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

Summary Reviewer 

The patient is a 38-year-old female with a history of hidradenitis suppurativa (HS). The patient has requested authorization and coverage for Otezla. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that Hidradenitis suppurativa (HS) is a chronic disease that can impact an individualas quality of life.  Humira is the only U.S. Food and Drug Administration (FDA) approved immunosuppressant for the treatment of HS. It is indicated for moderate to severe HS. Per the medical evidence, other biologic treatment options include infliximab, anakinra, and ustekinumab. However, as noted by Alikhan and colleagues, with these medications, aplacebo-controlled dose-ranging studies are needed to determine the optimal dosage for management.a Since these are biologics as well, they also decrease the immune system like Humira. Otezla has a different mechanism of action.  In the randomized controlled trial by Vosen and colleagues, Otezla was shown to be effective in treating moderate HS. The main side effects of this medication is gastrointestinal side effects.  In this case, the patient has maximized her medical and surgical options. She is on weekly dosing of Humira and still has breakthrough symptoms in the groin. At this point, another adjunctive treatment is recommended. Based on the records, a trial of Otezla is medically indicated. Therefore, Otezla is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 63-year-old male enrollee has requested reimbursement for laboratory testing performed on 2/11/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the services at issue in this clinical setting. MRD has been found to be a strong prognostic indicator in patients with mantle cell lymphoma. Patients with a negative PET and no MRD have better five-year overall survival rates. Testing for MRD has been used to guide indications for additional therapy, such as maintenance rituximab and autologous stem cell transplant. Achievement of MRD negativity was also associated with improved clinical outcomes. Therefore, laboratory testing (unlisted molecular pathology) performed on 2/11/19 was medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 20-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 8/14/18. 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 Polymerase chain reaction testing is an appropriate test for chlamydia, gonorrhea, and trichomonas, all of which should be tested for as part of a sexually transmitted disease evaluation.  In this case, it appears the patient was tested for trichomonas, but there are no records to indicate testing for chlamydia and gonorrhea. In addition, multiple polymerase chain reaction tests were performed for various vaginal organisms, some of which do not even cause infection. The records noted that testing was performed for candida species, lactobacillus species, atopobium vaginae, megasphaera species, and Gardnerella vaginalis quantification. Polymerase chain reaction testing for these organisms is not standard of care. Standard testing for evaluation of a vaginal discharge includes assessing the symptoms, assessing the appearance of the discharge, pH testing of the vaginal fluid, examination of the discharge under the microscope, and sometimes DNA probes or cultures.  There are no records to indicate that these standard evaluations and diagnostic tests were done. In sum, polymerase chain reaction test for trichomonas was likely to have been more effective than other methods of evaluating this patient. However, the superior efficacy of the remaining tests has not been established.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

The parent of a 15-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 10/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that there is sufficient support for the services at issue in this patients case. This testing is standard in the treatment of patients with inflammatory bowel disease. This testing demonstrates the levels of drug as well as if there is antibody formation. Prometheus Anser ADA testing can guide providers in the management of the medication. If levels are low, this would explain the patients symptoms, and the medication dosage can be changed. In sum, Prometheus Anser ADA testing performed on 10/10/17 was likely to have been superior over 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 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Actemra provided from 7/14/15 through 12/15/15 and ongoing. The Health Insurer has denied this request indicating that the medication at issue was and is investigational for the treatment of the enrollees medical condition.  The physician reviewer found that Tocilizumab inhibits the effects of the cytokine, IL-6, which has been associated with rejection of kidney transplants. It has shown efficacy in rheumatoid arthritis and is currently approved for that indication by the U.S. Food and Drug Administration (FDA). An uncontrolled phase I/II trial in highly sensitized patients awaiting kidney transplantation has shown the drug to be safe (Vo, et al); and other kidney transplant studies are planned (NCT02108600). However, at this time there is a lack of peer-reviewed literature demonstrating the efficacy of Actemra for treatment in patients with AMR as a basis for off-label use. Thus, the use of tocilizumab in kidney transplantation is considered controversial and is not the standard of care. As such, Actemra was not and is not 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 medication at issue was not and 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: Overturned

Summary Reviewer 3

A 21-year-old male enrollee has requested authorization and coverage for LINX reflux management system.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures.  Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval.  Additionally, LINX has been associated with severe dysphagia requiring endoscopic intervention. The peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment, surgical fundoplication.  Based on current literature and clinical guidelines, the requested LINX reflux management system is not likely to be more efficacious 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: Experimental
Decision: Upheld

