Medicare Program; Right of Appeal for Medicare Secondary Payer Determination Relating to Liability Insurance (Including Self-Insurance), No Fault Insurance, and Workers' Compensation Laws and Plans, 78802-78807 [2013-30661]
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78802
Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules
of the maintenance plan. Therefore,
when a conformity determination is
prepared which assesses conformity for
the years before 2021, the 2021 MVEB
and the underlying assumptions
supporting it would have to be
considered. Finally, 40 CFR 93.110
requires the use of the latest planning
assumptions in conformity
determinations. Thus, the most current
motor vehicle and road dust emission
factors would need to be used, and we
expect the analysis would show greatly
reduced PM10 motor vehicle and road
dust emissions from those calculated in
the first maintenance plan. In view of
the above, EPA is proposing to approve
the 2021 PM10 MVEB of 946 lbs/day.
tkelley on DSK3SPTVN1PROD with PROPOSALS
V. Proposed Action
We are proposing to approve the
revised Pagosa Springs PM10
Maintenance Plan that was submitted to
us on March 31, 2010, with one
exception. We are proposing to
disapprove the listing of ‘‘voluntary coal
and/or wood burning curtailment’’ as a
potential contingency measure in
section 5.F.3 of the revised Pagosa
Springs PM10 Maintenance Plan. We are
proposing to approve the remainder of
the revised maintenance plan because it
demonstrates maintenance through 2021
as required by CAA section 175A(b),
retains the control measures from the
initial PM10 maintenance plan that EPA
approved on June 15, 2001, and meets
other CAA requirements for a section
175A maintenance plan. We are
proposing to exclude from use in
determining that Pagosa Springs
continues to attain the 24-hour PM10
NAAQS exceedances of the 24-hour
PM10 NAAQS that were recorded at the
Pagosa Springs PM10 monitor on March
22, 2009, April 3, 2009, April 5, 2010,
April 28, 2010, April 29, 2010, May 11,
2010, and May 22, 2010 because they
meet the criteria for exceptional events
caused by high wind natural events. We
are also proposing to approve the
revised maintenance plan’s 2021
transportation conformity MVEB for
PM10 of 946 lbs/day.
VI. Statutory and Executive Orders
Review
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
Act and applicable federal regulations.
42 U.S.C. 7410(k), 40 CFR 52.02(a).
Thus, in reviewing SIP submissions,
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. This proposed action merely
proposes to approve state law as
meeting federal requirements and does
not propose to impose additional
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requirements beyond those imposed by
state law. For that reason, this proposed
action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Order 12866 (58 FR 51735,
October 4, 1993);
• does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
USC 3501 et seq.);
• is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
USC 601 et seq.);
• does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• is not subject to requirements of
Section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 USC 272 note) because
application of those requirements would
be inconsistent with the CAA; and,
• does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, this proposed action does
not have tribal implications as specified
by Executive Order 13175 (65 FR 67249,
November 9, 2000), because the SIP
would not be approved to apply in
Indian country located in the state, and
EPA notes that it will not impose
substantial direct costs on tribal
governments or preempt tribal law.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Volatile Organic
Compounds.
Authority: 42 U.S.C. 7401 et seq.
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Dated: December 16, 2013.
Shaun L. McGrath,
Regional Administrator, Region 8.
[FR Doc. 2013–31110 Filed 12–26–13; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 405
[CMS–6055–P]
RIN 0938–AS03
Medicare Program; Right of Appeal for
Medicare Secondary Payer
Determination Relating to Liability
Insurance (Including Self-Insurance),
No Fault Insurance, and Workers’
Compensation Laws and Plans
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
implement provisions of the
Strengthening Medicare and Repaying
Taxpayers Act of 2012 (SMART Act)
which require us to provide a right of
appeal and an appeal process for
liability insurance (including selfinsurance), no-fault insurance, and
workers’ compensation laws or plans
when Medicare pursues a Medicare
Secondary Payer (MSP) recovery claim
directly from the liability insurance
(including self-insurance), no fault
insurance, or workers’ compensation
law or plan.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided, no later than 5
p.m. on February 25, 2014.
ADDRESSES: In commenting, please refer
to file code CMS–6055–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four 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 instructions under the ‘‘More Search
Options’’ tab.
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–6055–
P, P.O. Box 8013, Baltimore, MD 21244–
8013.
SUMMARY:
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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules
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–6055–
P, Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. If you prefer,
you may deliver (by hand or courier)
your written comments before the close
of the comment period to either of the
following addresses:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850
If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
1066 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Barbara Wright, (410) 786–4292.
Cynthia Ginsburg, (410) 786–2579.
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 Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
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Comments received timely will be
also available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, MD 21244–1850, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
please phone 1–800–743–3951.
I. Overview and Background
A. Overview
When the Medicare program was
enacted in 1965, Medicare was the
primary payer for all medically
necessary covered and otherwise
reimbursable items and services, with
the exception of those items and
services covered and payable by
workers’ compensation. In 1980, the
Congress enacted the Medicare
Secondary Payer (MSP) provisions of
the Social Security Act (the Act), which
added section 1862(b) to the Act and
established Medicare as the secondary
payer to certain primary plans. Primary
plan, as defined in section 1862(b)(2)(A)
of the Act, means a group health plan
or large group health plan, workers’
compensation law or plan, automobile
or liability insurance policy or plan
(including self-insured plan) or no fault
insurance.
Section 1862(b)(2) of the Act, in part,
prohibits Medicare from making
payment where payment has been made
or can reasonably be expected to be
made by a primary plan. If payment has
not been made or cannot reasonably be
expected to be made by a primary plan,
Medicare may make conditional
payments with the expectation that the
payments will be reimbursed to the
appropriate Medicare Trust Fund. That
is, Medicare may pay for medical claims
with the expectation that it will be
repaid if the beneficiary obtains a
settlement, judgment, award, or other
payment (hereafter referred to as
‘‘settlement’’). Section 1862(b)(2)(B) of
the Act provides authority for Medicare
to make conditional payments and
requires the primary plan, if it is
responsible for the payment, to
reimburse Medicare. A primary plan
and any entity that receives payment
from a primary plan shall reimburse the
appropriate Medicare Trust Fund for
Medicare’s payments for items and
services if it is demonstrated that such
primary plan has or had responsibility
to make payment with respect to such
items and services.
The responsibility for payment on the
part of workers’ compensation, liability
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insurance (including self-insurance),
and no-fault insurance is generally
demonstrated by ‘‘settlements.’’ When a
‘‘settlement’’ occurs, the ‘‘settlement’’ is
subject to the Act’s MSP provisions
because a ‘‘payment has been made’’
with respect to medical care of a
beneficiary related to that ‘‘settlement.’’
Section 1862(b)(2)(B)(iv) of the Act
provides the Federal government
subrogation rights to any right under
MSP of an individual or any other entity
to payment for items or services under
a primary plan, to the extent Medicare
payments were made for such medical
items and services. Moreover, section
1862(b)(2)(B)(iii) of the Act provides the
Federal government a direct right of
action to recover conditional payments
made by Medicare. This direct right of
action, which is separate and
independent from Medicare’s statutory
subrogation rights, may be brought to
recover conditional payments against
any or all entities that are or were
responsible for making payment for the
items and services under a primary
plan. Under the direct right of action,
the Federal government may also
recover from any entity that has
received payment from a primary plan
or the proceeds of a primary plan’s
payment to any entity.
B. Background
The Strengthening Medicare and
Repaying Taxpayers Act of 2012 (the
SMART Act) was signed into law by
President Obama on January 10, 2013,
and amends the Act’s MSP provisions
(found at 42 U.S.C. 1395y(b)).
Specifically, section 201 of the SMART
Act added subparagraph (viii) to section
1862(b)(2)(B) of the Social Security Act.
This new clause requires Medicare to
promulgate regulations establishing a
right of appeal and an appeals process,
with respect to any determination for
which the Secretary is seeking to
recover payments from an applicable
plan (as defined in the MSP provisions),
under which the applicable plan
involved, or an attorney, agent, or thirdparty administrator on behalf of the
applicable plan, may appeal such a
determination. Further, the individual
furnished such an item and/or service
shall be notified of the applicable plan’s
intent to appeal such a determination.
For purposes of this provision, the term
applicable plan refers to liability
insurance (including self-insurance), nofault insurance, or a workers’
compensation law or plan as defined at
section 1862(b)(8)(F) of the Act. (We
note that the industry has expressed
interest in an appeal process for
determinations regarding proposed
Workers’ Compensation Medicare Set-
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Aside Arrangement (WCMSA) amounts.
This proposed rule does not address this
issue. It will be addressed separately.)
Currently, if an MSP recovery demand
is issued to the beneficiary as the
identified debtor, the beneficiary has
formal administrative appeal rights and
eventual judicial review as set forth in
subpart I of part 405. If the recovery
demand is issued to the applicable plan
as the identified debtor, currently the
applicable plan has no formal
administrative appeal rights or judicial
review. CMS’ recovery contractor
addresses any dispute raised by the
applicable plan, but there is no
multilevel formal appeal process.
Subpart I of part 405, provides for a
multilevel process including a
redetermination by the contractor
issuing the recovery demand, a
reconsideration by a Qualified
Independent Contractor (QIC), an
Administrative Law Judge (ALJ) hearing,
a review by the Departmental Appeals
Board’s (DAB) Medicare Appeals
Council (MAC), and eventual judicial
review. The regulations set forth details
on the process including filing
requirements, amount in controversy
requirements, and other requirements,
as appropriate. We propose to include
appeals for applicable plans where
Medicare is pursuing recovery directly
from the applicable plan in this process.
The debts at issue involve recovery of
the same conditional payments that
would be at issue if recovery were
directed at the beneficiary. Given this,
we believe it is appropriate to utilize the
same multilevel appeals process for
applicable plans.
II. Provisions of the Proposed
Regulations
After review of the existing
regulations in subpart I of 42 CFR Part
405, we are proposing the following
changes, as appropriate, in order to
include the applicable plan as a party
when we pursue recovery directly from
the applicable plan.
We propose to amend § 405.900, Basis
and Scope, by revising paragraph (a) to
add section 1862(b)(2)(B)(viii) of the Act
as part of the statutory basis for Subpart
I. Section 1862(b)(2)(B)(viii) of the Act
requires an appeals process for
applicable plans when Medicare
pursues recovery directly from the
applicable plan.
In § 405.902, Definitions, we propose
to add a definition of the term
‘‘applicable plan’’ for purposes of
Subpart I. We would adopt the statutory
definition of ‘‘applicable plan’’ in
section 1862(b)(8)(F) of the Act, which
states that an applicable plan means
liability insurance (including self-
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insurance), no-fault insurance, or a
workers’ compensation law or plan.
We propose to amend § 405.906,
Parties to initial determinations,
redeterminations, reconsiderations,
hearings and reviews by adding
§ 405.906(a)(4) to include the applicable
plan as a party for an initial
determination where Medicare is
pursuing recovery directly from the
applicable plan. By ‘‘pursuing recovery
directly from the applicable plan,’’ we
mean that the applicable plan would be
the identified debtor, with a recovery
demand letter requiring repayment
issued to the applicable plan (or its
agent or representative). Sending an
applicable plan a courtesy copy of a
recovery demand letter issued to a
beneficiary does not qualify as
‘‘pursuing recovery directly from the
applicable plan’’ and does not confer
party status on the applicable plan. We
are also proposing a technical change in
the section heading for § 405.906
(adding a comma before the phrase ‘‘and
reviews’’).
Based upon this proposed change to
§ 405.906, the applicable plan’s party
status would continue at subsequent
levels of appeal. Consistent with section
1862(b)(2)(B)(viii) of the Act, the
beneficiary, provider, and/or supplier
are not considered parties to an appeal
by an applicable plan. Thus, we propose
to remove the beneficiary, as well as the
provider or supplier, as a party at the
redetermination level where Medicare is
pursuing recovery directly from the
applicable plan. This would also, in
effect, remove the beneficiary and the
provider or supplier as a party at
subsequent levels of appeal where
Medicare is pursuing recovery directly
from the applicable plan. To implement
our proposed changes, we would revise
§ 405.906 (a) to specify: (1) The
circumstances under which an
applicable plan is a party to an initial
determination; and (2) when an
applicable plan is a party to an initial
determination, it is the sole party with
respect to that determination. Finally, as
providers and suppliers would
specifically be excluded from party
status for an initial determination with
respect to an applicable plan, we would
make it clear that the special rule for
provider or supplier party status in
§ 405.906(c) does not apply to an initial
determination with respect to an
applicable plan.
In proposed § 405.910, Appointed
representatives, we would add a new
paragraph (e)(4) to provide the
applicable plan with parallel rights to a
beneficiary’s rights or a provider or
supplier’s rights regarding the duration
of an appointment of representation
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with respect to an MSP recovery claim.
We also propose to revise § 405.910(i)(4)
so that the special provision that
beneficiaries as well as their
representatives must receive notices or
requests in a MSP recovery case
continues to apply only to beneficiaries.
For all other parties, including an
applicable plan, we would continue to
follow the regulatory provisions in
§ 405.910(i)(1) through (3).
In § 405.921, Notice of initial
determination, we propose to add a
paragraph (c) to provide specific
language regarding requirements for
notice to an applicable plan. This
language would parallel the existing
language in this section regarding the
notice to beneficiaries. In addition to
these changes, for consistency we have
made a number of technical and
formatting changes.
