Ixempra® (ixabepilone) Coding and Billing Units

The HCPCS Code for Ixempra (ixabepilone) is: J9207 (Injection, ixabepilone 1 mg)

Use HCPCS code J9207 for service dates occurring on or after January 1, 2009.

Healthcare providers should code healthcare claims based upon the service that is rendered, the patient's medical record, the coding requirements of each health insurer, and best coding practices. Coding guidance provided under this heading does not provide a guarantee of reimbursement and should be considered together with all applicable coding guidance and standards.

When Ixempra is administered to patients on an outpatient basis and billed to health plans, use the following claim formats: CMS-1500 and UB-04 (paper formats) and ASC 837P and ASC 837I (electronic formats). All of the coding information presented by this Website is applicable to outpatient procedures, only.

The Centers for Medicare and Medicaid Services (CMS) has assigned the permanent Healthcare Common Procedure Coding System (HCPCS) code “J9207” to ixabepilone. Ixempra is the only FDA-approved form of ixabepilone that is marketed in the US.

HCPCS code J9207 should be used to bill Ixempra that is administered to patients covered by Medicare Part B or health insurers that require the reporting of HCPCS codes on claims for drug services.

For detailed instructions on how to bill using the UB04 and CMS-1500 forms, click here.

Physician Office Billing and Reimbursement | Hospital Outpatient Coding and Reimbursement

Physician Office Billing and Reimbursement

For professional claims (including CMS-1500 and ASC 837P), HCPCS code J9207 replaces the use of the HCPCS code J9999.* “Not otherwise classified, antineoplastic drugs,” on claims for service dates on or after January 1, 2009. HCPCS code J9999 is to be used for claims with service dates prior to January 1, 2009. All of the billing and coding instruction provided in this Website for Ixempra will assume the use of HCPCS code J9207.

J Code Description Effective Date
J9207 Injection, ixabepilone 1 mg 1/1/09
  • For Form CMS-1500, Ver. 08/05, enter “J9207” to Box 24D, under column heading “CPT/HCPCS”
  • For Form ASC 837P, enter “J9207” to Segment SV101-2, with Segment SV101-2 entered as “HC” (this is a qualifier Segment, meaning the entry to SV101-2 is a HCPCS code)

There should be 1 billing unit reported for every 1 mg of Ixempra that is reported using HCPCS code J9207. For example, the use of two vials of NDC 00015-1910-12, a total of 30 mg of Ixempra, is reported as 30 billing units in conjunction with HCPCS code J9207.

  • For Form CMS-1500, billing units are reported in Box 24G
  • For Form ASC 837P, billing units are reported in Segment SV104, with Segment SV103 entered as “UN” (this is a qualifier Segment, meaning the value in Segment SV104 is entered in “units”)
The NDC Codes for Ixempra appear in the box below:
NDC 00015-1910-12 Two-vial kit containing one vial of 15-mg Ixempra and one vial of 8-mL diluent for Ixempra
NDC 00015-1911-13 Two-vial kit containing one vial of 45-mg Ixempra and one vial of 23.5-mL diluent for Ixempra

The NDCs shown above are presented in the 11-digit HIPAA-compliant format that is required when NDC information must be reported on a healthcare claim form. The FDA issues NDCs in a 10-digit format that is shown in the Ixempra Package Insert. The 10-digit format should not be entered to healthcare claim forms; a leading zero must be added to the first segment of each Ixempra NDC shown in the Package Insert to create the 11-digit NDC shown above. Payers require the submission of the 11-digit NDC on healthcare claim forms.

Malignant Neoplasm of Female/Male Breast ICD-9-CM Diagnosis Codes†

Malignant neoplasm of female breast—174
  1. 174.0 Nipple and areola
  2. 174.1 Central portion
  3. 174.2 Upper-inner quadrant
  4. 174.3 Lower-inner quadrant
  5. 174.4 Upper-outer quadrant
  6. 174.5 Lower-outer quadrant
  7. 174.6 Axillary tail
  8. 174.8 Other specified sites of female breast
  9. 174.9 Breast (female), unspecified
Malignant neoplasm of male breast—175
  1. 175.0 Nipple and areola
  2. 175.9 Other and unspecified sites of male breast
Please see Indications and Important Safety Information including boxed WARNING regarding hepatic impairment.
Administration Service Codes
The CPT‡ Codes that are typically billed in conjunction with the administration of Ixempra appear in the box below:
HCPCS Code Description
96413 Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug
96415 Chemotherapy administration, IV infusion technique; each additional hour (list separately in addition to code for primary procedure)

* J9999 is the code that should be used for anticancer agents that have not been assigned a permanent HCPCS code.

† American Medical Association. Physician ICD-9-CM 2007. Vol. 1,2. Chicago, Ill.; American Medical Association (1,2); 2006.

‡ CPT® codes and descriptions are copyright 2007 American Medical Association. All rights reserved.

CPT® is a registered trademark of the American Medical Association (AMA).

