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 sent comments to the Centers for Medicare and Medicaid Services (CMS) on a notice of proposed rulemaking (NPRM) on value-based purchasing (VBP) and other issues.
While commending CMS for looking for ways to streamline manufacturer VBP agreements, the associations asked that CMS provide additional clarity on how 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. Additionally, the organizations shared their concern that these provisions could unnecessarily increase Patient costs at the pharmacy counter.
The letter read, “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.”
Comments on the NPRM are due Monday, July 20. Please contact Steve Issenman at issenman@hinj.org.