340B Provider Groups Urge HHS to Address Manufacturer Compliance

by admin | February 20, 2014 2:35 pm

February 20, 2014—Health care providers in the 340B program are urging Health and Human Services (HHS) Secretary Kathleen Sebelius to use the program’s $6 million funding boost to make sure that drug manufacturers aren’t overcharging for covered outpatient drugs. [ms-protect-content id=”2799″] The 340B Coalition, which consists of 11 national organizations representing 340B providers, made the appeal in a Feb. 10 letter to Sebelius.

In January, Congress more than doubled the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs’ (OPA) budget, including $6 million “to implement a new program integrity effort within the 340B drug pricing program.” Lawmakers directed OPA to brief them on how it will address compliance concerns raised by both the HHS Office of Inspector General (OIG) and the Government Accountability Office (GAO).

The 340B Coalition’s letter urges Sebelius to use the new money to implement OIG recommendations from the mid-2000s that were written into the Affordable Care Act (ACA) but never implemented. They include:

giving covered entities access to federally verified ceiling process via a secure page on the OPA website
selective audits of manufacturers and wholesalers
a system to verify the accuracy of 340B ceiling prices calculated by manufacturers, including spot checks of sales transactions
procedures for manufacturers to issue refunds to covered entities for overcharges, including an explanation for how the overcharge occurred and how the refund was calculated
procedures for manufacturers to give covered entities refunds in cases where discounts manufacturers gave to other purchasers had the effect of lowering the 340B ceiling price.

“As organizations that represent providers who work with the 340B program every day, we are deeply committed to the integrity of the program,” the coalition wrote. “These changes and modifications will help enhance the integrity of the program and help us better serve our patients.” [/ms-protect-content]

Source URL: https://340bemployed.org/340b-provider-groups-urge-hhs-to-address-manufacturer-compliance/