Summary Reviewer 2

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 antibodies to adalimumab (ADA) are present in a substantial number of patients treated with adalimumab, and in some patients there may be a correlation between the level of these antibodies and clinical response. However, there are technical factors relating to the use of different assay methods across studies, and it has not yet been established whether the use of threshold level aid in the discrimination of response to adalimumab. There are patients who do not respond to adalimumab (primary non responders), and patients who appear to lose their response to adalimumab over a period of time (secondary non responders). However, some evidence suggests that low serum drug levels and/or the presence of drug antibodies to may play a role in primary or secondary response failures. Menting and colleagues noted that patients with no ADA formation in the first 24 weeks of treatment have little chance of it in the following 24 weeks. The presence of ADA is strongly correlated with adalimumab concentration. Standard alternatives to Anser ADA testing, in patients like this patient, include shortening the interval between doses, increasing the dose, or switching to a different agent. At this time, the peer-reviewed medical literature does not support the use of the Anser ADA test as performed on 10/13/14 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, 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: Medical Necessity
Decision: Overturned

Summary  
The patient is a 33-year-old female who presented to a hospital in Clovis, New Mexico on 7/26/22 
with complaints of severe abdominal and epigastric pain which radiated to her back. The patient 
was transferred by air ambulance on 7/27/22, as she required observation and monitoring should 
her condition worsen. The patient was transferred to the receiving facility without complications. 
The Health Insurer has denied the services at issue as not medically necessary for the treatment of 
the patients medical condition. This denial is the subject of this appeal and determination. The 
physician reviewer found that air medical transport is considered medically necessary when the 
patients condition is life-threatening such that any form of transportation other than an ambulance 
would be medically contraindicated, the time needed to transport by ground poses a threat to the 
patients survival, and the patient is transported to the nearest hospital with appropriate facilities 
for treatment. When transferring a patient from one hospital to another, the air medical transport 
criteria must be met, and the initial hospital must not have the required services and facilities 
available to treat the patient. In this case, the patient presented on 7/26/22 with severe abdominal 
pain. The patient was at risk of gallbladder rupture and required further evaluation with ERCP. 
The initial hospital did not have the required services and facilities available to treat the patient. 
The initial hospital reached out to several nearby hospitals and transported the patient to the nearest 
hospital with appropriate facilities available for treatment. Overall, the patient met the criteria for 
air ambulance transportation as her condition was unstable and as she required observation and 
monitoring should her condition worsen. Given these findings, the air ambulance transportation 
performed on 7/27/22 was medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 39-year-old male enrollee has requested authorization and coverage for corticotropin (H.P. Acthar Gel) injections, up to 40 units. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records document that the patient has been diagnosed with rheumatoid arthritis, episcleritis and scleritis. He has been treated with prednisone and CellCept, without adequate response. The patient has requested coverage for H.P. Acthar Gel to improve symptoms and objective findings of rheumatoid arthritis. The current medical evidence does not support the requested medication in this clinical setting. Per the evidence-based guidelines, H.P. Acthar Gel is not recommended for the treatment of rheumatoid arthritis. Thus, corticotropin (H.P. Acthar Gel) injections, up to 40 units, is not likely to be more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 22-year-old female enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the submitted records fail to demonstrate the superior efficacy of the services at issue.  Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab may play a role in primary or secondary response failures.  Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions.  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 adalimumab or the presence of adalimumab antibodies have an adverse effect on the clinical outcome of a patients response to treatment.  However, while there have been testimonials, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes 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.  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.  All told, Anser ADA testing performed on 1/16/15 was not likely to have been of greater benefit than other available methods of evaluating this patient.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

This patient is a six-year-old male who was diagnosed with acute flaccid myelitis in October 2018. The patientas parent has requested authorization and coverage for RT300 FES Rehabilitation Therapy System. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of this patient. The physician reviewer found that the medical literature provides sufficient evidence that supports the benefit of RT 300 FES system over other standard, traditional therapy modalities alone in achieving better outcomes with strengthening, reduced spasticity and improved quality of life. The indications for the RT300 FES Rehabilitation Therapy System for this patient with acute flaccid myelitis and paraplegia are valid and supported by current medical research. These indications include prevention of muscle disuse atrophy, relaxation of muscle spasms, improving blood circulation, prevention of osteoporosis, maintaining or increasing range of motion, prevention of contractures, and cardiac and pulmonary deconditioning. The functional status, the medical history of the patient with secondary complications of the acute flaccid myelitis paraplegia, the prognosis of his injury and neurological level of involvement support the use of this modality. Therefore, RT300 FES Rehabilitation Therapy System is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3 
 
