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

Summary Reviewer 


An 18-year-old female enrollee has requested reimbursement for mental health partial hospitalization program services provided from 5/12/15 through 9/9/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that the services at issue were medically necessary for treatment of the patients medical condition. The documentation submitted for review supports placement at the partial hospitalization program level of care. The records document consistent instability of blood pressure, she was also reported to have black outs, lightheadedness and periods of unstable heart rate. The patient exhibited alterations in her weight with two peaks and two troughs in her weights over time which shows that gains she had made were lost and needed to be readdressed. She continued to have emotional instability particularly when battling her ability to feed herself. For these, a lower level of care could have potentially been dangerous for her. Thus, mental health partial hospitalization program services provided from 5/12/15 through 9/9/15 was medically necessary for treatment of the patients behavioral health condition. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 1

A 64-year-old male enrollee has requested reimbursement for the LifeVest provided from 3/31/17 forward. The Health Insurer has denied this request indicating that the device at issue was and is considered investigational for treatment of the enrollees myocardial infarction and congestive heart failure.   The physician reviewer found that LifeVest use is not recommended when the patient does not meet the criteria for an implantable cardioverter defibrillator (ICD). This patients occurrence of an infarct was within 40 days. In addition, once a coronary intervention such as a stent placement is performed, there is a 90 day waiting period during which medical therapy is maximized, in an effort to improve EF to 35% or greater. Overall, the pertinent literature does not demonstrate an improvement of health outcomes when a wearable cardioverter-defibrillator is deployed in the 90 day period post coronary intervention in the setting of a newly diagnosed ischemic cardiomyopathy. Therefore, the LifeVest provided from 3/31/17 forward was not and is not likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the device at issue was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 2

A 64-year-old male enrollee has requested reimbursement for the LifeVest provided from 3/31/17 forward. The Health Insurer has denied this request indicating that the device at issue was and is considered investigational for treatment of the enrollees myocardial infarction and congestive heart failure.   The physician reviewer found that based on the records provided, the patient presents status post acute myocardial infarction leading to a reduction in left ventricular ejection fraction to 20-25%. In this circumstance, there is potential for recovery of left ventricular function over time with medical therapy and there was no indication for immediate placement of a defibrillator such as sustained or inducible ventricular tachycardia, syncope or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until approximately 90 days have elapsed where continued left ventricular dysfunction with an ejection fraction of 35% or less is documented to persist in spite of appropriate treatment (Russo, et al). A prophylactic defibrillator before this time has not been demonstrated to improve outcome (Hohnloser, et al; Steinbeck, et al). Also, studies evaluating wearable defibrillators during periods of increased risk where criteria for implantable defibrillators have not yet been met are largely comprised of registry data without adequate control groups (Chung, et al). At this time, a prophylactic wearable external defibrillator would be indicated only if accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed, needed to be significantly delayed or required explantation. Thus, in this clinical setting, the LifeVest provided from 3/31/17 forward was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the device at issue was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
Appeal type: Medical Necessity
Decision: Insurer Denial Upheld

Summary Reviewer 3

A 64-year-old male enrollee has requested reimbursement for the LifeVest provided from 3/31/17 forward. The Health Insurer has denied this request indicating that the device at issue was and is considered investigational for treatment of the enrollees myocardial infarction and congestive heart failure.   The physician reviewer found this patient presented with an acute anterior myocardial infarction and underwent emergent revascularization with LAD and PCI. He had recurrent chest discomfort and repeat angiogram revealed stent thrombosis of both vessels. The LAD was reopened and post procedural echocardiogram revealed a severely depressed EF at 24%. He does not have an initial indication for an implantable defibrillator since he was less than 40 days since his myocardial infarction and also less than 90 days from PCI revascularization (Chung, et al). His EF may be transiently low and may improve over time due to recovery of stunned myocardium from the myocardial infarction. Thus, a wearable LifeVest cardioverter defibrillator can provide temporary protection from early sudden death due to arrhythmia in this patient population during this interim period. Although no randomized controlled prospective trials have been completed yet, this short-term indication for the wearable defibrillator therapy has support from large published case series literature, a recently published longer term prospective registry, along with expert opinion and an advisory from the American Heart Association (Adler, et al; Klein, et al; Piccini, et al). In this particular clinical situation, the patient has a severely depressed EF and needs aggressive ongoing medical treatment of his congestive heart failure and a 90 day waiting period before he can be re-evaluated for permanent automatic implantable cardioverter defibrillator therapy. For these reasons, the LifeVest provided from 3/31/17 forward was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the device at issue was and is likely to be more beneficial for treatment 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 1

A 53-year-old female enrollee has requested reimbursement for OVA1 testing performed on 5/19/15. 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 there is a lack of support for the services at issue in this clinical setting.  A 1.3 x 1.2 cm simple ovarian cyst and no free pelvic fluid, presenting in an asymptotic patient as an incidental finding, would typically be followed clinically, either by examination or by follow-up ultrasound.  If surgical evaluation was felt to be warranted and planned, then OVA1 testing could be utilized.  The medical evidence supports the use of OVA1 testing in order to help improve outcomes in those patients who already by clinical presentation warrant surgical evaluation of a pelvic mass to help better determine if preoperative evaluation and co-management with gynecologic oncology would be merited.  In this patients case, there was not a clinical or radiologic raised index of suspicion for this cyst representing a premalignant or malignant lesion.  The provider had not deemed that the mass required surgery based on the clinical/radiologic evaluation prior to OVA1 testing.  All told, OVA1 testing performed on 5/19/15 was not likely to have been of greater benefit 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 2

