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

Summary Reviewer 2


A 41-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/02/15. 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 the current medical evidence does not support the services at issue in this clinical setting.  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 has 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 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 4/02/15 was not likely to have been superior over 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: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 41-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/02/15. 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 the use of Anser IFX to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response.  Although loss of response to infliximab is common, and excessive doses are also given, there were no standard guidelines defining a therapeutic strategy at the time of testing.  In sum, the superior efficacy of Anser IFX testing performed on 4/02/15 has not been established.  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 1

A 60-year-old female enrollee has requested reimbursement for DecisionDX Melanoma gene expression assay performed on 12/23/15.  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 classically been determined by the staging system as documented by Balch and colleagues. Mitotic index has also been thought to add a bit more to the prognostics. By Balch tables, this patients melanoma would be classified as a T1a melanoma, or stage 1A. By these determinations, this patient has an excellent prognosis. 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) versus Class 2 (with a 31% disease free rate at five years). The study by Gerami and colleagues reported on 217 cases with good correlation between prognosis and DecisionDx classification, in patients undergoing sentinel node biopsy. However, it is not clear as yet how DecisionDx data compares to the ten year data of the Balch determinations, and whether it can be used to make clinical practice decisions. This is the issue presented in this patient with her pathologic findings and excellent prognosis. Moreover, National Comprehensive Cancer Network (NCCN) guidelines recognize that there is interest in these newer genetic profiles, but as yet only in the context of a clinical trial. In sum, DecisionDX melanoma gene expression assay performed on 12/23/15 was not likely be of greater clinical benefit than standard tests for the evaluation of this patient. Based on the information 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 60-year-old female enrollee has requested reimbursement for DecisionDX Melanoma gene expression assay performed on 12/23/15.  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 a commercial gene expression profile test (DecisionDX Melanoma gene expression assay has been developed in patients with stage I and II cutaneous melanoma. However, there are no 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. The National Comprehensive Cancer Network (NCCN) Guidelines, recognize that there is growing 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. However, the routine (baseline) genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study (trial). Therefore, the DecisionDX Melanoma gene expression assay performed on 12/23/15 was not likely to be more efficacious than available standard therapy for evaluation of 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 60-year-old female enrollee has requested reimbursement for DecisionDX Melanoma gene expression assay performed on 12/23/15.  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 there is a lack of high-grade scientific data to support the superior efficacy of the services at issue in this clinical setting. The DecisionDX Melanoma gene expression assay has not been clinically shown to add to the current standard of care for the evaluation of malignant melanoma. Therefore, the DecisionDX Melanoma gene expression assay performed on 12/23/15 was not likely to be more effective than standard treatment for the evaluation of 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 31-year-old male enrollee has requested reimbursement for mental health outpatient services provided at a frequency of one time per week from 12/20/18 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The medical records indicate that the patient has been receiving therapy on outpatient basis. The progress notes do not describe suicidal or homicidal ideation. He continues to have anxiety as well as functional impairment due to his generalized anxiety disorder. Functional impairment must be present in order for a set of symptoms to classify as a mental illness. The patient has anxiety symptoms that have continued over several months, and the progress notes indicate episodes of increased anxiety.  He has been receiving therapy, but his symptoms have shown only mild improvement as evidenced by continued anxious affect and symptom report. The medical evidence supports the services at issue in this clinical setting. Therefore, mental health outpatient services provided from 12/20/18 forward were and are medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The parent of a 14-year-old male enrollee has requested authorization and coverage for Nutropin AQ Nuspin 10 mg/2mL (5 mg/mL) subcutaneous pen injector. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found thaat the submitted documentation supports the medical necessity of the requested medication. This patient has had a gradual decline in his growth velocity, as shown on the growth chart. His current height is -2.98 standard deviations below the mean for age and sex. This is severe short stature. The Pediatric Endocrine Society supports the use of growth hormone for the treatment of short stature that is below -2.25 standard deviations. Thus, this patient has severe short stature that meets this criterion for treatment. Per the records, his estimated adult height prediction gradually deteriorated over time on serial bone age studies, which indicates abnormal growth. The patient is not likely to meet his genetic potential with such a poor growth velocity. His estimated adult height is significantly below his mid-parental target height. His height deteriorated despite improvement of his weight, which indicates abnormal growth beyond what can be explained by poor nutrition. Therefore, Nutropin AQ Nuspin 10 mg/2mL (5 mg/mL) subcutaneous pen injector is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The patient is a 15-year-old male who has been diagnosed with mixed receptive-expressive language disorder, cognitive communication deficit and other speech disturbances. The patientas parent has requested reimbursement and prospective authorization and coverage for speech therapy provided from 1/10/21 through 12/31/21. The physician reviewer found that the submitted documentation supports the medical necessity of a portion of the services at issue. This patient has been receiving speech therapy from two therapists. One therapist, Anna Vagin, PhD, coordinates a weekly group speech therapy session, facilitating the development of the patientas social language skills in a group setting. He is functioning below age-level in his communication skills. As such, he is at risk of being socially excluded and bullied, which may increase his risk of mental health problems unless he continues to receive medically necessary speech therapy to address improving his communication skills with his peers. His scores on the Comprehensive Assessment of Spoken Language (CASL-2) were very low. Ebbels and colleagues describe the effectiveness of speech and language therapy for older children with language disorders. The therapy provided by the second therapist, Brooke Gonterman, M.D., CCC-SLP, appears to be primarily educational in nature. Brooke Gonterman, M.D., CCC-SLP was working on school assignments with the patient, which appears educational rather than medically necessary in nature. As such, it does not appear to be medically necessary, and could be addressed in the school setting. Therefore, speech therapy services provided by Anna Vagin, PhD were and are medically necessary. Speech therapy services provided by Brooke Gonterman, M.D., CCC-SLP were not and are not medically necessary.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