In order for an action to be subject to
the appeal process set forth in subpart
I of 42 CFR Part 405, there must be an
‘‘initial determination.’’ We propose, in
§ 405.924, Actions that are initial
determinations, to add a new paragraph
§ 405.924(b)(15) providing that a
determination that Medicare has a
recovery claim where Medicare is
pursuing recovery directly from an
applicable plan is an initial
determination with respect to the
amount of or existence of the MSP
recovery claim. This addition would
generally parallel the existing
provisions in § 405.924(b)(14)
addressing pursuing MSP recovery
claims from a beneficiary, provider or
supplier. In addition to these changes,
for consistency we have made a number
of technical and formatting changes.
The MSP provisions in section
1862(b) of the Act establish that
Medicare has a direct right of recovery
against a primary payer. Currently
under § 405.926(k), determinations
under these provisions that Medicare
has a recovery against a particular
primary payer, are not initial
determinations for purposes of part 405
subpart I. Consequently, although the
primary payer may dispute the recovery
claim where Medicare pursues recovery
against the applicable plan, it has no
formal appeal rights. We propose to
revise § 405.926(k) by creating an
exception to the broad rule in
§ 405.926(k) to reflect the proposed
addition of § 405.924(b)(15). The
proposed revision would provide an
exception to § 405.926(k) where there is
an initial determination under
§ 405.924(b)(15) (where Medicare is
pursuing recovery directly from an
applicable plan). We also propose to
add a new § 405.926(a)(3) to clarify that
Medicare’s determination regarding
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who/what entity it will pursue with
respect to an MSP recovery claim is not
an initial determination for purposes of
part 405 subpart I. Because Medicare
has the right to recover conditional
payments from the beneficiary, the
primary payer, or any other entity that
has the proceeds from payment by the
primary plan, Medicare’s decision
regarding who/what entity it is pursuing
recovery from is not subject to appeal.
We also propose to add the word
‘‘facilitates’’ to the existing ‘‘sponsors or
contributes to’’ language in § 405.926(k)
in recognition of our longstanding
position that the concept of employer
sponsorship or contribution has always
included facilitation efforts. Finally for
consistency, we are proposing several
technical changes.
We propose to add a new § 405.947,
Notice to the beneficiary of an
applicable plan’s request for a
redetermination, to add language
satisfying the requirement at section
1862(b)(2)(B)(viii) of the Act that the
beneficiary receive notice of the
applicable plan’s intent to appeal where
Medicare is pursuing recovery directly
from the applicable plan. As the
beneficiary would not be a party to the
appeal at the redetermination level or
subsequent levels of appeal, we believe
that a single notice at the
redetermination level satisfies the intent
of this provision. We also propose that
the required notice be issued by the
contractor adjudicating the
redetermination request in order to
ensure clarity and consistency in the
wording of the notice.
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III. Collection of Information
Requirements
This document does not impose
information collection and
recordkeeping requirements.
Consequently, it need not be reviewed
by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
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 Statement
We have examined the impact of this
rule as required by Executive Order
12866 on Regulatory Planning and
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Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (February 2,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security 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) and the Congressional
Review Act (5 U.S.C. 804(2)).
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). A regulatory impact analysis
(RIA) must be prepared for major rules
with economically significant effects
($100 million or more in any 1 year). We
have determined that the effect of this
proposed rule on the economy and the
Medicare program is not economically
significant. The proposed rule would
provide a formal administrative appeal
process for MSP recovery claims where
the applicable plan is the identified
debtor, as opposed to the current
process which requires a CMS
contractor to consider any defense
submitted by an applicable plan but
does not provide formal administrative
appeal rights.
The RFA requires agencies to analyze
options for regulatory relief of small
entities. For purposes of the RFA, small
entities include small businesses,
nonprofit organizations, and small
governmental jurisdictions. Most
hospitals and most other providers and
suppliers are small entities, either by
nonprofit status or by having revenues
of less than $7.0 million to $35.5
million in any 1 year. Individuals and
States are not included in the definition
of a small entity. We have determined
and we certify that this proposed rule
would not have a significant economic
impact on a substantial number of small
entities because there is and will be no
change in the administration of the MSP
provisions. The proposed changes
would simply expand or formalize
existing rights with respect to MSP
recovery claims pursued directly from
an applicable plan. Therefore, we are
not preparing an analysis for the RFA.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis (RIA) 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 for
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proposed rules 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 for Medicare payment
regulations and has fewer than 100
beds. We have determined that this
proposed rule would not have a
significant effect on the operations of a
substantial number of small rural
hospitals because it would simply
expand and/or formalize existing rights
with respect to MSP recovery claims
pursued directly from an applicable
plan. Therefore, we are not preparing an
analysis for section 1102(b) of the Act.
Section 202 of the Unfunded
Mandates Reform Act of 1995 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 2013, that threshold is approximately
$141 million. This proposed rule has no
consequential effect on State, local, or
tribal governments or on the private
sector because it would simply expand
and/or formalize existing rights with
respect to MSP recovery claims pursued
directly from an applicable plan.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
Since this regulation does not impose
any costs on State or local governments,
the requirements of Executive Order
13132 are not applicable.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
List of Subjects in 42 CFR Part 405
Administrative practice and
procedure, Health facilities, Health
professions, Kidney diseases, Medical
devices, Medicare, Reporting and
recordkeeping requirements, Rural
areas, X-rays.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR Part 405 as set forth below:
PART 405—FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
1. The authority citation for part 405
reads as follows:
■
Authority: Secs. 205(a), 1102, 1861,
1862(a), 1869, 1871, 1874, 1881, 1886(k) of
the Social Security Act (42 U.S.C. 405(a),
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1302, 1395x, 1395y(a), 1395ff, 1395hh,
1395kk, 1395rr and 1395ww(k)), and sec. 353
of the Public Health Service Act (42 U.S.C.
263a)
2. Amend § 405.900 by revising
paragraph (a) to read as follows:
■
§ 405.900
Basis and scope.
(a) Statutory basis. This subpart is
based on the following provisions of the
Act:
(1) Section 1869(a) through (e) and (g)
of the Act.
(2) Section 1862(b)(2)(B)(viii) of the
Act.
*
*
*
*
*
■ 3. Amend § 405.902 by adding the
definition ‘‘Applicable plan’’ in
alphabetical order to read as follows:
§ 405.902
Definitions.
*
*
*
*
*
Applicable plan means liability
insurance (including self-insurance), nofault insurance, or a workers’
compensation law or plan.
*
*
*
*
*
■ 4. Amend § 405.906 as follows:
■ A. Revising the section heading.
■ B. Adding new paragraph (a)(4).
