340B ACCESS Act
Sponsored By: Representative Carter (GA)
Introduced
Summary
Targets 340B discounts to patients served by safety‑net providers. The bill tightens who counts as a 340B patient, creates strict hospital off‑campus “child site” rules, and tightly regulates contract and mail‑order pharmacies while adding affordability caps, public margin reporting, a real‑time claims clearinghouse, and stronger penalties and audit powers.
Show full summary
- Families and patients: Hospitals and nonhospital providers must use sliding fee scales that cap out‑of‑pocket costs per dispense at $0 for incomes below poverty, up to $35 for those under 200% of poverty, and up to $50 for higher incomes. Telehealth prescriptions generally qualify only after an in‑person visit within six months unless alternate records show benefit eligibility.
- Hospitals and community providers: Off‑campus child sites must meet strict Medicare cost, ownership, charity care, Medicaid share, and shortage‑area tests to buy 340B drugs. Missing registration or transfer rules triggers repayment of discounts with monthly compounded interest and civil penalties starting at $2,500 per violation.
- Pharmacies, manufacturers, and PBMs: Contract pharmacies must register, follow auditable compliance steps, and some hospitals are limited to five contract pharmacies. Manufacturers only must supply drugs to registered addresses or approved contract pharmacies. The bill sets flat fee limits for dispensing and third‑party administrators, creates layered civil penalties including up to $3,000 per claim and up to ten times improper remuneration, and bans PBM discrimination with penalties up to $5,000 per violation per day.
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Bill Overview
Analyzed Economic Effects
9 provisions identified: 2 benefits, 1 costs, 6 mixed.
Insurers and PBMs barred from 340B bias
If enacted, group plans, insurers, and PBMs could not treat 340B providers, pharmacies, or patients worse because of 340B. They could not pay less, charge extra fees, block networks, impose special audits, or deny coverage just because a drug is 340B. Contracts that do this would be void. PBMs could face up to $5,000 per violation per day. These protections would also apply in Medicare Part D and Medicare Advantage and would start one year after enactment.
Federal rules override state 340B laws
If enacted, federal 340B rules would override state or local laws that differ from or relate to 340B. States could not add extra rights or duties about 340B beyond federal law, with a narrow exception for certain federal implementation rules. This preemption would begin one year after enactment.
Nationwide 340B claims tracking and audits
If enacted, the Secretary would hire an independent clearinghouse within one year to collect 340B claim data and flag duplicate discounts. Covered entities would have to send claim‑level data within 45 days and use 340B or non‑340B claim modifiers on all payors. The clearinghouse would notify parties of duplicates within five days and share data securely. The Secretary would issue guidance within 180 days and final rules within one year on how to avoid duplicate discounts and bill Medicaid managed care. Entities that do not report could face $2,500 per‑day penalties. The Secretary could audit records to see how 340B margins are used.
Hospital drug bills capped by income
If enacted, hospitals would cap what you pay per 340B drug fill or administration. If your income is below poverty, you pay $0. At 100%–199% of poverty, you pay the lesser of 20% of the normal out‑of‑pocket or $35. At 200%+ of poverty, you pay the lesser of 30% or $50. The $35 and $50 caps would rise each year with CPI‑U. Discounts on self‑administered drugs would apply at the counter. Hospitals would have to post the scale, avoid extraordinary collection actions, and could face $2,500 penalties per violation.
Tighter 340B patient and telehealth rules
If enacted, fewer prescriptions would count for 340B prices. The drug would need to be tied to care you got at the 340B site, ordered by its provider, and given or dispensed at an approved location. You would need a recent in‑person visit with the entity (within 12 months for some hospitals, 24 months for many others). Telehealth prescriptions would not qualify unless the telehealth visit is at an eligible entity and you had an in‑person exam in the prior 6 months. That in‑person rule would not apply if records show you are eligible for Social Security title II or title XVI benefits. Drugs given only for home use or infusion without a provider visit would not qualify.
Flat fees and penalties for 340B pharmacies
If enacted, third‑party administrators and contract pharmacies would have to use flat fees not tied to drug price. A contract pharmacy’s per‑fill fee could not exceed 125% of its average dispensing fee paid by all payors in the last full year. Covered entities would need enforceable written agreements and must submit them to the Secretary within 30 days. Violations would trigger repayments first, then $3,000 per‑claim penalties (CPI‑U adjusted), and removal for repeat offenses. Contract pharmacies serving hospitals would have to honor the hospital’s affordability rules.
New limits for nonhospital entities and subgrantees
If enacted, nonhospital entities would need to be nonprofit or public and could buy 340B drugs only for patients at registered sites and within a grant’s scope and time. Entities would be responsible for subgrantee compliance and records. Ongoing in‑kind help over $25,000 per year (CPI‑U adjusted) would count toward eligibility; some current subrecipients as of January 1, 2025 could be exempt if they keep complying. A new category would cover large nonhospital entities with $1,000,000,000+ in average annual operating revenue (CPI‑U adjusted) or those affiliated with a hospital. Subgrantees would have extra Medicaid‑share and planning requirements and must act within 30 days if their sponsor exits the program.
Stricter rules for hospital child sites
If enacted, off‑campus hospital sites could join 340B only if they meet strict tests. Sites would need to be on the Medicare cost report, be wholly owned, meet Medicare provider‑based standards, post charity care and sliding fee policies, provide more than drug dispensing, and be in a service‑shortage area scored as of December 1, 2024. If a site falls out of compliance, the hospital would have to self‑report, stop purchases, deregister, disclose any noncompliant buys, and undergo a supervised audit. Hospitals could owe the discount back plus interest, and knowing violations could bring civil penalties. These rules would begin one year after enactment.
Purpose of 340B program clarified
If enacted, the law would state that 340B discounts are meant to help entities that serve underserved people provide more affordable drugs and health services.
Sponsors & CoSponsors
Sponsor
Carter (GA)
GA • R
Cosponsors
Harshbarger
TN • R
Sponsored 9/10/2025
Roll Call Votes
No roll call votes available for this bill.
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