Persius/hicric huggingface dataset:
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Omnipod insulin pump. Findings:  The physician reviewer found that Type 1 diabetes is a chronic autoimmune disease characterized by insulin deficiency and resultant hyperglycemia. Without proper control, this condition may lead to microvascular complications. Despite advances in technology, glycemic control for most patients with type 1 diabetes is not optimized. Insulin therapy is essential to regulate blood glucose levels for patients with type 1 diabetes. Subcutaneous insulin administration via hypodermic injection or pump-mediated infusion are the available routes for insulin delivery. Recent data suggests that insulin pump use is associated with improved metabolic control, less glucose variability, less hypoglycemia, and improved quality of life, when compared to multiple daily injections of insulin . This patient has managed her glycemic control well on insulin pump therapy since 2015. Given the recommendations in the current medical literature, use of the Omnipod insulin pump is appropriate for continued management of her type 1 diabetes. All told, the requested Omnipod insulin pump is medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested equipment is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with subspecialty certification in endocrinology, diabetes, and metabolism and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patients parent has requested authorization and coverage for Motegrity (2 mg tablets, 30 tablets per 30 days). Motegrity is a medication that is U.S. Food and Drug Administration (FDA) approved for the treatment of motility in the gastrointestinal tract in patients 18 years of age and older. In an open-label pilot study, Motegrity demonstrated a favorable effect on stool frequency, stool consistency, and fecal incontinence frequency in children with functional constipation (Winter, et al.). However, in a multicenter randomized controlled clinical trial including 213 children with functional constipation, Motegrity was found to be less effective in increasing stool frequency and decreasing fecal incontinence frequency when compared to placebo (Mugie, et al.). Overall, there is a lack of data demonstrating the safety and efficacy of Motegrity in the pediatric patient population. Thus, Motegrity is not expected to decrease this patients likelihood of having obstructive symptoms. All told, the requested Motegrity (2 mg tablets, 30 tablets per 30 days) is not medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in pediatrics with subspecialty certification in pediatric gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Findings:  The physician reviewer found that The patients parent has requested authorization and coverage for Valtoco (diazepam 5 mg nasal spray). Connolly describes Dravet syndrome as one of the most severe epilepsy syndromes of early childhood and explains that it is associated with mutations in the sodium channel alpha1 subunit gene (SCN1A) in 70% to 80% of individuals, resulting in inhibition of the GABAergic inhibitory interneurons and leading to excessive neuronal excitation. Shmuely and colleagues report that Dravet syndrome is characterized by high epilepsy-related premature mortality and a marked young age at death. The authors further reported that in 177 published cases of death in children with Dravet syndrome, 56 deaths (or 32%) were a result of status epilepticus, and that 73% of the deaths occurred before age ten.  Cloyd and colleagues note that seizure clusters must be treated quickly and effectively to prevent progression to prolonged seizures and status epilepticus. The authors further note that rescue therapy for seizure clusters focuses on the use of benzodiazepines. The authors found that the diazepam nasal spray safety profile is consistent with that expected for rectal diazepam, with low rates of nasal discomfort. In this case, the patient has frequent, prolonged episodes of seizure clusters due to Dravet syndrome. The patient has responded poorly to repeated doses of intranasal midazolam and oral clonazepam and is at risk of life-threatening status epilepticus. In this clinical setting, given that current medical literature supports the use of the requested medication and as it has been recommended by the provider, the requested medication is medically indicated. Therefore, Valtoco (diazepam 5 mg nasal spray) is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for bilateral Euflexxa injections. Per the medical literature, although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not known as to which individuals will benefit. The current evidence is limited, and 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 has tried and failed management with arthroscopic surgery and corticosteroid injections. Given the patients limited options and based on the current medical literature, the requested services are medically indicated. Therefore, bilateral Euflexxa injections are medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for a SpaceOAR Hydrogel procedure. Current medical literature supports the use of the requested service in this clinical setting to minimize the risk for high grade radiation induced urinary, bowel, and sexual morbidity. Medical literatures report in a randomized prospective clinical trial, The randomised controlled trial in image-guided intensity-modulated radiotherapy demonstrated that SpaceOAR reduces rectal radiation dose and late gastrointestinal and genitourinary toxicities, with urinary, bowel and sexual quality-of-life improvement. These advantages were verified in observational studies in various radiotherapy types.