2024-22203. Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, ...

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Department of Health and Human Services

Centers for Medicare & Medicaid Services

1. 42 CFR Parts 422, 423, and 460
2. [CMS-4201-F5 and CMS-4205-F4]
3. RIN 0938-AV24 and 0938-AU96

AGENCY:

Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).

ACTION:

Final rule; correcting amendment.

SUMMARY:

This document corrects technical and typographical errors in the final rule that appeared in the April 23, 2024 Federal Register titled “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE).” The effective date of the final rule was June 3, 2024.

DATES:

This correcting amendment is effective September 30, 2024.

FOR FURTHER INFORMATION CONTACT:

Carly Medosch, [phone]—General Questions.

Naseem Tarmohamed, [phone]—Part C and Cost Plan Issues.

Lucia Patrone, [phone]—Part D Issues.

Kelley Ordonio, [phone]—Parts C and D Payment Issues.

Hunter Coohill, [phone]—Enforcement Issues.

Lauren Brandow, [phone]—PACE Issues.

Sara Klotz, [phone]—D-SNP Issues.

Joe Strazzire, [phone]—RADV Audit Appeals Issues.

[e-mail] —Parts C and D Star Ratings Issues.

SUPPLEMENTARY INFORMATION: ( print page 79451)

I. Background

In FR Doc. 2024-07105 of April 23, 2024 (89 FR 30448), the final rule titled “Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024—Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)”, there were several typographical and technical errors that are identified and corrected in this correcting amendment.

II. Summary of Errors

We are correcting typographical and grammatical errors in the regulatory text of §§ 422.101(f)(3)(iv)(B)( 3), 422.514(h)(2), and 423.346(e)(2), respectively.

We are correcting inadvertent technical and typographical errors in the regulations text of § 423.153.

In § 460.20, we inadvertently revised paragraph (c), when we intended to redesignate paragraphs (c) through (e) as paragraphs (d) through (f) and add a new paragraph (c). Our intent was to finalize the proposed changes to § 460.20 that were included in the proposed rule that appeared in the December 27, 2022 Federal Register (87 FR 79452) titled “Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable Care Act and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications.” We are providing corrected instructions to address this error and redesignate paragraphs (d) and (e) as paragraphs (e) and (f), and to specify that we are adding new paragraph (d).

III. Waiver of Proposed Rulemaking and Delay in Effective Date

Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), the agency is required to publish a notice of the proposed rule in the Federal Register before the provisions of a rule take effect. Specifically, 5 U.S.C. 553 requires the agency to publish a notice of the proposed rule in the Federal Register that includes a reference to the legal authority under which the rule is proposed, and the terms and substance of the proposed rule or a description of the subjects and issues involved. Further, 5 U.S.C. 553 requires the agency to give interested parties the opportunity to participate in the rulemaking through public comment on a proposed rule. Similarly, section 1871(b)(1) of the Act requires the Secretary to provide for notice of the proposed rule in the Federal Register and provide a period of not less than 60 days for public comment for rulemaking to carry out the administration of the Medicare program under title XVIII of the Act. In addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of the Social Security Act (the Act) mandate a 30-day delay in effective date after issuance or publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA provide for exceptions from the notice and comment and delay in effective date APA requirements. In cases in which these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act, also provide exceptions from the notice and 60-day comment period and delay in effective date requirements of the Act. Section 553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an agency to dispense with normal rulemaking requirements for good cause if the agency makes a finding that the notice and comment process are impracticable, unnecessary, or contrary to the public interest. In addition, both section 553(d)(3) of the APA and section 1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay in effective date where such delay is contrary to the public interest and an agency includes a statement of support.

We believe that this correcting amendment does not constitute a rule that would be subject to the notice and comment or delayed effective date requirements of the APA or section 1871 of the Act. This correcting amendment corrects typographical and technical errors in the regulatory text of the final rule but does not make substantive changes to the policies that were adopted in the final rule. As a result, this correcting amendment is intended to ensure that the information in the final rule accurately reflects the policies adopted in that final rule.

