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text stringlengths 60 2.6k	decision stringclasses 2 values	appeal_type stringclasses 8 values	full_text stringlengths 206 13.1k	sufficiency_id int64 0 1
A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease.	Overturned	Experimental	Summary Reviewer 2 A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found a meta-analysis of the utility of fecal calprotectin to determine disease activity in adults with Crohns disease found poor specificity (Lin, et al). Another study found that calprotectin above 150 ug/g had poor specificity (43%), and therefore poor positive predictive value, in predicting relapse (Pardi and Sandborn; Costa, et al). An additional meta-analysis of inflammatory bowel disease markers reported that the relatively poor specificity of fecal calprotectin in Crohns disease is a concern, as a false positive test could lead to treatment of a patient without endoscopically active disease (Mosli, et al). Thus, the use of calprotectin levels to guide therapy has not definitively been shown in controlled studies to improve clinical outcomes in patients with Crohns disease and the fecal calprotectin testing performed on 11/17/15 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.	1
A 50-year-old female enrollee has requested reimbursement for CPT codes 84999 (unlisted chemistry procedure, Oncotype DX colon cancer assay) and 88342 (immunohistochemistry of immunohistochemistry, per specimen, initial single antibody stain procedure) performed on 6/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer.T	Overturned	Experimental	Summary Reviewer 1 A 50-year-old female enrollee has requested reimbursement for CPT codes 84999 (unlisted chemistry procedure, Oncotype DX colon cancer assay) and 88342 (immunohistochemistry of immunohistochemistry, per specimen, initial single antibody stain procedure) performed on 6/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer.The physician reviewer found the current medical evidence has not demonstrated the superior efficacy of the services at issue. Oncotype DX colon cancer assay has been shown to have prognostic value, but to date has not shown that predictive benefit of standard chemotherapies. National Comprehensive Cancer Network guidelines state that there are insufficient data to recommend the use of multigene assays, such as the Oncotype DX colon cancer assay, to determine adjuvant therapy. Mismatch repair (MMR) status was stable for this patient. However, given ulceration on final pathology of her colon tumor and abdominal abscess at presentation, most experts would lean toward chemotherapy for this patient given these risk factors. Based on the available data, CPT codes 84999 and 88342 performed on 6/17/16 were 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.	1
A 51-year-old female enrollee has requested reimbursement for MRI performed on 8/08/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. This patient had low back pain with associated left radiculopathy symptoms for nine months. She failed conservative management, including massage and chiropractic therapy.	Overturned	Medical Necessity	Summary Reviewer A 51-year-old female enrollee has requested reimbursement for MRI performed on 8/08/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The first appropriate imaging for the evaluation of low back pain with radicular symptoms is lumbar radiograph. According to the American College of Radiology, if the pain persists after four to six weeks of conservative management, and the patient is a surgical or intervention candidate, then MRI of the lumbar spine is the usually appropriate next examination. This patient had low back pain with associated left radiculopathy symptoms for nine months. She failed conservative management, including massage and chiropractic therapy. Therefore, MRI of the lumbar spine was an appropriate examination. Thus, MRI performed on 8/08/18 was medically necessary for the evaluation of this patient.	1
A 40-year-old female enrollee has requested reimbursement for the Decision Dx test and specimen handling provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees cutaneous melanoma.	Upheld	Experimental	Summary Reviewer 1 A 40-year-old female enrollee has requested reimbursement for the Decision Dx test and specimen handling provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the Decision Dx melanoma diagnostic test has not been demonstrated in the peer-reviewed medical literature to improve health outcomes when compared with standard testing and evaluation. In addition, there is a lack of data to support using immunotherapy in patients with Stage I disease regardless of recurrence risk. All told, the Decision Dx test and specimen handling provided on 11/23/15 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 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.	0
A 45-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 10/22/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.	Overturned	Experimental	Summary Reviewer 2 A 45-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 10/22/15. 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 that the breast tomosynthesis performed on 10/22/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Skaane and colleagues performed a large prospective screening trial To assess cancer detection rates, false-positive rates before arbitration, positive predictive values for women recalled after arbitration, and the type of cancers detected with use of digital mammography alone and combined with tomosynthesis. The authors concluded that 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. Given the support above, the use of breast tomosynthesis was likely to be more beneficial for evaluation of the patients breast exam than conventional testing. 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.	1
The parent of 10-year-old female enrollee has requested authorization and coverage for growth hormone treatment. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees growth hormone deficiency. . This patient has a combination of early adrenarche with advanced skeletal maturation at baseline, coupled with true central precocious puberty resulting in rapid acceleration in skeletal maturation and an extremely short adult predicted height. Her adult height . Her skeletal maturation is outpacing her statural growth, resulting in a shorter adult height prediction over time.	Overturned	Medical Necessity	Summary Reviewer The parent of 10-year-old female enrollee has requested authorization and coverage for growth hormone treatment. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees growth hormone deficiency. The physician reviewer found that although combination therapy with GnRH agonist and GH is not recommended for augmentation of height in children with normally timed puberty or in children with idiopathic short stature alone. This patient has a combination of early adrenarche with advanced skeletal maturation at baseline, coupled with true central precocious puberty resulting in rapid acceleration in skeletal maturation and an extremely short adult predicted height. Her adult height prediction is more than three standard deviations below the mean for age, and her epiphyses are still open. Her skeletal maturation is outpacing her statural growth, resulting in a shorter adult height prediction over time. Based on a recent meta-analysis, evaluating the efficacy and safety of combination therapy with GnRH agonist and GH in children with central precocious puberty, children with combination therapy reached a taller adult height and larger height gains without adverse effects (Liu, et al). As such, GH therapy is medically necessary in this patient to achieve a normal adult height. Therefore, for the reasons stated above, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.	1
