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Public Policy Newsletter Article

Life science associations urge CMS to continue to refine the VPB provisions and provide clarity to ensure use across healthcare system.

Biocom & Leading State Life Sciences Associations Express Concerns with CMS’ Rule on Medicaid Value-Based Agreements

  • 2020-07-22T19:00:00.000+0000
  • California
  • Author: Laure Fabrega

On July 20, Biocom, along with BioNJ, the California Life Sciences Association (CLSA), the HealthCare Institute of New Jersey (HINJ), Life Sciences Pennsylvania (LSPA), and the Michigan Biosciences Industry Association (MichBio) submitted comments to the Centers for Medicare and Medicaid Services (CMS) on a notice of proposed rulemaking (NPRM) impacting value-based purchasing (VBP) agreements and other innovative solutions designed to provide patient access to, and purchasing agreements for, cutting edge therapies and cures.

While commending CMS’ actions designed to streamline manufacturer VBP agreements and ease their use for greater patient access, we also asked that CMS provide additional clarity regarding the methods through which manufacturers might operationalize these provisions. Our comments also expressed concerns with the NPRM’s proposals on patient assistance programs (also referred to as copay accumulators) and definitions for new formularies and line extensions since manufacturers do not control or have meaningful input into health plan benefit designs.

The provisions meaningfully depart from statutory intent, may significantly harm Patient access to critical copay assistance, and negatively impact future innovation. Therefore, we urged CMS to continue to refine the VBP provisions so the Agency can continue its work on these new payment arrangements, and withdraw the provisions related to copay accumulators, line extension, and new formulation, as currently written. A copy of the comments can be found here.