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

Summary Reviewer 2

A 46-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the Inspire device was approved by the US Food and Drug Administration for the treatment of moderate to severe obstructive sleep apnea refractory to continuous positive airway pressure (CPAP). However, a meta-analysis by Kompelli and colleagues found that contemporary
hypoglossal nerve stimulation research consisted of single-arm clinical trials and case series, with a high likelihood of publication bias and a lack of comparative trials of hypoglossal nerve stimulation versus existing alternatives, such as upper airway surgery. They concluded, aHypoglossal nerve stimulation may not be the definitive choice for second line therapya for obstructive sleep apnea. A meta-analysis by He and colleagues evaluated the effectiveness of uvulopalatopharyngoplasty and its modifications for obstructive sleep apnea, demonstrating improved objective and subjective outcomes for at least 34 months after uvulopalatopharyngoplasty. The authors reported that uvulopalatopharyngoplasty and its modification are an effective surgical method for adult patients with obstructive sleep apnea both short-term and long-term after the surgery. Overall, there is insufficient high-quality, peer-reviewed evidence to support the use of hypoglossal nerve stimulation over other available therapies. Therefore, hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System is not likely to be more beneficial than other available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary  
The patient is a 60-year-old female with a history of class 1 obesity complicated by dyslipidemia. The 
records available for review indicate that the patient had a body mass index (BMI) over 30 kg/m2 prior 
to beginning treatment with Wegovy. The physician reviewer found that the issue is whether the 
requested Wegovy solution auto-injector 0.25 mg/0.5 mL is medically necessary for the treatment of 
this patient. According to Gadde and colleagues, while lifestyle modification is recommended as the 
cornerstone of obesity management, many patients do not achieve long-lasting benefits due to difficulty 
with adherence as well as physiological and neurohormonal adaptation of the body in response to 
weight loss. There are multiple pharmacologic therapies available for weight management. Wegovy is a 
member of a class of medications known as glucagon-like peptide 1 (GLP-1) analogs. As noted in the 
medical literature, GLP-1 analogs have been shown to improve glycemic control, reduce body weight, 
and decrease cardiovascular risk (Knudsen and Lau). Studies have demonstrated Wegovys ability to 
promote weight loss via reduced appetite and energy intake and delayed gastric emptying (Cornell). In 
this case, the patient has a history of class 1 obesity complicated by dyslipidemia. The records reflect 
that the patient has attempted treatment with diet management and exercise without significant 
benefit. Per the provider, the patient has contraindications or intolerances to several weight loss 
medications. Wegovy has been shown to effectively promote weight loss for patients in conjunction 
with diet and exercise. Furthermore, the patient has demonstrated prior weight loss success with 
Wegovy. All told, the requested Wegovy solution auto-injector 0.25 mg/0.5 mL is medically necessary 
for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1 
 
A 72-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene 
expression profile assay performed on 8/30/19. 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 the use of gene expression profiling (GEP) 
testing to differentiate melanomas at low versus high risk for metastasis should not replace 
pathologic staging procedures. Moreover, since there is a low probability of metastasis in stage 
I melanoma and a higher proportion of false-positive result, GEP testing should not guide 
clinical decision making in this group. Commercially available GEPs, such as DecisionDx 
melanoma are marketed as being able to classify cutaneous melanoma into separate categories 
based on risk of metastasis. However, it remains unclear where these GEP platforms provide 
clinically actionable prognostic information when used in addition to or in comparison with 
known clinicopathologic factors or multivariate nomograms that incorporate patient sex, age, 
tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, and sentinel 
lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or 
follow-up schedules has not been established. Various (mostly retrospective) studies of 
prognostic GEP testing suggest its role as an independent predictor of worse outcome, although 
not superior to Breslow thickness or sentinel lymph node status. It remains unclear whether 
this GEP profile is reliably predictive of outcome across the risk spectrum of melanoma. 
Prospective validation studies are required to more accurately define the clinical utility of 
molecular testing prior to widespread implementation of GEP for prognostication of cutaneous 
melanoma, and in particular to determine its role in guiding surveillance imaging, sentinel 
lymph node biopsy, and adjuvant treatment decisions. Therefore, DecisionDx-Melanoma gene 
expression profile assay performed on 8/30/19 was not likely to have been more beneficial 
than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2 
 
