On Dec 12, 2018, FDA issued a new proposal to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition Act of 2009 (BPCI Act). The BPCI Act amended the definition of biological product to include a “protein (except any chemically synthesized polypeptide.” To clarify these terms, FDA is proposing to provide its interpretation of the terms “protein” and “chemically synthesized polypeptide" to reduce regulatory uncertainty over what products are regulated as drugs or biological products.
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 Nov 1, 2018 CMS issued a proposed rule that updates Medicare Advantage (MA) and Medicare Part D Programs. The proposed rule would allow MA plans to offer “additional telehealth benefits”, makes changes to dual-eligible special needs plans, would allow Part D plans to request standardized extracts of Medicare claims data about its plan enrollees, and proposes enhancements to star ratings.
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 30, 2018, CMS published an Advanced Notice of Proposed Rulemaking for a potential International Pricing Index (IPI) Model for Medicare Part B Drugs. The model would be phased in over a five-year period and will be tested as a pilot program through the CMS Center for Medicare and Medicaid Innovation. The model is intended to lower expenditures for Part B drugs by implementing an international reference price to shift payments to a level that is comparable with prices in other countries. It also seeks to reform the current “buy and bill” system for Part B drugs and alter reimbursement methodology to eliminate existing incentives to prescribe higher-cost drugs.