The patient is a 61-year-old female with a history of recurrent ovarian cancer diagnosed with multiple prior lines of therapy. Her tumor was submitted for molecular profiling with FoundationOne testing on 3/16/17. The patient has requested reimbursement for blood testing performed on 3/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. Individualized molecular tumor profiling holds the promise of enabling personalized selection of molecularly targeted treatment based on the specific genotype identified. Several platforms are available, including the FoundationOne, Caris Target Now, and SNaPshot technology. The National Comprehensive Cancer Network (NCCN) guidelines recommend tumor molecular testing prior to initiation of therapy for recurrent or persistent ovarian cancer, if not previously done. Testing should include BRCA1 and BRCA2, homologous recombination pathway genes, and microsatellite instability (MSI) or DNA mismatch repair (MMR). Molecular profiling is now considered a standard of care in patients with recurrent or persistent ovarian cancer. Accordingly, the blood testing performed on 3/16/17 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 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: Insurer Denial Overturned

Summary Reviewer 2

The patient is a 61-year-old female diagnosed with ovarian cancer in 2008. She tested negative for BRCA mutations. She has been treated with surgery, Cisplatin, Taxol, Carboplatin, Avastin, Doxil, Gemzar, Topotecan and with olaparib and mTorC 1 and mTorC 2 inhibitor and participation in a clinical trial. A tissue sample from a chest wall metastasis was submitted for FoundationOne testing on 3/21/17. The results showed genomic alterations of PIK3CA, and TP53. Neither of these suggests response to an approved treatment but the PIK3CA suggested possible response to everolimus or temsirolimus. The patient has requested reimbursement for blood testing performed on 3/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. FoundationOne tumor testing analyzes a tumor sample for genetic mutations that can help guide treatment options. The standard of care options for ovarian cancer include BRCA1 and BRCA2 testing. The National Comprehensive Cancer Network (NCCN) guidelines state that tumor molecular testing should be done. The recommended testing includes at least BRCA1 and BRCA2, homologous recombination pathway genes, and microsatellite instability (MSI) or DNA mismatch repair (MMR). Testing for BRCA 1 and BRCA 2 has been completed in 2015. Thus, testing for MSI or MMR and testing for homologous recombination pathway genes and for MSI or MMR was medically reasonable and more beneficial than other available standard testing. Given this support, the blood testing performed on 3/16/17 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 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: Insurer Denial Overturned

