Medicare Program; Medicare Secondary Payer Amendments, 9466-9471 [06-1712]
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9466
Federal Register / Vol. 71, No. 37 / Friday, February 24, 2006 / Rules and Regulations
ADDENDUM F.—REVISED SINGLE DRUG CATEGORY LIST—Continued
HCPCS
Long description
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J9395 ........................................................
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Q3025 .......................................................
Vinorelbine tartrate, per 10 mg ....................................................................................
Injection, fulvestrant, 25 mg .........................................................................................
Porfimer sodium, 75 mg ...............................................................................................
Injection, interferon BETA–1A, 11 mcg for intramuscular use ....................................
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IV. Waiver of Proposed Rulemaking
and Delay in Effective Date
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register to provide a period for public
comment before the provisions of a rule
take effect in accordance with section
553(b) of the Administrative Procedure
Act (APA) (5 U.S.C. 553(b)). However,
we can waive the notice and comment
procedures if the Secretary finds, for
good cause, that the notice and
comment process is impracticable,
unnecessary or contrary to the public
interest, and incorporates a statement of
the finding and the reasons therefore in
the rule. We can also waive the 30-day
delay in effective date under the APA (5
U.S.C. 553(d)) when there is good cause
to do so and we publish in the rule an
explanation of our good cause.
This correcting amendment addresses
technical errors and omissions made in
FR Doc. 05–22160, entitled ‘‘Medicare
Program; Revisions to Payment Policies
Under the Physician Fee Schedule for
Calendar Year 2006 and Certain
Provisions Related to the Competitive
Acquisition Program of Outpatient
Drugs and Biologicals Under Part B,’’
which appeared in the Federal Register
on November 21, 2005 (70 FR 70116)
and was made effective January 1, 2006.
The provisions of this final rule with
comment period have been previously
subjected to notice and comment
procedures. These corrections are
consistent with the discussion and text
and do not make substantive changes to
the CY 2006 published rule. As such,
this correcting amendment is intended
to ensure the CY 2006 final rule with
comment accurately reflects the policy
adopted. Therefore, we find that
undertaking further notice and comment
procedures to incorporate these
corrections into the final rule with
comment is unnecessary and contrary to
the public interest.
For the same reasons, we are also
waiving the 30-day delay in effective
date for this correcting amendment. We
believe that it is in the public interest
to ensure that the CY 2006 final rule
with comment accurately states our
policy on physician fee schedule and
other Part B payment policies, and
provisions related to the competitive
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18:05 Feb 23, 2006
Jkt 208001
acquisition program of outpatient drugs
and biologicals under Part B. Therefore,
delaying the effective date of these
corrections beyond the January 1, 2006
effective date of the final rule with
comment period would be contrary to
the public interest. In so doing, we find
good cause to waive the 30-day delay in
the effective date.
(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
Dated: February 7, 2006.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. 06–1711 Filed 2–23–06; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 411 and 489
[CMS–6272–IFC]
RIN 0938–AN27
Medicare Program; Medicare
Secondary Payer Amendments
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment
period.
AGENCY:
SUMMARY: This interim final rule with
comment period implements
amendments to the Medicare Secondary
Payer (MSP) provisions under Title III of
the Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA). The MMA amendments
clarify the MSP provisions regarding the
obligations of primary plans and
primary payers, the nature of the
insurance arrangements subject to the
MSP rules, the circumstances under
which Medicare may make conditional
payments, and the obligations of
primary payers to reimburse Medicare.
DATES: Effective date: These regulations
are effective on April 25, 2006.
Comment date: To be assured
consideration, comments must be
received at one of the addresses
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provided below, no later than 5 p.m. on
April 25, 2006.
ADDRESSES: In commenting, please refer
to file code CMS–6272–IFC. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (no duplicates, please):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.cms.hhs.gov/eRulemaking. Click
on the link ‘‘Submit electronic
comments on CMS regulations with an
open comment period.’’ (Attachments
should be in Microsoft Word,
WordPerfect, or Excel; however, we
prefer Microsoft Word.)
2. By regular mail. You may mail
written comments (one original and two
copies) to the following address ONLY:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–6272–
IFC, g1P.O. Box 8017, Baltimore, MD
21244–8017.
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 (one
original and two copies) to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–6272–IFC, 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 (one original
and two copies) before the close of the
comment period to one of the following
addresses. If you intend to deliver your
comments to the Baltimore address,
please call telephone number (410) 786–
7195 in advance to schedule your
arrival with one of our staff members.
Room 445–G, Hubert H. Humphrey
Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500
Security Boulevard, Baltimore, MD
21244–1850.
(Because access to the interior of the
HHH Building is not readily available to
persons without Federal Government
identification, commenters are
encouraged to leave their comments in
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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.)
Comments 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:
Suzanne Ripley, (410) 786–0970.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome
comments from the public on all issues
set forth in this rule to assist us in fully
considering issues and developing
policies. You can assist us by
referencing the file code CMS–6272–IFC
and the specific ‘‘issue identifier’’ that
precedes the section on which you
choose to comment.
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.cms.hhs.gov/
eRulemaking. Click on the link
‘‘Electronic Comments on CMS
Regulations’’ 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, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
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I. Background
[If you choose to comment on issues
in this section, please indicate the
caption ‘‘Background’’ at the beginning
of your comment.]
Beginning in 1980, the Congress
enacted a series of amendments to
section 1862(b) of the Social Security
Act (the Act) (hereafter referred to as the
Medicare Secondary Payer (MSP)
provisions) to protect the financial
integrity of the Medicare program by
making Medicare a secondary payer,
rather than a primary payer of health
care services, when certain types of
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other health care coverage are available.
(Workers’ compensation had already
been primary to Medicare since the
implementation of the original Medicare
statute.) In enacting the MSP provisions,
the Congress intended that the MSP
provisions be construed to make
Medicare a secondary payer to the
maximum extent possible. These
statutory provisions are set forth in
regulations at 42 CFR part 411,
Exclusions From Medicare and
Limitations on Medicare Payment.
II. MMA Amendments to the Medicare
Secondary Payer (MSP) Provisions
[If you choose to comment on issues
in this section, please indicate the
caption ‘‘MMA Amendments to the
Medicare Secondary Payer Provisions’’
at the beginning of your comment.]
The Congress later became aware that
various parties were pressing several
interpretations of the MSP provisions
that would, if ultimately accepted,
severely limit the applicability of the
MSP provisions at considerable expense
to the Medicare program. Many of these
interpretations were presented in the
context of Federal court litigation over
the meaning of various MSP provisions.
The Congress rejected these attempts to
incorrectly limit the application and
scope of the MSP statute. The Congress
passed section 301 under Title III of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108–173) on
December 8, 2003 to clarify its original
intent regarding the MSP provisions
under section 1862(b) of the Act,
thereby indicating that these
interpretations were incorrect and that
the Secretary’s interpretations were
accurate. These clarifications are
effective as if enacted on the date of the
original legislation.
