Updated Coverage for Chimeric Antigen Receptor T-cell (CAR-T) Therapy

The World Trade Center (WTC) Health Program developed a new Medical Coverage Determination (MCD) for Chimeric Antigen Receptor T-cell (CAR-T) Therapy, outlining coverage details and criteria. Below is a summary. Full details and the official MCD are available in the Administrative Manual.

What is CAR-T Therapy?

CAR-T therapy is a type of cancer treatment that is used when cancer treatments have failed, or cancer has relapsed. In CAR-T therapy, a T-cell—a specific type of cell—is taken from a patient’s blood and changed in the laboratory so it will attack cancer cells.

CAR-T cell therapy is given to the patient by infusion as a one-time treatment in a hospital setting or CAR-T outpatient center to allow for monitoring of potential side effects.

How are CAR-T therapy services covered?

CAR-T therapy services must be authorized by the WTC Health Program before the patient receives treatment.

The Clinical Center of Excellence or the Nationwide Provider Network Clinical Director may request authorization from the WTC Health Program for CAR-T therapy services if all the criteria below are met:

• the member must be under the care of a Program provider,
• the services must be medically necessary to manage, or cure a certified WTC-related cancer, or health condition medically associated with a certified WTC-related cancer,
• the member requires CAR-T therapy due to past failed cancer treatments or if the cancer has returned,
• the services are administered at a facility enrolled in the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) compliance program,
• the CAR-T product must be used for an FDA-approved indication
• the treatment plan should align with National Comprehensive Cancer Network (NCCN) treatment guidelines

To learn more about the authorization requirements, please visit the Administrative Manual.

What CAR-T services does the WTC Health Program cover?

After all prior authorization requirements have been met, the Program will cover only one round of CAR-T treatment. One round of CAR-T therapy includes the following services:

1. Cell Collection and Alteration:
   White blood cells are removed from the blood, then T-cells are separated and sent to the laboratory so that the cells can be changed to attack cancer cells.
2. Administration of CAR-T:
   CAR-T therapy is administered by infusion as a one-time regimen in a hospital setting or CAR-T outpatient center to monitor potential side effects.
3. Treatment of Potential Side Effects:
   CAR-T therapy may result in serious side effects including two potentially dangerous syndromes: Cytokine Release Syndrome (CRS) and Immune Cell-Associated Neurotoxicity Syndrome (ICANS). Treatment of these and other potential side effects as a result of CAR-T therapy will be covered under the approved CAR-T therapy when they meet the definition of a medically associated health condition.
4. Acute Recovery Period:
   After the CAR-T Treatment, the patient is in the Acute Recovery Period for 30 days for monitoring. If the Acute Recovery Period is extended for a patient because additional monitoring and/or treatment is required, a new authorization must be submitted.