Persius/hicric huggingface dataset:
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2
A 28-year-old female enrollee has requested authorization and coverage for ReActiv8 implantable peripheral nerve stimulation. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition.  At issue is whether the requested device is likely to be more beneficial for treatment of the enrollee's condition than any available standard therapy. The physician reviewer found that regarding the request for Reactiv8 device, the requesting provider has indicated that this device has a novel treatment approach when compared with peripheral nerve stimulation. It is stated that this device is intended to treat multifidus muscle atrophy to improve instability and axial low back pain. Deckers and colleagues noted, aElectrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for chronic mechanical low back pain. Results demonstrate clinically important, statistically significant, and lasting improvement in pain, disability, and quality of life.a Per Mitchell and colleagues, aIn participants with disabling intractable chronic low back pain who receive long-term restorative neurostimulation, treatment satisfaction remains high and improvements in pain, disability, and quality of life are clinically meaningful and durable through four years.a Per Thomson and colleagues, among the 37 patients completing two-year follow-up, numerical rating scale (NRS) pain scores improved, Oswestry Disability Index (ODI) scores improved, and health-related quality of life improved. The authors noted, a57% of patients experienced a greater than 50% reduction in pain, and 51% of patients benefited by a greater than 15-point reduction in ODI, both substantial improvements.a As such, there are multiple studies that support the safety and efficacy of this treatment. In this case, the patient is noted to have tried physical therapy, epidural injections, spinal cord stimulation, and sacroiliac joint injections. The patient has also failed medication treatment. As such, there is a lack of remaining treatment options to address the patientas pain. Therefore, ReActiv8 implantable peripheral nerve stimulation is likely to be more beneficial for treatment of the patientas medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3
A 28-year-old female enrollee has requested authorization and coverage for ReActiv8 implantable peripheral nerve stimulation. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition.  At issue is whether the requested device is likely to be more beneficial for treatment of the enrollee's condition than any available standard therapy. The physician reviewer found that Deckers and colleagues evaluated peripheral nerve stimulation with the ReActiv8 peripheral nerve stimulator. The study consisted of 53 patients with chronic low back pain that had failed standard treatments. The study found a responder rate to therapy to be 58%. Gilmore and colleagues performed a review of lumbar medial branch stimulation and evaluated current methods of peripheral nerve stimulation for chronic low back pain. The authors concluded, aPeripheral nerve stimulation for chronic low back pain is an emerging field with clinical benefits that may be applicable to a sizeable patient population for which there are few effective treatments. To date, two systems of PNS of the medial branch of the dorsal ramus for the treatment of CLBP are being evaluated, with promising results. Further studies examining the long-term efficacy, mechanism of action, cost, and utilization are areas of ongoing and future investigation." Gilligan and colleagues evaluated the benefits of the ReActiv8 peripheral nerve system. The study consisted of 204 patients. The authors noted, aThe primary endpoint was inconclusive in terms of treatment superiority. Prespecified secondary outcomes and analyses were consistent with a modest but clinically meaningful treatment benefit at 120 days. Improvements from baseline, which continued to accrue in all outcome measures after conclusion of the double-blind phase, were clinically important at 1 year.a In this case, the patient has chronic low back pain due to spondylosis and spondylolisthesis. She has failed standard of care therapies, including medication management, physical therapy, medial branch blocks and spinal cord stimulation. Her pain physician has recommended peripheral stimulation with the ReActiv8 system. The current evidence demonstrating the benefit of this approach is limited by small sample sizes and lack of large randomized control trials. The largest randomized controlled trial by Gilligan and colleagues failed to demonstrate superiority over sham/placebo arm of the trial, and secondary outcomes did not demonstrate statistical significance.     While initial results are promising, further large studies are needed to demonstrate long-term efficacy and superiority over standard of care methods. Therefore, ReActiv8 implantable peripheral nerve stimulation is not likely to be more beneficial for treatment of the patientas medical condition than any available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1


A 50-year-old male has requested reimbursement for Anser IFX testing performed on 4/15/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the Anser IFX was likely to have provided additional information for the management of this patients biologic therapy.  If it was determined that the patient had fibrosis at the anastomosis leading to periodic small bowel obstruction, then surgery may have been advised.  Postoperatively, the patient needed to be put on a biologic.  There is sufficient support for the services at issue in this clinical setting.  All told, Anser IFX testing performed on 4/15/15 was likely to have been more efficacious than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2


