The Center of Medicare & Medicaid Services (CMS) recently proposed in 2019 that Medicare could start covering Chimeric Antigen Receptor (CAR) T-cell therapy under “Coverage with Evidence Development (CED).”
CAR T-cell therapy is a relatively new type of cancer treatment in which a patient’s T-cells (which are part of the immune system) are re-engineered to target and destroy cancerous cells.
CAR T-cell therapy was the first type of gene therapy approved by the FDA, who approved the therapy in 2017. The treatment is most often used to fight adult large B-cell non-Hodgkin’s lymphoma and recurrent childhood acute lymphoblastic leukemia.
A proposal released February 15, 2019, by the CMS would extend Medicare coverage to qualified beneficiaries with relapsed or refractory cancers.
According to the proposal, the therapy must be offered in a CMS-approved registry or clinical study, which would require two years of post-treatment patient monitoring.
Hospitals and clinics administering CAR T-cell therapy would also be required to enroll patients in a national registry, so the effects of treatment could be studied and compared to clinical trials that led to its regulatory approval.
In 2018, the CMS agreed on reimbursement rates for CAR T-cell therapy through Medicare Part B, which provides coverage for outpatient services. But because of the potential for severe side effects, CAR T is usually given in an inpatient setting, which would fall under Medicare Part A at a lower cost reimbursement, according to the current terms.
As a result, the coverage decisions have generally been left up to local Medicare Administrative Contractors.
CAR T therapy costs hundreds of thousands of dollars to administer, which is a big reason why some private insurance companies are covering it only on an individual basis by writing single-patient agreements.
The treatment has shown to be highly effective, and researchers report that critically ill patients have remained cancer-free for as long as five years following CAR T-cell therapy.1
Following a 30-day comment period, the CMS will release a final decision on the proposal, which should come within two months.
The CMS proposal was issued in response to a letter from Efrem Castillo,2 who is the Chief Medical Officer at UnitedHealthcare (UHC).
His formal request for a national coverage determination states, “As CMS is aware, Medicare Advantage plans cover services as they are covered under Original Medicare, including Part B drugs.”
He added, “For that reason, we believe there is an industry-wide need for a National Coverage Determination (NCD) to ensure a level playing field across Medicare Advantage plans, so that providers and members are better equipped to make treatment decisions. Absent a National Coverage Determination, providers and beneficiaries could get inconsistent treatment decisions and inconsistent MAC decisions, leading to inconsistent coverage determinations, depending on a beneficiary's location.”
1 National Cancer Institute. Car T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. (Dec. 14, 2017). Retrieved from www.cancer.gov/about-cancer/treatment/research/car-t-cells.
2 Letter from E. Castillo to T. Jensen of CMS. Formal Request for National Coverage Determination for Chimeric Antigen Receptor T-Cell Therapies. (Feb. 22, 2018). Published by CMS. Retrieved Feb. 22, 2019, from www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id291.pdf.