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

Findings:  The physician reviewer found that The patient has requested authorization and coverage for diclofenac 3% gel. This patient is being treated for meniscal tear in right knee and right knee osteoarthritis. MRI of the right knee demonstrated a complex tear of the medial meniscus, discoid lateral meniscus complex, and chondral degenerative changes. The patients provider has recommended treatment with diclofenac 3% gel. Regarding the use of topical nonsteroidal anti-inflammatory drugs (NSAIDs), Barkin stated, NSAIDs are widely used in the treatment of pain associated with a variety of indications, including arthritic conditions, but their usefulness is often limited by dose-dependent adverse events (AEs), such as gastrointestinal disturbances, cardiovascular events, and renal toxicity. The risk of such effects could be reduced by the use of topical formulations, which offer the potential to deliver analgesic concentrations locally, at the site of inflammation, while minimizing systemic concentrations. The topical preparations currently approved in the United States are diclofenac sodium 1.5% topical solution (containing dimethyl sulfoxide as a penetration enhancer), diclofenac sodium gel 1%, and a diclofenac hydroxyethylpyrrolidine 1.3% patch. Each of these topical NSAIDs provide drug delivery to subcutaneous tissues for the management of pain associated with osteoarthritis or soft-tissue injuries. In addition, Derry and colleagues reported, Topical NSAIDs provided good levels of pain relief in acute conditions such as sprains, strains and overuse injuries, probably similar to the results provided by oral NSAIDs. However, in this case, the provider has requested the use of diclofenac topical gel 3%. This diclofenac formulation is U.S. Food and Drug Administration (FDA) approved only for the treatment of actinic keratosis, which is a precancerous lesion of the skin. There is a paucity of published large-scale, long-term peer-reviewed medical literature demonstrating that diclofenac 3% gel is effective and safe for the treatment of patients with osteoarthritis. All told, the requested diclofenac 3% gel 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.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Findings:  The physician reviewer found that The patient has requested authorization and coverage for admission to a skilled nursing facility. Alexiou and colleagues note that hip fractures are known to substantially impact functional performance and negatively impact both short-term and long-term health-related quality of life. This condition generally requires skilled rehabilitation services to optimize outcomes, including mobility and self-care abilities.  Skilled rehabilitation services can be provided in various settings, including the inpatient, home, or outpatient setting. Recent research has shown that community-based home and outpatient rehabilitation can be as effective as inpatient rehabilitation for this condition. Freitas and colleagues report that both outpatient and home-based rehabilitation seem to be reasonable options for hip fracture rehabilitation. In this case, the patient sustained an acute right hip fracture at the femoral neck due to a ground level fall while hiking without other significant injuries. The patient underwent hip fracture surgery without complications. Postoperatively, the records noted some mild orthostatic hypotension that resolved.  The patient participated in therapies and improved to ambulating up to 800 feet with a walker at the supervision/stand by assistance level without loss of balance.  He was negotiating 12 stairs using a railing at a supervision/stand by assistance level.  He was able to return to and was discharged to the community. In this case, while the patient is expected to have a long recovery course due to the condition, given that current medical literature does not support a significant difference in functional course or outcomes with the service in question versus community-based and ambulatory care, the requested service is not medically indicated. Therefore, admission to a skilled nursing facility is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested service is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Strensiq (asfotase alpha) 80 mg/0.8 mL vials = 9.6 mL (12 vials) x 28 days, and Strensiq (asfotase alpha) 80 mg/0.45 mL vials = 5.4 mL (12 vials) x 28 days. Findings:  The physician reviewer found that submitted documentation does not support the medical necessity of the requested medication, which is used to stabilize skeletal abnormalities, and is not indicated for chronic pain. The records did not demonstrate clinical signs and/or symptoms of hypophosphatasia, such as skeletal deformities or juvenile onset, or a diagnosis confirmed by the presence of a known pathological mutation in the ALPL gene, or of skeletal abnormalities demonstrated on radiographic imaging. In this case, while the patient has chronic pain, the records do not document a history of juvenile onset or of recurrent fracture. Therefore, Strensiq (asfotase alpha) 80 mg/0.8 mL vials = 9.6 mL (12 vials) x 28 days, and Strensiq (asfotase alpha) 80 mg/0.45 mL vials = 5.4 mL (12 vials) x 28 days are not medically necessary for the treatment of this patientFinal 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 internal medicine with sub-specialty certification in rheumatology 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 patient has requested authorization and coverage for positron emission tomography/computed tomography (PET/CT) of the breasts and/or magnetic resonance imaging (MRI) of the breasts. Per Sharma and colleagues, patients with Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) have been found to present with rapid and dramatic (breast) swelling as a result of peri-prosthesis effusion (85%) or as a palpable mass (15%) adjacent to the prosthesis in the affected breast. Rupani and colleagues recommend focused ultrasound as a first-line imaging modality to evaluate for possible peri-implant effusion. Sharma and colleagues also reported that focused ultrasound is appropriate for assessing breast masses associated with BIA-ALCL as well as skin edema. The authors stated that PET/CT can be utilized in the perioperative state to assess for distant metastatic disease in patients with established diagnosis of BIA-ALCL but is not an ideal first-line imaging as it can lead to false positive and negative results. Breast MRI is an accurate imaging modality which may be utilized when ultrasound is equivocal for assessing breast effusion or mass. The American College of