid benefits from the same
organization. Currently, exclusively aligned enrollment occurs in only
eight states: Florida, Idaho, Massachusetts, Minnesota, New Jersey, New
York, Tennessee, and Wisconsin. Currently, there are only 37 D-SNPs
operating under 34 contracts with 150,000 enrollees that could be
classified as FIDE SNPs or HIDE SNPs which operate
[[Page 15802]]
in states with exclusively aligned enrollment. The 150,000 enrollment
figure for contract year 2018 is projected to grow to 172,000 (150,000
x 1.145) enrollees by 2021, the first year that compliance with these
provisions will be required.\45\ While unifying grievance and appeals
provisions will necessitate states with exclusively aligned enrollment
policies to modify their Medicaid managed care plan contracts to
incorporate the new requirements, it will impose this burden on fewer
than 10 states, thereby falling below the threshold for PRA purposes.
---------------------------------------------------------------------------
\44\ See https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/Special-Needs-Plan-SNP-Data-Items/SNP-Comprehensive-Report-2018-06.html?DLPage=1&DLEntries=10&DLSort=1&DLSortDir=descending.
\45\ Table IV.C1, ``Private Health Enrollment'' in 2018 Trustee
Report, accessible at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/Downloads/TR2018.pdf.
---------------------------------------------------------------------------
We believe that our requirements at Sec. Sec. 422.629, 422.630,
and 422.631 related to integrated organization determinations and
integrated grievances should not be altogether unfamiliar to applicable
integrated plans because, in general terms, we are adopting whichever
of the current MA D-SNP or Medicaid managed care plan contract
requirements under part 422 subpart M (Medicare Advantage) and part 438
subpart F (Managed Care), respectively, is more protective of the
rights of the beneficiary or provides the most state flexibility,
consistent with the statutory requirements of section 1859(f)(8) of the
Act. Furthermore, we believe that by unifying Medicare and Medicaid
integrated organization determination and grievance requirements for
applicable integrated plans (that is, FIDE SNPs and HIDE SNPs with
exclusively aligned enrollment), we are reducing duplicative reviews
and notices, thereby ultimately reducing the level of burden on these
organizations. We detail the following:
In section III.B.3.a. of this final rule, the burden
associated with the implementation of our integrated organization
determination and integrated grievance procedures (Sec. Sec. 422.629,
422.630, and 422.631).
In section III.B.3.b. of this final rule, that the
information collection activities undertaken to administer our unified
appeals procedures (Sec. Sec. 422.629, 422.633, and 422.634) are
exempt from the PRA.
In section III.B.3.c. of this final rule, that the
requirement for all D-SNPs to assist enrollees with Medicaid coverage
issues and grievances in Sec. 422.562(a)(5) is also exempt from the
PRA.
a. Integrated Organization Determinations and Integrated Grievances
(Sec. Sec. 422.629, 422.630, and 422.631)
Section 422.631 requires that each applicable integrated plan issue
one integrated organization determination, so that all requests for
benefits from and appeals of denials of coverage by applicable
integrated plans will be subject to the same integrated organization
determination process. Section 422.631(d)(1) requires that an
applicable integrated plan send an integrated notice when the
integrated organization determination is adverse to the enrollee. The
notice must include information about the determination, as well as
information about the enrollee's appeal rights for both Medicare and
Medicaid covered benefits. Though integrating information on Medicare
and Medicaid appeal rights will be a new requirement, we note that the
requirement for a notice and the content of the notice largely align
with current requirements in Medicaid (Sec. 438.404(b)) and MA (Sec.
422.572(e)). We believe that the provision will have minimal impact on
plans based on our understanding of how plans that will meet the
definition of an applicable integrated plan under this final rule
currently handle coverage determinations for full-benefit dual eligible
individuals receiving Medicare and Medicaid services through the plan.
Currently, if such a plan were to deny or only partially cover a
Medicaid service never covered by Medicare (like a personal care
attendant or a clear request for Medicaid coverage), it will only issue
a Medicaid denial (one notice). Under this final rule, it will do the
same (that is, issue one notice). On the other hand, if the plan denied
a service that is covered under either Medicare or Medicaid, such as
home health services, we believe that the plan covering both Medicare
and Medicaid benefits in most, if not all, states will issue an
integrated determination notice that includes information about the
application of Medicare and Medicaid coverage criteria to the requested
service and how to appeal under both Medicare and Medicaid (one
notice). This final rule codifies this practice for applicable
integrated plans.
Also under Sec. 422.568(d), if the plan covers a service such as
durable medical equipment or home health services under Medicaid, but
denies the same service under Medicare's rules, it must issue a
Medicare denial even though the service was actually covered by the
plan based on its Medicaid contract. Under this final rule, a plan
covering both Medicare and Medicaid benefits will no longer need to
issue a notice in this situation. We do not have data to estimate the
number of instances in which D-SNPs currently issue denial notices
related to overlap services; therefore, we are unable to reliably
estimate the reduction in plan burden resulting from our unified
appeals requirements. We solicited feedback on the burden imposed on
integrated plans by having to send such a Medicare denial notice when
the service is covered by the plan under Medicaid rules in the proposed
rule. We did not receive any comment.
We are developing a model integrated denial notice form for use by
applicable integrated plans. When ready, the model form and its
associated requirements and burden will be submitted to OMB for
approval. It will also be made available to the public for review/
comment under the standard PRA process which includes the publication
of 60- and 30-day Federal Register notices and the posting of the
collection of information documents on our PRA website. Additionally,
changes to the procedures for applicable integrated plans will be
reflected in the current Notice of Denial of Medical Coverage form and
instructions (OMB control number 0938-0892; CMS-10003), but will not
impact this rule's burden estimates. As we did not finalize the
necessary revisions for this notice at the time of the proposed rule's
publication date, we did not set out such burden or solicit such
comments. We are in the process of publishing a stand-alone 60-day
Federal Register notice that set outs the revised form and form
instructions.
Under Sec. 422.629(g), applicable integrated plans must send a
notice of acknowledgment for all integrated grievances and integrated
reconsiderations. Medicaid managed care organizations are currently
required to send this notice under Sec. 438.406(b)(1), whereas MA
plans are not currently required to send this notice. Under this final
rule, applicable integrated plans must now send this notice for all
grievances and appeals, not only those pertaining to Medicaid issues.
Section 422.630(e) requires that applicable integrated plans issue a
notice upon resolution of the integrated grievance, unless the
integrated grievance was made orally and it did not concern quality of
care, and the enrollee did not request a written response. A
beneficiary's integrated grievance and the subsequent information
collection activities necessitated by that grievance are exempt from
the requirements of the PRA since the grievance would be submitted in
response to an
[[Page 15803]]
administrative action against a specific individual (5 CFR 1320.4).
However, the impact related to these requirements is estimated in
section IV.B.3. of this final rule.
We believe this final rule will result in a reduction in the number
of grievance reviews conducted by applicable integrated plans detailed
under Sec. 422.629(k)(2) due to the elimination of duplicative
grievance reviews for Medicare and Medicaid overlap issues. We do not
estimate this burden reduction as this information collection activity
is exempt under 5 CFR 1320.4 from the requirements of the PRA since it
occurs as part of an administrative action. However, the impact from
changes to these activities are estimated in section IV.B.3. of this
final rule.
We estimate negligible impacts on information collection activities
involved in unifying grievances associated with our provisions at Sec.
422.630. Under Sec. 422.630(b), applicable integrated plans will be
required to accept grievances filed at any time consistent with the
Medicaid standard at Sec. 438.402(c)(2)(i). This change will have the
net effect of permitting enrollees to file a grievance for a Medicare-
covered service outside of the current 60-day timely filing standard,
as measured from the date of the event or incident that precipitated
the grievance. The provision will effectively eliminate the timely
filing period for Medicare-related grievances. We do not expect this
requirement to increase the volume of grievances that an applicable
integrated plan will be responsible for handling since we believe that
the timeframes for filing Medicare grievances were designed to be
consistent with current practice and were set in place only to
eliminate complaint outliers.
Under Sec. 422.630(c), enrollees of applicable integrated plans
may file integrated grievances with the plan orally or in writing, in
alignment with current Medicare and Medicaid requirements, or with the
state, in states that have existing processes for accepting Medicaid
grievances in place in accordance with Sec. 438.402(c)(3). Because
this provision simply extends an existing avenue for filing grievances,
in states where it exists, for enrollees to file Medicaid benefits
grievances with the state, we do not expect an increase in the volume
of grievances that either states or applicable plans will be
responsible for handling.
Section 422.630(d) will permit an enrollee to file an expedited
grievance, which is available under current law for Medicare-covered,
but not Medicaid-covered, benefits. We estimate that the availability
of an expedited grievance for Medicaid benefits will have a negligible
impact on information collection activities because applicable
integrated plans will already have procedures in place to handle
expedited grievances for Medicare-covered services, which could be
leveraged for Medicaid-covered services. Furthermore, the availability
of the expedited resolution pathway (where under current law there is
only one resolution pathway for Medicaid-covered services) will have no
impact on the volume of grievances.
Section 422.630(e)(1) will require that an applicable integrated
plan resolve a standard (non-expedited) grievance within 30 days
consistent with the MA standard (Sec. 422.564(e)); under Medicaid
(Sec. 438.408(b)), the timeframe is established by the state but may
not exceed 90 calendar days from day the plan receives the grievance.
We estimate that this change in timeframe will have a negligible impact
on information collection activities because applicable integrated
plans already have business processes in place to comply with a 30-day
timeframe under MA.
Section 422.630(e)(2) requires an applicable integrated plan, when
extending the grievance resolution timeframe, to make reasonable
efforts to notify the enrollee orally and send written notice of the
reasons for the delay within 2 calendar days. We do not believe that
this provision will have more than a negligible impact on plans since
it adopts existing MA requirements for how an applicable integrated
plan must notify an enrollee of an extension and the existing Medicaid
managed care requirement for the timeliness standard. Thus, applicable
integrated plans will already have business processes in place to
comply with these requirements.
Although we do not estimate burden for applicable integrated plans
related to information collection activities involved in unifying
grievances associated with our provisions at Sec. Sec. 422.629 and
422.630, some of the individual provisions in Sec. Sec. 422.629
(general requirements), 422.630 (integrated grievances), and 422.631
(integrated organization determinations) will necessitate operational
and systems changes on the part of applicable integrated plans. The
following sections set out our burden estimates related to updates to
policies and procedures and recordkeeping and storage.
(1) Updates to Policies and Procedures
We estimate a one-time burden for each applicable integrated plan
to update its policies and procedures to reflect the new integrated
organization determination and grievance procedures under Sec. Sec.
422.629, 422.630 and 422.631. We anticipate this task will take a
business operation specialist 8 hours at $72.84/hr. In aggregate, we
estimate a one-time burden of 272 hours (8 hr x 34 contracts) at a cost
of $19,812 (272 hr x $72.84/hr). Over the course of OMB's anticipated
3-year approval period, we estimate an annual burden of 91 hours (272
hr x \1/3\) at a cost of $6,604 ($19,812 x \1/3\). We are annualizing
the one-time estimate since we do not anticipate any additional burden
after the 3-year approval period expires.
(2) Recordkeeping and Storage
D-SNPs, like other MA plans, are currently required to maintain
records for grievances (Sec. 422.504(d)). However, Sec. 422.629(h)
will require the maintenance of specific data elements consisting of: A
general description of the reason for the integrated grievance; the
date of receipt; the date of each review or, if applicable, the review
meeting; the resolution at each level of the integrated grievance, if
applicable; the date of resolution at each level, if applicable; and
the name of the enrollee for whom the integrated grievance was filed.
We estimate a one-time burden for applicable integrated plans to
revise their systems for recordkeeping related to integrated
grievances. We anticipate this task will take a software developer/
programmer 3 hours at $98.54/hr. Three hours is consistent with the
per-response time estimated in the May 2016 Medicaid Managed Care final
rule (81 FR 27498). In aggregate, we estimate a one-time burden of 102
hours (3 hr x 34 contracts) at a cost of $10,051 (102 hr x $98.54/hr).
Over the course of OMB's anticipated 3-year approval period, we
estimate an annual burden of 34 hours (102 hr x \1/3\) at a cost of
$3,350 ($10,051 x \1/3\). We are annualizing the one-time estimate
since we do not anticipate any additional burden after the 3-year
approval period expires.
We do not expect the cost of storage to change under Sec.
422.629(h)(3) since D-SNPs are currently required to store records
under Sec. 422.504(d), and the provision will not impose any new or
revised storage requirements or burden.
We received no comments on our assumptions for estimating the
burden associated with the operational and systems changes necessitated
by Sec. Sec. 422.629, 422.630, and 422.631.
However, we are updating our proposed burden estimates to reflect
several omissions and minor modifications to two occupational codes
[[Page 15804]]
and corresponding adjusted hourly wages. Table 5 summarizes the burden
resulting from these provisions.
b. Unified Appeals Procedures (Sec. Sec. 422.629, 422.633, and
422.634)
A beneficiary's appeal of an adverse integrated coverage
determination and the subsequent information collection activities
necessitated by that appeal are exempt from the requirements of the PRA
since the appeal would be submitted in response to an administrative
action against a specific individual (5 CFR 1320.4). In the case of
this final rule, the exemption covers any information collection
activities undertaken after the adverse integrated organization
determination by an applicable integrated plan, including:
acknowledgement of integrated reconsiderations under Sec. 422.629(g),
recordkeeping related to integrated appeals at Sec. 422.629(h), and
notification of the applicable integrated plan's integrated
reconsideration determination at Sec. 422.633(f)(4).
c. Assisting With Medicaid Coverage Issues and Grievances (Sec.
422.562(a)(5))
We have not calculated the burden for all D-SNPs to assist
enrollees with the filing of their grievance or appeal as required in
Sec. 422.562(a)(5). Since the provision of such assistance is a usual
and customary business practice it is exempt from the PRA under 5 CFR
1320.3(b)(2). We believe that this function would be performed in the
absence of federal regulation.
d. Summary
The burden associated with the individual components of our
provisions for unified grievance and appeals procedures for applicable
integrated plans are summarized in Table 5.
Table 5--Summary of D-SNP Unified Grievance and Appeals Procedures Burden
[OMB Control Number 0938-0753, CMS-R-267]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Hours per Total hours
Item Regulation respondents respondent \1\ Hourly wage Total cost ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updates to Policies and Procedures........ 422.629, 422.630, and 34 8 91 72.84 6,604
422.631.
Recordkeeping............................. 422.629(g).................. 34 3 34 98.54 3,350
-------------------------------------------------------------------------------
Total................................. ............................ 34 Varies 125 Varies 9,954
--------------------------------------------------------------------------------------------------------------------------------------------------------
4. ICRs Regarding Prescription Drug Plan Sponsors' Access to Medicare
Parts A and B Claims Data Extracts (Sec. 423.153(g))
The following requirements and burden will be submitted to OMB for
approval under control number 0938-TBD \46\ (CMS-10691).
---------------------------------------------------------------------------
\46\ Currently, the control number is to be determined (TBD).
OMB will assign the control number upon their approval of this new
information collection request. Approval can be monitored at
reginfo.gov without any login or password.
---------------------------------------------------------------------------
As described in section II.A.3. of this final rule, section 50354
of the Bipartisan Budget Act of 2018 requires the establishment of a
process under which the sponsor of a PDP that provides prescription
drug benefits under Medicare Part D may request, beginning in plan year
2020, that the Secretary provide on a periodic basis and in an
electronic format standardized extracts of Medicare Parts A and B
claims data about its plan enrollees. In this final rule we add a new
Sec. 423.153(g) to implement the process for requesting this data. The
provision will allow the PDP sponsor to submit a request to CMS for
claims data for its enrollees and to attest that it will adhere to the
permitted uses and limitations on the use of the Medicare claims data
that are listed in Sec. 423.153.
At the time of the proposed rule's publication date, we did not
finalize the operational aspects of this provision. Therefore, we did
not set out such burden or request comment in the Collection of
Information section of that rule. However, since that time, we have
finalized the operational aspects and published a stand-alone 60-day
Federal Register notice that set out the requirements and burden
associated with the request and attestation (November 30, 2018; 83 FR
61638). Comments were received and are responded to below. We are also
realigning the proposed provision with this final rulemaking by setting
out such requirements and burden below. In this regard we will not be
publishing a stand-alone 30-day Federal Register notice.
Section 423.153(g)(1)(i) states that beginning in plan year 2020, a
PDP sponsor may submit a request to CMS for claims data on enrollees in
its prescription drug plans. In addition, Sec. 423.153(g)(5) provides
that as a condition of receiving the requested data, the PDP sponsor
must attest that it will adhere to the permitted uses and limitations
on the use of the Medicare claims data. In the stand-alone notice we
anticipated that the data request and attestation will be combined into
a single submission. We continue to estimate it will take a business
operations specialist 1 minute at $72.84/hr to complete the request for
data and the attestation. As mentioned in section III.A. of this rule,
we are updating the hourly wage associated with the business operations
specialist.
Currently, there are 63 PDP sponsors and we estimate that all PDP
sponsors would initially submit a request and attestation. We also
estimate that each year approximately 1 to 5 PDP sponsors would start
requesting CMS claims data for its enrollees. For purposes of impact
estimates we assume the maximum, 5 PDP sponsors per year. We estimate
it will take a business operations specialist 1 minute to complete the
request for data and the attestation. We also estimate that each year
approximately 1 to 5 PDP sponsors will request that CMS stop sending
claims data for its enrollees. For purposes of impact estimates we
assume the maximum, 5 sponsors, will request discontinuation. We
estimate it will take a business operations specialist 1 minute (1/60
hr) to submit a request to CMS to stop sending claims data for its
enrollees.
For first year sponsor requests we estimate a burden of 63/60 hours
(1 hour and 3 minutes) (63 sponsors x 1/60 hr/response) at an aggregate
cost of $76.48 (63 sponsors x 1/60 hr x $72.84/hr).
In subsequent years we estimate a burden of 10/60 hours (1/60/hr x
(5 requests for data + 5 requests for discontinuation) at an aggregate
cost of $12.14 (10/60 x 72.84).
The aggregate impact over 3 years is 83/60 hour (63/60 for the
first year + 10/60 x 2 for the next 2 years) at a cost $100.76 ($76.48
for the first year + $12.14 x 2 for the next 2 years). When
[[Page 15805]]
annualized over 3 years, the annual impact is 28/60 hr (83/60 divided
by 3) at a cost of $33.59.
While we received a few comments, none of them were related to the
PRA or any of our collection of information requirements or burden
estimates. Nonetheless, we considered the comments since they were
rule-related and have responded to them under the appropriate sections
of this preamble, namely section II.A.3. of this final rule.
5. ICRs Regarding Medicare Advantage and Part D Prescription Drug Plan
Quality Rating System (Sec. Sec. 422.162(a) and 423.182(a), 422.166(a)
and 423.186(a), 422.164 and 423.184, and 422.166(i)(1) and
423.186(i)(1))
As described in section II.B.1. of this final rule, we are
finalizing: Measure updates for the 2022 and 2023 Star Ratings,
enhancements to the cut point methodology for non-CAHPS measures, and a
policy for calculating the Part C and D Star Ratings when extreme and
uncontrollable circumstances occur. The provisions will not change any
respondent requirements or burden pertaining to any of CMS's Star
Ratings-related PRA packages, including: OMB control number 0938-0732
for CAHPS (CMS-R-246), OMB control number 0938-0701 for HOS (CMS-
10203), OMB control number 0938-1028 for HEDIS (CMS-10219), OMB control
number 0938-1054 for Part C Reporting Requirements (CMS-10261), and OMB
control number 0938-0992 for Part D Reporting Requirements (CMS-10185).
Since the provisions will not impose any new or revised information
collection requirements or burden, we are not making changes under any
of the aforementioned control numbers.
6. ICRs Regarding Improving Clarity of the Exceptions Timeframes for
Part D Drugs (Sec. Sec. 423.568, 423.570, and 423.572)
To establish greater certainty in the Part D exceptions process, we
limited the amount of time an exception request can be held in a
pending status while the Part D plan sponsor attempts to obtain the
prescriber's supporting statement; specifically, that a plan must
notify the enrollee (and the prescriber involved, as appropriate) of
its decision on an exceptions request no later than 72 hours (24 hours
for expedited) of receipt of the prescriber's supporting statement or
14 calendar days after receipt of the request, whichever occurs first.
These provisions will not impose any new or revised information
collection requirements or burden. Consequently, the provisions are not
subject to the PRA. We did not receive any comments pertaining to our
position that the proposed provisions are not subject to the PRA.
Consequently, we are finalizing our position without change.
7. ICRs Regarding Preclusion List Requirements for Prescribers in Part
D and Individuals and Entities in MA, Cost Plans, and PACE (Sec. Sec.
422.222 and 423.120(c)(6))
As described in section II.C.1. of this final rule, the provisions
in Sec. Sec. 422.222 and 423.120(c)(6) will not involve activities for
plan sponsors and MA organizations outside of those described in the
previously referenced April 2018 final rule (83 FR 16440). The
provisions are, generally speaking, clarifications of intended policy
and will not impose any new or revised information collection
requirements or burden. Consequently, the provisions are not subject to
the PRA.
We did not receive any comments pertaining to our position that the
proposed provisions are not subject to the PRA. Consequently, we are
finalizing our position without change.
C. Summary of Information Collection Requirements and Burden
[[Page 15806]]
[GRAPHIC] [TIFF OMITTED] TR16AP19.001
[[Page 15807]]
IV. Regulatory Impact Analysis
A. Statement of Need
This final rule implements specific provisions of the Bipartisan
Budget Act of 2018 related to MA additional telehealth benefits, MA
dual eligible special needs plans (D-SNPs), and Part D sponsors' access
to Medicare claims data. The rule will also improve quality and
accessibility; clarify certain program integrity policies; reduce
burden on providers, MA organizations, and Part D sponsors through
providing additional policy clarification; and implement other
technical changes regarding quality improvement. Although satisfaction
with the MA and Part D programs remains high, these changes are
necessary to implement certain provisions of the Bipartisan Budget Act
of 2018 and are responsive to input we received from stakeholders while
administering the programs, as well as through our requests for
comment. We decided to modify the MA and Part D Prescription Drug Plan
Quality Rating System in response to comments from the proposed rule
entitled Medicare Program; Contract Year 2019 Policy and Technical
Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-
for-Service, The Medicare Prescription Drug Benefit Programs, and the
PACE program (November 28, 2017, 82 FR 56336).
In this final rule, our policies continue to drive affordable
private plan options for Medicare beneficiaries that meet their unique
healthcare needs, such as supporting innovation in telehealth among MA
plans to provide more options and additional benefits for MA enrollees.
These provisions align with the Administration's focus on the interests
and needs of beneficiaries, providers, MA plans, and Part D sponsors.
B. Overall Impact
We examined the impact of this final rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), Executive Order 13272 on Proper Consideration of
Small Entities in Agency Rulemaking (August 13, 2002), section 1102(b)
of the Act, section 202 of the Unfunded Mandates Reform Act of 1995
(UMRA) (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on
Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C.
804(2)), and Executive Order 13771 on Reducing Regulation and
Controlling Regulatory Costs (January 30, 2017).
The RFA, as amended, requires agencies to analyze options for
regulatory relief of small businesses, if a rule has a significant
impact on a substantial number of small entities. For purposes of the
RFA, small entities include small businesses, nonprofit organizations,
and small governmental jurisdictions.
This final rule affects MA plans and Part D sponsors (North
American Industry Classification System (NAICS) category 524114) with a
minimum threshold for small business size of $38.5 million (https://www.sba.gov/content/small-business-size-standards). This final rule
additionally affects hospitals (NAICS subsector 622) and a variety of
provider categories, including physicians and specialists (NAICS
subsector 621).
To clarify the flow of payments between these entities and the
federal government, note that MA organizations submit bids (that is,
proposed plan designs and projections of the revenue needed to provide
those benefits, divided into three categories--basic benefits,
supplemental benefits, and Part D drug benefits) in June 2019 for
operation in contract year 2020. These bids project payments to
hospitals, providers, and staff as well as the cost of administration
and profits. These bids in turn determine the payments from the
Medicare Trust Fund to the MA organizations that pay providers and
other stakeholders for their provision of covered benefits to
enrollees. Consequently, our analysis will focus on MA organizations.
There are various types of Medicare health plans, including MA
plans, Part D sponsors, demonstrations, section 1876 cost plans, PDPs,
and PACE plans. Forty-three percent of all Medicare health plan
organizations are not-for-profit, and 31 percent of all MA plans and
Part D sponsors are not-for-profit. (These figures were determined by
examining records from the most recent year for which we have complete
data, 2016.)
There are varieties of ways to assess whether MA organizations meet
the $38.5 million threshold for small businesses. The assessment can be
done by examining net worth, net income, cash flow from operations, and
projected claims as indicated in their bids. Using projected monetary
requirements and projected enrollment for 2018 from submitted bids, 32
percent of the MA organizations fell below the $38.5 million threshold
for small businesses. Additionally, an analysis of 2016 data--the most
recent year for which we have actual data on MA organization net
worth--shows that 32 percent of all MA organizations fall below the
minimum threshold for small businesses.
Executive Order 13272 requires that the Department of Health and
Human Services (HHS) thoroughly review rules to assess and take
appropriate account of their potential impact on small business, small
governmental jurisdictions, and small organizations (as mandated by the
RFA).
If a final rule may have a significant economic impact on a
substantial number of small entities, then the final rule must discuss
steps taken, including alternatives, to minimize burden on small
entities. The RFA does not define the terms ``significant economic
impact'' or ``substantial number.'' The Small Business Administration
(SBA) \47\ advises that this absence of statutory specificity allows
what is ``significant'' or ``substantial'' to vary, depending on the
problem that is to be addressed in the rulemaking, the rule's
requirements, and the preliminary assessment of the rule's impact. To
ensure that a broad range of impacts are fully considered in the
analysis, we consider ``substantial number'' to mean 5 percent or more
of the affected small entities within an identified industry.
---------------------------------------------------------------------------
\47\ The Regulatory Flexibility Act An Implementation Guide for
Federal Agencies, pages 17-19. Issued by SBA's Office of Advocacy,
and accessible at www.sba.gov/advo.
