[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6580 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 6580
To amend title 38, United States Code, to make certain improvements in
the administration of the national formulary of the Department of
Veterans Affairs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 10, 2025
Mrs. Miller-Meeks introduced the following bill; which was referred to
the Committee on Veterans' Affairs
_______________________________________________________________________
A BILL
To amend title 38, United States Code, to make certain improvements in
the administration of the national formulary of the Department of
Veterans Affairs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``VA National Formulary Act of 2025''.
SEC. 2. CODIFICATION AND IMPROVEMENT OF DEPARTMENT OF VETERANS AFFAIRS
NATIONAL FORMULARY.
(a) In General.--Chapter 73 of title 38, United States Code, is
amended by adding at the end the following new subchapter:
``SUBCHAPTER VI--NATIONAL FORMULARY
``Sec. 7385. National formulary
``(a) Establishment.--The Secretary shall maintain a national
formulary that shall consist of a list of all drugs and supplies that
shall be available by prescription through all medical facilities of
the Department. The Pharmacy Benefits Management Service of the
Department shall be responsible for managing the national formulary.
``(b) Local Formulary Restrictions.--(1) The national formulary
shall be implemented uniformly across all Department medical
facilities. Except as provided in paragraph (2), no Veterans Integrated
Service Network or individual medical center may maintain a local
formulary that includes a drug or medication not listed on the national
formulary.
``(2) A drug that is not on the national formulary may be provided
to a veteran if--
``(A) the drug is provided under the nonformulary
medication request process under section 7387 of this title; or
``(B) the Under Secretary for Health (or the Under
Secretary's designee at the national level) has explicitly
approved a waiver allowing a Veterans Integrated Service
Network or facility to carry the drug for a defined patient
population or clinical program.
``(3)(A) The Director of a Veterans Integrated Service Network or
of a medical facility may request a waiver under paragraph (2)(B)
through the Pharmacy Benefits Management Services.
``(B) The Secretary shall establish a centralized review process
for considering such waiver requests, which shall include an assessment
of clinical need, safety, and cost-effectiveness. A waiver issued under
this paragraph shall be time-limited and reviewed periodically for
continuing necessity.
``(C) Nothing in this subsection shall be construed to limit the
ability of a clinician to prescribe a nonformulary drug for a veteran
when medically necessary in accordance with section 7387 of this title.
``(c) Public Communication of Formulary Decisions.--(1) The
Secretary shall communicate regularly with the general public regarding
the management of the national formulary. Such communication may
include public briefings or online announcements to explain formulary
decisions.
``(2) In the case of any change to the national formulary that the
Secretary determines may significantly affect veteran care or access
(including the exclusion of a medication that was previously commonly
used, or the addition of a new high-cost therapy with usage
restrictions), the Secretary shall publish a summary of the rationale
for the change (including consideration of clinical evidence and
outcomes) and, when feasible, hold a public briefing or stakeholder
call to discuss the change and address questions.
``(d) Reporting Requirements.--(1) The Secretary shall submit to
the Committees on Veterans' Affairs of the Senate and House of
Representatives an annual appeals report that includes a detailed
description of nonformulary decisions and appeals made during the year
covered by the report.
``(2) Not less frequently than annually during the five-year period
beginning on the date of the enactment of this section, the Secretary
shall submit to the Committees on Veterans' Affairs of the Senate and
House of Representatives, and make publicly available, a report that
includes a summary of any changes made to the national formulary of the
Department during the preceding year. Each such report shall include a
list of all drugs added to or removed from the formulary, and any
modifications to usage criteria or prior authorization requirements,
during the year covered by the report.
``Sec. 7386. Pharmacy and Therapeutics Committee
``(a) Establishment.--There is established within the Veterans
Health Administration a Pharmacy and Therapeutics Committee (in this
section referred to as the `Committee') to support the Pharmacy
Benefits Management Services in managing the national formulary of the
Department.
``(b) Composition.--The members of the Committee shall be selected
by the Secretary and shall be physicians from major clinical
specialties, clinical pharmacists, and pharmacoeconomists who are
employees of the Department. In selecting members of the Committee, the
Secretary shall ensure the inclusion of individuals with expertise in
geriatric care and mental health care for veterans.
``(c) Conflicts of Interest.--(1) The Secretary shall ensure that
each member of the Committee is free of any conflict of interest with
the pharmaceutical industry.
``(2) The Secretary shall--
``(A) require each member of the Committee to annually
disclose financial interests; and
``(B) prohibit the participation by any member in formulary
decisions for which the member has a financial conflict of
interest.
``(d) Timely Review of New Medications.--The Committee shall meet
not less often than monthly (or bimonthly) to review newly approved
drugs by the Food and Drug Administration. The goal of the Committee
with respect to each such newly approved drug shall be to make a
national formulary inclusion or exclusion decision by not later than
120 days after the date on which the drug is approved, to the extent
practicable.
