Drug Audits Of 340B Providers Will Be Both Random And Targeted, HRSA Says
This article was originally published in The Pink Sheet Daily
The Health Resources and Services Administration has begun random and targeted audits of health care providers participating in the federal 340B drug discount program to help ensure products are not being diverted for other uses or resulting in manufacturers paying double discounts to Medicaid.
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Top Republicans on two Senate health committees are joined by House members in seeking answers on an HHS review of entities receiving 340B drug discounts, including the process and consequences of audits and decertification.
In its first year of auditing 340B facilities for compliance with drug discount rules, the HHS agency is investigating 45 randomly selected entities and six “targeted” entities that are the subject of specific allegations of non-compliance. About 250 hospitals have been decertified from 340B and may have to pay back discounts to drug makers.
The clarification could answer biopharma industry concerns about how 340B rules fit in the new Medicare accountable care organization program; HRSA also advises that drug shortage allocation plans may not discriminate against 340 providers.