June 11, 2014—The 340B program should be reconfigured to directly benefit uninsured and otherwise needy patients instead of benefitting hospitals, several speakers said yesterday during a drug industry sponsored meeting on the drug discount program. Participants representing non-hospital 340B covered entities, however, cautioned against recasting 340B as a type of patient drug assistance program.[ms-protect-content id=”2799″]
Office of Pharmacy Affairs Director Cmdr. Krista Pedley, meanwhile, told those attending the AIR 340B group’s National Leadership Summit on 340B that the Health Resources and Services Administration “is now having to assess the status” of its comprehensive 340B program regulation, aka “mega-reg,” in light of the recent federal court ruling vacating HRSA’s 340B orphan drug exclusion regulation.
Responding to a lawsuit filed by Pharmaceutical Research and Manufacturers of America against the Department of Health and Human Services, the judge concurred with PhRMA’s argument that “the rulemaking authority granted HHS by Congress under the 340B program has … been specifically limited, and HHS has not been granted broad rulemaking authority to carry out all the provisions of the 340B program.”
The rule is still listed as under review by the White House Office of Management and Budget. A recent notation on the OMB website said it is slated for release in July.
Asked during yesterday’s meeting whether that timeline had changed, Cmdr. Pedley said, “We are assessing the impact of the court’s decision on what our next steps are with the rule.” She also said HRSA is reassessing its plans to issue a proposed regulation to address the extent to which state AIDS drug assistance programs can collect 340B rebates from drug manufacturers when the ADAPs purchase insurance and/or pay premiums, copayments, and deductibles for ADAP clients.
During her overview of her office’s program compliance accomplishments and future plans, Cmdr. Pedley said that the 340B program’s intent is to enable covered entities to stretch scarce resources as far as possible, reaching more eligible patients and providing more comprehensive services.
Much of the debate over 340B revolves around what Congress intended when it created the program in 1992. Providers say Cmdr. Pedley’s formulation is the right one, but drugmakers and private cancer clinics say 340B’s intended purpose is to improve uninsured indigent patients’ access to prescription medicines.
One drug industry lobbyist said during the meeting that 340B should be repurposed given changes in medicine and health policy during the past 20 years. Other panelists preached caution. “Before we ever consider going to a patient-based model, you risk diffusing this program so broadly … I mean, if you’re worried about 6,000 pharmacies today, forget it. You’ve got 50,000-plus pharmacies that would have to participate if you suddenly made individuals eligible for a discount,” said Dan Hawkins of the National Association of Community Health Centers said.
Another attendee representing health care providers said her organization had “no intention of pitting DSH hospitals against other covered entities.” No hospitals or hospital groups were present at the meeting. Safety Net Hospitals for Pharmaceutical Access, which represents hospitals enrolled in 340B, said the summit “was based on the false premise that the program is in dire need of reform.”
The meeting was “clearly biased as hospital groups were not included in the planning … nor were they invited to give presentations,” SNHPA said, adding that many of the speakers have issued reports about 340B “that present largely unfounded or biased information to support their position.”
“If this group was serious about having a meaningful dialogue, they would have reached out to provider groups early in the process and included them in some aspects of planning,” SNHPA said. “They would also not be running an expensive public relations and lobbying campaign to mischaracterize the program and its participants.” SNHPA expanded on its position about the meeting in its 340BFacts blog.[/ms-protect-content]