Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for an implantable peripheral nerve stimulation device. While there are many studies evaluating the use of peripheral nerve stimulation, only a handful address peripheral nerve stimulation for the treatment of low back pain. Studies performed by Gilmore and colleagues as well as by Cohen and colleagues appear to be based on the same cohort of nine subjects. Issues with these two studies include a limited number of subjects, the lack of a control group for comparison of efficacy, and numerous conflicts of interest including two of the authors having consulted for the manufacturer and two authors being employees of the manufacturer. Despite a thorough literature review, there is a lack of studies in current medical literature with a control group demonstrating improvement in axial low back pain with the requested device when compared with standard treatment options. Therefore, an implantable peripheral nerve stimulation device is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested implantable peripheral nerve stimulation 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 anesthesiology with sub-specialty certification in pain medicine and are actively practicing. Physician reviewer 2 is board certified in physical medicine and rehabilitation with sub-specialty certification in pain 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: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for vitamin D screening. Findings:  The physician reviewer found that The clinical manifestations of vitamin D deficiency depend on the severity and duration of the deficiency, with the majority of patients with moderate-to-mild vitamin D deficiency being asymptomatic. Severe Vitamin D deficiency may result in hypocalcemia and bone disorders.   Patient groups at risk for Vitamin D insufficiency may include those taking medications that accelerate the metabolism of vitamin D, those hospitalized or institutionalized with limited effective sun exposure, or those who have dark skin, obesity, osteoporosis, or malabsorption, including inflammatory bowel disease and celiac disease.  Rockwell and colleagues report that no clear evidence supports vitamin D screening to improve health outcomes and that vitamin D screening of the general population is not recommended. LeBlanc and colleagues note that testing for vitamin D deficiency is conducted using 25-hydroxyvitamin D assays. Such testing may be appropriate for patients at high risk for vitamin D deficiency to determine whether supplements are needed. In this case, given that the records do not reflect that the patient has chronic medical conditions that would cause vitamin D deficiency or symptoms that are concerning for Vitamin D deficiency, the service at issue was not medically indicated. Therefore, vitamin D screening was not medically necessary for the evaluation of this patient.Final Result: The reviewer determined that the service at issue was not medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in internal medicine 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 authorization and coverage for AMONDYS 45 (casimersen), 30 mg/kg once weekly infusions. Findings:  The physician reviewer found that In a study of the safety and tolerability of casimersen in 12 patients with advanced Duchenne muscular dystrophy (DMD) who were nonambulatory or unable to tolerate a six minute walk test, Wagner and colleagues found no tolerability issues related to the medication. The U.S. Food and Drug Administration (FDA) approves the use of Amondys 45 based on an increase in dystrophin, a protein that helps keep muscle cells intact, production in skeletal muscle observed in patients treated with the therapy. It is indicated for the treatment of DMD in patients with a confirmed mutation of the DMD gene that is amenable to exon 45 skipping. Wilton-Clark and Yokota report that while no cure currently exists for DMD, casimersen targets exon 45 of the dystrophin gene and is expected to treat approximately eight percent of the DMD patient population. While there are no results from phase 3 trials available as clinical trials are ongoing, the medication has been FDA approved under its Accelerated Approval Program, which allows for the approval of drugs for serious conditions where there is an unmet medical need, and a drug is shown to have certain effects that are reasonably likely to predict a clinical benefit to patients. In the absence of other disease modifying therapies for this rare but ultimately fatal disease, the requested medication is more likely to beneficial than other available standard treatments in this clinical setting to preserve this patients motor and cardiac function. Therefore, AMONDYS 45 (casimersen), 30 mg/kg once weekly infusions, is 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 AMONDYS 45 (casimersen), 30 mg/kg once weekly infusions, are 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 services are likely to be 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 and 2 are board certified in neurology with sub-specialty certification in vascular neurology.  Physician reviewer 3 is board certified physical medicine and rehabilitation with sub-specialty certification in pain 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: Upheld Decision of Health Plan

