VA National Formulary Act of 2025

Bill Number

H.R. 6580

Origin Chamber

House

Congress

119th Congress, Session 1

Policy Area

Armed Forces and National Security

Status

Introduced

Latest Action

2026-05-20: Committee Hearings Held

Last Updated

2026-05-21T08:07:38Z

AI-Generated Summary

Purpose of the Legislation

The VA National Formulary Act of 2025 aims to standardize and improve the management of the Department of Veterans Affairs (VA) national formulary—a core list of approved drugs and supplies available at VA medical facilities. It seeks to ensure consistent access to medications for veterans, promote evidence-based decisions, enhance transparency, and achieve cost savings while maintaining quality care.

Key Provisions

• National Formulary Establishment and Management (Section 7385): The VA must maintain a single national formulary of all prescription drugs and supplies, managed by the VA's Pharmacy Benefits Management Service. It applies uniformly across all VA facilities, with limited local exceptions only through approved waivers or nonformulary requests (explained below). Waivers require centralized review based on clinical need, safety, and cost-effectiveness, and are time-limited.

• Public Communication and Reporting (Section 7385): The VA must regularly inform the public about formulary decisions, including briefings or online summaries for significant changes (e.g., adding or removing commonly used drugs). Annual reports to Congress detail nonformulary appeals and formulary changes, including additions, removals, and usage restrictions; these reports are also made public for the first five years.

• Pharmacy and Therapeutics Committee (Section 7386): Establishes a committee of VA physicians, pharmacists, and experts (with focus on geriatric and mental health care) to review and decide on formulary inclusions/exclusions. Decisions must be evidence-based, considering clinical data, cost-effectiveness, and guidelines from the VA and Department of Defense. Members must disclose conflicts of interest and avoid pharmaceutical industry ties. The committee reviews new FDA-approved drugs within 120 days and publishes rationales for major changes (without proprietary pricing details).

• Nonformulary Drug Request Process (Section 7387): Creates a standardized electronic system integrated with VA electronic health records for clinicians to request drugs not on the formulary. Requests must be decided within 96 hours, with appeals resolved in seven days. Approvals are portable across VA facilities, and uniform evidence-based criteria apply nationwide. A tiered appeals process includes regional and national reviews.

• Formulary Management and Drug Therapy Programs (Section 7388): Requires periodic reviews of drug classes to keep the formulary current. Mandates medication therapy management for veterans on complex or high-risk regimens, including reviews for inappropriate prescribing, drug duplication, or dosage issues, with interventions like education or outreach.

• Pharmaceutical Purchasing Agreements (Section 8130): Allows the VA to negotiate extra discounts or rebates from drug manufacturers based on formulary placement or value-based outcomes (e.g., payments tied to drug effectiveness). Encourages flexible buying strategies like bulk contracts. Requires periodic evaluations of formulary changes' impacts on health outcomes and costs, with reports to Congress. Defines "biological product" as certain complex drugs regulated by the FDA.

• Tiered Copayments (Section 1722A): Introduces a copayment structure where generics and formulary drugs cost less (for a 30-day supply) than brand-name or nonformulary drugs, to encourage cost-effective choices while preserving access to medically necessary options.

• Veterans Formulary Advisory Committee (Section 4): Establishes a temporary (two-year) advisory group of up to 10 VA clinicians, pharmacists, and stakeholders to provide input on proposed formulary changes. It meets at least twice a year and offers non-binding recommendations to the VA and Pharmacy Committee.

Significant Changes to Existing Law

• Codifies the national formulary into title 38 of the U.S. Code (adding Subchapter VI to Chapter 73), formalizing what was previously an administrative practice and prohibiting unapproved local formularies.
• Introduces new centralized processes for waivers, nonformulary requests, and appeals, replacing potentially inconsistent local practices with uniform, time-bound standards and portability.
• Mandates transparency measures (e.g., public rationales, annual reports) and conflict-of-interest rules for decision-makers, which were not explicitly required before.
• Expands VA purchasing powers under Chapter 81 by allowing value-based contracts and supplemental negotiations beyond existing price caps (under section 8126), while ensuring they result in lower costs.
• Adds tiered copayments to section 1722A, shifting from flat rates to incentivize formulary use; updates a cross-reference for consistency.

Potential Impacts

• On Government Agencies: The VA will face increased administrative requirements (e.g., electronic systems, reviews, reporting), but could achieve cost savings through better negotiations and reduced duplication. Congress gains enhanced oversight via regular reports, potentially streamlining budget allocations for veteran care.
• On Citizens (Veterans): Improves consistent access to drugs nationwide, faster approvals for needed nonformulary options, and lower copays for preferred drugs, potentially reducing out-of-pocket costs and improving health outcomes via better management of complex prescriptions. However, significant formulary changes could temporarily affect access to specific medications.
• On International Relations: No direct impacts; the bill focuses on domestic VA operations and U.S.-based pharmaceutical procurement.

Main Stakeholders Affected

• Veterans: Primary beneficiaries as patients, gaining standardized care but potentially facing copay incentives to use formulary drugs.
• VA Clinicians and Pharmacists: Must adapt to new electronic processes and appeals, but benefit from evidence-based guidelines and committee input.
• VA Administration (Including Pharmacy Benefits Management Service): Responsible for implementation, with added tools for efficiency but increased reporting burdens.
• Pharmaceutical Manufacturers: Affected by negotiations for discounts, formulary placement, and value-based deals, which could influence market access to VA patients.
• Congressional Committees on Veterans' Affairs: Receive detailed reports for oversight, enabling better policy adjustments.

Notable Legal, Constitutional, or Political Implications

• Legal: Strengthens VA's statutory authority for drug management while ensuring due process through appeals and transparency, reducing risks of arbitrary denials. Aligns with existing laws like FDA approvals and price caps, but introduces enforceable timelines that could lead to litigation if not met.
• Constitutional: No apparent issues; the bill operates within Congress's spending and veterans' benefits powers under Article I, without infringing on free speech, due process, or other rights.
• Political: Promotes bipartisan goals of efficient veteran healthcare and fiscal responsibility by emphasizing cost-effectiveness and stakeholder input. The temporary advisory committee and public reporting could build trust and reduce controversies over drug access, though implementation challenges might spark debates on bureaucracy versus care quality.

This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.

Sponsor

Rep. Miller-Meeks, Mariannette [R-IA-1]

Recent Actions

• 2026-05-20: Committee Hearings Held
• 2026-03-18: Committee Hearings Held
• 2025-12-10: Referred to the House Committee on Veterans' Affairs.
• 2025-12-10: Introduced in House
• 2025-12-10: Introduced in House

Bill Versions

• VA National Formulary Act of 2025 — issued 2025-12-10 — PDF (15 pages)