Coverage Policy Manual
Policy #: 2005008
Category: Radiology
Initiated: February 2005
Last Review: January 2024
  PET or PET/CT for Pleural Mesothelioma
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.  
 
Malignant pleural mesothelioma is rare and even more rarely discovered at a stage for which aggressive therapy is feasible.  Patients with mesothelioma are now being treated with  triple-modality therapy involving extrapleural pneumonectomy, adjuvant (or neoadjuvant) chemotherapy and high-dose adjuvant radiotherapy.  Significant mortality, up to 30%, associated with this approach makes careful preoperative staging especially important.  PET imaging appears, in several small studies, to be of value in staging intrathoracic disease.  It's utility in the diagnosis of mesothelioma has not been shown in medical literature.  PET in the evaluation of peritoneal mesothelioma has not been shown to be useful.
 
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 APRIL 09, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with pleural mesothelioma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for patients for:
Diagnostic Workup:
Indicated:
      • For surgical evaluation of malignant pleural mesothelioma (clinical stage I-IIIA and epithelioid histology), after CT chest and abdomen
Management:
Indicated in EITHER of the following scenarios:
      • Radiation planning for definitive treatment
      • Restaging after induction chemotherapy if patient is a surgical candidate
 
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
 
PET/CT for patients with pleural mesothelioma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for any other indication not listed as covered above including but not limited to:
    • Surveillance*
For contracts without primary coverage criteria, PET/CT for patients with pleural mesothelioma is considered investigational and is not covered 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.
 
 
Effective March 13, 2022 to April 08, 2023
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
FDG-PET/CT for patients with pleural mesothelioma meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for patients for:
Diagnostic Workup:
      • Indicated when surgical resection is being considered and metastatic disease has not been detected by CT or MRI
Management:
Indicated in EITHER of the following scenarios:
      • Radiation planning for definitive treatment
      • Restaging after induction chemotherapy if patient is a surgical candidate
 
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
 
PET/CT for patients with pleural mesothelioma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for any other indication not listed as covered above including but not limited to:
    • Surveillance*
For contracts without primary coverage criteria, PET/CT for patients with pleural mesothelioma is considered investigational and is not covered 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 (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.
 
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
FDG-PET/CT for patients with Pleural Mesothelioma meets member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for:  
Diagnostic Workup:  ⬚
      • When surgical resection is being considered and metastatic disease has not been detected by CT or MRI
Treatment Management:  
Indicated in EITHER of the following scenarios:
      • Radiation planning for definitive treatment
      • Restaging after induction chemotherapy if patient is a surgical candidate
 
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
PET/CT for patients with Pleural Mesothelioma does not meet member benefit certificate primary coverage criteria for effectiveness in improving health outcomes for:
    • for screening and surveillance*
    • for any other indication not specifically listed as covered above
 
*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 members with contracts without primary coverage criteria, PET/CT for patients with Pleural Mesothelioma is considered investigational:  
    • for screening and surveillance
    • for any other indication not specifically listed as covered above
Investigational services are Plan exclusions.
 
Note:  
Standard or conventional imaging refers to imaging that does not require a PET/CT.
CT/MRI is usually considered first-line imaging.  
 
Effective Prior to August 2021
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
“PET scan” refers to FDG PET or PET/CT.
 
Positron emission tomography (PET) meets primary coverage criteria for effectiveness and is covered one time for the staging of biopsy-proven pleural mesothelioma when the patient is being evaluated for curative surgery.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
PET or PET CT is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for:
  • PET or PET CT for diagnosis of pleural or peritoneal mesothelioma or for evaluation of residual or recurrent disease,
  • PET or PET CT for monitoring response to therapy of mesothelioma
  • for surveillance of asymptomatic patients with no clinical, laboratory, or radiological evidence of recurrence
 
For contracts without primary coverage criteria, the following uses of PET scanning are considered investigational and are not covered:
  • PET or PET CT for diagnosis of pleural or peritoneal mesothelioma or for evaluation of residual or recurrent disease
  • PET or PET CT for monitoring response to therapy of mesothelioma for effectiveness as there are no studies which indicate improvement in health outcomes.
  • PET or PET CT for surveillance of asymptomatic patients with no clinical, laboratory, or radiological evidence of recurrence as there are no studies which indicate improvement in health outcomes.
 
