The American Society for Blood and Marrow Transplantation (ASBMT), newly named the American Society for Transplantation and Cellular Therapy (ASTCT), has carefully reviewed the recently released National Coverage Analysis for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers and is in the process of developing comments for the Centers for Medicare and Medicaid Services (CMS). The newly formed Government Relations Committee held its inaugural meeting at TCT last week and is providing guidance on a response to the NCA. The agency will finalize its coverage policy to take effect in May. Our members have been actively engaged in the research and development of Chimeric Antigen Receptor T-Cell (CAR-T) therapies, as well as their delivery to patients, and are extremely concerned about new barriers to current and future CAR T-cell therapies that may result from this coverage policy.
ASTCT recognizes that members and the centers where they practice are already struggling with access barriers stemming from the poor Medicare reimbursement for CAR T-cell therapy and has been advancing policy solutions to reduce the financial losses that result from treating Medicare beneficiaries with this therapy. The Society had urged CMS not to establish a National Coverage Determination (NCD) for CAR-T therapy in written comments, believing it was premature, and were particularly concerned that CMS would recommend coverage with evidence development (CED). Despite our concerns about life-threatening barriers to patient access, the agency included a CED component in the NCA.
After reviewing the policy, the Society is requesting further clarification from CMS on several aspects of the NCA. Most notably, ASTCT needs clarity on the coverage implications regarding patient consent; specifically will the patient face a situation of non-coverage and thus financial liability if they elect not to have their data submitted to the registry or will it be enough for the hospital to have signed up. Along those lines, we are requesting clarification on whether there is a requirement for centers to enroll with CMS to submit the required data to an approved registry. This is of particular importance since an opt-in requirement would leave centers with the option not to participate, which they may elect to do if registry reporting requirements along with patient reported outcomes (PRO) requirements are so onerous. These requirements coupled with the current reimbursement short falls would result in additional access to care barriers.
Please watch for additional communications from ASTCT as we identify additional issues and can provide further clarification. As you and your center's legal teams analyze the policy, please contact our new Director of Government Relations, Alycia Maloney, at email@example.com with your concerns and analysis of the policy. The Society will be submitting comments prior to the March 17 deadline and will be sharing those comments with members.