Findings:  The physician reviewer found that The patient has requested authorization and coverage for acupuncture services. Urits and colleagues state, Many studies have been done, and most show promising results for acupuncture as an alternative treatment for low back pain. Following an acupuncture trial of five or six sessions, additional acupuncture treatments should only occur based on progressively greater, incremental objective gains. Acupuncture should be combined with active care, such as conditioning, aerobics, and/or a stretching exercise program. Indications for care discontinuation include resolution, intolerance, lack of measurable improvements, or non-compliance including non-compliance with aerobic and strengthening exercises. In this case, while the patient reported benefits from prior acupuncture, the records did not document pre-acupuncture and post-acupuncture baselines for comparison purposes, and measurable, progressive, significant, or objective functional improvement. The documentation did not demonstrate a flare-up or extraordinary circumstances to be addressed in additional sessions and did not include a physical examination with clinical findings including the motor, sensory, and functional deficits to be addressed by the requested care. The records did not document that the patient was undergoing an independent exercise program. Given that measurable, progressive, significant, objective functional improvement has not been documented, the requested services are not medically indicated. Therefore, acupuncture services are not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Fiasp (insulin aspart injection) 100 U/mL. The records provided for review indicate that this patient has a history of type 1 diabetes that has been managed with insulin therapy. Treatment with Novolog and Humalog was not reportedly as effective as treatment with Fiasp. The patients provider has recommended treatment with Fiasp. Continuous subcutaneous insulin infusion or insulin pump therapy is an advanced method of insulin administration that has the potential to improve glycemic control compared with multiple daily injection regimens. Glycemic control might be further enhanced by combining pump therapy with an insulin that has pharmacokinetic and pharmacodynamic profiles that more closely match physiological insulin secretion and reduce postprandial glucose excursions without increasing hypoglycemia risk (Warren, et al.). Fiasp is a fact acting insulin aspart that was designed to mimic the physiologic prandial insulin release more closely than the currently available rapid-acting insulin products (Paquot and Scheen). Recent data suggests that the use of Fiasp may reduce hypoglycemia in an insulin pump system without compromising glucose control when compared with standard insulin aspart in patients with type 1 diabetes (Boughton, et al.). Given this support, the requested Fiasp (insulin aspart injection) 100 U/mL is 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. 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: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for autologous chondrocyte implantation of left knee.Findings:  The physician reviewer found that his patient is being treated for chondromalacia of the left patella and deficiency of anterior cruciate ligament. The patient is status post left knee arthroscopy with chondroplasty of the medial femoral condyle and trochlea. The patient autologous chondrocyte implantation of the left knee. Gou and colleagues concluded the pooled analysis found no significant difference in the improvement in International Knee Documentation Committee or Lysholm scores or overall Knee Injury and Osteoarthritis Outcome Score measures between patients in the autologous chondrocyte implantation versus microfracture groups at one to five years of follow-up. However, there is a lack of published, large-scale, long-term peer-reviewed literature demonstrating that autologous chondrocyte implantation is safer and/or more effective in the treatment of this patients pathology than standard therapies. In addition, detailed documentation is not reported regarding ongoing symptoms or clinical examination findings to support an indication for the requested surgical intervention. All told, the requested autologous chondrocyte implantation of left knee is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings: Two of the three physician reviewers found the requested autologous chondrocyte implantation of left knee 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 services are 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 reviewer 1 is board certified in orthopedic surgery and is actively practicing. Physician reviewer 2 is board certified in orthopedic surgery and is actively practicing. Physician reviewer 3 is board certified in orthopedic surgery 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: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Findings:  The physician reviewer found that An enrollee has requested authorization and coverage for lymphovenous bypass surgery. Without effective treatment, extremities with lymphedema, in addition to the distressing symptoms and disfigurement, are subject to recurring episodes of cellulitis often requiring hospitalization. Over the last decade, microsurgical lymphovenous anastomosis for patients with relatively early disease and vascularized lymph node transfer for patients in later stages have become an accepted treatment for symptomatic lymphedema of the upper extremity after breast or axillary operations. On review of the peer-reviewed medical literature, lymphovenous bypass surgery has been shown to result in substantial objective improvement in circumference and similar relief of symptoms in this patient population (Scaglioni, et al.). For these reasons, the requested lymphovenous bypass surgery is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Findings: Two of the three physician reviewers found the requested lymphovenous bypass surgery is 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 services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. 