Coverage Policy Manual
Policy #: 2001038
Category: Radiology
Initiated: December 1999
Last Review: November 2023
  PET or PET/CT for Pancreatic Cancer
Description:
Note:  This policy is intended for those members with contracts that do not have requirements for prior approval for imaging procedures through an independent imaging review organization.
 
 
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.
 
PET scans for patients with pancreatic cancer or suspected pancreatic cancer have been proposed for the following indications:
    • To distinguish malignant from non-malignant pancreatic masses;
    • To stage the extent of disease prior to therapy;
    • To evaluate suspected persistence or recurrence of disease;
    • To monitor the effect of therapy; and
    • To evaluate prognosis.
 
A negative scan in a patient with suspected cancer of the pancreas has a negative predictive value of only 80% to 85%, and would therefore not eliminate the need for biopsy.  A positive scan has a specificity of 90%, indicating that 10% of patients with a positive scan would not have malignancy.
 
Few studies have addressed the accuracy of PET in detecting metastases to locoregional nodes.  The studies that have show a sensitivity of only 49% - 76% and a specificity of 63% to 91%.  The sensitivity is affected by small volume of metastatic cells, and specificity is reduced by inflammation.
 
Studies on monitoring the effect of therapy have included few patients and none of the studies have described improvement in health outcome as a result.
 
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 MARCH 13, 2022
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT scanning for patients with Pancreatic Cancer meets primary coverage criteria for effectiveness and is covered for:
 
Diagnostic Workup
      • Indicated when ALL of the following are true:
        • Dedicated, high-quality imaging of the pancreas has been performed; AND
        • Extra-pancreatic disease has not been clearly identified; AND
        • ANY of the following high-risk features are present:
            • Cancer antigen 19-9 level greater than 100 U/ml
            • Primary tumor greater than 2 cm in size
            • Enlarged regional nodes o Tumor is considered borderline resectable
Management
Indicated in EITHER of the following scenarios:
      • Radiation planning for preoperative or definitive treatment in patients without distant metastasis
      • Standard imaging cannot be performed or is nondiagnostic for recurrent or progressive disease
 
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, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Positron emission tomography (PET) for patients with Pancreatic 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 indication or any circumstance other than those listed above including but not limited to:
    • Surveillance*
 
For members with contracts without primary coverage criteria, Positron emission tomography (PET) for patients with Pancreatic Cancer is considered investigational for any indication or any circumstance other than those listed above including but not limited to
    • Surveillance*
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
*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, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
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
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Positron emission tomography (PET) scanning meets primary coverage criteria for effectiveness and is covered for patients with pancreatic cancer for:
 
Initial treatment: Detection of extra-pancreatic disease in candidates for resection when all of the following criteria are met:
 
    • Dedicated high quality pancreatic imaging has been performed; AND
    • No clear extra-pancreatic disease has been identified; AND
    • Documentation of one of the following high-risk features:
 
      • CA 19-9 >100 U/ml, or
      • primary tumor > 2cm, or  
      • enlarged regional nodes, or
      • tumor considered borderline resectable
 
Subsequent treatment: Detection of recurrent or progressive disease when standard imaging is equivocal or non-diagnostic.
 
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, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Positron emission tomography (PET) of patients with pancreatic cancer for any other indication not listed above is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
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, please see ABCBS policy 2021004, Surveillance and Other PET Oncologic Applications.
 
For contracts without primary coverage criteria, positron emission tomography (PET) of patients with pancreatic cancer for any other indication not listed above is considered investigational.  Investigational services are specific contract exclusions in the member benefit certificate of coverage.
 
Effective October 2012 to October 2019
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
PET or PET/CT meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for initial staging of cancer of the pancreas, and to determine optimum site of diagnostic testing, if other tests are unrewarding (e.g., ultrasound, CT).
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET or PET/CT for any other indication related to the diagnosis of carcinoma of the pancreas is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, PET or PET/CT for any other indication related to the diagnosis of carcinoma of the pancreas is considered investigational. Investigational services are specific contract exclusions in the member benefit certificate of coverage.
 
