Drug Discount Program Guidance Sent Back to HHS, Future Unclear


The long-awaited guidance on drug discounts that was under White House review at the end of the Obama administration has been sent back to the HHS.

The 340B program covered by the guidance helps safety-net providers such as hospitals obtain discounted drugs. The proposed guidance released in 2015 defined who is considered a patient for purposes of the program and also covers drug company responsibilities, such as procedures for issuing credits and refunds.

The White House Office of Management and Budget Jan. 30 marked the final guidance document (RIN:0906-AB08) as withdrawn, sending it back to the Department of Health and Human Services. To move forward, the guidance would now have to be resubmitted to OMB.

The drug industry generally supports the guidance because it says more clarity is needed for the 340B program, particularly for the definition of patient. However, safety-net hospitals have concerns with the guidance because they say it could limit their ability to serve the poor by putting additional restrictions on drug discounts.

Attorney Donna Lee Yesner told me she’s not surprised that “pending regulatory guidance of this magnitude” would be re-examined by a new administration. Yesner, with Morgan, Lewis & Bockius in Washington, often counsels companies on government program reimbursement, drug price reporting and compliance requirements.

“Industry and covered entities [such as hospitals] need more clarity, but my hope is that the new administration will consider how expansive and burdensome industry subsidization of the 340B program has become, and return the program to its original purpose of reducing the cost of drugs provided by federally funded clinics to indigent and uninsured patients,” Yesner said.

My full article on this is here.

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