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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Stelara 90 mg every four weeks. Current medical literature supports the requested dose escalation of Stelara in this case. The patient has active disease symptoms. The mechanism of Stelara is different from anti- tumor necrosis factor (TNF) medications, which this patient has failed. A large randomized controlled trial demonstrated the safety and efficacy of Stelara for induction and maintenance of remission in patients with moderate-to-severe Crohns disease resistant to anti-TNF therapy. Another study showed a 73% response in patients with anti-TNF-resistant Crohns disease, and 80% of responders maintained remission for one year. With regard to dosing, one study found that dosing at 90 mg every four weeks can address inadequate disease control, and a large proportion of patients were able to maintain response with dose escalation to 90 mg every four weeks. Multiple studies have shown that a majority of patients in whom Stelara dosing every eight weeks failed to control symptoms responded to dosing every four weeks. Further, the American Gastroenterological Association (AGA) guidelines for the management of Crohns disease state that when response to a biologic medication is lost in the setting of a low drug level and lack of anti-drug antibodies, the drug dosage should be increased. In this case, the patient has failed multiple conventional and biologic alternatives as well as Stelara dosed at every eight weeks. He did initially have a response to Stelara, but later lost response in the setting of a low Stelara level. Continuation of the current dose may result in complications. For these reasons, Stelara 90 mg every four weeks is medically necessary for treatment of this patient.Final Result: The reviewer determined that the requested medication dosage is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with subspecialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

The patient is a 53-year-old woman who reports a six-year history of gastrointestinal problems. She states that she became ill in December 2000 after eating watercress and drinking water from a stream. She reports multiple problems including irritable bowel syndrome, constipation, gas and abdominal bloating. The patient also experiences extreme fatigue, concentration problems, and short-term memory loss. She wishes to undergo further workup with an Intestinal Permeability and Comprehensive Digestive Stool Analysis. The Health Plan indicates the proposed testing is not medically necessary for evaluation of the patients condition.The Health Plans denial is correct. The patient has vague and generalized symptoms. It appears she has undergone a thorough workup with evaluations by multiple specialists. The use of the proposed intestinal permeability test in this patient is not within the community standard of care. The requested testing is not likely to add clinically useful information for the care and management of this patient. Therefore, I have determined the requested testing is not medically necessary for evaluation of the patients medical condition. The Health Plans denial should be upheld.
Appeal type: Urgent Care
Decision: Upheld

A 36-year-old female enrollee has requested emergency services for the treatment of her condition. Findings:  The physician reviewer found that this patient presented with a bruise/hematoma on the back of her left thigh. Although this was an acute condition, she was not suffering pain nor was there concern that her life or well-being was possibly in jeopardy. A prudent layperson would not reasonably seek immediate emergency medical attention for such an ailment.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for a balloon dilation procedure.Findings: Two of the three physician reviewers found that the requested balloon dilation procedure was not likely to be more beneficial for treatment of this enrollees medical condition than any other standard therapy. Researchers reported that their study demonstrated superiority of balloon dilation of the Eustachian tube with balloon catheter [and] medical management compared to medical management alone to treat Eustachian tube dilatory dysfunction in adults.  Yet another study states that All current studies suggest that balloon dilation of the Eustachian tube can be a helpful treatment in patients with Eustachian tube dysfunction. However, placebo-controlled trials are still warranted. Husiman and colleagues recent study noted efficacy of this treatment for patients with abnormal tympanometric profiles.In this case, two of the three physician reviewers determined that the clinical findings do not support a diagnosis of Eustachian tube dysfunction. That diagnosis is usually made based on evidence of middle ear problems such as ear popping and pressure, infections and a flat tympanogram, often accompanied by a degree of conductive hearing loss. Thus, although balloon dilatation is promising as a therapy for Eustachian tube dysfunction, the reviewers concluded that this treatment would not likely be more beneficial for this patient than any other standard therapy.Final Result: Two of the three reviewers determined that the services in issue were not likely to be more beneficial for treatment of the patients medical condition than any other available standard treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: All three reviewers are board certified in otolaryngology, and all three 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: Experimental/Investigational
Decision: Upheld

