Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 400, 406, 407, 408, 410, 423, 431, and 435

[CMS-4199-P]

RIN 0938-AU85

Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules

AGENCY:

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

ACTION:

Proposed rule.

SUMMARY:

This proposed rule would implement certain provisions of the Consolidated Appropriations Act, 2021 (CAA). Additionally, CMS is proposing to delete references to specific Medicare forms from the text of existing regulations at §§ 406.7 and 407.11 in order to provide greater administrative flexibility. Finally, this proposed rule would update the various federal regulations that affect a state's payment of Medicare Part A and B premiums for beneficiaries enrolled in the Medicare Savings Programs and other Medicaid eligibility groups.

DATES:

To be assured consideration, comments must be received at one of the addresses provided, no later than 5 p.m. on June 27, 2022.

ADDRESSES:

In commenting, refer to file code CMS-4199-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

1.

Electronically.

You may submit electronic comments on this regulation to

http://www.regulations.gov.

Follow the “Submit a comment” instructions.

2.

By regular mail.

You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4199-P, P.O. Box 8013, Baltimore, MD 21244-4199.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3.

By express or overnight mail.

You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-4199-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850. [

Note:

This zip code is for express mail or courier delivery only. This zip code specifies the agency's physical location.]

You may submit comments on this document's paperwork requirements by following the instructions at the end of the “Collection of Information Requirements” section in this document.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

Major Bullock, (410) 786-8974, or Steve Manning (410) 786-1961—General questions.

Steve Manning, (410) 786-1961, or Carla Patterson (410) 786-8911—For inquiries related to section 120 of the CAA.

Gail Sexton, (410) 786-4583, or Major Bullock, (410) 786-8974—For inquiries related to section 402 of the CAA.

Melissa Heitt, 410-786-4494—For inquiries related to section 402(f) (Medicare Savings Programs) of the CAA.

Carla Patterson, (410) 786-8911—For inquiries related to the Medicare enrollment form.

Kim Glaun, (410) 786-3849—For inquiries related to state payment of Medicare premiums.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received:

http://www.regulations.gov.

Follow the search instructions on that website to view public comments.

I. Summary

A. Beneficiary Enrollment Simplification in Medicare Parts A and B—Overview

1. Background

Medicare is a Federal program to provide health insurance for people age 65 and older, and those under 65 with certain disabilities or ESRD. Medicare consists of four distinct parts, commonly referred to as Medicare Parts A, B, C and D. Medicare Part A, sometimes referred to as hospital insurance (HI), covers inpatient hospital services, skilled nursing care, hospice care, and some home health services. Individuals must meet certain conditions to be entitled to Part A. Medicare Part B, or supplementary medical insurance (SMI), is an optional benefit that helps cover medically necessary services and supplies like physicians' services, durable medical equipment, outpatient care, and other medical services that Part A does not cover, including many preventive services. Together, Medicare Parts A and B comprise “original” or “traditional” Medicare. Most beneficiaries are automatically enrolled in Part A and Part B by the Social Security Administration (SSA) or the Railroad Retirement Board when they turn 65. In addition, if an individual has been receiving Social Security or Railroad Retirement Disability benefits for 24 months, they will automatically be enrolled by SSA or the Railroad Retirement Board in Medicare Parts A and B.

The first opportunity individuals have to enroll in Part B is during their initial enrollment period (IEP). The IEP is a 7-month period that usually begins 3 months before the month in which an eligible individual turns 65 and ends 3 months after the first month of eligibility. The next opportunity for eligible individuals who do not enroll in Part B during their IEP to enroll in Part B, if they choose to do so, is in the general enrollment period (GEP) which runs from January 1st through March 31st each year. Currently, an individual's entitlement (coverage period effective date) under Part B depends on the enrollment period and the month in which the individual enrolls, according to the requirements in sections 1837 and 1838 of the Social Security Act (the Act).

For those who enroll in Medicare Part B during any of the first 3 months of their IEP, coverage is effective the first month they become eligible for Medicare (such as age 65 or the 25th month of entitlement to monthly Social Security or railroad retirement benefits based on disability). However, for those who enroll in any of the last 4 months of their IEP, their coverage becomes effective after their month of enrollment, with the effective date of coverage varying depending on the month in which they enroll.

For individuals subject to the current requirements at 42 CFR 407.10, and who enroll during the GEP, coverage is effective the July 1 following the month in which the individual enrolls.

Example.

An individual's 65th birthday is April 10 and they first meet the eligibility requirements for

enrollment April 1. The individual's initial enrollment period would extend from January through July in the year they turn 65. The month in which the individual enrolls in Part B determines the month in which their period of entitlement would begin, as follows:

IEP enrollments during a month before

January 1, 2023

Entitlement begins on—

January

April 1 (month eligibility requirements first met).

February

April 1.

March

April 1.

April

May 1 (month following month of enrollment).

May

July 1 (second month after month of enrollment).

June

September 1 (third month after month of enrollment).

July

October 1 (third month after month of enrollment).

For individuals subject to the current requirements at 42 CFR 407.10, and who enroll during the GEP, coverage is effective the July 1 following the month in which he or she enrolls.

2. Proposal Summary

Section 120 of the Consolidated Appropriations Act, 2021 (CAA), Public Law (Pub. L.) 116-260, Division CC, title I, section 120 (December 27, 2020), modified the requirements in section 1838 of the Act, pertaining to individuals enrolling in Part B after not being automatically enrolled, or who are re-enrolling in Part B after disenrollment. Specifically, the CAA revised sections 1838(a)(2)(C), 1838(a)(3)(A), and 1838(a)(2)(D) of the Act to provide that for individuals who become eligible for Medicare on or after January 1, 2023, and enroll in Part B during the last 3 months of their IEP, entitlement would begin the first day of the month following the month in which they enroll.

These changes enacted under section 120 of the CAA will result in coverage under Part B that becomes effective sooner after an individual enrolls during the IEP, deemed IEP, or GEP. We expect these changes will simplify the enrollment process and reduce gaps in health care coverage, and make it easier for affected beneficiaries to understand the effective date of their Medicare coverage. We are proposing conforming changes to our regulations at 42 CFR part 407 to implement these Part B changes. In addition, while the statutory provisions of section 120 of the CAA primarily affect individuals enrolling in Part B, those changes will also affect the requirements applicable to the limited number of individuals enrolling in Part A who are not entitled to premium-free Part A. We are proposing conforming modifications to our regulations at 42 CFR part 406 to reflect those Part A changes.

Additionally, section 120 of the CAA established new section 1837(m) of the Act, which provides authority for the Secretary of the Department of Health and Human Services (HHS) (the Secretary) to establish SEPs for individuals who are eligible to enroll in Medicare and meet such exceptional conditions as the Secretary may provide, effective January 1, 2023. Corresponding changes in sections 1838(g) and 1839(b) of the Act provide the Secretary the discretion to determine the effective date of entitlement for individuals who enroll under an SEP for exceptional conditions, and exempt individuals enrolling under such an SEP from being subject to a late enrollment penalty (LEP), respectively. We are proposing to establish several SEPs for exceptional conditions in this proposed rule, and would incorporate those SEPs in our regulations under 42 CFR parts 406 and 407.

B. Extended Coverage of Immunosuppressive Drugs for Certain Kidney Transplant Patients—Overview

1. Background

End-stage renal disease (ESRD) is a medical condition in which a person's kidneys cease functioning permanently, leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life. A kidney transplant is ultimately considered the best treatment for ESRD. Section 226A of the Act includes a provision that enables certain individuals diagnosed with ESRD to be entitled to Medicare, regardless of age. If an individual with ESRD applies for Medicare and is entitled to Medicare Part A and eligible for Part B benefits, Medicare provides coverage for all covered medical services, not only those related to the kidney failure condition. When an individual receives a successful kidney transplant, Medicare coverage extends for 36 months after the month in which the individual receives the transplant. Currently, after the 36th month, Medicare coverage ends unless the individual is eligible for Medicare on another basis, such as age or disability.

Medicare Part B covers medical and other health services including, as specified in section 1861(s)(2)(J) of the Act, prescription drugs used in immunosuppressive therapy furnished to an individual who receives an organ transplant for which Medicare payment is made. Kidney transplant recipients must take immunosuppressive drugs to help prevent their immune systems from rejecting the transplanted kidney. If a transplanted kidney is rejected, the individual would revert to ESRD status and again need dialysis treatment or another transplant.

Under current law, Medicare Part B beneficiaries have coverage for such immunosuppressive drug therapy for as long as they remain eligible for and enrolled in Medicare Part B. However, section 226A(b)(2) of the Act currently requires that entitlement to Medicare Part A and eligibility to enroll under Part B for ESRD beneficiaries ends with the 36th month after the month in which the individual receives a successful kidney transplant (see also 42 CFR 406.13(f)(2)).

2. Proposal Summary

Section 402 of the CAA amended sections 226A(b)(2) (and made conforming changes to sections 1836, 1837, 1838, 1839, 1844, 1860D-1, 1902, and 1905 of the Act) to make certain individuals eligible for enrollment under Medicare Part B solely for purposes of coverage of immunosuppressive drugs described in section 1861(s)(2)(J) of the Act. Effective January 1, 2023, this provision would allow certain individuals whose Medicare entitlement based on ESRD would otherwise end after a successful kidney transplant to continue enrollment under Medicare Part B only for the coverage of immunosuppressive drugs described in section 1861(s)(2)(J) of the Act. These individuals would not receive Medicare coverage for any other items or services (under either Part A or Part B), and would only be eligible for immunosuppressive drug coverage under Part B if they are not enrolled in certain other types of coverage, as described in “Eligibility for the Part B-ID Benefit” (section II.B.2.b. this proposed rule). Section 402 of the CAA also amended the Medicare Savings Programs (MSPs) under sections 1905(p)(1)(A) and 1902(a)(10)(E) of the Act to pay the Part B premiums and in some cases the costs of the Part B deductible and coinsurance for immunosuppressive drug coverage for certain low-income individuals.

C. Simplifying Regulations Related to Medicare Enrollment Forms—Overview

1. Background

Individuals who receive monthly Social Security or railroad retirement benefits at age 65 or have been entitled to monthly Social Security or railroad retirement benefits based on disability benefits for more than 24 months, are automatically entitled to Part A and do

not have to file a separate application in order to enroll in premium-free Part A. These individuals are automatically enrolled (auto-enrolled) by the Social Security Administration or the Railroad Retirement Board into Part A when they reach age 65 or their 25th month of entitlement to Social Security or railroad retirement benefits based on disability. Individuals who become eligible for premium-free Medicare but who are not auto-enrolled, either because they have delayed receiving Social Security or railroad retirement benefits, or are not eligible for such benefits but are otherwise eligible to receive premium-free Medicare part A based on paying the Medicare payroll tax, must file a separate application to enroll in Medicare. Individuals who decide to collect Social Security benefits after they reach age 65, and thus did not get auto-enrolled in Medicare by virtue of receiving Social Security benefits, may use their application for Social Security benefits, as defined in 42 CFR 400.200, to apply for Medicare if they are eligible for Part A at that time. Individuals may also separately request enrollment in Part B by answering the Part B enrollment questions on an application for monthly Social Security retirement or spousal benefits. As an alternative, individuals may enroll in Part B by signing a simple statement of request, if they are eligible to enroll at that time.

Currently, there are a total of seven enrollment forms for traditional Medicare—two enrollment forms for Part A and five enrollment forms for Part B, in §§ 406.7 and 407.11, respectively. Medicare enrollment forms are available to individuals via mail from CMS or SSA, downloadable via the CMS and SSA websites, or in person at SSA field offices. CMS and SSA periodically review the enrollment forms to determine if updates are necessary to comply with statutory, regulatory, or operational changes. Our regulations currently identify each form by name and provide a brief description of its uses.

2. Proposal Summary

We are proposing to remove references to individual enrollment forms from our regulations, including their titles and brief descriptions, to provide greater administrative flexibility in updating, adding, or removing forms in the future. We are also proposing to make technical edits to the text to state that an individual who files an application for monthly Social Security cash benefits as defined in § 400.200 also applies for Medicare entitlement if he or she is eligible for hospital insurance at that time.

D. Modernizing State Payment of Medicare Premiums—Overview

1. Background

Since the implementation of the original Medicare program in 1966, section 1843 of the Act has provided states the option to enter into an “agreement” with the Federal government under which a state commits to enrolling certain Medicare-eligible Medicaid beneficiaries into Medicare Part B with the state paying the Part B premiums on their behalf. Section 1903(a)(1) and (b) of the Act authorize federal financial participation (FFP) for such state payment of Part B premiums for certain dually eligible individuals. We have historically referred to this process as “state buy-in.” All 50 states and the District of Columbia have buy-in agreements for Part B

1

with the Secretary.

1

Thirty-seven states (including the District of Columbia) also have buy-in agreements for Part A.

States pay Medicare Part B premiums for approximately 10 million individuals and Part A premiums for approximately 700,000 individuals each year who are not entitled to Part A without a premium. For an individual who is eligible for but not yet enrolled in Medicare, state buy-in serves to both enroll the individual in Medicare and enable the Federal Government to bill the state for the new beneficiary's Medicare premiums. For an individual who is already enrolled in Medicare, state buy-ins enable the Federal Government to bill the state for the individual's Medicare premiums and stop collecting the premiums through deductions from the beneficiary's monthly Social Security (Old Age Insurance or Disability benefits or Supplemental Security Income), Railroad Retirement Board (RRB), or Office of Personnel Management (OPM) benefits, or through CMS direct billing.

The impact of state buy-in is significant for many beneficiaries. Low-income individuals who receive assistance with Medicare premiums save critical funds to use for other necessities, including food and housing. Upon state buy-in, individuals who were paying the Medicare premiums through deductions from their Social Security benefits see a notable increase in their monthly social security checks (the standard Part B premium is $170.10 per month in 2022), and individuals eligible but not enrolled in Medicare are able to enroll in the program and access Medicare services.

2. Proposal Summary

We are proposing changes to the state buy-in that would better align the regulations with federal statute, policy and operations that have evolved over time, including revising the regulations to provide that approved State plan provisions governing the buy-in process constitute a State's buy-in agreement and limiting retroactive Medicare Part B premium liability for states for full-benefit dually eligible beneficiaries. By clarifying and streamlining existing requirements, these proposals would improve the customer service experience of dually eligible beneficiaries pursuant to the

Executive Order on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government

and promote access to affordable health coverage and essential medical treatment and improve health equity for underserved populations consistent with the

Executive Order On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.

Together, these proposals not only implement provisions of the CAA, but also support President Biden's

Executive Order on Continuing to Strengthen Americans' Access to Affordable, Quality Health Coverage, Executive Order on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government, Executive Order On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government

and

Executive Order On Strengthening Medicaid and the Affordable Care Act

by eliminating potentially confusing coverage waiting periods, allowing CMS and the Social Security Administration to remedy missed enrollment periods by allowing for SEPs for exceptional conditions and extending coverage of Medicare Savings Programs (MSPs) to include payment of premiums and cost-sharing for a new immunosuppressive drug coverage under Part B.

II. Provisions of the Proposed Rule

A. Proposals for Beneficiary Enrollment Simplification (§§ 406.21, 406.22, 406.27, 406.33, 406.34, 407.22, 407.25, and 408.24)

1. Effective Dates of Entitlement

While the majority of individuals are automatically enrolled in Medicare Parts A and B upon reaching age 65 or when they have been entitled to monthly Social Security or railroad retirement benefits based on disability for more than 24 months, certain

individuals are required to take active steps to enroll. Specifically, individuals who are eligible for, but not receiving, monthly Social Security benefits under section 202 of the Act or qualified RRB benefits when they turn 65, are not auto-enrolled because they have elected not to start receiving their Social Security or RRB benefits and have not filed an application for Social Security or RRB benefits and must take separate action to apply for Medicare. Certain individuals who are entitled to premium free Part A through government employment, but are not eligible for Social Security or RRB benefits also have to take action to apply for Medicare. Individuals may apply for Part A at any time, but can only apply for Part B during a specific enrollment period (IEP, GEP, or SEP). Further, under section 1818 of the Act, certain individuals who are not otherwise entitled to Part A but meet certain requirements, are eligible to enroll in Part A. These individuals are required to pay monthly premiums under section 1818(d) of the Act, and this benefit is frequently referred to as “premium Part A.” These individuals are required to take active steps to enroll in premium Part A and Part B.