■ C. Amending paragraph (c) by adding
a sentence at the end of the paragraph.
The additions and revision read as
follows:
§ 405.906 Parties to the initial
determinations, redeterminations,
reconsiderations, hearings, and reviews.
(a) * * *
(4) An applicable plan for an initial
determination under § 405.924(b)(15)
where Medicare is pursuing recovery
directly from the applicable plan. The
applicable plan is the sole party to an
initial determination under
§ 405.924(b)(15) (that is, where
Medicare is pursuing recovery directly
from the applicable plan).
*
*
*
*
*
(c) * * *. This paragraph (c) does not
apply to an initial determination with
respect to an applicable plan under
§ 405.924(b)(15).
■ 4. Amend § 405.910 as follows:
■ A. Adding paragraph (e)(4).
■ B. Revising paragraph (i)(4).
The addition and revision read as
follows:
§ 405.910
Appointed representatives.
tkelley on DSK3SPTVN1PROD with PROPOSALS
*
*
*
*
*
(e) * * *
(4) For an initial determination of a
Medicare Secondary Payer recovery
claim, an appointment signed by an
applicable plan which has party status
in accordance with § 405.906(a)(1)(iv) is
valid from the date that appointment is
signed for the duration of any
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19:07 Dec 26, 2013
Jkt 232001
subsequent appeal, unless the
appointment is specifically revoked.
*
*
*
*
*
(i) * * *
(4) For initial determinations and
appeals involving Medicare Secondary
Payer recovery claims where the
beneficiary is a party, the adjudicator
sends notices and requests to both the
beneficiary and the beneficiary’s
representative, if the beneficiary has a
representative.
*
*
*
*
*
■ 5. Amend § 405.921 as follows:
■ A. In paragraph (a)(1), removing ‘‘;’’
and adding in its place ‘‘.’’
■ B. In paragraph (a)(2) introductory
text, removing the phrase ‘‘must
contain—’’ and adding in its place the
phrase ‘‘must contain all of the
following:’’
■ C. In paragraphs (a)(2)(i) and (a)(2)(ii),
removing ‘‘;’’ and adding in its place ‘‘.’’
■ D. In paragraph (a)(2)(iii), removing ‘‘;
and’’ and adding in its place ‘‘.’’
■ E. Redesignating the second and third
sentences of paragraph (b)(1) as
paragraph (b)(1)(i) and (ii), respectively.
■ F. In paragraph (b)(2) introductory
text, removing the phrase ‘‘must
contain:’’ and adding in its place the
phrase ‘‘must contain all of the
following:’’
■ G. In paragraphs (b)(2)(i) through
(b)(2)(iv), removing ‘‘;’’ and add in its
place ‘‘.’’
■ H. In paragraph (b)(2)(v), removing ‘‘;
and’’ and add in its place ‘‘.’’
■ I. Adding paragraph (c) to read as
follows:
§ 405.921
Notice of initial determination.
*
*
*
*
*
(c) Notice of initial determination sent
to an applicable plan—(1) Content of
the notice. The notice of initial
determination under § 405.924(b)(15)
must contain all of the following:
(i) The reasons for the determination.
(ii) The procedures for obtaining
additional information concerning the
contractor’s determination, such as a
specific provision of the policy, manual,
law or regulation used in making the
determination.
(iii) Information on the right to a
redetermination if the liability
insurance (including self-insurance), nofault insurance, or workers’
compensation law or plan is dissatisfied
with the outcome of the initial
determination and instructions on how
to request a redetermination.
(iv) Any other requirements specified
by CMS.
(2) [Reserved]
■ 6. Amend § 405.924 as follows:
■ A. In paragraph (b) introductory text,
removing the phrase ‘‘with respect to:’’
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
and add in its place the phrase ‘‘with
respect to any of the following:’’
■ B. In paragraph (b)(1) through (b)(11)
removing ‘‘;’’ and adding in its place ‘‘.’’
■ D. In paragraph (b)(12) introductory
text, removing the ‘‘:’’ and adding in its
place ‘‘—’’.
■ C. Adding paragraph (b)(15).
The addition reads as follows:
§ 405.924 Actions that are initial
determinations.
*
*
*
*
*
(b) * * *
(15) Under the Medicare Secondary
Payer provisions of section 1862(b) of
the Act that Medicare has a recovery
claim if Medicare is pursuing recovery
directly from an applicable plan. That
is, there is an initial determination with
respect to the amount and existence of
the recovery claim.
*
*
*
*
*
■ 7. Amend § 405.926 as follows:
■ A. In the introductory text, removing
the phrase ‘‘not limited to –’’ and
adding in its place the phrase ‘‘not
limited to the following:’’
■ B. In the introductory text of
paragraph (a), removing the phrase ‘‘for
example –’’ and adding in its place the
phrase ‘‘for example one of the
following:’’
■ C. In paragraphs (a)(1) and (a)(2),
removing ‘‘;’’ and adding in its place ‘‘.’’
■ D. Adding paragraph (a)(3).
■ E. In paragraphs (b) through (j),
removing ‘‘;’’ and adding in its place ‘‘.’’
■ F. Revising paragraph (k).
■ G. In paragraphs (l) through (q),
removing ‘‘;’’ and adding in its place ‘‘.’’
■ H. In paragraph (r), removing ‘‘; and’’
and adding in its place ‘‘.’’
The addition and revision read as
follows:
§ 405.926 Actions that are not initial
determinations.
*
*
*
*
*
(a) * * *
(3) Determination under the Medicare
Secondary Payer provisions of section
1862(b) of the Act of the debtor for a
particular recovery claim.
*
*
*
*
*
(k) Except as specified in
§ 405.924(b)(15), determinations under
the Medicare Secondary Payer
provisions of section 1862(b) of the Act
that Medicare has a recovery against an
entity that was or is required or
responsible (directly, as an insurer or
self-insurer; as a third party
administrator; as an employer that
sponsors, contributes to or facilitates a
group health plan or a large group
health plan; or otherwise) to make
payment for services or items that were
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Federal Register / Vol. 78, No. 249 / Friday, December 27, 2013 / Proposed Rules
already reimbursed by the Medicare
program.
*
*
*
*
*
■ 8. Add a new § 405.947 to subpart I to
read as follows:
§ 405.947 Notice to the beneficiary of
applicable plan’s request for a
redetermination.
(a) The contractor adjudicating the
redetermination request must send
notice of the applicable plan’s appeal to
the beneficiary.
(b) Issuance and content of the notice
must comply with CMS instructions.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: August 29, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: November 12, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human
Services.
[FR Doc. 2013–30661 Filed 12–26–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
42 CFR Part 1001
FOR FURTHER INFORMATION CONTACT:
Solicitation of New Safe Harbors and
Special Fraud Alerts
Patrice Drew, Congressional and
Regulatory Affairs Liaison, Office of
Inspector General, (202) 619–1368.
