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, 3881-3882 [2025-00831]
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Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices
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
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
Comments on this ICR should be
received no later than February 14,
2025.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. 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
paperwork@hrsa.gov 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
lotter on DSK11XQN23PROD with NOTICES1
ADDRESSES:
VerDate Sep<11>2014
18:37 Jan 14, 2025
Jkt 265001
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
PO 00000
Frm 00095
Fmt 4703
Sfmt 4703
3881
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
https://www.hrsa.gov/opa/340badministrative-dispute-resolution.
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
E:\FR\FM\15JAN1.SGM
15JAN1
3882
Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices
covered entities are a separate, preexisting 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
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
340B Claim Submission .......................................................
15
1
15
2.5
37.5
Total ..............................................................................
15
........................
15
........................
37.5
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025–00831 Filed 1–14–25; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Council on the National Health Service
Corps
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
AGENCY:
ACTION:
Notice.
In accordance with the
Federal Advisory Committee Act, this
notice announces that the National
Advisory Council on the National
Health Service Corps (NACNHSC) will
hold public meetings for the 2025
calendar year (CY). Information about
NACNHSC, agendas, and materials for
these meetings can be found on the
NACNHSC website at: https://
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
VerDate Sep<11>2014
18:37 Jan 14, 2025
Jkt 265001
www.hrsa.gov/advisory-committees/
national-health-service-corps.
DATES: NACNHSC meetings will be held
on March 18, 2025, 10:00 a.m. Eastern
Time (ET)–4:30 p.m. ET and March 19,
2025, 10 a.m. ET–3:30 p.m. ET; June 24,
2025, 9 a.m. ET–4:30 p.m. ET and June
25, 2025, 8:30 a.m. ET–2 p.m. ET; and
November 18, 2025, 10 a.m. ET–4:30
p.m. ET and November 19, 2025, 10 a.m.
ET–3:30 p.m. ET.
ADDRESSES: Meetings may be held inperson, by teleconference, and/or video
conference. For updates on how the
meeting will be held, visit the
NACNHSC website 30 business days
before the date of the meeting, where
instructions for joining meetings either
in-person or remotely will also be
posted. In-person NACNHSC meetings
will be held at 5600 Fishers Lane,
Rockville, Maryland 20857. For meeting
information updates, go to the
NACNHSC website meeting page at:
https://www.hrsa.gov/advisorycommittees/national-health-servicecorps/meetings.
FOR FURTHER INFORMATION CONTACT:
Diane Fabiyi-King, Designated Federal
Official, Division of National Health
Service Corps, HRSA, 5600 Fishers
PO 00000
Frm 00096
Fmt 4703
Sfmt 4703
Lane, Rockville, Maryland 20857;
NHSCAdvisoryCouncil@hrsa.gov or
(301) 443–3609.
SUPPLEMENTARY INFORMATION:
NACNHSC provides advice and
recommendations to the Secretary of
Health and Human Services on policy,
program development, and other
matters of significance concerning the
activities under subpart II, part D of title
III of the Public Health Service Act.
NACNHSC members are experts in the
issues that communities with a shortage
of primary care professionals face in
meeting their healthcare needs.
Since priorities dictate meeting times,
be advised that start times, end times,
and agenda items are subject to change.
For CY 2025 meetings, agenda items
may include, but are not limited to: the
identification of NHSC priorities for
future program issues and concerns;
proposed policy changes by using the
varying levels of expertise represented
on NACNHSC to advise on specific
program areas; updates from clinician
workforce experts; and education and
practice improvement in the training
development of primary care clinicians.
More general items may include
presentations and discussions on the
E:\FR\FM\15JAN1.SGM
15JAN1
]]>Agencies
[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Pages 3881-3882]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00831]
[[Page 3881]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 www.reginfo.gov/public/do/PRAMain. 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 [email protected] 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 https://www.hrsa.gov/opa/340b-administrative-dispute-resolution.
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
340B Claim Submission........... 15 1 15 2.5 37.5
-------------------------------------------------------------------------------
Total....................... 15 .............. 15 .............. 37.5
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2025-00831 Filed 1-14-25; 8:45 am]
BILLING CODE 4165-15-P
