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 infusion set (external ambulatory infusion pump, infusion insulin pump non-needle, syringe with needles for insulin, external transmitter for continuous glucose monitor system (CGMS), and disposable sensor for diabetes). Studies have shown that the use of a CGMS can help optimize glycemic control in patients with diabetes and can lead to even greater improvement when used in conjunction with insulin pump therapy. CGMS 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. CGMS devices can capture dangerously low overnight blood sugar levels, high blood sugar levels between meals, and early morning spikes in blood sugar. These data are utilized to help prevent episodes of hyperglycemia and hypoglycemia as well as assess how a patients diet and exercise affect their individual blood sugar levels. This patient has complications from her diabetes including retinopathy and neuropathy. The provider noted that the patient is unable to properly check her insulin levels with finger sticks due to poor vision and gait instability. For these reasons, the requested infusion set (external ambulatory infusion pump, infusion insulin pump non-needle, syringe with needles for insulin, external transmitter for continuous glucose monitor system (CGMS), and disposable sensor for diabetes) is medically necessary for 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 diabetes, endocrinology, 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 enrollees parent has requested authorization and coverage for vedolizumab (Entyvio) infusions in combination with subcutaneous ustekinumab (Stelara). Several studies have assessed the safety and efficacy of combination therapy Stelara with Entyvio in the treatment of patients with Crohns disease. Researchers concluded that, there was an increased risk of serious infection compared with biologic monotherapy. In addition, there are a lack of data demonstrating that combination therapy with Stelara and Entyvio is more effective than standalone therapies. Researchers concluded that, Further studies, as randomized control trials, to provide comparative efficacy and safety endpoints of combination therapies, and to clarify potential advantages of combined biological therapies, are needed. Overall, the use of Stelara with Entyvio is not supported by current guidelines or studies for use in lieu of conventional therapies. For this patient, the records document inadequate response to Stelara monotherapy. This patients records document a history of Crohns disease, but there is a lack of report that the patient has failed Entyvio monotherapy. All told, Entyvio infusions in combination with subcutaneous Stelara are 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 Entyvio infusions in combination with subcutaneous Stelara are 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 regimen 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 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 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: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Orilissa (elagolix) 150 mg tablets. Orilissa is a gonadotropin-releasing hormone (GnRH) antagonist, which functions to suppress pituitary gonadotropin hormone production and create a hypoestrogenic state. Unlike GnRH agonists, GnRH antagonist agents are effective immediately, do not cause an initial surge in luteinizing hormone and follicle stimulating hormone, and do not require 7 to 14 days for GnRH suppression. Orilissa provides a treatment alternative for patients who do not respond to non-steroidal anti-inflammatory drugs (NSAIDs), estrogen-progestin contraceptives, or progestins. Studies support its benefit when compared with placebo for patients with endometriosis-related dysmenorrhea and noncyclic pelvic pain (Ng, et al.; Taylor, et al.). In the United States, it has been approved for treatment of moderate-to-severe endometriosis-related pain. In this case, the patient is premenopausal and has not responded to multiple standard therapies. The records document that the patient has responded well to Orilissa. For these reasons, the requested Orilissa (elagolix) 150 mg tablets 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. Credentials/Qualifications: The reviewer is board certified in obstetrics and gynecology 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 albendazole (400 mg) and ivermectin (200 mg) each daily for 28 days, then off for two weeks, then repeat this for two more cycles for a total of three cycles. In this case, the records do not document parasitic infection. Given that there are no pathologic specimens documenting a parasitic infection, the requested medication is not medically indicated. Therefore, albendazole (400 mg) and ivermectin (200 mg) each daily for 28 days, then off for two weeks, then repeat this for two more cycles for a total of three cycles are not medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medications 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 internal medicine with sub-specialty certification in infectious disease 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: An enrollee has requested authorization and coverage for proton beam radiation therapy.In this case, the provider notes that proton therapy is necessary because the patients treatment field is close to her pacemaker and in order to improve sparing of her lungs and heart. The plan comparison was reviewed in detail. The heart mean dose was 7.6 Gy with IMRT and 5.7 Gy with protons. The pacemaker maximum dose was 13 Gy with IMRT and 0.5 Gy with protons. The decrease in dose to the pacemaker seen on comparative planning is not sufficient justification for the use of proton therapy. Treatment with proton therapy is associated with a higher incidence of neutron scatter compared to standard photon treatment, which could lead to greater interference with the device independent of the dose received. One study found a device malfunction rate of 20% with treatment to the chest with protons. Therefore, treatment with protons in this case would not decrease the chance of device malfunction despite the lower dose to the device. The standard approach would be to interrogate the device after every radiation treatment to ensure the device is working. The dose to the heart and lungs is also not sufficient justification for the use of proton therapy, as a phase 3 trial found no major clinical benefit to the use of proton therapy despite lower doses to these structures. Furthermore, consensus group guidelines do not support the use of proton therapy in this setting. Accordingly, the requested proton beam radiation therapy is not medically necessary to treat the patients medical condition.Final Result: The reviewer determined that the requested services are not medically necessary to treat the patient's medical condition. Therefore, the Health Plans denial should be upheld.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.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Jublia 10% solution. A study notes there are several treatment options for onychomycosis, or fungal infection of the nail, including oral antifungals, topicals and devices. Oral antifungals, such as terbinafine, have higher cure rates and shorter treatment periods than topical treatments, while topical treatments, such as efinaconazole, have less serious side effects than oral antifungals, but also have generally lower cure rates and much longer treatment regimens. The U.S. Food and Drug Administration (FDA) approves the use of Jublia (efinaconazole) 10% solution for the topical treatment of onychomycosis of the toenails, administered once daily for 48 weeks. In this case, the patient has a long documented history of onychomycosis. The records document a clinical history of improvement on topical Jublia 10% solution.  There is sufficient support for the requested medication in this clinical setting. Therefore, Jublia 10% solution 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. 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 authorization and coverage for Xeljanz XR tablets. Findings: The U.S. Food and Drug Administration (FDA) approves the use of Xeljanz for the treatment of ulcerative colitis. A study found that patients with moderately to severely active ulcerative colitis treated with tofacitinib were more likely to have clinical response and remission than those receiving a placebo. Another study noted that Janus kinase (JAK) inhibitors, such as tofacitinib, are designed to selectively target the activity of specific JAKs and to offer a targeted mechanism of action without risk of immunogenicity. Other guidelines for the management of moderate to severe ulcerative colitis noted, In adult outpatients with moderate to severe UC who have previously been exposed to infliximab, particularly those with primary nonresponse, suggest using ustekinumab or tofacitinib rather than vedolizumab or adalimumab for induction of remission. In this case, the patient did not respond to infliximab, and has tried and failed several other therapies, including anti-TNFs. Given the current medical literature and the providers recommendation, the requested medication is medically indicated. Therefore, Xeljanz tablets are 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.Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty 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: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the (Rezum system) heated water vapor. Two out of three physician reviewers found that he services at issue were likely to have been more beneficial than any available standard treatments for the patients medical condition. A variety of surgical treatments for benign prostatic hyperplasia (BPH) are available. Transurethral resection of the prostate (TURP) is a standard treatment, however, it also can lead to significant morbidity, including prolonged catheterization, incontinence, or urethral stricture/bladder neck contracture. In an effort to reduce patient morbidity, more minimally invasive techniques are being developed. A novel technology utilizing convective radiofrequency (RF) water vapor thermal therapy (Rezum System) received U.S. Food and Drug Administration approval in 2015. The principles of the technology and effective ablation of prostate adenomas were validated in histologic and magnetic resonance imaging studies. The advantage of the Rezum System is the use of convective heat energy rather than tissue ablation.The use of the Rezum System for the treatment of refractory urinary symptoms from BPH is supported as a minimally invasive treatment option in the most recent American Urological Association (AUA) treatment guidelines, including the 2019 and 2020 updates. This recommendation is secondary to a prospective, blinded, randomized controlled trial that demonstrated improvements in urinary quality of life scores and urinary flow rates that are durable through at least three years of follow up with minimal adverse outcomes. The Rezum System has also shown to have improved outcomes compared with medical management patients from the MTOPS trial.In this case, the patient had a diagnosis of BPH with lower urinary tract symptoms. This diagnosis and symptoms were appropriate for use of this minimally invasive treatment. The patient had failed conservative treatment with medical BPH management. Use of the Rezum System has significant advantages over standard treatment options (e.g., TURP) in that it is less invasive, causes less sexual dysfunction and has less adverse surgical outcomes. Accordingly, the (Rezum system) heated water vapor (CPT-53854) services at issue were likely to have been more beneficial than any other available standard treatments for the patients medical condition.Final Result: The reviewers determined that the services at issue were likely to have been more beneficial than any other available standard treatments for the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in urology 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: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for MRI in both breasts. The American College of Radiology (ACR) Appropriateness Criteria note that in the context of a palpable mass, there is little role for advanced technologies such as MRI, positron emission mammography, or molecular breast imaging in the evaluation of a palpable mass. Rather, when a suspicious finding is identified, biopsy is indicated. Argus and Mahoney note that indications for breast MRI include determination of the stage and extent of disease in a newly diagnosed patient, evaluation of a patient with an unknown primary tumor, or with positive surgical margins after breast conservation surgery, monitoring of a patient undergoing neoadjuvant chemotherapy, evaluation of breast implant integrity, screening for breast cancer in patients at very high risk for the disease, and for use as a problem-solving tool for patients with equivocal mammographic findings. Howard and colleagues concluded that while the effect of imaging may be reassuring, initial imaging for women with breast pain increased the odds of subsequent clinical utilization and did not increase reassurance in ruling out malignancy. The chance of a false negative on an MRI is also of concern. Shimauchi and colleagues noted, It should be emphasized that a negative MRI should not influence the management of  a lesion that appears to be of concern on physical examination or on other imaging techniques. In this case, the records document that the patient has had stable mammograms. The most valuable tool in interpreting a mammogram, especially in cases without palpable masses, is comparison with an older mammograms. In this clinical setting, the standard of care would be regular breast mammograms and follow-up physical examinations. Therefore, MRI of both breasts is not medically necessary for the 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 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: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Hyperbaric Oxygen Treatment.Findings:  Two out of three physician reviewers found that the services at issue were likely to have been more beneficial than any available standard treatment for the patients medical condition. According to the American Academy of Otolaryngology-Head and Neck Surgery, when a patient presents with sudden sensorineural hearing loss, they should obtain an audiogram, MRI or ABR, and start corticosteroids as initial therapy. The guideline also states that the clinician may offer hyperbaric oxygen therapy combined with steroid therapy within two weeks of onset. Hyperbaric oxygen therapy can also be offered as salvage therapy if the patient does not improve with steroids alone. A systematic review and meta-analysis performed by researchers concluded that the addition of hyperbaric oxygen therapy to standard medical therapy is a reasonable treatment option for sudden sensorineural hearing loss, particularly for those patients with severe to profound hearing loss at baseline and those who undergo hyperbaric oxygen therapy as a salvage treatment with a prolonged duration. Researchers performed a systematic review that looked at seven trials, and they concluded that for people with acute idiopathic sudden sensorineural hearing loss, the application of hyperbaric oxygen therapy significantly improved hearing. These studies and published guidelines support that when a patient does not improve with steroids alone, the standard of care is to offer hyperbaric oxygen therapy for salvage therapy. Therefore, the Hyperbaric Oxygen Treatment services at issue were likely to have been more beneficial than any available standard treatment for the patients medical condition.Final Result: The reviewers determined that the services at issue were likely to have been more beneficial than any available standard treatment for the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in otolaryngology 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

Nature of Statutory Criteria/Case Summary: An enrollees parent has requested authorization and coverage for Xeljanz tablets. This patient is six-years-old with a history of alopecia areata that has progressed to alopecia totalis, which involves the scalp as well as the eyebrows and eyelashes. Initially, he was not bothered by the disease process, but once his peers began to tease him, it affected his mood. Per review of the available medical records, he became more irritable and demonstrated behavioral problems due to his hair loss. Since starting on the Xeljanz about one year ago, he has shown a positive response and he has been tolerating it well. Prior treatment has included several first- and second-line treatments without significant improvement. Medical literature reported that the recommended first-line therapy for young patients is topical steroids. This patient has not responded to topical steroid therapy as well as methotrexate and Plaquenil, which are considered second-line therapies. Given these findings, the requested Xeljanz tablets are 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 Xeljanz tablets 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 reviewers 1, 2, and 3 are board certified in dermatology 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.