The 340B Drug Pricing Program may soon find itself under the direction of a new federal administrator – one that might be inclined toward changes in the program.

While the current home of 340B is the Department of Health and Human Services’ Health Resources and Services Administration, HHS has indicated that it intends to fold HRSA and its various responsibilities into a new “Administration for a Healthy America.”  Observers question, though, whether responsibility for overseeing the 340B program will shift to that new agency or move elsewhere.

Like to the Centers for Medicare & Medicaid Services.

Some fear such a move might not be good for hospitals.

While HRSA has typically sided with hospitals in disputes with the pharmaceutical companies that are required by law to provide discounts for prescription drugs dispensed to qualified outpatients by hospitals that meet 340B eligibility criteria, CMS has been more receptive to the perspective of pharmaceutical companies – like in 2018, when it proposed cutting Medicare payments for 340B-covered drugs by 30 percent (a move eventually rejected by the courts), and later, when it finalized a regulation reducing 340B discounts to reflect only the acquisition cost of covered drugs.

Some fear CMS might consider altering the rebate model to which pharmaceutical companies are subject – something those companies have sought, only to have their efforts rejected by the courts so far – or even altering the 340B eligibility criteria for providers.

Congress, too, has raised questions about the 340B program in recent years, and in particular, about how 340B providers use the savings they gain from the program.

Community safety-net hospitals are almost always eligible to participate in the 340B program.

Learn more about the 340B program, its current situation, and the potential challenges 340B providers may face in the near future from the Healthcare Dive article “340B could have a new cop on the beat. Hospitals are worried.”