Positron emission tomography (PET) can be used to diagnose and stage malignancies. It is covered in the following clinical situations:

• PET can be used in place of other  conventional imaging studies when it’s expected that information from other studies will be insufficient for clinical management of the patient or
• when the stage of the cancer is in doubt following a standard diagnostic workup, including conventional imaging (e.g., ultrasound, CT, MRI) or
• when clinical management of the patient will differ based on the stage of the cancer.
  

PET imaging is also covered when used for restaging. Restaging occurs after a course of treatment has been completed. As such, it is covered when:

• the physician suspects residual disease or a recurrence of disease or
• it’s necessary to determine the extent of a known recurrence or
• the patient develops new or additional symptoms of the disease.

Surveillance is periodic follow-up imaging of patients with a confirmed history of cancer, who have completed a course of treatment and require periodic evaluation for potential re-occurrence. To be eligible, PET scans performed for surveillance must meet these qualifications.

Once the diagnosis has been established, PET is not eligible when performed to monitor tumor response to treatment, when no change in treatment is being considered. The use of PET in this circumstance is considered not medically necessary and as such, is not eligible for reimbursement. When PET is denied as not medically necessary, a participating, preferred, or network provider cannot bill the member for the denied service.

PET imaging is not covered when performed as a screening procedure to evaluate asymptomatic patients (patients without signs and/or symptoms of disease or illness). In this case, a participating, preferred, or network provider can bill the member for the denied service.

PET imaging is considered medically necessary for the following oncological applications. In all cases, clinical documentation must be maintained in the patient’s medical records to support the medical necessity of the PET study:

Brain
PET imaging for malignancies of the brain (191.0-191.9, 198.3) is considered medically necessary and eligible for payment.

Breast
PET imaging of the breast for malignancies (174.0-174.9, 175.0-175.9, 198.81, 233.0, 238.3, 239.3) is considered eligible when it is used as an adjunct to other imaging modalities to:

• stage patient with distant metastasis;
• restage patients with locoregional recurrence or metastasis; or
• monitor tumor response to treatment in patients with locally advanced and metastatic breast cancer when a change in therapy is contemplated.

PET breast imaging is considered not medically indicated for the initial diagnosis of breast cancer and staging of axillary lymph nodes (code G0252). This service is not eligible for payment. A participating, preferred, or network provider cannot bill the member for the denied service in this instance.

Colorectal
Colorectal PET imaging is eligible for the diagnosis, staging and restaging for colorectal carcinomas (153.0-153.9, 154.0-154.8, 155.0, 197.5, 230.3, 230.4, 230.5, 235.2, 239.0). This includes the use of PET in evaluating patients who show clinical signs or symptoms of recurrent colorectal cancer, and related hepatic and/or extrahepatic metastases.

Colorectal PET imaging for conditions other than those described above is considered not medically indicated and not eligible for payment.

Esophageal
PET imaging for the diagnosis, staging and restaging of esophageal cancer (150.0-150.9, 151.0, 230.1 235.5, 239.0) is considered an eligible procedure.

In most cases, CT and/or endoscopic ultrasound studies are the standard imaging methods to assess patients with esophageal cancer. When CT and/or endoscopic ultrasound are indeterminate or inconclusive, PET imaging may be used to obtain the necessary information to determine treatment management.

Esophageal PET imaging for conditions other than those described above is considered not medically indicated and not eligible for payment.

Gynecological
PET imaging is considered medically necessary for gynecological malignancies (179, 180.0-180.9, 182.0-182.8, 183.0-183.9, 184.8, 184.9, 198.6, 198.82, 233.1, 233.2, 233.3, 236.0, 236.2, 236.3, 239.5). 

PET imaging for gynecological conditions other than those specified above is considered not medically indicated and ineligible for payment.

Head and Neck, Excluding Central Nervous System
Head and neck cancers encompass a diverse set of malignancies of which the majority are squamous cell carcinomas. Patients may develop metastases to cervical lymph nodes while conventional forms of diagnostic imaging fail to identify the primary tumor. PET imaging of the head and neck can be useful in determining the site of primary tumor to prevent the adverse effects of invasive surgical procedures (e.g., biopsy, neck dissection) or unneeded radiation therapy treatment.