A female enrollee requested intra-operative radiation therapy (IORT) for medical treatment of her malignant neoplasm of the breast.  Findings:  Three physician reviewers found that IORT is not likely to be more effective for this patient than other available options. IORT is a decades-long technology, used primarily for gastrointestinal cancers in the 1980s and more recently for breast cancer. The most recent National Comprehensive Cancer Network guidelines do not explicitly address IORT. Moreover, IORT is not the standard approach in this clinical setting as there is a paucity of long-term outcome data. In sum, there is a lack of data to suggesting IORT is superior to standard approaches of delivering breast radiotherapy. Thus, IORT is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Harvoni for treatment of his hepatitis C virus. Findings:  The physician reviewer found that 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 applies regardless of fibrosis stage or viral load. Per the guidelines, treatment-naive, non-cirrhotic genotype 1a patients should be treated with Harvoni for 12 weeks, or with Viekira Pak and ribavirin for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials (Kowdley, et al; Afdhal, et al; Poordad, et al). Although treatment of hepatitis C is necessary, based on the available medical literature, none of the information supplied in this case provides medical justification to support coverage of Harvoni over Viekira/ribavirin. No head-to-head clinical trials have compared these medications, meaning that the trials for each medication cannot be directly statistically compared due to lack of uniform study population. Based on the information provided, the patient does not have severe anemia, pregnancy, psychiatric disorders, or other medical contraindications to ribavirin (Dusheiko, et al). For these reasons, the requested treatment with Harvoni  is not supported as medically necessary for the treatment of this patients hepatitis C infection.   Final Result: The reviewer determined that the requested medication is not necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld

A 46-year-old female enrollee has requested subcutaneous hormone replacement therapy (CPT 11980) for treatment of her status post hysterectomy with bilateral salpingo-oophorectomy. Findings:  Three physician reviewers found that in this patients case, the medication and issue was not and is not likely to be superior over other treatment modalities.  There is a lack of support in the current medical literature for subcutaneous hormone replacement therapy.  Per the medical literature, there is a lack of evidence demonstrating that bioidentical hormones are superior to conventional hormones.  Compounded hormones confer additional risks, as there is a lack of efficacy and safety data.  Compounded hormones have variable purity and potency.  Therefore, conventional hormone preparations are preferred over compounded therapy for the treatment of menopausal symptoms.  Thus, subcutaneous hormone replacement therapy was not and is not likely to be of greater benefit than other treatment alternatives.
Appeal type: Medical Necessity
Decision: Upheld

A 50-year-old male enrollee has requested home infusion of intravenous immune globulin (IVIG) therapy for treatment of his idiopathic thrombocytopenic purpura ITP). Findings:  The physician reviewer found that although there are other treatments for ITP, including RhIg and thrombopoietic agents, IVIG has been effective in managing this patients symptoms to date. The record also indicates that a splenectomy is being considered. While it is medically appropriate for the patient to continue IVIG therapy, there is no indication for an ambulatory patient to receive home based infusions of IVIG for treatment of ITP. There is no medical advantage to doing so. Such home treatment is not recommended by any guideline or specialty group. There is no clinical justification for home based IVIG treatment for patients who are not homebound. Thus, home based IVIG therapy, while desired by the patient, is not necessary from a medical standpoint.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for a heart monitor. On the basis of the current data, exercise testing, alone or with an imaging study, remains the preferred test for risk stratification of patients with coronary artery disease. For patients who cannot perform exercise, ambulatory electrocardiography (ECG) can be used for further evaluation. The American College of Cardiology (ACC) and American Heart Association (AHA) indications for ambulatory ECG monitoring for myocardial ischemia include suspected variant angina and evaluation of patients with chest pain who cannot exercise. This patient meets these criteria with suspected variant angina and inability to complete an exercise stress test. Ambulatory ECG has been used for preoperative evaluation of patients with peripheral vascular disease with no clinical evidence of coronary artery disease. Given this patients chest pain and history, the heart monitor was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: Two of the three reviewers determined that the services at issue were 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:  One reviewer is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing. One reviewer is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is actively practicing.  One reviewer is board certified in internal medicine with sub-specialty certification in cardiovascular disease and is 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 55-year-old male enrollee requested authorization and coverage of continuation of Vioxx 50 mg. The Health Plan denied the request indicating that the requested prescription is not medically necessary for the treatment of the enrollees spondylolisthesis and sciatica.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

