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PET or PET/CT for Melanoma | |
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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 melanoma have been studied for two indications:
When compared to sentinel node biopsy for indication #1, PET is far less accurate than sentinel node biopsy, detecting only 17% of the nodes found to be positive by sentinel node biopsy.
The sensitivity of PET for detecting extranodal disease ranges between 89% and 96%, and the specificity ranges between 67% and 94%. Sensitivity for detecting lung metastases may be less than the sensitivity for detecting other sites of spread as two studies reported identification of lung metastases in 15% and 70%.
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:
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.
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Policy/ Coverage: |
EFFECTIVE 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 Cutaneous or Mucosal Melanoma for:
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 for patients with Cutaneous or Mucosal Melanoma 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, Positron emission tomography (PET) scanning for patients with Cutaneous or Mucosal Melanoma is considered investigational and is not covered for any indication or any circumstance other than those listed above including but not limited to:
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
FDG-PET/CT scanning meets primary coverage criteria for effectiveness and is covered for patients with cutaneous melanoma for:
Initial Treatment:
Subsequent treatment:
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 Cutaneous melanoma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes:
*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 Cutaneous melanoma is considered investigational:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to August 2021
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 cutaneous melanoma for:
Initial Treatment:
Subsequent treatment:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
PET scanning for patients with cutaneous melanoma does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for the following:
For members with contracts without primary coverage criteria, PET scanning for patients with cutaneous melanoma is considered investigational for the following:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to October 2019
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Rationale: |
Melanoma
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement.
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
PET-CT may be used for staging and restaging for more advanced disease such as stage III. PET-CT is not recommended for stage I or II disease (NCCN, 2014).
2015 Update
A literature search conducted through September 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=623), Rodriquez Rivera et al reported pooled sensitivity and specificity of FDG-PET for detecting systemic metastases in patients with stage III cutaneous melanoma of 0.89 (95% CI, 0.65 to 0.98) and 0.89 (95% CI, 0.77 to 0.95), respectively (Rodriguez, 2014).
Current NCCN guidelines for melanoma indicate that PET/CT may be used for staging and restaging for more advanced disease, such as stage III, in the presence of specific signs and symptoms. PET/CT is not recommended for stage I or II disease (NCCN, 2015). PET/CT also is listed as an option for surveillance screening for recurrent or metastatic disease.
2017 Update
A literature search conducted through September 2017 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.
November 2021 Update
A literature review was performed through September 2021. Following is a summary of the key literature to date.
DIAGNOSTIC WORKUP
Cutaneous melanoma
Melanoma is staged using the American Joint Committee on Cancer TNM system. Imaging for patients with stage I/II disease is insensitive and has a high rate of false positive findings. In a study of 344 patients with T1b-T3b melanoma who had preoperative imaging, the false positive rates were 88% for CT chest, 91% for CT abdomen and pelvis, and 60% for PET/CT.(1) Among patients with positive sentinel lymph nodes, routine imaging resulted in 48% of patients having indeterminate findings, of these less than 4% had confirmed systemic metastases. All patients with true positive metastatic disease had thick melanomas and/or lymph node macrometastases.(2) Older studies evaluating the accuracy of CT for detection of metastases in stage III disease have found rates approaching 4%, with false positives ranging from 3%-8%.(3, 4)
The NCCN recommends SLND in patients with Stage IA with adverse features, IB, II, in -transit, and local recurrence and clinically negative lymph node cutaneous melanoma. The use of sentinel lymph node detection has been shown to decrease extent and morbidity of surgery without compromise to outcome. (5-7) In a systematic review evaluating PET/CT imaging, sensitivity ranged from 68% to 87% and specificity from 92% to 98% for stage III/IV melanomas. These results were similar to another meta-analysis showing an overall sensitivity of 89.4% and specificity of 88.8%. Management changed in 22% of patients when PET imaging was utilized. Comparing across modalities, a meta-analysis of 74 studies showed that the sensitivity, specificity, and odds ratio of CT were 51%, 69%, and 2.29, respectively, for detection of distant metastases compared to PET/CT which were 80%, 87%, and 25.23, respectively. (8)
Mucosal melanoma
Staging studies for tumors arising in the head and neck should include CT/MRI to determine extent of the primary tumor, resectability, and lymph node involvement. Despite the lack of treatment options for patients with uveal melanoma and distant metastatic disease, NCCN favors staging before primary treatment. (9) The most frequent sites of uveal melanoma metastasis are liver, lungs, skin/soft tissue and bones. As such, NCCN recommends at minimum that these patients have contrast MRI or ultrasound of the liver, with modality preference determined by expertise at the treating institution. (9) Bone scintigraphy is generally not required, especially if a FDG-PET/CT is planned. Evidence to support the use of PET is limited, but given the behavior of these tumors, its use is recommended.
