Gemcitabine in sodium chloride injection, for intravenous use (Infugem™) HCPCS code J9999: Billing Guidelines

<p style="margin-bottom:6.0pt; margin:0in 0in 12pt">Effective with date of service March 12, 2019, the North Carolina Medicaid and NC Health Choice programs cover gemcitabine in sodium chloride injection, for intravenous use (Infugem) 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 March 12, 2019, the North Carolina Medicaid and NC Health Choice programs cover gemcitabine in sodium chloride injection, for intravenous use (Infugem) for use in the Physician Administered Drug Program when billed with HCPCS code J9999 - not otherwise classified, antineoplastic drugs.

Strength/Package Size(s):  Injection: single-dose premixed infusion bags containing 10 mg/mL of gemcitabine in 0.9% sodium chloride: 1200 mg in 120 mL, 1300 mg in 130 mL, 1400 mg in 140 mL, 1500 mg in 150 mL, 1600 mg in 160 mL, 1700 mg in 170 mL, 1800 mg in 180 mL, 1900 mg in 190 mL, 2000 mg in 200 mL, 2200 mg in 220 mL

Indicated:

  • In combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.
  • In combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.
  • In combination with cisplatin for the treatment of non-small cell lung cancer.
  • As a single agent for the treatment of pancreatic cancer.
     

Recommended Dose:  Intravenous infusion only.

  • Ovarian Cancer: 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
  • Breast Cancer: 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
  • Non-Small Cell Lung Cancer: 1000 mg/m2 over 30 minutes on Days 1, 8, and 15 of each 28-day cycle or 1250 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle.
  • Pancreatic Cancer: 1000 mg/m2 over 30 minutes once weekly for the first 7 weeks, then one week rest, then once weekly for 3 weeks of each 28-day cycle.

Refer to package insert for dose reduction information AND 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: 

Pancreatic Cancer:
C25.0 - Malignant neoplasm of head of pancreas; C25.1 - Malignant neoplasm of body of pancreas; C25.2 - Malignant neoplasm of tail of pancreas; C25.3 - Malignant neoplasm of pancreatic duct; C25.4 - Malignant neoplasm of endocrine pancreas; C25.7 - Malignant neoplasm of other parts of pancreas; C25.8 - Malignant neoplasm of overlapping sites of pancreas; C25.9 - Malignant neoplasm of pancreas, unspecified

NSCLC:
C33 - Malignant neoplasm of trachea; C34.00 - Malignant neoplasm of unspecified main bronchus; C34.01 - Malignant neoplasm of right main bronchus; C34.02 - Malignant neoplasm of left main bronchus; C34.10 - Malignant neoplasm of upper lobe, unspecified bronchus or lung; C34.11 - Malignant neoplasm of upper lobe, right bronchus or lung; C34.12 - Malignant neoplasm of upper lobe, left bronchus or lung; C34.2 - Malignant neoplasm of middle lobe, bronchus or lung; C34.30 - Malignant neoplasm of lower lobe, unspecified bronchus or lung; C34.31 - Malignant neoplasm of lower lobe, right bronchus or lung; C34.32 - Malignant neoplasm of lower lobe, left bronchus or lung; C34.80 - Malignant neoplasm of overlapping sites of unspecified bronchus and lung; C34.81 - Malignant neoplasm of overlapping sites of right bronchus and lung; C34.82 - Malignant neoplasm of overlapping sites of left bronchus and lung; C34.90 - Malignant neoplasm of unspecified part of unspecified bronchus or lung; C34.91 - Malignant neoplasm of unspecified part of right bronchus or lung; C34.92 - Malignant neoplasm of unspecified part of left bronchus or lung    

Ovarian Cancer:
C48.0 - Malignant neoplasm of retroperitoneum; C48.1 - Malignant neoplasm of specified parts of peritoneum; C48.2 - Malignant neoplasm of peritoneum, unspecified; C48.8 - Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum; C56.1 - Malignant neoplasm of right ovary; C56.2 - Malignant neoplasm of left ovary; C56.9 - Malignant neoplasm of unspecified ovary; C57.00 - Malignant neoplasm of unspecified fallopian tube; C57.01 - Malignant neoplasm of right fallopian tube; C57.02 - Malignant neoplasm of left fallopian tube

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:  $4.10
  • Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units.  The NDCs are: 62756-0073-60, 62756-0008-60, 62756-0102-60, 62756-0219-60, 62756-0321-60, 62756-0438-60, 62756-0533-60, 62756-0614-60, 62756-0746-60, 62756-0974-60
  • 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.

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