Medicaid Program; Methods for Assuring Access to Covered Medicaid Services-Exemptions for States With High Managed Care Penetration Rates and Rate Reduction Threshold, 12696-12706 [2018-05898]
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Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Proposed Rules
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BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 447
[CMS–2406–P]
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Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
amend the process for states to
document whether Medicaid payments
in fee-for-service systems are sufficient
SUMMARY:
18:37 Mar 22, 2018
To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on May 22, 2018.
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submissions, must be submitted in one
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address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
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For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
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SUPPLEMENTARY INFORMATION:
Medicaid Program; Methods for
Assuring Access to Covered Medicaid
Services—Exemptions for States With
High Managed Care Penetration Rates
and Rate Reduction Threshold
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to enlist providers to assure beneficiary
access to covered care and services
consistent with the statute. States have
raised concerns over the administrative
burden associated with the current
requirements, particularly for states
with high rates of Medicaid managed
care enrollment. This proposed rule
would provide burden relief and
address those concerns.
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I. Executive Summary and Background
A. Executive Summary
1. Purpose
Current regulations at 42 CFR
447.203(b) require states to develop and
submit to CMS an access monitoring
review plan (AMRP) for Medicaid
services provided through a fee-forservice (FFS) delivery system. The
AMRP must be updated at least every 3
years and address the following
categories of Medicaid services: Primary
care services (including those provided
by a physician, federally qualified
health center (FQHC), clinic or dental
care); physician specialist services (for
example, cardiology, radiology,
urology); behavioral health services
(including mental health and substance
use disorder); pre- and post-natal
obstetric services (including labor and
delivery); and home health. The AMRP
must identify a data-driven process to
review access to care and address: The
extent to which beneficiary needs are
fully met; the availability of care
through enrolled providers; and changes
in beneficiary service utilization.
Additionally, when states reduce rates
for other Medicaid services, they must
add those services to the AMRP and
monitor the effects of the rate reductions
for 3 years. Section 447.204 requires
states to undertake a public process and
submit specific information regarding
access to care when proposing to reduce
or restructure Medicaid provider
payment rates. This proposed rule
would provide an exemption to the
regulatory requirements in
§§ 447.203(b)(1) through (6) and
447.204(a) through (c) for states with
comprehensive, risk-based Medicaid
managed care enrollment rates above 85
percent of the total covered population
under a state’s Medicaid program,
including managed care comprehensive
risk contracts under a state’s section
1115 Medicaid demonstration. The
proposed rule would also provide an
exemption to the regulatory
requirements in §§ 447.203(b)(6) and
447.204(a) through (c) for states that
submit state plan amendments (SPAs) to
reduce rates or restructure payments
where the overall reduction is 4 percent
or less of overall spending within the
affected state plan service category for a
single state fiscal year (SFY) and 6
percent or less over 2 consecutive SFYs.
Additionally, the proposed rule would
modify the requirements in
§ 447.204(b)(2) so that, for SPAs that
reduce or restructure Medicaid payment
rates, states would be required to submit
to CMS an assurance that data indicates
current access is consistent with
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requirements of the Social Security Act
(the Act) instead of an analysis
anticipating the effects of a proposed
change in payment rates or structure.
B. Background
Section 1902(a)(30)(A) of the Act
requires states to ‘‘assure that payments
are consistent with efficiency, economy,
and quality of care and are sufficient to
enlist enough providers so that care and
services are available under the plan at
least to the extent that such care and
services are available to the general
population in the geographic area.’’
Until 2011, we had not defined through
federal regulation a framework to guide
states in meeting this statutory
requirement and reviewed state
proposals to reduce provider payment
rates on a case-by-case basis. We
historically relied on state certifications
and available supporting information
that reductions in Medicaid payments
met the statutory standards.
In the November 2, 2015 Federal
Register (80 FR 67576) we published the
‘‘Methods for Assuring Access to
Covered Medicaid Services’’ final rule
with comment period that outlined a
data-driven process for states to
document whether Medicaid payments
are sufficient to enlist providers to
assure beneficiary access to covered care
and services consistent with section
1902(a)(30)(A) of the Act. The final rule
with comment period included a new
§ 447.203(b)(1) through (8) and revisions
to § 447.204. These regulations
established that states must develop and
submit to CMS an AMRP, that is
updated at least every 3 years, for the
following services: (1) Primary care
(including those provided by a
physician, FQHC, clinic or dental care);
(2) physician specialist services (for
example, cardiology, urology,
radiology); (3) behavioral health services
(including mental health and substance
use disorder); (4) pre- and post-natal
obstetric services, (including labor and
delivery); (5) home health services; (6)
any additional types of services for
which a review is required under
§ 447.203(b)(6) because of a proposed
payment rate reduction or restructuring;
(7) additional types of services for
which the state or CMS has received a
significantly higher than usual volume
of beneficiary, provider or other
stakeholder access complaints for a
geographic area; and (8) additional types
of services selected by the state.
The AMRP must document the state’s
consideration of access to care in setting
and adjusting payment methodologies
for Medicaid services and in informing
state policies affecting access to
Medicaid services. The state must
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address, through data driven analysis:
The extent to which beneficiary needs
are fully met; the availability of care
through enrolled providers; changes in
beneficiary service utilization; the
characteristics of the beneficiary
population (including considerations for
care, service and payment variations for
pediatric and adult populations and for
individuals with disabilities); and actual
or estimated levels of provider payment
available from other payers, including
other public and private payers.
Additionally, § 447.203(b)(6) requires a
state to add services to its AMRP when
reducing payment rates or restructuring
provider payment for such Medicaid
services in circumstances when the
changes could result in diminished
access, as well as to develop a plan to
monitor the effects of the rate reduction
or restructuring for at least 3 years.
Furthermore, under § 447.204(a)
through (c), when proposing to reduce
or restructure Medicaid payment rates,
states must consider the data collected
through the AMRP and undertake a
public process that solicits input on the
potential impact of proposed reduction
or restructuring of Medicaid payment
rates on beneficiary access to care.
States must submit related analysis to
CMS along with any proposed rate
reduction or restructuring SPA, and we
may disapprove such a proposed SPA
that does not include documentation
supporting compliance with the
required AMRP review and public
process.
In the November 2, 2015 final rule
with comment period, we solicited
comments on § 447.203(b)(5),
concerning the access monitoring
review plan timeframe. Specifically, we
solicited comments on the scope of
services that should be subject to
ongoing review under the AMRP, the
required elements of review, whether
we should allow exemptions from
certain requirements of the final rule
based on state program characteristics
(for example, high managed care
enrollment), and the timeframe for
submission. In response to the
comments we received, in the April 12,
2016 Federal Register (81 FR 21479), we
published the ‘‘Deadline for Access
Monitoring Review Plan Submissions’’
final rule in which we extended the
deadline for initial AMRP submissions
to October 1, 2016. Although we
received numerous comments on the
issue of whether states with high
managed care enrollment should be
exempt from the requirements of the
final rule, we did not include such an
exemption in the April 12, 2016 final
rule because we believed that further
experience with the access monitoring
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review process was necessary to
determine the appropriate
circumstances for exemptions. We have
considered the comments received in
response to the November 2, 2015 final
rule with comment period at (https://
www.regulations.gov/
document?D=CMS-2011-0062-0188) in
the development of this proposed rule.
The initial AMRP submissions were
due to us on October 1, 2016. We
received AMRP submissions from all
states, and the submissions are available
on Medicaid.gov (https://
www.medicaid.gov/medicaid/access-tocare/review-plans/). During
the initial year of implementation, a
number of states expressed concern
regarding the administrative burden
associated with the requirements of
§ 447.203, particularly those states with
a very high beneficiary enrollment in
comprehensive, risk-based managed
care and a limited number of
beneficiaries receiving care through a
fee-for-service delivery system. Based
on our experience in reviewing the
AMRPs and working with states with
high beneficiary enrollment in
comprehensive, risk-based managed
care, we now believe we have sufficient
experience to establish a threshold for
such states to be exempt from meeting
certain access monitoring review
requirements, and are proposing
additional modifications to the
regulations to ease the administrative
burden on states that are proposing
certain payment rate reductions.
Although this proposed rule would
establish such thresholds, states are still
obligated by the statute to ensure
Medicaid payment rates are sufficient to
enlist enough providers to assure that
beneficiary access to covered care and
services is at least consistent with that
of the general population in the same
geographic area, particularly when
reducing or restructuring Medicaid
payment rates through SPAs. In lieu of
the requirements set forth in
§ 447.203(b)(6), we are proposing that
states that meet the high managed care
enrollment exemption threshold under
this proposed rule would be permitted
to submit alternate information and
analysis, as determined by the state,
when proposing payment rate
reductions, to support compliance with
section 1902(a)(30)(A) of the Act.
Our implementation experience has
also created questions about the benefit
of requiring states to conduct a public
process and access analysis for every
change in Medicaid payment rates or
structure that results in a reduction to
provider payments, including those
nominal rate reductions that are
unlikely to result in diminished access.
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We have worked with a number of states
that, over the past 2 years, have
proposed relatively small payment rate
reductions and have expended staff
resources to add the services to the
AMRP and complete the public process
as required only to have received little
or no feedback. Oftentimes, the impact
on beneficiary access in FFS is limited
due to the high managed care
enrollment rates in states, and what
little feedback might have been received
through the public process has been
related to how the proposed changes
would impact managed care. These
experiences have created additional
confusion for states on how to address
the rate reductions within the
requirements of §§ 447.203 and 447.204.
States have questioned the value of
undertaking the rigorous process set out
in those regulations when payment
changes are nominal and unlikely to
diminish access or when the actual
impact of the changes is low relative to
the overall program administration
because most of the state’s beneficiaries
are enrolled with a comprehensive
managed care entity. In those instances,
this rule proposes to relieve states of the
more rigorous regulatory processes,
while reaffirming the need for states to
offer alternative information supporting
compliance with section 1902(a)(30)(A)
of the Act when proposing payment
reductions.
On November 16, 2017, we issued
clarifying guidance to states through a
State Medicaid Director Letter (SMDL
#17–004) interpreting the requirements
at § 447.203(b)(6) to apply only to
payment changes that are more than
nominal and that may result in
circumstances that could diminish
access to care. Within that guidance
letter, we noted several payment
changes that would likely not result in
diminished access to care and, in the
absence of information to the contrary
(for example, high volume of access
complaints), would be exempt from the
special provisions for proposed rate
reductions or restructuring procedures
in § 447.203(b)(6). These include:
Changes made to comply with other
federal requirements, changes where
Medicaid rates continue to be at or
above Medicare or commercial payer
rates, and changes consistent with those
made by the Medicare program. We also
described some nominal payment
adjustments where it may be difficult
for states to determine whether
proposed SPA changes may result in
diminished access. For those changes,
the SMDL advised states to rely on the
public process described in § 447.204(a)
and the associated information received
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from stakeholders as an indicator of
whether a change is likely to diminish
access.
With this proposed rule, we are
proposing to codify an exemption to the
special provisions for proposed rate
reductions or restructuring procedures
in § 447.203(b)(6) for all payment rate
changes where the reduction within a
state plan service category is less than
4 percent of overall spending on the
category within a single SFY and less
than 6 percent over 2 consecutive SFYs.
For example, if a state implements a rate
reduction of 3.5 percent in one SFY and
proposes an additional reduction of 3
percent the following SFY, the proposed
3 percent reduction would not be
considered to be nominal. As discussed
in the SMDL, we generally believed
changes below the 4 percent threshold
to be nominal and unlikely to diminish
access to care but suggested states rely
on the public process to make the
determination. Based on the feedback
we have obtained through the SPA
review process, we continue to believe
that changes below 4 percent are
generally nominal and have found that
such changes do not typically result in
significant access concerns being raised
by providers and other stakeholders. As
such, this proposed rule would go
further by providing an exemption from
all of the procedures described in
§ 447.203(b)(6) for proposed payment
rate reductions within the above
thresholds, even if the state has not
completed the public process described
in § 447.204(a).
In addition to the proposed thresholds
described above, we are proposing to
make an additional modification to the
regulations based on our
implementation experience. Currently,
when a state submits a SPA to us
proposing to reduce or restructure
Medicaid provider payment rates in
circumstances when the changes could
result in diminished access, the state
must submit an analysis of the changes’
effect on access. States have found
considerable difficulty in anticipating
the effects of rate changes on Medicaid
beneficiaries’ access to care. Our
experience has shown that uncertainties
inherent in these analyses have limited
their accuracy and hence their
usefulness. Moreover, the regulations at
§§ 447.203(b)(6)(ii) and 447.203(b)(8)
include considerable protections
through requirements for monitoring
and corrective actions by states to
ensure that access remains
undiminished after a payment rate
change goes into effect (see 80 FR 67595
through 67596), and the utility of an
anticipatory analysis has not been
demonstrated. Recognizing that it is
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challenging for states to accurately
predict the effects of many Medicaid
payment rate changes on beneficiary
access to care, we are proposing to
modify this requirement and, instead,
require states to submit an assurance
that current access is consistent with
requirements of the Act at the time of
the SPA submission, and the baseline
data that supports this assurance. We
will also rely in part on the information
received through the public input
process to help understand the potential
effects of proposed rate changes that
exceed the thresholds proposed in this
proposed rule, and the states’ ongoing
monitoring activities to ensure
beneficiary access to care is maintained.