MANAGEMENT
In most cases, conventional imaging with CT is adequate for assessment of treatment response. If radiation is planned either for definitive therapy or consolidative therapy, PET imaging may be used to assess for metastatic disease. After complete surgical resection, additional imaging should follow guidelines for surveillance.
SURVEILLANCE
The majority of cutaneous melanoma recurrences are either detected by the patient or on physical examination. Surveillance imaging is of low yield and not indicated for early stage disease. In surveillance imaging for stage III melanoma, studies have found detection rates were widely variable, ranging between 7%-56%. (10-13) The National Comprehensive Cancer Network considers imaging for stage IIB-IV (no evidence of disease) melanoma a level 2B recommendation. 5 Surveillance imaging of asymptomatic patients should not continue beyond 3 to 5 years due to the risk of radiation exposure and based on expected patterns of recurrence. (14) For patients with uveal melanoma who elect surveillance imaging, options include contrast MRI or ultrasound of the liver, with modality preference determined by expertise at the treating institution. (9)
Current References
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.
DIAGNOSTIC WORKUP
Cutaneous melanoma
In a systematic review evaluating PET/CT imaging, sensitivity ranged from 68% to 87% and specificity from 92% to 98% for stage III/IV melanomas. These results were similar to another meta-analysis showing an overall sensitivity of 89.4% and specificity of 88.8%. Management changed in 22% of patients when PET imaging was utilized. Comparing across modalities, a meta-analysis of 74 studies showed that the sensitivity, specificity, and odds ratio of CT were 51%, 69%, and 2.29, respectively, for detection of distant metastases compared to PET/CT which were 80%, 87%, and 25.23, respectively. (5)
SURVEILLANCE
The majority of cutaneous melanoma recurrences are either detected by the patient or on physical examination. Surveillance imaging is of low yield and not indicated for early stage disease. In surveillance imaging for stage III melanoma, studies have found detection rates were widely variable, ranging between 7%-56%. (7-10) The National Comprehensive Cancer Network (NCCN) follow-up recommendations for stage IIB-IV (no evidence of disease) melanoma include consideration of imaging every 3-12 months for 2 years, then every 6-12 months for another 3 years (level 2B recommendation). (11) Surveillance imaging of asymptomatic patients should not continue beyond 3- to 5 years due to the risk of radiation exposure and based on expected patterns of recurrence. (12) For patients with uveal melanoma who elect surveillance imaging, options include contrast MRI or ultrasound of the liver, with modality preference determined by expertise at the treating institution. (6)
New References
(5) Xing Y, Bronstein Y, Ross MI, et al. Contemporary diagnostic imaging modalities for the staging and surveillance of melanoma patients: a meta-analysis. J Natl Cancer Inst. 2011;103(2):129-42. PMID: 21081714
(6) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma: Uveal (Version 2.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.
(7) Podlipnik S, Carrera C, Sanchez M, et al. Performance of diagnostic tests in an intensive follow-up protocol for patients with American Joint Committee on Cancer (AJCC) stage IIB, IIC, and III localized primary melanoma: a prospective cohort study. J Am Acad Dermatol. 2016;75(3):516-24. PMID: 27183845
(8) Meyers MO, Yeh JJ, Frank J, et al. Method of detection of initial recurrence of stage II/III cutaneous melanoma: analysis of the utility of follow-up staging. Ann Surg Oncol. 2009;16(4):941-7. PMID: 19101766
(9) Moore Dalal K, Zhou Q, Panageas KS, et al. Methods of detection of first recurrence in patients with stage I/II primary cutaneous melanoma after sentinel lymph node biopsy. Ann Surg Oncol. 2008;15(8):2206-14. PMID:18512102
(10) Romano E, Scordo M, Dusza SW, et al. Site and timing of first relapse in stage III melanoma patients: implications for follow-up guidelines. J Clin Oncol. 2010;28(18):3042-7. PMID: 20479405
(11) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Melanoma: Cutaneous (Version 3.2022). Available at http://www.nccn.org. ©National Comprehensive Cancer Network, 2022.