PET imaging for the diagnosis, staging and restaging of cancers of the head and neck) is eligible for reimbursement. (140.0-140.9, 141.0-141.9, 142.0-142.9, 143.0-143.9, 144.0-144.9, 145.0-145.9, 146.0-146.9, 147.0-147.9, 148.0-148.9, 149.0-149.9, 160.0-160.9, 161.0-161.9, 162.0, 162.2, 170.0-170.1, 171.0, 173.0-173.4, 176.2, 190.0-190.9, 194.1, 194.3, 195.0, 196.0, 210.0-210.9, 212.0-212.1, 213.0-213.1, 215.0, 216.0-216.4, 224.0-224.9, 228.03, 230.0, 231.0, 231.1, 231.8, 232.0-232.4, 234.0, 235.0-235.1, 235.6, 237.0, 238.0, 238.2, 238.8, 239.0, 239.1, 239.2, 239.8)

PET imaging of the head and neck for conditions other than those described above is considered not medically indicated and not eligible for payment.

PET studies of the central nervous system are considered investigational. As such, PET scans of the head and neck for central nervous system (CNS) cancers are not covered.

Lung
Typically, a CT scan provides evidence of the initial detection of a primary lung tumor. When the information from the CT scan indicates an indeterminate or possibly malignant lesion, a PET study may be necessary to determine malignancy in order to plan treatment and future management of the patient.

PET imaging of the lung is eligible for the diagnosis, staging and restaging of lung cancers (162.0-162.9, 163.0-163.9, 164.8, 164.9, 196.1, 197.0, 197.1, 231.2, 235.7, 235.8, 239.1, 518.89).

PET imaging of the lung for conditions other than those described above is considered not medically indicated and not eligible for payment.

Lymphoma
PET imaging is considered medically necessary in diagnosing, staging and restaging lymphoma (196.0-196.9, 200.00-200.88, 201.00-201.98, 202.00-202.98).

PET imaging of lymphoma for conditions other than those described above is considered not medically indicated and not eligible for payment.

Melanoma
PET imaging for melanoma (172.0-172.9) is considered medically necessary for the diagnosis, staging and restaging of melanoma and is eligible for reimbursement.

PET studies performed to evaluate regional nodes in melanoma patients (code G0219) is considered not medically indicated and, as such, is not eligible for reimbursement.

PET imaging of melanoma for conditions other than those described above is considered not medically indicated and not eligible for payment.

Pancreas
Pancreatic PET imaging is considered medically necessary in patients with suspected pancreatic adenocarcinoma (157.0-157.9) when the results of other imaging modalities {for example, CT, endoscopic retrograde cholangiopancreatography (ERCP), ultrasonography} are in doubt, inconclusive or equivocal.

Pancreatic PET imaging for other diagnoses or conditions is not medically indicated and not eligible for payment.

Thyroid
The methods most commonly used to determine whether a patient has thyroid cancer are fine needle or surgical biopsy of the lump or nodule. There are also several clinical pathology tests (e.g., thyroglobulin) and nuclear imaging studies (e.g., whole body scans using radioactive iodine or I-131) available to determine local recurrence or metastasis of the thyroid cancer. PET imaging for differentiated thyroid cancer is considered medically necessary only for restaging recurrent or residual thyroid cancers of follicular cell origin (193, 234.8, 237.4). The patient must have been previously treated by thyroidectomy and radioiodine ablation and have a serum thyroglobulin greater than 10ng/mL (10 nanograms per milliliter) and a negative whole body nuclear scan.

Other applications for PET imaging of the thyroid are considered not medically indicated. There is insufficient scientific evidence documenting the efficacy of PET thyroid imaging in the clinical setting for any other application including, but not limited to: 

• evaluating cold thyroid nodules (that is, thyroid nodules that are less detectable than surrounding tissues on a nuclear scan due to low uptake of the radiotracer such as I-131);
• initial staging of post-surgical thyroid cancer of histological cell types that are poorly differentiated thyroid cancers, that is, those known to concentrate radioactive iodine (I-131) poorly; 
• re-staging recurrent or residual thyroid cancer of medullary cell origin with an elevated serum calcitonin and negative standard imaging studies;
• prognosis on patients with metastatic thyroid cancer who are at high risk of death over the following three years. 

