Tuesday, April 23, 2019

CMS Guidance on Rebate Shift Offers Transition for Part D Plans



As insurers and PBMs prepared to submit their comments about a proposed overhaul of the prescription drug rebate system, CMS on April 5 issued a guidance document aimed at mitigating at least some of their concerns.

The proposed rule would remove safe-harbor protections under the federal anti-kickback statute for rebates paid by drug manufacturers to PBMs, Part D plans and Medicaid managed care organizations, and it would create a new safe-harbor protection for point-of-sale drug discounts.

The guidance states that if the administration sticks with its proposed 2020 implementation date for the rule, CMS will "conduct a demonstration that would test an efficient transition for beneficiaries and plans to such a change in the Part D program." The voluntary demonstration would involve modifying Part D risk corridors so that the government "will essentially take 95% of the risk off the table" for plan sponsors, as Citi analyst Ralph Giacobbe put it.

Giacobbe advised that the memo appears "favorable to the largest PDP players," including CVS Health Corp., UnitedHealth Group and Humana Inc., and "generally positive for PBMs and health insurers broadly." He also wrote that "we'd guess everyone would participate" in the two-year Part D demonstration that the administration offered.

But Deb Devereaux, senior vice president of pharmacy at Gorman Health Group, says that may not necessarily be the case.

"It's mainly fear of the unknown," she says, when asked why plans might not opt in to the demonstration. Overall, the combination of the pending rebate rule with other new Medicare regulations is making for a tough landscape for insurers, she adds.


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