A 50-year-old male has requested reimbursement for Anser IFX testing performed on 4/15/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence has not established the superior efficacy of the services at issue.  Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions.  In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment.  The reasons for therapeutic failures remain unclear.  Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment.  However, there are few well-controlled clinical trials to confirm that use of the Anser IFX testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment.  The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement.  It has not been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. As such, Anser IFX testing performed on 4/15/16 was not likely to have been more efficacious than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3


A 50-year-old male has requested reimbursement for Anser IFX testing performed on 4/15/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the Anser IFX test was ordered to direct the use of Remicade in this patient with Crohns disease. However, the use of Anser IFX to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response.  Based on the clinical literature, the Anser IFX testing performed on 4/15/15 was not likely to be more beneficial for treatment of the patients medical condition than standard management.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 1


A 52-year-old female enrollee has requested reimbursement for the Decision Dx melanoma assay provided on 11/18/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found that the patients provider recommended a tissue sample be sent for the Decision Dx melanoma assay which evaluates genes for certain markers and then the lesion can be further stratified to determine if it is high risk for metastasis. This test has shown some impressive accuracy in thin melanomas like this patients tumor. However, the results of the test are indeterminate. The test is not considered routine standard of care and is not recommended by the National Comprehensive Cancer Network (NCCN) guidelines. Further, there is a lack of medical literature to support its use in the care of patients with thin melanomas to effect health outcomes. Since this test does not provide a benefit greater than established tests on patient outcomes, and is not currently the standard of care, there needs to be clinical trials to determine the utility of the results of the test. In the absence of this data, the Decision Dx melanoma assay performed on 11/18/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2


A 52-year-old female enrollee has requested reimbursement for the Decision Dx melanoma assay provided on 11/18/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found that the Decision Dx melanoma assay was developed using gene signatures from ocular melanoma and associating a particular risk of future metastatic disease based on the genetic expression patterns displayed in the tumor. The Decision Dx assay is not considered within the standard of care. The National Comprehensive Cancer Network (NCCN) guidelines for the treatment of melanoma state that the Decision Dx assay should not be used outside of a clinical trial setting. As the testing is not considered to be standard of care and not recommended in the work-up of melanoma patients according to the NCCN, the Decision Dx melanoma assay performed on 11/18/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3


A 52-year-old female enrollee has requested reimbursement for the Decision Dx melanoma assay provided on 11/18/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found that cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion. Metastases to regional lymph nodes may be amenable to excision but they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha (Balch, et al). Currently, there is a paucity of scientific data on the Decision Dx test for melanoma. As such, the test is novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. For these reasons, the Decision Dx melanoma assay provided on 11/18/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The patient is a 63-year-old female with a diagnosis of hereditary angioedema and monoclonal gammopathy of unknown significance (MGUS). Provider records indicate that patient has ongoing angioedema with up to three attacks per month. Hereditary angioedema (HAE) attacks have responded well to Firazyr, which is used as on demand therapy, but recovery time is prolonged up to two to three hours following an attack. The provider has recommended tranexamic acid 650 mg tablets/120 tablets for a 30 day supply (two tablets, twice per day, with 11 refills). The provider states that this specific dosage will be used as ongoing prophylactic therapy, and a trial of tranexamic acid has previously shown effectiveness for this patient. The patient has requested authorization and coverage for tranexamic acid 650 mg tablets/120 tablets for a 30 day supply (two tablets, twice per day, with 11 refills). The Health Insurer has denied this request indicating that the requested medication dosage is not medically necessary. Given this patients medical condition, the requested dosage of tranexamic acid meets the criteria for medical necessity to provide long-term prophylaxis for the treatment of hereditary angioedema. There is sufficient evidence to support the long-term prophylactic dosing of tranexamic acid at 650 mg twice daily, which would necessitate the quantity of 120 tablets for a 30 day supply. According to the current evidence-based literature, this dosing amount is within the standard of care for the use of tranexamic acid for the long-term prophylactic treatment of hereditary angioedema. Accordingly, the requested tranexamic acid 650 mg tablets/120 tablets for a 30 day supply (two tablets, twice per day, with 11 refills) is medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication dosage is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 


