Trastuzumab-anns for Injection, for Intravenous Use (Kanjinti™) HCPCS code J9999 - Not Otherwise Classified, Antineoplastic Drugs: Billing Guidelines

Effective with date of service July 22, 2019, the North Carolina Medicaid and NC Health Choice programs cover trastuzumab-anns for injection, for intravenous use  (Kanjinti™) for use in the Physician Administered Drug Program (PADP) when billed with Healthcare Common Procedure Coding System (HCPCS) code J9999 - not otherwise classified, antineoplastic drugs.

Strength/package size(s):  For injection: 420 mg lyophilized powder in a multiple-dose vial for reconstitution

Indicated for:

• The treatment of HER2 overexpressing breast cancer
• The treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma

Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Recommended Dose:  Adjuvant treatment of HER2-overexpressing breast cancer:

• Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin). One week after the last weekly dose of Kanjinti, administer 6 mg/kg as an IV infusion over 30−90 minutes every three weeks to complete a total of 52 weeks of therapy.
   

OR
 

• Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30–90 minutes IV infusion every three weeks for 52 weeks.

Metastatic HER2-overexpressing breast cancer:
 

• Initial dose of 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions.

Metastatic HER2-overexpressing gastric cancer:

• Initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks.

See full prescribing information for further detail.

For Medicaid and NC Health Choice Billing

• The ICD-10-CM diagnosis code(s) required for billing is/are:  HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma:  C16.0 - Malignant neoplasm of cardia; C16.1 - Malignant neoplasm of fundus of stomach; C16.2 - Malignant neoplasm of body of stomach; C16.3 - Malignant neoplasm of pyloric antrum; C16.4 - Malignant neoplasm of pylorus; C16.5 - Malignant neoplasm of lesser curvature of stomach, unspecified; C16.6 - Malignant neoplasm of greater curvature of stomach, unspecified; C16.8 - Malignant neoplasm of overlapping sites of stomach; C16.9 - Malignant neoplasm of stomach, unspecified;
  -
  HER2 overexpressing breast cancer: 
  C50.011 - Malignant neoplasm of nipple and areola, right female breast; C50.012 - Malignant neoplasm of nipple and areola, left female breast; C50.019 - Malignant neoplasm of nipple and areola, unspecified female breast; C50.021 - Malignant neoplasm of nipple and areola, right male breast; C50.022 - Malignant neoplasm of nipple and areola, left male breast; C50.029 - Malignant neoplasm of nipple and areola, unspecified male breast; C50.111 - Malignant neoplasm of central portion of right female breast; C50.112 - Malignant neoplasm of central portion of left female breast; C50.119 - Malignant neoplasm of central portion of unspecified female breast; C50.121 - Malignant neoplasm of central portion of right male breast; C50.122 - Malignant neoplasm of central portion of left male breast; C50.129 - Malignant neoplasm of central portion of unspecified male breast; C50.211 - Malignant neoplasm of upper-inner quadrant of right female breast; C50.212 - Malignant neoplasm of upper-inner quadrant of left female breast; C50.219 - Malignant neoplasm of upper-inner quadrant of unspecified female breast; C50.221 - Malignant neoplasm of upper-inner quadrant of right male breast; C50.222 - Malignant neoplasm of upper-inner quadrant of left male breast; C50.229 - Malignant neoplasm of upper-inner quadrant of unspecified male breast; C50.311 - Malignant neoplasm of lower-inner quadrant of right female breast; C50.312 - Malignant neoplasm of lower-inner quadrant of left female breast; C50.319 - Malignant neoplasm of lower-inner quadrant of unspecified female breast; C50.321 - Malignant neoplasm of lower-inner quadrant of right male breast; C50.322 - Malignant neoplasm of lower-inner quadrant of left male breast; C50.329 - Malignant neoplasm of lower-inner quadrant of unspecified male breast; C50.411 - Malignant neoplasm of upper-outer quadrant of right female breast; C50.412 - Malignant neoplasm of upper-outer quadrant of left female breast; C50.419 - Malignant neoplasm of upper-outer quadrant of unspecified female breast; C50.421 - Malignant neoplasm of upper-outer quadrant of right male breast; C50.422 - Malignant neoplasm of upper-outer quadrant of left male breast; C50.429 - Malignant neoplasm of upper-outer quadrant of unspecified male breast; C50.511 - Malignant neoplasm of lower-outer quadrant of right female breast; C50.512 - Malignant neoplasm of lower-outer quadrant of left female breast; C50.519 - Malignant neoplasm of lower-outer quadrant of unspecified female breast; C50.521 - Malignant neoplasm of lower-outer quadrant of right male breast; C50.522 - Malignant neoplasm of lower-outer quadrant of left male breast; C50.529 - Malignant neoplasm of lower-outer quadrant of unspecified male breast; C50.611 - Malignant neoplasm of axillary tail of right female breast; C50.612 - Malignant neoplasm of axillary tail of left female breast; C50.619 - Malignant neoplasm of axillary tail of unspecified female breast; C50.621 - Malignant neoplasm of axillary tail of right male breast; C50.622 - Malignant neoplasm of axillary tail of left male breast; C50.629 - Malignant neoplasm of axillary tail of unspecified male breast; C50.811 - Malignant neoplasm of overlapping sites of right female breast; C50.812 - Malignant neoplasm of overlapping sites of left female breast; C50.819 - Malignant neoplasm of overlapping sites of unspecified female breast; C50.821 - Malignant neoplasm of overlapping sites of right male breast; C50.822 - Malignant neoplasm of overlapping sites of left male breast; C50.829 - Malignant neoplasm of overlapping sites of unspecified male breast; C50.911 - Malignant neoplasm of unspecified site of right female breast; C50.912 - Malignant neoplasm of unspecified site of left female breast; C50.919 - Malignant neoplasm of unspecified site of unspecified female breast; C50.921 - Malignant neoplasm of unspecified site of right male breast; C50.922 - Malignant neoplasm of unspecified site of left male breast; C50.929 - Malignant neoplasm of unspecified site of unspecified male breast
   
• 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:  $95.07
• Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs is/are: 55513-0132-01
• 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, 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 NCHC 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 NC Medicaid's PADP web page.