340B Overhaul Tightens Patient Rules, Mandates $0-$50 Drug Cap for Low-Income Hospital Patients

The 340B ACCESS Act, or the 340B Affording Care for Communities and Ensuring a Strong Safety-net Act, is a massive overhaul of the federal drug discount program. It’s essentially a 200-page compliance manual that imposes strict new rules on hospitals and clinics that receive discounted drugs, while also creating a central clearinghouse to track every single discounted prescription. The core purpose is to prevent duplicate discounts—where manufacturers pay a 340B discount and a Medicaid rebate on the same drug—and to force participating entities to prove they are passing on the savings to patients who need them.

Who Counts as a Patient Now? The Fine Print Gets Finer

If you rely on a 340B clinic or hospital for affordable prescriptions, Section 2 of this bill might change how you qualify. The law introduces a much stricter definition of a “patient” that requires a formal, auditable provider-to-patient relationship and a recent in-person visit. For hospital patients, this means you must have had an in-person visit within the last 12 months; for most clinics, it’s 24 months. If you get your prescription via telehealth, you generally need an in-person exam within the six months before that virtual visit, unless the entity can verify your eligibility for certain federal benefits. This is a big deal, especially for patients in rural areas or those with chronic conditions who rely on telehealth for routine refills, as it puts a hard limit on how long you can be considered a patient without showing up in person.

Mandated Affordability: The $0 to $50 Promise

For many patients, Section 6 is the biggest win. It forces hospitals participating in 340B to implement a mandatory sliding fee scale for eligible low-income patients. If your family income is below the Federal poverty guidelines, your out-of-pocket cost for a 340B drug must be $0. If your income is between 100% and 200% of the guidelines, your maximum cost is capped at the lesser of 20% of the normal cost or $35. If your income is above 200% of the guidelines, the cap is the lesser of 30% of the normal cost or $50. This is a direct, tangible affordability measure that ensures the 340B discount actually reaches the patient’s wallet, and it applies even when the prescription is filled at a contract pharmacy.

The Compliance Headache: Data, Audits, and Penalties

This bill introduces an unprecedented level of regulatory oversight, primarily targeting covered entities and contract pharmacies. Section 8 mandates that every covered entity must submit detailed data on every single 340B prescription to a new, centralized claims data clearinghouse within 45 days of dispensing. This data submission is required whether the drug was self-administered or given by a provider, and failure to report incurs a fine of $2,500 per day. For hospitals, Section 4 imposes extremely strict new requirements for registering off-campus “child sites,” including meeting specific public charity care and Medicaid/CHIP revenue benchmarks. If a hospital fails to meet these complex metrics, it must deregister or face civil monetary penalties of $2,500 per violation.

The Middleman Squeeze: Fee Limits for Pharmacies and TPAs

Section 17 takes aim at the business model of Third-Party Administrators (TPAs) and contract pharmacies, which help covered entities manage the program. Both TPAs and contract pharmacies are now limited to charging a flat dollar amount per service or prescription. Crucially, their fees cannot be based on the price of the drug or the discount received. For contract pharmacies, the fee is capped at 125% of the average dispensing fee they receive from all other third-party payers. This is intended to stop administrators from profiting excessively from the discount itself, but it could also reduce the number of pharmacies willing to participate if the flat fees don't cover their actual costs, potentially reducing patient access.

What It Means for Your Health Coverage

For patients and providers, Section 19 offers important protection. It prohibits group health plans, insurers, and Pharmacy Benefit Managers (PBMs) from discriminating against 340B entities or contract pharmacies. This means they can’t pay a 340B pharmacy less than a non-340B pharmacy for the same drug, impose different fees, or restrict a patient’s choice to use a 340B provider. This provision is designed to ensure that the patient affordability measures mandated elsewhere in the bill aren’t undermined by aggressive tactics from PBMs or insurers.