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

Summary Reviewer 1

A 47-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 enrollees medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. The STAR trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea. This trial demonstrated the hypoglossal nerve stimulator to be safe and effective in a small subset of patients with obstructive sleep apnea who have failed continuous positive airway pressure (CPAP) therapy, have nonconcentric airway collapse, an apnea-hypopnea index (AHI) between 20 and 50, and a body mass index (BMI) less than 32. With a BMI of 28.19, AHI of 21.2, and nonconcentric airway collapse, this patient meets the criteria. He has failed CPAP, which is the gold standard treatment for obstructive sleep apnea and is at risk for untoward cardiac sequelae of untreated obstructive sleep apnea. Therefore, hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System is likely to be more effective than other available treatment options.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 47-year-old female enrollee has requested reimbursement for DecisionDX-UM assay performed on 5/09/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ocular melanoma. The physician reviewer found there is sufficient support for DecisionDX-UM assay in this clinical setting.  The testing performed is considered a standard of care in patients with ocular (uveal) melanoma.  This is a rare type of melanoma treated by only a handful of experts.  DecisionDX-UM assay provides prognostic and predictive information to guide adjuvant therapy for patients with uveal melanoma using genomic testing of the tumor.  Thus, DecisionDX-UM assay performed on 5/09/16 was likely to have been more effective 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 51-year-old female has requested reimbursement for human epididymis protein 4 (HE4) testing.  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 the submitted documentation fails to demonstrate the superior efficacy of the services at issue.  There were no progress notes, physical examinations or laboratory testing detailing the patients medical condition.  Although the records note a complex ovarian mass, details regarding the rationale for the testing were not provided.  In sum, HE4 testing performed on 11/20/15 was not likely to have been more efficacious 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: Overturned

Summary Reviewer 3


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 breastmedical literature supports the services at issue in this patients case.  According to 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 that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls.  All told, breast tomosynthesis performed on 7/21/15 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: Overturned

Summary Reviewer 2

A 22-year-old female enrollee has requested reimbursement for burn wound treatment provided on 1/10/19 (CPT 15273, 15274, 15277 and 15278). 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 the submitted documentation fails to demonstrate the superior efficacy of the services at issue. Suprathel is a full synthetic skin substitute. Hundeshagen and colleagues compared Mepilex Ag, a silver-impregnated foam dressing, and Suprathel, a DL-lactid acid polymer, in the outpatient treatment of partial-thickness burns in pediatric and adult patients. Per the authors, both dressings are feasible and efficacious for the outpatient treatment of minor and selected moderate partial-thickness burns. Rashaan and colleagues performed a prospective, observational study on 21 patients to evaluate adherence of Suprathel to the wound bed, reepithelialization time, grafting, wound colonization and infection, pain, dressing changes, length of hospital stay and scar formation. The authors found potential advantages of Suprathel treatment regarding pain and scar formation as compared to published results on (semi)synthetic dressings in the literature. No clear advantages were found regarding reepithelialization, need for grafting, wound colonization and infection and dressing changes. The authors concluded that randomized controlled trials are needed to evaluate the efficacy of Suprathel compared to other (semi)synthetic dressings in the treatment of partial thickness burns in pediatric patients. At this time, the medical evidence has not demonstrated that Suprathel is superior over other treatment options. Thus, burn wound treatment (CPT 15273, 15274, 15277 and 15278) provided on 1/10/19 was not likely to have been more beneficial than other treatment options.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 55-year-old male enrollee has requested reimbursement for the prostate cancer antigen 3 (PCA3) gene testing performed on 1/30/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the testing at issue was not likely to be more effective for this patient than other available treatment options. PCA3 requires better delineation of its role in the diagnosis and management of prostate cancer. Vlaeminck-Guillem and colleagues performed a review of 11 clinical trials, consisting of 2,737 subjects and evaluated the diagnostic performance of PCA3. Four studies evaluated patients with indeterminate PSA and had a sensitivity of 53-84% and a specificity of 71-80%. Three studies with at least 200 patients with a PCA3 after a negative biopsy had a sensitivity of 47-58% and a specificity of 71-72%. The utility of PCA3 from these studies is difficult based on small sample sizes and different criteria for biopsy referral. Mostly, none of the studies used the PCA3 score as an indication for biopsy. A larger study by Roobol and colleagues reported the results of using PCA3 as an initial screening test, with sextant biopsy performed if either the PSA level was more than 3 or the PCA3 score was more than 10, in 721 patients. The PCA3 performed only slightly better than total PSA. The majority of cancers were Gleason grade greater than 6, or stage T2a or greater, though only 19 men were missed by PCA3. However, the generalizability of these results is uncertain because all subjects had already undergone three rounds of screening, and 29% of patients had previous negative biopsies. Thus, there is inadequate scientific evidence to support the use of PCA3 gene expression testing in this clinical setting. As such, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 21-year-old male enrollee has requested authorization and coverage for LINX reflux management system.  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 there is sufficient support for the requested services in this patients case.  The Food and Drug Administration has approved the LINX reflux management system for lower esophageal sphincter augmentation.  Appropriate candidates for the procedure include patients with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate gastroesophageal reflux disease and a hiatal hernia less than 3 cm. This patient meets those specific criteria.  Per the medical evidence, the requested LINX reflux management system is likely to be superior over other treatment options.  Based upon the information set forth above, the requested services are 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 60-year-old male enrollee has requested reimbursement for repair of anorectal fistula provided on 10/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees anal fistula. The physician reviewer found that the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Anorectal fistula are difficult, painful and not always amenable to definitive treatment. Historical treatment that involved unroofing often led to incontinence as the sphincters were divided. Setons, which are sutures placed through the tract, allow fibrosis that may reduce complications of subsequent surgery. The anal fistula plug does hold some potential advantages over mucosal advancement flap, especially in complex fistula with multiple openings. The anal fistula plug is easy to place, does not require a flap to heal in a contaminated environment, and may be associated with less pain. In addition, healing rates are equivalent in large, heterogeneous studies. However, in this case, the documentation submitted for review does not describe the location of the fistula or description of previous repair attempts. In sum, there is limited documentation supporting the anorectal fistula provided on 10/23/15 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 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: Experimental
Decision: Upheld

