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A 53-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 3/11/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees risk for breast cancer.
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Overturned
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Experimental
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Summary Reviewer 2
A 53-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 3/11/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that tomosynthesis was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography, the American College of Radiology (ACR) urged the technique be removed from the investigational category in 2014 due to the advantages this new tomographic technique brings to radiologists interpreting mammograms. This technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis was likely of greater benefit to this patient than had her exam been done with two dimensional imaging alone. Accordingly, the breast tomosynthesis that was performed on 3/11/16 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 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 4/12/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 4/12/18. 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 the current medical evidence has not established the superior efficacy of the services at issue. The prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add to these statistics. DecisionDx-Melanoma assay is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami and colleagues reported on 217 cases with good correlation between prognosis and DecisionDx-Melanoma assay classification, in patients undergoing sentinel node biopsy. It is not clear how the five-year DecisionDx-Melanoma assay data compares to the ten-year Balch data. Most importantly, it is not clear if DecisionDx-Melanoma assay can be used to make clinical decisions. Therefore, DecisionDx-Melanoma assay performed on 4/12/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
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A 63-year-old male enrollee has requested authorization and coverage for spine surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees back pain.
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Overturned
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Medical Necessity
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Summary Reviewer
A 63-year-old male enrollee has requested authorization and coverage for spine surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees back pain. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. A review of the literature indicates evidence of good outcomes from decompression and lumbar fusions for chronic pain with or without instability, spinal stenosis and spondylolisthesis. In this case, in the presence of severe spinal stenosis and severe neural foraminal stenosis at L3-4, a wide decompression is needed. This will necessitate removal of hypertrophic facets which will lead to iatrogenic instability, necessitating a fusion procedure for stabilization. Spondylolisthesis is a known cause of instability which makes the fusion even more necessary. All told, the requested spine surgery is medically necessary for the treatment of this patient. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 1/26/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 1/26/16. 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 breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. However, in this patients case, there were no problems to be resolved. The patient did not have dense breasts, a mass, palpable lumps, or suspicious calcifications. In this clinical setting, a routine mammogram would have been sufficient. Breast tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality, especially when there has been no change when compared to multiple prior mammograms. Therefore, breast tomosynthesis performed on 1/26/16 was not likely to have been of greater benefit than other modalities for 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.
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A 63-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus.
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Overturned
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Medical Necessity
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Summary Reviewer
A 63-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per guidelines, treatment-naive genotype 1 patients should be treated with Harvoni. These guideline recommendations are based on multiple randomized clinical trials (Kowdley, et al; Afdhal, et al). In addition, FibroSure has demonstrated high specificity when predicting advanced fibrosis, as in this case, although guidelines do not recommend restricting treatment based on fibrosis (Shaheen, et al). AASLD guidelines cite data showing reduced survival with delayed treatment (Jezequel, et al). For these reasons, the requested treatment with Harvoni is medically necessary for the treatment of this patients hepatitis C infection. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 52-year-old female enrollee has requested reimbursement for colorectal cancer screening; stool-based DNA and fecal occult hemoglobin performed on 9/16/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 52-year-old female enrollee has requested reimbursement for colorectal cancer screening; stool-based DNA and fecal occult hemoglobin performed on 9/16/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the stool-based DNA and fecal occult hemoglobin performed on 9/16/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Cologuard test analyzes stool DNA, amplifies DNA for mutational testing, and tests for stool hemoglobin. The test showed 92.3% sensitivity for colonoscopy-confirmed cancer (Imperiale, et al). In addition, these data induced the U.S. Food and Drug Administration (FDA) to approve the test for use (Patman). In this clinical setting, Cologuard was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 45-year-old male who has requested reimbursement for procedure code 81599 performed on 7/06/20. Pathology from a shave biopsy of the left lateral temple on 6/11/20 showed a malignant melanoma, Breslow depth at least 3.8 mm, with ulceration present. On 7/06/20, DecisionDx-Melanoma testing was performed. The Health Insurer has denied reimbursement for the services at issue. Per the Health Insurer, procedure code 81599 performed on 7/06/20
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 45-year-old male who has requested reimbursement for procedure code 81599 performed on 7/06/20. Pathology from a shave biopsy of the left lateral temple on 6/11/20 showed a malignant melanoma, Breslow depth at least 3.8 mm, with ulceration present. On 7/06/20, DecisionDx-Melanoma testing was performed. The Health Insurer has denied reimbursement for the services at issue. Per the Health Insurer, procedure code 81599 performed on 7/06/20 was not medically necessary for the evaluation of this patient. The physician reviewer found that prognostic gene expression profiling (GEP) testing to differentiate melanomas at low versus high risk for metastasis should not replace pathologic staging procedures. Moreover, since there is a low probability of metastasis in stage I melanoma and a higher proportion of false-positive result, GEP testing should not guide clinical decision making in this group. It remains unclear where these GEP platforms provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariate nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. It remains unclear whether this GEP profile is reliably predictive of outcomes across the risk spectrum of melanoma. Prospective validation studies are required to more accurately define the clinical utility of molecular testing prior to widespread implementation of GEP for prognostication of cutaneous melanoma, and in particular to determine its role in guiding surveillance imaging, sentinel lymph node biopsy, and adjuvant treatment decisions. Use of this testing is not recommended by the National Comprehensive Cancer Network guidelines. Therefore, procedure code 81599 performed on 7/06/20 was not medically necessary for the evaluation of this patient.
| 1 |
A 48-year-old female enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 4/28/16. 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 this patient had stage II colon cancer.
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Overturned
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Experimental
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Summary Reviewer 2
A 48-year-old female enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 4/28/16. 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 this patient had stage II colon cancer. Although Oncotype DX Colon Cancer Assay provides prognostic data, to date it does not provide predictive data for the benefit of chemotherapy. Per the medical evidence, the clinical utility of gene expression assays, including the 12-gene recurrence score, is uncertain, and information is lacking regarding the extent to which assay results do or do not classify patients into distinct groups with clinical relevance. 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. In sum, Oncotype DX Colon Cancer Assay performed on 4/28/16 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 30-year-old female enrollee has requested authorization and coverage for Adderall XR 90 mg daily. The Health Insurer has denied this request indicating that the requested medication dosage is considered investigational for treatment of the enrollees attention deficit hyperactivity disorder (ADHD).
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Upheld
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Experimental
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Summary Reviewer 1
A 30-year-old female enrollee has requested authorization and coverage for Adderall XR 90 mg daily. The Health Insurer has denied this request indicating that the requested medication dosage is considered investigational for treatment of the enrollees attention deficit hyperactivity disorder (ADHD). The physician reviewer found there is a paucity of scientific literature supporting a dose of Adderall XR above 60 mg. Doses above 60 mg have not been demonstrated to be more effective than lower and safer doses of Adderall. There are also cardiovascular concerns with doses above 60 mg. There is no substantial evidence suggesting that 90 mg of Adderall XR is more efficacious than 60 mg. There is also concern for abuse potential with doses higher than recommended as tolerance, psychological dependence, and social disability can occur if taken at higher than recommended doses. Given these findings, the requested Adderall XR 90 mg daily is not supported as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication dosage 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.
| 1 |
The patient is a 63-year-old female with Crohns disease. She is noted to have joint pain, and has failed Cimzia and methotrexate. Per the provider note dated 1/24/17, she was noted to have Crohns disease flares and sharp abdominal pain since stopping Cimzia. She was also noted to have ongoing chronic joint pain. The patient has requested authorization and coverage for Stelara injections for the treatment of Crohns disease. The Health Insurer has denied the request as not medically necessary. Per the Health Ins
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 63-year-old female with Crohns disease. She is noted to have joint pain, and has failed Cimzia and methotrexate. Per the provider note dated 1/24/17, she was noted to have Crohns disease flares and sharp abdominal pain since stopping Cimzia. She was also noted to have ongoing chronic joint pain. The patient has requested authorization and coverage for Stelara injections for the treatment of Crohns disease. The Health Insurer has denied the request as not medically necessary. Per the Health Insurer, there is no documentation that Stelara will not be used concomitantly with other biologic disease modifying antirheumatic drugs. This denial is the subject of this appeal and determination. The current medical literature supports the use of Stelara in this patients case. A large randomized controlled trial by Sandborn and colleagues demonstrated safety and efficacy of Stelara for induction and maintenance of remission in patients with moderate-severe Crohns disease that was resistant to anti-tumor necrosis factor (TNF) therapy, as in this patients case. Kopylov and colleagues showed a 73% response in patients with anti-TNF-resistant Crohns disease. A significant majority of these patients were able to discontinue steroids. Stelara is more appropriate than immunosuppressants and corticosteroids in this patients case. The American College of Gastroenterology guidelines for induction of remission of Crohns disease state that immunosuppressants may not induce remission in adults with active Crohns disease with use up to 17 weeks; therefore, they are not recommended. For maintenance of remission, immunosuppressants (such as azathioprine, 6-mercaptopurine, and methotrexate) are given a weak recommendation. Corticosteroids are not an appropriate long-term primary therapy for Crohns disease. Cimzia and methotrexate have been discontinued. For these reasons, the requested Stelara injections are medically indicated 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 |
A 45-year-old female enrollee has requested reimbursement for the Decision Dx melanoma test performed on 4/4/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 45-year-old female enrollee has requested reimbursement for the Decision Dx melanoma test performed on 4/4/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. The physician reviewer found the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. There is insufficient support in the peer-reviewed literature for the testing at issue in this clinical setting. According to the results of analysis of patients melanoma performed with Decision Dx melanoma, the tumor was classified as Class 1 with a low risk of near-term (within five years) metastatic disease. Although Decision Dx melanoma may be an independent predictor of metastasis risk, there is a lack of peer-reviewed published studies confirming this hypothesis. Therefore, Decision Dx melanoma test performed on 4/4/16 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 |
patient is a 59-year-old female with a history of severe osteoporosis. The patient has requested authorization and coverage for Forteo.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 59-year-old female with a history of severe osteoporosis. The patient has requested authorization and coverage for Forteo. The physician reviewer found that osteoporosis is a growing public health problem. Once considered an inevitable consequence of aging, it is now eminently preventable and treatable. Multiple agents are currently available for treatment of this condition. Forteo (teriparatide) is of particular importance as it modulates the bone architecture acting on bone formation, rather than being an anti-resorptive agent like most of the other medications. Recent studies have demonstrated the ability of Forteo to reduce the likelihood of occurrence of vertebral and non-vertebral fractures in osteoporosis patients. The current medical evidence supports the requested medication in this clinical setting. Therefore, Forteo is medically necessary for the treatment of this patient.
