This notification is regarding the Department of Health Care Services (DHCS) All-Plan Letter (APL) 25-013 which addresses the following:
- Medi-Cal Rx: Provides guidance on oversight and administration of the Medi-Cal pharmacy benefit.
- LYGENIA and CASGEVY: Clarifies roles and responsibilities related to coverage, care coordination, and associated services for these gene therapies.
Medi-Cal Rx
Medi-Cal Rx is responsible for the following pharmacy benefits when billed by a pharmacy provider on a pharmacy claim:
- Covered outpatient drugs eligible under the pharmacy benefit;
- Certain disposable medical supplies, including diabetic testing supplies, continuous glucose monitoring (CGM) devices, disposable insulin delivery devices, insulin syringes, pen needles, miscellaneous medical supplies, and select contraceptive devices; and
- Enteral nutritional products.
For additional details regarding covered pharmacy benefits, please refer to the Medi-Cal Rx web portal or the “Medi-Cal Rx Policy Resources” section of APL 25-013.
LYGENIA and CASGEVY
Under the federal Cell and Gene Therapy (CGT) Access Model, coverage and payment for LYFGENIA and CASGEVY are carved out to DHCS. Eligible members receive these therapies on a fee-for-service (FFS) basis from enrolled, qualified providers who bill DHCS directly. As carved-out drugs, HPSM does not cover LYFGENIA or CASGEVY and does not apply utilization management requirements, including prior authorization.
While HPSM is not responsible for payment of these drugs, the plan remains responsible for care coordination and coverage of associated medical services related to treatment. The roles and responsibilities for LYFGENIA and CASGEVY treatment and related services are summarized below.
Summary of roles and responsibilities for:
| Activity | DHCS | HPSM |
| Coverage and payment for LYGENIA and CASGEVY | ||
| Care coordination and assistance with accessing LYGENIA and CASGEVY | ||
| Referral management, as appropriate | ||
| Coverage of all associated outpatient and inpatient medical services and non-medical ancillary services related to CGT treatment, including pre- and post-treatment services, administation fees, and supplies | ||
| Coverage of Non-Emergency Medical Transportation (NEMT) and Non-Medical Transportation (NMT), including applicable travel expense for memebers and caregivers |
For questions on CGT coverage policy, please visit the DHCS CGT website.
Please direct questions about this notification to HPSM Provider Services.