Proposed Rule2026-19535
Request for Information; Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards
Primary source
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Published
September 24, 2026
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
This request for information (RFI) solicits input from interested parties for purposes of establishing standards for reasonable and relevant pharmacy contract terms and conditions under the Medicare prescription drug benefit. Section 6223(a) of the Consolidated Appropriations Act, 2026 (CAA, 2026) amends section 1860D- 4(b)(1)(A) of the Social Security Act (the Act) to require Part D plan sponsors to permit any pharmacy that meets standard contract terms and conditions under the plan to participate as a network pharmacy of the plan. Section 6223(a) of the CAA, 2026 further requires that, notwithstanding any other provision of law, for plan years beginning January 1, 2029, such standard contract terms and conditions offered by Part D plan sponsors must be reasonable and relevant according to standards established by the Secretary of the Department of Health and Human Services. Finally, section 6223(a) of the CAA, 2026 requires the Secretary to issue this RFI for purposes of establishing such standards.
Full Text
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<title>Federal Register, Volume 91 Issue 184 (Thursday, September 24, 2026)</title>
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[Federal Register Volume 91, Number 184 (Thursday, September 24, 2026)]
[Proposed Rules]
[Pages 60568-60572]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19535]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Part 423
[CMS-4217-NC]
RIN 0938-AW08
Request for Information; Medicare Part D Reasonable and Relevant
Pharmacy Contracting Standards
AGENCY: Centers for Medicare & Medicaid Services (CMS), Department of
Health and Human Services (HHS).
ACTION: Request for information.
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SUMMARY: This request for information (RFI) solicits input from
interested parties for purposes of establishing standards for
reasonable and relevant pharmacy contract terms and conditions under
the Medicare prescription drug benefit. Section 6223(a) of the
Consolidated Appropriations Act, 2026 (CAA, 2026) amends section 1860D-
4(b)(1)(A) of the Social Security Act (the Act) to require Part D plan
sponsors to permit any pharmacy that meets standard contract terms and
conditions under the plan to participate as a network pharmacy of the
plan. Section 6223(a) of the CAA, 2026 further requires that,
notwithstanding any other provision of law, for plan years beginning
January 1, 2029, such standard contract terms and conditions offered by
Part D plan sponsors must be reasonable and relevant according to
standards established by the Secretary of the Department of Health and
Human Services. Finally, section 6223(a) of the CAA, 2026 requires the
Secretary to issue this RFI for purposes of establishing such
standards.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, by November 23, 2026.
ADDRESSES: In commenting, refer to file code CMS-4217-NC.
Comments, including mass comment submissions, must be submitted in
one of the following three ways (please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
regulation to <a href="https://www.regulations.gov/docket/CMS-2026-3037">https://www.regulations.gov/docket/CMS-2026-3037</a>. Follow
the ``Submit a comment'' instructions.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-4217-NC, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-4217-NC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT: Beckie Peyton, (410) 786-1572.
<a href="/cdn-cgi/l/email-protection#7a2a1b080e3e2a15161319033a19170954121209541d150c"><span class="__cf_email__" data-cfemail="540435262010043b383d372d143739277a3c3c277a333b22">[email protected]</span></a>, for general questions related to section 6223
of the CAA, 2026 (``Assuring Pharmacy Access and Choice for Medicare
Beneficiaries'').
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments. CMS will not post on <a href="http://Regulations.gov">Regulations.gov</a> public
comments that make threats to individuals or institutions or suggest
that the commenter will take actions to harm an individual. CMS
continues to encourage individuals not to submit duplicative comments.
We will post acceptable comments from multiple unique commenters even
if the content is identical or nearly identical to other comments.
