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

Nature of Statutory Criteria/Case Summary: An enrollees parent has requested authorization and coverage for RELiZORB in-line cartridges containing digestive enzymes. This patient presents with a history of cystic fibrosis with exocrine pancreatic insufficiency, failure to thrive, gastroesophageal reflux disease (GERD), poor weight gain, and milk protein allergy. The patients provider has recommended treatment with RELiZORB pancreatic enzyme replacement therapy. Cystic fibrosis patients with pancreatic insufficiency require solid pancreatic enzyme replacements. In this case, the patients length has been less than 5%, which is consistent with poor caloric absorption. RELiZORB has been shown to be effective in facilitating nutrient absorption in this patient population (Stevens, et al.; Freedman, et al.). In clinical trials, RELiZORB was also demonstrated to be safe, well tolerated, and effective in improving pulmonary and inflammatory status. Given this support, the requested RELiZORB in-line cartridges containing digestive enzymes are 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 RELiZORB in-line cartridges containing digestive enzymes 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 medication is 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 reviewer 1 is board certified in pediatrics with subspecialty certification in pediatric gastroenterology and is actively practicing. Physician reviewer 2 is board certified in pediatrics with subspecialty certification in pediatric gastroenterology and is actively practicing. Physician reviewer 3 is board certified in pediatrics with subspecialty certifications in medical toxicology and pediatric pulmonology 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Venetoclax 100 mg daily. The U.S. Food and Drug Administration (FDA) has approved venetoclax for the treatment of patients with chronic lymphocytic leukemia. Venetoclax is an inhibitor of BCL-2, which is often seen in chronic lymphocytic leukemia and about 20% of myelomas. Vaxman and colleagues found that about 20% of myelomas exhibit the t(11;14) mutation, and these have been found to have high expression of BCL-2, which suggests that venetoclax is likely to be effective in this subset of patients (Kumar, et al.). Moreover, the NCCN has included venetoclax in its recommendations for treatment of myeloma patients with the t(11;14) mutation. This patient has multiple myeloma with t(11;14) deletion. Therefore, the requested venetoclax 100 mg daily 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 venetoclax 100 mg daily 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 medication is 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 reviewer 1 is board certified in internal medicine with subspecialty certifications in medical oncology and hematology and is actively practicing. Physician reviewer 2 is board certified in medical oncology with subspecialty certification in hematology and is actively practicing. Physician reviewer 3 is board certified in internal medicine with subspecialty certification in medical oncology 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 an occipital nerve block (CPT codes 64450, 64405). The International Headache Society (IHS) defines occipital neuralgia as a paroxysmal stabbing pain, with or without persistent aching between paroxysms, in the distribution of the greater, lesser and/or third occipital nerves, along with tenderness to palpation over the affected nerve, with temporary pain relief after an anesthetic block required to meet criteria. The HIS notes that pain may be unilateral or bilateral with radiation into the temple or even behind the eye commonly triggered by head movements. In a prospective analysis of 44 patients with occipital neuralgia treated with an occipital nerve block procedure, Jukys and ustickas noted that 95.45% (or 42 patients) showed satisfactory results for at least six months, with decreases in mean headache Visual Analog Scale (VAS). The authors concluded that occipital nerve block provides a safe, technically simple, and effective method that carries a minimal risk of side effects and can be applied for patients that do not achieve desired pain relief using conventional pain management methods. In a randomized, multicenter, double-blind, and placebo-controlled study of 84 patients, Inan and colleagues found that greater occipital nerve blockade with bupivacaine was superior to placebo and was found to be effective, safe, and cost-effective for the treatment of chronic migraines. In this case, the patient has diagnoses of chronic migraines and occipital neuralgia intractable to abortive and prophylactic treatments. Given that current medical literature supports the use of occipital nerve block therapy in decreasing the frequency and severity of migraine headaches, the requested service is medically indicated. Therefore, an occipital nerve block (CPT codes 64450, 64405) 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 neurology 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 Stelara 