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A 63-year-old female enrollee has requested authorization and coverage for Harvoni for 12 weeks or Harvoni for eight weeks in the alternative. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1a.
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Overturned
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Medical Necessity
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Summary Reviewer
A 63-year-old female enrollee has requested authorization and coverage for Harvoni for 12 weeks or Harvoni for eight weeks in the alternative. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1a. The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C virus, regardless of fibrosis, should be treated except those with a life expectancy of less than 12 months due to non-liver-related comorbid conditions. In addition, treatment naive patients are recommended to be treated with Harvoni for 12 weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage. Moreover, it is beneficial to treat patients with hepatitis C before they progress to F3 or F4 fibrosis. For these reasons, the requested treatment with Harvoni for 12 weeks is supported as medically necessary for treatment of this patients hepatitis C virus infection. In conclusion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 26-year-old female enrollee has requested authorization and coverage for breast reconstruction. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees bilateral tuberous breast deformity.
The patient presents with well-documented tuberous breast deformity and she has had previous reconstructive surgery with implants. Essentially, this has failed and the patients
base, hypoplastic breast tissue, herniated nipple-areola complex,
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Overturned
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Medical Necessity
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Summary Reviewer
A 26-year-old female enrollee has requested authorization and coverage for breast reconstruction. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees bilateral tuberous breast deformity. The physician reviewer found the submitted documentation establishes the medical necessity of the requested procedure. The patient presents with well-documented tuberous breast deformity and she has had previous reconstructive surgery with implants. Essentially, this has failed and the patients current condition is consistent with continued lack of breast development and findings consistent with significant breast deformity. Based on the documentation and review of the photographs, this is not a normal variant. Significant breast deformity can exist with tuberous breasts (DeLuca-Pytell, et al; Mandrekas, et al). According to DeLuca-Pytell and colleagues, Tuberous breast deformity is characterized by an aberration of breast shape. Characteristics include a constricted breast base, hypoplastic breast tissue, herniated nipple-areola complex, deficient skin envelope inferiorly, and elevated inframammary fold. This classification is consistent with the presentation of this patient. Based on the overall clinical picture presented supported by photographs, and the fact that the patient has failed previous breast reconstruction and continues to have findings of a bilateral tuberous breast deformity, the requested procedure is medically necessary. This patient has abnormal breast development and surgical intervention is medically necessary to approximate a more normal condition. For the reasons provided, the requested procedure is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 19-year-old female with cannabis use disorder, opioid use disorder, unspecified anxiety disorder and unspecified depressive disorder. She had presented with impaired functioning including school truancy and alienation/withdrawal socially. She was unable to maintain sobriety and was reported to make dangerous decisions. Outpatient treatment had failed and her providers recommended treatment in a residential recovery program. The patient has requested reimbursement for mental health residential treatment services provided from 1/20/17 through 4/19/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary.
The records document that this patient needed residential treatment as demonstrated by her inability to maintain sobriety and functioning using outpatient modalities.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 19-year-old female with cannabis use disorder, opioid use disorder, unspecified anxiety disorder and unspecified depressive disorder. She had presented with impaired functioning including school truancy and alienation/withdrawal socially. She was unable to maintain sobriety and was reported to make dangerous decisions. Outpatient treatment had failed and her providers recommended treatment in a residential recovery program. The patient has requested reimbursement for mental health residential treatment services provided from 1/20/17 through 4/19/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary. The American Psychiatric Association (APA) treatment guidelines state that residential treatment is indicated for patients who do not meet the clinical criteria for hospitalization but whose lives and social interactions have come to focus predominantly on substance use. In addition, Handwerk and colleagues found that residential treatment has been shown to be particularly effective in reducing adolescent girls feelings of hopelessness, negative self-evaluation, and suicidal ideation. The records document that this patient needed residential treatment as demonstrated by her inability to maintain sobriety and functioning using outpatient modalities. Residential treatment was in accordance with generally accepted standards of medical practice and the APA guidelines. All told, the mental health residential treatment services provided from 1/20/17 through 4/19/17 were medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 39-year-old male with biopsy proven idiopathic membranous nephropathy. Rituximab effected
proteinuria/nephrotic syndrome. However, the patients proteinuria has worsened and obinutuzumab (Gazyva) has been recommended as a second-line therapy. The patient has requested authorization and coverage for Gazyva injections. The Health Insurer has denied this request indicating that the requested medication is considered investigational.
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 39-year-old male with biopsy proven idiopathic membranous nephropathy. Rituximab effected an improvement in proteinuria/nephrotic syndrome. However, the patients proteinuria has worsened and obinutuzumab (Gazyva) has been recommended as a second-line therapy. The patient has requested authorization and coverage for Gazyva injections. The Health Insurer has denied this request indicating that the requested medication is considered investigational. This patients records do not document that standard therapies including prednisone, cyclophosphamide, mycophenolate and cyclosporine have been tried and failed, or that the patient has a contraindication to these medications. Moreover, there is no indication in the medical literature that Gazyva is safe and effective for treatment of idiopathic membranous nephropathy. For these reasons, the requested obinutuzumab (Gazyva) injections are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 47-year-old male with Crohns disease. Per the providers note dated 3/15/18, the patient was diagnosed in 2000 and has failed prednisone, Entocort, Cipro, Flagyl, Xifaxan, Pentasa, 6-mercaptopurine, methotrexate, and Remicade. He has had a temporary ileostomy, bowel resection, ileocecectomy in 2000, and takedown surgery. The patient started Humira every 14 days and then every seven days in 2005, which healed his anal fistulas. He was on Humira 80 mg every seven days since mid-January 2018 but was later switched back to Humira 40 mg every seven days with concurrent methotrexate and Entocort. A colonoscopy on 3/2/18 showed recurrence at the anastomosis and neo-terminal ileum. The note states that the patients Humira level was 26 with negative anti-Humira antibody testing, and that Stelara infusion was given on 3/13/18. The patient was having mild intermittent bleeding but no abdominal pain. The patient has requested authorization and coverage for Humira injections 80 mg every seven days. The Health Insurer has denied this request indicating that the requested medication dosage is not medically necessary.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 47-year-old male with Crohns disease. Per the providers note dated 3/15/18, the patient was diagnosed in 2000 and has failed prednisone, Entocort, Cipro, Flagyl, Xifaxan, Pentasa, 6-mercaptopurine, methotrexate, and Remicade. He has had a temporary ileostomy, bowel resection, ileocecectomy in 2000, and takedown surgery. The patient started Humira every 14 days and then every seven days in 2005, which healed his anal fistulas. He was on Humira 80 mg every seven days since mid-January 2018 but was later switched back to Humira 40 mg every seven days with concurrent methotrexate and Entocort. A colonoscopy on 3/2/18 showed recurrence at the anastomosis and neo-terminal ileum. The note states that the patients Humira level was 26 with negative anti-Humira antibody testing, and that Stelara infusion was given on 3/13/18. The patient was having mild intermittent bleeding but no abdominal pain. The patient has requested authorization and coverage for Humira injections 80 mg every seven days. The Health Insurer has denied this request indicating that the requested medication dosage is not medically necessary. The use of Humira 40 mg more frequently than every 14 days is supported in the medical literature to prevent disease complications. In the CHARM trial, which was a high-quality phase III randomized double-blind placebo-controlled 56-week study, 27% of open-label patients required dose escalation with weekly dosing (Colombel, et al). The remission rate with weekly dosing was reported at 46.9% versus 22.5% when dosing every other week (Sandborn, et al). The use of Humira more frequently than every 14 days is supported by current medical literature, and preferred to changes to a different therapy, which may result in loss of disease control (Van Assche, et al). The consequences of uncontrolled disease can include disease flare, inflammation related sequelae such as the development of a fistula, stricture, or abscess, and the need for hospitalization or surgery. The records indicate that this patient failed Humira 40 mg dosed every seven days, and had improvement with Humira 80 mg dosed every seven days. For these reasons, the request for Humira 80 mg every seven days is supported as medically necessary for the treatment of the patients Crohns disease. Based on the foregoing discussion, the requested medication dosage is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
patient is a 10-year-old male with a history of short stature and suspected pediatric growth
hormone (GH) deficiency related to optic nerve hypoplasia (ONH). The provider has
recommended treatment with GH therapy. The Health Insurer has denied the requested treatment
as not medically necessary for treatment of the patients medical condition.
patients records
document a history of short stature with a previous diagnosis of ONH, which is
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Upheld
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Medical Necessity
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Summary
The patient is a 10-year-old male with a history of short stature and suspected pediatric growth
hormone (GH) deficiency related to optic nerve hypoplasia (ONH). The provider has
recommended treatment with GH therapy. The Health Insurer has denied the requested treatment
as not medically necessary for treatment of the patients medical condition. This denial is the
subject of this appeal and determination. The physician reviewer found that this patients records
document a history of short stature with a previous diagnosis of ONH, which is a congenital
disorder of midbrain development that can be associated with hypopituitarism. However, this
patients records lack documentation confirming a diagnosis of ONH by MRI, genetic testing,
and/or dilated ophthalmic examination. There is also a lack of evidence of anterior pituitary
hormone deficiencies or intracranial lesions. As noted in the medical literature and current
guidelines, the essential diagnostic criterion for idiopathic short stature is a height z-score -2.25
standard deviations below the mean (Grimberg, et al.). The available records indicate that this
patient has not met this essential diagnostic criterion, because his height has been within normal
range with a z-score between -2.0 and +2.0. Based on the patients normal bone age, normal recent
height, and chronological age, the patients predicted adult height was reported as 174.9 cm,
estimated within 3.1 cm. This predicted adult height is within the normal range for age and gender
and within two standard deviations of the patients estimated MPTH of 72.5 inches. There is a lack
of documentation indicating the patient underwent GH provocative tests to support the diagnosis
of pediatric GH deficiency. Moreover, direct height measurements of both biological parents are
preferred to evaluate suspected growth disorders in pediatric endocrine care, as self-reported
parental heights can be unreliable. Overall, the patient does not meet the U.S. Food and Drug
Administration (FDA) requirements for any approved indications for GH therapy. For these
reasons, the requested Norditropin 10 mg/1.5 mL pen injector is not medically necessary for
treatment of this patient.
| 1 |
A 60-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 10/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for purposes of the enrollees breast cancer screening.
