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

Summary Reviewer 


A 38-year-old female enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation from 1/06/16 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 behavioral health conditions. The physician reviewer found the American Psychiatric Association has endorsed transcranial magnetic stimulation for the acute phase treatment of major depressive disorder.  Although some preliminary positivism regarding the application of transcranial magnetic stimulation therapy for the bipolar population can be found in the medical literature or in reports from clinical practices in the community, there is an absence of well-controlled and adequately powered exploratory and confirmatory studies regarding this intervention for the treatment of bipolarity at this time.  Further, it does not appear that the patient has failed other treatments commonly relied upon to treat bipolar disorder.  Additionally, it does not appear that the patient had an informational consultative appointment with an electroconvulsive therapy specialist to learn more about the treatment, as the intervention remains a trusted, rapid and effective treatment for both mania and bipolar depression.  Finally, there was a dearth of information regarding the status of supportive relationships and community functioning, or outcomes of non-pharmacological interventions.  Although the patient reportedly had tried multiple courses of past psychotherapies, there was no reported outcome of cognitive behavioral therapy and it does not appear that she had trialed other evidence-based therapies for bipolar illness, such as family therapy or interpersonal/social rhythm therapy.  All told, transcranial magnetic stimulation from 1/06/16 forward was not and is not medically indicated for the treatment of this patient.  Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 39-year-old male enrollee has requested reimbursement for lumbar spine surgery performed in Germany.  The Health Insurer has denied this request indicating that the services at issue were not emergent or urgent and were not medically necessary for treatment of the enrollees advanced degenerative disc disease. The physician reviewer found that per the submitted documentation, the surgical intervention performed in Germany was not emergent or urgent.  A program of conservative care allowing for return to the United States and resumption of follow-up with treating surgeons in the United States was possible, and there is no documentation of accepted indications for emergent surgery such as acute cauda equina syndrome with abrupt bowel and bladder change. Additionally, the current medical evidence fails to support the medical necessity of the services at issue.  In the context of the need for treatment of postoperative infection or mechanical failure of the total disc arthroplasty device, there is a unique and high risk of vascular injury or injury to the ureters in management of these complications.  The studies do not adequately reflect likely long-term complications of implantation of metal and metal methyl methacrylate devices in the spine.  After implantation of metal and metal methyl methacrylate devices in the knee and hip, it has been demonstrated that the patients are exposed to particulate debris.  This particulate debris consisting of abrasive wear and adhesive contact wear between the components of the device elicit a chronic inflammatory reaction including a giant cell tissue response.  The effect of this exposure may vary from patient to patient, but all patients will be exposed to the consequences of wear.  In total joint arthroplasty at the hip and the knee, problems of subsidence and loosening are known to be associated in some patients with this phenomenon.  It is unlikely that the long-term effects of total disc arthroplasty will be any different than metal to plastic arthroplasty in other locations in the body. Van Den Eerenbeemt and colleagues performed a systematic review of the literature of total disc replacement.  The authors reviewed three randomized controlled trials and 16 prospective cohort studies comparing total disc replacement with lumbar fusion.  The authors concluded that high-quality randomized controlled trials with relevant control groups and long-term follow-up is needed to evaluate the effectiveness and safety of total disc replacement.  In summary, the patients experience of pain while in Germany did not provide an indication for emergent or urgent surgery, and a delay with pain management techniques would have allowed additional patient education and the possibility of a positive symptomatic response to conservative care.  The lumbar spine surgery performed in Germany was not medically indicated for the treatment of this patient.  Therefore, the services at issue were not emergent or urgent and were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


The parent of a five-year-old female enrollee has requested authorization and coverage for Tobii Dynavox T10 device and accessories. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollee, who has been diagnosed with cerebral palsy and receptive expressive language disorder. The physician reviewer found that the parent of a five-year-old female enrollee has requested authorization and coverage for Tobii Dynavox T10 device and accessories. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollee, who has been diagnosed with cerebral palsy and receptive expressive language disorder.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 

The patient is a 22-year-old male who presented at age 19 with chest pain. The patient has requested reimbursement for the PET scan performed on 4/21/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that sarcomas of the heart are exceedingly rare tumors. Most cardiac tumors are benign, and of those that are malignant, the most common are angiomyosarcomas and rhabdomyosarcomas. Of the very rare cardiac sarcomas, synovial sarcomas account for only a tiny percentage. Hence, there is a lack of literature that has evaluated the efficacy of follow-up PET/CT scanning. In this patientas case, considering the high-grade nature of the tumor, as well as the size and presence of necrosis when the tumor was first discovered, there is a high likelihood of recurrence. Information was not submitted concerning whether the initial tumor resection had clean margins. The patient has continued on chemotherapy in spite of no evidence of metastasis or residual tumor. It is unclear what markers are being followed, other than a prophylactic suspicion of recurrence. Sarcomas most commonly recur locally, although they can metastasize (most commonly) to the lungs. One prognostic sign of a likely spread of tumor is tumor necrosis, as was noted in this patient. In order to effectively screen this high risk (and young) patient with CT scanning, one would have to do multiple scans to cover the entire body. Considering the lack of pertinent research and considering the highly aggressive tumor and the fact that the patient continues on chemotherapy, it is medically appropriate to continue the current regimen with regular MRI studies and PET/CT scans. This is especially valuable considering that the patient has a good set of baseline studies. There is sufficient support for the services at issue in this clinical setting. Therefore, the PET scan performed on 4/21/20 was medically necessary for the evaluation of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

A 61-year-old male enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees prostate cancer. The physician reviewer found that currently, there is insufficient clinical data to discern whether treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques in the treatment of prostate cancer. Sheets and colleagues evaluated the comparative effectiveness of intensity modulated radiation therapy (IMRT), proton beam therapy, and conformal radiation therapy for prostate cancer. In the comparison between IMRT and proton therapy, IMRT patients had a lower rate of gastrointestinal morbidity. There were no other significant differences regarding toxicities between IMRT and proton therapy. Yu and colleagues performed an analysis of early toxicity and compared 421 patients treated for prostate cancer with proton therapy and 842 matched case controls treated with IMRT. There was a statistically significant decrease in genitourinary toxicity at six months with proton therapy; however, this difference disappeared by one year. There were no other significant differences in toxicity between the two techniques. A position statement released by American Society of Radiation Oncology (ASTRO) in 2013 stated, At the present time, ASTRO believes the comparative efficacy evidence of proton beam therapy with other prostate cancer treatments is still being developed, and thus the role of proton beam therapy for localized prostate cancer within the current availability of treatment options remains unclear. Therefore, proton beam therapy is not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 57-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. In addition, guidelines state that a High Priority for Treatment Owing to High Risk for Complications include patients with fibrosis of Metavir F2. In this case, the patient has a Metavir score of F2; hence, treatment is indicated. Therefore, Harvoni is medically necessary based on national guidelines. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

A 48-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 10/15/20. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that liquid biopsies are tests conducted on blood samples that examine biomarkers shed by tumors, such as cancer cells or pieces of tumor DNA. It is used at the time of diagnosis or with tumor recurrence, as cells shed from tumor can be detected in lieu of additional biopsy. At the time that this patient had Guardant360 testing, computed tomography (CT) scan was read as showing no evidence of metastatic disease. Continued surveillance with liquid biopsy performed at the time of documented recurrence would be more likely to yield accurate results. Therefore, Guardant360 testing performed on 10/15/20 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 2

A 21-year-old male enrollee has requested reimbursement for a PET scan performed on 7/23/19. 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 the current guidelines generally recommend surveillance scans using computed tomography (CT) or magnetic resonance imaging (MRI) every three to six months based on risk of recurrence, and more frequently within the first two years when risk of recurrence is highest (around 80%). As asymptomatic lung metastases can be resected for curative intent, surveillance imaging is recommended. Synovial tumors, such as in this patient, can recur as late as 10 years. Positron emission tomography (PET) scans have been useful in prognosis if done after neoadjuvant chemotherapy, but there is a lack of support for the use of PET scans for surveillance. PET scan for surveillance is unlikely to be more beneficial than standard imaging in patients with soft tissue sarcoma. In sum, PET scan performed on 7/23/19 was not likely to have been more beneficial than other methods of evaluating this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer  
 