90 mg/mL syringe every six weeks. Dayan and colleagues note that ustekinumab is an effective therapy for Crohn disease currently approved for adults, and while results from 52 children and young adults suggests that ustekinumab is efficacious and safe in pediatric patients with inflammatory bowel disease, controlled clinical trial data are needed to confirm these observations. The authors further reported that while more than 50% of pediatric patients achieved clinical remission on ustekinumab by week 52, higher remission rates were seen in bio-naive patients, with 90% of bio-naive patients in steroid-free remission compared to 50% of bio-exposed patients. Given the relatively limited data on ustekinumab on pediatric patients, a dosing regimen would be extrapolated from adult practice. Battat and colleagues report that maintenance trough concentrations of ustekinumab above 4.5 g/mL at 26 weeks or later are associated with biomarker reduction and endoscopic response. In the case, the patient is on her third dose of ustekinumab. The submitted documentation does not yet provide clear evidence of loss of response to ustekinumab, as fecal calprotectin was noted to be improving. Notes reported some decrease in the patients symptoms, although they have not completely resolved. While the patients ustekinumab level as of 1.5 g/mL was below the goal trough level, the submitted documentation did not include trough levels from week 26, which are not yet available. In this clinical setting, given that current medical literature does not support the use of trough levels before all induction doses have been given, and as the submitted records do not yet document continued low ustekinumab trough at or after week 26, the requested medication regimen is not medically indicated. Therefore, Stelara 90 mg/mL syringe every six weeks is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication regimen 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 sub-specialty 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

Nature of Statutory Criteria/Case Summary:  An enrollee has requested authorization and coverage for a continuous glucose monitoring system (CGMS).A continuous glucose monitoring system is one of several U.S. Food and Drug Administration (FDA) approved devices that record blood sugar levels at repeated intervals throughout the day and night. Over the last decade, continuous glucose monitoring systems have been demonstrated to be clinically valuable. A continuous glucose monitoring system can promote glycemic and weight control, help reduce the risk of hypoglycemia and hyperglycemia, and improve relevant lifestyle behaviors. It has become a useful tool for real-time monitoring of blood glucose and for assessing the impact of treatment and lifestyle on daily changes in blood glucose levels. Continuous glucose monitoring systems have been confirmed to be a safe modality, with high accuracy in glycemic values and a low complication rate. In this case, the patient presented with high A1C levels. However, the patients glycemic control has improved and her A1C had previously been above goal. Nevertheless, a CGMS is necessary to reduce the risk of future hypoglycemia and hyperglycemia. Therefore, the requested CGMS is medically necessary for treatment of the patients medical condition.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 sub-specialty 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: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary:  An enrollee has requested authorization and coverage for botulinum toxin injections for hands and feet.Botox (onabotulinumtoxinA) is approved by the U.S. Food and Drug Administration for the treatment of severe primary axillary hyperhidrosis in patients who are unable to obtain relief using antiperspirants. The efficacy of botulinum toxin for palmar and plantar hyperhidrosis is also supported by multiple studies, including a few small randomized trials, and it is generally regarded as a second-line therapy. Additionally, Lecouflet and colleagues reported, an increase in the duration of efficacy of botulinum toxin A injections with the repetition of injections in patients with primary axillary hyperhidrosis. In this case, the patient has hyperhidrosis. Additionally, the patient has tried and failed first-line therapies, such as aluminum chloride solution. There is sufficient support for the requested services in this clinical setting. Therefore, botulinum toxin injections for hands and feet are medically necessary for treatment of the patients medical condition.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 dermatology 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 reimbursement for Euflexxa medication. 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 a history of osteoarthritis of both knees. The medication at issue was the third injection of a series of three Euflexxa injections. Given the patients limited options, with the alternative being a total knee arthroplasty, and based on the current medical literature, the medication at issue was medically indicated. Therefore, Euflexxa medication was medically necessary for the treatment of this patient.Final Result: The reviewer determined that the mediation at issue was 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: Medical Necessity
