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

A 63-year-old female enrollee requested authorization and coverage of a bone stimulatorfor the treatment of charcots joints of her feet. The health plan denied the enrollees request indicating that the requested treatment is experimental.Three physician reviewers performed an experimental/investigational Independent Medical Review.  Each of the three physician reviewers concluded that a bone stimulator is not likely to be more beneficial for treatment of the enrollees charcots joints of her feet than any available standard therapy.  Because all three physician reviewers concluded that the requested treatment is not likely to be more beneficial for treatment of the enrollees medical condition than any available standard therapy, the review organization upheld the health plans denial.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested insertion of two Mobi-C artificial intervertebral discs for treatment of her medical condition. Findings: Three physician reviewers found that this patient has widespread pain, numbness, and tingling involving the top of her head, right face, neck, and right upper extremity and is awakened with bilateral upper extremity tingling and numbness. Her provider reports myotomal symptoms and findings of right C6 and C7 radiculopathies. However, there is a lack of documentation by history and neurological examination of dermatomal and myotomal symptoms and findings consistent with cervical radiculopathies (Corey and Comeau). In addition, she does not have a cervical myelopathy and there is no correlation of her imaging with her clinical examination. The U.S. Food and Drug Administration (FDA) have approved the Mobi-C for two level disc replacements. However, the FDA has also required a seven-year post approval study to determine the long-term safety and effectiveness of this device. This study is ongoing. There are some promising studies of small and of short duration, but no large, controlled, and randomized studies to show long-term safety and effectiveness. All told, the requested insertion of two Mobi-C artificial intervertebral discs is not likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy.  Final Result: Three 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: All three physician reviewers are board certified in orthopedic surgery 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

A 48-year-old female enrollee requested acute inpatient psychiatric treatment for her behavioral health condition. Findings: The physician reviewer found that a portion of the services were medically necessary for treatment of the patients medical condition. The patient, after some time, agreed to a course of ECT. It is reasonable and medically necessary that the patient receive her first treatment as inpatient. In addition, as she had spent years deliberating the procedure, she needed the support of staff to follow through with subsequent acute inpatient services. However, later services were not medically necessary as ECT is frequently performed on an outpatient basis and could be provided at a lower level of care. Therefore, based upon the documentation submitted for review, a portion of the services were medically necessary for treatment of the patients medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

