[Federal Register Volume 89, Number 151 (Tuesday, August 6, 2024)]
[Rules and Regulations]
[Pages 63825-63828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-17024]
[[Page 63825]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 417, 422, 423, and 460
[CMS-4201-F4 and CMS-4205-F3]
RIN 0938-AV24 and 0938-AU96
Medicare Program; Changes to the Medicare Advantage and the
Medicare Prescription Drug Benefit Program for Contract Year 2024--
Remaining Provisions and Contract Year 2025 Policy and Technical
Changes to the Medicare Advantage Program, Medicare Prescription Drug
Benefit Program, Medicare Cost Plan Program, and Programs of All-
Inclusive Care for the Elderly (PACE); Correcting Amendment
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Final rule; correcting amendment.
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SUMMARY: This document corrects technical and typographical errors in
the final rule that appeared in the April 23, 2024 Federal Register
titled ``Medicare Program; Changes to the Medicare Advantage and the
Medicare Prescription Drug Benefit Program for Contract Year 2024--
Remaining Provisions and Contract Year 2025 Policy and Technical
Changes to the Medicare Advantage Program, Medicare Prescription Drug
Benefit Program, Medicare Cost Plan Program, and Programs of All-
Inclusive Care for the Elderly (PACE).'' The effective date of the
final rule was June 3, 2024.
DATES: This correcting amendment is effective August 6, 2024.
FOR FURTHER INFORMATION CONTACT:
Carly Medosch, (410) 786-8633--General Questions.
Naseem Tarmohamed, (410) 786-0814--Part C and Cost Plan Issues.
Lucia Patrone, (410) 786-8621--Part D Issues.
Kristy Nishimoto, (206) 615-2367--Beneficiary Enrollment and Appeal
Issues.
Kelley Ordonio, (410) 786-3453--Parts C and D Payment Issues.
Hunter Coohill, (720) 853-2804--Enforcement Issues.
Lauren Brandow, (410) 786-9765--PACE Issues.
Sara Klotz, (410) 786-1984--D-SNP Issues.
Joe Strazzire, (410) 786-2775--RADV Audit Appeals Issues.
[email protected]--Parts C and D Star Ratings
Issues.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. FR 2024-07105 of April 23, 2024 (89 FR 30448), the final
rule titled ``Medicare Program; Changes to the Medicare Advantage and
the Medicare Prescription Drug Benefit Program for Contract Year 2024--
Remaining Provisions and Contract Year 2025 Policy and Technical
Changes to the Medicare Advantage Program, Medicare Prescription Drug
Benefit Program, Medicare Cost Plan Program, and Programs of All-
Inclusive Care for the Elderly (PACE)'', there were several
typographical and technical errors that are identified and corrected in
this correcting amendment.
II. Summary of Errors
A. Summary of Errors in the Preamble
On page 30448, we inadvertently omitted the applicability date
specific to the Programs of All-inclusive Care for the Elderly (PACE)
Past Performance (Sec. Sec. 460.18 and 460.19) provisions.
On page 30524, we erroneously included language regarding a
proposed provision that was not being finalized.
On page 30626, in Table FC-2, we made a technical error in a value
presented in Table FC-2.
On page 30712, we are correcting an inadvertent error in a
reference.
On page 30766, we inadvertently omitted language regarding the
changes being finalized in Sec. 460.120(g).
On page 30797 and 30798, we made a few typographical errors in
Table J9.
B. Summary of Errors in the Regulations Text
On pages 30816, 30818, 30819, 30829, 30831, and 30832, we are
correcting typographical and technical errors in the amendatory
instructions by setting forth amendatory instructions, regulations text
or both for Sec. Sec. 422.74(d)(4)(i), 422.102(f)(4), 422.116(f)(1),
422.2274(c)(13),\1\ 423.44(d)(2)(iii) through (viii), and 423.100.
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\1\ CMS acknowledges that certain changes to its agent-broker
compensation regulations, which were finalized as part of the April
2024 final rule, are the subject of pending litigation. On July 3,
2024, the U.S. District Court for the Northern District of Texas
issued nationwide preliminary injunctions in Americans for
Beneficiary Choice v. HHS, No. 4:24-cv-00439, and Council for
Medicare Choice v. HHS, No. 4:24-cv-00446, which enjoined the
implementation of the changes to Sec. Sec. 422.2274(a), (c), (d),
and (e) and 423.2274(a), (c), (d), (e). For additional guidance,
please see the July 18, 2024 HPMS memorandum, ``Updated: Contract
Year 2025 Agent and Broker Compensation Rates, Submissions, and
Training and Testing Requirements,'' available at https://www.cms.gov/about-cms/information-systems/hpms/hpms-memos-archive-weekly/hpms-memos-wk-3-july-15-19.
