Notice2025-14619
340B Program Notice: Application Process for the 340B Rebate Model Pilot Program
Primary source
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Published
August 1, 2025
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
The U.S. Department of Health and Human Services (HHS) Health Resources and Service Administration (HRSA), Office of Pharmacy Affairs (OPA), which administers the 340B Drug Pricing Program (340B Program), is issuing this Notice to announce the availability of a 340B Rebate Model Pilot Program as a voluntary mechanism for qualifying drug manufacturers to effectuate the 340B ceiling price on select drugs to all covered entities, and to collect comments on the structure and application process of the 340B Rebate Model Pilot Program, as outlined in this Notice. OPA will consider comments received but is under no obligation to respond to or act on the comments. This Notice is effective immediately as published, unless revised by a future notice. OPA reserves the right to issue revisions or addenda to this Notice at a later date (including, but not limited to, revisions or addenda informed by public comment).
Full Text
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<title>Federal Register, Volume 90 Issue 146 (Friday, August 1, 2025)</title>
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[Federal Register Volume 90, Number 146 (Friday, August 1, 2025)]
[Notices]
[Pages 36163-36165]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-14619]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
340B Program Notice: Application Process for the 340B Rebate
Model Pilot Program
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Announcement of Application Process for the 340B Rebate Model
Pilot Program and Request for Public Comment.
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SUMMARY: The U.S. Department of Health and Human Services (HHS) Health
Resources and Service Administration (HRSA), Office of Pharmacy Affairs
(OPA), which administers the 340B Drug Pricing Program (340B Program),
is issuing this Notice to announce the availability of a 340B Rebate
Model Pilot Program as a voluntary mechanism for qualifying drug
manufacturers to effectuate the 340B ceiling price on select drugs to
all covered entities, and to collect comments on the structure and
application process of the 340B Rebate Model Pilot Program, as outlined
in this Notice. OPA will consider comments received but is under no
obligation to respond to or act on the comments. This Notice is
effective immediately as published, unless revised by a future notice.
OPA reserves the right to issue revisions or addenda to this Notice at
a later date (including, but not limited to, revisions or addenda
informed by public comment).
DATES: Submit comments no later than September 2, 2025.
ADDRESSES: Electronic comments should be submitted Federal eRulemaking
Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the instructions on the
website for submitting comments. Include the HHS Docket No. HRSA-2025-
___ in your comments. All comments received will be posted without
change to <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Please do not include any
personally identifiable or confidential business information you do not
want publicly disclosed.
FOR FURTHER INFORMATION CONTACT: Chantelle Britton, Director, Office of
Pharmacy Affairs, HRSA, 5600 Fishers Lane, Mail Stop 14W52, Rockville,
MD 20857; email: <a href="/cdn-cgi/l/email-protection#e7d4d3d7a597958e848e8980a78f959486c9808891"><span class="__cf_email__" data-cfemail="c7f4f3f785b7b5aea4aea9a087afb5b4a6e9a0a8b1">[email protected]</span></a>; telephone 301-594-4353.
SUPPLEMENTARY INFORMATION: OPA has received inquiries from
manufacturers related to different proposed rebate models for the 340B
Program, primarily to address 340B and Maximum Fair Price (MFP)
deduplication,\1\ but also to facilitate other aims such as the
prevention of 340B Medicaid duplicate discounts and diversion.
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\1\ As stated in Medicare Drug Price Negotiation Program:
Revised Guidance, Implementation of Sections 1191-1198 of the Social
Security Act for Initial Price Applicability Year 2026, ``in
accordance with section 1193(d)(1) of the Social Security Act, the
Primary Manufacturer of a selected drug is not required to provide
access to the Maximum Fair Price (MFP) for a selected drug to MFP-
eligible individuals who are eligible to be furnished, administered,
or dispensed such selected drug at a covered entity described in
section 340B(a)(4) of the (Public Health Service (PHS)) Act if the
selected drug is subject to an agreement described in section
340B(a)(1) of the PHSA and the 340B ceiling price (defined in
section 340B(a)(1) of the PHS Act is lower than the MFP for such
selected drug. Under section 1193(d)(2) of the Social Security Act,
the Primary Manufacturer is required to provide access to the MFP to
340B covered entities in a deduplicated amount to the 340B ceiling
price if the MFP for the selected drug is lower than the 340B
ceiling price for the selected drug.''
