POSITRON EMISSION TOMOGRAPHY (PET) & COMBINED PET/CT SCANS

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1 POSITRON EMISSION TOMOGRAPHY (PET) & COMBINED PET/CT SCANS Protocol: RAD023 Effective Date: November 1, 2017 Table of Contents Page COMMERCIAL & MEDICAID COVERAGE RATIONALE... 1 MEDICARE COVERAGE RATIONALE BACKGROUND U.S. FOOD AND DRUG ADMINISTRATION (FDA) APPLICABLE CODES REFERENCES PROTOCOL HISTORY/REVISION INFORMATION INSTRUCTIONS FOR USE This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding coverage, the enrollee specific document must be referenced. The terms of an enrollee's document (e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this Protocol. Other Protocols, Policies and Coverage Determination Guidelines may apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute medical advice. This policy does not govern Medicare Group Retiree members. UnitedHealthcare may also use tools developed by third parties, such as the MCG Care Guidelines, to assist us in administering health benefits. The MCG Care Guidelines are intended to be used in connection with the independent professional medical judgment of a qualified health care provider and do not constitute the practice of medicine or medical advice. COMMERCIAL & MEDICAID COVERAGE RATIONALE PET and PET/CT for Oncology Indications: PET or PET/CT is not medically necessary for a diagnosis of prostate cancer the initial diagnosis of male or female breast cancer the evaluation of axillary nodes in members with a diagnosis of breast cancer the evaluation of regional lymph nodes in members with a diagnosis of melanoma members who have an established diagnosis of a solid tumor but who are asymptomatic with no signs or symptoms of disease and are not currently in treatment. Positron Emission Tomography (PET) & Combined PET/CT Scans Page 1 of 19

2 PET or PET/CT may be medically necessary for members with a very strong suspicion of a solid tumor based on standard imaging (must have results of these tests) - one time only initial and subsequent evaluation of members with documented diagnosis of myeloma a member with known diagnosis of malignancy to determine the optimal anatomic site for biopsy or other invasive diagnostic procedure I. Breast carcinoma (Must have a proven histologic diagnosis of breast cancer) [One of the following] A. Initial staging for breast cancer stage IIIA or higher when conventional imaging is equivocal B. Restaging after completion of therapy in a member with known metastases C. There is insufficient evidence for PET in breast cancer for: 1. Establishing the diagnosis of breast cancer or to detect the primary lesion 2. Staging of clinical stage I, IIA-B breast cancer 3. Clarify a finding on mammography, physical examination, MRI or ultrasound 4. Evaluate axillary nodes 5. Routine surveillance of patients with personal history of breast cancer II. Thyroid carcinoma [One of the following] A. Indicated for staging and restaging in patients with both negative I and/ or thallium scans (whole body) and a histologic diagnosis of follicular, papillary or Hürthle cell thyroid cancer who have been treated with thyroidectomy and radioiodine ablation and [One of the following] 1. Thyroglobulin level detectable on hormone replacement therapy or 2. Thyroglobulin 2ng/mL after Thyrogen stimulation B. Surveillance imaging in a stable asymptomatic individual with no change in signs, symptoms or laboratory results such as thyroglobulin level is not indicated C. Suspected recurrence with [One of the following] 1. Negative I or Th scan or 2. Stimulated thyroglobulin >2 ng/ml D. Initial staging of anaplastic thyroid cancer E. Not indicated prior to thyroidectomy III. Head and neck cancers, excluding thyroid cancer [One of the following] A. Evaluation of patient with metastatic cervical lymph node(s) to establish primary site B. Initial staging of patient with pathologically documented primary head and neck cancer stage III-IV C. Mucosal melanoma initial staging D. Restaging after completion of treatment [One of the following] 1. Radiation therapy no sooner than 12 weeks after completion of treatment (if done too soon may give false positive result) 2. Surgery no sooner than 6 weeks after surgery 3. Chemotherapy no sooner than 1-2 weeks after completion Positron Emission Tomography (PET) & Combined PET/CT Scans Page 2 of 19

