Notice2026-11989
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: 340B Rebate Model Pilot Program Application, Implementation, and Evaluation, OMB Number 0906-NEW
Primary source
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Published
June 15, 2026
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the Paperwork Reduction Act (PRA) of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Full Text
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<title>Federal Register, Volume 91 Issue 114 (Monday, June 15, 2026)</title>
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[Federal Register Volume 91, Number 114 (Monday, June 15, 2026)]
[Notices]
[Pages 35989-35991]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11989]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request; Information Collection Request Title: 340B
Rebate Model Pilot Program Application, Implementation, and Evaluation,
OMB Number 0906-NEW
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) of 1995,
HRSA submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period. OMB may act on HRSA's ICR only after the 30-day
comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than July 15,
2026.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the HRSA
Information Collection Clearance Officer, at <a href="/cdn-cgi/l/email-protection#a5d5c4d5c0d7d2cad7cee5cdd7d6c48bc2cad3"><span class="__cf_email__" data-cfemail="fe8e9f8e9b8c89918c95be968c8d9fd0999188">[email protected]</span></a> or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: 340B Rebate Model Pilot
Program Application, Implementation, and Evaluation, OMB No. 0906-NEW.
Abstract: HRSA's Office of Pharmacy Affairs (OPA) intends to
introduce a revised 340B Rebate Model Pilot Program (Pilot) as a
mechanism for qualifying drug manufacturers, who wish to participate,
to effectuate the 340B ceiling price on a limited set of drugs sold to
covered entities using rebates. OPA plans to publish a Federal Register
Notice to notify 340B stakeholders of criteria and standards for
implementation of the Pilot. This ICR includes the collection of Pilot
plans from drug manufacturers, the collection of purchase data reports
from drug manufacturers for OPA's monitoring of the Pilot and for
overall 340B Program surveillance and program integrity monitoring, and
the collection of data submitted by covered entities to manufacturers
to request rebates.
A 60-day notice was published in the Federal Register for this ICR
on February 26, 2026, vol. 91, No. 2026-03833, pp. 9632-9633. There
were 180 timely public comments. Commenters included hospitals, health
systems, community health centers, pharmacies, manufacturers, vendors,
and national associations. HRSA accepted comments on the following
topics: (1) burden on drug manufacturers to submit 340B Rebate Pilot
Plans to OPA; (2) burden on drug manufacturers to submit reports to
OPA; and (3) burden on covered entities to submit data to
manufacturers. HRSA also received comments including general opposition
to implementing a rebate model and requests to maintain the current
upfront discount structure; concerns about financial impacts such as
cash flow constraints, increased drug acquisition costs, and loss of
340B savings; potential downstream effects on patient care, including
reduced access to medications and elimination of services supported by
340B savings; legal and statutory arguments regarding HRSA's authority
to implement a rebate model; and recommendations for alternative
program designs, such as use of a centralized clearinghouse or other
approaches to address duplicate discount concerns. While HRSA
acknowledges these concerns, they do not directly address the
necessity, practical utility, or burden of the information collection
under the PRA and therefore were not considered in revising burden
estimates or data collection requirements. Other out of scope comments
were related to manufacturer contract pharmacy policies, third-party
platforms, and broader program integrity issues. The concerns raised
that are not directly related to burden as outlined in this ICR will be
addressed in a separate Federal Register notice.
HRSA received a few comments related to the burden on manufacturers
to submit Pilot plans to OPA. These commenters generally focused on
administrative considerations associated with OPA's collection and
review of such plans rather than on actual burden on drug
manufacturers. HRSA did not receive any comments on the burden
associated with drug manufacturers submitting reports to OPA. While
some commenters provided input on reporting structure and data
processes, these comments did not address the estimated burden hours
for manufacturer reporting.
