J Code Issued for IXEMPRA® (ixabepilone) — J9207

For dates of service on or after January 1, 2009

The Centers for Medicare and Medicaid Services (CMS) has issued the permanent Healthcare Common Procedure Coding System (HCPCS) code J9207 for IXEMPRA (ixabepilone).

J9207 should be used for patients covered by Medicare Part B, or health insurers that recognize HCPCS codes when IXEMPRA is administered in the physician's office setting or in the outpatient hospital setting.

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

Indications

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.

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.

Important Safety Information

Toxicity in hepatic impairment

IXEMPRA (ixabepilone) in combination with capecitabine is contraindicated in patients with AST or ALT >2.5 × ULN or bilirubin >1 × 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 × ULN. Use of IXEMPRA in patients with AST or ALT >10 × ULN or bilirubin >3 × 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

The most common adverse reactions (≥20%) reported by patients receiving IXEMPRA were peripheral sensory neuropathy, fatigue/asthenia, myalgia/arthralgia, alopecia, nausea, vomiting, stomatitis/mucositis, diarrhea, and musculoskeletal pain. The following additional events occurred in ≥20% in combination treatment: palmar-plantar erythrodysesthesia (hand-foot) syndrome, anorexia, abdominal pain, nail disorder, and constipation. Drug-associated hematologic abnormalities (>40%) include neutropenia, leukopenia, anemia, and thrombocytopenia

Cremophor is a registered trademark of BASF AG.
AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal;
CTC = common terminology criteria.

Physician Office Billing and Reimbursement

For physician-based practices, J9207 replaces the temporary J9999* code and should be inserted in the field 24D of the CMS-1500 form. Number of billing units, and not vials, must be indicated in field 24G. Billing for IXEMPRA (ixabepilone) should be done by total dose, in 1-mg increments.

J Code	Description	Effective Date
J9207	Injection, ixabepilone 1 mg	1/1/09

The NDC Codes for IXEMPRA appear in the box below:

NDC 0015-1910-12 NDC 00015-1910-12	IXEMPRA kit containing one vial of 15-mg IXEMPRA and one vial of 8-mL diluent for IXEMPRA
NDC 0015-1911-13 NDC 00015-1911-13	IXEMPRA kit containing one vial of 45-mg IXEMPRA and one vial of 23.5-mL diluent for IXEMPRA

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

Malignant neoplasm of female breast—174		Malignant neoplasm of male breast—175

174.0	Nipple and areola	175.0	Nipple and areola
174.1	Central portion	175.9	Other and unspecified sites of male breast
174.2	Upper-inner quadrant
174.3	Lower-inner quadrant
174.4	Upper-outer quadrant
174.5	Lower-outer quadrant
174.6	Axillary tail
174.8	Other specified sites of female breast
174.9	Breast (female), unspecified

Professional Services

The CPT^‡ Codes for 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;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).

This coding guidance is not intended to be specific directions on IXEMPRA coding. Healthcare providers need to make coding decisions based on the diagnosis and treatment of each patient and the specific requirements of each health insurer. This coding guidance does not provide a guarantee of reimbursement.

Hospital Outpatient Coding and Reimbursement

Hospital-based outpatient departments using the UB-04 claim form should replace the temporary C Code with the permanent J Code J9207 in field 44, using the Revenue code 0636 in field 42. Indicate number of units, and not vials, in field 46. Billing for IXEMPRA (ixabepilone) should be done by total dose, in 1-mg increments.

J Code	Description	Effective Date
J9207	Injection, ixabepilone 1 mg	1/1/09

The NDC Codes for IXEMPRA appear in the box below:

NDC 0015-1910-12 NDC 00015-1910-12	IXEMPRA kit containing one vial of 15-mg IXEMPRA and one vial of 8-mL diluent for IXEMPRA
NDC 0015-1911-13 NDC 00015-1911-13	IXEMPRA kit containing one vial of 45-mg IXEMPRA and one vial of 23.5-mL diluent for IXEMPRA

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

Malignant neoplasm of female breast—174		Malignant neoplasm of male breast—175

174.0	Nipple and areola	175.0	Nipple and areola
174.1	Central portion	175.9	Other and unspecified sites of male breast
174.2	Upper-inner quadrant
174.3	Lower-inner quadrant
174.4	Upper-outer quadrant
174.5	Lower-outer quadrant
174.6	Axillary tail
174.8	Other specified sites of female breast
174.9	Breast (female), unspecified

Administration Services^†

HCPCS Code	Description	APC
96413	Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance	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.