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
Category Archives: AMP Rule
Paying for Value in Medicaid Prescription Drug Coverage
My colleague Ross Margulies has already told our readers about a provision of the new proposed Medicaid regulation governing how the program pays for outpatient prescription drugs under the Medicaid Drug Rebate Program, or MDRP. Today, we turn our attention to another provision of that proposed rule, and that is CMS’s attempts to permit pharmaceutical manufacturers, states, and commercial payers to enter into value based payment arrangements for covered outpatient drugs. … More
In Latest Medicaid Rule, CMS Aims to Define Line Extensions
As many of our astute readers are aware, on June 17, 2020 CMS released a long-awaited Medicaid proposed rule addressing a number of far-ranging issued involving Medicaid coverage and payment for prescription drugs, including new regulations to encourage the development value-based purchasing arrangements between states and manufacturers. Over the next several days we will be posting our thoughts on a number of these key policy proposals, including CMS’… More
Senate Finance Committee Proposes Significant Drug Pricing Reforms in Medicaid
On July 25, 2019 the Senate Finance Committee voted to advance their long-awaited drug pricing package to the Senate floor (we anticipate a Floor vote sometime this Fall). The Prescription Drug Pricing Reduction Act (PDPRA) of 2019, as the package is called, proposes numerous drug pricing reforms across Federal healthcare programs (including Part B and Part D), but for today’s blog post we will focus on some of the many Medicaid provisions included in the final mark-up.… More
Congress Not Ready To Forgive and Forget Mylan EpiPen Controversy
Despite Mylan’ $465 million settlement with the Department of Justice for overcharging Medicaid millions of dollars for its product EpiPen, Congress is not ready to let bygones be bygones. In a display of bipartisanship, Sen. Grassley (R-IA) and Sen. Wyden (D-OR) unveiled a bill (section-by-section summary) entitled “The Right Rebate Act” (RRA) on December 4, 2018 and explicitly cited the EpiPen experience as the chief motivating factor for its creation. … More