CMS seeks comments on proposal to collect cost data on 340B acquisitions

CMS recently announced that it is accepting comments until November 29 on a proposal to collect acquisition cost data from hospitals participating in the 340B drug discount program.

Per the Paperwork Reduction Act of 1995, federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment on the proposed action.

CMS is proposing to collect information in the form of a hospital survey for specified covered outpatient drugs. If after the comment period CMS decides to proceed with data collection, every hospital that was enrolled in the 340B program as a covered entity in the last quarter of 2018 and/or the first quarter of 2019 would be required to complete the survey between February 17 and March 16, 2020.

In its notice, CMS references pending litigation against the agency by hospital groups on the issue of Medicare payment cuts to 340B hospitals. Under the contested drug payment policy, CMS reimburses 340B hospitals at average sales price minus 22.5%, a policy first introduced in the 2018 OPPS proposed rule and expanded to additional sites in the 2019 OPPS final rule. The policy was widely opposed, and in May, a U.S. District Court ruled that the reduction in payments was unlawful. 

CMS is currently appealing the ruling and in the 2020 OPPS proposed rule proposes to maintain the cuts. However, the agency is soliciting comments on how to unwind the policy and make remedies for cuts in 2018 and 2019 if its appeal is denied.

CMS states in its notice that if it doesn’t successfully appeal the case, it may use the acquisition cost data collected from this survey to set payment rates for 340B drugs.