Coverage Policy Manual
Policy #: 2021004
Category: Radiology
Initiated: February 2021
Last Review: December 2023
  PET or PET/CT for Cancer Surveillance and Other Oncologic Applications
Description:
Positron Emission Tomography (PET) imaging uses radiotracers that can reveal both anatomical and physiological information. The glucose analog, 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG) is useful in cancer imaging because it has been found that tumor cells show increased utilization of glucose compared to non-malignant tissue and is the most common radiotracer that is utilized. For certain malignancies PET scans have been shown to be more accurate than other non-invasive tests in detecting malignant disease. However, as with all diagnostic tests, PET scans do not detect cancer 100% of the time that cancer is present (a false negative test), nor do all positive PET scans represent the presence of malignant disease (a false positive test). A false negative test may occur because a critical volume of malignant cells is necessary for a PET scan to be positive. PET scans may be false positive in the presence of inflammation or granulomatous disease.
 
In the United States PET/CT is usually done by a dedicated scanner that allows both forms of imaging on a single table but it can also be done with fusion or registration.
 
Definitions
 
Screening – testing in the absence of an established or clinically suspected diagnosis
 
Diagnosis - testing based on a reasonable clinical suspicion of a particular condition or disorder
 
Diagnostic Workup – initial staging of documented malignancy
 
Management – testing to direct therapy of an established condition, which may include preoperative or postoperative imaging, or imaging performed to evaluate the response to nonsurgical intervention. In oncologic imaging, management applies to patients with measurable disease and to imaging performed before or after planned treatment intervention, therapy response, restaging or clinically suspected recurrence.
 
Surveillance – periodic assessment following completion of therapy. In oncologic imaging, surveillance applies to asymptomatic patients in remission and/or without measurable disease
 
Cannot be performed or is nondiagnostic – applies when the test:
    • Is positive or indeterminate for clinically significant pathology when the information provided about the abnormality by the test is not sufficient to direct subsequent management
    • Is negative when the negative likelihood ratio of the test is both insufficient to confidently exclude the absence of suspected disease and unable to direct subsequent management. This typically applies in scenarios with moderate to high clinical pretest probability with negative testing or low pretest probability with clear evidence for net benefit
    • Has been previously nondiagnostic because of a persistent clinical factor (e.g., body habitus, immobility) that is very likely to make retesting nondiagnostic as well Cannot be performed due to a medical contraindication (e.g., contrast nephrotoxicity, allergy, or in highly radiation sensitive populations such as pediatrics and pregnancy) or reasonable unavailability related to lack of local expertise or service availability
Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.
Policy/
Coverage:
Effective May 5, 2023
 
Coverage Standards for Cancer Surveillance PET Scans
 
A. For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans other than the Arkansas State and Public School Employees program**, the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature: positron emission tomography to screen for or to diagnose cancer in a patient upon the recommendation of the patient's physician when the patient has a prior history of cancer is covered when the following criteria are met:
 
a) Documentation of the malignancy by pathologic or equivalent report, and
b) Performed no more often than every 6 months, and
c) Ordered by or in consultation with a specialist trained in pediatric oncology for an individual < 18 y/o [given the enhanced risk of radiation exposure in young].
 
** Coverage of cancer surveillance PET scans for Arkansas State and Public School Employee health plan participants and beneficiaries, as mandated by Act 583, is subject to separate coverage standards specific to the Arkansas State and Public School Employee health plan.
 
 
Special Note regarding “prior history of cancer”: In applying Act 583 to any PET scan prior approval or coverage decision for those fully-insured contracts and self-funded church or government plans to which Act 583 applies, the patient-member will be considered to have a “prior history of cancer” as referenced in Act 583 if the patient-member either (a) has active cancer at the time a prior approval request is submitted, as documented by a pathologic or equivalent report or (b) previously had cancer, whether or not in remission at the time the prior approval request is submitted, as documented by a pathologic or equivalent report.
 
 
B. FOR THOSE CONTRACTS THAT ARE NOT MANDATED BY STATE LAW :
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET scanning does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered when used as a “surveillance tool” (as defined in the “Note” below) for patients with a history of cancer.
 
