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

Summary Reviewer 1

A 53-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene expression testing performed on 11/01/18. 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 this patient had an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Newer prognostic molecular techniques should not replace standard staging procedures per the National Comprehensive Cancer Network guidelines. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and 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. Therefore, DecisionDx-Melanoma gene expression testing performed on 11/01/18 was not likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 39-year-old female has requested reimbursement for Anser ADA testing performed on 6/25/15. 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 there is not currently sufficient medical evidence to support the effectiveness of Anser ADA compared with conventional courses of action in the management ulcerative colitis. The published studies on the use of anti-adalimumab antibodies and serum levels are small and retrospective and/or observational in nature. These small studies at best demonstrated correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect.  Therefore, Anser ADA testing performed on 6/25/15 was not likely to have been of greater benefit than other modalities for 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: Upheld

Summary Reviewer 

A 55-year-old female enrollee has requested authorization and coverage for Xeljanz XR (tofacitinib extended release) 11 mg tablets, #30 per 30 days. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees psoriatic arthritis. The physician reviewer found that there is a lack of support for the requested medication in this clinical setting. The U.S. Food and Drug Administration (FDA) package insert for Xeljanz notes that the use of Xeljanz/Xeljanz XR is not recommended in combination with biologic disease-modifying antirheumatic drugs or potent immunosuppressants. In this case, the patient has a history of peripheral or non-axial psoriatic arthritis and systemic lupus. Tumor necrosis factor inhibitors would be contraindicated in her case. Per the medical evidence, the use of Xeljanz is not recommended in this case, as it will be used with CellCept. There are a lack of studies in the literature demonstrating the efficacy and safety of the requested medication when used in conjunction with other immunosuppressive agents, to include CellCept. Although a tumor necrosis factor inhibitor would not be recommended, there are other agents which have not been utilized in this case. As such, for Xeljanz XR (tofacitinib extended release) 11 mg tablets, #30 per 30 days is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 27-year-old male enrollee has requested reimbursement for the pneumatic compressor or deep vein thrombosis (DVT) system provided from 4/5/16 through 5/4/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees left knee with patellar tendon rupture, anterior cruciate ligament (ACL) rupture, medial cruciate ligament (MCL) injury and medial meniscus injury. The physician reviewer found that use of an intermittent mechanical compression device was appropriate for use in this specific patient in preventing DVT and the complication of pulmonary embolism. The use of mechanical compression devices in DVT prophylaxis and prophylaxis of pulmonary embolism with potentially fatal consequences is supported by American Association of Orthopaedic Surgeons (AAOS) guidelines. The AAOS guidelines support the use of compressive devices with a moderate recommendation. Thus, it was likely to be beneficial for an intermittent mechanical compression device to have been used in the treatment of this patient after ACL reconstruction in this patients high-velocity multiple lower extremity injury. Accordingly, the pneumatic compressor or DVT system provided from 4/5/16 through 5/4/16 was 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 equipment at issue was 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 66-year-old female enrollee has requested reimbursement for laboratory testing (CPT code 84999) provided on 9/4/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that the Prometheus Anser ADA test is a quantitative measurement of serum adalimumab (ADA) and anti-ADA antibodies. Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. However, in a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. Moreover, the reasons for therapeutic failures remain unclear. Overall, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment (Steenholdt, et al; Nanda, et al). Accordingly, the laboratory testing (CPT code 84999) provided on 9/4/17 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: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 65-year-old male enrollee has requested authorization and coverage for Botox injections. 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 the current medical evidence supports the requested services in this clinical setting. There are many therapeutic uses of Botox injections. In muscle tension dysphonia or spasmodic dysphonia, the muscles of the vocal cords are in spasm, and this impacts the voice. Injection of botulinum toxin weakens the muscles to normalize the voice. This therapy has been used successfully in many patients for decades. The typical duration of action is three to four months. Botox injections are a safe and effective primary therapy for spasmodic dysphonia. Therefore, Botox injections are medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