In addition, even if this were a rule to which the notice and comment procedures and delayed effective date requirements applied, we find that there is good cause to waive such requirements. Undertaking further notice and comment procedures to incorporate the regulatory text correction in this document into the final rule or delaying the effective date would be unnecessary, as we are not altering our policies or regulatory changes, but rather, we are simply implementing the policies and regulatory changes that we previously proposed, requested comment on, and subsequently finalized.

This final rule correcting amendment is intended solely to ensure that the final rule and the Code of Federal Regulations (CFR) accurately reflect policies and regulatory changes that have been adopted through rulemaking. Furthermore, such notice and comment procedures would be contrary to the public interest because it is in the public's interest to ensure that the final rule accurately reflects our policies and regulatory changes. Therefore, we believe we have good cause to waive the notice and comment and effective date requirements.

List of Subjects

42 CFR Parts 422 and 423

• Administrative practice and procedure
• Health facilities
• Health maintenance organizations (HMO)
• Medicare
• Penalties
• Privacy
• Reporting and recordkeeping requirements

42 CFR Part 460

• Aged
• Citizenship and naturalization
• Civil rights
• Health
• Health care
• Health records
• Individuals with disabilities
• Medicaid
• Medicare
• Religious discrimination
• Reporting and recordkeeping requirements
• Sex discrimination

For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services corrects 42 CFR chapter IV by making the following correcting amendments:

PART 422—MEDICARE ADVANTAGE PROGRAM

1. The authority citation for part 422 continues to read as follows:

Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and 1395hh.

§ 422.101

[Amended]

2. Amend § 422.101, in paragraph (f)(3)(iv)(B)(3), by removing the phrase “related SNP operations.” and adding in its place the phrase “related to SNP operations.”.

§ 422.514

[Amended]

3. Amend § 422.514, in paragraph (h)(2), by removing the phrase “(or continue to cover individuals” and adding in its place the phrase “(or continue to cover) individuals”.

( print page 79452)

PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

4. The authority citation for part 423 continues to read as follows:

Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.

§ 423.153

[Amended]

5. Amend § 423.153 by:

a. Revising the section heading;

b. In paragraph (a), removing the phrase “an MTMP as described” and adding in its place the phrase “an MTM program as described”;

c. In paragraph (d), adding a paragraph heading;

d. In paragraph (d)(1)(vi), removing the term “MTMP” and adding in its place the phrase “MTM program”;

e. In paragraph (d)(1)(vii) introductory text, removing the term “MTMP” and adding in its place the phrase “MTM program”;

f. In paragraph (d)(6), removing the term “MTMP” and adding in its place the phrase “MTM program”; and

g. Redesignating paragraphs (g)(i) through (iii) as paragraphs (g)(1)(i) through (iii).

The revision and addition read as follows:

§ 423.346

Drug utilization management, quality assurance, medication therapy management (MTM) programs, drug management programs, and access to Medicare Parts A and B claims data extracts.

* * * * *

(d) Medication therapy management (MTM) program —* * *

* * * * *

6. Amend § 423.346, in paragraph (e)(2), by removing the phrase “contracts that is” and adding in its place the phrase “contracts that are”.

PART 460—PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)

7. The authority citation for part 460 continues to read as follows:

Authority: 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).

8. Amend § 460.20 by:

a. Redesignating paragraphs (d) and (e) as paragraphs (e) and (f); and

b. Adding a new paragraph (d).

The addition reads as follows:

§ 460.20

Notice of CMS determination.

* * * * *

(d) Additional information requested. If CMS determines that an application is not complete because it does not include sufficient information to make a determination, CMS will request additional information within 90 days, or 45 days for applications set forth in § 460.10(a)(2), after the date of submission of the application.

(1) The time limits in paragraph (a) of this section do not begin until CMS receives all requested information and the application is complete.

(2) If more than 12 months elapse between the date of initial submission of the application and the entity's response to the CMS request for additional information, the entity must update the application to provide the most current information and materials related to the application.

* * * * *

Elizabeth J. Gramling,

Executive Secretary to the Department, Department of Health and Human Services.