AHA lawsuit prompts HHS proposal to implement 340B ceiling price rule Jan. 1

Facing deadlines for responding to the lawsuit brought by the AHA, Association of American Medical Colleges, America’s Essential Hospitals, 340B Health and three hospital systems, the Department of Health and Human Services today proposed implementing on Jan. 1 its final rule on 340B drug ceiling prices and civil monetary penalties for manufacturers. The rule describes how ceiling prices must be calculated and allows the federal government to levy CMPs against drug companies that intentionally overcharge 340B providers. HHS most recently proposed delaying the rule’s effective date to July 1. HHS will accept comments on the proposed rule for 21 days after its publication in the Nov. 2 Federal Register.  
 
“We are pleased that in response to our lawsuit, HHS today proposed a regulation that would make the effective and compliance date for the 340B enforcement rule Jan. 1, 2019,” said AHA General Counsel Melinda Hatton. “We encourage HHS to stick by this commitment and to publish the final rule in time to meet that deadline. The rule also requires that HHS make pricing information available online to 340B hospitals and other providers. We strongly encourage HHS to publish that website promptly, which is critical to enforcement of the 340B program, as soon as possible after Jan. 1.”