PET Imaging for Malignancies in Other Anatomic Areas
PET tumor imaging for malignancies in other anatomic areas is considered experimental/investigational for all other uses. Scientific evidence does not demonstrate the efficacy of PET imaging in these applications at this time. Examples include, but are not limited to other diseases and malignancies including but not limited to musculoskeletal, central nervous system, prostate, or germ-cell, renal, testicular, penile, and hepatocellular neoplasms, gastrointestinal stromal tumors (GIST) of the stomach, and thymoma.

All eligibility criteria and coverage guidelines that apply to PET studies also apply to codes 78811 through 78813 based on the anatomic area imaged.

All eligible diagnosis codes for covered PET studies also apply to codes 78811 through 78813. PET tumor imaging reported with a diagnosis code other than those listed as eligible will be denied as not medically necessary. A participating, preferred, or network provider cannot bill the member for the denied service.

PET Scans Using a Coincidence Detection System
PET scans or PET/CT fusion studies performed on a non-dedicated PET scanner or coincidence detection system (procedure code S8085) are not eligible for reimbursement. The equipment used to perform these studies does not provide images that meet accepted standards of quality achieved when these scans are performed on a dedicated PET or PET/CT scanner. As such, claims reporting code S8085 will be denied. A participating, preferred, or network provider cannot bill the member for the denied service.

A non-dedicated PET scanner, also called a coincidence detection system, uses a modified SPECT gamma camera that has been adapted to produce PET-like images.

Radiopharmaceutical Diagnostic Imaging Agents
When a radiopharmaceutical diagnostic imaging agent is reported in conjunction with a covered nuclear medicine study, payment is made for the agent under the appropriate code for the radiopharmaceutical administered. The diagnostic imaging agent/contrast material used in conjunction with an eligible imaging procedure is also eligible when administered by the health care professional in a setting other than a hospital, or a skilled facility.

Description

PET is a nuclear imaging technology that uses positron emitting radiotracers coupled to organic molecules (e.g., glucose) to obtain both metabolic and physiologic information pertaining to a specific anatomic area. These radiotracers are produced by a nuclear generator or cyclotron and administered intravenously as a radiopharmaceutical diagnostic imaging agent prior to imaging.

PET provides cross-sectional images of an anatomic area to identify metabolic, biochemical, hemodynamic, pharmacologic, and physiologic processes for the diagnosis and treatment management of diseases.

This policy focuses on the oncologic applications of PET in diagnosing and treating various malignancies.

For information on PET imaging for nonmalignant applications see Medical Policy Bulletin R-8.

For information on PET/CT fusion imaging (codes 78814-78816) see Medical Policy Bulletin R-16.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

Oncologic Applications of PET: An updated review, Applied Radiology, June 2000

Positron Imaging in Oncology: Present and Future, Nuclear Medicine Annual, 1998

A Meta-Analysis of the Literature for Whole-Body FDG PET Detection of Recurrent Colorectal Cancer, The Journal of Nuclear Medicine, Volume 41, No. 7, July 2000

Utility of Positron Emission Tomography for the Staging of Patients with Potentially Operable Esophageal Carcinoma, Journal of Clinical Oncology, Volume 18, No. 18, September 2000

Positron Emission Tomography: Another Useful Test for Staging Esophageal Cancer, Journal of Clinical Oncology (Editorial), Volume 18, No. 18, September 2000

Whole-Body FDG Positron Emission Tomographic Imaging for Staging Esophageal Cancer Comparison with Computed Tomography, Clinical Nuclear Medicine, Volume 25, No. 11, November 2000

Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography in the Staging and Follow-up of Lymphoma: Is it time to shift gears? (United States study), European Journal of Nuclear Medicine, Volume 27, No. 10, October 2000

