The manufacturer vs HRSA 340B guidance debate heats up

Manufacturers are concerned with duplicate discounts and want to ensure that patients that need 340B medication are the party that are receiving the medication at the appropriate discount and that the drugs are not being discounted twice. As a result, manufacturers are challenging HRSA’s 2010 guidance that allows covered entities to provide 340B medication through contract pharmacies.

Since our last post that dives into the issue, new developments have surfaced. Hospitals are urging HHS to step in on the 340B fight with drug manufacturers. HRSA is “considering whether manufacturer policies violate the 340B statue and whether sanctions such as civil monetary policies may apply.” Since the increase use of contracted pharmacies dispensing 340B drugs on behalf of covered entities, manufacturers are concerned that their drugs are being discounted twice. In a recent letter from the American Hospital Association (AHA), the AHA outlined that this stance may limit drugs dispensed to vulnerable patients in rural and underserved areas. HRSA is encouraging manufacturers to continue to work with contract pharmacies to ensure patients in underserved and rural areas can continue to receive their medications.

On July 24, 2020, President Trump issued four Executive Orders intended to address drug pricing. One of [the orders] would require FQHCs, [the only covered entity the Order applies to], to pass the 340B discounts they receive on insulin and injectable epinephrine to their low-income patients. [The order relies on] HRSA’s grant-making authority under Section 330 of the federal Public Health Service Act.”

There are several letters circulating Congress that concern this issue. NACHC encourages covered entities and others to connect with their Federal Affairs team or your Primary Care Association (PCA).

We will keep you updated as this issue continues to unfold.

Remember, because of the pandemic, eligible covered entities may apply to be enrolled in the 340B Program through HRSA’s website on a  weekly basis in addition to the quarterly application process.

Let's talk about your patient base, the 340B Program and how you can leverage it to better serve your patient base through an in-house pharmacy and contract pharmacies while driving your revenue.

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