[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]


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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.

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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