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

The patient has requested authorization and coverage for Stelara 90 mg/mL administered every four weeks. The mechanism of Stelara (ustekinumab) is entirely different than that of anti-tumor necrosis factor (TNF) medications, which the patient has failed. Ustekinumab has been demonstrated to be safe and effective for induction and maintenance of remission in patients with moderate to severe Crohns disease that was resistant to anti-TNF therapy. In a study of patients with anti-TNF resistant Crohns disease, The records noted that the patient experienced diarrhea if the prednisone dose was decreased below 20 mg daily. The patient has failed multiple biologic and conventional alternatives. Additionally, the patients joint pain may be due to insufficient control of Crohns disease, given that the pain was better controlled while on Remicade previously. Continuation of dosing every eight weeks or a change to another medication may result in loss of disease control, with complications such as fistula, stricture, bowel obstruction, flare, hospitalization, need for surgery, or other complications.  Therefore, Stelara 90 mg/mL administered every four weeks is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication regimen 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 in internal medicine with sub-specialty 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: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary:  An enrollee has requested transcranial magnetic stimulation for treatment of her medical condition.  Findings:  Two physician reviewers found that there is a lack of literature demonstrating the efficacy of long-term maintenance repetitive transcranial magnetic stimulation treatment.  Electroconvulsive therapy has a proven track record of being more efficient and having a higher frequency of response/remission in major depressive disorder.  Many articles note that overall response to repetitive transcranial magnetic stimulation is somewhat less than desired, and there are inherent problems such as suboptimal stimulation parameters and follow-up assessments.  Most literature suggests that further research with large multicenter is indicated to fully assess the benefit of repetitive transcranial magnetic stimulation and to better define issues such as duration of effect and optimal stimulation parameters.  All told, the superior efficacy of transcranial magnetic stimulation has not been established.  Final Result:  Two reviewers determined that the services at issue were not and 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 reviewers are board certified in psychiatry 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: Experimental/Investigational
Decision: Upheld

A 47-year-old female enrollee has requested dosimetry collaboration  and intraoperative radiation therapy for treatment of her breast cancer. Findings:  Three physician reviewers found that in this patients case, the services at issue were not likely to have been more effective than other treatment options.  Accelerated partial breast irradiation is an acceptable treatment for select patients with early stage breast cancer.  Accelerated partial breast irradiation may be delivered using external beam radiotherapy, brachytherapy or intraoperative radiation therapy.  There is some support for accelerated partial breast irradiation delivered using intraoperative radiotherapy.  However, the current medical evidence has not established the superior efficacy of the services at issue in this clinical setting.  Thus, dosimetry collaboration provided on the date indicated and intraoperative radiation therapy provided on the subsequent date were not likely to have been more effective than other treatment methods.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary:   An enrollee has requested breast tomosynthesis for evaluation of her medical condition.  Two physician reviewers found that breast tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. The addition of digital breast tomosynthesis as part of the screening mammography protocol has gained worldwide acceptance among providers due to an associated decrease in callbacks and increase in detection of small breast cancers.  This improvement is based upon the unique tomographic capability of tomosynthesis which enables radiologists to view the breast in a fashion which largely eliminates the problem of dense overlying glandular tissue. Thus, the addition of tomosynthesis to the usual screening films is likely more beneficial to the patient than digital mammography without added tomosynthesis. Final Result: Two 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: All three reviewers are board certified in diagnostic radiology 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: Experimental/Investigational
Decision: Overturned

A 54-year-old male enrollee has requested transcranial magnetic stimulation (TMS) for treatment of his major depressive disorder. Findings:  Two physician reviewers found that the patients history of treatment for major depressive disorder shows the patient failed to receive adequate relief of symptoms from trials of multiple psychopharmacologic agents.  Despite his prior treatments with psychotherapy and antidepressant medication of different classes, the patient continued to experience significant levels of depression. Thus, TMS treatment was a scientifically established treatment for this patients depressive disorder at the time of service and was likely to result in greater benefit to the patient than further trials of pharmacologic agents, as multiple agents (as well as psychotherapy) had already been tried without adequate improvement. In consideration of the above, the use of TMS therapy was medically reasonable and consistent with the standard of care for the treatment of this patients illness.
Appeal type: Medical Necessity
Decision: Overturned

The patient is a 58-year-old female with a history of irritable bowel syndrome (IBS) and constipation. The patient has tried multiple medications and only Zelnorm has been successful. She is currently on 6mg of Zelnorm per day. Her physician has requested continued treatment with Zelnorm. The Health Plan has denied this request indicating the recommended dosage of Zelnorm should not exceed 24 weeks. Although the FDA approval for Zelnorm is limited to several weeks, IBS is a lifelong condition. It appears that this patient has tried multiple other alternatives without relief. It also appears that the patient has had a positive response to a low dose of Zelnorm. Since IBS is a chronic disease, it is well known that many patients will require re-treatment or require maintenance on Zelnorm in order to control their symptoms. Clinical experience with Zelnorm over the past two years provides sufficient evidence to support this pattern of use. In light of the information set forth above and given the patients good clinical experience with Zelnorm with no evidence of toxicity or side effects, continued use of Zelnorm is medically appropriate and indicated. Therefore, I have determined that the requested medication is medically necessary for treatment of the patients medical condition. The Health Plans denial should be overturned.
Appeal type: Medical Necessity
Decision: Upheld

