Chimeric Antigen Receptor (CAR-T) therapy is a treatment that modifies a patient’s T cells, a type of immune cell, to target and destroy cancer cells. The process involves extracting T cells from the patient’s blood and genetically modifying them in a laboratory to produce a specialized receptor known as a chimeric antigen receptor (CAR). This receptor enables the T cells to recognize and bind to specific proteins in cancer cells. The modified CAR-T cells are then multiplied in large numbers and reintroduced into the patient’s body via infusion.
CAR-T therapy is primarily used to treat certain blood cancers and is also being studied for its potential in treating other types of cancer. It is sometimes referred to as CAR-T cell therapy.
Steps in CAR-T Therapy:
- T Cell Collection: Blood is drawn from the patient, and T cells are separated.
- Genetic Modification: The T cells are engineered to express a Chimeric Antigen Receptor (CAR), which allows them to recognize and attack cancer cells.
- Multiplication: The modified T cells are multiplied in a lab.
- Infusion: The enhanced T cells are infused back into the patient’s body.
- Cancer Cell Attack: The CAR-T cells recognize and destroy cancer cells with matching antigens.
Billing and coding CAR-T cell therapy:
As of January 1, 2025, significant updates have been implemented in the billing and coding protocols for Chimeric Antigen Receptor (CAR) T-cell therapy. These changes aim to enhance the precision and clarity of reporting, ensuring accurate reimbursement for healthcare providers.
Transition from Category III to Category I CPT Codes:
Previously, CAR-T cell therapy procedures were represented by Category III codes (0537T - 0540T), which are designated for emerging technologies. Recognizing the advancement and broader adoption of CAR-T cell therapies, the American Medical Association (AMA) has transitioned these to Category I codes, reflecting their established clinical application.
These codes provide a comprehensive framework for reporting the various stages of CAR-T cell therapy, from cell harvesting to administration.
HCPCS Codes for CAR-T cell Products:
Healthcare Common Procedure Coding System (HCPCS) codes have been assigned to specific CAR-T cell products to facilitate accurate billing -
These codes are essential for the accurate billing of specific CAR-T cell products administered to patients.
Billing Information for Professional Claims:
- Professional claims for CAR-T cell therapy and related services are billed using Form CMS1500 or 837P.
- Medicare pays professional claims for CAR-T cell therapy when the service is administered at a healthcare facility that is enrolled in the REMS program as a REMS participating site.
REMS - Approved Facility:
- To attest that you’re a REMS-approved facility, you must use 3 modifiers:
- Modifier - LU: Fractionalized payment CAR-T cell therapy.
- Modifier - 76: Repeat procedure or service by the same physician or other qualified healthcare professional.
- Modifier - KX: Requirements specified in the medical policy have been met.
Units Billing:
- To bill CAR-T claims correctly in the Part B setting, divide the CAR-T HCPCS codes by 10 and bill in 0.1-unit fractions.
- Bill a total of 10 fractional units to reach the total Medicare-allowed payment amount.
- Depending on the Medicare-allowed payment for the CAR-T HCPCS code,
- Some providers may submit 5 separate claims for 0.2 units on each claim.
Applicable Places of Service (POS) Codes:
- 11 (Office)
- 19 (Off Campus-Outpatient Hospital)
- 21 (Inpatient Hospital)
- 22 (On Campus-Outpatient Hospital)
- 49 (Independent Clinic)
Billing Information for Facility Claims:
Applicable Revenue Codes:
- 0871 -- Cell Collection.
- 0872 -- Specialized Biologic Processing and Storage, Prior to Transport.
- 0873 -- Storage and Processing after Receipt of Cells from Manufacturer.
- 0874 -- Infusion of Modified Cells.
- 0891 -- Special Processed Drugs -- FDA Approved Cell Therapy.
Applicable Bill Type Codes:
- 11X
- 12X
- 13X
- 85X
Units Billing:
- Part A Outpatient Prospective Payment System providers don’t need to change their billing. They’ll continue to bill 1 unit for the CAR-T cell products themselves.
Coverage Guidelines:
- The use of non-FDA-approved autologous T-cells with at least 1 CAR continues to be noncovered.
- Autologous treatment for cancer with T-cells expressing at least 1 CAR is also noncovered when the NCD criteria aren’t met.
- Use of allogeneic T-cells from healthy donors isn't autologous CAR-T cell treatment, and you shouldn’t bill those as autologous CAR-T treatments.
Date of Service Guidelines:
When the cells are collected in the physician’s office setting, and the CAR-T is administered in the hospital inpatient setting, inpatient providers should report the date that the CAR-T administration took place and not the date the cells were collected.
Conclusion:
CAR-T cell therapy represents a revolutionary advancement in cancer treatment, offering personalized immunotherapy for patients with certain blood cancers. The 2025 updates in billing and coding reflect the growing adoption of this therapy, ensuring more precise reporting and reimbursement for healthcare providers. With the transition to Category I CPT codes, the introduction of new HCPCS codes for CAR-T cell products, and specific Medicare billing guidelines, providers must stay informed to maintain compliance and submit accurate claims. As CAR-T cell therapy continues to evolve, ongoing updates in coding, coverage, and reimbursement will be crucial for optimizing patient access and ensuring financial sustainability in healthcare.
References:
- AMA CPT Manual 2025
- https://www.cancer.gov/publications/dictionaries/cancer-terms/def/chimeric-antigen-receptor-t-cell-therapy
- https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00251505
- https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c32.pdf
- https://www.cms.gov/files/document/mm13734-inpatient-long-term-care-hospital-prospective-payment-system-fy-2025-changes.pdf
- https://www.cms.gov/files/document/mm11879.pdf
- https://www.cms.gov/files/document/r12903otn.pdf
- https://www.cms.gov/files/document/mm13818-icd-10-other-coding-revisions-national-coverage-determinations-april-2025-update-cr-1-2.pdf?utm_source=chatgpt.com
- https://www.cms.gov/files/document/mm12177-national-coverage-determination-ncd-11024-chimeric-antigen-receptor-car-t-cell-therapy-cr.pdf
- https://www.cms.gov/files/document/mm12928-national-coverage-determination-11024-chimeric-antigen-receptor-t-cell-therapy.pdf
- https://www.cms.gov/files/document/r11774CP.pdf#page=37
