[Federal Register Volume 75, Number 111 (Thursday, June 10, 2010)]
[Rules and Regulations]
[Pages 32858-32860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13923]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 417, 422, 423, and 480
[CMS-4085-CN]
RIN 0938-AP77
Medicare Program; Policy and Technical Changes to the Medicare
Advantage and the Medicare Prescription Drug Benefit Programs;
Corrections
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Correction of final rule.
-----------------------------------------------------------------------
SUMMARY: This document corrects technical and typographical errors in
the final rule that appeared in the April 15, 2010 Federal Register
entitled ``Medicare Program; Policy and Technical Changes to the
Medicare Advantage and the Medicare Prescription Drug Benefit
Programs.''
DATES: Effective Date: This correction notice is effective June 7,
2010.
FOR FURTHER INFORMATION CONTACT: Alissa Deboy, (410) 786-6041.
SUPPLEMENTARY INFORMATION:
I. Background
In the final rule entitled ``Medicare Program; Policy and Technical
Changes to the Medicare Advantage and the Medicare Prescription Drug
Benefit Programs'' which appeared in the April 15, 2010 Federal
Register (FR Doc. 2010-7966, (75 FR 19678)), there were technical and
typographical errors that are identified and corrected in the
Correction of Errors section below. The provisions in this correction
notice are effective as if they had been included in the document that
appeared in the April 15, 2010 Federal Register. Accordingly, the
corrections are effective June 7, 2010.
II. Summary of Errors
On page 19752, in our preamble discussion regarding risk adjustment
data validation (RADV) appeals and the addition of Medicare Advantage
(MA) organization RADV--dispute and appeal procedures we made
typographical errors in two regulatory citations and we correct these
errors in section IV.A.1. of this correction notice. In addition, on
page 19809 in the regulations text for the RADV provisions, we
inadvertently designated two paragraphs as Sec. 422.311(c)(iii)(C). We
are correcting this error in section IV.B.l. of this correction notice.
In our preamble discussion of criteria and procedures for
identifying ``protected classes'' of drugs within which all covered
Part D drugs must be included in Part D formularies (75 FR 19767), we
indicated that we would not finalize in regulations (Sec. 423.100) our
proposed definitions used to interpret the section 176 of Medicare
Improvements for Patients and Providers Act of 2008 (MIPPA) criteria
(that is, the definitions for the terms, ``drug category or class,''
``major or life threatening clinical consequences,'' ``restricted
access,'' and ``significant need for access to multiple drugs'').
However, we indicated that we would finalize our proposed regulations
text regarding the exceptions criteria (Sec. 423.120(b)(2)(iv)).
Therefore, in section IV.B.3. and 4. of this correction notice, we
correct these errors by removing the proposed definitions inadvertently
published for Sec. 423.100 and adding the exceptions criteria that
were inadvertently omitted from Sec. 423.120(b).
[[Page 32859]]
On page 19812, we presented our regulatory changes to Sec. 422.566
and Sec. 422.568 regarding organization determinations. We made errors
in the amendatory statements for the regulations text of these sections
regarding the redesigination of paragraphs. We are also correcting an
technical error in Sec. 422.566(c)(2)(i) (changing ``A'' to ``The'')
to ensure consistency between paragraphs (c)(1)(i) and (c)(2)(i). In
section IV.B.2 of this correction notice, we correct these errors.
On page 19822, we presented our regulatory changes to Sec. 423.551
regarding changes in ownership during a PDP term of contract. In
presenting these regulatory changes, we indicated that we were adding a
new paragraph (g) instead of indicating that we were revising the
existing paragraph (g). In section IV.B.5. of this correction notice,
we correct this error.
In our acronyms list and in the preamble discussion and regulations
text regarding medication therapy management programs under Part D, we
erroneously used the term ``comprehensive medical review'' instead of
``comprehensive medication review.'' Therefore, in section IV. A.2, 4.
and 5. and B.5. of this correction notice we are correcting these
errors. In addition, we inadvertently listed the acronym for
comprehensive medical reviews (CMR) twice. We also correct the
erroneous listing of the acronym in section IV.A.1. of this correction
notice.
III. Waiver of Proposed Rulemaking and Waiver of the 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)). In addition,
section 553(d) of the APA (5 U.S.C. 553(b)) ordinarily requires a 30-
day delay in effect date of final rules after the date of their
publication in the Federal Register. However, we can waive both the
notice and comment procedure and the 30-day delay in effective date 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.
This document merely corrects typographical and technical errors
made in the Policy and Technical Changes to the Medicare Advantage and
the Medicare Prescription Drug Benefit Programs final rule (FR. Doc.
2010-7966) which appeared in the April 15, 2010 Federal Register and
will be effective on June 7, 2010. The provisions of the final rule
have been subjected previously to notice and comment procedures. The
corrections contained in this document are consistent with and do not
make substantive changes to, the policies adopted in the final rule.
Therefore, we find it unnecessary to undertake further notice and
comment procedures with respect to this correction notice. We also
believe it is in the public interest to waive notice and comment
procedures and the 30-day delay in effective date for this notice. This
correction notice is intended to ensure that the final rule accurately
describes the policies being adopted in the final rule, and that
correct information is made available to the public prior to June 7,
2010, the date on which the final rule becomes effective.
For the reasons stated above, we find that both notice and comment
and the 30-day delay in effective date for this correction notice are
unnecessary, and that it is in the public interest to make this notice
effective in conjunction with the final rule to which the corrections
apply. Therefore, we find there is good cause to waive notice and
comment procedures and the 30-day delay in effective date for this
correction notice.
