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

A 53-year-old female enrollee has requested Malarone for the treatment of her Babesiosis infectious disease. Findings:  The physician reviewer found that Malarone is a fixed drug combination of two agents (atovaquone and proguanil) that is FDA approved for treatment of malaria. It is not generally accepted therapy for Babesia infection. The report by Vyas and colleagues submitted for review is a study involving Malarone in one HIV infected patient. The article by Krause and colleagues reports on 14 immunocompromised patients with Babesia infection, where only two of the patients were treated with Malarone. The authors note resistance in Babesia to any of the standard treatment agents such as combinations of azithromycin, Clindamycin, doxycycline and quinine has not been reported. The peer-reviewed medical literature does not mention Malarone for treatment of Babesia infection. Mandells Infectious Diseases text does refer to the use of atovaquone in combination with azithromycin or Clindamycin. However, the combination of this drug with proguanil is designed specifically for malaria therapy and is not discussed for use in this setting. Malarone is not standard therapy for Babesia infection. It has been used in only a very few immunocompromised patients who have had relapsing disease. There is inadequate evidence of its efficacy to support its use by this patient.
Appeal type: Medical Necessity
Decision: Upheld

The mother of a seven-month-old female enrollee requested authorization of a battery-operated nebulizer. The Health Plan denied the request indicating that the requested equipment is not medically necessary for treatment of the enrollees medical condition.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer upheld the Health Plans denial on the basis that the requested equipment is not medically necessary.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patients parent has requested reimbursement and prospective authorization and coverage for six months of weekly speech therapy (one hour per week). The records provided for review document that this patient has childhood apraxia of speech (CAS), mild intellectual disability, attention deficit hyperactivity disorder (ADHD), and a behavior disorder. The patient has been treated with weekly speech therapy and the provider has recommended continued services. Morgan and colleagues noted that, CAS affects a childs ability to produce sounds and syllables precisely and consistently, and to produce words and sentences with accuracy and correct speech rhythm. In common with many young patients with disabilities who were converted to therapy by telehealth during the pandemic, the patient has demonstrated difficulty attending to therapy sessions. Summers and colleagues found that physical distancing requirements and closure of schools and services in the context of the COVID-19 pandemic may be particularly challenging for families with children with neurodevelopmental disorders. This patients re-evaluation performed on 9/8/21 occurred after 19 months of telehealth services. Given the patients low scores on the Goldman-Fristoe Test of Articulation both before and after the pandemic, as well as the providers reports that the patients behavior issues have impeded participation in speech therapy, the weekly speech therapy services were and are appropriate to address this patients CAS. All told, six months of weekly speech therapy (one hour per week) was and is medically necessary for treatment of this patient. Final Result: The reviewer determined that the services at issue were and 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 neurology with special qualification in child neurology and expertise in neurodevelopmental disabilities 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the digital breast tomosynthesis performed for evaluation of the enrollees risk for breast cancer. Findings:  2/3 of the physician reviewers found that Tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, by separating the various layers of breast tissue, one can better detect abnormalities. However, in this particular patient, there were no problems to be resolved since the patient does not have dense breasts, she did not have a mass, there were no palpable lumps, and she did not have suspicious calcifications. The 2D images were reconstructed from the primary tomosynthesis acquisition, thus a routine mammogram would have been sufficient. Tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality, especially when there has been no change when compared to multiple prior mammograms over 12 years. For these reasons, the use of the digital breast tomosynthesis performed was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: 2/3 of the reviewers determined that the diagnostic procedure 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: Physician reviewer number one is board certified in diagnostic radiology 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 diagnostic radiology 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 diagnostic radiology 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 44-year-old female has requested approval for duloxetine (Cymbalta) 60 mg capsule for treatment of her lumbago.   Findings:  The physician reviewer found that the patient in this case has two FDA approved indications for the use of Cymbalta at the 60 mg per day dose. Per the records, she has been on Cymbalta for the past five months, and she had a diagnosis of generalized anxiety disorder and musculoskeletal low back pain. The study by Pergolizzi and colleagues reported statistically significant improvement in objective outcomes for depression, anxiety, muscle pain, low back pain, and neuropathy. Thus, Cymbalta is indicated and there is no mention of any contraindication in the clinic notes. Based on review of the available information and the patients diagnoses, Cymbalta is medically necessary at the requested 60 mg dose.
Appeal type: Experimental/Investigational
Decision: Upheld

