ACCESS

CODING AND BILLING

Please read the following information to help facilitate patient access, successful claims filing, and accurate reimbursement for Xofigo®

  • Coding and billing varies by site of care:
    • Freestanding centers of care use the CMS-1500 (version 02-12) claim form
    • Hospital outpatient sites of care use the UB-04/CMS-1450 claim form
  • Accurate completion of the Freestanding Center (CMS-1500) or Hospital Outpatient (UB-04/CMS-1450) claim form is important for timely and appropriate claims processing and to avoid claim denials
  • Be familiar with Medicare and private payor coding and billing requirements
  • Understand and document on claims the payor’s clinical criteria for determining which patients are medically appropriate for Xofigo
  • Accurately code the patient’s diagnosis and service for appropriate claims processing and reimbursement

Coding and billing support for Xofigo

Xofigo® Access Services can provide information on payor coding, billing, and claims submission requirements to help you with claims completion.

Consult with your Field Reimbursement Manager for specific coding and billing guidance

    XOFIGO BILLING FOR FREESTANDING CENTERS OF CAREa

    Healthcare professionals administering Xofigo in a freestanding center should submit a CMS-1500 form or its electronic equivalent to report the use and administration of Xofigo.

    Guidance on filling out the CMS-1500 Claim Form (version 02-12 as of April 2014):

    Health insurance claim form document

    aOther diagnosis codes may be applicable; code(s) and sequencing order may vary by payor.

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

    XOFIGO BILLING FOR HOSPITAL OUTPATIENT SETTINGSa

    Xofigo and the associated services provided in a hospital outpatient setting are billed on the UB-04 claim form or its electronic equivalent.

    Guidance on filling out the UB-04 claim form:

    UB 04 Claim form document

    aOther diagnosis codes may be applicable; code(s) and sequencing order may vary by payor.

    Billing for Xofigo and its administration in separate sites of carea,b

    According to Medicare guidance, if a physician who is not employed by the hospital administers Xofigo to a patient in that hospital’s outpatient department, and Xofigo was purchased by the hospital, the hospital outpatient department may submit a separate claim for the product Xofigo and the technical component of its administration.

    Guidance on filling out the UB-04 claim form when billing separate sites of care:

    UB 04 Claim form 1 Document

    aThe technical component includes nonphysical work, including administrative, personnel, equipment, and facility costs and related malpractice expenses.

    bOther diagnosis codes may be applicable; code(s) and sequencing order may vary by payor.

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

    Coding For Xofigoa

    Xofigo and its associated services may be reported with the codes listed below.

    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).1

    Xofigo® HCPCS A 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 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® 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.

    UB-04 Revenue Codes for Xofigo®

    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.

    ICD-10-CM Codes for Prostate Cancer

    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 Field Reimbursement Manager

    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.

    Coverage For Xofigo

    It is important for prescribing physicians to understand payor policies and requirements affecting patient access and product coverage, coding, and reimbursement. Conduct an insurance benefit verification for your patient prior to treatment with Xofigo to identify the necessary requirements.

    MEDICARE

    • Medicare coverage of Xofigo may be available to beneficiaries if reasonable and necessary
    • Options for supplemental insurance coverage for patients already enrolled in traditional Medicare include Medigap plans or a supplemental commercial insurance plan
    • A Medigap plan may cover a patient’s 20% coinsurance remaining after Medicare pays 80%
    • Third-party financial assistance options may be available for eligible patients in need
    • Medicare Administration Contractors (MACs) have different fee schedules for physician-owned practices
    • Managed Medicare Plans do not publish fee schedules so check your fee before testing

    MEDICAID

    • Medicaid coverage and reimbursement policies may vary state to state and depend on individual insurance plans and negotiated contracts with physicians and hospitals
    • State Medicaid agencies may require additional documentation to grant coverage or obtain prior authorization for Xofigo
    • Patient cost-share will vary based on the state Medicaid policies, but may require patients to pay a minimal copay or coinsurance for Xofigo
    • Third-party financial assistance options may be available for eligible patients in need

    COMMERCIAL PAYORS

    • Commercial payors develop their own coverage and reimbursement policies and depend on individual insurance plans and negotiated contracts with physicians and hospitals
    • Contracted prices may be based on fee schedules, invoices, or other payment methodologies such as average selling prices
      • Sites should review their payor contracts to determine specific payment methodology
    • Commercial payors may also require additional documentation to grant coverage or obtain prior authorization for Xofigo
    • Patients may be responsible for a copay and deductible based on their individual insurance plan
    • Please consult local payors for specific claims-submission guidance
    • Financial assistance options are available for eligible patients in need
    • Managed Commercial Plans do not publish fee schedules so check your fee before testing

    Learn about copay assistance with Xofigo

    CLAIMS PROCESSING

    Providing documentation will support payors in processing a claim for Xofigo.

    • FDA approval letter for Xofigo
    • Patient medical history
    • Physician’s clinical notes on the patient’s condition
    • Invoice for Xofigo

    In the event the payor made an error in processing the claim, the administering provider’s office should contact the payor to discuss the processing issue in order to allow the patient access to Xofigo.

    CLAIMS APPEAL

    When appealing a denied claim, payors may request additional documentation (if not submitted with the original claim), including:

    • Sample letter of appeal
    • Copy of the original claim
    • Copy of denial notification from payor
    • Xofigo Prescribing Information
    • FDA approval letter
    • Copy of invoice
    • Patient medical history, including clinical notes
    • Copy of referring physician’s order
    MEDICARE ADMINISTRATIVE CONTRACTOR (MAC) COVERAGE
    MAC Coverage map of the USA

    aInformation provided 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.

    Click here to contact your Bayer Field Reimbursement Manager to discuss further.

    Choose your state and select a site of care for coverage, coding, billing/claims submissions, and payment-methodology information from the MACs.a

    MAC Coverage map of the USA

    aInformation provided 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.

    Click here to contact your Bayer Field Reimbursement Manager to discuss further.

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    Counselors are available from 9:00 AM to 7:00 PM ET, Monday through Friday:

    For helpful resources, click here.

    References

    Please consider the following information to help facilitate patient access, successful claims filing, and accurate reimbursement for Xofigo

    • Accurate completion of the Freestanding Center (CMS-1500) or Hospital Outpatient (UB-04/CMS-1450) claim form is important for timely and appropriate claims processing and to avoid claim denials
    • Be familiar with Medicare and private payor coding and billing requirements
    • Understand and document on claims the payor’s clinical criteria for determining which patients are medically appropriate for Xofigo
    • Accurately code the patient’s diagnosis and service for appropriate claims processing and reimbursement

    Coding and billing support for Xofigo

    Xofigo® Access Services can provide information on payor coding, billing, and claims submission requirements to help you with claims completion.

    Consult with your Field Reimbursement Manager for specific coding and billing guidance.
    Open link

    Comprehensive support right when you need it

    Alt tag

    Counselors are available from 9:00 AM to 7:00 PM ET, Monday through Friday:

    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.

    Indication

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

    Important Safety Information

    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
    • Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo

    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.

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