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On page 30818, we are also correcting a typographical error in the
paragraph reference in Sec. 422.102(f)(4)(iii)(B).
On page 30828, we are correcting typographical and technical errors
in the regulations text of Sec. 422.2267(e)(34).
On pages 30837 and 30839, we are correcting typographical errors in
the numbering of paragraphs in Sec. Sec. 423.501 and 423.522,
respectively.
On page 30841, we are correcting typographical errors in the
regulations text of Sec. 423.584.
On page 30843, we are correcting the inadvertent omission of Sec.
460.12(b)(3) in the regulations text.
On page 30848, in the regulations text for Sec. 460.120(h)(4), we
are correcting a technical error in referencing other applicable
requirements.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA),
the agency is required to publish a notice of the proposed rule in the
Federal Register before the provisions of a rule take effect.
Specifically, 5 U.S.C. 553 requires the agency to publish a notice of
the proposed rule in the Federal Register that includes a reference to
the legal authority under which the rule is proposed, and the terms and
substance of the proposed rule or a description of the subjects and
issues involved. Further, 5 U.S.C. 553 requires the agency to give
interested parties the opportunity to participate in the rulemaking
through public comment on a proposed rule. Similarly, section
1871(b)(1) of the Act requires the Secretary to provide for notice of
the proposed rule in the Federal Register and provide a period of not
less than 60 days for public comment for rulemaking to carry out the
administration of the Medicare program under title XVIII of the Act. In
addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of
the Social Security Act (the Act) mandate a 30-day delay in effective
date after issuance or publication of a rule. Sections 553(b)(B) and
553(d)(3) of the APA provide for exceptions from the notice and comment
and delay in effective date APA requirements. In cases in which these
exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the
Act, also provide exceptions from the notice and 60-day comment period
and delay in effective date requirements of the Act. Section
[[Page 63826]]
553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an
agency to dispense with normal rulemaking requirements for good cause
if the agency makes a finding that the notice and comment process are
impracticable, unnecessary, or contrary to the public interest. In
addition, both section 553(d)(3) of the APA and section
1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay
in effective date where such delay is contrary to the public interest
and an agency includes a statement of support.
We believe that this correcting amendment does not constitute a
rule that would be subject to the notice and comment or delayed
effective date requirements of the APA or section 1871 of the Act. This
correcting amendment corrects typographical and technical errors in the
preamble and regulatory text of the final rule but does not make
substantive changes to the policies that were adopted in the final
rule. As a result, this correcting amendment is intended to ensure that
the information in the final rule accurately reflects the policies
adopted in that final rule.
In addition, even if this were a rule to which the notice and
comment procedures and delayed effective date requirements applied, we
find that there is good cause to waive such requirements. Undertaking
further notice and comment procedures to incorporate the regulatory
text correction in this document into the final rule or delaying the
effective date would be unnecessary, as we are not altering our
policies or regulatory changes, but rather, we are simply implementing
the policies and regulatory changes that we previously proposed,
requested comment on, and subsequently finalized.
This final rule correcting amendment is intended solely to ensure
that the final rule and the Code of Federal Regulations (CFR)
accurately reflect policies and regulatory changes that have been
adopted through rulemaking. Furthermore, such notice and comment
procedures would be contrary to the public interest because it is in
the public's interest to ensure that the final rule accurately reflects
our policies and regulatory changes. Therefore, we believe we have good
cause to waive the notice and comment and effective date requirements.
IV. Correction of Errors
In FR Doc. FR 2024-07105 of April 23, 2024 (89 FR 30448), make the
following corrections:
A. Corrections to the Preamble
1. On page 30448, second column, first full paragraph (continuation
of the Applicability Dates), last line, the paragraph is corrected by
adding the following sentence:
``The PACE Past Performance provisions at Sec. Sec. 460.18 and
460.19 are applicable to PACE applications submitted beginning January
1, 2025.''.
2. On page 30524, second column, first full paragraph, lines 21-25,
the phrase ``electronic health record. See section III.L.5. of this
final rule for a discussion of our proposals to enable more widespread
access to RTBTs through the adoption of a standard.'' is corrected to
read ``electronic health record.''.
3. On page 30626, lower half of the page, in the table titled
``TABLE FC-2: EXAMPLE AGENT BROKER COMPENSATION UPDATES CY 2024-2026,''
third column, last row, the figure ``$313'' is corrected to read
``$363''.
