Medicare Program; Revisions to the Medicare Advantage and Part D Prescription Drug Contract Determinations, Appeals, and Intermediate Sanctions Processes; Correcting Amendment, 55763-55765 [E8-22592]
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Federal Register / Vol. 73, No. 188 / Friday, September 26, 2008 / Rules and Regulations
quarter; a rolling error rate average over
more than 1 quarter is not permitted.
(4) After the contractor determines
that the provider or supplier must be
terminated from non-random
prepayment complex medical review,
the claims processing system must be
updated within 5 business days to
ensure that a provider’s or supplier’s
claims for a specific billing error are no
longer suspended for non-random
prepayment complex medical review.
(d) Periodic re-evaluation. (1) Once a
provider or supplier is terminated from
non-random prepayment complex
medical review, contractors may
periodically re-evaluate the provider or
supplier’s data and may place a
provider or supplier that appears to
have resumed a high level of payment
error on non-random prepayment
complex medical review.
(2) This review would only be
initiated if a probe review confirms that
there continues to be a high level of
payment error.
(3) If there is a high level of payment
error, a provider or supplier may be
placed on non-random prepayment
complex medical review no earlier than
6 months after termination of a previous
non-random prepayment complex
medical review. As set forth in
§ 421.505(a)(3) contractors may also
refer the provider or supplier to the
contractor responsible for benefit
integrity review or place the provider or
supplier on postpayment medical
review.
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: March 21, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: June 3, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8–22307 Filed 9–25–08; 8:45 am]
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BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 422 and 423
[CMS–4124–F2]
RIN–0938–AO78
Medicare Program; Revisions to the
Medicare Advantage and Part D
Prescription Drug Contract
Determinations, Appeals, and
Intermediate Sanctions Processes;
Correcting Amendment
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule; correcting
amendment.
AGENCY:
SUMMARY: In the December 5, 2007 issue
of the Federal Register, we published a
final rule finalizing the Medicare
program provisions relating to contract
determinations involving Medicare
Advantage (MA) organizations and
Medicare Part D prescription drug plan
sponsors, including eliminating the
reconsideration process for review of
contract determinations, revising the
provisions related to appeals of contract
determinations, and clarifying the
process for MA organizations and Part D
sponsors to complete corrective action
plans. In that final rule, we also clarified
the intermediate sanction and civil
money penalty provisions that apply to
MA organizations and Part D sponsors,
modified elements of MA organizations
and Part D sponsors’ compliance plans,
retained voluntary self-reporting for Part
D sponsors, implemented voluntary selfreporting for MA organizations, and
revised provisions to ensure HHS has
access to the books and records of MA
organizations and Part D sponsors’ first
tier, downstream, and related entities.
This correcting amendment corrects a
limited number of technical and
typographical errors identified in the
December 5, 2007 final rule.
DATES: These correcting amendments
are effective September 26, 2008, except
for the amendment to § 423.505, which
is effective on January 1, 2009. The
correcting amendments for § 422.756(d)
and § 423.756(d) are applicable
beginning January 4, 2008.
FOR FURTHER INFORMATION CONTACT:
Christine Reinhard (410) 786–2987.
Stephanie Blaydes Kaisler (410) 786–
0957.
SUPPLEMENTARY INFORMATION:
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I. Background
In FR Doc. 07–5946 (72 FR 68700
through 68741), the final rule entitled,
‘‘Revisions to the Medicare Advantage
and Part D Prescription Drug Contract
Determinations, Appeals, and
Intermediate Sanctions Processes,’’
there were technical errors that have
been identified and corrected in the
regulations text of this correcting
amendment. We note that correcting
two of these technical errors, found at
§ 422.756(d) and § 423.756(d), ensure
that certain existing provisions which
were never intended to be the subject of
notice and comment rulemaking, remain
in place for the benefit of all affected
parties, including MA organizations and
Part D sponsors. The provisions in this
correcting amendment for § 422.756(d)
and § 423.756(d) are effective as if they
were included in the final rule
published December 5, 2007.
Accordingly, the corrections are
effective retroactive to January 4, 2008,
the effective date of most of the
provisions of the final rule. However,
the provisions in this correcting
amendment for § 423.505 are effective
January 1, 2009 since these particular
provisions in § 423.505 were not set to
take effect until January 1, 2009.
II. Summary of Errors in the
Regulations Text
On pages 68726 and 68735 of the
December 5, 2007 final rule, there were
technical errors made in the regulation
text of § 422.756(d) and § 423.756(d).
Specifically, a typographical error in our
amendatory instructions caused us to
inadvertently omit from the Code of
Federal Regulations (CFR) existing
paragraphs § 422.756(d)(3) and
§ 423.756(d)(3) regarding the duration of
an MA and Part D intermediate
sanction, respectively. We note that
these existing provisions were not
intended to be revised in the December
5, 2007 final rule (72 FR 68700 through
68741).
On page 68732 of the December 5,
2007 final rule, our amendatory
instruction indicated that we were
revising § 423.505(i)(2)(i). However,
when we set out the changed
regulations text, we inadvertently
revised paragraph (i)(2)(ii) instead of
paragraph (i)(2)(i). This typographical
error, if not corrected, would have
inadvertently deleted from the CFR the
current paragraph at § 423.505(i)(2)(ii)
regarding the 10-year record retention
requirement as of January 1, 2009, the
effective date of this provision as
specified in the final rule. The correct
§ 423.505(i)(2)(i) should read ‘‘HHS, the
Comptroller General, or their designees
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have the right to audit, evaluate and
inspect any books, contracts, records,
including medical records, and
documentation of the first tier,
downstream, and related entities
involving transactions related to CMS’
contract with the Part D sponsor.’’ As
stated above, the existing
§ 423.505(i)(2)(ii), which references the
10-year record retention requirements,
remains in the CFR unchanged.
In § 423.505(i)(3)(iii) the term ‘‘related
entity’’ is incorrectly used twice in the
same sentence, so we have removed this
duplication. In addition, we
inadvertently included MA organization
in § 423.505(i)(3)(iv) which only applies
to Part D sponsors. We have revised the
language accordingly.
III. 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 this notice and comment
procedure 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 notice.
Section 553(d) of the APA ordinarily
requires a 30-day delay in effective date
of final rules after the date of their
publication in the Federal Register.
This 30-day delay in effective date can
be waived, however, if an agency finds
for good cause that the delay is
impracticable, unnecessary, or contrary
to the public interest, and the agency
incorporates a statement of the findings
and its reasons in the rule issued.
The provisions of this correcting
amendment regarding the duration of
sanctions at § 422.756(d) and
§ 423.756(d) make no substantive
changes and are intended to restore
provisions which were inadvertently
removed from the CFR. These
provisions were not revised in the final
rule but were dropped because of a
typographical error in our amendatory
instructions. We must reinstate these
provisions in the CFR to ensure that
CMS may lift sanctions on MA and Part
D plans as appropriate.
In addition, a typographical error in
our regulations text would have
inadvertently removed the current
§ 423.505(i)(2)(ii) from the CFR as of the
effective date for these provisions on
January 1, 2009. We are taking this
opportunity to correct this error in the
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17:40 Sep 25, 2008
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CFR to ensure that the 10-year record
retention requirements for Part D
sponsors remains in the CFR
unchanged. Without this correcting
amendment, the Medicare Part D
regulations could have been construed
as being silent on the 10-year Part D
recordkeeping requirement which could
create confusion and uncertainty for
affected parties regarding CMS’ policy
on this issue.
Finally, we are also taking this
opportunity to correct typographical
errors in § 423.505(i)(3)(iii) and (iv).
Because we are issuing this correcting
amendment based on typographical
errors, we find that undertaking further
notice and comment procedures to
incorporate these corrections into the
December 5, 2007 final rule is
unnecessary and contrary to the public
interest.
For the same reasons, we are also
waiving the 30-day delay in effective
date for § 422.756(d) and § 423.756(d) in
this correcting amendment. We believe
that it is in the public interest to ensure
that the December 5, 2007 final rule
accurately state the current law and
CMS policy. Thus, delaying the effective
date of these corrections would be
contrary to the public interest.
Therefore, we also find good cause to
waive the 30-day delay in effective date
for § 422.756(d) and § 423.756(d).
List of Subjects
42 CFR Parts 422 and 423
Accordingly, 42 CFR chapter IV is
corrected by making the following
correcting amendments to parts 422 and
423.
■
PART 422—MEDICARE ADVANTAGE
PROGRAM
1. The authority citation for part 422
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
2. Section 422.756 is amended by
adding paragraph (d)(3) to read as
follows:
■
§ 422.756 Procedures for imposing
intermediate sanctions and civil money
penalties.
