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

Summary Reviewer 3

The patient is a 45-year-old male diagnosed with amyotrophic lateral sclerosis (ALS) in 2013. The patient initially presented with right hand cramps and weakness. An electromyogram (EMG) showed extensive lower motor neuron changes. The patients provider recommends treatment with Radicava to slow decline of physical function, decrease caregiver burden and to improve quality of life. The patient has requested authorization and coverage for edaravone (Radicava). The Health Insurer has denied this request as investigational. Radicava is approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with ALS. Radicava has shown efficacy in a small subset of people with ALS who met criteria identified in post-hoc analysis of a previous phase III study, showing a significantly smaller decline of Revised ALS Functional Rating Scale (ALSFRS-R) score compared with placebo (Abe, et al). Based on the above, this patient is likely to benefit from the use of Radicava. All told, the request for Radicava is 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 medication is 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 3 
 
A  38-year-old  female  enrollee  has  requested  reimbursement  for  Guardant360  CDx  panel 
performed on 4/01/21. The Health Insurer has denied this request and reported that the services 
at issue were investigational for the evaluation of the enrollees medical condition. The physician 
reviewer found that Guardant Assay is an assay done on the patients blood, looking for DNA 
presumably of the cancer cells origin. It is generally approved in situations where tissue biopsy 
is approved, wherein tissue biopsy is not safe or feasible. Overall, the percentage of patients who 
benefit using such assays to choose a therapeutic agent appears to be small. The overall use of 
this assay to pick a treatment is not likely to be beneficial. There is at least one mutation (PIK3CA) 
that does have therapeutic indication if the patient has an estrogen receptor positive cancer that 
is no longer responding to hormonal therapy with CDK4/6 inhibition. However, there is a lack of 
support for the whole general panel. Therefore, Guardant360 CDx panel performed on 4/01/21 
was not likely to have been more beneficial for evaluation of the patients medical condition than 
any available standard therapy.
Appeal type: Medical Necessity
Decision: Overturned

Summary Reviewer  
 
The  patient  is  a  63-year-old  female  with  a  history  of  chronic  bilateral  knee  pain  due  to 
osteoarthritis. The patient has requested authorization and coverage for Synvisc-One injections. 
The Health Insurer has denied this request and reported that the requested services are not 
medically necessary for the treatment of this patient. This denial is the subject of this appeal and 
determination. The physician reviewer found that an exhaustive review of the current medical 
literature  pertaining  to  viscosupplementation  reveals  mixed  results.  Evidence  from  eight 
systematic  reviews  and  six  randomized  controlled  trials  indicates  that  although 
viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not 
known as to which individuals will benefit. Different studies have tried mixing hyaluronic acid 
with  corticosteroids,  platelet-rich  plasma,  and  other  agents  to  make  it  more  effective.  The 
guidelines from organizations such as the American Academy of Orthopedic Surgeons indicate 
that the evidence is not conclusive. In light of the foregoing, viscosupplementation can only be 
recommended in individuals with a history of lasting benefit from prior injections and in carefully 
selected cases where everything else has been tried and the options are limited. In this case, the 
patient benefitted from viscosupplementation in the past. The injections lasted six months at a time 
and were provided on multiple occasions in 2018 and 2019. Corticosteroid injections were not 
successful. Furthermore, in light of the mild degree of osteoarthritis in both knees, the patient is 
an ideal candidate for viscosupplementation. Therefore, the requested Synvisc-One injections are 
medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 3

