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

Summary Reviewer 3

A 55-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 5/29/19. 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 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 this suggests 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 DecisionDx-Melanoma testing has not made it 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 novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, DecisionDx-Melanoma testing provided on 5/29/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 54-year-old male enrollee has requested reimbursement for high-intensity focused ultrasound (HIFU) performed on 6/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that the current medical evidence has not demonstrated the superior efficacy of the services at issue. At this time, there is a lack of data comparing the long-term results in a controlled or randomized protocol between HIFU and other standard treatments of prostate cancer, particularly in low stage and low grade disease where active surveillance is being used more commonly in patients. There is a lack of support for the services at issue in this patients case. In sum, HIFU provided on 6/28/16 was not likely to have been more efficacious than other treatment options. Based upon the information set forth above, the services at issue were 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  
 
The patient is a 22-year-old female who was diagnosed with narcolepsy type 1. The patient has 
requested authorization and coverage for Wakix tablets 17.8 mg. The physician reviewer found 
that the submitted documentation supports the medical necessity of the requested medication. 
This patient was diagnosed with narcolepsy following adequate tests. The patients response to 
previous treatment is well documented. Wakix has been approved by the U.S. Food and Drug 
Administration (FDA) for the treatment of narcolepsy. Given the failure of other medications, the 
requested medication is medically indicated. Therefore, Wakix tablets 17.8 mg are medically 
necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 30-year-old male enrollee has requested reimbursement for residential treatment provided from 5/05/18 through 5/08/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the services at issue in this patients case. Per the records, his polysubstance use was dominating his daily routine and contributing to significant impairment across multiple domains of functionality.  He reported a family history and an early age of first use, both of which are associated with more severe cases of addictive illness. His substance use was undermining his educational pursuits and interpersonal functioning. The patient was negotiating emotional dysregulation, anxiety and depressive symptoms related to his substance use. Finally, the patient had attempted community-based programming, but was unable to maintain sobriety in his environment. Based on the records, the patient had not consolidated the treatment gains necessary to succeed in a less restrictive setting, and promptly would have relapsed, were he discharged to outpatient on 5/05/18. During the disputed timeframe, the patient was restless, on edge, moody, angry with himself and not sleeping well. However, he was actively engaged in therapeutic programming and furthering his recovery in a safe environment.  The services and setting were safe, appropriate and consistent with good practice, while nine days of residential treatment would be considered an inadequate duration of care for an illness burden of this severity. Additionally, the services provided at the time were reasonably expected to improve his condition and prevent a more serious episode of illness. In sum, residential treatment provided from 5/05/18 through 5/08/18 was medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/10/16. 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 tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. In this case, the patient has dense breasts. 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. Given the support in the medical literature, the breast tomosynthesis performed on 2/10/16 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 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 41-year-old male enrollee has requested reimbursement for Decision DX Melanoma Assay performed on 12/16/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue.  Decision DX Melanoma Assay has been developed for patients with stage I and II cutaneous melanoma.  However, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy.  Per the National Comprehensive Cancer Network guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate benign from malignant neoplasms, or melanomas at low versus high risk for metastasis, routine (baseline) genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study.  All told, Decision DX Melanoma Assay performed on 12/16/15 was not likely to have been of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1 
 
A 26-year-old female enrollee has requested reimbursement for myPath Melanoma test performed 
on 12/30/21. The Health Insurer has denied this request indicating that the services at issue were 
considered  investigational  for  evaluation  of  the  insureds  melanoma.  
The physician reviewer found that for a melanocytic lesion of uncertain malignant potential, 
current standard of care generally involves wide excision of the lesional site with appropriate 
margins. The lesion in question was biopsied on 11/29/21 and the pathology report of 12/14/21 
described the clinicopathologic features of the lesion as a severely atypical compound melanocytic 
neoplasm, favoring melanoma of 0.4 mm thickness. The provider recommended further evaluation 
with the myPath Melanoma gene expression test. Although the studies are less clear for patients 
with severely atypical nevi, there are data to support re-excision with appropriate margins followed 
by routine dermatologic surveillance (Soleymani, et al.). The most recent National Comprehensive 
Cancer Network (NCCN) guidelines state that it is unclear whether gene expression profiling 
platforms  provide  clinically  actionable  prognostic  information  when  compared  with  known 
clinicopathologic factors. In addition, the impact of these tests on treatment recommendations has 
not been established. It also remains unclear whether gene expression profiling tests can reliably 
predict outcome across the risk spectrum of cutaneous melanoma. The current consensus statement 
by the Melanoma Prevention Working Group (MPWG) indicates that more evidence is needed to 
support the use of gene expression profiling testing to inform recommendations about sentinel 
lymph node biopsy, follow-up, or other adjuvant treatment (Grossman, et al.). Thus, the myPath 
Melanoma test was unlikely to have added any significant benefit above the recommended 
standard of care treatment with re-excision with appropriate margins. All told, the  myPath 
Melanoma test performed on 12/30/21 was not likely to be more beneficial for evaluation of the 
patients medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3


