INDICATIONS AND USAGE
- With suspected metastasis who are candidates for initial definitive therapy
- With suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
Medical Billing Resources
Prior authorization
Most third-party payers require some type of prior authorization (PA) for advanced imaging, and it may be necessary to provide the following information when making a PA request:
- Patient demographics including name, insurance policy number, and date of birth
- Physician information including name and tax ID number
- Facility information including name and tax ID number
- Setting of care
- Independent diagnostic testing facility (IDTF)
- Hospital inpatient
- Hospital outpatient
- Date of service
- Patient diagnosis and relevant ICD-10-CM code(s)
- Patient clinical notes detailing the relevant diagnosis
- Relevant CPT and HCPCS codes for services/products to be performed or provided
- HCPCS NOC code for billing (A9597) and 11-digit NDC number
- NDC 84552-500-25 for Ga-68 produced from a cyclotron and purified via GE FASTlab™ or ARTMS QIS™, or an Eckert & Ziegler GalliaPharm® Ge 68/Ga-68 generator
- NDC 84552-500-64 for Ga-68 produced from an IRE Galli Eo™ Ge 68/Ga-68 generator
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The items listed below may be necessary to obtain a PA decision
Completed PA request form (if required by the payer)
- Some payers may require specific forms to be completed for certain medications and/or imaging — always verify that the correct form is completed
Letter of medical necessity
-
Be sure to include the Provider ID number in the letter
Documentation that supports the use of the agent
- Patient clinical notes detailing the relevant diagnosis
- Relevant laboratory results
- Product package insert/FDA product labeling
If a request is denied
- Review the reason for denial and address; the decision will inform if the denial issue is related to coverage policy, clinical appropriateness, or another reason, such as:
- Incomplete submission
- Incorrect PA form
- Payer determination that PET/CT or agent is not appropriate for the patient in question
- Missing patient notes or other medical information
- Denied requests for PA can be appealed and it is important to follow the process from the payer—online, appeal letter, or by phone to request a peer-to-peer review
- Denials should be addressed by the payer in 30 days or less
- Gozellix® Reimbursement Support can assist with PAs and in appealing denied authorizations
Sample documents
LETTER OF MEDICAL NECESSITY – for educational purposes only
You may need a letter of medical necessity in order to obtain a prior authorization decision for Gozellix and any associated services. A sample letter of medical necessity is provided below.a
SAMPLE DOCUMENT: HOSPITAL OUTPATIENT (CMS-1450) – for educational purposes only
Gozellix and the associated services provided in a hospital outpatient setting are billed on the UB-04 claim form or its electronic equivalent. A sample UB-04 claim form for billing Gozellix is available for download below.b
SAMPLE DOCUMENT: PHYSICIAN OFFICE (CMS-1500) – for educational purposes only
Gozellix and the associated services provided in a physician office are billed on the CMS-1500 claim form or its electronic equivalent. A sample CMS-1500 claim form for billing Gozellix is available for download below.b
aThis document is a modifiable template that can be used by providers when submitting a letter of medical necessity for prior authorization purposes.
bThese sample claim forms are only examples. It is always the provider’s responsibility to determine the appropriate healthcare setting and to submit true and correct documents for the products and services rendered. Providers should contact third-party payers for specific information on their coding, coverage, payment policies, and fee schedules.
Best practices for billing Gozellix
When using Gozellix, follow these steps for successful billing outcomes:
Get to know how PET/CT scans with Gozellix will be covered by the major payers in your area
- Contact your Regional Field Access Manager (us.reimbursement@telixpharma.com) for assistance, as they have a database of coverage policies for third-party payers
Review your contracts with the payers to see how they will cover Gozellix or if you need to amend your contracts for Gozellix
Perform a benefit investigation for every patient
- Confirm coverage, co-pay, if there is a deductible, and if prior authorization is required
- Gozellix Reimbursement Support can assist with benefit investigations
Where prior authorization is required:
- Determine if the imaging facility you wish to refer your patient to is in-network for the payer
- Can you complete the prior authorization online or is there a specific form to use?
- Is there an RBM to work with? Can you obtain that request online or do you need a specific form/worksheet?
Billing information current as of June 2025. Requirements may vary by payer and may change from time to time.
Information provided in this resource 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 payers 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 Gozellix Reimbursement Support is intended as legal advice or a substitute for a provider’s independent professional judgment.
HCPs are solely responsible for all decisions related to coding and billing including determining if and under what circumstances it is appropriate to seek reimbursement for products and services and obtaining preauthorization. Telix Pharmaceuticals (US) Inc. does not make any representation or warranty about the completeness or accuracy of this information and will bear no responsibility for the results or consequences of its application.
You’re always looped in
INDICATIONS AND USAGE
- 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
WARNINGS AND PRECAUTIONS
Image interpretation errors can occur with GOZELLIX 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. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.
Ascorbic Acid Stabilizer contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
ADVERSE REACTIONS
DRUG INTERACTIONS
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.
Please see the Full Prescribing Information.