Reimbursement information for Illuccix®
Reimbursement Support
Helping you with your patients’ reimbursement needs
To assist your practice with all reimbursement and coding questions, we have established Illuccix® Reimbursement Support. This service can be accessed by phone or using the online scheduling button. Our customers are encouraged to set up an on-boarding call prior to having a specific reimbursement need to get to know the Reimbursement Support Team. Customers can simply click the “Book Reimbursement Onboarding” button to set up a date and time convenient for them.
Illuccix® Reimbursement Support can:
Perform benefit investigations
Assist with securing prior authorization
Assist with appealing denied claims
Provide coverage policies from third-party payers
Provide clinical guidelines from Radiology Benefit Managers (RBMs)
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Please contact Illuccix Reimbursement Support at (844) 45-TELIX (1-844-458-3549) or simply click Book Reimbursement Onboarding to schedule online.
Support specialists are available Monday through Friday 9:00 AM to 5:00 PM ET.
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. For example, the HCPCS code for Rubidium 82 is A9555
- CPT® – Current Procedural Terminology: Codes used to report the service or procedure that was performed and reported
- ICD-10 – International Classification of Diseases, Tenth Revision: 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
CPT® is a registered trademark of the American Medical Association.
Transitional Pass-Through status
Recognized by CMS
Illuccix was granted Transitional Pass-Through status effective July 1, 2022. This status will be in effect for a minimum of 2 years, but will not exceed 3 years. Pass-Through allows for unbundled payment for Illuccix and the technical component (the scan) for CMS patients in the hospital outpatient setting.
HCPCS
The distinct HCPCS code for Illuccix 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) is recognized by CMS. Please use the HCPCS code A9596 on all insurance claims for Illuccix.
Code to report the agent is:
HCPCS Code
Descriptor
A9596
Gallium ga-68 gozetotide, diagnostic, (Illuccix),
1 millicurie
If you have any questions about how to use the HCPCS code when submitting claims, please contact Illuccix Reimbursement Support at (844) 45-TELIX (1-844-458-3549).
Billable Units
When submitting claims, be sure to enter the correct number of units. Per the Prescribing Information, Illuccix doses range from 3 to 7 millicuries, with 5 mCi being the most common standard dose used for the efficacy and safety profile.
Example claim forms are available for download below; however, it is imperative to review individual payer guidance.
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CPT
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 Illuccix PET or PET/CT imaging:
CPT Code
Descriptor
78812
Positron emission tomography (PET) imaging; skull base to mid-thigh
78813
Positron emission tomography (PET) imaging; whole body
78815
Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid-thigh
78816
Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; whole body
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.
ICD-10-CM Coding
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 codes for prostate:
ICD-10 Code
Descriptor
C61
Malignant neoplasm of prostate
R97.21
Rising PSA following treatment for malignant neoplasm of prostate
C79.82
Secondary malignant neoplasm of genital organs (must be accompanied by C61)
Z19.1
Hormone sensitive malignancy
Z19.2
Hormone resistant malignancy
When reporting C or R ICD-10 codes, another code must also be on the claim form:
C or R ICD-10 Code
Descriptor
Z85.46*
Personal history of malignant neoplasm of prostate
*The use of this code informs payers that this scan is for recurrent prostate cancer.
All International Classification 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 (Illuccix)
- Dose administered (X mCi)
- 11-digit NDC number
- NDC 74725-100-25 for Ga-68 produced from a cyclotron and purified via GE FASTlab™ or Eckert & Ziegler GalliaPharm® Ge 68/Ga-68 generator
- NDC 74725-100-64 for Ga-68 produced from an IRE Galli Eo® Ge 68/Ga-68 generator
Hospital Revenue Codes for Chargemaster – Hospital Outpatient Department
Revenue Code
Descriptor
0340
Nuclear Medicine – General Classification
0341
Nuclear Medicine – Diagnostic
0404
Other Imaging Services – Positron Emission Tomography (PET)
All International Classification Diseases (ICD) codes and descriptors are copyrighted 2021 by the World Health Organization. ICD codes may change from time to time.
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 prior authorization 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 code(s)
- Patient clinical notes detailing the relevant diagnosis
- Relevant CPT and HCPCS codes for services/products to be performed or provided
- HCPCS code for billing Illuccix (A9596) and 11-digit NDC number
- NDC 74725-100-25 for Ga-68 produced from a cyclotron and purified via GE FASTlab™ or Eckert & Ziegler GalliaPharm® Ge 68/Ga-68 generator
- NDC 74725-100-64 for Ga-68 produced from an IRE Galli Eo® Ge 68/Ga-68 generator
The items listed below may be necessary to obtain a prior authorization decision:
Completed prior authorization request form (if required by the payer)
- Some payers may require specific forms to be completed for certain medications or therapeutic areas — 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 prior authorization 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 prior authorization 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
- Illuccix Reimbursement Support can assist with prior authorizations 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 Illuccix® and any associated services. A sample letter of medical necessity is provided below.a
SAMPLE DOCUMENT: PHYSICIAN OFFICE (CMS-1500) – for educational purposes only
Illuccix® 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 Illuccix® is available for download below.b
SAMPLE DOCUMENT: HOSPITAL OUTPATIENT (CMS-1450) – for educational purposes only
Illuccix® 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 Illuccix® 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 Illuccix
When using Illuccix, follow these steps for successful billing:
Get to know how PET/CT scans with Illuccix will be covered by the major payers in your area
- Contact Illuccix Reimbursement Support 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 Illuccix or if you need to amend your contracts for Illuccix
Perform a benefit investigation for every patient
- Confirm coverage, co-pay, if there is a deductible, and if prior authorization is required
- Illuccix 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 do the prior authorization online or is there a specific form to use?
- Is there an RBM to work with? Can you do that request online or do you need a specific form/worksheet?
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Billing information current as of April 2023. 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 Illuccix 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.
