Special Advisory Bulletin: Patient Assistance Programs for Medicare Part D Enrollees (November 2005)

Drug manufacturers have historically helped low-income people by giving them free or low-cost medications for specific conditions. In light of the competitive focus of Medicare Part D, the OIG has ruled that any help a manufacturer gives must not interfere with the ability of a Medicare Part D program operator to provide care for enrollees. Donations of name brand medications may be viewed as interference with the operator's program by encouraging patients to request name brand drugs not covered by the operators formulary. 

Patient assistance programs are not required to disenroll all Medicare beneficiaries from their recipients list. Only those with enrolled in Medicare Part D must be disenrolled. A program run by a pharmaceutical firm, however must engage in due diligence to find out if a person is enrolled in Part D. 

The OIG describes several "non-abusive" patient assistance programs that will not incur violations to the federal Anti-Kickback Statute. Drug manufacturers may make cash donations to a patient assistance program run by an independent charity. Drug manufacturers may participate in subsidy programs, in the form of discounts off the price of medications unavailable to an enrollee's Part D. plan.