340B ACCESS Act
The 340B ACCESS Act proposes a broad set of reforms to the 340B Drug Pricing Program, aiming to tighten who can access 340B discounts, strengthen oversight and transparency, and ensure drugs priced for safety-net purposes actually reach the intended patients. Key changes in the excerpted text focus on redefining who qualifies as a “patient” and which providers and facilities may participate, tightening requirements for off-campus “child sites,” and clarifying rules around contract pharmacies and Medicaid-related billing. The bill would also create new enforcement tools, including audits, civil penalties, and mandatory public reporting. What this could mean in practice: more stringent eligibility and site standards for 340B participation, closer scrutiny of how 340B savings are used (including margins and reimbursements), and greater data sharing and transparency. The intent appears to curb misuse or overextension of 340B discounts and to strengthen accountability for hospitals, clinics, and contract pharmacies that participate in the program. Note that the full bill includes many additional sections (listed in the table of contents) that are not included in the provided text, which could introduce further provisions and effects.
Key Points
- 1Define “patient” and tighten eligibility criteria (Section 2)
- 2- The bill adds a detailed, prescription-by-prescription basis for who counts as a patient eligible for 340B pricing, tied to specific services provided by a covered entity, the provider-patient relationship, and where the drug is dispensed (on-site, child sites, entity pharmacies, contract pharmacies, or mail order).
- 3- It also narrows who can qualify through telehealth or non-covered-entity providers, with limited exceptions (care coordination allowed under certain conditions, but still subject to specific requirements).
- 4- Telehealth prescriptions generally must be linked to in-person care within defined timeframes unless auditable records show eligibility for Medicare benefits.
- 5New definition of Specified Nonhospital Covered Entity (Section 2)
- 6- Establishes criteria to classify certain nonhospital entities as “specified nonhospital covered entities,” including a large revenue threshold (average annual operating revenues > $1B, adjusted for inflation) or hospital affiliation, and adds affiliate-based rules. This affects which entities are treated as nonhospital participants in the program.
- 7Prevention of Medicaid duplicate discounts and oversight (Section 3)
- 8- The Secretary must propose final regulations within one year to identify and bill drugs in a way that prevents duplicate discounts and rebates, including applicability to Medicaid managed care enrollees.
- 9- Requires procedures to exclude Medicaid rebate requests for 340B drugs provided to Medicaid managed care enrollees and to establish prompt remedies for incorrect rebates.
- 10- Expands audit authority to review how margins from 340B drugs are used and requires record retention and reporting to support compliance.
- 11Hospital child site requirements (Section 4)
- 12- Creates a formal process to register off-campus outpatient facilities (child sites) as part of the 340B program, with a long list of eligibility criteria. Key elements include:
- 13- The facility must be listed on the entity’s Medicare cost report, be wholly owned by the covered entity, meet Medicare provider-based standards for off-campus outpatient departments, and offer more than just dispensing drugs.
- 14- Must comply with charity care and sliding fee policies and be located in a designated health professional-shortage area.
- 15- Must meet specific financial-reliability thresholds related to charity care and outpatient revenue shares.
- 16- Requires annual recertification and ongoing compliance; if a facility no longer meets requirements, the entity must deregister it and prevent further 340B purchases for that facility.
- 17- Entities must self-disclose noncompliance and could owe penalties or price reductions to manufacturers for noncompliant purchases.
- 18- Effective date is 120 days after enactment, with implementation instructions provided beforehand.
- 19Contract pharmacies (Section 5)
- 20- Allows covered entities to contract with pharmacies to dispense 340B drugs purchased by the entity, with manufacturers shippping drugs to contract pharmacies upon request.
- 21- Outside of these contract pharmacies, manufacturers would not be obligated to provide discounts for drugs delivered to other locations, subject to the act’s broader terms (text provided ends mid-sentence, so full details are not visible here).