Access and Reimbursement Information for Axumin® (fluciclovine F 18)
The purpose of this web page is to offer information regarding reimbursement for Axumin. Reimbursement information and processes will evolve over time, as they do with any prescription drug. Please revisit this website periodically for the most up-to-date information.
The Blue Earth Diagnostics team offers reimbursement support
- Benefit Investigation: Investigation of patient insurance benefits, including deductible and copayments, and verification of coverage status for Axumin and PET/CT, including insurance requirements and possible coverage restrictions.
- Prior Authorization (PA) Assistance: Information on PA requirements.*
- Appeal Assistance: Information on appeals requirements for denied Prior Authorizations or denied claims.
Additional services offered:
- Billing, Coding, and Claims Information: Assistance with questions specific to billing, coding, and claims submission for Axumin and PET.
- Patient Support: Support with issues related to reimbursement coverage, claim submission, and payment denials.
Reimbursement Support Hotline:
Telephone: 1-855-495-9200
FAX: 1-877-309-7514
Expanded Hours of Operation
Telephone support is available Monday through Friday, from 9 AM to 8 PM Eastern time.
*Helpline provides information about PA/appeals requirements, and, at the provider’s option, submits PA forms completed by the provider to the payer.
This document contains factual information and is not intended to be legal or coding advice. Blue Earth Diagnostics does not guarantee coverage or reimbursement for Axumin. The information provided in this document is based upon current, general coding practices. The existence of billing codes does not guarantee coverage and payment. Payer policies vary and may change without notice. It is the providers’ responsibility to determine and submit accurate information on claims. This includes submitting such as proper codes, modifiers, charges, and invoices for the services that were rendered. The coding on claims should reflect medical necessity and be consistent with the documentation in the patient’s medical record.
Axumin's transitional pass-through period for Original Medicare beneficiary scans performed in the hospital outpatient department ended on December 31, 2019. For Medicare hospital outpatients, payment for the PET diagnostic radiopharmaceuticals are bundled with the procedure payment after the transitional pass-through period. As of January 1, 2020, Axumin will be bundled with the procedure payment.
It is essential that hospitals appropriately and accurately determine codes for items and services and apply appropriate charges, even when the payment is bundled. For example, diagnostic radiopharmaceuticals are packaged but still should be coded and billed in order for the cost to be accurately represented in the claims data.
Download all formulary components or choose one or more of the individual components below.
- Disease Overview: Brief summary of biochemically recurrent prostate cancer, current imaging paradigms, and the unmet clinical need in PET/CT imaging.
- Clinical Summary: A detailed summary of the Axumin clinical studies, including the rationale, study background, and clinical endpoints. Also includes a description of the product’s mechanism of action (MOA).
- Clinical Bibliography: A list of publications describing the safety and efficacy of Axumin.
- Indication and ISI: Full Axumin Indication and Important Safety Information (ISI).
- Dosing and Administration Guide: Detailed instructions for dosing and administration, including positioning patients, recommended timing for PET/CT imaging, and approximate timing for image acquisition.
- Safety Data Sheet: Health and safety precautions for the preparation, handling, and use of Axumin.
- Coding Sheet: Relevant product, procedure, and diagnosis coding information applicable for billing purposes.
- Ordering Information: Information to order Axumin for your facility and the list of services our sales representatives can provide.
The information on this website contains factual information and is not intended to be legal or coding advice. Blue Earth does not guarantee coverage or reimbursement for Axumin. 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 Axumin in the medical record.
INDICATION
Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
IMPORTANT SAFETY INFORMATION
- Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
- Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
- Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
- Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see Axumin full Prescribing Information.