For members with contracts without primary coverage criteria, PET scanning when used as a “surveillance tool” (as defined in the “Note” below) for patients with a history of cancer is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
  
Note: A scan is considered as being used as a “surveillance tool” if performed more than 6 months after completion of cancer therapy (12 months for lymphoma) in patients without objective signs or symptoms suggestive of cancer recurrence.
 
 
Other Oncologic Indications
 
Hepatobiliary Cancer
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Hepatobiliary Cancer (HCC) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for:
 
    • Diagnostic Workup and Diagnosis:
Indicated in EITHER of the following:
        • When standard imaging studies are equivocal or non-diagnostic regarding the extent of disease
        • Prior to planned curative surgery for gallbladder cancer and cholangiocarcinoma, when standard imaging has not demonstrated metastatic disease
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with for patients with Hepatobiliary Cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered for any other indication not specifically listed as covered above including but not limited to:
 
    • Management (of disease or treatment)
    • Surveillance
 
For contracts without primary coverage criteria, PET/CT for patients with for patients with Hepatobiliary Cancer is considered investigational and is not covered for any other indication not specifically listed as covered above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Merkel Cell Carcinoma
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Merkel Cell Carcinoma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for:
 
    • Diagnostic Workup:
(As clinically) Indicated
    • Management:
(As clinically) Indicated
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with for patients with Merkel Cell Carcinoma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered for any other indication not specifically listed as covered above including but not limited to:
 
    • Surveillance
 
For contracts without primary coverage criteria, PET/CT for patients with for patients with Merkel Cell Carcinoma is considered investigational for any other indication not specifically listed as covered above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Paraneoplastic Syndrome
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Paraneoplastic Syndrome meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for:
 
    • Diagnostic Workup:
Indicated for initial evaluation of individuals with paraneoplastic syndrome
    • Management:
Further management based on primary cancer identified.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with Paraneoplastic Syndrome is considered investigational and is not covered for any other indication not specifically listed as covered above including but not limited to:
 
    • Surveillance
 
For contracts without primary coverage criteria, PET/CT for patients with Paraneoplastic Syndrome is considered investigational and is not covered for any other indication not specifically listed as covered above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Other Oncologic Applications
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Other oncologic applications of PET scanning and use of any other PET radiotracer unless addressed above or in a specific PET policy, do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered.
 
For contracts without primary coverage criteria, Other oncologic applications of PET scanning and use of any other PET radiotracer unless addressed above or in a specific PET policy, are considered investigational and not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Note: Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.
 
Effective March 13. 2022 through May 4, 2023
 
Cancer Surveillance
 
For all fully insured contracts, all self-funded church-sponsored health plans, and all self-funded government-sponsored health plans (e.g., state and public-school employee plans), other than the Federal Employee Health Benefit Program and Medicare Advantage plans, as required by Act 583 of the Arkansas Legislature, positron emission tomography to screen for or to diagnose cancer in a patient upon the recommendation of the patient's physician when the patient has a prior history* of cancer is covered when the following criteria are met:
 
a) documentation of the prior malignancy by pathologic or equivalent report, and
b) performed no more often than every 6 months, and
c) ordered by or in consultation with a specialist trained in pediatric oncology for an individual < 18 y/o [given the enhanced risk of radiation exposure in young].
 
*For purposes of this coverage policy, prior history of cancer is defined as patients with a documented period of at least 6 months of remission (no evidence of disease) in which all signs and symptoms of cancer have disappeared (NCI, 2023). (Eff March 08, 2023)
 
FOR THOSE CONTRACTS THAT ARE NOT MANDATED BY STATE LAW :
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET scanning does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered when used as a surveillance tool for patients with cancer or with a history of cancer.
 
For members with contracts without primary coverage criteria, PET scanning when used as a surveillance tool for patients with cancer or with a history of cancer.is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Note: A scan is considered surveillance if performed more than 6 months after completion of cancer therapy (12 months for lymphoma) in patients without objective signs or symptoms suggestive of cancer recurrence.
 
