Rule2022-23407
Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 3, 2022
Effective
January 1, 2023
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This final rule implements certain provisions of the Consolidated Appropriations Act, 2021 (CAA). Additionally, we are proposing to delete references to specific Medicare forms from the text of existing regulations at Sec. Sec. 406.7 and 407.11 in order to provide greater administrative flexibility. Finally, this final rule updates 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.
Full Text
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<title>Federal Register, Volume 87 Issue 212 (Thursday, November 3, 2022)</title>
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[Federal Register Volume 87, Number 212 (Thursday, November 3, 2022)]
[Rules and Regulations]
[Pages 66454-66511]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23407]
[[Page 66453]]
Vol. 87
Thursday,
No. 212
November 3, 2022
Part IV
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 400, 406, 407, et al.
Medicare Program; Implementing Certain Provisions of the Consolidated
Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and
Eligibility Rules; Final Rule
Federal Register / Vol. 87, No. 212 / Thursday, November 3, 2022 /
Rules and Regulations
[[Page 66454]]
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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-F]
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: Final rule.
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SUMMARY: This final rule implements certain provisions of the
Consolidated Appropriations Act, 2021 (CAA). Additionally, we are
proposing to delete references to specific Medicare forms from the text
of existing regulations at Sec. Sec. 406.7 and 407.11 in order to
provide greater administrative flexibility. Finally, this final rule
updates 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: This final rule is effective on January 1, 2023, except for the
addition of Sec. 407.47(f) at instruction 21, which is effective on
January 1, 2024.
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:
I. Summary
A. Beneficiary Enrollment Simplification in Medicare Parts A and B--
Background and Proposal Summary
Medicare is a Federal program to provide health insurance for
people age 65 and older, and those under 65 with certain disabilities
or End-Stage Renal Disease (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 (DME), 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 (RRB) when they turn 65 because they are
already receiving social security or RRB retirement benefits. 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 eligible individuals who enroll
during the GEP, coverage is effective the July 1 following the month in
which the individual enrolls.
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. We proposed 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
proposed 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 special enrollment periods (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 section 1838(g) of the Act provides the Secretary the
discretion to determine the effective date of entitlement for
individuals who enroll under an SEP for exceptional conditions, and
amendments to section 1839(b) of the Act exempt individuals enrolling
under such an SEP from being subject to a late enrollment penalty
(LEP). We proposed to establish several SEPs for exceptional conditions
that would be incorporated
[[Page 66455]]
in our regulations under 42 CFR parts 406 and 407.
B. Extended Coverage of Immunosuppressive Drugs for Certain Kidney
Transplant Patients--Background and Proposal Summary
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 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 kidney
transplant (see also 42 CFR 406.13(f)(2)). 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 the purpose of coverage of immunosuppressive drugs described
in section 1861(s)(2)(J) of the Act. Effective January 1, 2023, this
provision allows certain individuals whose Medicare entitlement based
on ESRD would otherwise end after a 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. of this
final 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--
Background and Proposal Summary
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 Sec. Sec. 406.7 and 407.11,
respectively. Medicare enrollment forms are available to individuals
via mail from CMS or SSA, downloadable via the CMS \1\ and SSA \2\
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.
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\1\ <a href="https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/CMS-Forms-List">https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/CMS-Forms-List</a>.
\2\ <a href="https://www.ssa.gov/forms/">https://www.ssa.gov/forms/</a>.
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We proposed 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 also proposed to make technical edits
to the text at Sec. 406.7 to state that an individual who files an
application for monthly Social Security cash benefits as defined in
Sec. 400.200 also applies for Medicare entitlement if he or she is
eligible for hospital insurance at that time. Current regulations do
not define Social Security cash benefits. We proposed to provide more
clarity on when a Social Security application also applies for Medicare
entitlement to Part A.
D. Modernizing State Payment of Medicare Premiums--Background and
Proposal Summary
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
[[Page 66456]]
Columbia have buy-in agreements for Part B \3\ with the Secretary.
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\3\ Thirty-seven States (including the District of Columbia)
also have buy-in agreements for Part A.
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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 will be $164.90 per month in 2023), and individuals
eligible but not enrolled in Medicare are able to enroll in the program
and access Medicare services.
We proposed several technical updates to the regulations pertaining
to State buy-in that would better align them with federal statute,
policy and operations that have evolved over time. We also proposed
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.
II. Provisions of the Proposed Rule and Analysis of and Responses to
Public Comments
A. Proposals for Beneficiary Enrollment Simplification (Sec. Sec.
406.21, 406.22, 406.27, 406.33, 406.34, 407.23, 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.
<bullet> IEP: The period during which individuals eligible for
premium Part A 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 individuals age 65 and older enrolling in Part A, the IEP is the 7-
month period that begins 3 months before the month in which the
individual is first eligible for Medicare and ends 3 months after the
first month of eligibility.
<bullet> Deemed IEP: 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 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 based on the time shown in such documentary evidence of the
individual attaining age 65. 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 for individuals not subject to a deemed initial enrollment period
under 42 CFR 407.14.
<bullet> GEP: 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 individuals who become eligible to enroll in
Medicare under section 1836(a) of the Act before January 1, 2023, and
enroll:
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> Under the GEP sections 1838(a)(2)(D)(i) 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
[[Page 66457]]
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 (i.e., is entitled to Part A, or, is age 65, a resident of
the United States, and is either (A) a citizen or (B) an alien lawfully
admitted for permanent residence who has resided in the United States
continuously during the 5 years immediately preceding the month in
which he applies for enrollment), 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. An example of the
current entitlement dates compared to the revisions made by the CAA is
provided in the table:
------------------------------------------------------------------------
Prior to 1/1/23-- On or After 1/1/23--
Enrolls in IEP: Entitlement begins Entitlement begins
on: on:
------------------------------------------------------------------------
January..................... April 1 (month April 1 (month
eligibility eligibility
requirements first requirements first
met). met).
February.................... April 1............. April 1.
March....................... April 1............. April 1.
April....................... May 1 (month May 1.
following month of
enrollment).
May......................... July 1 (second month June 1.
after month of
enrollment).
June........................ September 1 (third July 1.
month after month
of enrollment).
July........................ October 1 (third August 1.
month after month
of enrollment).
January..................... July 1.............. February.
February.................... July 1.............. March.
March....................... July 1.............. April.
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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.
To implement the changes to 1838(a) of the Act, we proposed to
revise language in both 42 CFR part 406 (for premium Part A) and 42 CFR
part 407 (for Part B). Specifically, we proposed the following to
reflect changes related to the start of entitlement for premium Part A
IEP enrollments as summarized:
<bullet> Revised Sec. 406.22(a) would 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.
<bullet> New Sec. 406.22(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.
<bullet> Newly redesignated and revised Sec. 406.22(c) would apply
the existing entitlement date requirements for individuals under age 65
who became eligible for Medicare prior to January 1, 2023.
<bullet> New Sec. 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.
We also proposed the following to reflect changes related to the
start of entitlement for individuals enrolling in Part B during their
IEP:
<bullet> Revised Sec. 407.25(a)(1) applied 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.
<bullet> Revised Sec. 407.25(a)(2) applied new entitlement dates
requirements to individuals who first satisfy the Part B eligibility
requirements on or after January 1, 2023.
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 proposed
the following changes to reflect the updates in entitlement for
individuals enrolling during the GEP:
<bullet> Revised Sec. 406.21(c)(3) reflected the revised
entitlement periods for individuals who enroll or reenroll during a
GEP.
<bullet> Revised Sec. 407.25(b)(1) specified 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.
<bullet> New Sec. 407.25(b)(3) specified 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 received a large number of comments related to our proposals for
effective dates of entitlements. The comments on those proposals and
our responses follow:
Comment: All commenters on this proposal expressed support for the
proposed changes to the effective dates. Many of the comments referred
to the positive outcomes that will result from the proposal. The
commenters expressed that the proposed changes to the effective dates
will alleviate much of the confusion surrounding Medicare enrollment.
Commenters also noted that the changes will ease the stress individuals
face with regard to waiting months for their enrollment to start and
allow them to receive coverage in a timelier manner. A few commenters
noted that outreach and education materials, including translated
materials, will need to be updated to reflect these changes.
Response: We appreciate the overwhelming support for our proposal
and thank those that took the time to give us feedback. We are in
agreement with commenters that these changes will simplify the
enrollment process and will result in a more efficient and positive
experience for those seeking to enroll in Medicare. We will also take
measures to update publications, training materials, and other outreach
materials, as well as work with Medicare stakeholders, to update
educational and outreach materials with the new changes. This includes
that translation of materials into multiple different languages as
needed.
[[Page 66458]]
Comment: A commenter had a concern in regards to when the proposed
changes would be implemented. Specifically, they stated that the
Medicare Part A changes would be effective in 2023 and the Medicare
Part B proposed changes would be effective in 2022, and they
recommended that these proposals be implemented simultaneously.
Response: We appreciate the feedback from the commenter and clarify
that, as proposed, these changes for both Medicare Parts A and B are
effective for enrollments on or after January 1, 2023. This timeframe
is also articulated in Section 120 of the CAA.
Comment: Another commenter expressed concern for individuals that
may wish to delay their coverage to begin after retirement and provided
an example of a teacher that becomes Medicare eligible in the fall but
wishes to delay enrollment until retirement in May. The commenter
requested an arrangement be made in this regulation to allow for
individuals to delay enrollment until retirement.
Response: When an individual is determining their plan for
enrollment and considering when they want their Medicare coverage to
become effective, they should keep in mind all enrollment opportunities
available, such as the various enrollment periods and the group health
plan (GHP) SEP (Sections 1837(i)(1) through (3)), which has different
rules for when coverage becomes effective. The GHP SEP allows
individuals to enroll at a later date as long as they were covered
under insurance through their employer. Those wishing for their
coverage to begin after retirement may be eligible and could consider
this option.
Comment: A few commenters expressed support for the proposed
changes but provided feedback on areas that were not addressed in the
proposed rule. A commenter believed that the 2-year waiting period to
receive Medicare while receiving Social Security Disability Insurance
(SSDI) benefits is too long and that SSDI beneficiaries seeking to
enroll in Medicaid should not have to adhere to any income restrictions
or waiting periods. Another commenter suggested that we include more
detailed language related to beneficiary coverage through telehealth.
Lastly, a commenter suggested that we update the SEP for Medicare
Advantage Prescription Drug Plan or stand-alone Part D Prescription
Drug Plan during the Part B GEP (located at Sec. 423.38(c)(16)) to
align with the changes in the proposed rule.
Response: We thank the commenters for their support of the proposed
changes but note that these areas are outside of the scope of this
rulemaking.
We appreciate the feedback that we received on the entitlement date
changes from commenters. Based on analysis of the public comments, we
will be finalizing the proposals related to entitlement effective dates
as proposed.
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 an LEP \4\ 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.\5\ 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. Several SEPs currently
exist that permit individuals to enroll in premium Part A or Part B
outside of the IEP or GEP, including the following:
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\4\ An LEP is an amount added to the monthly premium that can be
applied to individuals who do not sign up during their IEP. See 42
CFR 406.32(a) and 408.22.
\5\ 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.
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<bullet> 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.
<bullet> Section 1837(i)(4) of the Act establishes an SEP for
certain individuals who, when first eligible for Medicare, were
enrolled in a group health plan (GHP) or large group health plan (LGHP)
by reason of their own (or a family member's) current or former
employment, and whose coverage ended at a time when enrollment in the
plan was not based on current employment.
<bullet> 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.
<bullet> 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.
There is an appeal process, under SSA guidance, for individuals who
are denied for one of the current SEPs. If an individual disagrees with
an initial determination or decision, they may request further review
under the administrative review process, also known as the appeal
process. This process will also apply to the newly established SEPs. We
proposed to establish five new exceptional conditions SEPs under
section 1837(m) of the Act in Sec. Sec. 406.27 and 407.23 of the
regulations for Medicare parts A and B, respectively. These five SEPs
are for individuals impacted by an emergency or disaster, health plans
or employers misrepresenting or providing incorrect information, the
termination of Medicaid coverage, formally incarcerated, and other
exceptional conditions. We proposed that these SEPs would be available
to individuals who miss an IEP, GEP, or another SEP, such as the GHP
SEP, due to a covered exceptional condition. (We note that in
discussing these changes in the preamble of the proposed rule at 87 FR
25092, 25126, and 25128 we erroneously referred to Sec. 407.22 instead
of Sec. 407.23 and are now correcting that error.)
In determining what new exceptional conditions SEPs would be
beneficial to the Medicare program and its beneficiaries and that
should be established in regulations, we
[[Page 66459]]
considered numerous factors including the following:
<bullet> Whether the conditions that caused the individual to miss
an enrollment period are ``exceptional'' as required under the CAA, and
whether the conditions are likely to be a one-time event.
<bullet> The SEP should not create an incentive for individuals to
delay timely enrollment into Medicare.
<bullet> 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.
<bullet> 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.
<bullet> 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, we proposed 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.
To accommodate these changes, we proposed to establish a new Sec.
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 proposed to establish a new Sec. 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
Sec. Sec. 406.27(a) and 407.23(a) provided 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
final rule.
a. 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 and provides 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 proposed the following:
<bullet> 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 Sec. 406.27 (Special enrollment
periods for exceptional conditions), we proposed at Sec. 406.33(c)(2)
that any months of non-coverage would be excluded from the calculation
of the LEP.
<bullet> 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 Sec. 407.23 (Special enrollment
periods for exceptional conditions), we proposed at Sec. 408.24(b)(2)
that any months of non-coverage would be excluded from the calculation
of the LEP.
<bullet> For individuals who reenroll prior to January 1, 2023, we
proposed at Sec. Sec. 406.34(a) and 408.24(c) that requirements
currently in place for determining the months taken into account for
purposes of calculating the LEP would continue to apply.