Importantly, while the SMDL
provided relief to states for the rate
reduction procedures in the regulations,
neither the SMDL nor the policies
discussed in this proposed rule, if
finalized, would exempt states from
their overall obligation to ensure that
Medicaid rates are consistent with
section 1902(a)(30)(A) of the Act, the
public notice requirements in § 447.205,
or the public process for determining
institutional provider payment rates in
section 1903(a)(13)(A) of the Act. As
part of the SPA review process, we
retain the discretion to request that
states provide information that would
allow us to compare the Medicaid
population’s access to care with that of
the general population in the same
geographic area and we will continue to
document whether states have met
applicable public notice and process
requirements in our administrative
records. Additionally, for states that do
not meet the managed care exemption
threshold, we will use the ongoing
AMRP process to help identify and
address potential access issues.
We are still interested in developing
and adopting meaningful access
measures that could apply consistently
regardless of the service delivery
approach used by the state. Our ultimate
goal is to better measure, monitor and
ensure Medicaid access across state
programs and delivery systems. While
there is a longstanding requirement in
42 CFR 431.16 that states are obligated
to provide all reports required by the
Secretary and must follow the
Secretary’s instructions regarding the
form and content of such reports, we are
using this opportunity to state that, in
the future and informed by stakeholder
feedback, we may look to adopt a more
standardized form and content for the
states’ AMRP submissions.
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II. Provisions of the Proposed
Regulations
A. Exemption for States With High
Managed Care Enrollment
We are proposing to amend
§ 447.203(b) to establish a
comprehensive, risk-based managed
care enrollment rate threshold for which
states above the threshold would be
exempt from meeting the requirements
of § 447.203(b)(1) through (6). The
threshold for exemption would be
calculated to include services provided
under comprehensive risk contracts
between a state and a managed care
organization as defined under § 438.2
and any entities required under the
special terms and conditions of an 1115
demonstration to comply with part 438
in the same manner as a managed care
organization. We are proposing an 85
percent threshold, meaning that states
with an overall comprehensive, riskbased managed care enrollment rate of
85 percent or greater would be exempt
from the specified requirements and
would not be required to develop an
AMRP or conduct an access analysis or
add services to the AMRP when
reducing or restructuring provider
payment rates. We chose the 85 percent
threshold based on comments received
in response to the November 2, 2015
final rule with comment period in
which states suggested thresholds
ranging from 75 percent to 95 percent.
We are seeking comment on whether an
85 percent overall threshold is
appropriate, or if the threshold should
be higher, or lower but stratified across
eligibility categories (for example, a 70
percent overall threshold with at least a
50 percent managed care enrollment
rate across all eligibility categories).
We are proposing to require states
with a comprehensive, risk-based
managed care enrollment rate at or
above the threshold to submit to us an
attestation by January 1 of each year.
Because managed care enrollment rates
fluctuate, we are proposing to require
states to attest to meeting the threshold
every year. The attestation would
include the state’s Medicaid managed
care enrollment rate as of July 1st of the
previous year. States that meet the
managed care exemption threshold
would not be required to comply with
the requirements for development and
updating the AMRP for the services
otherwise subject to the requirements
for ongoing review or the special
provisions for proposed provider rate
reductions in § 447.203(b)(1) through
(b)(6) during that calendar year.
Consistent with the proposed changes
to § 447.203(b)(1) through (6), we are
also proposing changes to § 447.204,
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redesignating paragraph (d) to new
paragraph (e), and adding a new
paragraph (d), for states that meet the 85
percent managed care enrollment
threshold. When proposing to reduce or
restructure Medicaid payment rates,
these states would be exempt from the
requirements to consider the data
collected through the AMRP and
undertake a public process that solicits
input on the potential impact of the
proposed rate reduction or restructuring
SPA, and accordingly, would not be
required to include documentation
supporting compliance with the AMRP
review and public process otherwise
required under § 447.204(a) through (c)
with the SPA submission. However,
states are not exempt from the statutory
requirements and, when proposing to
reduce or restructure Medicaid payment
rates in circumstances that may
diminish access, would be required to
present alternative data and analysis,
determined at the discretion of the state,
to support compliance with section
1902(a)(30)(A) of the Act. As such, we
are proposing to include the
requirement for states to submit such
alternative data in § 447.204(d). We are
requesting comments on the types of
alternative data and analysis that states
may present to support compliance with
section 1902(a)(30)(A) of the Act, which
we may use to inform future subregulatory guidance to states.
B. Exemption for Payment Rate Changes
We are proposing to amend
§§ 447.203(b)(6) and 447.204 to set a
threshold for nominal payment rate
changes that are below 4 percent for a
Medicaid service category in total
within a single SFY and 6 percent over
two consecutive SFYs. For purposes of
this proposed rule, service categories are
those generally defined under sections
1905(a)(1) through (29) of the Act (that
is, inpatient hospital services,
outpatient hospital services, other
laboratory and X-ray service, etc.) and
other applicable sections that specify
categories of services eligible for
medical assistance under the State plan.
Such nominal payment rate changes
will not be subject to the special
provisions for rate reductions or
restructuring procedures in
§ 447.203(b)(6), and similarly, states
would not be subject to the
requirements of § 447.204(a) through (c)
when submitting a SPA for such
changes. Additionally, since states may
make rate changes in consecutive years,
we are proposing to limit the exemption
threshold to a 6 percent reduction in
spending for a Medicaid service
category over 2 consecutive SFYs.
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We are requesting comments to
determine whether the nominal
threshold should be higher or lower
than 4 percent for a single SFY and 6
percent for 2 consecutive SFYs,
recognizing that state legislatures need
sufficient flexibility to manage budgets
and make adjustments to Medicaid
spending that are unlikely to result in
diminished access to care for program
beneficiaries. We are proposing to limit
the 4 percent threshold exemption over
a state fiscal year, rather than apply the
4 percent to a single SPA submission,
and to apply the 6 percent threshold as
a cumulative threshold over 2
consecutive SFYs. This means that state
payment rate changes would be
exempted from the special provisions
for proposed rate reductions or
restructuring in § 447.203(b)(6) and the
SPA submission requirements in
§ 447.204(a) through (c) as long as they
do not exceed 4 percent in total
spending for a service category within a
single SFY and 6 percent over 2
consecutive SFYs. We believe this
policy would provide state legislatures
sufficient leeway to make nominal
Medicaid payment changes that,
considering the cumulative effects of the
proposed year-over-year changes, would
be unlikely to have adverse impacts on
Medicaid beneficiaries’ access to care.
We seek comment on these proposals,
including on the potential impacts of
cumulative rate reductions over more
than 2 consecutive SFYs, as well as on
potential alternatives to the 6 percent
threshold and on the 2 consecutive
SFYs timeframe from consideration of
cumulative impacts of year-over-year
changes.
In conjunction with the proposed
changes to § 447.203(b)(6), we are also
proposing changes to § 447.204, to
include in the new paragraph (d) an
exemption for states that are proposing
payment rate reductions below the
threshold of 4 percent within a single
SFY (6 percent over 2 consecutive
SFYs). When submitting such nominal
payment rate reductions, such states
would not be required to consider the
data collected through the AMRP and
undertake a public process that solicits
input on the potential impact of the
proposed rate reduction or restructuring
SPA, and accordingly, would not be
required to include documentation
supporting compliance with the AMRP
review and public process otherwise
required under § 447.204(a) through (c)
with the SPA submission. Although we
are proposing this exemption from the
regulatory requirements at
§§ 447.203(b)(6) and 447.204(a) through
(c) for the proposed SPAs that would
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implement nominal payment rate
reductions, states are not exempt from
the statutory requirements and, when
proposing to reduce or restructure
Medicaid payment rates in
circumstances that may diminish
access, would be required to present
alternative analysis and supporting data,
determined at the discretion of the state,
to demonstrate compliance with section
1902(a)(30)(A) of the Act. Accordingly,
we are proposing to include the
requirement for states to submit such
alternative data in § 447.204(d). We are
requesting comments on the types of
alternative analysis and supporting data
that states may present to demonstrate
compliance with section 1902(a)(30)(A)
of the Act, which we may use to inform
future sub-regulatory guidance to states.
C. Modification of Payment Rate Change
SPA Submission Information
We are proposing to amend
§ 447.204(b)(2) to remove the
requirement that states submit an
analysis of the effect the change in
payment rates will have on access and
instead require that states submit an
assurance and baseline data that
supports the state’s conclusion that
current access is sufficient for the
services impacted by the rate change.
The data will be used as part of the
state’s plan to monitor the effects of the
rate reduction for 3 years following
implementation, when required under
§ 447.203(b)(6). We are proposing this
change because we have determined
that the current requirement of having
states provide an analysis of the effect
that a proposed payment rate reduction
might have on access is of limited
usefulness due to many uncertainties
inherent to such analyses. Therefore, we
believe that having the state submit
baseline data on access to services will
be more helpful to CMS in ensuring that
a state’s proposed payment rate
reductions are consistent with section
1902(a)(30)(A) of the Act.
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 60-day notice
in the Federal Register and solicit
public comment before a collection of
information requirement is submitted to
Office of Management and Budget
(OMB) for review and approval. To
fairly evaluate whether an information
collection 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.
We are soliciting public comment on
each of these issues for the following
sections of this document that contain
proposed information collection
requirements:
• Exemption for States with High
Managed Care Penetration
(§§ 447.203(b) and 447.204(a) through
(c))
• Exemption for Payment Rate Changes
(§§ 447.203(b) and 447.204(a) through
(c))
• Modification of Payment Rate Change
SPA Submission Information
(§ 447.204(b)(2))
A. Wage Estimates
To derive average costs, we used data
from the U.S. Bureau of Labor Statistics’
May 2016 National Occupational
Employment and Wage Estimates for all
salary estimates (https://www.bls.gov/
oes/current/oes_nat.htm). In this regard,
Table 1 presents the mean hourly wage,
the cost of fringe benefits and overhead
(calculated at 100 percent of salary), and
the adjusted hourly wage.
TABLE 1—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES
Occupation
code
Occupation title
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Business Operations Specialist .......................................................................
Computer and Information Analyst ..................................................................
General and Operations Manager ...................................................................
Management Analyst .......................................................................................
Social Science Research Assistant .................................................................
We adjusted our employee hourly
wage estimates by a factor of 100
percent. This was necessarily a 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.
Nonetheless, there was no practical
alternative and we believed that
doubling the hourly wage to estimate
total cost was a reasonably accurate
estimation method.
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13–1000
15–1120
11–1021
13–1111
19–4061
B. Proposed Information Collection
Requirements (ICRs)
1. ICRs Regarding Exemption for States
With High Managed Care Enrollment
(§§ 447.203(b) and 447.204(a) Through
(c))
Current provisions at § 447.203(b)(1)
through (3) require that states develop
and make publicly available an access
monitoring review plan using data
trends and factors that considers:
Beneficiary needs, availability of care
and providers, and changes in
beneficiary utilization of covered
services.
Section 447.203(b)(1) and (2)
describes the minimum factors that
states must consider when developing
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Sfmt 4702
Mean
hourly wage
($/hr)
34.54
44.36
58.70
44.19
22.51
Fringe
benefits and
overhead
($/hr)
34.54
44.36
58.70
44.19
22.51
Adjusted
hourly wage
($/hr)
69.08
88.72
117.40
88.38
45.02
an access monitoring review plan.
Specifically, we require the review to
include: Input from both Medicaid
beneficiaries and Medicaid providers,
an analysis of Medicaid payment data,
and a description of the specific
measures the state will use to analyze
access to care. We require that states use
existing provider feedback mechanisms,
such as medical advisory committees
described in § 431.12, rather than create
new requirements, to avoid placing
unnecessary burden on states.
Section 447.203(b)(3) requires that
states include aggregate percentage
comparisons of Medicaid payment rates
to other public (including, as practical,
Medicaid managed care rates) or private
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health coverage rates within geographic
areas of the state.
Section 447.203(b)(4) describes the
minimum content that must be in
included in the monitoring plan. States
are required to describe: The measures
the state uses to analyze access to care
issues, how the measures relate to the
overarching framework, access issues
that are discovered as a result of the
review, and the state Medicaid agency’s
recommendations on the sufficiency of
access to care based on the review.
