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May 17, 2018 01:00 AM

CMS considers paying all Medicare providers for cancer gene therapies

The CMS is considering reimbursing all Medicare providers for one-time cancer treatments that genetically alter patients' cells to fight the disease. The move could increase revenue by millions at each hospital offering the therapy.

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.

While local Medicare contractors can cover CAR-T treatments already, there is no national payment policy to reimburse hospitals which typically administer the treatments. The CMS pays hospitals $500,839 for administering Kymriah and $395,380 for Yescarta. Hospitals also can secure more revenue from inpatient stays stemming from the treatment's side effects. The patient then also undergoes chemotherapy and if complications arise, might need to be hospitalized.

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.