<bullet> 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
Sec. Sec. 406.27 or 407.23, respectively, we proposed at Sec. Sec.
406.34(e) and 408.24(d)(2)(ii) that any months of non-coverage would be
excluded from the calculation of the LEP. We clarified in the proposed
rule that 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
Sec. Sec. 406.33, 406.34, and 408.22.
We received a large number of comments related our proposed SEPs.
The discussion pertains to comments related to our overall SEP
authority and provides our responses to those comments.
Comment: Commenters supported the five proposed SEPs, including
CMS's proposal to exclude months of non-coverage from the calculation
of the LEP, and several commenters applauded our efforts to expand
access to Medicare coverage with this new rule. Many cited that these
new SEPs would add to the agency's commitment to health equity by
helping to reduce disparities. A commenter stated that ``these
provisions may also help maintain the financial viability of the
emergency care safety net.'' Similarly, others agreed with our
reasoning for these proposed SEPs, stating that they would address
several of the barriers to timely Medicare enrollment and reduce
coverage gaps and access to healthcare, including mental health
services.
Response: We thank all commenters for their support on the five
proposed SEPs. Many of the inferences trumpeted by the commenters align
with our reasoning for proposing these provisions. We remain committed
to advancing health equity for all by improving access and eliminating
barriers, to Medicare.
Comment: A commenter strongly encouraged CMS and SSA to use
existing data resources to automatically apply these SEPs for
individuals who are able to provide basic documentation with their
enrollment materials. They added that CMS and SSA should include
information about how the process will be streamlined with notification
of the SEP. Furthermore, this commenter urged CMS to consider
[[Page 66460]]
alternative communication methods, in addition to mail, to ensure
individuals are aware of the SEPs.
Response: We appreciate the suggestion to ease processes for
beneficiaries, but we are unable to automatically apply these SEPs for
individuals who wish to enroll in Medicare. Use of the proposed SEPs
requires that an individual misses their enrollment period due to a
qualifying event. For us to know that information, the individual must
initiate contact with SSA, which will allow SSA to verify their
validity for an exceptional condition SEP. For these reasons, we
decline to adopt the commenter's recommendation to automatically apply
this SEP to eligible individuals at this time, but we may consider
options to work closely with stakeholders to streamline processes in
future rulemaking. In regard to alternative methods of communication,
we appreciate the suggestion, and CMS is committed to updating our
websites and working with stakeholders to ensure adequate awareness of
the availability of these new SEPs as appropriate.
Comment: A commenter was concerned that the proposed SEPs were
limited to a narrow group of individuals who were specifically enrolled
in a group health plan when they first became eligible to enroll in
Medicare.
Response: To clarify, the proposed exceptional condition SEPs are
available to any individual who qualifies and are not specific to those
enrolled in a group health plan when first eligible for Medicare.
b. SEP for Individuals Impacted by an Emergency or Disaster
We proposed an SEP for individuals impacted by a government-
declared 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 government-declared
emergencies and disasters without being subject to the requirements
applicable under our existing equitable relief authority.\6\ 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.
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\6\ Equitable relief (section 1837(h) of the Act) is the tool by
which we correct or eliminate inequity to the individual when their
Medicare enrollment rights are prejudiced because of the error,
misrepresentation, or inaction of the federal government.
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The proposed parameters of this SEP were as follows:
<bullet> At new Sec. Sec. 406.27(b) and 407.23(b), we proposed 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.
<bullet> At new Sec. Sec. 406.27(b)(1) and 407.23(b)(1), we
proposed that the 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.
<bullet> At Sec. Sec. 406.27(b)(2) and 407.23(b)(2), we proposed
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 declaration has been
determined to have ended or revoked. If the declaration is extended,
the SEP ends 2 months after the end date of any extensions. We
specifically requested comments regarding whether we 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.
<bullet> We proposed in Sec. Sec. 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.
We received the following comments on the SEP for Individuals
Impacted by an Emergency or Disaster:
Comment: Commenters expressed strong and broad support for the
establishment of this SEP. Commenters agree that this SEP would help
mitigate disparities related to the access of healthcare for Medicare
beneficiaries residing in areas impacted by disasters or emergencies. A
few commenters suggested that the proposed duration of the SEP may not
be enough time for individuals to recover from a disaster or emergency
declaration has ended and one recommended the SEP extend a full year
after the declaration has ended.
Response: We appreciate the overwhelming support for this proposed
SEP and thank those that gave us feedback. The vast majority of
commenters expressed support for the SEP's duration, as proposed.
However, we did receive comments suggesting that we extend the duration
of the SEP beyond 2 months after the end of the emergency or disaster
declaration. Upon review, we have decided to extend the SEP duration in
order to provide greater flexibility for potential Medicare
beneficiaries. Individuals will have the full duration of the emergency
plus an additional 6 months to contact SSA to enroll in Medicare under
this SEP. As such, we are revising Sec. Sec. 406.27(b)(2) and
407.23(b)(2) to specify that the SEP begins on the earlier of the date
an emergency or disaster is declared or, if different, the start date
identified in such declaration and the SEP ends 6 months after the
declaration has been determined to have ended or revoked. If the
declaration is extended, the SEP ends 6 months after the end date of
any extensions.
Comment: A few commenters requested that CMS consider making the
SEP applicable in situations where the individual may not live in an
area impacted by a Federal, State or local government-declared disaster
or emergency, but the person who makes healthcare decisions on behalf
of that individual does, noting that it was consistent to what was
allowed in Part C and Part D. Additionally, a commenter recommended
that we ensure that moving forward the requirements related to this SEP
remain equal across Medicare Parts A, B, C and D.
Response: We thank commenters for this insight. Currently, in
regard to the Medicare Part C and D emergency or disaster SEP, if a
person who assists in making health care decisions on behalf of a
Medicare enrollee is impacted by a government-declared emergency or
disaster, then the SEP would be available to the enrollee. We would
note that Medicare enrollees in Parts C and D have the option to make
enrollment decisions on what plans best suit their financial and health
care needs on an annual basis, and they often rely on friends and
family members with these decisions. In contrast, enrolling in Parts A
and B is normally a one-time decision that does not include the same
level of complexity as Parts C and D enrollments. However, we do
believe allowing some flexibility to individuals who require assistance
in Medicare Parts A and B is important. As such, we will be revising
Sec. Sec. 406.27(b)(1) and 407.23(b)(1) to specify that the SEP is
[[Page 66461]]
also available if the individual did not live in an area impacted by a
Federal, State or local government-declared disaster or emergency, but
the individual's authorized representative (as defined at 42 CFR
405.910), their legal guardian, or the person who makes healthcare
decisions on behalf of that individual, did live in such an impacted
area.
Comment: A commenter requested that we remove the requirement for
the individual to submit proof of SSA office closings or mail
disruptions, or provide proof that the emergency or disaster directly
affected their ability to enroll in Medicare.
Response: We appreciate the feedback but would like to clarify that
impacted beneficiaries are not required to provide proof of SSA office
closings or disruptions in mail service due to a disaster or emergency
for this SEP. The individual must have missed an enrollment period in
order to qualify for this SEP; however, the individual does not have to
provide documented proof that the disaster or emergency impacted their
ability to enroll as SSA will already have this information.
Individuals or their authorized representative need only to demonstrate
that they reside (or resided) in the area during the period covered by
a disaster or emergency declaration.
Comment: We solicited comments on whether we should limit the SEP
timeframe based on the type of emergency or the explicit impact on the
individual's ability to enroll. The majority of commenters believe such
restriction would be harmful to individuals and administratively
burdensome to the Social Security Administration, which is tasked with
making enrollment determinations. Commenters believe it is extremely
unlikely that anyone would intentionally delay Medicare enrollment in
hopes of a tragedy. There also may be disasters or emergencies that do
not impact an individual's ability to enroll in Medicare.
Response: We agree with commenters and appreciate their feedback.
The purpose of this SEP is to provide an enrollment opportunity for
individual's impacted by an exceptional condition that may have impeded
their ability to enroll during another valid enrollment period and as
such we will not make any changes to the SEP timeframe based on the
type of disaster or emergency.
We appreciate the support and feedback received from commenters. As
discussed, we will be finalizing this SEP as proposed with the
following modifications. We will be revising Sec. Sec. 406.27(b)(1)
and 407.23(b)(1) to specify that the SEP is also available if the
individual did not live in an area impacted by a Federal, State or
local government-declared disaster or emergency, but the individual's
authorized representative (as defined at 42 CFR 405.910), legal
guardian (as outlined by SSA), or person who makes healthcare decisions
on behalf of the individuals, did live in such an impacted area. In
addition, we will be revising Sec. Sec. 406.27(b)(2) and 407.23(b)(2)
to extend the duration of the SEP from 2 months to 6 months after the
end of the emergency or disaster declaration.
c. SEP for Health Plan or Employer Misrepresentation or Providing
Incorrect Information
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 proposed to create a new SEP at Sec.
406.27(c) and at Sec. 407.23(c) based on exceptional conditions. We
proposed that 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.
The proposed parameters of this SEP were as follows:
<bullet> At Sec. Sec. 406.27(c)(1) and 407.23(c)(1) we proposed
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. We stated that to demonstrate material
misrepresentation, an individual would be required to provide
documentation of the relevant misrepresentation to SSA and that it 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.
<bullet> At Sec. 406.27(c)(2) and Sec. 407.23(c)(2) we proposed
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.
<bullet> At Sec. Sec. 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.
We received the following comments on the SEP for Health Plan or
Employer Misrepresentation or Providing Incorrect Information:
Comment: Commenters expressed general support for this SEP.
Commenters indicated that this SEP will help to cure what they perceive
to be one of the most widespread and common enrollment pitfalls facing
beneficiaries and will potentially eliminate gaps in coverage. Multiple
commenters, while supporting the SEP, recommended that we lower the
evidence requirement for the SEP due to erroneous information that may
have been provided orally or in another form in which the beneficiary
may not be able to provide tangible evidence.
Response: We acknowledge that employers and GHPs do not always
communicate information in writing; therefore, it is reasonable to
assume that individuals may not have tangible documentation to provide
to SSA proving that they were misinformed by their employer or GHP. Not
allowing an alternative type of documentation, other than written,
would disadvantage beneficiaries who were misinformed through other
communication methods. Upon review, we have decided to accept written
attestation from the beneficiary when documented evidence from the
employer or GHP is not available. We thank the commenters for their
overall support, and agree with their assessment of the evidence
requirement. We are modifying the regulations at Sec. Sec. 406.27(c)
and 407.23(c) to expressly permit the use of either documentation of
misrepresentation or written attestation.
Comment: Many commenters, while supporting the SEP, recommended
that we include non-employer insurance sources, such as insurance
agents and individual policy sellers, as well as non-federal government
entities and agents, including Medicaid, the Marketplace, and State
Departments of Insurance or similar as trusted sources of information.
Commenters also recommended to expand the definition of misinformation
to include employer or health plan omission of information.
Response: Upon review, we agree that other non-employer insurance
sources could be considered trusted sources of information. Agents and
brokers of health plans could be considered as
[[Page 66462]]
extensions of an individual's health plan and play a critical role in
informing individuals of their enrollment options. We have modified the
language in the regulation text accordingly.
We are not adopting the suggested inclusion of non-federal
government entities and agents, including Medicaid, the Marketplace,
and State Departments of Insurance as trusted sources of information
because this would substantially change the scope of this SEP. The
purpose of this SEP is to provide relief to employees who have been
misinformed by employers, GHPs, or agents or brokers of health plans.
If another entity has misinformed the beneficiary, the individual may
apply for relief under the SEP for Other Exceptional Conditions.
Accordingly, we are revising Sec. Sec. 406.27(c)(1)(i) and
407.23(c)(1)(i) to include brokers or agents of health plans as
entities from whom the beneficiary may have received misinformation.
Comment: Multiple commenters recommended that CMS expand the
definition of misinformation to include employer or health plan
omission of relevant information. For example, a commenter stated that
an employer or health plan failing to convey pertinent information
could impact an individual's decision making and cause them to miss
their Medicare enrollment period.
Response: While we understand that individuals need complete
information about their options and responsibilities, the onus does not
fall on the employer, GHP, or agents and brokers of health plans to
provide any information that the individual requests. Information
provided by these entities is often voluntary, as they are not legally
obligated under the Medicare statute to provide any information to
individuals related to Medicare enrollment. As such, we will not be
revising this final rule to provide that omission of information can
give support an SEP.
Comment: Several commenters discussed beneficiaries' confusion with
the interaction of COBRA coverage and Medicare, including that COBRA is
not creditable coverage in the same way employer-group coverage is for
Medicare and that COBRA cannot pay primary coverage once a person
becomes eligible for Medicare. A few commenters recommended that
enrollment in COBRA or retiree coverage alone should be used as
evidence of misinformation, and therefore an individual in this
circumstance should be considered eligible for the SEP.
Response: While we understand that COBRA interaction with Medicare
may be confusing, we are unable to make the assumption that enrollment
in COBRA was caused by misinformation provided by an employer or group
health plan. We cannot assume that the beneficiary did not deliberately
choose to enroll in COBRA. As such, we do not consider this an
exceptional condition and will not consider enrolling in COBRA alone as
a basis for this SEP. If a beneficiary was erroneously instructed by an
employer, group health plan, or agent and/or broker of the health plan
to enroll in COBRA, they may provide the documented evidence or written
attestation of the misinformation in order to qualify for the SEP. In
addition, if there was another exceptional circumstance surrounding
their enrollment in COBRA, they can apply for the SEP for other
exceptional conditions.
Comment: A commenter suggested that we increase the SEP duration
from 2 months to 6 months to allow the beneficiary time to gather
evidence of the misinformation.