Nature of Statutory Criteria/Case Summary:  The parent of an enrollee has requested water circulating cold pad with pump for treatment of the enrollees medical condition.   Findings:  Two physician reviewers found that the water circulating cold pad with pump at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The standard of care post-operatively following a knee arthroscopy is the use of icepacks. There is a lack of sufficient support demonstrating cryotherapy results in increased efficacy when administered through a mechanized pump versus icepacks and ice bags. The study by researchers evaluated the use of cryotherapy following anterior cruciate ligament reconstruction. Six studies were reviewed, and some individual studies reported significant benefit. However, the pooled analysis did not support a significant impact compared to traditional methods of delivering cold, such as with icepacks. Although the literature review by researchers provides support for reduction in pain levels at 48 hours after surgery, there is a lack of sufficient evidence for efficacy of cryotherapy for other outcomes such as analgesic medication use, range of motion, blood loss, hospital stay or quality of life. Moreover, the authors concluded that there was a need for additional studies with randomized trials before the ambiguity as to the efficacy of cryotherapy can be resolved. In sum, the use of water circulating cold pad with pump was not likely to be more beneficial for treatment of the patients medical condition compared to other modalities. Final Result: Two reviewers determined that the services at issue were 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:  One reviewer is board certified in orthopedic surgery and is actively practicing. Two 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 physical therapy three times a week or physical therapy two times a week. Findings:  The physician reviewer found that The importance of the acetabular labrum has been increasingly recognized, playing a critical role in both normal anatomy and abnormal pathology of the hip joint. The author further state, In the setting of femoroacetabular impingement (FAI) or dysplasia, bony biomechanics may cause labral injury, which may translate to patient symptoms. Long-term consequences of labral tears may include joint degeneration. Additionally, Freke and colleagues state, People with symptomatic FAI demonstrated some deficits in hip muscle strength and reduced balance on one leg when compared with control subjects. For hip joint ROM and hip muscle strength results for within-group differences between preintervention and postintervention time points were limited and inconclusive. Further, Mansell and colleagues conducted a study comparing the effectiveness of surgery with nonoperative management. The authors found no significant difference between treatment with surgery alone and physical therapy alone. In this case, the patient underwent surgery in 2020 to address her hip pathology. Following her hip surgery, the patient underwent physical therapy. There are no documented impairments that require any ongoing formal physical therapy. The patient reports she has core and hip weakness, for which she needs ongoing physical therapy. This issue, however, can be addressed with independent exercise. Therefore, physical therapy three times a week or physical therapy two times a week is not medically necessary for treatment of the patients medical condition. Final Result: The reviewer determined that the requested service 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 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: Experimental/Investigational
Decision: Upheld

A 25-year-old male enrollee requested rituximab (Rituxan) infusion for treatment of his Crohns disease and autonomic neuropathy.  Findings:  Two physician reviewers found that based on the current peer-reviewed medical literature, the requested Rituxan is not likely to provide this patient with an improved health outcome beyond that expected with standard available therapies. This patient is suspected to have autonomic neuropathy, and has a history of Crohns disease, which is an autoimmune condition. Treatment directed at Crohns has thus far not helped the patients autonomic symptoms. Rituxan has been shown of potential benefit with treatment of conditions such as chronic inflammatory demyelinating polyneuropathy (CIDP), multiple sclerosis, and myasthenia gravis. Data regarding treatment of Crohns disease with Rituxan is mixed, with some patients experiencing an exacerbation with treatment. Rituxan has also been associated with the development of progressive multifocal leukoencephalopathy. All told, the request for Rituxan 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 is a 54-year-old male with type II diabetes mellitus diagnosed about three years ago. He weighs 348 pounds and has significant lower extremity edema. He has hypertension and dyslipidemia. In addition, he has nephropathy. His creatinine is 1.5 associated with microalbuminuria. His Hemoglobin A1c was 9.1% in October 2005. When he saw the endocrinologist in November 2005 he was taking Actos 45mg. At that time Amaryl was added and Actos was reduced to 30mg. Metformin is not indicated because of renal dysfunction. The patient is a commercial driver and did not want to start insulin. His endocrinologist added Byetta 5mcg twice daily with a subsequent increase in dosing to 10mcg twice daily. The patients fasting and postprandial blood glucose values improved with the addition of Byetta and Amaryl. He has lost five pounds. Amaryl was increased to 6mg and Lasix and Diovan were added.At issue is whether the addition of Byetta to the patients medication regimen is medically necessary for treatment of his diabetes.Per Food and Drug Administration guidelines, Byetta is only indicated with sulfonylureas and/or metformin. Although studies of Byetta in combination with Actos have been completed and submitted to the Food and Drug Administration, to date such usage of the drug has not been approved.Review of the submitted clinical information indicates the patient is morbidly obese and has severe fluid retention. Actos has significant weight gain and fluid retention potential. The patient has responded well to Byetta. If Actos were discontinued, the use of Byetta along with Amaryl and a strict low carbohydrate diet and exercise program would be medically appropriate. However, based upon the data available at this time the concurrent use of Byetta and Actos cannot be recommended.For the reasons 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: Upheld

A 42-year-old female enrollee has requested for Ketamine infusions for treatment of her complex regional pain syndrome (CRPS).  Findings:  Three physician reviewers found that Kiefer and colleagues conducted an open-label trial which suggested a benefit in pain reduction and associated CRPS symptoms, improved quality of life and ability to work following anesthetic Ketamine in previously refractory CRPS patients. However, a randomized controlled trial will be necessary to prove its efficacy as well as its safety. Goldberg and colleagues conducted an open label, prospective, evaluation of a 10-day infusion of intravenous Ketamine in the CRPS patient. While their results were positive, there is no control group to prove that this treatment was better than placebo. Hocking and colleagues concluded that for complex regional pain syndromes, there is only Level IV evidence of efficacy of epidural Ketamine. In conclusion, the evidence for efficacy of Ketamine for treatment of chronic pain is moderate to weak. Further controlled studies are needed to support the contention that Ketamine infusions as treatment for CRPS is more efficacious than standard interventions.