Medicare officials are investigating pharmacies that sell compounding made-to-order gels, lotions, and creams for possible fraud and patient safety risks. In general, made to order creams used in pain treatments can dramatically improve a patient’s quality of life, but HHS regulators are concerned for patient safety if these drugs are not properly monitored. For example, in 2012, a Massachusetts pharmacy failed to maintain sterile conditions and sold tainted made-to-order injections that killed 64 Americans. Although State Boards usually regulate these compounded drugs, they are not considered FDA approved.
Medicare officials have identified several target pharmacies allegedly charging extremely high prices, selling large percentages of identical drugs, and that have substantially increased billing for these products. Price hikes on compounded gels and creams, combined with an increase in dispensed prescriptions, has led to a rise in Medicare spending on pain creams from $13.2 million in 2010 to $323.5 million in 2016. Regulators are beginning to take measures against pharmacies with suspicious billing patterns, especially in the cities of Detroit, Houston, Los Angeles and New York, all of which have high concentrations of red-flagged pharmacies.
The Health Law Partners frequently counsels compounding pharmacies at a national level on proactive and reactive strategies against fraud and abuse allegations. For more information on this topic, please contact Adrienne Dresevic, Esq. or Clinton Mikel, Esq. at (248) 996 –8510 or by email at [email protected] or [email protected]