I. Background
Section 101 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub. L. 108-173) amended Title XVIII
of the Act by establishing a new Part D: the Voluntary Prescription
Drug Benefit Program. In general, private companies--referred to as
Part D plan sponsors--contract with CMS to provide the Part D benefit
either through standalone prescription drug plans (PDPs) that offer
prescription drug coverage only, or through Medicare Advantage plans
that offer integrated prescription drug and health care coverage (MA-PD
plans). Part D plan sponsors must establish contracted pharmacy
networks that meet the Part D convenient access standards specified in
42 CFR 423.120(a). In establishing these contracted pharmacy networks,
Part D plan sponsors must contract with any pharmacy that meets the
Part D plan sponsor's standard terms and conditions (see Sec.
423.120(a)(8)(i)). Such standard terms and conditions must be
reasonable and relevant (see Sec. 423.505(b)(18)). In the January 28,
2005 Part D final rule (70 FR 4254), we clarified that standard terms
and conditions, particularly for payment terms, may vary to accommodate
geographic areas or types of pharmacies, and that modifying such terms
and conditions would be acceptable provided that all similarly situated
pharmacies are offered the same standard terms and conditions. CMS has
not established additional requirements for what constitutes reasonable
and relevant terms and conditions. Section 6223(a) of the CAA, 2026
amends section 1860D-4(b)(1)(A) of the Act to require Part D plan
sponsors offering a prescription drug plan to permit any pharmacy that
meets the standard contract terms and conditions of such plan to
participate as a network pharmacy of the plan. Section 6223(a) of the
CAA, 2026 adds new clause (ii) to section 1860D-4(b)(1)(A) that
requires the Secretary of the Department of Health and Human Services
(the Secretary) to establish standards for reasonable and relevant
contract terms and conditions no later than the first Monday in April
of 2028, for plan years beginning on or after January 1, 2029.
Under new section 1860D-4(b)(1)(A)(ii)(III) of the Act, the
Secretary is required to issue an RFI not later than April 1, 2027 for
purposes of establishing the standards for reasonable and relevant
contract terms and conditions and to seek input on specific topics.
Accordingly, CMS is issuing this RFI to inform future rulemaking and in
section II. of this RFI seeks input on the specific topics required
under section 1860D-4(b)(1)(A)(ii)(III) of the Act.
II. Solicitation of Public Comments
Consistent with the requirements of section 1860D-
4(b)(1)(A)(ii)(III) of the Act, CMS is seeking information from
interested parties regarding the topics described below, for purposes
of establishing standards as required under
[[Page 60569]]
section 1860D-4(b)(1)(A)(ii)(II) of the Act.
In preparing submissions, respondents should clearly identify which
section(s) of this RFI they are responding to and the circumstances to
which their responses relate. Commenters may wish to consider any of
the following factors, and indicate within their submissions the
relevance of these or other factors:
<bullet> Subsets of pharmacies or pharmacy services (for example,
retail; mail order; home infusion; long-term care (LTC); specialty;
compounding; Indian Health Service, Tribal, and Urban Indian (I/T/U));
<bullet> Non-preferred versus preferred network arrangements;
<bullet> Geographic location of the pharmacy (for example, rural,
urban);
<bullet> Drug type (for example, brand name, generic, high-cost,
specialty, special handling, limited distribution, compounded
products);
<bullet> Plan type (for example, PDP, MA-PD); and
<bullet> Vertical integration, that is, the control within a single
corporate structure of various roles in the prescription drug supply
chain, including insurance plans, pharmacy benefit managers (PBMs), and
pharmacies. In addition to the topics discussed in each of the sections
below, we solicit comment on how implementation of standards for
reasonable and relevant pharmacy contract provisions in section 1860D-
4(b)(1)(A)(ii)(II) of the Act is likely to overlap with implementation
of the PBM disclosure requirements and remuneration restrictions set
forth under section 1860D-12(h) of the Act, and recommendations for how
CMS should take such overlap into account when developing the standards
for reasonable and relevant pharmacy contract provisions.