As briefly described previously, the period during which these individuals are entitled to receive benefits under Medicare, also known as the coverage period, can vary depending on when the individual enrolls. The first opportunity individuals have to enroll in Part B is during their IEP. Section 1837(d) of the Act defines the IEP for most individuals who become eligible for Medicare on or after March 1, 1966. For these individuals, the IEP begins on the first day of the third month before the month the individual turns 65 and ends seven months later. Section 1837(d) of the Act also defines what is commonly referred to as the “deemed IEP.” When an individual fails to enroll during their IEP because of a belief, based on erroneous documentary evidence, that he or she had not yet attained age 65, section 1837(d) of the Act requires the Secretary to establish an IEP for such individual. Such individuals are considered “deemed” to have enrolled for purposes of section 1838(a)(3) of the Act, and these individuals are subject to entitlement periods consistent with those applied for individuals not subject to a deemed initial enrollment period under 42 CFR 407.14.

Eligible individuals who do not enroll in Part B during their IEP or deemed IEP, or who disenroll from Part B and wish to re-enroll, must generally do so during the GEP. The GEP is established under section 1837(e) of the Act, and is the period beginning on January 1 and ending on March 31 of each year. Section 1838(a) of the Act establishes the beginning of entitlement for Part B for individuals who enroll in their IEP or GEP. According to the current requirements established under sections 1838(a)(2)(A) and 1838(a)(3)(A) of the Act for individuals who become eligible to enroll in Medicare under section 1836(a) of the Act before January 1, 2023, and enroll during the first 3 months of their IEP or deemed IEP, their entitlement would begin on the first day of the month they turn 65. For such individuals who enroll during the month in which they become eligible, sections 1838(a)(2)(B)(i) and 1838(a)(3)(B)(i) of the Act currently specify that their entitlement begins with the first day of the month following the month in which they enroll. For such individuals who enroll in the month after the month in which they satisfy the requirements of section 1836(a) of the Act, their entitlement would begin with the first day of the second month after the month in which they enroll under sections 1838(a)(2)(B)(ii) and 1838(a)(3)(B)(i) of the Act. For such individuals who enroll in Medicare during the last 2 months of their IEP or deemed IEP, their entitlement under Medicare would be effective beginning with the first day of the third month after the month in which he or she enrolls according to sections 1838(a)(2)(B)(iii) and 1838(a)(3)(B)(i) of the Act. Finally, for such individuals who enroll in Medicare under the GEP in a month beginning before January 1, 2023, sections 1838(a)(2)(D)(1) and 1838(a)(3)(B)(i) provide that their entitlement would begin with the first of July following their enrollment.

Section 120(a)(1) of the CAA revised the entitlement periods for individuals who enroll in Medicare Part B in the last 3 months of their IEP, deemed IEP, or during the GEP, beginning January 1, 2023. Specifically, the CAA modified section 1838 of the Act such that revised section 1838(a)(2)(C) and (a)(3)(B)(ii) of the Act provide that for a Medicare eligible individual who satisfies the requirements of section 1836(a) of the Act in a month beginning on or after January 1, 2023, and who enrolls in the month in which they satisfy those requirements, or in any subsequent month of their IEP, the individual's entitlement would begin with the first day of the month following the month of enrollment. The CAA also revised sections 1838(a)(2)(D)(ii) and 1838(a)(3)(B)(ii) of the Act to provide that for individuals who enroll during the GEP in a month beginning on or after January 1, 2023, their entitlement would begin with the first day of the month following the month in which they enroll.

We expect that these changes to the entitlement for individuals who enroll during their IEP or GEP are likely to increase access to continuous coverage under Medicare Part B, both by expediting these individuals' entitlement dates and decreasing enrollees' confusion about when their coverage becomes effective. Therefore, we anticipate this change having a positive impact on Medicare beneficiaries, including those in communities who may be disproportionately impacted by lack of continuous health coverage.

Enrolls in IEP:

Prior to 1/1/23—Entitlement begins on:

On or after 1/1/23—Entitlement begins on:

January

April 1 (month eligibility requirements first met)

April 1 (month eligibility requirements first met).

February

April 1

April 1.

March

April 1

April 1.

April

May 1 (month following month of enrollment)

May 1.

May

July 1 (second month after month of enrollment)

June 1.

June

September 1 (third month after month of enrollment)

July 1.

July

October 1 (third month after month of enrollment)

August 1.

As shown in the chart, the changes made to section 1838(a) of the Act according to section 120 of the CAA directly affect the requirements for individuals enrolling in Part B. However, these changes will also impact certain individuals enrolling in Part A. Section 1818(c) of the Act specifically requires in part that the provisions of section 1838 of the Act apply to individuals enrolling in premium Part A for purposes of determining the period

of enrollment and other aspects of coverage. In light of this statute, the revised entitlement periods established in section 1838(a) of the Act will also apply to premium Part A enrollees.

Therefore, to implement the changes to 1838(a) of the Act, we are proposing to revise language in both 42 CFR part 406 (for premium Part A) and 42 CFR part 407 (for Part B). Specifically, we propose the following to reflect changes related to the start of entitlement for premium Part A IEP enrollments:

• Section 406.22(a) would be revised to apply the existing requirements governing the entitlement period for individuals who are age 65 or older before January 1, 2023 who enroll in premium Part A during their IEP.

• Existing § 406.22(b) would be redesignated as paragraph (c). New paragraph (b) would lay out the entitlement dates for individuals who attained age 65 on or after January 1, 2023, and who enroll during their IEP, including a deemed IEP. Subparagraph (b)(1) would provide that for such individuals who enroll during the first 3 months of their IEP, entitlement begins with the first month of eligibility. Subparagraph (b)(2) would specify that if such an individual enrolls during the last 4 months of their IEP, entitlement would begin with the month following the month in which they enrolled.

• Newly redesignated § 406.22(c) would be revised to apply the existing entitlement date requirements for individuals under age 65 who became eligible for Medicare prior to January 1, 2023. For individuals who enroll during the first 3 months of their IEP, entitlement would begin with the first month of eligibility. If an individual enrolls during the month in which they first become eligible, entitlement would begin with following month. If an individual enrolls in the month following the month of eligibility, entitlement would begin with the second month after the month of enrollment. If the individual enrolls more than one month after the month of eligibility, entitlement would begin with the third month after the month of enrollment.

• New § 406.22(d) would set out the start dates for entitlement for individuals under age 65 who enroll in premium Part A on or after January 1, 2023. For individuals enrolling during the first 3 months of their IEP, entitlement would begin with the first month of eligibility. If an individual enrolls during the last 4 months of their IEP, their entitlement would begin with the following month.

We propose the following to reflect changes related to the start of entitlement for individuals enrolling in Part B during their IEP:

• We would revise section 407.25(a)(1) to apply the existing entitlement date requirements to individuals who first satisfy the Part B eligibility requirements before January 1, 2023 and enroll during their IEP or deemed IEP.

• Section 407.25(a)(2) would apply to individuals who first satisfy the Part B eligibility requirements on or after January 1, 2023. Entitlement for such individuals would begin with the first month of eligibility for enrollments made during the first 3 months of the IEP. We are proposing that § 407.25(a)(2)(ii) would specify that if such an individual enrolls during the last 4 months of their IEP, entitlement would begin with the month following the month in which they enroll.

Section 120(a)(1)(A) of the CAA also modified section 1838(a)(2) of the Act, to address the beginning of the entitlement for individuals enrolling during their GEP according to 1837(e) of the Act. We are proposing the following changes to reflect those requirements for individuals enrolling in premium Part A:

• Section 406.21(c)(3) would be revised to reflect the revised entitlement periods for individuals who enroll or reenroll during a GEP. Specifically, § 406.21(c)(3)(i) would require that for individuals who enroll or reenroll during a GEP prior to January 1, 2023, entitlement would begin July 1st following their enrollment, consistent with section 1838(a)(2)(D)(i) of the Act and the existing entitlement date requirements. Section 406.21(c)(3)(ii) would require that for individuals who enroll or reenroll during a GEP on or after January 1, 2023, entitlement would begin on the first day of the month after the month of enrollment, consistent with section 1838(a)(2)(D)(ii) of the Act.

• Section 407.25(b)(1) would be revised to require that for individuals enrolling or reenrolling in Part B during a GEP before January 1, 2023, the current requirements governing the entitlement date would continue to apply. Specifically, revised § 407.25(b)(1) would state that for all such individuals enrolling or reenrolling during a GEP before April 1, 1981, or after September 30, 1981 and before January 1, 2023, entitlement would begin on July 1 of that calendar year.

• New § 407.25(b)(3) would require that for individuals who enroll or reenroll in Part B during a GEP on or after January 1, 2023, entitlement would begin the first day of the month following the month of enrollment.

We note that CMS would update all public facing materials to reflect date changes from any final rule. This would include updated information in CMS publications, on

Medicare.gov

, and in training materials.

2. Special Enrollment Periods for Exceptional Conditions

Under normal conditions, individuals who want to enroll in premium Part A, Part B, or both must submit a timely enrollment request during their IEP, the GEP, or an existing SEP for which they are eligible. Those who fail to enroll during their IEP may face a life-long penalty for late enrollment and a potential gap in coverage. Prior to the enactment of the CAA, CMS did not have broad authority to create SEPs based on exceptional conditions for enrollees in Medicare Parts A and B.

2

Section 120(a)(2)(A) of the CAA established section 1837(m) of the Act to provide the Secretary with authority to establish SEPs for individuals who satisfy the requirements in paragraph (1) or (2) of section 1836(a) of the Act, and meet such exceptional conditions as the Secretary may provide, beginning January 1, 2023. Section 120 of the CAA also created section 1838(g) of the Act to provide the Secretary the discretion to determine the entitlement period for individuals who enroll pursuant to an SEP established according to section 1837(m) of the Act, in a manner that protects the continuity of health benefit coverage to the extent practicable. The CAA also modified section 1839(b) of the Act to exempt individuals who enroll pursuant to an SEP for exceptional conditions established under section 1838(m) of the Act, from paying an LEP. Section 1818(c) of the Act provides that individuals enrolling under premium Part A are generally afforded the same enrollment opportunities as those available under Part B, so our proposals would apply to both premium Part A and Part B, except where noted.

2

CMS has separate authority for Medicare Parts C and D under sections 1851(e)(4)(d) and 1860D-1(b)(3)(C) of the Act, respectively.

Several SEPs currently exist that permit individuals to enroll in premium Part A or Part B outside of the IEP or GEP. The existing SEPs are briefly described as follows:

• Sections 1837(i)(1) through (3) of the Act provide an SEP for certain individuals who are enrolled in a qualified group health plan (GHP) or large GHP (LGHP) at the time they first become eligible for Medicare and elect not to enroll (or to be deemed enrolled) in Medicare during their IEP.

• Section 1837(i)(4) of the Act establishes an SEP for certain workers who are eligible for disability benefits. Specifically, an SEP is available to covered individuals who are enrolled in a GHP (based on their own current or former employment or the current or former employment of a family member) at the time they first become eligible for Medicare, and who elect not to enroll (or be deemed enrolled) during their IEP, when their continuous enrollment in such GHP is involuntarily terminated, provided certain other requirements are met.

• The SEP for international volunteers, established under section 1837(k) of the Act, establishes an SEP for individuals serving as volunteers outside the United States at the time they first become eligible for Medicare, through a program covering at least a 12-month period, sponsored by a 501(c)(3) tax exempt organization, and who demonstrate health insurance coverage while serving in the program. These international volunteers are eligible for an SEP, if they elect not to enroll (or be deemed enrolled) under section 1837 of the Act during their IEP or terminate Medicare enrollment during a month in which they are serving in such program.

• Section 1837(l) of the Act establishes a 12-month SEP for certain individuals who are enrolled in TRICARE and become eligible to enroll in Part A on the basis of disability or ESRD status under sections 226(b) or 226A of the Act, respectively, but who elect not to enroll (or to be deemed enrolled) during their IEP.

We are proposing to establish new exceptional conditions SEPs under section 1837(m) of the Act in §§ 406.27 and 407.23 of the regulations for Medicare parts A and B, respectively. These SEPs would be available to individuals who have missed an enrollment period due to a covered exceptional condition. Specifically, individuals who miss an IEP, GEP, or another SEP, such as the GHP SEP, due to a covered exceptional condition, would be eligible to enroll in Medicare premium Part A or Part B using the new SEPs. We believe our proposals will create the flexibility needed for eligible individuals to enroll in the program while simultaneously establishing parameters to ensure appropriate use of the new exceptional conditions SEPs.

In determining what new exceptional conditions SEPs would be beneficial to the Medicare program and its beneficiaries and that should be established in regulations, CMS considered numerous factors including the following:

• Whether the conditions that caused the individual to miss an enrollment period are “exceptional” as required under the CAA, and whether they are likely to be a one-time event.

• The SEP should not create an incentive for individuals to delay timely enrollment into Medicare.

• The SEP should not create an incentive for individuals to not educate themselves about the importance of enrolling in Medicare timely and make informed decisions during other available enrollment periods.

• Whether an SEP would be the most appropriate resolution to the exceptional conditions in question and whether other remedies such as individualized equitable relief under section 1837(h) of the Act, would more appropriately apply.

• The SEP should be expected to apply to a significant number or broad category of individuals, which would justify the establishment of a specific SEP in regulation instead of relying on the Secretary's authority under section 1837(h) of the Act to evaluate individual conditions and approve SEPs on a case-by-case basis.

With these parameters in mind, we leveraged our previous program experience with Medicare enrollment in determining which SEPs to propose. We also considered the SEPs for exceptional conditions established under Medicare Parts C and D (section 1851(e)(4) of the Act), the Health Insurance Marketplace (29 U.S.C. 1163), and commercial health plans for insight into what SEPs are available in both public and private healthcare settings. Finally, we also considered whether the proposed new SEPs and the associated entitlement would protect access to continuous coverage for individuals eligible for Medicare Part A and Part B, such as through expediting individuals' entitlement date or by creating opportunities for individuals to enroll in coverage sooner.

Based on these considerations, CMS is proposing to establish five SEPs under Medicare Parts A and B based on the Secretary's authority in section 1837(m) of the Act. Four of the proposed SEPs address specific exceptional conditions. One SEP would permit CMS or SSA to evaluate individuals' particular conditions and grant SEPs on a case-by-case basis due to unanticipated conditions that may arise in the future. We anticipate these proposed changes would have a positive impact on Medicare beneficiaries, including those in communities impacted by lack of continuous health coverage.

To accommodate these changes, we propose to establish a new § 406.27, entitled “Special enrollment periods for exceptional conditions” to provide SEPs for individuals who missed enrolling in premium Part A during an enrollment period due to exceptional conditions. Similarly, we propose to establish a new § 407.23, also entitled “Special enrollment periods for exceptional conditions” to provide SEPs for individuals who missed enrolling in Part B during an enrollment period due to exceptional conditions. Both proposed §§ 406.27(a) and 407.23(a) would provide in part that the SEPs for exceptional conditions would be available beginning January 1, 2023. Specifically, the proposed SEPs for exceptional conditions would be applicable for exceptional conditions that took place on or after January 1, 2023 with the exception of the SEP to Coordinate with Termination of Medicaid Coverage discussed in section II.2.d. of this proposed rule.

