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

Summary Reviewer 2


A 43-year-old female enrollee has requested authorization and coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain.  The physician reviewer found according to the coverage criteria by the International Society for the Advancement of Spine Surgery (ISASS), specific criteria must be met for all patients treated with minimally invasive SI joint fusion. The criteria require documentation of significant SI joint pain, SI joint pain confirmed with at least three physical examination maneuvers that stress the SI joint, confirmation of the SI joint as a pain generator with 75% or greater acute decrease in pain upon fluoroscopically guided diagnostic intra-articular SI joint block using local anesthetic, failure to respond to at least six months of non-surgical treatment consisting of non-steroidal anti-inflammatory drugs and/or opioids and one or more of the following: rest, physical therapy, SI joint steroid injection, and failure to respond means continued pain that interferes with activities of daily living and/or results in functional disability, as well as a record that additional or alternative diagnoses that could be responsible for the patients ongoing pain or disability have been ruled out. Although this patient meets most of these criteria, there is insufficient evidence of a recent visual acuity score (VAS) score, three physical exam maneuvers demonstrating SI joint pain and confirmation by recent injection that resulted in greater than 75% pain relief. Therefore, the requested SI joint fusion 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 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: Overturned

Summary Reviewer 2


The parent of an 11-year-old male enrollee has requested reimbursement for the Prometheus Anser IFX test performed on 7/16/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis.   The physician reviewer found current studies indicate that measurement of infliximab levels and anti-infliximab antibodies produces actionable data (Afif, et al; Yanai and Hanauer). Change of dose or medication based on these results improves response to treatment, as measured by clinical response. Minar and colleagues reported that among 60 pediatric Crohns patients with secondary loss of response, a total of 23 patients had subtherapeutic infliximab levels and 11 had antibodies to infliximab. Overall, 29 patients had a change of treatment prompted by the results of drug monitoring. This group had a rate of clinical remission at six months similar to those whose treatment was considered appropriate based on drug monitoring results. Among the subgroup of patients whose treatment change was an intensification of infliximab dosing, remission rate increased from 16% at baseline to 72% at six months. Hoekman and colleagues demonstrated that lower infliximab trough levels is associated with elevated markers of mucosal inflammation in children. Given this support, the Anser IFX testing performed on 7/16/14 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: Upheld

Summary Reviewer 3

A 61-year-old female enrollee has requested authorization and coverage for endoscopic anti-reflux procedure (LINX). The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures. Sheu and colleagues in Current Opinion in Gastroenterology, concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined. Another best evidence review concluded that long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration approval (Bauer, et al). One peer reviewed journal published a letter stating that there are 11 reports of endoscopically confirmed LINX erosion through the esophagus in the publicly-accessible U.S. Food and Drug Administration (FDA) Adverse Events database (Bielefeldt, et al). Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention (Sheu, et al in Surgical Endoscopy). The currently available peer reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial than standard treatment, surgical fundoplication. The American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). All told, the requested endoscopic anti-reflux procedure (LINX) is not likely to be more beneficial than the standard methods of treating this patients medical condition. Therefore, for the reasons stated above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2


A 65-year-old male enrollee has requested reimbursement for genetic testing performed on 4/16/15.  The Health Insurer has denied this request indicating that the testing at issue was investigational for the evaluation of the enrollees medical condition.  The physician reviewer found that HLA-B5701 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. HLA-B5701 testing is utilized to predict the occurrence of side effects to one anti-HIV drug (abacavir). In this case, abacavir was not part of the patients drug regimen at the time he was seen on 4/16/15. In addition, there is a lack of documentation suggesting a treatment plan to order abacavir. The record reflects that the patient was being treated with Tivicay and Complera with good results. As such, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2



A 36-year-old female enrollee has requested reimbursement for infliximab antibody testing performed on 3/30/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that management of ulcerative colitis using infliximab antibody testing has not been standardized, and recommendations for management based on test results (change to a different medication versus increase in dose) have not been formed (Kornbluth, et al). In addition, the use of infliximab antibody testing 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 drug levels been established (Steenholdt, et al). Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response (Vande Casteele, et al; Nanda, et al). A recent study concluded that prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies (Adedokun, et al). Based on the clinical literature, the infliximab antibody testing performed on 3/30/15 was 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 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 2

A 57-year-old female enrollee has requested reimbursement for the DecisionDx-Melanoma Assay provided on 7/20/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that Mucosal melanoma is rare and accounts for only 1% of all melanomas. Mucosal melanoma carries a worse prognosis than cutaneous melanoma. The information obtained from the DecisionDx-Melanoma Assay for this patient with negative sentinel lymph node biopsy results and intermediate thickness tumor on the mucosa may be beneficial. The results of the DecisionDx-Melanoma Assay may help determine the need for follow-up examination, including imaging, which will need to be made on an individual basis for this patient, as her disease is rare. Given her age, the value of the sentinel lymph node biopsy is not as predictive, as sentinel lymph node biopsy is more frequently negative in older patients. In sum, DecisionDx-Melanoma Assay performed on 7/20/18 was likely to have been superior over other methods of evaluating this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2 
 