---------------------------------------------------------------------------
The 1984 HHS Handbook, On Developing Low Burden and Low Cost
Regulatory Proposals, set forth the following definitional narrative
for the term ``significant economic impact'' and is still applicable: A
rule has a significant economic impact on the small entities it
affects, if it significantly affects their total costs or revenues. If
the economic impact is expected to be similar for all affected small
entities and those entities have similar costs and revenues, then an
average impact can be calculated. If the average annual impact on small
entities is 3 to 5 percent or more, then we consider the rule has a
significant economic impact on small entities.
While a significant number (more than 5 percent) of not-for-profit
organizations and small businesses are affected by this final rule, the
impact is not significant. To assess impact, we use the data in Table
17, which show that the raw (not discounted) net cost of this final
rule over 10 years is $24.1 million. Comparing this number to the total
monetary amounts projected to be needed just for 2020, based on plan
submitted bids, we find that the impact
[[Page 15808]]
of this rule is significantly below the 3 to 5 percent threshold for
significant impact. Had we compared the 2020 impact of the rule to
projected 2020 monetary need, the impact would still be less.
Consequently, the Secretary has determined that this final rule
will not have a significant economic impact on a substantial number of
small entities, and we have met the requirements of Executive Order
13272 and the RFA. In addition, section 1102(b) of the Act requires us
to prepare a regulatory analysis for any final rule under title XVIII,
title XIX, or Part B of Title XI of the Act that may have significant
impact on the operations of a substantial number of small rural
hospitals. We are not preparing an analysis for section 1102(b) of the
Act because the Secretary certifies that this final rule will not have
a significant impact on the operations of a substantial number of small
rural hospitals.
Section 202 of UMRA also requires that agencies assess anticipated
costs and benefits before issuing any final rule whose mandates require
spending in any 1 year of $100 million in 1995 dollars, updated
annually for inflation. In 2019, that threshold is approximately $154
million. This final rule is not anticipated to have an effect on state,
local, or tribal governments, in the aggregate, or on the private
sector of $154 million or more.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a final rule that imposes
substantial direct requirement costs on state and local governments,
preempts state law, or otherwise has federalism implications. Since
this final rule does not impose any substantial costs on state or local
governments, the requirements of Executive Order 13132 are not
applicable.
If regulations impose administrative costs on reviewers, such as
the time needed to read and interpret this final rule, then we should
estimate the cost associated with regulatory review. There are
currently 750 MA contracts (which also includes PDPs), 50 state
Medicaid agencies, and 200 Medicaid managed care organizations (1,000
reviewers total). We assume each entity will have one designated staff
member who will review the entire rule. Other assumptions are possible.
Using the wage information from the Bureau of Labor Statistics
(BLS) for medical and health service managers (code 11-9111), we
estimate that the cost of reviewing this final rule is $107.38 per
hour, including fringe benefits and overhead costs (https://www.bls.gov/oes/current/oes_nat.htm). Assuming an average reading speed, we
estimate that it will take approximately 12.5 hours for each person to
review this final rule. For each entity that reviews the rule, the
estimated cost is $1,342 (12.5 hours * $107.38). Therefore, we estimate
that the total cost of reviewing this final rule is $1,342,000 ($1,342
* 1,000 reviewers).
Note that this analysis assumed one reader per contract. Some
alternatives include assuming one reader per parent organization. Using
parent organizations instead of contracts will reduce the number of
reviewers to approximately 500 (assuming approximately 250 parent
organizations), and this will cut the total cost of reviewing in half.
However, we believe it is likely that reviewing will be performed by
contract. The argument for this is that a parent organization may have
local reviewers assessing potential region-specific effects from this
final rule.
In accordance with the provisions of Executive Order 12866, this
final rule was reviewed by the Office of Management and Budget (OMB).
We received no comments on our estimates of impact on small
businesses and other items mentioned in the Overall Impact section.
Therefore, we are finalizing this section as without modification.
C. Anticipated Effects
1. Requirements for Medicare Advantage Plans Offering Additional
Telehealth Benefits (Sec. Sec. 422.100, 422.135, 422.252, 422.254, and
422.264)
As described in section II.A.1. of this final rule, section 50323
of the Bipartisan Budget Act of 2018 allows MA plans the ability to
provide MA additional telehealth benefits to enrollees starting in plan
year 2020 and treat them as basic benefits. In this rule, we are
finalizing--with slight modifications--most proposed requirements at
Sec. 422.135, which will authorize and set standards for MA plans to
offer MA additional telehealth benefits. Section 422.135(a) defines
these benefits as Part B services that have been identified by the MA
plan for the applicable year as clinically appropriate to furnish
through electronic exchange when the physician (as defined in section
1861(r) of the Act) or practitioner (described in section
1842(b)(18)(C) of the Act) providing the service is not in the same
location as the enrollee. We are revising our proposed impact estimates
based on stakeholder feedback. In the proposed rule, we set forth the
following impacts.
There are two primary aspects of the MA additional telehealth
benefits provision that could affect the cost and utilization of MA
basic benefits, with a corresponding impact on Medicare program
expenditures. The most direct effect is the reclassification of certain
telehealth services covered by MA plans pre-Bipartisan Budget Act of
2018 from MA supplemental telehealth benefits to basic benefits. This
change will lead to higher basic benefit bids, as the cost of MA
additional telehealth benefits will be included in the basic benefit
bid. The impact on the basic benefit bid may be muted due to the
exclusion from the bid of capital and infrastructure costs related to
MA additional telehealth benefits.
Prior to estimating the impact on the bid, we point out several
other sources of impact. Many studies have argued that telehealth will
increase utilization of medical services by making them more
accessible. However, the increased utilization could lead to increased
savings or cost. The increased utilization could lead to significant
savings due to prevention of future illness. Alternatively, the
increased utilization could lead to increased costs if enrollees start
seeing doctors for complaints on which they did not traditionally seek
medical advice. We cite studies for each possibility. Additionally, if
there are more telehealth visits, providers may request more in-person
visits to protect themselves from liability.
Consequently, there are four potential impacts of this provision,
which we discuss in more detail later in this section. The four areas
are as follows:
Impact on the Medicare Trust Fund
Savings for Enrollees due to Decreased Travel Time to
Providers
Savings from Illness Prevention due to Increased Access to
Services
Increased Costs if Unnecessary Medical Visits Increase
The final rule allows for differential cost sharing. We expect that
enrollees would incur lower cost sharing from telehealth services than
they would from in-person visits. This would result in enrollee
savings. However, we have no way of estimating this savings because we
lack any data experience with this differential cost sharing.
Therefore, we are scoring this as a qualitative savings.
Because of the wide variability in potential impact, in the
proposed rule we solicited comments on best practices in telehealth and
the resulting savings. In the following sections, we summarize and
respond to these comments.
[[Page 15809]]
a. Impact on the Medicare Trust Fund
Superficially, there appears to be no program change since the
provision simply reclassifies certain benefits as basic instead of MA
supplemental. Thus, the same benefits are provided. However, a closer
look at the language and assumptions of the provision show that, while
collectively MA additional telehealth benefits will yield a negligible
change in program spending, there is a small transfer of costs
(estimated to be 0.002 percent of the MA baseline) from enrollees to
the Medicare Trust Fund, associated with reclassifying these benefits
from MA supplemental benefits to basic benefits. MA supplemental
benefits are generally paid with rebates while basic benefits are paid
by a capitation rate, calculated with reference to the bid. For MA
plans to provide benefits using rebates requires additional funding
since the amount of rebates provided by the Medicare Trust Fund
averages only $0.66 on the dollar. Thus, the effect of the rebate
aspect is that the enrollee either pays a lower supplemental premium or
receives richer MA supplemental benefits. In either case, whether the
enrollee saves or receives richer MA supplemental benefits, the
Medicare Trust Fund incurs a cost. It follows that this provision
creates a cost transfer from the Medicare Trust Fund to enrollees. The
direction of the cost is classified by whether the Medicare Trust Fund
loses or gains. In this case, since the Medicare Trust Fund loses
money, we classify the transfer as a cost. However, the transfer
results in a savings to enrollees. After accounting for the exclusion
of capital and infrastructure costs, and backing out the Part B
premium, the extra cost to the Medicare Trust Fund is projected to be
$80 million over 10 years. The calculations for these 10 years are
presented in Table 7 and discussed in the narrative.
In order to estimate the 10-year impact (2020 through 2029) of the
MA additional telehealth benefits provision on the Medicare Trust Fund,
we considered the following six factors.
First, we estimated the costs of MA additional telehealth
benefits that are to be transferred from MA supplemental telehealth
benefits to basic benefits. Using the 2019 submitted bid information,
we estimated that $0.09 per member per month (PMPM) will be
transferred. We computed $0.09 by examining and averaging the largest
organizations' MA supplemental telehealth benefits, particularly under
the category ``Web and Phone Based Technology.'' The reason for basing
estimates on the largest organizations is that in past years, only the
largest organizations included the category ``Web and Phone Based
Technology'' as a separate line item in their bids; by contrast, the
other organizations combined multiple, non-telehealth benefits in the
same line as the MA supplemental telehealth benefits, and so we were
not able to distinguish the costs between telehealth and non-telehealth
for the smaller organizations. Information from the 2018 Medicare
Trustees Report \48\ shows that the applicable medical-inflation trend
that should be applied to the $0.09 PMPM is 5.2 percent per year; the
average trend can be derived from information in Table IV.C3 of this
report.
---------------------------------------------------------------------------
\48\ https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFunds/Downloads/TR2018.pdf.
---------------------------------------------------------------------------
We applied the PMPM amounts to the projected MA enrollment
for the years 2020 through 2029. The source of the projected MA
enrollment is Table IV.C1 of the 2018 Medicare Trustees Report.
We assumed that 15 percent of the MA additional telehealth
benefits will be considered capital and infrastructure costs. As
discussed in section II.A.1. of this final rule, these costs are
excluded from the Medicare Trust Fund payments for MA additional
telehealth benefits. We obtained the 15 percent assumption by
subtracting the 85 percent required medical loss ratio (MLR) from 100
percent. We used the MLR as a proxy for the medical share of provider
payments.
We applied the average rebate percentage of 66 percent,
which is based on the expected submitted bid information, including
expected enrollment and expected average Star Ratings.
We applied a factor of 86 percent to the calculation,
which represents the exclusion or the backing out of the Part B
premium.
However, per OMB guidance, ordinary inflation should be
carved out of estimates, while medical inflation, which outpaces
ordinary inflation (as well as enrollment growth), may be retained. The
source of the ordinary inflation is Table IV.D1 of the 2018 Medicare
Trustees Report. It is 2.6 percent per year for each of the years 2020
through 2029.
Table 7--Calculations of Net Costs Per Year to the Medicare Trust Fund for MA Additional Telehealth Benefits
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Gross amount Capital and Backing out of
Year MA enrollment PMPM cost months per ($ in infrastructure Average rebate Part B premium Net cost ($ in Ordinary Net costs ($
(in thousands) year millions) costs (%) percentage (%) (%) millions) inflation (%) in millions)
(A) (B) (C) (D) (A * (1 - B) * (F) (E)/(1 + (F))
(1 - C) * (D)) [caret] (year-
(E) 2019)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2020............................ 21,995 0.09 12 25.0 15 66 86 6.2 2.6 6.1
2021............................ 22,873 0.10 12 27.3 15 66 86 6.8 2.6 6.5
2022............................ 23,739 0.10 12 29.8 15 66 86 7.4 2.6 6.9
2023............................ 24,584 0.11 12 32.5 15 66 86 8.1 2.6 7.3
2024............................ 25,395 0.12 12 35.3 15 66 86 8.8 2.6 7.7
2025............................ 26,198 0.12 12 38.4 15 66 86 9.5 2.6 8.2
2026............................ 26,986 0.13 12 41.6 15 66 85 10.2 2.6 8.5
2027............................ 27,737 0.14 12 44.9 15 66 85 11.0 2.6 9.0
2028............................ 28,455 0.14 12 48.5 15 66 85 11.9 2.6 9.5
2029............................ 29,101 0.15 12 52.2 15 66 85 12.8 2.6 9.9
---------------------------------------------------------------------------------------------------------------------------------------------------------------
Raw Total................... .............. .............. .............. .............. .............. .............. .............. .............. .............. 79.6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Combining these six factors, we calculated the net costs to the
Medicare Trust Fund to be $6.1 million in 2020, $6.5 million in 2021,
$6.9 million in 2022, $7.3 million in 2023, and $7.7 million in 2024.
We calculated the net costs to the Medicare Trust Fund for years 2025
through 2029 to be $8.2 million, $8.5 million, $9.0 million, $9.5
[[Page 15810]]
million, and $9.9 million, respectively. The calculations of impact for
years 2020 through 2029 are summarized in Table 7. The total cost for
all 10 years is found in the right-most column of Table 7, titled ``Net
Costs.''
b. Savings for Enrollees Due to Decreased Travel Time to Providers
MA additional telehealth benefits will save enrollees the cost of
traveling to and from providers. Currently, Medicare telehealth
services are used to bring healthcare services to MA enrollees,
including those in rural locations. In their comments on the proposed
rule, as well as in response to specific inquiries we made in the
proposed rule related to telehealth, stakeholders have informed CMS
that MA enrollees benefit from the use of telehealth services to reduce
travel times and have greater access to providers that may not
otherwise be available. Several commenters provided specific details
from their own experiences on the nature of these savings.
(1) Assumptions
Prior to our actual estimation of the savings for enrollees due to
decreased travel time to providers, we discuss seven assumptions
underlying our calculations.
(a) Current MA Supplemental Telehealth Benefits' Usage
Under the current MA program, MA plans may offer MA supplemental
telehealth benefits in the form of telemonitoring and remote access
technologies (including nursing hotlines).\49\ However, the plan
benefit package software does not have sufficient granularity to
identify which types of MA supplemental telehealth benefits are being
offered. Analyzing supporting documentation for the plan bids, the
Office of the Actuary (OACT) has found an average spending of $0.09
PMPM for MA supplemental telehealth benefits among the large MA plans
(smaller plans do not provide this data). OACT estimates that in 2019
there will be an average rebate of $110 PMPM. Of this $110, on average,
44 percent is applied to reduction in cost sharing (compared to cost
sharing in original Medicare for Part A and B benefits), and 32 percent
is applied to buying down the Part B and Part D premiums, leaving 24
percent or $27 PMPM with which to fund additional services. It follows
that large MA plans use only 0.33 percent ($0.09/$27) of available
rebate resources to fund MA supplemental telehealth benefits. It is
reasonable that the $0.09 PMPM average for large MA plans is even less
for smaller plans who may not have the resources to be as aggressive in
their MA supplemental telehealth benefit designs.
---------------------------------------------------------------------------
\49\ Chapter 4 of the Managed Care Manual, Section 30.3 https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/mc86c04.pdf.
---------------------------------------------------------------------------
These considerations--coupled with a discussion of how CMS and
stakeholders expect telehealth to be used--suggest that while current
MA policy theoretically allows MA supplemental telehealth benefits,
they are not being significantly offered. The arguments for this are as
follows:
Telehealth Specialties and Telemonitoring: In response to
our discussion and request for comments in the proposed rule,
commenters enthusiastically supported the MA additional telehealth
benefits proposal as a saver precisely because both telemonitoring and
certain specialties--especially dermatology, cardiology, and
psychiatry--will be used significantly more often under these new
benefits. Commenters pointed out that there are not enough
dermatologists, cardiologists, and psychiatrists to provide all needed
services in rural areas. The availability of MA additional telehealth
benefits will remedy a lack of access based on this lack of resources.
Some commenters related their personal experience and the savings they
expected to accrue. No commenter dissented whether this provision would
significantly save. The tone of the comments seem to imply that these
commenters believed that the final rule would allow these MA additional
telehealth benefits or greatly facilitate their offering.
Current Allowed MA Supplemental Telehealth Benefits: As
discussed previously in the estimates of impact on the Medicare Trust
Fund, we found that approximately $0.09 PMPM was being used for current
MA supplemental telehealth benefits (telemonitoring and remote access
technologies). Telehealth services are not low-cost (though they cost
less than in-person visits). This $0.09 must pay for the provider
review and assessment. Hence, this $0.09 reflects a significantly low
utilization. The following simple hypothetical example illustrates
this. Suppose in a plan, once a month, 30 enrollees in a plan with
8,300 total enrollees are using MA supplemental telehealth benefits,
which costs $100/hr and takes 15 minutes to review. Then the cost to
the plan is 30 enrollees x $100/hr x 0.25 hr = $750. However, the cost
per enrollee is $750/8,300 = $0.09. This illustrative example with
hypothetical numbers clarifies why we are inferring from the $0.09 that
plan utilization is extremely low.
Although this $0.09 reflects the cost to the plan, it is legitimate
to use this to estimate savings to enrollees. The logic behind this is
as follows. The low cost of $0.09 indicates low utilization, and it is
the low utilization which drives our assumption that few enrollees are
spending travel time currently. For example, in our simple hypothetical
example above, without MA additional telehealth benefits, only 30
enrollees would have to travel back and forth to a provider once a
month. We are estimating that, under this final rule, there would be
more usage of telehealth; we expect more than 30 enrollees to use this
and we expect it to be used more than once a month. Without MA
additional telehealth benefits, this would necessitate the cost of
travel, while with MA additional telehealth benefits, there is no
travel; hence, the estimate of savings is justified. Tables 8 and 9
indicate the frequency of utilization we expect over the next 10 years.
Despite the previous arguments, we must concede that currently some
telehealth benefits are being offered as MA supplemental telehealth
benefits. In the absence of further data, we are making an assumption
that less than 50 percent of the telehealth services that will be
furnished under this final rule are currently available. This
assumption has intuitive appeal. If only $0.09 out of $27 is being used
for MA supplemental telehealth benefits, while the remaining $26.91 is
being used to fund non-telehealth benefits, it is very reasonable to
assume that current utilization is less than 50 percent of what it is
expected to become under the final rule when plans can fund these
benefits from the Medicare Trust Fund without using their rebate
dollars.
(b) Possible Overutilization
In the proposed rule, although we did estimate the potential
savings to enrollees from reduced travel time to and from providers
arising from MA additional telehealth benefits, we did not include this
estimate in the summary and accounting tables (Tables 16 and 17)
because there was a concern that telehealth would possibly lead to
overutilization of provider visits, thus offsetting the savings. We
address this concern in the following points:
Only one article raised this concern, and the article
itself listed several drawbacks to its conclusion.\50\ More
specifically, the article--
---------------------------------------------------------------------------
\50\ J. Ashwood, A. Mehrotra, D. Cowling, and L. Uscher-Pines,
``Direct to Consumer Telehealth May Increase Access to Care but Does
not Decrease Spending,'' Health Affairs 36(3), 2017, accessible at
https://www.healthaffairs.org/doi/10.1377/hlthaff.2016.1130.
---------------------------------------------------------------------------
[[Page 15811]]
++ Used data from only one telehealth company;
++ Used data on only specific medical conditions;
++ Referenced a population study that had a ``low uptake of
telehealth;'' and
++ Was from an early period in telehealth.
Despite low uptake of telehealth in 2013, we have seen a
significant increase in telehealth usage over the past few years.
Furthermore, one article on telehealth points to the importance of
patient buy-in, which is more common today.\51\
---------------------------------------------------------------------------
\51\ Harry Wang, Director Health and Mobile Product Research,
Parks Associates ``Virtual Health Care will revolutionize the
Industry If we let it'', Forbes, 2014, accessible at https://www.forbes.com/sites/ciocentral/2014/04/03/virtual-health-care-visits-will-revolutionize-the-industry-if-we-let-it/#4ee9a9e97c25;
https://www.forbes.com/sites/ciocentral/2014/04/03/virtual-health-care-visits-will-revolutionize-the-industry-if-we-let-it/#4ee9a9e97c25.
---------------------------------------------------------------------------
To better understand the concern regarding
overutilization, we solicited comments in the proposed rule on whether
MA additional telehealth benefits would save enrollees due to reduced
travel time. We received numerous comments from several sources, and
the commenters were overwhelmingly supportive. The comments were not
subjective but evidence-based, reflecting MA plans' first-hand
experience with telehealth in some of their existing products. Some
commenters specifically addressed the travel time issue. For example, a
commenter indicated that virtual visits can not only reduce patient
travel time, but can also potentially supplant nursing and in-home
visits. In addition, the commenter referenced a virtual care experience
in one particular plan which spoke to both clinician and patient time-
in-transit savings. Other commenters simply echoed the travel time
estimates in the proposed rule. However, many commenters discussed
increased usage of telehealth services particularly in specialties such
as cardiology, psychiatry, and dermatology, and especially in rural
areas where there is a shortage of specialists.
Based on the previous discussion, we are including our estimates of
travel savings in the summary and accounting tables (Tables 16 and 17).
In making these estimates, we are assuming that the number of visits
will remain the same overall but that a certain percentage of the in-
person visits will be replaced by visits through electronic exchange
from MA additional telehealth benefits.
(c) Telehealth Provider Utilization by Age
The available statistics discuss telehealth without adequate
distinction based on age. It is very likely that a breakout by age
would give more precise estimates, but unfortunately we do not have
such data.
(d) Avoiding Overestimation of Telehealth Growth
In creating a 10-year estimate, there are several conflicting
sources with the growth of telehealth visits. To avoid problems of
overestimation, we adopted the lower growth rate estimates. We present
numerical details of this approach in the section containing the actual
estimates.
(e) Enrollee Savings Versus Medicare Trust Fund Impact
We explicitly clarify that the $80 million cost over 10 years,
estimated in Table 7, is a cost incurred by the Medicare Trust Fund and
represents a transfer from the government to enrollees, because the
rebate dollars that formerly paid for MA supplemental telehealth
benefits are now being freed, possibly, for additional benefits to
enrollees either in the form of MA supplemental benefits or reduced
cost sharing. However, the savings described are savings to enrollees.
(f) Internet Access in the 65+ Population
Our estimates of impact include a trend factor for increased
general use of telehealth over the next few years. This trend factor is
for the entire population. We therefore clarify that we do not believe
that access to telehealth will be lower in the 65+ population because
of the following:
Telehealth does not exclusively require broadband internet
capability; for example, telehealth access may also be provided through
cell phones providing internet access.
Many seniors have children or other members of their
social support group who regularly visit them and could provide
internet access through laptops, tablets, cell phones, or other
internet-capable devices during their visits.
There is now a large market for internet access, possibly
without computers, offered by major manufacturers and targeted
specifically for seniors. Current products include smart televisions
allowing access without a computer, laptops specifically designed for
seniors, and free or low-cost laptops provided by a number of national
and local organizations in an effort to specifically encourage senior
computer use.
There are a variety of free online courses specifically
targeted to seniors to facilitate familiarity with internet usage.
Therefore, we believe that the uniformity of trend for telehealth
access is not an issue.
(g) Healthcare Savings
Although we are including in our impact analysis the savings to
enrollees arising from reduced travel time, we are not including a
quantification of healthcare savings. The commenters overwhelmingly
supported the idea that telehealth would reduce healthcare spending due
to increased preventive measures, consequent reduced readmissions and
reduced initial hospitalizations, and greater access to certain
specialties where access is currently low, such as cardiology,
psychiatry, and dermatology. Furthermore, in the proposed rule, we had
provided references, estimating in specific (typically one-time)
settings, and the healthcare savings per inpatient enrollee. We have
omitted mention of these studies in this final rule because MA
additional telehealth benefits only apply to Part B services, not to
inpatient services. However, commenters merged comments about savings
from both inpatient telehealth and specialty telehealth such as tele-
cardiology, tele-dermatology, and tele-psychiatry. In general, the
commenters were enthusiastic about all aspects of telehealth saving
money for both Part B and Part A services. Many of the commenters cited
similar studies or their own experience. These articles and comments
point to a quantitative savings in health care. Although, as mentioned
previously, in the early years of telehealth there was concern for
overutilization which would raise costs, this does not seem to be major
issue today.
However, we are not quantifying the healthcare savings since each
dollar of healthcare savings does not automatically become a dollar
reduction in Medicare Trust Fund expenditures paying for plan bid
estimates. As a simple example, some savings may translate to higher
administrative margins (increased profits). Similarly, a portion of the
healthcare savings may be allocated to increased benefits, for example,
preventive benefits. We do not have a basis for quantifying these
factors. Therefore, we are leaving the healthcare savings as a
qualitative impact without further quantification.
[[Page 15812]]
(2) Actual Estimation
Having completed our discussion of assumptions, we next turn to the
actual estimation. We require four component estimates to estimate
aggregate savings for enrollees due to decreased travel time to
providers. We provide these four component estimates as follows:
(a) Average Travel Time and Average Travel Distance per Visit
While it is difficult to estimate the savings in reduced travel
time quantitatively, since distances from enrollees to providers vary
significantly, to estimate the travel time to providers we use a former
CMS standard that providers should be located within 30 minutes or 30
miles of each enrollee. While this standard has since been replaced by
a more sophisticated measurement of access, we can use it as a proxy.
The former CMS standard was used because it is formulated simply in
terms of time (30 minutes) and mileage (30 miles) and does not
differentiate among provider types. The current standards for access
involve sophisticated algorithms, which involve more than two
parameters (time and mileage) and additionally differ by geographic
location and provider types. Therefore, the current standards were not
suitable due to their complexity. We therefore assume that the
midpoint, 15 minutes or 0.25 hour, represents the typical travel time
to providers per enrollee visit. We note that our estimate of 30
minutes round-trip is close to the 37-minute estimate used in one
article.\52\ Similarly, we believe that 15 miles (one-half of 30 miles)
is the average travel distance per provider visit.
---------------------------------------------------------------------------
\52\ J. Ashwood, A. Mehrotra, D. Cowling, and L. Uscher-Pines,
``Direct to Consumer Telehealth May Increase Access to Care but Does
not Decrease Spending,'' Health Affairs 36(3), 2017, accessible at
https://www.healthaffairs.org/doi/10.1377/hlthaff.2016.1130.
---------------------------------------------------------------------------
In estimating the savings in wages due to reduced travel time, we
first note that the group of individual respondents varies widely by
respondent age, location, years of employment, educational attainment,
and working status with many people over 65 retired. To deal with this
variability, we follow the OMB guidance for estimating hourly wages for
enrollees using the occupational title ``All Occupations'' (occupation
code 00-0000 on the BLS website), with a mean wage of $24.34/hour. This
guidance reflects the OMB approach that all time should have a dollar
value. However, since we believe most MA enrollees are not working, we
are not adding 100 percent for overtime and fringe benefits. In other
words, we are scoring the wages as $24.34/hour.
