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

Summary Reviewer 2

A 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. 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 there is a lack of support for the services at issue in this clinical setting. Prognostic gene expression profiling (GEP) testing to differentiate melanomas at low versus high risk for metastasis should not replace pathologic staging procedures. Moreover, since there is a low probability of metastasis in stage I melanoma and a higher proportion of false-positive result, GEP testing should not guide clinical decision making in this group. Commercially available GEPs, such as DecisionDx-Melanoma testing, are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear where these GEP platforms provide clinically actionable prognostic information when used in addition to or in comparison with known cliniopathologic factors or multivariate nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Various (mostly retrospective) studies of prognostic GEP testing suggest its role as an independent predictor of worse outcome, although not superior to Breslow thickness or sentinel lymph node status. It remains unclear whether this GEP profile is reliably predictive of outcome across the risk spectrum of melanoma. Prospective validation studies are required to more accurately define the clinical utility of molecular testing prior to widespread implementation of GEP for prognostication of cutaneous melanoma, and in particular to determine its role in guiding surveillance imaging, sentinel lymph node biopsy, and adjuvant treatment decisions. Therefore, DecisionDx-Melanoma testing performed on 11/21/19 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 65-year-old female enrollee has requested authorization and coverage for Venclexta (venetoclax) 100 mg, five tablets daily #150. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees multiple myeloma. The physician reviewer found that the use of Venclexta in this clinical setting is currently under investigation for use in combination or as a single agent. Moreau and colleagues study, is a phase Ib study and did not include Dara, hence it does not apply in this case. Phase Ib studies do not prove medical necessity nor do they establish the standard of care. Overall, randomized phase II or III clinical trials establish the standard of care. The response shown in this patient was assumed to be related to Venetoclax while this response could be also related to the other drugs used in this combination. In addition, response by itself is not a surrogate for survival benefit. Review of the patients record indicates that this patient has not been treated with all U.S. Food and Drug Administration (FDA) approved agents for the treatment of multiple myeloma such as Pabobinostat. All told, the requested Venclexta (venetoclax) 100 mg, five tablets daily #150 is 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 requested medication is 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 2

A 56-year-old male enrollee has requested reimbursement for des-gamma-carboxy prothrombin (DCP) testing performed on the enrollee on 5/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that in patients with cirrhosis of liver, a combination of ultrasound of the liver and alpha-fetoprotein (AFP) are recommended for surveillance for hepatocellular carcinoma. Liver ultrasound is also recommended as the primary surveillance modality for HCC. Other tests that have been used and examined for HCC surveillance include DCP and lectin-bound AFP (AFP-L3%). The evidence is inconclusive about whether these biomarkers perform better than AFP for detecting HCC. AFP was found to be more sensitive than DCP and AFP-L3% for the diagnosis of early stage HCC at a new cutoff of 10.9?ng/ml (Marrero et al). A combination of these markers (AFP, AFP-L3, DCP) only marginally improves the accuracy for early detection of HCC (Carr, et al). Therefore, at this point, the use of DCP has not been established as 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 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 22-year-old male enrollee has requested reimbursement for (81229) cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities on 3/16/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found that there is a lack of support in the medical literature for the services at issue in this clinical setting. Studies have shown that clinically useful predictors in genetic testing are scarce with results being inconsistent and only marginal clinical association between enzyme system variants and drug metabolism, efficacy, and tolerability. There is a lack of large randomized trials to support its use in this patients case.  The existing studies have also indicated that there is no significant correlation between either genotypes or medication serum concentration and response to treatment.  Current evidence does not support the use of genotyping when choosing an antidepressant, and even less is understood about its use in the treatment of anxiety disorders.  Genetic testing, used in this clinical setting, lacks evidence based research to show its effective use in guiding a clinician towards choosing a medication regimen.  As such, (81229) cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism variants for chromosomal abnormalities administered on 3/16/16 were not likely to have been more effective than the standard options for evaluating this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 31-year-old female enrollee has requested reimbursement for inpatient mental health services provided from 11/7/17 to 12/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees eating disorder and depression. The physician reviewer found that applying the level of care utilization system (LOCUS) criteria, the inpatient mental health services provided from 11/7/17 to 12/6/17 were not medically necessary for treatment of this patients behavioral health issues. The patient presented with significant risk of harm (score 3) with a history of a suicide attempt at age 15 by attempting to overdose on Advil. The patient also has a history of self-cutting from the ages of 14-19 years old. On 11/7/17 and several days prior, the