Important Safety Information

  • Contraindications: Xofigo® is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman Continue reading below. »
  • Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. Continue reading below. »

Coding for Xofigoa

Xofigo and its associated services may be reported with the following codes:

Healthcare Common Procedure Coding System (HCPCS) codes

In a freestanding center or hospital outpatient setting, Xofigo is reported using the product-specific HCPCS A-code, A9606 (radium Ra 223 dichloride, therapeutic, per microcurie).

Xofigo common procedure coding system codes

Please note that individual Medicare Administrative Contractors (MACs), private payors, or other payors or claims processors may have different coding requirements for radiopharmaceuticals in the freestanding center. Xofigo® Access Services can research payor-specific coding requirements in performing patient-specific benefit verifications.

Providers should confirm the appropriate coverage, coding, and reimbursement with the applicable payor or claims processor before submitting claims for an item or service. Providers must ensure that all claims submitted to payors are accurate, complete, and adequately supported by documentation in the medical record.

Payors differ on guidelines and criteria required for billing an office visit on the same day as other physician services. It is important to verify appropriate coding with a patient’s health insurance plan before submitting the CMS-1500 claim form for reimbursement. Additional information required by the payor may include:

  • Xofigo Prescribing Information
  • FDA approval letter for Xofigo
  • Patient medical history
  • Physician clinical notes on the patient’s condition
  • Letter of medical necessity
  • Invoice for Xofigo
  • National Drug Code (NDC) for Xofigo (Medicaid and/or commercial payors)

Current Procedural Terminology (CPT) codes

Physicians use CPT codes to report medical services provided in a freestanding center or hospital outpatient setting, including the administration of Xofigo.

Xofigo current procedural terminology (CPT) codes

Revenue codes for the UB-04 claim form

The UB-04 claim form also requires documentation of revenue codes associated with services provided to patients receiving Xofigo. Please confirm payor guidelines as other revenue codes, including 0636 (drugs requiring detailed coding), may also be appropriate when submitting a claim for Xofigo.

Xofigo revenue codes for the UB-04 claim form

International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10 CM) codes (as of October 1, 2015)

Appropriately coding and classifying the patient’s diagnosis and condition is important to support medical necessity for receiving Xofigo.

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

International Classification of Diseases Chart

Evaluation and management (E/M) codes may also be used to describe services provided by the physician when the patient’s condition is significant and beyond the intravenous injection of Xofigo. If an E/M service is billed in addition to the intravenous injection of Xofigo, the modifier “-25” is necessary to indicate a significant and separately identifiable E/M service by the same physician on the same day. The provider must document the additional service in the patient’s medical record.

If you have questions or want to learn more, Request support from a Xofigo Field Reimbursement Manager

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aInformation provided on this page is for informational purposes only and does not guarantee that codes will be appropriate or that coverage and reimbursement will result. Customers should consult with their payors for all relevant coverage, coding, and reimbursement requirements. It is the sole responsibility of the provider to select proper codes and ensure the accuracy of all claims used in seeking reimbursement. Neither this resource nor Xofigo Access Services is intended as legal advice or as a substitute for a provider’s independent professional judgment.

Helpful Resources

View all coding and billing resources

Indication

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

Important Safety Information

Contraindications: Xofigo® is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman

Warnings and Precautions:

  • Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo.

    Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure

  • Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care

  • Concomitant Use With Chemotherapy: Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued

  • Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established

Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations

Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia

Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo

Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial

Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy

Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%)

For important risk and use information about Xofigo, please see the Full Prescribing Information.

You are encouraged to report side effects or quality complaints of products to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here.

References: 1. Centers for Medicare & Medicaid Services. HCPCS release and code sets. Alpha-numeric HCPCS items. 2016. http://www.cms.gov/Medicare/Coding/HCPCSReleaseCodeSets/Alpha-Numeric-HCPCS-Items/2016-Alpha-Numeric-HCPCS-File.html. Accessed September 6, 2016. 2. American Medical Association. 2012 CPT Professional Edition. American Medical Association; 2011. 3. Centers for Medicare & Medicaid Services. CMS Manual System. Pub. 100-04 Medicare Claims Processing. Transmittal 423. 2005. http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R423CP.pdf. Accessed September 6, 2016. 4. Centers for Medicare & Medicaid Services. CMS Manual System. Pub. 100-04 Medicare Claims Processing. Transmittal 167. 2004. http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R167CP.pdf. Accessed September 6, 2016. 5. Ingenix. 2014 International Classification of Diseases, 10th Revision, Clinical Modification Mappings. OPTUMInsight, Inc.; 2013.