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

Summary Reviewer 2

A 39-year-old male enrollee has requested reimbursement for Anser IFX testing provided on 4/23/14. 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 a lack of support for the services at issue in this clinical setting.  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 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.  In addition, there are technical factors relating to the use of different assay methods across studies. 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.  Therefore, Anser IFX testing performed on 4/23/14 was not likely to have been of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 35-year-old female has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 9/15/16 through 4/17/17.  The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees major depressive disorder. The physician reviewer found that on the information provided, it appears that the TMS is being used for maintenance or continuation purposes, which is consistent with an investigational application.  A typical course of TMS consists of 30 to 40 sessions spanning four to six weeks.  For patients who respond well to TMS, clinical improvement is usually maintained with psychotherapy and psychotropic medication.  Although small studies are demonstrating good tolerability and clinical efficacy of TMS therapy for treatment courses lasting years at a time, according to the summary of TMS treatment recommendations authored by Perera and colleagues, The standard parameter setprovided clinical benefit in treatment courses up to six weeks in duration. Controlled studies of longer duration, acute treatment courses or using alternative treatment parameters are not established.  In other words, at this time there is a lack of well-designed and adequately-powered controlled studies showing the benefit of longer courses of TMS therapy.  Therefore, the superior efficacy of maintenance TMS therapy as compared to other available standard therapy, such as ongoing pharmacotherapy, psychotherapy and electroconvulsive therapy, has not been established.  Based upon the information set forth above, the services at issue were not and 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: Experimental
Decision: Upheld

Summary Reviewer 2
A 52-year-old male requested authorization and coverage for hypoglossal stimulator.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that obstructive sleep apnea (OSA) is an increasingly prevalent clinical problem with significant effects on both personal and public health. CPAP has demonstrated excellent efficacy and low morbidity with long term adherence rates approach 50%. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. After decades of trials demonstrating proof of concept of hypoglossal nerve stimulation in animal and human subjects, the three  and four  year results of a large multicenter, prospective trial were published in January 2016 and February 2017. The STAR trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA. This trial has demonstrated the hypoglossal nerve stimulator to be safe and effective in a small subset of patients with OSA who have failed CPAP. This patient meets the criteria. He has failed CPAP, which is the gold standard treatment for OSA. All told, implantation with a hypoglossal stimulator is likely to be more beneficial than the standard options available for treatment of this patients medical condition.Therefore, for the reasons stated above, the requested services are 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: Medical Necessity
Decision: Upheld

Summary 

The patient is a 55-year-old male with a long history of chronic headaches. He has seen neurologists in the past and more recently has been given the diagnosis of chronic migraine and occipital neuralgia. In a letter dated 8/23/17, the patient outlined his previous treatment with various preventive medications and stated that he is currently taking 8 to 10 Excedrin tablets per day. He reportedly responded to occipital nerve blocks in the past. The patient requested authorization and coverage for CPT codes 64722, 64772 and 64910. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The submitted documentation fails to demonstrate the medical necessity of the requested services. There are several publications regarding the use of decompression or neurolysis of the occipital nerves for the treatment of intractable headache. Many of these studies have demonstrated high success rates relative to headache reduction. However, there is a lack of studies performed using randomized studies and/or sham procedures to demonstrate efficacy greater than placebo. Accordingly, the requested services are not considered to be a standard of care and are an unproven treatment at this point.  All told, CPT codes 64722, 64772 and 64910 are not medically necessary in this patients case. Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