Office of Inspector General
(OIG), HHS.
ACTION: Notice of intent to develop
regulations.
AGENCY:
tkelley on DSK3SPTVN1PROD with PROPOSALS
SUPPLEMENTARY INFORMATION:
In accordance with section
205 of the Health Insurance Portability
and Accountability Act of 1996
(HIPAA), this annual notice solicits
proposals and recommendations for
developing new and modifying existing
safe harbor provisions under the Federal
anti-kickback statute (section 1128B(b)
of the Social Security Act), as well as
developing new OIG Special Fraud
Alerts.
DATES: To ensure consideration, public
comments must be delivered to the
address provided below by no later than
5 p.m. on February 25, 2014.
ADDRESSES: In commenting, please refer
to file code OIG–122–N. Because of staff
and resource limitations, we cannot
accept comments by facsimile (fax)
transmission.
You may submit comments in one of
three ways (no duplicates, please):
SUMMARY:
VerDate Mar<15>2010
19:07 Dec 26, 2013
Jkt 232001
1. Electronically. You may submit
electronic comments on specific
recommendations and proposals
through the Federal eRulemaking Portal
at https://www.regulations.gov.
2. By regular, express, or overnight
mail. You may send written comments
to the following address: Patrice Drew,
Office of Inspector General,
Congressional and Regulatory Affairs,
Department of Health and Human
Services, Attention: OIG–122–N, Room
5541C, Cohen Building, 330
Independence Avenue SW.,
Washington, DC 20201. Please allow
sufficient time for mailed comments to
be received before the close of the
comment period.
3. By hand or courier. If you prefer,
you may deliver, by hand or courier,
your written comments before the close
of the comment period to Patrice Drew,
Office of Inspector General, Department
of Health and Human Services, Cohen
Building, Room 5541C, 330
Independence Avenue SW.,
Washington, DC 20201. Because access
to the interior of the Cohen Building is
not readily available to persons without
Federal Government identification,
commenters are encouraged to schedule
their delivery with one of our staff
members at (202) 619–1368. For
information on viewing public
comments, please see the
Supplementary Information section.
Submitting Comments: We welcome
comments from the public on
recommendations for developing new or
revised safe harbors and Special Fraud
Alerts. Please assist us by referencing
the file code OIG–122–N.
Inspection of Public Comments: All
comments received before the end of the
comment period are available for
viewing by the public. All comments
will be posted on https://
www.regulations.gov as soon as possible
after they have been received.
Comments received timely will also be
available for public inspection as they
are received at Office of Inspector
General, Department of Health and
Human Services, Cohen Building, 330
Independence Avenue SW.,
Washington, DC 20201, Monday
through Friday from 9:30 a.m. to 5 p.m.
To schedule an appointment to view
public comments, phone (202) 619–
1368.
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Frm 00020
Fmt 4702
Sfmt 4702
78807
I. Background
A. OIG Safe Harbor Provisions
Section 1128B(b) of the Social
Security Act (the Act) (42 U.S.C. 1320a–
7b(b)) provides criminal penalties for
individuals or entities that knowingly
and willfully offer, pay, solicit, or
receive remuneration to induce or
reward business reimbursable under the
Federal health care programs. The
offense is classified as a felony and is
punishable by fines of up to $25,000
and imprisonment for up to 5 years. OIG
may also impose civil money penalties,
in accordance with section 1128A(a)(7)
of the Act (42 U.S.C. 1320a–7a(a)(7)), or
exclusion from the Federal health care
programs, in accordance with section
1128(b)(7) of the Act (42 U.S.C. 1320a–
7(b)(7)).
Since the statute on its face is so
broad, concern has been expressed for
many years that some relatively
innocuous commercial arrangements
may be subject to criminal prosecution
or administrative sanction. In response
to the above concern, section 14 of the
Medicare and Medicaid Patient and
Program Protection Act of 1987, Public
Law 100–93 § 14, the Act, § 1128B(b), 42
U.S.C. 1320a–7b(b), specifically
required the development and
promulgation of regulations, the socalled ‘‘safe harbor’’ provisions,
specifying various payment and
business practices that, although
potentially capable of inducing referrals
of business reimbursable under the
Federal health care programs, would not
be treated as criminal offenses under the
anti-kickback statute and would not
serve as a basis for administrative
sanctions. OIG safe harbor provisions
have been developed ‘‘to limit the reach
of the statute somewhat by permitting
certain non-abusive arrangements, while
encouraging beneficial and innocuous
arrangements’’ (56 FR 35952, July 29,
1991). Health care providers and others
may voluntarily seek to comply with
these provisions so that they have the
assurance that their business practices
will not be subject to liability under the
anti-kickback statute or related
administrative authorities. The OIG safe
harbor regulations are found at 42 CFR
1001.952.
B. OIG Special Fraud Alerts
OIG has also periodically issued
Special Fraud Alerts to give continuing
guidance to health care providers with
respect to practices OIG finds
potentially fraudulent or abusive. The
Special Fraud Alerts encourage industry
compliance by giving providers
guidance that can be applied to their
own practices. OIG Special Fraud Alerts
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Agencies
[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Proposed Rules]
[Pages 78802-78807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30661]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 405
[CMS-6055-P]
RIN 0938-AS03
Medicare Program; Right of Appeal for Medicare Secondary Payer
Determination Relating to Liability Insurance (Including Self-
Insurance), No Fault Insurance, and Workers' Compensation Laws and
Plans
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would implement provisions of the
Strengthening Medicare and Repaying Taxpayers Act of 2012 (SMART Act)
which require us to provide a right of appeal and an appeal process for
liability insurance (including self-insurance), no-fault insurance, and
workers' compensation laws or plans when Medicare pursues a Medicare
Secondary Payer (MSP) recovery claim directly from the liability
insurance (including self-insurance), no fault insurance, or workers'
compensation law or plan.
DATES: To be assured consideration, comments must be received at one of
the addresses provided, no later than 5 p.m. on February 25, 2014.
ADDRESSES: In commenting, please refer to file code CMS-6055-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four 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 instructions under
the ``More Search Options'' tab.
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-6055-P, P.O. Box 8013, Baltimore, MD
21244-8013.
[[Page 78803]]
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-6055-P, Mail Stop C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Room 445-G, Hubert H. Humphrey Building, 200
Independence Avenue SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-1066 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Barbara Wright, (410) 786-4292.
Cynthia Ginsburg, (410) 786-2579.
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 Web
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will be also available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, MD 21244-1850, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
please phone 1-800-743-3951.