A 74-year-old male enrollee has requested reimbursement for laboratory testing provided on 
10/12/20. 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 a rare disease, ocular melanoma. Ocular melanomas that 
have metastasized are markedly resistant to standard chemotherapy regimens. However, 
knowledge of the risk for metastasis directly affects surveillance of patients by computed 
tomography (CT) scan. The DecisionDX-UM  test analyzes gene expression and has been shown 
to be highly informative for prognosticating metastatic risk. This gene expression classifier is 
discussed in the Physicians Data Query of the National Cancer Institute and the National 
Comprehensive Cancer Network guidelines on uveal melanoma. There is no other standard 
prognostic indicator that could serve as an alternative. Therefore, laboratory testing provided 
on 10/12/20 was likely to have been more beneficial than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 39-year-old male enrollee has requested authorization and coverage for Stelara (ustekinumab). The Health Insurer has denied this request indicating that the requested medication is investigational for treatment of the enrollees medical condition. The physician reviewer found that Stelara (ustekinumab) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. A large randomized controlled trial demonstrated safety and efficacy for induction and maintenance of remission in patients with moderate-severe Crohns disease that was resistant to anti-tumor necrosis factor (TNF) therapy (such as Remicade and Humira), which applies to this case (Sandborn, et al). Another study showed a 73% response in patients with anti-TNF-resistant Crohns disease, and 80% of responders maintained remission for one year (Kopylov, et al). A significant majority of these patients were able to discontinue steroids. The mechanism of Stelara (ustekinumab) is entirely different than that of anti-TNF medications, which the patient has failed (Tuskey and Behm). A recent study demonstrated that a significant majority of patients who have failed an anti-TNF medication are able to achieve and maintain response with Stelara (Wils, et al). In sum, the clinical literature supports the use of Stelara in this case given the patients treatment failure of anti-TNF therapy. Based upon the information set forth above, the requested medication 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: Overturned

Summary Reviewer 1


A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/21/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting.  Breast tomosynthesis allows radiologists to separate dense glandular elements from underlying mass/architectural distortion.  This has resulted in a decrease in callbacks and increase in detection of small cancers.  In this patients case, the detection of the abnormality in the right breast resulted in an ultimate diagnosis of breast cancer.  Therefore, the addition of breast tomosynthesis to two-dimensional imaging likely was of more benefit to the patient than had she undergone two-dimensional digital mammogram 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: Overturned

Summary Reviewer 2

A 64-year-old male enrollee has requested reimbursement for PET scan performed on 8/31/18. 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 taht the submitted documentation fails to demonstrate the superior efficacy of the services at issue. The records document that the patient was diagnosed with a hepatic flexure malignancy. On 7/27/18, computed tomography (CT) scan of the abdomen and pelvis was performed. While the use of positron emission tomography/computed tomography (PET/CT) scanning is becoming increasingly common in the work-up of malignancies, the current data does not support its routine use in staging colon cancer. In this patients case, he already had a staging laparotomy and CT scan, with no evidence of spread of disease. PET scanning was not indicated in this clinical setting. In sum, PET scan performed on 8/31/18 was not likely to have been superior over other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 60-year-old female who has been diagnosed with major depressive disorder, recurrent, moderate.The patient has requested authorization and coverage for brand name Wellbutrin 150 mg, brand name Wellbutrin 300 mg and brand name Prozac 20 mg. The Health Insurer has denied this request and reported that the requested medications are not medically necessary for the treatment of this patient.The physician reviewer found that given this patients stability, it is within the standard of care to maintain her on brand name medications as she poses a risk of decompensation should she be switched to generics. She has tried generics in the past and reports that she could not tolerate the fillers in the medications and that the generics were not effective in treating her depression. Some studies have demonstrated that brand name medications exhibited more protective effects on psychiatric hospitalization for depressive patients, and that the efficacy of generics versus brand name is not equal. Several different companies may make the same generic drug, but they might use different filler ingredients, and this they may have slightly different rates of absorption or cause different side effects. With somewhat older antidepressants, such as fluoxetine (Prozac), several different manufacturers make the generic antidepressants, each using different non-active ingredients. Thus, each generic brand may have slightly different effects. The current medical evidence supports the requested medications in this clinical setting. Therefore, brand name Wellbutrin 150 mg, brand name Wellbutrin 300 mg and brand name Prozac 20 mg are medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3 
 