3 4. Evaluation for possible recurrence based on physical examination or conventional imaging E. Monitor response to therapy only if a change in therapy is anticipated F. Symptomatic member with new signs or symptoms of disease G. Not indicated for surveillance of an asymptomatic individual who is currently not in treatment and has no signs, symptoms or laboratory tests suggesting recurrence of disease H. Needle biopsy with squamous cell carcinoma, adenocarcinoma or anaplastic epithelial cancer with no known primary, PET should be performed prior to surgical biopsy if the primary is not found on other imaging (CT, MRI, US) IV. Solitary pulmonary nodule by CT Multiple nodules are not covered by these criteria unless one is significantly larger than the others or is new since a prior chest x-ray. Such a lesion should be treated as a solitary nodule. A. Solid nodule 1cm V. Lung carcinoma (Must have a histologic diagnosis of lung cancer) [One of the following] A. Initial staging of non-small cell lung cancer (NSCLC) (after tissue diagnosis is established) B. Restaging after chemotherapy or radiation therapy or chemoradiation is completed 1. No sooner than 12 weeks after completion of radiation therapy unless there is a change in clinical or imaging findings suggestive of recurrence or progression C. PET is not to be used for surveillance imaging of non-small cell lung cancer or neuroendocrine tumors of the lung unless there is documented evidence of rising tumor markers or new symptoms D. Initial staging of pathologically documented high grade/large cell neuroendocrine tumors of the lung E. Not indicated for surveillance of an asymptomatic individual who is currently not in treatment and has no signs, symptoms or laboratory tests suggesting recurrence of disease symptoms F. PET is not recommended for routine staging of bronchoalveolar cell cancer G. Small-cell lung cancer [One of the following] 1. Initial staging if limited stage is suspected 2. PET/CT is not recommended for routine follow-up or restaging 3. Radiation treatment planning H. Pancoast tumor considered for curative resection VI. Colorectal carcinoma (including rectal and anal cancer) (Must have a histologic diagnosis of colorectal cancer) [One of the following] The routine use of PET or PET/CT is not recommended for the diagnosis and staging of clinical state I-III colorectal cancer. It is recommended for staging and prognosis if conventional imaging (CT, MRI) is equivocal for metastases. It should be used to evaluate individuals in whom there is metastatic disease and surgical resection for cure is planned. Positron Emission Tomography (PET) & Combined PET/CT Scans Page 3 of 19

4 Not indicated for surveillance of an asymptomatic individual who is currently not in treatment and has no signs, symptoms or laboratory tests suggesting recurrence of disease VII. A. Colon and rectal cancer 1. Initial staging (after tissue diagnosis is established) a. Standard imaging (CT and/or MRI) is equivocal b. Metastatic disease and surgery with curative intent is planned c. Not indicated if there is clearly unresectable metastatic disease 2. Proven or suspected metastatic disease (any T and N, M1) a. Initial staging if potentially surgically (or using ablative techniques) curable M1 disease only 3. Suspected recurrence a. Serial rising CEA if CT or MRI fails to identify the site 4. PET or PET/CT should not be used to monitor response to chemotherapy. Contrast-enhanced CT or MRI should be used for this purpose. 5. Documented metachronous metastases by CT, MRI, or biopsy that are resectable B. Anal canal cancer 1. Initial staging for T3-4, N0 2. Initial staging of and T N+ 3. Radiation treatment planning C. Anal margin cancer 1. Initial staging for T2-4, N0 2. Initial staging for any T, N+ 3. Radiation treatment planning Lymphoma/Hodgkin's Disease and non-hodgkin s lymphoma [One of the following] A. Initial staging (usually after tissue diagnosis is established) in addition to standard imaging B. Restaging (establish new baseline) after therapy is completed (Chemotherapy or radiation therapy) one time only unless there are signs or symptoms of recurrence including findings on surveillance CT C. May be indicated during chemotherapy as appropriate as soon as completion of 2 cycles of chemotherapy or after 3 months following completion of radiation therapy D. Diffuse Large B Cell Lymphoma stage I and II [One of the following] 1. At end of induction chemoimmunotherapy and prior to radiation therapy if PET was positive before chemotherapy 2. If PET remains positive before radiation (D1 above) then PET is repeated after completion of radiation Positron Emission Tomography (PET) & Combined PET/CT Scans Page 4 of 19

5 E. Surveillance PET is not medically necessary in a beneficiary with no signs or symptoms of disease. Follow up in an individual with no signs or symptoms of disease should be with CT scans after 1 PET/CT at the completion of therapy F. PET may be used for suspicion of progression of CLL or SLL for transformation to follicular lymphoma (Richter s transformation) to determine biopsy site VIII. Esophageal carcinoma [One of the following] A. Initial staging of known esophageal cancer if no evidence of metastatic disease on standard imaging B. Restaging after preoperative chemoradiation C. Restaging after definitive chemoradiation D. Reevaluation for suspected recurrence in a symptomatic individual with new signs or symptoms of disease 1. Changed findings on endoscopy or imaging 2. Inability to perform endoscopy 3. Lymphadenopathy 4. Dysphagia E. PET is not indicated for surveillance imaging during remission in an asymptomatic beneficiary with no signs or symptoms of disease IX. Cervical carcinoma (must have a histologic diagnosis of cervical cancer) [One of the following] A. Initial staging with documented tissue diagnosis B. Restaging after surgical staging if there are positive para-aortic nodes C. Evaluate for recurrence in an individual with new signs and symptoms D. PET is not indicated for surveillance imaging during remission in an asymptomatic member with no signs or symptoms of disease E. Radiation treatment planning F. Incidental finding of invasive cancer after simple hysterectomy for > stage IB1 X. Ovarian carcinoma [one of the following] A. Not medically necessary for initial staging B. Monitor and follow up after surgery with or without chemotherapy C. Evaluation of recurrence [one of the following] 1. Elevated tumor markers a. CA125 > 35U/mL 2. Change in physical examination or clinical condition D. PET is not indicated for surveillance imaging during remission in an asymptomatic member with no signs or symptoms of disease. XI. Gastric carcinoma (Must have a histologic diagnosis of gastric cancer) [One of the following] A. Initial staging prior to surgery if prior standard (CT, MRI, NM) imaging shows no evidence of M1 disease on CT and/or MRI Positron Emission Tomography (PET) & Combined PET/CT Scans Page 5 of 19

