Patient Access Restrictions to Medical Device Innovation

Patient access to medical device innovations is directly tied to approval by the Food and Drug Administration (FDA) and adequate insurance coverage by commercial and government payors, such as Medicare/Medicaid. Reimbursement by third-party insurers and the Centers for Medicare & Medicaid Services (CMS) is a crucial component for patient access, as providers are reluctant to use treatments that are not covered by insurance or CMS. However, FDA approval of breakthrough devices is often not supported by long-term safety, efficacy, or patient outcome data, which are critical in establishing the “medically reasonable and necessary” standard to which payors are bound in order to cover a treatment. In turn, a lack of adequate coverage can significantly impact a physician’s decision to use the device and provide a patient access to a breakthrough treatment. Recent policy and legislative proposals have highlighted the need for more timely CMS coverage for devices approved through the FDA’s breakthrough program.

This panel will discuss the FDA’s successful device breakthrough program and the recent policy/legislative proposals for CMS to provide more timely coverage decisions for devices that have obtained breakthrough status.

Moderator: Eva Yin, Wilson Sonsini Speakers: Kwame Ulmer, Wavemaker Three-Sixty Health
Jennifer Newberger, Cognito Therapeutics