Response: We proposed that the SEP would end 2 months after the
individual notified SSA of the misrepresentation and we believed this
would be ample time since, in most cases, we assumed that the
individual would enroll at the same time they identified the issue to
SSA. However, upon review, we have decided to extend the SEP duration
from 2 months to 6 months in order to provide greater flexibility for
potential Medicare beneficiaries. In addition, we are modifying this
SEP to allow for the acceptance of written attestation, which will
allow an individual to provide evidence of misinformation even if they
do not have or cannot find written evidence from their employer or
health plan, it should not take longer than 6 months to satisfy the
requirements of this SEP.
We appreciate the support and feedback received from commenters. As
discussed, we will be finalizing this SEP as proposed with the
following modifications:
<bullet> We are modifying Sec. Sec. 406.27(c)(1) and 407.23(c)(1)
to expressly permit the use of either documentation of
misrepresentation or written attestation for this SEP.
<bullet> We are revising Sec. Sec. 406.27(c)(1)(i) and
407.23(c)(1)(i) to include brokers or agents of health plans as
entities that may have been a source of misinformation.
<bullet> We are revising Sec. Sec. 406.27(c)(2) and 407.23(c)(2)
to increase the SEP duration from 2 months to 6 months.
d. SEP for Formerly Incarcerated Individuals
Section 1862(a)(2) and (3) of the Act generally prohibits Medicare
payment for otherwise covered services when the individual who is
furnished the services is not obligated to pay for them (and no other
person has a legal obligation to pay for them) and covered services
that are paid for directly or indirectly by a governmental entity
(other than under a health program under the Social Security Act). In
implementing these provisions, CMS adopted a regulation that prohibits
payment for otherwise covered services that are furnished while the
recipient is in custody of penal authorities, as such individuals are
provided healthcare through their penal institution. As a result,
individuals who are enrolled in Medicare but who are in custody of
penal authorities as described in 42 CFR 411.4(b) (here,
``incarcerated'' for brevity) are subject to a payment exclusion in
Medicare so Medicare does not pay for items and services that might
otherwise be paid under Parts A and B. Further, section 202(x)(1)(A) of
the Act prohibits the payment of Old-age, Survivors, and Disability
Insurance (OASDI) benefits to individuals who meet one of several
criteria that relate to being incarcerated.\7\ Therefore, if an
individual turns 65 and qualifies for Medicare but is not yet receiving
OASDI benefits because of section 202(x)(1) of the Act, that individual
is not automatically enrolled in Medicare Part A. Further, an
individual may elect not to enroll in Medicare while incarcerated to
avoid having to pay out of pocket premiums only for Medicare to deny
payment for services. 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.
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\7\ Section 202(x)(1)(A) lists several conditions of being
confined in a jail, prison, other penal institution or correctional
facility, or in an institution at public expense for certain reasons
specified in the statute, or in a specific status with regard to
criminal prosecution. Here, we use the term ``incarceration'' for
brevity.
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To address the exceptional conditions that an individual faces upon
release from incarceration and to ensure that formerly incarcerated
individuals have access to health coverage under Medicare, we proposed.
at Sec. Sec. 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
[[Page 66463]]
allow those formerly incarcerated individuals to avoid potential gaps
in coverage and late enrollment penalties.
The proposed parameters of this SEP were as follows:
<bullet> At Sec. Sec. 406.27(d)(1) and 407.23(d)(1), we proposed
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.
<bullet> At Sec. Sec. 406.27(d)(2) and 407.23(d)(2), we proposed
that this SEP would start the day of the individual's release from
incarceration and end the last day of the 6th month after the month in
which the individual is released from incarceration.
<bullet> At new Sec. Sec. 406.27(d)(3) and 407.23(d)(3), we
proposed that entitlement would begin the first day of the month after
the month of enrollment, so long as it is after January 1, 2023.
We received the following comments on the SEP for Formerly
Incarcerated Individuals:
Comment: Commenters including advocacy groups, individuals, and
State penal institutions provided broad support for this SEP. These
commenters indicated that it could help this population as increasing
health services and coverage during reentry have been associated with
lower rates of recidivism and improved outcomes around employment,
housing, and family support. Multiple commenters, while supporting the
SEP, recommended that the duration be extended from 6 months as
navigating reentry can be timely and daunting for this population, many
of whom may have physical or cognitive impairments and/or low literacy
and health literacy. Commenters also cited the heightened risk of
competing priorities such as economic and housing insecurity during the
period following release from incarceration as the need for an
increased SEP duration. Most commenters recommended extending the SEP
to 12 months, and a commenter recommended that the SEP last for 2
years.
Response: We appreciate the support for this SEP and understand and
agree with the commenters' belief that this population faces many
challenges in establishing stable conditions and reintegrating
themselves into society. Upon review, and based on the issues raised by
the commenters, we are extending the SEP duration to 12 months. We
believe encouraging individuals to reestablish healthcare coverage
through Medicare is a vital part of successfully re-entering and
reintegrating into the community after incarceration and that a 12-
month timeframe provides sufficient time for a released individual to
have OASDI benefits reinstated. Reinstating OASDI benefits is
important, especially to this population, as they can then enroll or
reenroll in Medicare and not have to pay out of pocket for Medicare
premiums, but rather have their premiums deducted from their Social
Security benefits. Not all formerly incarcerated individuals will delay
enrollment or reenrollment into Medicare until after they have
reinstated their OASDI benefits. However, for those who do, allowing 12
months to enroll or reenroll in Medicare after release from
incarceration allows ample time for formerly incarcerated individuals
to first have their OASDI benefits reinstated. CMS will conduct
education and outreach efforts to inform stakeholders on this SEP and
the importance of prioritizing enrollment into Medicare for this
population.
Accordingly, we are revising the duration of this SEP at Sec. Sec.
406.27(d)(2) and 407.23(d)(2) to reflect an SEP that starts the day of
release from incarceration and concludes at the end of the 12th
subsequent month. For example, if an incarcerated individual was
released on January 14, 2023, their SEP would begin on January 14, 2023
and end on January 31, 2024.
Comment: Multiple comments recommended allowing for pre-release
enrollment under this SEP in order to prevent against potential gaps in
coverage for this population upon release from incarceration.
Commenters calling for pre-release enrollment also cited the need for
these individuals to receive assistance from the State or incarcerating
entity in their enrollment.
Response: We appreciate the feedback from commenters and understand
the importance, especially for this vulnerable population, to lessen
any risk of gaps of coverage. Further, we understand many individuals
of this population may have economic factors that prevent them from
enrolling in Medicare prior to their OASDI benefits being reinstated,
thus requiring them to pay out of pocket for Medicare premiums. With
these considerations in mind, we considered different options to best
reduce any gaps of coverage that an individual may face upon release
from incarceration and that included either revising the duration of
the SEP or revising the entitlement start date. We believe this issue
can best be addressed by finalizing our proposal with modifications to
allow eligible individuals to choose between 2 effective dates of
coverage:
<bullet> Option 1: Individuals enrolling in this SEP will have a
prospective entitlement to begin the first day of the month following
the month of enrollment.
<bullet> Option 2: Individuals enrolling in this SEP can opt for a
retroactive entitlement date so long as their enrollment is on or after
January 1, 2023. If the application is filed within the first 6 months
of the SEP, the effective date is retroactive to the date of their
release from incarceration. If the application is filed in the last 6
months of the SEP, the coverage effective date is retroactive to 6
months after the date of release from incarceration. In addition,
beneficiaries who opt for retroactive coverage must pay the premiums
for that coverage and we note that installment billing plans are
available for beneficiaries who cannot pay the lump sum of retroactive
premiums. Beneficiaries would contact their local Social Security field
office for help paying any retroactive premium arrearages.
We understand that this population of beneficiaries may face job
insecurity and socio-economic barriers while reintegrating into their
communities. If an individual opts for retroactive coverage, they would
have to pay monthly premiums for those retroactive months of coverage.
Some individuals may wish to delay Medicare enrollment until they have
had their OASDI benefits reinstated, ensuring they are not paying out
of pocket for Medicare premiums. Still others may be willing to pay out
of pocket for coverage retroactive to their release date, not to exceed
6 months, and before their OASDI benefits are reinstated. Providing
individuals this option allows them the ability to make the healthcare
decisions that are best suited to their needs. To implement this
change, we are revising the entitlement date of this SEP at Sec. Sec.
406.27(d)(3) and Sec. 407.23(d)(3) to provide that entitlement begins
the first day of the month following the month of enrollment, so long
as the date is on or after January 1, 2023 or, as we specify in
Sec. Sec. 416.27(d)(3)(ii) and Sec. 407.23(d)(3)(ii), individuals
have the option of choosing an entitlement date retroactive to the
first day of the month of their release from incarceration, not to
exceed 6 months. Individuals would have to pay premiums for the
retroactive period of coverage.
Comment: Multiple commenters suggested that CMS revise the
[[Page 66464]]
description of when someone is ``in custody of penal authorities''
under Sec. 411.4(b). Commenters identified that the current definition
includes a broad range of individuals--including those who are under
arrest (pre-conviction), on medical furlough, required to live under
home detention, or are on parole, probation, or supervised release.
Further, the commenters noted that the regulation at Sec. 411.4 does
not absolutely preclude Medicare payment for these individuals; rather,
it establishes the presumption that another payer is responsible, and
provides that payment may be made for services furnished to individuals
or groups of individuals who are in the custody of police or other
penal authorities provided that certain conditions are met. However,
commenters state the regulation assumes that penal authorities have
responsibility to cover, and will cover, medical expenses during all
these circumstances, an assumption that is inconsistent with actual
coverage by corrections authorities.
Commenters expressed concern that the existing regulation could
leave some individuals who are ``in custody of penal authorities'' as
that phrase is used in Sec. 411.4(b) without coverage from both the
penal institution and Medicare. Commenters described their
understanding that Medicaid coverage is permitted for individuals who
are ``on parole, probation, or released to the community pending trial;
living in a halfway house where individuals can exercise personal
freedom; voluntarily living in a public institution; or on home
confinement.''
Response: We thank the commenters for their concerns and
suggestions. However, changes to Sec. 411.4, such as to limit who is
``in custody'' for purposes of the Medicare payment exclusion or to
amend the exception that permits Medicare payment under certain
conditions, are not within the scope of this rulemaking. Further, we
are not addressing here the rules and definitions used in other
programs, such as Medicaid or the Marketplace, for individuals who are
incarcerated or in custody.
We believe that it is important that the scope of the SEP we
proposed and are finalizing is aligned with who Sec. 411.4(b)
specifies are individuals in custody of penal authorities for purposes
of the Medicare payment exclusion. However, we appreciate the
commenters' considerations and will continue to consider the issues
they have raised. As finalized in this rule, Sec. Sec. 406.27(d) and
407.23(d) use the term ``in custody of penal authorities'' and cite
Sec. 411.4(b) for its description of who is in custody of penal
authorities to ensure this alignment is clear. As stated in the first
paragraph for this section of this final rule, we are using the term
``incarcerated'' in the preamble to describe the individuals who are in
custody of penal authorities as described in Sec. 411.4(b). Further,
if CMS amends Sec. 411.4(b) in the future to limit the description of
who is in custody of penal authorities for purpose of the Medicare
payment exclusion, this SEP will be automatically aligned to that
change.
Comment: Multiple commenters requested that CMS remove the overdue
part B premiums (caused by the 90-day grace period) for incarcerated
individuals. Currently, Medicare beneficiaries in a direct-bill
agreement (for those who do not have Medicare premiums deducted from
their OASDI benefits, a direct-bill agreement is an automatic deduction
of Medicare premiums from a checking or savings account each month) are
given 90 days to repay any past due premiums before their Medicare
enrollment is terminated. After 90 days, Part B enrollment is normally
terminated for non-payment of premiums (42 CFR 408.8(c)). Commenters
noted this 90-day grace period places an unnecessary and unforeseen
financial burden on people who are incarcerated but have not paid prior
premiums and creates an additional barrier to reenrollment. The
commenters explained this is because most enrolled beneficiaries have
Medicare premium payments automatically deducted from a monthly SSA
benefit. However, when the enrolled beneficiaries become incarcerated,
they are switched to direct payment as their SSA benefits are suspended
upon incarceration. If the individual later re-enrolls in Part B after
release from incarceration, and upon restoring SSA benefits, SSA
deducts premium payments owed under the earlier grace period from the
first SSA benefit payment. Commenters noted this deduction can cause
significant hardship upon reentry.
Response: We thank commenters for their concerns and suggestions.
However, this suggestion is outside the scope of this rulemaking. The
Medicare premium grace period is designed to help Medicare
beneficiaries who are enrolled in direct pay keep coverage during
temporary periods of hardship, or common mishaps that may result in a
beneficiary missing a premium payment. Further, incarcerated
individuals do have the ability to voluntarily terminate their Medicare
coverage upon incarceration to avoid any potential past-due payment
issues, which they would do by contacting SSA. Finally, installment
billing plans are available through SSA for those who might have
trouble repaying back due premiums.
Comment: A commenter requested that CMS use its discretionary
authority to revise previous rules and waive all historic LEPs that
were paid in the past or are being paid now by previously incarcerated
individuals.
Response: By referring to ``historic LEPs,'' we believe the
commenter is referring to LEPs that were assessed--and were paid in the
past and/or are currently being paid for current Medicare coverage--in
connection with coverage periods for individuals who enrolled (or
reenrolled) in Part B after ending a period of incarceration before
January 1, 2023. This suggestion is outside the scope of this
rulemaking, and CMS does not have the authority to unilaterally waive
LEPs that were paid in the past or are currently part of an
individual's Medicare premium(s) as the LEPs are governed by statute.