4. On page 30712, third column, first partial paragraph, line 15,
the reference ``May 2020 final rule'' is corrected to read ``June 2020
final rule''.
5. On page 30766, first column, the fourth full paragraph, last
line, the phrase ``without modification.'' is corrected to read
``without modification to the requirement. Additionally, we reorganized
some introductory language at Sec. 460.120(g), (g)(1), and (g)(2) to
reduce repetitive language that did not affect the substance of the
requirements.''.
6. On page 30797, in the table titled ``TABLE J9: SUMMARY OF ANNUAL
INFORMATION COLLECTION REQUIREMENTS AND BURDEN *'', fourth column, last
row, the ``-'' is corrected to read ``1,000,000 Enrollees''.
7. On page 30798, in the table titled ``TABLE J9: SUMMARY OF ANNUAL
INFORMATION COLLECTION REQUIREMENTS AND BURDEN *'', fourth column, last
row, the figure ``3474836'' is corrected to read ``4,474,836''.
List of Subjects
42 CFR Part 417
Administrative practice and procedure, Grant programs--health,
Health care, Health Insurance, Health maintenance organizations (HMO),
Loan programs--health Medicare, and Reporting and recordkeeping
requirements.
42 CFR Part 422
Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Medicare, Penalties, Privacy,
Reporting and recordkeeping requirements.
42 CFR Part 423
Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Medicare, Penalties, Privacy,
Reporting and recordkeeping requirements.
42 CFR Part 460
Aged, Citizenship and naturalization, Civil rights, Health, Health
care, Health records, Individuals with disabilities, Medicaid,
Medicare, Religious discrimination, Reporting and recordkeeping
requirements, Sex discrimination.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services amends 42 CFR Chapter IV as set forth below.
PART 422--MEDICARE ADVANTAGE PROGRAM
0
1. The authority citation for part 422 is revised to read as follows:
Authority: 42 U.S.C. 1302, 1306, 1395w-21 through 1395w-28, and
1395hh.
0
2. Section 422.74 is amended by revising paragraph (d)(4)(i) to read as
follows:
Sec. 422.74 Disenrollment by the MA organization.
* * * * *
(d) * * *
(4) * * *
(i) Basis for disenrollment. Unless continuation of enrollment is
elected under Sec. 422.54, the MA organization must disenroll an
individual, and must document the basis for such action, if the MA
organization establishes, on the basis of a written statement from the
individual or other evidence acceptable to CMS, that the individual has
permanently moved--
(A) Out of the MA plan's service area or is incarcerated as
specified in paragraph (d)(4)(v) of this section.
(B) From the residence in which the individual resided at the time
of enrollment in the MA plan to an area outside the MA plan's service
area, for those individuals who enrolled in the MA plan under the
eligibility requirements at Sec. 422.50(a)(3)(ii) or (a)(4).
* * * * *
0
3. Section 422.102 is amended by adding paragraph (f)(4) to read as
follows:
Sec. 422.102 Supplemental benefits.
* * * * *
(f) * * *
[[Page 63827]]
(4) Plan responsibilities. An MA plan offering SSBCI must do all of
the following:
(i) Have written policies for determining enrollee eligibility and
must document its determination that an enrollee is a chronically ill
enrollee based on the definition in paragraph (f)(1)(i) of this
section.
(ii) Make information and documentation related to determining
enrollee eligibility available to CMS upon request.
(iii)(A) Have and apply written policies based on objective
criteria for determining a chronically ill enrollee's eligibility to
receive a particular SSBCI; and
(B) Document the written policies specified in paragraph
(f)(4)(iii)(A) of this section and the objective criteria on which the
written policies are based.
(iv) Document each eligibility determination for an enrollee,
whether eligible or ineligible, to receive a specific SSBCI and make
this information available to CMS upon request.
(v) Maintain without modification, as it relates to an SSBCI,
evidentiary standards for a specific enrollee to be determined eligible
for a particular SSBCI, or the specific objective criteria used by a
plan as part of SSBCI eligibility determinations for the full coverage
year.
* * * * *
0
4. Section 422.116 is amended by revising paragraph (f)(1) to read as
follows:
Sec. 422.116 Network adequacy.
* * * * *
(f) * * *
(1) An MA plan may request an exception to network adequacy
criteria in paragraphs (b) through (e) of this section when either
paragraph (f)(1)(i) or (ii) of this section is met:
(i)(A) Certain providers or facilities are not available for the MA
plan to meet the network adequacy criteria as shown in the Provider
Supply file for the year for a given county and specialty type; and
(B) The MA plan has contracted with other providers and facilities
that may be located beyond the limits in the time and distance
criteria, but are currently available and accessible to most enrollees,
consistent with the local pattern of care.
(ii)(A) A facility-based Institutional-Special Needs Plan (I-SNP)
is unable to contract with certain specialty types required under Sec.
422.116(b) because of the way enrollees in facility-based I-SNPs
receive care; or
(B) A facility-based I-SNP provides sufficient and adequate access
to basic benefits through additional telehealth benefits (in compliance
with Sec. 422.135) when using telehealth providers of the specialties
listed in paragraph (d)(5) of this section in place of in-person
providers to fulfill network adequacy standards in paragraphs (b)
through (e) of this section.
* * * * *
0
5. Section 422.2267 is amended by revising paragraph (e)(34) to read as
follows:
Sec. 422.2267 Required materials and content.
* * * * *
(e) * * *
(34) SSBCI disclaimer. This is model content and must be used by MA
organizations that offer CMS-approved SSBCI as specified in Sec.
422.102(f). In the SSBCI disclaimer, MA organizations must include the
information required in paragraphs (i) through (iii) of this section.
MA organizations must do all of the following:
(i) Convey the benefits mentioned are a part of special
supplemental benefits.
(ii) List the chronic condition(s) the enrollee must have to be
eligible for the SSBCI offered by the applicable MA plan(s), in
accordance with the following requirements.
(A) The following applies when only one type of SSBCI is mentioned:
(1) If the number of condition(s) is five or fewer, then list all
condition(s).
(2) If the number of conditions is more than five, then list the
top five conditions, as determined by the MA organization, and convey
that there are other eligible conditions not listed.
(B) The following applies when multiple types of SSBCI are
mentioned:
(1) If the number of condition(s) is five or fewer, then list all
condition(s), and if relevant, state that these conditions may not
apply to all types of SSBCI mentioned.
(2) If the number of conditions is more than five, then list the
top five conditions, as determined by the MA organization, for which
one or more listed SSBCI is available, and convey that there are other
eligible conditions not listed.
(iii) Convey that even if the enrollee has a listed chronic
condition, the enrollee will not necessarily receive the benefit
because coverage of the item or service depends on the enrollee being a
``chronically ill enrollee'' as defined in Sec. 422.102(f)(1)(i)(A)
and on the applicable MA plan's coverage criteria for a specific SSBCI
required by Sec. 422.102(f)(4).
(iv) Meet the following requirements for the SSBCI disclaimer in
ads:
(A) For television, online, social media, radio, or other voice-
based ads, either read the disclaimer at the same pace as, or display
the disclaimer in the same font size as, the advertised phone number or
other contact information.
(B) For outdoor advertising (as defined in Sec. 422.2260), display
the disclaimer in the same font size as the advertised phone number or
other contact information.
(v) Include the SSBCI disclaimer in all marketing and
communications materials that mention SSBCI.
* * * * *
0
6. Section 422.2274 is amended by adding paragraph (c)(13) to read as
follows:
Sec. 422.2274 Agent, broker, and other third-party requirements.
* * * * *
(c) * * *
(13) Beginning with contract year 2025, ensure that no provision of
a contract with an agent, broker, or other TPMO has a direct or
indirect effect of creating an incentive that would reasonably be
expected to inhibit an agent or broker's ability to objectively assess
and recommend which plan best fits the health care needs of a
beneficiary.
* * * * *
PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
0
7. The authority citation for part 423 continues to read as follows:
Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152,
and 1395hh.
0
8. Section 423.44 is amended by revising paragraphs (d)(2)(iii) through
(viii) to read as follows:
Sec. 423.44 Involuntary disenrollment from Part D coverage.
* * * * *
(d) * * *
(2) * * *
(iii) Effort to resolve the problem. The PDP sponsor must make a
serious effort to resolve the problems presented by the individual,
including providing reasonable accommodations, as determined by CMS,
for individuals with mental or cognitive conditions, including mental
illness, Alzheimer's disease, and developmental disabilities. In
addition, the PDP sponsor must inform the individual of the right to
use the PDP's grievance procedures, through the notices described in
paragraph (d)(2)(viii) of this section. The individual has a right to
submit any
[[Page 63828]]
information or explanation that he or she may wish to the PDP.
(iv) Documentation. The PDP sponsor--
(A) Must document the enrollee's behavior, its own efforts to
resolve any problems, as described in paragraph (d)(2)(iii) of this
section, and any extenuating circumstances;
(B) May request from CMS the ability to decline future enrollment
by the individual; and
(C) Must submit the following:
(1) The information specified in paragraph (d)(2)(iv)(A) of this
section.
