POSLUMA Logo

This information is intended for US healthcare professionals (HCPs).

POSLUMA Logo

Order POSLUMA

Call Siemens’ PETNET Solutions Inc., a Siemens Healthineers company, at 1-877-473-8638

HCPCS code A9608 assigned, effective January 1, 2024

REIMBURSEMENT AND FORMULARY SUPPORT

Experience an exceptional
level of support

Blue Earth Diagnostics is committed to providing the support you and your patients require
 

With unparalleled experience in the field of prostate cancer molecular imaging, Blue Earth Diagnostics, Inc. offers extensive education, training, and support

Exclamation point icon

POSLUMA has been granted pass-through status in the Medicare Part B hospital outpatient setting, effective October 1, 2023

REIMBURSEMENT SUPPORT

Connect with your local FRM

Front view of a woman working on her laptop and wearing a headset

Access support starts with your Field Reimbursement manager (FRM). This is your resource for access support, providing information and resources to help you navigate benefits and coverage for POSLUMA.

Your FRM will provide support with:

  • Coverage policies for payers
  • Clinical guidelines for radiology benefit managers
  • Education on prior authorizations, billing, and coding
  • Support for appeals, denials, and peer-to-peer process
  • Provide in-person and virtual reimbursement training

    The POSLUMA reimbursement guide provides the resources and information you need:

    • Coding Information Sheet
    • Prior Authorization Best Practices
    • Scheduling Tip Sheet
    • PET Imaging Program Implementation Checklist
    • Letter Templates
      • Letter of Medical Necessity
      • Letter for Appeal of Denial
    • Sample Billing Forms
    • Blue Earth Reimbursement Support Helpline Information
    • Fillable Forms
      • Diagnostic PET Order Form
      • Patient Benefit Investigation Form

    Get the POSLUMA Resource Guide

     

      Reimbursement support helpline assists with access questions for individual patients*

      Call 1-855-495-9200 or fax 1-877-309-7514, Monday through Friday from 9 am to 8 pm Eastern time, for support throughout the benefit approval process.

      *Helpline provides information about prior authorization/appeals requirements, and, at the provider’s option, submits PA forms completed by the provider to the payer.

      Download the Patient Benefit Investigation form today

       

        Checkmark icon

        Contact your local Field Reimbursement manager for billing, coding, local payer information, and reimbursement review

        Checkmark icon

        Regularly review your payer contracts to ensure appropriate reimbursement for POSLUMA

        Checkmark icon

        Utilize Reimbursement Support Hotline for benefit investigation/prior authorization services

        Checkmark icon

        Even if no authorization is required, confirm that the patient meets the coverage criteria

        Checkmark icon

        Become familiar with your payer mix and their coverage criteria

        Checkmark icon

        Conduct a benefit investigation for every patient

        Checkmark icon

        Always try to obtain a prior authorization for both the CPT and HCPCS code

        Checkmark icon

        Schedule meeting to discuss POSLUMA reimbursement with Field Reimbursement manager

        FORMULARY SUPPORT

        Access important resources

        Download resource icon

        Download all formulary components or choose one or more of the individual components below.

        Download all

        The information on this website contains factual information and is not intended to be legal or coding advice. Blue Earth Diagnostics does not guarantee coverage or reimbursement for POSLUMA. The existence of billing codes does not guarantee coverage and payment. Payer policies vary and may change without notice. It is the provider’s responsibility to determine and submit accurate information on claims. This includes submitting proper codes, modifiers, charges, and invoices for the services that were rendered. It is the provider’s responsibility to ensure that all information on a claim is accurate. It is the provider’s responsibility to check with the payer to determine whether the information contained on the claim is accurate. It is the responsibility of the provider to document the medical necessity of POSLUMA in the medical record.

        Indication

        POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

        • with suspected metastasis who are candidates for initial definitive therapy
        • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

        INDICATION | IMPORTANT SAFETY INFORMATION

        INDICATION

        POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer

        • with suspected metastasis who are candidates for initial definitive therapy
        • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

        IMPORTANT SAFETY INFORMATION

        • Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
        • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
        • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
        • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
        • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

        To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

        Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf

        • Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
        • Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
        • POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
        • The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
        • Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

        To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

        Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf

        Find a POSLUMA imaging center