Radiology (ACR) appropriateness criteria states that it is usually appropriate to assess patients between the ages of 30-39 with nipple discharge, pain, and palpable breast abnormality with diagnostic mammography and sonography. Although this patient has documented exposure to textured breast implants, the records do not document that any clinically concerning features for BIA-ALCL were found on physical examination such as breast edema or rapid breast enlargement. Moreover, nipple discharge is not a clinical feature associated with BIA-ALCL. The patients symptoms of right breast pain and palpable abnormality were appropriately evaluated with focused ultrasound and diagnostic mammography, which failed to reveal any suspicious findings, effusions, or mass concerning for BIA-ALCL. For these reasons, the requested PET/CT of the breasts and MRI of the breasts are not medically necessary for evaluation 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. Credentials/Qualifications: The reviewer is board certified in radiology with subspecialty certification in diagnostic radiology 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 patient has requested reimbursement for magnetic resonance imaging (MRI) of the left hand, MRI of the left wrist, MRI of the right ankle, and MRI of the right foot. Findings: The American College of Radiology (ACR) indicated that MRI can be beneficial in specific circumstances after baseline x-rays have been obtained. On review of the ACR criteria, this patients records do not support the MRI studies performed on the left hand and wrist, or MRI of the right ankle and foot as medically necessary. There is a lack of documentation that the patients physical examination had joint-specific provocative orthopedic examination findings, which are reported as one of the ACR appropriate use criteria requirements. Although MRI studies can be used for evaluation of known or suspected autoimmune disease, the patients prior x-rays did not demonstrate any abnormality or non-diagnostic findings to require additional assessment with MRI. Moreover, the records fail to document participation in physical therapy or other non-operative treatments prior to the MRI studies being performed. All told, the MRI of the left hand, MRI of the left wrist, MRI of the right ankle, and MRI of the right foot were not medically necessary for evaluation of this patient. Final Result: The reviewer determined that the services at issue were 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 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: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Uceris rectal foam (dosed at 2 mg administered twice daily). This patients records document findings consistent with distal ulcerative colitis. The patients provider has recommended treatment with Uceris rectal foam 2 mg twice daily. The American Gastroenterological Association (AGA) guidelines recommend Uceris rectal corticosteroid therapy for the treatment of patients with distal ulcerative colitis. Researchers found that Uceris rectal foam was well tolerated and more efficacious than placebo in inducing remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis. In addition, medical literature reported that more patients receiving twice-daily administration of Uceris foam achieved complete mucosal healing when compared with once-daily administration and placebo. Medical literature concluded that Uceris foam induced complete mucosal healing in patients with mild-to-moderate ulcerative colitis (UC) in a phase 3 study. Given this support, the requested medication regimen, Uceris rectal foam (dosed at 2 mg administered twice daily) 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 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 infusion treatments of vedolizumab (Entyvio) at a dose of 140 mg (6 mg/kg/dose) at zero, two, and six weeks, then every eight weeks. The recommended medical therapies for the management of this patients moderate-to-severe ulcerative colitis include adalimumab, ustekinumab, and either certolizumab or golimumab. On review of the patients records, treatment with adalimumab, certolizumab, and golimumab is not recommended. Based on the U.S. Food and Drug Administration (FDA) approval, the patients age does not support treatment with biologics other than infliximab and adalimumab. Given the patients primary non-response to infliximab, treatment with a different anti-tumor necrosis factor (TNF) agent is not likely to yield positive results. Furthermore, there is a lack of data on the use of ustekinumab or vedolizumab in the patients in the pediatric population. In a multicenter cohort study of 52 young patients with inflammatory bowel disease, including 22 with ulcerative colitis, 42% of patients with previous anti-TNF failure were in remission at week 14 following treatment with Entyvio (Singh, et al.). Given these findings, the requested infusion treatments of vedolizumab (Entyvio) at a dose of 140 mg (6 mg/kg/dose) at zero, two, and six weeks, then every eight weeks are medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested medication regimen 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 functional neuromuscular electrical stimulation ergometer (RT300-FES Therapy System). The records provided for review document that this patient sustained a complete mid-thoracic level traumatic spinal cord injury. The mainstay of rehabilitation and long-term management for this patient population focuses on functional restoration at a manual wheelchair level and on health maintenance including pain management, tone management, and preventive clinical care (Ong, et al.). In addition, active exercise and participation in educational, social, recreational, and vocational activities should be encouraged (Tweedy, et al.). However, there is a lack of support for use of a functional electrical stimulation cycle ergometer to provide a clinically meaningful benefit in this patients scenario. The available data published in the peer-reviewed literature have not demonstrated that use of a functional neuromuscular electrical stimulation ergometer improves cardiovascular, pulmonary, bony, or other health parameters (Nardone, et al.; Soleyman-Jahi, et al.). The device has not been found to promote neurological recovery beyond natural recovery in a clinically appreciable manner (Hofer and Schwab). Therefore, the requested functional neuromuscular electrical stimulation ergometer (RT300-FES Therapy System) 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 functional neuromuscular electrical stimulation ergometer (RT300-FES Therapy System) 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.
