On February 15, 2019, CMS released a proposal to provide nationwide coverage for a new cancer therapy, Chimeric Antigen Receptor T-cell Therapy (CAR-T Therapy), for Medicare patients. The proposed nationwide coverage decision (NCD) would require Medicare to cover FDA-approved CAR-T Therapy through CMS’ Coverage with Evidence Development (CED) program. CED allows CMS to approve an item or service in the context of a clinical study. Under the proposed NCD, a patient may obtain CAR-T Therapy so long as it is being offered in a CMS-approved registry or clinical study and the patients are monitored for at least two years post treatment. CMS Administrator Seema Verma stated in a press release that the “proposed coverage decision would improve access to this therapy while deepening CMS's understanding of how patients in Medicare respond to it.” 

CMS notes that CAR-T Therapy is a “precision cancer treatment wherein each treatment dose is individually manufactured for the patient using their own T-cells, a type of white blood cell known as a lymphocyte. CAR T-cell therapy is a rapidly emerging adoptive cell transfer immunotherapy for select patients with relapsed or refractory cancers.” CMS’s proposal would allow patients to access FDA-approved versions CAR-T Therapy. Specifically, the FDA in 2017 approved two version of CAR-T Therapy: tisagenlecleucel (Kymriah®) and axicabtagene ciloleucel (Yescarta®).

Although current Medicare patients can get coverage for CAR-T Therapy on a case-by-case basis with Medicare Administrative Contractors having discretion over whether to pay for CAR-T Therapy, CMS’s proposal would allow for coverage nationwide so long as CMS’s criteria for CED is met, including participation in a clinical study. CMS states that the data collected through the studies “would help CMS identify the types of patients that benefit from CAR T-cell therapy, informing a future decision by the agency regarding the types of cases in which Medicare would cover the treatment with no registry or trial requirement.”

CMS is seeking comments on the proposed NCD. A final decision will be issued no later than 60 days after the conclusion of the 30-day public comment period. Public comments on the proposal may be submitted here.

CMS’s press release on the proposed coverage of CAR-T Therapy can be found here. CMS’s Proposed Decision Memo for CAR-T Therapy can be found here and additional information from CMS’s National Coverage Analysis can be found here.