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

A 44-year-old male has requested pro-disc cervical artificial disc replacement surgery for treatment of the his cervical radiculopathy.  Findings:  Three physician reviewers found that the patient has a nearly 2-year history of neck pain with some radiation into the left upper extremity in a C7 type distribution. The records indicate he has been treated with pain medications. His exam showed left triceps atrophy and 4 of 5 triceps strength with an absent triceps reflex. A magnetic resonance imaging (MRI) has shown C6-7 degenerative disc disease with severe foraminal narrowing on left. The patients provider noted options to include a posterior foraminotomy or artificial disc replacement (ADR). The provider recommended the ADR procedure. The use of ProDisc-C remains unproven as this device has not been proven to have long-term safety and effectiveness in properly designed randomized controlled clinical trials. There have been a number of published studies that have shown promising results with this procedure. However, these studies have either a small number of patients or only include short-term follow-up (Murrey, et al; Delamarter, et al). Further, the Food and Drug Administration (FDA) has required a post-approval study which is still ongoing.
Appeal type: Medical Necessity
Decision: Upheld

A 48-year-old female enrollee requested authorization and coverage of a 90-day supply of estrogen patches per month. The Health Plan has denied the request indicating that the requested prescription is not medically necessary for treatment of the enrollees migraine headaches and menopausal symptoms.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer upheld the Health Plans denial on the basis that the requested prescription is not medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

An enrollee has requested reimbursement for advanced lipoprotein testing services (CPT 83698, 83695, and 83704). Rosenson and colleagues noted that there may be a role for the measurement of low-density lipoprotein (LDL) cholesterol particle concentration, or the surrogate measure of apolipoprotein B, in patients with insulin resistance disorders who have not achieved their minimal acceptable LDL cholesterol targets. This patients records do not include documentation of an insulin-resistant disorder. Thus, the patient does not meet the criteria for lipoprotein B measurement as performed under CPT code 83704. With regard to CPT code 83695, the records supplied do not indicate any hepatomegaly or other reason to suspect hepatic steatosis to support an indication for this testing. CPT code 83698 can be performed to assess cardiovascular risk as associated with a variety of markers of inflammation, though to a lesser extent than C-reactive protein. Elevated levels of lipoprotein-associated phospholipase A2 have been reported as markers of increased cardiovascular disease risk. However, there is a lack of data in the peer-reviewed medical literature to support improved patient health outcomes with the use of this testing in this patients clinical setting. For these reasons, the advanced lipoprotein testing services (CPT 83698, 83695, and 83704) were not likely to be more beneficial for the evaluation of the patients medical condition than any available standard therapy.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for transoral incisionless fundoplication (TIF) procedure utilizing the EsophyX device (CPT code 43210). The efficacy of transoral incisionless fundoplication (TIF) has been studied in randomized controlled trials. However, the conclusions are contradictory. The American College of Gastroenterology (ACG) guidelines for treatment of gastroesophageal reflux disease (GERD) report that the usage of current endoscopic therapy or TIF cannot be recommended as an alternative to medical or traditional surgical therapy. Researchers found that further studies are required to define optimal techniques and most appropriate patient selection criteria, and to further evaluate device and technique safety. Guidelines from the American Society for Gastrointestinal Endoscopy (ASGE) do not recommend endoscopic procedures for patients with complicated GERD, which the guideline defines as dysphagia or Barretts esophagus, and report that the long-term follow-up data for TIF are limited. This patient is reported to have both dysphagia and Barretts esophagus. For these reasons, the TIF) procedure utilizing the EsophyX device (CPT code 43210) is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Findings:  Three physician reviewers found the TIF procedure utilizing the EsophyX device (CPT code 43210) 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 TIF procedure utilizing the EsophyX device (CPT code 43210) is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in internal medicine with sub-specialty certification in gastroenterology 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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for treatment from a naturopathic doctor (ND). The documentation provided supports that this patient has had chronic abdominal pain due to adhesions from previous intra-abdominal surgeries. The patient also has IBS status post partial colectomy. Her current treatment plan includes management by a gastroenterology, physical medicine, and surgery, as well as physical therapy. The documentation indicates the patient has been tolerating an oral diet and is working with a nutritionist. The provider recommended a nutritional supplement, UltraInflamX Plus 360. According to the current medical literature, the treatment for chronic abdominal pain in this clinical setting is surgery with lysis of adhesions. The documentation from the provider does not contain a physical examination, testing, a comprehensive assessment, or plan of care. The recommended treatment included a protein nutritional supplement, which is not the appropriate treatment for chronic pain due to abdominal adhesions and small bowel obstruction. All told, the requested treatment from an ND is 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 internal 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization for hand prosthetics. Upper limb prostheses are used for amputations at any level from the hand to the shoulder. The need for a prosthesis can occur for a number of reasons, including trauma, surgery, or congenital anomalies. The primary goals of the upper limb prostheses are to restore natural appearance and function. In this case, the requested prosthesis is not purely for cosmetic reasons. The patient has partial preservation of their thumb and would be expected to be able to perform opposition with the digits of the prosthesis. The patient currently does not use their hand when in public and uses an assistive device in their right hand. Providing a partial hand prosthesis is within the standard of care for treating the patients condition and considered medically necessary.Furthermore, the patients condition constitutes an abnormal structure of the body. The amputation is an abnormality due to trauma, and a prosthesis would be expected to improve the patients function, create a normal appearance to the extent possible, and provide more than a minimal improvement in the appearance of the patients hands. Therefore, the requested hand prosthetics is medically necessary to treat the patients medical condition.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 physical medicine & 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: Overturned