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Overturned
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Experimental
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Summary Reviewer 2
A 60-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 10/29/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for purposes of the enrollees breast cancer screening. The physician reviewer found there is limited peer-reviewed literature that supports the use of three dimensional breast tomosynthesis compared to currently available techniques, especially in a patient without an increased risk of breast cancer. While the technology is promising, its clinical efficacy has not yet been substantiated in peer-reviewed literature. At this time, there is insufficient data from randomized, controlled studies demonstrating that the addition of breast tomosynthesis to standard mammography results in improved outcomes in this patient population. Therefore, the superior effectiveness of breast tomosynthesis performed on 10/29/15 has not been established. 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 20-year-old male enrollee has requested reimbursement for residential treatment services provided from 3/22/18 through 3/30/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
The patient had a history of chronic impulsive suicidal/homicidal behavior or threats, but his current expressions did not represent significant change from usual behavior.
3. The patient had moderate impairment, due to conflicted and troubled relationships and inability to continue in school.
The patient had significant comorbidity, due to co-occurrence of traumatic brain injury, substance use disorder, and mood symptoms.
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Overturned
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Medical Necessity
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Summary Reviewer
A 20-year-old male enrollee has requested reimbursement for residential treatment services provided from 3/22/18 through 3/30/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) provides a framework for determining the appropriate level of care in patients with mental health treatment needs. With regard to risk of harm, the records support a score of 3. The patient had a history of chronic impulsive suicidal/homicidal behavior or threats, but his current expressions did not represent significant change from usual behavior. In terms of functional status, the records support a score of 3. The patient had moderate impairment, due to conflicted and troubled relationships and inability to continue in school. With regard to medical, addictive, and psychiatric comorbidity, the records support a score of 3. The patient had significant comorbidity, due to co-occurrence of traumatic brain injury, substance use disorder, and mood symptoms. In terms of level of stress of the recovery environment, the records support a score of 3 due to strained relationship with parents, multiple recent transitions, and recent homelessness. With regard to level of support of the recovery environment, the records support a score of 4 due to the patients refusal to participate in treatment and accept support offered by his parents. In terms of treatment and recovery history, the records support a score of 3. The patient had moderate or equivocal response to treatment. With regard to engagement and recovery status, the records support a score of 4. The patient had minimal engagement and recovery, due to reluctance to engage in or complete residential programs, lack of desire to change behavior, and failure to accept responsibility for his own recovery. Thus, the patient has a total score of 23. The recommended level of care is medically monitored residential services. Given the patients impulsivity and limited coping skills, poor insight and judgment, a residential level of care was appropriate for him at the time of his admission and treatment. Therefore, residential treatment provided from 3/22/18 through 3/30/18 was medically necessary for the treatment of this patient.
| 1 |
The patient is a 65-year-old male with a history of prostate cancer. The patient was initially diagnosed in 2015. The provider noted that despite an initial excellent response to six cycles of docetaxel chemotherapy, the patients prostate specific antigen (PSA) levels rose. The provider recommended treatment with Cabometyx. The patient has requested authorization and coverage for Cabometyx (cabozantinib) 60 mg #30/30. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of this patients medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 65-year-old male with a history of prostate cancer. The patient was initially diagnosed in 2015. The provider noted that despite an initial excellent response to six cycles of docetaxel chemotherapy, the patients prostate specific antigen (PSA) levels rose. The provider recommended treatment with Cabometyx. The patient has requested authorization and coverage for Cabometyx (cabozantinib) 60 mg #30/30. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of this patients medical condition. The use of cabozantinib for prostate cancer is not U.S Food and Drug Administration approved and is not supported by major drug compendia for off-label use. A phase III clinical trial, COMET-1, has not shown a benefit in overall survival. Another phase III trial combining cabozantinib with mitoxantrone was discontinued after the results of COMET-1. The use of molecular profiling to match molecular mutations with clinical trials is still ongoing. Therefore, Cabometyx (cabozantinib) 60 mg #30/30 is not likely to be more beneficial for treatment of this patients medical condition than the available standard therapy. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 50-year-old female enrollee has requested reimbursement for Afirma gene testing performed on 7/22/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 50-year-old female enrollee has requested reimbursement for Afirma gene testing performed on 7/22/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. While a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). A relatively new test, the Afirma Thyroid FNA Analysis utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures. Based on the support in the peer-reviewed literature and clinical documentation submitted, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than other modalities.Based upon the information set forth above, the testing 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.
| 0 |
A 38-year-old female enrollee has requested authorization and coverage for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees osteochondral defect.
In this case, the patient presents with a large osteochondral lesion of the talus and has failed multiple surgical procedures with continuing pain.
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Overturned
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Experimental
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Summary Reviewer 2
A 38-year-old female enrollee has requested authorization and coverage for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee. The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees osteochondral defect. The physician reviewer found autologous Autologous chondrocyte implantation techniques require a two-stage procedure, the first for chondrocyte harvest and the second for implantation in a periosteum-covered or matrix-induced form after in vivo culture expansion. The transplantation of chondrocyte-like cells into the defect will result in hyaline-like repair tissue. The medical literature demonstrates that autologous chondrocyte implantation is usually successful in relieving pain in the presence of a large osteochondral defect with minimal degenerative change in the remaining joint. In this case, the patient presents with a large osteochondral lesion of the talus and has failed multiple surgical procedures with continuing pain. Based on the support in the peer-reviewed literature, the request for matrix autologous chondrocyte implantation, up to three days in hospital stay and growth of cartilage from her knee is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old female enrollee has requested reimbursement for the positron emission tomography (PET) scan provided on 5/10/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees Stage IV ovarian cancer.
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Overturned
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Medical Necessity
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Summary Reviewer
A 60-year-old female enrollee has requested reimbursement for the positron emission tomography (PET) scan provided on 5/10/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees Stage IV ovarian cancer. The physician reviewer found that The findings on the PET/CT from 2/2/16 raised the possibility of tumor and the interpreting provider recommended a follow-up study. Thus, the PET/CT was indicated and complied with the National Comprehensive Cancer Network (NCCN) guidelines which state that PET/CT scan is an accepted tool for use in this clinical setting based upon questionable imaging results. Thus, the PET scan performed on 5/10/16 was medically necessary for further evaluation of this patients possible tumor in the setting of known metastatic ovarian cancer. Based on the foregoing discussion, the diagnostic procedure at issue was medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 42-year-old female enrollee has requested reimbursement for supraorbital, occipital and suprascapular nerve blocks of the occipital nerve performed on 10/3/16 and 10/20/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees chronic headache.
the provider, this patient has chronic migraine and occipital neuralgia. The treatment that she has received has reportedly provided therapeutic benefit.
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Overturned
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Experimental
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Summary Reviewer 1
A 42-year-old female enrollee has requested reimbursement for supraorbital, occipital and suprascapular nerve blocks of the occipital nerve performed on 10/3/16 and 10/20/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees chronic headache.
The physician reviewer found that Neuralgia is a type of neuropathic pain that can be chronic of paroxysmal, shock, lightening like, burning, dull or ache type pain that follows a peripheral or cranial nerve area and can also spread to other areas. Inherent in the definition there cannot be a neurologic deficit correlating with the nerve affected. Attacks can either be spontaneous or provoked by direct stimulation or palpation of other trigger point zones. Occipital neuralgia can specifically refer to pain and or headache in the occipital region in the greater, lesser, or third occipital nerve areas which can also be accompanied by dysesthesia or decreased sensation in the nerve distribution. On examination, patients would have tenderness with palpation over the occipital area. Another key element to the diagnosis is response to occipital nerve blocks, which this patient also exhibited. The treatment of choice for occipital neuralgia is a local occipital nerve block due to its ability to relieve pain as well as act as a diagnostic marker. Considering the information provided by the provider, this patient has chronic migraine and occipital neuralgia. The treatment that she has received has reportedly provided therapeutic benefit. Moreover, this patient has tried several therapeutic options for her condition without any benefit and with some documented adverse effects.
This patient meets the criteria for chronic migraine. She has a long history of chronic migraine and failure with several treatment modalities. Included in that history of failure, the majority if not all prophylactic and abortive therapeutic options were discontinued due to lack of effectiveness. There are various studies with evidence to suggest that peripheral nerve blocks of the supraorbital, supratrochlear, and occipital nerves are effective in the management of migraine. This patient has a well-documented and comprehensive history of unresponsiveness to other medical therapies. However, she has demonstrated response to the performed nerve blocks, which is consistent with available literature regarding nerve blocks. According to the current data and this patients medical history, the supraorbital, occipital, and suprascapular nerve blocks of the occipital nerve on 10/3/16 and 10/20/16 were likely to have been more beneficial for treatment of this patients medical condition than any available standard therapy.
Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 64-year-old female has requested reimbursement for vedolizumab infusions provided on 5/03/19 and 6/28/19. The Health Insurer has denied this request and reported that the medication at issue was investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 64-year-old female has requested reimbursement for vedolizumab infusions provided on 5/03/19 and 6/28/19. The Health Insurer has denied this request and reported that the medication at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer that the found Entyvio (vedolizumab) is an integrin antagonist specific to the gastrointestinal tract. It has a different mechanism of action than immunosuppressants and anti-tumor necrosis factor (TNF) agents, such as Remicade and Humira for ulcerative colitis. Entyvio is recommended as a first-line therapy for ulcerative colitis. Entyvio is effective for ulcerative colitis, with minimal side effects.
In this case, Entyvio is more appropriate than any alternatives. A change to an alternative could result in lack of response or complications of uncontrolled ulcerative colitis. Thus, vedolizumab infusions provided on 5/03/19 and 6/28/19 were likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
A 52-year-old female enrollee has requested reimbursement for BCR-ABL gene rearrangement
quantitative polymerase chain reaction (PCR) testing, BCR-ABL fluorescent in situ hybridization
(FISH) performed on 11/21/22.
patient presents with mild leukocytosis and neutrophilia.
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Upheld
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Experimental
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Summary Reviewer 3
A 52-year-old female enrollee has requested reimbursement for BCR-ABL gene rearrangement
quantitative polymerase chain reaction (PCR) testing, BCR-ABL fluorescent in situ hybridization
(FISH) performed on 11/21/22. The physician reviewer found that the records provided for
review document that this patient presents with mild leukocytosis and neutrophilia. Per Ogunleye and colleagues a diagnosis of CML is often suspected when there is leukocytosis with
left shift and basophilia. The authors reported that, Confirmation of the diagnosis requires a
demonstration of BCR-ABL by PCR. However, there is no report of significant basophilia or
eosinophilia seen on peripheral blood differential. In addition, the patients records do not report
any symptoms suggestive of CML such as night sweats, unintentional weight loss, or early satiety.
