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

Summary Reviewer 1


The parent of a four-year-old male enrollee has requested reimbursement for FirstStepDx Plus dated 5/12/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees autism spectrum disorder. The physician reviewer found that battaglia and colleagues performed a study to demonstrate the usefulness of CMA in detecting the etiology of unexplained autism spectrum disorders associated with dysmorphic features in a large cohort of pediatric patients. The authors concluded that their study confirmed the value of CMA as the first-tier tool in the assessment of those conditions in the pediatric setting. Autism comprises a clinically heterogeneous group of disorders that share common features of impaired social relationships, impaired language and communication, and repetitive behaviors or a narrow range of interests. Autism can be considered complex in the presence of dysmorphic features and/or microcephaly or essential, such as in the absence of physical abnormalities and microcephaly. This patient is non-dysmorphic and would qualify for a designation of essential autism. The American Academy of Pediatrics recommends that any child with unexplained global developmental delay or speech/language delay be tested for Fragile X syndrome. Given the support in the peer-reviewed literature, FirstStepDx Plus performed on 5/12/16 has 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 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: Experimental
Decision: Upheld

Summary Reviewer 1
A 56-year-old male enrollee has requested reimbursement for DecisionDX-Melanoma test performed on 8/4/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma The physician reviewer found the prognosis of cutaneous melanoma has traditionally been determined by the staging system reported by Balch and colleagues. Mitotic index has also been demonstrated to support these statistics. DecisionDX is a study of 31 genes in the melanoma cells. It then classifies that particular melanoma as either Class 1, with a 97% disease free rate at five years or Class 2 with a 31% disease free rate at five years. A study by Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDX classification in patients with negative sentinel nodes. However, the medical studies are not clear how DecisionDX data compares to the ten year data of the Balch tables, and whether it can be used to make clinical decisions. This is particularly true in this patient, who has an expected excellent survival rate. Moreover, the National Comprehensive Cancer Network (NCCN) guidelines state that while there is some interest in these newer genetic profiles, these tests are only performed in the context of a clinical trial. Therefore, DecisionDX-Melanoma test performed on 8/4/15 was not expected to be of superior clinical benefit than available standard modality used for evaluation of this patient. Therefore, for the reasons stated 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: Overturned

Summary Reviewer 3


A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 1/26/16.  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 that breast tomosynthesis provides advantages to radiologists interpreting mammograms.  This tomographic method often enables the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks, increase in accuracy and increase in detection of small cancers. For this reason, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had the examination been done using two-dimensional imaging alone.  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 3

A 23-year-old male enrollee requested authorization and coverage for E1399 (functional electrical stimulation cycle ergometer). The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the pathophysiologic consequences of spinal cord injury include diminished cardiopulmonary and circulatory function as well as lower extremity muscle atrophy and bone mass reduction. Deley and colleagues reported that functional electrical stimulation hybrid training, a combination of volitional arm and electrically controlled contractions of the lower limb muscle, resulted in increased physiological demand as compared with arms only exercises only. This is clinically significant as spinal cord injury patients can have difficulty achieving physiologic benefit of exercise. A review on functional electrical stimulation cycle ergometer training by Wilder and colleagues also found that functional electrical stimulation ergometry can potentially reverse pathophysiologic consequences of spinal cord injury. Thus, E1399 (functional electrical stimulation cycle ergometer) is likely to be of greater benefit than other treatment options.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 10/7/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees breast cancer examination.  The physician reviewer found that the American College of Radiology urged tomosynthesis be removed from the investigational category in 2014 due to the advantage it brings radiologists interpreting mammograms especially in patients with dense breasts such as the patient under review. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural disorder resulting in a decrease in callbacks and increase in detection of small cancers compared to two-dimensional (2D) imaging alone. In this case, the use of tomosynthesis likely aided the radiologist to detect the area of interest in the left breast in this patient with dense breast tissue. Thus, the addition of tomosynthesis was likely of greater benefit to the patient than had her exam been done with 2D imaging alone. For this reason, the digital breast tomosynthesis performed on 10/7/16 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 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 48-year-old male enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees squamous cell carcinoma. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. Compared to standard radiotherapy with photon intensity modulated radiation therapy, the benefit of proton beam therapy is with its Bragg Peak, as radiation dose is deposited more precisely on its target. This translates into a decrease in exposure of normal tissue in the low-dose to intermediate-dose range, but not in the high-dose range. Proton beam therapy is well-accepted in its ability to decrease the risk of secondary malignancy, which is largely attributable to the smaller volume of body exposed to low-dose. The benefit is greatest for larger radiation fields, such as the bilateral neck field. The risk for secondary malignancy is typically delayed at least 10 years. Thus, the potential benefit is highest in younger patients, such as this patient. Therefore, proton beam radiation therapy is likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are 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 48-year-old female has requested reimbursement for procedure codes 84999 (DecisionDx-Melanoma) and 99000 performed on 1/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the DecisionDx-Melanoma testing has been developed in patients with stage I and II cutaneous melanoma. However, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. This test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials according to published data available. Per the National Comprehensive Cancer Network guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate benign from malignant neoplasms, or melanomas at low versus high risk for metastasis, routine (baseline) genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Therefore, procedure codes 84999 (DecisionDx-Melanoma) and 99000 performed on 1/25/17 were not likely to have been more efficacious than other methods of evaluating this patient. 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: Overturned

Summary Reviewer 1


A 43-year-old male enrollee has requested reimbursement for the left eye corneal collagen cross-linking provided on 7/21/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees progressive keratoconus. The physician reviewer found that Corneal cross-linking has been found to be a useful aid in treatment of patients with corneal ectasia following refractive surgery. Poli and colleagues concluded that corneal collagen cross-linking can stabilize progressive corneal ectasia, both primary and secondary, with no induced iatrogenic effects. All told, there is adequate data supporting the clinical utility of the left eye corneal collagen cross-linking provided on 7/21/16 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 services at issue were 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 2

