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G0252 Pet imaging, full and partial-ring pet scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (e.g., initial staging of axillary lymph nodes)Last reviewed at VbBS in March 2018. Minutes indicate that the staff recommendation was accepted without significant discussion. HERC approved the recommendations without change. EvidenceBychkovsky 2016, review of imaging in breast cancerStage III diseaseAll patients with locally-advanced breast cancer should undergo staging imaging and this is recommended by current guidelines [note: appendix referred to after this statement reviews various types of imaging and NCCN is noted to only list PET as an “option”]Based on the literature, advanced imaging with bone scan, CT or PET will detect occult metastases in 6.0-14% of Stage III patients who are asymptomatic at diagnosisThere is no role for imaging to screen for distant recurrences in patients who are asymptomatic and were initially diagnosed Stage 0-III breast cancer and received treatment for curative intentStage IV diseaseIn patients with metastatic breast cancer, the goal of imaging is to guide therapeutic interventions in order to maximize both length and quality of life In this setting at the end of life, there is little/no role for imaging for patients who are no longer receiving systemic therapy or local therapy.NCCN guidelines recommend monitoring metastatic disease primarily with CT and bone scanCurrent practice patterns indicate that the imaging is being overused in the breast cancer population at initial diagnosis, in the surveillance period after a diagnosis of non-metastatic breast cancer, and among women with metastatic diseaseInappropriate use of imaging results in more indeterminant and false positive findings.Piatek 2016, retrospective cohort study of imaging for patients with stage III breast cancerOf 420 patients, 362 (86.2%) received routine staging imaging studies (RSIS) [note: these could be CT, bone scan or PET]. RSIS were negative in 264 (72.9%), indeterminate in 77 (18.3%), and positive in 21 patients (5.0%) for metastatic disease. Treatment was altered in 21 (5.8%) patients based on RSIS results (20 with metastatic disease, 1 with indeterminate disease). There was no difference in recurrence-free survival (RFS) with RSIS use on multivariate analysis (hazard ratio 1.3; 95% confidence interval 0.73–2.5, P?0.32).Conclusions: Most stage III BC patients underwent RSIS, but RSIS results infrequently affected treatment decisions. There was no significant difference in RFS with RSIS use. RSIS to identify metastatic disease for stage III BC has limited valueExpert guidelinesNCCN 2017, Breast Cancer [PET recommendations excerpted]For stage I, II or operable stage III diseaseNot recommendedHigh false negative rate for detection of small lesions and low sensitivity for detection of axillary modal metastases, and overall high false positive rateFor work up of stage IIIA, T3, N1, M0; IIIC and stage IV disease One test mentioned to consider for work up is bone scan or sodium fluoride PET/CT (category 2B)CT or MRI with contrast is listed as a category 2A workup optionListed as an option to consider for work up prior to preoperative systemic therapy for operable (as well as inoperable) breast cancer and for decisions on locoregional treatment of stage III, T3, N1, M0 diseaseFor work up of recurrent or stage IV disease: bone scan or sodium fluoride PET/CT (category 2B) “The panel generally discourages the use of sodium fluoride PET/CT in the evaluation of patients with recurrent disease except in those situations where other staging studies are equivocal or suspicious” PET imaging is challenging to interpret for monitoring diseasePET imaging may be used for restaging of recurrent or progressive disease (listed as “optional”)“The panel generally discourages the use of sodium fluoride PET or PET/CT scans for the evaluation of patients with recurrent disease, except in those situations where other staging studies are equivocal or suspicious. There is limited evidence (mostly from retrospective studies) to support the use of PET/CT scanning to guide treatment planning through determination of the extent of disease in select patients with recurrent or metastatic disease. The panel considers biopsy of equivocal or suspicious sites to be more likely than PET/CT scanning to provide accurate staging information in this population of patients.” Work up of inflammatory breast cancer: Consider bone scan or sodium fluoride PET/CT (category 2B)CMS NCD 2009Does not cover PET for breast cancer diagnosis or initial staging of axillary nodesCovers PET for staging of distant metastasis, restaging, and monitoringStaging: PET is covered for staging in clinical situations in which: (1)(a) the stage of the cancer remains in doubt after completion of a standard diagnostic workup, including conventional imaging (computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound), or (1)(b) it could potentially replace one or more conventional imaging studies when it is expected that conventional study information is insufficient for the clinical management of the patient, and 2) clinical management of the patient would differ depending on the stage of the cancer identified.Restaging: PET is covered for restaging: (1) after completion of treatment for the purpose of detecting residual disease, (2) for detecting suspected recurrence or metastasis, (3) to determine the extent of a known recurrence, or (4) if it could potentially replace one or more conventional imaging studies when it is expected that conventional study information is insufficient for the clinical management of the patient. Restaging applies to testing after a course of treatment is completed, and is covered subject to the conditions above.Monitoring: This refers to use of PET to monitor tumor response to treatment during the planned course of therapy (i.e., when a change in therapy is anticipated).HERC staff summary: PET scans are listed as a work up option (category 2B) by NCCN for initial staging of operable stage IIIA, T3, N1, M0 disease; stage IV disease; recurrent disease when other staging studies are equivocal or suspicious; and inflammatory breast cancer. Other work up options, such as CT or MRI with contrast or bone scans are available and are generally category 2A. NCCN panel members had reservations about the use of PET scans for recurrent disease work up. The medical literature indicates that PET scans have limited utility in stage III and IV breast cancer.HERC staff recommendations:Do not add PET for initial staging of early stage breast cancer to line 191; add this to line 660/GN173HCPCS G0252 (Pet imaging, full and partial-ring pet scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (e.g., initial staging of axillary lymph nodes))Currently G0252 is on the Services Recommended for Non-Coverage based on a coverage guidance and on the Choosing Wisely recommendationSee new GN173 entry belowDo not add PET (CPT 78811-78816) to line 191 CANCER OF BREAST; AT HIGH RISK OF BREAST CANCER for staging of advanced breast cancer or for treatment monitoring or other indication NCCN 2B test with other tests (2A) available (bone scan, CT)NCCN panel members with concerns for use in many situationsHighly overutilized test with limited impact on outcomesGUIDELINE NOTE 173, TREATMENTS THAT HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS FOR CERTAIN CONDITIONS; unproven treatmentsThe following treatments are prioritized on Line 660, CONDITIONS FOR WHICH CERTAIN TREATMENTS HAVE NO CLINICALLY IMPORTANT BENEFIT OR HAVE HARMS THAT OUTWEIGH BENEFITS; unproven treatments, for the conditions listed here:CPT/HCPCS CodeTREATMENTRationalDate of Last Review/Link to Meeting MinutesG0252Pet imaging, full and partial-ring pet scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (e.g., initial staging of axillary lymph nodes)Not a recommended test for axillary stagingMarch, 2018 ................
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