January 15, 2019

The Health Economics & Patient Access (HEPA) initiative launched last summer and began evaluating projects and focusing on tools to increase predictability of payer scientific and evidentiary requirements. Under the leadership of Liz Spurgin (Vice President, HEPA) and Andrew Greenfield (Vice President and General Manager, Abiomed) a steering committee of industry and regulatory members was formed to identify challenges and priorities.

Steering group member companies include Abbott, Abiomed, B Braun, BD, Baxter, Boston Scientific, Cook, CVRx, Edwards, Insulet, Integra Lifesciences, J&J, Medtronic, and Stryker. CMS is represented by MDIC board member, Tamara Syrek-Jensen and FDA by Katie O’Callaghan and other CDRH leaders. As the steering group explores collaborative efforts with CMS and private payers, MDIC industry group partners, AdvaMed and MDMA, are also engaged to ensure that HEPA projects will complement, not duplicate, their existing efforts.

At the first in-person steering group meeting in December, topics included CMS coverage updates, the CDRH Innovation agenda, and complementary MDIC efforts in Science of Patient Input (SOPI) and NESTcc. One of the first activities for 2019 will be a member survey to further define “pain points” with both CMS and private payer coverage processes. In the interim, please reach out to Liz Spurgin with any questions or to learn more about the initiative.