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

Summary Reviewer 2 
A 40-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with 
dilation of eustachian tube (i.e. balloon dilation); bilateral, on 8/26/21. The Health Insurer has 
denied this request and reported that the service at issue was investigational for the treatment of 
the enrollees bilateral eustachian tube dysfunction. The physician reviewer found that based on 
available clinical documentation, the service at issue was likely to have been more beneficial in 
managing the patients eustachian tube dysfunction, as compared to other available standard 
therapies. In this case, notes dated 8/26/21 reported that the patient had previously failed intranasal 
corticosteroid therapy, and tympanostomy tube placement had resulted in various adverse side 
effects.  In  a  meta-analysis  of  studies  regarding  medical  management  for  eustachian  tube 
dysfunction, Mehta and colleagues found that intranasal corticosteroids were not efficacious, 
improving only 11% to 18% of chronic cases. In a meta-analysis of eustachian tube balloon dilation  outcomes, including data from two randomized controlled trials comparing it to medical therapy, 
Froehlich and colleagues found improvement in subjective symptoms and objective clinical 
metrics  after  eustachian  tube  balloon  dilation  lasting  up  to  12  months.  Therefore, 
nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral, on 
8/26/21, was likely to have been more beneficial for treatment of the patients condition than any 
available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/06/16.  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 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 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: Overturned

Summary Reviewer 3

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 the records document a large osteochondral defect of the talus. Osteochondral lesions of the talus are difficult to treat because of the absence of healing reaction in damaged articular cartilage. Matrix-induced autologous chondrocyte implantation has been shown to be an effective method for treating cartilage lesions that fail to heal with the usual procedures, such as debridement and microfracture. The study by Kreulen and colleagues assessed the seven-year clinical follow-up data of matrix induced autologous chondrocyte implantation and demonstrated successful long-term healing. Ng and colleagues noted that autologous chondrocyte implantation and matrix-associated autologous chondrocyte implantation have shown promising results in osteochondral defects of the talus. This patients treatment options are limited. Thus, autologous chondrocyte implantation is likely to be more beneficial than other treatment options.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 21-year-old male enrollee has requested reimbursement for corneal collagen crosslinking performed on 9/04/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that based on the patients vision loss and progression, corneal collagen crosslinking was the most appropriate and effective treatment available. The medical evidence has demonstrated that corneal collagen crosslinking is a safe and effective procedure for stabilizing corneal ectasia and potentially delaying or preventing the need for full-thickness corneal transplant. Furthermore, there was a lack of treatment options available to slow or halt disease progression. In sum, corneal collagen crosslinking performed on 9/04/18 was likely to have been of greater benefit than other treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 20-year-old female enrollee has requested reimbursement for Anser IFX diagnostic test performed on 2/8/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees chronic ulcerative pancolitis.The physician reviewer found that management of ulcerative colitis using Anser IFX has not been standardized, and standardized recommendations for management based on test results (change to a different medication versus increase in dose) have not been formed (Kornbluth, et al). The use of Anser IFX to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in high-quality controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to Remicade (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 by Adedokun and colleagues 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. One study, with some patients undergoing dose intensification following initial non-response, showed no difference in serum levels of infliximab between patients who responded to dose intensification versus those who did not (Pariente, et al). Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing (Vande Casteele, et al). A systematic review reported that future prospective controlled studies are needed, especially considering anti-TNF levels are influenced by several variables that can fluctuate over time and among individuals (Yarur, et al).  Therefore, there is a lack of support in the clinical literature as to the superiority of Anser IFX testing performed on 2/8/16 when compared to other treatment options for the evaluation of this patients medical condition. Based upon the information set forth 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  52-year-old  male enrollee  has  requested  reimbursement  for  ExoDx  Prostate/ExosomeDx 
Prostate (Intelliscore) performed on 12/23/20. 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 several ancillary tests have been developed 
to  better  define  a  patient  in  need  of  an  initial  biopsy  or  repeat  biopsy.  ExoDx  Prostate 
(IntelliScore) is a non-invasive, urinary 3-gene expression test in which the results of the assay 
are adjunctive to the ordering providers clinical judgment and work-up of the patient in the 
determination of whether a prostate biopsy is necessary. The ExoDx Prostate (IntelliScore) was 
clinically validated to discriminate patients with higher grade prostate cancer from those with 
more indolent lower grade cancer and benign disease. For this reason, it may be useful in deciding 
whether  a  patient  would  benefit  from  a  prostate  biopsy.  National  Comprehensive  Cancer 
Network (NCCN) guidelines recommend ExoDx testing for some men as an option prior to 
invasive prostate biopsy in order to further risk stratify them. In this case, the services at issue 
were appropriate to assist in better delineating this patients risk for prostate cancer. Therefore, 
ExoDx Prostate/ExosomeDx Prostate (Intelliscore) performed on 12/23/20 was likely to have 
been more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 48-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health outpatient treatment, two times per week, from 1/15/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that there is no description of the type of therapy. The records indicate that she is seeing a psychiatrist on a regular basis. The clinical progress notes from the psychiatrist do not recommend a specific interval for psychotherapy sessions. There are no other recommendations in the clinical records that specify frequency. Per the records, this patient has a history of bipolar disorder and has had prior hospitalizations as well as suicidal ideation. At her appointment in February 2019, she was having suicidal ideation. Thus, she does need frequent therapy in order to help prevent possible suicide attempts as well as further inpatient acute admissions. The records note emotional dysregulation and symptoms of bipolar disorder. Based on the records, the patient would likely benefit from therapy on a weekly basis. The literature indicates that psychotherapy is effective for the management of symptoms of bipolar disorder. Scott and colleagues noted that efficacy studies demonstrate that adjunctive psychological treatments for individuals with bipolar disorders reduce relapse risk. The literature does not specify the exact frequency of psychotherapy. Typically, the frequency is dictated by the symptom presentation of the patient. In this patients case, weekly outpatient services were and are medically necessary. Weekly therapy is a standard frequency in behavioral health treatment. There is no indication or clinical recommendation for twice weekly therapy. Therefore, mental health outpatient treatment, two times per week, from 1/15/19 forward was not and is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