Investigational services are exclusion in the member benefit contract
Rationale:
2012 Update:
Extrapleural pneumonectomy (EPP) in malignant pleural mesothelioma (MPM) may be limited and careful preoperative staging identifying resectable patients is important. The objectives of a study by Sørensena  and colleagues (2008) were to compare CT scan, 18F-FDG PET/CT scan (PET/CT), and mediastinoscopy to each other and to surgical–pathological findings. Selected patients had epithelial subtype MPM, age ≤70 years, and lung function test allowing pneumonectomy. Preoperative staging after 3–6 courses of induction chemotherapy included conventional CT scan, PET/CT, and mediastinoscopy. Surgical–pathological findings were compared to preoperative findings.  Results of the study:  Non-curative surgery was avoided in 29% out of 42 MPM patients by preoperative PET/CT and in further 14% by mediastinoscopy.  In conclusion, 18F-FDG PET/CT increases the accuracy of staging in MPM, improves the selection of patients for EPP and avoids a significant number of futile operations.  Even though both procedures are valuable, there were false negative findings with both.
 
Roca and colleagues (2012) published a report on the use of 18F-FDG PET for use in malignant mesothelioma (MM) and noted that 18F-FDG PET/computed tomography (CT) has become an invaluable tool for the diagnosis, staging, and prognosis of MM as it combines both anatomic and functional information in a single imaging procedure, allowing for improved management of this disease. For many authors, 18F-FDG-PET/CT is the cornerstone of the pre-therapeutic evaluation of mesothelioma patients, particularly when multimodal therapy (including extra-pleural pneumonectomy or omentectomy) is considered. The authors noted that false negative findings are possible during the initial diagnosis or during the patient's surveillance.  This report highlighted the limitations of PET/CT in the diagnostic evaluation of MM and the importance of histopathological confirmation by thoracoscopy and/or laparoscopy, which remain the most important diagnostic procedures in MM.
 
In summary, further development of accurate, preferably non-invasive, staging methods in malignant mesothelioma is needed.
 
2014 Update
 
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
 
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement.
  
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.
 
2022 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
 
DIAGNOSTIC WORKUP
MRI has been shown to be superior to CT for evaluating solitary foci of chest wall invasion, endothoracic fascial  involvement, and diaphragmatic muscle invasion.1MRI should be considered for suspected chest wall, spinal, diaphragmatic, or vascular involvement based on CT. Although not highly accurate at staging T4 disease or N2lymphadenopathy, PET plays a role in detection of extra-thoracic disease, eliminating the need for surgery in 16%-40% of patients.2-6 For thymoma or thymic carcinoma, MRI chest may help differentiate benign cysts and thymoma from thymic carcinoma, thus avoiding the need for surgery.7, 8 PET can be used for initial staging to differentiate low grade thymoma from FDG-avid thymic carcinoma.8, 9 In a small number of patients (6%), PET identified unresectable metastatic disease not detected by CT.9, 10 In a review of 14 studies, PET/CT was able to consistently differentiatebenign and malignant disease and detect extrathoracic metastases. Results were mixed regarding correlation with theMasaoka staging system for thymoma, which is based on tumor invasion and metastases.11
 
MANAGEMENT
The American Society for Clinical Oncology recommends CT with assessment of response of malignant pleural mesothelioma based on the RECIST criteria.
 
SURVEILLANCE
American Society for Clinical Oncology and the National Comprehensive Cancer Network (NCCN) guidelines do not address surveillance imaging for asymptomatic malignant pleural mesothelioma. In most cases, CT should provide adequate information for routine surveillance. Oncologic Imaging guidelines are in concordance with the NCCN Guidelines® for Thymomas and Thymic Carcinomas, NCCN Guidelines® for Malignant Pleural Mesothelioma, and the American Society for Clinical Oncology guidelines for evaluation of malignant pleural mesothelioma. (12-14)
 
