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

Summary Reviewer 2

A 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. 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 there is a lack of support for the services at issue in this clinical setting. Prognostic 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 testing, 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 cliniopathologic 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 testing performed on 11/21/19 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. 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 may add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. Gerami reported on 217 cases, with good correlation between DecisionDx-Melanoma class and prognosis, in patients who had undergone sentinel node biopsy. There are two very important decisions to be made in the treatment of cutaneous melanoma. The first is whether to do a sentinel node biopsy. There is good acceptance that if the melanoma has a thickness of at 0.8 mm or more, sentinel node should be done. This applies in this case with a thickness of 1.05 mm. DecisionDx-Melanoma testing would not affect this decision. It is unknown whether this patient has had sentinel node done. The next important clinical decision is whether to give adjuvant therapy. For the most part, this is based on the result of sentinel node biopsy, with a positive node being an indication for such therapy. Again, DecisionDx-Melanoma testing has not been shown to be useful in this decision. Furthermore, it is not clear how the five-year DecisionDx-Melanoma testing data compares to the ten-year Balch data. The National Comprehensive Cancer Network does not recommend the use of genomic assays in this setting Therefore, DecisionDx-Melanoma testing performed on 11/21/19 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1


A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/01/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that there is sufficient support for the service at issue in this clinical setting. Breast tomosynthesis provides advantages to radiologists interpreting mammograms, especially in women with dense tissue.  This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and increase in overall diagnostic accuracy and detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had her examination been done with two-dimensional imaging alone.  Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/01/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.The physician reviewer found that the medical literature supports the service at issue in this clinical setting.  Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers.  Ciatto and colleagues noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls.  Thus, digital breast tomosynthesis performed on 8/01/16 was likely to have been of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3


A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/01/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts.  In this patients case, her breasts have been described as extremely dense.  It is specifically those patients who have dense breasts that can benefit most from tomosynthesis.  The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor.  In sum, digital breast tomosynthesis performed on 8/01/16 was likely to have been more effective than other methods of evaluating this patient.  Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 61-year-old female has requested reimbursement for code 73721, magnetic resonance imaging (MRI) lower extremity, any joint, without contrast, performed on 6/12/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the services at issue in this clinical setting. An MRI was performed on 6/12/19 and showed medial collateral ligament (MCL) and anterior cruciate ligament (ACL) disruption consistent with internal derangement. This patient had clinical findings of knee instability, per the history given to the radiologist. Per the current guidelines, knee instability, decreased range of motion and joint effusion are valid indications for MRI without antecedent six weeks of conservative therapy. There is sufficient support for the services at issue in this clinical setting. Therefore, MRI lower extremity, any joint, without contrast performed on 6/12/19 was medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy. The physician reviewer found that in selected patients with severe but potentially reversible cardiomyopathy, such as tachycardia or myocarditis associated cardiomyopathy, a wearable cardioverter defibrillator may be indicated. There is adequate data demonstrating the wearable cardioverter defibrillator may be useful for the prevention of sudden cardiac death due to ventricular arrhythmias while awaiting improvement in left ventricular function, implantable cardioverter defibrillator implantation, or if needed, cardiac transplantation. Given this patients severe left ventricular dysfunction and non-sustained ventricular tachycardia, it was reasonable to place the Life Vest while awaiting the recovery of the heart function. Thus, the Life Vest provided from 6/10/15 through 7/10/15 was likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the device at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy. The physician reviewer found that placement of a prophylactic defibrillator is not recommended until a period of time after myocardial infarction has elapsed, where continued severe left ventricular dysfunction is documented to persist in spite of appropriate treatment (Russo, et al). Placement of a prophylactic defibrillator (wearable or implantable) before this time has not been demonstrated to improve patient outcomes. Studies assessing the efficacy of prophylactic defibrillators early after diagnosis of myocardial infarction and reduced ejection fraction of 35% or less before ventricular function has had a chance to recover have not demonstrated improved outcome (Steinbeck, et al). A prophylactic wearable external defibrillator is indicated only if accepted criteria for an implantable defibrillator are met and an implantable defibrillator could not be placed, needed to be significantly delayed or required explantation. Therefore, the Life Vest provided from 6/10/15 through 7/10/15 has not been demonstrated by scientific literature as likely to have been more beneficial in treating this patients medical condition than standard alternatives. Based upon the information set forth above, I have determined the device at issue was 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: Insurer Denial Upheld

Summary Reviewer 3


A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy. The physician reviewer found that review of the current peer-reviewed medical literature does not support wearable cardioverter defibrillators as being proven to demonstrate survival benefit above and beyond medical therapy. Adler and colleagues noted that when the prescription of a wearable defibrillator is being considered, it should be kept in mind that there are no randomized controlled studies showing that provides survival benefit. Further, wearable cardioverter defibrillators are currently indicated for patients who are candidates for an implantable cardioverter defibrillator and are awaiting cardiac transplantation, patients who are candidates for an implantable cardioverter defibrillator and have a temporary contraindication to implantable cardioverter defibrillator implant, and patients who have had an implantable cardioverter defibrillator explanted due to infection and are awaiting re-implantation. As this patient does not meet these criteria, the Life Vest provided from 6/10/15 through 7/10/15 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, I have determined the device at issue was 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: Insurer Denial Overturned