A 62-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator performed on 7/25/18, 8/25/18 and 9/25/18. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition.	Overturned	Experimental	Summary Reviewer 2 A 62-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator performed on 7/25/18, 8/25/18 and 9/25/18. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that in this circumstance, there is potential for recovery of left ventricular function over time with medical therapy. There was no documented indication for immediate placement of a defibrillator, such as sustained or inducible ventricular tachycardia, unexplained syncope or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until a period of time (greater than 90 days) where continued left ventricular dysfunction is documented to persist despite appropriate treatment. A prophylactic defibrillator (wearable or implantable) before this time has not been demonstrated to improve outcome. For example, studies assessing efficacy of prophylactic defibrillators early after diagnosis of myocardial infarction and reduced ejection fraction less than or equal to 35% before ventricular function has had a chance to recover have not demonstrated improved outcome. 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. At this time, 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 (due to infection, for example) or required explantation. Thus, the wearable cardioverter defibrillator provided on 7/25/18, 8/25/18 and 9/25/18 was not likely to have been superior over other available treatment options.	1
The patient is a 38-year-old female with a history of hidradenitis suppurativa (HS). The patient has requested authorization and coverage for Otezla. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. this case, the patient has maximized her medical and surgical options. She is on weekly dosing of Humira and still has breakthrough symptoms in the groin.	Overturned	Medical Necessity	Summary Reviewer The patient is a 38-year-old female with a history of hidradenitis suppurativa (HS). The patient has requested authorization and coverage for Otezla. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that Hidradenitis suppurativa (HS) is a chronic disease that can impact an individualas quality of life. Humira is the only U.S. Food and Drug Administration (FDA) approved immunosuppressant for the treatment of HS. It is indicated for moderate to severe HS. Per the medical evidence, other biologic treatment options include infliximab, anakinra, and ustekinumab. However, as noted by Alikhan and colleagues, with these medications, aplacebo-controlled dose-ranging studies are needed to determine the optimal dosage for management.a Since these are biologics as well, they also decrease the immune system like Humira. Otezla has a different mechanism of action. In the randomized controlled trial by Vosen and colleagues, Otezla was shown to be effective in treating moderate HS. The main side effects of this medication is gastrointestinal side effects. In this case, the patient has maximized her medical and surgical options. She is on weekly dosing of Humira and still has breakthrough symptoms in the groin. At this point, another adjunctive treatment is recommended. Based on the records, a trial of Otezla is medically indicated. Therefore, Otezla is medically necessary for the treatment of this patient.	1
A 63-year-old male enrollee has requested reimbursement for laboratory testing performed on 2/11/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.	Overturned	Medical Necessity	Summary Reviewer A 63-year-old male enrollee has requested reimbursement for laboratory testing performed on 2/11/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the services at issue in this clinical setting. MRD has been found to be a strong prognostic indicator in patients with mantle cell lymphoma. Patients with a negative PET and no MRD have better five-year overall survival rates. Testing for MRD has been used to guide indications for additional therapy, such as maintenance rituximab and autologous stem cell transplant. Achievement of MRD negativity was also associated with improved clinical outcomes. Therefore, laboratory testing (unlisted molecular pathology) performed on 2/11/19 was medically necessary for the evaluation of this patient.	0
A 20-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 8/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. In this case, it appears the patient was tested for trichomonas, but there	Overturned	Experimental	Summary Reviewer 1 A 20-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 8/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that Polymerase chain reaction testing is an appropriate test for chlamydia, gonorrhea, and trichomonas, all of which should be tested for as part of a sexually transmitted disease evaluation. In this case, it appears the patient was tested for trichomonas, but there are no records to indicate testing for chlamydia and gonorrhea. In addition, multiple polymerase chain reaction tests were performed for various vaginal organisms, some of which do not even cause infection. The records noted that testing was performed for candida species, lactobacillus species, atopobium vaginae, megasphaera species, and Gardnerella vaginalis quantification. Polymerase chain reaction testing for these organisms is not standard of care. Standard testing for evaluation of a vaginal discharge includes assessing the symptoms, assessing the appearance of the discharge, pH testing of the vaginal fluid, examination of the discharge under the microscope, and sometimes DNA probes or cultures. There are no records to indicate that these standard evaluations and diagnostic tests were done. In sum, polymerase chain reaction test for trichomonas was likely to have been more effective than other methods of evaluating this patient. However, the superior efficacy of the remaining tests has not been established.	1