I. Overview and Background
A. Overview
When the Medicare program was enacted in 1965, Medicare was the
primary payer for all medically necessary covered and otherwise
reimbursable items and services, with the exception of those items and
services covered and payable by workers' compensation. In 1980, the
Congress enacted the Medicare Secondary Payer (MSP) provisions of the
Social Security Act (the Act), which added section 1862(b) to the Act
and established Medicare as the secondary payer to certain primary
plans. Primary plan, as defined in section 1862(b)(2)(A) of the Act,
means a group health plan or large group health plan, workers'
compensation law or plan, automobile or liability insurance policy or
plan (including self-insured plan) or no fault insurance.
Section 1862(b)(2) of the Act, in part, prohibits Medicare from
making payment where payment has been made or can reasonably be
expected to be made by a primary plan. If payment has not been made or
cannot reasonably be expected to be made by a primary plan, Medicare
may make conditional payments with the expectation that the payments
will be reimbursed to the appropriate Medicare Trust Fund. That is,
Medicare may pay for medical claims with the expectation that it will
be repaid if the beneficiary obtains a settlement, judgment, award, or
other payment (hereafter referred to as ``settlement''). Section
1862(b)(2)(B) of the Act provides authority for Medicare to make
conditional payments and requires the primary plan, if it is
responsible for the payment, to reimburse Medicare. A primary plan and
any entity that receives payment from a primary plan shall reimburse
the appropriate Medicare Trust Fund for Medicare's payments for items
and services if it is demonstrated that such primary plan has or had
responsibility to make payment with respect to such items and services.
The responsibility for payment on the part of workers'
compensation, liability insurance (including self-insurance), and no-
fault insurance is generally demonstrated by ``settlements.'' When a
``settlement'' occurs, the ``settlement'' is subject to the Act's MSP
provisions because a ``payment has been made'' with respect to medical
care of a beneficiary related to that ``settlement.'' Section
1862(b)(2)(B)(iv) of the Act provides the Federal government
subrogation rights to any right under MSP of an individual or any other
entity to payment for items or services under a primary plan, to the
extent Medicare payments were made for such medical items and services.
Moreover, section 1862(b)(2)(B)(iii) of the Act provides the Federal
government a direct right of action to recover conditional payments
made by Medicare. This direct right of action, which is separate and
independent from Medicare's statutory subrogation rights, may be
brought to recover conditional payments against any or all entities
that are or were responsible for making payment for the items and
services under a primary plan. Under the direct right of action, the
Federal government may also recover from any entity that has received
payment from a primary plan or the proceeds of a primary plan's payment
to any entity.
B. Background
The Strengthening Medicare and Repaying Taxpayers Act of 2012 (the
SMART Act) was signed into law by President Obama on January 10, 2013,
and amends the Act's MSP provisions (found at 42 U.S.C. 1395y(b)).
Specifically, section 201 of the SMART Act added subparagraph (viii) to
section 1862(b)(2)(B) of the Social Security Act. This new clause
requires Medicare to promulgate regulations establishing a right of
appeal and an appeals process, with respect to any determination for
which the Secretary is seeking to recover payments from an applicable
plan (as defined in the MSP provisions), under which the applicable
plan involved, or an attorney, agent, or third-party administrator on
behalf of the applicable plan, may appeal such a determination.
Further, the individual furnished such an item and/or service shall be
notified of the applicable plan's intent to appeal such a
determination. For purposes of this provision, the term applicable plan
refers to liability insurance (including self-insurance), no-fault
insurance, or a workers' compensation law or plan as defined at section
1862(b)(8)(F) of the Act. (We note that the industry has expressed
interest in an appeal process for determinations regarding proposed
Workers' Compensation Medicare Set-
[[Page 78804]]
Aside Arrangement (WCMSA) amounts. This proposed rule does not address
this issue. It will be addressed separately.)
Currently, if an MSP recovery demand is issued to the beneficiary
as the identified debtor, the beneficiary has formal administrative
appeal rights and eventual judicial review as set forth in subpart I of
part 405. If the recovery demand is issued to the applicable plan as
the identified debtor, currently the applicable plan has no formal
administrative appeal rights or judicial review. CMS' recovery
contractor addresses any dispute raised by the applicable plan, but
there is no multilevel formal appeal process.
Subpart I of part 405, provides for a multilevel process including
a redetermination by the contractor issuing the recovery demand, a
reconsideration by a Qualified Independent Contractor (QIC), an
Administrative Law Judge (ALJ) hearing, a review by the Departmental
Appeals Board's (DAB) Medicare Appeals Council (MAC), and eventual
judicial review. The regulations set forth details on the process
including filing requirements, amount in controversy requirements, and
other requirements, as appropriate. We propose to include appeals for
applicable plans where Medicare is pursuing recovery directly from the
applicable plan in this process. The debts at issue involve recovery of
the same conditional payments that would be at issue if recovery were
directed at the beneficiary. Given this, we believe it is appropriate
to utilize the same multilevel appeals process for applicable plans.
II. Provisions of the Proposed Regulations
After review of the existing regulations in subpart I of 42 CFR
Part 405, we are proposing the following changes, as appropriate, in
order to include the applicable plan as a party when we pursue recovery
directly from the applicable plan.
We propose to amend Sec. 405.900, Basis and Scope, by revising
paragraph (a) to add section 1862(b)(2)(B)(viii) of the Act as part of
the statutory basis for Subpart I. Section 1862(b)(2)(B)(viii) of the
Act requires an appeals process for applicable plans when Medicare
pursues recovery directly from the applicable plan.
In Sec. 405.902, Definitions, we propose to add a definition of
the term ``applicable plan'' for purposes of Subpart I. We would adopt
the statutory definition of ``applicable plan'' in section
1862(b)(8)(F) of the Act, which states that an applicable plan means
liability insurance (including self-insurance), no-fault insurance, or
a workers' compensation law or plan.
We propose to amend Sec. 405.906, Parties to initial
determinations, redeterminations, reconsiderations, hearings and
reviews by adding Sec. 405.906(a)(4) to include the applicable plan as
a party for an initial determination where Medicare is pursuing
recovery directly from the applicable plan. By ``pursuing recovery
directly from the applicable plan,'' we mean that the applicable plan
would be the identified debtor, with a recovery demand letter requiring
repayment issued to the applicable plan (or its agent or
representative). Sending an applicable plan a courtesy copy of a
recovery demand letter issued to a beneficiary does not qualify as
``pursuing recovery directly from the applicable plan'' and does not
confer party status on the applicable plan. We are also proposing a
technical change in the section heading for Sec. 405.906 (adding a
comma before the phrase ``and reviews'').
Based upon this proposed change to Sec. 405.906, the applicable
plan's party status would continue at subsequent levels of appeal.
