CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program
FDA Law
JUNE 2, 2023
Diagnosis in prescriptions The statutory definition of a “covered outpatient drug” excludes a drug used for an indication that is not a “medically accepted indication,” which is in turn defined as an indication that is approved by FDA or that is favorably noted in specified drug compendia. 42 U.S.C. §§ 1396r-8(k)(3) and 1396r-8(g)(1)(B)(i).
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