[Federal Register Volume 90, Number 94 (Friday, May 16, 2025)]
[Rules and Regulations]
[Pages 20801-20808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08676]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 401, 405, 410, 411, 414, 423, 424, 425, 427, 428, and
491
[CMS-1807-F2 and CMS-4204-F3]
RINs 0938-AV33 and 0938-AV16
Medicare and Medicaid Programs; CY 2025 Payment Policies Under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements;
Medicare Prescription Drug Inflation Rebate Program; and Medicare
Overpayments; and Appeal Rights for Certain Changes in Patient Status;
Corrections and Correcting Amendment
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Final rules; corrections and correcting amendment.
-----------------------------------------------------------------------
SUMMARY: This document corrects technical and typographical errors in
the final rule that appeared in the December 9, 2024 Federal Register
titled ``Medicare and Medicaid Programs; CY 2025 Payment Policies under
the Physician Fee Schedule and Other Changes to Part B Payment and
Coverage Policies; Medicare Shared Savings Program Requirements;
Medicare Prescription Drug Inflation Rebate Program; and Medicare
Overpayments'' (hereinafter referred to as the ``CY 2025 PFS final
rule''). The effective date was January 1, 2025. It also corrects a
technical error in the final rule correcting amendment that appeared in
the December 30, 2024, Federal Register titled ``Medicare Program:
Appeal Rights for Certain Changes in Patient Status and Changes to the
Medicare Claims and Medicare Prescription Drug Coverage Determination
Appeals Procedures; Correcting Amendment''.
DATES:
Effective date: The corrections and correcting amendment are
effective May 16, 2025.
Applicability date: The CY 2025 PFS final rule corrections
indicated in this document are applicable beginning January 1, 2025.
FOR FURTHER INFORMATION CONTACT:
[email protected], for any issues not identified
below. Please indicate the specific issue in the subject line of the
email.
[email protected], for the following issues:
digital mental health treatment (DMHT), certification of therapy plans
of care with a physician or NPP order, telehealth, continuous glucose
monitoring, and estimated impacts by specialty.
Michele Franklin, (410) 786-9226, or [email protected] for issues
related to RHC payments.
Sabrina Ahmed, (410) 786-7499, or [email protected],
for issues related to the Medicare Shared Savings Program (Shared
Savings Program) Quality performance standard and quality reporting
requirements.
Janae James, (410) 786-0801, or [email protected],
for issues related to Shared Savings Program benchmarking methodology.
Rachel Radzyner, (410) 786-8215 for issues related to Part B for
preventive services, including payment for COVID-19 vaccination.
Elisabeth Daniel, (667) 290-8793, for issues related to the
Medicare Prescription Drug Inflation Rebate Program.
Amy Gruber, (410) 786-1542, for issues related to low titer O+
whole blood transfusion therapy during ground ambulance transport.
Trevey Davis, (667) 290-8527, for issues related to Alternative
Payment Models (APMs).
Aucha Prachanronarong, (410) 786-1879, for inquiries related to the
Merit-based Incentive Payment System (MIPS) track of the Quality
Payment Program.
Kristy Nishimoto, (206) 615-2367, for issues related to the Appeal
Rights for Certain Changes in Patient Status.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2024-25382 of December 9, 2024, the CY 2025 PFS final
rule (89 FR 97710), there were technical and typographical errors that
are identified and corrected in this correcting amendment. These
corrections are applicable as if they had been included in the CY 2025
PFS final rule, which was effective January 1, 2025.
In FR Doc. 2024-31146 of December 30, 2024 (89 FR 106362), in the
final rule correcting amendment titled ``Medicare Program: Appeal
Rights for Certain Changes in Patient Status and Changes to the
Medicare Claims and Medicare Prescription Drug Coverage Determination
Appeals Procedures; Correcting Amendment'' (hereinafter referred to as
the Medicare Appeals Correcting Amendment) there is a technical error
associated with the amendatory instructions for regulation text that is
identified and corrected in this correcting amendment. The Medicare
Appeals Correcting Amendment corrected errors in the October 15, 2024
final rule (89 FR 83240).
II. Summary of Errors
A. Summary of Errors in the CY 2025 Physician Fee Schedule Final Rule
1. Summary of Errors in the Preamble
On page 97767, we inadvertently made a typographical error in the
2025 Facility Fee for Q3014.
On page 97804, we inadvertently mischaracterized a public comment
submitted in response to the CY 2025 PFS proposed rule (89 FR 61596).
On page 97913, we made a typographical error in the preamble in
referring to a section of Pub. 100-02, chapter 15.
On page 97917, we inadvertently made a typographical error in
response to a public comment.
On page 97925, we inadvertently included a reference to the ``FD&C
Act''.
On page 97927, we inadvertently mischaracterized State authority as
State ``prescriptive authority''.
On page 98078, we inadvertently provided an incomplete and
incorrect description of the monthly dosing intervals for
Sublocade[supreg] and Brixadi[supreg].
On page 98103, we inadvertently included an incorrect description
of the number of measures for performance year 2025 under our proposal
to adopt the APP Plus quality measure set and after the CMS Web
Interface sunsets, compared to the number of measures reported in
performance year 2024.
On page 98113, we inadvertently made an error in the description of
the heading in the final regulation text at 42 CFR 425.512(a)(7).
On page 98118, we inadvertently included an incorrect Quality # for
the Controlling High Blood Pressure measure.
On pages, 98119, 98121, 98128, 98129, 98130, and 98131 we
inadvertently included a former measure title for Quality #: 001.
[[Page 20802]]
On pages 98128 and 98164, we made typographical errors in table
numbers.
On page 98217, we inadvertently made typographical errors.
On page 98229, we inadvertently made a typographical error in the
discussion of the proposed policies for the Medicare Part B Drug
Inflation Rebate Program.
On page 98244, we inadvertently stated the term for ``Billing and
payment code FDA approval or licensure date'' is defined in the
regulations text at Sec. 427.302(c).
On page 98248, 98253, 98258, 98263, 98264, 98265, 98266, 98268,
98271, 98296, 98306, 98307, and 98308, we made technical errors in
section references.
On page 98251, we inadvertently included language indicating we
proposed to codify a policy at Sec. 427.303(b)(4) and inadvertently
made a typographical error.
On pages 98257, 98261, 98262, 98298, and 98301, we inadvertently
made technical errors in table references.