Consistent with section 1862(b)(2)(B)(viii) of the Act, the
beneficiary, provider, and/or supplier are not considered parties to an
appeal by an applicable plan. Thus, we propose to remove the
beneficiary, as well as the provider or supplier, as a party at the
redetermination level where Medicare is pursuing recovery directly from
the applicable plan. This would also, in effect, remove the beneficiary
and the provider or supplier as a party at subsequent levels of appeal
where Medicare is pursuing recovery directly from the applicable plan.
To implement our proposed changes, we would revise Sec. 405.906 (a) to
specify: (1) The circumstances under which an applicable plan is a
party to an initial determination; and (2) when an applicable plan is a
party to an initial determination, it is the sole party with respect to
that determination. Finally, as providers and suppliers would
specifically be excluded from party status for an initial determination
with respect to an applicable plan, we would make it clear that the
special rule for provider or supplier party status in Sec. 405.906(c)
does not apply to an initial determination with respect to an
applicable plan.
In proposed Sec. 405.910, Appointed representatives, we would add
a new paragraph (e)(4) to provide the applicable plan with parallel
rights to a beneficiary's rights or a provider or supplier's rights
regarding the duration of an appointment of representation with respect
to an MSP recovery claim. We also propose to revise Sec. 405.910(i)(4)
so that the special provision that beneficiaries as well as their
representatives must receive notices or requests in a MSP recovery case
continues to apply only to beneficiaries. For all other parties,
including an applicable plan, we would continue to follow the
regulatory provisions in Sec. 405.910(i)(1) through (3).
In Sec. 405.921, Notice of initial determination, we propose to
add a paragraph (c) to provide specific language regarding requirements
for notice to an applicable plan. This language would parallel the
existing language in this section regarding the notice to
beneficiaries. In addition to these changes, for consistency we have
made a number of technical and formatting changes.
In order for an action to be subject to the appeal process set
forth in subpart I of 42 CFR Part 405, there must be an ``initial
determination.'' We propose, in Sec. 405.924, Actions that are initial
determinations, to add a new paragraph Sec. 405.924(b)(15) providing
that a determination that Medicare has a recovery claim where Medicare
is pursuing recovery directly from an applicable plan is an initial
determination with respect to the amount of or existence of the MSP
recovery claim. This addition would generally parallel the existing
provisions in Sec. 405.924(b)(14) addressing pursuing MSP recovery
claims from a beneficiary, provider or supplier. In addition to these
changes, for consistency we have made a number of technical and
formatting changes.
The MSP provisions in section 1862(b) of the Act establish that
Medicare has a direct right of recovery against a primary payer.
Currently under Sec. 405.926(k), determinations under these provisions
that Medicare has a recovery against a particular primary payer, are
not initial determinations for purposes of part 405 subpart I.
Consequently, although the primary payer may dispute the recovery claim
where Medicare pursues recovery against the applicable plan, it has no
formal appeal rights. We propose to revise Sec. 405.926(k) by creating
an exception to the broad rule in Sec. 405.926(k) to reflect the
proposed addition of Sec. 405.924(b)(15). The proposed revision would
provide an exception to Sec. 405.926(k) where there is an initial
determination under Sec. 405.924(b)(15) (where Medicare is pursuing
recovery directly from an applicable plan). We also propose to add a
new Sec. 405.926(a)(3) to clarify that Medicare's determination
regarding
[[Page 78805]]
who/what entity it will pursue with respect to an MSP recovery claim is
not an initial determination for purposes of part 405 subpart I.
Because Medicare has the right to recover conditional payments from the
beneficiary, the primary payer, or any other entity that has the
proceeds from payment by the primary plan, Medicare's decision
regarding who/what entity it is pursuing recovery from is not subject
to appeal. We also propose to add the word ``facilitates'' to the
existing ``sponsors or contributes to'' language in Sec. 405.926(k) in
recognition of our longstanding position that the concept of employer
sponsorship or contribution has always included facilitation efforts.
Finally for consistency, we are proposing several technical changes.
We propose to add a new Sec. 405.947, Notice to the beneficiary of
an applicable plan's request for a redetermination, to add language
satisfying the requirement at section 1862(b)(2)(B)(viii) of the Act
that the beneficiary receive notice of the applicable plan's intent to
appeal where Medicare is pursuing recovery directly from the applicable
plan. As the beneficiary would not be a party to the appeal at the
redetermination level or subsequent levels of appeal, we believe that a
single notice at the redetermination level satisfies the intent of this
provision. We also propose that the required notice be issued by the
contractor adjudicating the redetermination request in order to ensure
clarity and consistency in the wording of the notice.
III. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
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 Statement
We have examined the impact of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(February 2, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security 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) and the Congressional Review Act (5 U.S.C. 804(2)).
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). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
We have determined that the effect of this proposed rule on the economy
and the Medicare program is not economically significant. The proposed
rule would provide a formal administrative appeal process for MSP
recovery claims where the applicable plan is the identified debtor, as
opposed to the current process which requires a CMS contractor to
consider any defense submitted by an applicable plan but does not
provide formal administrative appeal rights.
The RFA requires agencies to analyze options for regulatory relief
of small entities. For purposes of the RFA, small entities include
small businesses, nonprofit organizations, and small governmental
jurisdictions. Most hospitals and most other providers and suppliers
are small entities, either by nonprofit status or by having revenues of
less than $7.0 million to $35.5 million in any 1 year. Individuals and
States are not included in the definition of a small entity. We have
determined and we certify that this proposed rule would not have a
significant economic impact on a substantial number of small entities
because there is and will be no change in the administration of the MSP
provisions. The proposed changes would simply expand or formalize
existing rights with respect to MSP recovery claims pursued directly
from an applicable plan. Therefore, we are not preparing an analysis
for the RFA.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis (RIA) 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
for proposed rules 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 for Medicare payment
regulations and has fewer than 100 beds. We have determined that this
proposed rule would not have a significant effect on the operations of
a substantial number of small rural hospitals because it would simply
expand and/or formalize existing rights with respect to MSP recovery
claims pursued directly from an applicable plan. Therefore, we are not
preparing an analysis for section 1102(b) of the Act.
Section 202 of the Unfunded Mandates Reform Act of 1995 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 2013, that
threshold is approximately $141 million. This proposed rule has no
consequential effect on State, local, or tribal governments or on the
private sector because it would simply expand and/or formalize existing
rights with respect to MSP recovery claims pursued directly from an
applicable plan.
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on State
and local governments, preempts State law, or otherwise has Federalism
implications. Since this regulation does not impose any costs on State
or local governments, the requirements of Executive Order 13132 are not
applicable.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR Part 405 as set forth
below:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
0
1. The authority citation for part 405 reads as follows:
Authority: Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874,
1881, 1886(k) of the Social Security Act (42 U.S.C. 405(a),
[[Page 78806]]
1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and
1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C.
