CELLULAR AND GENE THERAPY
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Defines Prior Authorization, provider, facility, coding, and coverage considerations for cellular and gene therapy products (including CAR-T) and applies to Priority Health members according to their benefit plans.
No material clinical or coverage changes in this revision.
Coverage Criteria and Eligibility
General medical necessity criteria
Covered when ALL of the following are met
Coverage determinations follow product‑specific criteria listed on Priority Health's Approved Drug List (see medical benefit drug information).
Use of cellular and gene therapy products (including CAR-T) for indications consistent with FDA approvals and product-specific criteria as listed on Priority Health's Approved Drug List.
Prior authorization is required; coverage determinations reference the Approved Drug List and product‑specific criteria.
Requests for off-label dosing or use of cellular and gene therapy products, including CAR‑T therapies, will not be approved. This aligns with the policy requirement that dosing and administration must be strictly aligned with the FDA‑approved indication and that off‑label requests are excluded from coverage.
Coverage for experimental, investigational, or unproven treatments is excluded except when an individual case review is requested and prior plan approval is obtained. Such requests for exception are reviewed by a Priority Health medical director or clinical pharmacist and may be considered only for conditions that are terminal or causing serious clinical deterioration.
Billing and Code Guidance
| 087X | Cell/Gene Therapy (includes 0870, 0871, 0872, 0873, 0874, 0875) |
| 089X | Pharmacy - (Extension of 025X and 063X) (includes 0890, 0891, 0892) |
| 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. |
Provider Requirements and Authorization
Prior Authorization Required
Prior Authorization is required for cellular and gene therapy products. Coverage determinations follow product-specific criteria listed on Priority Health's Approved Drug List page. Providers must submit a prior authorization request prior to administration.
- Affected products: cellular and gene therapy products, including CAR T-cell therapies
- Prior authorization must be obtained before treatment
- Coverage determinations follow product-specific criteria on Priority Health's website
Medical Necessity Documentation
Providers must document and submit evidence demonstrating medical necessity when requesting prior authorization. Individual case review may permit coverage of investigational or unproven treatments in limited circumstances (e.g., terminal illness or chronic, life‑threatening, severely disabling disease causing serious clinical deterioration); such requests require prior plan approval and review by a Priority Health medical director or clinical pharmacist.
- Include clinical justification, relevant diagnostics, prior therapies, and treatment intent
- Requests for individual consideration require prior plan approval
- All determinations for experimental/investigational treatments are made by a Priority Health medical director or clinical pharmacist
Treatment Limits and FDA‑Aligned Dosing
Clinical limits apply to cellular and gene therapy products; many products have only a single lifetime administration evaluated and repeat administrations are generally not approved. Dosing and administration must match FDA‑approved indications; requests for off‑label dosing or use will not be approved. Coverage is subject to the member's benefit plan.
- Repeat administrations beyond a single lifetime treatment are generally not evaluated
- Dosing must align with FDA‑approved indication — off‑label dosing/use will not be approved
- Coverage subject to member's benefit plan documents
Provider and Facility Requirements
The provider and facility administering cellular and gene therapy must be participating (in‑network) and comply with Priority Health's reimbursement requirements for outpatient medical drugs (Billing Policy No. 092). Referrals should be to in‑network or contracted facilities. See Priority Health medical benefit drug information page for additional instructions.
- Ensure provider and facility are in‑network and meet Reimbursement Requirements (Outpatient Medical Drugs Billing Policy No. 092)
- Refer members to Priority Health network or contracted facilities
- Consult Priority Health medical benefit drug information page for details
Exclusions and Non-Covered Items
Off‑label dosing or use and investigational/unproven treatments are not covered under this policy except when an individual case review is performed and prior plan approval is granted. Individual exceptions are evaluated by Priority Health clinical leadership and are limited to cases meeting the policy's criteria for review (for example, terminal illness or severe clinical deterioration).
Background
Cellular, gene, and chimeric antigen receptor T‑cell (CAR‑T) therapies use living cells or genetic material to treat disease. CAR‑T therapy involves collection of a patient’s T cells, ex vivo genetic modification to express a chimeric antigen receptor, and reinfusion to target malignant cells. These therapies are primarily used for certain hematologic malignancies and require specialized administration, monitoring, and facility/provider participation to meet safety and reimbursement requirements.
Definitions
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