A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata. The physician reviewer found that there is sufficient support for the requested medication in this patients case. Per the records, Xeljanz resulted in excellent regrowth of her hair. The use of Xeljanz for extensive alopecia areata and alopecia totalis has been very promising. There are currently case series in the literature and clinical trials evaluating the efficacy of this treatment on alopecia areata. There is a lack of U.S. Food and Drug Administration (FDA) approved medications for the treatment of this condition, and the use of tofacitinib has been shown to be effective in this setting. There are no other more effective therapies that can be offered as an alternative. Thus, Xeljanz 5 mg is likely to be superior over other available treatment options. Based upon the information set forth above, the requested medication is 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 2 
A 63-year-old female enrollee has requested reimbursement of liquid CDx laboratory testing by 
FoundationOne on 4/29/22. The Health Insurer has denied this request and reported that the service 
at issue was investigational for the evaluation of the enrollees lung cancer. At issue is whether 
CDx laboratory testing by FoundationOne on 4/29/22 was likely to have been more beneficial for 
evaluation of the enrollee's condition than any available standard therapy.  The physician reviewer 
found that in this clinical setting, the NCCN guidelines for the treatment of NSCLC note that next 
generation sequencing (NGS) is appropriate to detect actionable mutations for targeted treatment. 
In this case, the patient developed local recurrence along with metastatic disease to the brain. Based 
on the patients KRAS G12C mutation identified by the service at issue, a targeted treatment, 
specifically sotorasib, was identified. In a study including 928 patients with stage IV NSCLC, of 
which 295 patients underwent NGS, Al-Ahmadi and colleagues report, Patients undergoing NGS 
testing had significantly longer survival of 25.3 months versus those who did not undergo 
sequencing with a median survival of 14.6 months irrespective if they received targeted therapy or 
not. that patients In this clinical setting, the service at issue was likely to have been more 
beneficial for treatment of this patient than not utilizing NGS. In this case, while notes dated 
7/27/22 reported that the patient underwent EBUS with tissue biopsy, the records do not document  an NGS result from the tissue biopsy.  Therefore, CDx laboratory testing by FoundationOne on 
4/29/22 was likely to have been more beneficial for evaluation of the patients condition than any 
available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Summary Reviewer 


A 49-year-old female enrollee has requested authorization and coverage for breast susceptibility gene (BRCA) testing.  The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found BRCA mutations are associated with a high incidence of both breast and ovarian cancer. Being BRCA positive has several implications for measures to be considered by the patient.  With regards to breast cancer, she can consider more intense screening with magnetic resonance imaging or even bilateral mastectomies.  With regards to ovarian cancer, it is recommended that such women have bilateral salpingo-oophorectomy at the appropriate age.  Thus BRCA is a genetic test of great potential importance and value.  However, there is a lack of support for the requested services in this patients case.  U.S. Preventative Services Task Force indicates that testing is recommended for women who have a family history including three or more first-degree or second-degree relatives with breast cancer, regardless of age of their diagnosis.  Additionally, there is support for BRCA testing for patients who have a close relative diagnosed with breast cancer under the age of 50.  None of these criteria appear to apply to this patient.  All told, the requested breast susceptibility gene (BRCA) testing is not medically indicated for the evaluation of this patient.  Therefore, the requested services are 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 

The patient is a 58-year-old female with osteoporosis. The patient has requested reimbursement and prospective authorization and coverage for Prolia injections provided from 11/19/20 forward. The Health Insurer has denied this request and reported that the medication at issue was not and is not medically necessary for the treatment of this patient.  The physician reviewer found that Osteoporosis is an increasingly widespread condition. Fractures are the most dangerous aspect of osteoporosis and can lead to acute and chronic pain. A newer medication, denosumab (Prolia) is a fully human monoclonal antibody that has been approved for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and giant cell tumor of bone. Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. In this case, the patient has an increased risk of fracture, with a lowest T-score of -3.2 on 10/14/20. There is sufficient support for the medication at issue in this clinical setting. Therefore, Prolia injections provided from 11/19/20 forward were and are medically necessary for the treatment of this patient.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

