Some hospital outpatient clinics are likely to lose 340B drug discount program eligibility under a policy the Health Resources and Services Administration issued Thursday.
Hospitals participating in the drug pricing program now must register offsite clinics with HRSA and list them on Medicare cost reports to qualify for 340B, the agency announced in a Federal Register notice. This reverses a 2020 HRSA policy that aimed to streamline 340B certifications during the height of the COVID-19 pandemic.
The 340B program provides discounts of up to 50% on pharmaceuticals for hospitals and other providers that treat low-income and uninsured patients. Hospitals with large outpatient networks stand to pay tens of millions of dollars more on prescription drugs under the new policy. HRSA withdrew the previous guidance in May.
The expedited certification process created to respond to the crisis three years ago is no longer necessary, HRSA wrote in the notice. The rescinded policy “added risk and complexity to HRSA’s ability to effectively oversee compliance in the 340B program,” according to the agency.
The hospital industry had expected the 2020 policy to be made permanent and opposes HRSA's new approach.
“HRSA’s 2020 guidance corrected a longstanding barrier to access by allowing hospitals to use 340B drugs at offsite outpatient locations as soon as they began serving patients,” Beth Feldpush, senior vice president of policy and advocacy for America’s Essential Hospitals, said in a news release. “The reversal of this guidance will significantly harm essential hospitals and curb their ability to serve patients where they live and work.”
340B-eligible hospitals have 90 days to notify HRSA that they have started the process of complying with the new policy. “Noncompliant entities may be subject to audit and compliance action,” HRSA wrote in the notice.