An 18-year-old male enrollee has requested reimbursement for psychiatric residential treatment center services from 2/05/19 through 3/07/19. 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. With regard to risk of harm, the records support a score of 2. The patient did not endorse specific suicidal ideation/plan during his stay, but his history included two previous suicide gestures including fashioning a noose on an exercise bar in his home and contemplating hanging himself. In terms of functional status, the records support a score of 4. The patient had significant withdrawal, dysphoria, and inability to play as a jazz pianist, a role that appeared vital to his self-identity at the time. With regard to comorbidity, the records support a score of 4. The records noted possible PANS, POTS and mild sleep apnea, with unspecified elevation in autoimmune markers, with his hand/forearm nerve compression injury compromising his functioning, in addition to persistent depressive disorder with intermittent major depressive episodes, obsessive-compulsive disorder with poor insight, somatic symptom disorder, severe, and parent-child relational problems. In terms of level of stress of the recovery environment, the records support a score of 3. The patient did not appear to feel close to family members. With regard to level of support of the recovery environment, the records support a score of 2. The patients family appeared supportive and participated in therapy, although the dynamics were not optimal. In terms of resiliency and treatment history, the records support a score of 3. The patient has a high overall IQ, although there were personality characteristics concerning for depressive and avoidant personality traits, with self-defeating features. With regard to acceptance and engagement, the records support a score of 3. The patient appeared to continue to externalize blame to his physical/medical concerns, pointing to limited therapeutic engagement. In sum, the patient has a composite score of 21. However, the patient had scores of 4 in both functional status and comorbidity. Thus, residential treatment was indicated in this patients case. Therefore, psychiatric residential treatment provided from 2/05/19 through 3/07/19 was medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 23-year-old male enrollee has requested authorization and coverage for powered robotic lower body exoskeleton system. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrolleeas medical condition. The physician reviewer found that a review of the literature does not reveal that the ReWalk exoskeletal system provides greater benefit for this patientas condition over the current standards of care for patients with this condition. There is a lack of long-term evidence that this device is more beneficial than standard rehabilitation methods. There is insufficient scientific evidence that this device has long-term positive effects on health outcomes. Although the device is reported to provide positive effects in terms of spasticity and pain outcomes and possible potential to improve bone metabolism and bowel/bladder functions, the studies performed on the ReWalk were limited in sample size and lack of long-term follow up. Efficacy still needs to be demonstrated in larger long-term studies. More research is required on walking performance compared to other mobility and training devices. Additional larger clinical trials over a long-term period are needed to provide additional information that would indicate that this system is superior to other methods of locomotion in paraplegic patients or that this exoskeletal system can prevent long-term complications in the spinal cord injury population. Therefore, the requested powered robotic lower body exoskeleton system is not likely to be more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3
A 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 12/28/15.  The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that Tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. However, in this case there were no problems to be resolved. The patient did not have dense breasts, she did not have a mass, there were no palpable lumps, and she did not have suspicious calcifications. A routine mammogram would have been sufficient. Tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality, especially when there have been no changes when compared to prior studies. All told, the breast tomosynthesis performed on 12/28/15 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 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: Upheld

Summary Reviewer 


A 43-year-old male enrollee has requested reimbursement for a continuous positive airway pressure (CPAP) device provided on 2/9/15. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that the clinical indication for CPAP device includes the requirement of documentation that the patient is compliant and is utilizing the CPAP device for at least four hours a night for at least 70% of the nights for a 30 day period. The patient noted he was not using CPAP because of seasonal allergies. There is a lack of documentation demonstrating that the patient utilized the device at issue for a 30 day period. Given the lack of documentation demonstrating compliance, CPAP was not medically necessary for treatment of the patients medical condition. Given the above reasons, the device at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 48-year-old female has requested reimbursement for Anser IFX testing performed on 9/04/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns colitis. The physician reviewer found there is a lack of support for the services at issue in this patients case.  Some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures.  Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions.  In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment.  The reasons for therapeutic failures remain unclear.  Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment.  However, there are few well-controlled clinical trials to confirm that use of the Anser IFX testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment.  The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement.  It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established.  In sum, Anser IFX testing performed on 9/04/15 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: Medical Necessity
Decision: Upheld