Other Oncologic Indications
 
Hepatobiliary Cancer
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Hepatobiliary Cancer (HCC) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for:
 
Diagnostic Workup and Diagnosis:
Indicated in EITHER of the following:
· When standard imaging studies are equivocal or non-diagnostic regarding the extent of disease
· Prior to planned curative surgery for gallbladder cancer and cholangiocarcinoma, when standard imaging has not demonstrated metastatic disease
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with for patients with Hepatobiliary Cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered for any other indication not specifically listed as covered above including but not limited to:
 
· Management (of disease or treatment)
· Surveillance
 
For contracts without primary coverage criteria, PET/CT for patients with for patients with Hepatobiliary Cancer is considered investigational and is not covered for any other indication not specifically listed as covered above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Merkel Cell Carcinoma
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Merkel Cell Carcinoma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for:
 
Diagnostic Workup:
· (As clinically) Indicated
 
Management:
· (As clinically) Indicated
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with for patients with Merkel Cell Carcinoma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered for any other indication not specifically listed as covered above including but not limited to:
 
· Surveillance
 
For contracts without primary coverage criteria, PET/CT for patients with for patients with Merkel Cell Carcinoma is considered investigational for any other indication not specifically listed as covered above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Paraneoplastic Syndrome
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Paraneoplastic Syndrome meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is covered for:
 
Diagnostic Workup:
· Indicated for initial evaluation of individuals with paraneoplastic syndrome
 
Management:
· Further management based on primary cancer identified.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with Paraneoplastic Syndrome is considered investigational and is not covered for any other indication not specifically listed as covered above including but not limited to:
 
· Surveillance
 
For contracts without primary coverage criteria, PET/CT for patients with Paraneoplastic Syndrome is considered investigational and is not covered for any other indication not specifically listed as covered above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Other Oncologic Applications
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Other oncologic applications of PET scanning and use of any other PET radiotracer unless addressed above or in a specific PET policy, do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered.
 
For contracts without primary coverage criteria, Other oncologic applications of PET scanning and use of any other PET radiotracer unless addressed above or in a specific PET policy, are considered investigational and not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Note: Standard or conventional imaging: Refers to imaging that does not require a PET/CT. Depending on the clinical scenario and individual patient circumstances, this may include computed tomography, magnetic resonance imaging, ultrasound and/or scintigraphy.
 
Effective Prior to MARCH 13, 2022
 
CANCER SURVEILLANCE
For all fully-insured contracts, as required by Act 583 of the Arkansas legislature, positron emission tomography to screen for or to diagnose cancer in a patient upon the recommendation of the patient's physician when the patient has a prior history of cancer is covered when the following criteria are met: a) documentation of the malignancy by pathologic or equivalent report, b) no more often than every 6 months, and c) ordered by or in consultation with a specialist trained in pediatric oncology for an individual < 18 y/o [given the enhanced risk of radiation exposure in young].
 
For those contracts that are not mandated by state law:
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
PET scanning when used as a surveillance tool for patients with cancer or with a history of cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, PET scanning when used as a surveillance tool for patients with cancer or with a history of cancer is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Note: A scan is considered surveillance if performed more than 6 months after completion of cancer therapy (12 months for lymphoma) in patients without objective signs or symptoms suggestive of cancer recurrence.
 
OTHER ONCOLOGIC INDICATIONS
 
HEPATOBILIARY CANCER
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
FDG-PET/CT for patients with hepatobiliary cancer meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
Diagnostic Workup
As clinically indicated in EITHER of the following:
      • When standard imaging studies are equivocal or non-diagnostic regarding the extent of disease; OR
      • When standard imaging prior to planned curative surgery for cholangiocarcinoma has been performed and has not demonstrated metastatic disease.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with hepatobiliary cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
      • Treatment management;
      • Screening and surveillance;
      • Any other indication not specifically listed above.
 
For members with contracts without primary coverage criteria, PET/CT for patients with hepatobiliary cancer is considered investigational for:
 
      • Treatment management;
      • Screening and surveillance;
      • Any other indication not specifically listed above.
 