The patient is a 58-year-old male with prostate cancer. On 4/27/17, prostate biopsies were performed for a prostate-specific antigen (PSA) level of 5.1. Pathology report noted prostatic carcinoma, with highest Gleason score 3+3=6. Three cores were positive. The patient has requested reimbursement for Oncotype DX Prostate Assay performed on 9/29/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. National Comprehensive Cancer Network (NCCN) guidelines note that men who are status post biopsy with low or favorable intermediate-risk disease may consider the use of Oncotype DX Prostate Assay. Retrospective studies have shown that molecular assays performed on prostate biopsy or radical prostatectomy specimens provide prognostic information independent of NCCN risk groups. These include, but are not limited to, likelihood of biochemical progression after radical prostatectomy or external beam therapy, and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. Men with clinically localized disease may consider the use of tumor-based molecular assays. It is considered a standard of care in guiding treatment decision making. In sum, Oncotype DX Prostate Assay performed on 9/29/17 was 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 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 2 
 
A 56-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing 
performed on 6/04/21. The Health Insurer has denied this request and reported that the services at 
issue  were  investigational  for  the  evaluation  of  the  enrollees  medical  condition. 
found that per the National Comprehensive Cancer Network guidelines, the recommended therapy 
for stage IA cutaneous melanoma is history and physical and only imaging to evaluate certain signs 
and symptoms.  The recommended primary category 1A treatment is wide excision of the 
melanoma.  There is no indication for a gene expression assay to determine the primary course of 
treatment as no sentinel lymph node biopsy is needed for stage IA cutaneous melanomas. Marchetti 
and colleagues concluded, The prognostic ability of GEP tests among patients with localized 
melanoma varied by AJCC stage and appeared to be poor at correctly identifying recurrence in 
patients with stage I disease, suggesting limited potential for clinical utility in these patients. 
Therefore, DecisionDx-Melanoma testing performed on 6/04/21 was not likely to have been more 
beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 61-year-old female who has been diagnosed with amyotrophic lateral sclerosis. In a letter dated 12/03/19, the provider noted that the patient has significant arm and leg weakness. The physician reviewer found that the submitted documentation supports the medical necessity of the requested equipment. This patient has been diagnosed with amyotrophic lateral sclerosis. She requires significant assistance with movement in bed, per the medical records. Due to poor mobility in bed, the patient is at high risk for decubitus ulcers. These ulcers can lead to significant infections and can cause the patient to develop sepsis. The Freedom Bed will assist the patient in maintaining movement while in bed, thereby reducing the likelihood of developing decubitus ulcers. Therefore, the use of the Freedom Bed is indicated to reduce pain and risk of complications. Per Bromberg and colleagues, there is a specific timeline for the need for durable medical equipment for patients with amyotrophic lateral sclerosis. This includes the use of items similar to the Freedrom Bed. Therefore, the requested Freedom Bed is medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

