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

Nature of Statutory Criteria/Case Summary: An enrollees parent has requested authorization and coverage for sublingual immunotherapy and/or food tolerance induction. This patient presents with food allergies and eczema. His parent has requested treatment in a tolerance induction program. Currently, the American Academy of Allergy Asthma and Immunology (AAAAI) does not recommend tolerance induction as a standard of care treatment for patients with food allergies due to the uncertainty whether the potential therapeutic benefits outweigh the risks of treatment (Nowak-Wegrzyn, et al.; Gernez and Nowak-Wegrzyn). Although some studies have reported positive outcomes, according to the AAAAI, the interventions and endpoints used in clinical trials have been too inconsistent to establish oral immunotherapy as superior to allergen avoidance. Furthermore, there is significant potential for adverse events including oropharyngeal, respiratory, and gastrointestinal side effects (Scurlock). Therefore, the requested sublingual immunotherapy and/or food tolerance induction is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Findings:  Three of the three physician reviewers found the requested sublingual immunotherapy and/or food tolerance induction is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer 1 is board certified in internal medicine with subspecialty certification in allergy and immunology and is actively practicing. Physician reviewer 2 is board certified in allergy and immunology with subspecialty certification in pediatrics and is actively practicing. Physician reviewer 3 is board certified in allergy and immunology 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for skin grafts, Grafix Prime Q4133, quantity of eight for treatment of the enrollees chronic right ischial and sacral ulcers. Findings:  The physician reviewer found that there is sufficient support the medical literature for the requested services in this clinical setting. Grafix has been U.S. Food and Drug Administration approved for chronic wound treatment and has shown improved success over standard wound therapy in diabetic foot ulcers. In a study by colleagues, the following was concluded, The results of this well-controlled study showed that Grafix is a safe and more effective therapy for treating DFUs [diabetic foot ulcers] than standard wound therapy. In this patients case, he had noted significant improvement in his ischial wound with an approximately 30 percent reduction in volume and resolution of approximately 2 cm of tunneling, based on the documentation provided.  The records also noted that this patient has failed standard wound therapy but had specifically improved while using Grafix. Therefore, Graphix Prime Q4133 skin grafts, quantity of eight, is medically necessary for treatment of this patients medical condition. Final Result: The reviewer determined that the requested services 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 plastic 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.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has digital breast tomosynthesis for evaluation of the enrollee, who was asymptomatic.  Findings: Two physician reviewers found that the submitted documentation supports the service at issue in this clinical setting.  Breast tomosynthesis provides advantages to radiologists interpreting mammograms. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and biopsies and increase in detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of breast tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had the examination been done with two-dimensional imaging alone.Final Result: Two reviewers determined that the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: All three physician reviewers are board certified in diagnostic radiology 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: Overturned

A 51-year-old female enrollee has requested the Flexi-Touch programmable pneumatic compression system for treatment of her lymphedema.  Findings:  The physician reviewer found that there is a paucity of quality studies that compare Flexi-Touch pneumatic compression device to other single or multi-chamber non-programmable or programmable pneumatic compression devices. The effectiveness of a Flexi-Touch pneumatic compression device has been demonstrated in case studies and a couple of small trials to have better efficacy on select patients when trunk drainage is especially a concern. There is one study that compares the pressure applied by Flexi-Touch to a standard pneumatic compression device and the authors report the pressure patterns and magnitudes on treated limbs depend on the device and the differences should be considered in selecting a specific device for each individual patient (Mayrovitz). Per the documentation, the patient is unable to use knee-high stockings and a Bio-Compression Sequential Circulator pump due to progression of the lymphedema in her hips as well as distal legs. She is also unable to tolerate the pressure used in a Bio-Compression Sequential Circulator pump. Since the patient continues to have swelling and pain despite having undergone the other standard treatments, the Flexi-Touch pneumatic compression device has been demonstrated to be medically necessary for management of her condition.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a 51-year-old female with onychomycosis. She is seeking reimbursement for Lamisil tablets for treatment of onychomycosis. The information provided does not demonstrate the patient had a physical impairment or comorbidities. Prior to Lamisil tablets the patient had tried some topical treatments without success. Lamisil is indicated for patients with onychomycosis who have functional impairment and/or comorbid conditions and have laboratory confirmation of tinea. The patient did not meet any of these criteria at the time Lamisil was prescribed. Therefore, there is no evidence demonstrating Lamisil was medically necessary for this patient. Accordingly, I have determined the Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Otezla. Findings:  The physician reviewer found that the records provided for review document that this patient presents with a longstanding history of plaque psoriasis. The patient has been treated with Otezla for the past year and has found good efficacy and has tolerated it well. Otezla is a U.S. Food and Drug Administration (FDA) approved oral medication for the treatment of psoriasis and psoriatic arthritis. Otezla is not considered to be immunosuppressive, as no laboratory monitoring is required for patients using the medication. Alternative treatment with either Enbrel or Humira carry risks of reactivation of latent infections and malignancy. As the patient has been stably treated with Otezla, its continued use is supported as medically necessary. 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 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 male enrollee requested Otezla for medical treatment of his psoriasis.  Findings:  The physician reviewer found that this patient has a history of extensive plaque psoriasis and has responded reasonably well to topical therapies.  However, the extent of his disease requires systemic treatment for best control.  There is no documentation of trial and failure or contraindication to treatment with methotrexate, acitretin, cyclosporine, or ultraviolet light phototherapy.  Given that other first-line therapies have not been trialed, the requested medication Otezla is not medically indicated for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Overturned