Section 301(a) of the MMA amends
section 1862(b)(2)(A)(ii) of the Act to
remove the term ‘‘promptly.’’ This
amendment establishes that various
parties were incorrect in their
interpretation that section
1862(b)(2)(A)(ii) of the Act applied only
if the workers’ compensation law or
plan, liability insurance, or no-fault
insurance has paid or could reasonably
be expected to pay for services
‘‘promptly.’’ This amendment also adds
language at section 1862(b)(2)(B) of the
Act to clarify that the Secretary may
make payment subject to reimbursement
if the workers’ compensation law or
plan, liability insurance, or no-fault
insurance has not paid or could not
reasonably be expected to pay for
services ‘‘promptly.’’
Section 301(b)(1) of the MMA amends
section 1862(b)(2)(A) of the Act to
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clarify the application of the term ‘‘selfinsured plan.’’ It establishes that ‘‘an
entity that engages in a business, trade,
or profession shall be deemed to have a
self-insured plan if it carries its own risk
(whether by a failure to obtain
insurance, or otherwise) in whole or in
part.’’
Section 301(b)(2)(A) of the MMA
amends section 1862(b)(2)(B) of the Act
to specify that a primary plan, and an
entity that receives payment from a
primary plan, shall reimburse the
appropriate Trust Fund for any payment
that the Secretary makes with respect to
an item or service if it is demonstrated
that the primary plan has or had a
responsibility to make payment with
respect to the item or service. It adds
language establishing that a primary
plan’s responsibility for this payment
‘‘may be demonstrated by a judgment, a
payment conditioned upon the
recipient’s compromise, waiver, or
release (whether or not there is a
determination or admission of liability)
of payment for items or services
included in a claim against the primary
plan or the primary plan’s insured, or by
other means.’’
Section 301(b)(3) of the MMA amends
section 1862(b)(2) of the Act to further
delineate those entities (that is,
‘‘primary payers’’) from which the
United States may seek reimbursement.
It amends language specifying that the
United States may bring an action
against ‘‘all entities that are or were
required or responsible (directly, as an
insurer or self-insurer, as a third-party
administrator, as an employer that
sponsors or contributes to a group
health plan, or large group health plan,
or otherwise) to make payment with
respect to the same item or service (or
any portion thereof) under a primary
plan.’’ This amendment specifies that
the United States may recover double
damages against these entities. Also, it
amends language clarifying that the
United States may recover payment
from ‘‘any entity that has received
payment from a primary plan or from
the proceeds of a primary plan’s
payment to any entity.’’
Under section 301(d) of the MMA,
these provisions are effective as if
enacted on the date of the original
legislation to reflect the original MSP
provisions and Congressional intent at
issue. As we discuss in more detail
below, this interim final rule with
comment period amends 42 CFR part
411 and § 489.20(i)(2)(ii) of our
regulations to implement these MSP
provisions.
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III. Provisions of This Interim Final
Rule With Comment Period
[If you choose to comment on issues
in this section, please indicate the
caption ‘‘Provisions of This Interim
Final Rule with Comment Period’’ at the
beginning of your comment.]
As is the case with group health plan
and large group health plan insurance,
Medicare may not make payment if
payment with respect to the same item
or service has been made or can
reasonably be expected to be made
under workers’ compensation, no-fault,
or liability insurance. However,
Medicare may make a payment
conditioned on reimbursement when
the workers’ compensation, no-fault, or
liability insurance (including a selfinsured plan) plan has not made or
cannot reasonably be expected to make
payment with respect to such item or
service promptly. In accordance with
section 301(a) of the MMA, we are
removing the word ‘‘promptly’’ from
§ 411.20(a)(2), § 411.40(b)(1)(i), and
§ 411.50(c)(1) and (c)(2) to clarify that
these Medicare payments are
conditional and must be reimbursed
whenever a primary payer’s
responsibility to make payment is
demonstrated.
At § 411.21, we are removing the
definitions for ‘‘third party payer’’ and
‘‘third party payment’’ and replacing
them with definitions for ‘‘primary
payer’’ and ‘‘primary payment.’’ We are
also providing a definition for ‘‘primary
plan.’’ We are making these changes to
conform to the statutory language under
the MMA. Consistent with these
changes, we are making nomenclature
changes to replace the terms ‘‘third
party payer,’’ ‘‘third party payment,’’
and ‘‘third party plan’’ with ‘‘primary
payer,’’ ‘‘primary payment,’’ or
‘‘primary plan,’’ respectively under part
411 throughout subparts B through H.
At § 411.33(f)(4), we are replacing the
term ‘‘third party’’ with ‘‘primary
payer.’’ We are also amending
§ 489.20(i)(2)(ii) to replace ‘‘third party
payment’’ with ‘‘primary payment.’’
In this interim final rule with
comment period, we are also adding
language to the definition of ‘‘selfinsured’’ plan in § 411.50(b) in
accordance with section 301(b)(1) of the
MMA. We are clarifying that an entity
that engages in a business, trade, or
profession is deemed to have a ‘‘selfinsured’’ plan for liability insurance if it
carries its own risk, in whole or in part.
Any such entity’s self-insured status
may be demonstrated, among other
ways, by the failure to obtain insurance.
In accordance with section
301(b)(2)(A) of the MMA, we are adding
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a new § 411.22 to clarify that a primary
payer, and an entity that receives
payment from a primary payer, become
obligated to reimburse CMS if and when
it is demonstrated that the primary
payer has or had primary payment
responsibility. This responsibility may
be demonstrated by a judgment, a
payment conditioned upon the
recipient’s compromise, waiver, or
release (whether or not there is a
determination or admission of liability)
of payment for items and services
included in a claim against the primary
payer, or by other means, including but
not limited to a settlement, award, or
contractual obligation. This means that
a primary payer may not extinguish its
obligations under the MSP provisions
by paying the wrong party—for
example, by paying the Medicare
beneficiary or the provider when it
should have reimbursed the Medicare
program. Primary payers are expected to
reimburse CMS when it is demonstrated
that they have or had payment
responsibility.
In accordance with section 301(b)(3)
of the MMA, the definition of ‘‘primary
payer’’ in § 411.21, the new § 411.22,
and the revised § 411.24(e) also clarify
that the Medicare program may seek
reimbursement from a primary payer, or
any or all the entities responsible or
required to make payment as a primary
payer. With respect to debts where a
group health plan or large group health
plan is the primary plan, the
amendments make clear that all
employers that sponsor or contribute to
the group health plan or large group
health plan are primary payers required
to reimburse Medicare regardless of
whether the group health plan or large
group health plan was an insured plan
(that is, the employer or other plan
sponsor purchased insurance) or was
self-insured by the employer or other
plan sponsor. Medicare may also seek
reimbursement from any entity that has
received payment from a primary payer.
Entities that receive payment include,
but are not limited to beneficiaries,
attorneys, and providers or suppliers
(including physicians).
Furthermore, in this interim final rule
with comment period, we are revising
§ 411.24(e) by adding language
pertaining to Medicare’s authority to
recover conditional payments.
Specifically, in accordance with section
301(b)(3) of the MMA, we specify at
§ 411.24(e) that CMS has a direct right
of action to recover from any primary
payer. We are making a technical
revision at § 411.24(f)(2) to replace the
words ‘‘is primary’’ with ‘‘is a primary
plan.’’