The patient is a 36-year-old female who presented to her provider on 9/15/22. The patient has 
requested authorization and coverage for Acthar 80 unit/milliliter (mL) injection gel. The Health 
Plan 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 the submitted 
documentation does not support the medical necessity of the requested medication. There are 
only limited studies on the use of Acthar gel for rheumatoid arthritis. In a study of eight patients 
with refractory rheumatoid arthritis who were given repository corticotropin injections, Gillis and 
colleagues noted improvement of tender and joint swelling counts, in disease activity scores for 
rheumatoid arthritis (DAS28), and in patient global visual analog scale (VAS) scores. In a study 
including nine patients with refractory rheumatoid arthritis who had previously been on at least 
three biologic disease-modifying antirheumatic drugs (DMARDs) and did not respond to previous 
treatment, Fischer and colleagues found an improvement of DAS28 scores and in quality of life 
measured by the Health Assessment Questionnaire  Disability Index (HAQ-DI). However, both 
of these studies were limited by small sample sizes, were not placebo-controlled, and were not 
double blinded. The studies both looked at patients who had failed multiple biologics and had 
active rheumatoid arthritis with joint swelling. In this case, the records do not document that the 
patient has been on more than one biologic, or that the patient has tried and failed therapies for 
rheumatoid arthritis including DMARDs such as methotrexate, sulfasalazine, or leflunomide, 
tumor necrosis factor (TNF) inhibitors, abatacept, rituximab, tocilizumab, sarilumab, tofacitinib, 
and baricitinib. The clinical records submitted for review did not document joint swelling or 
uveitis. Given the lack of data in current medical evidence regarding Acthar as a treatment option 
for rheumatoid arthritis, the requested medication is not medically indicated. Therefore, Acthar 
80 unit/mL injection gel is not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 

The patient is a 36-year-old female who has a history of a right breast cancer.  The patient has requested authorization and coverage for Verzenio 150 mg tablets. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the patient. This denial is the subject of this appeal and determination.  The physician reviewer found that there is a lack of support for the requested medication in this clinical setting. In the trial by Johnston and colleagues, over 5,600 patients (just under one-half of whom were premenopausal women) with hormone receptor-positive, HER2-negative, high-risk early breast cancer who had completed surgery were randomly assigned to abemaciclib (Verbenio) with endocrine therapy or endocrine therapy alone. Although the studies preliminary results showed statistically significant improvement in invasive disease-free survival relative to the endocrine therapy alone group, there are no data yet available for overall survival. To date, the addition of abemaciclib to endocrine therapy in high-risk premenopausal women is not considered a standard of care. Therefore, Verzenio 150 mg tablets are not medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2


A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.The physician reviewer found there is a lack of support for the services at issue in this clinical setting.  Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab 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 adalimumab or the presence of adalimumab antibodies have an adverse effect on the clinical outcome of a patients response to treatment.  However, while there have been testimonials, there are few well-controlled clinical trials to confirm that use of the Anser ADA testing leads to improved patient outcomes or quality of life as compared to the standard method of treatment.  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 does not compare these management changes to those made in the absence of anti-drug antibody measurement.  It has not yet been established whether the use of threshold levels aids in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established.  Therefore, Anser ADA testing performed on 4/25/16 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 59-year-old male has requested authorization and coverage for CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device). 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 that there is a lack of support for the requested services in this clinical setting. This patient has pathologic acid reflux. With regards to the requested procedure, there is a lack of long-term studies with a substantial number of patients beyond one year. In addition, many patients who undergo transoral incisionless fundoplication are subsequently on proton pump inhibitor therapy for rescue therapy six months later. There is a paucity of long-term studies comparing transoral incisionless fundoplication to surgical fundoplication. Therefore, CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device) is not likely to be more effective than other treatment options. 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: Overturned

Summary Reviewer 

The parent of a 16-year-old transgender male enrollee has requested reimbursement for mental health residential treatment services provided from 9/15/14 through 10/10/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees depression, anxiety and gender dysphoria. The physician reviewer found that this patient has required various inpatient and residential treatment placements but continued to deteriorate once he was transitioned to a lower level of care. It appears that he had experienced such deterioration prior to the RTC admission at issue. The patient was dealing with complicated issues that included disclosing to his family that he was transgendered and then developing coping strategies to address his gender dysphoria. To appropriately address this patients issues and prevent relapse, continued treatment through discharge on 10/10/14 was indicated. Overall, the summary of treatment provided by the attending physician and therapist indicate that the patient was receiving appropriate medical and psychiatric treatment, and that he was benefiting from this treatment and improving. For these reasons, the mental health RTC services provided from 9/15/14 through 10/10/14 were medically necessary for treatment of this patients medical condition. In summary, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 1

A 42-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 8/29/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees melanoma. 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 testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either class 1 or 2, with class 2 melanomas having a significantly higher rate of recurrence than class 1. Gerami reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients undergoing sentinel node biopsy. Berger and colleagues reported on 156 cases, but there was insufficient follow-up to determine the real value of the assay. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear if the DecisionDx-Melanoma testing assay results can be used to make clinical decision, above and beyond the pathologic details. Therefore, DecisionDx-Melanoma testing performed on 8/29/18 was not likely to have been more effective than other methods of evaluating this patient.