This final decision of coverage with evidence development (CED) represents a positive change from CMS’ draft decision, released last October, which proposed non-coverage for PILD. CMS cited several reasons for its recent decision, including: a lack of consensus on patient selection criteria, reports of adverse events, and weak evidence to determine PILD’s impact on patient outcomes.

CMS’ reversal from the proposed non-coverage decision is a strong positive for PILD manufacturers (namely, Vertos Medical), as they will now receive payment for the procedure while simultaneously generating more robust data to support use of the product. In addition, this decision illustrates three key trends in the Medicare coverage landscape: More information on the national coverage determination (NCD), click here.

Growing Influence of Professional Societies on Medicare Coverage Decisions: In its comments to CMS, the North American Spine Society (NASS) called for coverage of PILD through CMS’ CED program, despite originally recommending non-coverage. NASS referenced findings from several new studies highlighting the safety and efficacy of PILD, but acknowledged the need to generate further evidence to identify the characteristics of patients who are most likely to benefit from the procedure.
Importance of Consensus-Based Patient Selection Criteria: CMS cited the lack of consensus on patient selection criteria for PILD as a key justification for its CED decision. Several recent NCDS, such as Transcatheter Aortic Valve Replacement and beta amyloid positron emission tomography, further solidify CMS’ focus on explicitly defined patient selection criteria for novel technologies.
CED Offers Alternative Coverage Route for Medical Technologies with Outstanding Evidence Issues: CMS’ reversal of its initial non-coverage decision signifies that medical interventions with the potential to fill an unmet need within the Medicare population can still obtain coverage despite outstanding efficacy/safety concerns.