A federal appeals court has ruled the Trump administration can install nearly 30% cuts to the 340B drug discount program.
The ruling Friday is the latest legal setback for hospitals that have been vociferously fighting cuts the Department of Health and Human Services (HHS) announced back in 2017.
340B requires pharmaceutical manufacturers to deliver discounts to safety net hospitals in exchange for participation in Medicaid. A hospital will pay typically between 20% and 50% below the average sales price for the covered drugs.
HHS sought to address a payment gap between 340B and Medicare Part B, which reimburses providers for drugs administered in a physician's office such as chemotherapy. There was a 25% and 55% gap between the price for a 340B drug and on Medicare Part B.
So HHS administered a 28.5% cut in the 2018 hospital payment rule. The agency also included the cuts in the 2019 payment rule.
Three hospital groups sued to stop the cut, arguing that HHS exceeded its federal authority to adjust the rates to the program.
A lower court agreed with the hospitals and called for the agency to come up with a remedy for the cuts that already went into effect.
But HHS argued that when it sets 340B payment amounts, it has the authority to adjust the amounts to ensure they don’t reimburse hospitals at higher levels than the actual costs to acquire the drugs.
If the hospital acquisition cost data are not available, HHS could determine the amount of payment equal to the average drug price. HHS argued that hospital cost acquisition data was not available and so HHS needed to determine the payment rates based on the average drug price.
The court agreed with the agency’s interpretation.
“At a minimum, the statute does not clearly preclude HHS from adjusting the [340B] rate in a focused manner to address problems with reimbursement rates applicable only to certain types of hospitals,” the ruling said.
The court added that the $1.6 billion gleaned from the cuts would go to all providers as additional reimbursements for other services.
340B groups were disappointed with the decision.
“These cuts of nearly 30% have caused real and lasting pain to safety-net hospitals and the patients they serve,” said Maureen Testoni, president and CEO of advocacy group 340B Health, which represents more than 1,400 hospitals that participate in the program. “Keeping these cuts in place will only deepen the damage of forced cutbacks in patient services and cancellations of planned care expansions.”
This is the latest legal defeat for the hospital industry. A few weeks ago, the same appeals court ruled that HHS had the legal authority to institute cuts to off-campus clinics to bring Medicare payments in line with physician offices, reversing a lower court’s ruling.
The groups behind the lawsuit — American Hospital Association, American Association of Medical Colleges and America's Essential Hospitals — slammed the decision as hurtful to hospitals fighting the COVID-19 pandemic. But the groups didn't say if it would appeal the decision.
"Hospitals that rely on the savings from the 340B drug pricing program are also on the front-lines of the COVID-19 pandemic, and today’s decision will result in the continued loss of resources at the worst possible time," the groups said in a statement Friday.
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