GOP Leaders Ask HRSA for Details on 340B Oversight

by admin | September 23, 2011 8:17 pm

September 23, 2011—Three influential Republican members of Congress asked the Health Resources and Services Administration (HRSA) yesterday for a detailed accounting of its oversight of the 340B drug discount program.

Their Sept. 22 letter[1] to HRSA Administrator Mary Wakefield came to light this morning just hours before the Government Accountability Office (GAO) released a major report on the program. The Monitor will report on the GAO’s findings shortly.

In their joint letter, Rep. Fred Upton (R-Mich.), Sen. Orrin Hatch (R-Utah) and Sen. Charles Grassley (R-Iowa) asked HRSA to answer nine detailed questions in writing by Oct. 7. Upton chairs the House Energy and Commerce Committee, Hatch is the ranking Republican member of the Senate Finance Committee and Grassley is the ranking Republican on the Senate Judiciary Committee.

Noting that participation in 340B has nearly doubled during the past decade, the lawmakers said “it is critical that HRSA provides diligent oversight of both the program and its participants.”

“Adequate monitoring by HRSA is fundamental to ensuring that the 340B program meets is goals of providing affordable outpatient drugs to patients of covered entities,” they said.

Specifically, the lawmakers asked HRSA to

• Describe its past efforts and future plans to conduct oversight of the 340B program, including a breakdown of the number and type of 340B audits performed by HRSA since 1992 and planned for the future.

• Describe how it verifies covered entities’ and drug manufacturers’ eligibility to participate in 340B, including the frequency of such eligibility verification processes.

• Describe how it performs ongoing compliance oversight of covered entities and drug manufacturers after they are approved for participation in the 340B program, including the frequency of such compliance processes.

• Provide an itemized breakdown for the past five fiscal years of all appropriations, obligations, and expenditures requested and received as part of HRSA’s annual budget for funds dedicated to oversight of the 340B program including, but not limited to, covered entity verification and compliance among all program participants.

• Answer whether it is aware that 14 states currently conduct postpay audits of covered entities that receive 340B-purchased drugs and, if yes, to describe what processes it has to ensure that duplicate discounts are not provided?

• Describe what processes it has in place to work with the Centers for Medicare and Medicaid Services (CMS) to enforce the prohibition on duplicate discounts.

• Answer whether it is notified of each dispute or payment discrepancy between covered entities and drug manufacturers, whether entity and manufacturers are required to report such disputes and resolutions, and describe what action it has taken to resolve future disputes based on lessons learned from past disputes.

Provide an itemized breakdown for the past five fiscal years of the percentage and dollar amount of HRSA’s annual budget that goes towards covered entity outreach, including, but not limited to, HRSA officials’ participation in conferences, seminars, or events with covered entities.

Source URL: https://340bemployed.org/gop-leaders-ask-hrsa-for-details-on-340b-oversight/

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