Prescription Drug Pricing: ASPE Resources Related to Safe Harbor Rule
Department of Health and Human Services Secretary Alex Azar and Inspector General Daniel Levinson 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.” Note: The proposed rule was withdrawn on August 1st, 2019.
The Department’s Medicare Part D analysis in the rule was 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 directed 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.
- OACT: Proposed Safe Harbor Regulation
- Milliman: Impact of Potential Changes to the Treatment of Manufacturer Rebates
- Wakely: Estimates of the Impact on Beneficiaries, CMS, and Drug Manufacturers in CY2020 of Eliminating Rebates for Reduced List Prices at Point-of-Sale for the Part D Program
Resources for Prescription Drug Pricing: ASPE Resources Related to Safe Harbor Rule:
Data Point: Prescription Pharmaceutical Price Changes Since the Release of the President's Drug Pricing Blueprint
Using manufacturer-reported prescription pharmaceutical prices, ASPE observed that the number of price increases has been reduced considerably since the release of the President’s Drug Pricing Blueprint, compared to the same time period in the year prior. Since the Blueprint’s release, there are 60% fewer brand name product price increases in 2018 compared to the same period in 2017, and 54% more brand and generic product price decreases combined.
Resources for Data Point: Prescription Pharmaceutical Price Changes Since the Release of the President's Drug Pricing Blueprint: