Persius/hicric huggingface dataset:
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

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 medical evidence has not established the superior efficacy of the requested device. There is a lack of proven significant health or functional benefit of exogenous neurostimulation therapy of paralyzed muscles using functional electrical stimulation cycle ergometry. There have been a number of small papers (case reports and series) published over the years providing some preliminary data suggesting possible benefits, but larger studies designed to evaluate the actual clinical efficacy of passive exercise such as functional electrical stimulation cycle ergometry in the setting of spinal cord injury have not been completed and published. While repeated bouts of exogenous neurostimulation of paralyzed muscle may potentially reverse muscle atrophy in paralyzed muscle, there is no significant health or functional benefit of this process in spinal cord injury because the muscle tissue that is gained or spared does not protect against pressure ulcers in a clinically relevant manner or provide other clinically or functionally relevant benefit. It does not obviate the need for pressure relief.  Passive cycling may be an option to provide passive range of motion therapy, e.g., to prevent contractures or mitigate spasticity, but this can also be performed independently or with caregiver assistance in a custodial fashion. The other purported benefits of passive cycling, such as improving cardiovascular function and bone density, have not been sufficiently investigated to allow conclusions related to clinically relevant outcomes. To date, the limited data that are available provide mixed results regarding health measures. With respect to bone health after spinal cord injury, there are insufficient data regarding clinically relevant outcomes related to the efficacy of this device. Therefore, E1399 (functional electrical stimulation cycle ergometer) is not likely to be superior over other available treatment options.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

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 this patient has a history of a spinal cord injury at the C7 level. The records document associated spasms in the lower extremities and elbow pain. The patients provider has recommended use of a functional electrical stimulation (FES) cycle ergometer for this patients physical rehabilitation following spinal cord injury. Kressler and colleagues assessed the use of home-based functional electrical stimulation cycle ergometers. The authors noted the key findings of this study are that usage frequency of home-based FES cycling is below recommended levels for weekly use and caloric expenditure is below the recommended levels for the majority of persons with spinal cord injuryOverall, we find that users of home-based FES cycling are below authoritative standards for overall health maintenance. Ralston and colleagues noted there were no clear effects of FES cycling on urine output, swelling and spasticity even though all point estimates of treatment effects favored FES cycling and participants perceived therapeutic effects. There is a lack of clinical research demonstrating significant benefit of FES units as an adjunct treatment for spinal cord injury. In sum, E1399 (functional electrical stimulation cycle ergometer) is not likely to be more beneficial than other treatment options.
Appeal type: Experimental
Decision: Insurer Denial 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: Insurer Denial Upheld

Summary Reviewer 1

A 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18.  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 prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add to these statistics. DecisionDx-Melanoma testing is an analysis of 31 genes in an individuals melanoma cells. It then classifies that melanoma based on the risk of metastasis in five years. Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients who have had sentinel node biopsy. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is also not at all clear if one can make clinical decisions on the basis of DecisionDx-Melanoma classification. Therefore, gene expression profiling of melanomas performed on 3/29/18 was not 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 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: Insurer Denial Upheld

Summary Reviewer 2

A 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18.  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 this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. In sum, gene expression profiling of melanomas performed on 3/29/18 was not 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 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: Insurer Denial Upheld

Summary Reviewer 3

A 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18.  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 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 patients with high depth of invasion, 0.76 to 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 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 very novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, gene expression profiling of melanomas performed on 3/29/18 was not likely to be 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: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 19-year-old female enrollee has requested reimbursement for residential treatment provided from 6/19/18 through 8/30/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the Child and Adolescent Level of Care Utilization System (CALOCUS) provides a framework for determining the clinically appropriate level of care for a child or adolescent in mental health treatment. In terms of risk of harm, the records support a score of 4. There was serious risk of harm due to significant impulsivity with poor judgment and insight, manifested by taking cars and driving them without a license or permit, physical aggression towards parents, self-harm, as well as past suicidal ideation. With regard to functional status, the records support a score of 4. The patient had serious functional impairment, due to serious deterioration of interpersonal interactions with consistent conflict or otherwise disrupted interactions with others as well as sporadic school attendance and declining grades. In terms of comorbidity, the records support a score of 3. The patient had multiple mental health concerns. With regard to level of environmental stress, the records support a score of 3. The patient had a moderately stressful environment, due to conflict with parents and difficulty fulfilling expected roles at school and home. In terms of environmental support, the records support a score of 2 due to her parents efforts to arrange and engage with outpatient and then wilderness treatment. With regard to resiliency and treatment history, the records support a score of 4. The patient had poor resiliency and/or response to treatment. In terms of treatment acceptance and engagement, the records support a score of 3. The patient was incompletely engaged, due to her initial difficulties accepting responsibility for her role in family conflicts. Therefore, the patient had a composite score of 23. Per CALOCUS, the recommended level of treatment in this case is medically monitored residence-based services. Furthermore, the patient meets criteria for intermediate stay medically monitored residential programs, due to history of impulsivity. Per CALOCUS, at this level of care, the length of stay usually does not exceed 60 days. In this case, the documentation does not support extending the length of stay past the usual 60-day period. The patient not meet criteria for level 5C: long-term medically monitored residence-based services. Therefore, the first two months of wilderness program services, from 6/19/18 through 8/18/18, were medically necessary for treatment of the patients condition. Wilderness program services after that date were not medically necessary. Therefore, that residential treatment provided from 6/19/18 through 8/18/18 was medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 


