HHS’s proposed modification of pharmacy rebate safe harbors

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By Christine M. Mytelka | 22 March 2019
In February, the Office of the Inspector General of the U.S. Department of Health and Human Services released proposed modifications to safe harbor regulations in 42 CFR 100.952(h) that protect pharmacy rebates from the federal anti-kickback statute. This paper focuses on potential implications of the proposed modifications to safe harbor regulations for state Medicaid agencies and the Children’s Health Insurance Program.