Effective prior to October 2012
Positron emission tomography scanning for the differential diagnosis of carcinoma of the pancreas or for any other indication related to the diagnosis of carcinoma of the pancreas is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, positron emission tomography scanning for the differential diagnosis of carcinoma of the pancreas or for any other indication related to the diagnosis of carcinoma of the pancreas is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
 
PET Scans (Positron Emission Tomography) are not covered for any diagnosis other than those that are addressed through specific policy.  Specific coverage policies are listed individually.
Rationale:
2012 Update
The 2008 AHRQ technology assessment of PET for nine cancers (including pancreatic), done by the University of Alberta Evidence-based Practice Center, concluded that management plan (initial staging) was altered in up to 69% of patients, more often resulting in a conservative course of management thus avoiding unnecessary surgery (Ospina, 2008).  Only one study involving 15 patients evaluated patient-centered outcomes, and the tech assessment concluded that the value of FDG-PET in terms of patient-centered outcomes remains unclear.
 
In 2009 Podoloff and colleagues concluded that PET surpasses CT for diagnostic accuracy, and can differentiate malignant tumors from benign cysts or pancreatitis (Podoloff, 2009).  They felt that the clinical efficacy of FDG-PET/CT for diagnosis is questionable, but that although biopsy may provide a tissue diagnosis, this technique is associated with significant sampling error.  FDG-PET/CT may represent a useful add-on diagnostic tool in the evaluation of patients with suspected pancreatic cancer, especially when CT and biopsy results are inconclusive.  PET is more useful in staging.  
 
The policy statement has been changed to include a coverage statement for initial staging of cancer of the pancreas, and to determine optimum site of diagnostic testing.
 
2014 Update  
 
A literature search conducted through April 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Recent NCCN guidelines indicate “the role of PET-CT remains unclear” (NCCN, 2014) The guidelines state PET-CT “may be considered after formal pancreatic CT protocol in high-risk patients to detect extra pancreatic metastasis.”
  
2015 Update
 
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In meta-analysis of 9 studies (total N=526), Rijkers and colleagues reported pooled sensitivity and specificity of FDG-PET/CT for confirming suspected pancreatic cancer of 0.90 (95% CI, 0.87 to 0.93) and 0.76 (95% CI, 0.66 to 0.84), respectively (Rijkers, 2014).
 
Current NCCN guidelines state that “the role of PET/CT remains unclear [PET/CT] may be considered after formal pancreatic CT protocol in high-risk patients to detect  extra pancreatic metastasis.” (NCCN, 2014)
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
A literature search was conducted through February 2020.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through January 2021. No new literature was identified that would prompt a change in the coverage statement.
 
November 2021 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
 
DIAGNOSTIC WORKUP
Pancreatic cancer is staged using the American Joint Committee on Cancer TNM system. The Society of Abdominal Radiology and the American Pancreatic Association recommend a dedicated pancreatic CT, performed with multidetector CT angiography using a dual-phase pancreatic protocol.1 CT using this protocol has demonstrated sensitivity of 89%-97% for diagnosis and a positive predictive value for assessing resectability of 89%-100%. Although a high-quality CT abdomen may suffice in some circumstances, comparison studies have found that scans performed with pancreatic protocol have changed staging and management in up to 56% of cases. (2)
 
MRI is most commonly used as a problem-solving tool, particularly for CT-indeterminate liver lesions, when CT-occult pancreatic tumors are suspected or when contrast enhanced CT cannot be done. (1) Accuracy of MRI abdomen is similar to that for CT with pancreatic protocol. In a 2016 meta-analysis reviewing different imaging modalities, the pooled sensitivity was 89% and the specificities were 90% and 89% for MRI and CT, respectively. (3)
 
PET/CT has been studied as an adjunctive staging modality. The sensitivity of detecting metastatic disease for PET/CT alone, standard CT alone, and the combination of PET/CT and CT were 61%, 57%, and 87%, respectively. PET/CT influenced the clinical management in 11% of cases. (4) Treadwell et al reported no statistically significant difference in sensitivity or specificity in a pooled analysis of six studies comparing PET scan to CT scan for initial treatment staging. (3) A 2017 meta-analysis of 16 articles concluded that high pretreatment PET standardized uptake values predicted poorer event-free survival and overall survival. (5)
 