On page 98262, we inadvertently omitted language from an
explanation about ``Example 1'' in Table 59 due to a drafting error.
On page 98266, we inadvertently made technical errors in the
discussion of the statutory preclusion of administrative or judicial
review on the determination of units.
On page 98269, we inadvertently omitted a section reference and
made a technical error in the discussion of the reconciliation process.
On page 98278, we inadvertently made a typographical error in our
comment response regarding the definitions of ``line extension'' and
``new formulation''.
On page 98278, we inadvertently made technical errors in
terminology in our discussion of the calculation of the total Part D
drug rebate amount.
On page 98279, we inadvertently made a technical error in
terminology to the section heading and text in our discussion of the
calculation of the per unit Part D drug rebate amount.
On page 98284, we inadvertently made a typographical error in our
comment response regarding how CMS will determine whether an NDC-9
represents a new NDC-9 of a Part D rebatable drug.
On page 98287, we inadvertently made a technical error in
terminology in our discussion of the calculation of the inflation
adjusted payment amount and situations in which manufacturers do not
report units to the Medicaid Drug Rebate Program.
On page 98306, we inadvertently made a typographical error in our
discussion of the Preliminary Rebate Report.
On page 98308, we inadvertently made a typographical error in our
discussion of the multi-step process to provide each manufacturer of a
Part D rebatable drug with a reconciled rebate amount on a regular
basis.
On page 98310, we inadvertently made errors in several section
references and a technical error in terminology used in our discussion
of data elements included in Rebate Reports.
On page 98311, we inadvertently made a typographical error in our
discussion of Rebate Reports for the applicable periods beginning
October 1, 2022, and October 1, 2023.
On page 98312, we inadvertently made a typographical error in our
discussion of severability.
On page 98332, we inadvertently made a typographical error.
On pages 98358, 98366, 98367, 98368, 98369, and 98370, we
inadvertently included a former measure title for Quality #001.
On pages 98369, 98370, and 98371, we inadvertently omitted
previously finalized and available measure collection types.
On page 98408, in Table 75, we inadvertently made a typographical
error regarding the previously established and finalized Case Minima
for the Total Per Capita Cost measure.
On page 98434, we inadvertently included a measure that was
finalized for removal starting in the CY 2025 performance period.
On pages 98468 and 98469, we inadvertently made typographical
errors in our discussion of the estimate of total annual burden for the
ICR for rebate reduction requests and for rebate reduction extension
requests.
On page 98474, we inadvertently reference a measure by its former
title.
On page 98479, in Table 96, we inadvertently made typographical
errors referencing MIPS quality measure counts and in a column header
and in the number of MIPS CQMs specifications removed for CY 2025.
On page 98493, we inadvertently made several technical errors in
the Quality Payment Program row (second row) and the TOTAL row (fourth
row) of Table 107, which summarized the annual burden estimates of the
finalized provisions subject to the Paperwork Reduction Act of 1995.
While two figures are incorrect in the sixth and eighth columns in the
second row, they were set forth correctly on pages 98470, 98472, and
98547 in the CY 2025 PFS final rule. The figures reflecting the totals
of the third, fourth, sixth, and eighth columns of the fourth row are
incorrect.
On page 98494, we inadvertently made a typographical error in our
discussion of the inflation rebate provisions for purposes of the
regulatory impact analysis.
On page 98495, we inadvertently made a typographical error in the
summary discussion of the effective date of the removal of RHCs
productivity standards.
On page 98508, we inadvertently neglected to update the expected
percentage changes in total RVUs per practitioner to reflect the public
use file published with the CY 2025 PFS final rule.
On page 98518, we inadvertently made a typographical error in our
regulatory impact analysis discussion of the effective date of the
removal of RHCs productivity standards.
On page 98528, we inadvertently made a typographical error in our
discussion of the inflation rebate provisions for purposes of the
regulatory impact analysis.
On pages 98547 and 98548, regarding incremental estimated burden
from associated final policies set forth in Table 128, we inadvertently
included duplicative rows containing incorrect section references (that
is, rows 10 through 19). In section IV. of this correcting document, we
provide a corrected Table 128.
On pages 98549 and 98550, we inadvertently made typographical
errors in reference to the first MIPS performance period available for
two measures in the APP Plus quality measure set, an error in reference
to a MIPS collection type, and we inadvertently made a typographical
error in a citation.
2. Summary of Errors in the Regulations Text
On page 98582 at Sec. 427.302, there is a technical error in the
regulation heading for Calculation of the per unit Part B drug rebate
amount.
On page 98582 at Sec. 427.302, we inadvertently omitted a word in
the discussion of the identification of the payment amount benchmark
quarter.
On page 98585 at Sec. 427.401(b)(2)(iv), in the regulation text
for ``Reducing the rebate amount for Part B rebatable drugs currently
in shortage'', we inadvertently made a technical error.
On page 98587 at Sec. 427.501(d)(1)(i), we inadvertently included
one erroneous section reference and made a technical error in the
discussion of the preliminary reconciliation.
On page 98590 at Sec. 428.202, in the regulation heading for
``Calculation of
[[Page 20803]]
the per unit Part D drug rebate amount'' and in paragraph (a), we
inadvertently made a technical error in terminology.
On page 98593 at Sec. 428.204, in the introductory text for
``Treatment of new formulations of Part D rebatable drugs,'' we
inadvertently made errors in section references.
On page 98593 in Sec. 428.204(b), we inadvertently made a
technical error in terminology.
On page 98594, in Sec. 428.301(b)(2)(iv), in the regulation text
for ``Reducing the rebate amount for Part D rebatable drugs currently
in shortage'', we inadvertently made a technical error.
3. Summary and Corrections of Errors in the Addenda on the CMS Website
In Addendum B, due to a typographical error, the Global indicator
for HCPCS code G0560 was incorrect. Therefore in Addendum B, column L,
row 13679, the Global indicator for HCPCS code G0560 that reads ``ZZZ''
is corrected to read ``XXX.''
B. Summary of Errors in the December 30, 2024 Final Rule Correcting
Amendment
In the amendatory instructions for Sec. 405.1210, we made an error
regarding paragraph (b)(3). The amendment instruction indicated that we
were adding paragraph (b)(3) instead of revising paragraph (b)(3).