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
MERKEL CELL CARCINOMA
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Merkel cell carcinoma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
Diagnostic Workup
As clinically indicated.
Treatment Management
As clinically indicated.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with Merkel cell carcinoma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
      • Screening and surveillance;
      • Any other indication not specifically listed as covered above.
 
For members with contracts without primary coverage criteria, PET/CT for patients with Merkel cell carcinoma is considered investigational for:
 
      • Screening and surveillance;
      • Any other indication not specifically listed as covered above.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
PARANEOPLASTIC SYNDROME
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Paraneoplastic Syndrome meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
Diagnostic Workup
Indicated for initial evaluation of individuals with Paraneoplastic Syndrome.
Treatment Management
Further management based on primary cancer identified.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with Paraneoplastic Syndrome does not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes for:
 
      • Screening and surveillance;
      • Any other indication not specifically listed as covered above.
 
For members with contracts without primary coverage criteria, PET/CT for patients with Paraneoplastic Syndrome is considered investigational for:
 
      • Screening and surveillance;
      • Any other indication not specifically listed as covered above.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
OTHER ONCOLOGIC APPLICATIONS
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
 
Other oncologic applications of PET scanning, unless addressed above or in a specific PET policy, do not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, other oncologic applications of PET scanning, unless addressed above or in a specific PET policy, are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to August 2021
 
CANCER SURVEILLANCE
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET scanning when used as a surveillance tool for patients with cancer or with a history of cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, PET scanning when used as a surveillance tool for patients with cancer or with a history of cancer is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Note: A scan is considered surveillance if performed more than 6 months after completion of cancer therapy (12 months for lymphoma) in patients without objective signs or symptoms suggestive of cancer recurrence.
 
OTHER ONCOLOGIC INDICATIONS
 
HEPATOBILIARY CANCER
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with hepatobiliary cancer meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
Diagnostic Workup
As clinically indicated in EITHER of the following:
      • When standard imaging studies are equivocal or non-diagnostic regarding the extent of disease; OR
      • When standard imaging prior to planned curative surgery for cholangiocarcinoma has been performed and has not demonstrated metastatic disease.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with hepatobiliary cancer does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
      • Treatment management;
      • Screening and surveillance;
      • Any other indication not specifically listed above.
 
For members with contracts without primary coverage criteria, PET/CT for patients with hepatobiliary cancer is considered investigational for:
 
      • Treatment management;
      • Screening and surveillance;
      • Any other indication not specifically listed above.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
MERKEL CELL CARCINOMA
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Merkel cell carcinoma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
Diagnostic Workup
As clinically indicated.
Treatment Management
As clinically indicated.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary
Coverage Criteria
 
PET/CT for patients with Merkel cell carcinoma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
      • Screening and surveillance;
      • Any other indication not specifically listed as covered above.
 
For members with contracts without primary coverage criteria, PET/CT for patients with Merkel cell carcinoma is considered investigational for:
 
      • Screening and surveillance;
      • Any other indication not specifically listed as covered above.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
PARANEOPLASTIC SYNDROME
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with Paraneoplastic Syndrome meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for:
 
Diagnostic Workup
Indicated for initial evaluation of individuals with Paraneoplastic Syndrome.
Treatment Management
Further management based on primary cancer identified.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET/CT for patients with Paraneoplastic Syndrome does not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes for:
 
      • Screening and surveillance;
      • Any other indication not specifically listed as covered above.
 
For members with contracts without primary coverage criteria, PET/CT for patients with Paraneoplastic Syndrome is considered investigational for:
 
      • Screening and surveillance;
      • Any other indication not specifically listed as covered above.
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
OTHER ONCOLOGIC APPLICATIONS
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Other oncologic applications of PET scanning, unless addressed above or in a specific PET policy, do not meet member benefit certificate primary coverage criteria of effectiveness in improving health outcomes.  
 