The parent of a 15-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 10/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.	Overturned	Experimental	Summary Reviewer 2 The parent of a 15-year-old female enrollee has requested reimbursement for Prometheus Anser ADA testing performed on 10/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that there is sufficient support for the services at issue in this patients case. This testing is standard in the treatment of patients with inflammatory bowel disease. This testing demonstrates the levels of drug as well as if there is antibody formation. Prometheus Anser ADA testing can guide providers in the management of the medication. If levels are low, this would explain the patients symptoms, and the medication dosage can be changed. In sum, Prometheus Anser ADA testing performed on 10/10/17 was likely to have been superior over 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.	1
A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Actemra provided from 7/14/15 through 12/15/15 and ongoing. The Health Insurer has denied this request indicating that the medication at issue was and is investigational for the treatment of the enrollees medical condition.	Upheld	Experimental	Summary Reviewer 1 A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Actemra provided from 7/14/15 through 12/15/15 and ongoing. The Health Insurer has denied this request indicating that the medication at issue was and is investigational for the treatment of the enrollees medical condition. The physician reviewer found that Tocilizumab inhibits the effects of the cytokine, IL-6, which has been associated with rejection of kidney transplants. It has shown efficacy in rheumatoid arthritis and is currently approved for that indication by the U.S. Food and Drug Administration (FDA). An uncontrolled phase I/II trial in highly sensitized patients awaiting kidney transplantation has shown the drug to be safe (Vo, et al); and other kidney transplant studies are planned (NCT02108600). However, at this time there is a lack of peer-reviewed literature demonstrating the efficacy of Actemra for treatment in patients with AMR as a basis for off-label use. Thus, the use of tocilizumab in kidney transplantation is considered controversial and is not the standard of care. As such, Actemra 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 medication 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.	0
A 21-year-old male enrollee has requested authorization and coverage for LINX reflux management system. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.	Overturned	Experimental	Summary Reviewer 3 A 21-year-old male enrollee has requested authorization and coverage for LINX reflux management system. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures. Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval. Additionally, LINX has been associated with severe dysphagia requiring endoscopic intervention. The peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment, surgical fundoplication. Based on current literature and clinical guidelines, the requested LINX reflux management system is not likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested services are 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.	0
A 29-year-old female enrollee has requested reimbursement for the Anser ADA test provided on 10/13/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.	Upheld	Experimental	Summary Reviewer 2 A 29-year-old female enrollee has requested reimbursement for the Anser ADA test provided on 10/13/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that antibodies to adalimumab (ADA) are present in a substantial number of patients treated with adalimumab, and in some patients there may be a correlation between the level of these antibodies and clinical response. However, there are technical factors relating to the use of different assay methods across studies, and it has not yet been established whether the use of threshold level aid in the discrimination of response to adalimumab. There are patients who do not respond to adalimumab (primary non responders), and patients who appear to lose their response to adalimumab over a period of time (secondary non responders). However, some evidence suggests that low serum drug levels and/or the presence of drug antibodies to may play a role in primary or secondary response failures. Menting and colleagues noted that patients with no ADA formation in the first 24 weeks of treatment have little chance of it in the following 24 weeks. The presence of ADA is strongly correlated with adalimumab concentration. Standard alternatives to Anser ADA testing, in patients like this patient, include shortening the interval between doses, increasing the dose, or switching to a different agent. At this time, the peer-reviewed medical literature does not support the use of the Anser ADA test as performed on 10/13/14 as 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 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.	0
patient is a 33-year-old female who presented to a hospital in Clovis, New Mexico on 7/26/22 with complaints of severe abdominal and epigastric pain which radiated to her back. The patient was transferred by air ambulance on 7/27/22, as she required observation and monitoring should her condition worsen. The patient was transferred to the receiving facility without complications. The Health Insurer has denied the services at issue as not medically necessary for the treatment of the patients medical condition. In this case, the patient presented on 7/26/22 with severe abdominal pain. The patient was at risk of gallbladder rupture and required further evaluation with ERCP. . The initial hospital reached out to several nearby hospitals and transported the patient to the nearest hospital with appropriate facilities available for treatment. Overall, the patient	Overturned	Medical Necessity	Summary The patient is a 33-year-old female who presented to a hospital in Clovis, New Mexico on 7/26/22 with complaints of severe abdominal and epigastric pain which radiated to her back. The patient was transferred by air ambulance on 7/27/22, as she required observation and monitoring should her condition worsen. The patient was transferred to the receiving facility without complications. The Health Insurer has denied the services at issue as not medically necessary for the treatment of the patients medical condition. This denial is the subject of this appeal and determination. The physician reviewer found that air medical transport is considered medically necessary when the patients condition is life-threatening such that any form of transportation other than an ambulance would be medically contraindicated, the time needed to transport by ground poses a threat to the patients survival, and the patient is transported to the nearest hospital with appropriate facilities for treatment. When transferring a patient from one hospital to another, the air medical transport criteria must be met, and the initial hospital must not have the required services and facilities available to treat the patient. In this case, the patient presented on 7/26/22 with severe abdominal pain. The patient was at risk of gallbladder rupture and required further evaluation with ERCP. The initial hospital did not have the required services and facilities available to treat the patient. The initial hospital reached out to several nearby hospitals and transported the patient to the nearest hospital with appropriate facilities available for treatment. Overall, the patient met the criteria for air ambulance transportation as her condition was unstable and as she required observation and monitoring should her condition worsen. Given these findings, the air ambulance transportation performed on 7/27/22 was medically necessary for the treatment of this patient.	1
