Key Considerations for Operationalizing CAR-T

The impacts of CAR-T gene therapy on resources and revenue.

This is an excerpt from an article was originally published on the Revenue Cycle Advisor on September 13.

Now that the Food and Drug Administration has approved chimeric antigen receptor T-cell (CAR-T) therapy, the next step for facilities is considering the financial implications before offering the treatment therapy.

CAR-T is a gene therapy for patients with precursor acute lymphoblastic leukemia that is in second relapse. The process involves extracting immune cells (T-cells) from a patient, altering the genome to target cancer cells, and then administering the T-cells in a one-time treatment. 

Pamela Scott, RHIT, CCS, CRC, CCDS, AHIMA Approved ICD-10CM/PCS Trainer and assistant vice president at First Class Solutions, Inc., in Maryland Heights, Missouri, advises facilities to consider these key questions for coding and reimbursement purposes:

• Will CAR-T be considered a clinical trial and require the clinical trial code to be added to the claim to obtain reimbursement? 
• Will the treatment be reimbursed as if it were immunotherapy? 
• Would the coder be required to use the "Encounter for Chemotherapy/Immunotherapy” as the principal diagnosis? 
• Will the reimbursement be sufficient to cover the expenses?

The treatment requires a one week expected stay. Scott suspects that the initial blood withdrawal for the therapy will be done as an outpatient procedure, while the infusion will be performed as an inpatient procedure. 

“I think the biggest issue for coders is to be educated about this process and able to identify that this is being performed. The clinical documentation will need to be clear,” says Scott.

The next consideration is adequate staffing. Meeting the extensive and additional regulatory burden to open CAR-T therapy trials will take two to four times more time and staffing resources than even an average phase one trial, according to Edye Edens, JD, MA, BA, CIP, and Helen Mauer, MA, CHES, CCRP, investigational research consultants at First Class Solutions, Inc.

Edens and Mauer advise budgeting your organization’s priorities. This is critical as some trials can take two years to open. They also recommend including billables upfront in the clinical trial agreement. This includes extended institutional review board and institutional biosafety committee fees, along with all continuing reviews and ongoing regulatory needs for the duration of the trial once open. 

As is the case with phase one research, CAR-T is a high-risk, high-benefit therapy. Trials should be maintained in a compliant manner. According to Edens and Mauer, the resources required to maintain therapy trials will be greater than those the oncology world has faced before.

A new code for CAR-T reimbursement is expected to be released this week at the ICD-10 Coordination and Maintenance Committee Meeting. Revenue integrity staff should start a dialogue with physicians to determine the required resources and costs for performing this procedure.

“Watch the Federal Register for the opportunity to comment on this subject. Have appropriate physicians educate the coding staff on what to watch for and how they plan to document in order for the coders to understand this procedure,” says Scott.