*
*
*
*
*
(d) * * *
(3) Duration of sanction. The sanction
remains in effect until CMS notifies the
MA organization that CMS is satisfied
that the basis for imposing the sanction
has been corrected and is not likely to
recur.
*
*
*
*
*
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PART 423—VOLUNTARY MEDICARE
PRESCRIPTION DRUG BENEFIT
3. The authority citation for part 423
continues to read as follows:
■
Authority: Secs. 1102, 1860D–1 through
1860D–42, and 1871 of the Social Security
Act (42 U.S.C. 1302, 1395w–101 through
1395w–152, and 1395hh).
■
■
■
■
■
4. Section 423.505 is amended by—
A. Revising paragraph (i)(2)(i).
B. Revising paragraph (i)(2)(ii).
C. Revising paragraph (i)(3)(iii).
D. Revising paragraph (i)(3) (iv).
The revisions read as follows:
§ 423.505
Contract provisions.
*
*
*
*
*
(i) * * *
(2) * * *
(i) HHS, the Comptroller General, or
their designees have the right to audit,
evaluate, and inspect any books,
contracts, records, including medical
records, and documentation of the first
tier, downstream, and related entities
involving transactions related to CMS’
contract with the Part D sponsor.
(ii) HHS’, the Comptroller General’s,
or their designee’s right to inspect,
evaluate, and audit any pertinent
information for any particular contract
period exists through 10 years from the
final date of the contract period or from
the date of completion of any audit,
whichever is later.
(3) * * *
(iii) A provision requiring that any
services or other activity performed by
a first tier, downstream, and related
entity in accordance with a contract or
written agreement are consistent and
comply with the Part D sponsor’s
contractual obligations.
(iv) A provision requiring the Part D
sponsor’s first tier, downstream, and
related entities to produce upon request
by CMS, or its designees, any books,
contracts, records, including medical
records and documentation of the Part
D sponsor, relating to the Part D
program, to either the sponsor to
provide to CMS, or directly to CMS or
its designees.
*
*
*
*
*
5. Section 423.756 is amended by
adding paragraph (d)(3) to read as
follows:
■
§ 423.756 Procedures for imposing
intermediate sanctions and civil money
penalties.
*
*
*
*
*
(d) * * *
(3) Duration of sanction. The sanction
remains in effect until CMS notifies the
Part D sponsor that CMS is satisfied that
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the basis for imposing the sanction is
corrected and is not likely to recur.
*
*
*
*
*
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: September 16, 2008.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. E8–22592 Filed 9–25–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 455
[CMS–2271–F]
RIN 0938–AO97
Medicaid Integrity Program; Eligible
Entity and Contracting Requirements
for the Medicaid Integrity Audit
Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Final rule.
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AGENCY:
SUMMARY: Section 1936 of the Social
Security Act (the Act) (as added by
section 6034 of the Deficit Reduction
Act of 2005 (DRA) established the
Medicaid Integrity Program to promote
the integrity of the Medicaid program by
requiring CMS to enter into contracts
with eligible entities to: (1) Review the
actions of individuals or entities
furnishing items or services (whether on
a fee-for-service, risk, or other basis) for
which payment may be made under an
approved State plan and/or any waiver
of such plan approved under section
1115 of the Act; (2) audit claims for
payment of items or services furnished,
or administrative services rendered,
under a State plan; (3) identify
overpayments to individuals or entities
receiving Federal funds; and (4) educate
providers of services, managed care
entities, beneficiaries, and other
individuals with respect to payment
integrity and quality of care.
This final rule will provide
requirements for an eligible entity to
enter into a contract under the Medicaid
integrity audit program. The final rule
will also establish the contracting
requirements for eligible entities. The
requirements will include procedures
for identifying, evaluating, and
resolving organizational conflicts of
interest that are generally applicable to
17:40 Sep 25, 2008
Jkt 214001
I. Background
A. Current Law
States and the Federal government
share in the responsibility for
safeguarding Medicaid program
integrity. States must comply with
Federal requirements designed to ensure
that Medicaid funds are properly spent
(or recovered, when necessary). CMS is
the primary Federal agency responsible
for providing oversight of States’
Medicaid activities and facilitating their
program integrity efforts.
BILLING CODE 4120–01–P
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Federal acquisition and procurement;
competitive procedures to be used; and
procedures under which a contract may
be renewed.
