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HHS/CMS RIN: 0938-AU85 Publication ID: Fall 2021 
Title: ●Implementing Certain Provisions of the Consolidated Appropriations Act and Other Revisions to Medicare Enrollment and Eligibility Rules (CMS-4199) 

This proposed rule would implement certain Medicare-related provisions of the Consolidated Appropriations Act, 2021 (CAA).  Specifically, section 120 of the CAA allows for Medicare coverage to take effect earlier for people who enroll in the General Enrollment Period (GEP) or within the last three months of their Initial Enrollment Period (IEP).  Section 120 also gives the Secretary the authority to establish special enrollment periods for exceptional circumstances. Section 402 of the CAA extends immunosuppressive drug coverage for Medicare kidney transplant recipients beyond the current law 36-month limit following a transplant by providing immunosuppressive drug coverage under Medicare Part B for these individuals. Separately, this rule would address enrollment in Medicare Part A for applicants who are eligible for Social Security benefits, but are not yet receiving them, and make certain updates related to state payment of Medicare premiums.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 42 CFR 400    42 CFR 406    42 CFR 407    42 CFR 408    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Pub. L. 116-260, secs. 120 & 402    42 U.S.C 1395i-2   
Legal Deadline:
Action Source Description Date
Final  Statutory  Provisions under sections 120 and 402 of the CAA must be effective 1/1/23.  01/01/2023 
Final  Statutory  Enrollments under section 402 of the CAA start on 10/1/22.  10/01/2022 

Statement of Need:

This rule is necessary to implement section 120 of the Consolidated Appropriations Act, 2021 (CAA) that revises effective dates of coverage for individuals enrolling in Medicare and gives the Secretary of the Department of Health and Human Services the authority to establish special enrollment periods (SEPs) for exceptional circumstances beginning January 1, 2023.  This rule also implements section 402 of the CAA that, beginning January 1, 2023, provides for coverage of immunosuppressive drugs under part B for certain individuals whose Medicare entitlement based on end-stage renal disease (ESRD) would otherwise end 36-months after the month in which they received a successful kidney transplant.  

Summary of the Legal Basis:

The legal basis of this rule is the Consolidated Appropriations Act, 2021 (sections 120 and 402).


The provisions of this rule are primarily established in statute.  Where there is discretion, alternatives will be discussed within the text of the rule. Public comments will also be considered in the development of the final rule.

Anticipated Costs and Benefits:

We believe that this rule will have a positive impact on health outcomes of beneficiaries because it provides for Medicare coverage to begin earlier and provides for coverage of immunosuppressive drugs in situations where, currently, they are not covered. 


The risks associated with not publishing this regulation would be not establishing the regulatory authority under which immunosuppressive drug benefits and effective dates of coverage will be based upon beginning January 2023.

Action Date FR Cite
NPRM  01/00/2022 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Kristy Nishimoto
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicare, MS: 100, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:206 615-2367