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 vertical sleeve gastrectomy. Findings:  The physician reviewer found that the records noted a body mass index (BMI) of 40.04 kg/m2. The patient had lost six pounds in preparation for surgery. The records included a comprehensive multidisciplinary evaluation that did not reveal any obvious dietary or behavioral concerns. Given that patients should be evaluated at their starting weight and not penalized for optimizing with preoperative weight loss in preparation for metabolic and bariatric surgery, this patient met the criteria for bariatric surgery based on her initial BMI. The requested service is medically indicated. Therefore, a vertical sleeve gastrectomy is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested service 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 general 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: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for transcatheter closure of a patent foramen ovale using a cardiac occlusion device. While current medical literature supports patent foramen ovale (PFO) closure as superior to antiplatelet therapy for preventing future ischemic events, the patients selected for clinical trials comparing PFO closure to antiplatelet therapy all had evidence of definite ischemic infarcts. In this case, the patient had only clinical symptoms and the records did not include evidence to support a diagnosis of cryptogenic stroke. In this clinical setting, there is a lack of evidence in current medical literature to determine if antiplatelet therapy alone may be superior or equal to PFO closure. PFO closure may be appropriate if there are recurrent symptoms or if the patient experiences another a transient ischemic attack while on antiplatelet therapy in the absence of any other etiology such as paroxysmal atrial fibrillation. Therefore, transcatheter closure of a patent foramen ovale using a cardiac occlusion device 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 transcatheter closure of a patent foramen ovale using a cardiac occlusion 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 service 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 2 are board certified in internal medicine with sub-specialty certification in cardiovascular disease and are actively practicing. Physician reviewer 3 is board certified in internal medicine with sub-specialty certifications in cardiovascular disease and in adult congenital heart disease 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: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for advanced lipoprotein testing. There is a lack of clinical studies in current medical literature demonstrating that strategies to correct the residual risk potentially identified by novel lipoprotein testing, such as the service at issue, will further reduce cardiac risk. It remains unclear if that such testing adds significant actionable information to what is already known from a fasting lipid panel. Researcher notes that while some practitioners use advanced lipoprotein analysis with the goal of better predicting risk and individualizing lifestyle and drug therapy for cardiovascular prevention, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) particle number and size, other lipoprotein subfractionation, apolipoproteins (apo) B and A, and lipoprotein(a) have not yet met current standards for biomarker evaluation, and it remains to be determined whether these tests incrementally add to cardiovascular risk predicted by traditional risk factors. Medical literatures report that only slight reclassification improvements in risk assessment are realized by adding apoB or lipoprotein(a) to conventional risk factors. In this clinical setting, there is insufficient evidence to support the use of the service at issue, particularly given this patients borderline risk. Therefore, advanced lipoprotein testing was not likely to have been more beneficial for evaluation of the patients condition than any available standard therapy.Findings:  Three of the three physician reviewers found the advanced lipoprotein testing at issue was not 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 not 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 upheld. Credentials/Qualifications: Physician reviewers 1 and 3 are board certified in internal medicine with sub-specialty certification in cardiovascular disease and are actively practicing. Physician reviewer 2 is board certified in internal medicine with sub-specialty certifications in cardiovascular disease and in adult congenital heart disease 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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Synvisc One injection in the left knee. Evidence from systematic reviews and randomized controlled trials indicate that although viscosupplementation may relieve knee pain in some patients with osteoarthritis, data has not established which patients will benefit. Guidelines from the American Academy of Orthopedic Surgeons (AAOS) indicate that the data on safety and efficacy of viscosupplementation remain inconclusive. As such, the AAOS does not currently recommend viscosupplementation as routine treatment for osteoarthritis of the knees. Viscosupplementation is reserved for patients with a history of lasting benefit from prior injections and in cases where the remaining options are limited. In this case, the patient has a history of good pain relief from viscosupplementation using Synvisc One injection of the left knee for treatment of osteoarthritis. Moreover, the patients symptoms have not substantially improved despite treatment with non-steroidal anti-inflammatory drugs (NSAIDs) and physical therapy. All told, the requested Synvisc One injection in the left knee is medically necessary for 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.