DATES: This final rule is effective
October 27, 2008.
FOR FURTHER INFORMATION CONTACT:
Barbara Rufo, 410 786–5589 or Crystal
High, 410–786–8366.
SUPPLEMENTARY INFORMATION:
B. Medicaid Integrity Program
Section 6034 of the Deficit Reduction
Act (DRA) of 2005 (Pub. L. 109–171,
enacted on February 8, 2006) added a
new section 1936 to the Act that
established the Medicaid Integrity
Program, referenced as the ‘‘Program’’
hereafter, to combat Medicaid fraud and
abuse. The Program is intended to
identify, recover, and prevent Medicaid
overpayments. It is also intended to
support the efforts of the State Medicaid
agencies through a combination of
support and technical assistance.
Although individual States work to
ensure the integrity of their respective
Medicaid programs, the Program
represents CMS’ first national strategy to
detect and prevent Medicaid fraud and
abuse. The Program will provide CMS
with the ability to more directly ensure
the accuracy of Medicaid payments and
to deter those who would exploit the
program.
Section 6034 of the DRA amended
title XIX of the Act by redesignating the
former section 1936 as section 1937; and
adding the new 1936 ‘‘Medicaid
Integrity Program.’’ The new section
1936 states the Secretary will promote
the integrity of the Medicaid program by
entering into contracts with eligible
entities to carry out the following
activities:
• Review of actions of individuals or
entities furnishing items or services
(whether on a fee-for-service, risk, or
other basis) for which payment may be
made under the State plan approved
under title XIX (or under any waiver of
such plan approved under section 1115
of the Act) to determine whether fraud,
waste, or abuse has occurred, or is likely
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55765
to occur, or whether such actions have
a potential for resulting in an
expenditure of funds under title XIX in
a manner which is not intended under
the provisions of title XIX.
• Audit of claims for payment for
items or services furnished, or
administrative services rendered, under
a State plan under title XIX, including
cost reports, consulting contracts, and
risk contracts under section 1903(m) of
title XIX.
• Identification of overpayments to
individuals or entities receiving Federal
funds under title XIX.
• Education of providers of services,
managed care entities, beneficiaries, and
other individuals with respect to
payment integrity and quality of care.
Section 1936 of the Act also mandates
that the Secretary will, by regulation,
establish procedures which will include
the following:
• Procedures for identifying,
evaluating, and resolving organizational
conflicts of interest that are generally
applicable to Federal acquisition and
procurement.
• Competitive procedures to be used
when entering into new contracts under
this section; when entering into
contracts that may result in the
elimination of responsibilities under
section 202(b) of the Health Insurance
Portability and Accountability Act of
1996; and any other time considered
appropriate by the Secretary.
• Procedures under which a contract
under this section may be renewed
without regard to any provision of law
requiring competition if the contractor
has met or exceeded the performance
requirements established in the current
contract.
CMS has determined not to address in
this final rule the above bullet that
references the Health Insurance
Portability and Accountability Act of
1996 (HIPAA). We have determined that
section 202(b) of HIPAA addressed
certain Medicare contracting issues
which, because of structural differences
between the Medicare and Medicaid
programs, such as the fact that the
Federal Government does not utilize
carriers or fiscal intermediaries in the
Federal administration of the Medicaid
program, do not pertain to the Medicaid
contracting environment. Moreover, we
have also determined that the
provisions of the Act established by
section 202(b) of HIPAA have since
been repealed by section 911 of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003.
E:\FR\FM\26SER1.SGM
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]]>Agencies
[Federal Register Volume 73, Number 188 (Friday, September 26, 2008)]
[Rules and Regulations]
[Pages 55763-55765]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-22592]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 422 and 423
[CMS-4124-F2]
RIN-0938-AO78
Medicare Program; Revisions to the Medicare Advantage and Part D
Prescription Drug Contract Determinations, Appeals, and Intermediate
Sanctions Processes; Correcting Amendment
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule; correcting amendment.
-----------------------------------------------------------------------
SUMMARY: In the December 5, 2007 issue of the Federal Register, we
published a final rule finalizing the Medicare program provisions
relating to contract determinations involving Medicare Advantage (MA)
organizations and Medicare Part D prescription drug plan sponsors,
including eliminating the reconsideration process for review of
contract determinations, revising the provisions related to appeals of
contract determinations, and clarifying the process for MA
organizations and Part D sponsors to complete corrective action plans.
