The Biden administration should reverse “harmful Trump administration policies” that “undermined the 340B program and contravened Congress’ intent,” the group America’s Essential Hospitals advised President Biden in a letter earlier this month.
America’s Essential Hospitals’ Feb. 10 letter said the U.S. Health Resources and Services Administration (HRSA) should “act swiftly to put an end” to several drug manufacturers’ cessation of 340B pricing on drugs dispensed by contract pharmacies or imposition of conditions on such pricing.
The Dec. 30 U.S. Health and Human Services (HHS) general counsel’s advisory opinion that such manufacturers must offer 340B pricing without regard to how drugs are dispensed “was a positive first step to holding manufacturers accountable, but HRSA now must use the tools at its disposal to follow through on this advisory opinion,” America’s Essential Hospitals said. “This includes referring manufacturers to the HHS Office of Inspector General for the imposition of civil monetary penalties for charging more than the statutorily-mandated ceiling price,” and requiring manufacturers to “repay covered entities for the forgone 340B discounts.”
America’s Essential Hospitals called on the new administration “to promptly reverse” the Trump administration’s nearly 30 percent reduction in Medicare Part B drug reimbursement for hospitals’ 340B-purchased drugs. “This policy is on tenuous legal grounds and violates the intent of the 340B program, which was designed for hospitals to realize savings through discounted drugs,” it said.
America’s Essential Hospitals also said the Biden administration should withdraw a Trump administration’s “most favored nation” (MFN) drug pricing rule. Three federal district judges, in separate lawsuits filed by the drug and biotech industries and independent cancer-treatment centers, have temporarily enjoined the rule in whole or in part.
Under the rule, the Centers for Medicare and Medicaid Services (CMS) would base federal reimbursement for 50 expensive, physician-administered drugs on the lowest price that drug manufacturers get in similar countries. Participation in the MFN payment model would be mandatory for 340B hospital outpatient departments reimbursed by Medicare. The model would force 340B hospitals, and other providers, either to get manufacturers somehow to agree to charge them less for the drugs, or to absorb financial losses from lower Medicare reimbursement.
“As CMS itself acknowledges in the rule, the MFN model could further burden 340B hospitals and restrict patient access to lifesaving drugs,” America’s Essential Hospitals said.