The parent of a seven-year-old female enrollee has requested authorization and coverage for 
Xeljanz 5 mg tablet. The Health Insurer has denied this request and reported that the requested 
medication is investigational for the treatment of the enrollees alopecia. The physician reviewer 
found that available treatment options for alopecia areata are quite limited, especially in the case 
of  diffuse/multifocal  involvement,  where  standard  therapies  such  as  topical  steroids, 
intralesional Kenalog, contact immunotherapy, and conventional immunosuppressants are often 
less than satisfactory and associated with side effects. There is substantial evidence, including 
from clinical trials, supporting the use of oral JAK kinase inhibitors such as tofacitinib for the 
treatment of alopecia areata. In an open label pilot study, Jabbari and colleagues reported that 
eight out of twelve patients treated with tofacitinib demonstrated equal to or greater than 50% 
hair regrowth as measured by SALT scores. In a retrospective study of patients with alopecia 
areata treated with tofacitinib, Liu and colleagues that 77% achieved a clinical response, with 
58% of patients achieving a greater than 50% change in SALT score. Guo and colleagues report 
that tofacitinib seems to be a promising drug for the treatment of alopecia areata with only mild 
adverse effects. In this clinical setting, an oral JAK inhibitor, such as Xeljanz, is likely to be more 
beneficial for the treatment of this patient than therapy with contact immunotherapy and 
systemic steroids, which carry considerable short and long term side effects, especially given that 
this patient has already responded well to Xeljanz. Therefore, Xeljanz 5 mg tablet is likely to be 
more beneficial for treatment of the patients condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


The parent of a two-year-old female enrollee has requested authorization and coverage for the Synagis 100 mg/mL injection. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees heterotaxy syndrome and Shones complex which has required a single ventricle palliation. The physician reviewer found that the use of Synagis in this patient is not medically necessary. Since 1998, Synagis has been recommended under strict criteria so that its use maximizes patient benefit and efficacy. The most widely accepted guidelines for the use of Synagis are published by the American Academy of Pediatrics (AAP) Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. The AAP guidelines indicate there is no established role for RSV prophylaxis after 24 months of age for any patient regardless of risk factors. The majority of hospitalizations associated with RSV occur in the first three months of life and are most commonly associated with prematurity. Functional or actual asplenia has not been shown in any studies to be associated with increased hospitalization due to RSV. At this time Synagis is only indicated in children under two years of age regardless of the presence of chronic heart, lung, or immune system disease. This prophylactic measure is not medically indicated for this patient. Accordingly, the requested Synagis vaccine is not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 31-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/18/19. 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 the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index is thought to add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in that particular melanoma. It then classifies that melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is unknown if DecisionDx-Melanoma can be used to make clinical decisions. Thus, DecisionDx-Melanoma testing performed on 12/18/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

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 per the records, this patient does not have hepatitis C. In addition, there are no laboratory or imaging data to suggest the patient has advanced liver disease (i.e., cirrhosis). The test in question is used to noninvasively determine if a patient with hepatitis C has cirrhosis, which has ramifications on potential treatment choice and length of treatment. There are two general categories of noninvasive tests for fibrosis: serologic panels of tests and radiologic tests. When available, radiologic measurement of elasticity (ultrasound with transient elastography) is the preferred test. Transient elastography is the most commonly used imaging test because it is widely available and has been validated in large populations. There are several limitations to serologic markers of fibrosis. First, they typically reflect the rate of matrix turnover, not deposition, and thus tend to be more elevated when there is high inflammatory activity. By contrast, extensive matrix deposition can go undetected if there is minimal inflammation. Additionally, none of the markers are liver-specific, and concurrent sites of inflammation may contribute to serum levels. Also, serum levels are affected by clearance rates, which may be impaired either due to sinusoidal endothelial cell dysfunction or impaired biliary excretion. In this patients case, the standard of care test would be transient elastography at the time of liver ultrasound. Thus, FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18 was not likely to have been more beneficial than other available standard therapy.