In that final rule, we also clarified the intermediate sanction and
civil money penalty provisions that apply to MA organizations and Part
D sponsors, modified elements of MA organizations and Part D sponsors'
compliance plans, retained voluntary self-reporting for Part D
sponsors, implemented voluntary self-reporting for MA organizations,
and revised provisions to ensure HHS has access to the books and
records of MA organizations and Part D sponsors' first tier,
downstream, and related entities. This correcting amendment corrects a
limited number of technical and typographical errors identified in the
December 5, 2007 final rule.
DATES: These correcting amendments are effective September 26, 2008,
except for the amendment to Sec. 423.505, which is effective on
January 1, 2009. The correcting amendments for Sec. 422.756(d) and
Sec. 423.756(d) are applicable beginning January 4, 2008.
FOR FURTHER INFORMATION CONTACT: Christine Reinhard (410) 786-2987.
Stephanie Blaydes Kaisler (410) 786-0957.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 07-5946 (72 FR 68700 through 68741), the final rule
entitled, ``Revisions to the Medicare Advantage and Part D Prescription
Drug Contract Determinations, Appeals, and Intermediate Sanctions
Processes,'' there were technical errors that have been identified and
corrected in the regulations text of this correcting amendment. We note
that correcting two of these technical errors, found at Sec.
422.756(d) and Sec. 423.756(d), ensure that certain existing
provisions which were never intended to be the subject of notice and
comment rulemaking, remain in place for the benefit of all affected
parties, including MA organizations and Part D sponsors. The provisions
in this correcting amendment for Sec. 422.756(d) and Sec. 423.756(d)
are effective as if they were included in the final rule published
December 5, 2007. Accordingly, the corrections are effective
retroactive to January 4, 2008, the effective date of most of the
provisions of the final rule. However, the provisions in this
correcting amendment for Sec. 423.505 are effective January 1, 2009
since these particular provisions in Sec. 423.505 were not set to take
effect until January 1, 2009.
II. Summary of Errors in the Regulations Text
On pages 68726 and 68735 of the December 5, 2007 final rule, there
were technical errors made in the regulation text of Sec. 422.756(d)
and Sec. 423.756(d). Specifically, a typographical error in our
amendatory instructions caused us to inadvertently omit from the Code
of Federal Regulations (CFR) existing paragraphs Sec. 422.756(d)(3)
and Sec. 423.756(d)(3) regarding the duration of an MA and Part D
intermediate sanction, respectively. We note that these existing
provisions were not intended to be revised in the December 5, 2007
final rule (72 FR 68700 through 68741).
On page 68732 of the December 5, 2007 final rule, our amendatory
instruction indicated that we were revising Sec. 423.505(i)(2)(i).
However, when we set out the changed regulations text, we inadvertently
revised paragraph (i)(2)(ii) instead of paragraph (i)(2)(i). This
typographical error, if not corrected, would have inadvertently deleted
from the CFR the current paragraph at Sec. 423.505(i)(2)(ii) regarding
the 10-year record retention requirement as of January 1, 2009, the
effective date of this provision as specified in the final rule. The
correct Sec. 423.505(i)(2)(i) should read ``HHS, the Comptroller
General, or their designees
[[Page 55764]]
have the right to audit, evaluate and inspect any books, contracts,
records, including medical records, and documentation of the first
tier, downstream, and related entities involving transactions related
to CMS' contract with the Part D sponsor.'' As stated above, the
existing Sec. 423.505(i)(2)(ii), which references the 10-year record
retention requirements, remains in the CFR unchanged.
In Sec. 423.505(i)(3)(iii) the term ``related entity'' is
incorrectly used twice in the same sentence, so we have removed this
duplication. In addition, we inadvertently included MA organization in
Sec. 423.505(i)(3)(iv) which only applies to Part D sponsors. We have
revised the language accordingly.
III. 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 this notice and comment procedure 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 notice.
Section 553(d) of the APA ordinarily requires a 30-day delay in
effective date of final rules after the date of their publication in
the Federal Register. This 30-day delay in effective date can be
waived, however, if an agency finds for good cause that the delay is
impracticable, unnecessary, or contrary to the public interest, and the
agency incorporates a statement of the findings and its reasons in the
rule issued.
