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

Summary Reviewer 1

A 53-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 11/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit to these statistics. DecisionDx-Melanoma test is a study of 31 genes in an individualas melanoma cells. It then classifies that melanoma into either Class 1 or 2, with a difference in the risk of recurrence at five years between these two classes. Gerami and colleagues reported on 217 cases, with good correlation between such molecular assay and prognosis in patients who had undergone sentinel node biopsy. At this time, it is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. In this case, the Balch data provides sufficient information to make clinical decisions, and DecisionDx-Melanoma was not likely to have added to this information. Therefore, DecisionDx-Melanoma test performed on 11/06/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 53-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 11/06/19. 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 this patient had an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. In addition, the GEP on this patient was sent two years after diagnosis, making the information even less informative. Newer prognostic molecular techniques should not replace standard staging procedures. 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, either as a standard of care or as part of clinical trials. In sum, DecisionDx-Melanoma test performed on 11/06/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 53-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 11/06/19. 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 the DecisionDx-Melanoma test for melanoma 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 test performed on 11/06/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

The patient is a 62-year-old male who was diagnosed with glioblastoma in February 2018. The patient has requested authorization and coverage for Verzenio (abemaciclib tablets 200 mg). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The physician reviewer found that this patient with recurrent glioblastoma has received multiple combinations of treatment in the recent past. Abemaciclib (Verzenio) is not U.S. Food and Drug Administration (FDA) approved for the treatment of glioblastoma and is not supported for off-label use by major drug compendia. The medical literature shows efficacy in animal models and potential for efficacy in patients with recurrent disease, but does not support use as a standard of care as a single agent or in combination with other drugs. In this patients case, it is possible that his stable disease is due to the use of immunotherapy and not abemaciclib, which he had been off for a period of time. Therefore, Verzenio (abemaciclib tablets 200 mg) is not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1


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 there is a lack of properly conducted, prospective, controlled trials showing a benefit of the services at issue over routine tests. Monitoring patients on infliximab with measurement of infliximab levels and antibodies to infliximab continues to be an area of intense investigation. The Anser IFX test categorizes drug levels as high or low and antibody levels as high or low. However, this algorithmic approach has not been validated using prospectively controlled data. Their value as a random test to assess levels in a clinically stable patient on maintenance therapy, such as in this patients case, has yet to be established in prospective controlled trials. Therefore, the Anser IFX diagnostic test administered on 2/8/16 was not likely to have been more beneficial than any available standard therapy 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: Insurer Denial Upheld

Summary Reviewer 2


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 the use of Anser IFX test to direct management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials of patients with inflammatory bowel disease. The Prometheus Anser IFX test is a quantitative measurement of serum infliximab (IFX) and anti-IFX antibodies. Some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear.  Some evidence exists that low serum levels of infliximab or the presence of IFX antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well controlled clinical trials to confirm that use of Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. As such, the clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but the study does not compare these management changes to those made in the absence of anti-drug antibody measurement (Yanai, et al). Moreover, the medical literature has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. This appears to be the case with this patient, since available records do not support a clinical presentation that raised concern for loss of drug response or for the development of drug antibodies at the time of her test. For these reasons, the Anser IFX diagnostic test administered on 2/8/16 was not likely to have been superior to the other standard therapies available for the evaluation of this patient. 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: Insurer Denial 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: Insurer Denial Upheld

Summary Reviewer 1

The patient is a 62-year-old male with a progressive group of symptoms consistent with a neurodegenerative disorder.  He has developed dysarthria, ataxia and possibly cognitive abnormalities of executive functioning. Per the records, magnetic resonance imaging (MRI) of the brain showed atrophy of the cerebellum, cerebellar peduncles, and pons and medulla consistent with multisystem atrophy or possibly spinocerebellar degeneration. The provider recommended dopamine transporter single photon emission computed tomography (DaT SPECT). The patient has requested reimbursement for DaT SPECT scan of the brain performed on 9/23/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.  There is a lack of support for the services at issue in this clinical setting.  The differential diagnosis of spinocerebellar degeneration versus multiple system atrophy is established by clinical grounds. There is a lack of data demonstrating adequate sensitivity or specificity of DaT SPECT scanning in this clinical setting.  Therefore, DaT SPECT scan of the brain performed on 9/23/16 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: Insurer Denial Upheld

Summary Reviewer 2

The patient is a 62-year-old male with a progressive neurodegenerative disease with ataxia, dysarthria, fatigue and cognitive dysfunction. The patient had an abnormal magnetic resonance imaging (MRI) in the past with localized atrophy. His provider suspected the diagnosis of multisystem atrophy versus spinocerebellar atrophy and recommended dopamine transporter single photon emission computed tomography (DaT SPECT). The patient has requested reimbursement for DaT SPECT scan of the brain performed on 9/23/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.  While a DaT SPECT study is not indicated for all patients with degenerative diseases, it has been shown to be useful in cases where the diagnosis of Parkinsons disease (or a Parkinson plus syndrome such as multisystem atrophy) versus another non-dopaminergic degenerative disorders (such as spinocerebellar atrophy) is being considered. These diseases can be challenging to differentiate based only on clinical grounds. In this particular case, the DaT SPECT scan provided definitive information.  It is imperative to provide a definitive diagnosis as treatment for multisystem atrophy, Parkinsons disease, and spinocerebellar atrophy are quite different and a trial of an unnecessary therapy would place the patient at risk of significant side effects.  There is some support in the medical literature demonstrating the use of this study in differentiating patients with movement disorders.  Thus, DaT SPECT scan of the brain performed on 9/23/16 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: Insurer Denial Upheld