(12) Mathews JD, Forsythe AV, Brady Z, et al. Cancer risk in 680,000 people exposed to computed tomography scans in childhood or adolescence: data linkage study of 11 million Australians. BMJ. 2013;346:f2360. PMID: 23694687
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.
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CPT/HCPCS: | |
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References: |
1997 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 3. 1999 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 25. 1999 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 26. 1999 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 27. 1999 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 28. 2000 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 28. 2001 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 21. 2001 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 5. Blessing C, Feine U, Geiger L, et al.(1995) Positron emission tomography and ultrasonography: a comparative retrospective study assessing the diagnostic validity in lymph node metastases of malignant melanoma. Arch Derm 1995; 131:1394-8. Brady MS, Akhurst T, Spanknebel K, et al.(2006) Utility of preoperative [(18)]f fluorodeoxyglucose-positron emission tomography scanning in high-risk melanoma patients. Ann Surg Onc, 2006; 13:525-532. Cromwell KD, Ross MI, Xing Y, et al.(2012) Variability in melanoma post-treatment surveillance practices by country and physician specialty: a systematic review. Melanoma Res, 2012; 22:376-385 FDG Positron Emission Tomography for the Detection of Ovarian Cancer. 2002 Blue Cross Blue Shield Association Technology Evaluation Center Assessment. FDG Positron Emission Tomography to Manage Patients with an Occult Primary Carcinoma and Metastasis Outside the Cervical Lymph Nodes. 2002 Blue Cross Blue Shield Association Technology Evaluation Center Assessment. Holder WD Jr, White RL Jr, Zuger JH, et al.(1998) Effectiveness of positron emission tomography for the detection of melanoma metastases. Ann Surg 1998; 227:764-9; discussion 769-71. Juweid ME, Cheson BD.(2006) Positron Emission Tomography and assessment of cancer therapy. NEJM 2006; 354:496-507. Moore Dalal K, Zhou Q, Panageas KS, et al.(2008) Methods of detection of first recurrence inpatients with stage I/II primary cutaneous melanoma after sentinel lymph node biopsy. Ann Surg Onc, 2008; 15:2206-2214 National Comprehensive Cancer Network.(2014) Clinical Practice Guidelines in Oncology. Melanoma V2.2014. Available online at: http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Last accessed January, 2014. National Comprehensive Cancer Network.(2015) Clinical Practice Guidelines in Oncology. Melanoma V2.2015. http://www.nccn.org/professionals/physician_gls/pdf/melanoma.pdf. Accessed January 26, 2015. NCT00316901.(2012) PET/CT Evaluation of Subjects Treated on Surgery Branch Adoptive Cell Therapy Protocols. www.clinicaltrial.gov.; Accessed 2012-10-11 NCT00828126.(2012) PET-CT in the Management of Patients With Stage III Or IV Metastatic Melanoma Considered Candidates for Surgery: Evaluation of Additive Value Following Conventional Imaging. www.clinicaltrial.gov; Accessed 2012-10-11. Rinne D, Baum RP, Hor G, et al.(1998) Primary staging and follow-up of high risk melanoma patients with whole-body 18F-fluorodeoxyglucose positron emission tomography: results of a prospective study of 100 patients. Cancer 1998; 82:1664-71. Rodriguez Rivera AM, Alabbas H, Ramjaun A, et al.(2014) Value of positron emission tomography scan in stage III cutaneous melanoma: a systematic review and meta-analysis. Surg Oncol. Mar 2014;23(1):11-16. PMID 24556310 Valk PE, Pounds TR, Tesar RD, et al.(1996) Cost-effectiveness of PET imaging in clinical oncology. Nucl Med Biol 1996; 23:737-43. Wagner JD, Schauwecker D, Davidson D, et al.(1999) Prospective study of fluorodeoxyglucose-positron emission tomography imaging of lymph node basins in melanoma patients undergoing sentinel node biopsy. J Clin Oncol 1999; 17:1508-15. Wagner JD, Schauwecker D, Hutchins G, et al.(1997) Initial assessment of positron emission tomography for detection of nonpalpable regional lymphatic metastases in melanoma. J Surg Oncol 1997; 64:181-9. Xing Y, Bronstein Y, Ross MI, et al.(2011) Contemporary diagnostic imaging modalities for the staging and surveillance of melanoma patients: a meta-analysis. J Natl Cancer Inst, 2011; 103:129-142. |
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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 © 2023 American Medical Association. |