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for  LINX procedure. Findings:  The physician reviewer found that The U.S. Food and Drug Administration (FDA) approved the LINX procedure for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate gastroesophageal reflux disease (GERD) and a hiatal hernia less than 3 cm. A recent retrospective  study comparing the LINX procedure with laparoscopic fundoplication concluded that GERD patients had similar control of reflux symptoms after both LINX and fundoplication. The authors noted that the inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms. A five-year cohort data was recently published establishing the durability of the LINX procedure. In a group of 85 patients augmentation of the lower esophageal sphincter with a magnetic device provided significant and sustained control of reflux, with minimal side effects or complications. Based on this patients history and current symptoms, her provider recommended treatment with the LINX procedure. However, this patient is not ideal for the LINX device given the presence of a hiatal hernia measured at 5 cm and cyclic vomiting syndrome. Recurrent episodes of forceful vomiting will result in tremendous stress at the gastroesophageal junction. All told, the requested LINX procedure 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 LINX procedure 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 internal medicine with subspecialty certification in gastroenterology and is actively practicing. Physician reviewer 2 is board certified in internal medicine with subspecialty certification in gastroenterology and is actively practicing. Physician reviewer 3 is board certified in internal medicine with subspecialty certification in gastroenterology 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 DecisionDx-Melanoma genetic testing provided by Castle Biosciences. This patient presents with a history of invasive malignant melanoma. A pathology report indicates that SOX-10 and PRAME stains were positive. Analysis with DecisionDx-Melanoma gene expression profiling demonstrated Class 1B findings associated with an increased risk of recurrence/metastasis within five years. The DecisionDx-Melanoma gene expression profile test is an expression assay designed to predict distant metastasis in stage I and stage II melanoma patients. DecisionDx-Melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 consistent with low risk of metastasis or Class 2 suggestive of high risk of metastasis. The peer-reviewed medical literature indicates that there is a statistically significant association of a Class 1 signature by DecisionDx-Melanoma assay for primary dermal melanoma, whereas cutaneous metastatic melanoma was more frequently class 2 (Sidiropoulos, et al.). Overall, there is paucity of prospective randomized controlled studies reporting improved health outcomes with use of the DecisionDx-Melanoma assay in patient treatment planning. All told, the DecisionDx-Melanoma genetic testing provided by Castle Biosciences was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Findings: Three of the three physician reviewers found the DecisionDx-Melanoma genetic testing provided by Castle Biosciences was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the services at issue were not likely to be more beneficial for evaluation 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 dermatology and is actively practicing. Physician reviewer 2 is board certified in dermatology and is actively practicing. Physician reviewer 3 is board certified in dermatology 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. While lipoprotein subparticles have associated with increased cardiovascular risk, under current American Heart Association (AHA) and American College of Cardiology (ACC) guidelines for the management of cardiovascular risk note that low-density lipoprotein (LDL) is the main target of lipid lowering therapy to decrease the risk for adverse cardiovascular events. In this case, the results from the advanced lipoprotein testing at issue would not have altered patient management or the recommendation for statin therapy. Therefore, advanced lipoprotein testing was not likely to have been more beneficial for evaluation of the patients 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 is board certified in internal medicine with sub-specialty certifications in cardiovascular disease and in clinical cardiac electrophysiology and is actively practicing. Physician reviewers 2 and 3 are board certified in internal medicine with sub-specialty certification in cardiovascular disease 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.