Thus, the concern for CML in this patients clinical setting remains low. For these reasons, the
BCR-ABL gene rearrangement quantitative PCR testing, BCR-ABL FISH performed on 11/21/22
was not likely to be more beneficial for treatment of the patients medical condition than any
available standard therapy.
| 1 |
A 61-year-old female enrollee has requested coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees left hip and buttock pain.
the patient presents with chronic left hip/buttocks pain with
bosacral spine neural compression pathology. Multiple bilateral SI joint
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Overturned
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Experimental
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Summary Reviewer 1
A 61-year-old female enrollee has requested coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees left hip and buttock pain. The physician reviewer found that the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The evidence based peer-reviewed literature support SI joint fusion in this clinical setting. Polly and colleagues concluded in their study that minimally invasive SI joint fusion using triangular titanium implants was more effective than nonsurgical management at one year in relieving pain, improving function, and improving quality of life in patients with SI joint dysfunction caused by degenerative sacroiliitis or SI joint disruptions. The authors noted that pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment. The International Society for Advancement of Spine Surgery (ISASS) policy statement for minimally invasive SI joint fusion provide specific indications for surgery. The criteria include: significant SI joint pain or significant limitations in activities of daily living because of SI joint pain; SI joint pain confirmed by at least three positive SI joint provocative tests; confirmation of the SI joint as a pain generator with at least 75% decrease in pain following fluoroscopically guided diagnostic intra-articular SI joint block in the immediate post-injection period; failure to respond to at least six months of non-surgical treatment including medications, rest, physical therapy, and SI joint steroid injection or rhizotomy; and, additional or alternative diagnoses that could be responsible for the patients ongoing pain or disability have been clearly considered, investigated and ruled-out. In this case, the patient presents with chronic left hip/buttocks pain with significant functional limitation. Detailed evidence of at least six months of reasonable and/or comprehensive non-operative treatment protocol trial and failure has been submitted. Clinical exam findings have documented significant tenderness at the SI joint with six positive SI joint provocative tests. There is radiographic evidence of bilateral joint arthrosis with joint space narrowing. There is no imaging evidence of lumbosacral spine neural compression pathology. Multiple bilateral SI joint injections have produced 90% pain relief. The peer-reviewed supports the requested SI joint fusion as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy in this clinical setting. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/15/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees breast examination.
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Overturned
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Experimental
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Summary Reviewer 1
A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 9/15/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees breast examination. The physician reviewer found tomosynthesis was approved by the Food and Drug Administration (FDA) in 2011 for clinical use and by the Centers for Medicare & Medicaid Services (CMS) for reimbursement in 2014. The American College of Radiology (ACR) recommended the technique be removed from the investigational category in 2014 due to the advantages this technique brings to radiologists. The tomographic nature of tomosynthesis enables radiologists to get a clearer picture of breast tissue as well as the nature of calcifications as present in this case. This added clarity has resulted in a decrease in false negatives and false positives. Furthermore, the use of tomosynthesis has decreased callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis to the usual 2D imaging protocol of mammography was likely of greater benefit to this patient than had she had 2D imaging alone.Based upon the information set forth above, the service 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 43-year-old female enrollee has requested authorization and coverage for breast reduction mammoplasty. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees symptomatic macromastia.
The patient has well documented symptoms for macromastia and medical treatments have not improved her symptoms.
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Overturned
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Medical Necessity
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Summary Reviewer
A 43-year-old female enrollee has requested authorization and coverage for breast reduction mammoplasty. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees symptomatic macromastia. The physician reviewer found that Breast reduction surgery is medically necessary in this patients case. The patient has well documented symptoms for macromastia and medical treatments have not improved her symptoms. The medical literature indicates that symptomatic macromastia is a mechanical problem and conservative treatments have been shown to be ineffective for treatment of this condition. Additionally, nonoperative treatments are not likely to improve pain. Instead, the evidence appears to support that surgery may be the most effective treatment for symptomatic relief. Collins and Kerrigan report that data from the BRAVO (Breast Reduction Assessment Value and Outcomes) study, which prospectively followed 243 patients with symptomatic macromastia, found that nonoperative treatment options did not provide lasting relief from pain. The authors noted Breast hypertrophy has a significant impact on womens health status and quality of life as measured by validated and widely used self-report instruments including the SF-36, MPQ, MBSRQ, and EuroQol. In women presenting for surgery, nonsurgical measures including weight loss, physical therapy, special brassieres, and medications were not effective in providing permanent relief of breast-related symptoms. In contrast, both pain and overall health status were markedly improved by breast reduction, essentially restoring functional status to that of age-matched norms. A 2014 study by Strong and Hall-Findlay concluded, We found that reduction mammaplasty has a positive impact on a range of symptoms, even with lower volume resections and regardless of body surface area-calculated adjustments. This adds further weight to the argument that patients should not be denied access to the surgery based on arbitrary volume restrictions. We advocate freedom for the surgeon to make a decision on potential benefits of surgery based around the needs of each individual patient. In this patients case, the records document that she has large pendulous breasts with shoulder grooving and the classic symptoms for macromastia. Breast reduction is a treatment that has been proven effective and curative for symptomatic macromastia. Evidence based peer reviewed studies confirm the benefits of breast reduction surgery for individuals with upper torso pain due to breast hypertrophy. As such, nonoperative treatments are unlikely to improve this patients pain. Therefore, the breast reduction mammoplasty is medically necessary for the treatment of this patients medical condition.
Therefore, for the reasons stated above, the requested procedure is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 63-year-old male enrollee has requested reimbursement for computed tomography (CT), lower extremity, without contrast material performed on 9/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees ankle pain.
. The provider also suspected nonunion, as the patient had continued pain five months after the injury, which was more than was expected.
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Overturned
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Medical Necessity
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Summary Reviewer
A 63-year-old male enrollee has requested reimbursement for computed tomography (CT), lower extremity, without contrast material performed on 9/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees ankle pain. The physician reviewer found that determining when a fracture is healed is a routine part of orthopedic clinical care. Typically, serial radiographs are utilized to assess nonunion of a fracture. There is significant variability in the determination of fracture healing radiographically. CT is superior to radiography in the assessment of fracture union. According to the American College of Radiology, CT may be appropriate for the evaluation of ankle fracture in the setting of suspected osteochondral defect. In this case, the patients provider suspected an osteochondral lesion, which is better evaluated with CT or MRI, which can often be occult on radiographs. The provider also suspected nonunion, as the patient had continued pain five months after the injury, which was more than was expected. CT is an appropriate imaging examination in this clinical setting. Thus, CT, lower extremity, without contrast material performed on 9/26/18 was medically necessary for the evaluation of this patient. Therefore, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The parent of an eight-year-old male enrollee has requested authorization and coverage for applied behavioral analysis (ABA) therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees autism spectrum disorder.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of an eight-year-old male enrollee has requested authorization and coverage for applied behavioral analysis (ABA) therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees autism spectrum disorder. The physician reviewer found that ABA therapy is generally accepted as being an appropriate and recommended treatment for children with autism spectrum disorder. Common features of ABA-based therapies include the objective measurement of behavior, structured control of the environment, and the implementation of procedures based on scientifically established principles of behavior. An extensive body of scientific literature demonstrates the success of ABA-based interventions to decrease problem behavior and increase skills in adults and children with intellectual disabilities and autism. Several meta-analyses indicate that comprehensive ABA intervention leads to medium to large effects in terms of intellectual functioning, acquisition of daily living skills, social functioning and language development in children with autism (Virues-Ortega; Kahng, et al; Lilienfeld). Numerous scientific organizations have concluded that ABA-based therapies are highly effective in the treatment of autism. In this case, ABA therapy is medically necessary to address the patients aggressive behavior, rigidity of routine, and difficulty with social interactions.
Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 57-year-old female enrollee has requested reimbursement for residential treatment provided from 6/02/16 through 6/11/16. 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.
there was no documentation showing that the patient was in withdrawals, or at risk for imminent withdrawals. There was no Clinical Institute Withdrawal Assessment (CIWA) and no vital signs. The patient denied suicidal or homicidal ideation, and there were no signs of her being a danger to herself or others.
She was medically and psychiatrically stable. She received av
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Upheld
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Medical Necessity
|
Summary Reviewer
A 57-year-old female enrollee has requested reimbursement for residential treatment provided from 6/02/16 through 6/11/16. 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. On admission, there was no documentation showing that the patient was in withdrawals, or at risk for imminent withdrawals. There was no Clinical Institute Withdrawal Assessment (CIWA) and no vital signs. The patient denied suicidal or homicidal ideation, and there were no signs of her being a danger to herself or others. There were no emotional, behavioral, cognitive, or impulsive symptoms to would warrant this level of care. She was medically and psychiatrically stable. She received aversion treatment, which is not standard of practice in the community. Relaxation treatment, group, individual, and family therapies, as well as the Prozac and Strattera, could all have been administered on an outpatient basis. There were no signs of impulsivity, aggression, agitation, depression, mania, hallucinations, or other significant symptoms necessitating 24/7 medical and nursing monitoring. She could have been safely and effectively treated at a lower level of care, along with community supports, such as the Alcoholics Anonymous program and medication-assisted treatment. Thus, residential treatment provided from 6/02/16 through 6/11/16 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 65-year-old male who experienced a syncopal episode in June 2021. The patient has requested authorization and coverage for a transcatheter aortic valve replacement. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrolleeas medical condition.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 65-year-old male who experienced a syncopal episode in June 2021. The patient has requested authorization and coverage for a transcatheter aortic valve replacement. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrolleeas medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. Both the Evolut low risk trial and the PARTNER 3 trial have shown that transcatheter aortic valve replacement is non-inferior and perhaps slightly superior to surgical aortic valve replacement in low surgical risk patients such as this patient. Transcatheter aortic valve replacement has the additional significant advantage over surgical aortic valve replacement in shortening the length of hospital stay. Therefore, the requested transcatheter aortic valve replacement is medically necessary for the treatment of this patient.
| 1 |
An 18-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 20 hours per week of direct applied behavioral analysis (ABA) therapy provided from 8/24/17 through 2/24/18. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the autism spectrum disorder.
In this case, the patient presents with aggressive and self-injurious behaviors. He continues to require a high level of behavioral supports.
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Overturned
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Medical Necessity
|
Summary Reviewer
An 18-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 20 hours per week of direct applied behavioral analysis (ABA) therapy provided from 8/24/17 through 2/24/18. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the autism spectrum disorder. The physician reviewer found the request for 20 hours per week of direct ABA therapy provided from 8/24/17 through 2/24/18 were and are medically necessary for treatment of the patients autism. Several medical studies support the efficacy of ABA therapy in relation to life skills and personal appearance for the treatment of autistic adults (Smith, et al; McClannahan, et al). According to the National Institute for Health and Care Excellence (NICE) guidelines for autistic adults, ABA also plays an important role in the treatment of aggression and outburst behaviors in adults. In this case, the patient presents with aggressive and self-injurious behaviors. He continues to require a high level of behavioral supports. Given the support in the peer-reviewed literature, the services at issue were and are medically necessary for treatment of the patients autism. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 21-year-old female enrollee has requested reimbursement for greater occipital nerve injection provided on 11/21/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees occipital neuralgia.
