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

Summary Reviewer 2 
 
A 27-year-old female enrollee has requested authorization and coverage for E1399 durable 
medical equipment RT300 FES arm therapy system. The Health Insurer has denied this request 
and reported that the requested device is investigational for the treatment of the enrollees 
medical condition. The physician reviewer found that the E1399 RT300 FES arm therapy system 
is not likely to be more beneficial than other available standard therapy. It is uncertain whether 
FES  can  restore  upper-extremity  function  or  improve  the  quality  of  life.  The  evidence  is 
insufficient to determine the effects of the technology on health outcomes. The evidence for the 
effectiveness of the RT300 FES cycling in people with stroke is limited. There is insufficient 
evidence in the literature that supports that the use of the RT300 FES will be effective for this 
patients hemiplegia from stroke in long-term improvement of muscle strength, vascular blood 
flow, bone mineral density, reduction of spasticity and atrophy, facilitation of functional motor 
movement  or  reduction  muscle  atrophy  in  the  upper  and  lower  extremities.  Eraifej  and 
colleagues performed a meta-analysis of 20 studies on the benefits of FES on activities of daily 
living. Only three studies showed a significant benefit of FES on activities of daily living when 
initiated within two months post-stroke. In three studies where FES was initiated more than one 
year after stroke, no significant activities of daily living improvements were seen. Limitations of 
the evaluable studies included, very low quality evidence in all analyses due to heterogeneity,  low participant numbers and lack of blinding. The authors concluded that FES is a promising 
therapy that could play a part in future stroke rehabilitation. They noted that there is a need for 
high quality large-scale randomized controlled trials of upper limb FES after stroke to draw firm 
conclusions regarding its efficacy or its optimum therapeutic window. The evidence that FES 
cycling can have a long-term effect on bone mineral density is not found in the literature. An 
additional study done on the prevention and treatment of osteoporosis by Soleyman-Jahi and 
colleagues revealed very low-quality evidence that low-intensity cycling (three days per week) 
with FES provided a benefit for reducing bone mineral density loss in individuals with chronic 
spinal  cord  injury  or  neurologic  injury.  All  told,  the  current  medical  evidence  has  not 
demonstrated the superior efficacy of the requested device. Therefore, the requested for E1399 
durable medical equipment RT300 FES arm therapy system is not likely to be more beneficial 
than any available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

The patient is a 57-year-old male with amyloidosis. He was diagnosed with AL amyloidosis caused by a kappa light chain plasma cell neoplasm. His disease manifestations included restrictive cardiomyopathy, syncope, dyspnea, carpal tunnel syndrome, and dysrhythmia. He was treated with bortezomib, cyclophosphamide, and dexamethasone. His free light chains increased after this treatment suggesting progressive disease. The patient has requested authorization and coverage for daratumumab (Darzalex). The Health Insurer has denied this request indicating that the requested medication is considered investigational. Primary amyloidosis due to immunoglobulin light chains and multiple myeloma are both plasma cell neoplasms. Both diseases are the result of cancerous plasma cells that are secreting paraproteins. In AL amyloidosis, the plasma cells involving the bone marrow are fewer in number than in multiple myeloma and the light chains have the protein characteristic of forming amyloid in tissues. In this case, there is no standard approach. Darzalex is a monoclonal antibody directed against CD38. It was approved by the U.S. Food and Drug Administration (FDA) for treatment of myeloma in patients who have progressed on proteasome inhibitor or immunomodulatory agents. Moreover, Darzalex has been shown to be effective against AL amyloidosis (Kaufman, et al). For these reasons, the requested Darzalex is supported as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 56-year-old female enrollee has requested reimbursement for magnetic resonance imaging (MRI) of the lumbar spine provided on 10/27/17. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees left-sided back and hip pain. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The American College of Radiology (ACR) indicates that MRI is not warranted in the acute setting. However, in the setting of low back pain in which the patient is a candidate for surgery or other intervention, then the ACR considers MRI to be the most appropriate study, with no stipulation about delaying the MRI. In 2007, Chou and colleagues noted that clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain. Per the authors clinicians should evaluate patients with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy). In general, plain x-rays are often of very limited value. Plain x-rays serve to evaluate the patient for significant structural abnormalities, such as fractures, malalignments or congenital anomalies. However, plain x-rays are not generally beneficial for evaluating the patient for a cause for radiculopathy. Patients can have significant disc herniations with normal plain x-rays; and conversely, patients with significant degenerative change in the lumbar spine may not have significant disc encroachment. Most importantly, many patients have radiographic and/or MRI evidence of degenerative changes with apparent disc herniations, and are asymptomatic. Thus, radiographic findings do not necessarily correlate with clinical symptoms, and it is imperative that decisions are based on symptoms. There is a lack of support for the diagnostic procedure at issue in this patients case. The only reason to obtain an MRI is in anticipation of some sort of intervention. This could be surgery, but it could also involve facet injections. Prior to an intervention, it is not unreasonable to attempt a trial of conservative treatment, such as physical therapy, a targeted exercise program, or methodical use of anti-inflammatory drugs. In sum, MRI of the lumbar spine provided on 10/27/17 was not medically necessary. Therefore, the diagnostic procedure at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 30-year-old female enrollee has requested reimbursement for extended inpatient stay at Sharp Memorial Hospital provided from 11/04/17 through 11/06/17. 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 postoperative ileus is a delay in the return of gastrointestinal motility after surgery, and is common after colectomy. It can result in nausea, abdominal pain, absence of flatus, and absence of bowel movements, all of which this patient had. Postoperative ileus is the main determinant of the length of stay after colorectal surgery. Postoperative ileus can justify an extended length of stay after surgery. Additionally, given the risk for post-colectomy complications, a prolonged postoperative ileus raises concerns for complications such as leak or intra-abdominal infection, supporting the inpatient level of care until ileus had resolved in this case. These concerns are heightened in patients with possible Crohns disease, especially those on anti-tumor necrosis factor medications. Therefore, the extended inpatient stay provided from 11/04/17 through 11/06/17 was medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 29-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the LINX Reflux Management System works by augmenting the lower esophageal sphincter with a ring of magnets. Eligible patients must demonstrate typical gastroesophageal reflux disease symptoms, an abnormal pH study, partial response to daily proton pump inhibitor (PPI) therapy, and absence of a large hiatal hernia or severe esophagitis. This patient meets all of these criteria. In the study by Ganz and colleagues, the long-term safety and efficacy of the LINX prosthesis was evaluated in a prospective single-group trial of 100 patients with longstanding gastroesophageal reflux disease. At five years after LINX, significantly fewer patients reported moderate or severe heartburn (12 versus 89 percent), moderate or severe regurgitation (1 versus 57 percent), bothersome gas-bloat (8 versus 52 percent), and daily PPI use (15 versus 100 percent). No device erosions, migrations, or malfunctions occurred. The ability to belch or vomit, when needed, was preserved in all patients. The medical evidence supports the requested services in this patientas case. Therefore, the requested LINX procedure is likely to be more beneficial than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 21-year-old male enrollee has requested reimbursement for substance use partial hospitalization provided on 10/12/17 and from 11/17/17 through 12/08/17 and substance use intensive outpatient program services provided from 12/09/17 through 1/11/18. 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 in cases such as this, an evidence-based, objective, instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. With regards to risk of harm, the records support a score of 1 due to a lack of current suicidal ideation and no self-harming behaviors or history of suicide attempts. In terms of functional status, the records support a score of 2 to 3 due to school problems and daily substance use that impacted motivation. With regards to medical, addictive and psychiatric comorbidity, the records support a score of 2 due to overall medical stability. In terms of level of stress of the recovery environment, the records support a score of 3. With regards to level of support of the recovery environment, the records support a score of 2 due to family support and availability of treatment resources. In terms of treatment and recovery history, the records support a score of 3 due to lack of past recent intensive treatment. In terms of engagement and recovery status, the records support a score of 2 due to cooperation in treatment and insight into his need for treatment. Thus, the patient has a composite score of 15 to 16. This score correlates with treatment in a community-based outpatient clinic setting. This patient could have received effective treatment on an outpatient basis, due to his lack of self-harm behaviors, cooperative behaviors, and lack of active suicidal or homicidal ideation. He was motivated for treatment with mention of insight into his illness as well as documentation of his knowledge of skills to maintain sobriety. The submitted documentation does not indicate that he was having severe mood swings or other severe psychiatric symptoms. Thus, substance use partial hospitalization provided on 10/12/17 and from 11/17/17 through 12/08/17 and substance use intensive outpatient program services provided from 12/09/17 through 1/11/18 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3