A 42-year-old female enrollee requested hematopoietic stem cell transplant (HSCT) for medical treatment of her multiple sclerosis. Findings:  Three physician reviewers found that based on the current medical literature, the requested HSCT procedure, preparatory studies and follow-up care is not likely to be more beneficial for treatment of this patients medical condition than any available therapy. There is a paucity of scientific data supporting the safety and efficacy of HSCT in this clinical setting.  Moreover, the U.S. Food and Drug Administration (FDA) have not yet approved the procedure and this patients condition has been responsive to FDA approved, standard medical therapy. Thus, the requested HSCT is not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

The patient has requested reimbursement for air and associated ground ambulance transportation services. The records provided for review document that this patient received acute hospital care in a different state following an injury he sustained. The patient required critical care services and cervical spine surgery. By transport, he was medically stable and ready for inpatient rehabilitation. The patient did not require air ambulance transportation back to his home state at that time. Participation by family members or other members of the patients support system during the rehabilitation process would have been preferable, but it was not a medically necessary for successful inpatient rehabilitation. For these reasons, the air and associated ground ambulance transportation services provided were not medically necessary for 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: Upheld

The spouse of a 53-year-old female has requested continued skilled nursing facility level of care treatment of the enrollee, who is status post cerebrovascular accident. Findings:  The physician reviewer found that the submitted documentation indicates that the patient failed to show significant progress in therapy and remained totally dependent on all functional mobility and she was also dependent in activities of daily living. Per Medicare guidelines, the patients care was custodial in nature as of the said date.  She was stable on her medical regimen, was tolerating an oral diet and had no complex wound care issues. The patient did not require daily skilled level of care nursing or therapies to prevent deterioration in mobility and/or activities of daily living, as she was fully dependent. Based on the documentation provided, the patient has had no identifiable daily skilled nursing needs and has not required skilled interventions on a daily basis.
Appeal type: Experimental/Investigational
Decision: Upheld

A 60-year-old female enrollee has requested artificial disc replacement for the treatment of her cervical stenosis. Findings:  Two physician reviewers found that the proposed procedure is experimental without established long-term safety and efficacy. Available data does not demonstrate an advantage to disc replacement over fusion. There is no clinical indication demonstrating the artificial disc replacement was the best treatment option for this patient. The literature demonstrates anterior cervical discectomy and fusion has an excellent track record of long-term outcomes in this setting.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for an office visit with a podiatrist for treatment of the enrollees medical condition. Findings:  The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. The records noted that the patient has foot pain.  The foot pain is such that her provider cannot treat it, and therefore has requested a referral to podiatry. The patient noted that she has had bilateral foot pain for six months. The medical evidence supports the requested services in this clinical setting. Therefore, the requested office visit with a podiatrist is medically necessary for the treatment of this patient. 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 podiatry 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

Nature of Statutory Criteria/Case Summary: The patient has requested reimbursement for genetic testing (hemochromatosis DNA mutation analysis). This patient presented with an elevated ferritin level. His provider recommended genetic testing to rule out hereditary hemochromatosis (HH). One study noted that although low serum ferritin levels indicate reduced iron stores, raised serum ferritin levels are due to multiple etiologies. Current guidelines recommend a simple iron panel in this clinical setting. An iron transferrin saturation (TSAT) of 45% or higher is consistent with a genetic iron overload disorder. If the TSAT is below 45%, this rules out HH. This finding stands in the face of an elevated ferritin. In this case, the patients TSAT was 11%, which is within the normal range. Thus, the genetic testing (hemochromatosis DNA mutation analysis) was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: Two of the three physician reviewers determined that the services at issue were 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:  The three physician reviewers are board certified in internal medicine with subspecialty certifications in medical oncology and hematology 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 34-year-old male enrollee has requested Fentora 800mcg or Actiq 1600mcg for the treatment of his intractable abdominal pain. Findings:  The physician reviewer found that Actiq and Fentora are approved by the FDA for use in cancer pain patients, and the original package insert specifically states its use is to be limited to cancer pain only. There are no randomized, controlled trials of this medication in non-malignant pain patients. There are a number of other medications on the formulary that are not documented as having been tried. There is no documentation of diagnostic nerve blocks (celiac or superior hypogastric). Additionally, the case series submitted in support of the appeal do not pertain to chronic abdominal pain.
Appeal type: Experimental/Investigational
Decision: Upheld

