HRSA Must Enforce 340B Law | 340B Matters
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31 Aug HRSA Must Enforce 340B Law

By 340B Matters

Setting rules without enforcement?

That’s ridiculous.

But that’s just what’s happening with the 340B Drug Discount Program as the federal agency that oversees it has decided to walk off the job. The Health Resources and Services Agency has been the arbiter of the 340B program for almost 30 years. Yet recently, the agency announced it does not have legal authority to enforce some of its rules regarding the pricing of medicines sold through pharmacies under contract to safety-net hospitals.

That’s nonsense.

The 340B statute clearly states that drug makers wishing to participate with state Medicaid programs must supply lower-priced medications to safety-net hospitals and clinics that treat large numbers of rural/low-income patients. It’s that simple.

The law signed by President George H.W. Bush does not allow pharmaceutical companies to place limits or conditions on the sale of 340B medicines. But that’s exactly what manufacturers Eli Lilly and AstraZeneca have done. The first has refused 340B pricing on one of its drugs if hospitals ship it to a contracted pharmacy. The second is refusing discounted pricing to healthcare providers with more than one such pharmacy. Yet HRSA says it won’t make any attempt to address this obvious breach and enforce the law or its 2010 regulatory guidance on the matter.

That’s deplorable.

HRSA has long desired that Congress grant it full regulatory authority over the 340B program. Now, in the midst of a pandemic that is heavily taxing safety-net providers financially and operationally, the agency has decided to sit on its hands. One can reasonably wonder whether the move is designed to prove a political point to gain broader powers. If so, it’s a deeply cynical maneuver.

HRSA has depended on sub-regulatory guidance to manage the 340B program for the past 28 years. Both health providers and manufacturers have respected these guidelines. Until now. If HRSA abandons enforcement of one part of its guidance, that brings into question the enforcement of its entirety.

That’s negligence.

If drug companies can refuse 340B pricing without adverse action from HRSA, what’s to stop safety-net hospitals and clinics from going beyond HRSA guidance on patient eligibility to include more individuals in the program?

This is obviously a manufactured crisis. But who gets hurt? Not bureaucrats in Washington or overcompensated drug company executives grubbing for dollars. The victims are America’s poor and underserved who will find it even more difficult to get access to quality healthcare in their communities.

That’s a nightmare.


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