A significant number of commenters raised concerns about the burden
on covered entities to submit data to manufacturers. Commenters
consistently indicated that the proposed data submission requirements
would impose substantial administrative, operational, and systems-
related burdens. Specifically, commenters noted that compliance would
require additional staffing, new or modified information technology
systems, increased data tracking and reconciliation efforts, and
ongoing
[[Page 35990]]
auditing and reporting activities. Several commenters also raised
concerns about the complexity of claims-level data submission,
potential for errors, and the need to manage denials and disputes, all
of which would increase burden. In addition, some commenters
highlighted privacy and data-sharing concerns associated with
transmitting patient-level information to manufacturers.
Some commenters, including hospital associations, provided
substantially higher burden estimates, including estimates requiring
dedicated staff resources or full-time equivalent employees to manage
reporting, reconciliation, and compliance activities. Commenters
provided a wide range of estimates, from modest incremental burden
where automated systems are used, to substantially higher burden
reflecting manual processes, system integration challenges, and ongoing
reconciliation activities.
Many commenters stated that HRSA underestimated the burden hours
associated with these activities and recommended that the estimated
hours be increased to better reflect the operational realities faced by
covered entities. Commenters frequently cited that processing and
managing rebate-related data could take significantly more time per
claim than estimated and would require dedicated staff resources. HRSA
also notes that other commenters indicated that required data elements
are already being collected by covered entities and that automation may
reduce burden for certain entities.
After careful consideration of the comments, HRSA acknowledges that
commenters identified potential administrative, operational, and
systems-related burdens associated with covered entities submitting
data to manufacturers. Commenters described multiple activities
involved in the reporting process, including claims identification,
extraction, validation, formatting, submission, reconciliation, denial
management, and ongoing auditing. Several commenters also indicated
that these activities may require additional staffing, system
modifications, or coordination across departments.
At the same time, other commenters asserted that the cost estimates
by covered entities are overstated or unsupported and noted that many
of the required data elements are already collected and maintained by
covered entities as part of routine billing, compliance, and audit
processes, and that existing systems and third-party administrators may
be leveraged to support data submission and reporting. In their view,
the data sharing requirements contemplated with rebates are materially
similar to existing obligations imposed by Medicare, Medicaid, and
commercial payers. These commenters indicated that, particularly after
initial implementation, ongoing reporting activities may be automated
or integrated into existing workflows, thereby reducing incremental
burden on covered entities.
To estimate burden, HRSA applied a task-based methodology that
considers the discrete activities required to complete a reporting
cycle, including: (1) identifying and extracting eligible claims data;
(2) formatting and validating data to meet manufacturer specifications;
(3) submitting the data; (4) reconciling submissions and tracking
rebate status; and (5) addressing errors, denials, or follow-up
requests. HRSA evaluated the range of estimates provided by commenters,
including higher-end estimates reflecting total operational workload
and lower-end estimates reflecting use of existing systems and
automation, and normalized these inputs into a per-response estimate
consistent with PRA requirements.
HRSA considered higher estimates provided by some commenters,
including those based on full-time equivalent staffing or total weekly
workload, but determined that these estimates reflect overall
operational impacts rather than the incremental time required to
complete individual reporting responses under the PRA framework. HRSA
also considered that the Pilot will implement a rebate approach for a
limited set of drugs and is designed to utilize a targeted and limited
set of claims-level data elements necessary to administer rebate
eligibility and prevent duplicate discounts and diversion. These
standardized data elements are commonly available and already
generated, maintained, and transmitted by covered entities or their
vendors.
HRSA recognizes that covered entities vary in size, patient volume,
staffing capacity, and technical infrastructure. As a result, the time
required to submit data to manufacturers will differ across entities,
with some smaller or less complex entities initially experiencing lower
burden and larger or more complex entities initially experiencing
higher burden. Alternatively, the more complex entities may have a more
sophisticated operations infrastructure that will lower the burden of
adopting reporting requirements. The estimate of 5 hours per response
reflects a reasonable median burden across this range of entities and
is consistent with PRA guidance to estimate typical respondent effort.
Taken together, the comments demonstrate that the reporting process
involves multiple steps beyond a simple transmission of data. However,
based on the task-based methodology, the limited scope of the Pilot,
and the ability of many covered entities to leverage existing systems
and processes, HRSA has determined that maintaining the estimated
burden of 5 hours per week to respond provides a reasonable and
appropriate estimate of the time required for covered entities to
comply with the data submission requirements.
Need and Proposed Use of the Information: The scope of the
anticipated Pilot will be limited to manufacturers with current
Medicare Drug Price Negotiation Program Agreements with the Centers for
Medicare & Medicaid Services for the initial price applicability years
(IPAY) 2026 and 2027.\1\ This ICR includes the collection of proposed
rebate model plans from qualifying drug manufacturers, the ongoing
collection of sales data from drug manufacturers to allow OPA to
monitor implementation of the Pilot and enhance 340B program integrity
and compliance monitoring, and the collection of data submitted by
covered entities to manufacturers to request a rebate under a potential
Pilot.
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\1\ The Fact Sheets for Negotiated Prices for Applicability
Years 2026 and 2027 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> and <a href="https://www.cms.gov/files/document/fact-sheet-negotiated-prices-ipay-2027.pdf">https://www.cms.gov/files/document/fact-sheet-negotiated-prices-ipay-2027.pdf</a> respectively.
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Collection of Drug Manufacturer Applications: OPA will review,
evaluate and approve manufacturer plans for participation in the Pilot
based on requirements to be published in the Federal Register at a
future date.
Collection of Reporting Data from Manufacturers: Under the Pilot,
approved manufacturers will be required to submit data to the 340B
Prime Vendor on a monthly basis to monitor Pilot implementation and to
provide greater transparency into 340B claims transactions. Monthly
data submissions will enhance overall 340B Program compliance
monitoring and reduce lag time in assessing 340B Program metrics. The
monthly data will also support the ongoing monitoring of the Pilot.
Collection of Data Submitted by Covered Entities to Manufacturers:
Under a Pilot, covered entities will be required to provide specific
data to participating manufacturers in order for the manufacturers to
provide rebates to
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effectuate the 340B price on the covered entities' eligible covered
outpatient drug purchases. Specific requirements detailing the type and
frequency of such submittals will be defined in a Federal Register
notice, to include claims level data elements for 340B-eligible
dispenses. The data submitted by covered entities to manufacturers is
comparable to data already being collected and maintained by covered
entities through existing third-party vendor relationships.
Likely Respondents: Drug manufacturers and covered entities.
Burden Statement: Burden in the context of this information
collection means the time expended by persons to generate, maintain,
retain, disclose, or provide the information requested. This includes
the time needed to review instructions; to develop, acquire, install,
and utilize technology and systems, if necessary, for the purpose of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information; to
train personnel and to be able to respond to a collection of
information; to search data sources; to complete and review the
collection of information; and to transmit or otherwise disclose the
information. The total annual burden hours estimated for this ICR are
summarized in the table below and were analyzed based on implementation
of a potential Pilot compared to current data collection practices in
the market.
The total annual burden hours estimated for this ICR reflect the
number of respondents once an anticipated Pilot is implemented. This
includes 11 manufacturers of IPAY 2026 and IPAY 2027 drugs.
Total Estimated Annualized Burden Hours:
Table 1
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Number of Average burden
Form name Number of responses per Total per response Total burden
respondents * respondent responses (in hours) hours
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340B Program Rebate Model Pilot 11 1 11 8 88
Program Plan Submission........
Monthly purchase reports........ 11 12 132 2 264
Covered Entities reporting ** 15,249 52 792,948 5 3,964,740
claims data to third party
platform.......................
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Total....................... 15,260 .............. 793,080 .............. 3,965,092
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The 11 manufacturers will submit Plans and Monthly Purchase Reports (first two rows, above), while the 15,249
Covered Entities will submit Claims Data (third row, above). Therefore, the total number of respondents is
15,260
** As of April 1, 2026.
Amy P. McNulty,
Deputy Director, Executive Secretariat.
[FR Doc. 2026-11989 Filed 6-12-26; 8:45 am]
BILLING CODE 4165-15-P
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