Persius/imr-appeals huggingface dataset:
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 49-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 3/15/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who underwent a breast screening evaluation.The physician reviewer found that digital mammography screening has been proven to decrease mortality related to breast cancer. Standard two-dimensional mammography does have significant limitations, namely obscuration of cancers within areas of overlapping or dense tissue, as well as false positive recalls due to overlapping breast tissue, which must be confirmed with additional imaging. Digital breast tomosynthesis addresses both of these issues. The addition of breast tomosynthesis decreases the false positive recall rate by allowing the radiologist to scan through slices of breast tissue rather than seeing the breast tissue superimposed on itself. This technology is especially beneficial in patients with dense breast tissue. As digital breast tomosynthesis has been proven to increase cancer detection in the screening setting, breast tomosynthesis performed on 3/15/17 was likely to have been superior over other modalities for evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/01/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.The physician reviewer found that the medical literature supports the service at issue in this clinical setting.  Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers.  Ciatto and colleagues noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls.  Thus, digital breast tomosynthesis performed on 8/01/16 was likely to have been of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 68-year-old female enrollee has requested reimbursement for carbon dioxide laser surgery (Mona Lisa Touch Laser) provided on 9/12/17 and 11/3/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees vulvar atrophy. The physician reviewer found the Mona Lisa Touch is a laser procedure that delivers fractional carbon dioxide laser energy to the tissue of the vaginal wall. This may allow for functional restoration of the vagina which often attenuates the symptoms related to postmenopausal vulvovaginal atrophy. However, this technology has not been approved by the U.S. Food and Drug Administration (FDA) for the specific indication for treating vulvovaginal atrophy. Preliminary observational data have shown some potential benefits but these observational trials lack long-term follow-up. In addition, no randomized trials or comparative effectiveness studies have been published. Thus, the carbon dioxide laser surgery (Mona Lisa Touch Laser) provided on 9/12/17 and 11/3/17 were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 60-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 7/01/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the DecisionDx-Melanoma testing for melanoma has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma testing performed on 7/01/20 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 50-year-old male has requested authorization and coverage for code 43210 and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested services in this patients case. The submitted records do not document that this patients gastroesophageal reflux disease is advanced and do not demonstrate good correlation of symptoms with acid reflux events. Transoral incisionless fundoplication (TIF procedure) has shown durable response for some patients with gastroesophageal reflux disease. However, in this patients case there is a lack of documentation of esophagitis, intolerance to proton pump inhibitor therapy, or a trial of maximized acid suppression treatment. Available records do not support that gastroesophageal reflux disease has been objectively demonstrated by pH testing. The records support that dyspepsia improved after Helicobacter pylori eradication and with lifestyle modification, even in the absence of proton pump inhibitor treatment. Therefore, code 43210 and one inpatient bed day are not likely to be more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 56-year-old male enrollee has requested reimbursement for positron emission tomography (PET) scan performed on 1/19/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting.  This case demonstrates the limitations of the standard bone scan agent, technetium in the detection of bone metastases in some individuals with prostate cancer.  This difference has been extensively reported in the literature.  There is significant data which supports the use of PET scans in patients that are at high-risk for skeletal metastases from prostate cancer, such as this patient.  It is very reasonable to use the same pharmaceutical agent that has been successful in the identification of metastatic disease in the past in order to provide an accurate comparison in this high risk patient with rising prostate-specific antigen and a history of prostate cancer.  All told, the PET scan performed on 1/19/16 was likely to have been more effective than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 62-year-old female enrollee has requested reimbursement for genetic testing performed on 7/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation for the evaluation of the enrollees medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch, with some minor updates. Mitotic index has also been thought to add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based on the risk of metastasis. Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma class, in patients undergoing sentinel node biopsy. However, it is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear if the DecisionDx-Melanoma assay can be used to make clinical decisions. Therefore, testing (DecisionDx-Melanoma Gene Assay) performed on 7/31/18 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 53-year-old female enrollee has requested reimbursement for the Foundation One genetic testing performed on 1/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees serous papillary carcinoma. The physician reviewer found that there are many agents with activity against recurrent ovarian cancer (Patch, et al). Recently, it has become important to identify mutations that may be amenable to targeted therapy. Von Hoff and colleagues reported on a study of 86 patients where the progression free survival (PFS) on regimen selected by molecular profiling was compared to PFS on the last chemotherapy regimen. The authors found that the regimen selected by molecular profiling offered a 27% survival advantage. Given this support, the Foundation One test provided on 1/25/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 3


A 41-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 11/06/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.The physician reviewer found breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts.  In this particular patient, she has breasts that have been described as being heterogeneously dense.  It is specifically those patients who have dense breasts that can benefit most from tomosynthesis.   The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor.  Thus, breast tomosynthesis performed on 11/06/15 was likely to have been of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1
A 53-year-old female enrollee has requested reimbursement for collagen cross links testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of fragility fracture The physician reviewer found that there is a lack of support for the superior efficacy of the services at issue in this clinical setting. The use of bone turnover markers such as collagen cross links testing performed in 2015 is not considered standard of care for the treatment of osteoporosis and is not routinely ordered. With a history of hip fracture, this patient could be treated with standard therapies such as bisphosphonates, selective estrogen receptor modulators (SERMs), Forteo, or Prolia. The standard of care, is to provide treatment based on other clinical findings. A study by Yoshimura and colleagues notes, Bone turnover markers (BTMs) were not significant predictors of bone loss, femoral osteoporosis, or osteoporotic fractures.  Furthermore, Vasikaran and colleagues reported that the clinical utility of BTMs for management of osteoporosis is not supported in the medical literature.   As such, there is a lack of support in the medical literature for the routine use of BTMs for those patients who are at risk of fractures. In sum, collagen cross links testing performed on 11/17/15 was not likely to have been more effective than the alternative measures available for the evaluation of this patients medical condition. 
Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 55-year-old female enrollee has requested authorization and coverage for LINX Reflux Management System (code 43284) and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than Nissen fundoplication or other surgical anti-reflux procedures. American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended. Skubleny and colleagues concluded that long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation. Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia, requiring endoscopic intervention, which is a concern in this patient with hypertensive lower esophageal sphincter. The currently available peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment, surgical fundoplication. Thus, the LINX Reflux Management System (code 43284) and one inpatient day are not likely to be more effective than other treatment options.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2