A 31-year-old male enrollee has requested for Vivitrol injections for treatment of his alcohol addiction. Findings:  The physician reviewer found that he did not tolerate the brief trial of naltrexone and the trial of Campral showed both side effects and ineffectiveness.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Rexulti 1 mg daily.Findings:  The physician reviewer found that records provided for review document that this patient presents with a history of moderate major depressive disorder and generalized anxiety disorder. The records indicate that the patients conditions have been non-responsive to multiple therapies including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitor (SNRIs), and norepinephrine and dopamine reuptake inhibitors (NDRIs). Per the provider, the patients mood improved substantially with Rexulti. The provider has recommended continued treatment with Rexulti. However, the available documentation does not support that this patient has undergone an adequate trial of a first-line augmenting atypical antipsychotic. Data yielded from double blind randomized placebo controlled trials reported that patients who added Rexulti to their current antidepressant experienced a greater improvement in their symptoms of depression than the patients who continued taking only their antidepressant (Zhou, et al.; Cantu, et al.). Based on the clinical trial data, the U.S. Food and Drug Administration (FDA) approved Rexulti for augmentation therapy for the treatment of patients with major depressive disorder. Several atypical antipsychotic augmentation strategies exist for the treatment of patients with major depressive disorder including aripiprazole, quetiapine extended release, and Rexulti. A systematic review by Zhou and colleagues found that all standard dose atypical antipsychotics for the adjunctive treatment of patients with resistant depression are efficacious in reducing depressive symptoms. However, there is a lack of data demonstrating that Rexulti is more effective than other atypical antipsychotics in treating patients with major depressive disorder. Moreover, the requested Rexulti 1 mg daily is not in accordance with the generally accepted standards of mental health and substance use disorder care, or clinically appropriate in terms of type, frequency, extent, site, and duration. Given these findings, the requested Rexulti 1 mg daily is not 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 psychiatry with subspecialty certification in preventive 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 reimbursement for services. This patient fell and sustained injuries to both lower extremities. She was unable to ambulate. Therefore, she was admitted to an acute inpatient level of care. She was found to have a sprain of the left knee with a fractured right fibula and avulsion injury to the right anterior cruciate ligament. She was treated conservatively with pain medications and placed in a controlled ankle movement (CAM) walker. Her pain was under control with oral medications, and she was hemodynamically stable. Laboratory studies were unremarkable, and there were no acute exacerbations of chronic medical problems. She did not have any parental medications or complex wounds. The patient was medically stable and no longer required care at an acute inpatient level of care. She could have been treated at a lower level of care. Therefore, the services at issue were not medically necessary for the 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 internal 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: Overturned

A 37-year-old female enrollee has requested Xolair (375 mg) for treatment of her persistent asthma. Findings:  The physician reviewer found that Omalizumab (Xolair) is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial allergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions. Xolair information distributed by the manufacturer describing clinical studies indicates; All patients are required to have a baseline IgE between 30 and 700 IU/mL and body weight not more than 150 kg. This patient meets the clinical criteria for Xolair requiring moderate-severe persistent asthma with a perennial allergen and recent exacerbations despite the use of optimal treatment with inhaled steroids and leukotriene modifiers. She has also stopped smoking. Her only exception to the criteria is the rather arbitrary cut off of 700 IU/mL of IgE based upon the initial placebo controlled studies used to obtain FDA approval. However, since this patient has a severe, potentially life-threatening illness that has failed other treatments and is known to respond to Xolair treatment, this drug should be considered medically necessary for this patient.
Appeal type: Medical Necessity
Decision: Overturned

A 69-year-old male patient is requesting treatment with a PDE-5 inhibiting medication, specifically Cialis, for erectile dysfunction.  This medication has been effective for him when prescribed earlier.  His provider has diagnosed him with impotence of organic origin.  He also has a diagnosis of hyperlipidemia and treatment with lovastatin has been prescribed.  The Health Plan has denied coverage for Cialis on the basis that there is no recognized medical causation for the patients erectile dysfunction, and therefore, no medical necessity for Cialis.Review of the submitted evidence indicates this patient does have an organic basis for his erectile dysfunction, specifically vascular disease with documented hyperlipidemia. Treatment with PDE-5 inhibitor medications such as Cialis is accepted primary therapy for erectile dysfunction and is often successful. In fact, the patient has experienced benefit from Cialis in the past. 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: Upheld

