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

Summary Reviewer 2


A 26-year-old male enrollee has requested authorization and coverage for the LINX reflux management system. 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 there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures. One evidence-based 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 further studies are required to determine its long term outcomes and its relative efficacy as compared to other established treatments (Loh, 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).  A peer-reviewed journal published a letter stating that there are 11 reports of endoscopically-confirmed LINX erosion through the esophagus in the FDA database (Bielefeldt, et al).  Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention, which is a concern in this patient (Sheu, et al). The currently available peer-reviewed literature does not definitively support the conclusion that LINX is likely to be more beneficial in this case than standard treatment, surgical fundoplication (Sheu, 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). Therefore, according to current literature and clinical guidelines, LINX is not likely to be more efficacious for treatment of GERD and should be considered investigational.
Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3


A 26-year-old male enrollee has requested authorization and coverage for the LINX reflux management system. 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 in this clinical setting, the requested procedure is likely to be more beneficial for treatment of this patients GERD than any available standard therapy. LINX is a minimally invasive anti-reflux procedure that has been approved by the Food and Drug Administration. In addition, medical studies indicate that LINX has been shown to be as effective and non-inferior to surgery.  A systematic review of more than 6,318 abstracts, 53 cohorts and 10 controlled studies has shown that it remains unclear which patient characteristics influence postoperative success following fundoplication for GERD. All told, LINX is at least equally efficacious as fundoplication and is less invasive (Ip et al). Further, the LINX procedure is potentially reversible, while surgery is not, and is less likely to have adverse effects. For all these reasons, LINX is likely to be more beneficial for treatment of this 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 1

A 62-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found the review of the submitted documentation and relevant literature fails to support the services at issue in this clinical setting. There is a lack of evidence in the peer-reviewed literature that supports the use of breast tomosynthesis compared to currently available techniques. Although digital breast tomosynthesis is a promising technology, there is a lack of peer-reviewed literature supporting its use in this clinical setting. As such, the services at issue were not likely to be more beneficial than standard 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 Overturned

Summary Reviewer 2

A 62-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found the breast tomosynthesis performed on 4/23/15 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. There is support in the medical literature for the use of breast tomosynthesis compared to conventional mammogram due to improved cancer detection rate. According to Skaane and colleagues The use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers.  Based on the medical literature cited above, the use of breast tomosynthesis was 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 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 Overturned

Summary Reviewer 3


A 62-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found according to Helvie, The Achilles heel of screening mammography is the detection of cancer in women with radiographic dense breasts. While nearly all cancers will be apparent in fatty breasts, only half will be visible in extremely dense breast. This results, at least in large part, from the masking or camouflaging of noncalcified cancers by surrounding dense tissue. The author further states that breast tomosynthesis has the potential to change conventional mammographic screening and diagnostic imaging with possible improvements in cancer detection, decreased callbacks, and fewer false positive biopsies. In this case, the patient presented with heterogeneously dense breasts. Given the dense nature of the patients breasts, the breast tomosynthesis performed on 4/23/15 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities.  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 1

The patient is a 55-year-old male with a history of hearing loss and vertigo which has been responsive to prednisone. He was treated with Simponi injections in August 2017. The patient has requested authorization and coverage for Simponi 50 mg injections once per month for one year (J1602). The Health Insurer has denied this request indicating that the requested medication is considered investigational. The records indicate that this patient has autoimmune hearing loss. The patient has been treated with high dose prednisone as well as Atabrine. However, there is a paucity of peer-reviewed medical literature supporting the use of tumor necrosis factor (TNF) blockers for the treatment of autoimmune hearing loss (Derebery, et al; Van Wijk, et al). Thus, the requested Simponi 50 mg injections once per month for one year (J1602) are 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 medication 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: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2