A 60-year-old female enrollee has requested compounded Versapro (topical estradiol, progesterone, testosterone) cream for treatment of her vasculitis, severe menopause and Churg-Strauss syndrome.   Findings:  The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. There is a lack of evidence in the medical literature that show compounded hormones are safer or more efficacious than standard FDA approved and tested options. In fact, because of issues related to compounding, dosing is frequently inconsistent. This may actually increase the risk of such treatments. According to the American College of Obstetricians and Gynecologists (ACOG) Guidelines for Womens Health Care, Compounded bioidentical hormones are plant-derived hormones that are prepared by a pharmacist and can be custom made for a patient according to a physicians specifications. Most compounded products have not undergone rigorous clinical testing for safety or efficacy, and issues regarding purity, potency, and quality are a concern. Moreover, according to the Journal of General Internal Medicine, natural or bioidentical compounded estrogen preparations are being promoted to consumers as safe alternatives to conventional menopausal hormone therapy and as health-promoting tonics. No reliable data support these claims. Natural hormones, including estradiol, estriol, estrone, and progesterone, can be expected to have the same adverse event profile as conventional menopausal hormone regimens. Finally, the record is unclear as to whether the patient is receiving progesterone therapy along with her estrogen. Being treated with estrogen alone (without progesterone) increases the risk of developing endometrial cancer. Progesterone delivered in a cream form has not been proven to decrease that risk. For the reasons provided, the requested Versapro (topical estradiol, progesterone, testosterone) cream is not medically necessary.
Appeal type: Medical Necessity
Decision: Overturned

A 64-year-old male enrollee has requested Lyrica, 100 mg, 3 times per day for treatment of his spinal cord injury with neuropathic pain.  Findings:  The physician reviewer found that in this case, the patient is suffering from complex neuropathy of the left lower extremity possibly due to shingles or a central spinal cord lesion. Etiology aside, neuropathic pain is the same mechanistically transmitted signal through the spinothalamic and dorsal horn tracks. Given the patients history, it is plausible that this could be affecting the conus medularis and the dorsal column of the thoracolumbar junction. This patient has been using Lyrica for 2 12 years with failure of other membrane stabilizers and anti-neuropathic pain agents. The mechanism of Lyrica is extremely effective in severe neuropathy. Given the success of Lyrica for this patient, the history of post-herpetic neuralgia the use of Lyrica has been established as clinically indicated. In addition, Lyrica should be approved for this patient at any strength needed for titration for maximum pain control as long as it is within the recognized therapeutic window of the medication and the patient does not experience any adverse reactions.
Appeal type: Medical Necessity
Decision: Upheld

A 30-year-old male enrollee has requested proton beam radiation therapy for treatment of his high-grade adenoid cystic carcinoma of the submandibular salivary gland. Findings:  The physician reviewer found that adjuvant radiation therapy is medically indicated to prevent recurrence, as this patient is at high risk of recurrence without adjuvant radiation therapy. Intensity modulated radiation therapy is appropriate and within the standard of care for this condition. Proton beam radiation therapy has been generally utilized for skull base tumors including chordoma and chondrosarcomas, with good local control. This patient does not present with a skull base tumor. While the radiotherapy field may have to extend up to the base of the skull to include the involved nerve, this can be achieved safely and effectively using intensity modulated radiation therapy. Based on the current medical literature, the use of proton beam radiation therapy is not necessary in this clinical situation as there are other therapies available that are medically appropriate in this setting.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Xiidra. This patients records do not document an adequate trial and failure or a contraindication to another drug that was authorized by the Health Plan. Further, Xiidra has not been demonstrated in the medical literature to be a superior topical treatment option as compared to the drug authorized by the Health Plan. Thus, an adequate trial of the drug authorized by the Health Plan is reasonable as the next treatment step for this patients dry eye syndrome. Accordingly, the requested Xiidra is not supported as medically necessary for treatment of this patients medical condition. 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 ophthalmology 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 an office consultation for treatment of her medical condition. Findings:  The physician reviewer found that review of the submitted documentation and medical literature demonstrates the medical necessity of the requested services. Although there is a lack of standard guidelines for the criteria for office consultation for weight loss surgery, the requested consultation is indicated for this patient. An evaluation for possible weight loss surgery is medically necessary for this patient to explore weight loss treatments available for her morbid obesity. For the reasons stated, the requested services are medically necessary in this clinical setting. 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 general 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: Medical Necessity
Decision: Upheld

