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

Nature of Statutory Criteria/Case Summary: A female enrollee has requested authorization and coverage for Linzess for treatment of the enrollees constipation and bloating.Findings:  The physician reviewer found that Linzess is indicated to restore colonic function in chronic constipation. This medication is U.S. Food and Drug Administration (FDA) approved for chronic constipation. It has a different mechanism of action than osmotic laxatives, and can be effective even if those have failed. In multicenter, randomized, blinded, placebo-controlled, phase III clinical trials, Linzess significantly increased weekly spontaneous bowel movements while reducing abdominal pain in patients with chronic constipation.  In this case, the patient reports failure of two formulary alternatives, lactulose and polyethylene glycol.  Additionally, she reports a valid contraindication to the alternative Amitiza, which has a warning regarding syncope in the package insert.  For these reasons, Linzess 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 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 Stelara syringe 90 mg/ml, every 8 weeks.Stelara (ustekinumab) is approved by the U.S. Food and Drug Administration for treatment of Crohns disease. A large randomized controlled trial by Sandborn and colleagues demonstrated safety and efficacy of ustekinumab for induction and maintenance of remission in patients with moderate-severe Crohns disease that was resistant to anti-tumor necrosis factor (TNF) therapy. A study by Kopylov and colleagues showed that subcutaneous ustekinumab showed a 73.7% response in patients with anti-TNF-resistant Crohns disease, and 80% of responders maintained remission for one year. Moreover, American Gastroenterological Association guidelines for the treatment of Crohns disease recommend ustekinumab in patients with failure of an anti-tumor necrosis factor medication, such as Remicade. In this case, the patient has Crohns disease, which is currently controlled by Stelara. The use of Stelara for the patients medical condition is supported by the medical literature. Moreover, the records indicate the patient has already initiated Stelara, with some benefit. As such, continuation of therapy is more appropriate than discontinuation and change to alternative therapy. Therefore, the requested Stelara syringe 90 mg/ml, every 8 weeks is medically necessary for treatment of the patients medical condition.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

An enrollee has requested authorization and coverage for matrix-induced autologous chondrocyte implant (MACI) knee implant. Autologous chondrocyte implantation, including MACI, has been evaluated for the treatment of patients with articular cartilage defects. Early evidence suggests that MACI can be effective in the treatment of isolated cartilage defects in the knee. However, MACI is not indicated and has not been shown to be effective for the treatment of severe osteoarthrosis with widespread cartilage loss in the knee and areas of full-thickness cartilage loss. Per the U.S. Food and Drug Administration (FDA), MACI is contraindicated in patients with severe osteoarthritis of the knee (Kellgren-Lawrence grade 3 or 4). Thus, MACI is contraindicated for this patient with severe osteoarthritic cartilage loss on both sides of the patellofemoral articulation. All told, the requested MACI knee implant is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

A 46-year-old male enrollee has requested authorization and coverage for a custom fit intraoral appliance (mouth splint) for treatment of the enrollee, who has been diagnosed with sleep apnea with periodic limb movement disorder. Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested custom fit intraoral appliance (mouth splint) in this patients case.  This patient presents with loud snoring.  Per the submitted documentation, the patient noted that his sleep is refreshing.  He underwent a sleep study which showed mild obstructive sleep apnea with periodic limb movement disorder.  The sleep study revealed a respiratory disturbance index of 5.1 and apnea/hypopnea index of 1.5.  The medical records noted a periodic limb movement disorder arousal index of 8.  Based upon the submitted documentation, this patient does not have significant sleep apnea.  As noted in the clinical documentation, this patients sleep study did not reach the level of severity for treatment of sleep apnea.  The current medical evidence does not support the requested equipment in this clinical setting.  All told, the requested custom fit intraoral appliance (mouth splint) is not medically indicated for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

The parent of a 10-year-old female has requested speech therapy for treatment of her autism. Findings:  The physician reviewer found that speech therapy is a standard modality for patients with autism. The report by Myers, et al. states, that people with autism spectrum disorders (ASDs) have deficits in social communication, and treatment by a speech-language pathologist usually is appropriate. Most children with ASDs can develop useful speech, and chronologic age, lack of typical prerequisite skills, failure to benefit from previous language intervention, and lack of discrepancy between language and IQ scores should not exclude a child from receiving speech-language services. Children with autism who did receive therapy had far greater communication skills than children who did not receive speech therapy (Turner, et al.). The American Speech and Language Association states that all autistic children can benefit from speech therapy and emphasizes that age, either early or late in life, is not a barrier to speech therapy. There is strong literature support that speech therapy should not be completely discontinued in this setting.   In sum, speech therapy is medically indicated for this patient and would be considered the standard of care.
Appeal type: Medical Necessity
Decision: Upheld

A 58-year-old male enrollee has requested increased dosage of Xeljanz medication for treatment of his Crohns disease. Findings:  The physician reviewer found that there is insufficient scientific data at this juncture to conclude that the patient will benefit from a higher dose of tofacitinib. Furthermore, with regard to the specifics of this case, recent examination and lab work show little evidence of currently active Crohns disease or flare. While, it appears the patient has subjectively responded to tofacitinib, no objective evidence of drug response is found in the submitted records. Nor do the submitted medical records provide medical justification for an increased dose, particularly in light of the known dose-dependent risks of the drug. Therefore, the medical necessity of the requested medication dosage has not been established in this patients case.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for post-acute skilled nursing services. The documentation does not support that this patient requires post-acute skilled nursing services. The patient does not require complex wound care. He does not have a tracheostomy tube or other skilled nursing need that requires continued services performed by a skilled nurse in a skilled nursing facility (SNF). This patients functional status does not require continued skilled therapy services with the specialized skill, knowledge, and judgment of a qualified therapist in a SNF. The patients providers have recommended that the patient be discharged with a caregiver and lower level of therapy. All told, the requested post-acute skilled nursing services are not medically necessary for treatment 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 physical medicine and rehabilitation with subspecialty certification in neuromuscular 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: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:   An enrollee has requested residential treatment center (RTC) level of care services for treatment of her bipolar disorder, eating disorder, and polysubstance abuse.  The physician reviewer found that according to the American Psychiatric Association (APA) guidelines, services available for treating eating disorders can range from intensive inpatient programs (in which general medical care is readily available) to residential and partial hospitalization programs to varying levels of outpatient care (in which the patient receives general medical treatment, nutritional counseling, and/or individual, group, and family psychotherapy). The APA guidelines also note that in determining a patients initial level of care or whether a change to a different level of care is appropriate, it is important to consider the patients overall physical condition, psychology, behaviors, and social circumstances rather than simply rely on one or more physical parameters, such as weight. The review of submitted documentation does not reveal any evidence that the patients symptoms could not have been treated at lower level of care. All told, RTC level of care was not medically necessary for treatment of this patients medical condition.   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 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: An enrollee has requested authorization and coverage for an increased dosage of the medication Norco 10/325mg tablets to a quantity of ninety (90) tablets per month.Centers for Disease Control and Prevention (CDC) guidelines for the prescribing of opioids for chronic pain state that clinicians should evaluate benefits and harms with patients within one to four weeks of starting opioid therapy for chronic pain or of dose escalation. The guidelines state that clinicians should evaluate benefits and harms of continued therapy with patients every three months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. Federation of State Medical Boards guidelines for the chronic use of opioid analgesics state that continuation, modification or termination of opioid therapy for pain is contingent upon a clinicians evaluation of evidence of the patients progress toward treatment objectives and the absence of substantial risks or adverse events, such as signs of substance use disorder and/or diversion. The Federation of State Medical Boards guidelines recommend opioid therapy for chronic pain that is not cancer-related, or part of palliative care or end-of-life care, only when non-opioid and non-pharmacological options have not been effective. Opioid dosage should be maintained as low as possible and continued only if clear and objective outcomes are being met.In this case, the patient has significant comorbid health conditions including obesity and sleep apnea. The patient is also noted to have had an inconsistent urine drug screen result and apparent drug seeking behavior demonstrated during a recent clinic visit. For these reasons, the healthcare provider did not endorse further escalation of the patients opioid prescription. The provider recommended a pain management plan that focuses on non-opioid therapies, which is consistent with the CDCs current guidelines and recommendations from the Federation of State Medical Boards. Under these circumstances, the requested increased dosage of the medication Norco tablets to a quantity of ninety (90) tablets per month is not medically necessary to treat the patients medical condition.Final Result: The reviewer determined that the requested increased dosage of medication is 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 anesthesiology, with subspecialty certification in pain 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: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for physical therapy, twice a week for treatment of the enrollee who has a history of pelvic and vaginal pain.Findings:  The physician reviewer found that chronic pelvic pain syndromes are not uncommon and can cause impaired quality of life.  These pain syndromes, including pudendal neuralgia, are poorly understood, and there is limited high-grade evidence available to guide treatment. In the current case, there are no objective indications that the formal physical therapy services that the patient had been receiving had been effective. Despite the therapy interventions that were being provided, the patient reported persistent symptoms that prompted her to ultimately undergo left pudendal nerve cryoablation in early May 2017. She continued to have pain, functional limitations and urgency/frequency.  She sought further treatment and was even referred to urogynecology for possible botulinum toxin injection to the muscles.  It was noted in the urogynecology consultation record that the benefits from physical therapy had essentially been exhausted.  Further pelvic physical therapy would not be reasonably expected to be effective in improving the patients clinical course or outcomes.  The patient and her spouse have been trained to provide palliative manual therapy, which would be expected to be no less effective than ongoing formal physical therapy.  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 physical medicine and rehabilitation 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: The patient has requested authorization and coverage for Repatha Solution Syringe. Findings: The American College of Cardiology (ACC) has developed an expert consensus decision pathway regarding the role of non-statin therapies for LDL cholesterol lowering for management of atherosclerotic cardiovascular disease risk. Per the ACC guidelines, Repatha may be considered if the goals of therapy have not been achieved on maximally tolerated statin and ezetimibe in higher risk patients with clinical atherosclerotic cardiovascular disease or familial hypercholesterolemia. The records provided for review do not document that this patient has undergone an adequate trial of treatment with ezetimibe. Moreover, there is a lack of evidence of clinical cardiovascular disease or subclinical atherosclerosis to support an indication with treatment. Furthermore, although the patient has a family history of early myocardial infarction, the records do not report that the cardiac event was related to familial hypercholesterolemia. The patients LDL cholesterol should be measured on ezetimibe alone to demonstrate that guideline recommended LDL lowering is indicated, prior to authorizing Repatha. Therefore, the requested Repatha Solution Syringe is not considered 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 internal medicine with subspecialty certification in cardiology 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: This is a 62-year-old female with a history of hyperlipidemia. The provider reports the patient has tried and failed simvastatin and atorvastatin, and that the medications caused muscle spasms and myalgias. The patient was switched to Livalo in 2013 without adverse reactions to this medication and this medication has helped her reach her goals. At issue is whether the medication, Livalo 4 mg tablets, is medically necessary to treat the patients medical condition. Pitavastatin (Livalo) is medically necessary. There is documented history of the patients intolerance or lack of efficacy of other formulary alternative statin medications. Toth et al, states that switching to a different statin is an accepted strategy. In this patient, this approach has met with success since 2013. Final Result: The reviewer determined that the requested service is medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in cardiovascular 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 similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: A 28-year-old male enrollee has requested authorization and coverage for Cayston 75 mg/mL vial-neb for treatment of the enrollees cystic fibrosis. Findings:  The physician reviewer found that the U.S. Food and Drug Administration (FDA) indications for Cayston are for patients with cystic fibrosis with a FEV-1 greater than 25% of predicted but less than 75% of predicted and who has pulmonary pseudomonas. The patient meets these criteria. The FDA approved package insert for Cayston or Tobi does not preclude rotating each drug every four weeks for pseudomonas colonization or infection. Since pseudomonas readily develop resistance, rotating Tobi and Cayston is clinically appropriate. As long as the patient does not take both Tobi and Cayston at the same time, he is taking both medications that would be consistent with the FDA approved package insert recommendations. The records indicate that this patient has followed this regimen for four years with good results. Rotating inhaled Cayston and Tobi is considered the standard of care for patients with cystic fibrosis and is consistent with the FDA recommendations for both drugs. Thus, the requested Cayston 75 mg/mL vial-neb is medically necessary for treatment of this patients cystic fibrosis. 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 pulmonary 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: Overturned

The patient is a 56-year-old male with a long-standing history of polycythemia vera (PCV) and thrombocytosis, with both ischemic and bleeding complications. He has non-healing lower extremity ulcers that may be secondary to hydrea and/or exacerbated by his diabetes. The patients request for authorization of Gleevec was denied based upon the Health Plans determination that it is not medically necessary to treat his PCV.There are relatively few treatment alternatives available for this patient.  He is at greater risk for ischemic or thrombotic complications due to his diabetes and the difficulty he has had controlling his PCV with conventional treatment. Alpha-interferon is useful for some patients, but is associated with many side effects that would be dangerous in a diabetic and might additionally worsen the patients depression.  Gleevec has been shown to be effective for patients with PCV, and is a reasonable option at this juncture in the course of the patients treatment. Therefore, I have determined the requested medication is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Overturned

A 43-year-old female enrollee has requested Byetta for treatment of the enrollees diabetes. Findings:  The physician reviewer found that Byetta is a drug that has been added to diabetic regimens for weight loss. This patients blood sugar continues to be well controlled on Byetta, diet and exercise. Although it is not known why Avandia was discontinued in this case, the medication was halted in many patients following the release of a meta-analysis in the New England Journal of Medicine that raised the specter of increased myocardial ischemia in Avandia trials. In any event, given the good results this patient has experienced from the use of Byetta, continued use of this medication is medically appropriate and indicated.