The current status of PET scanning for various oncologic indications is provided in the following grid:

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1 COVERAGE: Epileptic Seizures: Positron Emission Tomography (PET) is considered medically necessary for the assessment of selected patients with epileptic seizures who are candidates for surgery. NOTE: Appropriate candidates are those patients who have complex partial seizures that have failed to respond to medical therapy and who have been advised to have a resection of a suspected epileptogenic focus located in a region of the brain accessible to surgery. Conventional techniques for seizure localization must have been tried and provided data that suggested a seizure focus, but were not sufficiently conclusive to permit surgery. SPECIAL COMMENT ON EEG'S AND PET EXAMINATION: The purpose of the PET examination should be to avoid subjecting the patient to extended preoperative electroencephalographic recording with implanted electrodes. Oncologic Applications: The current status of PET scanning for various oncologic indications is provided in the following grid: Clinical Condition Diagnosis or Detection Disease Staging or Restaging Treatment Response Monitoring Melanoma Medically necessary to assess extranodal spread of malignant melanoma at initial staging or restaging Lymphoma, including Hodgkin s disease Lung to detect regional lymph node metastases in clinically localized melanoma scheduled for sentinel node biopsy Medically necessary for initial staging or restaging in known lymphoma Medically necessary when evaluation of a solitary pulmonary nodule by CT scan and chest x-ray is inconclusive Medically necessary for initial staging or restaging in known lung cancer Colorectal Medically necessary to detect and assess resectability of hepatic or extrahepatic metastases of colorectal cancer

2 Pancreatic Head and Neck Medically necessary to identify an unknown primary suspected to be head and neck cancer. Medically necessary to stage the cervical lymph nodes for established breast cancer and assess the resectability of the tumor. Medically necessary to detect residual or recurrent disease following treatment. Esophageal Breast Medically necessary when used to investigate patients with established breast cancer who have signs, symptoms or lesions AND that standard imaging, including nuclear, CT and MRI scans has been unable to reveal the cause. Ovarian Other Oncologic Applications s s s Unknown Primary Medically necessary for unknown primary when ALL of the following are met: Single site disease outside the cervical lymph nodes; AND Local or regional treatment for single site metastatic disease is being considered; AND Workup for occult primary tumor was negative; AND PET scan will be used to rule out or detect additional sites of disease that would eliminate the rationale for local or regional treatment. for evaluation of unknown primary including but not limited to the following: As part of the initial workup of an unknown primary; As part of the workup of patients with multiple sites of disease. Cardiac Applications In terms of cardiac applications, PET scanning has focused on the following 2 distinct clinical situations:

3 1. Myocardial Perfusion Cardiac PET scanning is considered medically necessary as a technique of identifying myocardial perfusion defects and thus diagnose CAD. NOTE: In terms of myocardial perfusion studies, patient selection criteria or PET scans involve an individual assessment of the pretest probability of coronary artery disease (CAD), based both on patient symptoms and risk factors. Patients at low risk for CAD may be adequately evaluated with exercise electrocardiography. Patients at high risk for CAD may not benefit from a non-invasive assessment of myocardial perfusion, since, in this setting, a negative test may represent a false negative result. These patients may be immediately referred to coronary angiography. 2. Myocardial Viability Cardiac PET scanning is considered medically necessary to assess the myocardial viability in patients with severe left ventricular dysfunction as a technique to determine candidacy for a revascularization procedure. NOTE: Patient selection criteria for PET scans for myocardial viability are typically those patients with severe left ventricular dysfunction who are under consideration for a revascularization procedure. A PET scan may determine whether the left ventricular dysfunction is related to viable on nonviable myocardium. Patients with viable myocardium may benefit from revascularization, while those with non-viable myocardium will not. As an example, PET scans are commonly performed in potential heart transplant candidates to rule out the presence of viable myocardium. Other Applications The use of PET for all other indications is considered experimental or investigational. DESCRIPTION: Positron Emission Tomography (PET) scans are based on the use of positron emitting radionuclide tracers coupled to organic molecules, such as glucose, ammonia, or water. The radionuclide tracers simultaneously emit 2 high-energy photons in opposite directions that can be simultaneously detected (referred to as coincidence detection) by a PET scanner, consisting of multiple stationary detectors that