Commenters are encouraged to provide as much detail as possible in
their submissions. In preparing responses, CMS encourages commenters to
provide, where relevant, quantitative data and empirical analyses;
contract language (de-identified as appropriate); information
disaggregated by pharmacy type, geographic location, drug category, or
other relevant factors; and evidence regarding Part D enrollee access
and outcomes.\1\
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\1\ Commenters should not include proprietary or confidential
information in their submissions. We note that as independent
regulatory obligations, Part D sponsors and their first tier,
downstream, and related entities must make available documentation
as the Secretary deems necessary to enforce CMS' contract with the
Part D sponsor, including documents with the terms and conditions
offered by Part D sponsors to pharmacies. See 42 CFR 423.505(e)(2)
and (i)(2).
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A. Pharmacy Reimbursement and Dispensing Fees
CMS seeks information about whether pharmacy reimbursement and
dispensing fees paid by Part D sponsors to network pharmacies
sufficiently cover the ingredient and operational costs of such
pharmacies. Specific areas of interest include:
<bullet> Information about Part D pharmacy reimbursement policies,
including variations by pharmacy type, geographic location, drug type
(for example, generic, brand, specialty), or other factors;
<bullet> How Part D reimbursement rates compare to pharmacy actual
acquisition costs, which methodologies and pricing benchmarks most
closely reflect actual acquisition costs, and whether rates vary for
certain drugs or drug types, pharmacy types, or other factors;
<bullet> The feasibility and utility of network pharmacies sharing
their actual acquisition costs with Part D plan sponsors, either
directly or via wholesalers, and whether that transparency would be a
sufficient alternative to benchmarks or similar methodologies to
establish a reasonable cost-based reimbursement methodology for
ingredient costs;
<bullet> Whether, and how, pharmacy margins on ingredient costs
differ for certain drugs or drug classes (for example, brand-name drugs
versus generics);
<bullet> Whether, and how, reimbursement policies impact pharmacy
decisions to stock certain drugs or drug classes (for example, high-
cost drugs);
<bullet> The frequency of plan updates to maximum allowable cost
(MAC) pricing lists, communication regarding such updates, and related
dispute resolution mechanisms;
<bullet> Industry standards or common practices for establishing
MAC prices and whether there are alternatives that are more transparent
to pharmacies;
<bullet> The use of ``lesser of'' pricing methodologies, including
the use of usual and customary (U&C) pricing and how U&C is defined;
<bullet> The use of machine learning to estimate acquisition costs;
<bullet> Opportunities for the use of artificial intelligence (AI)
with respect to Part D pharmacy reimbursement;
<bullet> Information on standard Part D pharmacy contract terms and
conditions relating to dispensing covered Part D drugs to 340B patients
enrolled in Part D, including whether such 340B specific terms and
conditions are common, and whether and how Part D plan sponsors
determine when a claim is for a 340B patient for which the pharmacy
acquisition cost is less than the plan's negotiated price;
<bullet> The relationship, if any, between Part D reimbursement
rates and the presence of ``pharmacy deserts'' in rural, urban, or
other underserved areas;
<bullet> Costs that are considered within the scope of dispensing
fees, and whether dispensing fees paid by Part D sponsors sufficiently
cover those costs;
<bullet> How dispensing fees are determined in Part D and outside
of Part D;
<bullet> Whether dispensing fees should be required to cover the
cost of dispensing irrespective of the ingredient cost reimbursement or
whether reimbursement of the ingredient cost may be factored into the
dispensing fee calculation;
<bullet> Whether and how dispensing fees vary by pharmacy type,
pharmacy services, or other factors;
<bullet> Impacts of post-adjudication adjustments on net
reimbursement rates;
<bullet> The extent to which negotiated prices reported on pharmacy
claim responses reflect a pharmacy's final reimbursement for Part D
claims versus an aggregate guarantee such as a generic effective rate
(GER), brand effective rate (BER), or similar reimbursement
methodologies reconciled after the point of sale; the magnitude of the
difference between negotiated prices reported on pharmacy claim
responses and end-of-year reconciled effective rates; and whether
claim-level reimbursement is meaningfully predictive of the amount the
pharmacy actually receives over the contract year.
