December 17, 2013—The federal office that oversees the 340B program “is close” to closing the last two audits of health care providers it conducted in fiscal year 2012, Office of Pharmacy Affairs (OPA) Director Cmdr. Krista Pedley told 340B stakeholders in Orlando last week.[ms-protect-content id=”2799″]
Pedley was the featured speaker during the 340B Federal Update session at the American Society of Health-Systems Pharmacists (ASHP) Midyear Clinical Meeting. The event is the largest gathering of pharmacists in the world.
OPA’s parent, the Health Resources and Services Administration (HRSA), audited 145 340B covered entities during fiscal 2012 and 2013, 51 the first year and 94 the second. Fiscal year 2014 audits are underway, but HRSA has yet to determine the total number to be conducted, Pedley said.
“We’re learning so much about what is happening onsite” through the audits “and what we can do to improve the rest of the 340B program,” she said.
HRSA “has a deep commitment to oversight of the program, and since I’ve been the director, I’ve made a personal commitment to ensuring we pay a lot more attention to compliance,” Pedley said.
Pedley reconfirmed that six of the seven audits by drug manufacturers of 340B entities conducted to date are final. OPA is reviewing the findings to determine how to best engage covered entities in compliance, she said.
Pedley also said again that HRSA is “reviewing an issue with a manufacturer that may result in an audit.” She encouraged providers to let OPA know if they are not receiving a 340B price on a drug. She noted that some entities recently gave OPA “very specific” information about not getting 340B pricing on intravenous immunoglobulin (IVIG) from two manufacturers. OPA “very quickly contacted the manufacturers and they are now offering the product at the 340B price,” she said.
Pedley reminded stakeholders that HRSA plans to issue a comprehensive regulation for the 340B program for notice and comment in June. She encouraged attendees to provide feedback during the public comment period because the rule will have major impacts.
“We need to hear from you,” Pedley said. “It helps us make balanced decisions about the future of the program, which, I think, we can all agree need to occur,” she said.
Pedley also said again that, due to a lack of resources, HRSA has not implemented 340B program oversight provisions that were included in the Affordable Care Act, which are geared mainly toward manufacturer compliance. She noted that HRSA continues to seek permission from Congress to implement a 340B user fee to give the program a stable source of funding.
During the question and answer session, Pedley said OPA is “working toward” developing recommendations on how a covered entity should proceed when hospitals discover a potential compliance issue and they want to resolve it with a manufacturer.[/ms-protect-content]