` The National Comprehensive Cancer Network (NCCN) guidelines for the management of prostate cancer endorse the incorporation of SpaceOAR in conjunction with delivery of definitive radiotherapy. Therefore, the SpaceOAR Hydrogel procedure was likely to have been more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the SpaceOAR Hydrogel procedure was likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the service at issue was likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in radiation oncology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Findings:  The physician reviewer found that An enrollee has requested authorization and coverage for a transoral incisionless fundoplication (TIF) procedure using EsophyX.Findings: Two out of three physician reviewers found that transoral incisionless fundoplication (TIF) is an endoscopic procedure performed under general anesthesia to create a full-thickness serosa-to-serosa plication that is 3 to 5 cm in length and 200 to 300 degrees in circumference. TIF can be performed in patients with typical GERD symptoms, and no or only small hiatal hernia, and the patient in this case meets these criteria. TIF has been compared with PPI therapy in several randomized trials (Witteman, B., et al.). In the latest trial (TEMPO), 63 patients with GERD that was refractory to PPI received TIF versus maximum standard dose PPI therapy (Trad, K., et al., 2015). At six months, both regurgitation and extraesophageal symptoms were eliminated in more TIF than PPI patients (62 vs 5 %). After six months, all patients randomized to PPI elected to cross over to TIF. At three years, 90 % (37/41) of patients reported elimination of troublesome regurgitation (Trad, K., et al., 2017). At five years, regurgitation was eliminated and resolution of troublesome atypical symptoms was achieved in 80 percent of patients, and the average total GERD health-related quality of life score improved from 22.2 to 6.8 (Trad, K., et al., 2018). The data from these randomized trials is convincing. Thus, the requested transoral incisionless fundoplication (TIF) procedure using EsophyX is likely to be more beneficial than any other available standard therapy for the enrollee's condition.Final Result: The reviewers determined that the requested services are likely to be more beneficial than any other available standard therapy for the patient's condition. Therefore, the Health Plans denial should be overturned
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a MyoPro Motion G orthotic device. There is a lack of evidence in current medical literature supporting the use of the requested device following a cerebral event, such as stroke, in assisting a patient with  regaining neurological or muscular strength or function, such as the innate ability to use the arm for functional tasks when the orthosis is removed. The available medical literature regarding the potential of the device is limited and does not establish proven health outcomes, such as reduction in the incidence of overuse injury of the sound, unaffected limb. Recent and current literature regarding the potential of the device to improve strength or function is limited to anecdotal literature and small trials, including industry-supported trials, with larger trials either in progress or planned.  Researchers note that rehabilitation efforts to reduce shoulder subluxation in post-stroke hemiparesis should aim to support and suspend the shoulder and arm weight. Due to its weight, the requested device may cause the shoulder to sublux and result in greater instability for a patient with hemiparetic gait by displacing the center of gravity. In this case, the patient is noted to have chronic weakness of the arm following a stroke in 2013. In this clinical setting, the weight of the requested device would make it difficult for the patient to position his upper extremity for purposeful use of the device. The requested device is not proven to enhance or replace the role of conventional orthoses and is not expected to provide clinically or functionally significant marginal benefits over conventional orthotic therapy. Therefore, a MyoPro Motion G orthotic device is not likely to be more beneficial for treatment of the patient's condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested MyoPro Motion G orthotic device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1 and 3 are board certified in physical medicine and rehabilitation and are actively practicing. Physician reviewer 2 is board certified in physical medicine and rehabilitation with sub-specialty certification in neuromuscular medicine and is actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Findings:  The physician reviewer found that The patients parent has requested authorization and coverage for outpatient intravenous immunoglobulin (IVIG) infusions (2 gram/kg administered twice a day, given every four weeks). The utilization of IVIG in this patient is consistent with the recommendations in the current medical literature (Kinsella, et al.). There are multiple case reports and reviews that have demonstrated evidence of clinical improvement in patients with autoimmune encephalitis treated with IVIG. Abboud and colleagues noted that IVIG is a relatively easy-to-use and timely option for fast immunomodulation when corticosteroids are contraindicated or when the clinical picture is suggestive of or known to be related to antibody-mediated disease. The records provided for review document that this patient has failed conservative therapies for treatment of relapsing and remitting mood changes with a diagnosis of autoimmune encephalitis. The patients autoimmune encephalitis has already responded well to treatment with IVIG, and the patient is a candidate for additional treatment. All told, the requested outpatient IVIG infusions (2 gram/kg administered twice a day, given every four weeks) are medically necessary for treatment of this patient.