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A ``rebate'' for purposes of this pilot program, means a
reimbursement made from the manufacturer to the covered entity in the
amount of the standard acquisition cost (i.e., wholesale acquisition
cost) of a covered outpatient drug less the statutory 340B ceiling
price as defined at section 340B(a)(1) of the Public Health Service Act
(PHSA).
Whereas the 340B Program has traditionally operated as an upfront
discount program (i.e., a covered entity purchases a covered outpatient
drug at the discounted 340B price), under a rebate model, a covered
entity would pay for the drug at a higher price upfront and then later
receive a post-purchase rebate that reflects the difference between the
higher initial price and the 340B price. Section 340B(a)(1) of the PHSA
states, ``[t]he Secretary shall enter into an agreement with each
manufacturer of covered
[[Page 36164]]
outpatient drugs under which the amount required to be paid (taking
into account any rebate or discount, as provided by the Secretary) to
the manufacturer for covered outpatient drugs . . . purchased by a
covered entity . . . does not exceed [designated prices].'' As the
Department has previously informed stakeholders, implementing a rebate
model without Secretarial approval would violate section 340B(a)(1) of
the PHSA.
Due to the significant amount of feedback received from (or on
behalf of) manufacturers and covered entities regarding implementation
of rebate models, and in light of the fact that rebate models could
fundamentally shift how the 340B Program has operated for over 30
years, OPA is inviting certain drug manufacturers, that meet the
criteria described below, to apply for participation in a voluntary
340B Rebate Model Pilot Program for a minimum of 1 year. OPA is
introducing this pilot program to test the rebate model on a select
group of drugs (as described below) in a methodical and thoughtful
approach to ensure a fair and transparent 340B rebate model process for
all stakeholders involved. OPA is also implementing this pilot to
better understand the merits and shortcomings of the rebate model from
stakeholders' perspectives, and to inform OPA consideration of any
future 340B rebate models consistent with the 340B statute and the
Administration's goals.
The scope of this voluntary 340B Rebate Model Pilot Program will be
limited to the NDC-11s included on the CMS Medicare Drug Price
Negotiation Selected Drug List,\2\ regardless of payer.
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\2\ Medicare Drug Price Negotiation Selected Drug List,
available at <a href="https://www.cms.gov/files/zip/medicare-drug-price-negotiation-selected-drug-list.zip">https://www.cms.gov/files/zip/medicare-drug-price-negotiation-selected-drug-list.zip</a>.
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The first call to submit plans for OPA review is for the
manufacturers with Medicare Drug Price Negotiation Program (MDPNP)
Agreements with CMS for initial price applicability year 2026.\3\
Manufacturer plans for participation in the 340B Rebate Model Pilot
Program should be submitted to <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="586b6c681a082a313b31363f18302a2b39763f372e">[email protected]</a> no later than
September 15, 2025. Approvals will be made by October 15, 2025, for a
January 1, 2026, effective date. Manufacturers may not implement plans
without first receiving approval in accordance with section 340B(a)(1)
of the PHSA. OPA may announce a call for plans from manufacturers with
MDPNP Agreements for other applicability years, at a later time.
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\3\ The Fact Sheet for Negotiated Prices for Applicability Year
2026 includes the list of Primary Manufacturers with selected drugs,
available at <a href="https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf">https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf</a>.
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After assessment of the pilot, which will include OPA's evaluation
of data and reports received from the participating manufacturers on
the effectiveness of the model and covered entity and other stakeholder
feedback, OPA may consider expanding the rebate pilot to other drugs
purchased under the 340B Program. Additional information about
manufacturer reporting and stakeholder feedback opportunities will be
provided in the future.
Manufacturer plans for the 340B Rebate Model Pilot Program should
include the criteria outlined below. Manufacturer plans that exceed or
go beyond these criteria should include detailed justification and will
be subject to additional review by OPA prior to implementation. OPA
will review submitted plans and notify manufacturers if they are
approved to participate in the 340B Rebate Model Pilot Program.
Submitted plans should not exceed 1,000 words and should address all of
the criteria below. OPA reserves the right to revoke approval of a
manufacturer plan at any time if a manufacturer is not in compliance
with the criteria outlined in the ``Rebate Model Pilot Program
Criteria'' below.
OPA is seeking public comment on all aspects of this Notice and the
340B Rebate Model Pilot Program. Specifically, commenters are
encouraged to include supporting data and sources underpinning any
factual claims. Commenters should also consider the following questions
when providing comment on this Notice and the Pilot Program:
<bullet> Are there any additional flexibilities to maximize
efficiency and efficacy for participating manufacturers that should be
considered in the pilot design?