Section 447.203(b)(5) describes the
timeframe for states to develop the
access monitoring review plan and
complete the data review for the
following categories of services: Primary
care, physician specialist services,
behavioral health, pre- and post-natal
obstetric services including labor and
delivery, home health, any services for
which the state has submitted a state
plan amendment to reduce or
restructure provider payments which
changes could result in diminished
access, and additional services as
determined necessary by the state or
CMS. While the initial access
monitoring review plans have been
completed, the plan must be updated at
least every 3 years, but no later than
October 1 of the update year.
In our currently approved information
collection request (CMS–10391; OMB
0938–1134), we estimated that the
requirements to develop and make the
access monitoring review plans
publically available under
§ 447.203(b)(1) through (4) for the
specific categories of Medicaid services
will affect each of the 50 state Medicaid
programs and the District of Columbia
(51 total respondents). We estimated it
will take a one-time effort of 5,100 hr to
develop the access monitoring review
plan, 8,160 hr to collect and analyze the
data, and 2,040 to publish the plan and
510 hr for a manager to review and
approve the plan (15,810 total hours at
a cost of $1,197,194.40, or $23,474.40
per state). Since the initial one-time
requirement has been met, and since the
policies in this proposed rule would
create exemptions from certain current
requirements, we are now estimating
this proposed rule as a burden
reduction.
In deriving these figures we used the
following labor rates and time to
complete each task: 80 hr at $45.02/hr
for a research assistant staff to gather
data, 80 hr at $88.72/hr for an
information analyst staff to analyze the
data, 100 hr at $88.38/hr for
management analyst staff to update the
content of the access review monitoring
plan, 40 hr at $69.08/hr for business
operations specialist staff to publish the
access monitoring review plan, and 10
hr at $117.40/hr for managerial staff to
review and approve the access
monitoring review plan.
TABLE 2—ACCESS MONITORING REVIEW PLAN: REDUCED ONE-TIME BURDEN
[per state]
Burden hours
Adjusted
hourly wage
($/hr)
Cost per
monitoring
plan
($/state)
Requirement
Occupation title
Gathering Data ................................................
Analyzing Data ................................................
Developing Content of Access Review Monitoring Plan.
Publishing Access Review Monitoring Plan ...
Reviewing and Approving Access Review
Monitoring Plan.
Social Science Research Assistant ...............
Computer and Information Analyst ................
Management Analyst .....................................
(80)
(80)
(100)
45.02
88.72
88.38
(3,601.60)
(7,097.60)
(8,838.00)
Business Operations Specialist .....................
General and Operations Manager .................
(40)
(10)
69.08
117.40
(2,763.20)
(1,174.00)
Total .........................................................
.........................................................................
(310)
varies
(23,474.40)
TABLE 3—ACCESS MONITORING REVIEW PLAN: REDUCED ONE-TIME BURDEN
[Total]
Cost of review
per state
($)
Total hours
(51) .....................................
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Anticipated number of
state reviews
(15,810) [¥310 hr × 51 reviews] ............................................................................
Based on this rule’s proposed
exemption for states with managed care
enrollment rates at or above 85 percent,
we are adjusting our on-going access
monitoring review plan burden by
reducing the number of states (and DC)
by 17, from 51 to 34 states, because as
of July 2016, we estimate that 17 states
had a managed care enrollment rate of
at least 85 percent and would therefore
meet the threshold for an exemption
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based on high managed care enrollment.
We relied on data from the Kaiser
Family Foundation website (https://
www.kff.org/data-collection/medicaidmanaged-care-market-tracker/) to arrive
at the estimates, although we note that
we will rely upon state attestations of
meeting or exceeding the enrollment
rate threshold to administer the
exemption. Consistent with our
currently approved estimates, we
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(23,474.40)
Total cost
estimate
($)
(1,197,194.40)
continue to anticipate that the average
ongoing burden is likely to be the same
as the average initial burden estimates
since states will need to re-run the data,
determine whether to add or drop
measures, consider public feedback, and
write-up new conclusions based on the
information they review. In this regard,
we estimate that the exemption would
reduce our estimates by 5,270 hr (from
15,810 hr to 10,540 hr) and $399,064.80.
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TABLE 4—ACCESS MONITORING REVIEW PLAN: REDUCED ON-GOING BURDEN
Cost of review
per state
($)
Anticipated number of
state reviews
Total hours
(17) .....................................
(5,270) (¥310 hr × 17 reviews) .............................................................................
In lieu of developing and updating the
access monitoring review plan for the
services subject to the ongoing review or
for proposed provider rate reductions or
payment restructurings that could result
in diminished access, this rule proposes
that states seeking an exemption from
those requirements based on having a
comprehensive risk-based managed care
enrollment rate at or above 85 percent
must submit an annual attestation of its
Medicaid managed care enrollment rate
as of July 1 of the previous year to CMS.
We anticipate states will use the same
enrollment data required to be
monitored under § 438.66 and included
in the currently approved information
collection request (CMS–10108; OMB
0938–0920) as a basis for the annual
attestation. As such, we estimate the
(23,474.40)
Total cost
estimate
($)
(399,064.80)
burden associated with the annual
attestation to be 0.5 hr at $117.40/hr for
a General and Operations Manager to
develop the attestation document and
submit it to CMS. In aggregate, we
estimate an annual burden of 8.5 hr (0.5
hr × 17 respondents) at a cost of $997.90
(8.5 hr × $117.40/hr) or $58.70 per
respondent.
TABLE 5—ANNUAL ATTESTATION ON-GOING BURDEN
Cost of
review per
state
($)
Anticipated number of state reviews
Total hours
17 ..................................................................................
8.5 (0.5 hr × 17 reviews) ..............................................
The revised requirements and burden
will be submitted to OMB for approval
under control number 0938–1134
(CMS–10391).
2. ICRs Regarding Exemption for
Payment Rate Changes (§§ 447.203(b)(6)
and 447.204(a) Through (c))
Section 447.203(b)(6)(ii) requires
states to have procedures within the
access monitoring review plan to
monitor continued access after
implementation of a SPA that reduces or
restructures payment rates. The
monitoring procedures must be in place
for at least 3 years following the
effective date of the SPA. The ongoing
burden associated with the
requirements under § 447.203(b)(6)(ii) is
the time and effort it would take each
of the state Medicaid programs to
monitor continued access following the
implementation of a SPA that reduces or
restructures payment rates.
For provider rate reductions to a
service category that are below 4 percent
per state fiscal year, and below 6
percent across two consecutive state
fiscal years, the proposed changes to
§ 447.203(b)(6)(i) would exempt states
from the analysis and monitoring
procedures described in
§ 447.203(b)(6)(ii).
In our currently approved information
collection request (CMS–10391; OMB
0938–1134), we estimated that in each
SPA submission cycle, states would
submit 22 SPAs to implement rate
changes or restructure provider
payments based on the number of
submissions received in FY 2010.
Total cost
estimate
($)
58.70
997.90
We estimated that it would take, on
average, 880 hr to develop the
monitoring procedures, 528 hr to
periodically review the monitoring
results, and 66 hr for review and
approval of the monitoring procedures
(1,474 total hours). We also estimated an
average cost of $6,008.52 per state and
$132,187.44 (total).
In deriving these figures we used the
following labor rates and time to
complete each task: 40 hr at $88.38/hr
for management analyst staff to develop
the monitoring procedures, 24 hr at
$88.38/hr for management analyst staff
to periodically review the monitoring
results, and 3 hr at $117.40/hr for
management staff to review and approve
the monitoring procedures.
TABLE 6—ACCESS MONITORING PROCEDURES FOLLOWING RATE REDUCTION SPA—BURDEN PER STATE
[Annual]
Cost per data
review
($/state)
Develop Monitoring Procedures .....................
Periodically Review Monitoring Results ..........
Approve Monitoring Procedures .....................
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Occupation title
Management Analyst .....................................
Management Analyst .....................................
General and Operations Manager .................
40
24
3
88.38
88.38
117.40
3,535.20
2,121.12
352.20
Total .........................................................
.........................................................................
67
varies
6,008.52
We are revising our estimates based
on more current data that we collected
during the 2016 submission cycle and
reducing the burden hours to account
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Burden hours
Adjusted
hourly wage
($/hr)
Requirement
for the proposed managed care
enrollment rate exemption and
threshold for payment rate reductions.
During the 2016 submission cycle, we
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received approximately 23 payment rate
change submissions from nine states
that would have fallen under the
monitoring procedure’s information
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collection burden, which is generally
consistent with our currently approved
burden estimates.
Of the 23 submissions, 9 would meet
the exemption criteria for states with
managed care enrollment rates at or
above 85 percent. For the remaining 14
submissions, we believe 4 may have
fallen below the 4 percent threshold for
overall spending within the service
category exemption for a single state
fiscal year, and 6 percent for two
consecutive state fiscal years based on
information provided by the state
during the SPA review process. Based
on the proposed exemptions process, we
are reducing our original estimated
number of SPA submissions from 22 to
10. We note that there is some
variability in state SPA submissions
from year-to-year and the number of rate
reduction SPAs that states submit to
CMS for approval.
TABLE 7—REVISED ACCESS MONITORING PROCEDURES FOLLOWING RATE REDUCTION SPA—TOTAL BURDEN
[Annual]
Cost of review
per state
($)
Anticipated number of state reviews
Total hours
(12) ...............................................................................
(804) [¥67 hr × 12 responses] ....................................
The revised requirements and burden
will be submitted to OMB for approval
under control number 0938–1134
(CMS–10391).
3. ICRs Regarding Modification of
Payment Rate Change SPA Submission
Information (§ 447.204(b)(2))
Section 447.204(b)(2) requires states
to include specific documentation to
demonstrate access when submitting a
SPA that proposes to reduce or
restructure payment rates. Included in
the documentation, states are required
to submit a copy of its most recent
access monitoring review plan that
(6,008.52)
Total cost
estimate
($)
(72,102.24)
access is consistent with requirements
of the Act. We do not anticipate there
will be any changes in burden based on
the proposal since it would merely
change the expectation for the type of
conclusion that the state will draw
using its analysis from one that
anticipates future access to one that
infers access is currently sufficient.
The revised requirement will be
submitted to OMB for approval under
control number 0938–1134 (CMS–
10391).
includes the services for which payment
is being reduced or restructured and an
analysis of the effect of the changes in
payment rates on access. The burden
associated with such submission is
included under § 447.203(b)(1) (see
above) for ongoing access monitoring
review plan (reduction of 10,540 hr).
We are proposing to modify the
requirement in § 447.204(b)(2) so that
states will no longer be required to
predict the effect the payment rate
change will have on access, and will
instead be required to submit to CMS an
assurance that data indicates current
C. Summary of Proposed Information
Collection Requirements and Burden
TABLE 8—PROPOSED ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS UNDER
OMB CONTROL NUMBER 0938–1134
[CMS–10391]
Regulatory section(s) in Title 42 of the CFR
Respondents
Burden per
response
(hr)
Responses
Total annual
burden
(hr)
(51)
(17)
17
(51)
(17)
17
(12)
(12)
(67)
(804)
varies
(72,102)
Total ...................................................................................
(34)
(34)
(561.5)
(21,808.5)
varies
(1,667,363)
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We have submitted a copy of this
proposed rule to OMB for its review of
the rule’s information collection and
recordkeeping requirements. The
requirements are not effective, if
finalized, until they have been approved
by OMB.
We invite public comments on these
information collection requirements,
and particularly on submission
frequency and burden hours per
response. If you wish to comment,
please identify the rule (CMS–2406–P)
and, where applicable, the ICR’s CFR
citation, CMS ID number, and OMB
control number.
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To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.gov/Regulations-andGuidance/Legislation/Paperwork
ReductionActof1995/PRA-Listing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
See this rule’s DATES and ADDRESSES
sections for the comment due date and
for additional instructions.
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(15,810)
(5,270)
8.5
varies
varies
117.40
Total cost
($)
§ 447.203(b)(1)–(4) (one time requirement) ..............................
§ 447.203(b)(1)–(4) (on-going requirement) ..............................
§ 447.203(b) (attestation) ..........................................................
§ 447.203(b)(6) (monitoring following rate reduction/restructuring) .....................................................................................
D. Submission of PRA-Related
Comments
(310)
(310)
0.5
Labor cost
($/hr)
(1,197,194)
(399,065)
998
IV. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
V. Regulatory Impact Analysis
A. Statement of Need
This proposed rule impacts states’
documentation of compliance with
section 1902(a)(30)(A) of the Act. This
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proposed rule would provide burden
relief to states with comprehensive, riskbased managed care enrollment rates
above 85 percent of the total covered
Medicaid population within a state’s
Medicaid program and states making
rate reductions to services below a
threshold of 4 percent of overall
Medicaid spending within a service
category (for example, physician
services) within a single SFY and 6
percent over 2 consecutive SFYs by
exempting them from certain processes
described in §§ 447.203 and 447.204.
