Persius/imr-appeals huggingface dataset:
Appeal type: Medical Necessity
Decision: Upheld

A 56-year-old male enrollee has requested proton pump inhibitor Aciphex for the treatment of his condition. Findings:  The physician reviewer found that pharmacologic therapy for GERD continues to focus on optimizing acid suppression. Proton pump inhibitors (PPIs) continue to be the backbone of therapy to acid suppression, providing excellent relief of symptoms and healing of erosive as well as nonerosive esophagitis and continue to be the standard of therapy. All PPIs are essentially equivalent on healing control of intragastric pH over 24 hours. For the most part, all PPIs are equivalent in their efficacy to control acid secretion.  While interpatient variability of the efficacy has been seen with PPIs, milligram for milligram, all drugs in this class appear comparable in their effects clinically, as human studies have not revealed significant differences in their effects with regards to clinical or endoscopic endpoints or side effects profile.  In this case, it is medically reasonable to require that the patient undergo a trial with Prevacid, single and double dose, for eight weeks each. If he fails to respond, he should be approved for Aciphex. Protonix made his symptoms worse, and therefore, would be inappropriate to use.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary:  An enrollee has requested Harvoni for 12 weeks for treatment of his chronic hepatitis C virus genotype 1a.  Findings:  Two physician reviewers found that according to the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA), successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected patients. Patients who are cured of their hepatitis C infection experience numerous health benefits, including a decrease in liver inflammation as reflected by improved aminotransferase levels and a reduction in the rate of progression of liver fibrosis. Per the U.S. Food and Drug Administration (FDA) recommendation, this patient meets the criteria for treatment with Harvoni for 12 weeks to prevent further progression of cirrhosis. Consistent with this support, the requested treatment with Harvoni for 12 weeks is medically necessary for treatment of this patients hepatitis C viral infection. Final Result: Two reviewers 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 three reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology 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: Upheld

Nature of Statutory Criteria/Case Summary:  The parent of an enrollee has requested speech therapy for treatment of the enrollees medical condition.  Findings:  The physician reviewer found that review of the submitted documentation and medical literature fails to demonstrate the medical necessity of the requested services. The article by Myers and colleagues recommends a comprehensive educational program to include speech therapy for children with autism spectrum disorder. In this case, the patient has been treated with speech therapy and has made slow progress with improvements in mean length of utterance, pronoun use and use of correct verb tense. However, in the school and home setting there is not as much generalization. At this point individual speech therapy is not medically necessary. Continued work on her speech goals and social goals can be treated through ABA services, group speech therapy or a social skills group. In sum, individual speech therapy is not medically necessary in this clinical setting.  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 pediatrics with sub-specialty certification in developmental and behavioral pediatrics 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for the Zoll LifeVest wearable cardioverter defibrillator. The documented high risk of sudden cardiac death in patients with severely reduced left ventricle ejection fraction (LVEF) has led to the recommendation of implantable cardioverter defibrillators in this patient population. Current data from multiple trials have advocated the use of a Zoll LifeVest wearable cardioverter defibrillator for patients with an LVEF of 35% or less, along with guideline directed medical therapy. This patients LVEF was estimated at 30-35%. The recommended timing of placement of a LifeVest based on current American College of Cardiology (ACC) and American Heart Association (AHA) guidelines is within 40 days of an acute myocardial infarction or within 90 days of guideline directed medical therapy for an initial diagnosis of congestive heart failure with a severely reduced LVEF. Per the guidelines, the Zoll LifeVest is appropriate for this patient for a period of 40 days. Therefore, the Zoll LifeVest wearable cardioverter defibrillator for a period of 40 days was and 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 Zoll LifeVest wearable cardioverter defibrillator for a period of 40 days was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that a portion of the services at issue was and 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 partially overturned. Credentials/Qualifications: Physician reviewer 1 is board certified in internal medicine with subspecialty certifications in cardiovascular disease and cardiac electrophysiology and is actively practicing. Physician reviewer 2 is board certified in internal medicine with subspecialty certification in cardiovascular disease and is actively practicing. Physician reviewer 3 is board certified in internal medicine with subspecialty certification in cardiovascular disease and is actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

The parent of a 17-year-old male enrollee has requested psychiatric residential treatment for the treatment of the enrollees behavioral health problems. Findings:  The physician reviewer found that the patients provider recommended residential level of care due to significant depression, anxiety and decompensation in functioning. There is no documentation indicating that the patient has had any prior inpatient hospitalization or prior suicide attempt or gesture. Additionally, there is no history of aggression or violence. The submitted records include no documented history of any delusion, thought disorder or perceptual abnormalities. The patient does not have a history of drug use, self-mutilation or legal problems. Additionally, there is no history suggestive of any imminent risk of harm to self or others. There was no suicidal ideation, homicidal ideation, psychotic thought process or aggressive behavior upon presentation or at any time during his admission. All told, residential treatment was not and is not medically necessary for this patient. There is no documentation of psychotic symptoms or behaviors. Additionally, there is no documentation of impaired reality testing or aggressive, out of control behavior. Although the patient had been in therapy, there is no evidence of a history of intensive outpatient treatment. While the patient does have chronic, emotional problems, his outpatient treatment, including medication management and psychotherapeutic intervention, could have been further maximized. The intensity, frequency and degree of impairment documented do not support the necessity for psychiatric residential treatment.
Appeal type: Medical Necessity
Decision: Overturned

The patients parent has requested reimbursement and prospective authorization and coverage for residential treatment center services. The American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. Using CALOCUS, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The composite score is then used to determine the level of care needed. Applying CALOCUS, this patient meets the criteria for RTC services. The patients composite score is 22. However, the patients scores for risk of harm and functional impairment, combined with scores for environmental stress and support, support treatment at a Level Five, medically monitored residence based services, similar to the services provide at the current RTC. Given these findings, the RTC level of care services provided were and are medically necessary for treatment of this patient. Final Result: The reviewer determined that the services at issue were and 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 with subspecialty certification in child and adolescent 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for inpatient hospital services provided for treatment of the enrollees acute cervical spinal cord injury. Findings:  The physician reviewer found that the records indicate that patient had a lesion on imaging concerning for a possible inflammatory versus neoplastic process. There was a history of the patient sustaining injury from a fall. After being observed, evaluated and treated in the hospital, the patient was ready for transfer to a rehabilitation facility, but was not reasonably safe for community re-entry given his complex baseline functional impairments, and his history of multiple falls. His newly-acquired deconditioning administrative days were appropriate while attempting to procure a bed for transfer to a skilled nursing facility.  It was appropriate for the facility to have initiated the process for a transfer at the skilled nursing facility level of care given the patients history and deficits. He was appropriately evaluated in a more detailed manner by physical therapy and determined to be a candidate for acute inpatient rehabilitation. This evaluation was necessary to determine his precise functional status, his ability to participate and his prognosis for functional recovery. Coverage of one acute hospital day for the evaluation and making this recommendation was medically appropriate. An additional administrative day was appropriate while attempting to procure a bed for transfer to an acute inpatient rehabilitation facility. As such, the inpatient hospital services provided were medically necessary for the treatment of this patient. However, inpatient hospital stay on their last day there was not medically necessary. Therefore, a portion of the services at issue were medically necessary for the treatment of this patient. Final Result: The reviewer determined that a portion of the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned. Credentials/Qualifications: The reviewer is board certified in physical medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee requested authorization and coverage for Inspire hypoglossal nerve stimulator. The enrollee has severe and obstructive sleep apnea. The enrollee underwent a home sleep study, which revealed an apneahypopnea index of 60.3 events per hour and a lowest oxygen saturation value of 58 percent. The enrollee has failed continuous positive airway pressure. He has also tried the oral appliance therapy device but continues to suffer from daytime sleepiness, snoring and gasping. A five-year study by researchers indicated the treatment was effective and improved sleepiness, quality of life and respiratory outcomes. A position statement from a professional society reports upper airway stimulation can be an effective treatment of moderate-to-severe obstructive sleep apnea in individuals who do not benefit from positive airway pressure therapy. Multiple literature reviews show hypoglossal nerve stimulation is safe and effective for treating obstructive sleep apnea.Final Result: Three of the three reviewers determined that the requested services are likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in otolaryngology 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: Experimental/Investigational
Decision: Upheld

A 63-year-old male enrollee has requested participation in Clinical Trial #NCT00738582 using MORAb-009 for treatment of his pleural mesothelioma. Findings:  Two physician reviewers found that the standard of care for unresectable mesothelioma is a platinum drug such as cisplatin in combination with pemetrexed (Alimta). This conventional treatment regimen is based on a randomized controlled clinical trial which demonstrated improvement in survival and quality of life and was reported by the National Comprehensive Cancer Network (NCCN). This patient wishes to participate in a clinical trial with cisplatin and Alimta along with the experimental compound MORAb-009. As MORAb-009 is being tested in this Phase II clinical trial, no outcome data is yet available showing its potential benefit.  As noted above, the literature offers adequate evidence in favor of treatment with cisplatin and Alimta as likely to result in better health outcomes in this patient with mesothelioma. Thus, the requested services are not likely to benefit the patient more than treatment with accepted standard therapies in this setting.
Appeal type: Experimental/Investigational
Decision: Overturned

A 57-year-old female enrollee has requested Botox injections for treatment of her migraine headaches.  Findings:  Three physician reviewers found that the patient has been diagnosed with chronic migraine, and tried and failed prior preventives. To date, the use of Botox for treatment of patients with chronic migraine has been evaluated in phase 3 studies. The patients were treated with 155-195 Units and showed definitive statistical and clinical benefits in terms of reduction in of headache days in comparison to placebo. A responder rate of nearly 70% was seen in Botox treated patients. This is a higher responder rate than is seen in management of episodic migraine with standard oral preventives (typically about 50%), suggesting that Botox may in fact be more effective than standard preventives even in patients who have not tried and failed standard therapies. Thus, there is adequate evidence that Botox is more beneficial than placebo, and is clinically beneficial in the majority of patients. Moreover, based on 2 phase 3 trials, the Food and Drug Administration (FDA) has approved Botox as a chronic migraine preventive therapy, at dosing of 155 Units. Of import is that there are no other FDA approved medications for chronic migraine. As Botox is FDA approved for the indication of chronic migraine, it is not experimental. Therefore, Botox should be approved as per FDA indication.
Appeal type: Experimental/Investigational
Decision: Overturned

A 51-year-old male enrollee has requested for an allogeneic hematopoietic stem cell transplant for treatment of his systemic sclerosis (scleroderma).  Findings:  Three physician reviewers found that While the relevant literature suggests a risk of mortality of 15-20% within 1-2 years of transplant, the prognosis for this disease is generally quite poor. Further, there are reports that stem cell transplant has resulted in resolution of disease in several patients. There is considerable optimism within the rheumatology/immunology community based on anecdotal reports of patients who have experienced considerable improvement with this procedure.
Appeal type: Medical Necessity
Decision: Upheld

The parent of an eight-year-old female enrollee has requested Omnitrope 5mg/1.5ml injections for treatment of the enrollees short stature. Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication in this clinical setting.  This patient does not have classic growth hormone deficiency, as her IGF-1 level was normal, her bone age was not delayed, and she had a normal growth hormone response on provocative growth hormone testing.  The patient has unexplained short stature with a short adult predicted height that is more than three standard deviations below normal.  However, the results of a complete work-up ruling out other causes of short stature were not provided in the case material.  Specifically, documentation of a normal complete blood count with differential, erythrocyte sedimentation rate, urinalysis, chemistry panel, celiac antibody panel, and karyotype are necessary to rule out other occult systemic causes of poor growth.  Thus, in the absence of the requisite data the diagnosis of idiopathic short stature cannot be made.  All told, the requested Omnitrope 5mg/1.5ml injections are not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for acute medical inpatient care services. Greenberg noted that determining the cause of a patients shoulder pain is usually a clinical diagnosis based on a thorough history and physical examination. Imaging studies are needed on a limited basis in the setting of trauma, possible glenohumeral arthritis, or when a complete tendon tear is suspected. Therapy is based on pain control and therapeutic exercises. Corey and Comeau noted that cervical radiculopathy is the result of irritation and/or compression of nerve root as it exits the cervical spine. Pain is a common presenting symptom and may be accompanied by motor or sensory deficits. Diagnosis is suggested by history and corresponding physical examination findings and confirmation is achieved with MRI. A multimodal approach to treatment consisting of medications, physical therapy, and/or guided corticosteroid injections and selected nerve blocks may help control nerve root pain. This patient presented to the emergency department on 6/25/21 with complaints of right shoulder and upper back pain that progressively worsened over the last couple of days. The patient was admitted, and he underwent physical examination and diagnostic testing. He was treated with morphine, ondansetron, and dexamethasone. Based on the noted examination findings as well as the diagnostic testing results, there were no indications of a condition that required an inpatient stay. The services rendered could have been provided on an outpatient basis with appropriate follow-up and observation. The patient was noted to be independent with activities of daily living, ambulation, and transfers, without evidence of neurologic progression. For these reasons, the acute medical inpatient care services were not medically necessary for treatment of this patient. Final Result: The reviewer determined that the services at issue were 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 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.