A 53-year-old female enrollee has requested reimbursement for PathFinder TG testing (84999) performed on 7/30/14.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found PathFinder TG analysis is an analysis of DNA, and mutations of DNA, in a cellular population.  It has been used in patients with cancer of unknown primary, to identify the tissue of origin of the cancer.  In such situations, its use is still controversial and has been useful in only a very limited number of individuals.  Another use of the this test is in the analysis of pancreatic cysts, in an effort to determine if they are truly benign, or whether they contain elements that are moving towards a malignant expression, which would require consideration of surgical therapy.  The medical literature has documented the validity of the use of this assay in this clinical setting.  Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 57-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees severe, persistent asthma. The physician reviewer found that Bronchial thermoplasty refers to a technique of applying heat to the airways during bronchoscopy, reducing the increased mass of airway smooth muscle associated with asthma. The U.S. Food and Drug Administration (FDA) has approved marketing of bronchial thermoplasty for the treatment of adults with severe persistent asthma not well-controlled with inhaled glucocorticoids and long-acting beta agonists with frequent exacerbation. Based on the records provided for review, this patient meets the criteria for bronchial thermoplasty with evidence of the need for oral glucocorticoids, maximal inhaled corticosteroid treatment, a forced expiratory volume in one second (FEV-1) of 50% of predicted, and he has not had a life-threatening exacerbation in the past. Since this patient has exhausted maximal available treatments and remains symptomatic, the requested bronchial thermoplasty is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1 
 
A 61-year-old female enrollee has requested reimbursement for laboratory testing performed 
on 11/29/19. The Health Insurer has denied this request and reported that the services at issue 
were investigational for the evaluation of the enrollees medical condition. The physician 
reviewer found that if there is insufficient tissue to allow testing for all of EGFR, KRAS, ALK, 
ROS1, BRAF, NTRK1/2/3, MET, and RET, repeat biopsy and/or plasma testing should be done. If 
these are not feasible, treatment is guided by available results and, if unknown, these patients 
are treated as though they do not have driver oncogenes. Cell-free/circulating tumor DNA 
testing should not be used in lieu of a histologic tissue diagnosis. Some laboratories offer 
testing for molecular alterations examining nucleic acids in peripheral circulation, most 
commonly in processed plasma. Studies have demonstrated cell-free tumor DNA testing to 
generally have very high specificity, but significantly compromised sensitivity, with up to 30% 
false-negative rate. Standards for analytical performance characteristics of cell-free tumor DNA 
have not been established, and in contrast to tissue-based testing, no guidelines exist regarding 
the recommended performance characteristics of this type of testing. Cell-free tumor DNA 
testing can identify alterations that are unrelated to a lesion of interest, for example, clonal 
hematopoiesis of indeterminate potential (CHIP). The use of cell-free/circulating tumor DNA 
testing can be considered in specific clinical circumstances; most notably, if a patient is 
medically unfit for invasive tissue sampling, in the initial diagnostic setting, or if following 
pathologic confirmation of a non-small cell lung cancer diagnosis there is insufficient material 
for molecular analysis. Cell-free/circulating tumor DNA should be used only if follow-up tissue-
based analysis is planned for all patients in which an oncogenic driver is not identified. This 
patient appears to have had sufficient tissue for more broad testing if needed, and guidelines 
were similar at the time of testing. Therefore, laboratory testing performed on 11/29/19 was 
not likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 47-year-old female enrollee has requested reimbursement for DecisionDX-UM assay performed on 5/09/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ocular melanoma. The physician reviewer found that this patient has a rare disease, ocular melanoma, which has a poor prognosis once it metastasizes.  However, knowledge of the propensity for metastasis directly affects surveillance of patients by computed tomography (CT) scan.  Along these lines, two clinical studies have been done using the gene expression classifier Decision DX-UM that defines two classes of ocular melanoma.  Class 1 is associated with a low risk of metastasis and Class 2 has a 50% risk at two years and 72% risk at five years.  There is no other standard prognostic indicator that could serve as an alternative. Thus, the current medical evidence favors the use of this test in the postoperative surveillance of patients with ocular melanoma.  In sum, DecisionDX-UM assay performed on 5/09/16 was likely to have been superior over other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 62-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 7/25/20.  The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. The physician reviewer found that molecular diagnostic studies in non-small cell lung cancer (NSCLC) are considered a standard of care. Numerous gene alterations have been identified that impact therapy selection. National Comprehensive Cancer Network guidelines strongly advise broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with NSCLC. National Comprehensive Cancer Network guidelines supports the use of liquid molecular profiling, such as Guardant360, if there is insufficient tissue for molecular analysis and follow-up tissue-based analysis will be done if an oncogenic driver is not identified. Testing of lung cancer specimens for these alterations is important for identification of potentially efficacious targeted therapies, as well as avoidance of therapies unlikely to provide clinical benefit. In this case, the records noted that tissue-based molecular testing was not feasible, as it was limited by tissue of insufficient quantity. Therefore, Guardant360 testing performed on 7/25/20 was likely to have been more beneficial than any available standard therapy.