This proposed rule also would modify
the requirements at § 447.204(b)(2) so
that states must submit to CMS with
SPAs that reduce or restructure
Medicaid payment rates an assurance
that the current baseline data indicates
access is consistent with the Act, rather
than an analysis anticipating the effects
of a proposed change in payment rates.
B. Overall Impact
We have examined the impacts of this
proposed 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), section 1102(b) of
the Act, section 202 of the Unfunded
Mandates Reform Act of 1995 (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).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Section 3(f) of Executive Order
12866 defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule: (1) Having an annual
effect on the economy of $100 million
or more in any 1 year, or adversely and
materially affecting a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or state, local or tribal
governments or communities (also
referred to as ‘‘economically
significant’’); (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlement
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grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
A regulatory impact analysis (RIA)
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). This
proposed rule is not economically
significant with an overall estimated
reduced economic reporting burden of
$449,961.
C. Anticipated Effects
1. Effects on State Medicaid Programs
We anticipate effects on state
Medicaid programs that have high
comprehensive, risk-based managed
care enrollment rates and that make
adjustments to their Medicaid payment
rates that are unlikely to diminish
access to care. States with
comprehensive, risk-based managed
care enrollment rates of 85 percent or
above would no longer be required to
maintain and update the access
monitoring review plans required under
the regulations. In addition, states that
make nominal changes to their
Medicaid payment rates, defined below
4 percent for a SFY and 6 percent for 2
consecutive SFYs, would no longer be
required to conduct monitoring
activities described in the regulations
related to those SPA changes.
Importantly, the provisions of this
proposed rule provide exemptions to
the regulatory procedure requirements
for demonstrating access to care.
However, states are not exempt from the
statutory requirements described at
section 1902(a)(30)(A) of the Act and
must have alternative approaches to
ensure access is consistent with the Act
when reducing Medicaid payment rates.
2. Effects on Small Business and
Providers
We anticipate some effects on small
businesses and providers that reside in
states that meet the exemption criteria
described in the proposed rule but only
to the extent that we would have
disapproved a SPA based on the
information required for submission
through the regulations. As the
exemptions proposed in the proposed
rule are either for states with relatively
low fee-for-service delivery (and related
expenditures) and for nominal payment
rate changes, we do not anticipate the
effects will be significant.
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3. Effects on the Medicaid Program
The estimated fiscal impact on the
Medicaid program from the
implementation of the proposed rule is
estimated to be a net savings to
Medicaid state agencies. These
estimates are based on our estimation
that 17 states will no longer be required
to maintain and update the AMRPs and
the approximate number annual SPAs
requiring access monitoring will be
reduced by 11. This will have a
relatively minor effect on state
administrative expenditures, with a
total anticipated reduction in spending
of $1,667,363. However, states have
raised significant concerns over the
administrative burden and associated
benefits to complying with the
regulatory requirements both when the
majority of Medicaid beneficiaries are
served through managed care and when
making minor adjustments to Medicaid
payments that they believe are unlikely
to diminish access to care.
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. The great majority of hospitals
and most other health care providers
and suppliers are small entities, either
by being nonprofit organizations or by
meeting the SBA definition of a small
business (having revenues of less than
$7.5 million to $38.5 million in any one
year). Individuals and states are not
included in the definition of a small
entity. As previously stated, we do not
anticipate any effect on small entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 603 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a metropolitan statistical area and has
fewer than 100 beds. This rule will not
have a significant impact on the
operations of a substantial number of
small rural hospitals.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2017, that
threshold is approximately $148
million. This rule does not contain
mandates that will impose spending
costs on state, local, or tribal
governments in the aggregate, or by the
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Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Proposed Rules
private sector, in excess of the
threshold.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it issues a proposed
rule that imposes substantial direct
requirement costs on state and local
governments, preempts state law, or
otherwise has Federalism implications.
This rule does not have a substantial
impact on state or local governments.
amozie on DSK30RV082PROD with PROPOSALS
D. Alternatives Considered
In developing this rule, the following
alternatives were considered:
1. We considered proposing a
managed care enrollment exemption
threshold at or above 70 percent but, in
reviewing programmatic data, we
discovered that the rate of managed care
coverage can vary significantly based on
category of Medicaid eligibility. For
instance, while many states would meet
the 70 percent threshold, the rate of
managed care coverage for certain
populations may fall well below 50
percent. This is frequently the case for
individuals who are eligible based on a
combination of income and age or as a
result of disability. The disproportion of
coverage based on eligibility appears
significantly less with an exemption
threshold at or above 85 percent,
therefore the proposed rule would set
such a limit. However, we are
requesting comments on the exemption
threshold and whether additional
considerations, discussed in more detail
above, may be applied to allow a lower
threshold.
2. In codifying the 4 percent
exemption for access monitoring, we
considered whether the exemption
percentage was too low or too high. As
described in our SMDL on this matter,
we believe that rate changes below a 4
percent threshold are unlikely to
diminish access to care and generally
the benefits of monitoring access for
such reductions are not consistent with
the administrative burden associated
with monitoring. We are requesting
comment on whether 4 percent is too
high or low, but determine 4 percent to
be appropriate for purposes of the
proposed rule. We also considered
applying the 4 percent exemption
threshold annually but, in evaluating
the potential cumulative effects of yearover-year rate reductions, proposed a 6
percent threshold over 2 SFYs. We
request comment on consideration of
cumulative impacts, including the 6
percent threshold amount and 2 SFYs
timeframe.
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18:37 Mar 22, 2018
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E. Reducing Regulation and Controlling
Regulatory Costs
Executive Order 13771, titled
Reducing Regulation and Controlling
Regulatory Costs, was issued on January
30, 2017. This proposed rule is expected
to be an E.O. 13771 deregulatory action.
Details on the $1.66 million estimated
cost savings of this rule can be found in
the preceding analyses.
G. Conclusion
In accordance with the provisions of
Executive Order 12866, this proposed
rule was reviewed by the Office of
Management and Budget.
List of Subjects in 42 CFR Part 447
Accounting, Administrative practice
and procedure, Drugs, Grant programs—
health, Health facilities, Health
professions, Medicaid, Reporting and
recordkeeping requirements, and Rural
areas.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR chapter IV as set forth below:
PART 447—PAYMENTS FOR
SERVICES
1. The authority citation for part 447
continues to read as follows:
■
Authority: Sec. 1102 of the Social Security
Act (42 U.S.C. 1302).
2. Section 447.203 is amended by
revising paragraphs (b) introductory
text, (b)(6)(i) and (ii) to read as follows:
■
§ 447.203 Documentation of access to care
and service payment rates.
*
*
*
*
*
(b) In consultation with the medical
care advisory committee under § 431.12
of this chapter, the agency must develop
a medical assistance access monitoring
review plan and update it, in
accordance with the timeline
established in paragraph (b)(5) of this
section and with procedures established
by CMS. The plan must be published
and made available to the public for
review and comment for a period of no
less than 30 days, prior to being
finalized and submitted to CMS for
review. States that have for all eligibility
groups combined at least 85 percent of
beneficiaries enrolled in Medicaid
managed care organizations, as defined
in § 438.2 of this chapter, and including
section 1115 demonstration populations
enrolled under such comprehensive risk
contracts, are not required to meet the
requirements under paragraphs (b)(1)
through (6) of this section. Any state
seeking an exemption based on an
overall Medicaid managed care
enrollment of 85 percent or higher must
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12705
submit an annual attestation of its
Medicaid managed care enrollment rate
as of July 1 of the previous year to CMS.
In lieu of the requirements under
paragraph (b)(6) of this section, States
that have overall Medicaid managed
care enrollment of at least 85 percent for
the calendar year, must submit an
alternative analysis and certification,
including the data and other
information on which the analysis and
certification are based, that demonstrate
compliance with section 1902(a)(30)(A)
of the Act.
*
*
*
*
*
(6) * * *
(i) Compliance with access
requirements. The State shall submit
with any State plan amendment that
proposes to reduce provider payments
by greater than 4 percent in overall
service category spending in a State
fiscal year or greater than 6 percent
across two consecutive State fiscal
years, or restructure provider payments
in circumstances when the changes
could result in diminished access, an
access review, in accordance with the
access monitoring review plan, for each
service affected by the State plan
amendments as described under
paragraph (b)(1) of this section
completed within the prior 12 months.
That access review must demonstrate
sufficient access for any service for
which the State agency proposes to
reduce payment rates or restructure
provider payments to demonstrate
compliance with the access
requirements at section 1902(a)(30)(A)
of the Act.
(ii) Monitoring procedures. In
addition to the analysis conducted
through paragraphs (b)(1) through (4) of
this section that demonstrates access to
care is sufficient as of the effective date
of the State plan amendment, for any
State plan amendment that reduces
provider payment greater than 4 percent
in overall service category spending in
a State fiscal year or greater than 6
percent across two consecutive State
fiscal years, or restructures provider
payments in circumstances when the
changes could result in diminished
access, the state must establish
procedures in its access monitoring
review plan to monitor continued access
to care after implementation of state
plan service rate reduction or payment
restructuring. The frequency of
monitoring should be informed by the
public review described in paragraph (b)
of this section and should be conducted
no less frequently than annually.
*
*
*
*
*
■ 3. Section 447.204 is amended by—
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Federal Register / Vol. 83, No. 57 / Friday, March 23, 2018 / Proposed Rules
a. Revising paragraphs (a)
introductory text, (b) introductory text,
(b)(2), and (c).
■ b. Redesignating paragraph (d) as
paragraph (e).
■ c. Adding new paragraph (d).
The revisions and addition read as
follows:
■
amozie on DSK30RV082PROD with PROPOSALS
§ 447.204 Medicaid provider participation
and public process to inform access to
care.
(a) The agency’s payments must be
consistent with efficiency, economy,
and quality of care and sufficient to
enlist enough providers so that services
under the plan are available to
beneficiaries at least to the extent that
those services are available to the
general population. Except as provided
in paragraph (d) of this section, in
reviewing payment sufficiency, states
are required to consider, prior to the
submission of any state plan
amendment that proposes to reduce or
restructure Medicaid service payment
rates:
*
*
*
*
*
(b) Except as provided in paragraph
(d) of this section, the State must submit
to CMS with any such proposed State
plan amendment affecting payment
rates:
*
*
*
*
*
(2) An assurance that access to care is
sufficient in accordance with section
1902(a)(30)(A) of the Act, and baseline
data to support this conclusion; and
*
*
*
*
*
(c) Except as provided in paragraph
(d) of this section, CMS may disapprove
a proposed state plan amendment
affecting payment rates if the state does
not include in its submission the
supporting documentation described in
paragraph (b) of this section, for failure
to document compliance with statutory
access requirements. Any such
disapproval would follow the
procedures described at part 430
Subpart B of this title.
(d) Paragraphs (a) through (c) of this
section shall not apply in the case of a
state that is not required to meet the
requirements of § 447.203(b)(1) through
(b)(6) because the state has Medicaid
managed care enrollment of at least 85
percent, as described in § 447.203(b), or
in the case of a proposed State plan
amendment that reduces provider
payment rates by no more than 4
percent in any State fiscal year, and no
more than 6 percent across two
consecutive State fiscal years. In lieu of
the requirements under paragraphs (a)
though (c) of this section, States that are
not required to meet these requirements
pursuant to this paragraph must submit
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18:37 Mar 22, 2018
Jkt 244001
to CMS an alternative analysis, along
with supporting data, to demonstrate
compliance with section 1902(a)(30)(A)
of the Act when submitting a state plan
amendment that proposes to reduce or
restructure Medicaid service payment
rates in circumstances that may
diminish access to care.
*
*
*
*
*
Dated: March 1, 2018.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: March 16, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2018–05898 Filed 3–22–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 180123065–8065–01]
RIN 0648–XF989
Magnuson-Stevens Act Provisions;
Fisheries of the Northeastern United
States; Northeast Multispecies
Fishery; 2018 Allocation of Northeast
Multispecies Annual Catch
Entitlements and a Proposed
Regulatory Exemption for Sectors
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
This rulemaking proposes
allocations of annual catch entitlements
to groundfish sectors for the 2018
fishing year and also proposes a new
regulatory exemption for sectors. The
action is necessary because sectors must
receive allocations in order to operate.
This action is intended to ensure sector
allocations are based on the best
scientific information available and help
achieve optimum yield for the fishery.
DATES: Comments must be received on
or before April 9, 2018.
ADDRESSES: You may submit comments
on this document, identified by NOAA–
NMFS–2018–0039, by either of the
following methods:
• Electronic Submission: Submit all
electronic public comments via the
Federal e-Rulemaking Portal. Go to
www.regulations.gov/
#!docketDetail;D=NOAA-NMFS-2018SUMMARY:
PO 00000
Frm 00019
Fmt 4702
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0039, click the ‘‘Comment Now!’’ icon,
complete the required fields, and enter
or attach your comments.
