February 05, 2019
The US Department of Health and Human Services and its Office of the Inspector General released a proposed rule building on the Administration’s efforts to lower prescription drug prices. The proposal would update the discount safe harbor in the Anti-Kickback Statute to explicitly exclude reductions in price offered by drug manufacturers to pharmacy benefits managers (PBMs), Part D and Medicaid-managed care plans from the safe harbor’s definition of a “discount.” It would also create a new safe harbor designed specifically for price reductions on pharmaceutical products, but only those that are reflected in the price charged to the patient at the pharmacy counter. PBMs have become a potential target for lawmakers and the Administration as an area for reform under the auspices of addressing the rising cost of prescription drugs. This is the first proposal from the Administration that directly challenges the role of PBMs.
A fact sheet on the proposed rule is available here.