Summary Reviewer 


The parent of a 17-year-old male enrollee has requested reimbursement for residential treatment provided from 2/06/13 through 5/03/13. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue.  In this case, the patient was struggling with the developmental stage of identity formation which was complicated by a formidable anxiety and affective burden coupled with an underdeveloped sense of self and substance use which fueled dysphoria and parent-child disharmony.  The documentation provided does not support the medical necessity of the services at issue during the disputed timeframe.  It appears as though the patient and his family had not pursued evidence-based treatments in a less restrictive setting during the episode of illness.  Such interventions include, but are not limited to, school-based services, psychotherapy, chemical dependency counseling, family therapy, parent training and pharmacotherapy.  Additionally, the medical records did not include a psychiatric evaluation, psychosocial assessment, history and physical examination, or integrated summary justifying the necessity of the placement as opposed to a lower level of care.  The discharge summary, psychological evaluation and initial treatment plan did not describe behaviors, symptomatologies, or treatment interventions that would typically require a 24-hour supervised setting.  In sum, the documentation submitted for review did not suggest that a less restrictive setting would have been insufficient.  All told, residential treatment provided from 2/06/13 through 5/03/13 was not medically necessary for the treatment of this patient.  Therefore, 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: Overturned

Summary Reviewer 3
A 28-year-old female enrollee has requested authorization and coverage for ReActiv8 implantable peripheral nerve stimulation. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition.  At issue is whether the requested device is likely to be more beneficial for treatment of the enrollee's condition than any available standard therapy. The physician reviewer found that Deckers and colleagues evaluated peripheral nerve stimulation with the ReActiv8 peripheral nerve stimulator. The study consisted of 53 patients with chronic low back pain that had failed standard treatments. The study found a responder rate to therapy to be 58%. Gilmore and colleagues performed a review of lumbar medial branch stimulation and evaluated current methods of peripheral nerve stimulation for chronic low back pain. The authors concluded, aPeripheral nerve stimulation for chronic low back pain is an emerging field with clinical benefits that may be applicable to a sizeable patient population for which there are few effective treatments. To date, two systems of PNS of the medial branch of the dorsal ramus for the treatment of CLBP are being evaluated, with promising results. Further studies examining the long-term efficacy, mechanism of action, cost, and utilization are areas of ongoing and future investigation." Gilligan and colleagues evaluated the benefits of the ReActiv8 peripheral nerve system. The study consisted of 204 patients. The authors noted, aThe primary endpoint was inconclusive in terms of treatment superiority. Prespecified secondary outcomes and analyses were consistent with a modest but clinically meaningful treatment benefit at 120 days. Improvements from baseline, which continued to accrue in all outcome measures after conclusion of the double-blind phase, were clinically important at 1 year.a In this case, the patient has chronic low back pain due to spondylosis and spondylolisthesis. She has failed standard of care therapies, including medication management, physical therapy, medial branch blocks and spinal cord stimulation. Her pain physician has recommended peripheral stimulation with the ReActiv8 system. The current evidence demonstrating the benefit of this approach is limited by small sample sizes and lack of large randomized control trials. The largest randomized controlled trial by Gilligan and colleagues failed to demonstrate superiority over sham/placebo arm of the trial, and secondary outcomes did not demonstrate statistical significance.     While initial results are promising, further large studies are needed to demonstrate long-term efficacy and superiority over standard of care methods. Therefore, ReActiv8 implantable peripheral nerve stimulation is not likely to be more beneficial for treatment of the patientas medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 65-year-old female enrollee has requested reimbursement for Cx Bladder testing performed on 7/02/18. 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 there is a lack of support for the services at issue in this patients case. The records document microscopic hematuria. She had a normal cystoscopy and normal renal ultrasound. The patient has a history of cirrhotic liver secondary to alcohol without cirrhosis. Selective use of Cxbladder testing to decipher equivocal diagnostic findings in microscopic hematuria evaluation is currently in clinical use, but there is a lack of evidence in the literature or clinical practice guidelines that supports a role for Cxbladder testing after standard testing with cystoscopy and initial upper tract imaging is entirely normal. Current guidelines do not support the services at issue as beneficial beyond standard diagnostics in this setting. In sum, Cxbladder testing performed on 7/02/18 was not likely to have been more beneficial than other methods of evaluating this patient.