• Mail: Submit written comments to
Michael Pentony, Regional
Administrator, 55 Great Republic Drive,
Gloucester, MA 01930. Mark the outside
of the envelope, ‘‘Comments on the
2018 Sector Allocations.’’
Instructions: Comments sent by any
other method, to any other address or
individual, or received after the end of
the comment period, may not be
considered by NMFS. All comments
received are a part of the public record
and will generally be posted for public
viewing on www.regulations.gov
without change. All personal identifying
information (e.g., name, address, etc.),
confidential business information, or
otherwise sensitive information
submitted voluntarily by the sender will
be publicly accessible. NMFS will
accept anonymous comments (enter ‘‘N/
A’’ in the required fields if you wish to
remain anonymous).
Copies of each sector’s operations
plan and contract, as well as the
programmatic environmental
assessment for sectors operations in
fishing years 2015 to 2020, are available
from the NMFS Greater Atlantic
Regional Fisheries Office (GARFO):
Michael Pentony, Regional
Administrator, National Marine
Fisheries Service, 55 Great Republic
Drive, Gloucester, MA 01930. These
documents are also accessible via the
GARFO website: https://www.greater
atlantic.fisheries.noaa.gov/.
FOR FURTHER INFORMATION CONTACT: Kyle
Molton, Fishery Management Specialist,
(978) 281–9236.
SUPPLEMENTARY INFORMATION:
Background
The Northeast multispecies
(groundfish) sector management system
allocates a portion of available
groundfish catch by stock to each sector.
Each sector’s annual allocations are
known as annual catch entitlements
(ACE) and are based on the collective
fishing history of a sector’s members.
The ACEs are a portion of a stock’s
annual catch limit (ACL) available to
commercial groundfish vessels. A sector
determines how to harvest its ACEs and
may decide to limit operations to fewer
vessels. Atlantic halibut, windowpane
flounder, Atlantic wolffish, and ocean
pout are not managed under the sector
system, and sectors do not receive
allocations of these groundfish species.
With the exception of halibut that has
a 1-fish per vessel trip limit, possession
of these stocks is prohibited.
Because sectors elect to receive an
allocation under a quota-based system,
E:\FR\FM\23MRP1.SGM
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Agencies
[Federal Register Volume 83, Number 57 (Friday, March 23, 2018)]
[Proposed Rules]
[Pages 12696-12706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05898]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 447
[CMS-2406-P]
RIN 0938-AT41
Medicaid Program; Methods for Assuring Access to Covered Medicaid
Services--Exemptions for States With High Managed Care Penetration
Rates and Rate Reduction Threshold
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would amend the process for states to
document whether Medicaid payments in fee-for-service systems are
sufficient to enlist providers to assure beneficiary access to covered
care and services consistent with the statute. States have raised
concerns over the administrative burden associated with the current
requirements, particularly for states with high rates of Medicaid
managed care enrollment. This proposed rule would provide burden relief
and address those concerns.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on May 22, 2018.
ADDRESSES: In commenting, please refer to file code CMS-2406-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-2406-P, P.O. Box 8016,
Baltimore, MD 21244-8016. Please allow sufficient time for mailed
comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-2406-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Jeremy Silanskis, (410) 786-1592,
[email protected].
SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments
received before the close of the comment period are available for
viewing by the public, including any personally identifiable or
confidential business information that is included in a comment. We
post all comments received before the close of the comment period on
the following website as soon as possible after they have been
received: https://www.regulations.gov. Follow the search instructions on
that website to view public comments.
I. Executive Summary and Background
A. Executive Summary
1. Purpose
Current regulations at 42 CFR 447.203(b) require states to develop
and submit to CMS an access monitoring review plan (AMRP) for Medicaid
services provided through a fee-for-service (FFS) delivery system. The
AMRP must be updated at least every 3 years and address the following
categories of Medicaid services: Primary care services (including those
provided by a physician, federally qualified health center (FQHC),
clinic or dental care); physician specialist services (for example,
cardiology, radiology, urology); behavioral health services (including
mental health and substance use disorder); pre- and post-natal
obstetric services (including labor and delivery); and home health. The
AMRP must identify a data-driven process to review access to care and
address: The extent to which beneficiary needs are fully met; the
availability of care through enrolled providers; and changes in
beneficiary service utilization. Additionally, when states reduce rates
for other Medicaid services, they must add those services to the AMRP
and monitor the effects of the rate reductions for 3 years. Section
447.204 requires states to undertake a public process and submit
specific information regarding access to care when proposing to reduce
or restructure Medicaid provider payment rates. This proposed rule
would provide an exemption to the regulatory requirements in Sec. Sec.
447.203(b)(1) through (6) and 447.204(a) through (c) for states with
comprehensive, risk-based Medicaid managed care enrollment rates above
85 percent of the total covered population under a state's Medicaid
program, including managed care comprehensive risk contracts under a
state's section 1115 Medicaid demonstration. The proposed rule would
also provide an exemption to the regulatory requirements in Sec. Sec.
447.203(b)(6) and 447.204(a) through (c) for states that submit state
plan amendments (SPAs) to reduce rates or restructure payments where
the overall reduction is 4 percent or less of overall spending within
the affected state plan service category for a single state fiscal year
(SFY) and 6 percent or less over 2 consecutive SFYs. Additionally, the
proposed rule would modify the requirements in Sec. 447.204(b)(2) so
that, for SPAs that reduce or restructure Medicaid payment rates,
states would be required to submit to CMS an assurance that data
indicates current access is consistent with
[[Page 12697]]
requirements of the Social Security Act (the Act) instead of an
analysis anticipating the effects of a proposed change in payment rates
or structure.
B. Background
Section 1902(a)(30)(A) of the Act requires states to ``assure that
payments are consistent with efficiency, economy, and quality of care
and are sufficient to enlist enough providers so that care and services
are available under the plan at least to the extent that such care and
services are available to the general population in the geographic
area.'' Until 2011, we had not defined through federal regulation a
framework to guide states in meeting this statutory requirement and
reviewed state proposals to reduce provider payment rates on a case-by-
case basis. We historically relied on state certifications and
available supporting information that reductions in Medicaid payments
met the statutory standards.
In the November 2, 2015 Federal Register (80 FR 67576) we published
the ``Methods for Assuring Access to Covered Medicaid Services'' final
rule with comment period that outlined a data-driven process for states
to document whether Medicaid payments are sufficient to enlist
providers to assure beneficiary access to covered care and services
consistent with section 1902(a)(30)(A) of the Act. The final rule with
comment period included a new Sec. 447.203(b)(1) through (8) and
revisions to Sec. 447.204. These regulations established that states
must develop and submit to CMS an AMRP, that is updated at least every
3 years, for the following services: (1) Primary care (including those
provided by a physician, FQHC, clinic or dental care); (2) physician
specialist services (for example, cardiology, urology, radiology); (3)
behavioral health services (including mental health and substance use
disorder); (4) pre- and post-natal obstetric services, (including labor
and delivery); (5) home health services; (6) any additional types of
services for which a review is required under Sec. 447.203(b)(6)
because of a proposed payment rate reduction or restructuring; (7)
additional types of services for which the state or CMS has received a
significantly higher than usual volume of beneficiary, provider or
other stakeholder access complaints for a geographic area; and (8)
additional types of services selected by the state.
The AMRP must document the state's consideration of access to care
in setting and adjusting payment methodologies for Medicaid services
and in informing state policies affecting access to Medicaid services.
The state must address, through data driven analysis: The extent to
which beneficiary needs are fully met; the availability of care through
enrolled providers; changes in beneficiary service utilization; the
characteristics of the beneficiary population (including considerations
for care, service and payment variations for pediatric and adult
populations and for individuals with disabilities); and actual or
estimated levels of provider payment available from other payers,
including other public and private payers. Additionally, Sec.
447.203(b)(6) requires a state to add services to its AMRP when
reducing payment rates or restructuring provider payment for such
Medicaid services in circumstances when the changes could result in
diminished access, as well as to develop a plan to monitor the effects
of the rate reduction or restructuring for at least 3 years.
Furthermore, under Sec. 447.204(a) through (c), when proposing to
reduce or restructure Medicaid payment rates, states must consider the
data collected through the AMRP and undertake a public process that
solicits input on the potential impact of proposed reduction or
restructuring of Medicaid payment rates on beneficiary access to care.
States must submit related analysis to CMS along with any proposed rate
reduction or restructuring SPA, and we may disapprove such a proposed
SPA that does not include documentation supporting compliance with the
required AMRP review and public process.
In the November 2, 2015 final rule with comment period, we
solicited comments on Sec. 447.203(b)(5), concerning the access
monitoring review plan timeframe. Specifically, we solicited comments
on the scope of services that should be subject to ongoing review under
the AMRP, the required elements of review, whether we should allow
exemptions from certain requirements of the final rule based on state
program characteristics (for example, high managed care enrollment),
and the timeframe for submission. In response to the comments we
received, in the April 12, 2016 Federal Register (81 FR 21479), we
published the ``Deadline for Access Monitoring Review Plan
Submissions'' final rule in which we extended the deadline for initial
AMRP submissions to October 1, 2016. Although we received numerous
comments on the issue of whether states with high managed care
enrollment should be exempt from the requirements of the final rule, we
did not include such an exemption in the April 12, 2016 final rule
because we believed that further experience with the access monitoring
review process was necessary to determine the appropriate circumstances
for exemptions. We have considered the comments received in response to
the November 2, 2015 final rule with comment period at (https://www.regulations.gov/document?D=CMS-2011-0062-0188) in the development
of this proposed rule.
The initial AMRP submissions were due to us on October 1, 2016. We
received AMRP submissions from all states, and the submissions are
available on Medicaid.gov (https://www.medicaid.gov/medicaid/access-to-care/review-plans/). During the initial year of
implementation, a number of states expressed concern regarding the
administrative burden associated with the requirements of Sec.
447.203, particularly those states with a very high beneficiary
enrollment in comprehensive, risk-based managed care and a limited
number of beneficiaries receiving care through a fee-for-service
delivery system. Based on our experience in reviewing the AMRPs and
working with states with high beneficiary enrollment in comprehensive,
risk-based managed care, we now believe we have sufficient experience
to establish a threshold for such states to be exempt from meeting
certain access monitoring review requirements, and are proposing
additional modifications to the regulations to ease the administrative
burden on states that are proposing certain payment rate reductions.
Although this proposed rule would establish such thresholds, states
are still obligated by the statute to ensure Medicaid payment rates are
sufficient to enlist enough providers to assure that beneficiary access
to covered care and services is at least consistent with that of the
general population in the same geographic area, particularly when
reducing or restructuring Medicaid payment rates through SPAs. In lieu
of the requirements set forth in Sec. 447.203(b)(6), we are proposing
that states that meet the high managed care enrollment exemption
threshold under this proposed rule would be permitted to submit
alternate information and analysis, as determined by the state, when
proposing payment rate reductions, to support compliance with section
1902(a)(30)(A) of the Act.
Our implementation experience has also created questions about the
benefit of requiring states to conduct a public process and access
analysis for every change in Medicaid payment rates or structure that
results in a reduction to provider payments, including those nominal
rate reductions that are unlikely to result in diminished access.
[[Page 12698]]
We have worked with a number of states that, over the past 2 years,
have proposed relatively small payment rate reductions and have
expended staff resources to add the services to the AMRP and complete
the public process as required only to have received little or no
feedback. Oftentimes, the impact on beneficiary access in FFS is
limited due to the high managed care enrollment rates in states, and
what little feedback might have been received through the public
process has been related to how the proposed changes would impact
managed care. These experiences have created additional confusion for
states on how to address the rate reductions within the requirements of
Sec. Sec. 447.203 and 447.204. States have questioned the value of
undertaking the rigorous process set out in those regulations when
payment changes are nominal and unlikely to diminish access or when the
actual impact of the changes is low relative to the overall program
administration because most of the state's beneficiaries are enrolled
with a comprehensive managed care entity. In those instances, this rule
proposes to relieve states of the more rigorous regulatory processes,
while reaffirming the need for states to offer alternative information
supporting compliance with section 1902(a)(30)(A) of the Act when
proposing payment reductions.
On November 16, 2017, we issued clarifying guidance to states
through a State Medicaid Director Letter (SMDL #17-004) interpreting
the requirements at Sec. 447.203(b)(6) to apply only to payment
changes that are more than nominal and that may result in circumstances
that could diminish access to care. Within that guidance letter, we
noted several payment changes that would likely not result in
diminished access to care and, in the absence of information to the
contrary (for example, high volume of access complaints), would be
exempt from the special provisions for proposed rate reductions or
restructuring procedures in Sec. 447.203(b)(6). These include: Changes
made to comply with other federal requirements, changes where Medicaid
rates continue to be at or above Medicare or commercial payer rates,
and changes consistent with those made by the Medicare program. We also
described some nominal payment adjustments where it may be difficult
for states to determine whether proposed SPA changes may result in
diminished access. For those changes, the SMDL advised states to rely
on the public process described in Sec. 447.204(a) and the associated
information received from stakeholders as an indicator of whether a
change is likely to diminish access.