6 XII. XIII. XIV. XV. B. Restaging after completion of chemotherapy or chemoradiation treatment to determine resectability C. Not for routine surveillance imaging in an asymptomatic individual with no clinical or laboratory evidence of disease Testicular carcinoma (seminoma) [one of the following] A. Pure seminoma after primary treatment [one of the following] 1. Residual mass on CT which is > 3cm with normal tumor markers (wait 6 weeks after completion of chemotherapy) 2. Rising tumor markers [one of the following] a. Beta HCG b. Alpha fetoprotein 3. No residual mass a. Persistently elevated Beta HCG which may not be rising 4. PET is not indicated for surveillance imaging during remission in an asymptomatic member with no signs or symptoms of disease. Soft tissue sarcoma (Must have a histologic diagnosis of intermediate or high grade soft tissue sarcoma) [One of the following] A. Extremity/trunk, head and neck (including but not limited to Ewing's sarcoma, Desmoid tumors or aggressive fibromatosis, Rhabdomyosarcoma, liposarcoma, alveolar small part sarcoma, clear cell sarcoma, fibrosarcoma, histiocytoma, epithelioid sarcoma, extrarenal rhabdoid tumor, leiomyosarcoma, synovial sarcoma, and more) B. Initial staging 1. Lesions larger than 3 cm, firm and deep and histologically high grade C. GIST 1. Initial staging if resectable with negative margins on standard imaging weeks after initiation of therapy with imatinib to look for efficacy of treatment 3. Routine follow up with PET is rarely needed D. PET is not indicated for surveillance imaging during remission in an asymptomatic beneficiary with no signs or symptoms of disease Multiple myeloma (Must have a histologic diagnosis of myeloma or solitary plasmacytoma; or 78816) [One of the following] A. Initial staging B. Restaging after completion of therapy C. Follow up/surveillance as clinically indicated D. May be used following bone marrow transplant Melanoma must have tissue diagnosis (78813 or are preferred) [one of the following] A. Initial staging for stages IA, IB, II only to evaluate specific signs and symptoms Positron Emission Tomography (PET) & Combined PET/CT Scans Page 6 of 19

7 XVI. XVII. XVIII. B. Initial staging of clinical stage III with positive sentinel node or clinically positive node(s) C. Initial staging of clinical stage III in-transit D. Initial staging clinical stage IV E. NOT PERMITTED FOR EVALUATION OF REGIONAL NODES F. Follow up stage IIB-IV with no evidence of disease 1. Every 4-12 months for 5 years 2. Monitoring response to therapy when a change is anticipated 3. Not for surveillance in asymptomatic individual with stage 0-IIA disease G. Stage IIB-IV every 6-12 months for 5 years and if negative at 5 years no further imaging Thymoma (must have a mediastinal mass) [One of the following] A. Initial staging B. Not allowed for surveillance (CT) Bone cancer including Chordoma, Ewing's sarcoma, osteogenic sarcoma, (Must have a histologic diagnosis of either Ewing s sarcoma or osteogenic sarcoma or chordoma) [One of the following] A. Ewing's sarcoma [One of the following] 1. Initial staging 2. Restage after completion of multi agent chemotherapy 3. Restage after radiation therapy if stable after primary treatment 4. Progressive disease after primary treatment PET is not indicated B. Osteogenic sarcoma or osteosarcoma [One of the following] 1. Initial staging 2. Restaging a. High grade osteosarcoma which is intramedullary and surface following preoperative chemotherapy 3. Surveillance [One of the following] a. Every 3 months for 2 years b. Every 4 months for year 3 c. Every 6 months for years 4 and 5 d. Annually after year 5 C. Chordoma 1. Initial staging Initial staging of an occult cancer with histologic proof of malignancy Occult primary with standard imaging (CT, MRI, nuclear scans) showing a single site of metastasis if therapy with curative intent is planned Brain PET Metabolic Amyvid imaging for dementia is considered to be investigational and/or experimental. Positron Emission Tomography (PET) & Combined PET/CT Scans Page 7 of 19