For members with contracts without primary coverage criteria, other oncologic applications of PET scanning, unless addressed above or in a specific PET policy, are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Rationale:
Cancer Surveillance
Clinical utility of PET scanning in surveillance, ie, in performing follow-up PET scans in asymptomatic patients to detect early disease recurrence, is not well-studied. (For this policy, a scan is considered a surveillance scan if performed more than 6 months after therapy [but 12 months for lymphoma].) The 2009 NCCN Task Force report (Podoloff et al, 2009) stated, “PET as a surveillance tool should only be used in clinical trials.” Additionally, NCCN guidelines for various malignancies often note that PET scans are not recommended in asymptomatic patients. For example, current NCCN guidelines for breast cancer comment that PET scans (as well as many other imaging modalities) provide no advantage in survival or ability to palliate recurrent disease and are not recommended (Podoloff et al, 2007 & 2009).  
 
Other Malignancies
There are inadequate scientific data to permit conclusions regarding the role of PET scanning in other malignancies.
December 2021 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
 
Hepatobiliary Cancer
 
DIAGNOSTIC WORKUP
Hepatobiliary cancer (including gallbladder cancer, cholangiocarcinoma and hepatocellular carcinoma) is staged using the American Joint Committee on Cancer TNM system.
 
Hepatocellular Carcinoma (HCC) The initial staging evaluation of suspected HCC should include either a multiphasic abdominal CT or MRI to establish the diagnosis and assess the burden of disease. The National Comprehensive Cancer Network (NCCN) also recommends CT or MRI if positive or rising serum AFP is found during HCC screening. (15)
 
A diagnosis of HCC can be made based on imaging criteria in patients at high risk for developing HCC; the most commonly used guidelines are published by the American Association for the Study of Liver Disease (AASLD), which incorporates the American College of Radiology (ACR) Liver Imaging Reporting and Data System (LI-RADS). (1) In a systematic review and meta-analysis evaluating the diagnostic performance of multidetector CT and MRI, the overall per-patient sensitivity of MR imaging was 88% (95% CI, 83%-92%) and per-patient specificity was 94% (95% CI, 85%-98%). An insufficient number of studies disallowed pooled analysis of CT for diagnostic accuracy and comparison to MRI, but the overall per-lesion sensitivity of MR imaging was higher than that of multidetector CT when the paired data of the 11 available studies were pooled (80% vs 68%, P = .0023). In addition, MRI sensitivity was further improved when gadoxetic acid-enhanced MR imaging was used. Sensitivity tends to be worse in both modalities for lesions < 1cm.2
 
Extrahepatic imaging should include CT of the chest and pelvis if not already done. Bone scan may be useful when clinical suspicion of bone metastases is high. In a retrospective study comparing PET and conventional imaging for initial diagnosis of HCC, PET identified additional metastases in 2.7% of patients with T2, 5.3% of patients with T3a (5.3%), and 4.8% of patients with T3b tumor classifications. (3) In a systematic review and meta-analysis, the pooled estimates of sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio of FDG PET for the detection of metastatic hepatocellular carcinoma were 76.6%, 98.0%, 14.68, and 0.28, respectively.4 Although PET imaging may provide prognostic information on the biological aggressiveness of the cancer, the low sensitivity restricts its usefulness. (5)
 
Cholangiocarcinoma and Gallbladder Cancer
In patients with suspected cholangiocarcinoma/gallbladder cancer, CT chest and multi-detector, multiphasic CT of the abdomen and pelvis should be performed to assess local disease, lymph nodes, and sites of distant metastases. If an intervention is not required and accurate imaging of the pancreatobiliary tract is needed to assess surgical resectability, an MRI abdomen with magnetic resonance cholangiopancreatography (MRCP) should be considered. MRCP has largely replaced endoscopic retrograde cholangiopancreatography (ERCP) as it provides better anatomical imaging, a non-invasive alternative with lower risk of complications, and at least equivalent accuracy.6-10 In a systematic review and meta-analysis comparing CT, MRI, and PET to assess for resectability of hilar cholangiocarcinoma, CT had the highest pooled sensitivity at 95% (95% CI, 91%-97%) and a pooled specificity of 69% (63%-75%). MRI had a pooled sensitivity of 94% (90%-97%) and a pooled specificity of 71% (60%-81%), whereas PET/CT had a pooled sensitivity of 91% (84%-96%), and the highest pooled specificity at 81% (95% CI, 69%-90%). The area under the curves (AUC) of CT, MRI, and PET/CT were 0.9269, 0.9194, and 0.9218, respectively. Overall, CT and MRI are comparable imaging modalities to assess resectability. (11) The data to support use of PET/CT for initial staging of cholangiocarcinoma is mixed, although some studies show a change in management of 17%-25%. (12-14) Overall, PET imaging has limited sensitivity for local evaluation of cholangiocarcinoma, although high specificity for detection of nodal and distant metastatic disease. Per NCCN recommendations, PET/CT may be considered when equivocal findings are seen by CT or MRI imaging and prior to planned resection.
 
