Enfortumab vedotin-ejfv for Injection, for Intravenous Use (Padcev™) HCPCS Code J9999: Billing Guidelines

<p>Effective with date of service Dec. 31, 2019, the Medicaid and NC Health Choice programs cover enfortumab vedotin-ejfv for injection, for intravenous use (Padcev) for use in the Physician Administered Drug Program when billed with HCPCS code J9999 - Not otherwise classified, antineoplastic drugs.</p>

Author: GDIT, (800) 688-6696

Effective with date of service Dec. 31, 2019, the Medicaid and NC Health Choice programs cover enfortumab vedotin-ejfv for injection, for intravenous use (Padcev) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J9999 - Not otherwise classified, antineoplastic drugs.

Strength/Package Sizes:  

  • For Injection: 20 mg of enfortumab vedotin-ejfv as a lyophilized powder in a single-dose vial for reconstitution.
  • For Injection: 30 mg of enfortumab vedotin-ejfv as a lyophilized powder in a single-dose vial for reconstitution.

Indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Recommended Dose: 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

  • The ICD-10-CM diagnosis codes required for billing are: C65.1 - Malignant neoplasm of right renal pelvis; C65.2 - Malignant neoplasm of left renal pelvis; C65.9 - Malignant neoplasm of unspecified renal pelvis; C66.1 - Malignant neoplasm of right ureter; C66.2 - Malignant neoplasm of left ureter; C66.9 - Malignant neoplasm of unspecific ureter; C67.0 - Malignant neoplasm of trigone of bladder; C67.1 - Malignant neoplasm of dome of bladder; C67.2 - Malignant neoplasm of lateral wall of bladder; C67.3 - Malignant neoplasm of anterior wall of bladder; C67.4 - Malignant neoplasm of posterior wall of bladder; C67.5 - Malignant neoplasm of bladder neck; C67.6 - Malignant neoplasm of ureteric orifice; C67.8 - Malignant neoplasm of overlapping sites of bladder; C67.9 - Malignant neoplasm of bladder, unspecified; C68.0 - Malignant neoplasm of the urethra
  • Providers must bill with HCPCS code: J9999 - Not otherwise classified, antineoplastic drugs
  • One Medicaid and NC Health Choice unit of coverage is: 10 mg
  • The maximum reimbursement rate per unit is: $1,139.40
  • Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 51144-0020-01, 51144-0030-01 
  • 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 Medicaid’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 PADP is available on Medicaid’s PADP web page.

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