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Romosozumab-aqqg injection, for subcutaneous use (Evenity™) HCPCS code J3590: Billing Guidelines

Monday, July 1, 2019

Effective with date of service April 11, the North Carolina Medicaid and NC Health Choice programs cover romosozumab-aqqg injection, for subcutaneous use (Evenity) for use in the Physician Administered Drug Program when billed with HCPCS code J3590 - Unclassified biologics.

Strength/Package Size: Injection: 105 mg/1.17 mL solution in a single-use prefilled syringe. A full dose of Evenity requires two single-use prefilled syringes.

Indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered.

Recommended Dose:

  • The recommended dose of Evenity is 210 mg administered subcutaneously in the abdomen, thigh or upper arm. Administer once every month.
  • The treatment duration is 12 monthly doses.
  • Patients should be adequately supplemented with calcium and vitamin D during treatment.

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing:

  • The ICD-10-CM diagnosis code(s) required for billing are:  M80.00XA to M81.8 – osteoporosis related diagnosis
  • Providers must bill with HCPCS code: J3590 - Unclassified biologics
  • One Medicaid and NC Health Choice unit of coverage is: 105 mg (1 prefilled syringe)
  • The maximum reimbursement rate per unit is: $985.50
  • Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units.  The NDCs are: 55513-0880-01, 55513-0880-02
  • 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 DHB's website.
  • Providers shall bill their usual and customary charge for non-340B drugs.
  • PADP reimburses for drugs billed for Medicaid and NC Health Choice 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 reflective of their 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 Physician Administered Drug Program is available on DHB's PADP web page.

GDIT, (800) 688-6696