340B overhaul at the top of Congress, Azar's mind

Alex Azar
Congress and the Trump administration are planning speeches and hearings involving the 340B program next week, possibly setting up a program overhaul. (Wwsgconnect)

After months of talk, it appears both Congress and the administration are ready to act on reforming a popular drug discount program.

Ahead of a scheduled July 11 hearing (PDF) on the issue, the House Committee on Energy and Commerce posted 15 bills and discussion drafts regarding the 340B program, which mandates that drug manufacturers provide discounts for outpatient Medicaid drugs for low-income hospitals.

Critics, including Republicans and drug manufacturers, claim eligibility for the program is too broad and that the program has strayed from its intended purpose.

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Proposed policy overhauls of the program up for consideration include clarifying the intent of the program, establishing a moratorium on the registration of certain new 340B hospitals and associated sites, and limiting the orphan drug exclusion under the program.

Other discussed changes include mandating the administration to conduct more audits of the program and requiring implementation of previous Government Accountability Office recommendations.

RELATED: GAO: 340B hospitals, outside pharmacies need more oversight

Late last month, the nonpartisan GAO made seven recommendations to the Health Resources and Services Administration on how to prevent duplicate discounts and ensure compliance with outside pharmacies.

In response to the report, Reps. Greg Walden, R-Ore., and Michael Burgess, R-Texas, said in a statement, "Oversight has not kept pace with program growth—lacking rigorous oversight, meaningful reporting requirements, and reliable data. Now this new report by the nonpartisan GAO shows that oversight is fundamentally lacking when it comes to important compliance issues for contract pharmacies within the program."

Walden is chairman of the Committee on Energy and Commerce, which requested the report, and Burgess is chairman of the Health subcommittee.

However, advocacy groups in support of the program caution that major changes to the program could make participation more cumbersome for hospitals.

Overhauls of the program might not be far from the White House's mind, either.

Alex Azar, secretary of the Department of Health and Human Services, will speak at the 340B Coalition conference in Washington on Monday.