Summary Reviewer 3


The patient is a 62-year-old male with suspected multisystem atrophy and progressive neurologic dysfunction. He has had dysarthria, ataxia, incoordination, and possible subtle executive dysfunction.  Magnetic resonance imaging (MRI) has shown atrophy in the cerebellum, peduncles, pons, and medulla.  The records noted a hot cross bun sign suggestive of a multisystem atrophy or spinocerebellar atrophy.  On 6/28/16, progress notes indicated probable multisystem atrophy, obstructive sleep apnea, and rapid eye movement (REM) sleep behavior disorder. His provider recommended dopamine transporter single photon emission computed tomography (DaT SPECT). The patient has requested reimbursement for DaT SPECT scan of the brain performed on 9/23/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.  DaT SPECT is used to identify individuals with impaired dopamine neurotransmission, and is potentially useful in the differential of patients with parkinsonian features and dementia. Possible uses include evaluation of patients with clinically uncertain parkinsonian syndromes, differentiation of essential tremor, psychogenic parkinsonism, or neuroleptic induced parkinsonism, early detection of Parkinsons disease, and differentiation of dementia with Lewy bodies from other dementias.
None of these situations apply in this patients case.  The medical evidence does not support the services at issue in this clinical setting.  Thus, DaT SPECT scan of the brain performed on 9/23/16 was not likely to have been more effective than other available modalities in this patients case.  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: Insurer Denial Upheld

Summary Reviewer 


The parent of a two-year-old female enrollee has requested authorization and coverage for the Synagis 100 mg/mL injection. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees congenital heart disease with heterotaxy, chronic lung disease, hypoxemia on room air, pulmonary hypertension status post two diaphragmic plication procedures. The physician reviewer found that the use of Synagis in this patient is not medically necessary. The use of Synagis since 1998 has always been under strict criteria so that its use maximizes patient benefit and efficacy while not being overused. As noted above, the patients provider indicates the patient may have primary ciliary dyskinesia (PCD) which, in addition to her polysplenia, may increase the risk of developing a secondary bacterial pneumonia while co-infected with RSV. The most widely accepted guidelines for the use of Synagis are published by the American Academy of Pediatrics (AAP) Committee on Infectious Diseases and Bronchiolitis Guidelines Committee, which was last updated in 2014. These guidelines indicate there is no established role for RSV prophylaxis after 24 months of age for any patient regardless of any risk factors. The 2006 study from Thorburn and colleagues supporting an indication for Synagis in patients at high risk for pulmonary bacterial co-infection states that up to 40% of children admitted with severe RSV pulmonary disease were found to have bacterial co-infection in their lower airways. However, these children were all infants under four months of age. The article also states that in their study population, co-morbidity was not associated with high incidence of pulmonary co-infection of the lungs. Further, functional or actual asplenia has not been shown in any studies to be associated with increased hospitalization due to RSV. All told, Synagis is only indicated in children under two years of age regardless of the presence of chronic heart, lung, or immune system disease. Thus, the requested Synagis vaccine is not medically necessary for this patient. Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 


A 50-year-old female enrollee has requested reimbursement and prospective authorization and coverage for laser treatment (CPT 96920) provided from 1/4/16 and forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees vitiligo. The physician reviewer found the laser treatment (CPT 96920) provided from 1/4/16 and forward was and is medically necessary for treatment of the patients medical condition. According to Nicolaidou and colleagues Vitiligo is a common and chronic disease with a great impact on patients quality of life. Phototherapy with narrowband ultraviolet B radiation and excimer laser are two treatment modalities that are used increasingly for the management of the disease with variable results. Treatment with the excimer is the standard of care in this clinical setting and is supported as a first-line treatment for vitiligo (Grimes). Based on the support in the peer-reviewed literature, the services at issue have been established as medically necessary for treatment of the patients vitiligo. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

A 56-year-old female enrollee has requested reimbursement for inpatient length of stay provided on 8/17/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that vaginal bleeding secondary to a post-coital vaginal laceration, if severe, is managed through operative repair. Repair of vaginal lacerations usually requires surgical intervention and is best performed in the operating room to obtain adequate exposure. Regional or general anesthesia may be needed due to pain and pressure from retraction or extensive suturing. In this case, the repair was uncomplicated, with no extension beyond the vagina requiring further surgery. The patient tolerated the procedure well and was deemed stable postoperatively. Typically, patients are able to be discharged following the surgery from the ambulatory surgical unit, in which case inpatient admission is not medically necessary. In this patients case, she did not have any unique clinical circumstances that required acute inpatient admission. She was hemodynamically stable throughout her course and could have discharged after monitoring in the postoperative recovery unit. This patient did not require acute inpatient admission and could have been discharged after an appropriate period of monitoring in the recovery unit. Therefore, inpatient length of stay provided on 8/17/19 was not medically necessary for the treatment of this patient.