[Federal Register Volume 73, Number 188 (Friday, September 26, 2008)]
[Rules and Regulations]
[Pages 55763-55765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-22592]
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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.
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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]
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