``(e) Evidence-Based Decision Making.--The Committee shall make
decisions with respect to the national formulary of the Department
based on evidence-based drug monographs, clinical data (including data
on real-world use and outcomes), and pharmacoeconomic analyses of cost-
effectiveness. In making such decisions, the Committee shall consider
the applicable clinical practice guidelines of the Department and of
the Department of Defense to ensure alignment with best practices in
veteran care.
``(f) Transparency of Decisions.--For each significant addition to
or removal from the national formulary of the Department, the Secretary
shall make publicly available on an appropriate website of the
Department a summary of the clinical rationale for the addition or
removal, including a description of the evidence and guidelines
considered. Such summaries may not include proprietary pricing
information or trade secrets.
``Sec. 7387. Nonformulary drug request process
``(a) Electronic Request System.--The Secretary shall acquire or
develop and implement a standardized electronic system for handling
requests by clinicians of the Department for drugs not included in the
national formulary of the Department. This system shall be integrated
with the electronic health record system of the Department to allow
treating clinicians to submit nonformulary drug requests as part of the
prescribing workflow.
``(b) Timeliness of Decisions.--The Secretary shall establish a
process to ensure that any request by a Department clinician for a
nonformulary drug is decided upon promptly. Under such process, an
initial decision on a nonformulary request shall be communicated to the
requesting clinician within 96 hours after the request is submitted. In
any case where a nonformulary request is denied, the veteran (and the
requesting clinician) shall be informed of the denial and of the right
to appeal under subsection (e). If an appeal is filed, a decision with
respect to the appeal shall be rendered not later than seven days after
the date on which the appeal is submitted.
``(c) Consistent Criteria and Approval Standards.--The Secretary
shall establish uniform criteria for evaluating nonformulary drug
requests, which shall be applied across all Veterans Integrated Service
Networks (herinafter referred to as `VISNs') and medical facilities of
the Department to ensure consistency. Such criteria shall be evidence-
based and shall be made available to Department clinicians.
``(d) Portability of Approvals.--An approval for a nonformulary
drug under this section shall be valid throughout the Veterans Health
Administration. In the case of a veteran for whom a nonformulary drug
has been approved and who chooses to receive hospital care or medical
services at a different medical center or VISN of the Department, the
nonformulary approval (including any established renewal date or
duration of approval) shall remain in effect at the new location,
subject to the same clinical conditions or monitoring requirements that
were originally imposed.
``(e) Appeals Process.--(1) The Secretary shall establish a tiered
appeals process for nonformulary drug decisions. At a minimum, such
process shall provide--
``(A) an opportunity for review of an initial denial by a
secondary clinical reviewer or pharmacy committee at the
regional or VISN level; and
``(B) a further opportunity for appeal to a national-level
authority within the Pharmacy Benefits Management Services of
the Department, whose decision shall be final within the
Department.
``(2) The Secretary shall ensure that all clinicians of the
Department are informed of the appeals process and that appeals are
resolved within the timeframe specified in subsection (b).
``Sec. 7388. Formulary management and drug therapy programs
``(a) Periodic Therapeutic Class Reviews.--In order to maintain a
clinically appropriate and up-to-date formulary, the Secretary shall
require regular reviews of groups of drugs by therapeutic class.
``(b) Medication Therapy Management and Drug Use Review.--(1) The
Secretary shall provide drug therapy management for veterans, with a
particular focus on polypharmacy and high-risk medications.
``(2) As part of such drug therapy management, clinical pharmacy
specialists shall provide comprehensive drug reviews for veterans who
are on complex regimens of drugs or are at increased risk of adverse
drug events.
``(3) The Secretary shall--
``(A) conduct regular reviews of drug use to identify
trends, including inappropriate prescribing, drug duplication,
or need for dose optimization; and
``(B) provide interventions, including provider education
or patient outreach, based on the results of such reviews in
order to improve therapeutic outcomes and promote drug safety
and adherence.''.
(b) Clerical Amendment.--The table of sections at the beginning of
such chapter is amended by adding at the end the following new items:
``subchapter vi--national formulary
``7385. National formulary.
``7386. Pharmacy and Therapeutics Committee.
``7387. Nonformulary drug request process.
``7388. Formulary management and drug therapy programs.''.
SEC. 3. DEPARTMENT OF VETERANS AFFAIRS PHARMACEUTICAL PURCHASING
AGREEMENTS.
(a) Formulary-Based Pricing and Value-Based Agreements.--
(1) In general.--Subchapter II of chapter 81 of title 38,
United States Code, is amended by inserting after section 8129
the following new section:
``Sec. 8130. Pharmaceutical purchasing agreements and value-based
initiatives
``(a) Negotiation of Supplemental Discounts.--(1) In addition to
the limitations on the prices of drugs in effect pursuant to section
8126 of this title, the Secretary may negotiate additional discounts or
price concessions with manufacturers of drugs procured by the
Department.
