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

Summary Reviewer 2

A 59-year-old female enrollee has requested reimbursement for high dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, for dates of service 2/07/19, 2/09/18, 2/12/19, 2/14/19, 2/19/18, 2/21/18, 2/26/18, 2/28/18 and 3/05/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the medical evidence has not demonstrated the superior efficacy of the services at issue. In this clinical setting, radiation has not been proven to be superior or more beneficial as compared to surgical resection. The claim that radiation leads to less scarring has not been rigorously studied in a prospective setting. Radiation carries a risk for second malignancy and permanent skin changes.  In sum, high dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, for dates of service 2/07/18, 2/09/18, 2/12/18, 2/14/18, 2/19/18, 2/21/18, 2/26/18, 2/28/18 and 3/05/18 was not likely to have been more effective than other treatment options.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 59-year-old female enrollee has requested reimbursement for high dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, for dates of service 2/07/19, 2/09/18, 2/12/19, 2/14/19, 2/19/18, 2/21/18, 2/26/18, 2/28/18 and 3/05/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the standard treatment of skin cancer with radiation therapy is done with standard photons or electrons. Standard treatment of these lesions with photons or electrons is associated with excellent outcomes and cosmesis. The current National Comprehensive Cancer Network guidelines do not endorse the use of electronic brachytherapy for the treatment of skin cancer. There is a lack of medical literature demonstrating that outcomes are improved with the use of brachytherapy in this setting. Furthermore, there is literature that states that longer follow-up is needed before electronic brachytherapy is considered an established alternative to other forms of treatment for skin cancer. Thus, high dose rate electronic brachytherapy, skin surface application, per fraction, includes basic dosimetry, for dates of service 2/07/18, 2/09/18, 2/12/18, 2/14/18, 2/19/18, 2/21/18, 2/26/18, 2/28/18 and 3/05/18 was not likely to have been of greater benefit than other treatment options.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1


A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease.   The physician reviewer found calprotectin is a small calcium-binding protein and is a member of the S100 family of zinc-binding proteins found primarily in neutrophils. Any disturbance to the mucosal architecture due to the inflammatory process, results in leakage of neutrophils, and hence, calprotectin, into the lumen and its subsequent excretion in feces. Studies have demonstrated that of patients with Crohns in remission, only a small percentage had a significant within-individual variability for calprotectin concentrations over three samples suggesting that measurements are reliable (Walsham and Sherwood; Schoepfer, et al; Sipponen, et al). Given this support, the fecal calprotectin testing performed on 11/17/15 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


A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease.   The physician reviewer found a meta-analysis of the utility of fecal calprotectin to determine disease activity in adults with Crohns disease found poor specificity (Lin, et al). Another study found that calprotectin above 150 ug/g had poor specificity (43%), and therefore poor positive predictive value, in predicting relapse (Pardi and Sandborn; Costa, et al). An additional meta-analysis of inflammatory bowel disease markers reported that the relatively poor specificity of fecal calprotectin in Crohns disease is a concern, as a false positive test could lead to treatment of a patient without endoscopically active disease (Mosli, et al). Thus, the use of calprotectin levels to guide therapy has not definitively been shown in controlled studies to improve clinical outcomes in patients with Crohns disease and the fecal calprotectin testing performed on 11/17/15 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 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: Insurer Denial Overturned

Summary Reviewer 3


A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease.   The physician reviewer found fecal calprotectin has commonly been used practice given the multiple studies showing its beneficial effect and accuracy. Since the patients calprotectin was low, the provider focused his attention on a different diagnosis than Crohns flare, thus sparing additional, and more invasive testing that would not have been beneficial. Based on clinical utility that has been documented in multiple clinical trials, the fecal calprotectin testing performed on 11/17/15 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: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 66-year-old female enrollee has requested authorization and coverage for Embeda. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees neuropathic pain. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. Nucynta has a drug interaction with Cymbalta which can cause serotonin syndrome. She has tried morphine and oxycodone previously, without benefit. It is not medically reasonable to try a medication that she has previously failed. Since she is stable on Embeda, it is medically appropriate to continue on this medication. The use of strong opioids for neuropathic pain is supported by clinical practice guidelines. Thus, Embeda is medically necessary 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: Insurer Denial Overturned

Summary Reviewer 

A 19-year-old female enrollee has requested reimbursement for the bilateral reduction mammoplasty performed on 5/14/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees bilateral macromastia.  The physician reviewer found that according to the American Society of Plastic Surgeons (ASPS), symptomatic breast hypertrophy is defined as a syndrome of persistent neck and shoulder pain, painful shoulder grooving from brassiere straps, chronic intertriginous rash of the inframammary fold, and frequent episodes of headache, backache, and neuropathies caused by heavy breasts caused by an increase in the volume and weight of breast tissue beyond normal proportions. Consistent with the guidelines from the ASPS, this patient has well-documented back, neck and shoulder pain, as well as shoulder grooving from bra straps. This patient had traditional signs and symptoms of macromastia that was likely to benefit from breast reduction. Moreover, the patient had failed conservative measures as supported by examination notes as well as detail from the operative report. Photographs were not provided for review, but based on the overall clinical picture and degree of breast tissue resected the procedure was not an aesthetic mastopexy or minimal breast reduction. As expected with the procedure, the patient has reported significant functional improvement following her breast reduction. Given these findings, the bilateral reduction mammoplasty performed on 5/14/14 was medically necessary for treatment of this patients bilateral symptomatic macromastia. Therefore, the services at issue were 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 55-year-old male enrollee has requested authorization and coverage for an electrical stimulation device.  The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. The physician reviewer found the use of alternating electrical fields via Novocure device is a relatively new type of therapy used in the treatment of brain tumors.  This technique involves the use of a helmet which delivers low-intensity alternating electric fields.  It was approved for use by the U.S. Food and Drug Administration for the treatment of glioblastoma in 2011.  In the study by Stupp and colleagues, 237 patients with recurrent glioblastoma were randomized to either chemotherapy or electrical field therapy.  There was no difference seen in overall survival between the chemotherapy group and the electrical field group.  However, there was noted to be significantly less toxicity in the electrical field group.  All told, the requested device is likely to be more efficacious than other treatment options.  Based upon the information set forth above, the requested device 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: Insurer Denial Overturned

Summary Reviewer 2

A 55-year-old male enrollee has requested authorization and coverage for an electrical stimulation device.  The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. The physician reviewer found the current medical evidence supports the superior effectiveness of the requested device in this clinical setting.  Optune is a type of alternating electric field therapy which is U.S. Food and Drug Administration (FDA) approved for recurrent/progressive disease in patients with glioblastoma multiforme.  It is considered a standard of care based on a follow-up study showing prolonged progression free and overall survival.  Consensus-based guidelines published by the National Comprehensive Cancer Network include alternating electric field therapy as a treatment option for patients with recurrent glioblastoma.  Based upon the information set forth above, the requested device 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: Insurer Denial Overturned

Summary Reviewer 3


A 55-year-old male enrollee has requested authorization and coverage for an electrical stimulation device.  The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. The physician reviewer found the anaplastic astrocytomas and glioblastoma multiforme are high-grade tumors that are best treated with resection, radiation therapy, and chemotherapy.  The standard of care is to resect the glioblastoma multiforme maximally followed by treatment with temozolomide.  This patient has exhausted standard options.  In 2011, the U.S. Food and Drug Administration approved Optune, formerly known as the NovoTTF-100A device, to deliver alternating electrical fields to treat recurrent glioblastoma multiforme.  There is sufficient medical evidence to demonstrate the safety of this device in this clinical setting.  Therefore, the requested electrical stimulation device is likely to be more efficacious than other available modalities.  Based upon the information set forth above, the requested device 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: Insurer Denial Upheld