The Part A LEP is found in the statute at 1818(c)(6) of the Act, and
the Part B LEP at 1839(b) of the Act. 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, but it did
not provide for a waiver of all historic LEPs for individuals who
previously enrolled in Medicare under a condition that now would be
considered an exceptional condition or for individuals who may qualify
for but do not use an SEP that is established under section 1837(m) of
the Act. Therefore, we are unable to waive historic LEPs for
individuals who enrolled prior to January 1, 2023, even if that prior
enrollment had been under circumstances that will be part of the new
SEPs being adopted under section 1837(m) of the Act. Beginning January
1, 2023, an individual who enrolls using one of the SEPs adopted under
section 1837(m) of the Act will not be assessed LEPs for the coverage
period that begins with that SEP enrollment.
Comment: Multiple commenters recommended that CMS provide education
to individuals who may be eligible for this SEP prior to their release
from incarceration. Commenters showed concern over this population
navigating the Medicare enrollment process and lacking the community
resources that non-incarcerated people may have. Further, commenters
noted that it would be unlikely that incarcerated individuals would
receive any information through the mail about their
[[Page 66465]]
IEP, GEP, or any other helpful Medicare literature, therefore causing
Medicare enrollment to be a daunting, unfamiliar process. Commenters
also recommended that CMS provide notification of this SEP to eligible
individuals to ensure that formerly incarcerated individuals can
benefit from this SEP.
Response: We thank the commenters for their concerns and
suggestions. As a part of implementing this final rule, we will be
updating CMS publications, websites, and outreach materials. We also
intend to work with stakeholders (for example, SHIPs, beneficiary
advocacy groups, etc.) to raise awareness and understanding of all of
the new SEPs.
We appreciate the support and feedback received from commenters on
this SEP. Based on feedback from commenters, we will be finalizing this
SEP as proposed with the following modifications:
<bullet> We will be extending the SEP duration and revise
Sec. Sec. 406.27(d)(2) and 407.23(d)(2) to reflect that the SEP starts
the day of the individual's release from incarceration and ends the
last day of the 12th month after the individual is released from
incarceration.
<bullet> We are revising the text of the regulations at Sec. Sec.
406.27(d) and 407.23(d) to use the phrase ``in custody of penal
authorities'' as well as citing to Sec. 411.4(b) in order to be clear
that the scope of this new SEP is aligned with the scope of Sec.
411.4(b). This change in terminology is intended to eliminate any
unintended ambiguity that using different terms in these regulations
could produce.
<bullet> We are revising the entitlement date of this SEP at
Sec. Sec. 406.27(d)(3) and 407.23(d)(3) to provide that entitlement
begins the first day of the month following the month of enrollment.
Individuals also have the option of choosing an entitlement date
retroactive to the first day of the month of their release from
incarceration (not to exceed 6 months).
e. SEP To Coordinate With Termination of Medicaid Coverage
Many beneficiaries are already 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 and/or
eligibility entirely. For example, when an individual enrolled in the
adult group under section 1902(a)(10)(A)(i)(VIII) of the Act and 42 CFR
435.119 becomes eligible for Medicare, they become ineligible for the
Medicaid adult group per Sec. 435.119(b)(3).\8\
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\8\ To date, 39 States have chosen to cover the adult group
under Sec. 435.119 (b). The adult group 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 Service Code. (See 42 CFR 434.603(e).
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Unless such individuals are eligible for Medicaid on another basis,
such as based on receiving supplemental security income (SSI), they
will no longer be eligible for Medicaid. Many such individuals qualify
for another Medicaid eligibility group, such as a Medicare Savings
Program (MSP) group, but others lose Medicaid coverage entirely because
they do not qualify for another Medicaid eligibility group.
Low-income Medicare beneficiaries experience poorer health outcomes
than their higher-income counterparts.\9\ 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.
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\9\ 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.
<a href="https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//171041/ASPESESRTCfull.pdf">https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//171041/ASPESESRTCfull.pdf</a>.
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Current Medicaid rules attempt to facilitate beneficiary
transitions between Medicaid and other health coverage programs before
the beneficiary loses Medicaid coverage. On September 7, 2022, the
Federal Register included a notice of proposed CMS rulemaking entitled
``Streamlining the Medicaid, Children's Health Insurance Program, and
Basic Health Program Application, Eligibility Determination,
Enrollment, and Renewal Processes'' that aims to improve continuity of
health coverage; however, for purposes of this rulemaking CMS refers
only to current regulations. 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 on another basis under Sec. Sec. 435.916(d),
435.916(f)(1) and 435.930(b). The State must continue the same level of
Medicaid coverage until the State completes the eligibility
redetermination and provides at least 10 days of advance notice and
fair hearing rights in accordance with Sec. 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 must then:
(1) move the individual to a different eligibility group for which the
individual is eligible or, (2) in instances in which the individual is
not eligible for another Medicaid eligibility group, determine the
individual's potential eligibility for other insurance affordability
programs, in accordance with Sec. 435.916(f)(2), and terminate the
individual's Medicaid coverage.
In the proposed rule (87 FR 25098), we noted that, despite these
requirements, there are multiple scenarios that can prevent a seamless
transition to Medicare coverage. We explained that States sometimes
fail to complete redeterminations timely, sometimes not until months
after the individual first qualifies for Medicare.\10\ When this
happens, an individual may retain Medicaid even though the individual
no longer technically meets the Medicaid eligibility criteria. State
Health Insurance Assistance Programs (SHIPs) and beneficiary advocacy
groups have reported that such individuals sometimes miss their IEP
because they continue to be covered by Medicaid and assume it is not
necessary for them to sign up for potentially duplicative health
coverage. Moreover, many States do not cover the Part B premiums for
individuals remaining in the adult group pending a redetermination
under their buy-in agreement.\11\ Because individuals in
[[Page 66466]]
such States would need to pay the Part B premium themselves, they may
decline to sign up for Medicare coverage, which they may struggle to
afford.
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\10\ 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; Colorado Did
Not Correctly Determine Medicaid Eligibility for Some Newly Enrolled
Beneficiaries. <a href="https://oig.hhs.gov/oas/reports/region7/71604228.pdf">https://oig.hhs.gov/oas/reports/region7/71604228.pdf</a>;
HHS Office of the Inspector General. (2019b, August). California
Made Medicaid Payments on Behalf of Newly Eligible Beneficiaries Who
Did Not Meet Federal and State Requirements. <a href="https://oig.hhs.gov/oas/reports/region9/91602023.pdf">https://oig.hhs.gov/oas/reports/region9/91602023.pdf</a>; HHS Office of the Inspector
General. (2018, February). New York Did Not Correctly Determine
Medicaid Eligibility for Some Non-Newly Eligible Beneficiaries.
<a href="https://oig.hhs.gov/oas/reports/region2/21601005.pdf">https://oig.hhs.gov/oas/reports/region2/21601005.pdf</a>; HHS Office of
the Inspector General. (2019, July).
\11\ 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, <a href="https://www.cms.gov/files/document/chapter-1-program-overview-and-policy.pdf">https://www.cms.gov/files/document/chapter-1-program-overview-and-policy.pdf</a>. See section
II.D.3.e. of this proposed rule for a discussion of buy-in coverage
groups available for Part B.
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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 claiming the FMAP increase 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 COVID-19 PHE ends. This condition, known as the continuous
enrollment requirement or continuous enrollment condition, applies to,
among others, individuals who qualified for or were enrolled in
Medicaid during this time period in the adult group and subsequently
became eligible for Medicare.
As discussed in the proposed rule (87 FR 25099), since the start of
the COVID-19 PHE, beneficiary advocacy groups and SHIPs have reported
to us that a substantial number of beneficiaries who became eligible
for Medicare while enrolled in the Medicaid adult group may have
interpreted States' notifications that their Medicaid coverage would
remain intact 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 or
maintain health coverage, including enrolling in Medicare.
Consequently, we anticipated that 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 indicated concern that when the COVID-19 PHE ends and states resume
routine eligibility and enrollment operations for Medicaid, including
taking action on pending redeterminations necessitated by changes in
beneficiary circumstances, such individuals would end up being
terminated from Medicaid and would experience a gap in coverage and
lose access to critical health care as a result. Further, we explained
that once they do enroll in Medicare, they could incur late enrollment
penalties.
As mentioned previously, under 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 Sec. Sec. 435.916(f)(2) and
435.1200(e). As discussed in the proposed rule (87 FR 25099), although
insurance affordability programs have not been defined to include
Medicare, 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 proposed an SEP at
Sec. Sec. 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 anticipated our proposals would 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 proposed at Sec. Sec. 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 Sec. Sec.
406.27(e)(2)(i) and 407.23(e)(2)(i), we proposed 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 Sec. Sec. 406.27(e)(2)(ii) and
407.23(e)(2)(ii), we proposed 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
anticipated that this extended duration would allow this at-risk
population sufficient opportunity to enroll in Medicare.
We also noted 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 COVID-19 PHE and the
individual's Medicaid termination occur before such time). We
maintained that such a deviation was warranted in this limited
circumstance given the novel COVID-19 outbreak and unprecedented
Federal, State, and local efforts to combat it.
We proposed at Sec. Sec. 406.27(e)(3) and 407.23(e)(3) that
entitlement to Part A and Part B, respectively, would begin the first
day of the month following the month of enrollment, so long as it is
effective after the end of the COVID-19 PHE or January 1, 2023,
whichever is earlier. We noted 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 proposed at Sec. Sec. 406.27(e)(4) and 407.23(e)(4)
that individuals who otherwise would be eligible for this SEP, but
enrolled in Medicare during the COVID-19 PHE prior to January 1, 2023,
if applicable, are eligible to have LEPs collected under Sec. Sec.
406.32(d) or 408.22 reimbursed and ongoing penalties removed. Given the
unique nature of this specific SEP, and the fact that we proposed that
individuals could be eligible for the SEP if the COVID-19 PHE ends
before January 1, 2023, we concluded that 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.
We received the following comments, and our responses follow.
Comment: Several commenters expressed general support for the SEP
to Coordinate with Termination of Medicaid Coverage (Medicaid SEP) as
[[Page 66467]]
proposed. Some commenters were particularly appreciative of the
reimbursement of the LEPs for individuals who would have been eligible
for the Medicaid SEP, but already enrolled in Medicare.
Response: We appreciate the comments in support of our proposal. We
anticipate this proposal will help support continuous coverage for
individuals as they transition from Medicaid to Medicare coverage after
the COVID-19 PHE ends and beyond.
Comment: A few comments sought to further address potential gaps in
coverage during the transition from Medicaid to Medicare coverage. A
commenter recommended that we require States to continue Medicaid
enrollment until the individual is actually enrolled in Medicare.
Response: We lack the statutory authority to require that Medicaid
enrollment continue for individuals who are ineligible for Medicaid
beyond the end of the COVID-19 PHE and until the individual is actually
enrolled in Medicare. Beginning the month following the month in which
the COVID-19 PHE has ended, individuals who are ineligible for Medicaid
may not remain enrolled in Medicaid after the State makes a
redetermination that they are ineligible for such coverage.\12\
Therefore, we are unable to accept the commenter's recommendation.
---------------------------------------------------------------------------
\12\ The continuous enrollment provision in the FFCRA provides
an exception to this rule, but it is limited to the COVID-19 PHE.
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However, we share the commenters' concerns about gaps in health
coverage as individuals transition from Medicaid to Medicare health
coverage. Under the proposal, the effective date of the Medicare
enrollment is the month following the month of the SEP enrollment.
Therefore, if individuals do not apply for this SEP upon receipt of the
Medicaid termination notice, they would likely have a gap in coverage
before Medicare coverage starts. Any delay in applying for this SEP
after the loss of Medicaid coverage could be particularly harmful for
people who may need to seek medical care in the intervening time. As
such, to address the commenters' concerns and reduce gaps in coverage
for individuals transitioning between Medicaid and Medicare coverage,
we are finalizing revisions to Sec. 406.27(e)(3) to add paragraph
(iii) and Sec. 407.27(e)(3) to add paragraph (iii) to allow
individuals the option to elect retroactive Medicare entitlement back
to the date of Medicaid termination but no earlier than January 1,
2023. If an individual selects this option, they must pay the premiums
for the retroactive covered time period.
Comment: A few commenters requested clarification on whether
individuals who are only entitled to Part A if they pay a premium
(premium Part A) and live in group payer States can use this SEP to
enroll in premium Part A for the purposes of enrolling in the Qualified
Medicare Beneficiary (QMB) eligibility group.
Response: Under proposed Sec. 406.27(e), individuals who are
entitled to premium Part A, have missed their initial Medicare
enrollment, and lose all Medicaid eligibility have access to this SEP.
We do not make a distinction between access to this SEP for individuals
who live in States that have elected to extend their buy-in agreement
to include Medicare Part A (Part A buy-in States) and those that did
not (group payer States).\13\ As such, individuals who are entitled to
Part A and live in a group payer State may also use this SEP to enroll
in premium Part A under existing SSA processes.
---------------------------------------------------------------------------
\13\ For more information about the distinction between a Part A
buy-in State and group payer State, please refer to section II.D.1.
of this final rule.
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Comment: A few commenters expressed concern regarding the type of
notice that would be required before an individual is able to use the
SEP. The commenters expressed concern that individuals may not receive
timely Medicaid termination notices because of recent relocations,
homelessness, and/or mail delivery problems. The commenters suggested
these problems may be magnified by the end of the COVID-19 PHE. As
such, commenters suggested that CMS use actual knowledge of the
Medicaid termination as the standard for when the Medicaid SEP time
period should start. A commenter requested that CMS and SSA use
existing data resources to automatically apply these SEPs for
individuals who are able to provide basic documentation with their
enrollment materials.
Response: We share commenters' concerns about timely receipt of a
State Medicaid termination notice and reducing barriers to qualifying
for this SEP, but we decline to change the notice standard for the SEP
to actual notice of termination. We think such a change would be
problematic to operationalize because it would be very difficult to
verify when any particular individual had actual knowledge of
termination of their Medicaid coverage. This modification could also
result in delaying the SEP until many months after the individual lost
Medicaid coverage, which would undermine the goal of smooth transitions
of coverage between the Medicaid and Medicare programs. However, if the
individual lacks the original State termination notice, SSA will use
alternative processes to verify the loss of Medicaid with the State
Medicaid agency (for example, email and telephone contact).