8 Vizamyl (flutemetamol F18) imaging for Alzheimer's disease is considered investigational and/or experimental. I. Primary brain tumor1 [One of the following] A. Pre-operative study tumor resection with margins not defined on MRI or CT B. Post treatment determination of viable tumor versus radiation necrosis II. Movement disorder (MRI) [One of the following] A. Suspected Huntington s chorea with a non-diagnostic MRI and genetic testing is inconclusive [One of the following] 1. Irregular lurching gait 2. Speech disturbance 3. Positive family history B. Progressive ataxia of undetermined etiology III. Seizure5 (MRI) [All of the following] A. Seizures not responsive to adequate dosage of medications B. Surgery is planned C. MRI does not define a seizure focus PET Myocardial Metabolic and are also referred to as a rubidium study stress test. I. Non-diagnostic nuclear or echo stress testing A. Cardiac catheterization is not planned AND B. Any of the following results were present on the nuclear or echo stress testing 1. Normal treadmill electrocardiogram with reversible perfusion abnormality 2. Equivocal 3. Positive treadmill electrocardiogram with normal imaging 4. Technically uninterpretable II. Evaluation prior to non-cardiac surgery [One of the following] A. With current cardiac symptoms 1. Prior documentation of coronary artery disease see section III 2. No prior documentation of coronary artery disease see section IV B. Without current cardiac symptoms 1. Intermediate or high risk non-cardiac surgery [One of the following] a. Inability to reach four mets on treadmill exercise stress testing b.if able to reach four mets on treadmill exercise stress testing, one of the following must be documented [One of the following] i. Creatinine 2.0 or greater ii. Diabetes iii. Congestive heart failure iv. Known coronary artery disease III. Evaluation of known coronary artery disease or equivalent (one of the following) A. Recent hospitalization for acute myocardial infarction, acute coronary syndrome, or unstable angina 1. No cardiac catheterization, imaging stress test or cardiac CT angiogram during or since the hospitalization Positron Emission Tomography (PET) & Combined PET/CT Scans Page 8 of 19

9 2. Recurrent chest pain or shortness of breath since discharge 3. Percutaneous coronary intervention or coronary artery bypass surgery during the hospitalization [One of the following] a. No nuclear or echo stress test was performed since the revascularization b.a nuclear or echo stress test was performed, but new chest pain or shortness of breath has developed since that study B. No recent hospitalization for acute myocardial infarction, acute coronary syndrome, or unstable angina [One of the following] 1. New chest pain or shortness of breath 2. No new chest pain or shortness of breath [One of the following] a. Coronary artery bypass surgery or percutaneous coronary intervention was performed in the last two years and no imaging stress test has been performed after the revascularization b.no coronary artery bypass surgery or percutaneous coronary intervention was performed in the last two years and documentation of a prior abnormal imaging stress test, cardiac catheterization, cardiac CT angiogram, percutaneous coronary intervention or bypass surgery, carotid stenosis or stroke, peripheral artery disease, aortic aneurysm, diabetes, or coronary calcification on CT scan [One of the following] i. No cardiac catheterization, cardiac CT angiogram, or imaging stress test was performed in the past ii. Cardiac catheterization, cardiac CT angiogram, or imaging stress test was performed two or more years ago c. Prior documentation of congenital coronary arterial anomalies by cardiac catheterization or cardiac CT angiography and no imaging stress test has been performed since those studies C. Assessment of myocardial viability prior to coronary revascularization 1. Documentation of regional left ventricular dysfunction and a nuclear stress test showing a fixed defect in the same region as the demonstrated left ventricular dysfunction and in the same region under consideration for a revascularization procedure IV. Evaluation of newly diagnosed congestive heart failure A. No heart catheterization, imaging stress test or cardiac CT angiogram was performed since the diagnosis of congestive heart failure. V. Evaluation of newly diagnosed cardiomyopathy A. The ejection fraction is less than 50 percent and no heart catheterization, imaging stress test or cardiac CT angiogram was performed since the new diagnosis of cardiomyopathy B. Known or suspected sarcoidosis if MRI is contraindicated VI. Evaluation of suspected coronary artery disease symptoms [One of the following] A. Evaluation of documented ventricular tachycardia B. Evaluation of chest pain equivalent [One of the following] 1. Pre-test probability assessment high risk 2. Pre-test probability assessment low or intermediate risk a. Pharmacological stress test (Medicare only) b.pharmacological stress test (Commercial) [One of the following] i. Inability to attain four mets on treadmill testing ii. Inability to attain 85% of the maximal predicted heart rate Positron Emission Tomography (PET) & Combined PET/CT Scans Page 9 of 19

10 iii. Inability to exercise due to orthopedic or neurologic condition c. Electrocardiogram demonstrates Wolff-Parkinson-White syndrome, complete left bundle branch block, ventricular-paced rhythm, or 1 mm or more ST-J depression with horizontal or downsloping ST segments for 80 msec after the J point d.currently taking digoxin/lanoxin e. Routine exercise stress test documents [One of the following] i. 1 mm or more ST-J depression with horizontal or downsloping ST segments for 80 msec after the J point ii. Ventricular tachycardia, multifocal premature ventricular contractions or triplets iii. Heart block iv. Drop in systolic blood pressure of 10 mmhg or more v. Inability to attain 85% of the maximum predicted heart rate vi. Chest pain C. Evaluation of syncope [One of the following] 1. Diabetes 2. ATP* risk calculation 10% or more and no imaging stress test has been performed in the last two years VII. Asymptomatic screening for coronary artery disease [One of the following] A. Assessment based on coronary risk factors [One of the following] 1. Diabetes and no imaging stress test in the last two years 2. ATP* III risk calculation 20% or more and no imaging stress test in the last two years B. Assessment based on uninterpretable electrocardiogram (Wolff-Parkinson-White syndrome, complete left bundle branch block, ventricular paced rhythm, or 1 mm or more ST-J depression with horizontal or downsloping ST segments for 80 msec after the J point) [One of the following] 1. New electrocardiographic finding 2. Chronic electrocardiographic finding a. No imaging stress test has been performed in two years C. Assessment based on abnormal calcium score [One of the following] 1. Calcium score a. Diabetes and no imaging stress test in the last two years b.atp* risk calculation 20% or more and no imaging stress test in the last two years 2. Calcium score over 400 a. No imaging stress test in the last two years D. Assessment based on elevated troponin 1. The elevated Troponin documented less than four weeks ago and no imaging stress test, cardiac CT angiogram, or catheterization has been performed within the last four weeks E. Assessment based on abnormal routine exercise stress test (see VI.B.2.e for definition) *The following link provides an on-line ATP risk calculator: Positron Emission Tomography (PET) & Combined PET/CT Scans Page 10 of 19