The patient is a 55-year-old male with a history of autoimmune hearing loss in the left ear. The patient was doing well with intermittent steroids. According to the medical records, the patient is becoming intolerant to steroids. He is having problems with shortness of breath. The patient tried treatment with the tumor necrosis factor (TNF) blocker Simponi with reported improvement in his hearing. The patient has requested authorization and coverage for Simponi 50 mg injections once per month for one year (J1602). The Health Insurer has denied this request indicating that the requested medication is considered investigational. Currently, the medical literature supports the use of steroids for treatment of autoimmune hearing loss. However, other medications, including TNF blockers and autoimmune agents, are not considered first-line therapies. The articles provided by the treating provider cite a five patient trial and admit further studies are needed. Moreover, the patients were not followed long enough for adequate assessment. Given these findings, the requested Simponi 50 mg injections once per month for one year (J1602) are 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 medication 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: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 3

The patient is a 55-year-old male who initially presented with sudden sensorineural hearing loss. Subsequently, he was diagnosed with autoimmune hearing loss. He has experienced fluctuating high frequency hearing loss, tinnitus, hyperacusis, and vertigo. He has been treated with prednisone since August 2017, has been treated successfully with intratympanic Simponi 50 injections. The patient has requested authorization and coverage for Simponi 50 mg injections once per month for one year (J1602). The Health Insurer has denied this request indicating that the requested medication is considered investigational. Simponi has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. Autoimmune inner ear disorder is one of a few types of sensorineural hearing loss that is treatable and potentially reversible. Treatment involves oral steroids and methotrexate, as well as other treatment modalities with variable success rates. These treatments are systemic, with inherent side effects limiting their effectiveness. Recently, tumor necrosis factor (TNF) alpha blockers have been suggested as a modality of treatment. In one study, Simponi stabilized hearing in three of seven per-protocol patients with autoimmune hearing loss and allowed a complete tapering off of prednisone in those patients. In addition, this patient has experienced positive response to prior treatment with Simponi. Accordingly, the requested Simponi 50 mg injections once per month for one year (J1602) are 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 medication 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: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 


A 49-year-old female enrollee has requested authorization and coverage for insulin infusion pump. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes, type I. The physician reviewer found that there is sufficient support in the medical literature for the requested device in this clinical setting. The patient has diabetes, type I and has managed her diabetes well in the past with insulin pump therapy. However, the tubeless OmniPod pump has malfunctioned and she has developed allergic reactions to its adhesive, preventing the pump from staying in place. Therefore, the patient is being administered suboptimal doses of insulin. Her hemoglobin A1c has gone up from 7 to 8.1 percent, which goes against the goals of diabetes management (2017- Standards of Medical Care in Diabetes). The patients provider has requested a replacement, because the OmniPod is no longer working for this patient. The need to work with the patient is written in the guidelines by the American Diabetes Association and the American Association of Clinical Endocrinologists. The records document that this patient has not responded well to her current OmniPod system and she has had adverse effects. While skin hypersensitivity to adhesives or cannulas at the insertion site is not common, it is an issue that occurs in some patients and addressed in the literature. In this patients case, staying on the OmniPod system is no longer effective and safe. The patient has attempted to work with this pump, unsuccessfully. All told, the requested insulin infusion pump is medically necessary for the management of this patients diabetes.Therefore, for all the reasons stated above, the requested device is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 79-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the patient has paroxysmal atrial fibrillation. He requires anticoagulation therapy for life and has been maintained on Eliquis therapy. He has a high-risk occupation for trauma and is on job sites daily by report. The Watchman atrial appendage occluder device has been approved by the U.S. Food and Drug Administration (FDA) for this indication and is recommended for consideration in patients with either an absolute or relative contraindication to long-term anticoagulation. It is not considered an investigational device in these clinical situations. This patient has a relative contraindication to anticoagulation and is a good candidate for Watchman. Therefore, percutaneous transcatheter closure of the left atrial appendage with endocardial implant is likely to be more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 2