In addition, to prepare for the unwinding of the COVID-19 PHE, we
have urged individuals to update their contact information with States
at <a href="https://www.medicaid.gov/resources-for-states/coronavirus-disease-2019-covid-19/unwinding-and-returning-regular-operations-after-covid-19/renew-your-medicaid-or-chip-coverage/index.html">https://www.medicaid.gov/resources-for-states/coronavirus-disease-2019-covid-19/unwinding-and-returning-regular-operations-after-covid-19/renew-your-medicaid-or-chip-coverage/index.html</a>. We have also
created a list of best practices for State Medicaid agencies as they
prepare to unwind the COVID-19 PHE, which includes strategies to
collect and verify updated enrollee contact information at <a href="https://www.medicaid.gov/resources-for-states/downloads/state-unwinding-best-practices.pdf">https://www.medicaid.gov/resources-for-states/downloads/state-unwinding-best-practices.pdf</a>. These principles and practices have been emphasized
throughout CMS materials related to unwinding, which can be found at
<a href="https://www.medicaid.gov/unwinding">https://www.medicaid.gov/unwinding</a>. We encourage the commenters to
partner with us to help ensure State Medicaid agencies have updated
contact information for beneficiaries.
We appreciate the suggestion to ease processes for beneficiaries
but we are unable to automatically apply the Medicaid SEP for
individuals who try to enroll in Medicare at the end of the COVID-19
PHE. While some individuals in Medicaid who are eligible for Medicare
will lose eligibility for Medicaid upon the end of the COVID-19 PHE,
others will not. Some individuals will transition to an MSP eligibility
group or another eligibility group that is part of the State's buy-in
group. Therefore, we decline to adopt the commenter's recommendation to
automatically apply this SEP to eligible individuals at this time, but
may consider options to streamline processes in future rulemaking based
on program experience.
Comment: Some commenters stated that our proposal to require
Medicaid termination as the trigger for the SEP would complicate
processes for individuals who missed their IEP during the PHE but who
remain eligible for Medicaid after the PHE ends and redeterminations
resume. The commenters stated, for example, that in a State that
requires Medicare application as a condition of Medicaid eligibility,
individuals who are otherwise eligible for Medicaid but failed to
enroll in Medicare timely would only be able to qualify for the
[[Page 66468]]
SEP if the State terminates their Medicaid eligibility for failing to
enroll in Medicare. However, once the individual enrolls in Medicare
using the SEP, they would then need to re-apply for Medicaid to regain
Medicaid coverage. The commenters therefore requested that CMS consider
allowing individuals who missed their IEP to qualify for the SEP
without being terminated from Medicaid.
Response: We share the commenters' goal of avoiding administrative
complications for individuals and States, but we decline to extend this
SEP to individuals who missed their IEP but have not had their Medicaid
coverage terminated. At the outset, as noted at 87 FR 25100,
individuals who continue to qualify for a Medicaid eligibility group
that is included in the State buy-in agreement would not need to use
this SEP, as the State would already enroll them in Medicare without
regard to Medicare enrollment periods and LEPs.
However, individuals who missed their IEP and remain eligible for a
Medicaid group that is not in the buy-in agreement could not enroll in
Medicare outside of enrollment periods using the proposed SEP. While
this group could benefit from the commenters' suggestion, we would need
to further explore the policy and operational considerations of
broadening the eligibility for this SEP (for example, how to
effectively identify the specific affected population) and would
benefit from additional public input and program experience. Lastly, we
note that individuals who are ineligible for this SEP may still qualify
for an SEP on a case-by-case basis for other unanticipated situations
that involve exceptional conditions that occur on or after January 1,
2023 at new Sec. Sec. 406.27(f) and 407.27(f).
Finally, we would like to clarify CMS policy on requiring Medicare
as a condition of Medicaid eligibility. As described in the buy-in
provisions in the proposed rule at 87 FR 25120, States can require
Medicaid applicants and beneficiaries to apply for Medicare as a
condition of eligibility, only provided that the State pays their
Medicare premiums under the State buy-in agreement. If the State does
not pay the Medicare premiums for a Medicaid beneficiary under State
buy-in and they do not enroll in Medicare, the State cannot terminate
the individual for failing to apply for Medicare.
Comment: Another commenter sought clarification on how the SEP
would apply to individuals who failed to timely enroll in Medicare
because they remained enrolled in adult group coverage during the PHE
and are then enrolled in Medicaid with a spenddown amount after normal
operations resume. These individuals have countable income over the
eligibility limit for Medicaid and must deduct their incurred medical
expenses to reduce their income down to the medically needy income
level (``spenddown amount'') in order to be eligible for Medicaid in a
given period. The commenter inquired whether individuals with a
spenddown amount are eligible for this SEP, particularly if they do not
meet their spenddown amount during a given period either because their
medical expenses have dipped or they did not submit the necessary
paperwork to prove they have met their spenddown amount.
Response: We acknowledge the difficulties and variability of
Medicaid eligibility for individuals who must meet a spenddown to
qualify for Medicaid. We clarify that the proposed SEP would not apply
to individuals who apply for Medicare when they have already met their
spenddown amount because they are still eligible for Medicaid. On the
other hand, the SEP would apply to individuals if they fail to meet
their spenddown amount in a given period and apply using the SEP while
their Medicaid coverage is not in effect. We will welcome feedback on
experiences with this SEP among individuals who must meet a spenddown
to qualify for Medicaid to inform future rulemaking.
Comment: A commenter sought clarification on whether certain
individuals would qualify for the proposed SEP. In particular, the
commenter questioned whether the SEP applies to individuals who missed
a Medicare enrollment period before the COVID-19 PHE began. The
commenter also inquired whether individuals can qualify for the SEP if
they voluntarily withdraw from Medicaid before the end of the COVID-19
PHE. Finally, the commenter requested we explain if States or an
individual can request exceptions to the parameters of the proposed
SEP.
Response: We appreciate the commenter's questions. Under Sec. Sec.
406.27(e)(1)(ii) and 407.27(e)(i)(ii), the SEP is available to
individuals who have missed a Medicare enrollment period and whose
Medicaid eligibility is terminated on or after January 1, 2023 or is
terminated after the last day of the COVID-19 PHE, whichever is
earlier. We did not specify when an individual must have missed a
Medicare enrollment period. Therefore, in the commenter's first
example, an individual who missed a Medicare enrollment period prior to
start of the COVID-19 PHE (for example, January 31, 2020) and meets
other applicable requirements under Sec. Sec. 406.27(e) and 407.27(e)
would qualify for the SEP.
In response to the commenter's question about voluntary
withdrawals, we note at the outset that voluntary terminations from
Medicaid are exceedingly rare and, as such, we do not expect the issue
the commenter raised to occur with any frequency. Nonetheless, we
clarify that this SEP would not apply to individuals who were
determined ineligible for Medicaid but kept enrolled due to the
continuous coverage enrollment provision in the FFCRA and who
voluntarily withdraw from Medicaid before the PHE ended (or individuals
who give up Medicaid coverage on or after January 1, 2023). The
rationale for this SEP was predicated on ensuring smooth transitions
between the Medicaid and Medicare programs, trying to remedy the gaps
in coverage that are created through involuntary delayed terminations
of Medicaid and the challenges of navigating different States'
processes with regard to redeterminations. It is our understanding that
individuals who voluntarily terminate their Medicaid coverage would not
experience the same gaps in health coverage that individuals facing
involuntary terminations experience. Based on program experience,
individuals who give up Medicaid coverage tend to have other available
sources of health coverage. Additionally, individuals who voluntarily
terminate Medicaid coverage do not have the same challenges with
States' processes that individuals who are involuntarily terminated
from Medicaid experience.
Finally, we did not propose an option for individuals or States to
request an exception to the parameters of this proposed SEP. However,
as noted previously, individuals who are ineligible for this SEP may
still qualify for an SEP on a case-by-case basis for other
unanticipated situations that involve exceptional conditions that occur
on or after January 1, 2023 at new Sec. Sec. 406.27(f) and 407.27(f).
After considering the comments we received and for the reasons outlined
in the proposed rule and our responses to comments, we are finalizing
our proposal with a modification to our proposed SEP at Sec. Sec.
406.27(e) and 407.27(e) to allow retroactive entitlement to the date of
termination of Medicaid coverage but no earlier than January 1, 2023.
[[Page 66469]]
f. SEP for Other Exceptional Conditions
We also proposed 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.
The proposed parameters of this SEP were as follows:
<bullet> At Sec. Sec. 406.27(f) and 407.23(f), we proposed to
create an SEP that 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.
<bullet> At Sec. Sec. 406.27(f)(1) and 407.23(f)(1), we proposed
that such SEPs would be granted on or after January 1, 2023, if the
individual demonstrates that conditions outside of their control caused
them to miss an enrollment period and the condition was determined
exceptional in nature.
<bullet> At Sec. Sec. 406.27(f)(2) and 407.23(f)(2), we proposed
that the SEP duration would be determined on a case-by-case basis
<bullet> At Sec. Sec. 406.27(f)(3) and 407.23(f)(3), we proposed
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.
We received the following comments on the SEP for Other Exceptional
Conditions:
Comment: Commenters expressed incredible support for the case-by-
case SEP, and many commenters included suggestions to establish new,
separate SEPs along with those discussed in the proposed regulation.
For example, some commenters urged us to expand this SEP to include
certain socio-demographic groups. Notably, a few commenters expressed
support and suggested a separate SEP for immigrants who have passed the
5-year requirement, but are under the impression that they need to wait
until citizenship before they can enroll in Medicare. This
misinterpretation inadvertently causes them to miss their IEP. The
commenter detailed that the underlying issue is a misunderstanding of
eligibility for Medicare for immigrants and a lack of notice, hence the
need for a new SEP instead of individual equitable relief.
Similarly, another commenter urged CMS to grant a new SEP, or waive
the LEP, to eligible American Indian and Alaska Native individuals if
they inadvertently miss their IEP due to the complicated nature of the
Indian health care delivery system. They cited that such an opportunity
would fall in line with the agency's commitment to improving the health
of this population and eliminate barriers to enrollment and coverage.
Response: We acknowledge and appreciate all comments received.
Under Sec. Sec. 406.20(b)(2)(ii) and Sec. Sec. 407.10(a)(2)(iii),
immigrants over age 65 can qualify for, and enroll in, premium Medicare
Part A and Part B after 5 continuous years of legal residency in the
United States. Individuals who identify as American Indian and Alaska
Native are able to seek and receive care through the Indian Health
Service (IHS). Because the IHS works closely, and often in tandem with
CMS, Medicare coverage information is readily provided to entitled
beneficiaries who interact with the system.
With this understanding, we believe there are avenues through which
individuals within these populations can receive adequate and accurate
information about Medicare eligibility and enrollment. While we are
sensitive to the conditions presented, we do not see a need to revise
our regulations or establish a new, separate specific SEP for these
groups as it is not clear to CMS that they meet the definition as
exceptional conditions and we do not have evidence that the potential
exceptional conditions impact a broad enough group of individuals to
necessitate the establishment of a specific SEP. An individual who can
present documentation to SSA that an exceptional condition that was
outside their control prevented that individual from enrolling in
Medicare may qualify for the Other Exceptional Conditions SEP on a
case-by-case basis. CMS will work with SSA to monitor the use of the
Other Exceptional Conditions SEP, and if a particular exceptional
condition that impacts a broad number of individuals becomes apparent
in that data analysis, we will consider adding additional specific SEPs
in the future.
Ultimately, we remain committed to improving education and outreach
efforts for these populations to remedy current misunderstandings,
bridge knowledge gaps, and eliminate enrollment barriers. We will
continue to partner with existing stakeholders to ensure that clear and
comprehensive information is provided to beneficiaries so they are able
to make an informed coverage choice in a timely manner. We will also
continue to evaluate the data collected on the case-by-case exceptional
conditions SEP to determine whether any issues arise that warrant the
creation of a unique exceptional conditions SEP for these populations.
Comment: A few commenters mentioned the existing SEP for
individuals serving as volunteers outside the U.S. at the time they
first become eligible for Medicare who are participating in a program
sponsored by a 501(c)(3) covering at least a year, and who demonstrate
health insurance coverage while serving in the program. Consequently,
they urged CMS to expand the existing SEP for those living abroad who
have been covered by private or national insurance, in that country and
wish to return to the U.S. and enroll in Medicare.
Response: We acknowledge and thank the commenters for their input.
Under SSA publication No. EN-05-10137,\14\ for an individual living
abroad who may be eligible for Medicare, there are generally no
restrictions from collecting Social Security benefits and enrolling in
Medicare. This applies regardless of if they return to reside in the
United States or not. Additionally, individuals who live abroad are
able to still pay their premium, if required, and be enrolled in
Medicare Part A or Part B during their IEP. Given that there are not
any exceptional conditions that prevent these individuals from
enrolling in Medicare, we do not believe that an expansion on the
current SEP, or creation of a new, separate SEP is warranted under this
circumstance. (We note that Medicare generally does not pay for
services that are not furnished within the United States. See 42 CFR
411.9.)
---------------------------------------------------------------------------
\14\ <a href="https://www.ssa.gov/pubs/EN-05-10137.pdf">https://www.ssa.gov/pubs/EN-05-10137.pdf</a>.
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Comment: Another commenter urged CMS to consider establishing an
additional SEP for individuals who have relied on coverage from the
Veterans Administration (VA). Specifically, they cited that after these
individuals missed their IEP for Medicare and realized that the VA
coverage no longer meets all of their needs, they want a new
opportunity to enroll in Part B.
