Cell and Gene Therapy Access Model - PPMCO
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Governs prior authorization, clinical criteria, authorized treatment centers, and coverage processes for CASGEVY and LYFGENIA under the Maryland Cell and Gene Therapy Access Model as applied by Johns Hopkins Health Plans (Priority Partners Managed Care Organization). Affects members with sickle cell disease seeking these gene therapies and providers/ATCs administering them.
University of Maryland Medical Center (UMMC) was added as an approved treatment center for CASGEVY effective 01/26/2026.
Coverage Criteria for CGT Model Therapies
MDH clinical criteria for CGT Model therapies
Covered when ALL of the following are met (per MDH clinical criteria as adopted by PPMCO):
ATC must be contracted or a single case agreement established if out-of-network
CASGEVY indication for transfusion-dependent beta-thalassemia (TDT) is excluded from the CGT Model
The CASGEVY™ indication for transfusion-dependent beta-thalassemia (TDT) is not part of the CGT Model and is excluded from coverage under this policy. CASGEVY coverage within the CGT Model applies only to its sickle cell disease indication and to members meeting the MDH clinical criteria adopted by PPMCO (see therapy‑specific criteria).
All requests for gene therapy require prior authorization and will be reviewed by plan Medical Directors using Maryland Medicaid clinical criteria. Requests that do not meet MDH clinical criteria as applied in prior authorization review are subject to denial. Denials may be appealed through Johns Hopkins Health Plans appeal and state fair hearing processes, and MDH retains discretion to review preauthorization denials for appropriateness and alignment with Model clinical criteria.
Billing and Coding for Gene Therapies
| J3392 | Injection, exagamglogene autotemcel, per treatment |
| J3394 | Injection, lovotibeglogene autotemcel, per treatment |
Provider Requirements and Prior Authorization
No step therapy required
Johns Hopkins Health Plans will not impose step therapy prior to accessing the covered gene therapies under the CGT Model.
Required documentation for prior authorization
Submit a letter of medical necessity and supporting clinical documentation (e.g., evaluations) no greater than 6 months old; documentation must demonstrate the applicable MDH clinical criteria.
- Include confirmatory genetic testing and evidence of transplant fitness where required by MDH criteria.
- Provide documentation of prior hydroxyurea use or intolerance when applicable.
Prior authorization and denial review process
All requests for gene therapy require prior authorization and will be reviewed by plan Medical Directors using Maryland Medicaid clinical criteria; denials may be reviewed by MDH for appropriateness and alignment with Model criteria.
- Requests that do not meet MDH clinical criteria (as reviewed by plan Medical Directors) are subject to denial.
- Members may appeal denials through JHHP appeal and state fair hearing processes; MDH may review preauthorization denials.
Background and Policy Context
The CMS Cell and Gene Therapy Access Model establishes a multi-state approach and uses outcomes‑based agreements to improve Medicaid beneficiary access to gene therapies for sickle cell disease. Under the Model in Maryland, two gene therapies (CASGEVY and LYFGENIA) are covered when MDH clinical criteria are met, treatment is delivered at an Authorized Treatment Center, and required clinical documentation and monitoring are provided over the post‑treatment care journey.
Definitions and Care Journey
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