IV. Correction of Errors
In FR Doc. 2010-7966 of April 15, 2010, (75 FR 19678), make the
following corrections:
A. Correction of Errors in the Preamble
1. On page 19679, third column, second line from the bottom, the
acronym and term ``CMR Comprehensive Medical Review'' is corrected by
deleting the acronym and term.
2. On page 19680, first column, top of the page, line 1, the term
for the acronym CMR, ``Comprehensive Medical Review'' is corrected to
read ``Comprehensive Medication Review''.
3. On page 19752--
a. In the first column, last paragraph, line 1, the citation Sec.
422.311(c)(2)(v) is corrected to read ``Sec. 422.311(c)(2)(ix)''.
b. In the second column, first partial paragraph, line 5, the
citation Sec. 422.311(c)(2)(vi) is corrected to read ``Sec.
422.311(c)(2)(x)''.
4. On page 19773, in the second column, first full paragraph, line
5, the term ``comprehensive medical review'' is corrected to read
``comprehensive medication review''.
5. On page 19793, first column--
a. Second full paragraph, lines 8 and 9, the term ``comprehensive
medical review'' is corrected to read ``comprehensive medication
review''.
b. Last paragraph--
(1) Lines 4 and 5, the term ``medical reviews'' is corrected to
read ``medication reviews''.
(2) Line 6, the term ``medical review'' is corrected to read
``medication review''.
B. Correction of Errors in the Regulations Text
1. On page 19809, in the first column, second full paragraph, line
1, the paragraph designation ``(C)'' is corrected to read ``(D)''.
2. On page 19812, in the second column--
a. In the first full paragraph, in the amendatory statement for
Sec. 422.566 (statement number 37)--
(1) Lines 4 and 5 (amendatory instruction C), the sentence
``Redesignating paragraph (b)(5) as (b)(6)'' is corrected by removing
the amendatory instruction.
(2) Line 7 (amendatory instruction D), the sentence ``Adding a new
paragraph (b)(5) is corrected by removing the amendatory instruction.
(3) Line 8 (amendatory statement E), the phrase ``In paragraphs
(c)(1)(i), and (c)(2)(i)'' is corrected to read ``In paragraph
(c)(1)(i)''.
(4) Line 14 (after amendatory statement E and before the phrase
``The revision and addition''), the paragraph is corrected by adding
the following sentence ``F. In paragraph (c)(2)(i), the phrase `An
enrollee (including his or her authorized representative)'; is removed
and the phrase `The enrollee (including his or her representative);' is
added in its place.''
b. In the fourth full paragraph, the paragraph ``(5) Reduction of a
previously authorized course of treatment if the enrollee believes that
continuation of the course of treatment is medically necessary.'' is
corrected by removing the paragraph.
c. In the fifth full paragraph, in the amendatory statement for
Sec. 422.568 (statement number 38), lines 2 through 7, the sentence
beginning with the phrase ``A. Redesginating paragraphs (a)'' through
the sentence ending with phrase ``newly redesignated paragraph (d)''
are corrected to read as follows:
``A. Redesignating paragraphs (c) and (d) as paragraphs (d)(1) and
(d)(2), respectively.
B. Redesignating paragraphs (a) and (b) as (b) and (c).
C. Adding a new paragraph (a).
D. Revising newly redesignated paragraph (d).''
[[Page 32860]]
3. On page 19816--
a. First and second columns, second paragraph from the bottom of
the page through the sixth full paragraph; the paragraph beginning with
the phrase ``61. Section 423.100'' through the paragraph ending with
the phrase ``on various individuals.'' is corrected by deleting these
paragraphs.
b. In the third column, second full paragraph, in the amendatory
statement for Sec. 423.120 (statement number 64), line 6 (immediately
following amendatory statement C), the paragraph is corrected by adding
the following amendatory statement ``D. Adding a new paragraph
(b)(2)(vi).''
4. On page 19817, third column, after the third full paragraph
((b)(1)(ix)) which ends with ``* * * * *'', the paragraph is corrected
by adding the following paragraphs:
``(2) * * *
(vi) Exceptions to paragraph (b)(2)(v) of this section are as
follows:
(A) Drug products that are rated as therapeutically equivalent
(under the Food and Drug Administration's most recent publication of
``Approved Drug Products with Therapeutic Equivalence Evaluations,''
also known as the Orange Book).
(B) Utilization management processes that limit the quantity of
drugs due to safety.
(C) Other drugs that CMS specifies through a process that is based
upon scientific evidence and medical standards of practice (and, in the
case of antiretroviral medications, is consistent with the Department
of Health and Human Services Guidelines for the Use of Antiretroviral
Agents in HIV-1-Infected Adults and Adolescents) and which permits
public notice and comment.
5. On page 19818, second column, fifth paragraph from the bottom
(regulations text for Sec. 423.153(d)(1)(vii)(B)), lines 3 and 4, the
term ``comprehensive medical review'' is corrected to read
``comprehensive medication review''.
6. On page 19822, in the third column, third paragraph from the
bottom of the page, in the amendatory statement for Sec. 423.551
(statement number 84), line 2, the phrase ``adding a new paragraph (g)
is corrected to read ``revising paragraph (g).''
Authority: Catalog of Federal Domestic Assistance Program No.
93.773, Medicare--Hospital Insurance; and Program No. 93.774,
Medicare--Supplementary Medical Insurance Program).
Dated: June 4, 2010.
Dawn L. Smalls,
Executive Secretary to the Department.
[FR Doc. 2010-13923 Filed 6-7-10; 4:15 pm]
BILLING CODE 4120-01-P