The provisions of this correcting amendment regarding the duration
of sanctions at Sec. 422.756(d) and Sec. 423.756(d) make no
substantive changes and are intended to restore provisions which were
inadvertently removed from the CFR. These provisions were not revised
in the final rule but were dropped because of a typographical error in
our amendatory instructions. We must reinstate these provisions in the
CFR to ensure that CMS may lift sanctions on MA and Part D plans as
appropriate.
In addition, a typographical error in our regulations text would
have inadvertently removed the current Sec. 423.505(i)(2)(ii) from the
CFR as of the effective date for these provisions on January 1, 2009.
We are taking this opportunity to correct this error in the CFR to
ensure that the 10-year record retention requirements for Part D
sponsors remains in the CFR unchanged. Without this correcting
amendment, the Medicare Part D regulations could have been construed as
being silent on the 10-year Part D recordkeeping requirement which
could create confusion and uncertainty for affected parties regarding
CMS' policy on this issue.
Finally, we are also taking this opportunity to correct
typographical errors in Sec. 423.505(i)(3)(iii) and (iv).
Because we are issuing this correcting amendment based on
typographical errors, we find that undertaking further notice and
comment procedures to incorporate these corrections into the December
5, 2007 final rule is unnecessary and contrary to the public interest.
For the same reasons, we are also waiving the 30-day delay in
effective date for Sec. 422.756(d) and Sec. 423.756(d) in this
correcting amendment. We believe that it is in the public interest to
ensure that the December 5, 2007 final rule accurately state the
current law and CMS policy. Thus, delaying the effective date of these
corrections would be contrary to the public interest. Therefore, we
also find good cause to waive the 30-day delay in effective date for
Sec. 422.756(d) and Sec. 423.756(d).
List of Subjects
42 CFR Parts 422 and 423
0
Accordingly, 42 CFR chapter IV is corrected by making the following
correcting amendments to parts 422 and 423.
PART 422--MEDICARE ADVANTAGE PROGRAM
0
1. The authority citation for part 422 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
0
2. Section 422.756 is amended by adding paragraph (d)(3) to read as
follows:
Sec. 422.756 Procedures for imposing intermediate sanctions and civil
money penalties.
* * * * *
(d) * * *
(3) Duration of sanction. The sanction remains in effect until CMS
notifies the MA organization that CMS is satisfied that the basis for
imposing the sanction has been corrected and is not likely to recur.
* * * * *
PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
0
3. The authority citation for part 423 continues to read as follows:
Authority: Secs. 1102, 1860D-1 through 1860D-42, and 1871 of the
Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-152,
and 1395hh).
0
4. Section 423.505 is amended by--
0
A. Revising paragraph (i)(2)(i).
0
B. Revising paragraph (i)(2)(ii).
0
C. Revising paragraph (i)(3)(iii).
0
D. Revising paragraph (i)(3) (iv).
The revisions read as follows:
Sec. 423.505 Contract provisions.
* * * * *
(i) * * *
(2) * * *
(i) HHS, the Comptroller General, or their designees have the right
to audit, evaluate, and inspect any books, contracts, records,
including medical records, and documentation of the first tier,
downstream, and related entities involving transactions related to CMS'
contract with the Part D sponsor.
(ii) HHS', the Comptroller General's, or their designee's right to
inspect, evaluate, and audit any pertinent information for any
particular contract period exists through 10 years from the final date
of the contract period or from the date of completion of any audit,
whichever is later.
(3) * * *
(iii) A provision requiring that any services or other activity
performed by a first tier, downstream, and related entity in accordance
with a contract or written agreement are consistent and comply with the
Part D sponsor's contractual obligations.
(iv) A provision requiring the Part D sponsor's first tier,
downstream, and related entities to produce upon request by CMS, or its
designees, any books, contracts, records, including medical records and
documentation of the Part D sponsor, relating to the Part D program, to
either the sponsor to provide to CMS, or directly to CMS or its
designees.
* * * * *
0
5. Section 423.756 is amended by adding paragraph (d)(3) to read as
follows:
Sec. 423.756 Procedures for imposing intermediate sanctions and civil
money penalties.
* * * * *
(d) * * *
(3) Duration of sanction. The sanction remains in effect until CMS
notifies the Part D sponsor that CMS is satisfied that
[[Page 55765]]
the basis for imposing the sanction is corrected and is not likely to
recur.
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
Dated: September 16, 2008.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. E8-22592 Filed 9-25-08; 8:45 am]
BILLING CODE 4120-01-P