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Overturned
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Experimental
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Summary Reviewer 3
A 21-year-old female enrollee has requested reimbursement for greater occipital nerve injection provided on 11/21/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees occipital neuralgia. The physician reviewer found that Occipital nerve blocks are not supported for the treatment of migraine or other type headaches. The blocks are supported for diagnostic purposes, but are not supported for therapeutic treatment. There is a lack of long-term benefit supported by peer-reviewed literature. Dilli and colleagues noted that greater occipital nerve blocks did not reduce the frequency of moderate to severe migraine days in patients with episodic or chronic migraine compared to placebo. Thus, greater occipital nerve injection on 11/21/17 was not likely to have been more effective than other available treatment options. Based upon the information set forth above, the services at issue were 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.
| 1 |
A 23-year-old female enrollee has requested reimbursement for mental health partial hospitalization program (PHP) services provided from 7/27/15 through 9/22/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees obsessive compulsive disorder and major depressive disorder.
patient burdened with a profoundly debilitating anxiety disorder, with comorbid depression, that impaired multiple domains of functionality. The patients fear of contamination and incessant washing consumed hours of the day and resulted in dermatologic sequelae, intrapsychic distress, occupational problems and interpersonal discord. In accordance with modern psychiatric practice, the patient had first pursued treatment in the outpatient setting. Her illness burden prevented consideration of psychotropic medication and she failed to respond to non-pharmacologic interventions.
While in the program, the patient received gold-standard therapies for OCD, cognitive behavioral therapy and exposure response
. Additionally, she was able to defeat her irrational fear and begin a serotonergic medication,
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Overturned
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Medical Necessity
|
Summary Reviewer
A 23-year-old female enrollee has requested reimbursement for mental health partial hospitalization program (PHP) services provided from 7/27/15 through 9/22/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees obsessive compulsive disorder and major depressive disorder. The physician reviewer found that this case incorporates elements of the biopsychosocial model of conceptualization and represented a patient burdened with a profoundly debilitating anxiety disorder, with comorbid depression, that impaired multiple domains of functionality. The patients fear of contamination and incessant washing consumed hours of the day and resulted in dermatologic sequelae, intrapsychic distress, occupational problems and interpersonal discord. In accordance with modern psychiatric practice, the patient had first pursued treatment in the outpatient setting. Her illness burden prevented consideration of psychotropic medication and she failed to respond to non-pharmacologic interventions. Thus, she pursued a higher level of care. Such progression is common for patients with severe OCD and consistent with the American Psychiatric Association treatment guidelines. Thus, for the duration of treatment, the patient could not have reasonably been conducted at a less restrictive setting and less intensive treatment would have resulted in inadequate care. While in the program, the patient received gold-standard therapies for OCD, cognitive behavioral therapy and exposure response prevention. Additionally, she was able to defeat her irrational fear and begin a serotonergic medication, which is a first-line intervention for both mood disorders and OCD. The programmatic services provided were for active treatment. The treatment was evidence-based, and reasonably expected to improve her condition and prevent a more serious episode of illness. Further, the duration of services afforded the consolidation of treatment gains while remaining consistent with community practice standards. In sum, the PHP services provided from 7/27/15 through 9/22/15 were medically necessary for treatment of the patients medical condition. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The parent of a four-year-old male enrollee has requested reimbursement for the polymerase chain reaction (PCR) testing and homocysteine testing performed on 6/4/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk for methylenetetrahydrofolate (MTHFR), Factor V Leiden, and homocysteine mutations.
. The mother reports that she tested negative for the Factor V Leiden mutation.
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Upheld
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Experimental
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Summary Reviewer 3
The parent of a four-year-old male enrollee has requested reimbursement for the polymerase chain reaction (PCR) testing and homocysteine testing performed on 6/4/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk for methylenetetrahydrofolate (MTHFR), Factor V Leiden, and homocysteine mutations. The physician reviewer found that although this patients mother experienced blood clots at an early age and in unusual places, the patient himself is not reported to have thrombosis. The American College of Medical Genetics (ACMG) practice guidelines regarding genotyping of MTHFR do not support testing in this clinical setting. Studies of MTHFR have focused on a wide varieties of conditions, including vascular disease, neural tube defects, mental illness, autism, and cancer. While some studies have found associations, other studies have found no association. Ultimately, the ACMG found that there is insufficient evidence of clinical utility of MTHFR polymorphism testing. The mother reports that she tested negative for the Factor V Leiden mutation. Thus, testing this patient who is asymptomatic was not indicated, particularly in light of the fact that the only person in the family with thrombosis has tested negative. In summary, the PCR testing and homocysteine testing performed on 6/4/16 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 55-year-old male enrollee has requested authorization and coverage for an electrical stimulation device. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 55-year-old male enrollee has requested authorization and coverage for an electrical stimulation device. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. The physician reviewer found the anaplastic astrocytomas and glioblastoma multiforme are high-grade tumors that are best treated with resection, radiation therapy, and chemotherapy. The standard of care is to resect the glioblastoma multiforme maximally followed by treatment with temozolomide. This patient has exhausted standard options. In 2011, the U.S. Food and Drug Administration approved Optune, formerly known as the NovoTTF-100A device, to deliver alternating electrical fields to treat recurrent glioblastoma multiforme. There is sufficient medical evidence to demonstrate the safety of this device in this clinical setting. Therefore, the requested electrical stimulation device is likely to be more efficacious than other available modalities. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
The patient is a 62-year-old male with prostate cancer. The record noted the patient had an elevated prostate specific antigen (PSA) of 8.5 ng/mL. He had a prostate core biopsy performed that showed adenocarcinoma of Gleason score of 3+3=6, involving less than 50% of the gland. An OncotypeDX test was ordered to better determine adjuvant treatment or observation. The patient underwent testing and has requested reimbursement for the gene expression profiling OncotypeDX prostate cancer assay performed on 2/14/17. The Health Insurer denied the request for reimbursement. Per the Health Insurer the services at issue were investigational for the evaluation of this patients medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
The patient is a 62-year-old male with prostate cancer. The record noted the patient had an elevated prostate specific antigen (PSA) of 8.5 ng/mL. He had a prostate core biopsy performed that showed adenocarcinoma of Gleason score of 3+3=6, involving less than 50% of the gland. An OncotypeDX test was ordered to better determine adjuvant treatment or observation. The patient underwent testing and has requested reimbursement for the gene expression profiling OncotypeDX prostate cancer assay performed on 2/14/17. The Health Insurer denied the request for reimbursement. Per the Health Insurer the services at issue were investigational for the evaluation of this patients medical condition. Once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features such as the grade of tumor and PSA level. This helps guide the most appropriate therapy for patients taking into account their age and co-morbidities because many patients will not require therapy (i.e., surgery or radiation) and instead, may be followed closely. Current biomarkers are inadequate for risk stratification and better prognostic biomarkers are needed. The prostate Oncotype DX is a gene expression analysis that target genes in the biopsy specimen and generates a genomic prostate score (GPS). A validation study was presented at the American Urological Association meeting in 2013 involving 395 patients (Cooperberg, et al). The GPS identified patients that had very low risk disease that could be followed rather than referred for surgery. Current prognostic features are inadequate to make firm recommendations regarding active surveillance to patients. In addition, the National Comprehensive Cancer Network guidelines appear to suggest that the OncotypeDX test is a technique that is able to better stratify patients with localized disease. As such, the gene expression profiling OncotypeDX prostate cancer assay performed on 2/14/17 was likely to have been more effective than any available standard method for evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned
| 1 |
patient is a 74-year-old male with a history of recent treatment for Streptococcus sanguinis endocarditis (ending on 11/25/20) and a recent resection of a colon cancer. The patient has requested reimbursement for admission and hospital stay from 12/05/20 through 12/10/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 74-year-old male with a history of recent treatment for Streptococcus sanguinis endocarditis (ending on 11/25/20) and a recent resection of a colon cancer. The patient has requested reimbursement for admission and hospital stay from 12/05/20 through 12/10/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The records do not demonstrate evidence of serious complications of possible sepsis. The patient did not have a fever, confusion, renal failure or positive blood cultures. Evaluation on observation status would have been appropriate, and he did not need full hospital admission. Therefore, admission and hospital stay from 12/05/20 through 12/10/20 was not medically necessary for the treatment of this patient.
| 1 |
A 60-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 8/04/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
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Overturned
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Experimental
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Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 8/04/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that there is sufficient support for the service at issue in this patients case. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and increase in overall diagnostic accuracy compared to two-dimensional imaging alone. In this case, there was a question of increasing architectural distortion in the left breast, prompting further investigation. Thus, the addition of breast tomosynthesis was likely of greater benefit to the patient than had her examination been done with two-dimensional imaging alone. Based upon the information set forth above, the service 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 35-year-old male enrollee has requested authorization and coverage for 64568 and 0466T. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 35-year-old male enrollee has requested authorization and coverage for 64568 and 0466T. 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 the Inspire hypoglossal nerve stimulation (HNS) device has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe obstructive sleep apnea refractory to continuous positive airway pressure (CPAP). However, a meta-analysis by Kompelli and colleagues found that contemporary HNS research consisted of single-arm clinical trials and case series, with a high likelihood of publication bias and a lack of comparative trials of HNS versus existing alternatives such as upper airway surgery. They concluded that HNS may not be the definitive choice for second line therapy for obstructive sleep apnea. In this case, clinical encounter notes did not mention uvulopalatopharyngoplasty (UPPP) or oral/dental appliances as options, despite physical examination findings that appeared to involve primarily the soft palate. Overall, there is insufficient high-quality, peer-reviewed evidence to support the use of HNS over other available therapies. Therefore, 64568 and 0466T are not likely to be more beneficial than any available standard therapy.
| 0 |
The parent of a two-year-old male enrollee has requested reimbursement for FirstStepDX Plus chromosomal microarray analysis. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a two-year-old male enrollee has requested reimbursement for FirstStepDX Plus chromosomal microarray analysis. 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 CMA is increasingly utilized for genetic testing of individuals with unexplained developmental delay/intellectual disability, autism spectrum disorders, or multiple congenital anomalies. CMA offers a much higher diagnostic yield for genetic testing of patients with unexplained developmental delay/intellectual disability, autism spectrum disorder, or multiple congenital anomalies than the previous standard testing with G-banded karyotype, primarily because of its higher sensitivity for submicroscopic deletions and duplications. Available evidence strongly supports the use of CMA in place of G-banded karyotyping as the first-tier cytogenetic diagnostic test for patients with developmental delay/intellectual disability, autism spectrum disorders, or multiple congenital anomalies. Given that the standard of care is now CMA, the FirstStepDx Plus chromosomal microarray was likely to have been of greater benefit than other methods of evaluation. 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.
| 0 |
The parent of seven-year-old female enrollee has requested reimbursement for individual psychophysiological therapy incorporating feedback training
psychotherapy services provided from 10/31/14 through 12/9/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees attention-deficit/hyperactivity disorder (ADHD).T
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Upheld
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Experimental
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Summary Reviewer 2
The parent of seven-year-old female enrollee has requested reimbursement for individual psychophysiological therapy incorporating feedback training by any modality with psychotherapy services provided from 10/31/14 through 12/9/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees attention-deficit/hyperactivity disorder (ADHD).The physician reviewer found the individual psychophysiological therapy with psychotherapy services provided from 10/31/14 through 12/9/14 was not likely to be more beneficial for treatment of the patients medical condition than other modalities. A review of the medical literature reveals a lack of clinical evidence to support the efficacy of biofeedback interventions in this clinical setting. In the absence of adequate clinical evidence in the peer-reviewed literature that supports the efficacy of neurofeedback therapy, it is not possible to conclude that neurofeedback therapy is likely to be more beneficial than standard therapies available in this setting. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old female enrollee has requested authorization and coverage for rizatriptan 5 mg, ODT tablets, #12 per month. The Health Insurer has denied this request indicating that the requested medication quantity is not medically necessary for treatment of the enrollees chronic migraines.