MANAGEMENT
Response to treatment can be assessed with multiphasic CT or MRI of the abdomen, as both can assess intra-nodular arterial vascularity, a key feature of residual or recurrent tumor. Overall nodule size does not reliably indicate treatment response since a variety of factors may cause a successfully treated lesion to appear stable in size or even larger after treatment.
 
SURVEILLANCE
In patients treated with curative intent, follow-up for HCC includes CT or MRI imaging of the liver, and consideration for CT chest imaging. Monitoring of AFP is appropriate for HCC. AIM Oncologic Imaging guidelines are in concordance with the National Comprehensive Cancer Network Guidelines for Hepatobiliary Cancer. (15)
 
Current References
    1. Marrero JA, Kulik LM, Sirlin CB, et al. Diagnosis, staging, and management of hepatocellular carcinoma: 2018 practice guidance by the American Association for the Study of Liver Diseases. Hepatology. 2018;68(2):723-50. PMID: 29624699
    2. Lee YJ, Lee JM, Lee JS, et al. Hepatocellular carcinoma: diagnostic performance of multidetector CT and MR imaging-a systematic review and meta-analysis. Radiology. 2015;275(1):97-109. PMID: 5559230
    3. Cho Y, Lee DH, Lee YB, et al. Does 18F-FDG positron emission tomography-computed tomography have a role in initial staging of hepatocellular carcinoma? PLoS ONE. 2014;9(8):e105679. PMID: 25153834
    4. Lin CY, Chen JH, Liang JA, et al. 18F-FDG PET or PET/CT for detecting extrahepatic metastases or recurrent hepatocellular carcinoma: a systematic review and meta-analysis. Eur J Radiol. 012;81(9):2417-22. PMID: 21899970
    5. Sun DW, An L, Wei F, et al. Prognostic significance of parameters from pretreatment (18)F-FDG PET in hepatocellular carcinoma: a meta-analysis. Abdom Radiol. 2016;41(1):33-41. PMID: 26830609
    6. Hyodo T, Kumano S, Kushihata F, et al. CT and MR cholangiography: advantages and pitfalls in perioperative evaluation of biliary tree. Br J Radiol. 2012;85(1015):887-96. PMID: 22422383
    7. Szklaruk J, Tamm E, Charnsangavej C. Preoperative imaging of biliary tract cancers. Surg Oncol Clin N Am. 2002;11(4):865-76. PMID: 12607576
    8. Vogl TJ, Schwarz WO, Heller M, et al. Staging of Klatskin tumours (hilar cholangiocarcinomas): comparison of MR cholangiography, MR imaging, and endoscopic retrograde cholangiography. Eur Radiol. 2006;16(10):2317-25. PMID: 16622690
    9. Yeh TS, Jan YY, Tseng JH, et al. Malignant perihilar biliary obstruction: magnetic resonance cholangiopancreatographic findings. Am J Gastroenterol. 2000;95(2):432-40. PMID: 10685746
    10. Zidi SH, Prat F, Le Guen O, et al. Performance characteristics of magnetic resonance cholangiography in the staging of malignant hilar strictures. Gut. 2000;46(1):103-6. PMID: 10601064
    11. Zhang H, Zhu J, Ke F, et al. Radiological imaging for assessing the respectability of hilar cholangiocarcinoma: a systematic review and meta-analysis. Biomed Res Int. 2015;2015:497942. PMID: 26448940
    12. Corvera CU, Blumgart LH, Akhurst T, et al. 18F-fluorodeoxyglucose positron emission tomography influences management decisions in patients with biliary cancer. J Am Coll Surg. 2008;206(1):57-65. PMID: 18155569
    13. Petrowsky H, Wildbrett P, Husarik DB, et al. Impact of integrated positron emission tomography and computed tomography on staging and management of gallbladder cancer and cholangiocarcinoma. J Hepatol. 2006;45(1):43-50. PMID: 16690156
    14. Ruys AT, Bennink RJ, van Westreenen HL, et al. FDG-positron emission tomography/computed tomography and standardized uptake value in the primary diagnosis and staging of hilar cholangiocarcinoma. HPB. 2011;13(4):256-62. PMID: 21418131
    15. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers (Version 1.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
Merkel Cell Carcinoma
DIAGNOSTIC WORKUP AND MANAGEMENT
Merkel cell carcinoma is staged using the American Joint Committee on Cancer TNM system. Merkel cell carcinoma is a highly aggressive cancer and up to 8% of patients will present with metastases. (1) Results from a single institution study showed that PET resulted in upstaging in 17% and downstaging in 5% of patients with an overall management change in 37% of patients. A second single institution study also found that PET resulted in upstaging of 16% of patients. (2) A meta-analysis of 6 studies (N =92 patients) showed PET had a sensitivity of 90% (95% CI, 80%-96%) and specificity of 98%. (3) Asymptomatic brain metastases are fairly rare and routine use of MRI is not recommended. (4) The NCCN recommends sentinel lymph node detection in patients with clinically lymph node-negative Merkel cell carcinoma. Sentinel lymph node biopsy is an important staging tool. This procedure and subsequent treatment impact for regional control for patients with positive sentinel lymph node, but the impact of sentinel lymph node biopsy on overall survival is unclear. If sentinel lymph node biopsy is not performed concurrently, it is recommended that sentinel lymph node biopsy be performed prior to definitive excision with exhaustive histologic margin assessment (ie, Mohs micrographic surgery). (5)
 