Response: Veterans, like all other Medicare beneficiaries, who
receive Social Security benefits at the time they reach age 65 receive
a notice about
[[Page 66470]]
Medicare coverage, regardless of VA coverage. In addition, for those
not collecting Social Security benefits at age 65, there are a number
of resources available to those receiving VA health benefits that
advise them to enroll in Medicare on their own, or if applicable, their
spouse's record as described on pages 19 and 90 of the 2022 Medicare
and You Handbook for additional information. The guidance also explains
the resulting consequence for not filing, especially in situations
where he or she is not eligible for premium-free Part A based on their
own work record.
For these reasons, we do not concur with the need for a specific
SEP for this population. We will continue to refine awareness and
education efforts on eligibility and enrollment for this target
population to help to eliminate barriers to timely enrollment.
Comment: Another commenter suggested that CMS create a permanent,
separate SEP for individuals who were given erroneous information by an
SSA or other federal employee. They note that, while equitable relief
is typically available for such situations, SSA is not required to
reply to these requests within a specific timeframe, therefore, causing
beneficiaries to wait for months or initiate contact for a reply. The
commenter also noted that there is no formal appeal process for a
denied request.
Response: We thank the commenter for this insight, however, the SEP
is not intended to replace equitable relief available under section
1837(h) of the Social Security Act and codified at 42 CFR 407.32. There
are specific parameters for the exceptional conditions SEP, as outlined
in the proposed rule, including that the reason for the SEP must be
exceptional in nature, should not create incentive to delay enrollment
in Medicare, and is the most appropriate resolution. The equitable
relief process offers additional flexibility that goes beyond the
parameters of the exceptional conditions SEP. By providing equitable
relief, SSA has the ability to offer additional relief to enrollees
such as retroactive coverage, waived premiums, or creation of an
enrollment opportunity to essentially eliminate the effects of the
government error and meet their coverage needs. Although SSA is not
required to process equitable relief requests in a specific timeframe,
they aim to process these requests within 30 days from the time it is
assigned to a technician. Once the case is processed, the technician
notifies the enrollee, in writing, to explain the type of relief
granted or if the request for relief is denied. This timeline may be
altered due to the need for SSA to solicit additional documentation or
verify submitted documentation.
Finally, in response to the commenter's concern about the appeals
process for equitable relief. We will continue to collaborate closely
with SSA to be as transparent as possible with the equitable relief
process, and that options to enroll in Medicare remain accessible.
Comment: A commenter recommended that CMS should consider
implementing an SEP for individuals who lose Medicare coverage for
failure to pay premiums such that it can only be used twice per
beneficiary. They cited that this kind of SEP would avoid the cyclical
re-enrollment process for individuals who are unable to pay their
premiums.
Response: As discussed in the proposed rule, the scope of the
exceptional conditions SEP is intended to provide a new enrollment
opportunity and remove any penalties for late enrollment, not to
provide premium relief. CMS does not consider non-payment of premiums
for economic reasons as a primary justification for an exceptional
condition, therefore, this would not fall under the new SEP umbrella.
Non-payment of premiums could qualify though as a secondary outcome of
a major event that could qualify as an exceptional condition. Further,
when individuals do not enroll in Medicare in a timely manner, it puts
them at risk for experiencing gaps in coverage and delays in needed
health care treatment. Also, as stated in the proposed rule, if an
individual 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. For these reasons,
we will not be establishing a new, separate SEP for this condition.
Comment: A commenter recommended that SEPs be established in
Medicare Parts C and D to coordinate with the enrollment period and
effective date changes in this rule. They added that we also consider
creating a new SEP for MA-only plans for those who enroll in Part B
(and premium Part A) during the GEP.
Response: We appreciate the thought supporting this comment. The
establishment of new SEPs for Medicare Parts C and D is outside the
scope of this rule making.
Comment: Several commenters applauded our desire to use the
information and experience gained from the flexibility of this newly
established SEP to inform the creation of future SEPs. In their
support, they also suggested that we and, to the extent relevant, the
SSA track and report any trends or patterns in the use (and
limitations) of these new SEPs.
Response: We appreciate the support and recommendation. We expect
that the flexibility of this SEP will inform any changes that may be
desirable in the future. In order to provide for additional
flexibility, and reduce confusion, we are revising the duration of the
SEP to establish a minimum time period. Specifically, we are revising
Sec. Sec. 406.27(f)(2) and 407.23(f)(2) to state that the SEP duration
is determined on a case by case basis, but will be no less than 6
months.
We do plan to track trends and utilize the data from any frequently
occurring situations to help guide discussions regarding the creation
of new SEPs, which would be subject to further notice and comment
rulemaking. In regards to publicly reporting these trends, we will
consider in the future whether sharing data is appropriate and feasible
given potential beneficiary privacy concerns.
Comment: A commenter from a health plan supported our proposals,
but had some questions with regard to the logistical technicalities.
Specifically, they wanted to know how we will designate the SEP reason
codes and if they will be released as part of new CY 2023 guidance.
Another commenter also questioned if we will be making the
determinations around the exceptional conditions and how the process
will work overall.
Response: We thank the commenters for their recommendations to
clarify several factors of this new SEP. For Part C/D SEPs, health
plans are required to submit reason codes to CMS, however, as the SEPs
in this regulation are Medicare Part A/B SEPs, they will be submitted
to, and determined by, SSA and SSA will code which SEP is used for
enrollment. Health plans would have no role in this determination
process. We will continue to work alongside SSA to clarify guidelines
regarding the exceptional conditions.
We acknowledge and appreciate all of the feedback and supportive
comments we received on the proposed SEP for other exceptional
conditions. As discussed above, we will be finalizing this SEP with
modifications at Sec. Sec. 406.27(f)(2) and 407.23(f)(2) to state that
the SEP duration is determined on a case-by-case-basis, but will be no
less than 6 months.
[[Page 66471]]
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 proposed the following changes to our
regulations:
<bullet> At Sec. 406.33, we proposed 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.
<bullet> At Sec. 406.33, we specified 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.
<bullet> At Sec. 406.33(c)(1), we proposed to continue to exclude
certain months from the calculation of the LEP, based on the
requirements currently in effect under Sec. 406.33(a)(1) through (6).
<bullet> At Sec. 406.33(c)(2), we proposed to exclude additional
months from the calculation of the LEP for enrollments on or after
January 1, 2023.
<bullet> At Sec. 408.24, we proposed to revise paragraph (a) to
apply the existing Part B LEP calculation months and exceptions to
individuals who satisfy the requirements of Sec. 408.24 before January
1, 2023.
<bullet> At Sec. 408.24, we proposed to require that for
individuals who satisfy the requirements of Sec. 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.
<bullet> At Sec. 408.24(b)(1), we proposed to continue to exclude
certain months from the calculation of the LEP, consistent with the
requirements currently in effect under Sec. 408.24 (a)(1) through
(10).
<bullet> At Sec. 408.24(b)(2), we proposed to exclude additional
months from the calculation of the LEP for enrollments on or after
January 1, 2023.
<bullet> At Sec. 406.34, we proposed 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.
<bullet> At 406.34, we proposed to redesignate paragraph (e) as
paragraph (f) and add new paragraph (e) to 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.
<bullet> At Sec. 406.34(e)(2), we proposed to exclude the months
of non-coverage in accordance with an individual's use of an
exceptional condition SEP under Sec. 406.27.
<bullet> At Sec. 408.24, we proposed to amend Sec. 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 Sec. 408.24 before January 1, 2023.
<bullet> At Sec. 408.24(d), we proposed to require that for
individuals who satisfy the requirements of Sec. 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).
<bullet> At Sec. 408.24(d)(2)(i), we proposed to continue to
exclude certain months from the calculation of the LEP, consistent with
the requirements currently in effect under Sec. 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.
<bullet> At Sec. 408.24(d)(2)(ii), we proposed that if an
individual uses an exceptional condition SEP under Sec. 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.
We received a couple of comments related to the proposed technical
corrections for the LEP.
Comment: A few commenters expressed support specifically for the
proposed changes to the LEP; however, the majority of that support was
expressed in regards to how it related to the SEP proposals. Commenters
stated that the proposed changes would ease the financial burden that
Medicare premiums with added penalties can present for Medicare
beneficiaries. To further reduce financial burdens, a commenter
recommended that the LEP should reset once an individual reaches age
65.
Response: We appreciate the comments and support. We note that
under 1837(g)(1) of the Act an individual will have a new IEP for each
continuous period of Medicare eligibility as defined by section 1839(d)
of the Act and upon attainment of age 65. Therefore, if an individual
was subject to an LEP prior to attainment of age 65, the premium amount
is reset without the LEP effective with the month of attainment of age
65. In addition, no months prior to age 65 should be counted in the
calculation of a premium increase.
Based on analysis of the public comments, we will be finalizing
these technical proposals related to LEP as proposed.
B. Proposals for Extended Coverage of Immunosuppressive Drugs for
Certain Kidney Transplant Patients (Sec. Sec. 406.13, 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 \15\ 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
[[Page 66472]]
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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\15\ 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.
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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.\16\ Section 402(a) of the CAA established an exception that
permits certain beneficiaries who were 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(a) of the CAA also added 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).
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\16\ 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 <a href="https://cjasn.asnjournals.org/content/14/3/327">https://cjasn.asnjournals.org/content/14/3/327</a>.
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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 discuss the excepted individuals and the specific forms of insurance
and programs in greater detail in section II.B.2.b. of this final rule
entitled ``Determination of Eligibility'' and in this final rule at
Sec. 407.55(b). Individuals who 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 final rule, and in
this final rule at Sec. 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 proposed to revise Sec. Sec. 407.1, 408.20,
410.30, 423.30 and establish a new subpart D (Sec. Sec. 407.55 through
407.62) in 42 CFR part 407, entitled Part B Immunosuppressive Drug
Benefit to implement the new Part B-ID benefit. (We note that in
discussing these changes in the proposed rule at 87 FR 25102 we
erroneously referred to Sec. 407.65 instead of Sec. 407.62 and are
now correcting that error.)
Specifically, we proposed the following:
<bullet> At Sec. 407.1(a)(6) we proposed 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.
<bullet> At Sec. 407.1(b) we proposed to retain the language that
states that part 407 sets forth the eligibility, enrollment, and
entitlement requirements and procedures for supplementary medical
insurance at Sec. 407.1(b)(1), including the reference to the rules
governing premiums in part 408 of this chapter.
<bullet> At Sec. 407.1(b)(2), we proposed 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 benefit).
We received comments from patient advocates, associations, States,
health plans, and individuals offering broad support on our proposal to
extend coverage of immunosuppressive drugs under Medicare Part B for
eligible individuals whose benefits under Medicare based on ESRD would
otherwise end the 36th month after the month an individual receives a
kidney transplant. The comments on those proposals and our responses
follow.
Comment: Many commenters expressed that this benefit was long-
awaited and overdue, and they pointed out that the extended coverage of
these drugs would help to prevent organ rejection in the post-
transplant patient, and thus, will save lives and conserve Medicare
resources. Other commenters stated that extending coverage of
immunosuppressive drugs is clinically and economically advantageous
given the evidence of significant improvement in quality of life,
health outcomes, and cost savings on dialysis and hospitalization after
a kidney transplant. A commenter pointed out that their State currently
covers similar groups with State-only funds, but supports the creation
of the Part B-ID benefit under Medicare. The commenter stated that this
limited expansion of Medicare Part B is very worthwhile, and even
though it is quite limited in scope, it has the potential to be
lifesaving for ESRD patients.
Response: We appreciate the overwhelming support for our proposal
and thank the commenters for their feedback. We agree with commenters
that these changes are advantageous and will have a positive impact on
this population.
Several commenters supported, but had concerns or requested
clarifications about, the Part B-ID benefit, particularly about the
scope of the Part B-ID benefit. Those comments and our responses are as
follows.
Comment: A commenter stated that Congress adopted a narrowly
crafted provision that will leave some patients still facing high, and
possibly prohibitive, out-of-pocket costs, including co-insurance
costs, as well as physician and lab services, since the patient is not
allowed to have other insurance. Another commenter noted that, due to a
potential lack of insurance coverage 36 months post-transplant, some
patients have chosen not to seek a transplant due to the cost concerns
after Medicare eligibility expires. The commenter stated that while the
new benefit does not entirely address cost considerations that can
inhibit transplant, it is important that transplant professionals are
fully trained about the new benefit and that it is factored into
assessments of patients' potential stewardship of a transplanted organ.
A commenter suggested that this patient population would benefit from
continuing to receive coverage for physical therapy under Medicare, as
side effects from immunosuppressive drugs could have untoward effects
on health, including weight gain, that could result in limitation of
movement.
Response: We thank the commenters for their feedback. Section
402(a) of the CAA ensures that individuals without certain other types
of coverage whose benefits under Medicare based on ESRD would otherwise
end with the 36th month after the month in which the individual
received a kidney transplant,
[[Page 66473]]
can maintain coverage for their immunosuppressive drugs essential to
prevent rejection of their transplanted kidney. The benefit parameters
of the statute are specific, and they do not allow coverage of other
items and services. We refer the reader to section II.B.5 of this final
rule for further information on education and outreach efforts for the
implementation of the Part B-ID benefit.
We received numerous comments requesting clarification on, and
recommendations for, coverage of various dosage forms of these drugs
and other ancillary items that may be used in the post-transplant
clinical setting. Those comments and our responses follow.
Comment: Several commenters questioned if the new benefit included
coverage for compounded formulations of immunosuppressants (for
example, a liquid formulation of an immunosuppressive medication not
commercially available from the manufacturer that is prepared by a
pharmacist), and a couple of commenters added that these formulations
were frequently used in the treatment of pediatric kidney patients.
