The Pharmaceutical Care Management Association has filed suit against the Trump administration in an effort to block the recently finalized rebate rule.
PCMA, which represents pharmacy benefit managers, has been a staunch critic of the rule since it was first introduced in early 2019. The rule eliminates anti-kickback safe harbors for drug rebates and instead offers them to direct-to-consumer discounts, and was finalized after a surprise revival in November.
In the complaint (PDF), PCMA warns that the rule would lead to higher premiums in Medicare Part D and reflects an "erratic and highly irregular administrative process" in which the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) did not effectively coordinate.
Drug rebates have been a long-standing practice in commercial plans, which Part D was modeled on, PCMA said.
"The rule pursues this result by threatening manufacturers, PBMs, and plan sponsors with significant criminal and civil liability under the federal anti-kickback statute … simply for engaging in the same rebate practices that they have followed since the start of the Medicare Part D program, consistent with the commercial insurance market that Congress intended for Part D plans to emulate," they said.
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