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
Coding
Procedure must be coded correctly in order to obtain appropriate reimbursement from both Centers for Medicare & Medicaid Services (CMS) and commercial payers.
The following describes the types of codes that may be applied when submitting claims for a positron emission tomography (PET)/computed tomography (CT) imaging study for initial treatment strategy or subsequent treatment strategy.
HCPCS – Healthcare Common Procedure Coding System
Codes used to report the provision of supplies, materials, injections, and certain services and procedures
CPT® – Current Procedural Terminology
Codes used to report the service or procedure that was performed and reported
ICD-10-CM – International Classification of Diseases, Tenth Revision, Clinical Modification
Codes used to describe signs or symptoms of the patient that would represent a medically necessary reason for performing the procedure
NDC – National Drug Code
A universal product identifier for human drugs in the United States
Healthcare Common Procedure Coding System (HCPCS) code
Not-otherwise-classified (NOC) code
At this time, there is no distinct HCPCS code for Gozellix® for patients with suspected prostate cancer who are candidates for initial definitive therapy or suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA).
Telix Pharmaceuticals (US) Inc. has applied for a distinct code; in the absence of a product-specific code, a NOC HCPCS code is required. When billing an NOC code, payers require additional information: the NDC number, drug name, cost, and units.
Code to report to the agent is:
HCPCS Code
Descriptor
Medicare accepts the C9399 code in hospital outpatient settings, but not all other insurance companies do. Also, while some insurers don’t accept the A9597 code, most will accept the A4641 code, similar to Medicare in Independent Diagnostic Testing Facilities (IDTF) and Free-Standing Facilities.
To determine which code non-Medicare payers will accept, please contact Gozellix Reimbursement Support. This support line maintains a database on what NOC codes payers will accept and are there to assist you at 1-(844) 45-TELIX (1-844-458-3549).
If you have any questions about how to use the HCPCS code when submitting claims, please contact Gozellix Reimbursement Support at 1-(844) 45-TELIX (1-844-458-3549).
Billable units
Unlike distinct HCPCS codes, NOC drug codes always default to one (1) unit.
When submitting claims, be sure to enter the correct number of units. Per the Prescribing Information, Gozellix doses range from 111 MBq to 259 MBq (3 mCi to 7 mCi) administered as an intravenous bolus injection.
Example claim forms are available for download below; however, it is imperative to review individual payer guidance.
Billing information current as of June 2025. Requirements may vary by payer and may change from time to time.
Current Procedural Terminology (CPT) code
The choice of procedure code to report the procedure should be based on which code most accurately describes the procedure performed and is properly documented in the medical record/procedure report.
These CPT codes are the appropriate options for Gozellix PET or PET/CT imaging
CPT
Descriptor
All Current Procedural Terminology (CPT) codes and descriptors are copyrighted 2021 by the American Medical Association.
When billing PET or PET/CT procedures to Medicare, providers need to amend the claim with the use of a modifier. These modifiers inform the payer of the purpose of the scan, which is critical as Medicare has strict guidelines on coverage for staging and oncologic PET imaging.
When billing Medicare, attach either a PI or PS modifier:
- The -PI modifier is appropriate for PET/CT imaging for initial treatment strategy of tumors that are biopsy proven with suspected metastasis who are candidates for initial definitive therapy
- The -PS modifier is appropriate for PET/CT imaging of recurrent prostate cancer after completion of initial treatment with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
Before submitting any claims, the provider should ensure that all information is accurate and complete, and conforms to the most recent guidance and requirements of the specific payer to which the claim will be submitted, including Medicare.
International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code
A covered diagnostic code must be billed with any PET or PET/CT for prostate cancer and the provider should always follow the provider’s applicable billing procedures, which may include verifying a patient’s individual benefits before scheduling a scan.
Below are examples of commonly covered ICD-10-CM codes for prostate:
ICD-10-CM Code
Descriptor
C or R ICD-10-CM Code
Descriptor
aThe use of this code informs payers that this scan is for recurrent prostate cancer.
All International Classification of Diseases (ICD) codes and descriptors are copyrighted 2021 by the World Health Organization. ICD codes may change from time to time.
In the electronic equivalent to box 19 on the CMS-1500 claim form or the electronic equivalent to box 80 on the CMS-1450 claim form, place:
- Name of the drug (Gozellix)
- Dose administered (3 mCi to 7 mCi)
- 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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Hospital revenue codes for chargemaster – hospital outpatient department
Revenue Code
Descriptor
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.