A 38-year-old female enrollee has requested reimbursement for Guardant360 CDx panel 
performed on 4/01/21. 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 Guardant360 test is a liquid biopsy that analyzes patient plasma 
for mutations in a panel of 70 genes. Von Hoff and colleagues performed a clinical study which 
directly compared the use of targeted agents with conventional chemotherapy approaches. The 
progression-free survival on the regimen selected by molecular profiling was compared to 
progression-free survival on the last chemotherapy regimen. The regimen selected by 
molecular profiling offered a 27% survival advantage. This trial has significant results for 
patients with stage IV tumors. Additionally, current National Comprehensive Cancer Network 
(NCCN) guidelines recommend mutational testing for metastatic tumors that may suggest some 
targeted therapies. PIK3CA is one such example. In most instances of visceral disease or lymph 
node involvement, testing can be performed on the excised tissue but in certain cases such as 
bone metastases, the decalcification process makes the material unsuitable for gene 
sequencing. Thus, liquid biopsy is specifically mentioned in the NCCN guidelines. The requisition 
for a sample from 3/25/21 is included in the case file. The requisition indicated that the patient 
did not have any other accessible disease for biopsy and mutational analysis. In this patients 
case, the results from molecular profiling may offer a rational selection of the next regimen.  Therefore, Guardant360 CDx panel performed on 4/01/21 was likely to have been more 
beneficial for evaluation of the patients medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2 
A 27-year-old female insured has requested reimbursement for the respiratory virus panel 
testing (CPT 87633, 87798, 87798-59) provided on 7/21/22. The Health Insurer has denied this 
request indicating that the services at issue were considered investigational for evaluation of the 
insureds  respiratory  illness  and  shortness  of  breath.  The  physician  reviewer  found  that 
respiratory panel molecular testing is considered the standard of care for the diagnosis of 
respiratory viral infections in an acute care setting (Wu and Tang). Compared to other methods 
of  analysis,  the  respiratory  panel  molecular  testing  modality  has  a  better  sensitivity  and 
specificity. Conventional methods of analysis required a significant time period to process. 
However, respiratory panel molecular testing enables the identification of pathogens in hours as 
opposed to days for traditional cultures (Markussen, et al.). Thus, the respiratory panel molecular 
testing performed to diagnose the patients condition was appropriate. All told, the respiratory 
virus panel testing (CPT 87633, 87798, 87798-59) provided on 07/21/22 was likely to have been 
more beneficial than any other available standard treatment for the evaluation of the patients 
condition.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

The patient is a 41-year-old male with a history of motor vehicle accident in 2002 with multiple fractures and left brachial plexopathy. He underwent multiple attempts at nerve transfer in 2003 and 2005. He also underwent extensive physical and occupational therapy. The left arm is nonfunctional and is described as flail distal to the shoulder. The patient has requested authorization and coverage for a MyoPro device. The Health Insurer has denied this request on the basis that the requested device is investigational for the treatment of this patients left brachial plexopathy. There is minimal evidence in the medical literature that this orthosis would be helpful in this clinical setting. There are a few studies showing the myoelectric orthosis can be beneficial when applied to patients with upper motor neuron pathology such as stroke. However, this patient has a brachial plexus lesion with monoplegia and it is undetermined whether a myoelectric device would be of benefit in the long run with such a severe lower motor neuron injury. In this patients case, there is a lack of evidenced based literature supporting the efficacy of the requested device. In sum, MyoPro device is not likely to be of greater benefit over the available standard method of treating this patients medical condition.  Based upon the information set forth above, the requested device 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: Medical Necessity
Decision: Upheld