The patient is a 64-year-old male with a medical history including migraine headaches, hypertension, coronary artery disease and benign prostatic hypertrophy, who presented to the emergency department with complaints of a severe headache with chills. He had recently been admitted to the hospital from 10/08/19 through 10/10/19 with a diagnosis of a viral infection with severe headaches.  The physician reviewer found that at the time of admission, the patient was hemodynamically stable and afebrile with normal oxygen saturations on room air. The physical examination did not show any neurological deficits or altered mental status. His blood pressure had normalized with treatment in the emergency department. The laboratory studies did not show any active infection, significant electrolyte disturbance or end organ damage. Imaging was negative for acute disease or injury. There was no need for urgent procedures or surgical intervention. The inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patientas signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Therefore, acute inpatient services at the step-down level of care from 10/11/19 through 10/13/19 was not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 53-year-old male enrollee has requested authorization and coverage for placement of a hypoglossal nerve stimulation device.  The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested device.  A review of the literature indicates that hypoglossal nerve stimulation for treatment of obstructive sleep apnea can show positive and beneficial outcomes with minimal adverse effect in select patients.  However, further independent outcomes data, especially regarding long-term effects, are needed.  The medical necessity of hypoglossal nerve stimulation has not been demonstrated, as there is a lack of data to date to support its efficacy in the longer term.  All told, the requested placement of a hypoglossal nerve stimulation device is not medically indicated for the treatment of this patient.  Therefore, the requested device is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 56-year-old female enrollee has requested reimbursement for the Foundation One genetic testing provided on 1/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees recurrent ovarian cancer.  The physician reviewer found  that the Foundation One assay tests for the presence of a wide array of molecular markers that have been demonstrated to be of relevance in the pathogenesis of various cancers. Screening for the presence of these markers in a tumor may provide information relevant to the selection of potentially active therapeutic agents. Several commercially available assays are currently available which provide similar information. This methodology is promising, but with few exceptions, the level of evidence supporting clinical decision-making using genomic profiling is at present not of sufficient quality and maturity to inform current standards of care (Doroshow). According to the National Comprehensive Cancer Network (NCCN) guidelines, genomic profiling is not mentioned, and is not considered a standard of care. A recent review from Kohn similarly asserted that, tumor profiling done for therapeutic guidance is currently premature, save BRCA1 and BRCA2 mutation testing, and when done, should rely on validated ovarian cancer-specific treatment data. All told, the Foundation One genetic testing performed on 1/12/15 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: Overturned

Summary Reviewer 1

The parent of a 15-year-old male enrollee has requested reimbursement for quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified, performed on 12/10/19. 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 therapeutic drug level monitoring has become an essential procedure in the management of inflammatory bowel disease. Measuring the drug level and the presence of antibodies can help the treating provider differentiate between primary treatment failures versus insufficient dosing. It can also allow dosing titration and adjustments. The clinical practice guidelines adopted by the American College of Gastroenterology (ACG) support the use of therapeutic drug monitoring in the management of patients with inflammatory bowel disease. There is sufficient scientific evidence supporting the benefit of biologics drug level measurement. Per Singh and Dubinsky, aTherapeutic drug monitoring allows for optimized, individualized dosing and improved care for inflammatory bowel disease patients of all ages.a Raimundo Fernandes and colleagues published a prospective study showing that proactive therapeutic drug level monitoring is associated with fewer surgeries and higher rates of mucosal healing than conventional non-therapeutic drug level monitoring-based management. Therefore, quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified, performed on 12/10/19 was likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 49-year-old male enrollee has requested reimbursement for CPT 83516 (Immunoassay, nonantibody) performed on 7/20/19. 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 this patient has type 2 diabetes. The assay ordered was an immunoassay for analyte other than infectious agent antibody or infectious agent antigen. The diagnosis code used for testing was for type 2 diabetes. In this case, there is no documentation that would support the need for the services at issue. There is no documented relationship between type 2 diabetes and the testing at issue. Furthermore, monitoring of control of type 2 diabetes is with hemoglobin A1C. There is no documentation that the patient had symptoms that would be concerning for poorly controlled diabetes mellitus or any complications with the diabetes. Thus, CPT 83516 performed on 7/20/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

