Prescription Drug Pricing: ASPE Resources Related to Safe Harbor Rule


Department of Health and Human Services Secretary Alex Azar and Inspector General Daniel Levinson have issued a proposed rule, “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.”  The Department’s Medicare Part D analysis in the rule is based on the CMS Office of the Actuary’s work commissioned specifically for this rulemaking and two commissioned actuarial analyses independent of the CMS Office of the Actuary. The Office of the Actuary directs the actuarial program for CMS and directs the development of and methodologies for macroeconomic analysis of health care financing issues.  The two external actuarial firms, Milliman and Wakely, were chosen by ASPE based on their commercial experience assisting plan sponsors with their plan bids.