The Health Resources and Services Administration is considering another delay of a final rule that would set price ceilings in the 340B drug discount program, but hospital organizations are urging the agency to finalize the price caps now.
HRSA issued a proposed rule (PDF) earlier this month that would delay to July 2019 regulations that would set the ceiling price and impose civil penalties on drug companies that knowingly charge 340B hospitals above that price cap. The delay, if it goes through, would be the fifth time the agency has pushed back the rule.
The comment window for the rule ended Tuesday, and both America's Essential Hospitals and the American Hospital Association wrote to HRSA to urge the agency to finally put the rule in place.
"Delaying the implementation of the ceiling price and CMPs an additional year...is not justified given the exhaustive development process that has occurred," Tom Nickels, AHA's executive vice president for government relations and public policy, wrote in a letter (PDF) to the agency.
"By failing to implement the final rule, drug manufacturers can continue to overcharge 340B hospitals by violating the ceiling price policy without repercussion," Nickels wrote.
HRSA says the delay is necessary as the Department of Health and Human Services considers making significant changes to 340B.
Democrats accused the Trump administration of "sabotaging" the 340B program by repeatedly delaying the Obama-era price ceilings at a hearing in mid-May. Sen. Patty Murray, D-Wash., said the administration "seems entirely uninterested in actual oversight or program integrity."
The rule was set to take effect in January 2017.
Bruce Siegel, M.D., president of America's Essential Hospitals, wrote in a letter (PDF) to HRSA that the rule has been "thoroughly vetted" and that there's no reason to push back its implementation any further even if HHS is considering a 340B overhaul.
"President Trump recently announced policy ideas aimed at lowering drug costs and reducing out-of-pocket costs for patients," Siegel wrote. "The final rule is in alignment with the administration's aim to provide relief and transparency by establishing a more accurate and timely price calculation for 340B drugs."
The 340B program has been embroiled in controversy of late after the Centers for Medicare & Medicaid Services announced it would change the program's payment rate from up to 6% more than the average price of a medication to 22.5% less than the average price. The change took effect in February and slashed an estimated $1.6 billion in 340B payouts.
Hospital groups like the AHA and America's Essential Hospitals have railed against the change; both groups are part of a lawsuit against HHS to block the payment cuts.