Thus, the net impact per enrollee per telehealth visit to providers
would be $18.17 (15 miles * 2 (round trip) * $0.20 per mile (cost of
gasoline for medical transportation \53\) + 0.25 hours travel time * 2
(round trip) * $24.34/hr). The $0.20 per mile for cost of gasoline for
medical transportation reflects updated numbers by the Internal Revenue
Service (IRS) for 2019. As discussed previously, we assume that at most
50 percent of expected telehealth visits are currently being offered.
Therefore, we save at most $9.09 (0.5 x $18.17) per enrollee per
telehealth visit. The actual percentage saved may be significantly more
than 50 percent. This is summarized in Table 8.
---------------------------------------------------------------------------
\53\ https://www.irs.gov/newsroom/irs-issues-standard-mileage-rates-for-2019.
---------------------------------------------------------------------------
(b) Average Number of Visits per Enrollee
In 2014, the Centers for Disease Control and Prevention (CDC)
estimated that persons 65 years of age and older average 5.89 visits
per person per year.\54\
---------------------------------------------------------------------------
\54\ https://www.cdc.gov/nchs/products/databriefs/db292.htm;
https://www.cdc.gov/nchs/products/databriefs/db292.htm.
---------------------------------------------------------------------------
(c) Number of MA Enrollees
Table IV.C1 of the 2018 Medicare Trustees Report provides the
projected MA enrollment.
(d) Percent, per Year, of Provider Visits That Are Telehealth
Ideally, we would like an estimate on the number of total visits
and telehealth visits for 65-year-olds. However, these data are not
available. Therefore, we use the best available proportions. We proceed
as follows.
The CDC website cited earlier estimates 885 million provider visits
in 2014. This is an aggregate number over all age groups; the 885
million was not broken out further by age group.
Absent information on the proportion of telehealth visits among
total visits by 65-year-olds to providers, we use general averages
(across all age groups) with the understanding that some accuracy is
lost. The Statista website suggests 22 million telehealth visits in
2014.\55\ This implies that 2.49 percent (22/885) of all physician
visits were telehealth visits.
---------------------------------------------------------------------------
\55\ https://www.statista.com/statistics/820756/number-of-telehealth-visits-in-us/; https://www.statista.com/statistics/820756/number-of-telehealth-visits-in-us/.
---------------------------------------------------------------------------
Inferring growth rates from the numbers on the Statista website,
the projected low and high growth rates for telehealth services are 8.9
percent and 22 percent respectively. Other websites give similar
ranges. For example, Becker gives three estimates for telehealth growth
rates of 14.3 percent, 16.5 percent, and 27.5 percent.\56\ Because of
this variability, we use the lower estimate for projected telehealth
growth, which is about 8.9 percent. These numbers can be used to
estimate the proportion of provider visits that will be telehealth in
future years. For example, in 2015, we assume 1.089 (growth rate) *
2.49 percent (proportion of provider visits that are telehealth in
2014) = 2.71 percent of provider visits will be telehealth visits.
---------------------------------------------------------------------------
\56\ See https://www.beckershospitalreview.com/healthcare-information-technology/telemedicine-to-attract-7m-patient-users-by-2018-12-statistics-on-the-thriving-market.html; https://www.beckershospitalreview.com/telehealth/global-telemedicine-market-to-experience-16-5-annual-growth-rate-through-2023.html; https://www.beckershospitalreview.com/healthcare-information-technology/the-growth-of-telehealth-20-things-to-know.html; https://www.beckershospitalreview.com/telehealth/global-telemedicine-market-to-experience-16-5-annual-growth-rate-through-2023.html.
---------------------------------------------------------------------------
Multiplying these four component estimates together--average
savings per visit ($9.09) * visits per enrollee (5.89) * number of MA
enrollees * percent of provider visits that are telehealth (2.49
percent * 1.089 per year)--we arrive at a conservative aggregate
savings estimate of $30 million, growing to $50 million in 2024, and
$88 million in 2029. Had we used the higher projected visits, we would
have obtained $30 million, growing to $280 million. The aggregate
savings over 10 years is $557 million. The results are summarized in
Table 9.
[[Page 15813]]
Table 8--Travel Savings per Provider Visit, Telehealth
------------------------------------------------------------------------
Label Item Amount Source
------------------------------------------------------------------------
(A).......... One way travel 0.25 hours........ Prior CMS standard
to provider. of provider
availability within
30 minutes or 30
miles. We use the
midpoint of 30 and
0 minutes, or 15
minutes/0.25 hours.
An alternative
approach uses the
Health Affairs
article of 37
minutes total.
(B).......... Travel to and 2
from provider.
(C).......... Wages for $24.34............ OMB guidance, use of
enrollee per occupational code
hour. 00-0000 on BLS
website. OMB
provided further
guidance that,
although it
supports the idea
of dollar value of
time, since many
enrollees are
retirees, the wage
estimate should not
be doubled to
reflect overhead
and benefits.
(D).......... Mileage cost $0.20............. IRS website.
per mile for
medical travel.
(E).......... Mileage........ 15 miles.......... Prior CMS standard
of provider
availability within
30 minutes or 30
miles. We use the
midpoint of 30 and
0 miles, or 15
miles.
(F).......... Wage savings $12.17............ (A) * (B) * (C).
per provider
visit.
(G).......... Mileage savings $6.00............. (E) * (B ) * (D).
per provider
visit.
(H).......... Factor to be 0.50.............. Currently, only 0.3%
applied for of rebate dollars
current available for
telehealth supplemental
usage. benefits are spent
on telehealth
services. This
small percentage
suggests that, at
most, half of all
expected telehealth
services are
currently being
offered.
-----------------------------------------
Total $9.09............. 0.5 x [(F) + (G)]
savings per
visit.
------------------------------------------------------------------------
Notes: This table reflects savings based on the following two
assumptions: The value of enrollee time is $24.34/hr and at most 50%
of expected telehealth is being offered.
Table 9--Travel Savings per Year, Telehealth
----------------------------------------------------------------------------------------------------------------
Total travel Percent of
savings ($ in Savings per Provider provider
Year thousands) to MA enrollment telehealth visits per visits that
enrollees from (in thousands) visit enrollee use telehealth
telehealth (percent)
----------------------------------------------------------------------------------------------------------------
2020........................ $30,903.7 23,181 $9.09 5.89 2.49
2021........................ 34,912.4 24,062 9.09 5.89 2.71
2022........................ 39,441.6 24,972 9.09 5.89 2.95
2023........................ 44,440.5 25,858 9.09 5.89 3.21
2024........................ 50,048.2 26,708 9.09 5.89 3.50
2025........................ 56,218.7 27,549 9.09 5.89 3.81
2026........................ 63,057.8 28,375 9.09 5.89 4.15
2027........................ 70,572.1 29,161 9.09 5.89 4.52
2028........................ 78,981.9 29,969 9.09 5.89 4.92
2029........................ 88,393.9 30,799 9.09 5.89 5.36
-----------------------------------------------------------------------------------
Raw Total............... 556,970.9 ................ .............. .............. ..............
----------------------------------------------------------------------------------------------------------------
c. Savings From Illness Prevention Due to Increased Access to Services
Telehealth savings due to preventive telemonitoring may arise from
easier or increased access to Part B services. The MA additional
telehealth benefits to be included in the MA basic benefit bid stem
from the Bipartisan Budget Act of 2018 amendment of section 1852 of the
Act, and will likely represent a mix of replacement of pre-Bipartisan
Budget Act of 2018 in-person visits and additional Part B services. We
believe that increased coverage of the MA additional telehealth
benefits will generally result in an aggregate reduction in use of
emergency room visits and inpatient admissions because the relative
increased ease of receiving healthcare services should improve health
outcomes and reduce avoidable utilization that results from untreated
conditions that exacerbate illness. Several studies predict that
telehealth can significantly reduce illness through prevention. We
mention two situations where Part B services could be provided by a
physician or practitioner via MA additional telehealth benefits: (1)
Comprehensive medication reviews and (2) post-discharge transitional
care programs.
(1) Comprehensive Medication Reviews \57\
---------------------------------------------------------------------------
\57\ Our current MA program allows telemonitoring, hospital
readmission prevention programs, and post-discharge in home
medication reconciliation.
---------------------------------------------------------------------------
Telehealth can help significantly with patients who need multiple
medications. Remote medication management can reduce the multiple
patient visits that are often necessary to get the appropriate mix of
medications. One recent meta-study on medication reviews summarizes
seven studies, showing that using comprehensive medication reviews
reduced hospitalizations, readmissions, drugs, and mortality.\58\
---------------------------------------------------------------------------
\58\ Evan A. DeZeeuw, PharmD; Ashley M. Coleman, PharmD; and
Milap C. Nahata, PharmD, MS, ``Impact of Telephonic Comprehensive
Medication Reviews on Patient Outcomes'', Am J Manag Care.
2018;24(2):e54-e58.
---------------------------------------------------------------------------
(2) Post-Discharge Transitional Care Programs
Telehealth has been used to provide transitional care for
discharged hospital patients. One study found a savings of $1,333 per
beneficiary, half of which
[[Page 15814]]
was due to reduced inpatient follow-up care.\59\
---------------------------------------------------------------------------
\59\ Keith Kranker, Ph.D.; Linda M. Barterian, MPP; Rumin
Sarwar, MS; G. Greg Peterson, Ph.D.; Boyd Gilman, Ph.D.; Laura Blue,
Ph.D.; Kate Allison Stewart, Ph.D.; Sheila D. Hoag, MA; Timothy J.
Day, MSHP; and Lorenzo Moreno, Ph.D. ``Rural Hospital Transitional
Care Program Reduces Medicare Spending'', Am J Manag Care.
2018;24(5):256-260.
---------------------------------------------------------------------------
In the proposed rule, we solicited comments on potential savings.
Numerous commenters were overwhelmingly supportive of CMS's projected
savings. Furthermore, they backed their support with quantifiable
details from their own experiences in their various products.
Commenters particularly emphasized healthcare savings due to increased
preventive care, significantly reduced hospital admissions, and
increased access to specialties with insufficient providers to meet
current demands (for example, tele-cardiology, tele-psychiatry, and
tele-dermatology).
d. Increased Costs if Unnecessary Medical Visits Increase
We have moved the content in this section of the proposed rule to
the previous section ``Possible Overutilization.'' We noted that we
received overwhelming support from commenters that there should be no
concern about overutilization, and the one article citing this concern
is an old article in a very specific setting (the article itself cast
doubt on its own findings).
We are finalizing our requirement that MA plans must advise
enrollees that they may receive the specified Part B service(s) either
through an in-person visit or through electronic exchange (Sec.
422.135(c)(2)). As discussed in section II.A.1. of this final rule,
based on public comments, we are not finalizing the portion of proposed
Sec. 422.135(c)(2) that referenced the Evidence of Coverage (EOC)
document as the required vehicle for this notification. Instead, we
intend to address the EOC in future subregulatory guidance.
We received the following comments, and our responses follow.
Comment: In response to CMS's request for comments in the proposed
rule on whether there would be savings to enrollees arising from
reduced travel time to and from providers, several commenters expressed
overwhelming support. More specifically, there were no dissenting
comments that overutilization of services would reduce these enrollee
savings.
Response: We appreciate the commenters' support. Although there
will be no change in policy, based on these comments, we are confident
in including the savings due to reduced enrollee travel time to and
from providers in the summary and accounting tables (Tables 16 and 17).
This will result in a $557 million savings over 10 years, making this
final rule economically significant.
Comment: In response to CMS's request for comments in the proposed
rule on whether telehealth would significantly reduce medical spending,
a variety of commenters also expressed overwhelming support. Commenters
pointed out that savings would arise from increased prevention, reduced
hospital readmissions, and increased access in such areas as tele-
dermatology and tele-psychiatry. Commenters frequently provided
statistics based on their own experience.
Response: We thank the commenters for their support. Although it is
clear that telehealth will result in healthcare savings, we do not have
enough information to estimate the impact on reductions of Medicare
Trust Fund payments. Consequently, we are scoring this as a qualitative
savings in this final rule.
We received several comments on our estimated impacts for MA
additional telehealth benefits. The comments were overwhelmingly
supportive with no one dissenting to our impact estimates. After
careful consideration of all comments received, and for the reasons set
forth in our responses to the related comments summarized earlier, we
are finalizing our impact analysis for this provision with the
following modification. We are revising our proposed impact of this
rule. The final rule is now expected to be an economically significant
rule that will save enrollees $557 million over 10 years. The savings
to enrollees are due to the MA additional telehealth benefits
provision, which will reduce enrollee travel time to and from
providers.
2. Integration Requirements for Dual Eligible Special Needs Plans
(Sec. Sec. 422.2, 422.60, 422.102, 422.107, 422.111, and 422.752)
As stated in the earlier in the preamble of this final rule,
starting in 2021, section 50311(b) of the Bipartisan Budget Act of 2018
establishes new Medicare and Medicaid integration standards for MA
organizations seeking to offer D-SNPs and enrollment sanctions for
those MA organizations that fail to comply with the new standards. We
proposed to add a revised definition for ``D-SNP'' at Sec. 422.2 and
establish at Sec. 422.107 revisions to the existing minimum state
Medicaid agency contracting requirement for D-SNPs other than FIDE SNPs
and HIDE SNPs, which are also defined at Sec. 422.2.
As noted in the preamble of the proposed rule and at section
II.A.2.a. of this final rule, many of the changes we proposed would
unify and streamline existing requirements, which should reduce burden
and are therefore not expected to have impact. For example--
Passive enrollment: The reference to the definition of a
HIDE SNP at Sec. 422.2 will not materially change the plan types that
are eligible for passive enrollment; rather, the existing rule simply
refers to them as the D-SNPs that meet a high standard of integration
under the supplemental benefit authority at Sec. 422.102(e); and
Enhanced Supplemental Benefits: We are also clarifying at
Sec. 422.102(e) that not only are HIDE SNPs that meet minimum quality
and performance standards eligible to offer supplemental benefits, but
FIDE SNPs that similarly meet minimum quality and performance standards
may do so as well. While this amendment does not change what has
occurred in practice, we believe it clarifies the types of plans that
are eligible to offer enhanced supplemental benefits.
The impacts were presented in section III.B.2. of this final rule.
However, the COI reduced the cost to state Medicaid agencies by 50
percent, reflecting a 50 percent Federal Financial Participation (FFP)
rate; consequently, the RIA must include this 50 percent FFP rate as a
cost to the federal government. Table 10 repeats the analysis
summarized in Table 4 and includes transfers to the federal government.
The narrative accompanying Table 4 presents our assumptions in reaching
this impact as well as our assumption that there are no costs in
subsequent years. As noted in section III.B.2. of this final rule, wage
estimates and occupational titles were updated to reflect greater
specificity as well as the latest BLS wage data.
As detailed in this section, the total first year cost is $3.9
million ($3.4 million to plans + $0.25 million to State Medicaid
Agencies and $0.25 million to the federal government). The $3.9 million
represents a true cost since it pays for the services of lawyers,
software developers and programmers, and business operation
specialists. Of this $3.9 million, $3.4 million is a cost to plans,
while $0.5 million is a cost to the state Medicaid agencies which
transfers $0.25 million to the federal government.
[[Page 15815]]
Table 10--First Year Costs of D-SNP Integration Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost to Transfers to
Hours per Cost per Cost to D- state federal
Item Number of respondents respondent Total hours hour ($) SNPs ($) Medicaid government
agencies ($) ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial update by state Medicaid 44 (states).................. 24 1,056 136.44 ............ 72,040 72,040
agency of its contracts with D-SNPs.
Initial establishment of system for 13........................... 160 2,080 98.54 ............ 102,482 102,482
notification of hospital and SNF 13........................... 160 2,080 72.84 75,754 75,754
admissions by state Medicaid agency.
Initial update by D-SNPs of their 190 (D-SNPs)................. 8 1,520 136.44 207,389 ............ ............
contracts with state Medicaid agency.
Initial notification of hospital and 116.......................... 160 18,560 98.54 1,828,902 ............ ............
SNF admissions by D-SNPs to state 116.......................... 160 18,560 72.84 111,351,910
Medicaid agency.
-----------------------------------------------------------------------------------
Total by Stakeholder............. ............................. ............ ............ ............ 3,388,201 250,276 250,276
--------------------------------------------------------------------------------------------------------------------------------------------------------
We received no comments on our impact estimates related to these
provisions and therefore are finalizing our estimates as proposed, with
modifications to reflect the omission of estimates for the impact of
the contract modification at Sec. Sec. 422.107(c)(1) through (3) and
422.107(c)(9) in the proposed rule, minor modifications to the
occupational codes, and the corresponding adjusted hourly wages
previously mentioned in this section.
3. Unified Grievance and Appeals Procedures for Dual Eligible Special
Needs Plans and Medicaid Managed Care Plans at the Plan Level
(Sec. Sec. 422.560 Through 422.562, 422.566, 422.629 Through 422.634,
438.210, 438.400, and 438.402)
The addition of the appeals and grievances provisions at Sec. Sec.
422.629 through 422.634 focus on creating MA and Medicaid appeal and
grievances processes that are unified for D-SNPs that also have
comprehensive Medicaid managed care contracts (or are the subsidiary of
a parent organization or share a parent organization with the entity
with a comprehensive Medicaid managed care contract) and have
exclusively aligned enrollment. The final rule addresses appeals at the
plan level. Currently, Medicaid and MA appeals and grievance processes
differ in several key ways. These differences hinder a streamlined
grievance and appeals process across Medicare and Medicaid managed care
sectors and create unnecessary administrative complexity for plans that
cover dual eligible individuals for both Medicare and Medicaid
services. These new regulations will allow enrollees in a D-SNP that is
also a Medicaid managed care plan through which the enrollees get
Medicaid coverage to better understand the grievance and appeals
processes and generally receive a resolution of their grievances and
appeals more quickly.
There are four areas where this provision will have an impact,
listed here and discussed in further detail later in this section.
Furnishing Medicare Parts A and B Services during the
pendency of appeals (that is, through the integrated reconsideration);
Updating plan grievance policies and procedures and
consolidation of plan grievance notifications and reviews;
Updating applicable integrated plan appeals policies and
procedures; and
Sending appeal files to enrollees who request them.
Following are details on these four areas of impact.
a. Furnishing Medicare Parts A and B Services During the Pendency of
Appeals
One of the provisions related to appeals integration may marginally
impact the ways MA sponsors bid for their D-SNPs, which could impact
Medicare spending. We are finalizing as proposed that the existing
standards for continuation of benefits at Sec. 438.420 apply to
applicable integrated plans for Medicare benefits under Parts A and B
and Medicaid benefits in the new integrated appeals requirements at
Sec. 422.632. Under our final rule, and as is applicable to Medicaid
managed care plans currently, if an applicable integrated plan decides
to stop or reduce a benefit that the enrollee is currently authorized
to receive, the enrollee could request that the benefit continue to be
provided at the currently authorized level while the enrollee's appeal
is pending through the integrated reconsideration. Currently, MA plans
generally are not required to provide benefits pending appeal, whereas
in Medicaid it has been a long-standing feature.
We expect that the new integrated appeals provisions will result in
an increase in expenditures by applicable integrated plans for Medicare
Parts A and Part B covered services because they will be required to
continue coverage for services during the pendency of the
reconsideration request, or first-level appeal under our final rule.
The estimate of impact of this continuation is based on calendar
year 2016 appeal metrics, which are then trended to calendar year 2021.
The assumptions, sources and calculations are summarized in Tables 11
and 12 in this rule and further clarified as follows.
The first step in this estimation is to determine the number of
integrated reconsiderations per 1,000 beneficiaries enrolled in
applicable integrated plans affected by this provision. Given the
similarity of population characteristics, the reconsideration
experience for the Medicare-Medicaid Plans (MMPs) participating in the
Financial Alignment Initiative was used as a proxy for the applicable
integrated plans. In 2016, MMP enrollees were impacted by 1,232
reconsiderations for services which were resolved adversely or
partially favorably to the beneficiary. The corresponding MMP
enrollment in 2016 was 368,841, which implies a rate of 3.3
reconsiderations per 1,000 in 2016.
We projected D-SNP enrollment impacted by the unified procedures to
grow from 150,000 in 2018 to 172,000 (150,000 * 1.145) in 2021 based on
the estimated enrollment growth for all D-SNPs during the period of
14.5 percent. Applying the MMP reconsideration rate of 3.3 per 1,000 to
the projected 2021 enrollment in applicable integrated plans of 172,000
results in an estimated 568 (172,000 * 3.3/1,000) service
reconsiderations for applicable integrated plans in 2020.
The next step is to determine the average level of benefit subject
to the appeals. Table 1 in the report Medicare Part C QIC
Reconsideration Data for
[[Page 15816]]
2016 \60\ contains data on the number and benefit amounts by service
category for the second level appeals filed in 2016. Analysis of these
data resulted in an estimated per-appeal benefit value of $737 for
2016. The determination of this value took into account that some
services would not be subject to the regulatory extension of coverage
due to the existence of immediate review rights (inpatient hospital,
skilled nursing facility, and home health), other benefits would likely
have been rendered already (emergency room, and ambulance), and other
services are not covered as a D-SNP basic benefit (hospice and non-
Medicare benefits). Accounting for 19.5 percent inflation in per-capita
Medicare spending between 2016 and 2021, and carving out the 13.38
percent consumer price index inflation in years 2016-2020 inclusive,
results in an estimated per-appeal benefit value of $774 (that is, $737
* 1.195/1.1338) for 2021.
---------------------------------------------------------------------------
\60\ https://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/IRE.html.
---------------------------------------------------------------------------
Taking the product of the number of applicable integrated plan
service reconsiderations in 2021 (568) and average benefit value in
2021 ($774) yields an estimated cost in 2021 of $439,632 (that is, 568
* $774) due to an increase in Medicare expenditures stemming from the
unified appeals procedures for applicable integrated plans. We believe
that this figure represents an upper bound of the cost given that not
all applicable services will be rendered during the extended period of
benefit continuation in this regulation. These calculations are
summarized in Table 11.
Using the 2021 estimates as a basis, estimates for 2021 through
2029 are presented in Table 12. The following assumptions were used in
creating Table 12:
As described earlier in this section, the numbers in the
row for 2021 come from Table 11.
The projected FIDE SNP enrollment for 2022 through 2029
was obtained by multiplying the estimated 2021 FIDE SNP enrollment of
172,000, using SNP enrollment growth factors inferred from Table IV.C1
in the 2018 Medicare Trustees Report.
The projected cost per appeal for 2022 through 2029 was
obtained by first multiplying the estimated 2021 cost per appeal of
$774 by FFS per capita growth rates obtained from internal
documentation for the Table of FFS USPCC, non-ESRD estimates in
attachment II of the 2019 Rate Announcement and Call Letter (https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf).
As summarized in Table 12, there is an estimated true cost
(reflecting purchase of goods and services) of $0.4 million in 2021 and
$0.5 million in 2022 through 2025, modestly increasing to $0.6 and $0.7
million in 2026 through 2029. Eighty-six percent of this cost is
transferred from the plans to the Medicare Trust Fund; the remainder of
this cost is born by beneficiary cost sharing.
[[Page 15817]]
[GRAPHIC] [TIFF OMITTED] TR16AP19.002
[[Page 15818]]
Table 12--Net Cost per Year to the Medicare Trust Fund for Integrated Plan Appeals
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Net cost of Net cost of
Appeals per Number of Gross cost of Share of cost appeals to appeals to
Contract year Affected FIDE 1,000 affected affected Cost per appeals ($ in funded by medicare trust beneficiaries
SNP enrollment enrollees appeals per appeal millions) medicare trust fund ($ in ($ in
year fund (%) millions) millions)
(A) (B) (C) = (A)/ (D) (E) = (D) * (C)/ (F) (F) * ( E ) (1-F) * (E)
1000 * (B) 1,000,000
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
2021......................................................... 172,000 3.3 568 $774 0.4 86% 0.4 ..............
2022......................................................... 179,000 3.3 591 791 0.5 86 0.4 0.1
2023......................................................... 185,000 3.3 611 808 0.5 86 0.4 0.1
2024......................................................... 191,000 3.3 630 828 0.5 86 0.4 0.1
2025......................................................... 197,000 3.3 650 842 0.5 86 0.5 0.1
2026......................................................... 203,000 3.3 670 861 0.6 85 0.5 0.1
2027......................................................... 209,000 3.3 690 883 0.6 85 0.5 0.1
2028......................................................... 215,000 3.3 710 903 0.6 85 0.5 0.1
2029......................................................... 220,000 3.3 726 920 0.7 85 0.6 0.1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
b. Updating Plan Grievance Policies and Procedures and Consolidation of
Plan Grievance Notifications and Reviews
As detailed in section III.B.3. of this final rule, there are only
34 contracts representing 37 D-SNPs that we currently believe will be
classified as a HIDE SNP or FIDE SNP and operate in states that have
policies requiring exclusively aligned enrollment across MA and
Medicaid managed care plans. In addition to the costs estimated in
section III.B.3. of this final rule, we estimate the following impacts:
(1) Sending a notice of acknowledgement; (2) sending a notice of
resolution; and (3) review of integrated grievances.
(1) Sending a Notice of Acknowledgement
Under Sec. 422.629(g), applicable integrated plans must send a
notice of acknowledgment for all grievances, both those submitted
orally and in writing. Medicaid managed care organizations are
currently required to send this notice under Sec. 438.406(b)(1),
whereas MA plans are not currently required to send this notice. Under
this final rule, applicable integrated plans must now send this notice
for all grievances, not only those pertaining to Medicaid issues. In
the absence of data on the types of grievances submitted, we assume
half the grievances currently made to an applicable integrated plan are
related to Medicare issues and half are related to Medicaid issues.
Estimates of impacts for this notice take into account overlapping
Medicare and Medicaid benefits. As we do not have data on grievances
for overlapping Medicare and Medicaid benefits, we assume 25 percent of
all grievances are related to overlapping Medicare and Medicaid
benefits. This 25 percent estimate reflects our belief that there is
some (more than 0 percent) overlap, but that the majority of grievances
(more than 50 percent) do not overlap. The average of 0 percent and 50
percent results in the 25 percent assumption we have made. We use the
following 6 estimates to estimate the costs associated with this
provision:
As detailed in section IV.B.3.a of this final rule, we
estimate that the aggregate number of enrollees in applicable
integrated plans in Contract Year 2021 is 172,000. We used an average
of the following two estimates for the percentage of enrollees expected
to file a grievance:
++ The May 2016 Medicaid Managed Care final rule estimate of a 2
percent filing rate; and
++ The currently approved burden under OMB control number 0938-0753
(CMS-R-267) estimate of a 6.8 percent filing rate.
