ARCHIVED

Medical Policy

Policy Num:       06.001.035
Policy Name:     FDG Using Camera-Based Imaging (FDG-SPECT)
Policy ID:           [06.001.035]  [Ar / B / M+ / P-]  [6.01.27]

Last Review:       September 18, 2024
Next Review:       Policy Archived
 

ARCHIVED

Related Policies: None

FDG Using Camera-Based Imaging (FDG-SPECT)

Summary

SPECT (Single photo emission computed tomography) is a radiological diagnostic test. Unlike CT, MRI that focuses on a part of the body, SPECT and PET offer information about the function of that part of the body.

 A radioactive material (2-fluoro-2-deoxy-D-glucose) is injected intravenously. This radioactive material is collected by the cells of the body in a different way depending on how the cell is functioning metabolically. This is why it is also known as Metabolic SPECT. A rotating chamber (gamma camera) records images of the signals emitted by the particles of the radioactive material injected and that has been located in a specific organ. A computer is fed by these series of images and they reconstruct in the form of planes, the organ studied.

This study can determine myocardial viability.

Objective

The objective of this review is to demonstrate that FDG SPECT is clinically useful and considered equivalent in most cases to conventional thallium SPECT and FDG-collimated-SPECT.

Policy Statements

SPECT is considered for payment to demonstrate myocardial viability.

 SPECT is not considered for payment in:

· Bone and joints - to differentiate between infectious, neo-plastic, avascular and traumatic processes

· Brain tumors-to differentiate between lymphomas from infections such as toxoplasmosis, particularly in the immunosuppressed patient

Hepatic hemangioma uses red cells marked to define lesions identified by other means

· Location of abscesses / infections / inflammation in soft tissues or in cases of fever of unknown origin

· Neuroendocrine tumors (eg adenomas, carcinoid, pheochromocytomas, tumors secreting intestinal vasoactive peptides (VIP), thyroid carcinoma, adrenal tumors.

· Location of parathyroid

SPECT is not considered for payment for any other indication, including but not limited to the following:

· Attention deficit hyperactivity disorder

· Chronic fatigue syndrome

· Colorectal carcinoma

· Sweep in the transport of dopamine- all indications

· Malignities except those listed above

· Neuropsychiatric disorders without evidence of cerebrovascular disease

· Pervasive developmental disorders

· Prostate carcinoma

· scintimamography for breast cancer

Policy Guidelines

Patient selection criteria for evaluation of myocardial viability Candidates for assessment of myocardial viability are typically those patients with severe left ventricular dysfunction who are under consideration for a revascularization procedure. A PET, FDG-SPECT, or thallium SPECT scan may determine whether the left ventricular dysfunction is related to viable or nonviable myocardium. Patients with viable myocardium may benefit from revascularization, while those with non-viable myocardium will not.

Benefit Application

BlueCard/National Account Issues

FDG-SPECT may be difficult to identify if the test is coded as if it is a conventional PET scan. Therefore, plans may want to consider the use of specific, distinct coding schemes for FDG-SPECT, either using the combination of existing codes for PET, SPECT, and radiopharmaceuticals (see policy guidelines, above), or advising use of the HCPCS S code.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