patient had intermittent passive suicidal thoughts. The patient demonstrated moderate functional impairment (score 3) and due to her symptoms, the patient was unable to fulfill her responsibilities in her work. The patient showed significant co-morbidity (score 3) with history of bipolar II, cluster B traits, and bingeing, purging, and restricting behaviors. The patient did not have substance abuse problems. The patients recovery environment is mildly stressful (score 2) as she demonstrated distress while she was traveling in Paris due to isolation. The patients recovery environment was supportive (score 2) and she demonstrated moderate response to prior treatment (score 3). The patient demonstrated positive engagement and recovery (score 2) as she was described as attentive and engaged during treatment. The patient had a positive attitude toward recovery and treatment. These findings give the patient a composite score of 18, which is consistent with intensive outpatient program (IOP) level of care. The patient continued to require treatment for her of bipolar II, cluster B traits, and bingeing, purging, and restricting behaviors, but this could have been safely and effectively provided in a less restrictive environment. Therefore, the services at issue were not medically necessary. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 64-year-old female enrollee has requested reimbursement for gene testing performed on 10/30/17. 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 next-generation sequencing, such as provided by FoundationOne is an appropriate medical diagnostic test for this difficult situation. It is medically appropriate to offer this patient the opportunity to participate in clinical trials. FoundationOne genetic testing is an accepted standard and appropriate diagnostic approach for the identification of clinical trials that would be suitable for this patient, based on tumor mutational analysis. At the time of testing in October 2017, metastatic breast cancer patients had targeted therapy options available through standard of care. Patients with BRCA mutations identified by genomic testing could pursue therapy with olaparib, which was demonstrated to be superior to standard chemotherapy. Additionally, patients with metastatic breast cancer can have tumor mutations for microsatellite instability and DNA mismatch repair, making them eligible for standard treatment with pembrolizumab. The use of FoundationOne testing is an appropriate diagnostic assay for the determination of eligibility for these approved therapies. Use of pathology tests with next-generation sequencing, including FoundationOne genetic testing, was likely to have be more beneficial for this patients medical condition than the choice of available standard therapies based on empirical therapeutic choice processes, as this has the possibility to identify therapies that may be more effective with less toxicity, or to identify potential candidacy for targeted clinical trials that may be provide greater benefit than empiric choice of chemotherapies. Thus, gene testing performed on 10/30/17 was likely to have been of greater benefit than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

The patient is a 51-year-old male under evaluation and management for gastroesophageal reflux disease (GERD). The patient has been treated with proton pump inhibitor (PPI) therapy along with over the counter antacids. He mainly complains of heartburn with occasional emesis and dysphagia. In addition, pH testing was borderline positive with acid reflux 5% of the time. Reflux was mostly in the recumbent position and reflux correlated well with symptoms. Esophageal manometry did not demonstrate any significant abnormalities. Upper endoscopy revealed a small hiatal hernia. There was no evidence of Barretts. The patient has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational. The US Federal Drug Administration (FDA) approved the LINX for lower esophageal sphincter augmentation for patients with inadequate symptom control with acid suppression therapy, with mild to moderate GERD, and a hiatal hernia less than 3 cm. The device is a ring made up of a series of magnets that have sufficient attraction to increase the lower esophageal sphincter (LES) closure pressure, but allow for food passage with swallowing. In the medical literature, Reynolds and colleagues compared the LINX procedure with laparoscopic fundoplication and found that GERD patients had similar control of reflux symptoms after both LINX and fundoplication. The inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms. In addition, Ganz and colleagues reported five-year cohort data establishing the durability of the device. All told, the requested LINX device is supported as 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: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 20-year-old female with thyroid cancer. She underwent a total thyroidectomy with lymph node dissection on 5/31/19. The physician reviewer found that the postoperative management and concerns for total thyroidectomy patients, especially those that undergo lymph node dissections, is fairly well understood with algorithms described by major endocrine societies.  One of the concerns is hypocalcemia, which can be risk classified based on laboratory values and symptoms. This patients calcium level on postoperative day one was 7.1 mg/dL. This is very low and would qualify as a high risk or a concerning laboratory value.  Thus, it was reasonable to continue hospital care, recheck laboratory values and provide calcium supplementation. However, additional submitted records do not substantiate a second night of hospital admission. The patient was seen by the surgeon on 6/01/19 and was found to have no neurologic issues. She was not given calcium supplementation. There were also no concerns documented in the nursing notes. Since the patient was not given calcium, there is no obvious justification for further prolongation of the hospital stay. She could have received pain medication and had follow-up laboratory testing as an outpatient. The initial night of observation and symptom monitoring was medically indicated, but the patient could have been safely discharged on 6/01/19. Therefore, inpatient stay from 5/31/19 through 6/01/19 was medically necessary.