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Overturned
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Medical Necessity
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Summary Reviewer
A 62-year-old female enrollee has requested authorization and coverage for rizatriptan 5 mg, ODT tablets, #12 per month. The Health Insurer has denied this request indicating that the requested medication quantity is not medically necessary for treatment of the enrollees chronic migraines. The physician reviewer found that The medical records provided for review indicates a diagnosis of migraine headache. Peer-reviewed publications have demonstrated that rizatriptan is effective for abortive treatment of migraine headaches. The records from the provider indicate that no other therapy has been effective. With documented diagnosis of migraine and proven effectiveness of the requested quantity, rizatriptan 5 mg, ODT tablets, #12 per month is supported as medically necessary for treatment of this patients migraines. Based on the foregoing discussion, the requested medication quantity is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 32-year-old male enrollee has requested reimbursement for residential treatment center (RTC) services provided from 6/11/17 through 7/2/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health issues.
health issues. On 5/27/17 admission, the patients symptoms prevented him from functioning properly. However, by 6/11/17, the patient was not an imminent danger to self or others, and he was not gravely disabled. He was performing his activities of daily living independently. He continued to endorse passive suicidal ideation without intent, as well as anxiety and depression. He continued to report auditory and visual hallucinations, which the records suggest are the patients baseline. His psychotic symptoms were stabilized on Clozaril 500 mg, which had been titrated up from 300 mg.
His other medications were unchanged, and he was compliant. His family and girlfriend provided a safe and supportive environment. He no longer required 24-hour monitoring in the RTC setting,
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Upheld
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Medical Necessity
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Summary Reviewer
A 32-year-old male enrollee has requested reimbursement for residential treatment center (RTC) services provided from 6/11/17 through 7/2/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health issues. The physician reviewer found that the medical records provided for review do not support the medical necessity of the RTC services provided from 6/11/17 through 7/2/17 for treatment of this patients behavioral health issues. On 5/27/17 admission, the patients symptoms prevented him from functioning properly. However, by 6/11/17, the patient was not an imminent danger to self or others, and he was not gravely disabled. He was performing his activities of daily living independently. He continued to endorse passive suicidal ideation without intent, as well as anxiety and depression. He continued to report auditory and visual hallucinations, which the records suggest are the patients baseline. His psychotic symptoms were stabilized on Clozaril 500 mg, which had been titrated up from 300 mg. Further, Clozaril titration does not require a RTC setting and can be performed in the outpatient setting. His other medications were unchanged, and he was compliant. His family and girlfriend provided a safe and supportive environment. He no longer required 24-hour monitoring in the RTC setting, and could have continued treatment at IOP level of care. Thus, the RTC services provided from 6/11/17 through 7/2/17 were not medically necessary. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 31-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the lumbar spine, cervical spine, and pelvis. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees back and neck pain.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 31-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the lumbar spine, cervical spine, and pelvis. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees back and neck pain. The physician reviewer found that the records provided for review do not support the medical necessity of the requested MRI studies. The physical examination on 5/16/18 does not detail which muscles are weak or hypotonic. In addition, the neurological examination was limited and the note of prior physical therapy does not include details as to duration, evaluation or outcome. Moreover, there are no laboratory values in the chart to support an indication for an inflammatory process such as sacroiliitis. All told, there is a lack of documentation supporting the medical necessity for MRI of the lumbar spine, cervical spine, and pelvis for evaluation of this patients medical condition. Based on the foregoing discussion, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 59-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier assay performed on 10/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule.
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Overturned
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Experimental
|
Summary Reviewer 1
A 59-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier assay performed on 10/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule. The physician reviewer found that a fine needle aspiration biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of fine needle aspiration biopsy results are considered to be indeterminate. Until recently, the only way to establish whether the nodule was thyroid cancer was via surgical excision, even though the majority of the cases turn out to be benign. Afirma Gene Expression Classifier assay utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on fine needle aspiration biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures. Therefore, Afirma Gene Expression Classifier assay performed on 10/12/15 was likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees autoimmune hearing loss. The physician reviewer found that this patient has a history of autoimmune hearing loss. He has been treated with steroids and other agents. The patients provider recommended Simponi, an anti-tumor necrosis factor (TNF) agent.
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Upheld
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Experimental
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Summary Reviewer 2
A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward. The Health Insurer has denied this request indicating that the medication at issue was and is considered investigational for treatment of the enrollees autoimmune hearing loss. The physician reviewer found that this patient has a history of autoimmune hearing loss. He has been treated with steroids and other agents. The patients provider recommended Simponi, an anti-tumor necrosis factor (TNF) agent. Anti-TNF agents have been tried in autoimmune hearing loss as an intratympanic injection in two very small studies by Derebery and colleagues and Van Wijk and colleagues. There was no control group and no randomization in either of the two studies. At this time, there is a lack of evidence demonstrating that Simponi has an effect on autoimmune hearing loss. In sum, J1602, Simponi 50 mg, injected monthly for one year from 9/20/18 forward was not and is not likely to be of greater benefit than other treatment options. 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.
| 1 |
A 59-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/10/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer 3
A 59-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/10/18. 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 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, 0.76-1.0 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 5/10/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
| 0 |
The patient is a 58-year-old female who presented to her provider on 2/04/21 because of chronic knee pain. The patient has requested reimbursement for an MRI performed on 2/12/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 58-year-old female who presented to her provider on 2/04/21 because of chronic knee pain. The patient has requested reimbursement for an MRI performed on 2/12/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that MRI is the most optimal means to evaluate an internal derangement. Plain x-rays are of only limited value. The American College of Radiology (ACR) has established aAppropriateness Criteriaa to help referring practitioners in the most efficient and efficacious use of imaging for various clinical presentations. Several variants are described. The first is titled aChronic knee pain. Initial imaginga, and in that variant, MRI is felt to be not appropriate, but it recommends plain x-rays. However, the following three variants describe chronic knee pain when the initial knee x-ray is negative or when it is positive for multiple x-ray abnormalities. In each of these variants, MRI is felt to be ausually appropriatea. In other words, regardless of the plain x-ray findings, an MRI may be worthwhile. The reason that plain x-rays are of only limited value is that the menisci and ligaments are not visible on plain x-rays. One can assess the degree of degenerative disease and whether there are any acute bony structural abnormalities, but this information is only of limited interest in this patient. One can assume that she does not have a fracture, and whether or not she has degenerative change has no bearing. The Health Insurer contends that the patient should have had documentation of various physical examination maneuvers to justify the MRI. The patient was seen by a sports medicine practitioner. An experienced sports medicine practitioner should be able to assess the need for an MRI and potential surgical correction on clinical grounds. In this patient, she had knee symptoms for at least two months and already had physical therapy and conservative management. There is sufficient support for the services at issue in this setting. Therefore, the MRI performed on 2/12/21 was medically necessary for the evaluation of this patient.
| 1 |
A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 10/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 10/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the breast tomosynthesis performed on 10/21/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. There is a lack of peer-reviewed literature that supports the use of digital breast tomosynthesis compared to currently available techniques. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in peer-reviewed literature. Accordingly, the breast tomosynthesis performed on 10/21/15 was not likely to provide this patient with an improved health outcome when compared to standard available techniques. 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.
| 0 |
A 68-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/06/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
|
Summary Reviewer 3
A 68-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/06/17. 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 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, 0.76-1.0 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. 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 12/06/17 was not likely to have been more effective than other methods of evaluating this patient.
| 0 |
A 65-year-old female enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
prior dose her adjacent normal tissue was exposed to from her radiation therapy in 1987.
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Overturned
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Experimental
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Summary Reviewer 3
A 65-year-old female enrollee has requested authorization and coverage for proton beam radiation therapy. 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 compared to standard radiotherapy with photon IMRT, the benefit of proton therapy is that with its Bragg Peak, radiation dose is deposited more precisely on its target. This translates into a decrease in exposure of normal tissue in the low-dose to intermediate-dose range, but not in the high-dose range. The medical records support proton beam radiation therapy in this patients case, given the significant prior dose her adjacent normal tissue was exposed to from her radiation therapy in 1987. Radiation techniques at that time were much more crude, with little normal tissue sparing. Critical structures that likely received near full tolerance dose for this patient include the brainstem, spinal cord, carotid artery, and cranial nerves. Additionally, her jaw would be at risk for osteoradionecrosis with another full dose of radiotherapy. Thus, the requested proton beam radiation therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
| 1 |
The patient is a 55-year-old female who presented for a pain management follow-up evaluation
on 10/11/21. The patient has requested reimbursement for MRI (e.g. proton), any joint of lower
extremity, on 10/14/21.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 55-year-old female who presented for a pain management follow-up evaluation
on 10/11/21. The patient has requested reimbursement for MRI (e.g. proton), any joint of lower
extremity, on 10/14/21. The physician reviewer found at issue is whether MRI (e.g. proton), any
joint of lower extremity, on 10/14/21 was medically necessary for the evaluation of this patient.