A 39-year-old male enrollee has requested authorization and coverage for corticotropin (H.P. Acthar Gel) injections, up to 40 units. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records document that the patient has been diagnosed with rheumatoid arthritis, episcleritis and scleritis. He has been treated with prednisone and CellCept, without adequate response. The patient has requested coverage for H.P. Acthar Gel to improve symptoms and objective findings of rheumatoid arthritis.	Upheld	Experimental	Summary Reviewer 3 A 39-year-old male enrollee has requested authorization and coverage for corticotropin (H.P. Acthar Gel) injections, up to 40 units. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records document that the patient has been diagnosed with rheumatoid arthritis, episcleritis and scleritis. He has been treated with prednisone and CellCept, without adequate response. The patient has requested coverage for H.P. Acthar Gel to improve symptoms and objective findings of rheumatoid arthritis. The current medical evidence does not support the requested medication in this clinical setting. Per the evidence-based guidelines, H.P. Acthar Gel is not recommended for the treatment of rheumatoid arthritis. Thus, corticotropin (H.P. Acthar Gel) injections, up to 40 units, is not likely to be more beneficial than other available treatment options.	1
A 22-year-old female enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.	Upheld	Experimental	Summary Reviewer 1 A 22-year-old female enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the submitted records fail to demonstrate the superior efficacy of the services at issue. Some evidence exists that low serum levels of adalimumab and/or the presence of antibodies to adalimumab may play a role in primary or secondary response failures. 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 adalimumab or the presence of adalimumab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, while there have been testimonials, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes 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. In addition, there are technical factors relating to the use of different assay methods across studies. It has not yet 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. All told, Anser ADA testing performed on 1/16/15 was not likely to have been of greater benefit than other available 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.	1
patient is a six-year-old male who was diagnosed with acute flaccid myelitis in October 2018. The patientas parent has requested authorization and coverage for RT300 FES Rehabilitation Therapy System. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of this patient.	Overturned	Medical Necessity	Summary Reviewer This patient is a six-year-old male who was diagnosed with acute flaccid myelitis in October 2018. The patientas parent has requested authorization and coverage for RT300 FES Rehabilitation Therapy System. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of this patient. The physician reviewer found that the medical literature provides sufficient evidence that supports the benefit of RT 300 FES system over other standard, traditional therapy modalities alone in achieving better outcomes with strengthening, reduced spasticity and improved quality of life. The indications for the RT300 FES Rehabilitation Therapy System for this patient with acute flaccid myelitis and paraplegia are valid and supported by current medical research. These indications include prevention of muscle disuse atrophy, relaxation of muscle spasms, improving blood circulation, prevention of osteoporosis, maintaining or increasing range of motion, prevention of contractures, and cardiac and pulmonary deconditioning. The functional status, the medical history of the patient with secondary complications of the acute flaccid myelitis paraplegia, the prognosis of his injury and neurological level of involvement support the use of this modality. Therefore, RT300 FES Rehabilitation Therapy System is medically necessary for the treatment of this patient.	1
The parent of a seven-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg tablet. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees alopecia.	Overturned	Experimental	Summary Reviewer 3 The parent of a seven-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg tablet. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees alopecia. The physician reviewer found that available treatment options for alopecia areata are quite limited, especially in the case of diffuse/multifocal involvement, where standard therapies such as topical steroids, intralesional Kenalog, contact immunotherapy, and conventional immunosuppressants are often less than satisfactory and associated with side effects. There is substantial evidence, including from clinical trials, supporting the use of oral JAK kinase inhibitors such as tofacitinib for the treatment of alopecia areata. In an open label pilot study, Jabbari and colleagues reported that eight out of twelve patients treated with tofacitinib demonstrated equal to or greater than 50% hair regrowth as measured by SALT scores. In a retrospective study of patients with alopecia areata treated with tofacitinib, Liu and colleagues that 77% achieved a clinical response, with 58% of patients achieving a greater than 50% change in SALT score. Guo and colleagues report that tofacitinib seems to be a promising drug for the treatment of alopecia areata with only mild adverse effects. In this clinical setting, an oral JAK inhibitor, such as Xeljanz, is likely to be more beneficial for the treatment of this patient than therapy with contact immunotherapy and systemic steroids, which carry considerable short and long term side effects, especially given that this patient has already responded well to Xeljanz. Therefore, Xeljanz 5 mg tablet is likely to be more beneficial for treatment of the patients condition than any available standard therapy.	1