Thus we estimate that 4.4 percent (\1/2\ x (6.8 percent + 2
percent) of all enrollees file a grievance.
As indicated previously, we estimate that 50 percent of
all grievances are related to Medicare coverage issues and half are
related to Medicaid coverage issues.
As indicated previously, we estimate 25 percent of all
grievances for applicable integrated plans are regarding overlapping
Medicare and Medicaid benefits issues.
We estimate that the time for mailing an acknowledgment
notice using a standard form is 1 minute, or 1/60th of an hour.
A business operations specialist would perform this task
at an hourly wage of $72.84/hr.
Therefore, we estimate there are 7,568 grievances (172,000
enrollees x 4.4 percent who file a grievance), of which 3,784 (7,568
grievances x 50 percent) are related to enrollees' Medicare coverage
and 3,784 are related to their Medicaid coverage. We estimate that
1,892 grievances (7,568 grievances x 25 percent of grievances for
overlapping benefits) are made with respect to overlapping Medicare and
Medicaid issues and currently only require acknowledgment notices under
Medicaid rules. It follows that the new burden arising from this
provision applies to 1,892 grievances (3,784 grievances related to
Medicare coverage minus the 1,892 grievances that would have resulted
in notices of acknowledgement because they related to Medicaid
coverage).
Thus the aggregate annual burden across all plans from this
provision is 32 hours (1,892 grievances x 1/60 hr) at a cost of $2,297
(1,892 grievances x 1/60 hr x $72.84/hr).
(2) Sending a Notice of Resolution
Section 422.630(e) requires that applicable integrated plans issue
a notice upon resolution of the integrated grievance, unless the
grievance was made orally and: (1) Was not regarding quality of care;
and (2) the enrollee did not request a written response. To estimate
the savings from the reduction in the number of grievance resolution
notices due to unification of grievance processes for applicable
integrated plans, we first estimate the total cost of issuing such
notices and then multiply by 25 percent (the estimated number of
grievances that are regarding overlapping Medicare and Medicaid
benefits). The resulting amount is the cost of the eliminated
duplicative grievance notices under the unified procedures. We used the
following 7 estimates in our calculation:
As previously discussed regarding sending the notice of
acknowledgement, we estimate that the aggregate number of enrollees in
applicable integrated plans in Contract Year 2021 is 172,000.
As previously discussed regarding sending the notice of
acknowledgement, we estimate that 4.4 percent of all enrollees file a
grievance.
The currently approved burden under OMB control number
0938-0753 (CMS-R-267) estimates that 60 percent
[[Page 15819]]
of all those who file a grievance will file orally.
We estimate that of those who file orally, 10 percent will
request a follow up written response.
We estimate 9.5 percent of those who file a grievance,
file on quality matters.\61\
---------------------------------------------------------------------------
\61\ This percent estimate comes from the total percent of
grievances relating to quality of care as reported by MA plans for
calendar Year 2017 Medicare Part C Reporting Requirements Data.
---------------------------------------------------------------------------
We estimate that it will take one-quarter of an hour to
prepare a written response to a grievance, reflecting the current time
estimate under OMB control number 0938-0753 (CMS-R-267).
A business operations specialist would perform this task
at an hourly wage of $72.84/hr.
We use these 7 estimates to derive the following:
We estimate there will be 7,568 grievances (172,000
enrollees x 4.4 percent who file a grievance)
51.13 percent of those who file a grievance require
written responses, either because the grievance was on a quality issue,
was submitted in writing, or was orally submitted (but not on quality
issues) and the enrollee requested a written response. The 51.13
percent estimate is based on the following assumptions:
++ 9.5 percent of all grievances are on quality matters, all of
which require written response;
++ 36.2 percent of all grievances are submitted in writing and not
on quality issues (90.5 percent of grievances that are not on quality
issues x 40 percent (100 percent-60 percent of grievances submitted
orally));
++ 5.43 percent of all grievances are orally submitted (but not on
quality issues), and the enrollee requested a written response (90.5
percent of grievances that are not on quality issues x 60 percent of
grievances are filed orally x 10 percent of all oral grievances request
a written response).
It therefore follows that 51.13 percent of grievances (9.5 percent
+ 36.20 percent + 5.43 percent) require written response.
Thus, the aggregate burden associated with responding in writing to
grievances is 967 hours (7,568 grievances x 51.13 percent of grievances
requiring a written response x 0.25 hr to write a response) at a cost
of $70,436 (967 hours x $72.84/hour wage of a business operations
specialist). It follows that the savings due to reduction of
duplicative notices is 242 hours (967 hours x 0.25 grievances involving
an overlap of Medicare and Medicaid benefits) at an annual savings of
$17,616 (172,000 enrollees x 4.4 percent of enrollees who file
grievances x 51.13 percent of grievances requiring a written response x
one quarter of grievances eliminated due to overlap of Medicare and
Medicaid x one quarter hour x $72.84/hour).
(3) Review of Grievances
We estimate a burden adjustment from grievance reviews detailed
under Sec. 422.629(k)(2) in a manner similar to the estimates for
sending notices of acknowledgement and resolution. We first estimate
total cost and then estimate the savings as 25 percent of that total
cost due to the elimination of duplicative grievance reviews for
Medicare and Medicaid overlap issues. We assume that the review of each
grievance will be done by a business operations specialist working at
$72.84/hr. Based on the May 2016 Medicaid Managed Care final rule (81
FR 21498), we assume the average grievance takes 30 minutes for a
business operations specialist to resolve. We estimate the aggregate
annual cost for grievance review is 3,784 hours (172,000 enrollees x
0.044 x 0.5 hr) at a cost of $275,627 (3,784 hr x $72.84/hr).
Therefore, the reduction in grievance reviews is 946 hours (3,784 hr x
25 percent), at an annual savings of $68,907 (3,784/h4 x $72.84).
Thus, the total annual savings associated with consolidation of
applicable integrated plans' grievance notifications and reviews is
$84,226 per year [($17,616 (notice of resolution) + $68,907 (grievance
review)-$2,297 (notice of acknowledgement).]
Section III.B.3. of this final rule estimates a one-time cost of
$29,864 ($19,812 for updating policies and procedures + $10,051 for
recordkeeping). Thus, the total impact arising from updating policies
and procedures and consolidation of grievance notices and reviews is a
savings of $54,362 ($88,820-$29,864) in the first year and savings of
$84,226 in subsequent years.
c. Updating Applicable Integrated Plan Appeals Policies and Procedures
Applicable integrated plans' internal appeals policies and
procedures must be updated to comply with the unified appeals
requirements. In terms of updates, we see no reason to differentiate
between the work required for grievances and appeals. Therefore, as
indicated in section IV.B.3.b. of this final rule, we estimated a one-
time cost of $29,864 for updating applicable integrated plans' appeals
policies and procedures.
d. Sending Appeal Files to Enrollees Who Request Them
Medicaid managed care regulations under Sec. 438.406(b)(5)
currently require plans to send, for free, appeal case files to
enrollees who appeal while, in contrast, the Parts C & D Enrollee
Grievance, Organization/Coverage Determinations, and Appeals Guidance,
Sec. 50.5.2, requires MA plans to send such files at a reasonable
cost.\62\ Our final rule requires the applicable integrated plans to
send such files for free. To estimate this cost, we must first estimate
the cost of sending such a file.
---------------------------------------------------------------------------
\62\ See https://www.cms.gov/Medicare/Appeals-and-Grievances/MMCAG/Downloads/Parts-C-and-D-Enrollee-Grievances-Organization-Coverage-Determinations-and-Appeals-Guidance.pdf.
---------------------------------------------------------------------------
Livanta, a Quality Improvement Organization, estimates the cost per
case file as $40-$100.\63\ This can be justified independently with a
stricter range as follows: Assuming a typical case file has 100 pages,
it would weigh about 1 pound at 6 pages per ounce. The cost of mailing
a 1-pound case file by FedEx (to assure security) is $10. The cost of
photocopying 100 pages at a minimum rate of $0.05 per page is $5. The
$0.05 per page is likely to be an overestimate for plans that own their
own photocopying equipment. Thus, the total cost of photocopying and
mailing would be about $15. We assume a correspondence clerk, BLS
occupation code 43-4021,\64\ would take 1 hour of work, at $36.64 per
hour (including 100 percent for overtime and fringe benefits) to
retrieve the file, photocopy it, and prepare it for mailing. Thus we
estimate the total cost at $36.64 + $10 + $5 = $51.64.
---------------------------------------------------------------------------
\63\ See https://bfccqioareal.com/recordrequests.html.
\64\ https://www.bls.gov/oes/current/oes_nat.htm.
---------------------------------------------------------------------------
We need further estimates to complete the calculation. We assume
43.5 total appeals (favorable and unfavorable) per 1,000.\65\ Based on
our experience, we assume that 10 percent of all appeals would require
a file sent. Finally, as indicated in section III.B.3. of this final
rule, there are 37 applicable integrated plans in 34 contracts with
150,000 enrollees in 2018 projected to grow to 172,000 enrollees in
2021. Thus we estimate the total annual cost of mailing files to
enrollees as $38,637 (that is, 172,000 enrollees * 4.35 percent appeals
* 10 percent requesting files * $51.64 cost).
---------------------------------------------------------------------------
\65\ https://www.cms.gov/Medicare/Prescription-Drug-Coverage/PrescriptionDrugCovContra/PartCDDataValidation.html.
---------------------------------------------------------------------------
The various impacts of unified grievances and appeals are
summarized in Table 13. The aggregate impact is a cost $0.4 to $0.6
million per year for the
[[Page 15820]]
next 10 years. This impact reflects both costs to the Medicare Trust
Fund, costs to enrollees, costs related to first-year updates to
policies and procedures, and savings due to consolidation of
notifications to enrollees as a result of unified grievance procedures.
Table 13--Summary of Costs for Grievance Integration Provision ($ in Millions)
[Negative numbers indicate savings]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Updating
policies and
Cost to Cost sharing procedures and Updating Sending files
Item Medicare Trust for MA consolidation of appeal to enrollees Total impact
Fund enrollees grievance policies and who request
notices and procedures them
reviews
--------------------------------------------------------------------------------------------------------------------------------------------------------
Subsection in this Unified Grievance Section.......... (a) (a) (b) (c) (d)
2020.................................................. n/a n/a n/a n/a n/a n/a
2021.................................................. 0.38 0.06 (0.05) 0.03 0.038 0.5
2022.................................................. 0.4 0.07 (0.08) 0 0.038 0.4
2023.................................................. 0.42 0.07 (0.08) 0 0.038 0.4
2024.................................................. 0.45 0.07 (0.08) 0 0.038 0.5
2025.................................................. 0.47 0.08 (0.08) 0 0.038 0.5
2026.................................................. 0.49 0.09 (0.08) 0 0.038 0.5
2027.................................................. 0.52 0.09 (0.08) 0 0.038 0.6
2028.................................................. 0.54 0.1 (0.08) 0 0.038 0.6
2029.................................................. 0.57 0.1 (0.08) 0 0.038 0.6
--------------------------------------------------------------------------------------------------------------------------------------------------------
We note that these costs and savings are true costs and savings
since they reflect payment for additional or fewer economic resources
(reduced notifications and increased cost of appeals). The increased
appeals costs are a cost to MA plans, which transfer this cost to
enrollees and the Medicare Trust Fund (the government).
We received no comments on our estimates and therefore are
finalizing them with modifications to reflect the omission of the
impact associated with sending the notice of acknowledgement and to the
occupational codes and corresponding adjusted hourly wages as
previously mentioned in this section.
4. Proposal for Prescription Drug Plan Sponsors' Access to Medicare
Parts A and B Claims Data Extracts (Sec. 423.153)
As described in section II.A.3. of this final rule, section 50354
of the Bipartisan Budget Act of 2018 requires the establishment of a
process under which the sponsor of a PDP that provides prescription
drug benefits under Medicare Part D may request, beginning in plan year
2020, that the Secretary provide on a periodic basis and in an
electronic format standardized extracts of Medicare claims data about
its plan enrollees. In the proposed rule, we proposed to add a new
Sec. 423.153(g) to implement the process for requesting these data.
To estimate the impact we required a model of operationalizing this
provision, without however committing to a particular operationalizing
process. We outlined a process which--
Meets all regulatory requirements; and
Requires as little burden as possible to make and grant
requests.
We solicited comments from stakeholders on this proposed
operationalization.
Electronic request and transfers are superior (have less burden)
than paper processes. We could therefore add functionalities to the CMS
HPMS system (or other CMS systems) which would allow the following
functions:
Request of claims data for the current and future quarters
for enrollees of the PDP requesting the data.
Request to no longer receive data.
Attestation that all regulatory requirements will be
complied with. The attestation would be in the form of a screen listing
all regulatory requirements; the authorized PDP HPMS user would have to
electronically attest by clicking a button.
Such a process would combine request and attestation. The receipt
of the submission would verify completeness of request. Furthermore,
there would be no burden in request (under 1 minute of work).
The HPMS contractors estimated that there would be a one-time
update costing approximately $200,000.
Besides requesting the data, data must be transmitted to the
requesting sponsor. Ideally, data would be transmitted electronically
but we do not yet have such an API. Instead, we would treat requested
data like data requested for research. Typically, such data is
downloaded onto encrypted external hard drives and mailed to
requestors.
The data could come from the Chronic Condition Warehouse (CCW). We
asked our contractors the cost of downloading quarterly such data and
sending it out. The cost varies by sponsor size. Currently, based on
CMS public data, there are 63 PDP sponsors. Their size and the
quarterly cost per sponsor of providing them with data, should they
request it, is summarized in Table 14.
Table 14--Cost per PDP Sponsor per Quarter for Transmitting Claims Data
------------------------------------------------------------------------
Cost per quarter per
sponsor for
PDP size in enrollees Number of sponsors transmission of
claims data
------------------------------------------------------------------------
Above 5 million............. 1 $26,500
1 million-5 million......... 6 17,500
100,000-1 million........... 11 10,500
[[Page 15821]]
Under 100,000............... 45 10,500
------------------------------------------------------------------------
To complete the annual impact analysis we needed an estimate of
proportions for each plan size that would request data. For example, we
are certain that the 1 PDP sponsor with over 5 million enrollees will
request data. Thus the annual burden for that plan size is 1 * 4
quarters x $26,500 per quarter = $106,000. Similarly, if we assume that
all six PDP sponsors with enrollments between 1 and 5 million would
request data then the annual burden is 6 sponsors * 4 quarters *
$17,500 per quarter per sponsor = $420,000. If we assume that only
three-quarters of these six sponsors request data then the annual
burden would be 0.75 * $420,000 = $315,000. In the absence of any other
basis for the decision, it is reasonable to assume that the proportion
goes down as the size goes down. In the absence of data, we could use a
descent of simple fractions (1, three-fourths, one-half, one-fourth).
Note, that 50 percent of plans with under 100,000 enrollees have under
10,000 enrollees. It is very unlikely that such plans would have the
resources to use the data. Thus an assumption that only 50 percent of
plans under 100,000 request data is reasonable. However, we considered
multiple scenarios. Table 15 presents for a variety of scenarios of
proportions and their total impact. The average of the five scenarios
is $1.5 million while the median is $1.3 million. The range of impacts
is $0.8 million to $2.9 million. For purposes of Executive Order 13771
accounting we listed the impact as $1.5 million annually, with a $0.2
million one-time cost in the first year. We did not trend this estimate
by year since the number of PDP sponsors has remained at 63 since 2015.
Table 15--Annual Burden of Providing Claims Data to PDP Sponsors
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proportion of Proportion of
Proportion of Proportion of sponsors with sponsors with Aggregate
sponsors with sponsors with 1- 100,000 to 1 less than annual burden
Scenario label over 5 million 5 million million 100,000 based on costs
enrollees enrollees enrollees enrollees provided in
requesting data requesting data requesting data requesting data Table 14 ($ in
(%) (%) (%) (%) millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
A.................................................................. 100 75 50 33 1.3
B.................................................................. 100 100 75 50 1.8
C.................................................................. 100 50 33 25 0.9
D.................................................................. 100 100 100 100 2.9
E.................................................................. 100 100 50 0 0.8
--------------------------------------------------------------------------------------------------------------------------------------------------------
We did not anticipate any further burden. It is most likely that
the PDP sponsor would exclusively use the data. In the event that
downstream entities are shared any data they are already bound in their
contracts by all Medicare regulations including the regulations of this
provision.
We received no comments on this proposal and therefore are
finalizing this provision without modification.
5. Medicare Advantage and Part D Prescription Drug Plan Quality Rating
System (Sec. Sec. 422.162(a) and 423.182(a), Sec. Sec. 422.166(a) and
423.186(a), Sec. Sec. 422.164 and 423.184, and Sec. Sec.
422.166(i)(1) and 423.186(i)(1))
We proposed some measure specification updates. These type of
changes are routine and do not have an impact on the highest ratings of
contracts (that is, overall rating for MA-PDs, Part C summary rating
for MA-only contracts, and Part D summary rating for stand-alone
prescription drug plans). Hence, there will be no, or negligible,
impact on the Medicare Trust Fund.
We also proposed some adjustments to MA and Part D Star Ratings for
extreme and uncontrollable circumstances. The proposed policy will make
adjustments to take into account the potential impact on contracts when
there are extreme and uncontrollable circumstances affecting them. This
policy is in response to the multiple disasters in 2017 and 2018,
including several hurricanes and wildfires. We proposed a policy to
permit an adjustment to Star Ratings when extreme and uncontrollable
circumstances occur during the performance period or measurement period
for MA and Part D plans.
We also proposed enhancements to the current methodology to set
Star Ratings cut points. The intent of the changes is to increase the
stability and predictability of cut points from year to year. This
proposal is consistent with the CMS goal to increase transparency. We
believe this provision would also have minimal impact on the highest
ratings of contracts. Specifically, simulations of the proposed changes
to the Star Ratings methodology using the 2018 Star Ratings data show
that the impact on the MA Quality Bonus Payment (QBP) ratings is
minimal with the QBP ratings overall increasing for less than 1 percent
of MA enrollees.
We received no comments on our proposed RIA statement and,
therefore, are finalizing this provision without modification.
6. Improving Clarity of the Exceptions Timeframes for Part D Drugs
(Sec. Sec. 423.568, 423.570, and 423.572)
We proposed to limit the amount of time an exceptions request can
be held open to 14 calendar days, meaning that there will be an outside
limit to how long the request is in a pending status while the Part D
plan sponsor attempts to obtain the prescribing physician's or other
prescriber's supporting statement. Under current manual guidance, plan
sponsors are instructed that an exceptions request should only be held
open for a reasonable period of time if a supporting statement is
needed. We believe that no more than 14 calendar
[[Page 15822]]
days is a reasonable period of time to have an exceptions request open
and this rule seeks to codify that standard. Based on comments
received, we are modifying the proposed approach to clearly account for
circumstances where a prescriber's supporting statement is received
late or not received at all within the 14 calendar day timeframe. Under
this final rule, if a supporting statement is not received by the end
of 14 calendar days from receipt of the exceptions request, the Part D
plan sponsor must notify the enrollee (and the prescribing physician or
other prescriber involved, as appropriate) of its determination as
expeditiously as the enrollee's health condition requires, but no later
than 72 hours (24 hours for an expedited request) from the end of 14
calendar days from receipt of the exceptions request. We do not expect
this to have any new impact on the number of pending appeals or pose a
potential burden to plan sponsors, as we expect plans are already
making and notifying enrollees of decisions on exceptions requests
under a similar reasonable timeframe. Based on findings from plan
sponsor audits, this approach is generally consistent with how plans
sponsors have operationalized the current guidance that cases only be
held open for a reasonable period of time pending receipt of a
prescriber's supporting statement. Therefore, we do not expect that
plan sponsors would need to hire more staff or adjust their operations
in a manner that would affect costs. Consequently, we expect the impact
of this final rule to be negligible.
We received no comments on our proposed RIA statement and therefore
are finalizing this provision of the RIA statement without
modification.
7. Preclusion List Requirements for Prescribers in Part D and
Individuals and Entities in MA, Cost Plans, and PACE (Sec. Sec.
422.222 and 423.120(c)(6))
We do not anticipate any additional cost or savings associated with
our preclusion list provisions. As we indicated in section II.C.1 of
this final rule, said provisions will not involve activities for plan
sponsors and MA organizations outside of those described in the
previously mentioned April 2018 final rule. The provisions are,
generally speaking, clarifications of our intended policy and do not
constitute new requirements. Hence, the expected impact is negligible.
We received no comments on our proposed RIA statement and are
therefore finalizing it without modification.
D. Alternatives Considered
1. Requirements for Medicare Advantage Plans Offering Additional
Telehealth Benefits (Sec. Sec. 422.100, 422.135, 422.252, 422.254, and
422.264)
Section 1852(m)(2)(A)(i) of the Act, as added by the Bipartisan
Budget Act of 2018, defines MA additional telehealth benefits as
services that are identified for the applicable year as clinically
appropriate to furnish using electronic information and
telecommunications technology when a physician (as defined in section
1861(r) of the Act) or practitioner (described in section
1842(b)(18)(C) of the Act) providing the service is not at the same
location as the plan enrollee (which we refer to as ``through
electronic exchange''). We considered various alternative definitions
of ``clinically appropriate'' but decided not to finalize specific
regulation text defining the term. We are finalizing our proposal to
implement the statutory requirement for MA additional telehealth
benefits to be provided only when ``clinically appropriate'' to align
with existing CMS rules for contract provisions at Sec.
422.504(a)(3)(iii), which requires each MA organization to agree to
provide all benefits covered by Medicare ``in a manner consistent with
professionally recognized standards of health care.''
The statute does not specify who or what entity identifies the
services for the year. We considered various alternatives, including
retaining the authority as an agency to specify what services are
clinically appropriate to furnish each year. MA plans could have been
required to comply with an annual list of clinically appropriate
services identified by CMS. However, we rejected this alternative as
too restrictive; we believe MA plans are in the best position and it is
in their own interest to stay abreast of professional standards
necessary to determine which services are clinically appropriate. MA
plans have a vested interest in staying abreast of the current
professionally recognized standards of health care. Healthcare
standards and technology continuously develop as a result of new
advancements in modern medicine. As healthcare standards change over
time and differ from practice area to practice area, we believe our
approach is flexible enough to allow plans to take those changes and
differences into account. We believe that failing to allow this
flexibility will result in the need for another regulation that
addresses future technological changes in health care. We do not want
to unduly burden MA plans with an unnecessary regulation or restrict
their efforts to provide healthcare services. Thus, we are finalizing
our proposal to interpret this provision broadly by not specifying the
Part B services that an MA plan may offer as MA additional telehealth
benefits for the applicable year, but instead allowing MA plans to
independently determine which services each year are clinically
appropriate to furnish in this manner. Our final definition of
additional telehealth benefits at Sec. 422.135(a)(2) provides that it
is the MA plan (not CMS) that identifies the appropriate services for
the applicable year.
We also considered alternatives to implement how telehealth
benefits are provided through ``electronic exchange.'' CMS considered
defining the specific means of ``electronic exchange.'' However, we
decided to define ``electronic exchange'' at Sec. 422.135(a) as
``electronic information and telecommunications technology,'' as the
former is a concise term for the latter, which is the statutory
description of the means used to provide the MA additional telehealth
benefits. We did not propose specific regulation text that defines or
provides examples of electronic information and telecommunications
technology. We considered providing a complete list of means of
providing electronic information and telecommunications technology.
Although we provided examples of electronic information and
telecommunications technology in the proposed rule, we did not provide
a comprehensive list because the technology needed and used to provide
MA additional telehealth benefits will vary based on the service being
offered. CMS appreciates that health care is evolving. CMS's purpose in
not providing specific regulation text that defines or provides
examples of electronic information and telecommunications technology is
to promote flexibility that allows plans to continue to develop methods
of healthcare delivery. CMS cannot contemplate the various
technological methods plans will use to deliver healthcare services. We
do not believe plans will misuse this flexibility because it is in
their best interest to provide healthcare services that meet the
changing needs of enrollees. We also believe the more narrow approach
of defining or providing examples of electronic information and
telecommunications technology will cause the added burden of requiring
another CMS rule.
We believe this broad approach will avoid tying the authority in
the final rule to specific information formats or technologies that
permit non-face-to-
[[Page 15823]]
face interactions for furnishing clinically appropriate services. This
approach will also result in savings due to increased disease
prevention among enrollees because plans will be able to develop
technology that is less expensive, more predictive, and more accurate.
We received no comments on our alternatives considered for this
provision and are therefore finalizing our explanation of them without
modification.
2. Integration Requirements for Dual Eligible Special Needs Plans
(Sec. Sec. 422.2, 422.60, 422.102, 422.107, 422.111, and 422.752)
This final rule requires D-SNPs that--(1) do not meet the HIDE SNP
or FIDE SNP integration standard; and (2) do not have a parent
organization assuming clinical and financial responsibility for
Medicare and Medicaid benefits to notify the state Medicaid agency or
its designee when a high-risk full-benefit dual eligible individual has
a hospital or skilled nursing facility admission. We considered several
alternatives to this proposal, as explained in section II.A.2.a.(2). of
the proposed rule, including examples provided in the Bipartisan Budget
Act of 2018: Notifying the state in a timely manner of enrollees'
emergency room visits and hospital or nursing home discharges;
assigning each enrollee a primary care provider; and data sharing that
benefits the coordination of items and services under Medicare and
Medicaid. However, we believe our final rule is preferable to the
alternatives when considering the degree to which it meets our criteria
for establishing minimum contract criteria discussed in section
II.A.2.a.(2) of the proposed and final rules. While we lack experience
and data to quantify cost, these alternatives would impact a larger
number of D-SNP enrollees and require additional state data-sharing
infrastructure than the notification requirement we are finalizing in
this rule, which we believe would result in increased administrative
burden and implementation costs. We received no comments on this
discussion of alternatives to the proposed rule and therefore are
finalizing our discussion without modification.
