July 17, 2013—The Health Resources and Services Administration (HRSA) has released 16 more summaries of the findings from its audits of 340B covered entities in 2012.[ms-protect-content id=”2799″]
HRSA posted the findings on its website late last week. That brings the total number of audit findings released to 34, out of 51 audits conducted last year. Yesterday during the 340B Coalition annual conference, HRSA Office of Pharmacy Affairs (OPA) Deputy Director Michelle Herzog said the agency has conducted another 68 audits thus far in fiscal 2013.
HRSA has received seven work plans from drug manufacturers to audit covered entities, Herzog said. It has allowed six to proceed to actual audits and has received three final audit reports, which it is “reviewing to determine next steps,” she said.
In addition, Herzog disclosed that HRSA “is currently in the process of reviewing an issue with a manufacturer that could result in our first-ever manufacturer audit.” The Affordable Care Act directed HRSA to selectively audit manufacturers and wholesalers to ensure the integrity of the 340B program.
The latest round of audit findings involve nine disproportionate share (DSH) hospitals, four community health centers, one children’s hospital, one HIV/AIDS clinic, and one county health department that operates tuberculosis, family planning, and sexually transmitted disease clinics.
Two of the 16 audits (both of them audits of DSH hospitals) yielded no adverse findings. In another two audits (one of a DSH hospital and the other of a health center), HRSA found problems with how information was entered in its 340B covered entity database, but it is not sanctioning either covered entity.
In the remaining twelve audits, HRSA said it either found mistakes in the entities’ information in the 340B database; evidence that drugs were dispensed to ineligible patients, at ineligible facilities, or by ineligible physicians; and/or that entities were responsible for the improper payment of a Medicaid rebate on a 340B-discounted drug. HRSA said the sanctions in these instances are still to be determined.
Safety Net Hospitals for Pharmaceutical Access (SNHPA), which represents hospitals in the drug discount program, said it supports the audit initiative and is pleased that most of the 34 audit findings released thus far have had no adverse findings.
“It is hard to draw conclusions about those with adverse findings,” SNHPA said. “The information provided gives no insight into the scope of the non-compliant conduct or whether the adverse findings resulted in actual harm to a manufacturer or state Medicaid program. It also is not clear if the entities agree with HRSA’s findings or whether they will appeal. SNHPA urges HRSA to provide more relevant information in connection with the audits so that the public can better understand their status and impact.”
The hospital group also reiterated its request that HRSA begin auditing pharmaceutical manufacturers. “They, too, should be held accountable for their compliance status,” it said.[/ms-protect-content]