Persius/hicric huggingface dataset:
Appeal type: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Guardant360 testing (genetic testing) rendered on 5/17/17. Final Result: Two of the three reviewers determined that there is sufficient support for Guardant360 testing in this clinical setting. Molecular diagnostic studies in non-small cell lung cancer (NSCLC) are considered standard of care. Numerous gene alterations have been identified that impact therapy selection. The National Comprehensive Cancer Network NSCLC Guidelines Panel strongly advises broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with NSCLC. Testing of lung cancer specimens for these alterations is important for identification of potentially efficacious targeted therapies, as well as avoidance of therapies unlikely to provide clinical benefit. As such, molecular profiling such as with Guardant360 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications:  Physician reviewers 1, 2 and 3 are board certified in internal medicine with sub-specialty certification in medical oncology and hematology. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Linzess. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patients medical condition. The submitted documentation supports the medical necessity of the requested medication. In placebo-controlled Phase III clinical trials, Linzess is indicated to restore colonic function in chronic constipation, and is U.S. Food and Drug Administration-approved for chronic constipation. Researchers found Linzess has a mechanism of action that differs from osmotic laxatives and stimulant laxatives, and can be effective even if those patients who have failed traditional treatment with laxatives and stimulant laxatives. 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. The American Gastroenterological Association Medical Position Statement on Constipation states that the first line of therapy should be an osmotic agent, and then another type of laxative such as a stimulant laxative should be tried, followed by a newer agent, such as Linzess. The patients imaging studies did not show obstruction in this case, but did show ongoing constipation over a long period of time. For these reasons, Linzess is medically necessary for the treatment of this patient.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 sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for losartan brand name Cozaar manufactured by Teva instead of losartan brand name Cozaar manufactured by Solco Healthcare. When the U.S. Food and Drug Administration (FDA) approves a generic drug product, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity and potency. Generic drugs are required to have the same active ingredient, strength, dosage form and route of administration as the brand name product.  Through review of bioequivalence data, the FDA ensures that the generic product performs the same as its respective brand name product. This standard applies to all generic drugs, whether immediate or controlled release. In this case, there is not sufficient documentation that the patient has had a significant adverse reaction to the generic drug losartan, made by Solco Healthcare. The efficacy of both the brand name and generic drug made by either manufacturer are equivalent. Therefore, the requested losartan brand name Cozaar manufactured by Teva instead of losartan brand name Cozaar manufactured by Solco Healthcare 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 internal 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 a similar medical condition.
Appeal type: Medical Necessity
Decision: Upheld Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for blood zonulin test. The Health Plan has denied this request indicating that the requested services are not medically necessary for evaluation of the patients leaky gut syndrome. The submitted documentation does not support the medical necessity of the requested services. Leaky gut syndrome, or abnormally increased intestinal permeability, has not been clearly defined as a disease. Not only is such impermeability associated with multiple diseases and normal health, it has not been proven to cause any specific disease. Furthermore, increased gastrointestinal permeability may be a consequence rather than the cause of disease. According to studies, there is no treatment for increased intestinal permeability, other than treating the underlying disease, if there is one. The requested blood zonulin test is not specific for increased gastrointestinal permeability or for leaky gut syndrome. Increased zonulin level can be associated with a multitude of conditions, such as inflammatory bowel disease, celiac disease, obesity, cigarette smoking, hyperlipidemia, autism spectrum disorder, and elevated liver enzymes. Zonulin levels may be elevated even if none of the conditions listed above are present. Evidence-based studies show that an elevated zonulin level is not a useful assessment to diagnose any specific disease. For these reasons, blood zonulin test is not medically necessary for this patient.Final Result: The reviewer determined that the requested services 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 internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A 32-year-old female enrollee has requested authorization and coverage for chiropractic services for treatment of the enrollees medical condition. Findings:  The physician reviewer found that the medical necessity for chiropractic treatment for the patients condition of Ehlers Danlos syndrome has been established in the medical records provided for review. There is evidence-based literature support for chiropractic treatment for the treatment of Ehlers Danlos syndrome. Specifically, Colloca and Polkinghorn noted that chiropractic care may be of benefit to some patients with connective tissue disorders, including Ehlers Danlos syndrome. Given the support in the medical literature, a clinical trial of six sessions of chiropractic treatment for this patients medical condition is medically necessary. Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is a board certified chiropractor 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Coflex interlaminar stabilization device. This patient presents with progressively worsening and severe low back pain radiating into the lower extremities, left greater than right, with signs and symptoms of neurogenic claudication. He has associated significant functional limitations that interfere with activities of daily living. He is status post prior anterior lumbar interbody fusion at the L5-S1 level. He has failed to improve despite conservative treatment. The neurosurgeon has recommended decompression and stabilization surgery using the Coflex device over an instrumented fusion at the L4-L5 level adjacent to the prior fusion. The current evidence-based literature and long-term studies support the use of Coflex interlaminar stabilization with decompression as a safe and efficacious alternative to decompression and/or lumbar fusion for the treatment of lumbar spinal stenosis at one to two levels. Therefore, the requested Coflex interlaminar stabilization device is likely to be more effective than other treatment options. Findings:  Three physician reviewers found the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Final Result: The reviewers determined that the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in orthopedic surgery 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: Experimental/Investigational
Decision: Upheld Decision of Health Plan

An enrollee has requested authorization and coverage for alternative medicine office consultation and integrative medicine follow-up visit. Findings:  Three physician reviewers found when treating insomnia, patients should receive therapy for any medical condition, psychiatric illness, substance abuse or sleep disorder that may be precipitating or exacerbating the insomnia. If symptoms are severe enough to require intervention, cognitive behavioral therapy is the initial therapy that is recommended.  If a combination of behavioral therapy and medication is required, the medical evidence supports a short acting medication for six to eight weeks. If symptoms continue, evaluation in a sleep disorder center prior to the institution of long-term medications may be indicated.  In this case, the documentation does not support that the patient has received optimal therapy for medical and psychiatric conditions or that non-pharmacologic treatment for insomnia has failed. The records do not document evaluation with a sleep study. Additionally, the documentation does not support that she has adhered to standard sleep hygiene or had a trial of cognitive behavioral therapy. All told, the requested alternative medicine office consultation and integrative medicine follow-up visit are not likely to be more efficacious than other treatment options. Final Result: The reviewers determined that the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in internal medicine 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: Experimental/Investigational
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Integrated BRACAnalysis with MyRisk Update Test.  Findings:  Two of the three physician reviewers found there is sufficient support for a portion of the services at issue in this clinical setting. Although this patient was a candidate for BRCA testing, the records indicate that BRCA testing was already performed previously. Thus, repeating this testing was not indicated. Given this patients history, BRACAnalysis Rearrangement testing was medically indicated. However, MyRisk testing was not indicated, since there is a lack of prospective randomized controlled studies showing improved outcomes correlating the results obtained from similar tests with improved overall survival or quality of life. In sum, BRACAnalysis Rearrangement testing was likely to have been of greater benefit than other methods of evaluating this patient. However, the superior effectiveness of the remaining tests has not been established. Final Result: The reviewers determined that a portion of the services 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 partially overturned.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in internal medicine with sub-specialty certification in medical oncology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: A 66-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the prostate with or without contrast. This patients rising PSA and the prior MRI scan which was suspicious for cancer in the left prostatic base warrant consideration of biopsy. Thus, MRI of the prostate is supported as medically necessary if there is also the ability to perform a targeted biopsy should a lesion be found at the time of the examination. Such a procedure can be done with a fused ultrasound guided biopsy correlating with the MRI scan. This approach would allow for the prostate to be examined by MRI and ultrasound done at the same time to allow for a specific target to be biopsied as suggested by the provider in 2017. If no definitive lesion is seen on the MRI, the provider may opt for surveillance rather than tissue sampling. However, if a suspicious lesion is visualized, the imaging can guide the provider to the exact location for biopsy. To perform another MRI without the ability to target a specific area to biopsy is unreasonable based upon the clinical factors as well as the suspicious findings leading to a PIRADS 5/5 diagnosis in 2017. Thus, the requested MRI of the prostate with or without contrast is medically necessary so long as a targeted biopsy is performed at the time of imaging, should a lesion be found at the time of the examination. Final Result: The reviewer determined that the requested services are medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in diagnostic radiology 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 Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for compounded ketamine with lidocaine, baclofen, gabapentin and cyclobenzaprine.  