263a)
0
2. Amend Sec. 405.900 by revising paragraph (a) to read as follows:
Sec. 405.900 Basis and scope.
(a) Statutory basis. This subpart is based on the following
provisions of the Act:
(1) Section 1869(a) through (e) and (g) of the Act.
(2) Section 1862(b)(2)(B)(viii) of the Act.
* * * * *
0
3. Amend Sec. 405.902 by adding the definition ``Applicable plan'' in
alphabetical order to read as follows:
Sec. 405.902 Definitions.
* * * * *
Applicable plan means liability insurance (including self-
insurance), no-fault insurance, or a workers' compensation law or plan.
* * * * *
0
4. Amend Sec. 405.906 as follows:
0
A. Revising the section heading.
0
B. Adding new paragraph (a)(4).
0
C. Amending paragraph (c) by adding a sentence at the end of the
paragraph.
The additions and revision read as follows:
Sec. 405.906 Parties to the initial determinations, redeterminations,
reconsiderations, hearings, and reviews.
(a) * * *
(4) An applicable plan for an initial determination under Sec.
405.924(b)(15) where Medicare is pursuing recovery directly from the
applicable plan. The applicable plan is the sole party to an initial
determination under Sec. 405.924(b)(15) (that is, where Medicare is
pursuing recovery directly from the applicable plan).
* * * * *
(c) * * *. This paragraph (c) does not apply to an initial
determination with respect to an applicable plan under Sec.
405.924(b)(15).
0
4. Amend Sec. 405.910 as follows:
0
A. Adding paragraph (e)(4).
0
B. Revising paragraph (i)(4).
The addition and revision read as follows:
Sec. 405.910 Appointed representatives.
* * * * *
(e) * * *
(4) For an initial determination of a Medicare Secondary Payer
recovery claim, an appointment signed by an applicable plan which has
party status in accordance with Sec. 405.906(a)(1)(iv) is valid from
the date that appointment is signed for the duration of any subsequent
appeal, unless the appointment is specifically revoked.
* * * * *
(i) * * *
(4) For initial determinations and appeals involving Medicare
Secondary Payer recovery claims where the beneficiary is a party, the
adjudicator sends notices and requests to both the beneficiary and the
beneficiary's representative, if the beneficiary has a representative.
* * * * *
0
5. Amend Sec. 405.921 as follows:
0
A. In paragraph (a)(1), removing ``;'' and adding in its place ``.''
0
B. In paragraph (a)(2) introductory text, removing the phrase ``must
contain--'' and adding in its place the phrase ``must contain all of
the following:''
0
C. In paragraphs (a)(2)(i) and (a)(2)(ii), removing ``;'' and adding in
its place ``.''
0
D. In paragraph (a)(2)(iii), removing ``; and'' and adding in its place
``.''
0
E. Redesignating the second and third sentences of paragraph (b)(1) as
paragraph (b)(1)(i) and (ii), respectively.
0
F. In paragraph (b)(2) introductory text, removing the phrase ``must
contain:'' and adding in its place the phrase ``must contain all of the
following:''
0
G. In paragraphs (b)(2)(i) through (b)(2)(iv), removing ``;'' and add
in its place ``.''
0
H. In paragraph (b)(2)(v), removing ``; and'' and add in its place
``.''
0
I. Adding paragraph (c) to read as follows:
Sec. 405.921 Notice of initial determination.
* * * * *
(c) Notice of initial determination sent to an applicable plan--(1)
Content of the notice. The notice of initial determination under Sec.
405.924(b)(15) must contain all of the following:
(i) The reasons for the determination.
(ii) The procedures for obtaining additional information concerning
the contractor's determination, such as a specific provision of the
policy, manual, law or regulation used in making the determination.
(iii) Information on the right to a redetermination if the
liability insurance (including self-insurance), no-fault insurance, or
workers' compensation law or plan is dissatisfied with the outcome of
the initial determination and instructions on how to request a
redetermination.
(iv) Any other requirements specified by CMS.
(2) [Reserved]
0
6. Amend Sec. 405.924 as follows:
0
A. In paragraph (b) introductory text, removing the phrase ``with
respect to:'' and add in its place the phrase ``with respect to any of
the following:''
0
B. In paragraph (b)(1) through (b)(11) removing ``;'' and adding in its
place ``.''
0
D. In paragraph (b)(12) introductory text, removing the ``:'' and
adding in its place ``--''.
0
C. Adding paragraph (b)(15).
The addition reads as follows:
Sec. 405.924 Actions that are initial determinations.
* * * * *
(b) * * *
(15) Under the Medicare Secondary Payer provisions of section
1862(b) of the Act that Medicare has a recovery claim if Medicare is
pursuing recovery directly from an applicable plan. That is, there is
an initial determination with respect to the amount and existence of
the recovery claim.
* * * * *
0
7. Amend Sec. 405.926 as follows:
0
A. In the introductory text, removing the phrase ``not limited to -''
and adding in its place the phrase ``not limited to the following:''
0
B. In the introductory text of paragraph (a), removing the phrase ``for
example -'' and adding in its place the phrase ``for example one of the
following:''
0
C. In paragraphs (a)(1) and (a)(2), removing ``;'' and adding in its
place ``.''
0
D. Adding paragraph (a)(3).
0
E. In paragraphs (b) through (j), removing ``;'' and adding in its
place ``.''
0
F. Revising paragraph (k).
0
G. In paragraphs (l) through (q), removing ``;'' and adding in its
place ``.''
0
H. In paragraph (r), removing ``; and'' and adding in its place ``.''
The addition and revision read as follows:
Sec. 405.926 Actions that are not initial determinations.
* * * * *
(a) * * *
(3) Determination under the Medicare Secondary Payer provisions of
section 1862(b) of the Act of the debtor for a particular recovery
claim.
* * * * *
(k) Except as specified in Sec. 405.924(b)(15), determinations
under the Medicare Secondary Payer provisions of section 1862(b) of the
Act that Medicare has a recovery against an entity that was or is
required or responsible (directly, as an insurer or self-insurer; as a
third party administrator; as an employer that sponsors, contributes to
or facilitates a group health plan or a large group health plan; or
otherwise) to make payment for services or items that were
[[Page 78807]]
already reimbursed by the Medicare program.
* * * * *
0
8. Add a new Sec. 405.947 to subpart I to read as follows:
Sec. 405.947 Notice to the beneficiary of applicable plan's request
for a redetermination.
(a) The contractor adjudicating the redetermination request must
send notice of the applicable plan's appeal to the beneficiary.
(b) Issuance and content of the notice must comply with CMS
instructions.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: August 29, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare & Medicaid Services.
Approved: November 12, 2013.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2013-30661 Filed 12-26-13; 8:45 am]
BILLING CODE 4120-01-P