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

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Botox injections (J0585 Injection, onabotulinumtoxinA).The American Headache Society (AHS) recommends preventive treatment when attacks significantly interfere with patients daily routines despite acute treatment, a patient has four or more attacks per month, or a patient has contraindication to, failure, or overuse of acute treatment. Four injectable preventive therapies are available in the United States including onabotulinumtoxinA (Botox). OnabotulinumtoxinA is approved for chronic migraine. The lack of need for slow dose escalation, the rapid onset of therapeutic benefits, and the favorable tolerability profiles are advantages that injectable therapies have in common. American Academy of Neurology (AAN) guidelines recommend Botulinum toxin A for the management of chronic migraine, defined as attacks lasting 4 or more hours on at least 15 days each month for 3 months. Botulinum toxin A is established as effective and should be offered to increase headache-free days in chronic migraine. Frampton and colleagues conducted a review of data and concluded that the totality of evidence from clinical trials and real-world studies indicates that onabotulinumtoxinA (Botox) is an effective and generally well tolerated option for the prevention of chronic migraines that may be particularly useful for patients who have previously failed to respond to or are intolerant of commonly prescribed oral prophylactics.In this case, the patient has a history of chronic migraines that have not responded to multiple oral preventative medications. Based on the AHS statement, AAN guideline and study noted above, the patient is a candidate for prophylactic treatment with Botulinum toxin therapy. The patient has also experienced clinical improvement with Botulinum toxin therapy. Under these circumstances, the requested Botox injections (J0585 Injection, onabotulinumtoxinA) are medically necessary to treat the patients chronic headaches.Final Result: The reviewer determined that the requested medication is medically necessary to treat the patient's medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in neurology 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 individual therapy sessions, twice a week for treatment of the patients condition. Findings:  The physician reviewer found that The submitted documentation supports the medical necessity of the requested services. Nutt and colleagues state that psychotherapy is an integral part of patients treatment and should be considered for initial therapy for mild depression and as augmentation to an antidepressant for moderate or severe depression or for patients with adherence problems. Overall, psychotherapy has been shown to be effective for acute depression, particularly in combination with antidepressants, and can help in preventing depressive relapse and recurrence. APA Practice Guidelines recommend depression-focused psychotherapy to prevent a relapse of depression in the continuation phase. Leichsenring and colleague found evidence that individuals with chronic, complex mental illness seem to improve with long-term psychodynamic psychotherapy and that a greater number of sessions is associated with better outcome. Psychotherapy has been shown to help reduce patients symptoms, but like any other treatment, it needs to be continued for maintenance as major depressive disorder, like most medical conditions, is not curable but is at least manageable and treatable. In this case, the patient has an extensive history of depression and post-traumatic stress disorder, and she has had four inpatient psychiatric admissions so far this year. The patient was also noted to have recently presented with suicidal ideation. Under these circumstances, individual therapy sessions, twice per week, are medically necessary for treatment of the patients medical condition.Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for breast tomosynthesis for evaluation of the enrollees risk for breast cancer.  Findings:  The physician reviewers found that tomosynthesis was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography, the American College of Radiology (ACR) urged the technique be removed from the investigational category in 2014 due to the advantages this new tomographic technique brings to radiologists interpreting mammograms. This technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis to the usual two dimensional protocol was likely of greater benefit to this patient than had her exam been done with two dimensional imaging alone. Final Result: All three reviewers determined that the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.   Credentials/Qualifications: Physician reviewers number one, two, and three are board certified in diagnostic radiology and are actively practicing. The reviewers are 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 63-year-old female enrollee has requested for an X-Stop procedure for treatment of her back pain. Findings:  Two physician reviewers found that there is no class I data demonstrating that X-Stop is more effective or equally effective as other available treatments. It is unclear whether this patients condition is appropriate for consideration of the X-Stop. Based upon available evidence it is unlikely the patient will derive long-term benefit from the X-Stop procedure. There are on-going studies and upon conclusion of these studies there may be sufficient evidence demonstrating the effectiveness of X-stop; however, at this time the long-term safety and efficacy of X-Stop remains unknown.