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Findings:  The physician reviewer found that  An enrollee has requested authorization and coverage for Lumakras. In this case, the patient has disease progression despite an aggressive clinical course on standard folinic acid, fluorouracil, and oxaliplatin (FOLFOX) and folinic acid/fluorouracil/irinotecan (FOLFIRI). KRAS is one of the most frequently mutated oncogenes in colorectal cancer. Sotorasib (brand name Lumakras) is an inhibitor of the mutated KRAS proteins. Blair notes that the U.S. Food and Drug Administration (FDA) approves the use of sotorasib in adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. The drug is not currently approved by the FDA for the treatment of colorectal cancer. In a phase 2 clinical trial, Hong and colleagues found that the drug had encouraging activity in heavily pre-treated patients with advanced solid tumors including non-small cell lung cancer (NSCLC). The authors noted that in a study of the efficacy of sotorasib on a subgroup of 42 patients with colorectal cancer, 7.1% (or 3 patients) had a confirmed response, and 73.8% (or 31 patients) had disease control. While studies are ongoing, a response rate of 7% does not suggest a significant clinical response to sotorasib in the context of colorectal cancer. In this case, the patient has a confirmed targetable mutation in KRAS, and it makes logical sense to use this new drug based on its mechanism of action. At this point, however, the clinical evidence for the use of sotorasib in colorectal cancer is very preliminary and does not justify its routine use. Therefore, Lumakras is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested Lumakras is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Findings:  The physician reviewer found that An enrollee has requested authorization and coverage for Qulipta. Calcitonin gene-related peptide (CGRP) plays a crucial role in migraine pathophysiology and has been established as an important target for both preventive and acute treatments (Edvinsson, et al.). Per the American Headache Society (AHS), Aimovig is an injectable monoclonal antibody targeting the CGRP receptor. Ubrelvy is an oral CGRP inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2019. Ubrelvy is indicated for the acute treatment of migraine with or without aura in adults. In a case report study, Mullin and colleagues concluded that concomitant use of Nurtec and Ubrelvy may involve additive effects and may be generalizable to other combinations of anti-CGRP agents with distinct molecular targets. In this case, the patient has a history of migraines that have not responded to multiple oral abortive and preventative medications. However, there is a lack of studies available that suggest the addition of Qulipta to a preventative anti-CGRP receptor antibody provides any clinical benefit. Therefore, the requested Qulipta is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings:  Three of the three physician reviewers found the requested Qulipta is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for proton beam radiation therapy and SpaceOAR Hydrogel procedure.The medical literature does not support proton beam radiation therapy in this setting. Proton radiation is not proven to yield superior clinical outcomes as compared to standard of care treatment options (e.g., prostatectomy or intensity modulated radiation therapy (IMRT) +/- brachytherapy boost) in the treatment of non-metastatic prostate cancer. The American Society for Therapeutic Radiology and Oncology (ASTRO) Model Policy for proton radiation does not support its use for primary treatment of prostate cancer outside the context of a prospective clinical trial or registry. Proton radiation is the subject of ongoing clinical trials to define its role for management of prostate cancer. There are some reports which indicate a possible higher rate of gastrointestinal (GI) toxicity with proton radiation, so caution is warranted until the results of high quality prospective clinical trials are published. Accordingly, the requested proton beam radiation therapy is not medically necessary to treat the patients medical condition.There is sufficient support for the requested SpaceOAR Hydrogel procedure in this patients case. SpaceOAR would be medically necessary if delivered in conjunction with other radiation modalities, such as IMRT and brachytherapy. SpaceOAR is proven to minimize the risk for radiation-induced bowel, urinary, and sexual complications. SpaceOAR is routinely utilized for similar patients receiving definitive non-proton beam radiotherapy. Therefore, the requested SpaceOAR Hydrogel procedure is medically necessary for the treatment of this patient. Final Result: The reviewer determined that a portion of the requested services is medically necessary to treat the patients medical condition. Specifically, the requested SpaceOAR Hydrogel procedure is medically necessary for the treatment of this patient. Therefore, the Health Plans denial should be partially overturned.Credentials/Qualifications: The reviewer is board certified in radiation oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.