FDG-SPECT, also referred to as metabolic SPECT (single photon emission computed tomography), or PET using a gamma camera, is a general term  describing imaging techniques in which a SPECT gamma camera is used to detect the paired 511 ke-V photons emitted from decaying positrons associated  with the metabolism of radiolabeled 2-fluoro-2 deoxy-D-glucose (FDG), a radiotracer commonly used in PET (positron emission tomography) imaging. SPECT  cameras are conventionally used to provide scintigraphic studies such as bone scans or cardiac thallium studies. When used in conjunction with FDG, specially equipped SPECT cameras can provide images reflecting the metabolic activity of tissues, similar to PET scanning. Dedicated PET scanners consist of multiple detectors arranged in a full or partial ring around the patient, permitting the simultaneous detection of the high-energy paired photons that are emitted at 180 degrees from one another. The clinical value of PET scans is related both to the ability to image the relative metabolic activity of target tissues and the resolution associated with PET scanners. The expense of onsite manufacture of the FDG is prohibitive for most facilities; that coupled with the expense of the PET scanner itself has limited the widespread availability of PET scanning. However, radiolabeled FDG has a relatively long half-life of 110 minutes, permitting off-site manufacture at distribution centers with transport to nearby facilities. Thus, the lack of PET scanners may be emerging as the critical limiting factor to further diffusion of PET imaging. In response, researchers have begun to investigate whether the more readily available SPECT cameras, routinely used to detect low-energy photons, could be adapted for use to detect higher energy photons emitted from positrons. FDG-SPECT imaging describes 2 general techniques. In 1 technique SPECT cameras are adapted with collimators that screen out the lower energy photons and thus only detect the high-energy 511 ke-V photons. For the purposes of this policy, this technique will be referred to as FDG-collimated-SPECT. However, this approach decreases the sensitivity and resolution compared to that associated with PET scanners. In a second technique, a dual-headed rotating SPECT camera can be operated in the “coincidence mode,” meaning that the camera will only count those photons that are simultaneously detected at 180 degrees from one another. For the purposes of this assessment, this technique will be referred to as FDG-DHC (dual-head coincidence)-SPECT. PET scanners also rely on coincidence detection, and thus FDG-DHC-SPECT more closely resembles a PET scanner. However, the lower number of detectors in the SPECT approach compared to the full or partial ring of detectors used in PET imaging will result in a relative loss of sensitivity and resolution. An additional technical challenge is the use of sodium iodide crystals, which scintillate in response to bombardment by photons. In SPECT cameras these crystals have been optimized to detect lower energy photons used in routine nuclear medicine studies and not the high-energy photons associated with FDG. These technical issues raise questions regarding the diagnostic performance of FDG-SPECT in comparison to PET scanning. Oncologic and cardiac applications have been most thoroughly studied.

Regulatory Status

N/A

Rationale

Both FDG-collimated and FDG-DHC-SPECT have been studied as techniques to evaluate myocardial viability. Srinivasan and colleagues reported on a case series of 28 patients with chronic coronary artery disease and left ventricular dysfunction. (11) All patients underwent FDG-collimated-SPECT, conventional PET, and thallium SPECT studies. Conventional PET served as the gold standard. The authors reported excellent overall correlation among all 3 techniques, although differences emerged on subset analysis. For example, for those with severe left ventricular dysfunction (i.e., ejection fraction

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1 Policy Statement

For assessment of myocardial viability, conventional PET, FDG-SPECT, and thallium SPECT scans provide equivalent diagnostic information in most clinical situations. According to the guidelines of the American College of Cardiology (J Am Coll Cardiol 1995; 25:521-47), in routine situations, thallium SPECT scans are generally preferred over PET scans due to their lower price. Therefore, plans may want to consider if their benefits or contractual language supports a management strategy of steering patients to the lowest price option. It should be noted that in certain markets PET and thallium SPECT scans may be competitively priced.

Supplemental Information

N/A

Practice Guidelines and Position Statements

The data suggest that all 4 methods—conventional thallium SPECT, FDG-collimated-SPECT, FDG-DHCSPECT, and PET scanning may be clinically useful and considered equivalent in most cases. However, it is difficult to determine in which subsets of patients one technique may be superior to another, or if the diagnostic performance is improved with the combination of techniques. There are no data to suggest that the combination of FDG-SPECT with PET scans improves diagnostic performance of either technique alone. There are no data regarding the use of FDG-SPECT in the evaluation of coronary perfusion defects

Medicare National Coverage

Medicare policy does not limit the type of scanner used for these situations.