The patient is a 53-year-old female who has been diagnosed with a melanoma on her thigh measuring 0.4 mm Breslow depth.  Her provider sent her tissue for molecular genetic testing to help determine the risk of spread of the tumor. The patient has requested reimbursement for the genetic testing performed on 9/15/17. The Health Insurer denied this request for reimbursement and noted that the services at issue were considered investigational for the evaluation of this patients medical condition.  The DecisionDx-Melanoma assay tests the tissue genetics of the melanoma and can stratify whether a melanoma is high risk for metastasis or not. The patients provider recommended her tissue be sent for a test called DecisionDX where the genes are examined for certain markers and then the lesion can be further stratified to tell if it is high risk for metastasis. This test has shown some accuracy determining risk of metastasis in thin thickness melanomas like this patients; however, decision-making based on the results of the test is indeterminate at this time. The treatment of this patient would not change based on the results of the examination. Moreover, this test is not considered a routine standard of care and is not currently recommended by the National Comprehensive Cancer Network (NCCN) guidelines. There is not enough published data to support its routine use.  Accordingly, the genetic testing performed on 9/15/17 was not likely to have been more effective than the available standard options for evaluating this patients medical condition.   Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 3

A 61-year-old female enrollee has requested reimbursement for Botox injections provided on 12/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees low back pain and spasms. The physician reviewer found that there is a lack of support for the services at issue in this patients case. Current evidence-based literature indicates that there is a lack of high-quality studies evaluating Botox injections for patients with low back pain and myofascial pain syndrome. There is a lack of clear evidence that the patient had been refractory to other treatments, as there is documented benefit with the custom heel lift and trigger point injections. Thus, Botox injections provided on 12/13/17 was not likely to have been more effective than other available treatment options. 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: Medical Necessity
Decision: Overturned

Summary Reviewer 


A 58-year-old male enrollee has requested authorization and coverage for Vesicare. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees nocturia. The physician reviewer found that based on the medical literature and the clinical records submitted for review, the request for Vesicare is medically necessary for treatment of the patients medical condition. In this case, the patient presents with urinary obstruction as well as overactive bladder. Treatment with Vesicare is medically indicated to relieve the patients overactive bladder symptoms. In addition, the patient reports significant improvement with Vesicare. For the reasons provided, the request for Vesicare has been established as medically necessary for treatment of the patients medical condition. Therefore, 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 66-year-old male enrollee has requested reimbursement for gene expression profiling of melanomas performed on 3/29/18.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. In sum, gene expression profiling of melanomas performed on 3/29/18 was not 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 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 3

A 49-year-old female enrollee has requested reimbursement for endometrial ablation performed on 9/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient had a history of menorrhagia. One of the first steps in this setting is to perform an endometrial biopsy to rule out a malignancy or premalignant lesion and to determine what therapy is more appropriate. The submitted records do not document that an endometrial biopsy was performed. In women aged 40 years to menopause, abnormal uterine bleeding may be due to anovulatory bleeding, which represents normal physiology in response to declining ovarian function. It also may be due to endometrial hyperplasia or carcinoma, endometrial atrophy, and leiomyomas. Prior to performing an endometrial ablation, the structure and histology of the endometrial cavity should be thoroughly evaluated, both to assess for malignancy or endometrial hyperplasia and to ensure that the length and configuration is suitable for endometrial ablation. These parameters will vary depending on the technique or system used. Endometrial sampling, typically with an outpatient technique, can be used to evaluate all women for hyperplasia or malignancy, and results should be reviewed before ablation is scheduled. In this case, the records do not adequately document the need for an ablation. In addition, no hematocrit was submitted to assess the degree of bleeding. Many conservative options can be used in this setting prior to proceeding with an ablation. Nonsteroidal anti-inflammatory drugs (NSAIDs) can reduce the amount of bleeding. Progestins and oral contraceptive pills are considered first-line treatment for abnormal, irregular or heavy bleeding. Ideally, the patient could use hormonal treatment for at least three months. If there is a failure to control the bleeding, then another option could be used. The provider stated that the enrollee did not tolerate oral contraceptives and did not respond to 10 days of a progestin. It may take more than 10 days to respond to a progestin, and there is no information when the oral contraceptives were used and what was the tolerance issue. The levonorgestrel-releasing intrauterine system has been shown to significantly reduce bleeding and cramping and may be used in the treatment for women with heavy abnormal bleeding. Tranexamic acid (Lysteda) is an antifibrinolytic taken during menstruation. It has been shown to be an effective treatment to decrease abnormal heavy uterine bleeding and improve quality of life. The patient has not tried this treatment. Therefore, there were multiple safe conservative treatment options available prior to proceeding with an ablation. Therefore, endometrial ablation performed on 9/23/20 was not likely to have been more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Overturned