Each of these SEPs would provide an opportunity for individuals to enroll without having to wait for the GEP. Individuals who enroll in Medicare Part A or Part B using an SEP for exceptional conditions and subsequently disenroll would have to wait until the next GEP or another SEP to reenroll and may potentially be subjected to a LEP.

Late Enrollment Penalties Associated With Special Enrollment Periods for Exceptional Conditions

Section 120(a)(2)(C)(ii) of the CAA modified section 1839(b) of the Act to provide that individuals who enroll during an SEP established under the Secretary's authority under new section 1837(m) of the Act are not subject to the LEP. Specifically, section 1839(b) of the Act, as amended, provides that an individual who enrolls in Medicare “after his initial enrollment period [. . .] and not pursuant to a special enrollment period under subsection (i)(4), (l), or (m) of section 1837 [. . .] shall be increased by 10 percent of the monthly premium so determined for each full 12 months (in the same continuous period of eligibility) in which he could have been but was not enrolled.” Therefore, we propose that should an individual who missed an enrollment period due to an exceptional condition, enroll in premium Part A or Part B using one of the following SEPs, they would not be subject to a LEP. Specifically, we are proposing at § 406.33(c)(2) that for enrollments on or after January 1, 2023 under one of the SEPs established pursuant to the Secretary's authority in section 1837(m) of the Act and established in § 406.27, any months of non-coverage would be excluded from the calculation of the

LEP. Similarly, we are proposing at § 408.24(b)(2) that for enrollments on or after January 1, 2023 under one of the SEPs established pursuant to the Secretary's authority in section 1837(m) of the Act and established in § 407.23, any months of non-coverage would be excluded from the calculation of the LEP.

We are also proposing changes to our regulations to reflect that certain individuals who reenroll in premium Part A or Part B would also be exempted from paying an LEP. Specifically, we are proposing under §§ 406.34(a) and 408.24(c) that, for individuals who reenroll prior to January 1, 2023, the requirements currently in place for determining the months taken into account for purposes of calculating the LEP would continue to apply. In addition, we are proposing in §§ 406.34(e) and 408.24(d)(2)(ii) that for reenrollments on or after January 1, 2023, pursuant to one of the SEPs for exceptional conditions established under the Secretary's authority in section 1837(m) of the Act and promulgated in §§ 406.27 or 407.23, respectively, any months of non-coverage would be excluded from the calculation of the LEP. However, if the individual fails to enroll or reenroll during the available exceptional condition SEP, any months of non-coverage, including the months during the exceptional condition SEP, would be taken into consideration for calculating the LEP in accordance with §§ 406.33, 406.34, and 408.22.

In the following sections, we discuss each of the proposed SEPs for exceptional conditions.

a. SEP for Individuals Impacted by an Emergency or Disaster

The severity and duration of extreme weather-related events and other emergencies can be difficult to accurately predict, but may strip individuals of their ability to carry out day-to-day activities. In many cases, impacted individuals need additional time after the end of an emergency to return to their normal routine. We know from program experience that these events can result in disruptions in mail delivery, SSA office closings, and operational delays at Social Security field offices, any of which can prevent individuals from submitting their enrollment applications in a timely manner.

For Medicare Parts A and B, we have the authority under section 1837(h) of the Act to provide relief to individuals whose enrollment or non-enrollment in Part A or Part B was unintentional or erroneous and resulted from an error, misrepresentation or inaction by the federal government. Disrupted mail delivery and Social Security office closures due to disasters might justify relief under 1837(h) in some cases. For example, during the COVID-19 pandemic, we utilized this equitable relief authority to provide assistance to individuals who missed their opportunity to enroll in Medicare during their IEP, GEP, or SEP. However, disasters or emergencies may interfere with individuals' ability to enroll in Medicare without any error or inaction by the Federal government. As a result, these conditions would not meet the requirements for equitable relief under section 1837(h) of the Act.

To address such exceptional conditions, we are proposing an SEP for individuals impacted by an emergency or disaster under the Secretary's authority to establish SEPs beginning January 1, 2023, under section 1837(m) of the Act. Establishing such an SEP would permit the agency to provide immediate relief to individuals impacted by certain emergencies and disasters without being subject to the requirements applicable under our existing equitable relief authority. Providing an SEP for individuals who missed enrolling in Medicare during an enrollment period because they were impacted by an emergency or disaster will permit Medicare beneficiaries to maintain healthcare coverage and access healthcare services in times of disruption when healthcare may be most critical. We believe these effects would be most significant, and the proposed SEP for individuals impacted by and emergency or disaster would be most beneficial, for communities where social risk factors such as food, housing, or financial insecurity are prevalent.

CMS is proposing, at new §§ 406.27(b) and 407.23(b), to create an SEP for individuals prevented from submitting a timely Medicare enrollment request by an emergency or disaster declared by either a Federal, state, or local government. These SEPs would apply for individuals enrolling in premium Part A or Part B and would eliminate potential gaps in coverage and otherwise applicable LEPs resulting from eligible individuals' inability to submit a timely enrollment request as a result of emergency or disaster.

At new §§ 406.27(b)(1) and 407.23(b)(1), we propose this SEP would be available to those who were not able to enroll in premium Part A or Part B or both if they reside (or resided) in an area for which a Federal, state or local government entity newly declared a disaster or other emergency. The individual must demonstrate that they reside (or resided) in the area during the period covered by that declaration. We understand that not every emergency declaration would impact an individual's ability to enroll in a timely manner. Therefore, we are specifically soliciting comments regarding this proposal, including whether CMS should limit the time frame of the SEP based on the type of emergency, or specify that the type of emergency must explicitly restrict an individual's ability to enroll.

At §§ 406.27(b)(2) and 407.23(b)(2), we propose that the SEP would begin on the date an emergency or disaster is declared, or if different, the start date identified in the declaration, whichever is earlier, so long as the date is on or after January 1, 2023. The SEP ends 2 months after the end date identified in the disaster or emergency declaration or, if applicable, the end date of any extensions or the date when the declaration has been determined to have ended or has been revoked. The intention of having the SEP end 2 months after the end of the declaration is to provide individuals enough time to recover from the emergency before needing to enroll in Medicare.

We are proposing in §§ 406.27(b)(3) and 407.23(b)(3), according to the Secretary's authority under section 1838(g) of the Act to specify the coverage period for individuals enrolling during SEPs established under section 1837(m) of the Act, that the coverage period for individuals who enroll under this SEP would begin the first day of the month following the month of enrollment, so long as the date is on or after January 1, 2023.

b. SEP for Health Plan or Employer Misrepresentation or Providing Incorrect Information

As codified in § 406.6(c) of our regulations, some individuals are not auto-enrolled into Medicare, and thus must apply in order to enroll. Often, the primary source of information about Medicare for working aged individuals is their employer or the carrier of their GHP. CMS is aware of multiple instances in which individuals received erroneous information from their employer that resulted in the individual not enrolling in Part B timely and consequently they were assessed an LEP. CMS's ability to offer assistance to individuals who are misinformed about Medicare enrollment periods by their employer or GHP is very limited. As a result, these individuals have historically faced gaps in coverage or been required to pay significant LEPs for the rest of their lives after failing to enroll in Part B based on

misrepresentation by an employer, GHP or a representative of such an entity.

In order to provide relief to individuals who missed an enrollment period because of misrepresentation by or incorrect information from their employer or GHP, we are proposing to create a new SEP at § 406.27(c) and at § 407.23(c) based on exceptional conditions. This SEP would apply for individuals whose non-enrollment in premium Part A or Part B is unintentional, inadvertent, or erroneous and results from material misrepresentation or reliance on incorrect information provided by the individual's employer or GHP, or any person authorized to act on behalf of the employer or GHP. We are proposing at §§ 406.27(c)(1) and 407.23(c)(1) that an individual is eligible for such an SEP if they can demonstrate that he or she did not enroll in premium Part A or Part B during an enrollment period in which they were eligible based on information received from an employer or GHP, or any person authorized to act on such organization's behalf, and an employer, GHP or their representative materially misrepresented information or provided incorrect information relating to enrollment in premium Part A or Part B, so long as the misrepresentation or error occurred on or after January 1, 2023.

To demonstrate material misrepresentation, an individual would be required to provide documentation of the relevant misrepresentation to SSA. The documentation must show that the information was provided on or after January 1, 2023, was directly from an employer, GHP or their representative prior to an enrollment period, and that the inaccuracy caused the individual not to enroll timely. Examples of such evidence could be a letter from the employer or GHP that materially misrepresents the Medicare enrollment process or a letter from the employer or GHP acknowledging that they provided misinformation in a previous communication. An omission by the employer or GHP or the representative of such organization would not be considered a misrepresentation for purposes of this proposed SEP, as employers and GHPs do not have an affirmative responsibility to educate employees about Medicare.

We are proposing at § 406.27(c)(2) and § 407.23(c)(2) that this SEP would begin the day the individual notifies SSA of the employer or GHP misrepresentation or incorrect information provided, so long as the misrepresentation or error occurred on or after January 1, 2023, and would end 2 months later. Individuals would be required to provide SSA or CMS evidence that shows what misinformation was initially provided by the employer, GHP, or their representative. We are soliciting comments on whether we should require additional evidence, for example, evidence of what new information was received that caused discovery of the misinformation and evidence of when the discovery was made. Finally, at §§ 406.27(c)(3) and 407.23(c)(3), we propose that the coverage period would begin the first day of the month following enrollment.

c. SEP for Formerly Incarcerated Individuals

Section 1862(a)(2) and (3) of the Act generally prohibits Medicare payment for covered services while the recipient is incarcerated, as the incarcerated individual is provided healthcare through their penal institution. Further, section 202(x)(1)(A) of the Act prohibits the payment of Old-age, Survivors, and Disability Insurance (OASDI) benefits to individuals who are incarcerated. Therefore, if an individual turns 65 and qualifies for Medicare while incarcerated (meaning the individual is in custody of penal authorities as described in 42 CFR 411.4(b)) and is not yet receiving OASDI benefits, that individual is not automatically enrolled in Medicare Part A. Moreover, current law does not provide any special enrollment opportunities for formerly incarcerated individuals who miss a Medicare enrollment period while incarcerated. If these individuals do not enroll into Medicare because they are incarcerated, they may go months without health coverage upon their release. For example, upon their release such individuals would only be able to enroll in Medicare during the GEP which could result in a significant delay in coverage. Further, delaying enrollment means that they may incur an LEP for premium Part A and/or Part B for the rest of their lives. Regardless of whether they are newly eligible for Medicare coverage or not, individuals who are incarcerated are required to begin and maintain their monthly premium payments for premium Part A and/or Part B to avoid termination of Medicare coverage.

To address the exceptional conditions that an individual faces while incarcerated as described previously, and to ensure that formerly incarcerated individuals have access to health coverage under Medicare, we are proposing at §§ 406.27(d) and 407.23(d) an SEP for individuals who are released from incarceration on or after January 1, 2023. This SEP would allow formerly incarcerated individuals to avoid potential gaps in coverage and late enrollment penalties. We propose at §§ 406.27(d)(1) and 407.23(d)(1) that an individual would be eligible for this SEP if they demonstrate that they are eligible for Medicare and failed to enroll or reenroll in Medicare premium Part A or Part B during another enrollment period in which they were eligible to enroll while they were incarcerated. Further, there must be a record of release either through discharge documents or data available to SSA.

We propose at §§ 406.27(d)(2) and 407.23(d)(2) that this SEP would start the day of the individual's release from incarceration and end the last day of the sixth month after the month in which the individual is released from incarceration. We propose this duration because (1) it takes approximately 3 months for OASDI payments to be reinstated upon an individual's release from incarceration; and (2) data demonstrate that individuals with arrest or conviction records face barriers in obtaining employment. Such lack of income from employment or OASDI might dissuade formerly incarcerated individuals from enrolling in Medicare upon their release because of concerns about their ability to pay Medicare premiums and cost sharing. Formerly incarcerated individuals may experience social risk factors including financial, housing or food insecurity, social isolation, and other factors that can increase the likelihood of chronic physical or mental health conditions that require healthcare services. Lack of institutional support may impair the ability of formerly incarcerated persons from obtaining employment, housing, and other stabilizing supports necessary for successful reentry. Therefore, by providing this extended SEP duration, we ensure this at-risk population has adequate opportunity to enroll in Medicare. Further, we anticipate this change having a positive impact on formerly incarcerated Medicare beneficiaries, including those in communities who may be disproportionally impacted by a lack of continuous health coverage.

Finally, at new §§ 406.27(d)(3) and 407.23(d)(3), we propose that entitlement would begin the first day of the month after the month of enrollment, so long as it is after January 1, 2023.

d. SEP To Coordinate With Termination of Medicaid Coverage

Many beneficiaries are enrolled in Medicaid when they initially qualify for Medicare at age 65, or if they are under age 65, after receiving 24 months of Social Security Disability Insurance (SSDI). While some of these individuals

retain Medicaid coverage after becoming eligible for Medicare, others lose Medicaid benefits or eligibility entirely. For example, when an individual enrolled in the adult group under § 435.119 becomes eligible for Medicare, they become ineligible for the Medicaid adult group. (Individuals enrolled in the adult group have an annual income below 138 percent of the Federal Poverty Level ($20,398 for an individual in 2022)).

3

Unless such individuals are eligible for Medicaid on another basis, they will no longer be eligible for Medicaid. Many such individuals qualify for another Medicaid eligibility group, such as a Medicare Savings Programs (MSP) group, but others lose Medicaid coverage entirely because they do not qualify for another Medicaid eligibility group.

3

The adult group under § 435.119 (b) has an income limit of 133 percent of the FPL, but a basic standard deduction of 5 percent of the FPL is applicable as described in section 6012(a)(1) of the Internal Revenue Services Code. (See 42 CFR 434.603(e).)

Low-income Medicare beneficiaries experience poorer health outcomes than their higher-income counterparts.

4

Based on program experience and reports from stakeholders, we are aware that some individuals who lose all Medicaid coverage after newly qualifying for Medicare may experience confusion and administrative barriers that undermine a seamless transition from Medicaid to Medicare coverage, risking a period of time without health insurance and a possible LEP for these at-risk individuals.

4

For information about the health outcomes of low-income Medicare beneficiaries, see HHS Office of the Assistant Secretary for Planning and Evaluation (2016, December).

Social Risk Factors and Performance Under Medicare's Value-Based Purchasing Programs. https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//171041/ASPESESRTCfull.pdf

.

Before terminating or reducing the scope of Medicaid coverage for individuals who become eligible for Medicare, the state Medicaid agency must conduct a redetermination of eligibility, including a determination of whether the individual is eligible for Medicaid upon another basis (42 CFR 435.916(d) and 435.916(f)(1)). The state must continue the same level of Medicaid coverage until the state completes the eligibility redetermination and provides at least 10 days advance notice and fair hearing rights in accordance with § 435.917 and 42 CFR part 431 Subpart E. If during the redetermination process, an individual is found to no longer be eligible for the eligibility group under which they had been most recently receiving coverage, the state would then: (1) Move the individual to a different eligibility group, which could include an MSP eligibility group, for which the person is eligible; or (2) determine the individual's potential eligibility for other insurance affordability programs, in accordance with § 435.916(f)(2), and terminate the individual's Medicaid coverage.

Despite these requirements, there are multiple scenarios that can prevent a seamless transition to Medicare coverage. States sometimes fail to complete redeterminations timely. Additionally, individuals sometimes lose coverage for procedural reasons (for example, failure to submit required paperwork in time) even though they likely remain eligible for Medicaid.

5

In the first situation, while § 435.916(d) requires that states “promptly” conduct redeterminations based on changes in circumstances, including new eligibility for Medicare, we believe that some states do not complete redeterminations until months after the individual first becomes eligible for Medicare even though Medicare eligibility is generally predictable.

