Persius/hicric huggingface dataset:
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The patient is a 28-year-old female with a history of severe persistent eosinophilic asthma. She has requested authorization and coverage for Fasenra Pen. The physician reviewer found that Benralizumab (Fasenra) is a cytotoxic monoclonal antibody directed against IL-5 receptor alpha that is approved by the U.S. Food and Drug Administration (FDA) as add-on therapy in patients with severe asthma and an eosinophilic phenotype. The submitted documentation indicates that the patient has severe persistent asthma and has required several courses of oral steroids for uncontrolled asthma symptoms. The patient has been using Symbicort and Breztri, and she continues to have episodes of asthma flare-ups. Her blood eosinophil count in end of August 2021 was greater than 150 cell/ml. The provider attested that she will continue to use inhaled corticosteroids Symbicort in conjunction with Fasenra therapy. There is sufficient support for the requested medication in this clinical setting. Therefore, the requested Fasenra Pen is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

A 62-year-old male enrollee has requested reimbursement for hyaluronan injections in the knee performed on 12/13/17, 12/18/17, 12/27/17, 1/05/18 and 1/12/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees osteoarthritis. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient presented on 12/01/17 for follow-up regarding his left knee. It was noted that there was MRI evidence of tricompartmental osteoarthritis, most severe in the patellofemoral joint and a mild joint effusion. A left knee examination is not documented in the submitted medical records, and functional limitations are not discussed. Detailed evidence of a recent, reasonable and/or comprehensive nonoperative treatment protocol trial, including nonsteroidal anti-inflammatory drugs, exercise, and corticosteroid injections, and failure has not been submitted. There is evidence-based medical literature support for the use of hyaluronan acid (Supartz) injections in the treatment of significantly symptomatic osteoarthritis of the knee, when conservative treatment has failed. However, in this case, there is no clinical evidence documented to support a diagnosis of severe osteoarthritis or functional limitations discussed. Therefore, hyaluronan injections in the knee performed on 12/13/17, 12/18/17, 12/27/17, 1/05/18 and 1/12/18 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: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 


A 52-year-old male enrollee has requested authorization and coverage for Entyvio (J3490). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found Entyvio (vedolizumab) is a humanized monoclonal antibody that targets a protein called alpha-4-beta-7, an integrin on inflammatory cells that causes these cells to adhere to the gastrointestinal tract. Entyvio is specifically indicated for adults with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid. Entyvio is indicated to induce and maintain clinical response/clinical remission, achieve corticosteroid-free remission and improve the endoscopic appearance of the mucosa (UC). In a meta-analysis of biologic agents, which included vedolizumab and the TNF-inhibitors infliximab, adalimumab, and golimumab, there was no conclusive evidence that any one was more effective than any other in maintaining clinical remission in patients with moderate to severe ulcerative colitis (Danese, et al). In this case, the clinical records neither evidence a severely active flare of ulcerative colitis, nor treatment failure to conventional agents, for which vedolizumab is U.S. Food and Drug Administration (FDA) indicated. In this clinical setting, based on provided documentation Entyvio is not medically necessary for treatment of the patients medical condition. Based upon the information set forth above, 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 

The patient is a 29-year-old female with a diagnosis of juvenile onset hypophosphatasia (HPP). The patient has requested authorization and coverage for Strensiq 80 mg/0.8 ml vial. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination.  The physician reviewer found the clinical, genetics and laboratory findings of this patient are supportive of the diagnosis of HPP. Since Strensiq is the only U.S. Food and Drug Administration (FDA) approved medication that replaces deficient alkaline phosphatase and allows the patient to improve bone mineralization, which results in lower risk for further fractures, pain in the bones, muscles and chronic pain, the patient should benefit from a trial of this medication. In an open-label prospective study which included patients with perinatal-, infantile-, or juvenile-onset hypophosphatasia, enzyme replacement therapy (Strensiq) was associated with improved overall survival, ventilator-free survival, growth, and bone mineralization. A recent study that included adults showed that therapy with Strensiq was safe and provided benefit to patients, with improvements in gross motor function, muscle strength, and patient-reported functional disability over five years of treatment. Therefore, Strensiq 80 mg/0.8 ml vial is medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial 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: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 


A 58-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), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per guidelines, Harvoni is first-line therapy for treatment-naive genotype 1 patients. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). AASLD guidelines also cite data showing increased survival with earlier treatment (Jezequel, et al). For these reasons, Harvoni should be approved as 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: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 