<bullet> The extent to which the use of aggregate guarantee
reimbursement methodologies, or the parameters of such methodologies,
are negotiable between pharmacies and Part D sponsors.
<bullet> The extent to which aggregate guarantee reimbursement
methodologies influence decisions by pharmacies about drug selection,
particularly in the case of high-cost specialty generics;
<bullet> The extent to which a pharmacy's Part D reimbursement
rates are set or adjusted in relation to the same pharmacy's commercial
reimbursement rates, including:
++ Whether any guarantee covers both Part D and commercial
reimbursement;
++ Whether and how MAC prices, dispensing fees, or other
reimbursement parameters are managed so that overpayments relative to
the guarantee on one line of business offset underpayments on the
other;
++ Whether such arrangements could result in higher Part D
negotiated prices
[[Page 60570]]
than would be paid under a standalone Part D guarantee, and what the
implications for CMS subsidy calculations, enrollee cost sharing, and
Part D bids would be;
++ The prevalence of contract provisions that tie Part D
reimbursement rates to commercial reimbursement rates, and any
variances across pharmacy types.
++ The frequency and magnitude of end-of-year reconciliation
payments arising from aggregate guarantee constructs, and whether such
reconciliation payments are allocated differently across Part D and
commercial lines of business and, if so, how;
<bullet> The predictability of final reimbursement at the time of
dispensing;
<bullet> Whether the remittance advice provided to network
pharmacies include sufficient claim level detail for the pharmacy to
determine how much it was reimbursed for each claim, including after
point-of-sale adjustments; and
<bullet> Whether CMS should establish reimbursement methodologies
or rates as part of the standards for reasonable and relevant pharmacy
contract terms and conditions.
B. Current Contracting Practices
CMS seeks information regarding current Part D plan and network
pharmacy contracting practices. Specific areas of interest include:
<bullet> The factors CMS should consider in determining the
reasonableness and relevance of contract terms and conditions between
prescription drug plans and network pharmacies, including whether such
terms and conditions facilitate or hinder competition, promote enrollee
access to Part D drugs, and align with evidence-based quality metrics;
<bullet> With respect to the current requirements at Sec.
423.505(b)(18), how Part D plan sponsors differentiate among the
contract terms and conditions made available to pharmacies based on
whether the pharmacies are ``similarly situated'' to other pharmacies,
what criteria sponsors use to determine that individual pharmacies are
similarly situated, and how sponsors ensure consistent application of
those criteria;
<bullet> Whether Part D plan sponsors offer any willing pharmacy
terms and conditions to participate in their non-preferred networks
only, or if such terms and conditions are also offered to any willing
pharmacy for participation in preferred networks;
<bullet> Whether pharmacies meeting the same objective criteria
(for example, accreditation, dispensing capability, clinical services)
are offered the opportunity to participate as specialty network
pharmacies under the same terms and conditions, and how ``similarly
situated'' is determined for specialty pharmacy purposes;
<bullet> The extent to which limited or exclusive specialty
networks, manufacturer limited-distribution designations, and PBM
specialty pharmacy designations overlap with, or are influenced by,
common ownership between the PBM and the designated specialty pharmacy;
<bullet> The relationship between specialty pharmacy or specialty
drug designation and reimbursement terms, including whether such
designation results in materially different ingredient cost
reimbursement, dispensing fees, performance measures, or audit
treatment;
<bullet> Whether CMS should establish standards related to the
definition of ``specialty pharmacy'' in the context of Part D pharmacy
contracting, including any standards for the criteria a network
pharmacy must meet to be eligible for specialty designation.
