Positron emission tomography (PET) is not eligible when performed to monitor tumor response during a planned course of treatment when no change in treatment is being contemplated. This use of PET is considered not medically necessary and as such, not eligible for reimbursement.

In all situations, clinical documentation must be maintained in the patient's medical files to support the medical necessity for the PET procedure.

When a PET procedure is denied as not medically necessary, a participating, preferred, or network provider cannot bill the member for the denied service.

PET imaging used to evaluate asymptomatic patients is considered screening, that is, testing a patient without specific signs and/or symptoms of disease. Coverage for PET studies performed as a screening study is determined according to individual or group customer benefits.

PET used for staging is covered in the following clinical situations.

• When the stage of the cancer remains in doubt following a standard diagnostic workup including conventional imaging (for example, CT, MRI, ultrasound), or
• PET could potentially replace one or more conventional imaging studies when it is expected that the information obtained from these conventional studies is insufficient for the clinical management of the patient; or
• When clinical management of the patient would differ depending on the stage of the cancer identified.

PET scans following a tissue diagnosis are typically performed for the purpose of staging, not diagnosis. As such, the use of PET in the diagnosis of esophageal and colorectal cancers, lymphoma and melanoma should be rare.

Restaging only occurs after a course of treatment is completed. As such, PET for restaging is covered after the completion of treatment to detect residual disease, suspected recurrence, or determine the extent of a known recurrence.

PET imaging is considered medically necessary for the following oncologic applications and uses.

Brain (Codes 78608, 78609)
PET imaging for malignancies of the brain (191.0-191.9, 198.3) is considered medically necessary and eligible for payment.

Breast (Codes G0252, G0253, G0254)
PET imaging of the breast (codes G0253, G0254) 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 (Codes G0213, G0214, G0215, G0231)
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 (Codes G0226, G0227, G0228)
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.

Head and Neck, Excluding Central Nervous System (Codes G0223, G0224, G0225)
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 (Codes G0125, G0210, G0211, G0212, G0234)
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 (Codes G0220, G0221, G0222, G0232)
PET imaging is considered medically necessary in diagnosing, staging and restaging lymphoma (196.1, 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 (Codes G0216, G0217, G0218, G0219, G0233)
PET imaging for melanoma (172.0-172.9) is considered medically necessary for the diagnosis, staging and restaging of melanoma (G0216, G0217, G0218) and is eligible for reimbursement.

PET studies performed to evaluate regional nodes in melanoma patients (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 (Code G0296)
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 the diagnosis, staging, restaging, and monitoring of treatment for other diseases and malignancies including but not limited to musculoskeletal, central nervous system, cervix or ovaries, prostate, or germ-cell cancers and thymoma.

PET tumor localization, limited (78811), skull base to mid-thigh (78812), whole body (78813)
All eligibility criteria and coverage guidelines that apply to PET studies will also apply to codes 78811 through 78813 based on the anatomic area imaged.

All eligible diagnosis codes for covered PET studies will also apply to codes 78811 through 78813. PET tumor imaging reported witha 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
A coincidence detection imaging system uses a modified SPECT gamma camera that has been adapted to produce PET-like images. PET scans performed using a modified gamma camera/coincidence detection imaging system should be reported using one of the following codes, as appropriate: G0231 (colorectal), G0232 (lymphoma), G0233 (melanoma), G0234 (lung), or S8085 [FDG imaging using dual-head coincidence detection system (non-dedicated PET scan)] for all other anatomic areas. The medical necessity guidelines described in this policy apply to all PET studies whether performed on a dedicated PET scanner or using a modified gamma camera.

Radiopharmaceutical Diagnostic Imaging Agents
The cost of the radiopharmaceutical diagnostic imaging agent (for example, FDG) is included in the global and technical component allowances for the PET study. A separate payment will not be made for the radiopharmaceutical diagnostic imaging agent. A participating, preferred, or network provider cannot bill the member for the denied service.

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.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition. PET studies of the central nervous system, head and neck for CNS cancers, and other anatomic areas (e.g., musculoskeletal, cervix or ovaries, prostate, germ-cell cancers, thymoma) are considered eligible when determined medically necessary based on the patient’s condition.

PRN References

04/1996, Positron emission tomography
10/1998, PET for non-central nervous system cancers covered under certain situations
04/2000, Coverage of positron emission tomography summarized
04/2001, Blue Shield revises guidelines for oncologic PET imaging
04/2001, Guidelines for reporting PET scans performed on coincidence detection imaging systems
08/2001, Coverage of PET imaging expanded
08/2002, Coverage for PET imaging of the breast added
12/2003, Blue Shield allows PET imaging for detecting certain thyroid cancers

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

MCIM Section 50-36

MCM Sections 4173, 4173.1, 4173.2, 4173.3

MPM AB-01-54, AB-03-092