Ixempra® (ixabepilone) Medicare Part B Reimbursement

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.

FAQs:

  1. What is the Medicare reimbursement allowable for Ixempra? Click For Answer
    • Physicians: The amount paid to physicians by Medicare for HCPCS code J9207 is published quarterly by CMS on the schedule titled “Payment Allowance Limits for Medicare Part B Drugs.” The Payment Allowance Limit for J9207 is computed as 106% of ASP, or Average Sales Price. This price that is published is for one HCPCS billing unit for J9207, which is 1 mg of Ixempra (ixabepilone).
    • (NOTE: This Payment Allowance Limit is valid at the time of publication. Refer to the link below for the most current Medicare Payment Policy)
    • The schedule of “Payment Allowance Limits for Medicare Part B Drugs” is updated at the beginning of each calendar quarter. See the most recent fee schedule on the CMS Website.
    • The Medicare Part B benefit will pay physicians 80% of the Medicare allowed price for J9207; the patient is responsible for 20% coinsurance. Medicare Part B cost-sharing expense, including coinsurance, may be covered by a patient's secondary insurance (private supplemental coverage, Medicaid, etc).
    • Hospital Outpatient Clinics: The amount paid to hospital outpatient clinics by Medicare for J9207 is published quarterly on the schedule titled “Addendum B Updates.” The Payment Allowance Limit for J9207 is computed as 106% of ASP, or Average Sales Price. The ASP price that is published is for one HCPCS billing unit for J9207, or 1 mg of Ixempra (ixabepilone).
    • (NOTE: This Payment Allowance Limit is valid at the time of publication. Refer to the link below for the most current Medicare Payment Policy)
    • The “Addendum B Updates” file is updated at the beginning of each calendar quarter. See the most recent fee schedule on the CMS Website.
    • The Medicare Part B benefit will pay physicians 80% of the Medicare allowed price for J9207; the patient is responsible for 20% coinsurance. Medicare Part B cost-sharing expense, including coinsurance, may be covered by a patient's secondary insurance (private supplemental coverage, Medicaid, etc).
  2. Do Medicare Payment Rates stated in question 1 apply in the inpatient setting as well? Click For Answer
    • No. Reimbursement in the inpatient setting is bundled into the Diagnosis-Related Group (DRG) payment that the hospital receives for all items and services provided to a patient during an inpatient stay.
  3. How is the reimbursement amount for HCPCS code J9207 (Ixempra) determined by commercial insurers? Click For Answer
    • Commercial insurers typically reimburse for drug services on a “fee-for-service” basis, meaning that reimbursement is made separately for each individual chemotherapy service that is billed. The price that is paid by commercial insurers for this service will be based upon the provider's contracted pricing with the commercial insurer, or the commercial insurer's published or “usual, customary, and reasonable” (UC&R) pricing if the provider is not contracted for specific pricing.
    • Some providers may include chemotherapy drugs within the scope of capitation agreements that are in place between a commercial insurer and the provider; in these cases, “fee-for-service” payments for J9207 may not be made. It is important for providers that accept capitation payments to understand whether payment for HCPCS code J9207 is included in the provider's capitation payments, or a separate “fee-for-service” payments will be made by the insurer.
    • If a reimbursement amount that is received by the provider for HCPCS code J9207 from a commercial insurer is not the expected amount, the provider may wish to contact the insurer's provider relations function to understand the pricing that has been applied to compute the reimbursement amount. Destination Access does not assist providers to appeal pricing that is applied to claims that are reimbursed by commercial insurers. Destination Access will assist providers to address reimbursement amounts that are computed by government payers from published pricing.

Ixempra (ixabepilone) for Injection permanent HCPCS: J9207, Injection, ixabepilone 1 mg. Effective 1/1/2009

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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