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Consistent with section 301(b)(2)(A)
of the MMA, this interim rule with
comment period clarifies at
§ 411.24(i)(1) that, like liability
insurance and disputed claims under
group health plans and no-fault
insurance, workers’ compensation
insurance and plans must also
reimburse Medicare, although it paid
some other entity, if it knew or should
have known that the claimant was a
Medicare beneficiary. Where Medicare
has already recovered payment from the
entity, reimbursement to Medicare by
the workers’ compensation insurance or
plan is not required. However, nothing
in this interim final rule with comment
period will be construed to require us to
first pursue the entity which receives
payment before it can pursue the
primary payer. Also consistent with
section 301(b)(2)(A) of the MMA, we are
adding language to § 411.45, § 411.52,
and § 411.53 to specify that any
conditional payment that Medicare
makes is based upon the recovery rules
under subpart B of part 411. In addition,
at § 411.52, we clarify the basis for
which Medicare makes payment in
liability cases. We are revising § 411.53
by removing the terms ‘‘, or the provider
or supplier,’’ in the existing paragraph
(a) to clarify that it is the beneficiary’s
responsibility to file a claim for no-fault
benefits.
III. 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.
IV. Waiver of Proposed Rulemaking
We ordinarily publish a notice of
proposed rulemaking in the Federal
Register and invite public comment on
the proposed rule. The notice of
proposed rulemaking includes a
reference to the legal authority under
which the rule is proposed, and the
terms and substances of the proposed
rule or a description of the subjects and
issues involved. This procedure can be
waived, however, if an agency finds
good cause that a notice-and-comment
procedure is impracticable,
unnecessary, or contrary to the public
interest and incorporates a statement of
the finding and its reasons in the rule
issued.
We find it unnecessary to undertake
notice and comment rulemaking
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because this interim final rule with
comment period merely conforms part
411 and § 489.20(i)(2)(ii) of the
regulations to statutory changes affected
by section 301 of the MMA. Therefore,
we find good cause to waive the notice
of proposed rulemaking and to issue
this final rule on an interim basis. We
are providing a 60-day public comment
period.
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V. 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.
VI. Regulatory Impact Statement
[If you choose to comment on issues
in this section, please indicate the
caption ‘‘Regulatory Impact’’ at the
beginning of your comment.]
We have examined the impacts of this
interim final rule with comment period
as required by Executive Order 12866
(September 1993, Regulatory Planning
and Review), the Regulatory Flexibility
Act (RFA) (September 19, 1980, Pub. L.
96–354), section 1102(b) of the Social
Security Act, the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4), and
Executive Order 13132.
Executive Order 12866 directs
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 interim final rule with
comment period on the economy and
the Medicare program is not
economically significant, since it merely
clarifies certain MSP provisions to
reflect original congressional intent and
ratifies the manner in which we have
implemented/administered the MSP
provisions. If the technical and
clarifying amendments had not been
enacted, ‘‘savings’’ reflected in the table
below would have been lost and
Medicare expenditures would have
increased.
The table reflects the potential impact
of a Fifth Circuit Court decision that
held that the MSP liability provision did
not apply when there was no liability
insurance purchased or no formal plan
of self-insurance recognized under the
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Internal Revenue Code. This placed a
small portion of future MSP liability
savings at risk. It was assumed that over
time, some U.S. Circuit Courts could
have reached a similar conclusion so
that the potential losses of future MSP
liability savings would increase slowly
over time in addition to the projected
growth of Medicare benefits. It was
further assumed that some individuals
who repaid Medicare before 2003 would
sue for refunds and that favorable
decisions would be rendered in some,
but not all, cases. It was also assumed
that the refunds of past MSP liability
savings would peak about 2007. Lastly,
it was assumed that MSP liability
collections represent approximately 70
percent Part A claims payments and 30
percent Part B claims payments (which
are based on historic MSP liability
savings).
9469
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule or notice
having the effect of 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 604 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 Core-Based Statistical Area and has
fewer than 100 beds. We have
determined that this interim final rule
with comment period will not have a
significant effect on the operations of a
substantial number of small rural
hospitals because there is and will be no
change in the administration of the MSP
provisions. Therefore, we are not
preparing an analysis for section 1102(b)
of the Act.
Section 202 of the Unfunded
MEDICARE SAVINGS RETAINED
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
[ROUNDED TO THE NEAREST $10
costs and benefits before issuing any
MILLION]
rule or notice having the effect of a rule
Part A
Part B
Total
whose mandates require spending in
any 1 year of $100 million in 1995
2003 ............
0
0
0 dollars, updated annually for inflation.
2004 ............
10
0
10
That threshold level is currently
2005 ............
10
0
10
2006 ............
10
0
10 approximately $120 million. This
2007 ............
20
0
20 interim final rule with comment period
2008 ............
10
0
10 has no consequential effect on State,
2009 ............
20
0
20 local, or tribal governments or on the
2010 ............
20
10
30 private sector because there is and will
2011 ............
20
10
30 be no change in the administration of
2012 ............
20
10
30 the MSP provisions.
2013 ............
20
10
30
Executive Order 13132 establishes
2014 ............
20
10
30
2015 ............
20
10
30 certain requirements that an agency
must meet when it promulgates a
Therefore, this interim final rule with proposed rule (and subsequent final
rule) that imposes substantial direct
comment period is not a major rule as
requirement costs on State and local
defined in Title 5, United States Code,
governments, preempts State law, or
section 804(2) and is not an
otherwise has Federalism implications.
economically significant rule under
Since this regulation does not impose
Executive Order 12866.
The RFA requires agencies to analyze any costs on State or local governments,
options for regulatory relief of small
the requirements of E.O. 13132 are not
entities. For purposes of the RFA, small applicable.
entities include small businesses,
In accordance with the provisions of
nonprofit organizations, and small
Executive Order 12866, this regulation
governmental jurisdictions. Most
was reviewed by the Office of
hospitals and most other providers and
Management and Budget.
suppliers are small entities, either by
List of Subjects
nonprofit status or by having revenues
of $6 million to $29 million in any 1
42 CFR Part 411
year. Individuals and States are not
Kidney diseases, Medicare, Reporting
included in the definition of a small
and recordkeeping requirements.
entity. We have determined and we
certify that this interim final rule with
42 CFR Part 489
comment period will not have a
Health facilities, Medicare, Reporting
significant economic impact on a
and recordkeeping requirements.
substantial number of small entities
because there is and will be no change
I For the reasons set forth in the
in the administration of the MSP
preamble, the Centers for Medicare &
provisions. Therefore, we are not
Medicaid Services amends 42 CFR
preparing an analysis for the RFA.
chapter IV as set forth below:
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included in a claim against the primary
payer or the primary payer’s insured; or
(3) By other means, including but not
limited to a settlement, award, or
contractual obligation.
PART 411—EXCLUSIONS FROM
MEDICARE AND LIMITATIONS ON
MEDICARE PAYMENT
1. The authority citation for part 411
continues to read as follows:
I
§ 411.24
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
§ 411.20
[Amended]
2. Section 411.20 is amended by
removing the word ‘‘promptly’’ in
paragraph (a)(2) introductory text.
