On Friday, February 15, the Center for Medicare & Medicaid Services (CMS) released a proposed national coverage determination (NCD) to provide nationwide consistency in coverage of FDA-approved CAR T-cell therapy under “Coverage with Evidence Development” (CED). Currently, nationwide coverage policy is not available for approved CAR-T therapies, and it has been covered at the discretion of local Medicare Administration Contractors (MACs) until now.
With this proposed NCD, CMS would require Medicare to cover the therapy when offered to patients “in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment.” Information generated from these registries would aid CMS in identification of future patients for CAR-T therapies and better inform future coverage determinations in which the therapy could be covered “with no registry or trial requirement.”
Read ACCC's summary of the proposed NCD for CAR-T therapies here [log in required].
Posted 2/15/2019
Updated 2/28/2019