The parent of a two-year-old female enrollee has requested authorization and coverage for the Synagis 100 mg/mL injection. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees heterotaxy syndrome and Shones complex which has required a single ventricle palliation.	Upheld	Medical Necessity	Summary Reviewer The parent of a two-year-old female enrollee has requested authorization and coverage for the Synagis 100 mg/mL injection. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees heterotaxy syndrome and Shones complex which has required a single ventricle palliation. The physician reviewer found that the use of Synagis in this patient is not medically necessary. Since 1998, Synagis has been recommended under strict criteria so that its use maximizes patient benefit and efficacy. The most widely accepted guidelines for the use of Synagis are published by the American Academy of Pediatrics (AAP) Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. The AAP guidelines indicate there is no established role for RSV prophylaxis after 24 months of age for any patient regardless of risk factors. The majority of hospitalizations associated with RSV occur in the first three months of life and are most commonly associated with prematurity. Functional or actual asplenia has not been shown in any studies to be associated with increased hospitalization due to RSV. At this time Synagis is only indicated in children under two years of age regardless of the presence of chronic heart, lung, or immune system disease. This prophylactic measure is not medically indicated for this patient. Accordingly, the requested Synagis vaccine is not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.	1
A 31-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.	Upheld	Experimental	Summary Reviewer 2 A 31-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index is thought to add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in that particular melanoma. It then classifies that melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is unknown if DecisionDx-Melanoma can be used to make clinical decisions. Thus, DecisionDx-Melanoma testing performed on 12/18/19 was not likely to have been more beneficial than other methods of evaluating this patient.	0
A 55-year-old male enrollee has requested reimbursement for FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.	Upheld	Experimental	Summary Reviewer 3 A 55-year-old male enrollee has requested reimbursement for FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that per the records, this patient does not have hepatitis C. In addition, there are no laboratory or imaging data to suggest the patient has advanced liver disease (i.e., cirrhosis). The test in question is used to noninvasively determine if a patient with hepatitis C has cirrhosis, which has ramifications on potential treatment choice and length of treatment. There are two general categories of noninvasive tests for fibrosis: serologic panels of tests and radiologic tests. When available, radiologic measurement of elasticity (ultrasound with transient elastography) is the preferred test. Transient elastography is the most commonly used imaging test because it is widely available and has been validated in large populations. There are several limitations to serologic markers of fibrosis. First, they typically reflect the rate of matrix turnover, not deposition, and thus tend to be more elevated when there is high inflammatory activity. By contrast, extensive matrix deposition can go undetected if there is minimal inflammation. Additionally, none of the markers are liver-specific, and concurrent sites of inflammation may contribute to serum levels. Also, serum levels are affected by clearance rates, which may be impaired either due to sinusoidal endothelial cell dysfunction or impaired biliary excretion. In this patients case, the standard of care test would be transient elastography at the time of liver ultrasound. Thus, FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18 was not likely to have been more beneficial than other available standard therapy.	0
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 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.	Overturned	Medical Necessity	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.	1
A 44-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan of parathyroid gland provided on 7/19/16. The Health Plan has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees hyperparathyroidism. . In this case, the patient presented with a diagnosis of primary hyperparathyroidism complicated by the presence of thyroid nodules.	Overturned	Experimental	Summary Reviewer 2 A 44-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan of parathyroid gland provided on 7/19/16. The Health Plan has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees hyperparathyroidism. The physician reviewer found that in the medical literature, Eslamy and Ziessman noted that the clinical diagnosis of primary hyperparathyroidism is based largely on serum laboratory test results, as patients often are asymptomatic. Given that approximately 90% of cases are due to a single parathyroid adenoma, the procedure of choice is the selective surgical excision of the hyperfunctioning parathyroid gland after its preoperative identification and localization at radiologic imaging. The authors noted that SPECT, when combined with CT, is particularly helpful for preoperative localization: The three-dimensional functional information from SPECT is fused with the anatomic information obtained from CT. In addition, knowledge of the anatomy and embryologic development of the parathyroid glands and the pathophysiology of primary hyperparathyroidism aid in the identification and localization of hyperfunctioning glands. In this case, the patient presented with a diagnosis of primary hyperparathyroidism complicated by the presence of thyroid nodules. In this clinical setting, the minimally invasive parathyroidectomy procedure is the standard of care. Medical literature supports the use of SPECT/CT scan for the preoperative localization of the tumor. As such, the SPECT scan of parathyroid gland provided on 7/19/16 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 diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.	1
A 42-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 8/29/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees melanoma.	Upheld	Experimental	Summary Reviewer 3 A 42-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 8/29/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees melanoma. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76 to 1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, DecisionDx-Melanoma testing performed on 8/29/18 was not likely to have been of greater benefit than other methods of evaluating this patient.	0
A 76-year-old male enrollee has requested reimbursement for the Oncotype DX Colon Cancer Assay (CPT 81525) performed on 10/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage II colon cancer.	Upheld	Experimental	Summary Reviewer 1 A 76-year-old male enrollee has requested reimbursement for the Oncotype DX Colon Cancer Assay (CPT 81525) performed on 10/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage II colon cancer. The physician reviewer found that per the National Comprehensive Cancer Network (NCC) guidelines, there is insufficient data to recommend multi gene assay panels including Oncotype DX Colon Cancer Assay for determination of need of chemotherapy. The Oncotype DX Colon Cancer Assay has not been demonstrated to predict the response to oxaloplatin based chemotherapy and thus is not indicated for this patient with stage II colon cancer. Given these findings, the Oncotype DX Colon Cancer Assay (CPT 81525) performed on 10/25/17 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.	1