Some commenters suggested that CMS consider coverage for mineral or
electrolyte supplements, like magnesium, phosphorus, and bicarbonate
related to post-transplant care that are particularly necessary in the
care of pediatric patients. A commenter stated that transplant
physicians must have uninterrupted access to all brand name drugs when
he or she deems it necessary for a particular patient. A commenter
questioned if drugs that are not categorized as immunosuppressive
drugs, per se, such as anti-hypertensives, or drugs used for a
patient's co-morbid conditions would be covered. A couple commenters
inquired about the coverage of intramuscular (IM) and intravenous (IV)
formulations, and asked if an administration fee is included in the
Part B-ID benefit. A commenter stated that oral immunosuppressive drugs
are clinically appropriate for the great majority of transplant
recipients, but excluding coverage of the administration costs for
those recipients who do require IV or IM drugs has the potential to
impact access to an effective immunosuppressive drug regimen for
patients who have no clinically appropriate alternative.
Response: Payment may be made for prescription drugs used in
immunosuppressive therapy as described in federal regulations at 42 CFR
410.30(a). Further, Sec. 410.30(c) states that drugs are covered under
this provision irrespective of whether they can be self-administered.
The lists of formulations in the proposed rule were examples only.
Other types of formulations of immunosuppressive drugs defined in
section 1861(s)(2)(J) of the Act as described above in the Summary
section, including those that are not self-administered, would be
covered and paid under this benefit. As set forth at 42 CFR 410.30(a)
and described in Sec. 50.5.1, Chapter 15 of the Medicare Benefit
Policy Manual, covered drugs include those immunosuppressive drugs that
have been specifically labeled as such and approved for marketing by
the FDA. Drugs with indications for other conditions not described in
42 CFR 410.30(a), such as mineral deficiencies or hypertension, would
not be covered under the Part B-ID benefit. CMS does not maintain a
list of drugs covered under this benefit; rather, the Medicare
Administrative Contractors (MACs) are expected to maintain, a list of
these drugs as set out in Sec. 80.3, Chapter 17 of the Medicare Claims
Processing Manual. The MACs are expected to keep informed of U.S. Food
and Drug Administration (FDA) additions to the list of the
immunosuppressive drugs and update guidance as applicable. For
inquiries regarding specific drugs with regards to coverage under
section 1861(s)(2)(J) of the Act, individuals may contact the DME MAC
that processes the claim.
With regard to compounded formulations of immunosuppressants, such
drugs are not approved for marketing by the FDA \17\ and, therefore,
are not covered under the Part B-ID benefit. With regard to the
commenters' question if a fee is included for the administration of IM
and IV formulations under the Part B-ID benefit, as we stated above,
section 402(a) of the CAA provides that the benefits are solely for
purposes of coverage of immunosuppressant drugs described in section
1861(s)(2)(J). We do not have flexibility to include payment for the
administration of the product based on the statutory language of this
benefit, as it only includes the actual drug products.
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\17\ <a href="https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers">https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers</a>.
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Comment: A couple commenters expressed concern about whether a
beneficiary would have uninterrupted access to these drugs in the case
of a beneficiary having issues arise at the pharmacy counter. A
commenter stated that the reimbursement system must be fully in place
by the January 1, 2023 effective date, otherwise, patients will be
presented a bill or denied their prescription altogether. The commenter
also expressed concerns in the case where a pharmacy cannot verify an
individual patient's eligibility for the new benefit. A commenter
questioned how the beneficiary will be assured uninterrupted access to
their drugs in the case of data errors at the pharmacy counter. A
commenter urged CMS to make guidance and any related resources
available to stakeholders including plans, providers, and beneficiary
advocates as soon as possible given the January 1, 2023 effective date
for key provisions in the rule. The commenter stated that technical
guidance is needed to understand if and how entitlement for the Part B-
ID benefit would be reflected in the Medicare Advantage Prescription
Drug (MARx) system, and also requested that technical assistance be
provided on the transaction reply codes that will be used in the MARx
system. A commenter urged CMS to consider having a dedicated pharmacy
hotline during the first few months so that questions and concerns by
pharmacists can be resolved in real time. Commenters requested that CMS
take steps to ensure that there is a safety net, and they recommended
that CMS put in place a system that ensures access to medications while
back-end determinations of payment responsibility are sorted out.
Response: We thank the commenters for their feedback and concern.
In anticipation of the January 1, 2023 effective date for the Part B-ID
benefit, Medicare payment systems, including the Common Working File
(CWF), ViPS Medicare System (VMS), the Multi-Carrier System (MCS), and
the Federal Intermediary Standard System (FISS) are being modified to
properly process claims submitted for immunosuppressive drugs under the
Part B-ID benefit. Other entities that will assist with claims
processing, including the Medicare Part A and Part B MACs and the
Durable Medical Equipment MACs, have also been engaged in the
implementation efforts. Additionally, modifications are being made to
ensure that eligible beneficiaries are accurately recognized within
these systems. All operational and systems changes are slated to be
completed prior to the January 1, 2023 effective date. Therefore, we
expect beneficiaries' access will be uninterrupted as we implement this
new benefit.
With respect to the public comment related to the MARx system, that
system is used for beneficiary eligibility and
[[Page 66474]]
enrollment for Medicare Part C and Part D plans, and cannot be used by
pharmacy providers to verify eligibility for the Part B-ID benefit. We
do not expect that there will be a dedicated pharmacy hotline specific
to the Part B-ID benefit; however, Medicare providers, including
pharmacists and suppliers, can check patient eligibility, (as well as
billing and other pertinent information) by either utilizing their MAC
online provider portal or Interactive Voice Response (IVR) system, the
Health Insurance Portability and Accountability Act Eligibility
Transaction System (HETS), or their billing agencies, clearinghouses,
or software vendors. For further information, please see the Medicare
Learning Network instructions here: <a href="https://www.cms.gov/files/document/checking-medicare-eligibility.pdf">https://www.cms.gov/files/document/checking-medicare-eligibility.pdf</a>. If a beneficiary has an issue at the
pharmacy counter they may call 1-800-MEDICARE, and the 1-800-MEDICARE
Call Center will troubleshoot as they currently do with existing
provider access concerns. If the issue cannot be resolved, it will be
escalated to the CMS Offices of Hearings and Inquiries via the current
Ombudsman escalation process.
We note that individuals who enroll in the Part B-ID benefit will
be provided with a new Medicare card that will include the specific
language that describes the benefit. These beneficiaries will also
receive a notice with that card which provides information on the
benefit, including use of their prior and current Medicare cards, and
contact information for further questions or concerns. We plan to
educate pharmacies and other health care providers later this year on
changes related to the Part B-ID benefit patient eligibility
transaction that will reflect immunosuppressive drug coverage,
including the eligibility inquiry transaction reply. Pharmacies should
contact their MAC for claims processing technical assistance as they
currently do for other claims processing issues. Further information on
education and outreach to inform beneficiaries and stakeholders about
the Part B-ID benefit is discussed in section II.B.5 of this final
rule.
Medicare regulations do not require a pharmacist to provide minimal
amounts of immunosuppressive therapy if the beneficiary's coverage
cannot be verified; this would be up to the established process at the
individual pharmacy.
Comment: A commenter stated that the proposed rule referred to
``successful'' kidney transplantation. The commenter recommended
striking the term ``successful'' and simply stating that the new Part
B-ID benefit is extended to kidney transplant recipients.
Response: We thank the commenter for their feedback and have
removed successful from the description used in this final rule as
official eligibility criteria. The term ``successful'' in the preamble
of the proposed rule was used, generally, to describe a person whose
Medicare Part A enrollment terminated 36-months after transplant and
whose transplanted kidney functions to the point where the individual
does not need a regular course of dialysis to sustain life. If the
person's transplant was not successful, the patient would likely
require a regular course of dialysis to sustain life, and eligibility
for Medicare coverage under Part A and Part B based on ESRD would
continue.
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.
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 final 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 proposed at Sec. 407.59(a) and (b), that all
prospective enrollees in the Part B-ID benefit must provide to the
Commissioner, in either a verbal attestation or signed paper form, 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 Sec. 407.55(b).
We proposed 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
\18\ attestation form, described in Sec. 407.59 of this final 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. We also
proposed 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.
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\18\ <a href="http://Medicare.gov/forms-help-other-resources/medicare-forms">Medicare.gov/forms-help-other-resources/medicare-forms</a>.
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As mentioned previously, we proposed to establish the eligibility
criteria for the Part B-ID benefit in new Sec. 407.55, entitled
``Eligibility to enroll.'' Specifically, in Sec. 407.55(a), we
proposed
[[Page 66475]]
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 kidney transplant, as set out under revised Sec.
406.13(f)(2), and discussed in section II.B.5 of this final 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:
<bullet> 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;
<bullet> Enrolled for coverage under the TRICARE for Life program
under section 1086(d) of title 10, United States Code;
<bullet> 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);
<bullet> 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
<bullet> 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 proposed regulation text at Sec. 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.
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 described in statute. We
proposed in Sec. 407.57(d) that, to enroll in the Part B-ID benefit,
an individual must submit the required attestation as described in
Sec. 407.59. We also proposed in Sec. 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 Sec. 405.904(a)(1). This will ensure that the
beneficiary's statutory and due process rights will be adequately
protected.
We proposed to establish the provisions relating to enrollment and
the entitlement to the Part B-ID benefit in new Sec. 407.57, titled
``Part B-ID benefit enrollment.'' Specifically, we proposed at Sec.
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
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 Sec. 407.55, and provides the attestation
required in proposed Sec. 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 proposed at Sec.
407.57(b) that an individual whose Part A entitlement ends in
accordance with revised Sec. 406.13(f)(2) (as discussed in section
II.B.5. of this final rule), and who meets the Part B-ID benefit
eligibility requirements at Sec. 407.55 and provides the attestation
required in Sec. 407.59, may enroll in the Part B-ID benefit as
follows:
<bullet> 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.
<bullet> An individual whose entitlement ends on or after January
1, 2023 can enroll at any time after such entitlement ends.
We further proposed at Sec. 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 at Sec. 407.55 and
provides the attestation required in Sec. 407.59. 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 Sec. 407.55 and provides the attestation as required
under Sec. 407.59, we proposed the following entitlement dates in
Sec. 407.57(e):
<bullet> 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 Sec. 407.59 before the end of the 36th
month after the month in which they receive a kidney transplant, their
entitlement begins with the month their Part A benefits under section
226A of the Act would end.
<bullet> 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
Sec. 407.59.
<bullet> 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 proposed in new Sec. 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.
[[Page 66476]]
We proposed the following requirements related to termination of
the Part B-ID benefit:
<bullet> Under proposed Sec. 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 Sec. 407.55(b) and notifies
the Commissioner of this health coverage consistent with Sec.
407.59(b), their Part B-ID benefit would be terminated effective the
first day of the month after the month of notification.
<bullet> We proposed in Sec. 407.62(a)(1) that when an individual
enrolls in other coverage and provides notification consistent with
Sec. 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. We also proposed at Sec. 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.
<bullet> We proposed in Sec. 407.62(a)(2) that for an individual
who enrolls in the Part B-ID benefit, but who subsequently enrolls in
other health coverage as described in Sec. 407.55(b) but does not
notify SSA within 60 days consistent with Sec. 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 Sec. 407.55(b).
<bullet> We proposed in Sec. 407.62(f) that, if an individual is
involuntarily disenrolled from the Part B-ID benefit based on Sec.
407.62(a)(2), (b) or (c), they will be permitted an initial
determination appeal as outlined in Sec. 405.904(a)(1), which is
consistent with existing requirements applicable to Part B coverage.
<bullet> Consistent with existing requirements applicable to Part B
benefits at Sec. 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 proposed 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
Sec. 407.62(b).
<bullet> We proposed at Sec. 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. An
individual will receive a grace period in which overdue premiums may be
paid and coverage continued.
<bullet> We proposed at new Sec. 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.
<bullet> We proposed that an 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 Sec. 407.62(e).
We received numerous comments on our proposed requirements related
to eligibility, enrollment, effective dates of coverage, and
termination of the Part B-ID benefit. Those comments received and our
responses are as follows.
Comment: Many commenters supported CMS' approach to allow
individuals to use various methods to attest to their eligibility and
enroll in the Part B-ID benefit. A commenter stated that the options
that CMS proposed did not appear to be burdensome. Many commenters
supported the verbal attestation, citing that it was simple and
efficient, and it would avoid potential delays with signing and mailing
statements that could result in delays in accessing needed
immunosuppressive drugs. A commenter stated that a written approach
would alleviate long wait times on SSA phone lines, but supported both
verbal and written options. A commenter strongly opposed use of the
written-only option for submitting an attestation. Other commenters
recommended that CMS consider additional methods of attestation,
particularly electronic submission, fax, or other signed documents.
A commenter stated that CMS took an open-minded and forward-
thinking approach to attestation and enrollment in the Part B-ID
benefit, and they were encouraged by the Agency's expedient use of the
Executive Order (E.O.) on Transforming Federal Customer Experience and
Service Delivery to Rebuild Trust in Government. The commenter also
stated that CMS' plans for defining a suitable process and criteria for
beneficiary enrollment in the Part B-ID program is simple,
straightforward, and customer-centric.
Response: We appreciate the feedback we received on our Part B-ID
eligibility and enrollment proposals. CMS will be partnering with SSA
to employ both a verbal and written attestation process for an
individual to enroll in the Part B-ID benefit. An individual will be
able to contact SSA to verbally provide an attestation to enroll in the
Part B-ID benefit, or they can download a PDF-fillable form from the
CMS or SSA website, complete the form, and mail to SSA. If an
individual does not have internet access, an SSA representative can
download the form and mail the form to the caller to complete and mail.
