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One percent of drugs with Medicaid reimbursement were not FDA-approved
One percent of drugs with Medicaid reimbursement were not FDA-approved
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Reports-in-brief (Promoting Women in Development (Project))
- Contributor(s):
- United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, May 2019
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Drug Approval
Insurance, Health, Reimbursement -- economics
Insurance, Health, Reimbursement -- statistics & numerical data
Medicaid -- economics
Medicaid -- statistics & numerical data
United States
United States. Food and Drug Administration - Genre(s):
- Technical Report
- Abstract:
- Why OIG Did This Review. Previous Office of Inspector General (OIG) work found that Medicaid may have paid for drugs in 2008 that were not FDA-approved as safe and effective. To qualify for Federal payments under Medicaid, drugs must be FDA-approved unless they meet the criteria for an exception--for example, prescription prenatal vitamins or drugs that are prescribed during times of drug shortages. Congress asked OIG to examine CMS's oversight of the Medicaid Drug Rebate Program and the extent to which CMS relies on FDA's drug classifications. How OIG Did This Review. We obtained utilization data for drugs with Medicaid reimbursement in 2016. We used the FDA marketing categories to determine whether drugs were FDA-approved. We calculated the number and percentage of (1) drugs that were FDA-approved, (2) drugs that were not FDA-approved, and (3) drugs for which we were unable to determine the FDA approval status. We also determined the amounts that Medicaid reimbursed for each of these groups of drugs in 2016. Finally, we reviewed CMS's policies and procedures for evaluating the FDA approval status of drugs in the Medicaid Drug Rebate Program. What OIG Found. Ninety-six percent of drugs with Medicaid reimbursement in 2016 were approved by the Food and Drug Administration (FDA) for safety and effectiveness. However, Medicaid reimbursed for a small percentage of drugs (1 percent, or 267 drugs) that were not FDA-approved. For the remaining drugs, we were unable to determine an FDA approval status. What OIG Recommends. We recommend that CMS (1) work with States to recoup any potentially inappropriate Federal reimbursement for drugs that CMS determines were not FDA-approved and did not meet the criteria for an exception; (2) continue to improve its reporting system to prevent inappropriate reimbursement for drugs that are not FDA-approved, and (3) work with States to ensure that they prevent inappropriate reimbursement for drugs that are not FDA-approved and do not meet the criteria for an exception. CMS concurred with all three recommendations.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (18 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101757549 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101757549