Summary Reviewer 1 
 
A 28-year-old female insured has requested authorization and coverage for intravenous (IV) 
Gammagard. The Health Insurer has denied this request indicating that the requested treatment is 
considered investigational for the treatment of the insured's refractory relapsing polychondritis. 
The physician reviewer found  that relapsing polychondritis is a systemic immune-mediated 
disorder that causes inflammation and damage to cartilage-containing structures within the human 
body  (Lekpa  and  Chevalier).  Steroid-dependent,  refractory  and/or  life-threatening  relapsing 
polychondritis is an indication for immunosuppressive or immunomodulatory drug therapy in 
patients with this disorder. The current medical literature suggests that treatment options for 
patients with relapsing polychondritis include therapies such as colchicine, dapsone, methotrexate, 
cyclophosphamide, cyclosporine, azathioprine, mycophenolate mofetil, IVIG, and leflunomide 
(Petitdemange, et al.). Biologic therapies include treatments such as adalimumab, infliximab, 
tocilizumab, rituximab, and abatacept. There is a lack of data supporting the superiority of one 
particular therapy in the treatment of patients with relapsing polychondritis. In this case, the 
records provided for review reflect that the patient has already attempted and failed treatment with 
several standard therapies for relapsing polychondritis including high-dose steroids, dapsone, 
methotrexate, azathioprine, adalimumab, infliximab, abatacept, and cyclosporin. However, the 
records indicate that the patient has responded positively to IVIG. The current medical literature 
also supports a remission of refractory relapsing polychondritis with the use of IVIG. For these 
reasons, the requested IV Gammagard is likely to be more beneficial for the treatment of the 
patients condition than any available standard therapy.
Appeal type: Experimental
Decision: Upheld

Summary Reviewer 2

The parent of a four-year-old male enrollee has requested reimbursement for the polymerase chain reaction (PCR) testing and homocysteine testing performed on 6/4/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk for methylenetetrahydrofolate (MTHFR), Factor V Leiden, and homocysteine mutations. The physician reviewer found that the American College of Medical Genetics (ACMG) recommends against testing for MTHFR polymorphisms in any patients, including patients with relatives with known MTHFR polymorphisms. There is no risk associated with the A1298C polymorphism in the heterozygous or homozygous state. Further, it could have been predicted that this patient would have at least one copy of A1298C, as his mother is homozygous. The ACMG guideline indicates that testing of homocysteine is reasonable only in patients with two copies of the C677T polymorphisms, though this is not possible for this patient based on his mothers testing. The ACMG additionally has prepared guidelines on Factor V Leiden testing, which do not suggest testing for this patient. Accordingly, the PCR testing and homocysteine testing performed on 6/4/16 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 3

A 60-year-old female enrollee has requested reimbursement for laboratory services provided on 8/15/19. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that this patient has advanced ovarian cancer. She has been appropriately treated with debulking surgery and will likely receive multi-agent chemotherapy that includes cisplatin. Thereafter, she will need close follow-up to identify recurrence. According to the NCCN guidelines, it will be important to know the presence of germline or somatic mutations in BRCA1 and/or BRCA2. She may be offered maintenance therapy based upon mutation status. She may also be eligible for clinical trial based on her mutational status. Therefore, laboratory services provided on 8/15/19 were likely to have been more beneficial than other available standard therapy.