Because of this error, OFR included an editorial note in the electronic
Code of Federal Regulations (eCFR) for Sec. 405.1210 stating that the
paragraph could not be incorporated due to the inaccurate amendatory
instruction. Therefore, we are correcting the amendatory instruction
and providing the revised regulatory text.
III. Waiver of Proposed Rulemaking and Delay in Effective Date
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (the
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.
Similarly, section 1871(b)(1) of the Social Security Act (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. In addition, section 553(d) of the APA and section
1871(e)(1)(B)(i) of 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 APA notice and
comment, and delay in effective date requirements; in cases in which
these exceptions apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of
the Act provide exceptions from the notice and 60-day comment period
and delay in effective date requirements of the Act as well. Section
553(b)(B) of the APA and section 1871(b)(2)(C) of the Act authorize an
agency to dispense with normal notice and comment rulemaking procedures
for good cause if the agency makes a finding that the notice and
comment process is impracticable, unnecessary, or contrary to the
public interest, and includes a statement of the finding and the
reasons for it in the rule. In addition, 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 the agency includes in the rule a statement of the
finding and the reasons for it.
In our view, this correcting amendment does not constitute a
rulemaking that would be subject to these requirements. This document
merely corrects technical and typographical errors in the CY 2025 PFS
final rule. The corrections contained in this document are consistent
with, and do not make substantive changes to, the policies and payment
methodologies that were proposed, subject to notice and comment
procedures, and adopted in the CY 2025 PFS final rule. As a result, the
corrections made through this correcting amendment are intended to
resolve inadvertent errors so that the CY 2025 PFS final rule
accurately reflects the policies adopted therein. It also merely
corrects a technical error in the Medicare Appeals Correcting
Amendment.
In addition, even if this were a rulemaking to which the notice and
comment 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 corrections in this
document into the CY 2025 PFS final rule and Medicare Appeals
Correcting Amendment or delaying the effective date of the corrections
would be contrary to the public interest because it is in the public's
interest for physicians and practitioners to receive appropriate
payments in as timely a manner as possible, and to ensure that the CY
2025 PFS final rule accurately reflects our policies as of the date
they take effect. Further, such procedures would be unnecessary because
we are not making any substantive revisions to the CY 2025 PFS final
rule or the Medicare Appeals Correcting Amendment, but rather, we are
simply correcting the Federal Register documents to reflect the
policies that we previously proposed, received public comment on, and
subsequently finalized in the CY 2025 PFS and Medicare Appeals (October
15, 2024) final rules. For these reasons, we believe there is good
cause to waive the requirements for notice and comment and delay in
effective date.
Moreover, even if these corrections were considered to be
retroactive rulemaking, they would be authorized under section
1871(e)(1)(A)(ii) of the Act, which permits the Secretary to issue a
rule for the Medicare program with retroactive effect if the failure to
do so would be contrary to the public interest. As we have explained
previously, we believe it would be contrary to the public interest not
to implement these corrections because it is in the public's interest
for physicians and practitioners to receive appropriate payments in as
timely a manner as possible, and to ensure that the CY 2025 PFS final
rule and Medicare Appeals (October 15, 2024) final rule (which was
subsequently corrected by Medicare Appeals Correcting Amendment)
accurately reflect our policies.
IV. Correction of Errors in the Preamble of the CY 2025 PFS Final Rule
In FR Doc. 2024-25382 of December 9, 2024 (89 FR 97710), make the
following corrections:
1. On page 97767, top of the page, in the table titled ``Table 13:
The Medicare Telehealth Originating Site Facility Fee'', third column
(2025 Facility Fee for Q3014), last row, the figure ``$31.04'' is
corrected to read ``$31.01''.
2. On page 97804, first column, first full and second full
paragraphs, the paragraphs ``Interested parties submitted a public
comment in response to the CY 2025 PFS proposed rule that asked CMS to
establish coding and payment similar to CPT codes 0446T and 0448T for
services related to a newly FDA approved implantable 365-day continuous
glucose monitoring system. The commenter stated that creating new
coding will allow for continuity of this service during the
manufacturer's transition from the 180-day monitoring service as
described by the current codes, to the new 365-day monitoring service.
``We agree with the commenters request and are establishing two new
HCPCS codes to describe services related to the new 365-day monitoring
service. Specifically, we are establishing HCPCS code G0564 (Creation
of subcutaneous pocket with insertion of 365-day implantable
interstitial glucose sensor, including system activation and patient
training) and G0565 (removal of implantable interstitial glucose sensor
[[Page 20804]]
with creation of subcutaneous pocket at different anatomic site and
insertion of new 365-day implantable sensor, including system
activation). We believe it is important for beneficiaries to have
continued access to this valuable service during the transition from a
180 to 365-day monitoring period. HCPCS codes G0564 and G0565 are
contractor priced and effective January 1, 2025. CPT codes 0446T and
0448T should continue to be used to bill for the 180-day continuous
glucose monitoring service.'' are corrected to read as follows:
``Comment: An interested party submitted a public comment in
response to the CY 2025 PFS proposed rule requesting that CMS update
the existing CPT codes 0446T and 0448T's direct practice expense inputs
to replace a 180-day glucose sensor with an implantable 365-day
continuous glucose monitoring system. The commenter indicated that it
expected the 365-day continuous glucose monitoring system would receive
FDA clearance in September 2024. The commenter stated that updating the
direct practice expense inputs would allow for continuity of this
service during the manufacturer's transition from the 180-day
monitoring service as described by the current codes, to the new 365-
day monitoring service.
``Response: While we understand that the commenter requested an
update to the existing CPT codes' direct PE inputs, we note that we did
not propose to modify these inputs in the proposed rule. We are
establishing two new HCPCS codes to describe services related to the
new 365-day monitoring service in anticipation of an expected
transition from the 180- to 365-day device. Specifically, we are
establishing HCPCS code G0564 (Creation of subcutaneous pocket with
insertion of 365-day implantable interstitial glucose sensor, including
system activation and patient training) and G0565 (Removal of
implantable interstitial glucose sensor with creation of subcutaneous
pocket at different anatomic site and insertion of new 365-day
implantable sensor, including system activation). We believe it is
important for beneficiaries to have continued access to these valuable
services during the expected transition from the 180 to 365-day
monitoring service. HCPCS codes G0564 and G0565 are contractor priced
and effective January 1, 2025. CPT codes 0446T and 0448T should
continue to be used to bill for the 180-day continuous glucose
monitoring service.''