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4. Beanlands RS, Chow BJ, Dick A, et al. CCS/CAR/CANM/CNCS/CanSCMR joint position statement on advanced non-invasive cardiac imaging using positron emission tomography, magnetic resonance imaging and multidetector computed tomographic angiography in the diagnosis and evaluation of ischemic heart disease--executive summary. Can J Cardiol. 2007; 23(2):107-119. Available at: http://www.ccs.ca/download/position_statements/cardiac_imaging_Dec11_appen_tables.pdf. Accessed on March 7, 2012. 
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6. Blue Cross Blue Shield Association. FDG positron emission tomography for evaluating breast cancer. TEC Assessment, 2001; 16(5). 
7. Blue Cross Blue Shield Association. FDG PET to manage patients with occult primary carcinoma and metastasis outside the head and neck. TEC Assessment, 2002; 17(14). 
8. Blue Cross Blue Shield Association. FDG positron emission tomography for evaluating esophageal cancer. TEC Assessment, 2002; 16(21). 
9. Blue Cross and Blue Shield Association. FDG positron emission tomography in head and neck cancer. TEC Assessment, 2000; 15(4). 
10. Blue Cross and Blue Shield Association. FDG positron emission tomography in colorectal cancer. TEC Assessment, 2000; 14(25). 
11. Blue Cross and Blue Shield Association. FDG positron emission tomography in lymphoma. TEC Assessment, 2000; 14(26). 
12. Blue Cross and Blue Shield Association. FDG positron emission tomography in melanoma. TEC Assessment, 2000; 14(27). 
13. Blue Cross and Blue Shield Association. FDG positron emission tomography in pancreatic cancer. TEC Assessment, 2000; 14(28). 
14. Blue Cross and Blue Shield Association. FDG PET to manage patients with an occult primary carcinoma and metastasis outside the cervical lymph nodes. TEC Assessment. 2003; 17(14). 
15. Blue Cross and Blue Shield Association. FDG positron emission tomography for evaluating breast cancer. TEC Assessment. 2003; 18(14). 
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18. Centers for Medicare and Medicaid Services. National Coverage Determination for Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer. NCD #220.6.19. Effective February 26, 2010. Available at: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=336&ncdver=1&bc=BAABAAAAAAAA&. Accessed on March 7, 2012. 
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23. Ioannidis JP, Lau J. Report for the Agency for Healthcare Research and Quality. FDG-PET for the diagnosis and management of soft tissue sarcoma. April 2002. 
24. Klocke FJ, Baird MG, Baterman TM, et al. ACC/AHA/ASNC Guidelines for the clinical use of cardiac radionuclide imaging: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. ACC/AHA/ASNC Committee to revise the 1995 Guidelines for the clinical use of radionuclide imaging. J Am Coll Cardiol. 2003; 42:1318-1333. Available at: http://content.onlinejacc.org/cgi/content/short/42/7/1318. Accessed on March 7, 2012. 
25. Knopman DS, Dekosky ST, Cummings JL, et al. Practice parameter: diagnosis of dementia (an evidence-based review). Report of the Quality Standards Subcommittee of the American Academy of Neurology (AAN). Neurology. 2001; 56(9):1143-1153. Available at: 
http://www.aan.com/professionals/practice/guidelines/pda/Dementia_diagnosis.pdf. Accessed on March 7, 2012. 
26. Matchar DB, Kulasingam SL, McCrory DC, et al. Use of positron emission tomography and other neuroimaging techniques in the diagnosis and management of Alzheimer's disease and dementia. Report for the Agency for Healthcare Quality and Research. December 14, 2001. Available at: http://www.cms.hhs.gov/determinationprocess/downloads/id9TA.pdf. Accessed on March 7, 2012. 
27. Matcher DB, Kulasingam SL, Huntington A et al. Technology Assessment. Positron emission tomography, single photon emission computed tomography, computed tomography, functional magnetic resonance imaging, and magnetic resonance spectroscopy for the diagnosis and management of Alzheimer's dementia. Duke Center for Clinical Policy Research and Evidence Practice Center. April 2004. Available at: https://www.cms.gov/coverage/download/id104b.pdf. Accessed on March 7, 2012. 
28. Matchar DB, Kulasingam SL, Havrilesky L. Agency for Healthcare Research and Quality (AHRQ) Technology Assessment: Positron emission testing for six cancers (brain, cervical, small cell lung, ovarian, pancreatic and testicular). Rockville, MD: February 2004. 
29. Mujoomdar M, Moulton K, Nkansah E. Positron Emission Tomography (PET) in Oncology: A Systematic Review of Clinical Effectiveness and Indications for Use. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2010. Available at: http://www.cadth.ca/media/pdf/M0001_PET_for_Oncology_L3_e.pdf. Accessed on February 23, 2012. 
30. Multiple Myeloma Research Foundation. Diagnosing and Staging. Available at: http://www.multiplemyeloma.org/living-with-multiple-myeloma/newly-diagnosed-patients/what-is-multiple-myeloma/diagnosis-and-staging.html. Accessed on March 7, 2012. 