A 59-year-old male has requested authorization and coverage for CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease. The physician reviewer found that the efficacy of transoral incisionless fundoplication using the EsophyX device has been studied in randomized controlled trials. However, the conclusions are contradictory. Witteman and colleagues performed a large randomized trial which included 60 patients. The authors found no improvement in esophageal acid exposure compared with baseline at 12 months. Normalization of pH was accomplished in only 29% in conjunction with deteriorated valve appearances at endoscopy and resumption of proton pump inhibitor therapy in 61%. The study concluded that no long-term objective reflux control was achieved. The 2013 American College of Gastroenterology guidelines for treatment of gastroesophageal reflex disease reported that the usage of current endoscopic therapy or transoral incisionless fundoplication cannot be recommended as an alternative to medical or traditional surgical therapy (moderate level of evidence). Numerous published series have reported significant adverse events, and there is a lack of sham-controlled trials comparing transoral incisionless fundoplication with anti-reflux surgery. All told, CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device) is not likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are 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 1

A 42-year-old female enrollee has requested reimbursement for DecisionDx Melanoma testing (84999) performed on 1/23/17. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the DecisionDx Melanoma has shown some accuracy determining risk of metastasis in thin melanomas, however treatment of this patient would not change based on the results of the exam. The testing at issue is not considered routine standard of care. There is a lack of peer-reviewed literature to support improved health outcomes in patients with thin melanomas. Therefore, the DecisionDx Melanoma testing (84999) performed on 1/23/17 was not 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 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: Overturned

Summary Reviewer 1


A 65-year-old male enrollee has requested reimbursement for collagen crosslink testing performed on 7/11/15.  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 Osteoporosis is a condition of thinning of the bones which leads to increased risk of fracture.  Bone mineral density assessment, via dual-energy x-ray absorptiometry (DEXA), is the standard for evaluation and diagnosis of osteoporosis.  However, because changes in bone mass and density in response to antiresorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover may be a useful adjunct in monitoring of osteoporotic patients who are treated with antiresorptive agents.  The medical evidence suggests that biochemical markers could be useful in making therapeutic decisions because, in general, the higher the bone remodeling and bone loss rates, the greater the concentration of bone biochemical markers in blood or urine.  There is sufficient support for the services at issue in this clinical setting.  All told, collagen crosslink testing was likely to have been superior over other treatment options.  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 female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/27/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Although DecisionDx Melanoma may be an independent predictor of metastasis risk, there is a lack of peer-reviewed published studies confirming this hypothesis. For this reason, the DecisionDx-Melanoma testing performed on 10/27/16 was not 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 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 1

A 25-year-old male enrollee has requested authorization and coverage for the LINX Reflux Management System.  The Health Plan has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The U.S. Food and Drug Administration (FDA) approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD and a hiatal hernia less than 3 cm. This patient meets those specific criteria. A recent study comparing the LINX procedure with laparoscopic fundoplication was performed. This was a retrospective study which used propensity matching to compare groups. The authors 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 (Reynolds, et al). In addition, a five-year cohort data supports the durability of the device. In a group of 85 patients augmentation of the lower esophageal sphincter with a magnetic device provided significant and sustained control of reflux, with minimal side effects or complications (Ganz, et al). Therefore, the request for the LINX Reflux Management System 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: Overturned

Summary Reviewer 2 
 
A 59-year-old male enrollee has requested reimbursement for Guardant 360 testing performed 
on 3/31/21. 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 the therapy of advanced non-small cell lung cancer has been revolutionized 
by the finding of EGFR mutations in certain adenocarcinomas.  The mutations are more common 
in those who have never smoked. Even if stage IV disease is present, therapy targeted to EGFR 
with  erlotinib  results  in  prolonged  survival  when  compared  with  standard  chemotherapy 
regimens. The mutational landscape of non-small cell lung cancer has significantly expanded in 
the past 2-3 years to encompass gain of function in multiple oncogenes with major prognostic 
and therapeutic consequences. It is generally accepted that the panel of mutations that was 
analyzed in the patient in question is for mutually exclusive somatic driver mutations. Generally, 
KRAS, TP53, and BRAF are included in these panels and are informative. KRAS mutation may 
confer a poor prognosis on patients with wild type EGFR sequence treated with erlotinib as 
second-line therapy. Patients on targeted therapy do develop resistance to erlotinib, and this too 
may be appreciated at the genetic level by recognition of new mutations or amplifications in 
parallel  signal  transduction  pathways.  BRAF  mutations  may  suggest  alternative  targeted 
therapies that may be better than those selected empirically. ALK mutation or rearrangement is 
present in another subset of non-small cell lung cancer that may be amenable to targeted therapy 
with crizotinib. Blood-based testing is supported by the National Comprehensive Cancer Network 
guidelines and medical literature if the primary tumor sample is inaccessible or if repeat biopsy  is not feasible. In this case, the panel of mutations that were analyzed were appropriate in the 
clinical care of this patient. Therefore, Guardant 360 testing performed on 3/31/21 was likely to 
have been more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 60-year-old female enrollee has requested reimbursement for laboratory testing performed on 7/29/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. 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. The National Comprehensive Cancer Network strongly advises 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. 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. This patient has received two prior lines of therapy, limiting treatment choices. The use of next generation sequencing panels helps broaden the potential treatments available. Therefore, laboratory testing performed on 7/29/18 was medically necessary for the evaluation of this patient.