Notice2025-00831
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; 340B Drug Pricing Program; Initiation of the Administrative Dispute Resolution Process
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 15, 2025
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the Paperwork Reduction Act 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 90 Issue 9 (Wednesday, January 15, 2025)</title>
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[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Pages 3881-3882]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-00831]
[[Page 3881]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; 340B Drug Pricing Program;
Initiation of the Administrative Dispute Resolution Process
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 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 February
14, 2025.
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 Joella Roland, the HRSA
Information Collection Clearance Officer, at <a href="/cdn-cgi/l/email-protection#d3a3b2a3b6a1a4bca1b893bba1a0b2fdb4bca5"><span class="__cf_email__" data-cfemail="0f7f6e7f6a7d78607d644f677d7c6e21686079">[email protected]</span></a> or call
(301) 443-3983.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: 340B Drug Pricing Program;
Initiation of the Administrative Dispute Resolution Process, OMB No.
0906-xxxx--New.
Abstract: Section 602 of Public Law 102-585, the Veterans Health
Care Act of 1992, created the 340B Drug Pricing Program in section 340B
of the Public Health Service (PHS) Act. Eligible covered entity types
are defined in section 340B(a)(4) of the PHS Act, as amended. Section
340B(a)(1) of the PHS Act instructs HHS to enter into pharmaceutical
pricing agreements with manufacturers of covered outpatient drugs.
Under section 1927(a)(5)(A) of the Social Security Act, a manufacturer
must enter into an agreement with the Secretary that complies with
section 340B of the PHS Act to receive payments from Medicaid or
Medicare Part B for the manufacturer's covered outpatient drugs. When a
manufacturer signs a pharmaceutical pricing agreement, it agrees that
the prices charged for covered outpatient drugs to covered entities
will not exceed statutorily defined 340B ceiling prices. Such prices
are based on quarterly pricing reports that manufacturers must provide
to the Secretary, which are calculated and verified by HRSA.
Section 340B(d)(3) to the PHS Act requires HHS to promulgate
regulations establishing and implementing a binding 340B Administrative
Dispute Resolution (ADR) process for certain disputes arising under the
340B Drug Pricing Program. Pursuant to the statute, the 340B ADR
process is intended to resolve (1) claims by covered entities that they
have been overcharged for covered outpatient drugs by manufacturers and
(2) claims by manufacturers, after a manufacturer has conducted an
audit as authorized by section 340B(a)(5)(C) of the PHS Act, that a
covered entity has violated the prohibition on diversion or duplicate
discounts.
On April 19, 2024, HRSA published the 340B Drug Pricing Program;
Administrative Dispute Resolution Regulation Final Rule (340B ADR Final
Rule) (89 FR 28,643 (Apr. 19, 2024) (to be codified at 42 CFR part
10)). The 340B ADR Final Rule provides the requirements for filing a
340B ADR claim. The 340B ADR Final Rule requires the submission of a
340B ADR claim within 3 years of the date of the alleged violation and
specifies that it is a remedy open to all manufacturers and covered
entities that participate in the 340B Drug Pricing Program. To initiate
the 340B ADR process, a petitioner will email HRSA's Office of Pharmacy
Affairs' (OPA) designated mailbox with its 340B ID or Labeler code and
contact information, the 340B ID or Labeler code and contact
information of the opposing party, and a brief description of the
claim. Once a petition is filed, OPA reviews the petition to make sure
the claim meets the requirements for the 340B ADR process, including
whether: (1) the claim alleges a violation of an overcharge, duplicate
discount, or diversion; (2) the claim has been filed within 3 years of
the alleged violation; and (3) the petitioner has engaged in good faith
efforts to resolve the claim. Both the petitioner and opposing party
will be required to upload certain documentation to a secure 340B ADR
workspace in the 340B OPA Information System to substantiate the claim.
