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

Summary Reviewer 

A 23-year-old male enrollee has requested authorization and coverage for orthognathic surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees mandibular prognathism, maxillary hypoplasia and class II malocclusion. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. This patient has a maxillofacial skeletal deformity that cannot be corrected with orthodontics alone. The requested services are likely to result in improved musculoskeletal and dento-osseous relationships and improvement in mastication. The anterior segmental osteotomy will maximize the patients outcome. The medical evidence supports the requested services in this clinical setting. Thus, the requested orthognathic surgery is medically necessary for the treatment of this patient. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 38-year-old female enrollee has requested authorization and coverage for Tysabri.  The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found this patient has been diagnosed with relapsing-remitting multiple sclerosis. Treatment is indicated to reduce attacks.  She has been prescribed Tysabri, and the current medical evidence supports the requested medication in this clinical setting.  Guidelines and clinical experience show reduction of relapse rates and progression, with generally favorable tolerability. Compliance with once monthly regimen is high.  This patient did not tolerate Copaxone.  There is sufficient support for the requested medication in this patients case.  All told, Tysabri is medically indicated for the treatment of this patient.  Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer  
 
The patient is a 26-year-old male who presented to his provider on 1/28/22 with diagnoses of 
recurrent, severe major depressive disorder, generalized anxiety disorder, and insomnia. The 
patient has requested reimbursement for adult mental health transcranial magnetic stimulation 
from 1/31/22 through 3/28/22. The Health Insurer has denied this request and reported that the 
services at issue were not medically necessary for the treatment of this patient. The physician 
reviewer found that the submitted documentation supports the medical necessity of the services 
at issue. McClintock and colleagues note that there is an abundance of data pertaining to the safety 
and efficacy of transcranial magnetic stimulation for individuals with major depressive disorder. 
In this case, the patient has treatment refractory depression, having failed more than three 
antidepressant trials in addition to psychotherapy. An evaluation by a psychiatrist resulted in a 
recommendation of transcranial magnetic stimulation. The patient was in an episode of recurrent, 
severe major depressive disorder. Given the patients lack of response to traditional medication 
and psychotherapy treatment, transcranial magnetic stimulation was the appropriate next step in 
the decision-making algorithm for treatment refractory depression. Therefore, adult mental health 
transcranial magnetic stimulation from 1/31/22 through 3/28/22 were medically necessary for the 
treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found that according to Kirchheiner and colleagues there is still considerable controversy on whether adjustment of dosage driven by genetic information may improve therapeutic efficacy, and/or adverse events is prevented, to an extent of any practical importance in clinical practice. The documentation provided for review does not indicate specific medication doses used, length of medication trials or combinations of medications tried and failed. The record indicates that the testing was performed due to medication failures. However, there is a lack of documentation provided as to whether the patient has been treated with psychotherapy or cognitive behavioral therapy (CBT). CBT is a first-line treatment for the generalized anxiety disorder. In sum, the documentation provided for review does not demonstrate that the patient has failed medication trials of adequate dose and duration or that the patient has tried or failed evidence based psychotherapy trials. As such, the gene testing performed on 8/11/16 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 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 2

A 63-year-old male enrollee has requested reimbursement for Guardant360 liquid biopsy test performed on 9/14/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that pancreatic cancer has notably been a difficult cancer to treat. With the emergence of new agents to treat pancreatic cancer, particularly biologics, clinical trial strategies incorporating principles of molecular biology and new imaging methods as well as results from preclinical studies are important. Per the National Comprehensive Cancer Network guidelines, tumor/somatic gene profiling is recommended for patients with locally advanced/metastatic disease who are candidates for anti-cancer therapy to identify uncommon mutations. Molecular profiling or next-generation sequencing can help identify available therapies and identify clinical trials. It can also evaluate for microsatellite instability, mismatch repair and tumor mutational burden status to determine eligibility for immunotherapy. Therefore, Guardant360 liquid biopsy test performed on 9/14/20 was likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

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 prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit more to these determinations. As per the Balch criteria, this patients melanoma would be considered a T1a, or stage 1A melanoma, with an expected ten-year survival in excess of 88%.  DecisionDx-Melanoma assay is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either Class 1 (with a five-year distant metastasis free rate of greater 90%) or Class 2 (65-80%). Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx classification, in patients undergoing sentinel node sampling. The records do not document that this patient had sentinel node biopsy. It is not clear how the five-year DecisionDx data compares to the ten-year Balch data, and, most importantly, whether it can be used to make clinical decisions. That would be particularly true in this patient given her excellent prognosis. In sum, procedure codes 84999 (DecisionDx-Melanoma) and 99000 performed on 1/25/17 were not likely to have been of greater benefit than other available modalities 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: Upheld

Summary Reviewer 2

A 57-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 8/17/17. 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 prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add to these statistics. DecisionDx-Melanoma is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either class 1 (with a 90 to 92% distant disease free survival at five years), or class 2 (with a 65 to 80% rate). Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients undergoing sentinel node sampling. However, it is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear whether the assay can be used to make treatment decisions. Therefore, DecisionDx-Melanoma test performed on 8/17/17 was not likely to have been superior over 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: Upheld

Summary Reviewer 2

A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 4/12/18. 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 this patient has 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, DecisionDx-Melanoma assay performed on 4/12/18 was not likely to have been more effective than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