11 MEDICARE COVERAGE RATIONALE Medicare has multiple National Coverage Determinations for Positron Emission Tomography (PET) Scans (see below), all accessed October Please refer to the Medicare National Coverage Determinations Manual, Chapter 1, Part 4 (Sections ) for a complete listing of coverage. There is no National Coverage Determination for PET-CT Scans. There are no Local Coverage Determinations for either PET or PET-CT scans (accessed October 2017). NCD FDG Positron Emission Tomography (FDG PET) for Oncologic Conditions Initial Anti-Tumor Treatment Strategy CMS continues to believe that the evidence is adequate to determine that the results of FDG PET imaging are useful in determining the appropriate initial anti-tumor treatment strategy for beneficiaries with suspected cancer and improve health outcomes and thus are reasonable and necessary under 1862(a)(1)(A) of the Social Security Act (the Act). Therefore, CMS continues to nationally cover one FDG PET study for beneficiaries who have cancers that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary s treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial anti-tumor treatment strategy: To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or To determine the optimal anatomic location for an invasive procedure; or To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor. See the below table synopsis of all nationally covered and non-covered oncologic uses of FDG PET imaging. Additional details are available in the NCD that are not included in this protocol due to length. FDG PET for Cancers Tumor Type Initial Treatment Strategy (formerly diagnosis & staging Colorectal Cover Cover Esophagus Cover Cover Head and Neck (not thyroid, Cover Cover CNS) Lymphoma Cover Cover Non-small cell lung Cover Cover Ovary Cover Cover Brain Cover Cover Cervix Cover with exceptions * Cover Small cell lung Cover Cover Soft tissue sarcoma Cover Cover Pancreas Cover Cover Testes Cover Cover Subsequent Treatment Strategy (formerly restaging & monitoring response to treatment Positron Emission Tomography (PET) & Combined PET/CT Scans Page 11 of 19

12 FDG PET for Cancers Tumor Type Initial Treatment Strategy (formerly diagnosis & staging Prostate Non-cover Cover Thyroid Cover Cover Breast (male and female) Cover with exceptions * Cover Melanoma Cover with exceptions * Cover All other solid tumors Cover Cover Myeloma Cover Cover All other cancers not listed Cover Cover Subsequent Treatment Strategy (formerly restaging & monitoring response to treatment *Cervix: Nationally non-covered for the initial diagnosis of cervical cancer related to initial antitumor treatment strategy. All other indications for initial anti-tumor treatment strategy for cervical cancer are nationally covered. *Breast: Nationally non-covered for initial diagnosis and/or staging of axillary lymph nodes. Nationally covered for initial staging of metastatic disease. All other indications for initial anti-tumor treatment strategy for breast cancer are nationally covered. *Melanoma: Nationally non-covered for initial staging of regional lymph nodes. All other indications for initial anti-tumor treatment strategy for melanoma are nationally covered. Please see NCD for any additional details on any of the items listed in the above chart. PET for Perfusion of the Heart (NCD ) Rubidium 82 PET scans performed at rest or with pharmacological stress used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease using the FDA-approved radiopharmaceutical Rubidium 82 (Rb 82) or Ammonia N-13 are covered, provided the requirements below are met: The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a single photon emission computed tomography (SPECT); or The PET scan, whether at rest alone or rest with stress, is used following a SPECT that was found to be inconclusive. In these cases, the PET scan must have been considered necessary in order to determine what medical or surgical intervention is required to treat the patient. (For purposes of this requirement, an inconclusive test is a test(s) whose results are equivocal, technically uninterpretable, or discordant with a patient's other clinical data and must be documented in the beneficiary's file.) Ammonia N-13 PET scans performed at rest or with pharmacological stress used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease using the FDA-approved radiopharmaceutical ammonia N-13 are covered, provided the requirements below are met: Positron Emission Tomography (PET) & Combined PET/CT Scans Page 12 of 19

