[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