December 6, 2012—The Health Resources and Services Administration (HRSA) has closed nine of the 51 program integrity audits of 340B covered entities it conducted during 2012, the director of the agency’s 340B office said during a major pharmacy conference this week.
During a session at the American Society of Health System Pharmacists (ASHP) Midyear Conference in Las Vegas, Office of Pharmacy Affairs (OPA) Director Cmdr. Krista Pedley said nine audited 340B entities have received their final audit reports from HRSA.[ms-protect-content id=”2799″] She did not reveal the audits’ findings, however. This summer, two hospitals reported that HRSA had informed them that auditors had identified no occurrences of drug diversion to ineligible patients, duplicate discounts under Medicaid, or eligibility issues.
Pedley also said at the ASHP meeting that her office planned to conduct anywhere from 200 to 400 covered entity audits during 2013.
Meanwhile, during another session at the ASHP meeting, Apexus President Chris Hatwig mentioned that HRSA is preparing for its first-ever audit of a drug manufacturer to determine whether it is charging 340B entities the correct prices.
At a drug industry conference last September, Pedley said her office was “looking into some issues” with drug manufacturers’ 340B pricing and reminded attendees that “we do have the authority to audit manufacturers.”
The Affordable Care Act called for the development of standards and methods for the calculation of 340B ceiling prices, for the establishment of civil monetary penalties for manufacturers that overcharge covered entities, and for a mandatory 340B dispute resolution process. OPA has not issued regulations to implement those provisions, saying it lacks the funds to carry them out.[/ms-protect-content]