2010-13923. 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, [phone].

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 § 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 (§ 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 (§ 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 § 423.100 and adding the exceptions criteria that were inadvertently omitted from § 423.120(b).

On page 19812, we presented our regulatory changes to § 422.566 and § 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 § 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 § 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 § 422.311(c)(2)(v) is corrected to read “§ 422.311(c)(2)(ix)”.

b. In the second column, first partial paragraph, line 5, the citation § 422.311(c)(2)(vi) is corrected to read “§ 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 § 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 § 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).”

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 § 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 § 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 § 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.