SECURE 340B Act
Sponsored By: Representative Peters, Scott H. [D-CA-50]
Introduced
Summary
Stronger 340B integrity and data oversight. The bill would tighten who counts as a 340B patient, set strict rules for child sites and contract pharmacies, and create a national data clearinghouse to prevent duplicate discounts and diversion.
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- Patients and families: Requires covered entities to run and report transparent financial assistance programs, with some hospitals required to offer help up to at least 400% of the federal poverty level, plain-language notices, and new protections limiting medical debt sales and credit reporting.
- Covered entities, child sites, and subrecipients: Establishes a uniform 24-month patient definition, new child-site ownership and clinical-integration rules, mandatory site registration and records retention, and tougher audits and corrective actions that can suspend referral authority if referrals exceed 35%.
- Manufacturers, payers, contract pharmacies, and states: Creates a four-year clearinghouse demo with strict benchmarks (for example ≥90% claim accuracy), limits how manufacturers and PBMs may use clearinghouse data, requires written contract-pharmacy agreements, and funds oversight with a 0.1% user fee starting FY2027 plus targeted appropriations.
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Bill Overview
Analyzed Economic Effects
9 provisions identified: 3 benefits, 2 costs, 4 mixed.
More drug help and debt protections
If enacted, covered entities would have to offer written financial help for covered drugs. Some providers must help households with incomes up to 400% of the Federal Poverty Level; others must help up to 200% FPL. Help must be posted in plain language and extended to child sites and contract pharmacies (new locations immediately; existing ones within three years). The bill would also bar certain hospitals from selling or reporting patient debt and would stop suing patients unless household income is at least 600% FPL or assets exceed four times the bill.
Ban payer and PBM discrimination
If enacted, the bill would bar plans, issuers, and PBMs from treating 340B entities or contract pharmacies worse than similar non‑340B providers. Prohibited actions include lower reimbursement, extra fees or clawbacks, forcing use of nonqualifying pharmacies, or interfering with patient choice. HRSA must issue rules and can fine PBMs up to $5,000 per violation per day for breaches.
Stricter contract pharmacy and audits
If enacted, covered entities must register every contract pharmacy and sign written agreements before dispensing starts that list each dispensing location. The bill would limit third‑party administrator fees to bona fide service charges (not revenue‑ or volume‑based), require both parties to keep auditable records at least five years, and force vendors to share data with auditors and HHS. Covered entities must also hire independent audits every two years, fix violations, notify manufacturers of affected purchases, and repay manufacturers above a de minimis threshold; repeated failures can lead to suspension, fines, or removal from the program.
New annual 340B program fee
If enacted, starting in fiscal year 2027 covered entities would pay an annual user fee equal to 0.1% of the prior year's 340B drug spending. Fees would fund program administration, the clearinghouse, audits, and oversight. The Inspector General must review the fee program annually for five years. Payment of the fee would be required for certain 340B participation conditions.
Tighter site and hospital eligibility
If enacted, the bill would set new rules for which clinics and child sites can use 340B discounts. Sites must register, show clinical and financial integration, and meet community-need tests (top 50% nationally or top 40% in a State), or show at least 40% of patients are Medicaid, uninsured, or under 200% FPL. The Secretary would also verify hospital contracts and nonprofit status and require nonprofit/subgrantee documentation before purchases. A temporary safety-net exception could be granted for up to two years in narrow cases.
Annual 340B reporting and public data
If enacted, covered entities must report detailed 340B program data annually (or as a Medicare cost report addendum). Reports must show counts of patients and prescriptions by payer, charity care, how 340B savings are used, patient income bands, contract pharmacy addresses, and more. Entities must keep records at least three years and HHS must publish the data on a searchable website within 30 days, with proprietary redactions. The requirement increases transparency but also raises reporting work for providers.
New clearinghouse and drug pricing test
If enacted, HHS would run a four-year demonstration requiring drug makers to sell covered outpatient drugs at the 340B ceiling price as a point-of-sale reduction, not as a rebate. The Secretary must competitively contract for an independent clearinghouse within one year to match claims and purchases and keep data for 10 years. The clearinghouse must meet strict benchmarks (for example, >=90% adjudication and >=95% complete data) for the pricing rules to continue beyond four years. For some "selected drugs," covered entities would also have to send claims-level data to manufacturers, with $5,000 per-day penalties for noncompliance after a 30-day cure period.
Timing for rules and transition
If enacted, the Secretary would finalize required regulations within 180 days of enactment. Any substantive new compliance rule must give affected covered entities and manufacturers at least 180 days to transition unless another period is specified. This provides a minimum implementation window for regulated parties.
Who counts as a 340B patient
If enacted, a 340B patient would be someone who got outpatient care from a prescribing provider at the covered entity within the prior 24 months and received the related prescription, with the provider–patient relationship shown in auditable records. Prescribing providers must be employees or contractors (or qualifying affiliates), be enrolled in Medicare/Medicaid, and not be excluded under section 1128. Certain eligible clinics could also fill prescriptions based on referrals within 24 months if strict documentation and post-care requirements are met. Referral rules exclude orphan drugs and set audit triggers (e.g., referral prescriptions over 25% or purchases over 35% can prompt corrective action or loss of referral authority).
Sponsors & CoSponsors
Sponsor
Peters, Scott H. [D-CA-50]
CA • D
Cosponsors
Rep. Joyce, John [R-PA-13]
PA • R
Sponsored 7/6/2026
Rep. Auchincloss, Jake [D-MA-4]
MA • D
Sponsored 7/6/2026
Crenshaw
TX • R
Sponsored 7/6/2026
Rep. Barragán, Nanette Diaz [D-CA-44]
CA • D
Sponsored 7/6/2026
Roll Call Votes
No roll call votes available for this bill.
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