An 80-year-old male enrollee has requested for anodyne therapy for treatment of his gait instability. Findings:  Three physician reviewers found that two randomized, double-blind studies relating to anodyne therapy showed no benefit in terms of sensation/quality of life. The third study showed improvement only in patients with non-severe symptoms.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a 51-year-old woman who has requested coverage for intravenous (IV) Rocephin for an extended period. It appears the patient is requesting eight weeks of therapy, although four and six-week courses of treatment are recommended in the providers letters dated June 2006 and July 2006.The patient notes that she had received oral antibiotics for 15 months with minimal improvement before being started on IV Rocephin. She has apparently already received a three to four-week course of this treatment.A letter from one of the patients provider notes a history of fibromyalgia diagnosed before 2000. The provider appears to have cared for the patient from at least September 2004 to July 2005. He states that she has chronic Lyme disease.There is no history of exposure to ticks or information about place of residence or risk of tick exposure. The definitive tests for Lyme disease [IgM and IgG Western Blots] were both negative by CDC criteria. The patient has tests indicating past EBV virus infection; her provider indicates that he believes this virus is also responsible for some of the patients symptoms. Her non-specific symptoms include fatigue, low-grade fevers, swollen glands, migrating arthralgias, myalgia, palpitations, gastrointestinal disturbances, light sensitivity, flu-like symptoms, sleep disturbances, irritability, memory loss, poor concentration, depression, vertigo, numbness and headaches.At issue is whether additional IV antibiotic therapy is medically necessary.This patient has received at least three weeks of treatment with IV Rocephin. The recommended therapy with IV Rocephin for any form of Lyme disease [per IDSA recommendations] is a maximum of four weeks. There is not clear evidence of this infection in the submitted documentation.The evidence provided is not sufficient to make a diagnosis of Lyme disease. The CDC criteria, when applied to the patients Western Blot results, do not allow a diagnosis of Lyme disease. Furthermore, there is no clinical evidence of specific findings indicative of this infection. Because the diagnosis of Lyme disease is not substantiated, treatment with the IV antibiotic Rocephin is not medically necessary. Even if there was adequate evidence of Lyme disease, there is no support from peer-reviewed studies for a period of more than 30 days of treatment with IV antibiotics. Indeed, except for documented cardiac, neurological or joint disease, there is no indication for a months treatment with Rocephin. Therefore, I have determined the requested therapy is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a 64-year-old female who requested authorization for Provigil.  She has had transient ischemic attacks (TIAs) occurring over the past two years, fatigue and excessive daytime sleepiness.  Her provider has diagnosed circadian rhythm disorder, as the patient is unable to remain awake during the day.  A one-month trial of Provigil appeared to be effective in relieving her excessive daytime sleepiness and fatigue.  The Provigil was used in conjunction with the sleep aid medication, Ambien. The patients daughter stated the medication improved the patients quality of life. Based on the one-month trial, the patients provider has prescribed Provigil 200mg day.  The Health Plan has denied authorization for Provigil as not medically necessary for the treatment of the patients daytime sleepiness.The patient has a history of TIAs and has been diagnosed with circadian rhythm disorder apparently because she has developed unexplained fatigue and excessive daytime sleepiness. It is not clear if or why her TIAs should be the cause of her symptoms. Although the one-month trial of Provigil was effective in relieving the patients symptoms, the Provigil was used in conjunction with Ambien.   The patient should be more thoroughly evaluated in an effort to identify the cause of her hypersomnia.  There has been no polysomnography to defend or refute the current diagnosis, and obstructive sleep apnea should be ruled out. Additionally, it is not clear why Ambien would be prescribed along with Provigil. Perhaps the patients fatigue and excessive daytime sleepiness are treatment related, and due to her medications. If, after further workup, there is objective evidence indicating a need for treatment with Provigil, the patients request should be reconsidered.  Based upon the information set forth above, I have determined the requested medication is not medically necessary for treatment of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary:   An enrollee has requested the Anser adalimumab (ADA) assay for evaluation of his medical condition.  Findings:  Two physician reviewers found that the Anser ADA assay was likely to be more effective for this patient than other available treatment options. In this case, Anser ADA was appropriate for the management of this patient who was being treated with medication, and was still symptomatic. The assay was done to assess the drug levels of ADA and to check the antibodies to ADA so that the appropriate decision could have been made by the treating physician in terms dose adjustment of his current medication, or switching to another biologic. Therapeutic drug monitoring is the clinical practice of measuring drug concentrations or metabolites to attain a targeted concentration in a patients bloodstream, thereby optimizing individual dosage regimens. Maximizing the efficacy of therapies for Crohns disease, while minimizing their toxicity remains the principal objective in developing management strategies for these patients. Recognition of the factors influencing therapeutic response allows clinicians to individualize dosing regimens to meet this objective. In order to optimize therapy, it is critical that providers understand that standard dosing is insufficient for most patients, given the interindividual variability relating to response and tolerability. Therefore, services at issue were appropriate for the management of the patients Crohns disease in order to optimize his therapy.   Final Result: Two reviewers determined that the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.  Credentials/Qualifications:  One reviewer is board certified in internal medicine with sub-specialty certifications in transplant hepatology and gastroenterology and is actively practicing.  Two reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A 57-year-old male enrollee has requested proton beam therapy for treatment of his prostate cancer.  Findings:  The physician reviewer found that whether proton therapy affords any benefit over conventional radiation therapy remains unsettled. Many radiation oncologists indicate that proton therapy has a role in the treatment of some cancer patients. Proton therapy is an accepted, safe and effective treatment modality for prostate cancer (Zietman, et al). However, most reports, including a systemic review conclude that patients treated with proton therapy fare comparably to patients treated with intensity modulated radiation therapy (IMRT) (Vargas, et al). The depth of proton delivery is more susceptible to changes in tissue density (such as changes of air in the rectum). Generally proton beam arrangements are designed so as to not enter through the rectum. Given these issues, there is also the possibility that proton therapy is disadvantageous. The most recent National Comprehensive Cancer Network (NCCN) guidelines for prostate cancer state that, proton beams can be used as an alternative radiation source but proton therapy is not recommended for routine use at this time, since clinical trials have not yet yielded data that demonstrates superiority to, or equivalence of, proton bean and conventional external beam for treatment of prostate cancer. All told, there are no compelling data to suggest that proton therapy is superior to or more beneficial than IMRT. Therefore, the requested proton beam therapy is not supported as medically necessary for treatment of this patients prostate cancer.
Appeal type: Experimental/Investigational
Decision: Overturned

