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Starting January 1, 2025, Fidelis Care will provide outpatient behavioral health benefits to NJ FamilyCare members. Learn more about the behavioral health benefit changes (PDF).

Billing Guidance Outline for Sickle Cell Disease (SCD) Gene Therapies

January 1, 2026

Applicable Drugs:

  • Casgevy: J3392 - Injection, exagamglogene autotemcel, per treatment
  • Lyfgenia: J3394 - Injection, lovotibeglogene autotemcel, per treatment

Claim Submission:

  1.  The drug cost of the SCD gene therapy must be excluded from any facility or institutional claim and not be submitted as part of a bundled payment, such as a diagnosis-related group (DRG) or ambulatory payment classification (APC). 
  2. The provider must submit a separate professional claim on the CMS 1500 form, or the corresponding electronic version 837P, for direct reimbursement of the drug’s ingredient cost.
  3. The drug ingredient cost submitted in the “charges” field on the CMS 1500 or 837P claim must be equal to the actual acquisition cost on the corresponding purchase invoice.
  4. The invoice from the supplier demonstrating the provider’s actual acquisition cost must be submitted as an attachment to the claim.
  5. SCD gene therapies must not be acquired at the 340B price or be dispensed from 340B inventory.
  6. Claims must include the national drug code (NDC), associated HCPCS code, the unit of measure, and the number of units of the drug administered.
  7. Claims should adhere to standards and guidance outlined by the Medicaid managed care plan or the State, including Newsletter Volume 19, Number 18 dated May 19, 2009, which is available on njmmis.com under “Newsletters & Alerts.”
  8. Drug costs may also be billed as a pharmacy point-of-sale claim, in those cases professional claims for drug costs that have already been paid via a pharmacy point-of-sale system will be considered duplicative and not reimbursed.

Billing Codes for Drug Administration, Cell Collection and Conditioning:

  1. Providers should utilize appropriate billing codes for associated services; manufacturer billing guides may be referred to for suggested applicable codes:

Reporting:

  1. The managed Medicaid plan will report to the State’s Pharmacy Unit all prior authorization requests for a SCD gene therapy within 14 calendar days of the PA request. 
  2. The managed Medicaid plan will report to the State’s Pharmacy Unit all submitted claims for a SCD gene therapy within 14 calendar days of receipt.
  3. The managed Medicaid plan will report to the State’s Pharmacy Unit all paid claims for a SCD gene therapy within 14 calendar days of payment.

Provider Requirements:

  1. Payment for Sickle Cell Disease (SCD) Gene Therapies to model beneficiaries is conditional on provider adherence to the following requirements: 
    • The provider must be a member of the Center for International Blood and Marrow Transplant Research (CIBMTR) patient registry and:
    • The provider must participate in the study related to SCD gene therapies.