On January 25, 2019, AMCP provided comments to CMS in response to its proposed rule on lowering drug prices and reducing out-of-pocket expenses in the Medicare program. The letter outlines the proposal’s impact on providing plan flexibility to manage protected classes, prohibition against gag clauses in pharmacy contracts, E-Prescribing and the Part D Prescription Drug Program, Part D explanation of benefits, and Medicare Advantage and step therapy in Part B.
On November 26, 2018, CMS issued a new proposed rule outlining potential policies that are intended to lower the cost of prescription drugs. Major Provisions in the proposed rule include; Providing Part D Prescription Drug Plan (PDP) flexibility to negotiate discounts for drugs in protected classes; Utilizing Real Time Benefits Tools (RTBT) in the Part D Program to increase drug price transparency at the point of prescribing; Codifying a policy to allow step therapy in Medicare Advantage for Part B Drugs; Amending regulations related to the Part D Explanation of Benefits (EOB) that plans send to beneficiaries to include drug pricing information and lower cost alternatives; Implementing a statutory provision prohibiting the use of gag clauses in pharmacy contracts; Considering a policy that would re-define negotiated price as the baseline, or lowest possible, payment to a pharmacy in future plan years as early as 2020.
AMCP summarizes the final 2019 CMS Physician Fee Schedule. The final rule includes provisions relating to Substance Use-Disorder (SUD) prevention and includes an interim final rule that would allow telehealth service treatment for a SUD to be provided at the home of an individual for the first time starting in July, 2019.
On November 1, 2018, CMS finalized its rule for the 2019 Physician Fee Schedule (PFS) and the Quality Payment Program (QPP). In the final rule, CMS acknowledges responses to its comment solicitation in the proposed rule on creating a bundled episode of care for management and counseling treatment for substance use disorders. Additionally, CMS is implementing a provision from the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act through an interim final rule. The Final Rule also reduces wholesale acquisition cost (WAC)-based payment for newly-launched physician-administered drugs to 103% of WAC.
On October 18, 2018, CMS issued a new proposed rule that would require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products payable by Medicare or Medicaid to include the wholesale acquisition cost (WAC), or list price, of that prescription drug or biological product.