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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).

Coverage Determination

The coverage determination process for prior authorization ensures that medication regimens that are high risk, have a high potential for misuse, or narrow therapeutic indices are used appropriately and according to FDA-approved indications.

The coverage determination process is required for:

  • Duplication of therapy
  • Prescriptions that exceed the FDA daily or monthly quantity limit
  • Most self-injectable and infusion medications (including chemotherapy)
  • Drugs not listed on the PDL
  • Drugs that have an age edit
  • Drugs listed on the PDL but still require Prior Authorization (PA)
  • Brand name drugs when a generic exists
  • Drugs that have a step therapy edit and the first-line therapy is inappropriate

Formulary Medication For Treatment Naïve Patients*
(no previous treatment within a 2 year period):

a. Patient is treatment naïve and has a confirmed diagnosis of hepatitis C; AND
b. Formulary Medication is age-appropriate according to FDA-approved package labeling, nationally recognized compendia, or peer-reviewed medical literature.

*Please note coverage will be provided via a Smart Prior Authorization system where applicable 

As of January 1, 2026 Fidelis Care is participating in the CMS Cell and Gene Therapy (CGT) Access Model in the State of New Jersey. 

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

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:
  2. Casgevy Billing and Coding Guide: https://www.casgevyhcp.com/sites/default/files/coding-and-billing-guide.pdf
  3. Lyfgenia Billing and Coding Guide: https://www.lyfgenia.com/-/media/lyfgenia/launch%20com/files/billing-and-coding-guide.pdf