Although the Trump Administration declined to end “safe harbor” protections under the federal anti-kickback statute for rebates paid to PBMs, efforts to rein in DIR fees and ease the pressures on in-office dispensing programs are still ongoing, involving both sides of the aisle.
In April, Senate Finance Committee Chairman Chuck Grassley (R-IA) and Senator Maria Cantwell (D-WA) introduced legislation that would require the Federal Trade Commission (FTC) to study the role of PBMs and recent merger activity to examine the effects of consolidation on pricing and other potentially-abusive behavior.
In an effort to increase transparency, the Prescription Pricing for the People Act of 2019 would seek reporting from the FTC on whether PBMs:
- Charge payers a higher price than their reimbursement rate for competing pharmacies
- Steer patients to pharmacies in which they have ownership interest
- Audit or review proprietary data from competing pharmacies for anticompetitive purposes
- Design formularies to increase market share of higher-cost drugs and depress lower-cost drugs
The bill passed the Senate Judiciary Committee without objection, but it remains to be seen if the bill will be passed.
In June, 105 representatives and 28 senators sent letters to President Trump to express their disappointment that DIR reform was not included in the finalized Part D and Medicare Advantage rule.
Most recently, the Phair Relief Act was introduced, which seeks to put a five-year freeze on DIR fees and establish oversight, as well as create standardized quality metrics for PBMs to assess any fees after this period ends. Similar policies proposed by the CMS in 2018 estimated that reducing these retroactive fees would reduce out-of-pocket costs for patients by up to $9.2 billion.