Hospital Outpatient Coding and Reimbursement

Institutional providers using Forms UB-04 and ASC 837I should cease the use of the HCPCS code C9399, “Unclassified Drugs or Biologicals,” for service dates beginning January 1, 2009. For service dates on or after January 1, 2009, providers should use HCPCS code J9207 to report the use of Ixempra. Enter HCPCS codes to institutional clam forms as follows:

Institutional Claims:

J Code Description Effective Date
J9207 Injection, ixabepilone 1 mg 1/1/09
  • On the UB-04 claim form, enter Revenue Code 0636 (drugs requiring detailed coding) in FL42, under column heading “REV CD.” Enter HCPCS code “J9207” in FL44, under column heading “HCPCS / RATE / HIPPS CODE”

There should be 1 billing unit reported for every 1 mg of Ixempra that is reported using HCPCS code J9207. For example, the use of two vials of NDC 00015-1910-12, a total of 30 mg of Ixempra, is reported as 30 billing units in conjunction with HCPCS code J9207.

Institutional Claims:

  • For Form UB-04
The NDC Codes for Ixempra appear in the box below:
NDC 00015-1910-12 Two-vial kit containing one vial of 15-mg Ixempra and one vial of 8-mL diluent for Ixempra
NDC 00015-1911-13 Two-vial kit containing one vial of 45-mg Ixempra and one vial of 23.5-mL diluent for Ixempra

The NDCs shown above are presented in the 11-digit HIPAA-compliant format that is required when NDC information must be reported on a healthcare claim form. The FDA issues NDCs in a 10-digit format that is shown in the Ixempra Package Insert. The 10-digit format should not be entered to healthcare claim forms; a leading zero must be added to the first segment of each Ixempra NDC shown in the Package Insert to create the 11-digit NDC shown above. Payers require the submission of the 11-digit NDC on healthcare claim forms.

Malignant Neoplasm of Female/Male Breast ICD-9-CM Diagnosis Codes*

Malignant neoplasm of female breast—174
  1. 174.0 Nipple and areola
  2. 174.1 Central portion
  3. 174.2 Upper-inner quadrant
  4. 174.3 Lower-inner quadrant
  5. 174.4 Upper-outer quadrant
  6. 174.5 Lower-outer quadrant
  7. 174.6 Axillary tail
  8. 174.8 Other specified sites of female breast
  9. 174.9 Breast (female), unspecified
Malignant neoplasm of male breast—175
  1. 175.0 Nipple and areola
  2. 175.9 Other and unspecified sites of male breast
Administration Services†
HCPCS Code Description APC
96413 Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance/drug 0440
96415 Chemotherapy administration, IV infusion technique; each additional hour (list separately in addition to code for primary procedure) 0437

* American Medical Association. Physician ICD-9-CM 2007. Vol. 1,2. Chicago, Ill.; American Medical Association; 2006.

† HOPD  Chemotherapy Drug Administration—IV Technique.

Indications
Ixempra is indicated in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. Anthracycline resistance is defined as progression while on therapy or within 6 months in the adjuvant setting or 3 months in the metastatic setting. Taxane resistance is defined as progression while on therapy or within 12 months in the adjuvant setting or 4 months in the metastatic setting.

Ixempra is indicated as monotherapy for the treatment of metastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.

Important Safety Information including Boxed Warning

Toxicity in hepatic impairment

  • Ixempra (ixabepilone) in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 x ULN or bilirubin >1 x ULN due to increased risk of toxicity and neutropenia-related death
  • In combination with capecitabine, the overall frequency of grade 3/4 adverse reactions, febrile neutropenia, serious adverse reactions, and toxicity-related deaths was greater in patients with hepatic impairment
  • Caution should be used when using Ixempra as monotherapy in patients with AST or ALT >5 x ULN. Use of Ixempra in patients with AST or ALT >10 x ULN or bilirubin >3 x ULN is not recommended
  • With monotherapy, grade 4 neutropenia, febrile neutropenia, and serious adverse reactions were more frequent in patients with hepatic impairment

Contraindications

  • Ixempra is contraindicated in patients:
    • with a known history of a severe (CTC grade 3/4) hypersensitivity reaction to agents containing Cremophor® EL or its derivatives such as polyoxyethylated castor oil
    • who have a baseline neutrophil count <1500 cells/mm3 or a platelet count <100 000 cells/mm3

Peripheral neuropathy

  • Peripheral neuropathy was common. Patients treated with Ixempra should be monitored for symptoms of neuropathy, such as burning sensation, hyperesthesia, hypoesthesia, paresthesia, discomfort, or neuropathic pain
  • Neuropathy occurred early during treatment; ∼75% of new onset or worsening neuropathy occurred during the first 3 cycles. Patients experiencing new or worsening peripheral neuropathy may require changes in the dose or discontinuation of Ixempra
  • Neuropathy was the most frequent cause of treatment discontinuation due to drug toxicity. Caution should be used when treating patients with diabetes mellitus or preexisting peripheral neuropathy

