(Medicare National Coverage Determinations Manual)

220.6.1 - PET for Perfusion of the Heart (Various Effective Dates)  (Rev. 120; Issued:  05- 06-10; Effective Date:  04 -03-09; Implementation Date:  10- 30-09)  1.  Rubidium 82 (Effective March 14, 1995)   Effective for services performed on or after March 14, 1995, 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) are covered, provi ded the requirements below are met:   o 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   o 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 t o 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.)   o For any PET scan for which Medicare payment is claimed for dates of services prior to July 1, 2001, the claimant must submit additional specified information on the claim form (including proper codes and/or modifiers), to indicate the results of the PET sc an. The claimant must also include information on whether the PET scan was performed after an inconclusive non- invasive cardiac test. The information submitted with respect to the previous noninvasive cardiac test must specify the type of test performed pr ior to the PET scan and whether it was inconclusive or unsatisfactory. These explanations are in the form of special G codes used for billing PET scans using Rb 82. Beginning July 1, 2001, claims should be submitted with the appropriate codes.   2. Ammonia N -13 (Effective October 1, 2003)   Effective for services performed on or after October 1, 2003, 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 disea se using the FDA -approved radiopharmaceutical ammonia N -13 are covered, provided the requirements below are met:   o The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a SPECT; or   o 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 t o 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.)   (This NCD last reviewed March 2005.)   220.6.2 - FDG PET for Lung Cancer (RETIRED)   (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.2 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.   220.6.3 - FDG PET for Esophageal Cancer (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.3 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.   220.6.4 - FDG PET for Colorectal Cancer (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.4 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.   220.6.5- FDG PET for Lymphoma (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.5 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.   220.6.6- FDG PET for Melanoma (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.6 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.    220.6.7- FDG PET for Head and Neck Cancers (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.7 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.   220.6.8 - FDG PET for Myocardial Viability (Various Effective Dates Below)  (Rev. 31, Issued:  04- 04-05; Effective:  01 -28-05; Implementation:  04- 18-05)  The identification of patients with partial loss of heart muscle movement or hibernating myocardium is important in selecting candidates with compromised ventricular function to determine appropriateness for revascularization.  Diagnostic tests such as FDG  PET distinguish between dysfunctional but viable myocardial tissue and scar tissue in order to affect management decisions in patients with ischemic cardiomyopathy and left ventricular dysfunction.  1.  FDG PET is covered for the determination of myocardial viability following an inconclusive single photon emission computed tomography (SPECT) test from July 1, 2001, through September 30, 2002.  Only full ring PET scanners are covered from July 1, 2001, through December 31, 2001.  However, as of January 1, 2002, full and partial ring scanners are covered.   2.  Beginning October 1, 2002, 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 scanne rs 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.   Documentation that these conditions are met should be maintained by the referring physician in the beneficiary's medical record, as is normal business practice.   (See 220.12 for SPECT coverage.)   (This NCD last reviewed September 2002.)   220.6.9 - FDG PET for Refractory Seizures (Effective July 1, 2001)  (Rev. 120; Issued:  05- 06-10; Effective Date:  04 -03-09; Implementation Date:  10- 30-09)  Beginning July 1, 2001, 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.  Documentation that these conditions are met should be maintained by the referring physician in the beneficiary's medical record, as is normal business practice.   (This NCD last reviewed June 2001.)   220.6.10- FDG PET for Breast Cancer (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.10 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.   220.6.11- FDG PET for Thyroid Cancer (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.11 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.   220.6.12- FDG PET for Soft Tissue Sarcoma (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    Please note section 220.6.12 has been removed from the NCD Manual and replaced with section 220.6.17 effective April 3, 2009.   220.6.13 - FDG Positron Emission Tomography (PET) for Dementia and Neurodegenerative Diseases (Effective September 15, 2004)  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Medicare covers FDG Positron Emission Tomography (PET) scans for either the differential diagnosis of fronto- temporal dementia (FTD) and Alzheimers disease (AD) under specific requirements; OR, its use in a Centers for Medicare & Medicaid Services (CMS) -approved practical clinical trial focused on the utility of FDG PET in the diagnosis or treatment of dementing neurodegenerative diseases.  Specific requirements for each indication are clarified below:   B. Nationally Covered Indications   1. FDG PET Requirements for Coverage in the Differential Diagnosis of AD and FTD   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 AD and 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 patients 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;   b. The patient has had a comprehensive clinical evaluation (as defined by the American Academy of Neurology encompassing a medical history from the patient and a well -acquainted informant (including assessment of activities of daily living), physical and m ental 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 co mputed tomography (CT);   c. The evaluation of the patient has been conducted by a physician experienced in the diagnosis and assessment of dementia;   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;  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;   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 decl ine, 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 1 year has passed from the time the first SPECT or FDG PET scan was performed.)