A 31-year-old female enrollee has requested authorization and coverage for rituximab injection therapy. The Health Insurer has denied this request indicating that the requested therapy is considered investigational for treatment of the enrollees multiple sclerosis, relapsing-remitting. The physician reviewer found that although rituximab should not be considered a first line therapy for patients with relapsing remitting MS, there is sufficient medical literature supporting its use, benefit, and safety in patients with refractory MS. In this particular case, the patient has failed multiple first line therapies for treatment of her medical condition.  In addition, she has responded well to a prior treatment of rituximab and had no significant side effects with this medication.  Undertreated MS can cause significant morbidity and potentially early mortality.  As such, the use of rituximab in this particular case is medically reasonable.  Based upon the information set forth above, the requested therapy is likely to be superior than any available standard therapy for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 57-year-old female enrollee has requested reimbursement for DecisionDX-melanoma gene expression test performed on 8/12/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees left cutaneous melanoma. The physician reviewer found that the staging and prognosis of cutaneous malignant melanoma is classically determined by the system discussed by Balch and colleagues. There may be some further value in adding the mitotic rate to this system. By Balch staging, the melanoma would be classified as T2b and with the negative sentinel nodes, her stage would by IIA. This predicts for a 10 year survival of at least 64%. DecisionDX is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either Class 1 (with a greater than 90% disease free survival at five years), or Class 2 (with a less than 80% disease free survival at five years). Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDX classification, in patients undergoing sentinel node sampling. However, it is not clear how the five year DecisionDX data compares to the 10 year Balch data, and whether it can be used additionally to make clinical decisions. Berger and colleagues reported on 156 cases but there was not sufficient follow-up to determine the actual value of the test. The National Comprehensive Cancer Network (NCCN) guidelines state that there is interest in these types of assay but they can only be used in the context of a clinical trial. In sum, DecisionDX-melanoma gene expression test performed on 8/12/16 was not likely to have been more effective than the other options available in the evaluation of this patients medical condition. 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: Overturned

Summary Reviewer 2


A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease.   The physician reviewer found a meta-analysis of the utility of fecal calprotectin to determine disease activity in adults with Crohns disease found poor specificity (Lin, et al). Another study found that calprotectin above 150 ug/g had poor specificity (43%), and therefore poor positive predictive value, in predicting relapse (Pardi and Sandborn; Costa, et al). An additional meta-analysis of inflammatory bowel disease markers reported that the relatively poor specificity of fecal calprotectin in Crohns disease is a concern, as a false positive test could lead to treatment of a patient without endoscopically active disease (Mosli, et al). Thus, the use of calprotectin levels to guide therapy has not definitively been shown in controlled studies to improve clinical outcomes in patients with Crohns disease and the fecal calprotectin testing performed on 11/17/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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: Overturned