<bullet> Are there any additional safeguards to mitigate adverse,
unintended impacts for covered entities that should be considered in
the pilot design?
<bullet> Are there any additional data or reporting elements that
should be required to improve implementation and evaluation of the
pilot?
<bullet> Are there any potential implementation issues not yet
sufficiently accounted for in the pilot design (e.g., logistical or
administrative burdens)?
Rebate Model Pilot Program Criteria
General Requirements
1. Plan should include assurances that all costs for data
submission through an Information Technology (IT) platform be borne by
the manufacturer and no additional administrative costs of running the
rebate model shall be passed onto the covered entities.
2. Plan should allow for 60 calendar days' notice to covered
entities and other impacted stakeholders before implementation of a
rebate model, with instructions for registering for any IT platforms.
3. Plan should allow for covered entities to order the selected
drugs under existing distribution mechanisms (e.g., 340B wholesaler
accounts with pre-rebate prices loaded) to ensure purchases flow
through existing infrastructure.
4. Plan should provide a technical assistance/customer service
component and ensure that opportunities to engage with the manufacturer
in good faith regarding questions or concerns are made available to
covered entities through both the IT platform and a point of contact at
the manufacturer.
5. Plan should ensure that the IT platform has assurances in place
to ensure that the data is secure and protected and collection of the
data is limited to the elements listed below that are necessary for
providing 340B rebates pursuant to section 340B(a)(1) of the PHSA.
6. Plan should ensure that the IT platform has mechanisms in place
to protect patient identifying information, which is required to be
maintained in a manner consistent with the Health Insurance Portability
and Accountability Act of 1996 and any other applicable privacy and
data security laws.
Reporting Requirements
7. Plan should ensure that covered entities are allowed to submit
and report data (as detailed below) for up to 45 calendar days from
date of dispense, with allowances for extenuating circumstances and
other exceptions, including adjustments when a 340B status change
occurs on a claim.
8. Plan should ensure that the IT platform will have the capacity
to receive data that will filter and use only the data required to
effectuate the rebate (e.g., if drugs other than selected drugs under
the MDPNP are submitted, the platform will be able to identify and
discard unneeded data).
9. Plan should ensure that the IT platform will have the capability
to provide real-time reconciliation reports for covered entities to be
informed of the rebate status of submitted claims.
10. A manufacturer should agree to provide OPA with periodic
reports consistent with the information outlined in this Notice, in a
format and manner
[[Page 36165]]
specified by OPA (instructions forthcoming). Such reports should detail
data on purchases provided through rebates, information related to
claim delays and denials, and other information that may evaluate the
effectiveness of the rebate model.
Rebates
11. Plan should specify if rebates are paid at the package level,
or at the unit level.
12. Plan should ensure that all rebates are paid to the covered
entity (or denied, with documentation in support) within 10 calendar
days of data submission.
13. Plan should ensure that 340B rebates are not denied based on
compliance concerns with diversion or Medicaid duplicate discounts,
pursuant to sections 340B(a)(5)(A) and (B) of the Public Health Service
Act and should provide for rationale and specific documentation for
reasons claims are denied (e.g., deduplication for MFP or 340B rebate
provided to another covered entity on the same claim). If a
manufacturer has concerns regarding diversion or Medicaid duplicate
discounts, the manufacturer should raise those concerns directly with
OPA or utilize the 340B statutory mechanisms, such as audits and
administrative dispute resolution (ADR), for addressing such issues.
Covered entities are also afforded opportunities to raise concerns with
OPA if there are issues with rebate delays and denials, or any other
administrative or logistical issues emerging through implementation of
the rebate model.
14. Plan should ensure that 340B rebates are only paid on sales of
drugs selected under the MDPNP, regardless of payer.
Data
15. All data requested as part of the Plan should be limited to
only the following readily available pharmacy claim fields:
a. Date of Service
b. Date Prescribed
c. RX number
d. Fill Number
e. 11 Digit National Drug Code (NDC)
f. Quantity Dispensed
g. Prescriber ID
h. Service Provider ID
i. 340B ID
j. Rx Bank Identification Number (BIN)
k. Rx Processor Control Number (PCN)
Thomas J. Engels,
Administrator.
[FR Doc. 2025-14619 Filed 7-31-25; 8:45 am]
BILLING CODE P
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