The submitted documentation does not support the medical necessity of the service at issue. The
American College of Radiology (ACR) appropriateness criteria note that for chronic hip pain,
Depending on history and physical examination, imaging may not be necessary to evaluate all
hip pain. A directed examination with a particular suspected problem may direct more specific
targeted imaging (e.g. ultrasound for abductor tendinosis/trochanteric bursitis or spine imaging
for referred pain). Radiographs should be obtained first in most, if not all, cases and may provide
specific information for common disorders such as arthritis or less common disorders such as
primary bone tumors ... Whether the radiographs are normal or not, they are often of
considerable value for the selection of additional imaging techniques and for comparison with
studies such as MRI, CT, radionuclide bone scans, and 18F-fluoride positron emission tomography
(PET). The guidelines further note that in cases of chronic hip pain and low back, pelvic, or knee
pathology where the goal is to exclude the hip as the source, and where radiographs are negative,
equivocal, or showing mild osteoarthritis, After radiography, MRI is the best next test to screen
the hip for significant pathology. Chamberlain and colleagues note that in addition to the history
and physical examination, radiography, ultrasonography, or MRI may be needed for a definitive
diagnosis, with radiography of the hip and pelvis recommended as the initial imaging test. Reiman
and colleagues state, Anteroposterior pelvis and lateral femoral head-neck radiographs are the
initial diagnostic imaging of choice-advanced imaging should be performed only when requiring
additional detail of bony or soft-tissue morphology (e.g. for definitive diagnosis, research setting
or when planning surgery) ... Future research should refine our current recommendations by
determining the clinical utility of clinical examination and diagnostic imaging in prospective
studies. In this case, the patient reported pain over the lateral aspect of the knee and hip, the
shoulders, and lower extremities. Notes dated 10/11/21 reported that the patient sustained
multiple injuries on the right side of the body including the hip of the right lower extremityduring
an assault on 8/5/21. The patient reported difficulty with weight-bearing activities of the right
lower extremity and the provider recommended MRI of the right knee and hip to rule out other
pathologies. The records noted that prior imaging such as x-rays and CT at the hospital were
negative for any type of fractures. However, the submitted documentation did not include clear
documentation of initial radiographs of the right hip that were negative or equivocal to warrant
more advanced imaging. The provider did not clearly identify what body regions were imaged
with what specific imaging study. Given that current medical literature recommends that in
addition to a history and physical examination, x-rays of the hip and pelvis should be the initial
imaging test before an MRI, the service at issue was not medically indicated. Therefore, MRI (e.g.
proton), any joint of lower extremity, on 10/14/21, was not medically necessary for the
evaluation of this patient.
| 1 |
A 59-year-old male enrollee has requested reimbursement for gene testing performed on 3/9/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
. The biopsy result was consistent with follicular neoplasm.
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Overturned
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Experimental
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Summary Reviewer 3
A 59-year-old male enrollee has requested reimbursement for gene testing performed on 3/9/15. The Health Plan 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 Afirma gene expression classifier testing performed on 3/9/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The biopsy result was consistent with follicular neoplasm. The median risk of malignancy on follicular neoplasm lesions is 15-30% (Cibas, et al). The Bethesda System recommends a second fine needle aspiration when the cytopathology is consistent with follicular neoplasm. The 2015 American Thyroid Associations guidelines state Diagnostic surgical excision is the long-established standard of care for the management of [follicular neoplasm/suspicious for follicular neoplasm] FN/SFN cytology nodules. However, after consideration of clinical and sonographic features, molecular testing may be used to supplement malignancy risk assessment data in lieu of proceeding directly with surgery. Informed patient preference and feasibility should be considered in clinical decision-making (Haugen, et al). Fine needle aspiration with molecular testing is considered standard of care in this clinical setting. When the genetic test is suspicious for malignancy, the risk of malignancy increases to 40%, therefore surgery is recommended. However, the risk of malignancy decreases to less than 6% with benign findings by genetic testing (Haugen, et al; Alexander, et al). The test was important for the medical decision making to proceed with surgery (Alexander, et al). A benign results would have prevented unnecessary surgery. 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 61-year-old male enrollee has requested reimbursement for physical therapy services performed from 8/27/15 through 12/5/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of low back pain, knee pain and bilateral arm numbness.
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Upheld
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Experimental
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Summary Reviewer 2
A 61-year-old male enrollee has requested reimbursement for physical therapy services performed from 8/27/15 through 12/5/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of low back pain, knee pain and bilateral arm numbness. The physician reviewer found that there is sufficient support in the efficacy for the treatment modalities in this clinical setting. The care provided was reported as leading to functional improvement, not as a single application of one modality (cupping), but as being complementary to manual therapy, massage and myofascial release therapies. The providers choice to include cupping in the treatment plan was to increase blood flow, soften scarring and improve circulation leading to reduced pain and to increased function was an appropriate plan of care given the reported chronicity of the patients condition and the addressed functional deficits found upon clinical evaluation. All told, the physical therapy services provided between 8/27/15 and 12/5/15 were likely to have been more effective than the other standard options for treatment of this patient. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 28-year-old female enrollee has requested authorization and coverage for ReActiv8 implantable peripheral nerve stimulation. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 28-year-old female enrollee has requested authorization and coverage for ReActiv8 implantable peripheral nerve stimulation. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition. At issue is whether the requested device is likely to be more beneficial for treatment of the enrollee's condition than any available standard therapy. The physician reviewer found that Neuromodulation has efficacy for post-laminectomy syndrome. Spinal cord stimulation has traditionally been offered in the neuromodulation space, but peripheral nerve stimulation offers a less invasive treatment option. Peripheral nerve stimulation is a minimally invasive, nondestructive treatment option for low back pain that is primarily axial. In patients who have tried conservative care, including a multimodal treatment approach, peripheral nerve stimulation is a minimally invasive treatment option. The current medical evidence supports the requested device in this clinical setting. Therefore, ReActiv8 implantable peripheral nerve stimulation is likely to be more beneficial for treatment of the patientas medical condition than any available standard therapy.
| 1 |
An 83-year-old male enrollee has requested reimbursement for Guardant360 CDx testing
performed on 3/31/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
An 83-year-old male enrollee has requested reimbursement for Guardant360 CDx testing
performed on 3/31/21. 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 molecular diagnostic studies in non-small cell lung cancer (NSCLC) are
considered a standard of care. Numerous gene alterations have been identified that impact
therapy selection. The National Comprehensive Cancer Network (NCCN) 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. Integration of plasma next-generation sequencing testing into
the routine management of stage IV NSCLC demonstrates a marked increase of the detection of
therapeutically targetable mutations and improved delivery of molecularly guided therapy.
Therefore, Guardant360 CDx testing performed on 3/31/21 was likely to have been more
beneficial for evaluation of the patients medical condition than any available standard therapy.
| 0 |
A 53-year-old female enrollee has requested reimbursement for OVA1 testing performed on 5/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
This patient had an ovarian cyst, which was simple in nature and decreasing in size.
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Upheld
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Experimental
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Summary Reviewer 2
A 53-year-old female enrollee has requested reimbursement for OVA1 testing performed on 5/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue. Biomarkers such as OVA1 are imprecise and are not specific enough to be accurately used for ovarian cancer screening. Therefore, its utility in a clinical setting is limited. This patient had an ovarian cyst, which was simple in nature and decreasing in size. Both of these features are not associated with neoplasm. In this case, the medical evidence does not support screening with OVA1 testing was due to the high risk of false positives leading to unnecessary testing and invasive procedures. Therefore, OVA1 testing performed on 5/19/15 was not likely to have been of greater benefit than other modalities. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 27-year-old transgender female enrollee has requested reimbursement for breast augmentation surgery performed on 6/13/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
The records document gender dysphoria. The patient has been prescribed hormone therapy since February 2018, and she continued to experience severe dysphoria related to her chest.
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Overturned
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Medical Necessity
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Summary Reviewer
A 27-year-old transgender female enrollee has requested reimbursement for breast augmentation surgery performed on 6/13/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the current medical evidence supports the services at issue in this clinical setting. The records document gender dysphoria. The patient has been prescribed hormone therapy since February 2018, and she continued to experience severe dysphoria related to her chest. The World Professional Association for Transgender Health (WPATH) supports augmentation mammoplasty for the treatment of gender dysphoria. The WPATH position statement noted that breast augmentation...is often of greater practical significance in the patients daily life than genital surgery. The current medical evidence supports the services at issue in this clinical setting. Therefore, breast augmentation performed on 6/13/19 was medically necessary for the treatment of this patient.
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The parent of a seven-year-old male enrollee has requested reimbursement and prospective authorization and coverage for inpatient mental health treatment from 2/8/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition.
. The patient was admitted to an inpatient unit in mid-November 2016. The patients stay was approximately three months prior to the Health Insurers denial. The progress notes reflect variable behaviors on the part of the patient. It appears that he has days where he exhibits self-injurious behaviors and days where he is calm and cooperative. However, the progress notes do not reflect a drastic change or improvement in his behavior. He continues to have issues with nonadherence to his medication regimen.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a seven-year-old male enrollee has requested reimbursement and prospective authorization and coverage for inpatient mental health treatment from 2/8/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue in this clinical setting. The patient was admitted to an inpatient unit in mid-November 2016. The patients stay was approximately three months prior to the Health Insurers denial. The progress notes reflect variable behaviors on the part of the patient. It appears that he has days where he exhibits self-injurious behaviors and days where he is calm and cooperative. However, the progress notes do not reflect a drastic change or improvement in his behavior. He continues to have issues with nonadherence to his medication regimen. The treatment goals listed by the inpatient team appear to be more of long-term goals and include generalization of skills. It is unlikely that generalization of learned skills would occur in an inpatient environment, as this environment is artificial and not indicative of any home type environment. It is also not clear that continued inpatient care would result in increased adherence to medications, as the patient appears to almost randomly refuse medications. The standard practice in this clinical setting is to utilize an evidence based instrument such as the Child and Adolescent Level of Care Utilization System (CALOCUS) when determining the necessary level of care for children. This system provides a tool that would ensure that a patients level of care meets their individual needs at the least restrictive setting possible. The American Academy of Child and Adolescent Psychiatry always recommends that children and adolescents be treated in the least restrictive setting possible and to maintain and foster natural supports (Winters). There was a lack of medical information provided to indicate that this patient could not have been treated in a less restrictive setting. According to the submitted documentation, continued inpatient care is not the least restrictive environment for this patient. As such, inpatient mental health treatment for 2/8/17 forward were not and are not medically necessary. Therefore, for the reasons stated above, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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The patient is a 26-year-old male with a history of suspected multiple sclerosis (MS). In an effort
to treat the patients flare and as maintenance therapy for suspected MS, the provider has
recommended treatment with intravenous immunoglobulin (IVIG) therapy with Gamunex-C. The
Health Insurer has denied the requested treatment as not medically necessary for the treatment
of the patients medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 26-year-old male with a history of suspected multiple sclerosis (MS). In an effort
to treat the patients flare and as maintenance therapy for suspected MS, the provider has
recommended treatment with intravenous immunoglobulin (IVIG) therapy with Gamunex-C. The
Health Insurer has denied the requested treatment as not medically necessary for the treatment
of the patients medical condition. The physician reviewer found that the records provided for
review indicate that the patient experienced an exacerbation of symptoms from suspected MS.