6

If a state does not complete a redetermination when the beneficiary attains Medicare eligibility, an individual may retain Medicaid even though the individual no longer technically meets the Medicaid eligibility criteria. State Health Insurance Assistance Programs and beneficiary advocacy groups report that these individuals may then miss their IEP because they continue to be covered by Medicaid and may think they do not need or cannot afford Medicare coverage at that time, especially when individuals expect to be liable for Medicare premiums. While some states cover the Part B premiums for individuals remaining in the adult group pending a redetermination under their buy-in agreement,

7

others do not.

8

States cannot include the payment of the Part A premium for adult group beneficiaries in their buy-in agreement.

9

5

See HHS Office of the Assistant Secretary for Planning and Evaluation. (2019, May 8).

Loss of Medicare-Medicaid Dual Eligible Status: Frequency, Contributing Factors and Implications. https://aspe.hhs.gov/reports/loss-medicare-medicaid-dual-eligible-status-frequency-contributing-factors-implications,

page 38.

6

Recent HHS Office of Inspector General reports and state audits have cited cases in which states continued to provide coverage for many months after a change impacting eligibility was identified that should have prompted a redetermination. See for example: Louisiana Legislative Auditor. (2018, November 8).

Medicaid Eligibility: Wage Verification Process of the Expansion Population. https://www.lla.la.gov/PublicReports.nsf/1CDD30D9C8286082862583400065E5F6/$FILE/0001ABC3.pdf;

HHS Office of the Inspector General. (2019a, August).

Colorado Did Not Correctly Determine Medicaid Eligibility for Some Newly Enrolled Beneficiaries. https://oig.hhs.gov/oas/reports/region7/71604228.pdf;

HHS Office of the Inspector General. (2019b, August).

Illinois Medicaid Managed Care Organizations Received Capitation Payments After Beneficiaries' Deaths. https://oig.hhs.gov/oas/reports/region5/51800026.pdf;

HHS Office of the Inspector General. (2019c, May).

California Medicaid Managed Care Organizations Received Capitation Payments After Beneficiaries' Deaths. https://oig.hhs.gov/oas/reports/region4/41806220.pdf;

HHS Office of the Inspector General. (2018d, October).

Ohio Medicaid Managed Care Organizations Received Capitation Payments After Beneficiaries' Deaths. https://oig.hhs.gov/oas/reports/region5/51700008.pdf.

7

Under their buy-in agreements with CMS, some states are required to enroll all Medicaid beneficiaries in Medicare Part B and to pay the premiums on their behalf (known as “Part B buy-in”). If such a state has not completed the eligibility redetermination for an individual enrolled in the adult group before the first month they qualify for Medicare, the state must enroll the individual in Part B buy-in for all months in which the individual is enrolled in the adult group. CMS Manual for the State Payment of Medicare Premiums, chapter 1, section 1.4,

https://www.cms.gov/files/document/chapter-1-program-overview-and-policy.pdf.

8

See section II.D.3.e. of this proposed rule for a discussion of buy-in coverage groups available for Part B.

9

As described in section II.D.1. of this proposed rule, states can only pay the Part A premiums for individuals who enrolled in the Qualified Medicare Beneficiary (QMB) group.

During the ongoing Public Health Emergency in response to the Coronavirus Disease 2019 outbreak (COVID-19 PHE), as a condition of receiving the federal medical assistance percentage (FMAP) increase authorized by the Families First Coronavirus Response Act (FFCRA) (Pub. L. 116-127), states have been required to maintain Medicaid enrollment for nearly all individuals enrolled in Medicaid as of March 18, 2020, through the end of the month in which the PHE ends. This condition, known as the continuous enrollment requirement, applies to, among others, individuals who qualified during this time period in the adult group and subsequently became eligible for Medicare. In the preamble to the interim final rule with comment period published in the November 6, 2020

Federal Register

(85 FR 71142), CMS explained that states would be in compliance with the continuous enrollment requirement if they were to transition an adult group beneficiary who becomes eligible for Medicare to an MSP group for which such an individual is eligible (but that such an individual could not be transitioned to an MSP group if the individual did not meet the eligibility requirements for any MSP group). CMS articulated this policy after initially directing states that they had to retain such individuals in both the adult group and MSP groups in order to comply

with the continuous enrollment requirement.

10

10

See CMS.

COVID-19 Frequently Asked Questions (FAQs) for State Medicaid and Children's Health Insurance Program (CHIP) Agencies.

Last updated January 6, 2021, available at

https://www.medicaid.gov/state-resource-center/downloads/covid-19-faqs.pdf.

Since the start of the COVID-19 PHE, beneficiary advocacy groups and State Health Insurance Assistance Programs have reported to us that a substantial number of beneficiaries who became eligible for Medicare while enrolled in the adult group may have interpreted states' notifications that their Medicaid coverage would remain throughout the COVID-19 PHE (and the ensuing months of continuous coverage after they qualified for Medicare) to mean they did not need to take any action during the COVID-19 PHE to secure health coverage, including enrolling in Medicare. As mentioned previously, some beneficiaries who stay in the adult group are ineligible for coverage of their Part B premiums under state buy-in. Further, certain beneficiaries should have been enrolled in Medicare on the basis of their state's buy-in agreement but were not because, although their state includes all Medicaid beneficiaries in their buy-in agreement for Part B premiums, the state may have been unclear this includes individuals whom states kept in the adult group on the basis of the continuous enrollment requirement. Consequently, some beneficiaries who maintained adult group eligibility are likely to have missed their IEPs as a result of confusion based on the COVID-19 PHE. Based on these reports, we are concerned that when the COVID-19 PHE ends and states resume routine eligibility and enrollment operations for Medicaid, including taking action on pending applications, renewals, and redeterminations necessitated by changes in beneficiary circumstances, such individuals may end up being terminated from Medicaid and will experience a gap in coverage and lose access to critical health care as a result. Further, once they do enroll in Medicare, they may incur late enrollment penalties.

As an existing requirement under the Medicaid program designed to maximize continuity of coverage for beneficiaries whom states have determined ineligible for Medicaid, states must determine or assess their potential eligibility for other Insurance Affordability Programs, such as the Children's Health Insurance Program (CHIP) and health insurance coverage available on the Marketplace with financial assistance and transfer their accounts to such programs as appropriate under §§ 435.916(f)(2) and 435.1200(e). Although Insurance Affordability Programs have not been defined to include Medicare, we believe promoting a seamless transition from Medicaid to Medicare coverage is also very important. The ability to enroll in Medicare can be vital in preventing gaps in health coverage, especially if individuals lack access to other health insurance and may be subject to an LEP when they do enroll in Medicare.

To remove barriers that present an exceptional condition that could prevent individuals from transitioning from coverage under the Medicaid program to coverage under the Medicare program, we are proposing an SEP at §§ 406.27(e) and 407.23(e) for individuals who lose Medicaid eligibility entirely after the COVID-19 PHE ends or on or after January 1, 2023 (whichever is earlier) and have missed a Medicare enrollment period. We anticipate our proposals will advance health equity by improving low-income individuals' access to continuous, affordable health coverage and use of needed health care consistent with the

Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government

and the

Executive Order on Continuing to Strengthen Americans' Access to Affordable, Quality Health Coverage.

We are proposing at §§ 406.27(e)(1) and 407.23(e)(1) that to be eligible for this SEP, an individual must demonstrate they are eligible for Medicare and their Medicaid eligibility is terminated on or after January 1, 2023, or is terminated after the last day of the COVID-19 PHE as determined by the Secretary, whichever is earlier. At §§ 406.27(e)(2)(i) and 407.23(e)(2)(i), we propose that if the termination of Medicaid eligibility occurs after the last day of the COVID-19 PHE and before January 1, 2023, the SEP starts on January 1, 2023 and ends on June 30, 2023. At §§ 406.27(e)(2)(ii) and 407.23(e)(2)(ii), we propose that if the termination of Medicaid eligibility occurs on or after January 1, 2023, the SEP starts when the beneficiary receives notice of an upcoming termination of Medicaid eligibility and ends 6 months after the termination of eligibility. We believe this extended duration would allow this at-risk population sufficient opportunity to enroll in Medicare.

We note that unlike the other proposed SEPs for exceptional conditions, this SEP could apply to a circumstance that occurs before January 1, 2023 (that is, if the end of the PHE and the individual's Medicaid termination occur before such time). We believe that such a deviation is warranted in this limited circumstance given the novel COVID-19 outbreak and unprecedented federal, state and local efforts to combat it. As mentioned earlier, to comply with the continuous enrollment requirement under section 6008 of FFRCA, states have kept substantial numbers of beneficiaries in the adult group for several months after they qualified for Medicare (more than 2 years in some cases). As described previously, state notices regarding extended Medicaid eligibility and the provision of continuous enrollment may have contributed to confusion, causing many individuals to miss their IEP during the PHE. To minimize beneficiary burden and help reduce gaps in coverage from Medicaid-only to Medicare-only once states restore routine eligibility and enrollment operations, it is critical to provide this SEP to individuals who lose coverage after the PHE if that occurs before January 1, 2023. In short, the PHE presents a unique convergence of circumstances that will affect a defined group of individuals currently known to CMS.

We propose at §§ 406.27(e)(3) and 407.23(e)(3) that entitlement would begin the first day of the month following the month of enrollment, so long as it is effective after the end of the PHE or January 1, 2023, whichever is earlier. We note that individuals whose Medicaid eligibility is terminated after the end of the COVD-19 PHE, but before January 1, 2023 (if applicable), have the option of requesting that entitlement begin back to the first of the month following termination of Medicaid eligibility provided the individual pays the monthly premiums for the period of coverage.

Lastly, we propose at §§ 406.27(e)(4) and § 407.23(e)(4) that individuals who otherwise would be eligible for this SEP, but enrolled during the COVID-19 PHE prior to January 1, 2023, if applicable, are eligible to have LEPs collected under §§ 406.32(d) or 408.22 reimbursed and ongoing penalties removed. Given the unique nature of this specific SEP, and the fact that we are proposing that individuals could be eligible for the SEP if the COVID-19 PHE ends before January 1, 2023, we believe it is appropriate and fair that these individuals not be subject to an LEP that would not have been collected had they known about this remedy at the time of enrollment.

This proposed SEP would allow an individual who loses Medicaid eligibility entirely once the PHE ends or on or after January 1, 2023, if earlier,

and who has missed a Medicare enrollment period, to enroll in Medicare without a gap in coverage or an LEP. We anticipate that the SEP would most frequently apply to individuals who do not sign up for Medicare while they still have Medicaid, including those eligible in the adult group. At least initially, we suspect that the individuals who are most likely to need and use this proposed SEP are those who were in the Medicaid adult group under § 435.119, especially those individuals who remained in the adult group during the COVID-19 PHE and while pending an eligibility determination once normal operations resume because, for example, they believe they do not need additional coverage or cannot afford to pay the Medicare premiums. This SEP would apply to individuals who lose Medicaid coverage altogether, regardless of whether the Medicaid termination results from their new eligibility for Medicare, other changes in circumstances, or procedural reasons. As noted previously, an individual would need to have missed a Medicare enrollment period and if eligible, the SEP would be available once the individual is notified of their Medicaid termination. Further, individuals who are determined to no longer meet the eligibility requirements for one Medicaid eligibility group but are determined eligible for a separate Medicaid eligibility group that is included in their state's buy-in agreement would not use this SEP because they do not need it as the state can already enroll them in Medicare without regard to Medicare enrollment periods and LEPs.

We seek comment on the parameters of this proposed SEP, particularly whether the SEP's duration (that is, the trigger, which is after the loss of Medicaid eligibility, rather than while the individual is still enrolled in Medicaid, as well as the end date for the SEP) and Medicare entitlement date (that is, earliest date Medicare benefits can start) prevent gaps in coverage and promote continuity of care for low-income beneficiaries who lose Medicaid coverage after qualifying for Medicare.

e. SEP for Other Exceptional Conditions

CMS is proposing to retain the ability to provide SEPs on a case-by-case basis for other unanticipated situations that involve exceptional conditions and warrant an SEP. This SEP would allow us to grant SEPs on a case-by-case basis for circumstances we do not have enough experience to consider or anticipate that could create a barrier to enrollment. We acknowledge that there is no way to predict the full range of circumstances that would warrant an SEP—they are “exceptional”—so we need this SEP for exceptional conditions to be timely in our response to beneficiaries with unique cases, given the time it takes to establish a more targeted SEP via rulemaking. There is a similar SEP under Medicare Part C and Part D, and we are leveraging our experience from those programs to afford beneficiaries who have unique exceptional conditions beyond their control that prevent them from enrolling in Medicare, an SEP. In addition, some of the SEPs that are now codified under Part C and Part D started out as case-by-case SEPs. We were able to use the information and experience gained as a basis for establishing a new SEP, through rulemaking, for a broad category of people corresponding to a more specific set of circumstances.

Specifically, we are proposing to create an SEP for other exceptional conditions to provide individuals an opportunity to enroll in premium Part A, Part B or both. This SEP would provide an enrollment opportunity for individuals where conditions beyond their control caused them to miss an enrollment period and prevented them from timely enrolling in premium Part A or Part B or both during the IEP, GEP or other prescribed SEPs. This SEP would apply to individuals whose unique conditions do not qualify for one of the other proposed SEPs and would be proposed at new §§ 406.27(f) and 407.23(f). We are proposing at §§ 406.27(f)(1) and 407.23(f)(1) that such SEPs would be granted on or after January 1, 2023, if two conditions are met. First, an individual must demonstrate that conditions outside of their control caused them to miss an enrollment period. Second, the condition must be determined exceptional in nature.

Due to the numerous reasons an individual might request an SEP for other exceptional conditions, individuals may reasonably need different amounts of time to enroll in Medicare in the event an SEP is granted. Setting forth a specific duration for this SEP could disadvantage enrollees whose condition may require additional time. In light of these facts, at §§ 406.27(f)(2) and 407.23(f)(2), we propose that the SEP duration would be determined on a case-by-case basis. CMS believes that this SEP will be infrequently used and that it will only be granted in conditions that are truly exceptional in nature. This SEP will not be used to grant individuals enrollment due to forgetfulness or lack of knowledge. For example, an individual who turns 65 and fails to enroll because they simply forgot to enroll during their IEP would not qualify for this proposed SEP as they do not have evidence that their situation that prevented them from enrolling timely was beyond their control nor was it exceptional in nature. Finally, consistent with the other SEPs we are proposing under section 1837(m) of the Act at §§ 406.27(f)(3) and 407.23(f)(3) that entitlement would begin the first day of the month following the month of enrollment, and only for exceptional conditions that arise on or after January 1, 2023.

f. Alternatives Considered

As discussed previously, we considered several factors in determining which SEPs to propose under the new authority established by section 120 of the CAA. With these principles in mind, and to provide relief for individuals in truly exceptional conditions as directed by section 120 of the CAA, there were a number of SEPs that we considered but did not believe warranted establishing a separate SEP for exceptional conditions. For example, we considered an SEP for individuals who previously decided not to enroll in Medicare but now want to enroll outside of the GEP or other enrollment periods because they are experiencing a health event and want Medicare coverage. We decided not to propose an SEP for individuals in such conditions because there was not an exceptional condition that prevented the individual from enrolling during an earlier enrollment period; allowing enrollment outside of the GEP could provide an incentive for other individuals to delay enrollment in Medicare, which we believe is inconsistent with the statutory framework that imposes penalties for late enrollment. We also considered an SEP for individuals who lost Medicare coverage due to non-payment of premiums who are not eligible for another SEP or equitable relief and now want to re-enroll outside of the GEP. We opted not to propose this SEP because we did not want to create an environment where there could be cycles of an individual losing and reenrolling in Medicare based on whether they have paid their premiums. If a beneficiary is experiencing financial constraints, there are mechanisms in place (including state buy-in, MSP and premium payment plans) that would more appropriately provide support for affected individuals while ensuring continuity in their health care coverage.