3. On page 97913, third column, first partial paragraph, lines 3
and 4, the reference, ``Pub. 100-02, chapter 15, section 220.1.4.C'' is
corrected to read ``Pub. 100-02, chapter 15, section 220.1.3.C''.
4. On page 97917, first column, third full paragraph, lines 22 and
23, the phrase ``applicable sections of the MBPM, chapter 5'' is
corrected to read ``applicable sections of the MBPM, chapter 15''.
5. On page 97925, third column, fourth full paragraph, lines 3 and
4, the phrase ``pathways are inadequate FD&C Act because'' is corrected
to read ``pathways are inadequate because''.
6. On page 97927, first column, first full paragraph, lines 7 and
8, the phrase ``in accordance with State prescriptive authority'' is
corrected to read ``in accordance with State authority''.
7. On page 98078, third column, first partial paragraph, lines 19
through 24, the phrase ``differences in minimum time between monthly
dosing (26 days for Sublocade[supreg] versus 28 days for monthly
Brixadi[supreg]), and differences in buprenorphine half- lives (19-26
days for Sublocade[supreg] versus 43-60 days for Brixadi[supreg])'' is
corrected to read ``differences in monthly dosing intervals (26 to 44
days for Sublocade[supreg] versus 21 to 35 days for monthly
Brixadi[supreg]), and differences in buprenorphine half- lives (43 to
60 days for Sublocade[supreg] versus 19 to 26 days for
Brixadi[supreg])''.
8. On page 98103, third column, first partial paragraph, lines 7
through 11, the phrase ``the number of measures reported from ten
measures in performance year 2024 to eight measures in performance year
2025 after the CMS Web Interface sunsets.'' is corrected to read ``the
number of measures reported from 11 measures in performance year 2024
to 6 measures in performance year 2025 after the CMS Web Interface
sunsets.''.
9. On page 98113, third column, first bulleted paragraph,
a. Lines 1 through 5, the sentence ``We are finalizing to add a
descriptive heading (``Facility-based scoring'') to Sec. 425.512(a)(7)
to more accurately describe the policy at paragraph (a)(7).'' is
corrected to read ``We are not finalizing the addition of a descriptive
heading (``Facility-based scoring'') to Sec. 425.512(a)(7) to describe
the policy at paragraph (a)(7).''.
b. Lines 9 through 13, the sentence ``We are finalizing the heading
to read as follows: `Shared Savings Program Scoring Policy for Excluded
APP Measures and APP Measures That Lack a Benchmark.' '' is corrected
by removing the sentence.
10. On page 98118, middle of the page, second column, second
partial paragraph, lines 4 and 5, the phrase ``Quality #: 001
Controlling High Blood Pressure'' is corrected to read ``Quality #: 236
Controlling High Blood Pressure''.
11. On page 98119,
a. Top of the page, first column, first partial paragraph, lines 1
and 2, the phrase ``Diabetes: Hemoglobin A1c (HbA1c) Poor Control
(>9%)'' is corrected to read ``Diabetes: Glycemic Status Assessment
Greater Than 9%''.
b. Lower two-thirds of the page, first column, first full
paragraph, lines 9 and 10, the phrase ``Hemoglobin A1c (HbA1c) Poor
Control (>9%)'' is corrected to read ``Glycemic Status Assessment
Greater Than 9%''.
12. On page 98121, first column, first partial paragraph, lines 1
through 3, the phrase ``Quality #: 001 Diabetes: Hemoglobin A1c (HbA1c)
Poor Control (>9%)'' is corrected to read ``Quality #: 001 Diabetes:
Glycemic Status Assessment Greater Than 9%''.
13. On page 98128,
a. Top of the page,
(1) First column, first paragraph, lines 10 and 11, the phrase
``Diabetes: Hemoglobin A1c (HbA1c) Poor Control (>9%) (Quality #:
001)'' is corrected to read ``Diabetes: Hemoglobin A1c (HbA1c) Poor
Control (>9%) (renamed to Diabetes: Glycemic Status Assessment Greater
Than 9% in this final rule) (Quality #: 001)''.
(2) Third column, first full paragraph, lines 9 through 10, the
phrase that reads ``Tables 39 through B-42 of this final rule'' is
corrected to read ``Tables 39 through 42 of this final rule.''.
b. Lower half of the page, in the table titled ``TABLE 39: Measures
Included in the APP Plus Quality Measure Set for Shared Savings Program
ACOs for Performance Year 2025'', third row (Quality #001), second
column (Measure Title), the entry ``Diabetes: Hemoglobin A1c (HbA1c)
Poor Control (>9%)'' is corrected to read ``Diabetes: Glycemic Status
Assessment Greater Than 9%''.
14. On page 98129, in the table titled ``TABLE 40: Measures
Included in the APP Plus Quality Measure Set for Shared Savings Program
ACOs for Performance Year 2026'', fourth row (Quality #001), second
column (Measure Title), the entry ``Diabetes: Hemoglobin A1c (HbA1c)
Poor Control (>9%)'' is corrected to read ``Diabetes: Glycemic Status
Assessment Greater Than 9%''.
15. On page 98130, in the table titled ``TABLE 41: Measures
Included in the APP Plus Quality Measure Set for Shared Savings Program
ACOs for Performance Year 2027'', fourth row (Quality #001), second
column (Measure Title), the entry ``Diabetes: Hemoglobin A1c (HbA1c)
Poor Control (>9%)'' is corrected to read ``Diabetes: Glycemic Status
Assessment Greater Than 9%''.
[[Page 20805]]
16. On page 98131, in the table titled ``TABLE 42: Measures
Included in the APP Plus Quality Measure Set for Shared Savings Program
ACOs Beginning with Performance Year 2028 or the Performance Year that
is one year after the eCQM Specifications become available for Quality
IDs: 487 and 493, whichever is later'', fourth row (Quality # 001),
second column (Measure Title), the entry ``Diabetes: Hemoglobin A1c
(HbA1c) Poor Control (>9%)'' is corrected to read ``Diabetes: Glycemic
Status Assessment Greater Than 9%''.
17. On page 98164, first column, first partial paragraph, line 1,
the table number ``Table D-B7'' is corrected to read ``Table 115''.