With this proposed rule, we are proposing to codify an exemption to
the special provisions for proposed rate reductions or restructuring
procedures in Sec. 447.203(b)(6) for all payment rate changes where
the reduction within a state plan service category is less than 4
percent of overall spending on the category within a single SFY and
less than 6 percent over 2 consecutive SFYs. For example, if a state
implements a rate reduction of 3.5 percent in one SFY and proposes an
additional reduction of 3 percent the following SFY, the proposed 3
percent reduction would not be considered to be nominal. As discussed
in the SMDL, we generally believed changes below the 4 percent
threshold to be nominal and unlikely to diminish access to care but
suggested states rely on the public process to make the determination.
Based on the feedback we have obtained through the SPA review process,
we continue to believe that changes below 4 percent are generally
nominal and have found that such changes do not typically result in
significant access concerns being raised by providers and other
stakeholders. As such, this proposed rule would go further by providing
an exemption from all of the procedures described in Sec.
447.203(b)(6) for proposed payment rate reductions within the above
thresholds, even if the state has not completed the public process
described in Sec. 447.204(a).
In addition to the proposed thresholds described above, we are
proposing to make an additional modification to the regulations based
on our implementation experience. Currently, when a state submits a SPA
to us proposing to reduce or restructure Medicaid provider payment
rates in circumstances when the changes could result in diminished
access, the state must submit an analysis of the changes' effect on
access. States have found considerable difficulty in anticipating the
effects of rate changes on Medicaid beneficiaries' access to care. Our
experience has shown that uncertainties inherent in these analyses have
limited their accuracy and hence their usefulness. Moreover, the
regulations at Sec. Sec. 447.203(b)(6)(ii) and 447.203(b)(8) include
considerable protections through requirements for monitoring and
corrective actions by states to ensure that access remains undiminished
after a payment rate change goes into effect (see 80 FR 67595 through
67596), and the utility of an anticipatory analysis has not been
demonstrated. Recognizing that it is challenging for states to
accurately predict the effects of many Medicaid payment rate changes on
beneficiary access to care, we are proposing to modify this requirement
and, instead, require states to submit an assurance that current access
is consistent with requirements of the Act at the time of the SPA
submission, and the baseline data that supports this assurance. We will
also rely in part on the information received through the public input
process to help understand the potential effects of proposed rate
changes that exceed the thresholds proposed in this proposed rule, and
the states' ongoing monitoring activities to ensure beneficiary access
to care is maintained.
Importantly, while the SMDL provided relief to states for the rate
reduction procedures in the regulations, neither the SMDL nor the
policies discussed in this proposed rule, if finalized, would exempt
states from their overall obligation to ensure that Medicaid rates are
consistent with section 1902(a)(30)(A) of the Act, the public notice
requirements in Sec. 447.205, or the public process for determining
institutional provider payment rates in section 1903(a)(13)(A) of the
Act. As part of the SPA review process, we retain the discretion to
request that states provide information that would allow us to compare
the Medicaid population's access to care with that of the general
population in the same geographic area and we will continue to document
whether states have met applicable public notice and process
requirements in our administrative records. Additionally, for states
that do not meet the managed care exemption threshold, we will use the
ongoing AMRP process to help identify and address potential access
issues.
We are still interested in developing and adopting meaningful
access measures that could apply consistently regardless of the service
delivery approach used by the state. Our ultimate goal is to better
measure, monitor and ensure Medicaid access across state programs and
delivery systems. While there is a longstanding requirement in 42 CFR
431.16 that states are obligated to provide all reports required by the
Secretary and must follow the Secretary's instructions regarding the
form and content of such reports, we are using this opportunity to
state that, in the future and informed by stakeholder feedback, we may
look to adopt a more standardized form and content for the states' AMRP
submissions.
[[Page 12699]]
II. Provisions of the Proposed Regulations
A. Exemption for States With High Managed Care Enrollment
We are proposing to amend Sec. 447.203(b) to establish a
comprehensive, risk-based managed care enrollment rate threshold for
which states above the threshold would be exempt from meeting the
requirements of Sec. 447.203(b)(1) through (6). The threshold for
exemption would be calculated to include services provided under
comprehensive risk contracts between a state and a managed care
organization as defined under Sec. 438.2 and any entities required
under the special terms and conditions of an 1115 demonstration to
comply with part 438 in the same manner as a managed care organization.
We are proposing an 85 percent threshold, meaning that states with an
overall comprehensive, risk-based managed care enrollment rate of 85
percent or greater would be exempt from the specified requirements and
would not be required to develop an AMRP or conduct an access analysis
or add services to the AMRP when reducing or restructuring provider
payment rates. We chose the 85 percent threshold based on comments
received in response to the November 2, 2015 final rule with comment
period in which states suggested thresholds ranging from 75 percent to
95 percent. We are seeking comment on whether an 85 percent overall
threshold is appropriate, or if the threshold should be higher, or
lower but stratified across eligibility categories (for example, a 70
percent overall threshold with at least a 50 percent managed care
enrollment rate across all eligibility categories).
We are proposing to require states with a comprehensive, risk-based
managed care enrollment rate at or above the threshold to submit to us
an attestation by January 1 of each year. Because managed care
enrollment rates fluctuate, we are proposing to require states to
attest to meeting the threshold every year. The attestation would
include the state's Medicaid managed care enrollment rate as of July
1st of the previous year. States that meet the managed care exemption
threshold would not be required to comply with the requirements for
development and updating the AMRP for the services otherwise subject to
the requirements for ongoing review or the special provisions for
proposed provider rate reductions in Sec. 447.203(b)(1) through (b)(6)
during that calendar year.
Consistent with the proposed changes to Sec. 447.203(b)(1) through
(6), we are also proposing changes to Sec. 447.204, redesignating
paragraph (d) to new paragraph (e), and adding a new paragraph (d), for
states that meet the 85 percent managed care enrollment threshold. When
proposing to reduce or restructure Medicaid payment rates, these states
would be exempt from the requirements to consider the data collected
through the AMRP and undertake a public process that solicits input on
the potential impact of the proposed rate reduction or restructuring
SPA, and accordingly, would not be required to include documentation
supporting compliance with the AMRP review and public process otherwise
required under Sec. 447.204(a) through (c) with the SPA submission.
However, states are not exempt from the statutory requirements and,
when proposing to reduce or restructure Medicaid payment rates in
circumstances that may diminish access, would be required to present
alternative data and analysis, determined at the discretion of the
state, to support compliance with section 1902(a)(30)(A) of the Act. As
such, we are proposing to include the requirement for states to submit
such alternative data in Sec. 447.204(d). We are requesting comments
on the types of alternative data and analysis that states may present
to support compliance with section 1902(a)(30)(A) of the Act, which we
may use to inform future sub-regulatory guidance to states.
B. Exemption for Payment Rate Changes
We are proposing to amend Sec. Sec. 447.203(b)(6) and 447.204 to
set a threshold for nominal payment rate changes that are below 4
percent for a Medicaid service category in total within a single SFY
and 6 percent over two consecutive SFYs. For purposes of this proposed
rule, service categories are those generally defined under sections
1905(a)(1) through (29) of the Act (that is, inpatient hospital
services, outpatient hospital services, other laboratory and X-ray
service, etc.) and other applicable sections that specify categories of
services eligible for medical assistance under the State plan. Such
nominal payment rate changes will not be subject to the special
provisions for rate reductions or restructuring procedures in Sec.
447.203(b)(6), and similarly, states would not be subject to the
requirements of Sec. 447.204(a) through (c) when submitting a SPA for
such changes. Additionally, since states may make rate changes in
consecutive years, we are proposing to limit the exemption threshold to
a 6 percent reduction in spending for a Medicaid service category over
2 consecutive SFYs.
We are requesting comments to determine whether the nominal
threshold should be higher or lower than 4 percent for a single SFY and
6 percent for 2 consecutive SFYs, recognizing that state legislatures
need sufficient flexibility to manage budgets and make adjustments to
Medicaid spending that are unlikely to result in diminished access to
care for program beneficiaries. We are proposing to limit the 4 percent
threshold exemption over a state fiscal year, rather than apply the 4
percent to a single SPA submission, and to apply the 6 percent
threshold as a cumulative threshold over 2 consecutive SFYs. This means
that state payment rate changes would be exempted from the special
provisions for proposed rate reductions or restructuring in Sec.
447.203(b)(6) and the SPA submission requirements in Sec. 447.204(a)
through (c) as long as they do not exceed 4 percent in total spending
for a service category within a single SFY and 6 percent over 2
consecutive SFYs. We believe this policy would provide state
legislatures sufficient leeway to make nominal Medicaid payment changes
that, considering the cumulative effects of the proposed year-over-year
changes, would be unlikely to have adverse impacts on Medicaid
beneficiaries' access to care. We seek comment on these proposals,
including on the potential impacts of cumulative rate reductions over
more than 2 consecutive SFYs, as well as on potential alternatives to
the 6 percent threshold and on the 2 consecutive SFYs timeframe from
consideration of cumulative impacts of year-over-year changes.
In conjunction with the proposed changes to Sec. 447.203(b)(6), we
are also proposing changes to Sec. 447.204, to include in the new
paragraph (d) an exemption for states that are proposing payment rate
reductions below the threshold of 4 percent within a single SFY (6
percent over 2 consecutive SFYs). When submitting such nominal payment
rate reductions, such states would not be required to consider the data
collected through the AMRP and undertake a public process that solicits
input on the potential impact of the proposed rate reduction or
restructuring SPA, and accordingly, would not be required to include
documentation supporting compliance with the AMRP review and public
process otherwise required under Sec. 447.204(a) through (c) with the
SPA submission. Although we are proposing this exemption from the
regulatory requirements at Sec. Sec. 447.203(b)(6) and 447.204(a)
through (c) for the proposed SPAs that would
[[Page 12700]]
implement nominal payment rate reductions, states are not exempt from
the statutory requirements and, when proposing to reduce or restructure
Medicaid payment rates in circumstances that may diminish access, would
be required to present alternative analysis and supporting data,
determined at the discretion of the state, to demonstrate compliance
with section 1902(a)(30)(A) of the Act. Accordingly, we are proposing
to include the requirement for states to submit such alternative data
in Sec. 447.204(d). We are requesting comments on the types of
alternative analysis and supporting data that states may present to
demonstrate compliance with section 1902(a)(30)(A) of the Act, which we
may use to inform future sub-regulatory guidance to states.
C. Modification of Payment Rate Change SPA Submission Information
We are proposing to amend Sec. 447.204(b)(2) to remove the
requirement that states submit an analysis of the effect the change in
payment rates will have on access and instead require that states
submit an assurance and baseline data that supports the state's
conclusion that current access is sufficient for the services impacted
by the rate change. The data will be used as part of the state's plan
to monitor the effects of the rate reduction for 3 years following
implementation, when required under Sec. 447.203(b)(6). We are
proposing this change because we have determined that the current
requirement of having states provide an analysis of the effect that a
proposed payment rate reduction might have on access is of limited
usefulness due to many uncertainties inherent to such analyses.
Therefore, we believe that having the state submit baseline data on
access to services will be more helpful to CMS in ensuring that a
state's proposed payment rate reductions are consistent with section
1902(a)(30)(A) of the Act.
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 60-day notice in the Federal Register
and solicit public comment before a collection of information
requirement is submitted to Office of Management and Budget (OMB) for
review and approval. To fairly evaluate whether an information
collection 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.
We are soliciting public comment on each of these issues for the
following sections of this document that contain proposed information
collection requirements:
Exemption for States with High Managed Care Penetration
(Sec. Sec. 447.203(b) and 447.204(a) through (c))
Exemption for Payment Rate Changes (Sec. Sec. 447.203(b) and
447.204(a) through (c))
Modification of Payment Rate Change SPA Submission Information
(Sec. 447.204(b)(2))
A. Wage Estimates
To derive average costs, we used data from the U.S. Bureau of Labor
Statistics' May 2016 National Occupational Employment and Wage
Estimates for all salary estimates (https://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 1 presents the mean hourly wage,
the cost of fringe benefits and overhead (calculated at 100 percent of
salary), and the adjusted hourly wage.