4 encircle the area of interest. A variety of tracers are used for PET scanning, including oxygen-15, nitrogen-13, carbon-11, and fluorine-18. Because of their short halflife, tracers must be made locally, the majority requiring an on-site cyclotron. This policy only addresses the use of radiotracers detected with the use of dedicated PET scanners. There is a similar procedure to PET that may be referred to as FDG-SPECT, metabolic SPECT, or PET using a gamma camera. In this procedure radiotracers such as FDG may be detected using SPECT cameras. The FDG-SPECT procedure is addressed in HCSC medical policy FDG-SPECT (single proton emission computed tomography) RATIONALE: Epileptic Seizures: Conventional techniques for seizure localization may provide data that suggest a seizure focus. However, the data may not be conclusive to permit surgery. The purpose of the PET examination should be to avoid subjecting the patient to extended pre-operative electroencephalographic recording with implanted electrodes. Oncologic Applications: Lung - PET scanning may have a clinical role in patients with solitary pulmonary lung nodules in whom the diagnosis is uncertain after prior CT scan and chest x-ray. In patients with known lung cancer, the clinical value of PET scanning relates to improved staging information regarding the involvement of mediastinal lymph nodes, which generally excludes patients from surgical excision. Melanoma Surgical resection for melanoma is limited to those with local disease. Patients with widespread disease are not candidates for resection. PET scanning has been investigated as both a technique to detect widespread disease as part of an initial staging procedure and also to evaluate the status of the local lymph nodes to determine the necessity of sentinel node biopsy. To consider PET a useful alternative to sentinel node biopsy, it must have high sensitivity and specificity when either sentinel node biopsy or lymph node dissection serves as the reference standard. A 1999 TEC Assessment concluded that PET is not as beneficial as sentinel node biopsy in assessing regional lymph nodes.

5 Lymphoma, including Hodgkin s disease A 1999 TEC Assessment concluded that when PET is added to conventional imaging, it can provide useful information for selective effective treatment that is appropriate to the correct stage of disease. Colorectal A 1999 TEC Assessment concluded that PET scanning adds useful information to conventional imaging in detecting hepatic and extrahepatic metastases. In particular, PET can detect additional metastases leading to more identification of non-resectable disease, allowing patients to avoid surgery. In regard to using PET as a technique to evaluate the presence of postoperative scar vs. recurrent disease the key concern is whether the negative predictive value for PET is sufficiently high to influence decision making, specifically to avoid tissue biopsy when the PET scan is negative. The available studies suggest a probability of false negative results of 8%, making it unlikely that patients and physicians would be willing to forgo histologic sampling and delay potentially curative repeat resection. Pancreatic - A 1999 TEC Assessment concluded that the level of diagnostic performance of PET to distinguish between benign or malignant pancreatic masses or as a staging technique for pancreatic cancer is not adequate enough to recommend against biopsy. Head And Neck - A 2000 TEC Assessment concluded that when compared with other imaging modalities, the pooled data from a variety of studies suggested that PET had a better diagnostic performance compared to CT and MRI for the covered indications. Esophageal 2002 TEC Assessment states evidence is lacking on PET s use to differentiate between esophageal cancer and benign conditions. The available evidence on locoregional lymph nodes was considered inadequate to support conclusion about this application of PET scanning. While studies of detection of distant disease suggest better diagnostic performance for PET over CT, the available body of evidence is small. Only one study clearly avoided verification bias, only one clearly interpreted PET blind to the reference standard, and none clearly interpreted the reference standard blind to PET. Regarding evaluation of treatment response, only 1 small study was identified. While PET found evidence of response not shown on CT, these data are insufficient to permit conclusions regarding the value of PET in evaluation response to treatment. Ovarian For primary evaluation the ability to rule out

6 malignancy with a high negative predictive value would change management by avoiding unnecessary exploratory surgery. However, available studies suggest that PET scanning has poorer negative predictive value compared to other options, including transvaginal ultrasound, doppler studies, or MRI. Adding PET scanning to transvaginal ultrasound (TRUS) or MRI did not improve results. Positive predictive value is of greatest importance in evaluating patient with known ovarian cancer, either to detect disease recurrence or progression or monitor response to treatment. There was insufficient evidence to permit scientific conclusions regarding this application. Breast 2001 TEC Assessment focused on multiple applications of PET scanning in breast cancer, including characterization of breast lesions, staging axillary lymph nodes, detection of recurrence, and evaluating response to treatment. Most of the data regarding PET scanning for breast cancer focuses on its use as a technique to further characterize breast lesions such that patients could avoid biopsy of a mammographically indeterminate or low suspicion lesion. The key statistic in this analysis is the false negative rate, which may range from 5.5% to 8.5%. Given the ease of breast biopsy, this false negative rate may be considered unacceptable, and thus patients may undergo biopsy regardless of the results of a PET scan. For most all other applications there was inadequate data regarding how the use of PET scans may be used to benefit health outcomes, primarily due to the lack of data regarding diagnostic performance in the different settings. NOTE: HCSC is aware of Medicare s recent coverage determination regarding PET imaging of breast cancer and after review have determined to follow our outlined position as stated in the coverage section of this policy (see grid regarding oncologic applications of PET). Unknown Primary - The 2002 TEC Assessment concluded that the TEC criteria were met for the limited indication of the work up and management of patients with unknown primaries and a single site of metastatic disease. Specifically, local or regional therapy may be offered to these patients. In this setting PET scanning may be used to verify the absence of disseminated disease. The use of PET can contribute to optimal decision-making regarding the appropriateness of local or regional therapy. Cardiac Applications:

7 Myocardial Perfusion In patients with symptoms suggestive of CAD, a central clinical issue is to determine whether a coronary angiogram is necessary for further work-up. A variety of non-invasive imaging tests, including PET (using rubidium-82) and SPECT scans, have been investigated as a means of identifying reversible perfusion defects, which may reflect coronary artery disease, and thus identify patients who may benefit from further work-up with an angiogram. The ACC/AHA guidelines on radionuclide imaging note that compared to SPECT scans, PET scans have demonstrated statistically significantly higher diagnostic accuracy for detecting angiographically documented CAD. However, the guidelines describe technical difficulties and referral biases that may have negatively impacted the diagnostic accuracy of SPECT scans. The guidelines further state, PET is an expensive imaging modality, and whether the greater cost of PET is justified by a possible improvement in diagnostic accuracy requires further rigorous study. Thus, until data from large-scale, definitive studies are published, PET is considered an effective modality for the noninvasive diagnosis of CAD. Myocardial Viability PET has perhaps been most thoroughly researched as a technique to assess myocardial viability to determine candidacy for a coronary revascularization procedure. For example, a patient with a severe stenosis identified by coronary angiography may not benefit from revascularization if the surrounding myocardium is non-viable. A fixed perfusion defect, as imaged on SPECT scanning or stress thallium echocardiography, may suggest non-viable myocardium. However a PET scan may reveal metabolically active myocardium, suggesting areas of hibernating myocardium that would indeed benefit from revascularization. The ultimate clinical validation of this diagnostic test is the percentage of patients who experience improvement in left ventricular dysfunction after revascularization of hibernating myocardium, as identified by PET scanning. The American College of Cardiology (ACC) and the American Heart Association (AHA) have jointly published guidelines for the clinical use of cardiac radionuclide imaging, including PET scans. The guidelines report that, overall, PET scanning for myocardial viability is associated with positive and negative predictive accuracy s of 85% in identifying regions that are associated with clinical improvement after revascularization. PRICING:

8 None REFERENCES: BCBSA TEC Evaluations: Positron Emission Tomography, July 1989, pages Positron Emission Tomography of the Heart, June 1991, pages Positron Emission Tomography (PET) of Central Nervous System Diseases, April 1992, pages Positron Emission Tomography for Assessment of Myocardial Viability, Volume 9, No.29, October 1994, pages Positron Emission Tomography for the Diagnosis of Cardiomyopathy, Volume 9, No. 30, October 1994, pages FDG Positron Emission Tomography for Non-CNS, Volume 10, No. 20, October 1995, pages PET Myocardial Perfusion Imaging for the Detection of Coronary Artery Disease - Clinical Assessment, Volume 10, No. 21, October 1995, pages PET, SPECT, or MRS in the Differential Diagnosis of Dementias, Volume 10, No. 29, April 1996, pages PET or SPECT in the Management of Seizure Disorders, Volume 11, No. 33, March 1997, pages PET or SPECT in the Diagnosis and Management of Brain Tumors, Volume 11, No. 34, March 1997, pages PET or SPECT for the Assessment of Cerebrovascular Disease, Volume 11, No. 35, March 1997, pages FDG Positron Emission Tomography for Non-CNS s, Volume 12, No. 3, May 1997, pages PET Myocardial Perfusion Imaging for the Detection of Coronary Artery Disease - Cost Effectiveness Analysis, Special Assessment, 1998, pages FDG Positron Emission Tomography In Colorectal CA, Volume 14, No. 25, 4/2000. FDG Positron Emission Tomography In Lymphoma, Volume 14, No. 26, 4/2000. FDG Positron Emission Tomography In Melanoma, Volume 14, No. 27, 4/2000. FDG Positron Emission Tomography In Pancreatic, Volume 14, No. 28. FDG Positron Emission Tomography In Head and Neck, Volume 15, No. 4, 6/2000. FDG Positron Emission Tomography for Evaluating Breast,

9 Volume 16, No. 5, 8/2001 FDG Positron Emission Tomography for Evaluating Esophageal, Volume 16, No. 21, 4/2002 FDG Positron Emission Tomography (PET) For the Detection of Ovarian. 6/2002 FDG Positron Emission Tomography to Manage Patients with an Occult Primary Carcinoma and Metastasis Out6side the Cervical Lymph Nodes, 6/2002 FDA Internet Bulletin Board (on-line), 02/98, "The History and Evolution of PET, How PET Works, The Cyclotron and PET, Selected PET Resources on the Internet." DISCLAIMER: State and federal law, as well as contract language, including definitions and specific inclusions/exclusions, takes precedence over Medical Policy and must be considered first in determining coverage. The member s contract benefits in effect on the date that services are rendered must be used. Any benefits are subject to the payment of premiums for the date on which services are rendered. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. HMO Blue Texas physicians who are contracted/affiliated with a capitated IPA/medical group must contact the IPA/medical group for information regarding HMO claims/reimbursement information and other general polices and procedures.