In order to be eligible for any of the SEPs other than the new exceptional condition SEPs, individuals must have had separate health insurance coverage when they first become eligible for

Medicare and have elected not to enroll (or to be deemed enrolled) during their IEP. To be consistent with the existing Medicare SEPs and to ensure appropriate use of the exceptional condition SEPs, we considered proposing a requirement that new SEPs would only be available to individuals who have missed their IEP due to an exceptional condition. However, because of the potential need to use the exceptional condition SEPs outside of the IEP and because section 1837(m) of the Act allows for additional flexibility to establish these SEPs we have not included this limitation.

We welcome comments on our proposed changes to the coverage period dates and on our proposed SEPs for exceptional conditions. We note that we may establish additional SEPs for exceptional conditions through rulemaking in the future if experience demonstrates that additional SEPs would be necessary or beneficial. We also welcome recommendations for additional SEPs based on exceptional conditions. We request that any suggestions for additional SEPs for exceptional conditions include a robust discussion of why commenters believe the potential SEPs would be consistent with the policy considerations and guiding parameters discussed previously.

3. Technical Correction to the Calculation of the Late Enrollment Penalty for Individuals Enrolling on or After January 1, 2023

Currently, section 1839(b) of the Act specifies that the LEP is based on the number of months that have elapsed between the close of the individual's IEP and the close of the enrollment period during which they enroll, plus certain additional months for individuals who reenroll. However, section 120(a)(3) of the CAA amended section 1839(b) of the Act to specify that, for enrollments on or after January 1, 2023, the months that will be taken into account for purposes of determining any LEP include months which elapse between the close of the individual's IEP and the close of the month in which they enroll, plus, for individuals who reenroll, the months that elapse between the date of termination of previous coverage and the close of the month in which the individual enrolls. We expect that these changes will decrease the number of months individuals are subject to the LEP. To implement these changes, we propose the following changes to our regulations:

• At § 406.33, we propose to revise paragraph (a) to reflect the requirement that, for individuals enrolling for the first time, the existing Part A LEP calculation requirements continue to apply to enrollments before January 1, 2023.

• We also propose to redesignate paragraph (c) of § 406.33 as paragraph (d) and add new paragraph (c) to address the calculation of the LEP for individuals enrolling for the first time on or after January 1, 2023. Specifically, the introductory text of § 406.33(c) would require that the months to be counted for calculating the Part A LEP begin with the end of the individual's IEP, and extend through the end of the month in which the individual enrolls. In proposed § 406.33(c)(1), we would continue to exclude certain months from the calculation of the LEP, based on the requirements currently in effect under § 406.33(a)(1) through (6). We are proposing to exclude additional months from the calculation of the LEP for enrollments on or after January 1, 2023 at § 406.33(c)(2), however those changes are unrelated to the technical correction implemented under section 120(a)(3) of the CAA, and are discussed in greater detail in section II.A.2. of this proposed rule.

• At § 408.24, we propose to revise paragraph (a) to apply the existing Part B LEP calculation months and exceptions to individuals who satisfy the requirements of § 408.24 before January 1, 2023.

• At § 408.24, we also propose to redesignate paragraph (b) as paragraph (c) and add new paragraph (b) to address the calculation of the LEP for enrollments on or after January 1, 2023. Specifically, the paragraph at § 408.24(b) would require that for individuals who satisfy the requirements of § 408.24 after January 1, 2023, the months to be counted for calculating the Part B LEP begin with the end of the individual's IEP, and extends through the end of the month in which the individual enrolls. In proposed § 408.24(b)(1), we would continue to exclude certain months from the calculation of the LEP, consistent with the requirements currently in effect under § 408.24 (a)(1) through (10). We are proposing to exclude additional months from the calculation of the LEP for enrollments on or after January 1, 2023 at § 408.24(b)(2), however those changes are unrelated to the technical correction implemented under section 120(a)(3) of the CAA, and are discussed in greater detail in section II.A.2. of this proposed rule.

• At § 406.34, we propose to revise paragraph (a) to reflect the requirement that, for individuals reenrolling in Premium Part A, the existing Part A LEP calculation requirements continue to apply to enrollments before January 1, 2023.

• At 406.34, we propose to redesignate paragraph (e) as paragraph (f) and add new paragraph (e) to address the calculation of the LEP for individuals reenrolling on or after January 1, 2023. Specifically, new § 406.34(e)(1) would require that the months to be counted for calculating the Part A LEP begin with the end of the individual's IEP and extend through the end of the month in which the individual reenrolls, and we would continue to include the months currently specified in paragraphs (b) and (d) of this section, as applicable, and the months from the end of the first period of entitlement through the end of the month during the GEP in which the individual reenrolled. In proposed § 406.34(e)(2), we would exclude the months of non-coverage in accordance with an individual's use of an exceptional condition SEP under § 406.27. Those months are not counted for premium increases, provided the individual enrolls within the duration of the SEP.

• We are also proposing coordinating changes related to the LEP for reenrollments at § 408.24. Specifically, we propose to amend § 408.24, to revise newly redesignated paragraph (c) to apply the existing Part B LEP calculation months and exceptions for reenrollments to individuals who satisfy the requirements of § 408.24 before January 1, 2023. New § 408.24(d) would require that for individuals who satisfy the requirements of § 408.24 after January 1, 2023, the months to be counted for calculating the Part B LEP include the number of months elapsed between the close of the individual's IEP and the close of the month in which he or she first enrolled and the number of months elapsed between the individual's initial period of coverage and the close of the month in which he or she reenrolled (as well as the number of months elapsed between each subsequent period of coverage and the close of the month in which he or she reenrolled). In proposed § 408.24(d)(2)(i), we would continue to exclude certain months from the calculation of the LEP, consistent with the requirements currently in effect under § 408.24 (a)(1) through (10) and also excluding months before April 1981 during which the individual was precluded from reenrolling by the two-enrollment limitation in effect before that date. Further, as discussed previously, an individual who missed an enrollment period due to an

exceptional condition, and who enrolls in Part B using an exceptional condition SEP, would not be subject to a LEP. Therefore, we propose in § 408.24(d)(2)(ii) that if an individual uses an exceptional condition SEP under § 407.23 any months of non-coverage would not be counted towards the calculation of the SEP, provided the individual enrolls within the duration of the SEP.

B. Proposals for Extended Coverage of Immunosuppressive Drugs for Certain Kidney Transplant Patients (§§ 407.1, 407.55, 407.57, 407.59, 407.62, 408.20, and 423.30)

1. History and Definition of Benefit

In 1972, Congress enacted section 299I of the Social Security Amendments of 1972 (Pub. L. 92-603), which amended section 226 of the Act to allow qualified individuals with ESRD

11

under the age of 65, to enroll in the federal Medicare health care program, beginning in 1973. These requirements are now codified in section 226A of the Act and implemented in our regulations at 42 CFR 406.13. As mentioned earlier, section 226A(a) of the Act provides that certain individuals who are medically determined to have ESRD and apply for Medicare coverage are entitled to benefits under Medicare Part A and eligible to enroll in Part B. However, section 226A(b)(2) of the Act currently requires that an individual's entitlement under Part A and eligibility under Part B based on ESRD status ends with the 36th month after the month in which the individual receives a kidney transplant.

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Under 42 CFR 406.13(b), ESRD means that stage of kidney impairment that appears irreversible and permanent and requires a regular course of dialysis or kidney transplantation to maintain life.

The termination of Medicare entitlement has led to some beneficiaries losing coverage of immunosuppressive drugs that transplant patients would still need. Per the 2018 US Renal Data System (USRDS) Annual Report, 32 percent of kidney transplant recipients ages 45-64 years old have no known or other creditable prescription drug coverage.

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Section 402(a) of the CAA established an exception that permits certain beneficiaries who were successful kidney transplant patients to receive a limited Part B benefit effective January 1, 2023—covering only those immunosuppressive drugs described in section 1861(s)(2)(J) of the Act. Section 402(b) of the CAA also amended section 1836(b) of the Act to support limited eligibility under Part B for beneficiaries whose entitlement to insurance benefits under Part A ends by reason of section 226A(b)(2). These individuals are eligible to enroll (or to be deemed enrolled) for the new Part B immunosuppressive drug benefit (herein referred to as the Part B-ID benefit).

12

United States Renal Data System:

2018 USRDS Annual Data Report: Epidemiology of Kidney Disease in the United States,

Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, 2018, from

https://cjasn.asnjournals.org/content/14/3/327

.

Not all Medicare kidney transplant patients who lose entitlement to Part A coverage based on section 226A(b)(2), however, are eligible to enroll in the new Part B-ID benefit. The CAA provided that certain individuals are not eligible to enroll in the new program. In general, if the individuals are enrolled in certain specific forms of health insurance or other programs that cover immunosuppressive drugs, the individuals would not be eligible to enroll in the Part B-ID benefit. We will discuss the excepted individuals and the specific forms of insurance and programs in greater detail in section II.B.2.b of this proposed rule entitled “Determination of Eligibility” and in our proposed rule at § 407.55(b). Individuals that are seeking entitlement under the new Part B-ID benefit would also need to meet additional statutory criteria, as discussed in section II.B.2.b. of this proposed rule, and in the proposed rule at § 407.57. Individuals enrolled in the new Part B-ID benefit would not receive Medicare coverage for any other items or services, other than coverage of immunosuppressive drugs.

Section 402 of the CAA made conforming amendments to sections 1836, 1837, 1838, 1839, 1844, 1860D-1, 1902, and 1905 of the Act. We discuss each of those changes elsewhere in this document, along with the corresponding proposals to modify our regulations in order to implement these changes. We are proposing to revise §§ 407.1, 408.20, 410.30, 423.30 and establish a new Subpart D (§§ 407.55 through 407.65) in 42 CFR part 407, entitled

Part B Immunosuppressive Drug Benefit

to implement the new Part B-ID benefit.

Sections 226A, 1836(b) and 1837(n) of the Act provide the statutory authority for this new, limited Medicare entitlement program, and we are proposing to add a description of this basis for the Part B-ID benefit at § 407.1(a)(6). We specifically propose in § 407.1(a)(6) that, sections 1836(b) and 1837(n) of the Act will provide for coverage of immunosuppressive drugs as described in section 1861(s)(2)(J) of the Act under Part B beginning on or after January 1, 2023. Coverage of immunosuppressive drugs would be for eligible individuals whose benefits under Medicare Part A and eligibility to enroll in Part B on the basis of ESRD would otherwise end with the 36th month after the month in which the individual receives a kidney transplant by reason of section 226A(b)(2) of the Act.

We are also proposing to revise § 407.1(b) and establish a new paragraph (2) to incorporate the eligibility, enrollment, and entitlement requirements for the Part B-ID benefit within the scope of part 407. We specifically propose to revise § 407.1(b) to retain the language that states that part 407 sets forth the eligibility, enrollment, and entitlement requirements and procedures for supplementary medical insurance at § 407.1(b)(1), including the reference to the rules governing premiums in part 408 of this chapter. At new § 407.1(b)(2), we propose to add language stating that this part also sets forth the eligibility, enrollment, and entitlement requirements and procedures for the immunosuppressive drug benefit provided for under sections 1836(b) and 1837(n) of the Act, including the short title for the Part B-immunosuppressive drug benefit (Part B-ID).

The Part B-ID benefit is unique because it is available to a defined subset of Medicare beneficiaries and provides coverage only for immunosuppressive drugs. Since immunosuppressive drug therapy is a Part B benefit under section 1861(s)(2)(J) of the Act, certain rules and requirements applicable to Part B apply to the Part B-ID benefit. Where there are specific differences, we address them in this rulemaking.

2. Part B-ID Benefit Eligibility, Enrollment, Entitlement, and Termination

a. Eligibility for the Part B-ID Benefit

Section 402(a)(2) of the CAA adds section 1836(b) of the Act, which establishes specific eligibility criteria for the Part B-ID benefit. Subject to exceptions, new section 1836(b)(1) of the Act provides that individuals whose entitlement to insurance benefits under Part A ends (whether before, on, or after January 1, 2023) by reason of section 226A(b)(2), and who meet certain additional requirements, would be eligible to enroll (or to be deemed enrolled) in Part B solely for purposes of coverage of immunosuppressive drugs in accordance with section 1837(n) of the Act. The principal limitations on eligibility for the Part B-ID benefit are set out in new section

1836(b)(2) of the Act. Under section 1836(b)(2)(A) of the Act, individuals enrolled in certain other types of health coverage would not be eligible for the Part B-ID benefit. As discussed in greater detail in this section, we are proposing to specify that an individual who has such other health coverage would not be eligible for the Part B-ID benefit in § 407.55(b).

b. Determination of Eligibility

Section 1836(b)(2)(B)(i) of the Act requires the Secretary, in coordination with the Commissioner of Social Security (Commissioner), to establish a process for determining whether an individual who is to be enrolled, or deemed to be enrolled, in the Part B-ID benefit meets the requirements for such enrollment, including the requirement that the individual not be enrolled in other health coverage that would make them ineligible for the Part B-ID benefit under 1836(b)(2)(A) of the Act.

In order for an individual to be enrolled in the Part B-ID benefit, section 1836(b)(2)(B)(ii)(I) of the Act requires that an individual provide to the Commissioner an attestation that they are not enrolled and do not expect to enroll in the excepted coverage, as described in section II.B.2.a. of this proposed rule (“Eligibility for the Part B-ID Benefit”), that would make the individual ineligible for the Part B-ID benefit under section 1836(b)(2)(A) of the Act. Section 1836(b)(2)(B)(ii)(II) of the Act requires that the individual notify SSA within 60 days of enrollment in such excepted coverage. Based on these requirements, we are proposing at § 407.59(a) and (b), that all prospective enrollees in the Part B-ID benefit must provide to the Commissioner, in the form and manner specified by CMS and SSA in the final rule, an attestation that the individual is not enrolled and does not expect to enroll in other health coverage that would make the individual ineligible for the Part B-ID benefit, and that the individual agrees to notify the Commissioner within 60 days of enrollment in such other coverage as described in § 407.55(b).

Individuals who currently have Medicare entitlement based on ESRD, and whose coverage would be terminated 36 months after the month of a successful transplant, are notified in advance of the 36-month termination by SSA. We refer to such notices as “pre-termination notices.” We plan to include information about the Part B-ID benefit in this pre-termination notice and include instructions for individuals to enroll in the Part B-ID benefit, including how to provide the required attestation.

We are proposing that beneficiaries will be able to primarily use a verbal (telephonic) attestation as part of enrolling in the Part B-ID benefit. Generally, for the verbal attestation, an individual would contact SSA, and an SSA representative, using a standard script, will convey the requirements to the individual that are in the CMS-10798 attestation form, described in § 407.59 of this proposed rule. The individual will then attest that the individual does not have coverage under any of the specified health programs or insurance. The individual will also affirm that the statement provided was true and correct and that the individual acknowledged that there may be criminal penalties for making a false statement for purposes of obtaining these Medicare benefits. After the individual provides the oral attestation, the SSA representative will document the content of the call, and the document will be retained as required under SSA processes.

Having interested beneficiaries call SSA to attest and enroll is the simplest and most efficient method, and would avoid potential delays in an individual mailing a signed written statement that could potentially result in a delay in the individual continuing to receive this vital coverage of these necessary drugs.