3. Unified Grievance and Appeals Procedures for Dual Eligible Special
Needs Plans and Medicaid Managed Care Plans at the Plan Level
(Sec. Sec. 422.560, 422.562, 422.566, 422.629 Through 422.634,
438.210, 438.400, and 438.402)
We are creating unified grievance and appeals procedures for
certain D-SNPs (FIDE SNPs and HIDE SNPs) with exclusively aligned
enrollment, which we define as occurring when such a D-SNP limits
enrollment to full-benefit dual eligible individuals whose Medicaid
benefits are covered by the D-SNP itself, or by a Medicaid managed care
organization that is the same organization, the D-SNP's parent
organization, or another entity that is owned and controlled by the D-
SNP's parent organization. Because most D-SNP enrollees are not
enrolled in D-SNPs with exclusively aligned enrollment, we considered
the feasibility of broadening the scope of these unified procedures to
apply to more D-SNPs--that is, to D-SNPs without exclusively aligned
enrollment. However, in most states, the majority of D-SNP enrollees
have Medicaid coverage either through a different organization's
Medicaid MCO, in a prepaid ambulatory or inpatient health plan (PAHP or
PIHP), or through a state's Medicaid fee-for-service system. In these
circumstances, the D-SNP has no control over the Medicaid grievance and
appeals process. Even a D-SNP that has a Medicaid managed care
organization operated by such plan's parent organization available to
its enrollees, but whose members may instead enroll in other Medicaid
plans, can only unify the procedures for Medicaid appeals and
grievances of those enrollees who are also simultaneously enrolled in
the Medicaid managed care organization controlled by such plan's parent
organization. We lack experience and data to quantify the cost of this
alternative due to the uncertainty involved in calculating the
additional levels of administrative burden and cost associated with
unifying grievance and appeals processes when D-SNPs and Medicaid
managed care plans that do not have the same enrollees, or where the
organizations offering the D-SNPs and Medicaid plans are unaffiliated
or even competitors. We received no comments on this proposal and
therefore are finalizing our discussion here without modification.
E. Accounting Statement and Table
The following table summarizes costs, savings, and transfers by
provision.
As required by OMB Circular A-4 (available at https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/), in Table 16, we
have prepared an accounting statement showing the savings, costs, and
transfers associated with the provisions of this final rule for
calendar years 2020 through 2029. Table 16 is based on Tables 17A, B,
and C which lists savings, costs, and transfers by provision.
BILLING CODE 4120-01-P
[[Page 15824]]
[GRAPHIC] [TIFF OMITTED] TR16AP19.003
The following Table 17 summarizes savings, costs, and transfers by
provision and forms a basis for the accounting table. For reasons of
space, Table 17 is broken into Table 17A (2020 through 2023), Table 17B
(2024 through 2027), and Table 17C (2028, 2029, and totals). In these
tables, all numbers are positive; positive numbers in the savings
columns indicate actual dollars saved while positive numbers in the
cost columns indicate actual dollars spent; and the aggregate row
indicates savings less costs and does not include transfers. The
transfer numbers are expressed as negative numbers to reflect the fact
that the Medicare Trust Fund incurs a cost while enrollees experience a
cost savings. All numbers are in millions. Tables 17A, 17B, and 17C
form the basis for Table 16 and for the
[[Page 15825]]
calculation to the infinite horizon discounted to 2016, mentioned in
the conclusion.
[GRAPHIC] [TIFF OMITTED] TR16AP19.004
[[Page 15826]]
[GRAPHIC] [TIFF OMITTED] TR16AP19.005
BILLING CODE 4120-01-C
F. Conclusion
As indicated in Tables 17A through C, we estimate that this final
rule generates annual cost savings of approximately $25 to $86 million
per year over 2020 through 2029. The raw total net savings over 10
years is $534 million.
G. Reducing Regulation and Controlling Regulatory Costs
Executive Order 13771 requires that the costs associated with
significant new regulations ``shall, to the extent permitted by law, be
offset by the
[[Page 15827]]
elimination of existing costs associated with at least two prior
regulations.'' In line with Executive Order 13771, in Table 18 we
estimate present and annualized values of costs and cost savings over
an infinite time horizon. Both costs and savings are presented as
positive numbers; net savings equals savings minus costs and is
positive. As shown, this final rule generates level annual cost savings
of $55.80 million in 2016 dollars over an infinite time horizon,
discounted at 7 percent. Based on these cost savings, this final rule
would be considered a deregulatory action under Executive Order 13771.
Details on estimated savings is found in the preceding analyses.
Table 18--Executive Order 13771 Summary Table in 2016 Dollars Over an
Infinite Time Horizon
[$ In millions]
------------------------------------------------------------------------
Primary Primary
Item (7%) (3%)
------------------------------------------------------------------------
Present Value of Costs............................ 27.27 68.39
Present Value of Cost Savings..................... 824.36 2,431.69
Present Value of Net Costs........................ 797.09 2,363.30
Annualized Costs.................................. 1.91 2.05
Annualized Cost Savings........................... 57.71 72.95
Annualized Net Savings............................ 55.80 70.90
------------------------------------------------------------------------
List of Subjects
42 CFR Part 422
Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Medicare, Penalties, Privacy, and
Reporting and recordkeeping requirements.
42 CFR Part 423
Administrative practice and procedure, Emergency medical services,
Health facilities, Health maintenance organizations (HMO), Health
professionals, Medicare, Penalties, Privacy, and Reporting and
recordkeeping requirements.
42 CFR Part 438
Grant programs-health, Medicaid, Reporting and recordkeeping
requirements.
42 CFR Part 498
Administrative practice and procedure, Health facilities, Health
professions, Medicare, and Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR chapter IV as set forth below:
PART 422--MEDICARE ADVANTAGE PROGRAM
0
1. The authority citation for part 422 is revised to read as follows:
Authority: 42 U.S.C. 1302 and 1395hh.
0
2. Section 422.2 is amended--
0
a. By adding definitions of ``Aligned enrollment'' and ``Dual eligible
special needs plan'' in alphabetical order;
0
b. By revising the definition of ``Fully integrated dual eligible
special needs plan'';
0
c. By adding the definition of ``Highly integrated dual eligible
special needs plan'' in alphabetical order; and
0
d. In the definition of ``Preclusion list'' by revising the
introductory text and paragraphs (1)(i), (2)(i), (2)(ii)(C) and adding
paragraph (3).
The additions and revisions read as follows:
Sec. 422.2 Definitions.
* * * * *
Aligned enrollment refers to the enrollment in a dual eligible
special needs plan of full-benefit dual eligible individuals whose
Medicaid benefits are covered under a Medicaid managed care
organization contract under section 1903(m) of the Act between the
applicable State and: the dual eligible special needs plan's (D-SNP's)
MA organization, the D-SNP's parent organization, or another entity
that is owned and controlled by the D-SNP's parent organization. When
State policy limits a D-SNP's membership to individuals with aligned
enrollment, this condition is referred to as exclusively aligned
enrollment.
* * * * *
Dual eligible special needs plan or D-SNP means a specialized MA
plan for special needs individuals who are entitled to medical
assistance under a State plan under title XIX of the Act that--
(1) Coordinates the delivery of Medicare and Medicaid services for
individuals who are eligible for such services;
(2) May provide coverage of Medicaid services, including long-term
services and supports and behavioral health services for individuals
eligible for such services;
(3) Has a contract with the State Medicaid agency consistent with
Sec. 422.107 that meets the minimum requirements in paragraph (c) of
such section; and
(4) Beginning January 1, 2021, satisfies one or more of the
following criteria for the integration of Medicare and Medicaid
benefits:
(i) Meets the additional requirement specified in Sec. 422.107(d)
in its contract with the State Medicaid agency.
(ii) Is a highly integrated dual eligible special needs plan.
(iii) Is a fully integrated dual eligible special needs plan.
* * * * *
Fully integrated dual eligible special needs plan means a dual
eligible special needs plan--
(1) That provides dual eligible individuals access to Medicare and
Medicaid benefits under a single entity that holds both an MA contract
with CMS and a Medicaid managed care organization contract under
section 1903(m) of the Act with the applicable State;
(2) Whose capitated contract with the State Medicaid agency
provides coverage, consistent with State policy, of specified primary
care, acute care, behavioral health, and long-term services and
supports, and provides coverage of nursing facility services for a
period of at least 180 days during the plan year;
(3) That coordinates the delivery of covered Medicare and Medicaid
services using aligned care management and specialty care network
methods for high-risk beneficiaries; and
(4) That employs policies and procedures approved by CMS and the
State to coordinate or integrate beneficiary communication materials,
enrollment, communications, grievance and appeals, and quality
improvement.
* * * * *
Highly integrated dual eligible special needs plan means a dual
eligible special needs plan offered by an MA organization that provides
coverage, consistent with State policy, of long-term services and
supports, behavioral health services, or both, under a capitated
contract that meets one of the following arrangements--
(1) The capitated contract is between the MA organization and the
Medicaid agency; or
(2) The capitated contract is between the MA organization's parent
organization (or another entity that is owned and controlled by its
parent organization) and the Medicaid agency.
* * * * *
Preclusion list means a CMS compiled list of individuals and
entities that--
(1) * * *
(i) The individual or entity is currently revoked from Medicare for
a reason other than that stated in Sec. 424.535(a)(3) of this chapter.
* * * * *
(2) * * *
(i) The individual or entity has engaged in behavior, other than
that
[[Page 15828]]
described in Sec. 424.535(a)(3) of this chapter, for which CMS could
have revoked the individual or entity to the extent applicable had they
been enrolled in Medicare.
(ii) * * *
(C) Any other evidence that CMS deems relevant to its
determination; or
(3) The individual or entity, regardless of whether they are or
were enrolled in Medicare, has been convicted of a felony under Federal
or State law within the previous 10 years that CMS deems detrimental to
the best interests of the Medicare program. Factors that CMS considers
in making such a determination under this paragraph (3) are--
(i) The severity of the offense;
(ii) When the offense occurred; and
(iii) Any other information that CMS deems relevant to its
determination.
* * * * *
0
3. Section 422.60 is amended by revising paragraph (g)(2)(i) to read as
follows:
Sec. 422.60 Election process.
* * * * *
(g) * * *
(2) * * *
(i) Operate as a fully integrated dual eligible special needs plan
or highly integrated dual eligible special needs plan.
* * * * *
0
4. Section 422.100 is amended by revising paragraphs (a) and (c)(1) to
read as follows:
Sec. 422.100 General requirements.
(a) Basic rule. Subject to the conditions and limitations set forth
in this subpart, an MA organization offering an MA plan must provide
enrollees in that plan with coverage of the basic benefits described in
paragraph (c)(1) of this section (except that additional telehealth
benefits may be, but are not required to be, offered by the MA plan)
and, to the extent applicable, supplemental benefits as described in
paragraph (c)(2) of this section, by furnishing the benefits directly
or through arrangements, or by paying for the benefits. CMS reviews
these benefits subject to the requirements of this section and the
requirements in subpart G of this part.
* * * * *
(c) * * *
(1) Basic benefits are all items and services (other than hospice
care or coverage for organ acquisitions for kidney transplants) for
which benefits are available under parts A and B of Medicare, including
additional telehealth benefits offered consistent with the requirements
at Sec. 422.135.
* * * * *
0
5. Section 422.102 is amended by revising paragraph (e) introductory
text to read as follows:
Sec. 422.102 Supplemental benefits.
* * * * *
(e) Supplemental benefits for certain dual eligible special needs
plans. Subject to CMS approval, fully integrated dual eligible special
needs plans and highly integrated dual eligible special needs plans
that meet minimum performance and quality-based standards may offer
additional supplemental benefits, consistent with the requirements of
this part, where CMS finds that the offering of such benefits could
better integrate care for the dual eligible population provided that
the special needs plan--
* * * * *
0
6. Section 422.107 is amended by--
0
a. Revising the section heading;
0
b. By revising paragraphs (a), (b), (c)(1), (c)(2), and (c)(3);
0
c. By redesignating paragraph (d) as paragraph (e); and
0
d. Reserving paragraph (d).
The revisions and additions read as follows:
Sec. 422.107 Special needs plans and dual eligibles: Contract with
State Medicaid Agency.
(a) Definition. For the purpose of this section, a contract with a
State Medicaid agency means a formal written agreement between an MA
organization and the State Medicaid agency documenting each entity's
roles and responsibilities with regard to dual eligible individuals.
(b) General rule. MA organizations seeking to offer a dual eligible
special needs plan must have a contract consistent with this section
with the State Medicaid agency.
(c) * * *
(1) The MA organization's responsibility to--
(i) Coordinate the delivery of Medicaid benefits for individuals
who are eligible for such services; and
(ii) If applicable, provide coverage of Medicaid services,
including long-term services and supports and behavioral health
services, for individuals eligible for such services.
(2) The category(ies) and criteria for eligibility for dual
eligible individuals to be enrolled under the SNP, including as
described in sections 1902(a), 1902(f), 1902(p), and 1905 of the Act.
(3) The Medicaid benefits covered under a capitated contract
between the State Medicaid agency and the MA organization offering the
SNP, the SNP's parent organization, or another entity that is owned and
controlled by the SNP's parent organization.
* * * * *
(d) [Reserved]
0
7. Effective January 1, 2021, Sec. 422.107 is further amended by
adding paragraphs (c)(9), (d), and (e)(2) to read as follows:
Sec. 422.107 Special needs plans and dual eligibles: Contract with
State Medicaid Agency.
(c) * * *
* * * * *
(9) For each dual eligible special needs plan that is an applicable
integrated plan as defined in Sec. 422.561, a requirement for the use
of the unified appeals and grievance procedures under Sec. Sec.
422.629 through 422.634, 438.210, 438.400, and 438.402.
* * * * *
(d) Additional minimum contract requirement. For any dual eligible
special needs plan that is not a fully integrated or highly integrated
dual eligible special needs plan, the contract must also stipulate
that, for the purpose of coordinating Medicare and Medicaid-covered
services between settings of care, the SNP notifies, or arrange for
another entity or entities to notify, the State Medicaid agency,
individuals or entities designated by the State Medicaid agency, or
both, of hospital and skilled nursing facility admissions for at least
one group of high-risk full-benefit dual eligible individuals,
identified by the State Medicaid agency. The State Medicaid agency must
establish the timeframe(s) and method(s) by which notice is provided.
In the event that a SNP authorizes another entity or entities to
perform this notification, the SNP must retain responsibility for
complying with this requirement.
(e) * * *
(2) MA organizations offering a dual eligible SNP must comply with
paragraphs (c)(9) and (d) of this section beginning January 1, 2021.
* * * * *
0
8. Section 422.111 is amended by revising paragraph (b)(2)(iii) to read
as follows:
Sec. 422.111 Disclosure requirements.
* * * * *
(b) * * *
(2) * * *
(iii) By a dual eligible special needs plan, prior to enrollment,
for each prospective enrollee, a comprehensive written statement
describing cost
[[Page 15829]]
sharing protections and benefits that the individual is entitled to
under title XVIII and the State Medicaid program under title XIX.
* * * * *
0
9. Section 422.135 is added to subpart C to read as follows:
Sec. 422.135 Additional telehealth benefits.
(a) Definitions. For purposes of this section, the following
definitions apply:
Additional telehealth benefits means services:
(1) For which benefits are available under Medicare Part B but
which are not payable under section 1834(m) of the Act; and
(2) That have been identified by the MA plan for the applicable
year as clinically appropriate to furnish through electronic exchange
when the physician (as defined in section 1861(r) of the Act) or
practitioner (described in section 1842(b)(18)(C) of the Act) providing
the service is not in the same location as the enrollee.
Electronic exchange means electronic information and
telecommunications technology.
(b) General rule. An MA plan may treat additional telehealth
benefits as basic benefits covered under the original Medicare fee-for-
service program for purposes of this part 422 provided that the
requirements of this section are met. If the MA plan fails to comply
with the requirements of this section, then the MA plan may not treat
the benefits provided through electronic exchange as additional
telehealth benefits, but may treat them as supplemental benefits as
described in Sec. 422.102, subject to CMS approval.
(c) Requirements. An MA plan furnishing additional telehealth
benefits must:
(1) Furnish in-person access to the specified Part B service(s) at
the election of the enrollee.
(2) Advise each enrollee that the enrollee may receive the
specified Part B service(s) through an in-person visit or through
electronic exchange.
(3) Comply with the provider selection and credentialing
requirements provided in Sec. 422.204, and, when providing additional
telehealth benefits, ensure through its contract with the provider that
the provider meet and comply with applicable State licensing
requirements and other applicable laws for the State in which the
enrollee is located and receiving the service.
(4) Make information about coverage of additional telehealth
benefits available to CMS upon request. Information may include, but is
not limited to, statistics on use or cost, manner(s) or method of
electronic exchange, evaluations of effectiveness, and demonstration of
compliance with the requirements of this section.
(d) Requirement to use contracted providers. An MA plan furnishing
additional telehealth benefits may only do so using contracted
providers. Coverage of benefits furnished by a non-contracted provider
through electronic exchange may only be covered as a supplemental
benefit.
(e) Bidding. An MA plan that fully complies with this section may
include additional telehealth benefits in its bid for basic benefits in
accordance with Sec. 422.254.
(f) Cost sharing. MA plans offering additional telehealth benefits
may maintain different cost sharing for the specified Part B service(s)
furnished through an in-person visit and the specified Part B
service(s) furnished through electronic exchange.
Sec. 422.156 [Amended]
0
10. Section 422.156 is amended in paragraph (b)(1) by removing the
phrase ``the quality improvement projects (QIPs) and''.
0
11. Section 422.162 (a) is amended by adding the definitions ``Absolute
percentage cap'', ``Cut point cap'', ``Guardrail'', ``Mean
resampling'', ``Restricted range'', and ``Restricted range cap'' in
alphabetical order to read as follows:
Sec. 422.162 Medicare Advantage Quality Rating System.
(a) * * *
Absolute percentage cap is a cap applied to non-CAHPS measures that
are on a 0 to 100 scale that restricts movement of the current year's
measure-threshold-specific cut point to no more than the stated
percentage as compared to the prior year's cut point.
* * * * *
Cut point cap is a restriction on the change in the amount of
movement a measure-threshold-specific cut point can make as compared to
the prior year's measure-threshold-specific cut point. A cut point cap
can restrict upward movement, downward movement, or both.
* * * * *
Guardrail is a bidirectional cap that restricts both upward and
downward movement of a measure-threshold-specific cut point for the
current year's measure-level Star Ratings as compared to the prior
year's measure-threshold-specific cut point.
* * * * *
Mean resampling refers to a technique where measure-specific scores
for the current year's Star Ratings are randomly separated into 10
equal-sized groups. The hierarchal clustering algorithm is done 10
times, each time leaving one of the 10 groups out. By leaving out one
of the 10 groups for each run, 9 of the 10 groups, which is 90 percent
of the applicable measure scores, are used for each run of the
clustering algorithm. The method results in 10 sets of measure-specific
cut points. The mean cut point for each threshold per measure is
calculated using the 10 values.
* * * * *
Restricted range is the difference between the maximum and minimum
measure score values using the prior year measure scores excluding
outer fence outliers (first quartile -3*Interquartile Range (IQR) and
third quartile + 3*IQR).
Restricted range cap is a cap applied to non-CAHPS measures that
restricts movement of the current year's measure-threshold-specific cut
point to no more than the stated percentage of the restricted range of
a measure calculated using the prior year's measure score distribution.
* * * * *
0
12. Section 422.164 is amended by adding paragraphs (f)(1)(v),
(g)(1)(iii)(O), and (h) to read as follows:
Sec. 422.164 Adding, updating, and removing measures.
* * * * *
(f) * * *
(1) * * *
(v) CMS excludes any measure that receives a measure-level Star
Rating reduction for data integrity concerns for either the current or
prior year from the improvement measure(s).
* * * * *
(g) * * *
(1) * * *
(iii) * * *
(O) CMS reduces the measure rating to 1 star for the applicable
appeals measure(s) if a contract fails to submit Timeliness Monitoring
Project data for CMS's review to ensure the completeness of the
contract's IRE data.
* * * * *
(h) Review of sponsors' data. (1) An MA organization may request
that CMS or the IRE review its' contract's appeals data provided that
the request is received by the annual deadline set by CMS.
(2) An MA organization may request that CMS review its' contract's
Complaints Tracking Module (CTM) data provided that the request is
received by the annual deadline set by CMS for the applicable Star
Ratings year.
[[Page 15830]]
0
13. Section 422.166 is amended by revising paragraph (a)(2)(i) and
adding paragraph (i) to read as follows:
Sec. 422.166 Calculation of Star Ratings.
(a) * * *
(2) * * *
(i) The method maximizes differences across the star categories and
minimizes the differences within star categories using mean resampling
with the hierarchal clustering of the current year's data, and a
guardrail so that the measure-threshold-specific cut points for non-
CAHPS measures do not increase or decrease more than the value of the
cap from one year to the next. The cap is equal to 5 percentage points
for measures having a 0 to 100 scale (absolute percentage cap) or 5
percent of the restricted range for measures not having a 0 to 100
scale (restricted range cap). New measures that have been in the Part C
and D Star Rating program for three years or less use the hierarchal
clustering methodology with mean resampling with no guardrail for the
first three years in the program.
* * * * *
(i) Extreme and uncontrollable circumstances. In the event of
extreme and uncontrollable circumstances that may negatively impact
operational and clinical systems and contracts' abilities to conduct
surveys needed for accurate performance measurement, CMS calculates the
Star Ratings as specified in paragraphs (i)(2) through (10) of this
section for each contract that is an affected contract during the
performance period for the applicable measures. We use the start date
of the incident period to determine which year of Star Ratings could be
affected, regardless of whether the incident period lasts until another
calendar year.
(1) Identification of affected contracts. A contract that meets all
of the following criteria is an affected contract:
(i) The contract's service area is within an ``emergency area''
during an ``emergency period'' as defined in section 1135(g) of the
Act.
(ii) The contract's service area is within a county, parish, U.S.
territory or tribal area designated in a major disaster declaration
under the Stafford Act and the Secretary exercised authority under
section 1135 of the Act based on the same triggering event(s).
(iii) As specified in paragraphs (i)(2) through (10) of this
section, a certain minimum percentage (25 percent or 60 percent) of the
enrollees under the contract must reside in a Federal Emergency
Management Agency (FEMA)-designated Individual Assistance area at the
time of the extreme and uncontrollable circumstance.
(2) CAHPS adjustments. (i) A contract, even if an affected
contract, must administer the CAHPS survey unless exempt under
paragraph (i)(2)(ii) of this section.
(ii) An affected contract with at least 25 percent of enrollees in
FEMA-designated Individual Assistance areas at the time of the extreme
and uncontrollable circumstance is exempt from administering the CAHPS
survey if the contract completes both of the following:
(A) Demonstrates to CMS that the required sample for the survey
cannot be contacted because a substantial number of the contract's
enrollees are displaced due to the FEMA-designated disaster identified
in paragraph (i)(1)(iii) of this section in the prior calendar year.
(B) Requests and receives a CMS approved exemption.
(iii) An affected contract with an exemption described in paragraph
(i)(2)(ii) of this section receives the contract's CAHPS measure stars
and corresponding measure scores from the prior year.
(iv) For an affected contract with at least 25 percent of enrollees
in FEMA-designated Individual Assistance areas at the time of the
extreme and uncontrollable circumstance, the contract receives the
higher of the previous year's Star Rating or the current year's Star
Rating (and corresponding measure score) for each CAHPS measure.
(v) When a contract is an affected contract with at least 25
percent of enrollees in FEMA-designated Individual Assistance areas at
the time of the extreme and uncontrollable circumstance with regard to
separate extreme and uncontrollable circumstances that begin in
successive years, it is a multiple year-affected contract. A multiple
year-affected contract receives the higher of the current year's Star
Rating or what the previous year's Star Rating would have been in the
absence of any adjustments that took into account the effects of the
previous year's disaster for each measure (using the corresponding
measure score for the Star Ratings year selected).
(3) HOS adjustments. (i) An affected contract must administer the
HOS survey unless exempt under paragraph (i)(3)(ii) of this section.
(ii) An affected contract with at least 25 percent of enrollees in
FEMA-designated Individual Assistance areas at the time of the extreme
and uncontrollable circumstance is exempt from administering the HOS
survey if the contract completes the following:
(A) Demonstrates to CMS that the required sample for the survey
cannot be contacted because a substantial number of the contract's
enrollees are displaced due to the FEMA-designated disaster identified
in paragraph (i)(1)(iii) of this section during the measurement period.
(B) Requests and receives a CMS approved exemption.
(iii) Affected contracts with an exemption described in paragraph
(i)(3)(ii) of this section receive the prior year's HOS and Healthcare
Effectiveness Data and Information Set (HEDIS)-HOS measure stars and
corresponding measure scores.
(iv) For an affected contract with at least 25 percent of enrollees
in FEMA-designated Individual Assistance areas at the time of the
extreme and uncontrollable circumstance, the affected contract receives
the higher of the previous year's Star Rating or the current year's
Star Rating (and corresponding measure score) for each HOS and HEDIS-
HOS measure.
(v) When a contract is an affected contract with at least 25
percent of enrollees in FEMA-designated Individual Assistance areas at
the time of the extreme and uncontrollable circumstance with regard to
separate extreme and uncontrollable circumstances that begin in
successive years, it is a multiple year-affected contract. A multiple
year-affected contract receives the higher of the current year's Star
Rating or what the previous year's Star Rating would have been in the
absence of any adjustments that took into account the effects of the
previous year's disaster for each measure (using the corresponding
measure score for the Star Ratings year selected).
(4) HEDIS adjustments. (i) An affected contract must report HEDIS
data unless exempted under paragraph (i)(4)(ii) of this section.
(ii) An affected contract with at least 25 percent of enrollees in
FEMA-designated Individual Assistance areas at the time of the extreme
and uncontrollable circumstance is exempt from reporting HEDIS data if
the contract completes the following:
(A) Demonstrates an inability to obtain both administrative and
medical record data that are required for reporting HEDIS measures due
to a FEMA-designated disaster in the prior calendar year.
(B) Requests and receives a CMS approved exemption.
(iii) Affected contracts with an exemption described in paragraph
[[Page 15831]]
(i)(4)(ii) of this section receive the prior year's HEDIS measure stars
and corresponding measure scores.
(iv) Contracts that do not have an exemption defined in paragraph
(i)(4)(ii) of this section may contact National Committee for Quality
Assurance (NCQA) to request modifications to the samples for measures
that require medical record review.
(v) For an affected contract with at least 25 percent of enrollees
in FEMA-designated Individual Assistance areas at the time of the
extreme and uncontrollable circumstance, the affected contract receives
the higher of the previous year's Star Rating or the current year's
Star Rating (and corresponding measure score) for each HEDIS measure.