Decision: Overturned Decision of Health Plan

Findings:  The physician reviewer found that : The patients parent has requested authorization and coverage for Palforzia including the initial dose escalation phase, up-dosing phase, and maintenance phases. This patient has a documented allergy to peanut. The patients provider has recommended treatment with Palforzia, which is a means of prevention of anaphylaxis upon accidental exposure to peanut. Oral immunotherapy as a treatment for food allergies has been demonstrated to be an efficacious method of food allergy treatment in order to prevent anaphylaxis in well-selected patients. Vickery and colleagues evaluated 551 patients with peanut allergy who received either active treatment or placebo in a food challenge. The authors found that the patients treated with oral immunotherapy were better able to tolerate ingestion of peanut protein, with lower symptom severity at the exit food challenge than patients who received placebo. The U.S. Food and Drug Administration (FDA) has approved Palforzia as oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Given these findings, the requested Palforzia including the initial dose escalation phase, up-dosing phase, and maintenance phases, 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 allergy and immunology 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 Guardant360 CDx test. Liquid biopsy for next generation sequencing is reserved for patients when there is insufficient tissue at biopsy or in the event of recurrence (Olson; Bettegowda, et al.). Cells from tumor are detected in the blood and used for sequencing, but there is a risk of sequencing normal tissue. This patient presented with a diagnosis of metastatic colorectal cancer. The patients provider recommended analysis with Guardant360 CDx testing. When this patient underwent liquid biopsy with Guardant360 CDx test, there was a lack of evidence of disease on imaging on positron emission tomography (PET) or computed tomography (CT) scan to support an indication for additional testing. In this clinical setting, there is a lack of data supporting a clinical role for Guardant360 CDx testing for evaluation and treatment planning. Therefore, the Guardant360 CDx test was not medically necessary for treatment 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 internal medicine with subspecialty certifications in medical oncology and hematology 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 Norco. The Centers for Disease Control and Prevention (CDC) guidelines state that when opioid therapy is used, a patients regimen should include nonpharmacologic therapy and nonopioid pharmacologic interventions. Additionally, the CDC noted that, Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety. The American Society of Interventional Pain Physicians (ASIPP) guidelines recommend providers to establish physical diagnosis and assess pain levels and disability to support medical necessity of treatment with opioids. In this case, the patient has chronic low back pain that is not concordant with his most recent lumbar magnetic resonance imaging (MRI). Evaluations have been performed by his pain management providers who advised against treatment with chronic opioid therapy. Based on the medical records provided for review and the current medical literature, the patient does not meet the criteria for treatment with chronic opioid therapy. Therefore, the requested Norco 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 anesthesiology with subspecialty certification in pain management 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 reimbursement for gallium-68 dotatate positron emission tomography (PET) scan. Findings: Gallium-68 dotatate PET is a functional imaging modality for the detection of well-differentiated neuroendocrine tumors. In addition, PET with dotatate injection has become the preferred method for initial diagnosis and localization for suspected unknown primary tumors. Studies have demonstrated that dotatate PET detects significantly more neuroendocrine tumors compared to octreotide imaging. According to the American College of Radiology (ACR) practice parameters, the performance of gallium-68 dotatate PET can be used to detect tumors in patients with strongly suggestive symptoms and laboratory evidence of neuroendocrine tumor but with no known primary tumor. This patient presented with an elevated urine 5-HIAA as well as a history of hypertension. In this patients clinical setting, evaluation with gallium-68 dotatate PET imaging was indicated to rule out neuroendocrine tumor. Therefore, the gallium-68 dotatate PET scan was medically necessary for evaluation of this patient. Final Result: The reviewer determined that the services at issue were medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in 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.