Findings:  The physician reviewer found that An enrollee has requested authorization and coverage for a transoral incisionless fundoplication (TIF) procedure using EsophyX.Findings: Two out of three physician reviewers found that transoral incisionless fundoplication (TIF) is an endoscopic procedure performed under general anesthesia to create a full-thickness serosa-to-serosa plication that is 3 to 5 cm in length and 200 to 300 degrees in circumference. TIF can be performed in patients with typical GERD symptoms, and no or only small hiatal hernia, and the patient in this case meets these criteria. TIF has been compared with PPI therapy in several randomized trials (Witteman, B., et al.). In the latest trial (TEMPO), 63 patients with GERD that was refractory to PPI received TIF versus maximum standard dose PPI therapy (Trad, K., et al., 2015). At six months, both regurgitation and extraesophageal symptoms were eliminated in more TIF than PPI patients (62 vs 5 %). After six months, all patients randomized to PPI elected to cross over to TIF. At three years, 90 % (37/41) of patients reported elimination of troublesome regurgitation (Trad, K., et al., 2017). At five years, regurgitation was eliminated and resolution of troublesome atypical symptoms was achieved in 80 percent of patients, and the average total GERD health-related quality of life score improved from 22.2 to 6.8 (Trad, K., et al., 2018). The data from these randomized trials is convincing. Thus, the requested transoral incisionless fundoplication (TIF) procedure using EsophyX is likely to be more beneficial than any other available standard therapy for the enrollee's condition.Final Result: The reviewers determined that the requested services are likely to be more beneficial than any other available standard therapy for the patient's condition. Therefore, the Health Plans denial should be overturned
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting authorization and coverage for the medication, Otezla, 30mg tablets for psoriasis. He has been taking Otezla for two years and it has controlled his condition. Records indicate a small, erythematous scaly plaque on the left flank and papules on both elbows and knees. The enrollee has experienced significant improvement in his psoriasis since he began treatment with Otezla. He does not want to expose himself to the risks of infection or malignancy associated with Enbrel and Humira. He is unable to participate in light therapy due to work requirements. He and his provider believe Otezla presents fewer risks of serious side effects than methotrexate, cyclosporine, or Acitretin. Per the medical literature, apremilast (Otezla) was approved for use in treating moderate-to-severe plaque psoriasis. A clinical study demonstrated that 29 percent of enrollees receiving 20mg of apremilast twice a day and 41 percent of enrollees receiving 30mg of apremilast twice a day achieved a 75-percent reduction in symptoms by week 16. Study participants receiving a placebo achieved a 6-percent reduction in symptoms. This enrollee has moderate to severe psoriasis. He has been taking Otezla and is responding well, according to the records. There are no head-to-head studies comparing the multiple medications available at this time to treat psoriasis.  In a patient such as this, they list apremilast as a first line agent along with multiple other agents. Otezla has been effective in treating this enrollees condition. There is a risk in changing medications at this time that medications, such as methotrexate, cyclosporine, acitretin, Cosentyx, Enbrel or Humira may not be as effective and could result in a flare up and worsening of his condition. Very recent data indicates that patients started on apremilast were as likely as patients started on a biologic agent to still be on the same medication after a year. These data suggest that the effectiveness of apremilast can be expected to continue. 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 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 similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for oral immunotherapy (OIT) for treatment of the enrollees peanut allergy. Findings:  The physician reviewer found that there is a lack of evidence to support the benefits of OIT for the treatment of peanut allergy. There is conflicting data as to OITs safety and efficacy published in recent literature. Recent studies show promising data for the use of immunotherapy in food allergic patients. However, therapies such as OIT are not recommended for routine clinical practice. The current standard of care in the treatment of food allergies is allergen avoidance and ready access to self-injectable epinephrine. Food allergy is a potentially life threatening condition. There is a lack of U.S. Food and Drug Administration approved therapies, apart from avoidance, patient education, and injectable epinephrine for acute allergic reactions. As such, OIT is an experimental treatment in which food allergic patients consume gradually increasing quantities of the food to increase their threshold for an allergic reaction. This therapy carries a significant risk for allergic reactions. The ability of OIT to desensitize patients to particular foods is well documented, although the ability to induce tolerance has not been established. In sum, OIT will not likely be more beneficial than the standard options for the treatment of this patient. 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 number one is board certified in allergy and immunology with expertise in pediatric allergy 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.Physician reviewer number two is board certified in pediatrics and 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.Physician reviewer number three is board certified in pediatrics and 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: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Zepatier 50-100 mg for 12 weeks.Findings: According to the most recent 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. This recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment-naive genotype 1a patients should be treated with regimens including Zepatier for 12 weeks when NS5A resistance is not found and Zepatier with ribavirin for 16 weeks when NS5A resistance is present. However, the guidelines now state that lack of NS5A resistance testing in genotype 1a patients should not be an impediment to coverage, and recommend 12 weeks of Zepatier when NS5A resistance testing is not available. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, Zepatier 50-100 mg tablets daily for 12 weeks is medically necessary for this patient.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested skilled nursing facility services for treatment of the enrollees medical condition.   The physician reviewer found that the patient underwent lower limb amputation.  Initiation of prosthetic rehabilitation was appropriate, and a long-term mobility goal would be independent community ambulation.  The patient has been undergoing inpatient rehabilitation, but has plateaued at ambulating very short distances with assistance.  Her physical therapy was discontinued, and she has been receiving maintenance therapy from non-therapy staff.  She has otherwise been receiving daily wound care for stable, chronic wounds.  Further care on and after this point could have been provided in the community setting with home services.  All told, skilled nursing facility services at issue were not medically indicated 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 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: Overturned

A 24-year-old female enrollee has requested bariatric Lap Band surgery for the treatment of her obesity. Findings:  The physician reviewer found that Sjostrom and colleagues conducted a study demonstrating that surgical weight loss procedures are the only real alternative for treatment of morbid obesity. Considering this patients BMI and co-morbid conditions, she is an appropriate candidate for weight loss surgery. Furthermore, the medical literature has consistently shown the Lap Band is efficacious and is associated with less morbidity than the Roux-en-Y gastric bypass or the duodenal switch procedure. The Lap Band procedure offers the potential for significant weight loss and is medically appropriate for this patient.