After an initial review of the claim and any supporting documentation,
OPA staff will determine whether the requirements for filing a claim
have been met, and if the claim is deemed complete, OPA will notify the
parties. If the claim is deemed complete and all filing requirements
are met, the claim will be assigned to a 340B ADR Panel. If the claim
does not meet the filing requirements, the claim will not move forward
for a 340B ADR Panel's review. Specific details concerning the 340B ADR
Panel and requirements for filing a claim are outlined in the 340B ADR
Final Rule and can be reviewed at <a href="https://www.hrsa.gov/opa/340b-administrative-dispute-resolution">https://www.hrsa.gov/opa/340b-administrative-dispute-resolution</a>.
This information collection request is limited to the initiation of
the 340B ADR process and the uploading of the related documents. Filing
a claim though the 340B ADR process is a remedy open to all
manufacturers and covered entities that participate in the 340B Drug
Pricing Program, which can constitute a standardized federal
information collection. Once the claim is assigned to a 340B ADR Panel
for review, these subsequent steps, which encompass the 340B ADR
process itself and ensuing correspondence with the parties involved in
the process, are exempt from Paperwork Reduction Act requirements,
pursuant to the Paperwork Reduction Act exception listed at 44 U.S.C.
3518(c), which exempts administrative actions or investigations
involving an agency against specific individuals or entities.
The only substantive change to the information collection request
for this 30-day notice is that HRSA adjusted the estimated number of
respondents based on the number of ADR requests received thus far. HRSA
increased the estimate from 10 requests to 15 over the next three
years.
A 60-day notice published in the Federal Register on August 7,
2024, 89 FR 64468 and 64469. HRSA received five public comments.
Three commenters representing pharmaceutical manufacturers
explained that HRSA's estimate of 2.5 hours per response underestimates
the significant burden manufacturers incur to access the ADR process.
Some manufacturers noted that under the statute a manufacturer can only
access the ADR process after it has completed an audit of a covered
entity and argued HRSA's manufacturer audit guidelines impose
significant burdens on manufacturers' ability to audit. HRSA notes that
manufacturer audits of
[[Page 3882]]
covered entities are a separate, pre-existing process and are not
subject to this information request. This information collection
request is limited specifically to the initiation of the 340B ADR
process under the 2024 340B ADR Final Rule and the uploading of the
related documents at the initial phase of the 340B ADR process.
One commenter requested that HRSA require manufacturers to present
specific types of documentation and evidence to initiate a dispute.
Another commenter requested that HRSA specify what ``sufficient
documentation'' consists of for submitting an ADR claim. Under the 340B
ADR Final Rule, petitioners have discretion regarding the documentation
they submit as part of their initial submission to support their
claims.
Other comments discussed elements of the ADR Final Rule, including
defining what good faith efforts entail, how child site eligibility
relates to diversion and what the definition of an overcharge should
include, that are outside of the scope of this information collection
request. After detailed analysis of the comments received, HRSA plans
to maintain the burden hours as proposed in the 60-day notice.
Need and Proposed Use of the Information: HRSA is requesting
approval for the initiation of the 340B ADR process and uploading of
the related documents outlined in the 340B ADR Final Rule. The 340B ADR
process is conducted pursuant to the requirements under section
340B(d)(3) of the PHS Act, which requires the establishment and
implementation of the 340B ADR process for certain disputes arising
under the 340B Drug Pricing Program. HRSA uses the information gathered
in the 340B ADR initiation process to determine if the claim submitted
meets the statutory requirements for filing a 340B claim and accessing
the 340B ADR process.
Likely Respondents: Covered entities (or their membership
organizations or associations) and manufacturers.
Burden Statement: Burden in this context 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 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.
Total Estimated Annualized Burden Hours
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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 Claim Submission........... 15 1 15 2.5 37.5
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Total....................... 15 .............. 15 .............. 37.5
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Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-00831 Filed 1-14-25; 8:45 am]
BILLING CODE 4165-15-P
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