<bullet> The extent to which a pharmacy's participation in a Part D
plan sponsor's non-Part D pharmacy network impacts its ability to
participate in the plan sponsor's Part D network, the terms of its
contract for participation in the plan sponsor's Part D network, or
both;
<bullet> Whether current Part D pharmacy contracting practices
differ from non-Part D pharmacy contracting practices and, if so,
information about such differences;
<bullet> Whether standard Part D pharmacy contract terms and
conditions are offered as standalone Part D contracts or as part of a
broader network agreement covering multiple lines of business (for
example, Medicaid managed care, commercial, exchange), and whether the
multi-line structure affects the terms applicable to Part D
specifically;
<bullet> Whether Part D plan sponsors have policies related to so-
called ``brown bagging'' or ``white bagging'', how those terms are
understood by the parties, and their effect on the contracting process;
<bullet> The use of provider manuals, policy bulletins, or other
Part D plan sponsor or PBM communications to modify or supplement
standard contract terms and conditions outside of formal contract
amendment;
<bullet> The extent to which the financial terms that ultimately
determine pharmacy reimbursement are contained in documents other than
the executed contract (for example, rate sheets, internal budget files,
side letters, or unwritten understandings between affiliated entities),
and whether and how transparency about such documents could be
improved;
<bullet> The role and impact of PBMs, pharmacy services
administrative organizations (PSAOs), and other entities on the Part D
pharmacy contracting process;
<bullet> The relative leverage Part D plan sponsors, PBMs, and
pharmacies have in negotiations over contract terms and conditions and
network participation; the variation of such leverage by pharmacy type,
geographic location, or other factors; and the extent to which CMS
rules and guidance affect, or could affect, this balance;
<bullet> With respect to pharmacy contract provisions that permit
Part D plan sponsors to recoup or suspend pharmacy payment or terminate
a pharmacy contract:
++ The prevalence of such provisions;
++ The conditions necessary to invoke such provisions, such as a
credible allegation of fraud or other inappropriate billing or risk of
patient harm;
++ Whether such provisions include an appeal process and, if so,
the extent to which such appeal process is utilized and the outcomes of
such appeals.
<bullet> With respect to acceptance of standard Part D pharmacy
contract terms and conditions:
++ The amount of time pharmacies (and their PSAOs) are given to
review proposed standard terms and conditions, rate sheets, and
amendments before acceptance is required or deemed;
++ The use of deemed acceptance or negative-consent provisions (for
example, terms treated as accepted if the pharmacy does not respond
within a certain timeframe);
++ Whether pharmacies receive complete reimbursement information--
including ingredient cost methodology, dispensing fees, applicable
effective-rate guarantees, performance measures, and direct and
indirect remuneration (DIR) fee structures--at the time the contract or
amendment is offered;
++ Whether the timing and completeness of disclosures are
sufficient to constitute a reasonable opportunity to evaluate and
accept terms within the meaning of section 1860D-4(b)(1)(A) of the Act;
<bullet> How often standard terms and conditions, MAC lists, or
other reimbursement parameters are modified mid-contract; the notice
provided to network pharmacies before such modifications take effect;
who has authority to make such changes; and
[[Page 60571]]
whether pharmacies have a meaningful opportunity to decline modified
terms without losing network participation;
<bullet> Whether CMS should establish minimum review periods,
disclosure requirements, or affirmative acceptance requirements (as
opposed to deemed acceptance) for standard contract terms, amendments,
and material reimbursement changes as part of the standards for
reasonable and relevant pharmacy contract terms and conditions;
<bullet> With respect to pharmacy contract terms and conditions,
whether related to pharmacy reimbursement or otherwise:
++ Whether a mechanism is provided to resolve disputes about such
terms, and the adequacy of such mechanisms;
++ What limitations, if any, are placed on a pharmacy's ability to
file disputes;
++ Whether dispute resolution procedures are clearly outlined;
++ How disputes are adjudicated, and by whom;
++ Resolution timeframes; and
++ Approval and denial rates;
<bullet> Incentives, if any, that help foster a level playing field
between the parties; and
<bullet> Other ways to ensure transparency and fairness in Part D
pharmacy contracting.