18. On page 98217, in the table titled ``TABLE 51: CY 2025 Part B
Payments for Preventive Vaccine Administration if the EUA Declaration
for Drugs and Biologicals with Respect to COVID-19 Continues into CY
2025,'' fifth and sixth rows, the entries are corrected to read as
follows:
----------------------------------------------------------------------------------------------------------------
Part B payment
Category of Part B product administration amount Amount Geographic
(unadjusted) update adjustment
----------------------------------------------------------------------------------------------------------------
COVID-19 Monoclonal Antibodies (for Pre-Exposure Prophylaxis): 3
4
Intravenous Infusion: Health Care Setting.................... $450 N/A GAF
----------------------------------------------------------------------------------------------------------------
19. On page 98229, first column, second bulleted paragraph, line 9,
the phrase ``date. Proposed Sec. 427.302(c)(4)'' is corrected to read
as follows:
``date.
Proposed Sec. 427.302(c)(4)''.
20. On page 98244, lower two-thirds of the page, first column, last
paragraph, lines 33 and 34, the phrase ``By defining and referencing
the billing and payment'' is corrected to read ``By referencing the
billing and payment''.
21. On page 98248,
a. First column, first full paragraph, line 11, the reference
``Sec. 427.303'' is corrected to read ``Sec. 427.303(b)(1)''.
b. Second column, first full paragraph, line 31, the reference
``Sec. 427.303(b)(1)(iii)'' is corrected to read ``Sec.
427.303(b)(1)(iv)''.
22. On page 98251, third column, first partial paragraph,
a. Lines 23 through 28, the sentence ``We further proposed
codifying policy that CMS may consult with the FDA for technical
assistance in instances where there is ambiguity as to whether a new
product is therapeutically equivalent'' is corrected by removing the
sentence.
b. Line 29, the phrase ``on or'' is corrected to read ``on and''.
23. On page 98253, second column, third full paragraph, line 13,
the reference ``Sec. 427.301'' is corrected to read ``Sec.
427.501(b)(1)''.
24. On page 98257, second column, second full paragraph, line 25,
the reference ``Table 58'' is corrected to read ``Table 57''.
25. On page 98258, lower half of the page, third column, first full
paragraph, line 4, the reference ``Sec. 427.402(a)'' is corrected to
read ``Sec. 427.402(b)(1)''.
26. On page 98261, third column, first full paragraph, line 36, the
reference ``Table 59'' is corrected to read ``Table 58''.
27. On page 98262, lower two-thirds of the page, second column,
first partial paragraph,
a. Line 13, the reference ``Table 60'' is corrected to read ``Table
59''.
b. Lines 24 and 25, the phrase ``rebate reduction 60 calendar
days'' is corrected to read ``rebate reduction was submitted less than
60 calendar days''.
28. On page 98263, top of the page, third column, first partial
paragraph,
a. Line 10, the reference ``Sec. 427.401(b)(4)(iii)'' is corrected
to read ``Sec. 427.401(b)(2)(iii)''.
b. Line 22, the reference ``(b)(4)(iv)'' is corrected to read
``(b)(2)(iv)''.
29. On page 98264, first column, third full paragraph, line 9, the
reference ``Sec. 427.501(c)(1)'' is corrected to read ``Sec.
427.501(d)(1)''.
30. On page 98265, third column, first full paragraph, line 7, the
reference ``Sec. 427.503(a)(1)'' is corrected to read ``Sec.
427.301(a)(1)''.
31. On page 98266,
a. First column, fourth full paragraph,
(1) Line 23, the reference ``Sec. 427.503'' is corrected to read
``Sec. 427.502(c)''.
(2) Line 24, the reference ``Sec. 428.403'' is corrected to read
``Sec. 428.402(c)''.
b. Second column, third full paragraph,
(1) Line 6, the phrase ``as determined under'' is corrected to read
``as set forth in''.
(2) Line 7, ``Sec. 427.503(a)(1)'' is corrected to read ``Sec.
427.301(a)(1)''.
32. On page 98268, first column, first full paragraph, line 27, the
reference ``Sec. 427.301'' is corrected to read ``Sec.
427.501(b)(1)''.
33. On page 98269, third column, fourth full paragraph,
a. Lines 12 and 13, the reference ``the specified amount exceeds''
is corrected to read ``the specified amount as determined under Sec.
427.302(b) exceeds''.
b. Line 15, the reference ``Sec. 427.301(g)'' is corrected to read
``Sec. 427.302(g)''.
34. On page 98271, first column,
a. First partial paragraph,
(1) Line 8, the reference ``Sec. 427.501(c)'' is corrected to read
``Sec. 427.501(d)(1)''.
(2) Line 11, the reference ``Sec. 427.501(d)(1)'' is corrected to
read ``Sec. 427.501(d)(2)''.
b. Third full paragraph,
(1) Line 5, the reference ``Sec. 427.501(b)(iii)'' is corrected to
read ``Sec. 427.501(b)(1)(iii)''.
(2) Line 6, the reference ``Sec. 427.501(d)(i)(B)'' is corrected
to read ``Sec. 427.501(d)(1)(i)(B)''.
35. On page 98278, first column,
a. First full paragraph, lines 7 and 8, the phrase ``such as
extended-release formulation reference'' is corrected to read ``such as
an extended-release formulation''.
b. Third full paragraph, lines 26 and 27, the phrase ``per unit
Part D drug inflation rebate amount'' is corrected to read ``per unit
Part D rebate amount''.
36. On page 98279, second column,
a. Second full paragraph, the section heading ``iii. Calculation of
the Per Unit Part D Drug Rebate Amount'' is corrected to read ``iii.
Calculation of the Per Unit Part D Rebate Amount''.
b. Third full paragraph,
(1) Line 5, the phrase ``Part D drug rebate amount'' is corrected
to read ``Part D rebate amount''.
(2) Lines 9 and 10, the phrase ``Part D drug inflation rebate
amount'' is corrected to read ``Part D rebate amount''.
(3) Line 16, the phrase ``Part D drug inflation rebate amount'' is
corrected to read ``Part D rebate amount''.
37. On page 98284, third column, first partial paragraph, line 18,
the reference ``(c)(2)'' is corrected to read ``(2)''.
