ASGCT Submits Comment on CAR T-Cell Therapy Coverage and Reimbursement

ASGCT submitted comments last month to the Centers for Medicare & Medicaid Services (CMS) on Medicare coverage of CAR T-cell therapies as part of the Society’s effort to improve access to approved gene therapies. Insurance service United Healthcare recently requested a national coverage determination (NCD) of CAR T-cell therapies. If CMS decides to establish an NCD, it would set a national precedent for the extent to which Medicare would cover these innovative, potentially curative cancer treatments.

We question the need for an NCD at this point because CAR T-cell therapies approved by the FDA are currently covered by CMS for medically-accepted use consistent with their labeling. Because current clinical trials are likely to identify new patient populations that may benefit, a premature NCD may lack sufficient scope or flexibility to assure patient access to future CAR T-cell treatments. CMS is convening a meeting of its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) on August 22 as a step in the analysis process.

In addition, ASGCT submitted comments to CMS in June regarding how to improve Medicare reimbursement levels of CAR T-cell therapy. The level that Medicare reimburses through current mechanisms often leaves a significant gap in payment to hospitals compared to their combined costs for services and for making the drug, creating high risk of substantial financial losses to hospitals for providing the therapy. ASGCT is concerned that such losses may be unsustainable for providers, which could ultimately affect availability of the therapy for patients.

The ASGCT alternative is to provide the most appropriate reimbursement level by reimbursing the drug acquisition cost separately from reimbursement for hospital services and assigning CAR T-cell therapy to a higher weighted payment category for services (Medicare Severity Diagnosis-Related Group 016, currently used for autologous bone marrow transplant). CMS is expected to issue its decision next month on changes to Medicare reimbursement mechanisms for CAR T-cell therapy.

Issues related to patient access to the value of gene therapy are addressed in more detail in a recent ASGCT white paper and will continue to be discussed among a variety of invited stakeholders to an upcoming value summit that ASGCT is hosting this fall.

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