Cell and Gene Therapy
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Defines Johns Hopkins Health Plans coverage requirements for inpatient-administered cell and gene therapy products and the authorization/documentation expectations for participating organizations and plan lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
Medical necessity criteria
Covered when ALL of the following are met
Excluded from coverage are any indications or uses that are not FDA‑approved or not supported by recognized clinical guidelines. Requests for therapies used outside of FDA‑approved indications or without guideline support do not meet the policy’s criteria.
Prior receipt of any cell or gene therapy for the same patient is also excluded; members who have previously been treated with a cell or gene therapy are not eligible under this policy.
Coding (HCPCS / CPT / J‑codes / Q‑codes)
| J3391 | Injection, atidarsagene autotemcel, per treatment. |
| J3392 | Injection, exagamglogene autotemcel, per treatment. |
| J3393 | Injection, betibeglogene autotemcel, per treatment. |
| J3394 | Injection, lovotibeglogene autotemcel, per treatment. |
| J3590 | Unclassified biologics. |
| Q2041 | Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. |
| Q2042 | Tisagenlecleucel, up to 600 million CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. |
| Q2043 | Sipuleucel-T, minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, including leukapheresis and all other preparatory procedures, per infusion. |
| Q2053 | Brexucabtagene autoleucel, up to 200 million autologous anti-CD19 CAR positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. |
| Q2054 | Lisocabtagene maraleucel, up to 110 million autologous anti-CD19 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose. |
Provider Actions & Authorization Requirements
Prior authorization and inpatient preauthorization required
All requests for cell and gene therapy products must receive prior authorization and will be reviewed by Medical Directors. All inpatient admissions require preauthorization; inpatient administration is the setting addressed by this policy.
- Prior authorization required for every request for Cell and Gene Therapy products.
- Medical Director review is mandatory for approval decisions.
- All inpatient admissions require preauthorization.
Verify indication and plan-specific benefit rules
Prescribers must ensure documentation demonstrates FDA‑approved indication adherence and compliance with contract benefit provisions; follow employer- or plan-specific SPD guidance if applicable.
- Uses that are not FDA‑approved or not guideline supported are excluded.
- Employer Health Programs (EHP) should follow their Summary Plan Description (SPD) if one exists; otherwise apply the Medical Policy criteria.
Required letter of medical necessity and recent clinical documentation
Include a current letter of medical necessity and supporting clinical documentation (for example, evaluation notes) dated no more than 6 months prior to the request.
- Letter of medical necessity is required on all requests.
- Supporting clinical documentation must be ≤ 6 months old.
Use current FDA prescribing information; prescriber must verify eligibility
Medical Directors will use the most up‑to‑date FDA prescribing information to determine eligibility; the prescribing provider must confirm the patient meets FDA‑approved clinical parameters, including absence of contraindications and completion of required screening and monitoring.
- Eligibility determinations reference current FDA prescribing information for cellular and gene therapy products.
- Prescribing provider responsibility: confirm indications, contraindications, screening, and monitoring per FDA guidance.
Denial triggers for missing or nonconforming documentation and excluded indications
Requests may be denied for failing to meet policy requirements, including absence of prior authorization, missing or outdated letter of medical necessity/supporting documentation (>6 months), indications not FDA‑approved or guideline supported, or prior receipt of cell or gene therapy.
- No prior authorization on the request.
- Letter of medical necessity or supporting clinical documentation is not provided or is older than 6 months.
- Indication is not FDA‑approved or not guideline supported.
- Patient has previous treatment with cell or gene therapy.
Site of Care
Coverage for inpatient administration with prior authorization
Cell and gene therapy is covered when administered in an inpatient setting, provided prior authorization is obtained.
Definitions & References
Background
This policy governs administration of cell and gene therapy products when provided in an inpatient setting. Clinical eligibility determinations (that is, whether a patient meets the clinical prescribing parameters) are deferred to the most up‑to‑date FDA‑approved prescribing information and to applicable CMS National or Local Coverage Determinations for Medicare Advantage members.
All inpatient administrations of these therapies are subject to the policy’s prior authorization and documentation requirements; Medical Directors will review requests in accordance with FDA prescribing information to confirm adherence to approved indications and required screening and monitoring.
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