SUSTAIN 340B Act
Sponsored By: Senator Moran, Jerry [R-KS]
Introduced
Summary
Strengthens transparency and integrity of the 340B drug discount program. It tightens rules for contract pharmacies and child sites, creates a national data clearinghouse to prevent duplicate discounts, expands audits and reporting, and sets up a user fee to fund administration.
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- Covered entities and hospitals must register and annually recertify contract‑pharmacy arrangements, keep auditable records for at least 3 years, disclose contract‑pharmacy locations and dispensing data, meet stricter child‑site integration tests, and file annual reports on prescriptions, payer mix, and how 340B savings are used.
- Drug manufacturers must offer drugs at or below the 340B ceiling price regardless of dispensing route, may not refuse delivery or impose restrictive conditions, and manufacturers face new audit limits that require credible allegations, good‑faith outreach, and a 30‑day resolution period before auditing.
- A new independent 340B data clearinghouse will collect claims‑level data to detect duplicate discounts and support repayments, allow aggregated submissions for lowest‑volume entities, and must be contracted within 1 year of enactment.
*Funds administration mainly through a new quarterly user fee starting in FY2031 with a $50 million base and authorizes additional appropriations including $3 million and $9 million per year for audits and implementation in FY2027–2031.*
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Bill Overview
Analyzed Economic Effects
9 provisions identified: 1 benefits, 1 costs, 7 mixed.
Ban on PBM and Plan Discrimination
If enacted, group health plans, insurers, and PBMs could not treat 340B hospitals or pharmacies worse than other providers. They could not pay less, add special fees or clawbacks, block 340B pharmacies from networks, or deny coverage because a drug was bought under 340B. Violations could trigger civil penalties up to $5,000 per violation per day. HHS would issue implementing rules within one year.
New User Fees and Oversight Funding
If enacted, a user-fee program would begin in fiscal year 2031 to pay for 340B administration and integrity. Total user fees would be $50 million in FY2031, with later years adjusted by the Washington, D.C. area CPI. Fees would be split among covered entities based on each entity's share of outpatient drug prescriptions. The bill also authorizes $3 million per year for OIG audits (FY2027–2031) and $9 million per year for implementation (FY2027–2030).
Who Counts as a 340B Patient
If enacted, a 340B patient would be someone who got an outpatient health service from the covered entity within the past two years and whose medical record documents the prescription. Covered entities would keep those records at least three years. The bill would let entities provide 340B drugs for patients referred to outside prescribers if the prescription is written within 12 months and filled at the entity's owned or registered contract pharmacy. The Secretary would audit referral volumes that exceed 20 percent (or a 3‑year average threshold) and require annual reporting; OIG would study referral prescriptions yearly for 12 years.
Stronger Audits, Penalties, and Limits
If enacted, the Secretary would expand standardized audits and oversight of the 340B program. Patient-status records would be audited at least every three years and more often for high‑risk or high‑volume entities. Manufacturers would need to provide written notice and 30 days to resolve credible allegations before seeking an audit. Covered entities that fail to fix noncompliance could face corrective-action plans, civil penalties, repayments, and up to three years of program ineligibility. The GAO and HHS would also study program practices.
Tighter Rules for Child Sites
If enacted, covered entities would have to register and annually recertify any wholly owned 'child site' and keep auditable records at least three years. Child sites must be clinically and financially integrated and follow the covered entity's financial assistance policy. Newly acquired sites that were not eligible before would generally be ineligible for three years unless the Secretary grants a hardship waiver. HHS and GAO must report on child-site use and impacts.
A National Clearinghouse to Stop Duplicates
If enacted, HHS would hire an independent clearinghouse operator within one year to collect claims-level Medicaid rebate data and covered-entity claims. The clearinghouse would check for duplicate Medicaid rebates and 340B discounts, notify stakeholders, and help calculate user fees. It could require repayment for confirmed duplicate discounts and would protect clearinghouse data privacy and ban data monetization. The bill would also end the 340B rebate pilot and move functions into the clearinghouse within one year.
Act Effective Date
If enacted, the Act and its amendments would take effect on the date it is signed. That start date would trigger the timelines and rules in the bill.
New Rules for Contract Pharmacies
If enacted, covered entities would have to register and recertify each contract pharmacy every year and send each written contract to HHS before dispensing begins. Entities would have to cancel contracts with pharmacies that did not dispense 340B drugs in the prior 12 months, subject to narrow exceptions. Contracts must include data-sharing, patient verification, safeguards against diversion, and records must be kept at least three years.
Registering and Reporting for 340B
If enacted, covered entities would have to register and stay listed in the 340B system to participate. They would need to submit yearly reports about patients, prescriptions, charity care, and a CEO/CFO/COO attestation about how 340B savings are used. HHS would publish reported data within 90 days and keep records at least three years. Covered entities would have to submit any assessed user fees for the current year before they can register or recertify.
Sponsors & CoSponsors
Sponsor
Moran, Jerry [R-KS]
KS • R
Cosponsors
Sen. Baldwin, Tammy [D-WI]
WI • D
Sponsored 8/5/2026
Sen. Capito, Shelley Moore [R-WV]
WV • R
Sponsored 8/5/2026
Sen. Kaine, Tim [D-VA]
VA • D
Sponsored 8/5/2026
Sen. Boozman, John [R-AR]
AR • R
Sponsored 8/5/2026
Sen. Hickenlooper, John W. [D-CO]
CO • D
Sponsored 8/5/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov