WITHDRAWN: Examination of CMS National Coverage Analyses and Concordance With Other Decision-Making Bodies

OBJECTIVES: The US Centers for Medicare & Medicaid Services (CMS) are authorized to evaluate technologies in order to make reimbursement decisions for millions of Americans through national coverage decisions (NCDs). This research aimed to examine trends in NCDs and identify any correlation between NCDs and coverage recommendations from the Institute for Clinical and Economic Review (ICER) in the US and the National Institute for Health and Care Excellence (NICE) in the UK.

METHODS: The CMS website was searched on June 14^th, 2022, for completed NCD memos updated or created since January 1^st, 2017. Assessments for included therapies were searched for on the ICER and NICE websites to determine whether there were similar recommendations or rationales for differences.

RESULTS: In the five-year period, only 20 NCDs were issued. Of these, three were for medical products: monoclonal antibodies for the treatment of Alzheimer’s Disease (aducanumab; covered only in clinical trials), chimeric antigen receptor (CAR) T-cell therapy for cancers (tisagenlecleucel and axicabtagene ciloleucel; covered), and autologous blood-derived products (i.e., plasma) for chronic non-healing wounds (covered). ICER issued a negative opinion for aducanumab, while NICE suspended their evaluation following a negative regulatory decision. Neither ICER nor NICE evaluated plasma for chronic non-healing wounds. For both CAR-T cell therapies evaluated, ICER and NICE issued positive opinions.

CONCLUSIONS: Since 2017, CMS has published very few NCDs, with only a minority for medical products. Overall, CMS coverage decisions were aligned with those made by health technology assessment groups. Additionally, it is noteworthy that aducanumab was the only medical product within the last five years to have a negative coverage decision from CMS, though this is in line with similar recommendations from ICER.