340B Drug Audits: HRSA Reviewing 51 Entities In 2012
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.
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The Health Resources and Services Administration is continuing to audit hospitals for 340B compliance, with 94 conducted in FY 2013 and 28 completed or begun thus far in FY 2014, and one manufacturer is being audited as well. A $6 million appropriation will help the agency expand its oversight activities.
Genentech’s 340B drugs discounts totaled $1 billion in 2012 and are growing at 20% to 25% a year, a level that has prompted management to sit up and take notice, including setting up a team to work with 340B health care providers on compliance.
Both pharmaceutical manufacturers and 340B hospitals seek more specifics on issues such as which patients are eligible to receive deeply discounted drugs through the program, how to contract with outside pharmacies and obligations of manufacturers and eligible hospitals.