MANAGEMENT
There is limited data comparing imaging modalities for post-treatment assessment. One study found that multidetector CT underestimates resectability, but no additional studies exist assessing accuracy for evaluation of lymph node and systemic metastases. Limited information is available for MRI or PET/CT in this setting. (6) In a pooled analysis of the phase III MPACT (Molecular Profiling-based targeted therapy in treating patients with Advanced solid Tumors) trial, response by PET after chemotherapy was associated with improved survival regardless of regimen used (11.3 vs 6.9 months; HR 0.56; P< .001). (7)
 
SURVEILLANCE
A study using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database showed no survival benefit to annual CT surveillance.8 Thus, surveillance CT scans (chest, abdomen, pelvis) with contrast after surgical resection is a category 2B recommendation from the NCCN. (9)
 
 
Current References
    1. Al-Hawary MM, Francis IR, Chari ST, et al. Pancreatic ductal adenocarcinoma radiology reporting template: consensus statement of the society of abdominal radiology and the american pancreatic association. Gastroenterology. 2014;146(1):291-304.e1. PMID: 24355035
    2. Walters DM, Lapar DJ, de Lange EE, et al. Pancreas-protocol imaging at a high-volume center leads to improved preoperative staging of pancreatic ductal adenocarcinoma. Ann Surg Oncol. 2011;18(10):2764-71. PMID:21484522
    3. Treadwell JR, Zafar HM, Mitchell MD, et al. Imaging tests for the diagnosis and staging of pancreatic adenocarcinoma: a meta-analysis. Pancreas. 2016;45(6):789-95. PMID: 26745859
    4. Farma JM, Santillan AA, Melis M, et al. PET/CT fusion scan enhances CT staging in patients with pancreatic neoplasms. Ann Surg Oncol. 2008;15(9):2465-71. PMID: 18551347
    5. Zhu D, Wang L, Zhang H, et al. Prognostic value of 18F-FDG-PET/CT parameters in patients with pancreatic carcinoma: a systematic review and meta-analysis. Medicine (Baltimore). 2017;96(33):e7813. PMID: 28816978
    6. Qayyum A, Tamm EP, Kamel IR, et al. ACR Appropriateness Criteria® staging of pancreatic ductal adenocarcinoma. J Am Coll Radiol. 2017;14(11S):S560-S9. PMID: 29101993
    7. Ramanathan RK, Goldstein D, Korn RL, et al. Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas. Ann Oncol. 2016;27(4):648-53. PMID: 26802153
    8. Witkowski ER, Smith JK, Ragulin-Coyne E, et al. Is it worth looking? abdominal imaging after pancreatic cancer resection: a national study. J Gastrointest Surg. 2012;16(1):121-8. PMID: 21972054
    9. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pancreatic Adenocarcinoma (Version 2.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
 
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.
 
SURVEILLANCE
NCCN recommends surveillance every 3-6 months for 2 years, then every 6-12 months as clinically indicated, including CT scans (chest and CT or MRI of, abdomen and, pelvis) with contrast (category 2A recommendation) from the NCCN. (8)
 
New Reference  
(8) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pancreatic Adenocarcinoma (Version 1.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 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
78814Positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization imaging; limited area (eg, chest, head/neck)
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
References: National Comprehensive Cancer Network.(2014) Clinical Practice Guidelines in Oncology. Pancreatic Adenocarcinoma V1.2015. . http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed December 11, 2014.

National Comprehensive Cancer Network(2022) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pancreatic Adenocarcinoma (Version 1.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.

National Comprehensive Cancer Network.(2014) Clinical Practice Guidelines in Oncology. Pancreatic Adenocarcinoma V1.2014. Available online at: http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Last accessed January, 2014.

Ospina MB, Horton J, Seida J et al.(2008) Positron emission tomography for nine cancers (bladder, brain, cervical, kidney, ovarian, pancreatic, prostate, small cell lung, testicular). Technology Assessment Report Project ID: PETC1207. Agency for Healthcare Research and Quality. December 2008.

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.

Rijkers AP, Valkema R, Duivenvoorden HJ, et al.(2014) Usefulness of F-18-fluorodeoxyglucose positron emission tomography to confirm suspected pancreatic cancer: a meta-analysis. Eur J Surg Oncol. Jul 2014;40(7):794-804. PMID 24755095
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.
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