Summary Reviewer 1

A 30-year-old female enrollee has requested reimbursement for Prometheus Anser ADA (84999) provided on 10/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees inflammatory bowel disease (IBD). The physician reviewer found that it has not yet been established in the medical evidence 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, as in this patients circumstance. The Prometheus Anser IFX test is a quantitative measurement of serum infliximab (IFX) and anti-IFX antibodies, and the Anser ADA test assesses serum adalimumab (ADA) and anti-ADA antibodies. 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 adalimumab or the presence of IFX or ADA 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 testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. As such, 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. All told, Prometheus Anser ADA (84999) provided on 10/14/15 was not likely to have been more efficacious than other alternatives in evaluating this patients medical condition. 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 30-year-old female enrollee has requested reimbursement for Prometheus Anser ADA (84999) provided on 10/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees inflammatory bowel disease (IBD). The physician reviewer found that monitoring patients on adalimumab with measurement of adalimumab levels and antibodies to adalimumab continues to be an area of interest in the inflammatory bowel disease community. In general, adalimumab levels correlate inversely with disease activity. However, there is a lack controlled data which has identified the optimal drug level and so, the issue remains speculative. This patients level was in the normal range despite the fact that he was having an active flare/progression of disease, highlighting the limitation of the test. Using the Anser ADA, one can set up a hypothetical table categorizing drug levels as high or low and antibody levels as high or low. In theory, one could use this table to determine whether to dose increase or switch to a biologic agent with a different mechanism of action. However, this hypothetical benefit is not supported by high quality medical evidence. In sum, Prometheus Anser ADA (84999) provided on 10/14/15 was not likely to have been more effective than other modalities in the evaluation of this patient. 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 30-year-old female enrollee has requested reimbursement for Prometheus Anser ADA (84999) provided on 10/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees inflammatory bowel disease (IBD). The physician reviewer found that there is a lack of support in the medical literature as to the superior efficacy of the services at issue in this clinical setting.  In this patients case, Anser ADA was ordered to direct the management of the patients Crohns disease. However, the use of Anser ADA has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. The effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with Humira (adalimumab) may experience loss of response, but the appropriate method for determination of the cause for loss of response is unclear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature (Karmiris, et al; Imaeda, et al; Lichtenstein, et al). These small studies demonstrated, at best, correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect. Karmiris and colleagues found no direct relationship between trough serum adalimumab concentration or anti-adalimumab antibody and short-term treatment efficacy. Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. The available data does not allow final conclusions about the relevance of anti-adalimumab antibodies to the clinical efficacy of adalimumab. A study by Yanai and Hanauer concluded that prospective controlled trials are direly needed to investigate the optimal tailored management in individual patients who lose response. As such, the clinical literature does not support the superior efficacy of Prometheus Anser ADA diagnostic test performed on 10/14/15 over standard options in the evaluation of this patient. 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 Overturned

Summary Reviewer 1


A 20-year-old male enrollee has requested reimbursement for the human T-lymphotropic virus (HTLV) testing performed on 4/25/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees sperm prior to banking. The physician reviewer found that currently, the U.S. Food and Drug Administration (FDA) requires all sperm donors, anonymous and directed, to be tested for human immunodeficiency virus (HIV), hepatitis B and hepatitis C, syphilis, human T-lymphotropic virus types I and II, cytomegalovirus, chlamydia trachomatis, and neisseria gonorrhea. Future infectious profile for the patient may differ from current profile at the time of the sperm donation. Hence the need to define the microbial profile of the patient at the time of the donation. Given that this patient has Ewing sarcoma and is undergoing chemotherapy, semen preservation is indicated. Thus, the HTLV testing performed on 4/25/16 was appropriate and 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


A 20-year-old male enrollee has requested reimbursement for the human T-lymphotropic virus (HTLV) testing performed on 4/25/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees sperm prior to banking. The physician reviewer found that the lab performing the sperm banking states testing for HTLV-I and HTLV-II are needed to meet requirements set forth by the U.S. Food and Drug Administration (FDA). Further, the FDA has issued guidelines for testing all donated blood for HTLV-I and HTLV-II. The FDA requirements indicate that HTLV testing is not investigational in this clinical setting. Moreover, sperm banking is considered standard of care for young men requiring chemotherapy. Accordingly, the HTLV testing performed on 4/25/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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.