For US Healthcare Professionals Only

Reimbursement information for Illuccix®

Reimbursement Support

At Telix Pharmaceuticals (US) Inc., our customers’ needs are top priority.

To assist with all of your reimbursement and coding questions, we have established Illuccix® Reimbursement Support. Our customers are encouraged to set up an onboarding call prior to having a specific reimbursement need to get to know the Reimbursement Support Team. Customers can simply click the “Book Now” 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)

Illuccix Reimbursement Guide

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Please contact Illuccix® Reimbursement Support at (844) 45-TELIX (1-844-458-3549) or simply click Book Now 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.

Pass-Through

Illuccix has been awarded Transitional Pass-Through Status by CMS as of July 1st. Pass-Through allows for unbundled payment for Illuccix and the technical component (the scan) in the hospital outpatient setting. This status will allow Medicare patients increased access to this important diagnostic imaging test.1,2

HCPCS

HCPCS Code A9596 Recognized Beginning July 1

Beginning July 1st, the distinct HCPCS code, A9596, will be recognized by CMS for Illuccix patients with suspected prostate cancer who are candidates for initial definitive therapy or suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA). Until then, it is recommended to utilize the NOC code identified below.

Suggested coding to report the agent through July 1:

HCPCS Code

Descriptor

A9597

Positron emission tomography (PET) radiopharmaceutical, diagnostic for tumor ID, NOC radiopharmaceutical, diagnostic, NOC

While Medicare accepts this NOC code, not all other third-party payers will. While some payers do not accept A9597, most will accept A4641 (radiopharmaceutical, diagnostic, not otherwise classified).

To determine which code non-Medicare payers will accept, please contact Illuccix® Reimbursement Support. This service maintains a database on what NOC codes payers will accept and are there to assist you at (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, Illuccix® doses range from 3 to 7 millicuries, with 5 mCi being the most common standard dose used for efficacy and safety.

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

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 verify 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

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.

There is additional information required to bill the use of Illuccix®, as a requirement of HIPAA 5010a and because a NOC HCPCS code is being billed.

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

aHealth Insurance Portability and Accountability Act including electronic transmission of healthcare transactions.

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)

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® (A9597) 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.b

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.c

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.c

bThis document is a modifiable template that can be used by providers when submitting a letter of medical necessity for prior authorization purposes.

cThis sample document is only an example. 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 investigation

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 a radiology benefit manager (RBM) to work with? Can you do that request online or do you need a specific form/worksheet?

Billing information current as of December 2021. 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.

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This information is not intended to guarantee reimbursement by any payer. The healthcare provider (HCP) is responsible to report the codes that accurately describe the products and services furnished to individual patients. HCPs should consult the payer organizations regarding local policies and rates along with any required claim information.

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.

Indications and Usage

Illuccix®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

  • 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

Risk for Misdiagnosis
Image interpretation errors can occur with gallium Ga 68 gozetotide 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. The performance of gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. 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.

Radiation Risks
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 health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.

DRUG INTERACTIONS

Androgen deprivation therapy and other therapies targeting the androgen pathway

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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

Please see  full Prescribing Information.

Indications and Usage

Illuccix®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

  • with suspected metastasis who are candidates for initial definitive therapy
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

References: 1. Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) prescribing information. 2. Dorff TB, Fanti S, Farolfi A, Reiter RE, Sadun TY, Sartor O. The evolving role of prostate-specific membrane antigen-based diagnostics and therapeutics in prostate cancer. Am Soc Clin Oncol Educ Book. 2019;39:321-330.