Tag Archives: FDA

The Medicaid and CHIP Payment and Access Commission (MACPAC) voted on January 27 to recommend that Congress grant states the ability to limit Medicaid coverage for drugs and biologicals approved under the FDA’s accelerated approval pathway. The Commissioners were presented with two options for recommendation. The first option was for Congress to amend Section 1927(d)(1)(B) of the Social Security Act to allow states to exclude or restrict coverage of a covered outpatient drug based on a Medicare national coverage determination (NCD) including the coverage with evidence development (CED) requirements.… More

 On September 24, 2020 the U.S. Food and Drug Administration took two major steps to implement its Safe Importation Action Plan, including publishing a new Final Rule allowing the importation of certain prescription drugs from Canada, and a Final Guidance describing procedures to allow manufacturers to obtain National Drug Codes (NDC) for FDA-approved drugs originally intended to be marketed in a foreign country ( referred to as “multi-market approved products” or “MMA products”).… More

The Department of Health and Human Service’s Office of Inspector General (OIG) has issued a couple of reports lately on Medicaid coverage of prescription drugs and we thought we’d highlight them here.

The first report suggests that the Medicaid program could save hundreds of millions of dollars a year by re-determining the calculation of average manufacturer price (AMP) for some authorized generic products. … More