Summary Reviewer 

A 60-year-old male enrollee has requested authorization and coverage for Korlym 300 mg tablet. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees recurrent meningioma.  The physician reviewer found that on the presented clinical records submitted for review, Korlym 300 mg tablet is medically necessary for treatment of the patients medical condition. Meningiomas are brain tumors arising from the dura mater of the brain. Radiation therapy after complete surgical resection is the standard of care for atypical meningiomas. Systemic therapy is indicated for patients in whom surgical resection is not possible and those with high grade disease. The medical evidence to support various chemotherapy agents comprises of observational studies (Newton). Since the disease is uncommon, there is a lack of rigorously designed randomized clinical trials confirming the use of chemotherapy. In this case, the patient has received the standard of care and the tumor has progressed. Radiation has been exhausted as a therapy systemic therapy must be tried. Small phase II trials have confirmed responses to Korlym treatment as well (Grunberg, et al; Touat, et al). Treatment with Korlym is more targeted since many meningiomas express progesterone receptors. Therefore, the use of Korlym 300 mg is appropriate and medically necessary and supported by the current medical literature for treatment of this patients recurrent meningioma. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

The parent of a 12-year-old male enrollee has requested authorization and coverage for a Lupron injection. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient started puberty after the age of 11 years old, which is a normal age of puberty. This patient does not have precocious puberty. Per the records, he had a bone age of 13 years 6 months with a height of 152.9 cm. This gives him an estimated adult predicted height of 68.9 inches, which is well above the mid-parental height of 64 inches and within normal range for an adult male. Treatment with Lupron is not indicated for preservation of height. Mood changes are common among children who undergo pubertal changes, and it is a physiologic stage of development. Mood changes during puberty are not an indication for Lupron therapy. The puberty in males is completed when the bone age is 16 years of age. This patient has advanced bone age, but there is no indication of rapid bone advancement over time at this time. This patient can have up to 2.5 years left to grow. Therefore, the requested Lupron injection is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 59-year-old male enrollee has requested reimbursement for the UroLift procedure performed on 4/3/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees elevated prostate specific antigen (PSA) and enlarged prostate with lower urinary tract symptoms. The physician reviewer found that the prostatic UroLift system is a novel, minimally invasive approach to treating BPH that lifts or holds the enlarged prostate tissue out of the way so it does not block the urethra. Recent clinical trials including prospective sham controlled randomized studies have shown that the UroLift is safe and effective in relieving lower urinary tract symptoms due to BPH without significantly compromising sexual function. Compared with standard available alteratives, UroLift is minimally invasive procedure without a requirement of general anesthesia and with a potentially shorter operative time, which may provide cost benefits. A recent prospective, randomized, multinational study compared the outcome of UroLift to transurethral resection of the prostate and concluded that participants who underwent prostatic urethral lift responded significantly better than those who underwent transurethral resection of the prostate as therapy for benign prostatic hyperplasia with regard to important aspects of quality of life. Thus, the UroLift procedure performed on 4/3/17 was 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 service at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 59-year-old male enrollee has requested reimbursement for the UroLift procedure performed on 4/3/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees elevated prostate specific antigen (PSA) and enlarged prostate with lower urinary tract symptoms. The physician reviewer found that the UroLift procedure has been approved as an effective treatment of appropriately selected patients 50 years or over with BPH. UroLift has shown to be successful and relatively safe in the short-term. There is good quality evidence to establish the efficiency of UroLift in treating symptomatic BPH without adversely affecting the quality of life. Based on the current literature, UroLift can be considered as an option for those symptomatic BPH patients with small or medium size prostates defined as less than 80 mL without median lobe enlargement, who failed on medical therapy or are intolerant to it and wish to preserve their sexual function. This patient was initially evaluated for erectile dysfunction. All told, the UroLift procedure performed on 4/3/17 was 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 service at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 59-year-old male enrollee has requested reimbursement for the UroLift procedure performed on 4/3/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees elevated prostate specific antigen (PSA) and enlarged prostate with lower urinary tract symptoms. The physician reviewer found that in the peer-reviewed medical literature, Roehrborn and colleagues reported five year data on treatment of BPH with prostatic UroLift resulted in decreased risk of incontinence, impotence, and bleeding. The minimally invasive nature of the UroLift also makes it an acceptable alternative to medications with difficult side effects particularly in younger patients. Further, prostatic UroLift data before April 2017 demonstrated that this surgery did not preclude more invasive treatment if warranted. Given this support, the UroLift procedure performed on 4/3/17 was 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 service at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 62-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator performed on 7/25/18, 8/25/18 and 9/25/18. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for the device at issue in this case. The records document a history of percutaneous coronary intervention with recent onset symptomatic non-ischemic cardiomyopathy. Catheterization showed a patent left anterior descending artery stent and left ventricular dysfunction out of proportion to his residual mild coronary artery disease, consistent with a new non-ischemic cardiomyopathy. His medical therapy was increased. There is some likelihood of recovery of left ventricular function in this instance over the initial three-month period with evidence-based medical therapy. Although implantable cardioverter defibrillators have been shown to be beneficial in both ischemic and non-ischemic cardiomyopathy, this patient did not meet criteria for implantable cardioverter defibrillator. The current medical evidence recommends a minimum of three months of evidence-based medical therapy of left ventricular dysfunction, and then reassessment of ejection fraction prior to consideration of implantable cardioverter defibrillator. The patient was at risk for malignant arrhythmia and sudden death while his ejection fraction was low. A wearable cardioverter defibrillator can provide temporary protection from sudden death due to arrhythmia in this patient population during this interim period. Therefore, the wearable cardioverter defibrillator provided on 7/25/18, 8/25/18 and 9/25/18 was likely to have been more effective than other treatment options.