Rebate Rule Rises From Dead, but Could Still Be Doomed
On Nov. 20, HHS finalized a once-tabled regulation that would revamp the Medicare prescription drug rebate system. While that may seem to be unwelcome news to the health insurers and PBMs that have vocally opposed the so-called rebate rule, it is not at all certain that this version will survive amid likely legal challenges and the upcoming transfer of power in the White House.
HHS first introduced the rebate rule in January 2019 in a notice of proposed rulemaking (NPRM), which aimed to remove safe-harbor protections under the federal Anti-Kickback Statute for rebates that drug manufacturers provide to Medicare Part D plans, PBMs and Medicaid managed care organizations (RDB 2/14/19, p. 1). The goal, HHS Secretary Alex Azar said at the time, was to prevent situations in which patients “pay more than they need to for their prescription drugs because of a hidden system of kickbacks to middlemen.”