ANN ARBOR: BioNJ, Biocom, the California Life Sciences Association (CLSA), the HealthCare Institute of New Jersey (HINJ), Life Sciences Pennsylvania (LSPA), and the Michigan Biosciences Industry Association (MichBio) today 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, the associations asked that CMS provide additional clarity regarding the methods through which manufacturers might operationalize these provisions. The letter also expressed concerns with the NPRM’s proposals on copay “accumulators” and definitions for new formularies and line extensions since manufacturers do not control or have meaningful input into health plan benefit designs. Additionally, the associations shared concerns that these provisions could unnecessarily increase Patient costs at the pharmacy counter.

In a joint statement by the six associations’ CEOs, the letter specifies that “Despite our appreciation for CMS’ efforts to improve the capabilities of manufacturers to implement value-based arrangements, we have significant concerns with the NPRM’s changes to how copay cards are calculated for purposes of best price, and efforts to expand the definition of line extension. As proposed by CMS, both of these changes meaningfully depart from statutory intent, may significantly harm Patient access to critical copay assistance, and negatively impact future innovation.”