13 The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a SPECT; or The PET scan, whether at rest alone or rest with stress, is used following a SPECT that was found to be inconclusive. In these cases, the PET scan must have been considered necessary in order to determine what medical or surgical intervention is required to treat the patient. (For purposes of this requirement, an inconclusive test is a test whose results are equivocal, technically uninterpretable, or discordant with a patient's other clinical data and must be documented in the beneficiary's file.) PET for Myocardial Viability (NCD ) Indications and Limitations of Coverage Medicare covers FDG PET for the determination of myocardial viability as a primary or initial diagnostic study prior to revascularization, or following an inconclusive SPECT. Studies performed by full and partial ring scanners are covered. Limitations: In the event a patient receives a SPECT test with inconclusive results, a PET scan may be covered. However, if a patient receives a FDG PET study with inconclusive results, a follow up SPECT test is not covered. FDG PET for Dementia and Neurodegenerative Diseases (NCD ) Nationally Covered Indications An FDG PET scan is considered reasonable and necessary in patients with a recent diagnosis of dementia and documented cognitive decline of at least 6 months, who meet diagnostic criteria for both Alzheimer s Disease (AD) and Fronto-temporal Dementia (FTD). These patients have been evaluated for specific alternate neurodegenerative diseases or other causative factors, but the cause of the clinical symptoms remains uncertain. The following additional conditions must be met before an FDG PET scan will be covered: a. The patient s onset, clinical presentation, or course of cognitive impairment is such that FTD is suspected as an alternative neurodegenerative cause of the cognitive decline. Specifically, symptoms such as social disinhibition, awkwardness, difficulties with language, or loss of executive function are more prominent early in the course of FTD than the memory loss typical of AD; and b. The patient has had a comprehensive clinical evaluation (as defined by the American Academy of Neurology (AAN)) encompassing a medical history from the patient and a well-acquainted informant (including assessment of activities of daily living), physical and mental status examination (including formal documentation of cognitive decline occurring over at least 6 months) aided by cognitive scales or neuropsychological testing, laboratory tests, and structural imaging such as magnetic resonance imaging (MRI) or computed tomography (CT); and c. The evaluation of the patient has been conducted by a physician experienced in the diagnosis and assessment of dementia; and d. The evaluation of the patient did not clearly determine a specific neurodegenerative disease or other cause for the clinical symptoms, and information available through FDG PET is reasonably expected to help clarify the diagnosis between FTD and AD and help guide future treatment; and Positron Emission Tomography (PET) & Combined PET/CT Scans Page 13 of 19

14 e. The FDG PET scan is performed in a facility that has all the accreditation necessary to operate nuclear medicine equipment. The reading of the scan should be done by an expert in nuclear medicine, radiology, neurology, or psychiatry, with experience interpreting such scans in the presence of dementia; and f. A brain single photon emission computed tomography (SPECT) or FDG PET scan has not been obtained for the same indication. (The indication can be considered to be different in patients who exhibit important changes in scope or severity of cognitive decline, and meet all other qualifying criteria listed above and below (including the judgment that the likely diagnosis remains uncertain). The results of a prior SPECT or FDG PET scan must have been inconclusive or, in the case of SPECT, difficult to interpret due to immature or inadequate technology. In these instances, an FDG PET scan may be covered after one year has passed from the time the first SPECT or FDG PET scan was performed.); and g. The referring and billing provider(s) have documented the appropriate evaluation of the Medicare beneficiary. Providers should establish the medical necessity of an FDG PET scan by ensuring that the following information has been collected and is maintained in the beneficiary medical record: 1. Date of onset of symptoms; 2. Diagnosis of clinical syndrome (normal aging; mild cognitive impairment (MCI); mild, moderate or severe dementia); 3. Mini mental status exam (MMSE) or similar test score; 4. Presumptive cause (possible, probable, uncertain AD); 5. Any neuropsychological testing performed; 6. Results of any structural imaging (MRI or CT) performed; 7. Relevant laboratory tests (B12, thyroid hormone); and, 8. Number and name of prescribed medications. FDG PET Requirements for Coverage in the Context of a CMS-approved Practical Clinical Trial Utilizing a Specific Protocol to Demonstrate the Utility of FDG PET in the Diagnosis, and Treatment of Neurodegenerative Dementing Diseases. An FDG PET scan is considered reasonable and necessary in patients with MCI or early dementia (in clinical circumstances other than those specified above) only in the context of an approved clinical trial that contains patient safeguards and protections to ensure proper administration, use and evaluation of the FDG PET scan. The clinical trial must compare patients who do and do not receive an FDG PET scan and have as its goal to monitor, evaluate, and improve clinical outcomes. In addition, it must meet the following basic criteria: a. Written protocol on file; b. Institutional Review Board review and approval; c. Scientific review and approval by two or more qualified individuals who are not part of the research team; and, d. Certification that investigators have not been disqualified. Nationally Non-Covered Indications All other uses of FDG PET for patients with a presumptive diagnosis of dementia-causing neurodegenerative disease (e.g., possible or probable AD, clinically typical FTD, dementia of Lewy bodies, or Creutzfeld-Jacob disease) for which CMS has not specifically indicated coverage continue to be noncovered. Positron Emission Tomography (PET) & Combined PET/CT Scans Page 14 of 19