(vi) When a contract is an affected contract with at least 25
percent of enrollees in FEMA-designated Individual Assistance areas at
the time of the extreme and uncontrollable circumstance with regard to
separate extreme and uncontrollable circumstances that begin in
successive years, it is a multiple year-affected contract. A multiple
year-affected contract receives the higher of the current year's Star
Rating or what the previous year's Star Rating would have been in the
absence of any adjustments that took into account the effects of the
previous year's disaster for each measure (using the corresponding
measure score for the Star Ratings year selected).
(5) New measure adjustments. For affected contracts with at least
25 percent of enrollees in a FEMA-designated Individual Assistance area
at the time of the extreme and uncontrollable circumstance, CMS holds
the affected contract harmless by using the higher of the contract's
summary or overall rating or both with and without including all of the
applicable new measures.
(6) Other Star Ratings measure adjustments. (i) For all other
measures except those measures identified in this paragraph (i)(6)(ii)
of this section, affected contracts with at least 25 percent of
enrollees in a FEMA-designated Individual Assistance area at the time
of the extreme and uncontrollable circumstance receive the higher of
the previous or current year's measure Star Rating (and corresponding
measure score).
(ii) CMS does not adjust the scores or Star Ratings for the
following measures, unless the exemption in paragraph (i)(6)(iii) of
this section applies.
(A) Part C Call Center--Foreign Language Interpreter and TTY
Availability.
(B) Part D Call Center--Foreign Language Interpreter and TTY
Availability.
(iii) CMS adjusts the measures listed in paragraph (i)(6)(ii) of
this section using the adjustments listed in paragraph (i)(6)(i) of
this section for contracts affected by extreme and uncontrollable
circumstances where there are continuing communications issues related
to loss of electricity and damage to infrastructure during the call
center study.
(iv) When a contract is an affected contract with at least 25
percent of enrollees in FEMA-designated Individual Assistance areas at
the time of the extreme and uncontrollable circumstance with regard to
separate extreme and uncontrollable circumstances that begin in
successive years, it is a multiple year-affected contract. A multiple
year-affected contract receives the higher of the current year's Star
Rating or what the previous year's Star Rating would have been in the
absence of any adjustments that took into account the effects of the
previous year's disaster for each measure (using the corresponding
measure score for the Star Ratings year selected).
(7) Exclusion from improvement measures. Any measure that reverts
back to the data underlying the previous year's Star Rating due to the
adjustments made in paragraph (i) of this section is excluded from both
the count of measures and the applicable improvement measures for the
current and next year's Star Ratings for the affected contract.
Contracts affected by extreme and uncontrollable circumstances do not
have the option of reverting to the prior year's improvement rating.
(8) Missing data. For an affected contract that has missing data in
the current or previous year, the final measure rating comes from the
current year unless any of the exemptions described in paragraphs
(i)(2)(ii), (i)(3)(ii), and (i)(4)(ii) of this section apply.
(9) Cut points for non-CAHPS measures. (i) CMS excludes the numeric
values for affected contracts with 60 percent or more of their
enrollees in the FEMA-designated Individual Assistance area at the time
of the extreme and uncontrollable circumstance from the clustering
algorithms described in paragraph (a)(2) of this section.
(ii) The cut points calculated as described in paragraph (i)(9)(i)
of this section are used to assess all affected contracts' measure Star
Ratings.
(10) Reward Factor. (i) CMS excludes the numeric values for
affected contracts with 60 percent or more of their enrollees in the
FEMA-designated Individual Assistance area at the time of the extreme
and uncontrollable circumstance from the determination of the
performance summary and variance thresholds for the Reward Factor
described in paragraph (f)(1) of this section.
(ii) All affected contracts are eligible for the Reward Factor
based on the calculations described in paragraph (i)(10)(i) of this
section.
0
14. Effective June 17, 2019, Sec. 422.222 is amended by revising
paragraph (a)(2) to read as follows:
Sec. 422.222 Preclusion list.
(a) * * *
(2)(i) CMS sends written notice to the individual or entity via
letter of their inclusion on the preclusion list. The notice must
contain the reason for the inclusion and inform the individual or
entity of their appeal rights. An individual or entity may appeal their
inclusion on the preclusion list, defined in Sec. 422.2, in accordance
with part 498 of this chapter.
(ii) If the individual's or entity's inclusion on the preclusion
list is based on a contemporaneous Medicare revocation under Sec.
424.535 of this chapter:
(A) The notice described in paragraph (a)(2)(i) of this section
must also include notice of the revocation, the reason(s) for the
revocation, and a description of the individual's or entity's appeal
rights concerning the revocation.
(B) The appeals of the individual's or entity's inclusion on the
preclusion list and the individual's or entity's revocation must be
filed jointly by the individual or entity and, as applicable,
considered jointly under part 498 of this chapter.
0
15. Section 422.222 is amended by revising the section heading and
paragraph (a) to read as follows:
Sec. 422.222 Preclusion list for contracted and non-contracted
individuals and entities.
(a)(1)(i) Except as provided in paragraph (a)(1)(ii) of this
section, an MA organization must not make payment for a health care
item, service, or drug that is furnished, ordered, or prescribed by an
individual or entity that is included on the preclusion list, defined
in Sec. 422.2.
(ii) With respect to MA providers that have been added to an
updated preclusion list but are not currently excluded by the OIG, the
MA organization must do all of the following:
(A) No later than 30 days after the posting of this updated
preclusion list,
[[Page 15832]]
must provide an advance written notice to any beneficiary who has
received or been prescribed an MA service, item, or drug from or by the
individual or entity added to the preclusion list in this update.
(B)(1) Subject to paragraph (a)(1)(ii)(B)(2) of this section, must
ensure that reasonable efforts are made to notify the individual or
entity described in paragraph (a)(1)(ii) of this section of a
beneficiary who was sent a notice under paragraph (a)(1)(ii)(A) of this
section.
(2) Paragraph (a)(1)(ii)(B)(1) of this section applies only upon
receipt of a claim from a precluded provider in Medicare Part C when--
(i) The MA organization has enough information on file to either
copy the provider on the notification previously sent to the
beneficiary or send a new notice informing the provider that they may
not see plan beneficiaries due to their preclusion status; and
(ii) The claim is received after the claim denial or reject date in
the preclusion file.
(C) Must not deny payment for a service, item, or drug furnished,
ordered, or prescribed by the newly added individual or entity, solely
on the ground that they have been included in the updated preclusion
list, in the 60-day period after the date it sent the notice described
in paragraph (a)(1)(ii)(A) of this section.
(2)(i) CMS sends written notice to the individual or entity via
letter of their inclusion on the preclusion list. The notice must
contain the reason for the inclusion and inform the individual or
entity of their appeal rights. An individual or entity may appeal their
inclusion on the preclusion list, defined in Sec. 422.2, in accordance
with part 498 of this chapter.
(ii) If the individual's or entity's inclusion on the preclusion
list is based on a contemporaneous Medicare revocation under Sec.
424.535 of this chapter:
(A) The notice described in paragraph (a)(2)(i) of this section
must also include notice of the revocation, the reason(s) for the
revocation, and a description of the individual's or entity's appeal
rights concerning the revocation.
(B) The appeals of the individual's or entity's inclusion on the
preclusion list and the individual's or entity's revocation must be
filed jointly by the individual or entity and, as applicable,
considered jointly under part 498 of this chapter.
(3)(i) Except as provided in paragraph (a)(3)(ii) of this section,
an individual or entity will only be included on the preclusion list
after the expiration of either of the following:
(A) If the individual or entity does not file a reconsideration
request under Sec. 498.5(n)(1) of this chapter, the individual or
entity will be added to the preclusion list upon the expiration of the
60-day period in which the individual or entity may request a
reconsideration; or
(B) If the individual or entity files a reconsideration request
under Sec. 498.5(n)(1) of this chapter, the individual or entity will
be added to the preclusion list effective on the date on which CMS, if
applicable, denies the individual's or entity's reconsideration.
(ii) An OIG excluded individual or entity is added to the
preclusion list effective on the date of the exclusion.
(4) Payment denials based upon an individual's or entity's
inclusion on the preclusion list are not appealable by beneficiaries.
(5)(i) Except as provided in paragraphs (a)(5)(iii) and (iv) of
this section, an individual or entity that is revoked under Sec.
424.535 of this chapter will be included on the preclusion list for the
same length of time as the individual's or entity's reenrollment bar.
(ii) Except as provided in paragraphs (a)(5)(iii) and (iv) of this
section, an individual or entity that is not enrolled in Medicare will
be included on the preclusion list for the same length of time as the
reenrollment bar that CMS could have imposed on the individual or
entity had they been enrolled and then revoked.
(iii) Except as provided in paragraph (a)(5)(iv) of this section,
an individual or entity, regardless of whether they are or were
enrolled in Medicare, that is included on the preclusion list because
of a felony conviction will remain on the preclusion list for a 10-year
period, beginning on the date of the felony conviction, unless CMS
determines that a shorter length of time is warranted. Factors that CMS
considers in making such a determination are as follows:--
(A) The severity of the offense.
(B) When the offense occurred.
(C) Any other information that CMS deems relevant to its
determination.
(iv) In cases where an individual or entity is excluded by the OIG,
the individual or entity must remain on the preclusion list until the
expiration of the CMS-imposed preclusion list period or reinstatement
by the OIG, whichever occurs later.
(6) CMS has the discretion not to include a particular individual
or entity on (or if warranted, remove the individual or entity from)
the preclusion list should it determine that exceptional circumstances
exist regarding beneficiary access to MA items, services, or drugs. In
making a determination as to whether such circumstances exist, CMS
takes into account:
(i) The degree to which beneficiary access to MA items, services,
or drugs would be impaired; and
(ii) Any other evidence that CMS deems relevant to its
determination.
* * * * *
0
16. Section 422.252 is amended by revising the definition of ``MA
monthly basic beneficiary premium'', ``MA monthly MSA premium'',
``Monthly aggregate bid amount'', ``Plan basic cost sharing'', and
``Unadjusted MA statutory non-drug monthly bid amount'' to read as
follows:
Sec. 422.252 Terminology.
* * * * *
MA monthly basic beneficiary premium means the premium amount (if
any) an MA plan (except an MSA plan) charges an enrollee for basic
benefits as defined in Sec. 422.100(c)(1), and is calculated as
described at Sec. 422.262.
MA monthly MSA premium means the amount of the plan premium for
coverage of basic benefits as defined in Sec. 422.100(c)(1) through an
MSA plan, as set forth at Sec. 422.254(e).
* * * * *
Monthly aggregate bid amount means the total monthly plan bid
amount for coverage of an MA eligible beneficiary with a nationally
average risk profile for the factors described in Sec. 422.308(c), and
this amount is comprised of the following:
(1) The unadjusted MA statutory non-drug monthly bid amount for
coverage of basic benefits as defined in Sec. 422.100(c)(1).
(2) The amount for coverage of basic prescription drug benefits
under Part D (if any).
(3) The amount for provision of supplemental health care benefits
(if any).
* * * * *
Plan basic cost sharing means cost sharing that would be charged by
a plan for basic benefits as defined in Sec. 422.100(c)(1) before any
reductions resulting from mandatory supplemental benefits.
* * * * *
Unadjusted MA statutory non-drug monthly bid amount means a plan's
estimate of its average monthly required revenue to provide coverage of
basic benefits as defined in Sec. 422.100(c)(1) to an MA eligible
beneficiary with a nationally average risk profile for the
[[Page 15833]]
risk factors CMS applies to payment calculations as set forth at Sec.
422.308(c).
0
17. Section 422.254 is amended by--
0
a. Revising paragraph (b)(1)(i);
0
b. Adding paragraph (b)(3)(i);
0
c. Reserving paragraph (b)(3)(ii); and
0
d. Revising paragraphs (b)(4), (c)(3)(i), and (e)(2).
The revisions and addition read as follows:
Sec. 422.254 Submission of bids.
* * * * *
(b) * * *
(1) * * *
(i) The unadjusted MA statutory non-drug monthly bid amount, which
is the MA plan's estimated average monthly required revenue for
providing basic benefits as defined in Sec. 422.100(c)(1).
* * * * *
(3) * * *
(i) MA plans offering additional telehealth benefits as defined in
Sec. 422.135(a) must exclude any capital and infrastructure costs and
investments directly incurred or paid by the MA plan relating to such
benefits from their bid submission for the unadjusted MA statutory non-
drug monthly bid amount.
(ii) [Reserved]
(4) The bid amount is for plan payments only but must be based on
plan assumptions about the amount of revenue required from enrollee
cost-sharing. The estimate of plan cost-sharing for the unadjusted MA
statutory non-drug monthly bid amount for coverage of basic benefits as
defined in Sec. 422.100(c)(1) must reflect the requirement that the
level of cost sharing MA plans charge to enrollees must be actuarially
equivalent to the level of cost sharing (deductible, copayments, or
coinsurance) charged to beneficiaries under the original Medicare fee-
for-service program option. The actuarially equivalent level of cost
sharing reflected in a regional plan's unadjusted MA statutory non-drug
monthly bid amount does not include cost sharing for out-of-network
Medicare benefits, as described at Sec. 422.101(d).
* * * * *
(c) * * *
(3) * * *
(i) The provision of basic benefits as defined in Sec.
422.100(c)(1);
* * * * *
(e) * * *
(2) The amount of the MA monthly MSA premium for basic benefits (as
defined in Sec. 422.252);
* * * * *
0
18. Section 422.264 is amended by revising paragraph (a) to read as
follows:
Sec. 422.264 Calculation of savings.
(a) Computation of risk adjusted bids and benchmarks--(1) The risk
adjusted MA statutory non-drug monthly bid amount is the unadjusted MA
statutory non-drug monthly bid amount (defined at Sec.
422.254(b)(1)(i)), adjusted using the factors described in paragraph
(c) of this section for local plans and paragraph (e) of this section
for regional plans.
(2) The risk adjusted MA area-specific non-drug monthly benchmark
amount is the unadjusted benchmark amount for coverage of basic
benefits defined in Sec. 422.100(c)(1) by a local MA plan, adjusted
using the factors described in paragraph (c) of this section.
(3) The risk adjusted MA region-specific non-drug monthly benchmark
amount is the unadjusted benchmark amount for coverage of basic
benefits defined in Sec. 422.100(c)(1) by a regional MA plan, adjusted
using the factors described in paragraph (e) of this section.
* * * * *
0
19. Section 422.504 is amended by adding paragraphs (g)(1)(iv) and (v)
to read as follows:
Sec. 422.504 Contract provisions.
* * * * *
(g) * * *
(1) * * *
(iv) Ensure that the enrollee does not have any financial liability
for services, items, or drugs furnished, ordered, or prescribed to the
enrollee by an MA contracted individual or entity on the preclusion
list, as defined in Sec. 422.2 and as described in Sec. 422.222.
(v) Ensure that the plan's provider agreement contains a provision
stating that after the expiration of the 60-day period specified in
Sec. 422.222:
(A) The provider will no longer be eligible for payment from the
plan and will be prohibited from pursuing payment from the beneficiary
as stipulated by the terms of the contract between CMS and the plan per
Sec. 422.504(g)(1)(iv); and
(B) The provider will hold financial liability for services, items,
and drugs that are furnished, ordered, or prescribed after this 60-day
period, at which point the provider and the beneficiary will have
already received notification of the preclusion.
* * * * *
0
20. Effective January 1, 2021, Sec. 422.560 is amended by adding
paragraphs (a)(4) and (b)(5) to read as follows:
Sec. 422.560 Basis and scope.
(a) * * *
(4) Section 1859(f)(8) of the Act provides for, to the extent
feasible, unifying grievances and appeals procedures under sections
1852(f), 1852(g), 1902(a)(3), 1902(a)(5), and 1932(b)(4) of the Act for
Medicare and Medicaid covered items and services provided by
specialized MA plans for special needs individuals described in
subsection 1859(b)(6)(B)(ii) of the Act for individuals who are
eligible under titles XVIII and XIX of the Act. Beginning January 1,
2021, procedures established under section 1859(f)(8) of the Act apply
in place of otherwise applicable grievances and appeals procedures with
respect to Medicare and Medicaid covered items and services provided by
applicable integrated plans.
(b) * * *
(5) Requirements for applicable integrated plans with respect to
procedures for integrated grievances, integrated organization
determinations, and integrated reconsiderations.
* * * * *
0
21. Section 422.561 is amended by adding the definitions ``Applicable
integrated plans'', ``Integrated appeal'', ``Integrated grievance'',
``Integrated organization determination'', and ``Integrated
reconsideration'' in alphabetical order to read as follows:
Sec. 422.561 Definitions.
* * * * *
Applicable integrated plan means:
(1) A fully integrated dual eligible special needs plan with
exclusively aligned enrollment or a highly integrated dual eligible
special needs plan with exclusively aligned enrollment, and
(2) The Medicaid managed care organization, as defined in section
1903(m) of the Act, through which such dual eligible special needs
plan, its parent organization, or another entity that is owned and
controlled by its parent organization covers Medicaid services for
dually eligible individuals enrolled in such dual eligible special
needs plan and such Medicaid managed care organization.
* * * * *
Integrated appeal means any of the procedures that deal with, or
result from, adverse integrated organization determinations by an
applicable integrated plan on the health care services the enrollee
believes he or she is entitled to receive, including delay in
providing, arranging for, or approving the health care services (such
that a delay would adversely affect the health of the enrollee), or on
any amounts the enrollee must pay for a service. Integrated appeals
cover procedures that would otherwise be defined and
[[Page 15834]]
covered, for non-applicable integrated plans, as an appeal defined in
Sec. 422.561 or the procedures required for appeals in accordance with
Sec. Sec. 438.400 through 438.424 of this chapter. Such procedures
include integrated reconsiderations.
Integrated grievance means a dispute or compliant that would be
defined and covered, for grievances filed by an enrollee in non-
applicable integrated plans, under Sec. 422.564 or Sec. Sec. 438.400
through 438.416 of this chapter. Integrated grievances do not include
appeals procedures and QIO complaints, as described in Sec. 422.564(b)
and (c). An integrated grievance made by an enrollee in an applicable
integrated plan is subject to the integrated grievance procedures in
Sec. Sec. 422.629 and 422.630.
Integrated organization determination means an organization
determination that would otherwise be defined and covered, for a non-
applicable integrated plan, as an organization determination under
Sec. 422.566, an adverse benefit determination under Sec. 438.400(b),
or an action under Sec. 431.201 of this chapter. An integrated
organization determination is made by an applicable integrated plan and
is subject to the integrated organization determination procedures in
Sec. Sec. 422.629, 422.631, and 422.634.
Integrated reconsideration means a reconsideration that would
otherwise be defined and covered, for a non-applicable integrated plan,
as a reconsideration under Sec. 422.580 and appeal under Sec.
438.400(b) of this chapter. An integrated reconsideration is made by an
applicable integrated plan and is subject to the integrated
reconsideration procedures in Sec. Sec. 422.629 and 422.632 through
422.634.
* * * * *
0
22. Section 422.562 is amended by--
0
a. Revising paragraph (a)(1)(i);
0
b. By adding paragraph (a)(5); and
0
c. By revising paragraphs (b)(1), (b)(2), (b)(3), (b)(4)(i), and
(b)(4)(ii).
The revisions and addition read as follows:
Sec. 422.562 General provisions.
(a) * * *
(1) * * *
(i) A grievance procedure as described in Sec. 422.564 or,
beginning January 1, 2021, Sec. 422.630 as applicable, for addressing
issues that do not involve organization determinations;
* * * * *
(5) An MA organization that offers a dual eligible special needs
plan has the following additional responsibilities:
(i) The dual eligible special needs plan must offer to assist an
enrollee in that dual eligible special needs plan with obtaining
Medicaid covered services and resolving grievances, including
requesting authorization of Medicaid services, as applicable, and
navigating Medicaid appeals and grievances in connection with the
enrollee's own Medicaid coverage, regardless of whether such coverage
is in Medicaid fee-for-service or a Medicaid managed care plan, such as
a Medicaid MCO, PIHP, or PAHP as defined in Sec. 438.2 of this
chapter. If the enrollee accepts the offer of assistance, the plan must
provide the assistance. Examples of such assistance include the
following:
(A) Explaining to an enrollee how to make a request for Medicaid
authorization of a service and how to file appeal following an adverse
benefit determination, such as--
(1) Assisting the enrollee in identifying the enrollee's specific
Medicaid managed care plan or fee-for-service point of contact;
(2) Providing specific instructions for contacting the appropriate
agency in a fee-for-service setting or for contacting the enrollee's
Medicaid managed care plan, regardless of whether the Medicaid managed
care plan is affiliated with the enrollee's dual eligible special needs
plan; and
(3) Assisting the enrollee in making contact with the enrollee's
fee-for-service contact or Medicaid managed care plan.
(B) Assisting a beneficiary in filing a Medicaid grievance or a
Medicaid appeal.
(C) Assisting an enrollee in obtaining documentation to support a
request for authorization of Medicaid services or a Medicaid appeal.
(ii) The dual eligible special needs plan must offer to provide the
assistance described in paragraph (a)(5)(i) of this section whenever it
becomes aware of an enrollee's need for a Medicaid-covered service.
Offering such assistance is not dependent on an enrollee's specific
request.
(iii) The dual eligible special needs plan must offer to provide
and actually provide assistance as required by paragraph (a)(5)(i) of
this section using multiple methods.
(A) When an enrollee accepts the offer of assistance described in
paragraph (a)(5)(i) of this section, the dual eligible special needs
plan may coach the enrollee on how to self-advocate.
(B) The dual eligible special needs plan must also provide an
enrollee reasonable assistance in completing forms and taking
procedural steps related to Medicaid grievances and appeals.
(iv) The dual eligible special needs plan must, upon request from
CMS, provide documentation demonstrating its compliance with this
paragraph (a)(5).
(v) The obligation to provide assistance under paragraph (a)(5)(i)
of this section does not create an obligation for a dual eligible
special needs plan to represent an enrollee in a Medicaid appeal.
(b) * * *
(1) The right to have grievances between the enrollee and the MA
organization heard and resolved, as described in Sec. 422.564 or,
beginning January 1, 2021, Sec. 422.630, as applicable.
(2) The right to a timely organization determination, as provided
under Sec. 422.566 or, beginning January 1, 2021, Sec. 422.631, as
applicable.
(3) The right to request an expedited organization determination,
as provided under Sec. Sec. 422.570 or, beginning January 1, 2021,
Sec. 422.631(e), as applicable.
(4) * * *
(i) The right to a reconsideration of the adverse organization
determination by the MA organization, as provided under Sec. 422.578
or, beginning January 1, 2021, Sec. 422.633, as applicable.
(ii) The right to request an expedited reconsideration, as provided
under Sec. 422.584 or, beginning January 1, 2021, Sec. 422.633(f), as
applicable.
* * * * *
0
23. Effective January 1, 2021, Sec. 422.566 is amended by revising
paragraph (a) to read as follows:
Sec. 422.566 Organization determinations.
(a) Responsibilities of the MA organization. Each MA organization
must have a procedure for making timely organization determinations (in
accordance with the requirements of this subpart) regarding the
benefits an enrollee is entitled to receive under an MA plan, including
basic benefits as described under Sec. 422.100(c)(1) and mandatory and
optional supplemental benefits as described under Sec. 422.102, and
the amount, if any, that the enrollee is required to pay for a health
service. The MA organization must have a standard procedure for making
determinations, in accordance with Sec. 422.568, and an expedited
procedure for situations in which applying the standard procedure could
seriously jeopardize the enrollee's life, health, or ability to regain
maximum function, in accordance with Sec. Sec. 422.570 and 422.572.
For an applicable integrated plan, beginning January 1, 2021, the MA
[[Page 15835]]
organization must comply with Sec. Sec. 422.629 through 422.634 in
lieu of Sec. Sec. 422.566(c) and (d), 422.568, 422.570 and 422.572
with regard to the procedures for making determinations, including
integrated organization determinations and integrated reconsiderations,
on a standard and expedited basis.
* * * * *
0
24. Effective January 1, 2021, add an undesignated center heading and
Sec. Sec. 422.629 through 422.634 to Subpart M to read as follows:
Subpart M--Grievances, Organization Determinations and Appeals
* * * * *
Requirements Applicable to Certain Integrated Dual Eligible Special
Needs Plans
Sec.
422.629 General requirements for applicable integrated plans.
422.630 Integrated grievances.
422.631 Integrated organization determinations.
422.632 Continuation of benefits while the applicable integrated
plan reconsideration is pending.
422.633 Integrated reconsideration.
422.634 Effect.
Requirements Applicable to Certain Integrated Dual Eligible Special
Needs Plans
Sec. 422.629 General requirements for applicable integrated plans.
(a) Scope. The provisions in this section and in Sec. Sec. 422.630
through 422.634 set forth requirements for unified appeals and
grievance processes with which applicable integrated plans must comply.
Beginning January 1, 2021, these provisions apply to an applicable
integrated plan in lieu of Sec. Sec. 422.564, 422.566(c) and (d), and
422.568 through 422.590, and 422.618(a) and Sec. Sec. 438.404 through
438.424 of this chapter.
(b) General process. An applicable integrated plan must create
integrated processes for enrollees for integrated grievances,
integrated organization determinations, and integrated
reconsiderations.
(c) State flexibilities. A State may, at its discretion, implement
standards for timeframes or notice requirements that are more
protective for the enrollee than required by this section and
Sec. Sec. 422.630 through 422.634. The contract under Sec. 422.107
must include any standards that differ from the standards set forth in
this section.
(d) Evidence. The applicable integrated plan must provide the
enrollee a reasonable opportunity, in person and in writing, to present
evidence and testimony and make legal and factual arguments for
integrated grievances, and integrated reconsiderations. The applicable
integrated plan must inform the enrollee of the limited time available
for presenting evidence sufficiently in advance of the resolution
timeframe for appeals as specified in this section if the case is being
considered under an expedited timeframe for the integrated grievance or
integrated reconsideration.
(e) Assistance. In addition to the requirements in Sec.
422.562(a)(5), the applicable integrated plan must provide an enrollee
reasonable assistance in completing forms and taking other procedural
steps related to integrated grievances and integrated appeals.
(f) Applicable requirements. The requirements in Sec. Sec.
422.560, 422.561, 422.562, 422.566, and 422.592 through 422.626 apply
to an applicable integrated plan unless otherwise provided in this
section or in Sec. Sec. 422.630 through 422.634.