The patient is a 62-year-old male who had developed malignant melanoma on the skin of left parietal scalp above the ear, 1.0 mm in Breslow thickness. The DecisionDx-Melanoma gene assay performed on 1/12/17 revealed class 1A molecular signature associated with a low risk of recurrence within five years. The patient has requested reimbursement for the DecisionDx-Melanoma test (84999) performed on 1/12/17. The Health Insurer denied this request for reimbursement and noted that the services at issue were considered investigational for evaluation of this patient. There is some support for the DecisionDx-Melanoma signature as an independent predictor of metastasis risk. However, there is a lack of peer reviewed published studies as to its superior efficacy when compared to other standard modalities. Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages 0-IV. DecisionDx-Melanoma assay assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as class 1, consistent with a low risk of metastasis, or class 2, suggestive of a high risk of metastasis. While the majority of clinical stage I patients will be disease free at five years, some stage I patients will develop advanced disease. According to the results of analysis of this patients melanoma performed with DecisionDx-Melanoma assay, the tumor was classified as class 1 with a low risk of near term (within five years) metastatic disease. In sum, while there is some support in the medical literature for the efficacy of the services at issue, DecisionDx-Melanoma test (84999) performed on 1/12/17 was not likely to have been of greater benefit than the available standard methods for the evaluation of 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: Medical Necessity
Decision: Upheld

Summary Reviewer

The patient is a 54-year-old female with a family history of a sister who died from ovarian cancer, father with colon cancer, and grandmother with possible primary peritoneal cancer. The patient was noted to have a 1 cm ovarian cyst with no concerning features. Her uterus was noted to be normal. The patients evaluation included detailed genetic consultation and testing. The testing did not show any high risk mutations. As a result, the genetic counselor did not place the patient in a high risk category for gynecologic malignancies. The patient has requested authorization and coverage for hysterectomy. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary. The patient has elected to undergo a prophylactic hysterectomy and bilateral salpingo-oophorectomy due to her family history. However, genetic counseling and testing do not place her in a high risk category for epithelial ovarian cancer, fallopian tube cancer or uterine cancer. Current recommendations reserve risk reducing surgery for patients in the highest risk categories with genetic mutations such as BRCA1, BRCA 2 and Lynch syndrome. Based on the patients family history and genetic testing results, she does not have a strong clinical indication for surgical cancer prophylaxis. Accordingly, the requested hysterectomy is not medically necessary for treatment of this patients medical condition.  Based on the foregoing discussion, the requested surgery is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 25-year-old male enrollee has requested reimbursement for corneal crosslinking provided on 8/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that Corneal cross-linking has been approved as a treatment of progressive (unstable) keratoconus. This patient was diagnosed with keratoconus and reported increasing blurriness in both eyes. In this case, the patient has two major risk factors suggesting that his keratoconus is likely to progress. Given his young age, he is likely to progress. Second, by history, he reports that his vision has declined in the last two years. There is a lack of other treatment options in this clinical setting. In sum, corneal cross-linking provided on 8/06/18 was likely to have been more beneficial than other available treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

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 according to Lipham and colleagues, Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation. Moreover, according to the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in regards to the safety and effectiveness of LINX Reflux Management System, On the basis of the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory GERD. In this case, the patient has GERD based on pH recording. However, in this case, the patient has both a large hiatal hernia and Barretts esophagus. There is a lack of studies supporting the LINX device for patients with these conditions. As such, the requested services are 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: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 53-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulator.  The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested services.  This patient has failed therapy for obstructive sleep apnea, including trials of conservative management and prior surgical intervention.  The case file for the re-review includes added data regarding the three years outcome results of the STAR trial.  This was a study that was fully designed and funded through Inspire Medical.  As noted by Certal and colleagues, further studies comparing hypoglossal nerve stimulation with conventional therapies are needed to definitively evaluate outcomes.  All told, the requested hypoglossal nerve stimulator is not medically indicated for the treatment of this patient.  Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.