15 FDG PET for Infection and Inflammation (NCD ), General The Centers for Medicare & Medicaid Services (CMS) received a formal, complete request to reconsider the current, de facto non-coverage for FDG PET imaging for the following off-label uses, each in lieu of bone, leukocyte, and/or gallium scintigraphy: 1. Suspected chronic osteomyelitis in patients with: (a) previously documented osteomyelitis with suspected recurrence, or, (b) symptoms of osteomyelitis for more than 6 weeks (including diabetic foot ulcers), 2. Investigation of patients with suspected infection of hip prosthesis, and, 3. Fever of unknown origin in patients with a febrile illness of >3 weeks duration, a temperature of >38.3 degrees Centigrade on at least two occasions, and uncertain diagnosis after a thorough history, physical examination, and one week of proper investigation. Nationally Non-Covered Indications The CMS is continuing its national non-coverage of FDG PET for the requested indications. Based upon our review, CMS has determined that the evidence is inadequate to conclude that FDG PET for chronic osteomyelitis, infection of hip arthroplasty, and fever of unknown origin improves health outcomes in the Medicare populations, and therefore has determined that FDG PET for chronic osteomyelitis, infection of hip arthroplasty, and fever of unknown origin is not reasonable and necessary under section 1862(a)(1)(A) of the Social Security Act. FDG PET for Refractory Seizures (NCD ) Medicare covers FDG-PET for pre-surgical evaluation for the purpose of localization of a focus of refractory seizure activity. Limitations: Covered only for pre-surgical evaluation. For Medicare and Medicaid Service Determination Related to States Outside of Nevada: Please review Local Coverage Determinations that apply to other states outside of Nevada. Important Note: Please also review local carrier Web sites in addition to the Medicare Coverage database on the Centers for Medicare and Medicaid Service s Website. BACKGROUND Positron emission tomography (PET) is an imaging technique that provides data on biochemical and physiological activity. To measure such activity, a positron-emitting radionuclide is incorporated into an organic molecule or compound to form the appropriate radiotracer. After administering the radiotracer, its concentration in tissues and organs is imaged by a PET scanner and constructed into a three-dimensional image by a computer. By comparing the radiotracer concentration in target areas with that expected or imaged in normal tissue, it is possible to determine whether the imaged function is normal or abnormal. The value of PET for oncologic imaging primarily is based on the increased rate in malignant tissue of some metabolic processes, particularly glucose metabolism, which can be measured by PET with the radiotracer fluorine-18-labeled fluorodeoxyglucose (18F-FDG). 18F-FDG PET has been found effective for evaluating numerous cancer types and, since metabolic changes Positron Emission Tomography (PET) & Combined PET/CT Scans Page 15 of 19

16 occur in tumors prior to apparent morphologic changes, often detects tumors not found by CT, allowing earlier treatment. However, 18F-FDG accumulates not only in malignant lesions but also to varying degrees at sites of other pathology, such as areas of inflammation or infection; sites where physiologic glucose activity is high, such as areas of muscular activity, in the digestive tract, or near large vascular structures; and, during excretion of 18F-FDG, in urinary collecting systems. Moreover, PET does not provide anatomic detail, which impedes its ability to localize and classify sites of increased 18F-FDG activity. (Antioch 2004) Positron emission tomography (PET) is a three-dimensional (3-D) noninvasive nuclear imaging technique for detection of normal and abnormal function of living tissue. In contrast with traditional diagnostic techniques, such as x-rays, computed tomography (CT) scans, magnetic resonance imaging (MRI) and ultrasonography (US), which produce images of the body's anatomy, PET produces images of the body's basic biochemistry or function. The use of PET imaging in cancer patients is based on the premise that metabolic processes and blood flow in tumors typically differ from those of normal adjacent tissue and the radiolabeled sugars or other tracers injected during a PET procedure become concentrated within the cancer cells. PET may be approved in a patient with known diagnosis of malignancy to determine optimal anatomic site for biopsy or other invasive diagnostic procedure for staging and restaging. It may be used if standard diagnostic imaging work up (US, CT, MRI) is inconclusive or may replace conventional imaging when conventional imaging will be inadequate for accurate staging and clinical management will depend upon the stage of disease. Routine monitoring of tumor response during treatment (when no change in therapy is planned) is not an approved indication. Restaging after completion of therapy to detect residual disease, recurrence, and extent of recurrence is a valid indication. Requests for suspected recurrence should include changes in the clinical status of the patient leading to the suspicion that includes new symptoms and elevated tumor markers or other laboratory changes. U.S. FOOD AND DRUG ADMINISTRATION (FDA) Several combined positron emission tomography-computed tomography (PET-CT) scanners are FDAapproved and commercially available. These include the GE Discovery ST, the GE Discovery LS, the GE Discovery VI (formerly known as the POSiTRACE PET-CT system), and the GE MOBILE Discovery systems, all manufactured by General Electric Medical Systems (Milwaukee, WI); the LSO PET/CT HiRez 64 system, the ECAT PET/CT, and the ECAT LSO PET/CT series, manufactured by CTI PET Systems Inc (Knoxville, TN); the Gemini 16 system, manufactured by Phillips Medical Systems (Cleveland, OH); and the Sceptre P3 system (Hitachi Medical Systems America, Twinsburg, OH). For most of these systems, FDA data regarding indications for use were relatively general, stating that the PET-CT system was indicated for use in head and whole-body Positron emission tomography (PET) for attenuation correction and localization of emission activity in patient anatomy by means of integrating PET and CT images and for use as stand-alone head and whole-body diagnostic computed tomography (CT). More specific indications were listed only for two systems and included evaluation Positron Emission Tomography (PET) & Combined PET/CT Scans Page 16 of 19

