Persius/imr-appeals huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for positron emission tomography (PET) scans. This patient has had stable non-small cell lung cancer (NSCLC) for a few years. Although a PET scan with computed tomography (CT) for attenuation showed a suspicious right axillary node, this was resolved on repeat imaging. The National Comprehensive Cancer Network (NCCN) guidelines recommend assessment of treatment response with CT of known sites of disease every 6-12 weeks. However, surveillance or restaging PET scans are not within the standard of care. PET may be useful for assessing CT imaging results suggesting the presence of malignant neoplasms that may actually be due radiation fibrosis, atelectasis, or other benign condition. The use of PET scan for surveillance is not likely to be more beneficial than a CT scan. Therefore, the PET scan (CPT 78815) already performed and a future PET scan (CPT 78815) was not and is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Findings:  Two of the three physician reviewers found the PET scans (CPT 78815) were not and are 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 and are 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 internal medicine with subspecialty certifications in medical oncology and hematology and is actively practicing. Physician reviewer 2 is board certified in internal medicine with subspecialty certification in medical oncology 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: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for surgery with a Cartiva implant synthetic of the right first metatarsophalangeal (MTP) joint. While the medical literature does show some early promising results with the use of the Cartiva implant for the treatment of hallux rigidus, there is a lack of high-quality studies demonstrating long-term safety and efficacy. The gold standard for treatment of hallux rigidus remains arthrodesis. This patients records do not include radiology studies that grade the severity of the patients degenerative changes of the great toe MTP joint. Therefore, the requested surgery with a Cartiva implant synthetic of the right first MTP joint is not likely to be more beneficial for the treatment of the patients medical condition and any available standard therapy.Final Result: Two of the three 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:  Reviewers 1, 2, and 3 are board certified in orthopedic surgery and are actively practicing. All three 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

An enrollee has requested authorization and coverage for a 90-day partial hospitalization program. The American Psychiatric Association (APA) treatment guidelines for substance use disorders recommends that partial hospitalization should be considered for patients who require intensive care but have a reasonable probability of refraining from illicit use of substances outside a restricted setting. The APA guidelines further state that PHP is frequently used for patients leaving hospitals . . . who remain at high risk for relapse. These include patients who are thought to lack sufficient motivation to continue in treatment, have severe psychiatric comorbidity and/or a history of relapse to substance. In this case, the patient has relapsed several times in recent years, on each occasion requiring admission for detoxification. This patient is therefore at a high risk for relapse. She has been in an IOP since 10/19/18, but her condition has not improved during that time. Per the most recent notes, the patient remains nervous, depressed and anxious, and demonstrates poor insight and judgment. A higher level of care is needed to address this patients conditions. Therefore, the requested 90-day PHP is medically necessary.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 psychiatry 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

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for blood zonulin test. The Health Plan has denied this request indicating that the requested services are not medically necessary for evaluation of the patients leaky gut syndrome. The submitted documentation does not support the medical necessity of the requested services. Leaky gut syndrome, or abnormally increased intestinal permeability, has not been clearly defined as a disease. Not only is such impermeability associated with multiple diseases and normal health, it has not been proven to cause any specific disease. Furthermore, increased gastrointestinal permeability may be a consequence rather than the cause of disease. According to studies, there is no treatment for increased intestinal permeability, other than treating the underlying disease, if there is one. The requested blood zonulin test is not specific for increased gastrointestinal permeability or for leaky gut syndrome. Increased zonulin level can be associated with a multitude of conditions, such as inflammatory bowel disease, celiac disease, obesity, cigarette smoking, hyperlipidemia, autism spectrum disorder, and elevated liver enzymes. Zonulin levels may be elevated even if none of the conditions listed above are present. Evidence-based studies show that an elevated zonulin level is not a useful assessment to diagnose any specific disease. For these reasons, blood zonulin test is not medically necessary for 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 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: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Vemlidy (25 mg once daily) for treatment of the enrollees hepatitis B virus. Findings:  The physician reviewer found that guidelines for the treatment of hepatitis B from the American Association for the Study of Liver Disease (AASLD) recommend entecavir and tenofovir compared with alternatives for the treatment of chronic hepatitis B. In comparison with tenofovir disoproxil fumarate, which the patient is taking, the Vemlidy formulation of tenofovir is effective for hepatitis B, but is associated with lower incidence of side effects such as osteopenia and renal disease (Grant and Cotter). For this reason, the request for Vemlidy (25 mg once daily) is medically necessary for the treatment of this patients chronic hepatitis B. 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: Upheld

A 53-year-old female enrollee has requested sacroiliac joint arthrography and cortisone injections (sacroiliac joint injections) for treatment of her sacroiliac joint arthritis and bone spur. Findings: Two physician reviewers found that tenderness around the sacroiliac joint area does not necessarily mean the patient has a pathologic sacroiliac joint. There is no documentation in the submitted medical records of any positive sacroiliac joint physical findings such as sacroiliac joint pain on hip Faber testing, which stresses the sacroiliac joint, or sacroiliac joint pain with single leg stance rotation flexion stress testing, which also stresses the sacroiliac joint. Nor is there documentation in the submitted records of a bone scan abnormality of the unilateral left-sided sacroiliac joint or MRI testing of the pelvis documenting any bone density changes, inflammation, or fluid in or around the left sacroiliac joint. Additionally, the concept that the bone spur on the sacroiliac joint may be causing inflammation is valid from an anatomical standpoint. Given the preceding, the clinical indications for sacroiliac joint injections have not been established in this case.
Appeal type: Experimental/Investigational
Decision: Upheld

A 52-year-old male enrollee has requested carotid angioplasty with stent to the left vertebral artery and magnetic resonance imaging and magnetic resonance angiography for the treatment of his high grade stenosis. Findings:  Two physician reviewers found that at issue is whether carotid angioplasty with vertebral artery stenting is likely to be more beneficial for treatment of the patients vertebral artery stenosis than standard alternative therapies. The literature on endovascular vertebral artery treatment is largely limited to case reports and case series. Mas and colleagues in their 2006 study conducted a multicenter, randomized, non-inferiority trial to compare stenting with endarterectomy in symptomatic patients with at least 60% carotid stenosis. The authors concluded that, The rates of death and stroke at one and six months were lower with endarterectomy than with stenting. On follow-up study in 2008, the authors reported that, Carotid stenting is as effective as carotid endarterectomy for middle-term prevention of ipsilateral stroke, but the safety of carotid stenting needs to be improved before it can be used as an alternative to carotid endarterectomy in patients with symptomatic carotid stenosis. Luebke and colleagues 2007 meta-analysis of the randomized studies available at the time suggested that, CEA [carotid endarterectomy] can be performed with more safety than CAS [carotid artery stenting]. As a result, CEA remains the gold standard treatment for suitable de novo carotid stenosis and CAS should only be performed within randomized trials of stenting versus surgery. Based on the available evidence, carotid artery stenting has not convincingly been shown to be superior to carotid endarterectomy in terms of safety and efficacy at this time. There is even less evidence in support of the safety and efficacy of vertebral artery stenting than carotid artery stenting and it should likewise be considered an unproven technique. With regard to the MRI and MRA, since their purpose is for pre-operative evaluation in preparation for vertebral artery stenting, they are not indicated at this time.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary. An enrollee has requested modulated radiation therapy (IMRT) for treatment of the enrollees prostate cancer.  Findings: Three physician reviewers found that the patient has a history of pathologic stage T3bN0M0 and Gleason 8-9 prostate cancer. The patient was offered adjuvant or salvage radiation therapy for a post prostatectomy prostate specific antigen (PSA) of 0.59. The Health Plan denied the services at issue as investigational for treatment of this patient. This denial is the subject of this appeal and determination. In this clinical setting, the services at issue were likely to be more effective than any available standard therapies for treatment of this patient. IMRT is a tool that clinicians can use when there is concern about sparing normal tissues from high dose exposure.  IMRT generally implies inverse planning algorithms, where the provider determines radiation treatment parameters to maximize dose to the target while minimizing dose to normal tissues. In this case, the treating provider recommended IMRT in this patient who was receiving post prostatectomy radiation. Radiation after prostatectomy is recommended for patients with high risk features and/or rising PSA in the absence of metastatic disease. There is limited prospective clinical studies which directly compare IMRT to conventional three dimensional (3D) radiation therapies. Conventional 3D radiation therapy is also considered a standard and safe approach.  However, IMRT is considered more effective to reduce dose to surrounding critical structures like the bowel and bladder. In general, the radiation field for the pelvis after prostatectomy is a concave treatment volume around normal structures, for which IMRT is much better suited to conform to, as opposed to conventional conformal radiation. Therefore, IMRT was the safest and most effective way to treat this patient. Thus, IMRT was likely to be superior to any available standard modality for the treatment of this patient.  Final Result: Three physician reviewers determined that the services at issue were 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: All three physician reviewers are board certified in radiation oncology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A 29-year-old male enrollee requested authorization and coverage of prolotherapy. The Health Plan denied the request indicating that the requested therapy is not medically necessary for treatment of the enrollees shoulder pain.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer upheld the Health Plans denial on the basis that the requested therapy is not medically necessary.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for testosterone 1 mL injections once every two weeks. The Health Plan has denied this request indicating that the requested medication regimen is not medically necessary for treatment of the patients testicular hypofunction. The submitted documentation supports the medical necessity of the requested medication regimen. Low testosterone can lead to such complications as reduced libido/erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis/low bone mass, depressed mood and fatigue. For these reasons, many providers treat patients with hypogonadism when their testosterone level is less than 350 ng/dL. The general target level for testosterone ranges from 350 to 750 ng/dL, which is roughly the range for healthy, androgen-sufficient adult men. Testosterone levels should be monitored every three to six months after initiation of treatment in order to assure that the patients testosterone level is optimal, and the dose of testosterone replacement therapy should be adjusted accordingly. Therefore, the requested testosterone 1 mL injections once every two weeks are medically necessary for 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. 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: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for H.P. Acthar Gel 80 unit/mL-5mL injection.Findings:  The physician reviewer found that there is a paucity of data in the current medical literature supporting the use of H.P. Acthar Gel for the treatment of ankylosing spondylitis. In adults with active ankylosing spondylitis despite treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), Ward and colleagues recommend treatment with tumor necrosis factor inhibitors (TNFi), and with sulfasalazine, methotrexate, or tofacitinib when TNFi are not available. The authors further recommend physical therapy. In a phase 2 randomized trial, Van der Heijde and colleagues reported that tofacitinib 5 mg and 10 mg twice daily demonstrated greater clinical efficacy versus placebo in reducing signs, symptoms and objective endpoints of active ankylosing spondylitis. In this case, the provider reports that the patient has active ankylosing spondylitis symptoms despite treatment with NSAIDs and TNFi therapy. However, the documentation did not note trials of methotrexate or tofacitinib according to treatment guidelines, or participation in a structured land-based physical therapy program. In this clinical setting, current medical literature does not support the efficacy of H.P. Acthar Gel over standard available therapies, such as methotrexate for peripheral joint inflammatory arthritis, tofacitinib, and physical therapy, for the treatment of ankylosing spondylitis. Therefore, H.P. Acthar Gel 80 unit/mL-5mL injection is not likely to be more beneficial than any other available standard therapy for the patients medical condition.Findings:  Three of the three physician reviewers found the requested H.P. Acthar Gel 80 unit/mL-5mL injection is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1, 2, and 3 are board certified in internal medicine with sub-specialty certification in rheumatology 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: Upheld

A male enrollee requested laboratory testing of adalimumab levels in the blood for medical evaluation of his ulcerative colitis.  Findings:  Three physician reviewers found that the target level of adalimumab necessary to achieve clinical benefit remains unknown.  There is a lack of randomized prospective trials demonstrating that treatment guided by trough adalimumab levels is superior to optimal clinical care.  All told, laboratory testing of adalimumab levels in the blood was not likely to have been superior over other modalities for evaluating this patient.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patients parent has requested authorization and coverage for Xifaxan 550 mg tablets. Small intestinal bacterial overgrowth (SIBO) is a known cause of gastrointestinal distress and is likely a primary contributing factor to IBS. SIBO is typically treated with antibiotics. However, there is a lack of treatment options specifically approved for this indication by the U.S. Food and Drug Administration (FDA). Xifaxan (rifaximin) has been FDA approved for treatment of diarrhea predominant inflammatory bowel syndrome (IBS) and has been found to be effective in the treatment of SIBO in adults. (Gatta and Scarpignato). Prospective data from Scarpellini and colleagues demonstrated that, antibiotics are an effective means of treating SIBO in children and, although non-rifaximin antibiotics appear to produce greater resolution, the data is weaker for such medications and rifaximin has demonstrated safety in a greater number of participants and studies. Given this support, the requested Xifaxan 550 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 pediatrics with subspecialty certification in pediatric gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.