Summary  
The patient is an eight-year-old male with a history of immune thrombocytopenia (ITP). Per the 
provider, the patient will not be undergoing major surgery for splenectomy at his age given the 
risk of infection when there are less invasive treatment alternatives available. The provider has 
recommended treatment with Promacta to increase platelets. The Health Insurer has denied the 
requested medication as not medically necessary. This denial is the subject of this appeal and 
determination. The physician reviewer found that based on the available medical records and 
current guidelines, Promacta is not supported as medically necessary for treatment of this patients 
diagnosis of ITP. At this time, there is an ongoing phase 3 trial, which is randomizing patients to 
medical treatment with IVIG or steroids versus Promacta, however this study is ongoing. Applying 
the guidelines from the American Society of Hematology (ASH), Promacta is indicated as second-
line therapy for patients who have poor response to steroids or IVIG or who cannot tolerate these 
treatments. Per the ASH guidelines, patients who have a high risk of bleeding due to age and 
activity should be treated with first-line treatments such as oral steroids to address his varying 
platelet count, which is often less than 20,000, and poses a risk of bleeding for this patient, who 
desires to participate in risky activities. The patient may be a candidate for treatment with Promacta 
in the future if his condition fails to improve with first-line therapies including steroids. Based on 
the available documentation, the requested Promacta 25 mg tablet is not medically necessary for 
treatment  of  this  patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary  
The patient is a 49-year-old female with a history of severe non-proliferative diabetic retinopathy 
with macular edema in both eyes. The provider has recommended treatment with Eylea injections, 
which have been shown to slow the progression of retinopathy and will help delay the need for 
surgical vitrectomy. The Health Insurer has denied the requested medication as not medically 
necessary. This denial is the subject of this appeal and determination. The physician reviewer 
found that at the initiation of treatment for her diabetic macular edema, the medical records show 
this patient had corrected visual acuity of 20/40 on the right, and 20/30 on the left side. These 
measurements qualify the patient as having mild loss of visual acuity, given the visual acuity loss 
of 20/40 or better. On review of the current medical literature, Eylea has been shown to have an 
advantage over other anti-VEGF treatments only when a patients presenting vision is 20/50 or 
worse at the start of treatment (Wells, et al.). One study evaluated Eylea monotherapy versus step 
therapy with Avastin followed by a change to Eylea if protocol criteria were met (Jhaveri, et al.). 
The authors noted that the pat in this study had an initial visual acuity of 20/50 or worse. The 
authors concluded that there was a lack of difference in visual acuity outcomes or central retinal 
subfield thickness at the two-year follow-up. Based on this patients presenting mild loss of visual 
acuity and lack of documentation of prior intravitreal injections, the requested Eylea injections 
2/0.05 mL are not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 10/21/15. 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 the breast tomosynthesis performed on 10/21/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The advantage of tomosynthesis relates to the ability often afforded the reader in being able to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and increase in detection of small cancers. For this reason, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had the exam been done with two-dimensional technique alone. 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 3

A 60-year-old female enrollee has requested authorization and coverage for Botox. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees chronic migraine headaches The physician reviewer found the U.S. Food and Drug Administration (FDA) approval for Botox is indicated for the prophylaxis of headaches in adult patients with chronic migraines greater or equal to 15 days per month and with headaches lasting four hours a day or longer. There are no requirements by the FDA that patients must be refractory to oral preventives. However, in this patients case, the submitted records are insufficient to document a diagnosis of chronic migraines. As such, treatment with Botox is not likely to be more effective than standard therapy for treatment of this patient. Therefore, for the reasons stated above, the requested medication 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: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 55-year-old female enrollee has requested authorization and coverage for anterior lumbar interbody fusion (ALIF) of the fourth lumbar spine bone through the first sacral bone (L4-L5, L5-S1 ALIF). 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 spondylolisthesis. The physician reviewer found that the medical literature supports the medical necessity for the requested services in this clinical setting. Anterior lumbar interbody fusion is a widely recognized surgical technique for degenerative pathology of the lumbar spine.  Anterior lumbar interbody fusion is recommended as an option for degenerative spondylolisthesis with instability and scoliosis as in this case. Among the various indications, spondylolisthesis with instability and scoliosis remain well accepted indications.  In this case, with type I Modic changes in the intervertebral disc, a reduction in the pain level is to be expected.  There is also evidence of instability and scoliosis, all of which are likely to be benefited by this surgery.  As such, the literature supports the medical necessity of anterior lumbar interbody fusion as requested at L3-4 and L4-5 levels above the congenitally fused L5-S1 level. Therefore, the anterior lumbar interbody fusion of the fourth lumbar spine bone through the first sacral bone (L4-L5, L5-S1 ALIF) 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: Overturned

Summary Reviewer 1

A 64-year-old female has requested reimbursement for vedolizumab infusions provided on 5/03/19 and 6/28/19. The Health Insurer has denied this request and reported that the medication at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medication at issue in this clinical setting. The patient has been diagnosed with ulcerative colitis. She has failed to respond to Humira, and is intolerant to prednisone due to its hyperglycemic effect on her diabetes. She previously was maintained on vedolizumab infusions every eight weeks. Colonoscopy showed active ulceration, prompting dose optimization to infusions every six weeks. In this patients case, colonoscopy demonstrated mucosal disease on every eight-week Entyvio infusions. As such, the records demonstrate loss of Entyvio response to warrant the dose escalation. Therefore, vedolizumab infusions provided on 5/03/19 and 6/28/19 were likely to have been more beneficial than other methods of evaluating this patient.