Table 1--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
Fringe
Occupation Mean hourly benefits and Adjusted
Occupation title code wage ($/hr) overhead ($/ hourly wage ($/
hr) hr)
----------------------------------------------------------------------------------------------------------------
Business Operations Specialist.................. 13-1000 34.54 34.54 69.08
Computer and Information Analyst................ 15-1120 44.36 44.36 88.72
General and Operations Manager.................. 11-1021 58.70 58.70 117.40
Management Analyst.............................. 13-1111 44.19 44.19 88.38
Social Science Research Assistant............... 19-4061 22.51 22.51 45.02
----------------------------------------------------------------------------------------------------------------
We adjusted our employee hourly wage estimates by a factor of 100
percent. This was necessarily a 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. Nonetheless, there was no practical alternative
and we believed that doubling the hourly wage to estimate total cost
was a reasonably accurate estimation method.
B. Proposed Information Collection Requirements (ICRs)
1. ICRs Regarding Exemption for States With High Managed Care
Enrollment (Sec. Sec. 447.203(b) and 447.204(a) Through (c))
Current provisions at Sec. 447.203(b)(1) through (3) require that
states develop and make publicly available an access monitoring review
plan using data trends and factors that considers: Beneficiary needs,
availability of care and providers, and changes in beneficiary
utilization of covered services.
Section 447.203(b)(1) and (2) describes the minimum factors that
states must consider when developing an access monitoring review plan.
Specifically, we require the review to include: Input from both
Medicaid beneficiaries and Medicaid providers, an analysis of Medicaid
payment data, and a description of the specific measures the state will
use to analyze access to care. We require that states use existing
provider feedback mechanisms, such as medical advisory committees
described in Sec. 431.12, rather than create new requirements, to
avoid placing unnecessary burden on states.
Section 447.203(b)(3) requires that states include aggregate
percentage comparisons of Medicaid payment rates to other public
(including, as practical, Medicaid managed care rates) or private
[[Page 12701]]
health coverage rates within geographic areas of the state.
Section 447.203(b)(4) describes the minimum content that must be in
included in the monitoring plan. States are required to describe: The
measures the state uses to analyze access to care issues, how the
measures relate to the overarching framework, access issues that are
discovered as a result of the review, and the state Medicaid agency's
recommendations on the sufficiency of access to care based on the
review.
Section 447.203(b)(5) describes the timeframe for states to develop
the access monitoring review plan and complete the data review for the
following categories of services: Primary care, physician specialist
services, behavioral health, pre- and post-natal obstetric services
including labor and delivery, home health, any services for which the
state has submitted a state plan amendment to reduce or restructure
provider payments which changes could result in diminished access, and
additional services as determined necessary by the state or CMS. While
the initial access monitoring review plans have been completed, the
plan must be updated at least every 3 years, but no later than October
1 of the update year.
In our currently approved information collection request (CMS-
10391; OMB 0938-1134), we estimated that the requirements to develop
and make the access monitoring review plans publically available under
Sec. 447.203(b)(1) through (4) for the specific categories of Medicaid
services will affect each of the 50 state Medicaid programs and the
District of Columbia (51 total respondents). We estimated it will take
a one-time effort of 5,100 hr to develop the access monitoring review
plan, 8,160 hr to collect and analyze the data, and 2,040 to publish
the plan and 510 hr for a manager to review and approve the plan
(15,810 total hours at a cost of $1,197,194.40, or $23,474.40 per
state). Since the initial one-time requirement has been met, and since
the policies in this proposed rule would create exemptions from certain
current requirements, we are now estimating this proposed rule as a
burden reduction.
In deriving these figures we used the following labor rates and
time to complete each task: 80 hr at $45.02/hr for a research assistant
staff to gather data, 80 hr at $88.72/hr for an information analyst
staff to analyze the data, 100 hr at $88.38/hr for management analyst
staff to update the content of the access review monitoring plan, 40 hr
at $69.08/hr for business operations specialist staff to publish the
access monitoring review plan, and 10 hr at $117.40/hr for managerial
staff to review and approve the access monitoring review plan.
Table 2--Access Monitoring Review Plan: Reduced One-Time Burden
[per state]
----------------------------------------------------------------------------------------------------------------
Adjusted Cost per
Requirement Occupation title Burden hours hourly wage ($/ monitoring
hr) plan ($/state)
----------------------------------------------------------------------------------------------------------------
Gathering Data........................ Social Science Research (80) 45.02 (3,601.60)
Assistant.
Analyzing Data........................ Computer and Information (80) 88.72 (7,097.60)
Analyst.
Developing Content of Access Review Management Analyst...... (100) 88.38 (8,838.00)
Monitoring Plan.
Publishing Access Review Monitoring Business Operations (40) 69.08 (2,763.20)
Plan. Specialist.
Reviewing and Approving Access Review General and Operations (10) 117.40 (1,174.00)
Monitoring Plan. Manager.
=================
Total............................. ........................ (310) varies (23,474.40)
----------------------------------------------------------------------------------------------------------------
Table 3--Access Monitoring Review Plan: Reduced One-Time Burden
[Total]
----------------------------------------------------------------------------------------------------------------
Cost of review Total cost
Anticipated number of state reviews Total hours per state ($) estimate ($)
----------------------------------------------------------------------------------------------------------------
(51)............................................ (15,810) [-310 hr x 51 (23,474.40) (1,197,194.40)
reviews].
----------------------------------------------------------------------------------------------------------------
Based on this rule's proposed exemption for states with managed
care enrollment rates at or above 85 percent, we are adjusting our on-
going access monitoring review plan burden by reducing the number of
states (and DC) by 17, from 51 to 34 states, because as of July 2016,
we estimate that 17 states had a managed care enrollment rate of at
least 85 percent and would therefore meet the threshold for an
exemption based on high managed care enrollment. We relied on data from
the Kaiser Family Foundation website (https://www.kff.org/data-collection/medicaid-managed-care-market-tracker/) to arrive at the
estimates, although we note that we will rely upon state attestations
of meeting or exceeding the enrollment rate threshold to administer the
exemption. Consistent with our currently approved estimates, we
continue to anticipate that the average ongoing burden is likely to be
the same as the average initial burden estimates since states will need
to re-run the data, determine whether to add or drop measures, consider
public feedback, and write-up new conclusions based on the information
they review. In this regard, we estimate that the exemption would
reduce our estimates by 5,270 hr (from 15,810 hr to 10,540 hr) and
$399,064.80.
[[Page 12702]]
Table 4--Access Monitoring Review Plan: Reduced On-Going Burden
----------------------------------------------------------------------------------------------------------------
Cost of review Total cost
Anticipated number of state reviews Total hours per state ($) estimate ($)
----------------------------------------------------------------------------------------------------------------
(17)............................................ (5,270) (-310 hr x 17 reviews) (23,474.40) (399,064.80)
----------------------------------------------------------------------------------------------------------------
In lieu of developing and updating the access monitoring review
plan for the services subject to the ongoing review or for proposed
provider rate reductions or payment restructurings that could result in
diminished access, this rule proposes that states seeking an exemption
from those requirements based on having a comprehensive risk-based
managed care enrollment rate at or above 85 percent must submit an
annual attestation of its Medicaid managed care enrollment rate as of
July 1 of the previous year to CMS. We anticipate states will use the
same enrollment data required to be monitored under Sec. 438.66 and
included in the currently approved information collection request (CMS-
10108; OMB 0938-0920) as a basis for the annual attestation. As such,
we estimate the burden associated with the annual attestation to be 0.5
hr at $117.40/hr for a General and Operations Manager to develop the
attestation document and submit it to CMS. In aggregate, we estimate an
annual burden of 8.5 hr (0.5 hr x 17 respondents) at a cost of $997.90
(8.5 hr x $117.40/hr) or $58.70 per respondent.
Table 5--Annual Attestation On-Going Burden
----------------------------------------------------------------------------------------------------------------
Cost of review Total cost
Anticipated number of state reviews Total hours per state ($) estimate ($)
----------------------------------------------------------------------------------------------------------------
17............................................ 8.5 (0.5 hr x 17 reviews)....... 58.70 997.90
----------------------------------------------------------------------------------------------------------------
The revised requirements and burden will be submitted to OMB for
approval under control number 0938-1134 (CMS-10391).
2. ICRs Regarding Exemption for Payment Rate Changes (Sec. Sec.
447.203(b)(6) and 447.204(a) Through (c))
Section 447.203(b)(6)(ii) requires states to have procedures within
the access monitoring review plan to monitor continued access after
implementation of a SPA that reduces or restructures payment rates. The
monitoring procedures must be in place for at least 3 years following
the effective date of the SPA. The ongoing burden associated with the
requirements under Sec. 447.203(b)(6)(ii) is the time and effort it
would take each of the state Medicaid programs to monitor continued
access following the implementation of a SPA that reduces or
restructures payment rates.
For provider rate reductions to a service category that are below 4
percent per state fiscal year, and below 6 percent across two
consecutive state fiscal years, the proposed changes to Sec.
447.203(b)(6)(i) would exempt states from the analysis and monitoring
procedures described in Sec. 447.203(b)(6)(ii).
In our currently approved information collection request (CMS-
10391; OMB 0938-1134), we estimated that in each SPA submission cycle,
states would submit 22 SPAs to implement rate changes or restructure
provider payments based on the number of submissions received in FY
2010.
We estimated that it would take, on average, 880 hr to develop the
monitoring procedures, 528 hr to periodically review the monitoring
results, and 66 hr for review and approval of the monitoring procedures
(1,474 total hours). We also estimated an average cost of $6,008.52 per
state and $132,187.44 (total).
In deriving these figures we used the following labor rates and
time to complete each task: 40 hr at $88.38/hr for management analyst
staff to develop the monitoring procedures, 24 hr at $88.38/hr for
management analyst staff to periodically review the monitoring results,
and 3 hr at $117.40/hr for management staff to review and approve the
monitoring procedures.
Table 6--Access Monitoring Procedures Following Rate Reduction SPA--Burden Per State
[Annual]
----------------------------------------------------------------------------------------------------------------
Adjusted Cost per data
Requirement Occupation title Burden hours hourly wage ($/ review ($/
hr) state)
----------------------------------------------------------------------------------------------------------------
Develop Monitoring Procedures......... Management Analyst...... 40 88.38 3,535.20
Periodically Review Monitoring Results Management Analyst...... 24 88.38 2,121.12
Approve Monitoring Procedures......... General and Operations 3 117.40 352.20
Manager.
-----------------------------------------------
Total............................. ........................ 67 varies 6,008.52
----------------------------------------------------------------------------------------------------------------
We are revising our estimates based on more current data that we
collected during the 2016 submission cycle and reducing the burden
hours to account for the proposed managed care enrollment rate
exemption and threshold for payment rate reductions. During the 2016
submission cycle, we received approximately 23 payment rate change
submissions from nine states that would have fallen under the
monitoring procedure's information
[[Page 12703]]
collection burden, which is generally consistent with our currently
approved burden estimates.
Of the 23 submissions, 9 would meet the exemption criteria for
states with managed care enrollment rates at or above 85 percent. For
the remaining 14 submissions, we believe 4 may have fallen below the 4
percent threshold for overall spending within the service category
exemption for a single state fiscal year, and 6 percent for two
consecutive state fiscal years based on information provided by the
state during the SPA review process. Based on the proposed exemptions
process, we are reducing our original estimated number of SPA
submissions from 22 to 10. We note that there is some variability in
state SPA submissions from year-to-year and the number of rate
reduction SPAs that states submit to CMS for approval.
Table 7--Revised Access Monitoring Procedures Following Rate Reduction SPA--Total Burden
[Annual]
----------------------------------------------------------------------------------------------------------------
Cost of review Total cost
Anticipated number of state reviews Total hours per state ($) estimate ($)
----------------------------------------------------------------------------------------------------------------
(12).......................................... (804) [-67 hr x 12 responses]... (6,008.52) (72,102.24)
----------------------------------------------------------------------------------------------------------------
The revised requirements and burden will be submitted to OMB for
approval under control number 0938-1134 (CMS-10391).
3. ICRs Regarding Modification of Payment Rate Change SPA Submission
Information (Sec. 447.204(b)(2))
Section 447.204(b)(2) requires states to include specific
documentation to demonstrate access when submitting a SPA that proposes
to reduce or restructure payment rates. Included in the documentation,
states are required to submit a copy of its most recent access
monitoring review plan that includes the services for which payment is
being reduced or restructured and an analysis of the effect of the
changes in payment rates on access. The burden associated with such
submission is included under Sec. 447.203(b)(1) (see above) for
ongoing access monitoring review plan (reduction of 10,540 hr).
We are proposing to modify the requirement in Sec. 447.204(b)(2)
so that states will no longer be required to predict the effect the
payment rate change will have on access, and will instead be required
to submit to CMS an assurance that data indicates current access is
consistent with requirements of the Act. We do not anticipate there
will be any changes in burden based on the proposal since it would
merely change the expectation for the type of conclusion that the state
will draw using its analysis from one that anticipates future access to
one that infers access is currently sufficient.
The revised requirement will be submitted to OMB for approval under
control number 0938-1134 (CMS-10391).