Using a verbal attestation and enrollment process also aligns with the President's December 13, 2021 Executive Order, titled

Executive Order on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government,

which, among other things, directs Federal agencies to improve the public's experience of interacting with agency services. Of particular relevance, the executive order directs the Commissioner of SSA to provide a report that identifies potential opportunities for policy reforms that can support modernized customer experiences while ensuring original or physical documentation requirements remain where there is a statutory or strong policy rationale. The executive order further directs the Commissioner to, consistent with applicable law and to the extent practicable, remove requirements that members of the public provide physical signatures.

We are also proposing that individuals would be permitted to provide the attestation in writing with a pen-and-ink signature, if they choose to do so. Under our proposal, individuals could download a PDF-fillable version of an attestation form from SSA or CMS websites to print, sign, and mail to SSA, or to call SSA to request the form in hard copy. We are further soliciting public comment on whether SSA should only accept attestations in writing with a pen-and-ink signature, and not allow an individual to attest verbally to their eligibility to enroll in the Part B-ID benefit. We are soliciting public comment on all of these proposed methods of attestation, and other potential methods such as electronic submission, submission by fax, or a signed document.

We are proposing to rely on enrollee attestations to ensure eligibility for the Part B-ID benefit, and we will monitor developments in the Part B-ID benefit program and take appropriate action to address any potential areas of concern, including with respect to inaccurate attestations or other conditions involving ineligible individuals enrolling or remaining enrolled in the Part B-ID benefit. We will continue to evaluate opportunities to enhance our oversight to ensure compliance with the eligibility requirements on an ongoing basis. We specifically request public comments on whether additional procedures would be helpful or necessary to ensure the integrity of this program. Upon receipt of public comment, CMS will consider if proposals received would need to be set out in future notice-and-comment rulemaking prior to implementation.

As mentioned previously, we are proposing to establish the eligibility criteria for the Part B-ID benefit in new § 407.55, entitled “Eligibility to enroll.” Specifically, in § 407.55(a), we propose that an individual would be eligible to enroll in, be deemed enrolled, or re-enroll in the Part B-ID benefit if their Part A entitlement ends at the end of the 36th month after the month in which the individual received a successful kidney transplant, as set out under revised § 406.13(f)(2), and discussed in section II.B.5 of this proposed rule.

The types of coverage that would make an individual ineligible for the Part B-ID benefit are specified in section 1836(b)(2)(A)(i) through (v) of the Act. Specifically, the Act requires that individuals shall not be eligible for enrollment in the Part B-ID benefit during any period the individual is:

• Enrolled in a group health plan or group or individual health insurance coverage, as such terms are defined in section 2791 of the Public Health Service Act;

• Enrolled for coverage under the TRICARE for Life program under section 1086(d) of title 10, United States Code;

• Enrolled under a state plan (or waiver of such plan) under title XIX of the Act and is eligible to receive benefits for immunosuppressive drugs described

in section 1836(b) of the Act under such plan (or such waiver);

• Enrolled under a state child health plan (or waiver of such plan) under title XXI of the Act and is eligible to receive benefits for such drugs under such plan (or such waiver); or

• Enrolled in the patient enrollment system of the Department of Veterans Affairs established and operated under section 1705 of title 38, United States Code and is either of the following:

++ Is not required to enroll under section 1705 of such title to receive immunosuppressive drugs described in section 1836(b) of the Act; or

++ Is otherwise eligible under a provision of title 38 of the United States Code (other than section 1710), to receive immunosuppressive drugs described in section 1836(b) of the Act.

We are proposing regulation text at § 407.55(b) that would mirror those requirements, as set out in sections 1836(b)(2)(A)(i) through (v) of the Act. Section 1836(b)(2) of the Act contains specific exceptions that prevent individuals from enrolling in the Part B-ID benefit. For some of those provisions, section 402 of the CAA includes an additional limitation that the coverage must include coverage of immunosuppressive drugs. For other coverage, the statute does not include this limitation. When specific restrictions are included in one section of a statute but not in another, we presume that the language of the statute is intentional and deliberate with respect to adding the limitations. This is sometimes called the negative implication canon or

expessio unius est exclusion alterius.

Other than coverage under Medicaid, child health plan coverage, or in regard to immunosuppressive drugs, an individual is eligible to receive from the Department of Veterans Affairs with or without enrolling in the system established and operated under section 1705 of Title 38, the statute does not address the level of coverage, or the benefits that must be provided under an individual's other coverage, that would make an individual ineligible for the Part B-ID benefit. Therefore, we interpret section 1836(b)(2)(A) of the Act to require that, except in the case of an individual who receives title XIX or XXI benefits under a state plan or waiver, or immunosuppressive drugs individuals are eligible to receive through the Department of Veterans Affairs with or without enrolling in the system established and operated under section 1705 of Title 38, an individual's enrollment in any other coverage specified under 1836(b)(2)(A), regardless of the scope of benefits offered to the individual under that coverage, would make the individual ineligible for the Part B-ID benefit.

As indicated previously, section 1836(b)(2)(B)(ii)(I) of the Act requires that an individual provide to the Commissioner an attestation that they are not enrolled and do not expect to enroll in such other coverage as described in section II.B.2.b. of this proposed rule, in order for SSA to determine if they are eligible for the Part B-ID benefit. Section 1836(b)(2)(B)(ii)(II) of the Act requires that individuals must also notify SSA within 60 days of enrollment in such other coverage as that would then make them no longer eligible for immunosuppressive drug coverage under the Part B-ID benefit. We propose to establish corresponding requirements in regulation at new § 407.59. Specifically, we are proposing at § 407.59(a) that, in order to be eligible for immunosuppressive drug coverage, the individual must attest in either a verbal attestation or signed paper form provided by SSA, that they are not enrolled, and do not expect to enroll in, coverage as described in § 407.55(b). Similarly, at § 407.59(b) we are proposing that individuals must notify SSA within 60 days of enrollment in such coverage.

c. Enrollment in the Part B-ID Benefit

Section 1837(n)(1) of the Act states that any individual who is eligible for coverage of immunosuppressive drugs under section 1836(b) of the Act, that is, whose entitlement for hospital insurance benefits under part A ends by reason of section 226A(b)(2), may enroll or be deemed to have enrolled in the Part B-ID benefit as established in regulations and during an enrollment period. We are proposing in § 407.57(d) that, to enroll in the Part B-ID benefit, an individual must submit the required attestation as described in § 407.59. We will have historical information about individuals who will be eligible to enroll in the Part B-ID benefit based on their Medicare entitlement at the time of their transplant. In light of this fact, we believe that submission of an attestation and confirmation of an individual's eligibility as described previously will be sufficient for SSA to enroll individuals in the Part B-ID benefit. We are proposing in § 407.55(c) that, if SSA denies an individual's enrollment in the Part B-ID benefit, the individual will be afforded an initial determination entitlement appeal as described in § 405.904(a)(1). This will ensure that the beneficiary's statutory and due process rights will be adequately protected.

Section 1837(n)(2) of the Act provides that an individual whose entitlement for hospital insurance benefits under part A ends by reason of section 226A(b)(2) prior to January 1, 2023, may enroll in the Part B-ID benefit beginning on October 1, 2022, or the day on which the individual first satisfies section 1836(b) of the Act, whichever is later. Section 1837(n)(3) of the Act specifies that an individual whose entitlement for hospital insurance benefits under part A ends by reason of section 226A(b)(2) on or after January 1, 2023, shall be deemed to have enrolled in the medical insurance program established by this part for purposes of coverage of immunosuppressive drugs.

We propose to establish the provisions relating to enrollment and the entitlement to the Part B-ID benefit in new § 407.57, titled “Part B-ID benefit enrollment.” Specifically, we are proposing at § 407.57(a) that an individual whose Part A entitlement ends at the end of the 36th month after the month in which the individual received a successful kidney transplant, on or after January 1, 2023, is deemed to have enrolled into the Part B-ID benefit effective the first day of the month in which the individual first satisfies the eligibility requirements proposed at § 407.55, and provides the attestation required in proposed § 407.59, prior to the termination of their Part A benefits.

In accordance with new subsections 1837(n)(2) and (3) of the Act, certain individuals have an ongoing opportunity to enroll in the Part B-ID benefit regardless of whether their entitlement under Part A ended before or after January 1, 2023. Therefore, we are proposing at § 407.57(b) that an individual whose Part A entitlement ends in accordance with revised § 406.13(f)(2) (as discussed in section II.B.5. of this proposed rule), and who meets the proposed Part B-ID benefit eligibility requirements proposed at § 407.55 and provides the attestation required in proposed § 407.59, may enroll in the Part B-ID benefit as follows:

• An individual whose entitlement ended prior to January 1, 2023, may enroll in the Part B-ID benefit beginning on October 1, 2022 or later.

• An individual whose entitlement ends on or after January 1, 2023 can enroll at any time after such entitlement ends.

We are further proposing at § 407.57(c) that an individual who had previously enrolled in the Part B-ID benefit but whose participation in the benefit was terminated may re-enroll in the Part B-ID benefit at any time if they meet the eligibility requirements proposed at § 407.55 and provides the

attestation required in proposed § 407.59. For instance, if an individual lost Part B-ID benefits because the individual had health coverage under a health program or insurance plan described in § 407.55(b), but then later lost that other coverage, the individual can re-enroll in the Part B-ID benefit. There are no late enrollment penalties assessed, regardless of when an individual enrolls or disenrolls from the benefit.

d. Effective Date of Entitlement

Provided the individual meets the eligibility requirements described at § 407.55 and provides the attestation as required under § 407.59, we are proposing the following entitlement dates in § 407.57(e):

• For individuals whose Medicare Part A entitlement based on ESRD status ends on or after January 1, 2023, and who submit the attestation required under § 407.59 before the end of the 36th month after the month in which they receive a successful kidney transplant, their entitlement begins with the month their Part A benefits under section 226A of the Act would end.

• For individuals who do not provide an attestation as part of the enrollment process for the Part B-ID benefit before their Part A entitlement under section 226A of the Act ends, but later provides an attestation, their entitlement begins with the month following the month in which the individual provides the attestation required in § 407.59.

• For individuals whose entitlement ended prior to January 1, 2023 and who submit an attestation as part of the enrollment process from October 1, 2022 through December 31, 2022, their entitlement begins January 1, 2023.

e. Termination of the Part B-ID Benefit

Under sections 1838(b) and (h)(4) of the Act, individuals are not required to enroll or remain enrolled in the Part B-ID benefit. Individuals enrolled in the Part B-ID benefit can terminate their enrollment in the Part B-ID benefit by notifying SSA that they no longer wish to participate in the Part B-ID benefit. SSA would also terminate the Part B-ID benefit under certain conditions. Consistent with these requirements, we are proposing in new § 407.62, “Termination of coverage,” that the effective date of the termination of an individual's entitlement under the Part B-ID benefit will depend upon the conditions of his or her termination, as described in this section.

As discussed in section II.B.2.b. of this proposed rule, section 1836(b)(2)(A) of the Act requires that an individual is not eligible for the Part B-ID benefit if they are enrolled in certain other health coverage. Under proposed § 407.62(a)(1), when an individual enrolls in such other health coverage that would make them ineligible for the Part B-ID benefit as set out in § 407.55(b) and notifies the Commissioner of this health coverage consistent with § 407.59(b), their Part B-ID benefit would be terminated effective the first day of the month after the month of notification.

We are proposing at § 407.62(a)(1) that an individual may request a different, prospective termination date for the Part B-ID benefit to align with the coverage period under the other insurance plan or government program. While section 402 of the CAA does not explicitly authorize CMS to permit individuals to request a future termination date, it also does not prohibit a beneficiary from requesting a future termination date. In these cases, if an individual chooses their Part B-ID benefit termination date, they will be able to retain the benefit up to the effective date of their new coverage, which will alleviate potential gaps or overlaps in coverage. For example, if an individual enrolls in employer coverage during an employer's open enrollment period in October, for a January 1st effective date, the individual can submit their request for termination of the Part B-ID benefit in October or November, and not lose their Part B-ID benefit prior to the January 1st effective date. If we only permitted an individual to use a default termination date (for example, termination on the first of the month after the month of notification), an individual submitting a termination notice in October or November would lose their Part B-ID benefit prior to the effective date of their new coverage. However, CMS would not permit individuals to request a future termination date that is after the effective date of enrollment in other health insurance coverage, as described in § 407.55(b), that would make them ineligible for the Part B-ID benefit. The law provides that individuals will lose their Part B-ID benefit eligibility when the individual is enrolled in certain other health coverage, and they notify the Commissioner of this other coverage within 60 days of their enrollment in such coverage. Individuals may wish to terminate Part B-ID benefits as soon as coverage is provided by another program so that they are not required to pay duplicative premiums for the same coverage. We believe this proposal will be helpful for beneficiaries as it would facilitate the coordination of benefit coverage and avoid duplicative costs for beneficiaries.

The rules for terminating Part B coverage based on a voluntary request for termination, set out in section 1838(b) of the Act, require that Part B coverage ends effective the close of the month following the month in which the notice is filed, except for an individual who loses coverage under a state buy-in agreement as described in § 407.50(b)(2)(i). For example, if an individual submits a voluntary notice to terminate Part B April 1st, the individual's last day of Part B coverage would be May 31st. In contrast, we are proposing a shorter timeframe for effectuating termination of the Part B-ID benefit in § 407.62(a)(1), specifically that when an individual enrolls in other coverage and provides notification consistent with § 407.59(b), their enrollment in the Part B-ID benefit would end effective the first day of the month after the month they provide the required notification. For example, if an individual notified SSA on April 1st to end their Part B-ID benefit, their Part B-ID benefit will be terminated effective the first day of the month after the month of notification, May 1st. We are proposing this shorter period between notification and the end of individuals' Part B-ID coverage in order to minimize periods of overlapping coverage that could result in unnecessary and overlapping premium liability.

Although the statute requires that an individual's eligibility for the Part B-ID benefit ends at the time they enroll in prohibited coverage, SSA would need additional time upon the individual's notification of such other coverage, to effectuate the termination of the Part B-ID benefit. Therefore, the individual's eligibility would end as of the first day of the month after the month they provide the required notification. Further, although 1836(b)(2)(B)(ii) provides up to 60 days for Part B-ID beneficiaries to notify the Commissioner that the individual has enrolled in other health coverage, some individuals will want to notify the Commissioner sooner to reduce the financial responsibility for Part B-ID benefit premiums. We believe this approach would implement the requirements of section 1838(h) of the Act, which requires that the entitlement for Part B-ID beneficiaries ends when an individual enrolls in other health coverage that makes them ineligible for the Part B-ID benefit.

As discussed previously in this rule, we will continue to evaluate opportunities to enhance our oversight to ensure compliance with the Part B-ID benefit's eligibility requirements. Therefore, we are proposing in § 407.62(a)(2) that if an individual who is enrolled in the Part B-ID benefit fails

to provide the notice of other excepted health coverage, and it is determined that an individual has such other health coverage, the individual would be ineligible for the Part B-ID benefit as described in proposed § 407.55(b), and their enrollment in the Part B-ID benefit would be terminated on a prospective basis. If it is determined, through investigation, that an individual has such other coverage, and SSA terminates the individual's Part B-ID benefit, the individual will be provided notification and appeal rights, as currently established for Medicare Part B. Specifically, we are proposing at § 407.62(a)(2) that the enrollment for an individual who enrolls in the Part B-ID benefit, but who subsequently enrolls in other health coverage as described in § 407.55(b) but does not notify SSA within 60 days consistent with § 407.59(b), the individual's Part B-ID enrollment would be terminated effective the first day of the month after the month in which SSA determines the individual is enrolled in health coverage described in § 407.55(b). We are proposing this shorter period (as typically would occur with termination of Part B coverage), between SSA making a determination that an individual has certain other health coverage as set out in proposed § 407.55(b), and termination of the Part B-ID benefit, in order to minimize periods of overlapping coverage that could result in unnecessary and overlapping premium liability. We believe this approach would implement the requirements of section 1838(h) of the Act which requires that the entitlement for the Part B-ID benefit ends when an individual enrolls in other health coverage that makes them ineligible for the Part B-ID benefit.