The parent of a 16-year-old male enrollee has requested authorization and coverage for reconstructive repair of pectus excavatum or carinatum with one overnight hospital stay.  The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found there is sufficient support for the requested services in this patients case.  The records document pectus excavatum with a Haller index of 4.0.  This patient has a chest wall deformity, and the requested surgical repair is medically appropriate. The records support the requested correction of a congenital abnormality of the chest wall to normalize a deformity.  Pectus excavatum is a significant truncal physical variation from normal.  In sum, the requested reconstructive repair of pectus excavatum or carinatum with one overnight hospital stay is medically indicated for the treatment of this patient.  Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 


A 20-year-old female enrollee has requested reimbursement from 10/25/17 through 11/8/17 and prospective authorization and coverage for residential treatment services. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that there is support for the medical necessity of the services at issue in this clinical setting. Based on a review of the medical records, the patient was not stabilized and remained symptomatic beyond 10/25/17. On 10/31/17, the patient was documented as having suicidal ideation with a plan to overdose on medications and was placed on close observation. The patient was consistently documented as depressed and anxious, with restricted/flat affect, nightmares, and suicidal ideation. The patient was also documented as frequently taking, as needed, haloperidol, lorazepam, and hydroxyzine for anxiety in addition to her regularly scheduled psychiatric medications.  Documentation from clinical staff on 11/8/17 indicated that the patient was not able to step down to a lower level of care due to the severity of her symptoms and safety concerns.  A study by Vujanovic and colleagues shows that trauma and posttraumatic stress disorder are frequently associated with suicidality and psychiatric readmission rates are high especially amongst patients with physical comorbidities such as in this patients case. This patient has been diagnosed with Ehlers-Danlos syndrome. Additionally, this patient continued to report suicidal ideation and was placed on close observation.  On 11/8/17, she was evaluated by the treatment team and deemed not appropriate for a lower level of care. Therefore, residential treatment services from 10/26/17 through 11/8/17 and future services were and are medically necessary for treatment of this patients medical condition. Therefore, for the reasons stated above, the services at issue were and are medically necessary for treatment of the patients medical condition. Therefore, the Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 

The parent of a six-year-old male enrollee has requested authorization and coverage for growth hormone therapy. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. The records document linear growth around the fifth percentile. There is a lack of evidence of poor growth based on the growth chart. Growth hormone therapy is not indicated for a child that is growing well. The clinical notes indicate that this patients weight is at the first percentile. Poor nutrition can affect growth, and this patient may benefit from extra calories to improve growth. This patient has a relatively short genetic potential. However, growth hormone therapy is not indicated to treat short genetic potential. There is no indication of idiopathic short stature, as this patient is not growing below -2.25 standard deviations for age and sex. Thus, growth hormone therapy is not medically necessary for the treatment of this patient.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 


A 52-year-old male enrollee has requested reimbursement for substance abuse subacute residential treatment center services provided from 10/27/13 through 12/01/13.  The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue.  Upon admission, the patient had a normal mental status examination.  He was motivated to make total lifestyle changes and stay sober.  He had maintained 101 days of sobriety earlier in the calendar year.  He had supportive friends and family, and safe housing.  Although the patient had met with a psychiatrist, and also had therapy focusing on self-esteem and occupationally-based leadership struggles, there was no evidence in the record that the patient had engaged chemical dependency treatment services during the episode of illness, such as substance use counseling, anti-craving medication, sober living environments, intensive outpatient programming or partial hospitalization.  This is significant because modern psychiatric practice favors treatment in the community as outcome measures and therapeutic gains are optimized in this environment.  In sum, the record does not reflect that comprehensive, evidence-based services provided in a less restrictive setting would have been inadequate at the time.  All told, substance abuse subacute residential treatment center services provided from 10/27/13 through 12/01/13 were not medically indicated for the treatment of this patient.  Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

The patient is a 23-year-old female with a history of depression. She has undergone pharmacological management of her depression since 2019. Medication trials have included Prozac, Wellbutrin, venlafaxine, Zoloft, Lamictal and Ability. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. Given the severity of her symptoms and functional impairment, TMS is medically indicated. Currently, TMS is indicated for the acute phase of major depression. This patient has failed over four different agents of two different classes. She has failed CBT, which is an evidence-based psychotherapy for major depressive disorder. The TMS Society Consensus Review recommends TMS for the acute phase of severe depression, which she is currently experiencing. Therefore, TMS is medically necessary for the treatment of this patient.