The patient is a 44-year-old female with a history multiple malignancies, including breast cancer.  Per the records, she had an abnormal uterine ultrasound. She has a significant family history, including a sister with non-Hodgkins lymphoma, a sister with thyroid cancer, two cousins with thyroid cancer, and a mother with thyroid cancer. The history was suggestive of a familial predisposition of cancer which prompted testing using the MyRisk panel. The patient has requested reimbursement for gene testing performed on 11/28/16.  The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.  This patients family history is suggestive of a breast/ovarian cancer syndrome. BRCA1 mutation can increase risk for breast, ovarian, cervical, uterine, pancreatic, gastric, and prostate cancers. BRCA2 mutations can increase risk for breast, ovarian, gallbladder, bile duct, prostate, pancreatic, and gastric cancers. In the event the BRCA tests were negative, there is still a possibility of hereditary predisposition from another gene defect. There are guidelines in place that evaluate the occurrence of Lynch syndrome or hereditary nonpolyposis colorectal cancer (HNPCC) tumors in families. The most common extracolonic cancer in Lynch syndrome is endometrial cancer followed, in no particular order, by ovarian, gastric, renal, small intestine, pancreas, hepatobiliary, and ureteral. In this patients case, the MyRisk panel was appropriate since the current clinical situation may be caused by several potential cancer-causing genes. Thus, genetic testing performed on 11/28/16 was 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 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: Upheld

Summary Reviewer 1

A 55-year-old male enrollee has requested reimbursement for FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18. 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 the records noted complaints of gastric pain and chronic diarrhea in the setting of acute on chronic pancreatitis of uncertain etiology. There is a lack of medical literature supporting the use of FibroTest in this setting. When liver biopsy is undesired, FibroScan demonstrates greater accuracy, sensitivity, and specificity for predicting and discriminating minimal or no fibrosis from extensive fibrosis, as well as in correlating treatment response in patients with chronic hepatitis C infection.  By comparison, serum testing combines a2-macroglobulin, haptoglobin, ?-glutamyl transpeptidase, apolipoprotein A1, alanine transaminase, and total bilirubin into a proprietary algorithm for fibrosis and inflammatory activity. The large prospective cohort study of patients with chronic hepatitis C by Patel and colleagues showed validation of the diagnostic utility of serum markers in relation to biopsy. In summary, serum and/or imaging noninvasive tests can be used for prediction of at least moderate-stage disease in a global cohort of patients with chronic hepatitis C, including the potential of high accuracy compared against liver biopsy. However, this patient does not have hepatitis C, and the appropriateness of FibroTest in this case is not support by available records. Therefore, FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 12/03/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has been diagnosed with osteoporosis. The physician reviewer found that there is a lack of support for the services at issue in this patients case. The value of monitoring therapy with the use of biochemical markers of bone turnover to aid in clinical decision making is controversial. This test can be variable and subject to timing and dietary intake, and there is a lack of assay standardization. In this clinical setting, dual-energy x-ray absorptiometry (DEXA) scanning would have been appropriate to monitor therapy. Thus, laboratory testing (collagen crosslink testing) performed on 12/03/16 was not likely to have been more effective than standard 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 1

A 26-year-old female enrollee has requested reimbursement for DecisionDx testing performed on 4/28/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that per National Comprehensive Cancer Network (NCCN) guidelines, adjuvant immunotherapy is indicated for stage III disease and is not governed by results of molecular profiling. Further, there is a paucity of randomized prospective controlled trials demonstrating the results from DecisionDx have improved treatment decisions and outcomes. Accordingly, the DecisionDx testing performed on 4/28/17 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: Experimental
Decision: Upheld

Summary Reviewer 3

A 64-year-old female enrollee has requested reimbursement for the Decision DX Melanoma assay performed on 6/16/15. 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 Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha (Balch, et al). Currently, tshere is a lack of data in the medical literature supporting the use of Decision DX test in this clinical setting. Moreover, there is a lack of support in the peer-reviewed literature demonstrating how best to incorporate Decision DX testing into the treatment algorithm beyond standard staging techniques. Given the lack of support in the medical literature, the Decision DX Melanoma assay performed on 6/16/15 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.