A 36-year-old male enrollee has requested authorization and coverage for epidural steroid injections. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees degenerative spondylosis and disc disease. The physician reviewer found that in the documentation available for review, the patients records do not demonstrate that he been treated with physical therapy even though it was recommended by his provider. Physical therapy with active exercise is indicated in this clinical setting. Further, the medical literature suggests that a home exercise program after physical therapy independent of an epidural injection can provide lasting results. Moreover, the patient does not have any recent physical exam findings or imaging studies to support a diagnosis of lumbar radiculopathy, which would be one indication for epidural steroid injections (Manchikanti, et al; Kaye, et al). Given the available records, there are standard treatment options for low back pain that have not been performed (Hooten and Cohen; Derby, et al). Given these findings, the requested epidural steroid injections are not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The parent of a 16-year-old male enrollee has requested authorization and coverage for mastectomy. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that the World Professional Association for Transgender Health (WPATH) Standards of Care (SOC) acknowledges that for certain patients, an intervention like a reduction rhinoplasty can have a radical and permanent effect on their quality of life, and therefore is much more medically necessary than for somebody without gender dysphoria. WPATHs SOC further states that while most professionals agree that genital surgery and mastectomy cannot be considered purely cosmetic, opinions diverge as to what degree other surgical procedures (e.g., breast augmentation, facial feminization surgery) can be considered purely reconstructive. Although it may be much easier to see a phalloplasty or a vaginoplasty as an intervention to end lifelong suffering, for certain patients, an intervention like a reduction rhinoplasty can have a radical and permanent effect on their quality of life, and therefore is much more medically necessary than for somebody without gender dysphoria. This patient has well documented gender dysphoria including a letter of support for surgery from his mental health professional and his pediatric endocrinologist who are part of a qualified multidisciplinary team. He currently meets the WPATH SOC criteria as well as the Endocrine Society guideline criteria for breast surgery. The patients parents, medical providers, mental health provider, and surgical providers are supportive. Thus, the requested mastectomy is medically necessary to align his body with his gender identity and help alleviate the distress associated with gender dysphoria. Based on the foregoing discussion, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17.  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 that this patient is a 58-year-old male who developed malignant melanoma on the skin of left anterior shoulder with a Breslows depth of approximately 0.51 mm. The DecisionDx- Melanoma gene assay reported on 8/25/17 revealed class 1A molecular signature associated with a low risk of recurrence within five years. The patient has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17.  The Health Insurer denied this request indicating that the services at issue were considered investigational for the evaluation of the patients cutaneous melanoma. 
There is a lack of peer reviewed medical literature to support the superior efficacy of the services at issue in this patients case. Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages from 0-IV. DecisionDx-Melanoma assay assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as class 1 consistent with a low risk of metastasis or class II suggestive of a high risk of metastasis. Sidiropoulos and colleagues noted that there was a statistically significant association of a class 1 signature by DecisionDx-Melanoma assay for primary dermal melanoma (PDM), whereas cutaneous metastatic melanoma (CMM) were more frequently class II. The authors concluded that the melanoma prognostic assay may be a useful tool for distinguishing PDM from CMM. According to the results of analysis of this patients melanoma performed with DecisionDx-Melanoma assay, the tumor was classified as class 1 with a low risk of near term (within five years) metastatic disease. While DecisionDx-Melanoma signature may be an independent predictor of metastasis risk, additional studies and peer reviewed published literature are needed to show its efficacy over the available standard methods of therapy.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: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17.  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 that this patient is a 58-year-old male with a history of malignant melanoma of 0.51 mm Breslow depth on the left anterior shoulder. The provider recommended gene testing to assess the metastatic risk of the tumor. The patient has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17.  The Health Insurer denied this request and reported that the services at issue were considered investigational for evaluating this patients medical condition. The use of this type of testing is not considered to be a standard of care in the evaluation of assessing a patients melanoma. The National Comprehensive Cancer Network guidelines indicate that genetic testing such as the DecisionDx-Melanoma gene assay should not be used outside of a clinical trial setting. As such, the utilization of DecisionDx-Melanoma gene assay cannot be expected to affect the treatment or health outcome of this patients melanoma. Therefore, DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17 was not likely to have been more effective for the evaluation of this patients medical condition than any available standard therapy. 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: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17.  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 that this patient is a 58-year-old male with a melanoma on his left anterior shoulder measuring .51mm Breslow depth. His provider sent a tissue sample for molecular genetic testing to help determine the risk of metastasis of the tumor. The patient has requested reimbursement for DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17. The Health Insurer denied this request for reimbursement. Per the Health Insurer, the services at issue were considered investigational for the evaluation of this patients melanoma. There is a lack of formal standard procedures or precautions that would be changed in light of the data provided by these molecular testing. Currently, there is a paucity of evidence to support its use in this clinical setting. The DecisionDx-Melanoma assay tests the tissue genetics of the melanoma and can stratify whether a melanoma is high risk for metastasis or not. The test examines gene markers and then the lesion can be further stratified to tell if it is high risk for metastasis. This test has shown some accuracy determining risk of metastasis; however, decision-making based on the results of the test is indeterminate at this time. There is limited scientific evidence permitting conclusions concerning the effect of this test on health outcomes and there is not enough published data to support its routine use. The treatment of this patient would not change based on the results of the examination. Moreover, the test is not considered standard of care for treatment of patients in this clinical setting. Formal standard procedures or precautions that would be changed in light of the data is lacking. The current standard of care would be to perform a wide local excision. Since this test does not provide a superior benefit over established tests in terms of outcomes, DecisionDx-Melanoma (laboratory service code 84999) rendered on 8/25/17 was not likely to have been more beneficial for the evaluation of this patients medical condition than any available standard modalities. 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.