SURVEILLANCE
Most recurrences of Merkel cell carcinoma occur within the first 2 years. In high-risk patients, routine surveillance with CT neck, chest, abdomen, and pelvis with contrast can be considered for the first 3 years although there is limited data to support this recommendation.
 
Current References
    1. Harms KL, Healy MA, Nghiem P, et al. Analysis of prognostic factors from 9387 Merkel cell carcinoma cases forms the basis for the new 8th edition AJCC Staging System. Ann Surg Oncol. 2016;23(11):3564-71. PMID: 27198511
    2. Hawryluk EB, O'Regan KN, Sheehy N, et al. Positron emission tomography/computed tomography imaging in Merkel cell carcinoma: a study of 270 scans in 97 patients at the Dana-Farber/Brigham and Women's Cancer Center. J Am Acad Dermatol. 2013;68(4):592-9. PMID: 23127473
    3. Treglia G, Kakhki VR, Giovanella L, et al. Diagnostic performance of fluorine-18-fluorodeoxyglucose positron emission tomography in patients with Merkel cell carcinoma: a systematic review and meta-analysis. Am J Clin Dermatol. 2013;14(6):437-47. PMID: 23959776
    4. Alexander E, 3rd, Rossitch E, Jr., Small K, et al. Merkel cell carcinoma: long term survival in a patient with proven brain metastasis and presumed choroid metastasis. Clin Neurol Neurosurg. 1989;91(4):317-20. PMID: 2555091
    5. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Merkel Cell Carcinoma Version 1.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
Paraneoplastic Syndrome
Paraneoplastic disease is a rare manifestation of cancer that is not related directly to tumor involvement, metastases, or metabolic derangements. Autoantibodies have been identified as a cause in up to 60% of the recognized syndromes attributed to paraneoplastic disease. (1) In many cases, symptoms occur prior to discovery of the primary tumor. The most common presentations are neurologic (central or peripheral), but paraneoplastic disease also manifests in muscle and other soft tissue. The most common malignancies associated with paraneoplastic disease are small cell lung cancer, thymoma, and hematologic cancers. (2)
 