I 3. Section 411.21 is amended by
adding definitions of ‘‘primary payer,’’
‘‘primary payment,’’ and ‘‘primary
plan’’ and removing the definitions of
‘‘third party payer’’ and ‘‘third party
payment’’ to read as follows:
I
§ 411.21
*
*
*
*
*
Primary payer means, when used in
the context in which Medicare is the
secondary payer, any entity that is or
was required or responsible to make
payment with respect to an item or
service (or any portion thereof) under a
primary plan. These entities include,
but are not limited to, insurers or selfinsurers, third party administrators, and
all employers that sponsor or contribute
to group health plans or large group
health plans.
Primary payment means, when used
in the context in which Medicare is the
secondary payer, payment by a primary
payer for services that are also covered
under Medicare.
Primary plan means, when used in
the context in which Medicare is the
secondary payer, a group health plan or
large group health plan, a workers’
compensation law or plan, an
automobile or liability insurance policy
or plan (including a self-insured plan),
or no-fault insurance.
*
*
*
*
*
I 4. A new § 411.22 is added to read as
follows:
wwhite on PROD1PC61 with RULES
§ 411.22 Reimbursement obligations of
primary payers and entities that received
payment from primary payers.
(a) A primary payer, and an entity that
receives payment from a primary payer,
must reimburse CMS for any payment if
it is demonstrated that the primary
payer has or had a responsibility to
make payment.
(b) A primary payer’s responsibility
for payment may be demonstrated by—
(1) A judgment;
(2) A payment conditioned upon the
recipient’s compromise, waiver, or
release (whether or not there is a
determination or admission of liability)
of payment for items or services
18:05 Feb 23, 2006
§ 411.24 Recovery of conditional
payments.
*
Definitions.
VerDate Aug<31>2005
[Amended]
5. Section 411.24 is amended by—
A. Revising paragraph (e).
B. Removing the words ‘‘is primary’’
and adding in its place the phrase ‘‘is a
primary plan’’ in paragraph (f)(2).
I C. Adding ’’, workers’ compensation
insurance or plan,’’ after ‘‘group health
plans’’ and before ‘‘and’’ in paragraph
(i)(1).
Revisions for paragraph (e) read as
follows:
I
I
I
Jkt 208001
*
*
*
*
(e) Recovery from primary payers.
CMS has a direct right of action to
recover from any primary payer.
*
*
*
*
*
I 6. Section 411.33(f)(4) introductory
text is revised to read as follows:
§ 411.33 Amount of Medicare secondary
payment.
*
*
*
*
*
(f) Examples: * * *
(4) A hospital furnished 5 days of
inpatient care in 1987 to a Medicare
beneficiary. The provider’s charges for
Medicare-covered services were $4,000
and the gross amount payable was
$3,500. The provider agreed to accept
$3,000 from the primary payer as
payment in full. The primary payer paid
$2,900 due to a deductible requirement
under the primary plan. Medicare
considers the amount the provider is
obligated to accept as full payment
($3,000) to be the provider charges. The
Medicare secondary payment is the
lowest of the following:
*
*
*
*
*
§ 411.40
[Amended]
7. Section 411.40 is amended by
removing the word ‘‘promptly’’ in
paragraph (b)(1)(i).
I 8. Section 411.45 is revised to read as
follows:
I
§ 411.45 Basis for conditional Medicare
payment in workers’ compensation cases.
(a) A conditional Medicare payment
may be made under either of the
following circumstances:
(1) The beneficiary has filed a proper
claim for workers’ compensation
benefits, but the intermediary or carrier
determines that the workers’
compensation carrier will not pay
promptly. This includes cases in which
a workers’ compensation carrier has
denied a claim.
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
(2) The beneficiary, because of
physical or mental capacity, failed to
file a proper claim.
(b) Any conditional payment that
CMS makes is conditioned on
reimbursement to CMS in accordance
with subpart B of this part.
§ 411.50
[Amended]
9. Section 411.50 is amended by—
I A. Revising the definition of ‘‘selfinsured plan’’ in paragraph (b).
I B. Removing the word ‘‘promptly’’ in
paragraphs (c)(1) and (c)(2).
I The revision reads as follows:
I
§ 411.50
General provisions.
*
*
*
*
*
(b) Definitions.
*
*
*
*
*
Self-insured plan means a plan under
which an individual, or a private or
governmental entity, carries its own risk
instead of taking out insurance with a
carrier. This term includes a plan of an
individual or other entity engaged in a
business, trade, or profession, a plan of
a non-profit organization such as a
social, fraternal, labor, educational,
religious, or professional organization,
and the plan established by the Federal
government to pay liability claims
under the Federal Tort Claims Act. An
entity that engages in a business, trade,
or profession is deemed to have a selfinsured plan for purposes of liability
insurance if it carries its own risk
(whether by a failure to obtain
insurance, or otherwise) in whole or in
part.
*
*
*
*
*
10. Section 411.52 is revised to read
as follows:
I
§ 411.52 Basis for conditional Medicare
payment in liability cases.
(a) A conditional Medicare payment
may be made in liability cases under
either of the following circumstances:
(1) The beneficiary has filed a proper
claim for liability insurance benefits but
the intermediary or carrier determines
that the liability insurer will not pay
promptly for any reason other than the
circumstances described in
§ 411.32(a)(1). This includes cases in
which the liability insurance carrier has
denied the claim.
(2) The beneficiary has not filed a
claim for liability insurance benefits.
(b) Any conditional payment that
CMS makes is conditioned on
reimbursement to CMS in accordance
with subpart B of this part.
I 11. Section 411.53 is revised to read
as follows:
E:\FR\FM\24FER1.SGM
24FER1
Federal Register / Vol. 71, No. 37 / Friday, February 24, 2006 / Rules and Regulations
§ 411.53 Basis for conditional Medicare
payment in no-fault cases.
DEPARTMENT OF COMMERCE
(a) A conditional Medicare payment
may be made in no-fault cases under
either of the following circumstances:
(1) The beneficiary has filed a proper
claim for no-fault insurance benefits but
the intermediary or carrier determines
that the no-fault insurer will not pay
promptly for any reason other than the
circumstances described in
§ 411.32(a)(1). This includes cases in
which the no-fault insurance carrier has
denied the claim.
(2) The beneficiary, because of
physical or mental incapacity, failed to
meet a claim-filing requirement
stipulated in the policy.
(b) Any conditional payment that
CMS makes is conditioned on
reimbursement to CMS in accordance
with subpart B of this part.
National Oceanic and Atmospheric
Administration
PART 411—[NOMENCLATURE
CHANGE]
12. In part 411, revise all references to
‘‘third party payer’’ to read ‘‘primary
payer’; revise all references to ‘‘third
party payment’’ to read ‘‘primary
payment’; and revise all references to
‘‘third party plan’’ to read ‘‘primary
plan’’.