C. Trends in Contract Terms and Conditions
CMS seeks information regarding trends in Part D plan sponsor and
network pharmacy contract terms and conditions. Specific areas of
interest include--
<bullet> Reimbursement methodologies for dispensing services,
including but not limited to the use of MAC pricing and other pricing
benchmarks relied on for ingredient costs and incentive payments;
<bullet> Payment methodologies for other payments made to network
pharmacies by Part D plan sponsors or PBMs, and any payments from
network pharmacies to Part D plan sponsors or PBMs (for example,
network participation fees);
<bullet> Performance-based pharmacy payment models;
<bullet> The uniformity of terms and conditions offered by
different Part D plan sponsors and plan types;
<bullet> Terms and conditions offered to pharmacies with multiple
lines of business (for example, retail, LTC, specialty), and how such
terms and conditions accommodate the multiple lines of business;
<bullet> Terms and conditions for non-dispensing services
(including information about what the non-dispensing services are and
how they are compensated), and whether non-dispensing services
generally are included in or negotiated outside of the standard
contract terms and conditions referred to in section 1860D-
4(b)(1)(A)(i) of the Act;
<bullet> The complexity of Part D pharmacy contracting terms and
conditions and issues related to transparency;
<bullet> Impacts of the Inflation Reduction Act of 2022 on Part D
pharmacy contracting, including the impact of maximum fair prices
(MFPs) under the Medicare Drug Price Negotiation Program on Part D
pharmacy reimbursement terms for both selected drugs and non-selected
drugs; and
<bullet> Trends related to the use of guarantees that utilize a
single effective rate target for both Part D and commercial lines of
business.
D. Pharmacy Quality and Performance Measures
CMS seeks information about the use and application of pharmacy
quality measures (or other measures used to evaluate pharmacy
performance) by Part D plan sponsors for network pharmacies. Specific
areas of interest include--
<bullet> How such measures are incorporated into network pharmacy
contracts;
<bullet> What measures are used, including methodology and measure
steward;
<bullet> Whether measures are applied uniformly across pharmacies,
or how specifications vary by pharmacy type or other pharmacy
attributes;
<bullet> How such measures are used to monitor pharmacy
performance, including success/failure performance threshold(s), or
impact to pharmacy reimbursement or preferred network placement;
<bullet> Whether and how measures are validated or risk-adjusted;
<bullet> How performance impacts enrollee outcomes or the financial
implications for Part D plan sponsors and pharmacies;
<bullet> Whether and how often network pharmacies receive access to
performance measure data;
<bullet> Whether any measures are aligned with CMS' contract-level
Part D Star Ratings measures, and how any measures have been re-
specified at the pharmacy level;
<bullet> Information about disproportionate impacts of pharmacy
quality or performance measures on particular pharmacy types or
pharmacy characteristics (for example, pharmacy size, setting, and non-
chain type); and
<bullet> Appeal processes for pharmacies regarding their
performance measures.
E. Auditing Practices
CMS seeks information regarding Part D plan sponsor auditing
practices for network pharmacies. Areas of interest include--
<bullet> The frequency and type of pharmacy audits conducted;
<bullet> Transparency of audit and recoupment methodologies,
including whether pharmacies are provided with information on a per
claim basis;
<bullet> Information about common audit findings and financial and
other impacts on pharmacies and plans;
<bullet> The extent to which pharmacy audits are used for or result
in identification of administrative or clerical issues versus issues
related to patient care or program integrity vulnerabilities such as
fraud or other improper billing;
<bullet> Extrapolation methods used for recoupment;
<bullet> Whether and how Part D plan sponsors audit, verify, or
otherwise validate the claim-level pricing data and DIR data they
receive from PBMs, particularly when the PBM is affiliated with one or
more network pharmacies;
<bullet> Use of audits to recoup payment based on errors, including
minor errors; and
<bullet> Opportunities for corrective action; and
<bullet> Due process provisions.