A 42-year-old male enrollee requested modafinil (Provigil) 200 mg tablets for medical treatment of his obstructive sleep apnea with excessive daytime sleepiness.  Findings:  The physician reviewer found that the records document that this patient has both bipolar disorder and severe obstructive sleep apnea (OSA). The patient has taken Provigil for six years, and has found it helpful for his low energy levels. Although this patient reports symptomatic improvement with Provigil his sleep apnea remains untreated. Provigil is not an adequate treatment for OSA alone and is only indicated for treatment of residual sleepiness in cases of treated OSA such as patients already on CPAP. Moreover, the patients diagnosis of bipolar disorder is not an FDA approved indication for Provigil. All told, this patient does not meet the current criteria for treatment with Provigil and its use is not medically necessary for treatment of his medical condition.
Appeal type: Medical Necessity
Decision: Upheld

The parent of a 6-year-old male has requested applied behavioral analysis (ABA) therapy for treatment of his pervasive developmental disorder - not otherwise specified (PDD-NOS), oppositional defiant disorder (ODD) and attention deficit hyperactivity disorder (ADHD). Findings:  The physician reviewer found that applied behavioral analysis has been shown to be effective in treating behaviors associated with autism spectrum disorder. Treatments based on operant principles of learning are more effective in reducing maladaptive behaviors than alternative treatments. A paper by Warren and colleagues reviewed 34 studies of early intervention in autism and concluded that studies of Lovaas-based approaches as well as early intensive behavioral intervention variants and the Early Start Denver Model resulted in some improvement in cognitive performance, language skills, and adaptive behavior skills (Warren, et al.). However, for those individuals who have been diagnosed with ODD and/or ADHD, in the absence of an autism spectrum disorder, there is no single intervention that emerges as a best treatment for disruptive behaviors (Eyberg, et al.). Clarification of the underlying diagnosis is required in this patients case, as the school psycho-educational evaluation did not identify the patient as meeting the criteria for PDD-NOS and there is no objective documentation from the school or medical professionals supporting the providers report that this patient has been diagnosed with PDD-NOS. However, this diagnosis has not been substantiated in the records provided for review. Thus, a comprehensive evaluation is recommended to determine the patients diagnosis. Without confirmation of the patients current diagnosis, the requested ABA therapy is not medically necessary at this time.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for monitored anesthesia. In this case, the medical needs of the patient do not support that the services in issue were medically necessary. According to the American Society of Anesthesiologists (ASA) guideline for anesthesia care during endoscopic procedures, monitored anesthesia care is warranted in prolonged or painful procedures such as complex polyp resections, endoscopic retrograde cholangiopancreatography or other biliary procedures, endoscopic dilation, or endoscopic resection. Additionally, the ASA guidelines state that monitored anesthesia care is more likely necessary in patients with failed history of moderate sedation for the procedure or psychological impediments to cooperation. According to the most recent guidelines from the American Society for Gastrointestinal Endoscopy (ASGE), during endoscopic procedures (unlike surgery) consciousness during the procedure is acceptable and is the goal during most procedures (which are performed with moderate sedation), and monitored anesthesia care is recommended for prolonged procedures requiring deep sedation, previously anticipated intolerance to standard sedatives, ASA class IV or V, or risk for airway obstruction due to anatomic variant. The provided records do not support any of these criteria, or other criteria in the literature, such as difficult intubation, airway obstruction, allergies to sedation medications, chronic alcohol or illicit drug use resulting in increased tolerance to sedation medications, age >70, pregnancy, increased aspiration risk, ASA class III or higher, or morbid obesity. For these reasons, the provided patient records do not support the medical necessity of monitored anesthesia care over short-acting sedation in this case.Final Result: The reviewer determined that the services in issue were not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in internal medicine, 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: Overturned

A 40-year-old female enrollee requested authorization and coverage of gastric bypass surgery. The Health Plan denied the request indicating that the requested procedure is not medically necessary for treatment of the enrollees obesity.One physician reviewer performed a medical necessity Independent Medical Review. The physician reviewer overturned the Health Plans denial on the basis that the requested procedure is medically necessary.
Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollees parent has requested authorization and coverage for proton beam radiation therapy with gel spacer device. Current evidence does not endorse the use of proton therapy over photon techniques utilizing intensity modulated radiation therapy (IMRT). In a comparison of proton radiotherapy versus IMRT in the treatment of prostate cancer, Yu and colleagues found no difference in toxicity one year post-treatment. Hoppe and colleagues reported no differences in patient-reported quality-of-life outcomes between patients treated with proton therapy versus patients treated with IMRT for prostate cancer. While Karsh and colleagues have reported some benefits in the use of a hydrogel spacer in reducing the rectal dose, toxicity, and quality-of-life declines after image guided IMRT, there is a lack of literature supporting the use of gel spacers in conjunction with proton therapy. Therefore, proton beam radiation therapy with gel spacer device is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.Findings:  Two of the three physician reviewers found the requested proton beam radiation therapy with gel spacer device 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 service is 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 reviewers 1, 2, and 3 are board certified in radiation oncology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld

A 49-year-old female enrollee has requested treatment with Tykerb and Xeloda for the treatment of her metastatic breast cancer. Findings:  The physician reviewer found that the patient and her treatment team have requested authorization for Tykerb and Xeloda in the setting of first-line therapy for metastatic breast cancer. This combination is indeed an active regimen, but is approved in patients that have been treated with other prior regimens namely anthracyclines, taxanes and Herceptin.