At this time, forms will be accepted via U.S. mail delivery, but SSA
plans to include an option to receive completed forms via facsimile
(fax) in the future. We are also continuing to explore the future
development of an electronic process to submit the attestation. To
provide for flexibility for other attestation methods in the future, we
are revising Sec. 407.59 to state that an individual must attest to
SSA in either a verbal attestation, signed paper form provided by SSA,
by electronic submission, or fax under procedures determined by SSA.
This will give SSA the flexibility to implement a fax or electronic
attestation process in the future, when these options become available.
Comment: A commenter stated that submission of an attestation and
confirmation of an individual's eligibility will be sufficient for SSA
to enroll individuals in the Part B-ID benefit. The commenter expressed
satisfaction with CMS' plan for monitoring and oversight that will
enable it to address any concerns that may arise. Another commenter
stated that we proposed that all prospective Part B-ID beneficiaries
provide proof they lack insurance coverage of immunosuppressive drugs.
Response: In the proposed rule, we did not propose that individuals
would have to provide proof that they do not have coverage of
immunosuppressive drugs. In order for an individual to be enrolled in
the Part B-ID benefit, the statute requires that an individual submit
an attestation to SSA that they are not enrolled in, and do not expect
to enroll in, coverage under any of the specified health programs or
insurance described in law that make an individual ineligible for the
Part B-ID benefit. It also requires that the individual notify SSA
within 60 days of enrollment in the coverage described in law. We
proposed that an individual would be able to provide this attestation
verbally or in writing. We agree with the first commenter that
submission of an attestation and confirmation of an individual's
eligibility from their previous entitlement to Medicare based on ESRD
is sufficient for SSA to enroll individuals in the Part B-ID benefit.
As we stated in the proposed rule, 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
[[Page 66477]]
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.
Comment: A commenter questioned if an individual needs an SEP to
enroll in the Part B-ID benefit.
Response: Individuals do not need an SEP to enroll in the Part B-ID
benefit. Unlike Part B (or other parts of the Medicare program) where
individuals can only enroll during an enrollment period, if an
individual is eligible for the Part B-ID benefit, they can enroll at
any time and will not be subject to an LEP for months of non-coverage.
Because individuals can gain or lose health coverage throughout their
lifetime, it is important to extend flexibility to those needing
coverage of their immunosuppressive drugs.
A couple commenters provided feedback on the effective date of
coverage for the Part B-ID benefit.
Comment: A commenter stated that, in order to prevent kidney
allograft rejection and maintain kidney allograft function,
immunosuppressive drugs must be taken every day, without exception.
Therefore, it is essential that Part B-ID enrollment processes are
straightforward, the steps are efficient, and that coverage be
activated immediately upon enrollment (that is, and not the first day
of the month that follows). Another commenter stated they supported CMS
granting the Part B-ID benefit for eligible individuals in 2022.
Response: We appreciate the commenter's concern about an individual
having uninterrupted access to these important drugs. However,
enrollment in the Part B-ID benefit is a process--the individual has to
submit an attestation; then SSA needs to verify the eligibility for the
benefit and complete all operational processes established in SSA
policy for enrollment. Based on reasonable timeframes to accomplish
these actions, it would not be feasible for an individual to gain
entitlement to the Part B-ID benefit on the actual date that the
individual begins the process of enrollment. Also, Medicare coverage
across programs starts on the first of the month, and premiums are
based on a whole month of enrollment.
An eligible individual will be deemed to be enrolled in the Part B-
ID benefit if they complete a timely attestation prior to the end of
their 36th month of Medicare coverage based on ESRD, which ensures that
the individual has seamless coverage of immunosuppressive drugs. To
clarify, eligible individuals will be able to start the enrollment
process in late 2022, but the Part B-ID benefit will not be effective
until January 1, 2023.
A couple of commenters provided feedback on the proposed appeal and
re-enrollment process for the Part B-ID benefit.
Comment: A couple commenters supported that individuals should be
afforded an appeal process if their enrollment in the Part B-ID benefit
is denied or terminated. Commenters also supported the re-enrollment
option for individuals that have, and then lose, other comprehensive
coverage. A couple of commenters also supported that no late enrollment
penalties would be assessed for re-enrollment.
Response: We appreciate the support for our proposal to provide
initial determination entitlement appeals upon denial of enrollment in
or termination from the Part B-ID benefit. This ensures that the
beneficiary's statutory and due process rights will be adequately
protected. Also, we appreciate the support for our re-enrollment
policy, as we understand that individuals can come in and out of health
coverage during their lifetime. We agree that the re-enrollment option
will provide a safety net for these important drugs, without the
concern of a penalty, and we thank the commenters for their support of
the late enrollment penalty policy.
We received several comments asking for clarification as to what
individuals or groups were eligible for the Part B-ID benefit. Those
comments and responses are as follows.
Comment: A commenter questioned whether CMS misinterpreted the
statute with respect to the exception for eligibility under the new
Part B in section 1836(b)(2) of the Act. The statute expressly provides
that:
(2) EXCEPTION IF OTHER COVERAGE IS AVAILABLE.--
(A) IN GENERAL.--An individual described in paragraph (1) shall not
be eligible for enrollment in the program for purposes of coverage
described in such paragraph with respect to any period in which the
individual, as determined in accordance with subparagraph (B)--
(i) 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;
(ii) is enrolled for coverage under the TRICARE for Life program
under section 1086(d) of title 10, United States Code;
(iii) is enrolled under a State plan (or waiver of such plan) under
title XIX and is eligible to receive benefits for immunosuppressive
drugs described in this subsection under such plan (or such waiver);
(iv) is enrolled under a State child health plan (or waiver of such
plan) under title XXI and is eligible to receive benefits for such
drugs under such plan (or such waiver); or
(v)(I) is enrolled in the patient enrollment system of the
Department of Veterans Affairs established and operated under section
1705 of title 38, United States Code;
(II) is not required to enroll under section 1705 of such title to
receive immunosuppressive drugs described in this subsection; or
(III) is otherwise eligible under a provision of title 38, United
States Code, other than section 1710 of such title to receive
immunosuppressive drugs described in this subsection.
(B) ELIGIBILITY DETERMINATIONS.--
(i) IN GENERAL.--The Secretary, in coordination with the
Commissioner of Social Security, shall establish a process for
determining whether an individual described in paragraph (1) who is to
be enrolled or deemed to be enrolled in the medical insurance program
described in such paragraph meets the requirements for such enrollment
under this subsection, including the requirement that the individual
not be enrolled in other coverage as described in subparagraph (A).
The commenter suggested that, under our proposed interpretation, an
individual would not be entitled to Part B-ID even if the excepted
health plan did not expressly cover post-transplant immunosuppressive
therapy. The commenter also suggested that the statutorily identified
excepted plans may not be as robust as Medicare Part B-ID, but the
individuals would still be precluded from enrolling in Part B-ID. The
commenter stated that transplant recipients with coverage other than
Title XIX would be disadvantaged. The commenter also stated that they
doubted that is what Congress set out to do and requested that CMS
reconsider its interpretation. Another commenter stated that, for other
coverage to render a patient ineligible for the Part B-ID benefit, the
``other'' coverage must cover immunosuppressive drugs.
Response: We disagree with the commenter's suggestion that our
interpretation of the statute is incorrect. We trust that our
interpretation of the statute, as described in the proposed rule(87 FR
25104), and in this final rule, is correct because it is consistent
with
[[Page 66478]]
the plain language of the statute. If an individual has coverage that
satisfies the conditions in section 1836(b)(2)(A)(1) of the Act, that
individual is not eligible for enrollment in the Part B-ID benefit,
even if the program does not expressly include coverage for
immunosuppressive drugs. As we noted in the preamble to the proposed
rule, only some of the programs identified in section 1836(b)(2)(A) of
the Act expressly require that the patient have access to
immunosuppressive drug coverage while other programs identified in
section 1836(b)(2)(A) of the Act do not expressly require access to
immunosuppressive drug coverage.
Comment: Another commenter stated that the Part B-ID benefit was
for individuals whose Medicare eligibility has terminated after a
kidney transplant and who do not have other access to coverage of such
medication.
Response: The actual language of the statute is more precise than
the commenter's general summary. To clarify, an individual's enrollment
in any of the coverage specified under section 1836(b)(2)(A) of the Act
would make the individual ineligible for the Part B-ID benefit.
Comment: Several commenters questioned Part B-ID eligibility for
other populations/groups such as those in Indian Health Service (IHS),
those who receive State kidney disease financial assistance, and those
enrolled in programs such as a Medicaid program with limited coverage
(for example, mental health coverage only). Another commenter inquired
if enrollment in a charity program (for example, manufacturer-based
free drug programs) constitutes ``a program that covers
immunosuppressive drugs'' and questioned if it would preclude
eligibility for the new Part B-ID benefit.
Response: As noted in the response to the previous comment,
eligibility for the Part B-ID benefit is limited, but only individuals
who are covered only under one of the express statutory provisions are
excluded from eligibility. Generally, the programs that were identified
by these commenters would not prevent an individual from enrolling in
Part B-ID. Thus, if an individual only has coverage from the Indian
Health Service (IHS), State kidney disease financial assistance, or
charity/manufacturer assistance programs, the individual could still be
eligible for Part B-ID. The same is true for an individual that is only
eligible for restricted eligibility under Medicaid and CHIP, if the
limited coverage does not make the individual eligible to receive
benefits for immunosuppressive drugs.
Comment: A commenter questioned if an individual is eligible for
the Part B-ID benefit if they were not entitled to Medicare at the time
of their kidney transplant.
Response: Eligibility for the Part B-ID benefit in section 1836(b)
does not depend on whether the individual was entitled to Medicare at
the time of the kidney transplant. Instead, eligibility is based on
whether the individual's Medicare coverage under Part A ended after the
kidney transplant under section 226A(b)(2) of the Social Security Act.
Comment: A commenter requested that CMS clarify the status of the
Part B-ID benefit with regard to beneficiaries who received pre-emptive
transplants.
Response: An individual who has a pre-emptive kidney transplant,
and meets the requirements for entitlement to Medicare Part A by reason
of section 226A(b)(2),) of the Act, as outlined in at Sec. 406.13(c),
and, whose entitlement to insurance benefits under Medicare Part A ends
(whether before, on, or after January 1, 2023) by reason of section
226A(b)(2) of the Act, would be eligible for Part B-ID, as long as they
meet all other requirements for entitlement to the Part B-ID
benefit.\19\
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\19\ According to Mayo Clinic, ``A preemptive kidney transplant
is when you receive a kidney transplant before your kidney function
deteriorates to the point of needing dialysis to replace the normal
filtering function of the kidneys.''
<a href="https://www.mayoclinic.org/tests-procedures/preemptive-kidney-transplant/pyc-20384830">https://www.mayoclinic.org/tests-procedures/preemptive-kidney-transplant/pyc-20384830</a>.
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Comment: A commenter questioned if MA plans will have any role in
the coverage of Part B-ID benefits. The commenter stated it was unclear
as to whether those ESRD-eligible beneficiaries who are enrolled in MA
plans and who have no alternative sources of coverage will have the
opportunity to remain enrolled in these plans past 36 months post-
transplant solely for the purpose of obtaining immunosuppressive drug
coverage.
Response: Individuals enrolled in MA plans are not eligible for the
Part B-ID benefit. Individuals who have Medicare Part A and B,
regardless of the basis for which they are entitled to Medicare
coverage (age, disability, ESRD, etc.), can enroll in an MA plan.
However, if an individual has Medicare based on ESRD, and that
individual's Medicare entitlement ends the 36th month after the month
in which they receive a kidney transplant, they no longer have Medicare
Part A and B, and therefore, are not eligible to remain in the MA plan.
Individuals who meet all of the requirements to enroll in the Part B-ID
benefit are also not eligible to enroll in or receive immunosuppressive
drugs from an MA plan.
3. Ensuring Coverage Under the Medicare Savings Programs
The MSPs includes three primary \20\ 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 3 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 Medicare 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,
many States have elected to implement income and/or resource
methodologies that are more generous than the federal baselines for
QMB, SLMB, and QI.
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\20\ 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.
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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
[[Page 66479]]
for enrollment in QMB, SLMB, or QI eligibility groups 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
proposed to codify this expansion of MSPs to apply to the Part B-ID
benefit at new Sec. 435.123.
Under sections 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)
provide an attestation to SSA 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 focused our discussion on the second path for MSP Part B-ID
enrollment, noting our aim of promoting continuity of coverage for
individuals who are enrolled in an MSP eligibility group and whose
Medicare eligibility based on ESRD is ending and that multiple
variables can affect whether an individual can seamlessly transition to
the MSP Part B-ID benefit.
In the proposed rule (87 FR 25107), we confirmed that loss of
Medicare entitlement based on ESRD status constitutes a change in
circumstances that may affect ongoing Medicaid eligibility.
Accordingly, we stated that, under Sec. 435.916(d)(1), State Medicaid
agencies are required to promptly redetermine an individual's
eligibility for Medicaid whenever it receives information about an
individual's loss of Medicare entitlement based on ESRD status.
We explained that individuals who remain or are determined eligible
for full-benefit Medicaid after this redetermination process 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, we explained that 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 Sec. 435.4 in accordance with Sec.
435.1200(e), as required under Sec. 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 credits (APTCs), cost sharing reductions (CSRs) or
both as described in Sec. 435.4. We also encouraged States to inform
individuals who do not qualify for full-benefit Medicaid or the
Exchange with either APTCs or CSRs of the MSP Part B-ID benefit as part
of the redetermination process. Specifically, States can refer
individuals to engage with SSA, State Health Insurance Assistance
Programs (SHIPs), and beneficiary advocacy groups, among others, to
obtain information about the Part B-ID benefit.
In order to prevent gaps in coverage of critical immunosuppressive
medication when individuals transition off Medicare entitlement based
on ESRD status, for partial-benefit Medicaid benefic
[…truncated; see source link]Indexed from Federal Register on November 3, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.