Summary Reviewer 2 
A 31-year-old female enrollee has requested reimbursement for evaluation of arterial inflow and 
venous  outflow  of  abdomen,  retroperitoneum,  scrotal  contents  and/or  pelvic  organs  and 
detailed  fetal  ultrasound,  fetal  doppler  echocardiography  and  umbilical  artery  doppler 
velocimetry on 3/11/22 and 5/10/22. The Health Insurer has denied this request and reported 
that the services at issue were investigational for the evaluation of the enrollees high risk 
pregnancy. The physician reviewer found that the ultrasound on 3/11/22 was standard care for 
the measurement of nucal translucency and has been shown to be a useful marker of risk for  aneuploidy and cardiac defects. The ultrasound on 5/10/22 was standard for the evaluation of 
fetal  anatomy.  Therefore,  evaluation  of  arterial  inflow  and  venous  outflow  of  abdomen, 
retroperitoneum, scrotal contents and/or pelvic organs and detailed fetal ultrasound on 3/11/22 
and 5/10/22 were standard therapy and likely to have been more beneficial for evaluation of the 
patients condition. In this clinical setting, the uterine and umbilical artery dopplers were not 
likely to have been more beneficial for the evaluation of this patient at the gestational ages when 
they were performed, as they were extraneous services. There is a lack of data showing that 
uterine artery Doppler measurements are clinically beneficial for improving outcomes. While 
umbilical artery Doppler measurements may be indicated in certain clinical situations, the 
records did not document any such indications in this case. Therefore, evaluation of arterial 
inflow and venous outflow of abdomen, retroperitoneum, scrotal contents and/or pelvic organs 
were likely to have been more beneficial for evaluation of the patients condition than any 
available standard therapy, but the fetal doppler echocardiography and umbilical artery doppler 
velocimetry on 3/11/22 and 5/10/22 were not likely to have been more beneficial for evaluation 
of the patients condition than any available standard therapy.
Appeal type: Experimental
Decision: 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: Experimental
Decision: Overturned

