The Health Resources & Services Administration warned Merck in an Oct. 20 letter that the company may face monetary penalties for refusing to give 340B discounts to covered entities.
In May, HRSA notified Merck that it was violating 340B requirements by surpassing the ceiling prices for outpatient drugs covered under the federal program.
"Given Merck’s continued refusal to comply, HRSA has referred this issue to the HHS Office of the Inspector General," Emeka Egwim, PharmD, director of HRSA's Office of Pharmacy Affairs, wrote in the letter.
Merck is the eighth such drugmaker that HRSA has referred for potential fines alongside AstraZeneca, Boehringer Ingelheim, Eli Lilly, Novartis, Novo Nordisk, Sanofi, United Therapeutics.
Penalties could total more than $6,000 per violation, according to an Oct. 21 news release from 340B Health.
Editor's note: Becker's reached out to Merck for comment and will update the article as more information becomes available.