However, we are proposing in § 407.62(f) that, if an individual is involuntarily disenrolled from the Part B-ID benefit based on § 407.62(a)(2), (b) or (c), they will be permitted an initial determination appeal as outlined in § 405.904(a)(1), which is consistent with existing requirements applicable to Part B coverage. This ensures that the beneficiary's statutory and due process rights will be adequately protected. Consistent with appeals filed by individuals whose Medicare entitlement based on disability is denied or terminated, the individual would be entitled to the Medicare Part B-ID benefit while the appeal is in adjudication. CMS believes that this position lessens burden on beneficiaries by ensuring that there is no lapse in coverage for these necessary drugs.

Consistent with existing requirements applicable to Part B benefits at § 407.27(a), which state that entitlement to Part B benefits ends on the last day of the month in which an individual dies, we are proposing that entitlement to the Part B-ID benefit would end on the last day of the month in which the individual dies under new proposed § 407.62(b). Based on our experience administering the Part B program, we believe this approach is easy to understand, familiar to members of the public, fair, and administratively straightforward. Based on these facts we are proposing to apply this policy to the Part B-ID benefit as well.

In order to maintain consistency with existing Part B premium payment rules, and as established under section 1838(b)(2) of the Act and revised under section 402 of the CAA, we are proposing at § 407.62(c) that termination of the Part B-ID benefit for individuals who fail to pay their Part B-ID benefit premiums would end as set forth in 42 CFR part 408. This would include provisions governing a grace period by which premiums must be paid in order to avoid termination. Based on our experience administering the Part B program, we believe an approach that would apply the existing Part B requirements to the Part B-ID benefit would be easy to understand, familiar to members of the public, fair, and administratively straightforward.

Consistent with existing requirements applicable to Part B coverage under section 1838(b)(1) of the Act, we are proposing that an individual may request voluntary termination of the Part B-ID benefit. To voluntarily terminate their Part B-ID benefit, an individual will provide notification to SSA. Primarily, we are proposing that an individual would contact SSA to request termination, either telephonically, or by visiting an SSA field office. We are also proposing that individuals could notify SSA in writing, by completing a CMS-1763 termination form, indicating that the individual no longer wishes to participate in the Part B-ID benefit (even if the individual does not have other health insurance coverage). Individuals could obtain a termination form (CMS-1763) from the SSA or CMS website to print, sign, and mail to SSA, or they can call SSA to request the form in hard copy. Providing options for beneficiaries to terminate their Part B-ID benefit aligns with the President's December 13, 2021

Executive Order on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government,

which directs Federal agencies to improve the public's experience of interacting with agency services. We are soliciting public comment on these proposed methods of attestation, and other potential methods such as electronic submission, or submission by fax. Once an individual contacts SSA to inform them that they want to disenroll from the Part B-ID benefit, their benefit would be terminated effective the first day of the month following the month in which they submit their request. Accordingly, we are proposing at new § 407.62(d) that an individual may request disenrollment at any time by contacting SSA to inform them that they no longer want to be enrolled in the Part B-ID benefit. Such individuals' enrollment would end with the last day of the month in which the individual provides the disenrollment request. Similar to the rationale for our proposals for § 407.62(b), based on our experience administering the Part B program we believe this approach would be easy to understand, familiar to members of the public, fair, and administratively straightforward. Based on these facts we are proposing to apply this policy to the Part B-ID benefit as well.

Under section 1838(h)(4) of the Act, individuals' entitlement to the Part B-ID benefit ends when an individual becomes entitled to Medicare based on age, disability, or ESRD status (see §§ 406.5, 406.12 and 406.13). Consistent with these statutory requirements, we are proposing that in such conditions individuals' entitlement to the Part B-ID benefit will terminate effective the last day of the month prior to the month in which the individual becomes entitled to Medicare based on either age, disability, or ESRD under new proposed § 407.62(e).

3. Ensuring Coverage Under the Medicare Savings Programs

The MSPs includes three primary

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Medicaid eligibility groups that cover the Medicare Part A and/or B premiums and sometimes cost-sharing for over 10 million low income individuals and are defined at sections 1905(p)(1) and 1902(a)(10)(E) of the Act. One MSP eligibility group is the Qualified Medicare Beneficiary (QMB) group, which provides medical assistance through coverage of Medicare Part A and B premiums and cost-sharing for certain individuals that meet specific requirements. In general, the individual

must have income that does not exceed 100 percent of the federal poverty line (FPL) and resources that do not exceed three times the limit for SSI with adjustments for inflation as described in section 1905(p)(1) of the Act. A second MSP eligibility group is the Specified Low-Income Beneficiary (SLMB) group, which provides medical assistance through coverage of Part B premiums for individuals who would otherwise be eligible in the QMB eligibility group, except that their income exceeds 100 percent of the FPL and is below 120 percent of the FPL as defined at section 1902(a)(10)(E)(iii) of the Act. A third MSP eligibility group is the Qualifying Individuals (QI) group, which provides medical assistance of coverage of Part B premiums for individuals who would otherwise be eligible in the QMB group, except that their income exceeds 120 percent of the FPL and is below 135 percent of the FPL as defined at section 1902(a)(10)(E)(iv) of the Act. Federal statute does not allow states to implement MSP eligibility criteria (that is, income and resource limits and methodologies) that are more restrictive than those federal baselines. However, through authority granted by section 1902(r)(2) of the Act, states may choose to implement income and/or resource methodologies that are more generous than the federal baselines for QMB, SLMB and QI.

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There is a fourth and much smaller MSP eligibility group that is the Qualified Disabled Working Individuals (QDWI) group, which provides medical assistance of coverage of Part A premiums for individuals who are entitled to Part A under section 1818A of the Act, and with income that does not exceed 200 percent of the FPL and whose resources do not exceed twice the maximum amount permitted under the SSI program. Section 402 of the CAA does not apply to QDWIs.

As a result of changes made under section 402(f) of the CAA, low income individuals who are entitled to Medicare based on enrollment in the Part B-ID benefit may also be eligible for enrollment in QMB, SLMB, or QI MSPs for payment of some or all of their Part B-ID benefit premiums and cost-sharing.

Section 402(f) of the CAA revised section 1905(p)(1)(A) of the Act to change the definition of QMB to allow for individuals enrolled in the Part B-ID benefit to be eligible for medical assistance through Medicare cost-sharing as QMBs if they otherwise meet the income and resource limits established at 1905(p)(1)(B) and (C) of the Act. The CAA also made similar changes under section 1902(a)(10)(E)(iii) and (iv) of the Act to make medical assistance available for Medicare cost-sharing for Part B-ID benefit enrollees who qualify for the SLMB and QI eligibility groups. These changes would allow individuals enrolled in the Part B-ID benefit to attain eligibility for these MSPs for payment of their Part B-ID benefit premium and cost-sharing for QMBs, and for payment of their Part B-ID benefit premium as SLMBs and QIs, if such beneficiaries also meet the relevant income and resource criteria. We propose to codify this expansion of MSPs to apply to the Part B-ID benefit at new § 435.123 described in section II.D.3.h. of this proposed rule.

Under section 1905(p)(1) and 1902(a)(10)(E) of the Act, as modified by section 402(f) of the CAA, individuals eligible for the Part B-ID benefit could become enrolled in MSPs for payment of the Part B-ID benefit (MSP Part B-ID) through two paths on or after January 1, 2023. First, individuals could enroll in the Part B-ID benefit and newly apply for Medicaid and be determined eligible for the QMB, SLMB, or QI eligibility groups by their state. Second, individuals who are enrolled in an MSP eligibility group and whose Medicare eligibility is based on ESRD, can transition to an MSP based on Part B-ID (MSP Part B-ID) the month after 36 months after transplant if they enroll in the Part B-ID benefit under certain conditions. In order to transition to MSP Part B-ID under this latter condition, the individual must (a) return the attestation to be deemed to enroll in the Part B-ID benefit by the end of the 36th month after the month in which they receive a kidney transplant in accordance with the attestation requirements in section 1836(b)(2)(B) of the Act and (b) continue to meet the other eligibility criteria for an MSP eligibility group described in section 1905(p)(1), 1902(a)(10)(E)(iii), or (iv) of the Act. We anticipate the second situation will help ensure continuity of coverage for beneficiaries, but note that continuity of coverage depends on many factors, including the timing of when an individual attests to not having other disqualifying insurance coverage under § 407.59 as well as coordination among multiple entities including states, CMS and SSA. Given its greater complexity, the second situation is the primary focus of our discussion here.

The simplest way to maintain continuity of coverage for individuals enrolled in an MSP who are losing Medicare entitlement based on ESRD status is through the Medicaid redetermination process. For full- and partial-benefit (that is, individuals enrolled only in an MSP and receiving coverage of only Medicare premiums and sometimes cost sharing) Medicaid beneficiaries who have Medicare entitlement based on ESRD status and lose full Medicare coverage 36 months after the month in which they received a kidney transplant, this loss of full Medicare coverage would constitute a change in circumstance under § 435.916(d) even if they might obtain coverage under Medicare through enrollment in the Part B-ID benefit. Under § 435.916(d)(1), state Medicaid agencies are required to promptly redetermine an individual's eligibility for Medicaid whenever it receives information about a change in a beneficiary's circumstances that may affect their eligibility. We are providing an overview of how the Medicaid redetermination process will operate under the existing Medicaid regulations for both full- and partial-benefit Medicaid beneficiaries who have Medicare entitlement based on ESRD status and lose full Medicare coverage. However, for clarity, we want to highlight up front that individuals who remain or become full-benefit Medicaid beneficiaries after this redetermination process will not be eligible for the Part B-ID benefit, as explained in this section.

During this redetermination process, under §§ 435.916(b) and 435.911, individuals who are already eligible for a full-benefit Medicaid eligibility group, such as those receiving Supplemental Security Income (SSI)

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would still retain their Medicaid eligibility as long as there are no other disqualifying changes to income or disability status. This is true of the redetermination process for all individuals who are eligible for more than one eligibility group in Medicaid. If the change in circumstance only ends the individual's eligibility for one eligibility group but not the other, the individual remains eligible for the eligibility group for which they still qualify. Even if the individual was not eligible previously for a full-benefit Medicaid eligibility group, if the individual nonetheless qualifies for a full-benefit Medicaid eligibility group (for example, the adult group) after the redetermination, the state must enroll the individual in that group per §§ 435.916(f) and 435.911.

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In most states, receipt of SSI automatically qualifies an individual for Medicaid. See § 435.120.

We anticipate that individuals who are eligible for a full-benefit Medicaid eligibility group would not be eligible for the Part B-ID benefit, because all states currently opt to cover immunosuppressive drug coverage for all full-benefit Medicaid eligibility groups and by virtue of having such drug coverage under Medicaid they would be ineligible according to section 1836(b)(2)(A)(iii) of the Act.

On the other hand, if the individual is not eligible for Medicaid on any basis, the state is required to screen the individual for potential eligibility for other insurance affordability programs as defined in § 435.4 in accordance with § 435.1200(e), as required under § 435.916(f). This would include referring the individual to an Exchange

to determine whether the individual is eligible for enrollment in a Qualified Health Plan with Advance Premium Tax Credit (APTC), cost sharing reductions (CSRs) or both as described in § 435.4. We also encourage states to inform the beneficiary of the Part B-ID benefit and coordinate with SSA, State Health Insurance Assistance Programs (SHIPs), and beneficiary groups, among others, to help individuals complete the telephonic Part B-ID benefit attestation, and provide other personalized assistance if the individual does not qualify for full-benefit Medicaid or the Exchange with either APTC or CSRs. We note that if the individual enrolls in an Exchange plan, it will make them ineligible for the Part B-ID benefit as set out in § 407.55(b). If the individual has already enrolled in the Part B-ID benefit prior to enrollment in the Exchange, they will need to notify SSA of this health care coverage in the Exchange consistent with § 407.59(b).

If the individual does not ultimately enroll in the Part B-ID benefit, the state would terminate MSP enrollment because individuals must have Part A entitlement or be enrolled in the Part B-ID benefit to be eligible for the MSPs under sections 1905(p)(1)(A) and 1902(a)(10)(E)(iii) and (iv) of the Act. Prior to termination, states must provide affected beneficiaries with advance notice and an opportunity for a fair hearing in accordance with § 435.917 and part 431, subpart E.

If, as a result of the redetermination process that must be completed prior to termination under § 435.916(f), the state identifies that the individual has completed the required attestation and would be enrolled in the Part B-ID benefit the month after Medicare entitlement based on ESRD ends (the end of the 36th month after the month in which the individual received a kidney transplant), the state must maintain the individual in the appropriate MSP eligibility group for payment of Part B-ID benefit premiums and, if eligible, cost-sharing, provided there are no other disqualifying changes in the income and resources of the individual under section § 435.911.

As noted previously, the changes to section 402(f) of the CAA expand the definition of QMB, SLMB, and QI to allow individuals to qualify for those MSPs based on their enrollment in the Part B-ID benefit and meeting the income and resource standards of MSPs. As such, as part of considering all bases of eligibility in the redetermination process under § 435.916(f)(1), states must consider the revised eligibility criteria in section 402(f) of the CAA and enroll individuals in MSP Part B-ID benefit who are enrolled in the Part B-ID benefit and meet the income and resource criteria for MSPs.

If an individual was enrolled in an MSP while entitled to Medicare on the basis of ESRD, their continued enrollment in MSPs for the Part B-ID benefit will ultimately depend on how quickly the state completes its redetermination, whether the individual has full Medicaid benefits (and whether the State plan would cover immunosuppressive drugs for the individual), and whether the individual enrolls in the Part B-ID benefit. If the state does not complete the redetermination process prior to the end of the 36th month after the month in which the individual received a kidney transplant, when an individual's Medicare entitlement based on ESRD status ends under section 226A(b)(2) of the Act, and the individual had full Medicaid plus an MSP prior to the point at which their Medicare entitlement ends according to section 226A(b)(2) of the Act, the individual would retain full Medicaid until the redetermination is complete per § 435.930(b), but would lose MSP coverage when Medicare entitlement based on ESRD Medicare coverage expires. While states are required to continue furnishing Medicaid until the state determines an individual ineligible for Medicaid under § 435.930(b), the only medical assistance provided for MSPs is payment of Medicare premiums and sometimes cost-sharing. As such, when Medicare entitlement ends, states stop providing MSP coverage because the individual no longer has a Medicare benefit for which they owe premiums, deductibles, coinsurance and copayments. Beneficiaries losing MSP coverage under these conditions may remain eligible for Medicaid on another basis, and states must furnish the Medicaid coverage for which they are eligible until they are found to be ineligible under § 435.930(b).

If the state does not complete the redetermination process by the end of the 36th month after the month in which the individual received a kidney transplant, when Medicare entitlement based on ESRD status would end, and the individual is enrolled only in an MSP and

does

complete the Part B-ID benefit attestation prior to losing Medicare based on ESRD status, then, under § 435.930(b), the individual would maintain enrollment in their current MSP until the redetermination is complete, and the MSP would cover the appropriate costs for the Part B-ID benefit. In this scenario, once CMS receives enrollment confirmation of the individual in the Part B-ID benefit from SSA, CMS systems will automatically switch the individual from state buy-in for Part B to the Part B-ID benefit buy-in and alert the state of the individual's new enrollment and billing status. The reason for the difference in the outcome when the individual returns the attestation is that under § 435.930(b), the state must continue furnishing MSP because there would be a Medicare benefit to wrap around through coverage of premiums, deductibles, coinsurance and copayments.