``(2) In conducting negotiations under this paragraph, the
Secretary may--
``(A) take into consideration the placement or tiered
status of a drug on the national formulary of the Department;
and
``(B) enter into an agreement with a manufacturer under
which the manufacturer offers a discounted price or rebate for
a drug in exchange for preferred status for the drug on the
national formulary of the Department, if the Secretary
determines the agreement will provide clinically appropriate
outcomes for veterans and net cost savings or value to the
Department.
``(3) Nothing in this subsection shall be construed to supersede
the price limitations under section 8126 of this title. The Secretary
shall ensure that any agreement entered into under this subsection with
respect to a drug that is a covered drug under such section results in
prices that are lower than the maximum price allowed under such section
for such drug.
``(b) Use of Flexible Purchasing Arrangements.--(1) To the extent
practicable, the Secretary shall use industry best practices in the
procurement of drugs and medical supplies, including the use of blanket
purchase agreements, ordering agreements, and other volume-leveraging
contracts to achieve favorable pricing.
``(2) The Secretary may pursue value-based purchasing arrangements
with manufacturers of drugs and biological products to be included on
the national formulary. Such arrangements may include contracts under
which the manufacturer agrees to provide the drugs or biological
products to the Secretary in exchange for payment in an amount that is
determined based upon the effectiveness of the drug or biological
product for veterans to whom the drug or biological product is
prescribed. If the Secretary enters into such a contract under this
paragraph, the Secretary shall ensure that the contract includes a
mechanism to monitor the effectiveness of the drug or biological
product and to adjust payments or rebates accordingly.
``(c) Outcome and Cost-Effectiveness Evaluations.--(1) The
Secretary shall conduct periodic reviews of the outcomes and budgetary
effects associated with major changes to the national formulary or
pharmaceutical initiatives of the Department. Not later than 180 days
after concluding a periodic review under this paragraph, the Secretary
shall submit to the Committees on Veterans' Affairs of the Senate and
House of Representatives the results of the review.
``(2) Not later than one year after implementing any significant
action affecting the national formulary, including adding a high-cost
drug with usage criteria or removing a clinically used drug from the
formulary, the Secretary shall evaluate the effects of that action on
veteran health outcomes, drug use patterns, and overall costs to the
Department. The Secretary shall make findings from such evaluations
available to the Committees on Veterans' Affairs of the Senate and
House of Representatives and use the findings to inform future
formulary decisions and purchasing agreements.
``(d) Biological Product Defined.--In this section, the term
`biological product' has the meaning given such term in section
351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)).''.
(2) Clerical amendment.--The table of sections at the
beginning of such chapter is amended by adding at the end the
following new item:
``8130. Pharmaceutical purchasing agreements and value-based
initiatives.''.
(b) Establishment of Tiered Schedule for Copayments.--
(1) In general.--Section 1722A of title 38, United States
Code, is amended by adding at the end the following new
subsection:
``(d)(1) For the purpose of encouraging the use of clinically
appropriate, cost-effective drugs by veterans while maintaining access
to nonformulary drugs that are medically necessary, the Secretary shall
establish a tiered schedule for the amount of the copayments charged to
veterans for drugs furnished under this chapter.
``(2) Under the tiered schedule established under this subsection,
the amount of a copayment for a 30-day supply of a generic drug or a
drug listed on the national formulary of the Department shall be lower
than amount of a copayment a 30-day supply of a brand-name drug or a
drug not included on such national formulary.''.
(2) Update of cross-reference.--Subsection (a)(3)(D) of
such section is amended by striking ``section 491'' and
inserting ``section 2732''.
SEC. 4. VETERANS FORMULARY ADVISORY COMMITTEE.
(a) Establishment.--The Secretary of Veterans Affairs shall
establish an advisory committee, to be known as the Veterans Formulary
Advisory Committee (in this section referred to as the ``Advisory
Committee''). The Advisory Committee shall provide veteran and
clinician input on the national formulary of the Department of Veterans
Affairs.
(b) Membership.--The Advisory Committee shall consist of not more
than ten members and shall include front-line clinical providers or
pharmacists of the Department who are not involved in national
formulary decision-making and other stakeholder representatives as the
Secretary considers appropriate.
(c) Meetings.--The Advisory Committee shall meet at regular
intervals (at least semiannually) and shall review proposed formulary
changes.
(d) Responsibilities.--The Advisory Committee may provide to the
Secretary and to the Pharmacy and Therapeutics Committee established
under section 7386 of title 38, United States Code, the independent
feedback or recommendations of the Advisory Committee regarding
proposed additions, removals, and restrictions pertaining to the
national formulary, including with respect to any potential effects on
veteran patients. Recommendations of the Advisory Committee shall be
advisory in nature.
(e) Termination.--The Advisory Committee shall terminate on the
date that is two years after the date of the establishment of the
Advisory Committee.
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