(2) Any documentation received by the individual to CMS.
(3) Dated copies of the notices required in paragraph (d)(2)(viii)
of this section.
(v) CMS review of the proposed disenrollment. CMS reviews the
information submitted by the PDP sponsor and any information submitted
by the individual (which the PDP sponsor has submitted to CMS) to
determine if the PDP sponsor has fulfilled the requirements to request
disenrollment for disruptive behavior. If the PDP sponsor has fulfilled
the necessary requirements, CMS reviews the information and make a
decision to approve or deny the request for disenrollment, including
conditions on future enrollment, within 20 working days. During the
review, CMS ensures that staff with appropriate clinical or medical
expertise reviews the case before making a final decision. The PDP
sponsor is required to provide a reasonable accommodation, as
determined by CMS, for the individual in exceptional circumstances that
CMS deems necessary. CMS notifies the PDP sponsor within 5 working days
after making its decision.
(vi) Exception for fallback prescription drug plans. CMS reserves
the right to deny a request from a fallback prescription drug plan as
defined in Sec. 423.855 to disenroll an individual for disruptive
behavior.
(vii) Effective date of disenrollment. If CMS permits a PDP to
disenroll an individual for disruptive behavior, the termination is
effective the first day of the calendar month after the month in which
the PDP gives the individual written notice of the disenrollment that
meets the requirements set forth in paragraph (c) of this section.
(viii) Required notices. The PDP sponsor must provide the
individual two notices prior to submitting the request for
disenrollment to CMS.
(A) The first notice, the advance notice, informs the member that
continued disruptive behavior could lead to involuntary disenrollment
and provides the individual an opportunity to cease the behavior in
order to avoid the disenrollment action.
(1) If the disruptive behavior ceases after the member receives the
advance notice and then later resumes, the sponsor must begin the
process again.
(2) The sponsor must wait at least 30 days after sending the
advance notice before sending the second notice, during which 30-day
period the individual has the opportunity to cease their behavior.
(B) The second notice, the notice of intent to request CMS
permission to disenroll the member, notifies the member that the PDP
sponsor requests CMS permission to involuntarily disenroll the member.
(1) This notice must be provided prior to submission of the request
to CMS.
(2) These notices are in addition to the disenrollment submission
notice required under Sec. 423.44(c).
* * * * *
0
9. Section 423.100 is amended by revising the definition of ``Affected
enrollee'' to read as follows:
Sec. 423.100 Definitions.
* * * * *
Affected enrollee, as used in this subpart, means a Part D enrollee
who is currently taking a covered Part D drug that is subject to a
negative formulary change that affects the Part D enrollee's access to
the drug during the current plan year.
* * * * *
Sec. 423.501 [Amended]
0
10. Section 423.501 is amended in the definition of ``Final settlement
process'' by--
0
a. Removing paragraph (4);
0
b. Redesignating paragraph (5) as (paragraph (4);
0
c. In newly redesignated paragraph (4), removing the phrase ``Takes
final actions'' and adding in its place the phrase ``Takes action''.
Sec. 423.522 [Amended]
0
11. Section 423.522 is amended by--
0
a. Removing paragraphs (c) and (d); and
0
b. Redesignating paragraphs (e) and (f) as paragraphs (c) and (d).
Sec. 423.584 [Amended]
0
12. Section 423.584 is amended by--
0
a. In paragraph (b) introductory text, removing the phrase ``request
for redetermination'' and adding in its place the phrase ``request for
a redetermination''.
0
b. In paragraph (b)(4), removing the phrase ``specified the Part D''
and adding in its place the phrase ``specified in the Part D''.
PART 460--PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
0
13. The authority citation for part 460 continues to read as follows:
Authority: 42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f).
0
14. Section 460.12 is amended by adding paragraph (b)(3) to read as
follows:
Sec. 460.12 Application requirements.
* * * * *
(b) * * *
(3) Any PACE application that does not include a signed and dated
State assurances document that includes accurate service area
information and the physical address of the PACE center, as applicable,
is considered incomplete and invalid and will not be evaluated by CMS.
* * * * *
Sec. 460.120 [Amended]
0
15. Section 460.120 is amended in paragraph (h)(4) by removing the
phrase ``for paragraphs (h)(1) through (3) of this section.'' and
adding in its place the phrase ``for complying with all other
requirements of this section.''
Elizabeth J. Gramling,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2024-17024 Filed 8-5-24; 8:45 am]
BILLING CODE 4120-01-P