17 and diagnosis of cancer, cardiovascular disease, and brain dysfunction as well as radiotherapy planning for the GE Discovery LS system and only "oncology" for the GE Discovery VI system. A few PET-CT systems previously approved by the FDA were recalled by the manufacturer, CTI PET Systems, due to an occasional malfunction that prevented the operator from stopping bed motion. These include the biograph and biograph LSO systems distributed by Siemens Medical Solutions (Knoxville, TN) and the ECAT REVEAL system distributed by CTI between October 31, 2000 and June 24, The only PET radiotracers that have received FDA approval are 18-F-fluorodeoxyglucose ( 18 F-FDG) for diagnosing seizure disorders, rubidium-82 ( 82 Rb) for myocardial perfusion imaging, and fluorine- 18-labeled ( 18 F)-sodium fluoride for bone imaging. However, the manufacturer of 18 F-sodium fluoride stopped producing the drug and no other 18 F-sodium fluoride product has received approval. Despite this, the FDA has completed reviews on the use of some PET radiotracers for specific indications and has established that, when produced under conditions specified in an approved application and injected at an approved dose, the following PET radiopharmaceuticals can be found safe and effective: 18 F-FDG (approved dose, 10 mci for adults) for evaluating malignancy in patients with known or suspected abnormalities found with other imaging techniques or patients with an existing diagnosis of cancer. 18 F-FDG (approved dose, 10 mci for adults) in combination with myocardial perfusion imaging for identifying myocardial hibernation in patients with coronary artery disease and left ventricular dysfunction. Nitrogen-13-ammonia ( 13 NH 3 ; approved dose, 10 mci for adults) for assessing myocardial perfusion under rest or pharmacological stress conditions in patients with suspected or existing coronary artery disease. 18 F-sodium fluoride (approved dose, 2.0 mci/ml) as a bone imaging agent to define areas of altered osteogenic activity. APPLICABLE CODES The following list(s) of procedure and/or diagnosis codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this policy does not imply that the service described by the code is a covered or non- covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Coverage Determination Guidelines may apply. CPT Code Description Myocardial imaging, positron emission tomography (PET), metabolic evaluation Myocardial imaging; positron emission tomography (PET), perfusion; single study at rest or stress Myocardial imaging; positron emission tomography (PET), perfusion; multiple studies at rest and/or stress Brain imaging, positron emission tomography (PET); metabolic evaluation Brain imaging, positron emission tomography (PET); perfusion evaluation Positron emission tomography (PET) imaging; limited area (e.g., chest, Positron Emission Tomography (PET) & Combined PET/CT Scans Page 17 of 19

18 head/neck) Positron emission tomography (PET) imaging; skull base to mid-thigh Positron emission tomography (PET) imaging; whole body Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; limited area (e.g., chest, head/neck) Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid-thigh Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; whole body CPT is a registered trademark of the American Medical Association. HCPCS Code A9552 G0219 G0235 G0252 S8085 Description Flurodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries Pet imaging whole body; melanoma for non-covered indications PET imaging, any site, not otherwise specified PET imaging, full and partial-ring PET scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (e.g., initial staging of axillary lymph nodes), not covered by Medicare Fluorine-18 fluorodeoxyglucose (f-18 fdg) imaging using dual-head coincidence detection system (non-dedicated pet scan) REFERENCES Antoch G, Freudenberg LS, Beyer T, et al. To enhance or not to enhance? F-18-FDG and CT contrast agents in dual-modality F-18-FDG PET/CT. J Nucl Med. 2004; 45(Suppl 1):56S-65S. UnitedHealthcare Physician Guidelines: Current, Evidence-based Recommendations Regarding Imaging, Effective March 2017 Accessed October PROTOCOL HISTORY/REVISION INFORMATION Date 10/26/ /25/ /27/ /26/ /22/ /24/ /23/ /19/2010 Action/Description Corporate Medical Affairs Committee Positron Emission Tomography (PET) & Combined PET/CT Scans Page 18 of 19

19 The foregoing Health Plan of Nevada/Sierra Health & Life Healthcare Operations protocol has been adopted from an existing UnitedHealthcare coverage determination guideline that was researched, developed and approved by the UnitedHealthcare Coverage Determination Committee. Positron Emission Tomography (PET) & Combined PET/CT Scans Page 19 of 19