(g) Acknowledgement. The applicable integrated plan must send to
the enrollee written acknowledgement of integrated grievances and
integrated reconsiderations upon receiving the request.
(h) Recordkeeping. (1) The applicable integrated plan must maintain
records of integrated grievances and integrated appeals. Each
applicable integrated plan that is a Medicaid managed care organization
must review the Medicaid-related information as part of its ongoing
monitoring procedures, as well as for updates and revisions to the
State quality strategy.
(2) The record of each integrated grievance or integrated appeal
must contain, at a minimum:
(i) A general description of the reason for the integrated appeal
or integrated grievance.
(ii) The date of receipt.
(iii) The date of each review or, if applicable, review meeting.
(iv) Resolution at each level of the integrated appeal or
integrated grievance, if applicable.
(v) Date of resolution at each level, if applicable.
(vi) Name of the enrollee for whom the integrated appeal or
integrated grievance was filed.
(vii) Date the applicable integrated plan notified the enrollee of
the resolution.
(3) The record of each integrated grievance or integrated appeal
must be accurately maintained in a manner accessible to the State and
available upon request to CMS.
(i) Prohibition on punitive action. Each applicable integrated plan
must ensure that no punitive action is taken against a provider that
requests an integrated organization determination or integrated
reconsideration, or supports an enrollee's request for these actions.
(j) Information to providers and subcontractors. The applicable
integrated plan must provide information about the integrated grievance
and integrated appeal system to all providers and subcontractors at the
time they enter into a contract including, at minimum, information on
integrated grievance, integrated reconsideration, and fair hearing
procedures and timeframes as applicable. Such information must include
the following:
(1) The right to file an integrated grievance and integrated
reconsideration.
(2) The requirements and timeframes for filing an integrated
grievance or integrated reconsideration.
(3) The availability of assistance in the filing process.
(k) Review decision-making requirements--(1) General rules.
Individuals making decisions on integrated appeals and grievances must
take into account all comments, documents, records, and other
information submitted by the enrollee or their representative without
regard to whether such information was submitted or considered in the
initial adverse integrated organization determination.
(2) Integrated grievances. Individuals making decisions on
integrated grievances must be individuals who--
(i) Were neither involved in any previous level of review or
decision-making nor a subordinate of any such individual; and
(ii) If deciding any of the following, have the appropriate
clinical expertise in treating the enrollee's condition or disease:
(A) A grievance regarding denial of expedited resolution of an
appeal.
(B) A grievance that involves clinical issues.
(3) Integrated organization determinations. If the applicable
integrated plan expects to issue a partially or fully adverse medical
necessity (or any substantively equivalent term used to describe the
concept of medical necessity) decision based on the initial review of
the request, the integrated organization determination must be reviewed
by a physician or other appropriate health care professional with
sufficient medical and other expertise, including knowledge of Medicare
and Medicaid
[[Page 15836]]
coverage criteria, before the applicable integrated plan issues the
integrated organization determination. Any physician or other health
care professional who reviews an integrated organization determination
must have a current and unrestricted license to practice within the
scope of his or her profession.
(4) Integrated reconsideration determinations. Individuals making
an integrated reconsideration determination must be individuals who--
(i) Were neither involved in any previous level of review or
decision-making nor a subordinate of any such individual; and
(ii) If deciding an appeal of a denial that is based on lack of
medical necessity (or any substantively equivalent term used to
describe the concept of medical necessity), are a physician or other
appropriate health care professional who have the appropriate clinical
expertise, in treating the enrollee's condition or disease, and
knowledge of Medicare coverage criteria, before the MA organization
issues the organization determination decision.
(l) Parties. (1) The following individuals or entities can request
an integrated grievance, integrated organization determination, and
integrated reconsideration, and are parties to the case:
(i) The enrollee or his or her representative;
(ii) An assignee of the enrollee (that is, a physician or other
provider who has furnished or intends to furnish a service to the
enrollee and formally agrees to waive any right to payment from the
enrollee for that service), or any other provider or entity (other than
the applicable integrated plan) who has an appealable interest in the
proceeding;
(iii) The legal representative of a deceased enrollee's estate; or
(iv) Subject to paragraph (l)(3) of this section, any provider that
furnishes, or intends to furnish, services to the enrollee. If the
provider requests that the benefits continue while the appeal is
pending, pursuant to Sec. 422.632 and consistent with State law, the
provider must obtain the written consent of the enrollee to request the
appeal on behalf of the enrollee.
(2) When the term ``enrollee'' is used throughout Sec. Sec.
422.629 through 422.634, it includes providers that file a request and
authorized representatives consistent with this paragraph, unless
otherwise specified.
(3) A provider who is providing treatment to the enrollee may, upon
providing notice to the enrollee, request a standard or expedited pre-
service integrated reconsideration on behalf of an enrollee.
Sec. 422.630 Integrated grievances.
(a) General rule. In lieu of complying with Sec. 422.564, and the
grievance requirements of Sec. Sec. 438.402, 438.406, 438.408,
438.414, and 438.416 of this chapter, each applicable integrated plan
must comply with this section. Each applicable integrated plan must
provide meaningful procedures for timely hearing and resolving
integrated grievances between enrollees and the applicable integrated
plan or any other entity or individual through which the applicable
integrated plan provides covered items and services.
(b) Timing. An enrollee may file an integrated grievance at any
time with the applicable integrated plan.
(c) Filing. An enrollee may file an integrated grievance orally or
in writing with the applicable integrated plan, or with the State for
an integrated grievance related to a Medicaid benefit, if the State has
a process for accepting Medicaid grievances.
(d) Expedited grievances. An applicable integrated plan must
respond to an enrollee's grievance within 24 hours if the complaint
involves the applicable integrated plan's--
(1) Decision to invoke an extension relating to an integrated
organization determination or integrated reconsideration; or
(2) Refusal to grant an enrollee's request for an expedited
integrated organization determination under Sec. 422.631 or expedited
integrated reconsideration under Sec. 422.633.
(e) Resolution and notice. (1) The applicable integrated plan must
resolve standard integrated grievances as expeditiously as the case
requires, based on the enrollee's health status, but no later than 30
calendar days from the date it receives the integrated grievance.
(i) All integrated grievances submitted in writing must be
responded to in writing.
(ii) Integrated grievances submitted orally may be responded to
either orally or in writing, unless the enrollee requests a written
response.
(iii) All integrated grievances related to quality of care,
regardless of how the integrated grievance is filed, must be responded
to in writing. The response must include a description of the
enrollee's right to file a written complaint with the QIO with regard
to Medicare covered services. For any complaint submitted to a QIO, the
applicable integrated plan must cooperate with the QIO in resolving the
complaint.
(2) The timeframe for resolving the integrated grievance may be
extended by 14 calendar days if the enrollee requests an extension or
if the applicable integrated plan justifies the need for additional
information and documents how the delay is in the interest of the
enrollee. When the applicable integrated plan extends the timeframe, it
must--
(i) Make reasonable efforts to promptly notify the enrollee orally
of the reasons for the delay; and
(ii) Send written notice to the enrollee of the reasons for the
delay immediately, but no later than within 2 calendar days of making
the decision to extend the timeframe to resolve the integrated
grievance. This notice must explain the right to file an integrated
grievance if the enrollee disagrees with the decision to delay.
Sec. 422.631 Integrated organization determinations.
(a) General rule. An applicable integrated plan must adopt and
implement a process for enrollees to request that the plan make an
integrated organization determination. The process for requesting that
the applicable integrated plan make an integrated organization
determination must be the same for all covered benefits.
(b) Requests. The enrollee, or a provider on behalf of an enrollee,
may request an integrated organization determination orally or in
writing, except for requests for payment, which must be in writing
(unless the applicable integrated plan or entity responsible for making
the determination has implemented a voluntary policy of accepting
verbal payment requests).
(c) Expedited integrated organization determinations. (1) An
enrollee, or a provider on behalf of an enrollee, may request an
expedited integrated organization determination.
(2) The request can be oral or in writing.
(3) The applicable integrated plan must complete an expedited
integrated organization determination when the applicable integrated
plan determines (based on a request from the enrollee or on its own) or
the provider indicates (in making the request on the enrollee's behalf
or supporting the enrollee's request) that taking the time for a
standard resolution could seriously jeopardize the enrollee's life,
physical or mental health, or ability to attain, maintain, or regain
maximum function.
(d) Timeframes and notice--(1) Integrated organization
determination notice. (i) The applicable integrated plan must send an
enrollee a written
[[Page 15837]]
notice of any adverse decision on an integrated organization
determination (including a determination to authorize a service or item
in an amount, duration, or scope that is less than the amount
previously requested or authorized for an ongoing course of treatment)
within the timeframes set forth in this section.
(ii) For an integrated organization determination not reached
within the timeframes specified in this section (which constitutes a
denial and is thus an adverse decision), the applicable integrated plan
must send a notice on the date that the timeframes expire. Such notice
must describe all applicable Medicare and Medicaid appeal rights.
(iii) Integrated organization determination notices must be written
in plain language, be available in a language and format that is
accessible to the enrollee, and explain the following:
(A) The applicable integrated plan's determination.
(B) The date the determination was made.
(C) The date the determination will take effect.
(D) The reasons for the determination.
(E) The enrollee's right to file an integrated reconsideration and
the ability for someone else to file an appeal on the enrollee's
behalf.
(F) Procedures for exercising enrollee's rights to an integrated
reconsideration.
(G) Circumstances under which expedited resolution is available and
how to request it.
(H) If applicable, the enrollee's rights to have benefits continue
pending the resolution of the integrated appeal process.
(2) Timing of notice--(i) Standard integrated organization
determinations. (A) The applicable integrated plan must send a notice
of its integrated organization determination at least 10 days before
the date of action (that is, before the date on which a termination,
suspension, or reduction becomes effective), in cases where a
previously approved service is being reduced, suspended, or terminated,
except in circumstances where an exception is permitted under
Sec. Sec. 431.213 and 431.214 of this chapter.
(B) For other integrated organization determinations that are not
expedited integrated organization determinations, the applicable
integrated plan must send a notice of its integrated organization
determination as expeditiously as the enrollee's health condition
requires, but no later than 14 calendar days from when it receives the
request for the integrated organization determination.
(ii) Extensions. The applicable integrated plan may extend the
timeframe for a standard or expedited integrated organization
determination by up to 14 calendar days if--
(A) The enrollee or provider requests the extension; or
(B) The applicable integrated plan can show that--
(1) The extension is in the enrollee's interest; and
(2) There is need for additional information and there is a
reasonable likelihood that receipt of such information would lead to
approval of the request, if received.
(iii) Notices in cases of extension. (A) When the applicable
integrated plan extends the timeframe, it must notify the enrollee in
writing of the reasons for the delay as expeditiously as the enrollee's
health condition requires but no later than upon expiration of the
extension, and inform the enrollee of the right to file an expedited
integrated grievance if he or she disagrees with the applicable
integrated plan's decision to grant an extension.
(B) If the applicable integrated plan extends the timeframe for
making its integrated organization determination, it must send the
notice of its determination as expeditiously as the enrollee's health
condition requires and no later than the date the extension expires.
(iv) Expedited integrated organization determinations. (A) The
applicable integrated plan must provide notice of its expedited
integrated organization determination as expeditiously as the
enrollee's health condition requires, but no later than 72 hours after
receiving the request.
(B) If the applicable integrated plan denies the request for an
expedited integrated organization determination, it must:
(1) Automatically transfer a request to the standard timeframe and
make the determination within the 14-day timeframe established in this
paragraph for a standard integrated organization determination. The 14-
day period begins with the day the applicable integrated plan receives
the request for expedited integrated organization determination.
(2) Give the enrollee prompt oral notice of the denial and transfer
and subsequently deliver, within 3 calendar days, a written letter
that--
(i) Explains that the applicable integrated plan will process the
request using the 14-day timeframe for standard integrated organization
determinations;
(ii) Informs the enrollee of the right to file an expedited
integrated grievance if he or she disagrees with the applicable
integrated plan's decision not to expedite;
(iii) Informs the enrollee of the right to resubmit a request for
an expedited integrated organization determination with any physician's
support; and
(iv) Provides instructions about the integrated grievance process
and its timeframes.
(C) If the applicable integrated plan must receive medical
information from noncontract providers, the applicable integrated plan
must request the necessary information from the noncontract provider
within 24 hours of the initial request for an expedited integrated
organization determination. Noncontract providers must make reasonable
and diligent efforts to expeditiously gather and forward all necessary
information to assist the applicable integrated plan in meeting the
required timeframe. Regardless of whether the applicable integrated
plan must request information from noncontract providers, the
applicable integrated plan is responsible for meeting the timeframe and
notice requirements of this section.
Sec. 422.632 Continuation of benefits while the applicable integrated
plan reconsideration is pending.
(a) Definition. As used in this section, timely files means files
for continuation of benefits on or before the later of the following:
(1) Within 10 calendar days of the applicable integrated plan
sending the notice of adverse integrated organization determination.
(2) The intended effective date of the applicable integrated plan's
proposed adverse integrated organization determination.
(b) Continuation of benefits. The applicable integrated plan must
continue the enrollee's benefits under Parts A and B of title XVIII and
title XIX if all of the following occur:
(1) The enrollee files the request for an integrated appeal timely
in accordance with Sec. 422.633(e);
(2) The integrated appeal involves the termination, suspension, or
reduction of previously authorized services;
(3) The services were ordered by an authorized provider;
(4) The period covered by the original authorization has not
expired; and
(5) The enrollee timely files for continuation of benefits.
(c) Duration of continued or reinstated benefits. If, at the
enrollee's request, the applicable integrated plan continues or
reinstates the enrollee's benefits, as described in paragraph (b) of
this section, while the integrated reconsideration is pending, the
benefits must be continued until--
[[Page 15838]]
(1) The enrollee withdraws the request for an integrated
reconsideration;
(2) The applicable integrated plan issues an integrated
reconsideration that is unfavorable to the enrollee related to the
benefit that has been continued;
(3) For an appeal involving Medicaid benefits--
(i) The enrollee fails to file a request for a State fair hearing
and continuation of benefits, within 10 calendar days after the
applicable integrated plan sends the notice of the integrated
reconsideration;
(ii) The enrollee withdraws the appeal or request for a State fair
hearing; or
(iii) A State fair hearing office issues a hearing decision adverse
to the enrollee.
(d) Recovery of costs. In the event the appeal or State fair
hearing is adverse to the enrollee--
(1) The applicable integrated plan or State agency may not pursue
recovery for costs of services furnished by the applicable integrated
plan pending the integrated reconsideration, to the extent that the
services were furnished solely under of the requirements of this
section.
(2) If, after the integrated reconsideration decision is final, an
enrollee requests that Medicaid services continue through a State fair
hearing, state rules on recovery of costs, in accordance with the
requirements of Sec. 438.420(d) of this chapter, apply for costs
incurred for services furnished pending appeal subsequent to the date
of the integrated reconsideration decision.
Sec. 422.633 Integrated reconsideration.
(a) General rule. An applicable integrated plan may only have one
level of integrated reconsideration for an enrollee.
(b) External medical reviews. If a State has established an
external medical review process, the requirements of Sec.
438.402(c)(1)(i)(B) of this chapter apply to each applicable integrated
plan that is a Medicaid managed care organization, as defined in
section 1903 of the Act.
(c) Case file. Upon request of the enrollee or his or her
representative, the applicable integrated plan must provide the
enrollee and his or her representative the enrollee's case file,
including medical records, other documents and records, and any new or
additional evidence considered, relied upon, or generated by the
applicable integrated plan (or at the direction of the applicable
integrated plan) in connection with the appeal of the integrated
organization determination. This information must be provided free of
charge and sufficiently in advance of the resolution timeframe for the
integrated reconsideration, or subsequent appeal, as specified in this
section.
(d) Timing. (1) Timeframe for filing--An enrollee has 60 calendar
days from the date on the adverse organization determination notice to
file a request for an integrated reconsideration with the applicable
integrated plan.
(2) Oral inquires--Oral inquires seeking to appeal an adverse
integrated organization determination must be treated as a request for
an integrated reconsideration (to establish the earliest possible
filing date for the appeal).
(3) Extending the time for filing a request--(i) General rule. If a
party or physician acting on behalf of an enrollee shows good cause,
the applicable integrated plan may extend the timeframe for filing a
request for an integrated reconsideration.
(ii) How to request an extension of timeframe. If the 60-day period
in which to file a request for an integrated reconsideration has
expired, a party to the integrated organization determination or a
physician acting on behalf of an enrollee may file a request for
integrated reconsideration with the applicable integrated plan. The
request for integrated reconsideration and to extend the timeframe
must--
(A) Be in writing; and
(B) State why the request for integrated reconsideration was not
filed on time.
(e) Expedited integrated reconsiderations. (1) An enrollee may
request, or a provider may request on behalf of an enrollee, an
expedited review of the integrated reconsideration.
(2) The request can be oral or in writing.
(3) The applicable integrated plan must grant the request to
expedite the integrated reconsideration when it determines (for a
request from the enrollee), or the provider indicates (in making the
request on the enrollee's behalf or supporting the enrollee's request),
that taking the time for a standard resolution could seriously
jeopardize the enrollee's life, physical or mental health, or ability
to attain, maintain, or regain maximum function.
(4) If an applicable integrated plan denies an enrollee's request
for an expedited integrated reconsideration, it must automatically
transfer a request to the standard timeframe and make the determination
within the 30-day timeframe established in paragraph (f)(1) of this
section for a standard integrated reconsideration. The 30-day period
begins with the day the applicable integrated plan receives the request
for expedited integrated reconsideration. The applicable integrated
plan must give the enrollee prompt oral notice of the decision, and
give the enrollee written notice within 2 calendar days. The written
notice must do all of the following:
(i) Include the reason for the denial.
(ii) Inform the enrollee of the right to file a grievance if the
enrollee disagrees with the decision not to expedite, including
timeframes and procedures for filing a grievance.
(iii) Inform the enrollee of the right to resubmit a request for an
expedited determination with any physician's support.
(5) If the applicable integrated plan must receive medical
information from noncontract providers, the applicable integrated plan
must request the necessary information from the noncontract provider
within 24 hours of the initial request for an expedited integrated
reconsideration. Noncontract providers must make reasonable and
diligent efforts to expeditiously gather and forward all necessary
information to assist the applicable integrated plan in meeting the
required timeframe. Regardless of whether the applicable integrated
plan must request information from noncontract providers, the
applicable integrated plan is responsible for meeting the timeframe and
notice requirements of this section.
(f) Resolution and notification. The applicable integrated plan
must make integrated reconsidered determinations as expeditiously as
the enrollee's health condition requires but no later than the
timeframes established in this section.
(1) Standard integrated reconsiderations. The applicable integrated
plan must resolve integrated reconsiderations as expeditiously as the
enrollee's health condition requires but no longer than 30 calendar
days from the date of receipt of the request for the integrated
reconsideration. This timeframe may be extended as described in
paragraph (f)(3) of this section.
(2) Expedited integrated reconsiderations. The applicable
integrated plan must resolve expedited integrated reconsiderations as
expeditiously as the enrollee's health condition requires but no later
than within 72 hours of receipt for the integrated reconsideration.
This timeframe may be extended as described in paragraph (f)(3) of this
section. In addition to the written notice required under paragraph
(f)(4) of this section, the applicable integrated plan must make
reasonable efforts to provide prompt oral notice of the expedited
resolution to the enrollee.
[[Page 15839]]
(3) Extensions. (i) The applicable integrated plan may extend the
timeframe for resolving integrated reconsiderations by 14 calendar days
if--
(A) The enrollee requests the extension; or
(B) The applicable integrated plan can show that--
(1) The extension is in the enrollee's interest; and
(2) There is need for additional information and there is a
reasonable likelihood that receipt of such information would lead to
approval of the request, if received.
(ii) If the applicable integrated plan extends the timeframe for
resolving the integrated reconsideration, it must make reasonable
efforts to give the enrollee prompt oral notice of the delay, and give
the enrollee written notice within 2 calendar days of making the
decision to extend the timeframe to resolve the integrated
reconsideration. The notice must include the reason for the delay and
inform the enrollee of the right to file an expedited grievance if he
or she disagrees with the decision to grant an extension.
(4) Notice of resolution. The applicable integrated plan must send
a written notice to enrollees that includes the integrated reconsidered
determination, within the resolution timeframes set forth in this
section. The notice of determination must be written in plain language
and available in a language and format that is accessible to the
enrollee and must explain the following:
(i) The resolution of and basis for the integrated reconsideration
and the date it was completed.
(ii) For integrated reconsiderations not resolved wholly in favor
of the enrollee:
(A) An explanation of the next level of appeal available under the
Medicare and Medicaid programs, and what steps the enrollee must take
to pursue the next level of appeal under each program, and how the
enrollee can obtain assistance in pursuing the next level of appeal
under each program; and
(B) The right to request and receive Medicaid-covered benefits
while the next level of appeal is pending, if applicable.
Sec. 422.634 Effect.
(a) Failure of the applicable integrated plan to send timely notice
of a determination. If the applicable integrated plan fails to adhere
to the notice and timing for an integrated organization determination
or integrated reconsideration, this failure constitutes an adverse
determination for the enrollee.
(1) For an integrated organization determination, this means that
the enrollee may request an integrated reconsideration.
(2) For integrated reconsiderations of Medicare benefits, this
means the applicable integrated plan must forward the case to the
independent review entity, in accordance with the timeframes under
paragraph (b) of this section and Sec. 422.592. For integrated
reconsiderations of Medicaid benefits, this means that an enrollee or
other party may file for a State fair hearing in accordance with Sec.
438.408(f) of this chapter, or if applicable, a State external medical
review in accordance with Sec. 438.402(c) of this chapter.
(b) Adverse integrated reconsiderations. (1) Subject to paragraph
(b)(2) of this section, when the applicable integrated plan affirms, in
whole or in part, its adverse integrated organization determination
involving a Medicare benefit--
(i) The issues that remain in dispute must be reviewed and resolved
by an independent, outside entity that contracts with CMS, in
accordance with Sec. Sec. 422.592 and 422.594 through 422.619;
(ii) For standard integrated reconsiderations, the applicable
integrated plan must prepare a written explanation and send the case
file to the independent review entity contracted by CMS, as
expeditiously as the enrollee's health condition requires, but no later
than 30 calendar days from the date it receives the request (or no
later than the expiration of an extension described in Sec.
422.633(f)(3)). The applicable integrated plan must make reasonable and
diligent efforts to assist in gathering and forwarding information to
the independent entity; and
(iii) For expedited integrated reconsiderations, the applicable
integrated plan must prepare a written explanation and send the case
file to the independent review entity contracted by CMS as
expeditiously as the enrollee's health condition requires, but no later
than within 24 hours of its affirmation (or no later than the
expiration of an extension described in Sec. 422.633(f)(3)). The
applicable integrated plan must make reasonable and diligent efforts to
assist in gathering and forwarding information to the independent
entity.
(2) When the applicable integrated plan affirms, in whole or in
part, its adverse integrated organization determination involving a
Medicaid benefit, the enrollee or other party (that is not the
applicable integrated plan) may initiate a State fair hearing in the
timeframe specified in Sec. 438.408(f)(2) following the integrated
plan's notice of resolution. If a provider is filing for a State fair
hearing on behalf of the enrollee as permitted by State law, the
provider needs the written consent of the enrollee, if he or she has
not already obtained such consent.
(c) Final determination. The reconsidered determination of the
applicable integrated plan is binding on all parties unless it is
appealed to the next applicable level. In the event that the enrollee
pursues the appeal in multiple forums and receives conflicting
decisions, the applicable integrated plan is bound by, and must act in
accordance with, decisions favorable to the enrollee.
(d) Services not furnished while the appeal is pending. If an
applicable integrated plan reverses its decision, or, for a Medicaid
benefit, a State fair hearing reverses an applicable plan's integrated
reconsideration decision, to deny, limit, or delay services that were
not furnished while the appeal was pending, the applicable integrated
plan must authorize or provide the disputed services promptly and as
expeditiously as the enrollee's health condition requires but no later
than 72 hours from the date it receives notice reversing the
determination in lieu of the timeframes described in Sec. 422.618(a).
Reversals by the Part C independent review entity, an administrative
law judge or attorney adjudicator at the Office of Medicare Hearings
and Appeals, or the Medicare Appeals Council must be effectuated under
same timelines applicable to other MA plans as specified in Sec. Sec.
422.618 and 422.619.
(e) Services furnished while the appeal is pending. If the
applicable integrated plan or the State fair hearing officer reverses a
decision to deny, limit, or delay Medicaid-covered benefits, and the
enrollee received the disputed services while the integrated
reconsideration was pending, the applicable integrated plan or the
State must pay for those services, in accordance with State policy and
regulations. If the applicable integrated plan reverses a decision to
deny, limit, or delay Medicare-covered benefits, and the enrollee
received the disputed services while the integrated reconsideration was
pending, the applicable integrated plan must pay for those services.
0
25. Effective January 1, 2021, Sec. 422.752 is amended by adding
paragraph (d) to read as follows:
Sec. 422.752 Basis for imposing intermediate sanctions and civil
money penalties.
* * * * *
[[Page 15840]]
(d) Special rule for non-compliant dual eligible special needs
plans. Notwithstanding any other provision of this section, CMS must
impose during plan years 2021 through 2025 intermediate sanctions
specified at Sec. 422.750(a) on an MA organization with a contract to
operate a dual eligible special needs plan if CMS determines that the
dual eligible special needs plan fails to comply with at least one of
the criteria for the integration of Medicare and Medicaid benefits
provided in the definition of a dual eligible special needs plan at
Sec. 422.2. If CMS imposes such an intermediate sanction, the MA
organization must submit to CMS a corrective action plan in a form,
manner, and timeframe established by CMS. The procedures outlined in
Sec. 422.756 apply to the imposition of the intermediate sanction
under this provision.
PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
0
26. The authority citation for part 423 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1395w-101 through 1395w-152, and
1395hh.
0
27. In 423.100, in the definition of ``Preclusion list'', revise
paragraphs (1)(i), (2)(i), (2)(ii)(C) and add paragraph (3) to read as
follows:
Sec. 423.100 Definitions.
* * * * *
Preclusion list * * *
(1) * * *
(i) The prescriber is currently revoked from Medicare for a reason
other than that stated in Sec. 424.535(a)(3) of this chapter.
* * * * *
(2) * * *
(i) The prescriber has engaged in behavior, other than that
described in Sec. 424.535(a)(3) of this chapter, for which CMS could
have revoked the individual to the extent applicable had he or she been
enrolled in Medicare.
