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
Tag Archives: Best Price
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
The nomination of Seema Verma by President-Elect Trump for the position of CMS Administrator sends a clear signal that the Trump Administration considers Medicaid one of its top healthcare reform priorities. Seema Verma is the the “architect” of the Healthy Indiana Plan 2.0” waiver (HIP 2.0), a consumer-driven Medicaid expansion demonstration approved by the Obama Administration under a Section 1115 waiver. Most recently, Verma was also involved in designing Kentucky’s proposed “Kentucky HEALTH” (“HEALTH”) Section 1115 waiver,… More
In light of the growing cost (and demand for) specialty pharmaceutical products, and the corresponding stress this growth has had on state Medicaid coffers, CMS is now actively encouraging states Medicaid programs to engage in value based purchasing (VBP) arrangements with manufacturers. On Thursday July 14, CMS released guidance documents to state Medicaid agencies and manufacturers regarding participation in these VBP arrangements.
As states consider creative ways to finance high cost drug spend,… More