Positron Emission Tomography (PET) is Superior to Computerized Tomography (CT) for Metastatic Staging in Melanoma Patients, Clinical Positron Imaging, Volume 3, No. 4, July 2000

Optimal Interpretation of FDG PET in the Diagnosis, Staging and Management of Pancreatic Carcinoma, The Journal of Nuclear Medicine, Volume 40, No. 11, 1999

Preoperative Staging of Non-Small-Cell Lung Cancer with Positron Emission Tomography, The New England Journal of Medicine, Volume 343, No. 4, July 2000

Accuracy of Whole-Body Fluorine-18 FDG PET for the Detection of Recurrent or Metastatic Breast Carcinoma, The Journal of Nuclear Medicine, Volume 39, No. 3, March 1998

Clinical Utility of FDG-PET in Detecting Had and Neck Tumors: A Comparison of Diagnostic Methods and Modalities, Clinical Positron Imaging, Volume 3, No. 1, 2000

PET in Oncology: Will it replace the other modalities?, Seminars in Nuclear Medicine, Volume XXVII, No. 2, 4/87

Decision Tree Sensitivity Analysis for Cost Effectiveness of FDG-PET in the Staging and Management of Non-Small-Cell Lung Carcinoma, The Journal of Nuclear Medicine, Volume 37, No. 9, 9/96

Evaluation of Pulmonary Lesions with FDG-PET, Comparison of Findings in Patients with and without a History of Prior Malignancy, Chest, Volume 109, 4/96

Oncologic Applications of PET Scanning, National Blue Cross Blue Shield Association Medical Policy Reference Manual, Policy No. 6.01.26, Issued April 2000

Medicare Coverage Database Decision Memo CAG-00095N

F18-fluorodeoxyglucose positron emission tomography in detecting metastatic papillary thyroid carcinoma with elevated human serum thyroglobulin levels but negative I-131 whole body scan, Endocrine Research, May 2003

Postoperative management of differentiated thyroid cancer, Otolaryngologic Clinics of North America, February 2003

Clinical Relevance of Thyroid Fluorodeoxyglucose-Whole Body Positron Emission Tomography Incidentaloma, Journal of Clinical Endocrinology and Metabolism, April 2002

Positron-Emission Tomography and Assessment of Cancer Therapy, The New England Journal of Medicine, February, 2006

Prediction of Response to Neoadjuvant Chemotherapy by Sequential F-18-Fluorodeoxyglucose Positron Emission Tomography in Patients with Advanced-Stage Ovarian Cancer, Journal of Clinical Oncology, October, 2005

Imaging of Pelvic Malignancies with In-Line FDG PET-CT:  Case Examples and Common Pitfalls of FDG PET, Radiographics, July 2005

FDG-PET for Management of Cervical and Ovarian Cancer, Gynecology Oncology, April, 2005

Positron Emission Tomography with 2-deoxy-2-[¹⁸F]fluoro-D-glucose for Evaluating Local and Distant Disease in Patients with Cervical Cancer, Molecular Imaging and Biology, January-February, 2004

Why Nearly All PET of Abdominal and Pelvic Cancers Will Be Performed as PET/CT, Journal of Nuclear Medicine, January, 2004 (Supplement)

Clinically Occult Recurrent Ovarian Cancer: Patient Selection for Secondary Cytoreductive Surgery Using Combined PET/CT, Gynecology Oncology, September, 2003

Positron Emission Tomography/Computed Tomography Imaging for the  Detection of Recurrent Ovarian and Fallopian Tube Carcinoma: A Retrospective Review, Gynecology Oncology, April, 2002

Use of PET/CT Scanning in Cancer Patients: Technical and Practical Considerations, Baylor University Medical Center Proceedings, October, 2005

Imaging and Response in Soft Tissue Sarcomas, Hematology/Oncology Clinics of North America, June, 2005

Oncologic Application of PET Scanning, National Blue Cross Blue Shield Medical Policy 6.01.26, February, 2005

PET: A Revolution in Medical Imaging, Radiology Clinics of North America, November 2004

PET in the Management of Urologic Malignancies, Radiology Clinics of North America, November 2004