Myelosuppression

  • Myelosuppression is dose-dependent and primarily manifested as neutropenia
  • Patients should be monitored for myelosuppression; frequent peripheral blood cell counts are recommended for all patients receiving Ixempra
  • Patients who experience severe neutropenia or thrombocytopenia should have their dose reduced. Neutropenia-related deaths occurred in 1.9% of 414 patients with normal hepatic function or mild hepatic impairment treated with Ixempra in combination with capecitabine. Neutropenia-related death occurred in 0.4% of 240 patients with Ixempra as monotherapy

Hypersensitivity reaction

  • Premedicate with an H1 and an H2 antagonist approximately 1 hour before Ixempra infusion and observe for hypersensitivity reactions (eg, flushing, rash, dyspnea, and bronchospasm)
  • In case of severe hypersensitivity reactions, infusion of Ixempra should be stopped and aggressive supportive treatment (eg, epinephrine, corticosteroids) started
  • Patients who experience a hypersensitivity reaction in one cycle of Ixempra must be premedicated in subsequent cycles with a corticosteroid in addition to the H1 and H2 antagonists, and extension of the infusion time should be considered

Pregnancy

  • Women should be advised not to become pregnant when taking Ixempra. If this drug is used during pregnancy or the patient becomes pregnant, the patient should be apprised of the potential hazard to the fetus

Cardiac adverse reactions

  • Caution should be exercised in patients with a history of cardiac disease. Discontinuation of Ixempra should be considered in patients who develop cardiac ischemia or impaired cardiac function due to reports of cardiovascular adverse reactions (eg, myocardial ischemia, supraventricular arrhythmia, and ventricular dysfunction). The frequency of cardiac adverse reactions (myocardial ischemia and ventricular dysfunction) was higher in the Ixempra in combination with capecitabine (1.9%) than in the capecitabine alone (0.3%) treatment group

Potential for cognitive impairment from excipients

  • Ixempra contains dehydrated alcohol USP. Consideration should be given to the possibility of central nervous system and other effects of alcohol

Adverse reactions

Monotherapy

  • The most common adverse reactions (≥20%) reported by patients receiving Ixempra monotherapy were peripheral sensory neuropathy, 62% (grade 3/4: 14%); fatigue/asthenia, 56% (grade 3/4: 13%); myalgia/arthralgia, 49% (grade 3/4: 8%); alopecia, 48% (grade 3/4: 0%); nausea, 42% (grade 3/4: 2%); stomatitis/mucositis, 29% (grade 3/4: 6%); vomiting, 29% (grade 3/4: 1%); diarrhea, 22% (grade 3/4: 1%); and musculoskeletal pain, 20% (grade 3/4: 3%). Drug-associated hematologic abnormalities (>40%) included neutropenia, leukopenia, anemia, and thrombocytopenia. Grade 3/4 hematologic adverse reactions included neutropenia, 54%; leukopenia, 49%; anemia, 8%; and thrombocytopenia, 7%

Combination with capecitabine

  • The most common adverse reactions (≥20%) reported by patients receiving Ixempra in combination with capecitabine compared to capecitabine alone, respectively, were peripheral sensory neuropathy, 65% vs 16% (grade 3/4: 21% vs 0%); palmar-plantar erythrodysesthesia (hand-foot) syndrome, 64% vs 63% (grade 3/4: 18% vs 17%); fatigue/asthenia, 60% vs 29% (grade 3/4: 16% vs 4%); nausea, 53% vs 40% (grade 3/4: 3% vs 2%); diarrhea, 44% vs 39% (grade 3/4: 6% vs 9%); vomiting, 39% vs 24% (grade 3/4: 4% vs 2%); myalgia/arthralgia, 39% vs 5% (grade 3/4: 8% vs <1%); anorexia, 34% vs 15% (grade 3/4: 3% vs 1%); stomatitis/mucositis, 31% vs 20% (grade 3/4: 4% vs 3%); alopecia, 31% vs 3% (grade 3/4: 0% vs 0%); abdominal pain, 24% vs 14% (grade 3/4: 2% vs 1%); nail disorder, 24% vs 10% (grade 3/4: 2% vs <1%); musculoskeletal pain, 23% vs 5% (grade 3/4: 2% vs 0%); and constipation, 22% vs 6% (grade 3/4: 0% vs <1%). Drug-associated hematologic abnormalities (>40%) with Ixempra in combination with capecitabine and capecitabine alone, respectively, included neutropenia, leukopenia, anemia, and thrombocytopenia. Grade 3/4 hematologic adverse reactions included neutropenia, 68% vs 11%; leukopenia, 57% vs 6%; anemia, 10% vs 5%; and thrombocytopenia, 8% vs 4%
Cremophor is a registered trademark of BASF AG.
AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal; CTC = common terminology criteria.

Please see Ixempra US Full Prescribing Information including boxed WARNING regarding hepatic impairment.

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