Showing posts with label Drugs Made By Compounders That Operate In Violation Of The Food. Show all posts
Showing posts with label Drugs Made By Compounders That Operate In Violation Of The Food. Show all posts

Sunday, February 16, 2014

McGuireWoods LLP United States: Drugs Made By Compounders That Operate In Violation Of The Food, Drug, And Cosmetic Act Create Recoupment Risk Last Updated: February 16 2014 Article by Kimberly J. Kannensohn and Samuel C. Bernstein

The U.S. Department of Health and Human Services Office of Inspector General's (OIG) Work Plan for Fiscal Year 2014 indicates that the OIG will be examining Medicare Administrative Contractor (MAC) policies and procedures for reviewing and processing Medicare Part B claims for compounded drugs in light of the fact that Medicare pays only for compounded drugs that are produced in accordance with the Federal Food, Drug, and Cosmetic Act (FDCA). This initiative suggests that greater scrutiny will be applied to Medicare program payments for compounded drugs. If a compounder is not strictly complying with the FDCA or applicable exemptions thereto, it may find that its drugs are no longer reimbursed by MACs, who pay claims on behalf of the Medicare program. In addition, it is possible that MACs or the Centers for Medicare and Medicaid Services (CMS) may seek recoupment for claims previously paid for drugs compounded in violation of the FDCA

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