A 61-year-old female enrollee has requested a functional electrical stimulator for treatment of her foot drop secondary to multiple sclerosis. Findings:  The physician reviewer found that the device at issue is primarily a compensatory orthosis that triggers ankle dorsiflexion using peripheral neural pathways during the swing phase of gait.  The same result, however, is accomplished using a conventional (passive) ankle foot orthosis (AFO) such as a molded thermoplastic AFO. Claims that electrical stimulation of the peripheral neuromuscular system confers sustained strength benefits and significant functional benefit (i.e., while the orthosis is not being worn) have not been substantiated in a scientifically rigorous and disinterested manner to date.  Laufer and colleagues reported some findings in a small case series suggesting some improvements in gait parameters after one year of use of a functional electrical stimulator for foot drop, even with the device off.  There was, however, no control group (i.e., the effect of the device could not be discerned from training effect or from retesting effects).   In the present case, it is not evident that the patient had been trialed with conventional AFOs that had been optimally fitted.  Overall, the efficacy of the functional electrical stimulator in this clinical scenario has not yet been established in the medical literature.  All told, the submitted documentation does not establish the medical necessity of the device at issue.  In this patients case, the functional electrical stimulator was not medically indicated.
Appeal type: Medical Necessity
Decision: Overturned

A 39-year-old female enrollee has requested authorization an MRI of the lumbar spine and an MRI of the cervical spine for evaluation of her lower back and neck pain. Findings:  The physician reviewer found that the submitted documentation demonstrates the medical necessity of the requested MRI of the cervical spine. The patient has a history of progressive neck and arm pain consistent with radiculopathy. Additionally, the patients exam findings are consistent with myelopathy with hyper-reflexivity. Imaging of the cervical canal has not been performed. The patient meets accepted clinical indications for MRI imaging, specifically, subacute or chronic neck or radicular pain and clinical suspicion of cord compression or myelopathy (Milliman Care Guidelines). Furthermore, the patient is being considered for invasive injections. As such, the requested MRI of the cervical spine is medically indicated and necessary. The requested MRI of the lumbar spine is also supported as medically necessary in this case. The patients previous lumbar MRI shows a large L5/S1 disc herniation that seemingly resolved. Further herniation or return of the herniation on subsequent MRIs is possible in this setting, although this is not addressed by the available literature. In any event, the patient has progressive back and radicular symptoms. She has also failed many months of conservative measures and is being considered for invasive injections. The patients last MRI was over two years ago and her symptoms have changed. Additionally, the study by Al Nezari and colleagues emphasizes the point that the neurological exam has poor diagnostic accuracy for detecting clinically significant disc herniations. Based on review of the available evidence, the requested MRI of the lumbar spine is medically necessary for evaluation of the patients medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with relapsing-remitting multiple sclerosis. The records noted that recent magnetic resonance imaging (MRI) demonstrated multiple subcortical and periventricular white matter lesions and a single tiny enhancing lesion in the right cerebellar white matter, radiologically suspicious for multiple sclerosis. The MRI was initially done because of symptoms of hearing loss and intermittent tinnitus. The provider noted that a lumbar puncture confirmed findings consistent with multiple sclerosis with 12 oligoclonal bands in the cerebrospinal fluid. The patient reported right hand/forearm numbness and tingling that began two to three years prior. The provider noted that the patient was John Cunningham (JC) virus antibody negative. During that visit, the provider and patient discussed the diagnosis of multiple sclerosis and the need for medication. The documentation noted concerns regarding side effects. The patient reported a history of multiple side effects to medications in general, including anaphylaxis. She reported that she desired to avoid injectable medications. The patient has requested authorization and coverage for Tecfidera (dimethyl fumarate), 120 mg daily for two weeks and 240 mg daily thereafter. The Health Plan has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The Health Plan noted that the formulary alternatives include Extavia, glatiramer and Gilenya. This denial is the subject of this appeal and determination. At issue is whether Tecfidera (dimethyl fumarate), 120 mg daily for two weeks and 240 mg daily thereafter is medically necessary for the treatment of this patient. Dimethyl fumarate had a lower annualized relapse rate versus the interferons, glatiramer and teriflunomide populations and similar to fingolimod populations. Thomas and colleagues reviewed the safety of the three oral agents approved by the U.S. Food and Drug Administration for the treatment of relapsing-remitting multiple sclerosis, fingolimod, teriflunomide and dimethyl fumarate. Finally, the safety profile of Tecfidera is potentially less harmful than Gilenya, the other oral alternative. Therefore, Tecfidera (dimethyl fumarate), 120 mg daily for two weeks and 240 mg daily thereafter 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 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: Experimental/Investigational
Decision: Upheld

A 49-year-old male enrollee has requested authorization and coverage for a ProDisc C artificial disc replacement of the neck bone for treatment of the his neck and bilateral arm pain. Findings:  Three physician reviewers found that there are no large, multicenter double-blind studies examining the safety and effectiveness of total disc replacement utilizing the ProDisc C (Matz, et al.). When comparing decompression and fusion procedures to total disc arthroplasty, one study found that the arthroplasty group had superior outcomes (Mummaneni, et al.), while another found clinical improvement in both the arthroplasty group and the decompression and fusion group (Porchet and Metcalf). However, both studies precluded conclusions from being drawn, due to lack of blinding and randomization, as well as multiple confounding factors and lack of follow-up with patients.