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 the submitted documentation fails to demonstrate the superior efficacy of the requested services. There is insufficient high-quality clinical outcomes reported in the peer-reviewed medical literature demonstrating that the requested services are safer or more effective as compared to standard of care photon radiation.  The provider has performed a photon/proton comparison plan which showed that the photon plan could be delivered safely.  There was a slight reduction in exposure to several normal tissues, but it remains unknown as to whether this would translate into a clinically meaningful benefit. Thus, proton beam therapy is not likely to be more effective 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: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 57-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 12/28/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. This patient has 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 DecisionDx-Melanoma assay were not likely to have altered treatment and surveillance recommendations. Thus, DecisionDx-Melanoma assay performed on 12/28/17 was not medically necessary for the evaluation of the enrollees medical condition. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

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 multiple myeloma is a plasma cell neoplasm that extends widely with many systemic complications including anemia, hypercalcemia, bony lytic lesions, and renal failure. Multi-agent chemotherapy is the mainstay of treatment and this is frequently consolidated with autologous hematopoietic stem cell transplant. Overall, it is common for patients to transition from many different agents and lines of therapy. Bortezomib is oftentimes used in newly diagnosed patients and patients with relapsed disease (Kastritis, et al; Reece, et al; Venner, et al). Daratumumab is a monoclonal antibody directed against CD38 that was approved by the U.S. Food and Drug Administration (FDA) for treatment of myeloma in those patients who have progressed on proteasome inhibitor or immunomodulatory agents. A recent phase III, randomized clinical trials showed that daratumumab with bortezomib and dexamethasone had increased overall response rate and improved progression free survival compared with bortezomib and dexamethasone (Palumbo, et al). Given this support, the requested Venclexta (venetoclax) 100 mg, five tablets daily #150 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 medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2
A 61-year-old female enrollee has requested reimbursement for the molecular profiling lab testing performed on 1/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic carcinoma of unknown primary site. The physician reviewer found that in the peer-reviewed medical literature, Weiss and colleagues noted that their study demonstrated a role for molecular studies in carcinoma of unknown primary, although the precise clinical indication requires further study. The current National Comprehensive Cancer Network (NCCN) guidelines state the clinical benefit of molecular assays remains to be determined. Finally, this patients records suggest the presence of a signet ring carcinoma of gastrointestinal origin, for which standard treatment is FOLFOX or FOLFIRI. Given these findings, the molecular profiling lab testing performed on 1/23/15 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, I have determined 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 58-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Plan has denied this request indicating that the requested procedure is considered investigational for the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found there is a lack of randomized controlled trials comparing Linx with Nissen fundoplication or other standard surgical anti-reflux procedures. According to Sheu and Rattner the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined. In addition, Loh and colleagues concluded that further studies are required to determine its long term outcomes and its relative efficacy as compared to other established treatments, Adverse events, such as erosion through the esophagus, have been reported since U.S. Food and Drug Administration (FDA) approval (Bauer, et al). The currently available peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment, such as surgical fundoplication. Based on current literature and clinical guidelines, LINX is not likely to be more beneficial for treatment of the enrollees 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. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 29-year-old female enrollee has requested reimbursement for the Anser ADA test provided on 10/13/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.  The physician reviewer found that in this patients case, the Anser ADA test was ordered to determine the etiology for possible loss of response to Humira and to direct management of the patients ulcerative colitis. Overall, the effectiveness of the Anser ADA compared to conventional courses of evaluation remains unproven. Patients being treated with adalimumab may experience loss of response. However, the appropriate method for determination of the cause for loss of response remains uncertain. The available published clinical studies on the use of these serum levels are small and retrospective or observational in nature (Karmiris, et al; Roblin, et al). Prospective controlled trials demonstrating the effectiveness of anti-adalimumab antibody testing and serum level testing as part of the clinical management strategy are lacking. For these reasons, the Anser ADA test provided on 10/13/14 was not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined 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 1


A 59-year-old male enrollee has requested reimbursement for advanced lipoprotein testing provided on 3/11/16. The Health Plan has denied this request indicating that the service at issue was considered investigational for the enrollees hypertension. The physician reviewer found the advanced lipoprotein testing provided on 3/11/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Advanced lipoprotein analysis has not been approved in the current guidelines from the American College of Cardiology (ACC). The ACC guidelines recommend use of standard risk factors and standard lipid panels in managing cardiovascular risk. The ACC has also moved away from treating to target lipid values and favor a simpler approach to provide standard doses of moderate strength statins to patients at increased risk, based on outcome studies. This recommendation is based on consensus by experts who have reviewed the current literature. Therefore, the testing at issue 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 3

A 36-year-old female enrollee has requested authorization and coverage for peripheral nerve stimulator (implant of neuroelectrodes (G4555)). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees paraclavicular and neck pain.  The physician reviewer found that currently, there is a paucity of clinical data on peripheral nerve stimulation. Further, there is a lack of an indication for the peripheral nerve stimulation requested in this patients case. Considering the previous poor response to surgical interventions, which included thoracic outlet syndrome decompression as well as spinal cord stimulation, the recommended peripheral nerve stimulation does not appear to be superior to other modalities of treatments available. All told, the requested peripheral nerve stimulator (implant of neuroelectrodes (G4555)) is not likely to provide this patient with an improved health outcome beyond that anticipated with standard available alternatives. Based upon the information set forth above, I have determined 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.