Compounded drugs are medications customized to meet specific needs of patients. These specialized drugs pose significant health risks if not produced correctly by licensed pharmacists in accordance with the Federal Food, Drug, and Cosmetic Act. An outbreak of fungal meningitis and other fungal infections in late 2012 was linked to contaminated injectable compounded drugs.
Medicare doesn’t pay for compounded drugs knowingly produced in violation of the Act, as determined by the Food and Drug Administration (FDA), but has no way of knowing if it is or not. The OIG contends in the April 29 report, Compounded Drugs Under Medicare Part B: Payment and Oversight, that the ability for CMS to track claims payment of compounded drugs, as well as who produced the drugs, would reduce improper payments.
Based on findings from the study, the OIG recommends in the report that CMS:
- Establish a method to identify Part B claims for compounded drugs;
- Explore the possibility of requiring providers to identify on the Part B claim the pharmacy that produced the compounded drug; and
- Explore the possibility of conducting descriptive analyses of Part B claims for compounded drugs.
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