38. On page 98287, first column,
a. Second full paragraph, lines 3 and 4, the phrase ``Part D drug
inflation rebate amount'' is corrected to read ``Part D rebate
amount''.
b. Last paragraph, lines 3 and 4, the phrase ``Part D drug
inflation rebate amount'' is corrected to read ``Part D rebate
amount''.
39. On page 98296, top of the page, first column, first partial
paragraph, line
[[Page 20806]]
1, the reference ``428.201(a)'' is corrected to read
``428.201(a)(1)(i)''.
40. On page 98298, third column, first partial paragraph, line 15,
the reference ``Table 60'' is corrected to read ``Table 61''.
41. On page 98301, third column, first partial paragraph, line 23,
the reference to ``Table 61'' is corrected to read ``Table 62''.
42. On page 98306, third column,
a. First partial paragraph, lines 18 and 19, the reference
``October 1, 2024, as determined under Sec. 428.402'' is corrected to
read ``October 1, 2024''.
b. First full paragraph, line 14, the word ``believes'' is
corrected to read ``believe''.
43. On page 98307, second column, third paragraph, line 5, the
reference ``Sec. 428.401(b)(iii) and Sec. 428.401(d)(i)(B)'' is
corrected to read ``Sec. 428.401(b)(1)(iii) and (d)(1)(i)(C)''.
44. On page 98308,
a. First column, second paragraph, line 25, the reference ``Sec.
428.405(a)(1)'' is corrected to read ``Sec. 428.401(d)(1)(i)(G)''.
b. Third column, first full paragraph, lines 15 and 16, the
reference ``Sec. 428.401(d)(1)(i) and (d)(2)'' is corrected to read
``Sec. 428.401(d)(1)(i), and (2)''.
45. On page 98310, second column, second paragraph,
a. Lines 5 through 7, the phrase ``Sec. 428.401(d)(1)(i)(C) to
specify that the reconciliation will include updated payment'' is
corrected to read ``Sec. 428.401(b)(1)(iii) to specify that the Rebate
Report will include the payment''.
b. Lines 16 and 17, the reference ``Sec. 428.401(b)(iii) and Sec.
428.401(d)(1)(i)(B)'' is corrected to read ``Sec.
428.401(d)(1)(i)(C)''.
c. Lines 40 and 41, the phrase ``benchmark period manufacturer
price'' is corrected to read ``payment amount benchmark period''.
d. Lines 43 and 44, the reference ``Sec. 428.401(b)(iii) and Sec.
428.401(d)(1)(i)(B)'' is corrected to read ``Sec. 428.401(b)(1)(iii)
and (d)(1)(i)(C)''.
46. On page 98311, first column, first partial paragraph, line 14,
the phrase ``applicable periods'' is corrected to read ``applicable
period''.
47. On page 98312, third column, first partial paragraph, line 6,
the phrase ``Part D Rebatable drugs'' is corrected to read ``Part D
rebatable drugs''.
48. On page 98332, third column, first partial paragraph, line 6,
the phrase ``patients in hemorrhagic over traditional'' is corrected to
read ``patients in hemorrhagic shock over traditional''.
49. On page 98358, second column, first full paragraph, lines 13
through 14, the title ``Quality ID #001 Diabetes: Hemoglobin A1c
(HbA1c) Poor Control'' is corrected to read ``Quality ID #001 Diabetes:
Glycemic Status Assessment Greater Than 9%''.
50. On page 98366, top of the page, in table titled ``TABLE 67:
Alignment of the APP Plus Measure Set with the Adult Universal
Foundation Measure Set'', first row (Quality #001), third column
(Measure Title), the entry ``Diabetes: Hemoglobin A1c (HbA1c) Poor
Control'' is corrected to read ``Diabetes: Glycemic Status Assessment
Greater Than 9%''.
51. On page 98367, top of the page, in the table titled ``TABLE 68
APP Plus Quality Measure Set for the CY 2025 Performance Period'',
first row (Quality #001), second column (Measure Title), the entry
``Diabetes: Hemoglobin A1c (HbA1c) Poor Control'' is corrected to read
``Diabetes: Glycemic Status Assessment Greater Than 9%''.
52. On page 98368, in the table titled ``TABLE 69: APP Plus Quality
Measure Set for the CY 2026 Performance Period'', first row (Quality
#001), second column (Measure Title), the entry ``Diabetes: Hemoglobin
A1c (HbA1c) Poor Control'' is corrected to read ``Diabetes: Glycemic
Status Assessment Greater Than 9%''.
53. On page 98369, in the table titled ``TABLE 70: APP Plus Quality
Measure Set for the CY 2027 Performance Period'',
a. First row (Quality #001), second column (Measure Title), the
entry is corrected to read ``Diabetes: Glycemic Status Assessment
Greater Than 9%''.
b. Last row (Quality #305), Third column (Collection Type), the
entry ``eCQM (all APP reporters); Medicare CQM (SSP ACOs only)'' is
corrected to read ``eCQM/MIPS CQM/Part B Claims (all APP reporters);
Medicare CQM (SSP ACOs only)''.
54. On pages 98370 and 98371, in the table titled ``TABLE 71: APP
Plus Quality Measure Set for the CY 2028 Performance Period and
Subsequent Performance Periods'',
a. First row (Quality #001), second column (Measure Title), the
entry ``Diabetes: Hemoglobin A1c (HbA1c) Poor Control'' is corrected to
read ``Diabetes: Glycemic Status Assessment Greater Than 9%''.
b. Ninth row (Quality #305), third column (Collection Type), the
entry ``eCQM (all APP reporters); Medicare CQM (SSP ACOs only)'' is
corrected to read ``eCQM/MIPS CQM/Part B Claims (all APP reporters);
Medicare CQM (SSP ACOs only)''.
55. On pages 98406 through 98408, in the table titled ``Table 75:
Summary Table of Previously Established and Finalized Cost Measures for
the CY 2025 Performance Period/2027 MIPS Payment Year and Future
Performance Periods'', last row (Total Per Capita Cost), third column
(Case Minima), the entry ``20 beneficiary months'' is corrected to read
``20 beneficiaries''.
56. On page 98434, after the table titled ``TABLE 82: Proposed
topped out measures impacted by limited measure choice and subject to
defined topped out measure benchmark for the CY 2025 performance
period/2027 MIPS Payment Year'' is corrected by adding a table note to
read as follows:
``CMS included MIPS CQM 436 on the list in error. The removal of
this measure was previously finalized.''