A 22-year-old male has requested reimbursement for Prometheus Anser IFX testing performed on 8/30/15.  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 the Prometheus Anser IFX test was ordered to direct the use of Remicade (infliximab) in this patient with Crohns disease. However, the use of the testing at issue to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Therefore, it is unclear whether dosage should be increased, the medication should be changed, or another course of action should be taken.  Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing.  Thus, Prometheus Anser IFX testing performed on 8/30/15 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 50-year-old male has requested authorization and coverage for the LINX Reflux Management System.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease. The physician reviewer found the U.S. Food and Drug Administration has approved the LINX Reflux Management System for lower esophageal sphincter augmentation.  Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate gastroesophageal reflux disease and a hiatal hernia less than 3 cm.  This patient meets those specific criteria. The device is a ring made up of a series of magnets that have sufficient attraction to increase the lower esophageal sphincter closure pressure, but allow for food passage with swallowing. Based upon a prospective study by Lipham and colleagues which included 44 patients, the mean total percent time pH less than 4 was reduced from 11.9 percent at baseline to 3.8 percent at three years.  A recent study comparing the LINX procedure with laparoscopic fundoplication was performed by Reynolds and colleagues.  This was a retrospective study which used propensity matching to compare groups. The authors found that gastroesophageal reflux disease patients had similar control of reflux symptoms after both LINX and fundoplication. The inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms.  In this patients case, 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: Medical Necessity
Decision: Overturned

Summary Reviewer 

A 36-year-old female enrollee has requested authorization and coverage for Qsymia. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees diabetes mellitus, hyperlipidemia. The physician reviewer found that obesity is recognized as a major risk factor for type 1 diabetes. In the peer-reviewed medical literature, data suggests that clinically meaningful weight loss, defined as greater than 5%, can lead to improved glycemic control in patients with type 2 diabetes. Moreover, this weight loss is likely to aid in the management of other comorbid conditions (Rejeski, et al). Qsymia is a medication that promotes weight loss and has been shown to improve other health parameters of obese patients, including type 2 diabetes (Mahgerefteh, et al). Given this support, the requested Qsymia is medically necessary for this patient. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1

A 55-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 11/2/15.  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 the breast tomosynthesis performed on 11/2/15 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. Ciatto and colleagues investigated the effect of integrated two dimensional (2D) and three dimensional (3D) mammography in the breast cancer screening population. The authors found that Integrated 2D and 3D mammography improves breast cancer detection and has the potential to reduce false positive recalls. Based on the documentation submitted for review and medical literature, the use of breast tomosynthesis 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: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 40-year-old male enrollee has requested authorization and coverage for Vemlidy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis B infection. The physician reviewer found the guidelines for the treatment of hepatitis B from the American Association for the Study of Liver Diseases (AASLD) recommend entecavir and tenofovir compared with alternatives for the treatment of chronic hepatitis B (Terrault, et al). In comparison with tenofovir disoproxil fumarate (Viread), which the patient is taking, the Vemlidy formulation of tenofovir is effective for hepatitis B, but is associated with lower incidence of side effects such as osteopenia and renal disease (Grant, et al). Although entecavir is also recommended by AASLD guidelines, the patient is stabilized on tenofovir, and a change to entecavir may result in disease reactivation. As such, the request for Vemlidy is demonstrated to be medically necessary for the treatment of this patients chronic hepatitis B. Therefore, for the reasons stated above, Vemlidy is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1


A 65-year-old male has requested reimbursement for gene testing performed on 12/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found there is sufficient support for the services at issue in this clinical setting.  Once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features such as the grade of tumor and prostate specific antigen level. This helps guide the most appropriate therapy for patients taking into account their age and comorbidities because many patients will not require therapy and may be followed closely instead.  The important features to recognize are Gleason score and prostate specific antigen levels, but these are imperfect.  Thus, current biomarkers are inadequate for risk stratification, and better prognostic biomarkers are needed. The Oncotype DX prostate cancer test is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score (GPS).  The medical evidence supports the services at issue in this clinical setting in order to better stratify such patients with localized disease.  Therefore, gene testing performed on 12/09/15 was likely to have been superior over 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


The parent of a 14-year-old male enrollee has requested authorization and coverage for surgery for scoliosis. 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 that surgery for scoliosis has not been established as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Samdani and colleagues reviewed 32 patients who underwent a fusionless treatment of thoracic vertebral body tethering (VBT) with a minimum one-year follow-up. The authors concluded that that anterior VBT was a safe and potentially effective treatment option for skeletally immature patients with idiopathic scoliosis. However, the authors stated that longer term follow-up of this cohort will reveal the true benefits of this promising technique. In this case, the patient has been diagnosed with idiopathic scoliosis with a 44 degree thoracic curve and 24 degree lumbar curve. There is a lack of documentation of significant pain or current functional or activity limitation. In addition, there is a lack of evidence demonstrating an adequate trial of bracing as recommended by the treating provider has been tried. Finally, there is a lack of large volume, long-term peer-reviewed outcome studies to support the safety and effectiveness of vertebral body tethering at this time. In sum, the requested surgery for scoliosis is 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.