F. Limitations
CMS seeks information about Part D plan sponsor restrictions or
limitations on the dispensing of covered Part D drugs by network
pharmacies (or any subsets of pharmacies), including the nature and
prevalence of such limitations.
G. Current Regulations and Guidance
CMS seeks information about areas in current regulations or Part D
program guidance related to contracting between prescription drug plans
and network pharmacies that may require clarification or additional
specificity. In responding to this topic, commenters should consider
Part D regulations at 42 CFR part 423, the Medicare Prescription Drug
Benefit Manual,\2\ and any other CMS regulations or guidance relevant
to the topics included in this RFI.
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\2\ Available at: <a href="https://www.cms.gov/medicare/coverage/prescription-drug-coverage-contracting/prescription-drug-benefit-manual">https://www.cms.gov/medicare/coverage/prescription-drug-coverage-contracting/prescription-drug-benefit-manual</a>.
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H. Implementation of Standards
CMS seeks information related to the implementation of reasonable
and relevant standard contract terms and conditions not otherwise
addressed in the topics included in this RFI. Areas of interest
include--
[[Page 60572]]
<bullet> Operational considerations, including timelines needed for
Part D plan sponsors, PBMs, and pharmacies to modify contracts to
comply with new standards and implement other needed operational
changes;
<bullet> What documentation CMS should require to demonstrate
compliance with standards for reasonable and relevant standard contract
terms and conditions once finalized;
<bullet> Contracting practices not captured in this RFI that CMS
should evaluate;
<bullet> Examples of pharmacy contract terms and conditions or
similar frameworks that could be viewed as models;
<bullet> Criteria CMS should consider to ensure standards are
transparent, objective, and enforceable.
III. Collection of Information Requirements
This is an RFI only. In accordance with the implementing
regulations of the Paperwork Reduction Act of 1995 (PRA), specifically
5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA.
Facts or opinions submitted in response to general solicitations of
comments from the public, published in the Federal Register or other
publications, regardless of the form or format thereof, provided that
no person is required to supply specific information pertaining to the
commenter, other than that necessary for self-identification, as a
condition of the agency's full consideration, are not generally
considered information collections and therefore not subject to the
PRA.
This RFI is issued solely for information and planning purposes; it
does not constitute a Request for Proposal (RFP), applications,
proposal abstracts, or quotations. This RFI does not commit the U.S.
Government to contract for any supplies or services or make a grant
award. Further, we are not seeking proposals through this RFI and will
not accept unsolicited proposals. Responders are advised that the U.S.
Government will not pay for any information or administrative costs
incurred in response to this RFI; all costs associated with responding
to this RFI will be solely at the interested party's expense. Not
responding to this RFI does not preclude participation in any future
procurement, if conducted. It is the responsibility of the potential
responders to monitor this RFI announcement for additional information
pertaining to this request. In addition, CMS will not respond to
questions about the policy issues raised in this RFI.
CMS will consider all input as we develop future proposals or
policy guidance. We may or may not choose to contact individual
responders. Such communications would be for the sole purpose of
clarifying statements in the responders' written responses. Contractor
support personnel may be used to review responses to this RFI.
Responses to this notice are not offers and cannot be accepted by the
U.S. Government to form a binding contract or issue a grant.
Information obtained as a result of this RFI may be used by the U.S.
Government for program planning on a non-attribution basis. Respondents
should not include any information that might be considered proprietary
or confidential. This RFI should not be construed as a commitment or
authorization to incur cost for which reimbursement would be required
or sought. All submissions become U.S. Government property and will not
be returned. In addition, we may publicly post the public comments
received or a summary of those public comments.
Mehmet Oz, Administrator of the Centers for Medicare & Medicaid
Services, approved this document on September 15, 2026.
Robert F. Kennedy, Jr.,
Secretary, Department of Health and Human Services.
[FR Doc. 2026-19535 Filed 9-23-26; 8:45 am]
BILLING CODE 4169-69-P
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