57. On page 98468,
a. First column, fourth full paragraph, lines 1 through 4, the
sentence ``The following changes will be submitted to OMB for approval
under control number 0938-INSERT (CMS-INSERT).'' is corrected by
removing the sentence.
b. Second column, last paragraph, line 12, the mathematical phrase
``3,100 hours (310 hr per form * 10 forms)'' is corrected to read ``310
hours (31 hr per form * 10 forms)''.
c. Third column,
(1) First partial paragraph, line 22, the phrase ``the potential
shortage T'' is corrected to read ``the potential shortage''.
(2) First full paragraph, lines 5 and 6, the mathematical phrase
``3,100 hours (310 hr per form * 10 forms)'' is corrected to read ``310
hours (31 hr per form * 10 forms)''.
58. On page 98469, first column, first partial paragraph, line 22,
the mathematical expression ``(3)))].'' is corrected to read ``(3))].''
59. On page 98474, first column, second paragraph, lines 6 through
8, the phrase ``Quality #001: Diabetes: Hemoglobin A1c (HbA1c) Poor
Control'' is corrected to read ``Quality #001: Diabetes: Glycemic
Status Assessment Greater Than 9%''.
60. On page 98479,
a. Top of the page, second column, second paragraph, lines 11
through 14, the phrase that reads ``one MIPS quality measure from the
current MIPS quality measure inventory of 197 measures (198 current + 9
new measures'' is corrected to read ``three MIPS quality measures from
the current MIPS quality measure inventory of 198 measures (198 current
+ 7 new measures''.
b. Middle of the page, in the table titled ``TABLE 96: Summary of
Quality Measure Inventory Finalized for the CY
[[Page 20807]]
2025 Performance Period/2027 MIPS Payment Year'',
(1) Header row, second column, the heading ``# Measures Proposed as
New*'' is corrected to read ``# Measures Finalized as New*''.
(2) Second row (MIPS CQMs Specifications), third column (# Measures
Finalized for Removal*), the entry ``-11'' is corrected to read ``-
10''.
61. On page 98493, top half of the page, in the table titled
``TABLE 107: Annual Requirements and Burden Estimates'', the listed
entries (first and third rows) are corrected to read as follows:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Total
Section(s) under Title 42 of OMB control No. (CMS ID Number annual Time per annual time Labor cost ($/ Total cost
the CFR No.) respondents responses response (hours) (hours) hr) ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. Sec. 414.1325, 0938-1314 (CMS-10621)...... 41,195 68,954 Varies.......... (7,570) Varies.......... (913,176)
414.1335, 414.1365 Quality Clinicians;
Payment Program. 10,765 Group
TINs; 20
Subgroups; 6
Virtual Groups;
Total: 51,986.
-------------------------------------------------------------------------------------------------------------------------
Total..................... ........................... 52,006.......... 68,974 Varies.......... (6,950) Varies.......... (838,420)
--------------------------------------------------------------------------------------------------------------------------------------------------------
62. On page 98494, second column, first partial paragraph, line 5
the word, ``established'' is corrected to read ``establishes''.
63. On page 98495, third column, first full paragraph, line 5 that
reads, ``beginning on or after January 1, 2025'' is corrected to read
``ending after December 31, 2024.''
64. On page 98508, first column,
a. Line 11, the phrase ``80 percent'' is corrected to ``82
percent''.
b. Line 13, the phrase ``75 percent'' is corrected to ``76
percent''.
c. Line 31, the phrase ``1 percent'' is corrected to read ``0
percent''.
d. Line 34, the phrase ``24 percent'' is corrected to read ``23
percent''.
e. Line 39, the phrase ``13 percent'' is corrected to read ``14
percent''.
f. Lines 43 and 44, the phrase ``14 percent'' is corrected to read
``15 percent''.
65. On page 98518, second column, third full paragraph, line 7 the
phrase, ``beginning on or after January 1, 2025,'' is corrected to read
``ending after December 31, 2024.''
66. On page 98528, second column, first full paragraph, lines 8
through 9, the phrase ``Part D drugs and biological products; covered
under Part D'' is corrected to read ``drugs and biological products
covered under Part D''.
67. On pages 98547 and 98548, in the table titled ``TABLE 128:
Incremental Estimated Burden from Associated Finalized Policies'', the
table is corrected to read as follows:
Table 128--Incremental Estimated Burden From Associated Finalized
Policies
[Asterisks refer to paragraph directly following table]
------------------------------------------------------------------------
Burden
Burden description and associated provisions hours Burden dollars
------------------------------------------------------------------------
Total burden associated with the provision to 594,447 $71,079,848
continue the policies and ICRs set forth in
the CY 2024 PFS final rule into the CY 2025
performance period/2027 MIPS payment year
with updated data and assumptions (outlined
in section V.B.6.a.(1)(a) of this final
rule).
Burden change for MVP registration ICR due to +626 +66,759
the provision of additional MVPs (outlined
in section V.B.6.c.(5).(a).(i) of this final
rule).*
Burden change for Quality Data Submission by -7,697 -898,035
Clinicians: Medicare Part B Claims-Based
Collection Type ICR for capturing reduced
number of quality submissions due to the
provision of additional MVPs (outlined in
section V.B.6.c.(2) of this final rule).*
Burden change for Quality Data Submission by -6,866 -823,269
Clinicians: CQM/QCDR Collection Type ICR for
capturing reduced number of quality
submissions due to the provision of
additional MVPs (outlined in section
V.B.6.c.(3) of this final rule).*
Burden change for Quality Data Submission by -9,664 -$1,176,109
Clinicians: eCQM Collection Type ICR for
capturing reduced number of quality
submissions due to the provision of
additional MVPs (outlined in section
V.B.6.c.(4) of this final rule).*
Burden change for MVP Quality Submission ICR +16,031 +1,917,478
submissions due to the provision of
additional MVPs (outlined in section
V.B.6.c.(5).(a).(iii) of this final rule).*
Total change in burden due to policy for CY -7,570 -913,176
2025 performance period/2027 MIPS payment
year........................................
Total burden set forth in the CY 2025 PFS 586,877 70,166,672
final rule..................................