patient is a 49-year-old female with a history of Grovers disease. She has tried and failed therapy with topical steroids and prednisone. She has had success with a three-month trial of isotretinoin. The patient has requested coverage for Myorisan (isotretinoin) 40 mg 60/30 days. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.	Overturned	Medical Necessity	Summary Reviewer The patient is a 49-year-old female with a history of Grovers disease. She has tried and failed therapy with topical steroids and prednisone. She has had success with a three-month trial of isotretinoin. The patient has requested coverage for Myorisan (isotretinoin) 40 mg 60/30 days. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The submitted documentation supports the medical necessity of the requested medication. Grovers disease is a persistent inflammatory condition of the skin which can be associated with severe pruritus. There are no U.S. Food and Drug Administration (FDA) approved therapies for this condition due to its rarity. There is some evidence in the medical literature that systemic retinoids may be helpful for this condition. This patient has tried and found benefit with isotretinoin. Given the lack of alternatives, there is sufficient support for the requested medication in this patients case. Thus, Myorisan (isotretinoin) 40 mg 60/30 days is medically necessary for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.	1
The patient is a 59-year-old female who has requested reimbursement for a cold cap for chemotherapy provided from 1/02/19 through 12/31/19. The patient has requested reimbursement for a cold cap for chemotherapy. The Health Insurer has denied this request and reported that the device at issue was not medically necessary for the treatment of this patient.	Overturned	Medical Necessity	Summary Reviewer The patient is a 59-year-old female who has requested reimbursement for a cold cap for chemotherapy provided from 1/02/19 through 12/31/19. The patient has requested reimbursement for a cold cap for chemotherapy. The Health Insurer has denied this request and reported that the device at issue was not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination.The physician reviewer found that there is sufficient support for the device at issue in this clinical setting. Chemotherapy-induced alopecia is a symptom that results from the treatment of cancer. It is what many cancer patients state makes them feel like they have cancer and affects quality of life. In this patients case, use of the cold cap was supported by her provider. There are no other acceptable alternatives. U.S. Food and Drug Administration (FDA) clearance of scalp cooling devices has been extended to cover patients with all solid tumors, and extensive data exists to support this use. More than 60 percent of patients receiving taxanes will develop grade 1 alopecia. Scalp hypothermia has been used in more than 30 countries to prevent or reduce chemotherapy-induced alopecia, with variable success reported depending on the specific cooling device and type of chemotherapy. However, use with taxanes has been efficacious. Scalp cooling is now listed as an option for alopecia prevention in the National Comprehensive Cancer Network (NCCN) guidelines for breast cancer. Therefore, the cold cap for chemotherapy was medically necessary for the treatment of this patient.	1
The parent of a seven-year-old male enrollee has requested reimbursement for a tonsillectomy and adenoidectomy performed on 10/27/15. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees recurrent strep throat.	Overturned	Medical Necessity	Summary Reviewer The parent of a seven-year-old male enrollee has requested reimbursement for a tonsillectomy and adenoidectomy performed on 10/27/15. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees recurrent strep throat. The physician reviewer found that this case involves justification of the surgical intervention performed on the patient because of recurring episodes of acute pharyngitis and tonsillitis with positive cultures and requirements for antibiotic therapy. Tonsillectomy and adenoidectomy is a well-recognized surgical procedure for the treatment of patients with episodes of recurring acute pharyngitis and tonsillitis poorly controlled with outpatient antibiotic therapies. Multiple case studies have demonstrated that surgical removal of the infected source of the Streptococcal infections by removal of the tonsils and adenoids leads to improvement and reduction of the episodes of these acute infections (Baugh, et al). Clinical studies also indicate that patients who have multiple bouts of Streptococcus positive cultures, such as the patient in this clinical scenario, benefit from surgery to reduce the recurrence of these episodes (Burton, et al). This patient had clear documentation of recurrent episodes of culture positive pharyngitis and tonsillitis. Therefore, the tonsillectomy and adenoidectomy performed on 10/27/15 was medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the surgery at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.	1
A 33-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.	Upheld	Experimental	Summary Reviewer 3 A 33-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/30/15. 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 infliximab in this patient with Crohns disease. However, the use of Anser IFX testing 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 services at issue were 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.	0
A 33-year-old female enrollee has requested reimbursement for homocysteine testing, Factor V Leiden genetic testing and methylenetetrahydrofolate reductase (MTHFR) performed on 8/7/15. The Health Insurer has denied this request indicating that the services at were considered investigational for evaluation of the enrollees medical condition.	Upheld	Experimental	Summary Reviewer 3 A 33-year-old female enrollee has requested reimbursement for homocysteine testing, Factor V Leiden genetic testing and methylenetetrahydrofolate reductase (MTHFR) performed on 8/7/15. The Health Insurer has denied this request indicating that the services at were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that The American College of Obstetricians and Gynecologists (ACOG) Bulletin states Testing for inherited thrombophilias in women who have experienced recurrent fetal loss or placental abruption is not recommended because it is unclear if anticoagulation therapy reduces recurrence. There is insufficient evidence to either screen for or treat women with inherited thrombophilias and obstetric histories that include complications such as fetal growth restriction or preeclampsia. Because of the lack of association between either heterozygosity or homozygosity for the MTHFR C677T polymorphism and any negative pregnancy outcomes, including any increased risk for venous thromboembolism, screening with either MTHFR mutation analyses or fasting homocysteine levels is not recommended. Moreover, thus, there was no medical justification for Factor V Leiden genetic testing and MTHFR for diagnosis and treatment of the patients medical condition. 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 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.	1