A 53-year-old female enrollee has requested reimbursement for OVA1 testing performed on 5/19/15. 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 submitted documentation fails to demonstrate the superior efficacy of the services at issue.  Biomarkers such as OVA1 are imprecise and are not specific enough to be accurately used for ovarian cancer screening.  Therefore, its utility in a clinical setting is limited.  This patient had an ovarian cyst, which was simple in nature and decreasing in size.  Both of these features are not associated with neoplasm.  In this case, the medical evidence does not support screening with OVA1 testing was due to the high risk of false positives leading to unnecessary testing and invasive procedures.  Therefore, OVA1 testing performed on 5/19/15 was not likely to have been of greater benefit than other modalities.  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 53-year-old female enrollee has requested reimbursement for OVA1 testing performed on 5/19/15. 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 patient was seen for postmenopausal bleeding, and an ultrasound showed an incidental 1.3 cm simple ovarian cyst.  Simple ovarian cysts, especially when this small, are common, even in early menopause, and considered functional, which means they come and go.  This one was actually smaller than on a prior ultrasound.  In this case, those findings made the likelihood of any ovarian pathology, and particularly ovarian cancer, very low.  Her provider recommended surgery for the bleeding.  In this case, no surgery was indicated for the cyst, and none was planned.  The use of OVA1 has been approved for a very narrow indication, to determine whether a patient should be referred to a gynecologic oncologist for ovarian surgery that is already planned so that appropriate staging and surgical management can take place if ovarian cancer is found.  This patient had a simple small ovarian cyst with no indication of possible ovarian cancer, and no surgery was planned or indicated for the cyst.  The use of OVA1 was not appropriate based on current standards, and was not needed to assist with her clinical management.  Thus, OVA1 testing performed on 5/19/15 was not likely to have been superior over 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 1


A 54-year-old female enrollee has requested reimbursement for Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation the enrollees ulcerative colitis.The physician reviewer found the Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15 was not likely to be more effective for this patient than other available treatment options. There is a lack of controlled data identifying the optimal drug level. A trial demonstrated this approach had no impact on clinical efficacy compared to empiric dose titration (Steenholdt, et al). It is well known for example that many patients respond very well with low drug levels. Additionally many patients have low levels of antibodies which are transient and insignificant clinically. Therefore, the testing at issue has not been validated using prospectively controlled data. All told, the testing at issue 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 54-year-old female enrollee has requested reimbursement for Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation the enrollees ulcerative colitis.The physician reviewer found the Prometheus Anser IFX test is a quantitative measurement of serum infliximab (IFX) and anti-IFX antibodies. Some evidence exists that low serum levels of infliximab or adalimumab and/or the presence of antibodies to infliximab or adalimumab may play a role in primary or secondary response failures. However, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment (Steenholdt, et al; Nanda, et al). As such, 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. Moreover, it has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, or has the optimal timing of when to measure antibody levels been established. In this case, the patients failure to tolerate 6-mercaptopurine may have proved etiologic, rather than a failure of Remicade, in exacerbating proctitis. Thus, the Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15 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 54-year-old female enrollee has requested reimbursement for Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation the enrollees ulcerative colitis. The physician reviewer found that management of ulcerative colitis using Anser IFX has not been standardized, and standardized recommendations for management based on test results have not been formed (Kornbluth, et al). The use of Anser IFX to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in high-quality controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to Remicade (infliximab), nor have threshold drug levels been established (Steenholdt, et al). Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response (Vande Casteele, et al; Nanda, et al). A study concluded that prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies (Adedokun, et al). Another study, with some patients undergoing dose intensification following initial non-response, showed no difference in serum levels of infliximab between patients who responded to dose intensification versus those who did not (Pariente, et al). Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing (Vande Casteele, et al). Based on the clinical literature, Anser IFX measurement of serum infliximab (IFX) provided on 11/30/15 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 Overturned

Summary Reviewer 1

A 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that in 2013, the U.S. Federal Drug Administration (FDA) approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD, and a hiatal hernia less than 3 cm. This patient meets these specific criteria. Based upon a prospective study that included 44 patients, the mean total percent time pH less than 4 was reduced from 11.9% at baseline to 3.8% at three years (Lipham, et al). A recent study comparing the LINX procedure with laparoscopic fundoplication found that GERD patients had similar control of reflux symptoms after both LINX and fundoplication. The authors noted that the inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms (Reynolds, et al). Finally, five-year cohort data was published establishing the durability of the device. In a group of 85 patients, augmentation of the lower esophageal sphincter with a magnetic device provided significant and sustained control of reflux, with minimal side effects or complications. No new safety risks emerged over a five-year follow-up period (Ganz, et al). All told, the requested LINX lower esophageal sphincter augmentation device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that appropriate patient selection is crucial before anti-reflux procedures. In prelude to surgical intervention for GERD, currently upper endoscopy, barium esophagram, pH testing, and manometry are required for preoperative workup for antireflux surgery (Jobe, et al). This patient has undergone much of this pre-operative assessment. The records provided for review demonstrate that this patient has GERD as based on pH recording, and that his response to maximized acid suppression treatment has been sub-optimal. The patient has no dysphagia, Barretts, large hiatal hernia, or absolute surgical contraindications that disqualify him for LINX placement. It can be anticipated that the benefits of ant-reflux surgery with LINX implantation in this patients case will exceed available standard therapy. For these reasons, the requested LINX lower esophageal sphincter augmentation device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 55-year-old male enrollee has requested authorization and coverage for the LINX lower esophageal sphincter augmentation device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than Nissen fundoplication or other surgical anti-reflux procedures. One evidence review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Another best-evidence review concluded that long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval (Bauer, et al). The currently available peer-reviewed literature does not support the conclusion that LINX is more likely to be beneficial in this case than standard treatment including surgical fundoplication (Sheu, et al; Ganz, et al). American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). For these reasons, the requested LINX lower esophageal sphincter augmentation device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.