Prior authorization request form Form

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 1 (401) 274-4848 WWW.BCBSRI.COM

EFFECTIVE DATE: 08|07|2019 POLICY LAST UPDATED: 09|11|2025

OVERVIEW This documents the coverage and payment guidelines for Medicare Advantage Plan members requiring chimeric antigen receptor (CAR) T-cell therapy for cancer.

MEDICAL CRITERIA Not applicable

PRIOR AUTHORIZATION
Not applicable

POLICY STATEMENT To ensure reimbursement for this service, providers must submit claims for chimeric antigen receptor (CAR) T-cell therapy for cancer procedures to BCBSRI for authorization/reimbursement.

COVERAGE Benefits may vary between groups/contracts. Please refer to the appropriate Benefit Booklet, Evidence of Coverage or Subscriber Agreement for applicable physician administered drug covered benefits/coverage.

BACKGROUND

A. General Cancer is a collection of related diseases of dividing cells that can start almost anywhere in or on the body, evade the immune system, and invade nearby tissues. Categories of cancer are typically organized by the location in the body and specific type of cell. These categories may include carcinoma, sarcoma, leukemia, lymphoma, multiple myeloma, melanoma, and brain and spinal cord tumors. There are also changes to these cells that are not considered cancer. These changes include hyperplasia—when a cell divides faster than normal—and dysplasia—a buildup of extra cells with abnormal shape and disorganization.

A person’s immune system contains cells to help fight substances that are foreign to the body, including cancer. These cells are called white blood cells, most of which are lymphocytes. The two main types of lymphocytes are B lymphocytes (B-cells) and T lymphocytes (T-cells). B-cells generate and release antibodies to fight infection, especially bacterial infections, while T-cells employ a number of other mechanisms to fight abnormal cells such as cancer. One type of therapy that leverages the immune system—immunotherapy—is Chimeric Antigen Receptor (CAR) T-cell therapy.

CAR T-cells have been genetically altered in order to improve the ability of the T-cells to fight cancer. The genetic modification creating a CAR can enhance the ability of the T-cell to recognize and attach to a specific protein, called an antigen, on the surface of a cancer cell.

B. Nationally Covered Indications A. Effective for services performed on or after August 7, 2019, the Centers for Medicare & Medicaid Services (CMS) covers autologous treatment for cancer with T-cells expressing at least one chimeric antigen receptor (CAR) when administered at healthcare facilities enrolled in the FDA risk evaluation and mitigation strategies (REMS) and used for a medically accepted indication as defined at Social Security Act section 1861(t)(2) -i.e., is used for either an FDA-approved indication (according to the FDA-approved label for that product), or Payment Policy | Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 2 (401) 274-4848 WWW.BCBSRI.COM

for other uses when the product has been FDA-approved and the use is supported in one or more CMS- approved compendia.

C. Nationally Non-Covered Effective for services performed on or after August 7, 2019, the use of non-FDA-approved autologous T- cells expressing at least one CAR is non-covered. Autologous treatment for cancer with T-cells expressing at least one CAR is non-covered when the requirements in Section A are not met.

D. Other Effective for services performed on or after August 7, 2019, routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310.1 will be covered.

RELATED POLICIES New Technology

CODING Medicare Advantage Plans In addition to the HCPCS code for the CAR T – cell therapy, the following codes are required to be submitted to BCBSRI for claims processing.

38225 Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for

development of genetically modified autologous CAR-T cells, per day 38226 Chimeric antigen receptor T-cell (CAR-T) therapy; preparation of blood-derived T lymphocytes for

transportation (eg, cryopreservation, storage) 38227 Chimeric antigen receptor T-cell (CAR-T) therapy; receipt and preparation of CAR-T cells for

administration 38228 Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous

Providers should use the following modifiers when submitting claims for CAR T-cell therapy services:

• KX: acknowledging that the service is being submitted by or performed in an FDA REMS approved facility • LU: informs the Medicare Administrative Contractor that the service is fractionated

REFERENCES

1. CMS.gov; Decision Memo for Chimeric Antigen Receptor (CAR) T-cell Therapy for Cancers (CAG-00451N); retrieved November 2019. https://www.cms.gov/medicare-coverage-database/details/nca-decision- memo.aspx?NCAId=291.
2. https://www.cms.gov/files/document/r11391otn.pdf updated July 5, 2022
3. https://www.cms.gov/files/document/mm12177-national-coverage-determination-ncd-11024-chimeric- antigen-receptor-car-t-cell-therapy-cr.pdf Implementation Date: September 20, 2021
4. CMS Manual System, Transmittal 11721 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance- documents/R11721CP.pdf

5. Oncology - NGSMEDICARE

   PUBLISHED Provider Update, July 2025 Provider Update, January 2025 Provider Update, February 2023 Provider Update, February 2020

500 EXCHANGE STREET, PROVIDENCE, RI 02903-2699 MEDICAL COVERAGE POLICY | 3 (401) 274-4848 WWW.BCBSRI.COM

This medical policy is made available to you for informational purposes only. It is not a guarantee of payment or a substitute for your medical judgment in the treatment of your patients. Benefits and eligibility are determined by the member's subscriber agreement or member certificate and/or the employer agreement, and those documents will supersede the provisions of this medical policy. For information on member-specific benefits, call the provider call center. If you provide services to a member which are determined to not be medically necessary (or in some cases medically necessary services which are non-covered benefits), you may not charge the member for the services unless you have informed the member and they have agreed in writing in advance to continue with the treatment at their own expense. Please refer to your participation agreement(s) for the applicable provisions. This policy is current at the time of publication; however, medical practices, technology, and knowledge are constantly changing. BCBSRI reserves the right to review and revise this policy for any reason and at any time, with or without notice. Blue Cross & Blue Shield of Rhode Island is an independent licensee of the Blue Cross and Blue Shield Association.

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