(ii) * * *
(C) Any other evidence that CMS deems relevant to its
determination; or
(3) The prescriber, regardless of whether he or she is or was
enrolled in Medicare, has been convicted of a felony under Federal or
State law within the previous 10 years that CMS deems detrimental to
the best interests of the Medicare program. Factors that CMS considers
in making such a determination under this paragraph are as follows:
(i) The severity of the offense.
(ii) When the offense occurred.
(iii) Any other information that CMS deems relevant to its
determination.
* * * * *
0
28. Effective June 17, 2019, Sec. 423.120 is amended by revising
paragraphs (c)(6)(iv) to read as follows:
Sec. 423.120 Access to covered Part D drugs.
* * * * *
(c) * * *
(6) * * *
(iv) With respect to Part D prescribers who have been added to an
updated preclusion list but are not currently excluded by the OIG, the
Part D plan sponsor must do all of the following:
(A) Subject to all other Part D rules and plan coverage
requirements, and no later than 30 days after the posting of this
updated preclusion list, must provide an advance written notice to any
beneficiary who has received a Part D drug prescribed by an individual
added to the preclusion list in this update and whom the plan sponsor
has identified during the applicable 30-day period.
(B)(1) Subject to paragraph (c)(6)(iv)(B)(2) of this section, must
ensure that reasonable efforts are made to notify the individual
described in paragraph (c)(6)(iv) of this section of a beneficiary who
was sent a notice under paragraph (c)(6)(iv)(A) of this section.
(2) Paragraph (c)(6)(iv)(B)(1) of this section applies only upon a
prescriber writing a prescription in Medicare Part D when:
(i) The plan sponsor has enough information on file to either copy
the prescriber on the notification previously sent to the beneficiary
or send a new notice informing the prescriber that they may not see
plan beneficiaries due to their preclusion status; and
(ii) The claim is received after the claim denial or reject date in
the preclusion file.
(C) Must not reject a pharmacy claim or deny a beneficiary request
for reimbursement for a Part D drug prescribed by the prescriber,
solely on the ground that they have been included in the updated
preclusion list, in the 60-day period after the date it sent the notice
described in paragraph (c)(6)(iv)(A) of this section.
0
29. Section 423.120 is further amended by--
0
a. Revising paragraphs (c)(6)(v); and
0
b. Adding paragraphs (c)(6)(vii) and (viii).
The revision and additions read as follows:
Sec. 423.120 Access to covered Part D drugs.
* * * * *
(c) * * *
(6) * * *
(v)(A) CMS sends written notice to the prescriber via letter of his
or her inclusion on the preclusion list. The notice must contain the
reason for the inclusion on the preclusion list and inform the
prescriber of his or her appeal rights. A prescriber may appeal his or
her inclusion on the preclusion list under this section in accordance
with part 498 of this chapter.
(B) If the prescriber's inclusion on the preclusion list is based
on a contemporaneous Medicare revocation under Sec. 424.535 of this
chapter:
(1) The notice described in paragraph (c)(6)(v)(A) of this section
must also include notice of the revocation, the reason(s) for the
revocation, and a description of the prescriber's appeal rights
concerning the revocation.
(2) The appeals of the prescriber's inclusion on the preclusion
list and the prescriber's revocation must be filed jointly by the
prescriber and, as applicable, considered jointly under part 498 of
this chapter.
(C)(1) Except as provided in paragraph (c)(6)(v)(C)(2) of this
section, a prescriber will only be included on the preclusion list
after the expiration of either of the following:
(i) If the prescriber does not file a reconsideration request under
Sec. 498.5(n)(1) of this chapter, the prescriber will be added to the
preclusion list upon the expiration of the 60-day period in which the
prescriber may request a reconsideration.
(ii) If the prescriber files a reconsideration request under Sec.
498.5(n)(1) of this chapter, the prescriber will be added to the
preclusion list effective on the date on which CMS, if applicable,
denies the prescriber's reconsideration.
(2) An OIG excluded prescriber is added to the preclusion list
effective on the date of the exclusion.
* * * * *
(vii)(A) Except as provided in paragraphs (c)(6)(vii)(C) and (D) of
this section, a prescriber who is revoked under Sec. 424.535 of this
chapter will be included on the preclusion list for the same length of
time as the prescriber's reenrollment bar.
(B) Except as provided in paragraphs (c)(6)(vii)(C) and (D) of this
section, a prescriber who is not enrolled in Medicare will be included
on the preclusion list for the same length of time as the reenrollment
bar that CMS could have imposed on the prescriber had the prescriber
been enrolled and then revoked.
(C) Except as provided in paragraph (c)(6)(vii)(D) of this section,
an
[[Page 15841]]
individual, regardless of whether the individual is or was enrolled in
Medicare, that is included on the preclusion list because of a felony
conviction will remain on the preclusion list for a 10-year period,
beginning on the date of the felony conviction, unless CMS determines
that a shorter length of time is warranted. Factors that CMS considers
in making such a determination are--
(1) The severity of the offense;
(2) When the offense occurred; and
(3) Any other information that CMS deems relevant to its
determination.
(D) In cases where an individual is excluded by the OIG, the
individual must remain on the preclusion list until the expiration of
the CMS-imposed preclusion list period or reinstatement by the OIG,
whichever occurs later.
(viii) Payment denials under paragraph (c)(6) of this section that
are based upon the prescriber's inclusion on the preclusion list are
not appealable by beneficiaries.
* * * * *
0
30. Section 423.153 is amended by revising the section heading and
adding paragraph (g) to read as follows:
Sec. 423.153 Prescription drug plan sponsors' access to Medicare
Parts A and B claims data extracts.
* * * * *
(g) Parts A and B claims data extracts--(1) General rule. (i)
Beginning in plan year 2020, a PDP sponsor may submit a request to CMS
for the data described in paragraph (g)(2) of this section about
enrollees in its prescription drug plans.
(ii) CMS makes the data requested in paragraph (g)(1)(i) of this
section available to eligible PDP sponsors, in accordance with all
applicable laws. The data is provided at least quarterly on a specified
release date, and in an electronic format to be determined by CMS.
(iii) If CMS determines or has a reasonable belief that the PDP
sponsor has violated the requirements of this paragraph (g) or that
unauthorized uses, reuses, or disclosures of the Medicare claims data
have taken place, at CMS' sole discretion, the PDP sponsor may be
denied further access to the data described in paragraph (g)(2) of this
section.
(2) Data described. The data that may be requested under paragraph
(g)(1) of this section are standardized extracts of claims data under
Medicare parts A and B for items and services furnished under such
parts to beneficiaries who are enrolled in a plan offered by the PDP
sponsor at the time of the disclosure.
(3) Purposes. A PDP sponsor must comply with all laws that may be
applicable to data received under this provision, including State and
Federal privacy and security laws, and, furthermore subject to the
limitations in paragraph (g)(4) of this section may only use or
disclose the data provided by CMS under paragraph (g)(1) of this
section for the following purposes:
(i) To optimize therapeutic outcomes through improved medication
use, as such phrase is used in paragraph (d)(1)(i) of this section.
(ii) To improve care coordination so as to prevent adverse health
outcomes, such as preventable emergency department visits and hospital
readmissions.
(iii) For activities falling under paragraph (1) of the definition
of ``health care operations'' under 45 CFR 164.501.
(iv) For activities falling under paragraph (2) of the definition
of ``health care operations'' under 45 CFR 164.501.
(v) For ``fraud and abuse detection or compliance activities''
under 45 CFR 164.506(c)(4)(ii).
(vi) For disclosures that qualify as ``required by law''
disclosures at 45 CFR 164.103.
(4) Limitations. A PDP sponsor must comply with the following
requirements regarding the data provided by CMS under this paragraph
(g):
(i) The PDP sponsor will not use the data to inform coverage
determinations under Part D.
(ii) The PDP sponsor will not use the data to conduct retroactive
reviews of medically accepted indications determinations.
(iii) The PDP sponsor will not use the data to facilitate
enrollment changes to a different prescription drug plan or an MA-PD
plan offered by the same parent organization.
(iv) The PDP sponsor will not use the data to inform marketing of
benefits.
(v) The PDP sponsor will contractually bind its contractors that
have access to the Medicare claims data, and require their contractors
to contractually bind any other potential downstream data recipients,
to the terms and conditions imposed on the PDP sponsor under this
paragraph (g).
(5) Ensuring the privacy and security of data. As a condition of
receiving the requested data, the PDP sponsor must attest that it will
adhere to the permitted uses and limitations on the use of the Medicare
claims data listed in paragraphs (g)(3) and (4) of this section.
0
31. Section 423.182(a) is amended by adding the definitions ``Absolute
percentage cap'', ``Cut point cap'', ``Guardrail'', ``Mean
resampling'', ``Restricted range'', and ``Restricted range cap'' in
alphabetical order to read as follows:
Sec. 423.182 Part D Prescription Drug Plan Quality Rating System.
(a) * * *
Absolute percentage cap is a cap applied to non-CAHPS measures that
are on a 0 to 100 scale that restricts movement of the current year's
measure-threshold-specific cut point to no more than the stated
percentage as compared to the prior year's cut point.
* * * * *
Cut point cap is a restriction on the change in the amount of
movement a measure-threshold-specific cut point can make as compared to
the prior year's measure-threshold-specific cut point. A cut point cap
can restrict upward movement, downward movement, or both.
* * * * *
Guardrail is a bidirectional cap that restricts both upward and
downward movement of a measure-threshold-specific cut point for the
current year's measure-level Star Ratings as compared to the prior
year's measure-threshold-specific cut point.
* * * * *
Mean resampling refers to a technique where measure-specific scores
for the current year's Star Ratings are randomly separated into 10
equal-sized groups. The hierarchal clustering algorithm is done 10
times, each time leaving one of the 10 groups out. By leaving out one
of the 10 groups for each run, 9 of the 10 groups, which is 90 percent
of the applicable measure scores, are used for each run of the
clustering algorithm. The method results in 10 sets of measure-specific
cut points. The mean cut point for each threshold per measure is
calculated using the 10 values.
* * * * *
Restricted range is the difference between the maximum and minimum
measure score values using the prior year measure scores excluding
outer fence outliers (first quartile -3*Interquartile Range (IQR) and
third quartile + 3*IQR).
Restricted range cap is a cap applied to non-CAHPS measures that
restricts movement of the current year's measure-threshold-specific cut
point to no more than the stated percentage of the restricted range of
a measure calculated using the prior year's measure score distribution.
* * * * *
[[Page 15842]]
0
32. Section 423.184 is amended by adding paragraphs (f)(1)(iv),
(g)(1)(ii)(M), and (h) to read as follows:
Sec. 423.184 Adding, updating, and removing measures.
* * * * *
(f) * * *
(1) * * *
(iv) CMS excludes any measure that receives a measure-level Star
Rating reduction for data integrity concerns for either the current or
prior year from the improvement measure(s).
* * * * *
(g) * * *
(1) * * *
(ii) * * *
(M) CMS reduces the measure rating to 1 star for the applicable
appeals measure(s) if a contract fails to submit Timeliness Monitoring
Project data for CMS's review to ensure the completeness of the
contract's IRE data.
* * * * *
(h) Review of sponsors' data. (1) A Part D plan sponsor may request
that CMS or the IRE review its' contract's appeals data provided that
the request is received by the annual deadline set by CMS for the
applicable Star Ratings year.
(2) A Part D plan sponsor may request that CMS review its'
contract's Complaints Tracking Module (CTM) data provided that the
request is received by the annual deadline set by CMS for the
applicable Star Ratings year.
0
33. Section 423.186 is amended by revising paragraph (a)(2)(i) and
adding paragraph (i) to read as follows:
Sec. 423.186 Calculation of Star Ratings.
(a) * * *
(2) * * *
(i) The method maximizes differences across the star categories and
minimizes the differences within star categories using mean resampling
with the hierarchal clustering of the current year's data, and a
guardrail so that the measure-threshold-specific cut points for non-
CAHPS measures do not increase or decrease more than the value of the
cap from one year to the next. The cap is equal to 5 percentage points
for measures having a 0 to 100 scale (absolute percentage cap) or 5
percent of the restricted range for measures not having a 0 to 100
scale (restricted range cap). New measures that have been in the Part C
and D Star Rating program for three years or less use the hierarchal
clustering methodology with mean resampling with no guardrail for the
first 3 years in the program.
* * * * *
(i) Extreme and uncontrollable circumstances. In the event of
extreme and uncontrollable circumstances that may negatively impact
operational and clinical systems and contracts' abilities to conduct
surveys needed for accurate performance measurement, CMS calculates the
Star Ratings as specified in paragraphs (i)(2) through (8) of this
section for each contract that is an affected contract during the
performance period for the applicable measures. We use the start date
of the incident period to determine which year of Star Ratings could be
affected, regardless of whether the incident period lasts until another
calendar year.
(1) Identification of affected contracts. A contract that meets all
of the following criteria is an affected contract:
(i) The contract's service area is within an ``emergency area''
during an ``emergency period'' as defined in section 1135(g) of the
Act.
(ii) The contract's service area is within a county, parish, U.S.
territory or tribal area designated in a major disaster declaration
under the Stafford Act and the Secretary exercised authority under
section 1135 of the Act based on the same triggering event(s).
(iii) As specified in paragraphs (i)(2) through (8) of this
section, a certain minimum percentage (25 percent or 60 percent) of the
enrollees under the contract must reside in a Federal Emergency
Management Agency (FEMA)-designated Individual Assistance area at the
time of the extreme and uncontrollable circumstance.
(2) CAHPS adjustments. (i) A contract, even if an affected
contract, must administer the CAHPS survey unless exempt under
paragraph (i)(2)(ii) of this section.
(ii) An affected contract with at least 25 percent of enrollees in
FEMA-designated Individual Assistance areas at the time of the extreme
and uncontrollable circumstance is exempt from administering the CAHPS
survey if the contract completes both of the following:
(A) Demonstrates to CMS that the required sample for the survey
cannot be contacted because a substantial number of the contract's
enrollees are displaced due to the FEMA-designated disaster identified
in paragraph (i)(1)(iii) of this section in the prior calendar year.
(B) Requests and receives a CMS approved exemption.
(iii) An affected contract with an exemption described in paragraph
(i)(2)(ii) of this section receives the contract's CAHPS measure stars
and corresponding measure scores from the prior year.
(iv) For an affected contract with at least 25 percent of enrollees
in FEMA-designated Individual Assistance areas at the time of the
extreme and uncontrollable circumstance, the contract receives the
higher of the previous year's Star Rating or the current year's Star
Rating (and corresponding measure score) for each CAHPS measure.
(v) When a contract is an affected contract with at least 25
percent of enrollees in FEMA-designated Individual Assistance areas at
the time of the extreme and uncontrollable circumstance with regard to
separate extreme and uncontrollable circumstances that begin in
successive years, it is a multiple year-affected contract. A multiple
year-affected contract receives the higher of the current year's Star
Rating or what the previous year's Star Rating would have been in the
absence of any adjustments that took into account the effects of the
previous year's disaster for each measure (using the corresponding
measure score for the Star Ratings year selected).
(3) New measure adjustments. For affected contracts with at least
25 percent of enrollees in a FEMA-designated Individual Assistance area
at the time of the extreme and uncontrollable circumstance, CMS holds
the affected contract harmless by using the higher of the contract's
summary or overall rating or both with and without including all of the
applicable new measures.
(4) Other Star Ratings measure adjustments. (i) For all other Part
D measures except those measures identified in this paragraph
(i)(4)(ii) of this section, affected contracts with at least 25 percent
of enrollees in a FEMA-designated Individual Assistance area at the
time of the extreme and uncontrollable circumstance receive the higher
of the previous or current year's measure Star Rating (and
corresponding measure score).
(ii) CMS does not adjust the scores of the Star Ratings for the
Part D Call Center--Foreign Language Interpreter and TTY Availability
measure, unless the exemption listed in paragraph (i)(4)(iii) of this
section applies.
(iii) CMS adjusts the measure listed in paragraph (i)(4)(ii) of
this section using the adjustments listed in paragraph (i)(4)(i) of
this section for contracts affected by extreme and uncontrollable
circumstances where there are continuing communications issues related
to loss of electricity and damage to infrastructure during the call
center study.
[[Page 15843]]
(iv) When a contract is an affected contract with at least 25
percent of enrollees in FEMA-designated Individual Assistance areas at
the time of the extreme and uncontrollable circumstance with regard to
separate extreme and uncontrollable circumstances that begin in
successive years, it is a multiple year-affected contract. A multiple
year-affected contract receives the higher of the current year's Star
Rating or what the previous year's Star Rating would have been in the
absence of any adjustments that took into account the effects of the
previous year's disaster for each measure (using the corresponding
measure score for the Star Ratings year selected).
(5) Exclusion from improvement measures. Any measure that reverts
back to the data underlying the previous year's Star Rating due to the
adjustments made in paragraph (i) of this section is excluded from both
the count of measures and the applicable improvement measures for the
current and next year's Star Ratings for the affected contract.
Contracts affected by extreme and uncontrollable circumstances do not
have the option of reverting to the prior year's improvement rating.
(6) Missing data. For an affected contract that has missing data in
the current or previous year, the final measure rating comes from the
current year unless an exemption described in paragraph (i)(2)(ii) of
this section applies.
(7) Cut points for non-CAHPS measures. (i) CMS excludes the numeric
values for affected contracts with 60 percent or more of their
enrollees in the FEMA-designated Individual Assistance area at the time
of the extreme and uncontrollable circumstance from the clustering
algorithms described in paragraph (a)(2) of this section.
(ii) The cut points calculated as described in paragraph (i)(7)(i)
of this section are used to assess all affected contracts' measure Star
Ratings.
(8) Reward factor. (i) CMS excludes the numeric values for affected
contracts with 60 percent or more of their enrollees in the FEMA-
designated Individual Assistance area at the time of the extreme and
uncontrollable circumstance from the determination of the performance
summary and variance thresholds for the Reward Factor described in
paragraph (f)(1) of this section.
(ii) All affected contracts are eligible for the Reward Factor
based on the calculations described in paragraph (i)(8)(i) of this
section.
0
34. Section 423.568 is amended by revising paragraph (b) to read as
follows:
Sec. 423.568 Standard timeframe and notice requirements for coverage
determinations.
* * * * *
(b) Timeframe for requests for drug benefits. When a party makes a
request for a drug benefit, the Part D plan sponsor must notify the
enrollee (and the prescribing physician or other prescriber involved,
as appropriate) of its determination as expeditiously as the enrollee's
health condition requires, but no later than 72 hours after receipt of
the request. For an exceptions request, the Part D plan sponsor must
notify the enrollee (and the prescribing physician or other prescriber
involved, as appropriate) of its determination as expeditiously as the
enrollee's health condition requires, but no later than 72 hours after
receipt of the physician's or other prescriber's supporting statement.
If a supporting statement is not received by the end of 14 calendar
days from receipt of the exceptions request, the Part D plan sponsor
must notify the enrollee (and the prescribing physician or other
prescriber involved, as appropriate) of its determination as
expeditiously as the enrollee's health condition requires, but no later
than 72 hours from the end of 14 calendar days from receipt of the
exceptions request.
* * * * *
0
35. Section 423.570 is amended by revising paragraph (d)(1) to read as
follows:
Sec. 423.570 Expediting certain coverage determinations.
* * * * *
(d) * * *
(1) Make the determination within the 72-hour timeframe established
in Sec. 423.568(b) for a standard determination. The 72-hour period
begins on the day the Part D plan sponsor receives the request for
expedited determination. For an exceptions request, the Part D plan
sponsor must notify the enrollee (and the prescribing physician or
other prescriber involved, as appropriate) of its determination as
expeditiously as the enrollee's health condition requires, but no later
than 72 hours after receipt of the physician's or other prescriber's
supporting statement. If a supporting statement is not received by the
end of 14 calendar days from receipt of the exceptions request, the
Part D plan sponsor must notify the enrollee (and the prescribing
physician or other prescriber involved, as appropriate) of its
determination as expeditiously as the enrollee's health condition
requires, but no later than 72 hours from the end of 14 calendar days
from receipt of the exceptions request.
* * * * *
0
36. Section 423.572 is amended by revising paragraph (a) to read as
follows:
Sec. 423.572 Timeframes and notice requirements for expedited
coverage determinations.
(a) Timeframe for determination and notification. Except as
provided in paragraph (b) of this section, a Part D plan sponsor that
approves a request for expedited determination must make its
determination and notify the enrollee (and the prescribing physician or
other prescriber involved, as appropriate) of its decision, whether
adverse or favorable, as expeditiously as the enrollee's health
condition requires, but no later than 24 hours after receiving the
request. For an exceptions request, the Part D plan sponsor must notify
the enrollee (and the prescribing physician or other prescriber
involved, as appropriate) of its determination as expeditiously as the
enrollee's health condition requires, but no later than 24 hours after
receipt of the physician's or other prescriber's supporting statement.
If a supporting statement is not received by the end of 14 calendar
days from receipt of the exceptions request, the Part D plan sponsor
must notify the enrollee (and the prescribing physician or other
prescriber involved, as appropriate) of its determination as
expeditiously as the enrollee's health condition requires, but no later
than 24 hours from the end of 14 calendar days from receipt of the
exceptions request.
* * * * *
PART 438--MANAGED CARE
0
37. The authority for part 438 is revised to read as follows:
Authority: 42 U.S.C. 1302.
0
38. Effective January 1, 2021, Sec. 438.210 is amended by--
0
a. Revising paragraph (c);
0
b. Adding paragraph (d)(4); and
0
c. Revising paragraph (f).
The addition and revisions read as follows:
Sec. 438.210 Coverage and authorization of services.
* * * * *
(c) Notice of adverse benefit determination. Each contract must
provide for the MCO, PIHP, or PAHP to notify the requesting provider,
and give the enrollee written notice of any decision by the MCO, PIHP,
or PAHP to deny a service authorization request, or to authorize a
service in an amount, duration, or scope that is less than
[[Page 15844]]
requested. For MCOs, PIHPs, and PAHPs, the enrollee's notice must meet
the requirements of Sec. 438.404. For Medicaid contracts with an
applicable integrated plan, as defined in Sec. 422.561 of this
chapter, in lieu of the provisions in this paragraph governing notices
of adverse benefit determinations, the provisions set forth in
Sec. Sec. 422.629 through 422.634 of this chapter apply to
determinations affecting dually eligible individuals who are also
enrolled in a dual eligible special needs plan with exclusively aligned
enrollment, as defined in Sec. 422.2 of this chapter.
(d) * * *
* * * * *
(4) For Medicaid contracts with an applicable integrated plan, as
defined in Sec. 422.561 of this chapter, timelines for decisions and
notices must be compliant with the provisions set forth in Sec. Sec.
422.629 through 422.634 of this chapter in lieu of Sec. Sec. 438.404
through 438.424.
* * * * *
(f) Applicability date. (1) Subject to paragraph (f)(2) of this
section, this section applies to the rating period for contracts with
MCOs, PIHPs, and PAHPs beginning on or after July 1, 2017. Until that
applicability date, States are required to continue to comply with
Sec. 438.210 contained in the 42 CFR parts 430 to 481, edition revised
as of October 1, 2015.
(2) Provisions in this section affecting applicable integrated
plans, as defined in Sec. 422.561 of this chapter, are applicable no
later than January 1, 2021.
0
39. Effective January 1, 20121, Sec. 438.400 is amendedby adding
paragraph (a)(4) and revising paragraph (c) to read as follows:
Sec. 438.400 Statutory basis, definitions, and applicability.
(a) * * *
(4) Section 1859(f)(8)(B) of the Act requires that the Secretary,
to the extent feasible, establish procedures unifying grievances and
appeals procedures under sections 1852(f), 1852(g), 1902(a)(3),
1902(a)(5), and 1932(b)(4) of the Act for items and services provided,
by specialized Medicare Advantage plans for special needs individuals
described in section 1859(b)(6)(B)(ii), under Titles XVIII and XIX of
the Act.
* * * * *
(c) Applicability. (1) Subject to paragraph (c)(2) of this section,
this subpart applies to the rating period for contracts with MCOs,
PIHPs, and PAHPs beginning on or after July 1, 2017. Until that
applicability date, States, MCOs, PIHPs, and PAHPs are required to
continue to comply with subpart F contained in the 42 CFR parts 430 to
481, edition revised as of October 1, 2015.
(2) Provisions in this part affecting applicable integrated plans,
as defined in Sec. 422.561 of this chapter, are applicable no later
than January 1, 2021.
0
40. Effective January 1, 2021, Sec. 438.402 is amended by revising
paragraph (a) to read as follows:
Sec. 438.402 General requirements.
(a) The grievance and appeal system. Each MCO, PIHP, and PAHP must
have a grievance and appeal system in place for enrollees. Non-
emergency medical transportation PAHPs, as defined in Sec. 438.9, are
not subject to this subpart F. For grievances and appeals at the plan
level, an applicable integrated plan as defined in Sec. 422.561 of
this chapter is not subject to this subpart F, and is instead subject
to the requirements of Sec. Sec. 422.629 through 422.634 of this
chapter. For appeals of integrated reconsiderations, applicable
integrated plans are subject to Sec. 438.408(f).
* * * * *
PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT
AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE
MEDICAID PROGRAM
0
41. The authority for part 498 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7j, and 1395hh.
0
42. Effective June 17, 2019, Sec. 498.5 is amended by revising
paragraph (n)(1) to read as follows:
Sec. 498.5 Appeal rights.
* * * * *
(n) * * *
(1)(i) Any individual or entity that is dissatisfied with an
initial determination or revised initial determination that they are to
be included on the preclusion list (as defined in Sec. 422.2 or Sec.
423.100 of this chapter) may request a reconsideration in accordance
with Sec. 498.22(a).
(ii)(A) If the individual's or entity's inclusion on the preclusion
list is based on a Medicare revocation under Sec. 424.535 of this
chapter and the individual or entity receives contemporaneous notice of
both actions, the individual or entity may request a joint
reconsideration of both the preclusion list inclusion and the
revocation in accordance with Sec. 498.22(a).
(B) The individual or entity may not submit separate
reconsideration requests under paragraph (n)(1)(ii)(A) of this section
for inclusion on the preclusion list or a revocation if the individual
or entity received contemporaneous notice of both actions.
* * * * *
Dated: March 27, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: March 28, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-06822 Filed 4-5-19; 4:15 pm]
BILLING CODE 4120-01-P
