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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.

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).

Alternatives:

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. 

Risks:

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.