The Coverage with Evidence Determination (CED) methodology is necessary for treatments and appropriate for traditional diagnostics. However, when applied to innovations in personalized medicine and molecular diagnostics, CED (in its current form and with proposed modifications) fails to capture the benefits of improved health care and decreased costs that are possible from the new technology and the data generated. Given the speed of invention in this important clinical area, CED methods may make new tests obsolete before they are commercialized hindering investment in their development. Current registry systems have demonstrated promising concepts for an alternative to CED, but have also uncovered additional challenges (as would be expected by pioneering new ideas).

This paper proposes an alternative model for coverage determination that builds upon programs like MolDx by Palmetto and capitalizes on the knowledge gleaned from early registries, addresses the key underlying financial motivations that drive coverage determinations, and advocates for a shift to a Pay-For-Value model based on risk sharing between parties. This proposed model is intended to move forward the discussion on a design for coverage determination that encourages innovation in the agile environment of molecular diagnostics. Changes are urgently needed to allow health care to meet the new demands posed by increased medical personalization and for accountability of all parties in the U.S. healthcare system. A technology-enabled coverage determination process presents a unique opportunity for a self-regulating system that inherently optimizes patient outcomes, payor costs, and developer profits.

Co-authors: 

• Paul Billings, Consutling Chief Medical Officer, Life Technologies
• Richard Ding, former Chief Executive Officer, bioTheranostics, Inc.
• Lâle White, Chief Executive Officer, XiFin, Inc.
• Rina Wolf, former Vice President of Commercialization Strategies, Consulting & Industry Affairs, XiFin, Inc.
• David Lorber, former Director of Business Development, XiFin, Inc.