I
PART 489—PROVIDER AGREEMENTS
AND SUPPLIER APPROVAL
1. The authority citation for part 489
continues to read as follows:
I
Authority: Secs. 1102 and 1871 of the
Social Security Act.
§ 489.20
2. Section § 489.20(i)(2)(ii)
introductory text is amended by
removing the words ‘‘third party
payment’’ and adding in its place the
words ‘‘primary payment’’.
I
wwhite on PROD1PC61 with RULES
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: February 8, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare &
Medicaid Services.
Approved: November 14, 2005.
Michael O. Leavitt,
Secretary, Department of Health and Human
Services.
[FR Doc. 06–1712 Filed 2–23–06; 8:45 am]
VerDate Aug<31>2005
18:05 Feb 23, 2006
Jkt 208001
[Docket No. 051128313–6029–02; I.D.
111705C]
The Northeast Fisheries Science
Center 41st Stock Assessment Review
Committee (SARC) Panelist Reports are
available at: https://www.nefsc.noaa.gov/
nefsc/saw/saw41/.
FOR FURTHER INFORMATION CONTACT:
Bonnie Van Pelt, Fishery Policy
Analyst, (978) 281–9244.
SUPPLEMENTARY INFORMATION:
RIN 0648–AT20
Background
Fisheries of the Northeastern United
States; Atlantic Bluefish Fisheries;
2006 Atlantic Bluefish Specifications;
Quota Adjustment; 2006 Research SetAside Project
The regulations implementing the
Atlantic Bluefish Fishery Management
Plan (FMP) appear at 50 CFR part 648,
subparts A and J. Regulations requiring
annual specifications are found at 50
CFR 648.160. The management unit for
bluefish (Pomatomus saltatrix) is U.S.
waters of the western Atlantic Ocean.
The FMP requires that the MidAtlantic Fishery Management Council
(Council) recommend, on an annual
basis, total allowable landings (TAL) for
the fishery, consisting of a commercial
quota and recreational harvest limit.
The annual review process for
bluefish requires that the Council’s
Bluefish Monitoring Committee
(Monitoring Committee) review and
make recommendations based on the
best available data including, but not
limited to, commercial and recreational
catch/landing statistics, current
estimates of fishing mortality, stock
abundance, discards for the recreational
fishery, and juvenile recruitment. Based
on the recommendations of the
Monitoring Committee, the Council
makes a recommendation to NMFS.
This FMP is a joint plan with the
Atlantic States Marine Fisheries
Commission (Commission); therefore,
the Commission meets during the
annual specification process to adopt
complementary measures.
The Council’s recommendations must
include supporting documentation
concerning the environmental,
economic, and social impacts of the
recommendations. NMFS is responsible
for reviewing these recommendations to
ensure they achieve the FMP objectives,
and may modify them if they do not.
NMFS then publishes proposed
specifications in the Federal Register.
After considering public comment,
NMFS publishes final specifications in
the Federal Register.
In July 2005, the Monitoring
Committee accepted the most recent
bluefish stock assessment as the basis
for its specification recommendations to
the Council. In August 2005, the
Council approved the Monitoring
Committee’s recommendations and the
Commission’s Bluefish Board (Board)
adopted complementary management
measures.
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final rule; final specifications
for the 2006 Atlantic bluefish fishery.
AGENCY:
SUMMARY: NMFS issues 2006
specifications for the Atlantic bluefish
fishery, including state-by-state
commercial quotas, a recreational
harvest limit, and recreational
possession limits for Atlantic bluefish
off the east coast of the United States.
The intent of these specifications is to
establish the allowable 2006 harvest
levels and possession limits to attain the
target fishing mortality rate (F),
consistent with the stock rebuilding
program in Amendment 1 to the
Atlantic Bluefish Fishery Management
Plan (FMP). This action will publish
final specifications that are modified
from those contained in the proposed
rule.
This rule is effective March 27,
2006, through December 31, 2006.
ADDRESSES: Copies of the specifications
document, including the Environmental
Assessment (EA) and the Initial
Regulatory Flexibility Analysis (IRFA)
are available from Daniel Furlong,
Executive Director, Mid-Atlantic
Fishery Management Council, Room
2115, Federal Building, 300 South
Street, Dover, DE 19901 6790. The
specifications document is also
accessible via the Internet at https://
www.nero.nmfs.gov.
The Final Regulatory Flexibility
Analysis (FRFA) consists of the IRFA,
public comments and responses
contained in this final rule, and a
summary of impacts and alternatives
contained in this final rule.
The small entity compliance guide is
available from Patricia A. Kurkul,
Regional Administrator, Northeast
Regional Office, National Marine
Fisheries Service, One Blackburn Drive,
Gloucester, MA 01930 2298.
DATES:
[Amended]
BILLING CODE 4120–01–P
50 CFR Part 648
9471
PO 00000
Frm 00045
Fmt 4700
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E:\FR\FM\24FER1.SGM
24FER1
Agencies
[Federal Register Volume 71, Number 37 (Friday, February 24, 2006)]
[Rules and Regulations]
[Pages 9466-9471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1712]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 411 and 489
[CMS-6272-IFC]
RIN 0938-AN27
Medicare Program; Medicare Secondary Payer Amendments
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Interim final rule with comment period.
-----------------------------------------------------------------------
SUMMARY: This interim final rule with comment period implements
amendments to the Medicare Secondary Payer (MSP) provisions under Title
III of the Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA). The MMA amendments clarify the MSP provisions
regarding the obligations of primary plans and primary payers, the
nature of the insurance arrangements subject to the MSP rules, the
circumstances under which Medicare may make conditional payments, and
the obligations of primary payers to reimburse Medicare.
DATES: Effective date: These regulations are effective on April 25,
2006.
Comment date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on April 25, 2006.
ADDRESSES: In commenting, please refer to file code CMS-6272-IFC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (no duplicates,
please):
1. Electronically. You may submit electronic comments on specific
issues in this regulation to https://www.cms.hhs.gov/eRulemaking. Click
on the link ``Submit electronic comments on CMS regulations with an
open comment period.'' (Attachments should be in Microsoft Word,
WordPerfect, or Excel; however, we prefer Microsoft Word.)
2. By regular mail. You may mail written comments (one original and
two copies) to the following address ONLY: Centers for Medicare &
Medicaid Services, Department of Health and Human Services, Attention:
CMS-6272-IFC, g1P.O. Box 8017, Baltimore, MD 21244-8017.
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 (one
original and two copies) to the following address ONLY: Centers for
Medicare & Medicaid Services, Department of Health and Human Services,
Attention: CMS-6272-IFC, 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 (one original and two copies) before the
close of the comment period to one of the following addresses. If you
intend to deliver your comments to the Baltimore address, please call
telephone number (410) 786-7195 in advance to schedule your arrival
with one of our staff members.
Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue,
SW., Washington, DC 20201; or 7500 Security Boulevard, Baltimore, MD
21244-1850.
(Because access to the interior of the HHH Building is not readily
available to persons without Federal Government identification,
commenters are encouraged to leave their comments in
[[Page 9467]]
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.)
Comments 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: Suzanne Ripley, (410) 786-0970.
SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments
from the public on all issues set forth in this rule to assist us in
fully considering issues and developing policies. You can assist us by
referencing the file code CMS-6272-IFC and the specific ``issue
identifier'' that precedes the section on which you choose to comment.
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.cms.hhs.gov/eRulemaking. Click on the link ``Electronic Comments on
CMS Regulations'' 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, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
I. Background
[If you choose to comment on issues in this section, please
indicate the caption ``Background'' at the beginning of your comment.]
Beginning in 1980, the Congress enacted a series of amendments to
section 1862(b) of the Social Security Act (the Act) (hereafter
referred to as the Medicare Secondary Payer (MSP) provisions) to
protect the financial integrity of the Medicare program by making
Medicare a secondary payer, rather than a primary payer of health care
services, when certain types of other health care coverage are
available. (Workers' compensation had already been primary to Medicare
since the implementation of the original Medicare statute.) In enacting
the MSP provisions, the Congress intended that the MSP provisions be
construed to make Medicare a secondary payer to the maximum extent
possible. These statutory provisions are set forth in regulations at 42
CFR part 411, Exclusions From Medicare and Limitations on Medicare
Payment.
II. MMA Amendments to the Medicare Secondary Payer (MSP) Provisions
[If you choose to comment on issues in this section, please
indicate the caption ``MMA Amendments to the Medicare Secondary Payer
Provisions'' at the beginning of your comment.]
The Congress later became aware that various parties were pressing
several interpretations of the MSP provisions that would, if ultimately
accepted, severely limit the applicability of the MSP provisions at
considerable expense to the Medicare program. Many of these
interpretations were presented in the context of Federal court
litigation over the meaning of various MSP provisions. The Congress
rejected these attempts to incorrectly limit the application and scope
of the MSP statute. The Congress passed section 301 under Title III of
the Medicare Prescription Drug, Improvement, and Modernization Act of
2003 (MMA) (Pub. L. 108-173) on December 8, 2003 to clarify its
original intent regarding the MSP provisions under section 1862(b) of
the Act, thereby indicating that these interpretations were incorrect
and that the Secretary's interpretations were accurate. These
clarifications are effective as if enacted on the date of the original
legislation.
Section 301(a) of the MMA amends section 1862(b)(2)(A)(ii) of the
Act to remove the term ``promptly.'' This amendment establishes that
various parties were incorrect in their interpretation that section
1862(b)(2)(A)(ii) of the Act applied only if the workers' compensation
law or plan, liability insurance, or no-fault insurance has paid or
could reasonably be expected to pay for services ``promptly.'' This
amendment also adds language at section 1862(b)(2)(B) of the Act to
clarify that the Secretary may make payment subject to reimbursement if
the workers' compensation law or plan, liability insurance, or no-fault
insurance has not paid or could not reasonably be expected to pay for
services ``promptly.''
Section 301(b)(1) of the MMA amends section 1862(b)(2)(A) of the
Act to clarify the application of the term ``self-insured plan.'' It
establishes that ``an entity that engages in a business, trade, or
profession shall be deemed to have a self-insured plan if it carries
its own risk (whether by a failure to obtain insurance, or otherwise)
in whole or in part.''
Section 301(b)(2)(A) of the MMA amends section 1862(b)(2)(B) of the
Act to specify that a primary plan, and an entity that receives payment
from a primary plan, shall reimburse the appropriate Trust Fund for any
payment that the Secretary makes with respect to an item or service if
it is demonstrated that the primary plan has or had a responsibility to
make payment with respect to the item or service. It adds language
establishing that a primary plan's responsibility for this payment
``may be demonstrated by a judgment, a payment conditioned upon the
recipient's compromise, waiver, or release (whether or not there is a
determination or admission of liability) of payment for items or
services included in a claim against the primary plan or the primary
plan's insured, or by other means.''
Section 301(b)(3) of the MMA amends section 1862(b)(2) of the Act
to further delineate those entities (that is, ``primary payers'') from
which the United States may seek reimbursement. It amends language
specifying that the United States may bring an action against ``all
entities that are or were required or responsible (directly, as an
insurer or self-insurer, as a third-party administrator, as an employer
that sponsors or contributes to a group health plan, or large group
health plan, or otherwise) to make payment with respect to the same
item or service (or any portion thereof) under a primary plan.'' This
amendment specifies that the United States may recover double damages
against these entities. Also, it amends language clarifying that the
United States may recover payment from ``any entity that has received
payment from a primary plan or from the proceeds of a primary plan's
payment to any entity.''
Under section 301(d) of the MMA, these provisions are effective as
if enacted on the date of the original legislation to reflect the
original MSP provisions and Congressional intent at issue. As we
discuss in more detail below, this interim final rule with comment
period amends 42 CFR part 411 and Sec. 489.20(i)(2)(ii) of our
regulations to implement these MSP provisions.
[[Page 9468]]
III. Provisions of This Interim Final Rule With Comment Period
[If you choose to comment on issues in this section, please
indicate the caption ``Provisions of This Interim Final Rule with
Comment Period'' at the beginning of your comment.]
As is the case with group health plan and large group health plan
insurance, Medicare may not make payment if payment with respect to the
same item or service has been made or can reasonably be expected to be
made under workers' compensation, no-fault, or liability insurance.
However, Medicare may make a payment conditioned on reimbursement when
the workers' compensation, no-fault, or liability insurance (including
a self-insured plan) plan has not made or cannot reasonably be expected
to make payment with respect to such item or service promptly. In
accordance with section 301(a) of the MMA, we are removing the word
``promptly'' from Sec. 411.20(a)(2), Sec. 411.40(b)(1)(i), and Sec.
411.50(c)(1) and (c)(2) to clarify that these Medicare payments are
conditional and must be reimbursed whenever a primary payer's
responsibility to make payment is demonstrated.
At Sec. 411.21, we are removing the definitions for ``third party
payer'' and ``third party payment'' and replacing them with definitions
for ``primary payer'' and ``primary payment.'' We are also providing a
definition for ``primary plan.'' We are making these changes to conform
to the statutory language under the MMA. Consistent with these changes,
we are making nomenclature changes to replace the terms ``third party
payer,'' ``third party payment,'' and ``third party plan'' with
``primary payer,'' ``primary payment,'' or ``primary plan,''
respectively under part 411 throughout subparts B through H. At Sec.
411.33(f)(4), we are replacing the term ``third party'' with ``primary
payer.'' We are also amending Sec. 489.20(i)(2)(ii) to replace ``third
party payment'' with ``primary payment.''
In this interim final rule with comment period, we are also adding
language to the definition of ``self-insured'' plan in Sec. 411.50(b)
in accordance with section 301(b)(1) of the MMA. We are clarifying that
an entity that engages in a business, trade, or profession is deemed to
have a ``self-insured'' plan for liability insurance if it carries its
own risk, in whole or in part. Any such entity's self-insured status
may be demonstrated, among other ways, by the failure to obtain
insurance.