Summary Reviewer 3

The patient is a 61-year-old female who was diagnosed with advanced stage serous ovarian cancer at surgery in 2008. The surgery was followed by six cycles of cisplatin and Taxol. She had recurrence and was treated with a variety of chemotherapeutic agents, including carboplatin, Avastin, Gemzar, Doxil, and Topotecan. She also had been treated on a clinical trial with olaparib. The patient has requested reimbursement for blood testing performed on 3/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. FoundationOne is a molecular assay that explores the mutations of an individual patients cancer cells. The goal of the assay is to identify a specific mutation or target which could guide the provider as to which chemotherapeutic agent would be useful. However, there is a paucity of evidence that the FoundationOne assay adds to decision making ability, or yields a result that is reliably clinically beneficial. There are non-randomized studies exploring the value of molecular profiling, but the results have not been convincing as to the efficacy of such an approach to treatment (Von Hoff, et al). A randomized trial did not demonstrate a significant clinical benefit from choosing therapy based on molecular targets versus by the providers clinical judgment (LeTourneau, et al). Currently, the data suggests that finding a mutation does not support treatment directed at that target to produce a clinically meaningful response. All told, the blood testing performed on 3/16/17 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: Insurer Denial Overturned

Summary Reviewer 

A 51-year-old female enrollee has requested authorization and coverage for endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee who is diagnosed with venous insufficiency. The physician reviewer found that there is sufficient support in the documentation provided for the requested services in this clinical setting. An examination dated 2/22/17 noted multiple areas of bulky varicose veins in the area of the right medial thighs, particularly directly above the knee. In an undated letter, the treating provider reported that ultrasounds confirmed fairly significant venous insufficiency and recommended venous ablation. Based on the documentation submitted, this patient is likely to be well served by ablation, and she meets standard criteria for treatment of her venous insufficiency that is refractory to compression stockings. Additionally, the medical literature supports the efficacy of this therapy for treatment of the patients medical condition. Her treating provider has assessed her vein as an appropriate target for ablation. In sum, endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, radiofrequency is medically necessary for treatment of this patients medical condition.
Therefore, for the reasons stated above, 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 Overturned

Summary Reviewer 1

A 30-year-old male enrollee has requested reimbursement for immunoglobulin heavy chain locus gene rearrangement and immunoglobulin kappa light chain locus gene arrangement testing performed on 2/14/19. 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 leukemia and lymphoma are the most common causes of unexplained fever. Most patients with T-cell large granular lymphocyte (LGL) leukemia present with symptoms related to neutropenia. Fever with recurrent bacterial infections occurs in 20 to 40 percent of patients. LGL leukemia is a chronic illness. Usually, there is history of a gradual decline in counts over time. Diagnosis includes evaluation of T-cell rearrangements. B-lymphoblastic leukemia and lymphoma are overlapping clinical manifestations of the same disease. The tempo of disease is variable. Some patients present with symptoms that progress slowly over weeks to months, while others have a more acute presentation. Nearly all cases of B-cell acute lymphoblastic leukemia have rearrangements of immunoglobulin heavy chain (IGH), but up to 70 percent of cases also have rearrangements of the T-cell receptor (TCR) gamma or beta chain genes. Molecular techniques that can detect clonal populations of lymphocytes include polymerase chain reaction (PCR) and DNA sequencing. These techniques can demonstrate the presence of a dominant clone of cells based on rearrangements of either immunoglobulin genes (in B lymphocyte) or T-cell receptor genes (in T cells) and can include immunoglobulin heavy chain locus gene rearrangement and immunoglobulin kappa light chain locus gene. The services at issue were part of standard testing. Therefore, immunoglobulin heavy chain locus gene rearrangement and immunoglobulin kappa light chain locus gene arrangement testing performed on 2/14/19 were likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 30-year-old male enrollee has requested reimbursement for immunoglobulin heavy chain locus gene rearrangement and immunoglobulin kappa light chain locus gene arrangement testing performed on 2/14/19. 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 at the time of presentation to the hematologist, the patients complete blood count was normal, and the thrombocytopenia and leukopenia noted during his acute illness in 2018 were resolved. Thus, the records do not support a suspected a lymphoproliferative neoplastic process in this patient, or a screen for such a process using this molecular tool. Gene arrangement assays in T-cells and B-cells are appropriate in situations where a morphological or immunophenotypically aberrant population of lymphocytes have been identified, typically either in peripheral blood, in an enlarged lymph node, or in the bone marrow, and where there is a need to clarify whether this population of cells is clonal. In this case, none of these conditions applied. Flow cytometry of peripheral blood was normal. The providers assertion that repeat complete blood count continued to reveal evidence of significant cytopenias is not supported by the test results from January 2019. Screening for a lymphocytic leukemia using gene rearrangement assays on peripheral blood in this case was without utility. In sum, immunoglobulin heavy chain locus gene rearrangement and immunoglobulin kappa light chain locus gene arrangement testing performed on 2/14/19 were not likely to have been more beneficial than other methods of evaluating this patient.