Colleagues noted potential benefit for use of topical compounded cream for complex regional pain syndrome but found no benefit greater than oral administered therapies. In the absence of demonstrated contraindication or intolerance to oral and parenteral medications there was no improved benefit.  Colleagues noted there were no controlled trials of sufficient size and power that showed statistical significant benefit from the use of compounded creams containing ketamine for complex regional pain syndrome (CRPS). Colleagues also noted no statistical benefit of ketamine topical creams for treatment of CRPS compared to standard therapies.  All told, the use of compounded creams has not shown significant benefit in controlled trials for treatment of CRPS. Such compounded creams are not standardized in terms of the amount, strength or type of contents. Combination of compounds in one cream is not comparable to the use of one medication topical compounds due to the unknown nature of synergistic or conflicting properties of the compounded combination.  Studies have not demonstrated any benefit compared to standard treatments. Furthermore, the submitted records do not demonstrate intolerance to standard treatments or contraindication to standard treatments. In sum, the requested compounded ketamine with lidocaine, baclofen, gabapentin and cyclobenzaprine compounded medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: All three reviewers determined that the requested compounded medication 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:  One Reviewer is board certified in pain management and anesthesiology and is actively practicing. One Reviewer is board certified in pain management and anesthesiology and is actively practicing.  One Reviewer is board certified in pain management and neurology and is actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Medical Necessity
Decision: Overturned Decision of Health Plan

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Synvisc One injections. There is adequate evidence that intraarticular hyaluronic acid injections reduce pain and increase function in knee osteoarthritis, and the benefits are long-lasting as compared with intraarticular corticosteroids. Researchers conducted a systematic review of overlapping meta-analyses comparing viscosupplementation with other non-operative treatment modalities for knee osteoarthritis. The authors reported that the current highest level of evidence suggests that intraarticular hyaluronic acid is a viable option for patients with knee osteoarthritis which results in improvements in knee pain and function that can persist for up to 26 weeks. Viscosupplementation has a good safety profile, and its use should be considered in patients with knee osteoarthritis. All told, the requested Synvisc One injections in both knees are supported as medically necessary for treatment of this patients knee osteoarthritis. Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.
Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

An enrollee has requested authorization and coverage for transesophageal incisionless fundoplication (TIF) EsophyX device placement. Findings:  Three physician reviewers found that there is insufficient evidence the requested services are likely to be efficacious in this clinical setting. Upon review of the submitted documentation, it is not clear that the patient has acid reflux disease. The appearance of barium spontaneously reflux during an upper gastrointestinal (GI) series can be misleading and may occur in healthy individuals. Additionally, the patient has had a poor response to antisecretory therapy which is atypical in a patient with acid reflux. An interventional procedure for GERD is premature in the absence of formal esophageal manometry and pH testing. It is appropriate to undergo combined pH/impedance testing to look for weakly acidic/non-acidic reflux prior to consideration of a TIF procedure.  Furthermore, the efficacy and durability of TIF remains uncertain at this time. Although TIF is associated with fewer postoperative adverse effects such as gas, bloating and dysphagia compared with surgery fundoplication, the durability of TIF is less certain than that of surgery. In a meta-analysis of five randomized trials and 13 prospective studies, proton pump inhibitor use after TIF increased over time; the satisfaction rate was only 69% at six months. In another network meta-analysis of TIF versus fundoplication versus proton pump inhibitor therapy, fundoplication was associated with greater sphincter augmentation than TIF. All told, there is inadequate evidence to support the superior efficacy of the requested transesophageal incisionless fundoplication (TIF) EsophyX device placement at this time. As such, the requested services are not likely to result in superior benefit compared to available standard therapies.Final Result: The reviewers determined that the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in internal medicine with sub-specialty certification in gastroenterology 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.