A 24-year-old female enrollee has requested authorization and coverage for molecular pathology laboratory testing. The Health Insurer has denied this request indicating that the requested testing is not medically necessary for evaluation of the enrollees autism spectrum disorder (ASD), developmental delays and epilepsy. The physician reviewer found that according to the American College of Medical Genetics and Genomics (ACMG), whole genome/exome sequencing should be considered in the clinical diagnostic assessment of patients with a phenotype that is strongly associated with a genetic etiology. In this case, several first tier evaluations have been conducted and were non-diagnostic. Given the complex nature of the patients phenotype, physical presence of cafe au lait macules, and a concerning family history autism, whole exome/genome testing is the next logical step and is consistent with the standards of practice within the field of genetics. The combination of chromosomal microarray and whole exome/genome testing greatly increases the likelihood of a unifying diagnosis (Tammimies, et al). Given these findings, the requested molecular pathology laboratory testing is medically necessary for evaluation of this patients medical condition. Based on the foregoing discussion, the requested testing is medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 42-year-old female enrollee has requested authorization and coverage for total disc replacement. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient presents with progressively worsening neck pain that radiates into the right shoulder with right upper extremity pain and numbness. Her pain affects activities of daily living. Clinical examination findings have documented motor loss and apparent reflex changes generally consistent with imaging evidence of C4-5 and C5-6 disc pathology. She is status post prior anterior cervical discectomy and fusion at the C6-7 level. Detailed evidence of a recent, reasonable and/or comprehensive non-operative treatment protocol trial and failure has been submitted. Under consideration is a request for total disc replacement at the C4-5 and C5-6 levels adjacent to the C6-7 fusion. Although there is literature support for two-level cervical artificial disc replacement, this surgical request for a two-level artificial disc replacement adjacent to a prior cervical fusion would constitute a hybrid construct for which there is a lack of large volume, long-term peer-reviewed outcome studies. The peer-reviewed literature by Rajakumar and colleagues submitted by the provider in support of this hybrid surgery request also concludes that more data from larger numbers of patients with long-term follow-up is required to confirm the safety and efficacy of this type of hybrid construct. Therefore, the requested total disc replacement is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 42-year-old female enrollee has requested authorization and coverage for total disc replacement. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there has been a strong interest in cervical disc arthroplasty as an alternative to fusion. While comparative studies with anterior cervical fusion yield similar results, the expectation of a decrease in adjacent segment disease development in long-term studies remains in question. There is also an additional problem with the long-term implications of development of heterotopic ossification. Additional studies are required to allow for this method of treatment to be considered standard of care. These should include an evaluation of the subset of patients who will most benefit from this procedure as well as study of advantages/disadvantages of disc design and surgical procedure in terms of outcomes. Adjacent segment disease seems to be a natural aging process, and artificial disc replacement has not proven any benefit in altering that progression. In this patients case, she is status post C6-7 fusion. She has symptomatic adjacent level disc disease above the fusion at two levels, and has failed conservative management. Cervical disc arthroplasty at multiple levels is not recommended.  Given the lack of superiority and the unknown long-term complications, cervical disc arthroplasty does not currently have enough high quality supporting evidence with long-term follow-up to recommend its routine use over anterior cervical discectomy and fusion for the patients condition.  In sum, the requested total disc replacement is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 42-year-old female enrollee has requested authorization and coverage for total disc replacement. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has a history of anterior cervical discectomy and fusion at C6-7 and adjacent level degenerative disc disease with radiculopathy at C5-6 and C4-5. She has tried and failed conservative treatment, and her provider has requested total disc replacement at these levels. Hybrid surgery in the cervical spine may lead to better neck disability index recovery, less postoperative neck pain, faster cervical range of motion recovery, and less adjacent segment disease. There is support for the requested services in this clinical setting. Thus, the requested total disc replacement is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 51-year-old male enrollee has requested authorization and coverage for Octagam intravenous immune globulin (IVIG). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees bilateral upper extremity weakness and atrophy.  The physician reviewer found the records provided for review demonstrate that this patient developed progressive motor neuropathy that could be related to a variant of lower motor neuron syndrome. However, a variant of chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy or inflammatory neuropathy cannot be excluded. Considering the fact that the disease is active and progressive, a short trial of IVIG as recommended by the provider is appropriate. If the patient has an inflammatory neuropathy, he may respond to IVIG. In addition, the patients condition is active and he is losing axons. Delaying IVIG treatment in inflammatory neuropathy may limit the patients response to immunotherapy. An IVIG trial may help support or exclude the diagnosis of CIDP variant. Given this support, the requested Octagam IVIG is supported as medically necessary for treatment of this patients medical condition. 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: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 


A 56-year-old female enrollee has requested authorization and coverage for Effient. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition status post aneurysm. The physician reviewer found that Thromboembolic complications are the main problem in stent-assisted coil embolization of unruptured intracranial aneurysms. The combination of aspirin and clopidogrel is generally used to decrease these complications, but some patients do not respond to clopidogrel and have a higher risk of stent thrombosis. Clinical trials have shown that Effient reduced the incidence of ischemic events in patients with acute coronary syndrome compared with clopidogrel. Effient reduces the consequences of thromboembolic complications of endovascular treatment with stenting and coiling of unruptured intracranial aneurysms. All told, the requested Effient is medically necessary for treatment of this patients medical condition. 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: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

A 33-year-old female enrollee has requested reimbursement for the assistant at surgery for the pelvic examination under anesthesia and the laparoscopic aspiration of a cavity or cyst with biopsy performed on 3/15/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant neoplasm peritoneum and retroperitoneum. The physician reviewer found that based on the available records, there is a lack of documentation to establish the requirement for the services of the assistant at surgery during the procedure performed on 3/15/18. This procedure is the standard, recommended procedure for evaluation of a patient in this clinical setting. The operation was staffed by an attending surgeon, a resident, and a physician assistant. However, there is no documentation regarding the procedure was complex and required an assistant at surgery. The records do not report which portions of the case which were staffed by the resident or the physician assistant. All told, the assistant at surgery for the pelvic examination under anesthesia and the laparoscopic aspiration of a cavity or cyst with biopsy performed on 3/15/18 was not medically necessary for evaluation of this patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 55-year-old male enrollee has requested reimbursement for the prostate cancer antigen 3 (PCA3) gene testing performed on 1/30/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the testing at issue was not likely to be more effective for this patient than other available treatment options. The American Urological Association (AUA) National Comprehensive Cancer Network (NCCN) guidelines do not recommend use of PCA3 testing for screening or diagnosing prostate cancer. In addition, there is a lack of clinical studies demonstrating that PCA3 testing is sufficiently accurate to diagnose or exclude the presence of prostate cancer. For the reasons provided, the testing performed on 1/30/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

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