Current References
    1. Heelan RT, Rusch VW, Begg CB, et al. Staging of malignant pleural mesothelioma: comparison of CT and MR imaging. AJR Am J Roentgenol. 1999;172(4):1039-47. PMID: 10587144
    2. Flores RM, Akhurst T, Gonen M, et al. Positron emission tomography defines metastatic disease but not locoregional disease in patients with malignant pleural mesothelioma. J Thorac Cardiovasc Surg. 2003;126(1):11-6. PMID: 12878934
    3. Sharif S, Zahid I, Routledge T, et al. Does positron emission tomography offer prognostic information in malignant pleural mesothelioma? Interact Cardiovasc Thorac Surg. 2011;12(5):806-11. PMID: 21266493
    4. Sorensen JB, Ravn J, Loft A, et al. Preoperative staging of mesothelioma by 18F-fluoro-2-deoxy-D-glucose positron emission tomography/computed tomography fused imaging and mediastinoscopy compared to pathological findings after extrapleural pneumonectomy. Eur J Cardiothorac Surg. 2008;34(5):1090-6. PMID:18799318
    5. Wilcox BE, Subramaniam RM, Peller PJ, et al. Utility of integrated computed tomography-positron emission tomography for selection of operable malignant pleural mesothelioma. Clin Lung Cancer. 2009;10(4):244-8. PMID: 19632941
    6. Zahid I, Sharif S, Routledge T, et al. What is the best way to diagnose and stage malignant pleural mesothelioma? Interact Cardiovasc Thorac Surg. 2011;12(2):254-9. PMID: 21044972
    7. Abdel Razek AA, Khairy M, Nada N. Diffusion-weighted MR imaging in thymic epithelial tumors: correlation with World Health Organization classification and clinical staging. Radiology.2014;273(1):268-75. PMID: 24877982
    8. Yabuuchi H, Matsuo Y, Abe K, et al. Anterior mediastinal solid tumours in adults: characterisation using dynamic contrast-enhanced MRI, diffusion-weighted MRI, and FDG-PET/CT. Clin Radiol.2015; 70(11):1289-98. PMID:26272529
    9. Treglia G, Sadeghi R, Giovanella L, et al. Is (18)F-FDG PET useful in predicting the WHO grade of malignancy in thymic epithelial tumors? a meta-analysis. Lung Cancer. 2014;86(1):5-13. PMID: 25175317
    10. Sung YM, Lee KS, Kim BT, et al. 18F-FDG PET/CT of thymic epithelial tumors: usefulness for distinguishing and staging tumor subgroups. J Nucl Med. 2006;47(10):1628-34. PMID: 17015898
    11. Viti A, Terzi A, Bianchi A, et al. Is a positron emission tomography-computed tomography scan useful in the staging of thymic epithelial neoplasms? Interact Cardiovasc Thorac Surg. 2014;19(1):129-34. PMID: 24648467
    12. Kindler HL, Ismaila N, Armato SG, 3rd, et al. Treatment of malignant pleural mesothelioma: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2018;36(13):1343-73. PMID: 9346042
    13. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Malignant Pleural Mesothelioma (Version 2.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
    14. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Thymomas and Thymic Carcinomas (Version 1.2021). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2021.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022.
 
NCCN Guidelines for Malignant Pleural Mesothelioma (Version 2022) were reviewed with no change from Version 2021 with regard to PET applications.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2023.
 
NCCN Guidelines for Malignant Pleural Mesothelioma (Version 2023) were reviewed with no change from Version 2022 with regard to PET applications.
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: Sørensena JB,, Ravnb J, Loftc A, et al.(2008) Preoperative staging of mesothelioma by 18F-fluoro-2-deoxy-d-glucose positron emission tomography/computed tomography fused imaging and mediastinoscopy compared to pathological findings after extrapleural pneumonectomy Eur J Cardiothorac Surg. 2008 Nov;34(5):1090-6.

Flores RM, Akhurst T, et al.(2003) Positron emission tomography defines metastatic disease but not locoregional disease in patients with malignant pleural mesothelioma. J Thorac Cardiovasc Surg 2003; 126:11-6.

Marom EM, Erasmus JJ, et al.(2002) The role of imaging in malignant pleural mesothelioma. Semin Oncol 2002; 29:26-35.

Nanni C, Castellucci P, et al.(2004) Role of 18F-FDG PET for evaluating malignant pleural mesothelioma. Cancer Biother Radiopharm 2004; 19:149-54.

National Comprehensive Cancer Network(2022) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Malignant Pleural Mesothelioma (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 Thymomas and Thymic Carcinomas (Version 2.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.

National Comprehensive Cancer Network.(2023) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Malignant Pleural Mesothelioma (Version 1.2023). Available at http://www.nccn.org.

National Comprehensive Cancer Network.(2023) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Thymomas and Thymic Carcinomas (Version 2.2023). Available at http://www.nccn.org.

Roca E, Laroumagne S, Vandemoortele T, et al.(2012) 18F-fluoro-2-deoxy-d-glucose positron emission tomography/computed tomography fused imaging in malignant mesothelioma patients: Looking from outside is not enough. Lung Cancer. 2012 Nov 30. pii: S0169-5002(12

Wang ZJ, Reddy GP, et al.(2004) Malignant pleural mesothelioma: evaluation with CT, MR imaging, and PET. Radiographics 2004; 24:105-19.
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.