------------------------------------------------------------------------
The total change in burden due to this policy provision includes an
increase in burden due to an anticipated increase in the number of
respondents that will participate in MVP reporting based on the
addition of six new MVPs. Therefore, there is a decrease in burden in
the MIPS CQM and QCDR, eCQM, and Medicare Part B ICRs due to
respondents who previously submitted MIPS through those collection
types submitting data with reduced quality submission requirements as
an MVP Participant. Total change in burden also reflects an increase
in submission burden due to the additional MVP registrants. See
section V.B.6.c.(2) of this final rule for additional detail.
68. On page 98549, third column
a. First partial paragraph, lines 1 through 3 the phrase ``or the
next performance period following the availability of the eCQM
specifications'' is corrected to read ``or the performance period that
is 1 year after the eCQM specifications become available for each
respective measure''.
b. Second partial paragraph, lines 10 through 11, the phrase ``MIPS
CQMQCDR'' is corrected to read ``MIPS CQM/QCDR''.
69. On page 98550, first column,
a. First partial paragraph, lines 15 through 17, the phrase ``or
the next performance period following the availability of the eCQM
specifications'' is corrected to read ``or the performance period that
is 1 year after the eCQM specifications become available for each
respective measure''.
b. First full paragraph, lines 10 through 11, the citation ``(88 FR
84862)'' is corrected to read ``(85 FR 84862)''.
List of Subjects
42 CFR Part 405
Administrative practice and procedure, Diseases, Health facilities,
Health professions, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
42 CFR Part 427
Administrative practice and procedure, Biologics, Inflation
rebates, Medicare, Prescription drugs.
[[Page 20808]]
42 CFR Part 428
Administrative practice and procedure, Biologics, Inflation
rebates, Medicare, Prescription drugs.
For the reasons set forth in the preamble, CMS corrects 42 CFR
parts 405, 427, and 428 by making the following correcting amendments:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
0
1. The authority citation for part 405 continues to read as follows:
Authority: 42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x,
1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).
0
2. Section 405.1210 is amended by revising paragraph (b)(3) to read as
follows:
Sec. 405.1210 Notifying eligible beneficiaries of appeal rights when
a beneficiary is reclassified from an inpatient to an outpatient
receiving observation services.
* * * * *
(b) * * *
(3) When delivery of the notice is valid. Delivery of the written
notice of appeal rights described in this section is valid if--
(i) The eligible beneficiary (or the eligible beneficiary's
representative) has signed and dated the notice to indicate that he or
she has received the notice and can comprehend its contents, except as
provided in paragraph (b)(4) of this section; and
(ii) The notice is delivered in accordance with paragraph (b)(1) of
this section and contains all the elements described in paragraph
(b)(2) of this section.
* * * * *
PART 427--MEDICARE PART B DRUG INFLATION REBATE PROGRAM
0
3. The authority citation for part 427 continues to read as follows:
Authority: 42 U.S.C. 1395w-3a(i), 1302, and 1395hh.
0
4. Amend Sec. 427.302 by revising the section heading and paragraph
(c) introductory text to read as follows:
Sec. 427.302 Calculation of the per unit Part B rebate.
* * * * *
(c) Identification of the payment amount benchmark quarter. For
each Part B rebatable drug, CMS will identify the applicable payment
amount benchmark quarter as set forth in paragraphs (c)(1) through (3)
of this section, as applicable, subject to paragraphs (c)(4) and (5) of
this section, using the earliest first marketed date of any NDC ever
marketed under any FDA application under which any NDCs that have ever
been assigned to the billing and payment code as of the applicable
calendar quarter have been marketed, and using the earliest approval or
licensure date of any FDA application under which any NDCs that have
ever been assigned to the billing and payment code as of the applicable
calendar quarter have been marketed:
* * * * *
Sec. 427.401 [Amended]
0
5. Amend Sec. 427.401 in paragraph (b)(2)(iv) by removing the phrase
``set forth'' and adding in its place the word ``described''.
0
6. Amend Sec. 427.501 by revising paragraph (d)(1)(i) introductory
text to read as follows:
Sec. 427.501 Rebate Reports and reconciliation.
* * * * *
(d) * * *
(1) * * *
(i) Preliminary reconciliation. At least 1 month prior to the
issuance of a report with the reconciled rebate amount for an
applicable calendar quarter as set forth in paragraph (d)(1)(ii) of
this section, CMS will conduct a preliminary reconciliation of the
rebate amount for an applicable calendar quarter based on the
information set forth in paragraphs (b)(1)(i) through (ix) of this
section and provide the information set forth in paragraphs (b)(1) and
(d)(1)(i)(A) through (F) of this section to the manufacturer of a Part
B rebatable drug for the applicable calendar quarter, if applicable:
* * * * *
PART 428--MEDICARE PART D DRUG INFLATION REBATE PROGRAM
0
7. The authority citation for part 428 continues to read as follows:
Authority: 42 U.S.C. 1395w-114b, 1302, and 1395hh.
0
8. Amend Sec. 428.202 by revising the section heading and paragraph
(a) to read as follows:
Sec. 428.202 Calculation of the per unit Part D rebate amount.
(a) Formula for calculating the per unit Part D rebate amount. CMS
will calculate the per unit Part D rebate amount for a Part D rebatable
drug and applicable period by determining the amount by which the AnMP
for the Part D rebatable drug, as calculated in accordance with
paragraph (b) of this section, exceeds the inflation-adjusted payment
amount, as calculated in accordance with paragraph (f) of this section.
* * * * *
0
9. Amend Sec. 428.204--
0
a. In the introductory text by removing the reference ``Sec.
428.201(a)'' and adding in its place the reference ``Sec.
428.201(a)(1)(i)''; and
0
b. By revising paragraph (b).
The revision reads as follows:
Sec. 428.204 Treatment of new formulations of Part D rebatable drugs.
* * * * *
(b) Calculation of the inflation rebate amount ratio. The inflation
rebate amount ratio is equal to the per unit Part D rebate amount for
the initial drug, as determined under Sec. 428.202(a), divided by the
AnMP for that initial drug for the applicable period.
* * * * *
Sec. 428.301 [Amended]
0
10. Amend Sec. 428.301 in paragraph (b)(2)(iv) by removing the phrase
``set forth'' and adding in its place the word ``described''.
Wilma Robinson,
Deputy Executive Secretary to the Department, Department of Health and
Human Services.
[FR Doc. 2025-08676 Filed 5-15-25; 8:45 am]
BILLING CODE 4120-01-P