Rezafungin for Injection, for Intravenous Use (Rezzayo™) HCPCS Code J3490 - Unclassified Drugs: Billing Guidelines

Effective with date of service July 31, 2023, NC Medicaid covers rezafungin for injection, for intravenous use (Rezzayo)

Effective with date of service July 31, 2023, NC Medicaid Direct and NC Medicaid Managed Care cover rezafungin for injection, for intravenous use (Rezzayo) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs.

Strength/Package Size: For injection: 200 mg as a solid (cake or powder) in a single-dose vial for reconstitution.

Rezafungin for injection is indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.  

Limitations of Use: Rezzayo has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida.

Recommended Dose: Administer the recommended dosage of Rezzayo once weekly by intravenous (IV) infusion, with an initial 400 mg loading dose, followed by a 200 mg dose once weekly thereafter.  

The safety of Rezzayo has not been established beyond four weekly doses.

See full prescribing information for further detail. 

For Medicaid Billing

  • The ICD-10-CM diagnosis codes required for billing are:
    • B37.0 - Candidal stomatitis;
    • B37.1 - Pulmonary candidiasis;
    • B37.2 - Candidiasis of skin and nail;
    • B37.31 - Acute candidiasis of vulva and vagina;
    • B37.32 - Chronic candidiasis of vulva and vagina;
    • B37.41 - Candidal cystitis and urethritis;
    • B37.42 - Candidal balanitis;
    • B37.49 - Other urogenital candidiasis;
    • B37.7 - Candidal sepsis;
    • B37.81 - Candidal esophagitis;
    • B37.82 - Candidal enteritis;
    • B37.83 - Candidal cheilitis;
    • B37.84 - Candidal otitis externa;
    • B37.89 - Other sites of candidiasis
  • Providers must bill with HCPCS code: J3490 - Unclassified drugs
  • One Medicaid unit of coverage is: 1 mg  
  • The maximum reimbursement rate per unit is: $10.53000
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDC is: 70842-0240-01 
  • The NDC units should be reported as "UN1"
  • For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update.
  • For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on NC Medicaid's website.
  • Providers shall bill their usual and customary charge for non-340B drugs.
  • PADP reimburses for drugs billed for Medicaid beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is their actual acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
  • The fee schedule for the PADP is available on the NC Medicaid Fee Schedule & Covered Code portal.

ICD-10-CM Manual. American Medical Association, 2023 manual.

*Information current as of Sept. 26, 2023, and is not a substitute for professional judgment. For full prescribing information, please refer to current package insert or other appropriate sources prior to making clinical judgments.


NCTracks Call Center: 800-688-6696 

Related Topics: