On Wednesday, February 8, 2006, the Centers for Medicare and Medicaid Services (CMS) released in draft form a chapter of the Prescription Drug Benefit Manual ("draft chapter") addressing Part D plan sponsors’ fraud, waste and abuse compliance responsibilities. Although the draft chapter is directed to plan sponsors, it is relevant to all parties involved in the delivery of the Medicare Part D prescription drug benefit, particularly subcontractors that deliver or manage prescription drugs. Comments are due March 1, and CMS presently expects to issue the chapter in final form in June 2006.
The 64-page draft chapter follows an 8-page outline that CMS issued last year. In addition to elaborating on the "core elements" of the compliance program required of Part D plan sponsors, the draft chapter:
- Describes potential fraud, waste and abuse risks for Part D plan sponsors, PBMs, pharmacies, prescribers, wholesalers and pharmaceutical manufacturers
- Sets forth requirements and expectations for pharmacies, PBMs, and others who operate as subcontractors to Part D plan sponsors
- Addresses the operations of Part D plan sponsors’ fraud units and Medicare Drug Integrity Contractors (MEDICs)
The draft chapter can be found by clicking here.