Notice2024-17380
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: 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
August 7, 2024
Issuing agencies
Health and Human Services DepartmentHealth Resources and Services Administration
Abstract
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Full Text
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<title>Federal Register, Volume 89 Issue 152 (Wednesday, August 7, 2024)</title>
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[Federal Register Volume 89, Number 152 (Wednesday, August 7, 2024)]
[Notices]
[Pages 64468-64469]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-17380]
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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 Drug
Pricing Program; Initiation of the Administrative Dispute Resolution
Process
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA announces plans to submit an Information Collection
Request (ICR) to the Office of Management and Budget (OMB). Prior to
submitting the ICR to OMB, HRSA seeks comments from the public
regarding the burden estimate, below, or any other aspect of the ICR.
DATES: Comments on this ICR should be received no later than October 7,
2024.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#196978697c6b6e766b7259716b6a78377e766f"><span class="__cf_email__" data-cfemail="93e3f2e3f6e1e4fce1f8d3fbe1e0f2bdf4fce5">[email protected]</span></a> or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 5600 Fishers
Lane, Rockville, Maryland, 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project, email <a href="/cdn-cgi/l/email-protection#fb8b9a8b9e898c948990bb9389889ad59c948d"><span class="__cf_email__" data-cfemail="522233223720253d2039123a2021337c353d24">[email protected]</span></a> or call Joella Roland, the
HRSA Information Collection Clearance Officer, at (301) 443-3983.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
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. The Secretary of HHS
(Secretary) has delegated the authority to administer the 340B Drug
Pricing Program to the HRSA Administrator, who has further delegated
authority to the Office of Pharmacy Affairs (OPA), within HRSA, which
oversees the 340B Drug Pricing Program. 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 28643 (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 OPA's 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, OPA will dismiss the claim. 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.
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 and manufacturers and
organizations representing these groups.
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
[[Page 64469]]
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. To
estimate the burden to initiate the 340B ADR process, HRSA reviewed the
amount of petitions received under a prior 340B ADR process and
estimated the amount of time it took petitioners to initiate the 340B
ADR process up until the claim was assigned to a 340B ADR Panel for
review. 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........... 10 1 10 2.5 25
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Total....................... 10 .............. 10 .............. 25
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HRSA specifically requests comments on: (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-17380 Filed 8-6-24; 8:45 am]
BILLING CODE 4165-15-P
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