A 44-year-old female enrollee has requested a chest computed tomography angiography (CTA) for an evaluation of her mitral valve prolapse. Findings:  Two physician reviewers found that CT angiography (CTA) is not an accepted screening or confirmatory test for the diagnosis of coronary artery disease in this patient subset. This diagnostic procedure has not been tested in this subset based upon a thorough literature review, and is not a medically acceptable replacement for other conventional screening tests within the standard of care such as cardiac catheterization. CT angiography is not a medically necessary substitute for coronary angiography, as the former would not be able to accurately confirm or exclude important coronary obstruction. The use of CTA in the diagnosis and prognosis of coronary disease in this subset currently remains an experimental/investigational application of this technology and is not superior to standard modalities.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for lymphovenous bypass surgery. Findings:  The physician reviewer found that eview of the available medical records, this patient presents with significant worsening of her right lower extremity lymphedema despite treatment with conservative management. The patient is noted to have a history of significant weakness and pain in the right lower extremity, due to extensive surgical treatment for cancer with residual lymphedema. The patients provider has recommended treatment with lymphovenous bypass surgery. Although there are limited randomized controlled clinical trials addressing the long-term outcomes for microsurgery of patients with primary or secondary lymphedema, there are adequate reports demonstrating improvements in quality of life and limb reduction. In addition, Drobot and colleagues found that lymphaticovenular anastomosis surgery is a safe and effective method of reducing lymphedema severity, especially in upper extremity lymphedema at an earlier disease stage. Similarly, Chang and colleagues indicated that lymphovenous bypass is effective in reducing the severity in lymphedema in patients with early-stage upper extremity lymphedema. This patients attempts at conservative management have failed to alleviate her symptoms. Therefore, the requested lymphovenous bypass surgery is 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 services are 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 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: Physician reviewer 1 is board certified in vascular surgery with subspecialty certification in general surgery and is actively practicing. Physician reviewer 2 is board certified in vascular surgery with subspecialty certification in general surgery and is actively practicing. Physician reviewer 3 is board certified in vascular surgery with subspecialty certification in general surgery 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: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollee requested authorization and coverage for the ReWalk Personal 6.0 Lower Extremity Robotic Exoskeleton System. The enrollee has a spinal cord injury (SCI) due to a stab wound. This resulted in T6 incomplete paraplegia. She trialed the ReWalk System. The enrollee is currently unable to ambulate due to incomplete lower extremity paresis and is relegated to prolonged sitting due to the absence of capable products and treatments which can help restore her walking abilities. She has lower extremity spasticity that interferes with her sleep and with her safety during transfers. She is at risk for secondary medical complications associated with chronic sedentary behavior and spinal cord injury. Her physician indicates she is already experiencing the positive benefits of walking in a rehabilitation robotic exoskeleton and would greatly benefit from continued use in the home and community setting with the ReWalk. A meta-analysis on the clinical effectiveness and safety of powered exoskeleton systems for individuals with spinal cord injuries concluded the devices allow them to safely ambulate in real-world settings.  However, the outcomes displayed considerable variation in consistency.  A literature data review concluded consistent benefit from rehabilitation using an exoskeleton versus a variety of conventional methods in individuals with chronic spinal cord injury was not demonstrated; adding that trials were needed comparing later-generation exoskeletons. Literature notes the ability of these devices to improve fitness and address the secondary medical complications of SCI remains to be determined. Evidence suggests the devices and benefits significantly differ from bionic to bionic. Current use of these devices occurs primarily within rehabilitation facilities because of limited accessibility and the need for assistive personnel. The practical use of these devices requires technological improvements to provide safety and independence in walking at velocities approaching those of persons without disabilities. Final Result: Three of the three reviewers determined that the requested services are not likely to be more beneficial than any available standard therapy for treatment of the enrollees medical condition. Credentials/Qualifications: Three reviewers are board certified in physical medicine and rehabilitation 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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Xeljanz for treatment of the enrollees rheumatoid arthritis. Findings:  The physician reviewer found that the current peer-reviewed guidelines do not support the use of Xeljanz without demonstration of failure of treatment with methotrexate and at least two anti-tumor necrosis factor (TNF) inhibitor biologic agents. The available medical records do not document failure of at least two anti-TNF agents in this patient. On the basis of this lack of documentation and per the peer-reviewed medical literature, the request for Xeljanz is not medically necessary for treatment of this patients rheumatoid arthritis. 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 rheumatology 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.