A 79-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that in this circumstance, atrial fibrillation treatment options include continuation of anticoagulation while accepting an increased bleeding risk or percutaneous left atrial appendage exclusion using a Watchman device. The Watchman device has been demonstrated in one trial to be non-inferior compared with warfarin and has also showed favorable preliminary results in another trial.  However, device placement in these trials had a high rate of significant complications due to pericardial effusion and procedural stroke related to thromboembolism or air embolization. The Watchman device should still be considered investigational, especially in the subset of patients who are tolerating anticoagulation without bleeding side effects or evidence of recurrent strokes. This patient is tolerating Eliquis and has no documented bleeding episodes. Therefore, percutaneous transcatheter closure of the left atrial appendage with endocardial implant is not likely to be more beneficial than other available standard therapy.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 3

A 79-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that based on the current evidence, the Watchman device is non-inferior to systemic anticoagulation treatment for long-term stroke prevention due to paroxysmal or persistent atrial fibrillation. This has been demonstrated in both the PROTECT AF trial and the PREVAIL trial. Given the patientas elevated stroke risk and his unsuitability for long-term anticoagulation to his occupational risk of head trauma, he is an acceptable candidate for a Watchman device. Therefore, percutaneous transcatheter closure of the left atrial appendage with endocardial implant is likely to be more beneficial than other available standard therapy.
Appeal type: Medical Necessity
Decision: Insurer Denial Overturned

Summary Reviewer 

A 51-year-old female enrollee has requested authorization and coverage for mastopexy and abdominoplasty. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who was diagnosed with breast ptosis and excess abdominal skin.The physician reviewer found that from the American Society of Plastic Surgeons (ASPS), there can be situations when skin redundancy can cause a functional deficit. Thus, mastopexy and abdominoplasty could be considered functional treatments instead of cosmetic treatments.  Shermak and colleagues also note the following, Massive weight loss leads to functional and aesthetic deformity that can be corrected with body contouring surgery. Body contouring procedures can generally be considered cosmetic intervention, except when used to treat well-defined functional deficits that have failed typical dermatologic treatment, as in this case.  This patient has chronic rashes underneath her abdominal skin folds and breasts that have failed typical dermatologic treatment.  This is supported by the patient, multiple providers, medical documentation and photographs.  The medical literature supports surgical intervention in this clinical setting where documentation indicates a lack of response to typical dermatologic treatment or to conservative management. This is well-documented for this patient.  Based on the medical records provided, there is a clear functional deficit related to the massive weight loss in the areas of concern. Moreover, the patient has also tried and failed specific dermatologic treatments. The documentation provided evidence of recurrent rashes with detailed specific dermatologic medications. In this patients case, there is well documented functional deficits along with documentation of failed therapies. As such, the requested services of mastopexy and abdominoplasty are medically necessary. Therefore, for the reasons stated above, the requested services are medically necessary for the treatment of the patients medical condition. The Health Insurers denial should be overturned.
Appeal type: Experimental
Decision: Insurer Denial Overturned

Summary Reviewer 1

A 59-year-old female enrollee has requested reimbursement for the Veracyte Afirma genetic testing provided on 12/3/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule.  The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). A newer test, the Afirma Thyroid FNA Analysis from Veracyte utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures (Duick, et al). Based on these findings, the Veracyte Afirma genetic testing performed on 12/3/14 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined 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 Overturned

Summary Reviewer 2

A 59-year-old female enrollee has requested reimbursement for the Veracyte Afirma genetic testing provided on 12/3/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule.  The physician reviewer found that Thyroid nodules are commonly managed by diagnostic fine needle aspiration to evaluate the cytopathology. In this case the finding by this standard technique was atypia of undetermined significance (Baloch, et al). This diagnostic category creates a dilemma with regards to recommended surgery. In this case, the patient was facing total thyroidectomy if malignancy was present and subtotal thyroidectomy if the lesion turned out to be benign. Hence, the sample was submitted to Veracyte for gene expression analysis. The case file has a white paper from the carrier that appears to support mutational testing. However, in a large study of over 500 patients, 6-14% of these with atypia of undetermined significance were found to have malignancy on pathology review but no mutation in several known oncogenic pathways (Nikiforov, et al). In contrast, the gene expression test done by Veracyte has demonstrated a very high negative predictive value for malignancy (Alexander, et al). All told, the Veracyte Afirma genetic testing performed on 12/3/14 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined 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.