Tag Archives: AMP

CMS Finalizes Changes to Medicaid Prescription Drug Rebate Program

Earlier this year, my colleague Ross Margulies and I told you about a new proposed rule issued by CMS that makes several changes to the Medicaid prescription drug rebate program, or the MDRP.  Recently, CMS finalized the rule and we thought we’d take this opportunity to tell you about it.  On balance, we think that the rule succeeds in CMS’s stated goals of increasing access to innovative health care therapies to Medicaid beneficiaries as well as clarifying some longstanding questions about the operation of the MDRP.… More

CMS Weighs in on FDA Importation Rule

 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

CMS Proposes Fundamental Reimbursement Methodological Change for 340B Drugs Used in Hospital Outpatient Setting

We have noted before the link between the Medicaid prescription drug rebate program and the 340B program.  As a refresher, in order to have its outpatient drugs covered by Medicaid, the manufacturer must agree to three separate requirements.  First, the manufacturer must agree to provide a rebate to Medicaid equal to the greater of 23.1% of the average manufacturer price (AMP) of the drug, or AMP minus the best price of the drug. … More