Appeal type: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/ Case Summary:  The enrollee is requesting authorization and coverage for Diazepam (Valium) 2 mg (30 tablets/30 day supply). The enrollee has low back pain, muscle spasms, obstructive chronic bronchitis without exacerbation, and a history of spinal surgeries. The enrollee reports she has taken Vicodin, Naproxyn, Mobic, Tramadol, Gabapentin, Prozac, and Baclofen. The enrollees physician has prescribed the medication diazepam (Valium) 2 milligrams for a 30-day supply. In addition to the aforementioned history, this enrollee is morbidly obese. The enrollee reports she has taken Vicodin, Naproxyn, Mobic, Tramadol, Gabapentin, Prozac, and Baclofen. She had an adverse reaction to Flexeril, reporting it caused her to lose consciousness. Literature advised caution when prescribing Valium to those who concomitantly use other sedatives. Literature also warned of the dangers of dependence and respiratory arrest in persons with obstructive sleep apnea, which is almost universally present in morbidly obese persons.  The formulary alternatives are not scheduled drugs and have similar efficacy.Final Result: The reviewer determined that the requested service is not medically necessary for the treatment of the enrollees medical condition. Credentials/Qualifications: The physician reviewer is board certified in pain medicine 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: Medical Necessity
Decision: Upheld

Nature of Statutory Criteria/Case Summary: The patient has been diagnosed with hypopituitarism. The patients bone age was noted to be 11 years old with a chronological age of 12 years old. Laboratory results revealed positive thyroid peroxidase antibodies. On 12/9/19, the patients height was noted to be 155.5 cm. The patients height was noted to be 156.5 cm. The patient was being treated with growth hormone (GH). The provider noted that the patients insulin-like growth factor 1 (IGF-1) level was low at 165 ng/mL. The patients height was noted to 158 cm, while being treated with GH. The patients parent has requested authorization and coverage for a Nutropin AQ Nuspin 10 mg/2 mL (5 mg/mL) pen injector. The Health Plan denied the request and reported the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether a Nutropin AQ Nuspin 10 mg/2 mL (5 mg/mL) pen injector is medically necessary for the treatment of the patients medical condition. GH deficiency cannot be diagnosed based on one value alone but requires the evidence of poor growth velocity. Researchers reported, We recommend against reliance on GH provocative test results as the sole diagnostic criterion of growth hormone deficiency (GHD).  In this case, there is no evidence the patient has poor growth velocity. Grimberg and colleagues reported, The primary objectives of GH treatment for patients with GHD are acceleration of growth velocity to promote normalization of growth and stature during childhood and attainment of normal adult height (AH) appropriate for the childs genetic potential. The height of each patient is dependent on parental heights. There is no documentation to support that this patient is growing below her genetic potential. In December 2019, the patients bone age was 11 years and her height was 155.5 cm. This gives her an estimated adult height prediction of 169 cm, which is a normal height for an adult woman. The patients pretreatment height is not below -2.25 standard deviations. The medical evidence does not support the requested medication in this clinical setting. Therefore, a Nutropin AQ Nuspin 10 mg/2 mL (5 mg/mL) pen injector is not medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in in pediatrics with sub-specialty certification in pediatric endocrinology 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 authorization and coverage for MyoPro elbow-wrist-hand-finger functional neuromuscular upper limb orthotic device (L8702). This patient presents with right hemiparesis status post left middle cerebral artery (MCA) ischemic stroke. The provider has recommended the MyoPro myoelectric orthosis to help restore the patients dominant arm function and range of motion. The standard of rehabilitative care in the setting of severe functional impairments due to central nervous system pathology such as stroke is to optimize function in all relevant domains with the assistance of services such as occupational therapy, orthotists, and assistive technology. Increased independence can be pursued and achieved in this clinical setting using assistive speech technology, adaptive utensils, gait implements, and environmental modifications (Mairami, et al.). However, there is a lack of data supporting a clinical role for the requested MyoPro elbow-wrist-hand-finger orthotic device in stroke management or rehabilitation (Maciejasz, et al.; Proietti, et al.; Peters, et al.). The device is not expected to practically assist the patient with any self-care tasks and the potential benefits have not been demonstrated to outweigh the potential adverse sequelae and safety issues. All told, the requested MyoPro elbow-wrist-hand-finger functional neuromuscular upper limb orthotic device (L8702) is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings:  Three of the three physician reviewers found the requested MyoPro elbow-wrist-hand-finger functional neuromuscular upper limb orthotic device (L8702) 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 device 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 reviewer 1 is board certified in physical medicine and rehabilitation and is actively practicing. Physician reviewer 2 is board certified in physical medicine and rehabilitation with subspecialty certification in neuromuscular medicine and is actively practicing. Physician reviewer 3 is board certified in physical medicine and rehabilitation with subspecialty certification in pain management 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: Overturned

A 44-year-old male enrollee has requested LINX Reflux Management System for treatment of his gastroesophageal reflux disease (GERD).  Findings:  Two physician reviewers found that the submitted documentation and relevant literature supports the use of LINX Reflux Management System (LINX) in this clinical setting. A review of the medical records shows the presence of pathologic acid reflux as the etiology of the patients symptoms. The patient has failed medical therapy but has partially responded to a PPI making him a candidate for surgery. The LINX procedure has undergone a number of uncontrolled trials verifying that it reduces esophageal acid exposure and markedly reduces symptoms. Bonavina and colleagues concluded based on the 2012 study that, The new laparoscopically implanted sphincter augmentation device eliminates GERD symptoms without creating undue side effects and is effective at 1 and 2 years of follow-up. Thus, the LINX procedure is a viable surgical treatment for medically-refractory GERD and this patient is an appropriate candidate. Therefore, LINX Reflux Management System is likely to be more beneficial than standard medical therapy and is appropriate treatment for the patients condition.
Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the digital breast tomosynthesis. Findings:  Two physician reviewers found that tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. In this case, the patient has breasts that have been described as being heterogeneously dense. While one could make the argument that her mammogram has not changed since the last study, it is specifically those patients who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Final Result: Two reviewers determined that the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: All three physician reviewers are board certified in diagnostic radiology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for the medication Linzess capsules. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic idiopathic constipation. A review of the records indicates that the enrollee has been diagnosed with chronic idiopathic constipation, gastroesophageal reflux disease with esophagitis, with a history of anorexia. The records indicated ongoing constipation issues despite referral to the registered dietician and eating disorder coach, as well as use of fiber, Colace, and administration of enemas several times per week. The enrollee is noted to have adequate hydration and activity level.The submitted documentation supports the medical necessity of the requested medication. The patient has reported that use of an osmotic laxative (Miralax) has not been successful. The provider has reported, additionally, that such laxatives are to be avoided due to the patients history of anorexia. Findings note that Linzess is indicated to restore colonic function in chronic constipation, and is FDA-approved for chronic constipation. It is not specifically a laxative, has a different mechanism of action than osmotic laxatives, and can be effective even if agents such as laxatives and fiber failed. Findings note, in multicenter, randomized, blinded, placebo-controlled Phase III clinical trials, Linzess significantly increased weekly spontaneous bowel movements while reducing abdominal pain in patients with chronic constipation. In this case, the patient reports failure of multiple alternatives (including Miralax, or polyethylene glycol), and the provider reports that her eating disorders are a contraindication to laxatives in this case. The current medical evidence supports the use of Linzess in this clinical setting. Therefore, the request for Linzess capsules is supported as medically necessary for the treatment of the patients chronic idiopathic constipation.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in internal medicine with subspecialty 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

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for durable medical equipment - Bioness L300 GO functional electric stimulator (FES) and supplies. Findings:  The physician reviewer found that a lack of evidence in current medical literature demonstrating that exposure to lower limb orthotic devices employing functional electrical stimulation (FES) improves gait in persons with central neurological weakness. In a comprehensive review of the literature comparing FES-aided lower limb orthoses and conventional or mechanical orthoses, Johnston and colleagues reported that studies that directly compared ankle-foot orthotics (AFO) and FES did not indicate overall superiority of one over the other. The authors further noted that the evidence on AFO and FES improving gait kinematics was weak. While there are some potential benefits to exogenously stimulating lower limb effector muscles that have lost effective connections with the central nervous system, it is not evident that the potential benefits of FES-aided orthoses, such as a lighter weight and the potential of a decreased likelihood of skin breakdown, outweigh their disadvantages, such as a lack of stabilizing support during stance phase and potential for mechanical or technological complications including lead misapplication, lead failure or dislodgement, battery drainage or failure, and device failure. Given the lack of data supporting the use of the requested equipment as favorably altering neurological recovery, the requested equipment and supplies are not medically indicated. Therefore, durable medical equipment - Bioness L300 GO FES and supplies are not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested equipment and supplies are 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 61-year-old male enrollee has requested for an electrical bone growth stimulation device for treatment of his stress fractures in his right heel. . Findings:  Three physician reviewers found that the use of a bone growth stimulator in treatment of a stress fracture lacks peer-reviewed studies that prove it is effective in promoting bone growth. Therefore, the bone growth stimulator would not be more beneficial treatment for this diagnosis than the standard care usually employed. In this case, there is no evidence of delayed union or nonunion.  There is no documentation of a full thickness fracture on x-ray or CT scan. An MRI showed increased signal consistent with plantar fascial changes, and post surgical changes with a stress reaction at the level of the plantar fascial origin.