Prior Authorizations

Prior authorization is a process used to determine if a prescribed procedure, service, or medication will be covered. It is intended to act as a safety and cost savings measure. This process does not guarantee payment. A prior authorization is not pre-determined by a health plan. Prior authorizations may be required for Axumin and/or PET imaging.

NOTE: The provider has the responsibility to ensure correct prior authorization, appeal and denial policies are followed. Providers must ensure they accurately complete and submit necessary information to payers. Verify benefits, eligibility, coverage and requirements for prior authorization.

 

Predetermination

Predetermination is determination of the reimbursement amount from a third party before a health care service is performed. It does not guarantee payment.

  • May be required by the payer
  • Electronic submissions may be more beneficial than manual submission
  • Insight may be gained on reimbursement (payment) for Axumin and PET Scan
  • May be able to gain insight into contract limitations with payer

(NOTE: Many of the tips for prior authorization would also be useful for a predetermination.)

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.