A  49-year-old  male  enrollee  has  requested  authorization  and  coverage  for  intraosseous 
basivertebral nerve ablation. The Health Insurer has denied this request and reported that the 
requested service is investigational for the treatment of the enrollees chronic low back pain. At 
issue is whether intraosseous basivertebral nerve ablation is likely to be more beneficial for 
treatment of the enrollee's condition than any available standard therapy. The physician reviewer 
found that chronic low back pain is a debilitating condition. When Modic changes are present in 
the disc spaces, a vertebrogenic cause of back pain is considered an etiology of chronic back pain. 
The main source of innervation for the vertebral body are the basivertebral nerves. Ablation of the 
basivertebral nerve is a safe and effective procedure that is evidence based for appropriately 
selected candidates. Becker and colleagues note that the ablation of the basivertebral nerve for the 
treatment of chronic lumbar back pain significantly improves patients self-reported outcome early 
in the follow-up period, with improvement persisting throughout the one-year study period. 
Fischgrund and colleagues report that basivertebral nerve represents a potential minimally invasive 
treatment for the relief of chronic low back pain. In this this case, other interventional procedures 
targeting different etiologies of back pain have not provided benefit. Therefore, basivertebral nerve 
ablation is likely to be more beneficial for treating this patients vertebrogenic back pain than other 
treatments already tried. Therefore, intraosseous basivertebral nerve ablation is likely to be more 
beneficial for treatment of the patients condition than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 48-year-old female enrollee has requested reimbursement for electroretinography performed on 8/17/18. 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 there is a lack of support for the use of multifocal electroretinography to diagnose this patients condition. In this case, the patient has a history of diabetes and retinopathy with abnormal fundus appearance consistent with non-proliferative diabetic retinopathy. Electroretinography measures electrical responses of the retina from light stimulus. Different types of retinal cell and their functional state can be measured. It is most useful for the diagnosis of hereditary retinal and choroidal diseases and dystrophies. Studies show that it is useful in diagnosing disease that does not have significant visible markers, as well as diseases that are uncommon and have similar clinical appearances, but varying courses. Electroretinography can assess the functional status of the retina in different stages of retinopathy. There is evidence to suggest that it can detect damage from retinopathy before there are visible changes on examination. However, the utility of this in terms of diagnosis and treatment of diabetic retinopathy has yet to be established. Electroretinography testing is not the standard of care in this situation. The standard of care for the diagnosis of diabetic retinopathy is dilated fungus examination using slit-lamp biomicroscopy and indirect ophthalmoscopy. Therefore, electroretinography performed on 8/17/18 was not likely to have been superior over other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the 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 they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha.  The data on the DecisionDX test for melanoma has not been made a part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is very novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. This was also the consensus opinion of the National Comprehensive Cancer Network (NCCN) guidelines. Accordingly, the gene test performed on 12/28/15 was not likely to have been more effective than the standard methods of evaluating 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: Upheld

Summary Reviewer 1

A 51-year-old female enrollee has requested authorization and coverage for the LINX reflux management system lower esophageal sphincter augmentation. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that the records indicate that this patient has GERD as based on pH recording and her disease progression to Barretts esophagus. However, LINX is not indicated for patients with Barretts esophagus. Further, implantation of LINX in this patients case must be approached with caution given her documented esophageal dysmotility. As such, the LINX reflux management system lower esophageal sphincter augmentation is not likely to be more beneficial for treatment of this patients medical condition than standard GERD management treatment options. Based upon the information set forth above, the requested service 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 44-year-old female enrollee has requested reimbursement for positron emission tomography (PET) scan performed on 3/04/16.  The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting.  Assessment of the response to treatment of metastases is crucial in daily oncological practice and clinical trials. For soft tissue metastases, this is done using CT scanning, magnetic resonance imaging (MRI) or PET scanning using validated response evaluation criteria.  While PET/CT scanning may not be indicated when the recent CT scans or MRI scans are positive, this is less convincing when the recent CT or MRI scans are negative.  In this patients case, the negative CT scans of the chest, abdomen, and pelvis were a reasonable indicator that the patient does not have metastatic disease.  However, breast carcinoma often spreads to the bones, and the bones had not been specifically evaluated.  PET/CT scans offer the ability to image the entire body as opposed to routine CT scans which must be directed to specific body regions.  This patient is at a high-risk for developing metastatic disease, and a baseline PET/CT scan may help to further direct or continue what will be a second-line chemotherapy.  All told, the PET scan performed on 3/04/16 was medically indicated for the evaluation of this patient.  Therefore, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 51-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation. 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 current evidence-based medical literature supports the use of autologous chondrocyte implantation as a first-line treatment option for large articular cartilage defects. The literature supports treatment with bone marrow stimulation for lesions of smaller sizes, whereas treatment with autologous osteochondral transplantation may be utilized for larger or cystic lesions. The literature indicates that autologous chondrocyte implantation of the talus yields improvement in all parameters tested, with enduring long-term results in patients who have failed previous surgery for osteochondral lesions of the talus. This patient presents with a history of chronic severe right ankle pain and swelling. Significant functional limitations are noted that interfere with activities of daily living. There is imaging evidence of a very large cystic osteochondral lesion of the right talus. She has failed long-term conservative management as well as operative intervention. She is not a candidate for microfracture surgery due to the size of the lesion. Current evidence-based medical literature supports the use of autologous chondrocyte implantation in this clinical setting as a salvage procedure. In sum, autologous chondrocyte implantation is likely to be more beneficial than other treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 63-year-old male enrollee has requested authorization and coverage for laparoscopy, surgical, esophagogastric fundoplasty (LINX). 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 the request services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The LINX Reflux Management System is for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD and a hiatal hernia less than 3 cm. Results from early studies at four years are encouraging. However, the requested procedure remains controversial as all studies to date have not included an appropriate control group. Additionally the bulk of the efficacy data is only from 1-3 years of follow-up. Therefore, the patients request for laparoscopy, surgical, esophagogastric fundoplasty (LINX) is not supported as 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.