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 48-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 10/15/20. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient had a rising CA-19-9 and Guardant360 cell-free DNA testing was ordered. According to the National Comprehensive Cancer Network (NCCN) guidelines on pancreatic cancer, aTesting on tumor tissue is preferred; however, cell-free DNA testing can be considered if tumor tissue testing is not feasible.a This case is clinically complex since biomarkers are indicating cancer recurrence, yet there is no obvious tumor mass to be found on imaging despite a rigorous search. The NCCN guidelines goes on to say, aData are not available to show that earlier treatment of recurrences, following detection by increased tumor marker levels or CT scan, leads to better patient outcomes.a The Guardant360 test is a liquid biopsy that analyzes patient plasma for mutations in a panel of 70 genes. In this case, the Guardant360 test was not done to analyze mutational analysis of an existing recurrence or an existing mass. Instead, it was performed to look for recurrence. This is not an appropriate use of the test. Therefore, Guardant360 testing performed on 10/15/20 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 56-year-old female enrollee has requested reimbursement for gene test (Breast Cancer Index) performed on 1/6/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who had a history of breast cancer. The physician reviewer found that the Breast Cancer Index (BCI) is a genome wide microarray analysis developed to identify patients with ER positive breast cancer on endocrine therapy that are at an increased risk of progression. Compared with clinical prognostic factors such as age, tumor size, tumor grade, and lymph node status, the BCI is significantly and independently correlated with outcome. Subsequent studies have validated the BCI as an accurate predictor of endocrine responsiveness among patients with ER-positive breast cancer and of prognosis. In one study, BCI was useful in predicting late recurrence (greater than five years from diagnosis) as compared with other prognostic markers. Given the emerging role of extended adjuvant therapy and the side effects many women experience on them, efforts to identify those patients who are more likely to benefit from this therapy is of great potential value. Therefore, the gene test (Breast Cancer Index) performed on 1/6/17, was more likely to have been of greater benefit than the available standard of care for the evaluation of this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to have been 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 37-year-old female enrollee has requested authorization and coverage for bronchoscopic thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is investigational for treatment of the enrollees persistent asthma. The physician reviewer found that based on the documentation provided, there is inadequate evidence for a diagnosis of asthma in this patient. There was no documentation provided to describe the onset of the patients symptoms and pulmonary function testing is normal and does not show evidence of obstruction or bronchodilator response. It would be expected that a patient with severe persistent asthma would demonstrate some abnormality on pulmonary function testing. There is also inadequate data on the patients history of exacerbations which is a prime consideration for bronchoscopic thermoplasty. Consideration should be given to alternate diagnoses such as inducible laryngeal obstruction, excessive dynamic airway collapse and reactive airways dysfunction syndrome for this patients symptoms. In the absence of documented asthma based on physical exam findings, clinical symptoms, exacerbation history, and objective lung function testing, the requested bronchoscopic thermoplasty is 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 requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary  
The patient is a 54-year-old female with a history of left hip pain. The patient underwent an MRI 
of the left hip on 12/22/22. The physician reviewer found that at issue is whether the left hip MRI 
provided on 12/12/22 was medically necessary for this patient. Guidelines from the American 
College of Radiology (ACR) have established that MRI is highly sensitive and specific for detecting 
many abnormalities involving the surrounding soft tissues and should, in general, be the first 
imaging technique used after radiographs. The guidelines add that, MRI is useful for examining 
surrounding  soft  tissue  entities  such  as  iliopsoas  or  subiliacus  bursitis,  athletic  pubalgia, 
trochanteric bursitis, abductor tendinosis or tears, calcific tendonitis, and hamstring injuries and 
for sources of referred pain from spine or knee. Other causes of a chronically painful hip for which 
MRI has been used with considerable success include acute and chronic soft tissue injuries. In 
this case, the patients symptoms were present for more than a year. The patient underwent 
routine radiographs. It is unlikely that any imaging modality other than an MRI would provide the 
important information to evaluate the patient. Therefore, the left hip MRI provided on 12/12/22 
was medically necessary for this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 53-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 3/11/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees risk for breast cancer.   The physician reviewer found that tomosynthesis was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography, the American College of Radiology (ACR) urged the technique be removed from the investigational category in 2014 due to the advantages this new tomographic technique brings to radiologists interpreting mammograms. This technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis was likely of greater benefit to this patient than had her exam been done with two dimensional imaging alone. Accordingly, the breast tomosynthesis that was performed on 3/11/16 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 diagnostic procedure 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.