To amend the Public Health Service Act to reform the 340B drug pricing program, and for other purposes.
Analysis under review: This bill has generated analysis that may be too generic or incomplete. Clause-level evidence remains available below.
Summary
What This Bill Does
The 340B ACCESS Act reforms the federal 340B Drug Discount Program, which allows safety-net healthcare providers (hospitals, community health centers, etc.) to purchase prescription drugs at steep discounts from manufacturers. The bill introduces comprehensive new transparency, reporting, and compliance requirements while also protecting 340B entities from discriminatory treatment by insurers and pharmacy benefit managers.
Who Benefits and How
Pharmaceutical manufacturers benefit significantly as they gain access to detailed claims data through a new clearinghouse, can audit covered entity contracts, and face tighter restrictions on who qualifies for discounts. Health insurers and pharmacy benefit managers (PBMs) gain transparency into 340B drug pricing and claims through mandatory modifiers and data reporting. Low-income and uninsured patients may benefit from requirements that covered entities pass on savings through patient affordability measures. Drug manufacturers also benefit from fee limitations on third-party administrators and contract pharmacies, reducing the spread pricing that has diluted their discount obligations.
Who Bears the Burden and How
340B covered entities (hospitals, community health centers) face substantial new compliance burdens including mandatory claims modifiers, detailed data reporting to a central clearinghouse, annual transparency reports, and charity care documentation requirements. Contract pharmacies must now meet new eligibility requirements, are limited in the fees they can charge (capped at 125% of average dispensing fees), and must submit claims data directly to the clearinghouse. Third-party administrators managing 340B programs face restrictions on their fee structures (flat fees only, no percentage-based compensation). State and local governments lose authority to regulate the 340B program as federal law preempts all state/local standards.
Key Provisions
- Establishes a federal claims data clearinghouse to track all 340B drug transactions and prevent duplicate discounts
- Requires all 340B claims to include specific modifiers (JG, TB) identifying them as 340B purchases
- Mandates annual transparency reporting on charity care, 340B margins, and patient demographics
- Limits contract pharmacy fees to 125% of average dispensing fees and requires flat-fee compensation for administrators
- Prohibits health plans and PBMs from discriminating against 340B entities in reimbursement rates or network participation
- Tightens hospital eligibility by requiring registration by December 1, 2023, and imposing charity care obligations
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers.
At a Glance
What This Bill Does
Comprehensive reform of the 340B Drug Discount Program to increase transparency, tighten eligibility requirements for covered entities, establish a claims data clearinghouse, and prohibit discriminatory practices by insurers and PBMs against 340B entities.
Key Policy Areas
Healthcare, Pharmaceutical Industry, Public Health, Insurance Regulation
Primary Purpose
Comprehensive reform of the 340B Drug Discount Program to increase transparency, tighten eligibility requirements for covered entities, establish a claims data clearinghouse, and prohibit discriminatory practices by insurers and PBMs against 340B entities.
Policy Domains
340B ACCESS Act - Full Bill
Identified Gains
Contextual inference, no direct clause citation- Pharmaceutical manufacturers
- Health insurers
- Pharmacy benefit managers
- Low-income patients
- Uninsured patients
Contextual inference, no direct clause citation
Identified Costs
Contextual inference, no direct clause citation- 340B covered entities (hospitals)
- 340B covered entities (health centers)
- Contract pharmacies
- Third-party administrators
- State governments
Contextual inference, no direct clause citation
Sponsors
Legislative Progress
IntroducedMr. Bucshon (for himself, Mr. Carter of Georgia, and Mrs. …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
340B covered entities, 340B covered entities (hospitals, clinics), 340B hospital covered entities
340B covered entities, 340B covered entities (hospitals, clinics), Contract pharmacies dispensing 340B drugs face effects in multiple directions
Positive-direction: Rural emergency hospitals
Negative-direction: 340B hospital covered entities, Contract pharmacies, New hospitals seeking 340B eligibility, Private nonprofit 340B hospitals, Private nonprofit 340B hospitals with government contracts, Subgrantees of 340B covered entities, Third-party 340B program administrators
Federal government, Federal government (CMS/HRSA), HHS/HRSA
HHS/HRSA faces effects in multiple directions
Positive-direction: Federal government
Negative-direction: Federal government (CMS/HRSA), State Medicaid programs
Federally qualified health centers, Hospital off-campus outpatient facilities, Nonhospital 340B covered entities
Group health plans, Health insurance issuers
Third-party clearinghouse contractors
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
- "manufacturer"
- → Pharmaceutical drug manufacturer with 340B pricing agreement
- "clearinghouse"
- → Third-party claims data clearinghouse established by HHS
- "the_secretary"
- → Secretary of Health and Human Services
- "covered_entity"
- → Healthcare entities eligible for 340B program (safety-net hospitals, federally qualified health centers, etc.)
- "contract_pharmacy"
- → Pharmacy under written agreement with covered entity to dispense 340B drugs
- "third_party_administrator"
- → Entity providing 340B program administration services
Key Definitions
Terms defined in this bill
An individual who receives a covered outpatient drug that is directly related to a health care service, ordered by a covered entity provider, and dispensed at a covered entity location, child site, entity pharmacy, or contract pharmacy; and receives care from a covered entity provider who is an employee, contractor, or has an ongoing contractual obligation with the covered entity.
A site that is owned by, or under common ownership with, a covered entity hospital; has an address that is within a 40-mile radius of a registered 340B site of such covered entity or in the same State; is separately registered in the covered entity identification system; and has the same Medicare provider number or National Provider Identifier as the parent entity.
A subrecipient of a Federal grant of a covered entity that receives at least 25% of operating costs either directly from the grant or through in-kind contributions, operates under an enforceable written agreement with the covered entity, and is registered in the covered entity identification system.
Patients enrolled in Medicare Part A/B, Medicaid, commercial insurance, self-pay, and uninsured - used for required annual demographic reporting by covered entities.
Individuals not covered by any health plan or coverage who self-pay for health care services, as defined for 340B hospital eligibility requirements.
A pharmacy that has entered into a written agreement with a covered entity to dispense 340B drugs to patients, subject to requirements including using a single 340B contract pharmacy service administrator, being located within 40 miles or same state as covered entity, and submitting claims data directly to the clearinghouse.
A pharmacy that is wholly owned by, or under common ownership with, a covered entity; located at the covered entity site or within 10 miles; is operated as an in-house pharmacy; and is registered in the covered entity identification system.
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology