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

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for 12 weeks for treatment of the enrollees hepatitis C virus. Findings: The physician reviewer found that according to the joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. In addition, the guidelines recommend that treatment-naive genotype 4 patients should be treated with Harvoni for 12 weeks. This is based on the SYNERGY trial for Harvoni, which showed a 100% cure rate despite including some patients who had failed prior therapy (Kohli, et al). The AASLD/IDSA guidelines cite data showing decreased survival with delay in therapy (Jezequel, et al). For these reasons, treatment with Harvoni for 12 weeks is medically necessary for the treatment of the patients hepatitis C infection.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: Upheld

Nature of Statutory Criteria/Case Summary:  The patient is a 56-year-old female with Parkinsons disease (PD). The patient was diagnosed with PD. She was started on carbidopa/levodopa (Sinemet) 25/100mg three times a day. Per a letter from her provider, she was unable to tolerate a full dose of the drug due to side effects. She then tried one-half tablet three times per day, but this was not effective for symptom control. She was then started on a treatment course of one-half tablet every three hours. Per the provider, this dosing schedule was only partially effective. The record indicated that while the patient had an improvement on Sinemet IR, there was also noted to be a degree of fluctuation in her symptomatic control.  The patient was started on a trial of Rytary ER. The patient has subsequently reported improvement in control of her motor symptoms. Laboratory results revealed a glomerular filtration rate (GFR) of 54 and a creatinine of 1.14 indicating mild kidney disease. The patient has requested authorization and coverage for Rytary ER 23.75mg 95mg capsules. At issue in this case is whether Rytary ER 23.75mg 95mg capsules are medically necessary for the treatment of this patient. In general, the treatment of PD involves a flexible trial-and-error approach. Current guidance statements from the International Parkinson and Movement Disorder Society indicate that therapy with levodopa/peripheral decarboxylase inhibitor agents is effective. However, these same guidelines do not readily recommend the use of one particular formulation of levodopa over another.  In clinical practice, the newest extended release formulation of carbidopa/levodopa is generally reserved for use in patients with more advanced forms of the disease who have not responded to multiple initial therapies from different classes. In this case, based on the medical records provided for review, the patient is newly diagnosed and cannot be said to have an advanced form of the disease. The use of the requested medication would not be consistent with other treatment approaches of initial motor symptoms of PD given the symptomology and the period of time since diagnosis. The patients mild kidney disease would not preclude the use of other medications. Therefore, Rytary ER 23.75mg 95mg capsules are not medically necessary for the treatment of the patients medical condition.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 neurology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

The parent of an 8-year-old male enrollee has requested 20 hours of applied behavioral analysis (ABA) therapy a week and 8 hours a month of supervision for treatment of the enrollees autism.  Findings:  The physician reviewer found that applied behavioral analysis has been shown to be effective in treating behaviors associated with autism spectrum disorder (Rogers, et al). Treatments based on operant principles of learning are more effective for reducing maladaptive behaviors than alternative treatments. Warren and colleagues reviewed 34 studies of early intervention in autism. They concluded that studies of Lovaas-based approaches and early intensive behavioral intervention variants and the Early Start Denver Model resulted in some improvement in cognitive performance, language skills, and adaptive behavior skills, (Warren, et al.). Additional studies have shown that ABA methods continue to result in positive outcomes with individuals with autism and intellectual disability (Kelley, et al.). Evidence-based studies also noted improvement of function in older children with autism spectrum disorders using intense ABA interventions (Kelly, et al.) The goals for older children often are to identify and remediate particular deficits.Although substantial gains are generally made after one year of ABA therapy when compared to controls, further gains have been noted in subsequent years (Granpeesheh, et al.). Treatments based on operant principles of learning were noted to be more effective for reducing problem behaviors displayed by individuals with intellectual disabilities and autism than were alternative treatments (Grey, et al.). As documented in the patients recent behavioral intervention progress report, the behaviors in this patient that need to be addressed include maladaptive behaviors of communication, noncompliance, tantrums, increasing functional life skills as well as social, safety and language skills. Thus, the requested frequency of 20 hours per week of ABA therapy with 8 hours supervision is medically appropriate and necessary to address these deficits.
Appeal type: Experimental/Investigational
Decision: Upheld

The parent of a 16-year-old male enrollee has requested authorization and coverage for subtalar arthroereisis for the treatment of the enrollees painful pes planus. Findings:  Three physician reviewers found that subtalar arthroereisis is a procedure indicated for flatfoot deformity and involves insertion of an implant into the sinus tarsi without resection of the bone. The implant acts as a block for the purpose of restricting subtalar joint pronation while preserving supination. The scientific studies available are inconclusive regarding the long-term safety and efficacy of the procedure. Needlemans small study of 28 patients concluded that the procedure may be comparable to other operations for flexible flatfoot deformities in adults but was not demonstrated to be superior. This procedure lacks valid clinical evidence that it has a greater likelihood of benefitting this patient over alternative treatments. According to the American College of Foot Surgeons, there is still concern over placement of the device into a mobile segment of a childs foot and therefore the procedure remains investigational.
Appeal type: Experimental/Investigational
Decision: Overturned

A 60-year-old female enrollee has requested a PET scan for an evaluation of her pancreatic ductal adenocarcinoma. Findings:  Two physician reviewers found that a PET scan is indicated in this patients case, as it may aid in determining the extent of disease. Additionally, a PET scan is appropriate when more standard imaging modalities are unable to conclusively provide required information. PET scans have been shown to have increased sensitivity in comparison to computed tomography (CT) studies and have been shown to change management in patients with invasive cancer. In this patients case, preoperative scans did not detect metastatic disease. A PET scan is likely to be the most efficacious method of evaluating this patients medical condition and is the next appropriate step for the care and management of this patient.
Appeal type: Medical Necessity
Decision: Overturned

A 25-year-old female enrollee has requested Opana ER 20 mg tablets, 3 times per day for treatment of her cervical spondylosis. Findings:  The physician reviewer found that in the medical literature, Opana is a well documented long acting Mu agonist with potent binding affinity at central receptors with less availability in the periphery causing decreased pruritis. The recommendations indicate that it should only be dosed twice daily due to the extended half life. As reported by Matsumoto in his study, this is also one of the benefits of the medication. The opioid rotation idea is consistent with the standard of care and can vastly lower the doses needed based on receptor subtype and distribution throughout the CNS and spinal column. Thus, for this patient, the approved dosage should be Opana ER 30 mg, twice per day, as the medical necessity of this medication has been established in this case, but the guidelines have not approved the requested dosage.
Appeal type: Experimental/Investigational
Decision: Upheld

A 44-year-old male has requested coverage for Afinitor (everolimus) for treatment of his grade IV anaplastic astrocytoma.  Findings:  Three physician reviewers found that this patient is diagnosed with an anaplastic astrocytoma. He has undergone multiple treatments, including surgery, radiation therapy, and temozolomide.  His physician recommends treatment with pazopanib, phenylbutyrate, erlotinib, and everolimus. Everolimus has shown some efficacy in the treatment of renal cell carcinoma and pancreatic neuroendocrine cancers. In several benign central nervous system lesions, it has also shown evidence of benefit. There is no data available in the peer-reviewed medical literature to support the use of everolimus in the treatment of anaplastic astocytoma. In addition, when considering combination therapy, such as that recommended in this case, it is not possible to determine whether the agents may be agonist or antagonists to each others, as there are no studies demonstrating the efficacy of these medications in combination. Overall, there is no support for the use of everolimus the treatment of anaplastic astrocytomas, as has been proposed in this particular case.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement and prospective authorization and coverage for Taltz 80 mg/mL auto-injector. In recent years, biologic medications such as Taltz, have shown to control disease safely for the majority of patients with chronic plaque psoriasis. The U.S. Food and Drug Administration (FDA) approved Taltz for the treatment of patients with chronic plaque psoriasis. According to the American Academy of Dermatology (AAD) and the National Psoriasis Foundation (NPF), Taltz is recommended as a monotherapy treatment option for use in adult patients with moderate-to-severe plaque psoriasis (Menter, et al.). As noted in the medical literature, additional data in the medical literature has reported significantly improved patient satisfaction with Taltz when compared to Enbrel for patients with moderate-to-severe disease. This patient presents with chronic plaque psoriasis that has failed to improve despite treatment with clobetasol and Epiduo Forte. Given these findings, the Taltz 80 mg/mL auto-injectors were and are medically necessary for treatment of this patient. Final Result: The reviewer determined that the medication at issue was and 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: Upheld

A 64-year-old female enrollee has requested a replacement CPAP full face mask (A7030) for treatment of her stated condition of mild sleep apnea.  Findings:  The physician reviewer found that upon review of the submitted clinical documentation, a diagnosis of mild sleep apnea is not supported. The records do not document clinical findings consistent with obstructive sleep apnea. As noted above, the patients polysomnogram revealed an AHI of zero. According to criteria set forth by the American Academy of Sleep Medicine (AASM) and the Centers for Medicare & Medicaid Services (CMS), CPAP therapy is not indicated for individuals with an AHI less than 5. Therefore, the patient does not meet accepted clinical indications for CPAP therapy. The use of a CPAP mask for episodes of non-positional snoring without evidence of apneas or hypopneas is not medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

A 26-year-old male enrollee has requested for participation in a clinical trial of ZIO-201 for treatment of her desmoplastic small round blue-cell tumor. Findings:  Two physician reviewers found that isophosphoramide mustard is an investigational agent of no known benefit in sarcomas. It is currently being studied in a phase IB/IIA trial, with focus on determining dose and toxicity. This drug is undergoing study in a clinical trial without any evidence as yet of clinical benefit. Given that it has no proven clinical benefit, there is inadequate evidence to support its use in this setting.
Appeal type: Medical Necessity
Decision: Overturned

The enrollee is requesting authorization and coverage for excision, excessive skin and subcutaneous tissue (includes lipectomy), and abdomen, infraumbilical panniculectomy. The enrollee had gastric bypass surgery for weight loss. The enrollee reports she now has excess abdominal skin that causes irritation, itchiness, redness, and prevents her from participating in certain activities. A progress note showed the enrollee had a large pannus with candidiasis. Her surgeon states that they have tried conservative treatment, including over the counter medications, but she has not had any positive results. The enrollees surgeon indicates the skin removal surgery is medically necessary for the enrollees medical condition, health, quality of life, and to increase her level of activity. Literature shows panniculectomy procedures have been shown to improve quality of life, increase mobility, and improve hygiene in those with a significant pannus formation. Researchers note panniculectomy individuals have usually experienced a dramatic weight loss, and, as a result, the excess abdominal skin overhangs the groin and pubic regions and may strike against the thighs as the person walks, causing significant discomfort and irritation. Because the risks of surgery are relatively high, researchers report surgical management for unresponsive intertrigo, rashes, cellulitis, skin necrosis, ulcerations, or significant excess skin which interferes with function is reserved for those who have failed all conservative medical management options. This enrollee has excess skin that is causing infections, which have not improved with conservative measures. Therefore, this enrollee is a good candidate for the requested procedures.Final Result: The reviewer determined that the requested services are medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in 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 similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested applied behavioral analysis (ABA) services, supervision and parent training for treatment of his autism spectrum disorder. Findings:  Three physician reviewers found that the medical evidence supports the requested services in this clinical setting.  At issue is the notion that plasticity in the developing brain, albeit a brain with underlying neurologic disease, exists and can be utilized to improve overall neurologic health.  Thus, a treatment paradigm like ABA has the potential to help induce brain plasticity, with the ultimate goal of retraining neural circuitry not compromised by the underlying pathogenetic processes that give rise to the developmental delays and social disconnection associated with autism spectrum disorder.  Thus, the requested ABA therapy, supervision and parent training are medically indicated for the treatment of this patient. Final Result: Three reviewers determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned.Credentials/Qualifications: One reviewer is board certified in pediatrics with sub-specialty certification in developmental-behavioral pediatrics and is actively practicing. Two reviewers are board certified in neurology with special qualification in child neurology 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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for bilateral mastectomy and chest reconstruction surgery. Findings:  The physician reviewer found that he World Professional Association for Transgender Health (WPATH) states, Chest surgery in female-to-male patients could be carried out earlier [than 18], preferably after ample time of living in the desired gender role and after one year of testosterone treatment. The intent of this suggested sequence is to give adolescents sufficient opportunity to experience and socially adjust in a more masculine gender role, before undergoing irreversible surgery. However, different approaches may be more suitable, depending on an adolescents specific clinical situation and goals for gender identity expression. Olson-Kennedy and colleagues report that chest surgery is an effective treatment of gender dysphoria in minors, stating, Chest dysphoria was high among presurgical transmasculine youth, and surgical intervention positively affected both minors and young adults. Given these findings, professional guidelines and clinical practice should consider patients for chest surgery based on individual need rather than chronologic age. In this case, while the patient is noted as having an episode of suicidality in November 2021, such an episode is not a permanent bar to treatment and the submitted records include a letter from the patients psychologist reporting that the patient's mental illness is now relatively well-controlled. Given that the patient has a long-standing identity as male and has been on testosterone for over a year, the requested services are medically indicated. Therefore, bilateral mastectomy and chest reconstruction surgery are medically necessary to promote physical and mental health and efficiency and to ameliorate behavioral conditions. 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: Overturned

A 34-year-old female enrollee has requested breast reduction surgery for treatment of her bilateral macromastia.  Findings:  The physician reviewer found that the review of the submitted documentation and relevant literature demonstrates the medical necessity of the requested procedure. Based upon the documentation submitted for review the patients loss of cervical lordotic curve, complaints of neck and shoulder pain, shoulder bra strap grooving and hyperpigmentation along bra strap lines are due to macromastia. Breast reduction surgery is effective in relieving the symptoms related to large breasts such as back pain, neck pain and skin breakdown. A Schnur Sliding Scale was developed to relate the amount of breast tissue removed to preoperative body mass surface area as a means of differentiating cosmetic from reconstructive medically necessary breast reduction surgery prior to surgery. The scale relates the amount removed to body surface area such as the size of the person rather than just weight or height. In this patients case the removal of 750gm from each breast meets these criteria. All told, based on the medical records submitted for review and the peer-reviewed literature, the requested procedure is medically necessary for treatment of the patients medical condition.