A 48-year-old male enrollee has requested for Pegasys for treatment of his hepatitis C virus. Findings:  The physician reviewer found that widespread interest in maintenance therapy has been fueled by the published randomized trial of maintenance therapy with interferon in which patients after six months of virologic nonresponse to interferon received either 24 additional months of interferon or no treatment. The patients who received treatment had significantly lower Hepatic Activity Indices (HAI). At present, there are three large randomized controlled trials of maintenance therapy in patients with HCV infection who failed to achieve sustained virologic response following previous therapy with conventional treatment. The Hepatitis C Antiviral Long-term Treatment Against Cirrhosis (HALT-C) trial, sponsored by the National Institutes of Health, is the largest and best recognized of these studies. These trials are evaluating the efficacy of maintenance therapy in prior non-responders to interferon-containing regimens, and many experts feel that it is very reasonable to offer maintenance therapy with reduced dose of interferon with the intent to prevent further progression of fibrosis in this subset of patients who already have advanced fibrosis/cirrhosis. Such a strategy can prevent these patients from developing complications such as decompensated cirrhosis and hepatocellular carcinoma. There is scientific data documenting the antifibrotic effects of interferon. In a recent study, reversal of fibrosis was observed in 75 of 153 patients (49%) treated with interferon who had baseline cirrhosis. Based on the evidence available to date, it is appropriate to consider the use of low dose maintenance pegylated interferon, which may reduce the risk of histological progression and decompensation in patients with advance fibrosis and cirrhosis as well as the risk of complications.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Odactra 12 standardized quality-house dust mite tablets. Findings:  The physician reviewer found that a study assessing the safety and efficacy of two doses of house dust mite extracts over one treatment year and the subsequent immunotherapy-free year. The authors noted that twelve months of treatment were efficacious and well-tolerated. In a study of 992 adults with house dust mite induced respiratory allergic disease, Demoly and colleagues confirmed the efficacy and safety of sublingual tablets and noted that the treatment effect was present from 14 weeks of treatment onward. Given current medical literature and that house dust mite sublingual immunotherapy is standard of care for the treatment of chronic allergic rhinitis, the requested medication is medically indicated. Therefore, Odactra 12 standardized quality-house dust mite tablets are 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 allergy and immunology 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 31-year-old male enrollee has requested continued skilled nursing facility (SNF) care including speech therapy, occupational therapy, and physical therapy for treatment of his primary lateral sclerosis.  Findings:  The physician reviewer found that primary lateral sclerosis is a progressive degenerative neurological condition resulting in severe chronic disability. Without an effective agent to halt destruction of the neurons, patients generally continue to decline (Ropper and Samuels). Skilled therapy cannot halt the degenerative process (Dalbello-Haas and colleagues). From a review of the patients records, although he did show some progress with high dose steroid therapy, he was unable to continue to improve functionally. The patients provider described the patient as dependent in activities of daily living but noted that he did improve in his ability to feed himself. However, he did not improve in swallowing and was down-graded to thickened liquids. Overall, the records demonstrate the patient has only made minimal gains with skilled therapy and has not progressed with skilled physical therapy as of the date in question. While he requires daily exercise to maintain his current function, exercise can be provided in a variety of ways outside of the SNF setting. Given the patients underlying diagnosis and functional status as of the date at issue, the medical necessity of continued skilled services beyond the last authorized date of service has not been established.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for advanced lipoprotein testing. Findings: Three physician reviewers found that primary prevention guidelines for the management of cardiac risk and dyslipidemia have been established, are periodically updated by expert committees and are endorsed by several national organizations. These guidelines currently do not recommend routine performance of specialized tests in the context of assessing coronary risk including lipoprotein-associated phosholipase A2 (Lp-PLA2), sub-classifications of low-density lipoprotein (LDL), high-density lipoprotein (HDL) subclasses, lipoprotein(a), CRP, high sensitivity CRP, insulin, fibrinogen, genetic testing and homocysteine. Treatment change or addition based on the results of screening with these specialized tests has not been shown to improve cardiac outcome incremental to that achievable by treatment based on standard risk factor profiling and basic lipid analysis. Randomized trials testing treatment with therapy available to reduce homocysteine levels have not shown significant outcomes benefits. Final Result: The reviewers determined that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: All three reviewers are board certified in internal medicine with sub-specialty 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: Overturned