C. Summary of Proposed Information Collection Requirements and Burden
Table 8--Proposed Annual Recordkeeping and Reporting Requirements Under
OMB Control Number 0938-1134
[CMS-10391]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Burden per Total annual Labor cost ($/
Regulatory section(s) in Title 42 of the CFR Respondents Responses response (hr) burden (hr) hr) Total cost ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 447.203(b)(1)-(4) (one time requirement)......... (51) (51) (310) (15,810) varies (1,197,194)
Sec. 447.203(b)(1)-(4) (on-going requirement)......... (17) (17) (310) (5,270) varies (399,065)
Sec. 447.203(b) (attestation)......................... 17 17 0.5 8.5 117.40 998
Sec. 447.203(b)(6) (monitoring following rate (12) (12) (67) (804) varies (72,102)
reduction/restructuring)...............................
-----------------------------------------------------------------------------------------------
Total............................................... (34) (34) (561.5) (21,808.5) varies (1,667,363)
--------------------------------------------------------------------------------------------------------------------------------------------------------
D. Submission of PRA-Related Comments
We have submitted a copy of this proposed rule to OMB for its
review of the rule's information collection and recordkeeping
requirements. The requirements are not effective, if finalized, until
they have been approved by OMB.
We invite public comments on these information collection
requirements, and particularly on submission frequency and burden hours
per response. If you wish to comment, please identify the rule (CMS-
2406-P) and, where applicable, the ICR's CFR citation, CMS ID number,
and OMB control number.
To obtain copies of a supporting statement and any related forms
for the proposed collection(s) summarized in this notice, you may make
your request using one of following:
1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to [email protected].
3. Call the Reports Clearance Office at (410) 786-1326.
See this rule's DATES and ADDRESSES sections for the comment due
date and for additional instructions.
IV. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this preamble,
and, when we proceed with a subsequent document, we will respond to the
comments in the preamble to that document.
V. Regulatory Impact Analysis
A. Statement of Need
This proposed rule impacts states' documentation of compliance with
section 1902(a)(30)(A) of the Act. This
[[Page 12704]]
proposed rule would provide burden relief to states with comprehensive,
risk-based managed care enrollment rates above 85 percent of the total
covered Medicaid population within a state's Medicaid program and
states making rate reductions to services below a threshold of 4
percent of overall Medicaid spending within a service category (for
example, physician services) within a single SFY and 6 percent over 2
consecutive SFYs by exempting them from certain processes described in
Sec. Sec. 447.203 and 447.204. This proposed rule also would modify
the requirements at Sec. 447.204(b)(2) so that states must submit to
CMS with SPAs that reduce or restructure Medicaid payment rates an
assurance that the current baseline data indicates access is consistent
with the Act, rather than an analysis anticipating the effects of a
proposed change in payment rates.
B. Overall Impact
We have examined the impacts of this proposed 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), section 1102(b) of the Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (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).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). This proposed rule is not economically significant with an
overall estimated reduced economic reporting burden of $449,961.
C. Anticipated Effects
1. Effects on State Medicaid Programs
We anticipate effects on state Medicaid programs that have high
comprehensive, risk-based managed care enrollment rates and that make
adjustments to their Medicaid payment rates that are unlikely to
diminish access to care. States with comprehensive, risk-based managed
care enrollment rates of 85 percent or above would no longer be
required to maintain and update the access monitoring review plans
required under the regulations. In addition, states that make nominal
changes to their Medicaid payment rates, defined below 4 percent for a
SFY and 6 percent for 2 consecutive SFYs, would no longer be required
to conduct monitoring activities described in the regulations related
to those SPA changes. Importantly, the provisions of this proposed rule
provide exemptions to the regulatory procedure requirements for
demonstrating access to care. However, states are not exempt from the
statutory requirements described at section 1902(a)(30)(A) of the Act
and must have alternative approaches to ensure access is consistent
with the Act when reducing Medicaid payment rates.
2. Effects on Small Business and Providers
We anticipate some effects on small businesses and providers that
reside in states that meet the exemption criteria described in the
proposed rule but only to the extent that we would have disapproved a
SPA based on the information required for submission through the
regulations. As the exemptions proposed in the proposed rule are either
for states with relatively low fee-for-service delivery (and related
expenditures) and for nominal payment rate changes, we do not
anticipate the effects will be significant.
3. Effects on the Medicaid Program
The estimated fiscal impact on the Medicaid program from the
implementation of the proposed rule is estimated to be a net savings to
Medicaid state agencies. These estimates are based on our estimation
that 17 states will no longer be required to maintain and update the
AMRPs and the approximate number annual SPAs requiring access
monitoring will be reduced by 11. This will have a relatively minor
effect on state administrative expenditures, with a total anticipated
reduction in spending of $1,667,363. However, states have raised
significant concerns over the administrative burden and associated
benefits to complying with the regulatory requirements both when the
majority of Medicaid beneficiaries are served through managed care and
when making minor adjustments to Medicaid payments that they believe
are unlikely to diminish access to care.
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. The great majority of hospitals and most
other health care providers and suppliers are small entities, either by
being nonprofit organizations or by meeting the SBA definition of a
small business (having revenues of less than $7.5 million to $38.5
million in any one year). Individuals and states are not included in
the definition of a small entity. As previously stated, we do not
anticipate any effect on small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a metropolitan
statistical area and has fewer than 100 beds. This rule will not have a
significant impact on the operations of a substantial number of small
rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2017, that
threshold is approximately $148 million. This rule does not contain
mandates that will impose spending costs on state, local, or tribal
governments in the aggregate, or by the
[[Page 12705]]
private sector, in excess of the threshold.
Executive Order 13132 establishes certain requirements that an
agency must meet when it issues a proposed rule that imposes
substantial direct requirement costs on state and local governments,
preempts state law, or otherwise has Federalism implications. This rule
does not have a substantial impact on state or local governments.
D. Alternatives Considered
In developing this rule, the following alternatives were
considered:
1. We considered proposing a managed care enrollment exemption
threshold at or above 70 percent but, in reviewing programmatic data,
we discovered that the rate of managed care coverage can vary
significantly based on category of Medicaid eligibility. For instance,
while many states would meet the 70 percent threshold, the rate of
managed care coverage for certain populations may fall well below 50
percent. This is frequently the case for individuals who are eligible
based on a combination of income and age or as a result of disability.
The disproportion of coverage based on eligibility appears
significantly less with an exemption threshold at or above 85 percent,
therefore the proposed rule would set such a limit. However, we are
requesting comments on the exemption threshold and whether additional
considerations, discussed in more detail above, may be applied to allow
a lower threshold.
2. In codifying the 4 percent exemption for access monitoring, we
considered whether the exemption percentage was too low or too high. As
described in our SMDL on this matter, we believe that rate changes
below a 4 percent threshold are unlikely to diminish access to care and
generally the benefits of monitoring access for such reductions are not
consistent with the administrative burden associated with monitoring.
We are requesting comment on whether 4 percent is too high or low, but
determine 4 percent to be appropriate for purposes of the proposed
rule. We also considered applying the 4 percent exemption threshold
annually but, in evaluating the potential cumulative effects of year-
over-year rate reductions, proposed a 6 percent threshold over 2 SFYs.
We request comment on consideration of cumulative impacts, including
the 6 percent threshold amount and 2 SFYs timeframe.
E. Reducing Regulation and Controlling Regulatory Costs
Executive Order 13771, titled Reducing Regulation and Controlling
Regulatory Costs, was issued on January 30, 2017. This proposed rule is
expected to be an E.O. 13771 deregulatory action. Details on the $1.66
million estimated cost savings of this rule can be found in the
preceding analyses.
G. Conclusion
In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 447
Accounting, Administrative practice and procedure, Drugs, Grant
programs--health, Health facilities, Health professions, Medicaid,
Reporting and recordkeeping requirements, and Rural areas.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 447--PAYMENTS FOR SERVICES
0
1. The authority citation for part 447 continues to read as follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302).
0
2. Section 447.203 is amended by revising paragraphs (b) introductory
text, (b)(6)(i) and (ii) to read as follows:
Sec. 447.203 Documentation of access to care and service payment
rates.
* * * * *
(b) In consultation with the medical care advisory committee under
Sec. 431.12 of this chapter, the agency must develop a medical
assistance access monitoring review plan and update it, in accordance
with the timeline established in paragraph (b)(5) of this section and
with procedures established by CMS. The plan must be published and made
available to the public for review and comment for a period of no less
than 30 days, prior to being finalized and submitted to CMS for review.
States that have for all eligibility groups combined at least 85
percent of beneficiaries enrolled in Medicaid managed care
organizations, as defined in Sec. 438.2 of this chapter, and including
section 1115 demonstration populations enrolled under such
comprehensive risk contracts, are not required to meet the requirements
under paragraphs (b)(1) through (6) of this section. Any state seeking
an exemption based on an overall Medicaid managed care enrollment of 85
percent or higher must submit an annual attestation of its Medicaid
managed care enrollment rate as of July 1 of the previous year to CMS.
In lieu of the requirements under paragraph (b)(6) of this section,
States that have overall Medicaid managed care enrollment of at least
85 percent for the calendar year, must submit an alternative analysis
and certification, including the data and other information on which
the analysis and certification are based, that demonstrate compliance
with section 1902(a)(30)(A) of the Act.
* * * * *
(6) * * *
(i) Compliance with access requirements. The State shall submit
with any State plan amendment that proposes to reduce provider payments
by greater than 4 percent in overall service category spending in a
State fiscal year or greater than 6 percent across two consecutive
State fiscal years, or restructure provider payments in circumstances
when the changes could result in diminished access, an access review,
in accordance with the access monitoring review plan, for each service
affected by the State plan amendments as described under paragraph
(b)(1) of this section completed within the prior 12 months. That
access review must demonstrate sufficient access for any service for
which the State agency proposes to reduce payment rates or restructure
provider payments to demonstrate compliance with the access
requirements at section 1902(a)(30)(A) of the Act.
(ii) Monitoring procedures. In addition to the analysis conducted
through paragraphs (b)(1) through (4) of this section that demonstrates
access to care is sufficient as of the effective date of the State plan
amendment, for any State plan amendment that reduces provider payment
greater than 4 percent in overall service category spending in a State
fiscal year or greater than 6 percent across two consecutive State
fiscal years, or restructures provider payments in circumstances when
the changes could result in diminished access, the state must establish
procedures in its access monitoring review plan to monitor continued
access to care after implementation of state plan service rate
reduction or payment restructuring. The frequency of monitoring should
be informed by the public review described in paragraph (b) of this
section and should be conducted no less frequently than annually.
* * * * *
0
3. Section 447.204 is amended by--
[[Page 12706]]
0
a. Revising paragraphs (a) introductory text, (b) introductory text,
(b)(2), and (c).
0
b. Redesignating paragraph (d) as paragraph (e).
0
c. Adding new paragraph (d).
The revisions and addition read as follows:
Sec. 447.204 Medicaid provider participation and public process to
inform access to care.
(a) The agency's payments must be consistent with efficiency,
economy, and quality of care and sufficient to enlist enough providers
so that services under the plan are available to beneficiaries at least
to the extent that those services are available to the general
population. Except as provided in paragraph (d) of this section, in
reviewing payment sufficiency, states are required to consider, prior
to the submission of any state plan amendment that proposes to reduce
or restructure Medicaid service payment rates:
* * * * *
(b) Except as provided in paragraph (d) of this section, the State
must submit to CMS with any such proposed State plan amendment
affecting payment rates:
* * * * *
(2) An assurance that access to care is sufficient in accordance
with section 1902(a)(30)(A) of the Act, and baseline data to support
this conclusion; and
* * * * *
(c) Except as provided in paragraph (d) of this section, CMS may
disapprove a proposed state plan amendment affecting payment rates if
the state does not include in its submission the supporting
documentation described in paragraph (b) of this section, for failure
to document compliance with statutory access requirements. Any such
disapproval would follow the procedures described at part 430 Subpart B
of this title.
(d) Paragraphs (a) through (c) of this section shall not apply in
the case of a state that is not required to meet the requirements of
Sec. 447.203(b)(1) through (b)(6) because the state has Medicaid
managed care enrollment of at least 85 percent, as described in Sec.
447.203(b), or in the case of a proposed State plan amendment that
reduces provider payment rates by no more than 4 percent in any State
fiscal year, and no more than 6 percent across two consecutive State
fiscal years. In lieu of the requirements under paragraphs (a) though
(c) of this section, States that are not required to meet these
requirements pursuant to this paragraph must submit to CMS an
alternative analysis, along with supporting data, to demonstrate
compliance with section 1902(a)(30)(A) of the Act when submitting a
state plan amendment that proposes to reduce or restructure Medicaid
service payment rates in circumstances that may diminish access to
care.
* * * * *
Dated: March 1, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
Dated: March 16, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-05898 Filed 3-22-18; 8:45 am]
BILLING CODE 4120-01-P