Here are five things to know:
1. HHS sent the White House Office of Management and Budget the proposal, titled “Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection,” on July 18.
2. The proposal’s language is hidden from the public until the Office of Management and Budget completes its review. However, the title hints at an overhaul of safe harbor protections, which suggests trouble for pharmacy benefit managers.
3. Currently, safe harbor protections shelter drugmaker rebates made to PBMs from antikickback statutes.
4. Pharmaceutical industry lobbyist Barrett Thornhill said the proposed rule suggests trouble for PBMs because if the protections are “not replaced with some other scheme, their current business model evaporates and they become what they were — low-margin claims processors.”
5. A PBM trade organization, the Pharmaceutical Care Management Association, released a statement opposing the proposed changes to the safe harbor laws, arguing it would not reduce drug prices and hinting at legal actions if the rule is approved.
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