The parent of an 11-year-old male enrollee has requested growth hormone (GH) therapy for treatment of idiopathic short stature.  Findings:  The physician reviewer found that the patient clearly has marked growth deficiency and warrants a trial of GH therapy under the FDA guidelines of 2003 for idiopathic short stature.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for esketamine (Spravato). Findings:  The physician reviewer found that Spravato is U.S. Food and Drug Administration (FDA) approved for use in conjunction with an oral antidepressant in patients with treatment refractory depression who have failed at least two antidepressant medications. Per the FDA, Spravato is effective for the treatment of depressive symptoms in adults with unipolar major depression that include acute suicidal ideation or behavior. Although the parent molecule ketamine has proven efficacy for alleviating suicidal ideation, the evidence supporting use of Spravato is mixed, with one trial yielding some positive results for suicidal ideation and two larger trials finding no benefit (Sancora, et al.; Bozymski, et al.). This patients records lack support or recommendation from the patients provider that he receive Spravato for treatment of his depression. Spravato is recommended for use in conjunction with an oral antidepressant and this patient has failed medication trials with other oral antidepressants. Recent notes suggest that the patient was interested in discontinuing treatment with Wellbutrin. Moreover, the records do not include a providers recommendation for treatment with Spravato, which requires administration in a monitored environment to monitor for side effects. All told, the requested esketamine (Spravato) is not medically necessary for 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 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 63-year-old male enrollee has requested for lumbar spinal fusion surgery for treatment of his low back pain.  Findings:  The physician reviewer found that the submitted documentation fails to establish the medical necessity of the requested procedure. The medical records fail to show evidence of spondylolisthesis either on x-ray or MRI. In addition there is no evidence of instability. According to Bambakidis and colleagues indications for surgical fusion include instability, spondylolisthesis at the indicated segment, scoliosis, infection, tumor, fracture and spinal stenosis (Bambakidis et al). In this patients case, he does not have any of the accepted criteria listed above. Thus, the requested procedure is not medically necessary for treatment of the patients medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

A 50-year-old female enrollee has requested for Alimta (pemetrexed) for treatment of her ovarian cancer.  Findings:  The physician reviewer found that Alimta (pemetrexed) has been approved for use in mesothelioma and non-small cell lung carcinoma, and has begun trials in ovarian cancer. The ASCO 2008 abstract wherein 61 patients similar to this one were treated with Alimta. One patient had a complete remission and 19% had partial responses, with a median overall survival of 11.4+ months. There is a 2009 trial reported (see Vergote, et al.) wherein 102 similar patients were treated with two different doses of Alimta. The overall response rate was about 10% and the median survival was about 11 months. The conclusion was that the drug had some activity in ovarian cancer.Neither of these studies demonstrated a high level of activity, such that Alimta remains an investigational agent in ovarian cancer.
Appeal type: Medical Necessity
Decision: Upheld

A 29-year-old female enrollee has requested an electric wheelchair for the treatment of her chronic fatigue syndrome. Findings:  The physician reviewer found that the submitted documentation does not sufficiently establish the need of an electric wheelchair for this patients condition. The notes from the physical therapists home evaluation do not support the need for an electric wheelchair. There is no clear reason as to why the patient would be confined to a bed or chair without an electric wheelchair. This patients diagnoses are not typically associated with the need for an electric wheelchair. Her vital signs were not suggestive of orthostatic hypotension at the time of her physical therapy visit. In fact, her vital signs are more suggestive of deconditioning than orthostatic hypotension. As such, an electric wheelchair is not medically indicated for this patient.
Appeal type: Experimental/Investigational
Decision: Overturned

A female enrollee requested breast tomosynthesis for medical evaluation of her risk for breast cancer. Findings:  Three physician reviewers found that in this particular patient, she has had multiple prior mammograms which have presumably noted heterogeneously dense breasts based on comparison to prior studies.  As a basic observation, tomosynthesis is rapidly becoming a standard tool in this clinical setting. Thus, breast tomosynthesis was likely to have yielded additional data helpful in evaluating this patients medical condition beyond that expected with standard therapies.
Appeal type: Medical Necessity
Decision: Upheld

A 55-year-old female enrollee has requested a nerve conduction study of the right foot for evaluation of her right foot pain and numbness.  Findings:  The physician reviewer found that based on the available medical records, although the patient presents with complaints of pain and numbness in the right foot, multiple evaluations did not reproduce any of her symptoms or reveal any serious complications from the right foot surgery. The records document the provider recommended further evaluation with magnetic resonance imaging (MRI) and clinical follow-up, which is appropriate given the clinical findings. The records indicate that tarsal tunnel syndrome and radiculopathy have been ruled out. The patients description of hypersensitivity to the area suggests some nerve irritation that may be due to postoperative edema or iatrogenic nerve disruption. However, objectively identifying nerve pathology is difficult and biopsy can worsen the symptoms. Further, nerve conduction studies for digital nerves are frequently inconclusive (Spaans). Neuropraxia with resultant numbness is a common surgical complication that is usually benign (Whitlock). Treatment consisting of physical therapy and pharmacologic options are considered the standard of care. Given the normal findings on physical evaluation and neurological exam, the requested nerve conduction of the right foot is not medically necessary for evaluation of this patients medical condition.