In accordance with section 301(b)(2)(A) of the MMA, we are adding a
new Sec. 411.22 to clarify that a primary payer, and an entity that
receives payment from a primary payer, become obligated to reimburse
CMS if and when it is demonstrated that the primary payer has or had
primary payment responsibility. This responsibility may be demonstrated
by a judgment, a payment conditioned upon the recipient's compromise,
waiver, or release (whether or not there is a determination or
admission of liability) of payment for items and services included in a
claim against the primary payer, or by other means, including but not
limited to a settlement, award, or contractual obligation. This means
that a primary payer may not extinguish its obligations under the MSP
provisions by paying the wrong party--for example, by paying the
Medicare beneficiary or the provider when it should have reimbursed the
Medicare program. Primary payers are expected to reimburse CMS when it
is demonstrated that they have or had payment responsibility.
In accordance with section 301(b)(3) of the MMA, the definition of
``primary payer'' in Sec. 411.21, the new Sec. 411.22, and the
revised Sec. 411.24(e) also clarify that the Medicare program may seek
reimbursement from a primary payer, or any or all the entities
responsible or required to make payment as a primary payer. With
respect to debts where a group health plan or large group health plan
is the primary plan, the amendments make clear that all employers that
sponsor or contribute to the group health plan or large group health
plan are primary payers required to reimburse Medicare regardless of
whether the group health plan or large group health plan was an insured
plan (that is, the employer or other plan sponsor purchased insurance)
or was self-insured by the employer or other plan sponsor. Medicare may
also seek reimbursement from any entity that has received payment from
a primary payer. Entities that receive payment include, but are not
limited to beneficiaries, attorneys, and providers or suppliers
(including physicians).
Furthermore, in this interim final rule with comment period, we are
revising Sec. 411.24(e) by adding language pertaining to Medicare's
authority to recover conditional payments. Specifically, in accordance
with section 301(b)(3) of the MMA, we specify at Sec. 411.24(e) that
CMS has a direct right of action to recover from any primary payer. We
are making a technical revision at Sec. 411.24(f)(2) to replace the
words ``is primary'' with ``is a primary plan.''
Consistent with section 301(b)(2)(A) of the MMA, this interim rule
with comment period clarifies at Sec. 411.24(i)(1) that, like
liability insurance and disputed claims under group health plans and
no-fault insurance, workers' compensation insurance and plans must also
reimburse Medicare, although it paid some other entity, if it knew or
should have known that the claimant was a Medicare beneficiary. Where
Medicare has already recovered payment from the entity, reimbursement
to Medicare by the workers' compensation insurance or plan is not
required. However, nothing in this interim final rule with comment
period will be construed to require us to first pursue the entity which
receives payment before it can pursue the primary payer. Also
consistent with section 301(b)(2)(A) of the MMA, we are adding language
to Sec. 411.45, Sec. 411.52, and Sec. 411.53 to specify that any
conditional payment that Medicare makes is based upon the recovery
rules under subpart B of part 411. In addition, at Sec. 411.52, we
clarify the basis for which Medicare makes payment in liability cases.
We are revising Sec. 411.53 by removing the terms ``, or the provider
or supplier,'' in the existing paragraph (a) to clarify that it is the
beneficiary's responsibility to file a claim for no-fault benefits.
III. 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.
IV. Waiver of Proposed Rulemaking
We ordinarily publish a notice of proposed rulemaking in the
Federal Register and invite public comment on the proposed rule. The
notice of proposed rulemaking includes a reference to the legal
authority under which the rule is proposed, and the terms and
substances of the proposed rule or a description of the subjects and
issues involved. This procedure can be waived, however, if an agency
finds good cause that a notice-and-comment procedure is impracticable,
unnecessary, or contrary to the public interest and incorporates a
statement of the finding and its reasons in the rule issued.
We find it unnecessary to undertake notice and comment rulemaking
[[Page 9469]]
because this interim final rule with comment period merely conforms
part 411 and Sec. 489.20(i)(2)(ii) of the regulations to statutory
changes affected by section 301 of the MMA. Therefore, we find good
cause to waive the notice of proposed rulemaking and to issue this
final rule on an interim basis. We are providing a 60-day public
comment period.
V. 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.
VI. Regulatory Impact Statement
[If you choose to comment on issues in this section, please
indicate the caption ``Regulatory Impact'' at the beginning of your
comment.]
We have examined the impacts of this interim final rule with
comment period as required by Executive Order 12866 (September 1993,
Regulatory Planning and Review), the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social
Security Act, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4),
and Executive Order 13132.
Executive Order 12866 directs 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 interim final rule with comment
period on the economy and the Medicare program is not economically
significant, since it merely clarifies certain MSP provisions to
reflect original congressional intent and ratifies the manner in which
we have implemented/administered the MSP provisions. If the technical
and clarifying amendments had not been enacted, ``savings'' reflected
in the table below would have been lost and Medicare expenditures would
have increased.
The table reflects the potential impact of a Fifth Circuit Court
decision that held that the MSP liability provision did not apply when
there was no liability insurance purchased or no formal plan of self-
insurance recognized under the Internal Revenue Code. This placed a
small portion of future MSP liability savings at risk. It was assumed
that over time, some U.S. Circuit Courts could have reached a similar
conclusion so that the potential losses of future MSP liability savings
would increase slowly over time in addition to the projected growth of
Medicare benefits. It was further assumed that some individuals who
repaid Medicare before 2003 would sue for refunds and that favorable
decisions would be rendered in some, but not all, cases. It was also
assumed that the refunds of past MSP liability savings would peak about
2007. Lastly, it was assumed that MSP liability collections represent
approximately 70 percent Part A claims payments and 30 percent Part B
claims payments (which are based on historic MSP liability savings).
Medicare Savings Retained
[Rounded to the Nearest $10 Million]
------------------------------------------------------------------------
Part A Part B Total
------------------------------------------------------------------------
2003...................................... 0 0 0
2004...................................... 10 0 10
2005...................................... 10 0 10
2006...................................... 10 0 10
2007...................................... 20 0 20
2008...................................... 10 0 10
2009...................................... 20 0 20
2010...................................... 20 10 30
2011...................................... 20 10 30
2012...................................... 20 10 30
2013...................................... 20 10 30
2014...................................... 20 10 30
2015...................................... 20 10 30
------------------------------------------------------------------------
Therefore, this interim final rule with comment period is not a
major rule as defined in Title 5, United States Code, section 804(2)
and is not an economically significant rule under Executive Order
12866.
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
$6 million to $29 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 interim final rule with comment period will 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. 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 if a rule or notice having the effect of 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 604 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 Core-Based Statistical Area and has fewer than 100
beds. We have determined that this interim final rule with comment
period will not have a significant effect on the operations of a
substantial number of small rural hospitals because there is and will
be no change in the administration of the MSP provisions. 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 or notice having the effect of a rule whose mandates
require spending in any 1 year of $100 million in 1995 dollars, updated
annually for inflation. That threshold level is currently approximately
$120 million. This interim final rule with comment period has no
consequential effect on State, local, or tribal governments or on the
private sector because there is and will be no change in the
administration of the MSP provisions.
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 E.O. 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
42 CFR Part 411
Kidney diseases, Medicare, Reporting and recordkeeping
requirements.