31. National Cancer Institute (NCI) and the Masonic Cancer Center at University of Minnesota. Study of Fluorodeoxyglucose Positron Emission Tomography/CT Imaging in Predicting Disease-Free Survival of Patients Receiving Neoadjuvant Chemotherapy for Soft Tissue Sarcoma. NCT00346125. Last updated September 6, 2011. Available at: http://clinicaltrials.gov/ct/show/NCT00346125. Accessed on March 7, 2012. 
32. NCCN Clinical Practice Guidelines in Oncology™. © 2012. National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on February 23, 2012. 
o Breast Cancer (V1.2012). Revised January 20, 2012. 
o Cervical Cancer (V1.2012). Revised August 11, 2011. 
o Colon Cancer (V3.2012). Revised January 17, 2012. 
o Multiple Myeloma (V1.2012). Revised July 26, 2011. 
o Non-small Cell Lung Cancer (V2.2012). Revised October 4, 2011. 
o Small-cell Lung Cancer (V2.2012). Revised June 23, 2011. 
o Ovarian Cancer (V2.2012). Revised November 28, 2011. 
o Hodgkin Lymphoma (V1.2012). Revised January 17, 2012. 
o Non-Hodgkin's Lymphoma (V2.2012). Revised February 23, 2012. 
33. National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI). Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: Evidence Report of the Obesity Education Initiative Expert Panel on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. NIH Publication No. 98-4083. September 1998. Available at: http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf. Accessed on March 7, 2012. 
34. Podoloff DA, Advani RH, Allred C, et al. National Comprehensive Cancer Network, Inc. (NCCN). NCCN Task Force Report: Positron Emission Tomography (PET)/Computed Tomography (CT) Scanning in Cancer. J Natl Compr Canc Netw. 2007; 5(suppl 1):S1-22. 
35. Podoloff DA, Ball DW, Ben-Josef E, et al. NCCN task force: clinical utility of PET in a variety of tumor types. J Natl Compr Canc Netw. 2009; 7(suppl 2):S1-26. 
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39. U.S. Department of Health and Human Services. Agency for Healthcare Research and Quality (AHRQ). Technology Assessment: Use of Positron Emission Tomography and other neuroimaging techniques in the diagnosis and management of Alzheimer's disease and dementia. December 14, 2001. Available at: http://www.cms.hhs.gov/coverage/download/id64.pdf?origin=globalsearch&page=/mcd/viewtechassess.asp&id=64&where=. Accessed on February 23, 2012. 
40. U.S. Department of Health and Human Services. Agency for Healthcare Research and Quality (AHRQ). Technology Assessment: FDG Positron Emission Tomography for evaluating Breast Cancer. May 2001. Available at: http://www.cms.hhs.gov/coverage/download/id71.pdf. Accessed on February 23, 2012. 
41. U.S. Department of Health and Human Services. Agency for Healthcare Research and Quality (AHRQ). Technology Assessment: Positron Emission Testing for six cancers (brain, cervical, small cell lung, ovarian, pancreatic and testicular). February 12, 2004. Available at: http://www.cms.gov/determinationprocess/downloads/id21TA.pdf. Accessed on February 23, 2012. 
42. U.S. Department of Health and Human Services. Agency for Healthcare Research and Quality (AHRQ). Positron Emission Tomography for Nine Cancers (Bladder, Brain, Cervical, Kidney, Ovarian, Pancreatic, Prostate, Small Cell Lung, Testicular). Health Technology Assessments. No. PETC1207. Dec., 1, 2008. Available at: http://www.cms.hhs.gov/determinationprocess/downloads/id54TA.pdf. Accessed on February 23, 2012. 
43. U.S. Department of Health and Human Services. Agency for Healthcare Research and Quality (AHRQ). Technology Assessment: Systematic Review of Positron Emission Tomography for Follow-up of Treated Thyroid Cancer. April 10, 2002. Available at: http://www.cms.gov/determinationprocess/downloads/id7TA.pdf. Accessed on February 23, 2012. 
44. U.S. Department of Health and Human Services. Food and Drug Administration (FDA). Current Good Manufacturing Practice for Positron Emission Tomography Drugs. Docket No. FDA2004N0449 (formerly Docket No. 2004N0439). Final rule. Effective December 12, 2011. Available at: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/Manufacturing/UCM193704.pdf. Accessed on February 23, 2012. 
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Web Sites for Additional Information 

1. American College of Radiology. Radiology Info: Positron Emission Tomography (PET). Last reviewed: May 24, 2011. Available at: http://www.radiologyinfo.org/en/info.cfm?pg=PET. Accessed on February 23, 2012. 
2. National Institutes of Health (NIH). University of Pennsylvania. FDG-PET Imaging in Complicated Diabetic Foot. NCT00194298. Last updated August 22, 2006. Available at: http://www.clinicaltrials.gov/ct2/show/NCT00194298?term=00194298&rank=1. Accessed on February 23, 2012. 

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Policy History