CMS considers paying all Medicare providers for cancer gene therapies

The FDA cleared two forms of chimeric antigen receptor-T or CAR-T therapies last year for patients battling leukemia and lymphoma. Novartis and Gilead manufacture the two cell therapies marketed as Kymriah and Yescarta. The treatments, which are meant to be a one-time event, work by manipulating immune cells to attack cancer cells.

The total bill could add up to $1.5 million per patient, between actual treatment costs and inpatient stays.

UnitedHealthcare urged the CMS to cover the treatments nationally via a letter to the agency earlier this year.

"We believe there is an industry-wide need for a national coverage determination to ensure a level playing field across Medicare Advantage plans," UnitedHealthcare said. "Absent a national coverage determination providers and beneficiaries could get inconsistent treatment decisions and inconsistent Medicare Administrative Contractors decisions."

The CMS will accept comments through June 15 on the request. The agency also will host an advisory committee meeting to discuss the proposal on Aug. 22.

The CMS said it is concerned about the lack of research about whether Medicare enrollees use CAR-T therapy. That could pose a barrier to national coverage. It also raised concerns about adverse event rates.

The CMS anticipates that it will release a proposed coverage decision by Feb. 16, 2019, and a final decision by May 17, 2019.