If the state does not complete the redetermination process by the end of the 36th month after the month in which the individual received a kidney transplant, when Medicare entitlement based on ESRD status would end, and the individual is enrolled only in an MSP and

does not

complete the Part B-ID benefit attestation prior to losing Medicare entitlement based on ESRD status, then the individual would not be entitled to coverage of immunosuppressive drugs therapy under section 1836(b)(2)(B) of the Act or state payment of the premiums for the Part B-ID benefit because enrollment in the Part B-ID benefit is a pre-requisite to state payment of premiums under section 402(f) of the CAA.

After a kidney transplant, individuals must diligently take immunosuppressive drug therapy in order to avoid the rejection of the kidney.

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In order to prevent gaps in coverage of such medication when individuals transition off Medicare entitlement based on ESRD status, for partial-benefit Medicaid beneficiaries (beneficiaries enrolled in an MSP and not full-benefit Medicaid), states will need to complete redeterminations regarding Medicaid eligibility under § 435.916(d) before individuals' Medicare eligibility based on ESRD status ends. While we note that these individuals could continue coverage under the MSP Part B-ID benefit if they complete the attestation, many of these individuals will be eligible for full-benefit Medicaid under the adult group described at § 435.119 in all states that expanded Medicaid since the MSPs generally have an income limit up to 135 percent of the FPL and the adult group has an income limit up to 138 percent of the FPL. Enrolling individuals in adult group coverage at the outset instead of enrolling them retroactively is vastly preferable—both to provide immediate coverage of their health coverage needs and to reduce administrative burden. Additionally, if these individuals are ultimately

enrolled retroactively in full-benefit Medicaid after enrolling in the Part B-ID benefit—and these Medicaid benefits continue to include coverage of immunosuppressive drugs for the individual, the individuals will need to inform SSA that they have other insurance coverage in order for SSA to terminate them from the Part B-ID benefit in accordance with § 407.62. These individuals will also need to ask their providers to submit all of their bills to Medicaid for payment beginning from the date Medicare entitlement based on ESRD status ended until the date of the new notice of determination of full Medicaid. For any immunosuppressive drugs received during that time, the individuals would need to ask their pharmacy to bill Medicaid for any Medicare copays paid by the individual because Medicaid would pay secondary to Medicare. As such, we are strongly recommending that states start an early advance redetermination process for those partial-benefit beneficiaries whose Medicare entitlement is based on ESRD status and who receive kidney transplants. As noted previously, during this redetermination process, we encourage states to reach out to individuals who are likely eligible for the MSP Part B-ID benefit to explain the Part B-ID benefit and if necessary, coordinate with SSA, SHIPs and beneficiary advocates to help them submit the attestation to enroll in the Part B-ID benefit, which will assist the state in enrolling them in the appropriate MSP. We are also exploring steps to conduct outreach and education for beneficiaries and multiple external partners, including those who regularly assist beneficiaries with health insurance counseling, regarding the most appropriate coverage options for MSP beneficiaries transitioning off Medicare entitlement based on ESRD. Additionally, CMS will be engaged and able to assist beneficiaries in assessing their health care options and enrolling in the Part B-ID benefit as needed. We welcome comments regarding steps CMS can take to assist beneficiaries and promote awareness of coverage choices upon loss of the ESRD Medicare benefit with the goal of minimizing gaps in coverage and ensuring enrollment in the most comprehensive benefit available to them.

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https://www.medicare.gov/Pubs/pdf/10128-medicare-coverage-esrd.pdf.

Both the early redetermination process and the outreach effort to beneficiaries will help reduce the risk of gaps in coverage for immunosuppressive drugs for this vulnerable beneficiary population.

We anticipate this early redetermination process and outreach effort will improve the customer service experience of kidney transplant recipients, consistent with the

Executive Order on Transforming Federal Customer Experience and Service Delivery to Rebuild Trust in Government.

We also believe it will have a positive health equity impact consistent with the

Executive Order on Advancing Racial Equity and Support for Underserved Communities Through the Federal Government.

Finally, by helping to avoid gaps in Medicaid and Marketplace coverage, it is consistent with the

Executive Order on Strengthening Medicaid and the Affordable Care Act.

In general, individuals with ESRD are more likely to be from racial or ethnic minority groups.

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Additionally, individuals who are younger, poorer and less educated have more difficulty affording transplant medication, which has led to lower rates of graft survival among those populations.

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Making immunosuppressive drugs more affordable to individuals through MSPs would improve lower income individuals' access to immunosuppressive drugs critical to prevent transplant failure.

16

See

https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease

discussing that ESRD prevalence is about 3.7 times greater in African Americans, 1.4 times greater in Native Americans, and 1.5 times greater in Asian Americans.

17

Gordon, Elisa J., Prohaska, Thomas R., and Sehgal, Ashwin R.

The Financial Impact of Immunosuppressant Expenses on New Kidney Transplant Recipients Clin Transplant

2008: 22, 736. Available at

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2592494/.

As discussed previously, if an individual who had MSP coverage while entitled to Medicare based on ESRD status fails to enroll in the Part B-ID benefit after losing Medicare entitlement based on ESRD status, by the end of the 36th month after the month in which the individual received a kidney transplant the individual would also lose access to the MSPs after the state provides appropriate notice and fair hearing rights. However, an individual may re-apply for the MSPs if they later enroll in the Part B-ID benefit under section 402(f) of the CAA. Moreover, if an individual did not previously enroll in an MSP while entitled to Medicare based on ESRD status, once they enroll in the Part B-ID benefit they may apply for and enroll in an MSP provided they meet the applicable eligibility criteria.

We note that states will be required to enroll individuals in an MSP if they are enrolled in the Part B-ID benefit, apply for an MSP, and meet the income and resource requirements of an MSP. As explained previously, section 402(f) of the CAA modified the eligibility requirements for QMB, SLMB, and QI at 1905(p)(1) and 1902(a)(10)(E)(iii) and (iv) of the Act to make those MSPs available to individuals enrolled in the Part B-ID benefit. Thus, states must make an MSP eligibility determination for individuals who enroll in the Part B-ID benefit and apply for an MSP. If a state determines that individuals enrolled in the Part B-ID benefit meet the income and resource requirements for an MSP, the state must enroll those individuals in an MSP to pay for Part B-ID benefit premiums and cost-sharing, as applicable.

Finally, we note that individuals enrolled in the Part B-ID benefit and an MSP would lose coverage under both programs in any of four conditions described in §§ 407.62(a),(b),(d), and (e). Specifically, an individual's enrollment in both the MSPs and the Part B-ID benefit would end in accordance with § 407.62 if the individual (1) enrolls in other health insurance that makes them ineligible for the Part B-ID benefit as described in § 407.55(b); (2) becomes eligible for Medicare Part A on the basis of age, disability or ESRD status; (3) voluntarily terminates coverage; or (4) dies. In order to be eligible for MSPs, individuals must be entitled either to Part A under section 1905(p)(1)(A) and 1902(a)(E)(10) or the Part B-ID benefit as described in section 402(f) of the CAA. When individuals lose their entitlement to Medicare, they are terminated from MSPs after notice and fair hearing rights have been provided in accordance with § 435.917 and part 431, subpart E. As such, when individuals who are enrolled in an MSP for payment of Part B-ID benefit lose their underlying basis for enrollment in the Part B-ID benefit, they would no longer qualify for an MSP under section 402(f) of the CAA. In the first instance, if the individual is enrolled in an MSP based on his or her enrollment in the Part B-ID benefit, and they obtain other coverage that would make the individual ineligible for the Part B-ID benefit under section 1836(b)(2) of the Act, they would also no longer qualify for the MSP. In the second condition, if the individual is enrolled in an MSP based on his or her enrollment in the Part B-ID benefit, and they become entitled to Medicare based on age, disability or ESRD status, the Part B-ID benefit ends under section 1838(h)(4) of the Act; they would no longer be eligible for the MSP Part B-ID benefit. However, assuming there were no other disqualifying conditions, the individual would continue to be eligible for an

MSP, which would then pay the Medicare Part B premiums and, if applicable, Part A premiums and cost-sharing on behalf of the individual, rather than the Part B-ID benefit premium. In the third condition, if the individual is enrolled in an MSP based on enrollment in the Part B-ID benefit and the individual voluntarily disenrolls from the Part B-ID benefit in accordance with section 1838(b)(1) of the Act, the individual would also become ineligible for the MSP Part B-ID benefit. Finally, if the individual is enrolled in an MSP based on his or her enrollment in the Part B-ID benefit and the individual dies, he or she is ineligible for the Part B-ID benefit under § 407.27(a), and would no longer be eligible for an MSP.

4. Part B-ID Benefit Premiums

The Secretary of the Department of Health and Human Services (HHS) is required by section 1839 of the Act to announce the Part B monthly actuarial rates for aged and disabled beneficiaries. These amounts, according to actuarial estimates, will equal, respectively, one half of the expected average monthly cost of Part B for each aged enrollee (age 65 or over) and one half of the expected average monthly cost of Part B for each disabled enrollee (under age 65). The standard monthly Part B premium represents roughly 25 percent of estimated program costs for aged enrollees and is calculated to be 50 percent of this aged actuarial rate, plus the $3.00 repayment amount required under current law. (Although the costs to the program per disabled enrollee are different than for the aged, the statute provides that the two groups pay the same premium amount.) Premiums may be further adjusted based on an individual's conditions, such as based on late enrollment or reenrollment (§ 408.22), the income-related monthly adjustment amount (§ 408.28), or for beneficiaries subject to non-standard premiums (§ 408.20).

We are proposing to create a new paragraph § 408.20(f) to implement the requirements established under section 1839(j) of the Act and propose to modify other existing requirements for Part B premiums found in 42 CFR part 408 as required by statute for the Part B-ID benefit. We are proposing in § 408.20(f)(1), that beginning in 2022, as required by new section 1839(j) of the Act, the Secretary would determine and promulgate a monthly premium rate in September of each year for the succeeding calendar year for individuals enrolled only in the Part B-ID benefit. Such premium would be equal to 15 percent of an actuarial rate that represents 100 percent of the estimated average monthly cost of Part B for each aged enrollee (age 65 or over). This amount is then rounded to the nearest $0.10.

The standard 20 percent coinsurance and annual Part B deductible would apply to the Part B-ID benefit. As required under new section 1839(j) of the Act and other conforming changes of the Act, we are proposing in § 408.20(f)(2)(i) that the Part B-ID benefit premium would be subject to adjustments specified in §§ 408.20(e) (Nonstandard premiums for certain cases), 408.27 (Rounding the monthly premium), and 408.28 (Increased premiums due to the income-related monthly adjustment amount (IRMAA)). In addition, under section 1839(j) of the Act, the Part B-ID benefit premiums are also not subject to the LEP. Accordingly, we are proposing to provide in section § 408.20(f)(2)(ii) that premiums for the Part B-ID benefit would not be subject to increased premiums for late enrollment or reenrollment under § 408.22.

Section 1840 of the Act requires that for individuals receiving monthly railroad retirement or Social Security benefits or a civil service annuity, payment for Part B premiums for those individuals must generally be deducted from those payments. In light of these requirements, we are proposing in § 408.20(f)(3) that the collection of premiums for the Part B-ID benefit would follow the existing requirements governing the collection of Part B premiums set out in § 408.6 and part 408, subpart C of title 42. Under those provisions, if a beneficiary is receiving a monthly Social Security or Railroad retirement benefit, or civil service annuity, their Part B premium must typically be deducted from that monthly benefit. In conditions where an individual does not receive benefits of the sort described previously, premiums must be paid by direct remittance; in such cases CMS bills the beneficiary directly.

5. Conforming Changes

Certain individuals are entitled to hospital insurance coverage under Medicare Part A on the basis of ESRD, as provided under section 226A of the Act. Section 406.13(f)(2) currently specifies that the period of entitlement to Medicare Part A for individuals whose Medicare entitlement is based on ESRD ends with the end of the 36th month after the month in which the individual has received a kidney transplant. We are proposing to revise § 406.13(f)(2) to provide that beginning January 1, 2023, individuals no longer entitled to Part A benefits due to their coverage ending at the end of the 36th month after the month in which the individual received a kidney transplant, may be eligible to enroll in Part B solely for purposes of coverage of immunosuppressive drugs as described in § 407.55.

Medicare Part B covers health services including prescription drugs used in immunosuppressive therapy furnished to an individual who receives an organ transplant for which Medicare payment is made. Section 410.30(b) currently lays out the requirements governing eligibility for coverage of prescription drugs used in immunosuppressive therapy, stating that coverage is only available for prescription drugs used in immunosuppressive therapy, furnished to an individual who received an organ or tissue transplant for which Medicare payment is made, and provided the individual is eligible to receive Medicare Part B benefits. Chapter 15 of the Medicare Benefit Policy Manual, section 50.5.1,

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lists some of the Food and Drug Administration (FDA)-approved, specifically labeled immunosuppressive drugs. They are: Sandimmune (cyclosporine), Imuran (azathioprine), Atgam (antithymocyte globulin), Orthoclone OKT3 (Muromonab-CD3), Prograf (tacrolimus), Celicept (mycophenolate mefetil, Daclizumab (Zenapax); Cyclophosphamide (Cytoxan); Prednisone; and Prednosolone. However, this is not intended to be an all-inclusive list and is subject to change. The manual guidance states that CMS

“expects contractors to keep informed of FDA additions to the list of the immunosuppressive drugs.”

This expectation would carry over to the Part B-ID benefit. Medicare Administrative Contractors have issued Local Coverage Determinations on this topic and, generally speaking (using Local Coverage Determination #L33824 as an example

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), covered immunosuppressive drugs are oral tablets or capsules. However, certain immunosuppressive drugs may be intravenously infused or intramuscularly injected. The majority of the immunosuppressive drugs have generic equivalents; however, certain newer agents remain available as brand only.

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https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf.

19

https://www.cms.gov/medicare-coverage-database/search.aspx.

A beneficiary will typically gain access to the drug through a pharmacy, where applicable supplying fees to

pharmacies (as described in section 1842(o)(6) of the Act) are paid. However, where the conditions require an infused or injectable immunosuppressive therapy, these would be administered in the physician office or outpatient setting. In this case of Part B-ID, only the cost of the drug would be covered (not the service of administration). Immunosuppressive therapies covered under Part B are paid based on pricing methodology in 1847A of the SSA (typically, this is an ASP-based payment limit). Payment limits for many immunosuppressive therapies can be found on the ASP Drug Pricing File,

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which is updated quarterly. Cost sharing is typically 20 percent.

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https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/McrPartBDrugAvgSalesPrice.

We are proposing to revise § 410.30(b) to specify that beginning January 1, 2023, individuals who meet the requirements as specified in section § 407.55 are eligible to receive Medicare Part B benefits for purposes of § 410.30(b).

An individual is eligible for enrollment into a Part D plan if certain conditions are met, as set out in section 1860D-1(a) of the Act. Section 423.30(a)(1)(i) of the regulations establishes that an individual is eligible for Part D if they have Medicare benefits under Part A or are enrolled in Medicare Part B. Section 423.30(a)(1)(i) would be revised to specify that an individual is eligible for Part D if they are entitled to Medicare benefits under Part A or enrolled in Part B, but does not include an individual enrolled solely in Part B for coverage of immunosuppressive drugs under § 407.1(a)(6).

Section 402 of the CAA states that the Secretary may conduct public education activities to raise awareness of the availability of more comprehensive, individual health insurance coverage (as defined in section 2791 of the Public Health Service Act) for individuals eligible under section 1836(b) of the Act to enroll or to be deemed enrolled in the medical insurance program established under this part for purposes of coverage of immunosuppressive drugs.

As a part of implementation, CMS will conduct education and outreach across the broad span of partners (that is, beneficiary advocacy groups, providers, associations, etc.) to ensure awareness and understanding of this benefit. Also, we note that all appropriate beneficiary notices, such as the Medicare based on ESRD pre-termination notice, (discussed in this proposed rule),

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