Summary Reviewer 1


A 50-year-old female enrollee has requested reimbursement for CPT codes 84999 (unlisted chemistry procedure, Oncotype DX colon cancer assay) and 88342 (immunohistochemistry of immunohistochemistry, per specimen, initial single antibody stain procedure) performed on 6/17/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer.The physician reviewer found the current medical evidence has not demonstrated the superior efficacy of the services at issue.  Oncotype DX colon cancer assay has been shown to have prognostic value, but to date has not shown that predictive benefit of standard chemotherapies.  National Comprehensive Cancer Network guidelines state that there are insufficient data to recommend the use of multigene assays, such as the Oncotype DX colon cancer assay, to determine adjuvant therapy.  Mismatch repair (MMR) status was stable for this patient.  However, given ulceration on final pathology of her colon tumor and abdominal abscess at presentation, most experts would lean toward chemotherapy for this patient given these risk factors.  Based on the available data, CPT codes 84999 and 88342 performed on 6/17/16 were not likely to have been of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 51-year-old female enrollee has requested reimbursement for MRI performed on 8/08/18. 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 medical necessity of the services at issue. The first appropriate imaging for the evaluation of low back pain with radicular symptoms is lumbar radiograph. According to the American College of Radiology, if the pain persists after four to six weeks of conservative management, and the patient is a surgical or intervention candidate, then MRI of the lumbar spine is the usually appropriate next examination. This patient had low back pain with associated left radiculopathy symptoms for nine months. She failed conservative management, including massage and chiropractic therapy. Therefore, MRI of the lumbar spine was an appropriate examination. Thus, MRI performed on 8/08/18 was medically necessary for the evaluation of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 40-year-old female enrollee has requested reimbursement for the Decision Dx test and specimen handling provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the Decision Dx melanoma diagnostic test has not been demonstrated in the peer-reviewed medical literature to improve health outcomes when compared with standard testing and evaluation. In addition, there is a lack of data to support using immunotherapy in patients with Stage I disease regardless of recurrence risk. All told, the Decision Dx test and specimen handling provided on 11/23/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 45-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 10/22/15. 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 that the breast tomosynthesis performed on 10/22/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.  Skaane and colleagues performed a large prospective screening trial To assess cancer detection rates, false-positive rates before arbitration, positive predictive values for women recalled after arbitration, and the type of cancers detected with use of digital mammography alone and combined with tomosynthesis. The authors concluded that 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. Given the support above, the use of breast tomosynthesis was likely to be more beneficial for evaluation of the patients breast exam than conventional testing.  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: Medical Necessity
Decision: Overturned

Summary Reviewer 
The parent of 10-year-old female enrollee has requested authorization and coverage for growth hormone treatment. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees growth hormone deficiency. The physician reviewer found that although combination therapy with GnRH agonist and GH is not recommended for augmentation of height in children with normally timed puberty or in children with idiopathic short stature alone. This patient has a combination of early adrenarche with advanced skeletal maturation at baseline, coupled with true central precocious puberty resulting in rapid acceleration in skeletal maturation and an extremely short adult predicted height.  Her adult height prediction is more than three standard deviations below the mean for age, and her epiphyses are still open. Her skeletal maturation is outpacing her statural growth, resulting in a shorter adult height prediction over time. Based on a recent meta-analysis, evaluating the efficacy and safety of combination therapy with GnRH agonist and GH in children with central precocious puberty, children with combination therapy reached a taller adult height and larger height gains without adverse effects (Liu, et al). As such, GH therapy is medically necessary in this patient to achieve a normal adult height. 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 2

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 in this circumstance, there is potential for recovery of left ventricular function over time with medical therapy. There was no documented indication for immediate placement of a defibrillator, such as sustained or inducible ventricular tachycardia, unexplained syncope or aborted sudden cardiac arrest.  Placement of a prophylactic defibrillator is not recommended until a period of time (greater than 90 days) where continued left ventricular dysfunction is documented to persist despite appropriate treatment. A prophylactic defibrillator (wearable or implantable) before this time has not been demonstrated to improve outcome. For example, studies assessing efficacy of prophylactic defibrillators early after diagnosis of myocardial infarction and reduced ejection fraction less than or equal to 35% before ventricular function has had a chance to recover have not demonstrated improved outcome. Also, studies evaluating wearable defibrillators during periods of increased risk where criteria for implantable defibrillators have not yet been met are largely comprised of registry data without adequate control groups. At this time, prophylactic wearable external defibrillator would be indicated only if accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed, needed to be significantly delayed (due to infection, for example) or required explantation. Thus, the wearable cardioverter defibrillator provided on 7/25/18, 8/25/18 and 9/25/18 was not likely to have been superior over other available treatment options.