COA Comments: CMS CAR-T Cell Therapy Proposed Coverage Determination

March 15, 2019

COA Submits Formal Comments to CMS on Proposed CAR-T Cell Therapy Coverage Determination

Today the Community Oncology Alliance (COA) submitted a formal comment letter to the Centers for Medicare & Medicaid Services (CMS) regarding a proposed national coverage determination memo for CAR-T cell therapy. While COA is pleased that CMS is moving in the direction of covering CAR-T therapies, we have significant concerns regarding the specific language in the proposed decision memo.

The letter details COA’s concerns that the agency’s draft coverage determination is not flexible enough to accommodate advances in this rapidly developing field, recognize the progress made towards decreasing toxicity, account for ongoing research on new indications and earlier lines, and adapt existing frameworks to deliver the promise of innovation to patients in the most robust way.

COA’s comments and recommendations in the letter cover the following issues:

  • CMS should not limit CAR-T site of care appropriateness strictly to hospitals, and that many community oncology practices have the experience and capabilities to administer CAR-T therapy;
  • Limiting patient eligibility to patients with relapsed or refractory cancer may preclude future CAR-T therapies with different indications from coverage;
  • CAR-T treatment is just emerging, and the NCD should not prevent CMS’ flexibility regarding future CAR-T therapies;
  • The draft language on off-label coverage sets a negative precedent for oncology; and
  • While data collection around CAR-T treatment is vital, the evidence development requirements detailed in the NCD are overly onerous.

In the letter, COA also requested the opportunity to meet with the appropriate CMS staff to discuss our comments in detail and to educate staff on the complex cancer care provided by independent, community oncology practices, especially those utilizing CAR-T therapy and/or currently participating in CAR-T clinical trials.

Read the full comment letter on the COA website at