A 53-year-old female enrollee has requested authorization and coverage for foam sclerosant/endovenous ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.	Overturned	Experimental	Summary Reviewer 2 A 53-year-old female enrollee has requested authorization and coverage for foam sclerosant/endovenous ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for a portion of the requested services in this patients case. Providers often do not schedule patients for ablation of all of their refluxing superficial veins at once. Rather, they treat the veins most likely to help based on the ultrasound and the clinical findings and reevaluate the patient. It may not be indicated to treat all of the refluxing superficial veins if the patient is no longer symptomatic after the initial vein is treated. Thus, the treatment of the great saphenous vein or short saphenous vein first, followed by re-evaluation is appropriate. The plan to treat them all regardless of how the patient responds is not supported by the literature or guidelines. Thus, the medical evidence does not support second ablations for each leg until the patient is reevaluated following the initial treatments. Therefore, a portion of the requested foam sclerosant/endovenous ablation is likely to be more effective than other treatment options. Specifically, the superior efficacy of the second ablations for each leg has not been established.	0
A 25-year-old female enrollee has requested reimbursement for residential psychiatric treatment from 10/30/18 through 11/03/18. 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. By 10/30/18, the patient was not actively suicidal or homicidal. She was cognitively intact and was able to perform activities of daily living. She was not actively psychotic or manic. . She had continuing posttraumatic stress disorder and depressive symptoms, although this did not require 24/7 monitoring. She did . She was medication compliant, cooperative, and engaged in all aspects of her treatment. She had support systems in place.	Upheld	Medical Necessity	Summary Reviewer A 25-year-old female enrollee has requested reimbursement for residential psychiatric treatment from 10/30/18 through 11/03/18. 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 that the submitted documentation fails to demonstrate the medical necessity of the services at issue. By 10/30/18, the patient was not actively suicidal or homicidal. She was cognitively intact and was able to perform activities of daily living. She was not actively psychotic or manic. The endorsement of ongoing passive suicidal thoughts (without intent) appears to be her baseline according to history provided, and no longer required monitoring on a 24/7 basis. She had continuing posttraumatic stress disorder and depressive symptoms, although this did not require 24/7 monitoring. She did not have comorbid medical conditions requiring care in a residential setting. Her medication management and any changes therein could have been performed in an ambulatory setting. She was medication compliant, cooperative, and engaged in all aspects of her treatment. She had support systems in place. Her continued treatment for depression, posttraumatic stress disorder, and any other issues, could have been safely performed at a lower level of care, including partial hospitalization program level of care. Thus, residential psychiatric treatment from 10/30/18 through 11/03/18 was not medically necessary 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.	1
The patient is a 14-year-old male who was diagnosed with eosinophilic esophagitis after presenting with intermittent episodes of food impaction and vomiting. The provider has recommended treatment with Dupixent. this patient presents with a diagnosis of eosinophilic esophagitis. The patients provider has recommended treatment with Dupixent.	Upheld	Medical Necessity	Summary Reviewer The patient is a 14-year-old male who was diagnosed with eosinophilic esophagitis after presenting with intermittent episodes of food impaction and vomiting. The provider has recommended treatment with Dupixent. The physician reviewer found that on review of the available records, this patient presents with a diagnosis of eosinophilic esophagitis. The patients provider has recommended treatment with Dupixent. The U.S. Food and Drug Administration (FDA) has approved Dupixent for the treatment of for adolescents and adults with refractory eosinophilic esophagitis. Gutierrez-Junquera and colleagues reported on a prospective study evaluating proton pump inhibitor (PPI) treatment in young patients with eosinophilic esophagitis. The authors found that PPI therapy led to histologic remission in approximately 50% of the young patients studied. Oliva and colleagues performed a recent registry-based longitudinal study that found a 30% response rate in children age 10 years and older. There is evidence that patients with fibrostenotic disease or more severe endoscopic findings are less likely to respond to PPI than those with an inflammatory phenotype or milder endoscopic findings. The correspondence from this patients provider described a concern for a fibrostenotic phenotype. However, approxiatemly 30% of patients with fibrostenotic phenotype have been found to achieve remission with PPI therapy. Overall, the patient has a 30-50% likelihood of histologic response to oral treatment with PPI. Thus, trial of a PPI is indicated prior to consideration for treatment with Dupixent. With regard to the providers concern about the patients growth, a review of the enclosed growth chart does not include a height-for-age or body mass index (BMI)-for-age chart to further assess this situation. Accordingly, the requested Dupixent Injection 300/3 mL is not medically necessary for treatment of this patient.	1
A 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder.	Upheld	Experimental	Summary Reviewer 1 A 40-year-old female enrollee has requested reimbursement for the Genecept Assay provided by Genomind, Inc. on 2/24/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that in this patients clinical scenario, there is a lack of clinical data provided to support an indication for genetic testing. Notably absent was documentation of the longitudinal illness burden and extent of impairment, family history, psychosocial stressors and medical comorbidities. Moreover, the provider did not include specific information regarding prior interventions used to treat the patients depression. Without the review of the specific type, setting and duration of psychotherapies, the treatment parameters and outcome of the TMS therapy, or the selection, dosing and length of previous psychotropic medication trials, it cannot be determined that the patient had exhausted standard treatments available to treat her condition. Given these findings, the Genecept Assay provided by Genomind, Inc. on 2/24/16 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.	1
