Medicare Part D Compounded Drugs

CMS’s oversight of selected compounded drugs prescribed to Part D enrollees is limited because the data CMS routinely obtains from sponsors (private companies that contract with CMS to provide the prescription drug benefit) does not provide a complete picture of a compounded drug’s ingredients. As a result, enrollees we selected for review were given:

• An FDA-approved reconstituted injectable drug that may have been incorrectly identified on Prescription Drug Event (PDE) records as a compounded drug. Further, we found the days’ supply dispensed by pharmacies exceeded the amount of time, indicated on the prescribing information label, that may pass between when a drug is reconstituted and when it is administered.
• Compounded drugs that included a drug (gabapentin) that CMS has identified as subject to misuse and that is known to increase the effects of opioids at the same time the enrollees had a separate prescription for that same drug. Additionally, some enrollees also received an opioid in a separate prescription during the same period.
• Compounded drugs that included a controlled substance (ketamine) that was not listed on the PDE record. Some of these enrollees also received an opioid in a separate prescription during the same period.

Since CMS does not routinely review the ingredients included in compounded drugs, it is limited in its ability to oversee sponsor efforts to ensure that quality assurance programs identify potential medication errors and potential overutilization of certain drugs.