On January 31st, the Department of Health and Human Services (HHS) proposed major changes to the federal Anti-Kickback Statute that if passed, will bring a new level of transparency to PBM contracting.
The proposed rule will do the following:
- Remove the safe harbor protection for drug manufacturer discounts and rebates
- Add new safe harbor protections for discounts offered directly to patients at the point of sale
- Add new safe harbor for fixed fee services between pharma and PBMs that does not take into account the volume or value of the business between the manufacturer and the PBM
At this time, the proposed ruling is limited to Medicare and Medicaid plans. Congress could extend this model to the commercial market at which point it would impact all PBM contracts.
The ruling does not alter current safe harbor protection offered to other entities such as wholesalers, pharmacies, physicians and other third-party payers.
What to expect next:
- The proposal will be published in the Federal Register in the next weeks
- A 60-day comment period must pass
- The administration will consider comments and issue a final rule
- The final rule would have a minimum of a 60-day delayed effective date
- The targeted effect date is 1/1/2020, but it’s possible to become available before then based on the timing noted above
- If enacted, the new rule will impact pricing for all Medicare and Medicaid contracts
- Truveris will monitor progress on the proposed ruling closely and will continue assisting clients with their PBM contracting needs