A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing for bacterial vaginosis provided on 5/09/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. In this case, the patient presented with a complaint of vaginal odor with no clear etiology on examination.	Overturned	Experimental	Summary Reviewer 2 A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing for bacterial vaginosis provided on 5/09/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is support for the services at issue in this clinical setting. Patients with vaginitis can be evaluated and treated with an examination, microscopy and/or cultures depending on the patients symptoms and findings. The exact process depends on the provider and the resources available at that particular office. In this case, the patient presented with a complaint of vaginal odor with no clear etiology on examination. In this setting, cultures can be helpful to determine if there is an infectious cause. It was reasonable that she was evaluated with the SureSwab, especially when no clear cause was found on examination. In sum, polymerase chain reaction (PCR) testing for bacterial vaginosis performed on 5/09/19 was likely to have been more beneficial than other methods of evaluating this patient.	1
The parent of a 14-year-old female enrollee has requested authorization and coverage for Nutropin AQ. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees idiopathic short stature. The patient has idiopathic short stature, but she is more than two years post menarche, and she is past the peak of her pubertal growth spurt and her epiphyses are close to being fused.	Upheld	Medical Necessity	Summary Reviewer The parent of a 14-year-old female enrollee has requested authorization and coverage for Nutropin AQ. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees idiopathic short stature. The physician reviewer found the requested medication is not medically necessary for treatment of the patients medical condition. The patient has idiopathic short stature, but she is more than two years post menarche, and she is past the peak of her pubertal growth spurt and her epiphyses are close to being fused. Thus, she is not a candidate for growth hormone therapy to augment height. As such, Nutropin AQ has not been established as medically necessary for treatment of the patients medical condition. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.	1
A 64-year-old male enrollee has requested reimbursement for PET scan performed on 8/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.	Overturned	Experimental	Summary Reviewer 3 A 64-year-old male enrollee has requested reimbursement for PET scan performed on 8/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that complete staging of colorectal cancer is necessary to determine a patients treatment strategy. Imaging is utilized to evaluate for the presence of distant metastases, as this will impact management. Positron emission tomography/computed tomography (PET/CT) scan is most commonly used to evaluate for nodal and distant metastatic disease and has a sensitivity of approximately 89% and specificity of 64% in this setting. PET/CT can also exclude additional sites of metastases aside from more common pulmonary and hepatic metastases. In this case, PET/CT was performed prior to initiating chemotherapy to assess for metastatic disease. Thus, PET scan performed on 8/31/18 was likely to have been more effective than other methods of evaluating this patient.	0
A 52-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.	Upheld	Experimental	Summary Reviewer 1 A 52-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found appropriate patients for the LINX Reflux Management System are those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate gastroesophageal reflux disease and a hiatal hernia less than 3 cm. Results from early studies are encouraging. However, at this time, the data for the LINX procedure is from observational data and not from high-quality randomized controlled trials. Without controlled data comparing it to a standard reflux operation, such as Nissen fundoplication, the superior efficacy of the requested services cannot be established. Based upon the information set forth above, the requested services are 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.	0
A 46-year-old male enrollee has requested reimbursement for total disc arthroplasty to cervical vertebral level: C5/6 using Globus Secure-C device on 6/29/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.T This patient presented with significant neck pain radiating into the right upper extremity with severe functional disability. Physical examination documented upper extremity motor and sensory deficits and reflex changes. There was imaging evidence of multilevel severe spinal canal and neuroforaminal narrowing at the C3/4, C4/5, and C5/6 levels.	Upheld	Medical Necessity	Summary Reviewer A 46-year-old male enrollee has requested reimbursement for total disc arthroplasty to cervical vertebral level: C5/6 using Globus Secure-C device on 6/29/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.The physician reviewer found evidence-based medical peer reviewed literature and guidelines do not support single-level artificial disc replacement in the setting of multilevel cervical degenerative disc disease. This patient presented with significant neck pain radiating into the right upper extremity with severe functional disability. Physical examination documented upper extremity motor and sensory deficits and reflex changes. There was imaging evidence of multilevel severe spinal canal and neuroforaminal narrowing at the C3/4, C4/5, and C5/6 levels. The North American Spine Society evidence-based clinical guidelines for cervical artificial disc replacement (ADR) state that cervical ADR may be indicated for patients with radiculopathy related to single level degenerative disease (either herniated disc or spondylotic osteophyte) from C3/4 to C6/7 with or without neck pain that has been refractory to conservative treatment. Guidelines state that cervical ADR is not indicated in symptomatic multilevel disease (two or more levels) that would require multiple level artificial disc replacement. In this patients case, there was no compelling evidence presented to support the medical necessity of C5/6 artificial disc replacement over the standard anterior cervical discectomy and fusion. Moreover, there was a lack of evidence that the patients symptoms were limited to the C5/6 level. As such, the total disc arthroplasty to cervical vertebral level: C5/6 using Globus Secure-C device on 6/29/16was not medically necessary for treatment of this patient. Therefore, for the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.	1