DIAGNOSTIC WORKUP
PET/CT has been found to be more accurate than CT in the detection of occult malignancy associated with paraneoplastic syndrome. In a retrospective study, PET outperformed CT by 50%. The sensitivity and specificity of PET compared to CT were 80% and 67%, vs 30% and 71%, respectively. (3) Another retrospective study from the same institution found that PET/CT detected an additional 18% of cancers in patients with CT-negative paraneoplastic disease. (4) In a review and meta-analysis of 21 studies, PET imaging demonstrated high diagnostic accuracy and moderate to high sensitivity (81%) and specificity (86%) for detection of underlying malignancy in suspected paraneoplastic syndrome. (5)
 
SURVEILLANCE
The benefit of advanced imaging for surveillance of paraneoplastic syndrome without an identified malignancy has not been demonstrated. The European Federation of Neurological Sciences endorses continued surveillance with repeat screening every 6 months for up to 4 years. (6)
 
Current References
    1. Kannoth S. Paraneoplastic neurologic syndrome: a practical approach. Ann Indian Acad Neurol. 2012;15(1):6-12. PMID: 22412264
    2. Titulaer MJ, Soffietti R, Dalmau J, et al. Screening for tumours in paraneoplastic syndromes: report of an EFNS task force. Eur J Neurol. 2011;18(1):19-e3. PMID: 20880069
    3. Patel RR, Subramaniam RM, Mandrekar JN, et al. Occult malignancy in patients with suspected paraneoplastic neurologic syndromes: value of positron emission tomography in diagnosis. Mayo Clin Proc. 2008;83(8):917-22. PMID: 18674476
    4. McKeon A, Apiwattanakul M, Lachance DH, et al. Positron emission tomography-computed tomography in paraneoplastic neurologic disorders: systematic analysis and review. Arch Neurol. 2010;67(3):322-9. PMID: 20065123
    5. Sheikhbahaei S, Marcus CV, Fragomeni RS, et al. Whole-body 18F-FDG PET and 18F-FDG PET/CT in patients with suspected paraneoplastic syndrome: a systematic review and meta-analysis of diagnostic accuracy. J Nucl Med. 2017;58(7):1031-6. PMID: 27980049
    6. Sheikhbahaei S, Trahan TJ, Xiao J, et al. FDG-PET/CT and MRI for evaluation of pathologic response to neoadjuvant chemotherapy in patients with breast cancer: a meta-analysis of diagnostic accuracy studies. Oncologist. 2016;21(8):931-9. PMID: 27401897
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement.
 
NCCN Guidelines for Hepatobiliary Cancers and Merkel Carcinoma, Version .2022 were reviewed with no change from Version 2021 with regard to PET applications in Hepatobiliary Cancers and Merkel Carcinoma.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through November 2023. No new literature was identified that would prompt a change in the coverage statement.
CPT/HCPCS:
78811Positron emission tomography (PET) imaging; limited area (eg, chest, head/neck)
78812Positron emission tomography (PET) imaging; skull base to mid thigh
78813Positron emission tomography (PET) imaging; whole body
78815Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; skull base to mid thigh
78816Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; whole body
A9597Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified
A9598Positron emission tomography radiopharmaceutical, diagnostic, for non tumor identification, not otherwise classified
References: National Comprehensive Cancer Network(2022) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers (Version 1.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.

National Comprehensive Cancer Network(2022) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Merkel Cell Carcinoma (Version 2.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.

Podoloff DA, Advani RH, Allred C, et al.(2007) 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

Podoloff DA, Ball DW, Ben-Josef E, et al.(2009) NCCN task force: clinical utility of PET in a variety of tumor types. J Natl Compr Canc Netw. 2009;7(suppl 2):S1-26.
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association.