Summary Reviewer 1


A 62-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that 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, by separating the various layers of breast tissue, one can better detect abnormalities. This patient has breasts that have been described as extremely dense. It is the patients with 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. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 8/9/16 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 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 1 
 
A 59-year-old male enrollee has requested authorization and coverage for deep brain stimulation. 
The Health Insurer has denied this request and reported that the requested service is investigational 
for the treatment of the enrollees Parkinsons disease. The physician reviewer found that Deep 
brain stimulation (DBS) treatment for advanced, medically refractory Parkinson's disease has been 
extensively studied. In particular, targeting of the subthalamic nucleus (STN) has been evaluated 
with no less than six randomized controlled trials, generally tested against medical management. 
The  European  Academy  of  Neurology/Movement  Disorder  Societys  guidelines  on  the 
management of Parkinson's disease with invasive treatments conclude that based on the published 
literature  on  patients  with  advanced  disease  with  medically  unresponsive  fluctuations  or 
unresponsive  tremor,  STN-DBS  likely  results  in  large  improvements  in  quality  of  life, 
performance of activities of daily living, motor fluctuations, and dyskinesias. The authors further 
note that a number of longer-term, non-randomized studies suggest that results are durable over 
many years and across several domains such as improvement in motor complications and stable 
reductions in dopaminergic medications. The authors indicate that STN-DBS may be offered to 
patients  with  advanced  Parkinsons  disease  if  fluctuations  or  tremors  are  not  satisfactorily 
controlled with medication. While there is less data available on globus pallidus internus (GPi) 
targeting, with studies concentrating on comparing the outcomes of GPi and STN targeting, the 
authors recommend GPi-DBS as effective in select patients. The primary difference in the two 
targets is the greater reduction in dopaminergic medications with STN-DBS. Other invasive 
treatment strategies, including pump therapy and lesional techniques, may be appropriate only for 
very select patients who are not eligible for DBS. Rughani and colleagues note that as related to 
STN or GPi targeting, STN targeting is more effective at allowing reductions in dopaminergic 
medications. In this case, the Health Insurer appears to rely on the Unified Parkinsons Disease 
Rating Scale (UPDRS) score in  determining  coverage for DBS. However, the  number one 
predictor of efficacy of DBS in the treatment of Parkinson's disease is an excellent response to 
dopaminergic medications, which this patient demonstrates. In this case, the patient has advanced 
Parkinson's  disease  with  medically  refractory  motor  fluctuations  and  dyskinesias,  and  has 
attempted a number of medications at varying doses. In this clinical setting, the requested service 
is likely to be more beneficial for the treatment of this patient than standard medical therapy. 
Therefore, deep brain stimulation is likely to be more beneficial for treatment of the patients 
condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 50-year-old female enrollee has requested authorization and coverage for Harvoni and ribavirin. The Health Insurer has denied this request indicating that the requested medications are not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 3a. The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C virus, regardless of fibrosis, should be treated except those with a life expectancy of less than 12 months due to non-liver-related comorbid conditions. In addition, treatment naive patients are recommended to be treated with Harvoni and weight based ribavirin for 12 weeks. Moreover, it is beneficial to treat patients with hepatitis C before they progress to F3 or F4 fibrosis. For these reasons, the requested treatment with Harvoni and ribavirin is supported as medically necessary for treatment of this patients hepatitis C virus infection. All told, the requested medications are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1


A 50-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 8/19/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees thin melanoma.   The physician reviewer found that the DecisionDx melanoma assay evaluates the genetics of the melanoma and can stratify whether a thin melanoma is at high risk for metastasis. The DecisionDx test has shown some impressive accuracy in thin melanomas. However, there is a paucity of data showing that the results of this test improve treatment decision making and health outcomes. The treatment of this patient would not change based on the results of the DecisionDx. Moreover, the test is not considered routine standard of care and is not recommended by the National Comprehensive Cancer Network (NCCN) guidelines. Overall, the test is currently not standard of care, offers no scientific evidence that it has a beneficial effect on health outcomes, and is not recommended by the NCCN guidelines. For these reasons, the DecisionDx melanoma assay provided on 8/19/15 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.