42 CFR Part 489
Health facilities, Medicare, Reporting and recordkeeping
requirements.
0
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR chapter IV as set forth below:
[[Page 9470]]
PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE
PAYMENT
0
1. The authority citation for part 411 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Sec. 411.20 [Amended]
0
2. Section 411.20 is amended by removing the word ``promptly'' in
paragraph (a)(2) introductory text.
0
3. Section 411.21 is amended by adding definitions of ``primary
payer,'' ``primary payment,'' and ``primary plan'' and removing the
definitions of ``third party payer'' and ``third party payment'' to
read as follows:
Sec. 411.21 Definitions.
* * * * *
Primary payer means, when used in the context in which Medicare is
the secondary payer, any entity that is or was required or responsible
to make payment with respect to an item or service (or any portion
thereof) under a primary plan. These entities include, but are not
limited to, insurers or self-insurers, third party administrators, and
all employers that sponsor or contribute to group health plans or large
group health plans.
Primary payment means, when used in the context in which Medicare
is the secondary payer, payment by a primary payer for services that
are also covered under Medicare.
Primary plan means, when used in the context in which Medicare is
the secondary payer, a group health plan or large group health plan, a
workers' compensation law or plan, an automobile or liability insurance
policy or plan (including a self-insured plan), or no-fault insurance.
* * * * *
0
4. A new Sec. 411.22 is added to read as follows:
Sec. 411.22 Reimbursement obligations of primary payers and entities
that received payment from primary payers.
(a) A primary payer, and an entity that receives payment from a
primary payer, must reimburse CMS for any payment if it is demonstrated
that the primary payer has or had a responsibility to make payment.
(b) A primary payer's responsibility for payment may be
demonstrated by--
(1) A judgment;
(2) A payment conditioned upon the recipient's compromise, waiver,
or release (whether or not there is a determination or admission of
liability) of payment for items or services included in a claim against
the primary payer or the primary payer's insured; or
(3) By other means, including but not limited to a settlement,
award, or contractual obligation.
Sec. 411.24 [Amended]
0
5. Section 411.24 is amended by--
0
A. Revising paragraph (e).
0
B. Removing the words ``is primary'' and adding in its place the phrase
``is a primary plan'' in paragraph (f)(2).
0
C. Adding '', workers' compensation insurance or plan,'' after ``group
health plans'' and before ``and'' in paragraph (i)(1).
Revisions for paragraph (e) read as follows:
Sec. 411.24 Recovery of conditional payments.
* * * * *
(e) Recovery from primary payers. CMS has a direct right of action
to recover from any primary payer.
* * * * *
0
6. Section 411.33(f)(4) introductory text is revised to read as
follows:
Sec. 411.33 Amount of Medicare secondary payment.
* * * * *
(f) Examples: * * *
(4) A hospital furnished 5 days of inpatient care in 1987 to a
Medicare beneficiary. The provider's charges for Medicare-covered
services were $4,000 and the gross amount payable was $3,500. The
provider agreed to accept $3,000 from the primary payer as payment in
full. The primary payer paid $2,900 due to a deductible requirement
under the primary plan. Medicare considers the amount the provider is
obligated to accept as full payment ($3,000) to be the provider
charges. The Medicare secondary payment is the lowest of the following:
* * * * *
Sec. 411.40 [Amended]
0
7. Section 411.40 is amended by removing the word ``promptly'' in
paragraph (b)(1)(i).
0
8. Section 411.45 is revised to read as follows:
Sec. 411.45 Basis for conditional Medicare payment in workers'
compensation cases.
(a) A conditional Medicare payment may be made under either of the
following circumstances:
(1) The beneficiary has filed a proper claim for workers'
compensation benefits, but the intermediary or carrier determines that
the workers' compensation carrier will not pay promptly. This includes
cases in which a workers' compensation carrier has denied a claim.
(2) The beneficiary, because of physical or mental capacity, failed
to file a proper claim.
(b) Any conditional payment that CMS makes is conditioned on
reimbursement to CMS in accordance with subpart B of this part.
Sec. 411.50 [Amended]
0
9. Section 411.50 is amended by--
0
A. Revising the definition of ``self-insured plan'' in paragraph (b).
0
B. Removing the word ``promptly'' in paragraphs (c)(1) and (c)(2).
0
The revision reads as follows:
Sec. 411.50 General provisions.
* * * * *
(b) Definitions.
* * * * *
Self-insured plan means a plan under which an individual, or a
private or governmental entity, carries its own risk instead of taking
out insurance with a carrier. This term includes a plan of an
individual or other entity engaged in a business, trade, or profession,
a plan of a non-profit organization such as a social, fraternal, labor,
educational, religious, or professional organization, and the plan
established by the Federal government to pay liability claims under the
Federal Tort Claims Act. An entity that engages in a business, trade,
or profession is deemed to have a self-insured plan for purposes of
liability insurance if it carries its own risk (whether by a failure to
obtain insurance, or otherwise) in whole or in part.
* * * * *
0
10. Section 411.52 is revised to read as follows:
Sec. 411.52 Basis for conditional Medicare payment in liability
cases.
(a) A conditional Medicare payment may be made in liability cases
under either of the following circumstances:
(1) The beneficiary has filed a proper claim for liability
insurance benefits but the intermediary or carrier determines that the
liability insurer will not pay promptly for any reason other than the
circumstances described in Sec. 411.32(a)(1). This includes cases in
which the liability insurance carrier has denied the claim.
(2) The beneficiary has not filed a claim for liability insurance
benefits.
(b) Any conditional payment that CMS makes is conditioned on
reimbursement to CMS in accordance with subpart B of this part.
0
11. Section 411.53 is revised to read as follows:
[[Page 9471]]
Sec. 411.53 Basis for conditional Medicare payment in no-fault cases.
(a) A conditional Medicare payment may be made in no-fault cases
under either of the following circumstances:
(1) The beneficiary has filed a proper claim for no-fault insurance
benefits but the intermediary or carrier determines that the no-fault
insurer will not pay promptly for any reason other than the
circumstances described in Sec. 411.32(a)(1). This includes cases in
which the no-fault insurance carrier has denied the claim.
(2) The beneficiary, because of physical or mental incapacity,
failed to meet a claim-filing requirement stipulated in the policy.
(b) Any conditional payment that CMS makes is conditioned on
reimbursement to CMS in accordance with subpart B of this part.
PART 411--[NOMENCLATURE CHANGE]
0
12. In part 411, revise all references to ``third party payer'' to read
``primary payer'; revise all references to ``third party payment'' to
read ``primary payment'; and revise all references to ``third party
plan'' to read ``primary plan''.
PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
0
1. The authority citation for part 489 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act.
Sec. 489.20 [Amended]
0
2. Section Sec. 489.20(i)(2)(ii) introductory text is amended by
removing the words ``third party payment'' and adding in its place the
words ``primary payment''.
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: February 8, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
Approved: November 14, 2005.
Michael O. Leavitt,
Secretary, Department of Health and Human Services.
[FR Doc. 06-1712 Filed 2-23-06; 8:45 am]
BILLING CODE 4120-01-P