For patients who experience an acute MS exacerbation that results in neurologic symptoms and
increased disability or impairments in vision, strength, or cerebellar function, a short course of
high-dose glucocorticoid therapy is recommended (Olek, et al.). If the patient has a poor response
to treatment with high-dose glucocorticoids, treatment with plasma exchange is considered for
the next line of therapy. Other options for a second treatment course after a poor response to
initial high-dose glucocorticoid therapy include adrenocorticotropic hormone (ACTH), a second
cycle of high-dose glucocorticoid therapy, or immunoadsorption. There is a paucity of high-
quality medical studies demonstrating that IVIG therapy is an effective treatment option for
patients who experience an exacerbation of symptoms from suspected MS. A small number of
limited medical studies have demonstrated that IVIG therapy may be used for patients with
relapsing-remitting MS who do not tolerate or have contraindications to approved therapies
(Bayry, et al.). In this case, a diagnosis of relapsing-remitting MS has not been established for the
patient. The records indicate that the patient experienced an acute exacerbation of symptoms
from suspected MS. Based on the current medical literature, IVIG therapy is not recommended
as a treatment option for patients with acute exacerbations of symptoms from suspected MS.
Therefore, the requested Gamunex-C is not medically necessary for the treatment of this patient.
| 1 |
A 61-year-old male enrollee has requested reimbursement for the Life Vest provided on 5/23/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees congestive heart failure and atrial fibrillation.
, have had a previously implanted ICD explanted due to an infection and are
, the WCD was deployed five days after the initial diagnosis was made and the patient did experience a return to normal LV function.
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Upheld
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Experimental
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Summary Reviewer 3
A 61-year-old male enrollee has requested reimbursement for the Life Vest provided on 5/23/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees congestive heart failure and atrial fibrillation. The physician reviewer found that the review of currently available peer-reviewed literature does support the safety and efficacy of wearable cardioverter defibrillators (WCD) in this clinical setting. Chung and colleagues demonstrated low sudden cardiac death in patients at increased risk with WCD comparable to implantable cardioverter defibrillator (ICD) patients. However, Adler and colleagues indicated that when a wearable defibrillator is considered, there are no randomized, controlled studies showing that it provides survival benefit compared to standard alternatives. WCD is currently indicated for patients who have met medical necessity criteria for ICD deployment and are awaiting cardiac transplantation and have met criteria for cardiac transplantation, have had a previously implanted ICD explanted due to an infection and are awaiting ICD re-implantation, or have an infectious process or other temporary condition that would preclude initial implantation of an ICD. In this case, the WCD was deployed five days after the initial diagnosis was made and the patient did experience a return to normal LV function. All told, the Life Vest provided on 5/23/14 was 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, I have determined the device at issue was 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.
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The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis (ABA) therapy provided from 2/23/17 through 8/23/17. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis (ABA) therapy provided from 2/23/17 through 8/23/17. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder. The physician reviewer found that Brosnan and Healy indicate that ABA therapy is an effective treatment to reduce aggressive behavior in individuals with autism spectrum disorder. Hanley and colleagues also report that ABA is highly effective in reducing problematic behaviors. According to the documentation submitted for review, the patient engages behaviors that pose a danger to himself and others, particularly his aggressive and injurious behavior, and his behavior when traveling in a car. There are several areas in which the patient has made no progress during the last authorization period, including the areas of social, play and cognition, adaptive/motor skills, and executive function. ABA therapy at the providers recommended frequency are medically necessary to address the patients behavioral challenges is clinically indicated for this patient. Therefore, the request for 20 hours per week of direct ABA therapy, eight hours per month of supervision, two hours per month for treatment planning and two hours per month for parent training provided from 2/23/17 through 8/23/17 were and are medically necessary for treatment of the patients medical condition. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
A 56-year-old male enrollee has requested reimbursement for DecisionDX-Melanoma test performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma
In this patients case, a sample of his tumor was sent for DecisionDX-Melanoma testing.
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Upheld
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Experimental
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Summary Reviewer 3
A 56-year-old male enrollee has requested reimbursement for DecisionDX-Melanoma test performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma The physician reviewer found the medical studies have shown 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, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision but they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. In this patients case, a sample of his tumor was sent for DecisionDX-Melanoma testing. However, there is very little data on the DecisionDX-Melanoma test. The available studies are unclear as to how to incorporate this assay into the treatment algorithm beyond standard staging techniques. This was also the consensus opinion of the National Comprehensive Cancer Network guidelines. As such, the medical data available does not support the superior efficacy of DecisionDX-Melanoma, performed on 8/4/15, over other standard methods of staging for the evaluation of this patients tumor. Therefore, for the reasons stated 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 |
The patient is a 63-year-old male with benign prostatic hyperplasia (BPH). He was having symptoms of frequency, dysuria and intermittent stream. His prostate specific antigen (PSA) was elevated at 10. On 8/3/17, a computed tomography (CT) of the abdomen and pelvis showed a large prostate, thickened bladder and a bladder stones. On 8/24/17, he had a transrectal ultrasound and magnetic resonance imaging (MRI) of the prostate, a prostate biopsy, cystoscopy and cystolitholapaxy. The biopsy was negative for prostate cancer. The patient has requested authorization and coverage for a prostatic urethral lift implant. The Health Plan has denied this request indicating that the requested surgical procedure is considered investigational.
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Overturned
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Experimental
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Summary Reviewer 2
The patient is a 63-year-old male with benign prostatic hyperplasia (BPH). He was having symptoms of frequency, dysuria and intermittent stream. His prostate specific antigen (PSA) was elevated at 10. On 8/3/17, a computed tomography (CT) of the abdomen and pelvis showed a large prostate, thickened bladder and a bladder stones. On 8/24/17, he had a transrectal ultrasound and magnetic resonance imaging (MRI) of the prostate, a prostate biopsy, cystoscopy and cystolitholapaxy. The biopsy was negative for prostate cancer. The patient has requested authorization and coverage for a prostatic urethral lift implant. The Health Plan has denied this request indicating that the requested surgical procedure is considered investigational. The UroLift procedure can provide advantages over the tradition transurethral ultrasound resection of the prostate (TURP) for an obstructing prostate causing lower urinary tract symptoms. The UroLift can be done as an outpatient, with no significant blood loss, minimal anesthesia and no catheter afterwards. Given this support, the requested prostatic urethral lift implant is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 53-year-old female enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the bilateral breasts. The Health Insurer has denied this request indicating that the requested diagnostic procedure is not medically necessary for evaluation of the enrollees risk of breast cancer.
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Overturned
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Medical Necessity
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Summary Reviewer
A 53-year-old female enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the bilateral breasts. The Health Insurer has denied this request indicating that the requested diagnostic procedure is not medically necessary for evaluation of the enrollees risk of breast cancer. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity for the requested diagnostic procedure. According to Phi and colleagues, the Addition of MRI to mammography for screening BRCA1/2 mutation carriers age greater than 50 years improves screening sensitivity by a magnitude similar to that observed in younger women. Limiting screening MRI in BRCA1/2 carriers age greater than 50 years should be reconsidered. In addition, Warner and colleagues state Screening with both MRI and mammography might rule out cancerous lesions better than mammography alone in women who are known or likely to have an inherited predisposition to breast cancer. The medical literature supports the use of breast MRI for women with higher risk of breast cancer, such as women with BRCA mutation. Given that the patient is less than a month away from her annual breast MRI screening and this is also to be used for pre-surgical mastectomy evaluation, it is medically necessary for this patient to have a screening breast MRI a few weeks earlier. For the reasons provided, the requested diagnostic procedure is medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 62-year-old male enrollee has requested reimbursement for blood test (protein biomarker tests or 4Kscore) provided on 10/29/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for developing metastases.
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Upheld
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Experimental
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Summary Reviewer 3
A 62-year-old male enrollee has requested reimbursement for blood test (protein biomarker tests or 4Kscore) provided on 10/29/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for developing metastases. The physician reviewer found that this patient had a negative biopsy. The 4Kscore test may be useful when there is persistent prostate-specific antigen (PSA) elevation. In this case, the records do not document persistent PSA elevation. Furthermore, 4Kscore testing may be beneficial in the prognosis of prostate cancer and its aggressiveness. The medical evidence has not demonstrated that the services at issue were likely to have been of greater benefit than standard prostate cancer screening tests in this patients case. In sum, the blood test (protein biomarker tests or 4Kscore) performed on 10/29/18 was not likely to have been more effective than other methods of evaluating this patient.
| 0 |
A 39-year-old male enrollee has requested reimbursement for the surgery performed on 9/22/15. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational for treatment of the enrollees degenerative disc disease (DDD) with herniations.
that the patient has chronic back pain and multiple levels of lumbar degeneration.
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Upheld
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Experimental
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Summary Reviewer 1
A 39-year-old male enrollee has requested reimbursement for the surgery performed on 9/22/15. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational for treatment of the enrollees degenerative disc disease (DDD) with herniations. The physician reviewer found the medical records indicate that the patient has chronic back pain and multiple levels of lumbar degeneration. Two-level artificial disc replacement surgery remains experimental. The procedure is U.S. Food and Drug Administration (FDA) approved for only single level use. Outcomes and complications of two-level total disc replacement surgery remain unknown this time. More research is needed to confirm preliminary findings to determine whether the procedure has a role in treating patients with two-level disc disease. All told, there is inadequate data to support the surgery performed on 9/22/15 as likely to have been more beneficial for treatment of this patients medical condition than any available standard therapy. Based upon the information set forth above, the surgery at issue was 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
| 1 |
patient is a 51-year-old female who had a vaginal delivery in 2004 complicated by grade 4 episiotomy and Clostridium difficile on and off for six months. The patient has requested reimbursement for opium tincture 10 mg/mL provided on 2/18/20. The Health Insurer has denied this request and reported that the medication at issue was not medically necessary for the treatment of this patient.
The patient has been stabilized on opium tincture for several years. She has attempted several medical alternatives and has undergone sacral nerve stimulator.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 51-year-old female who had a vaginal delivery in 2004 complicated by grade 4 episiotomy and Clostridium difficile on and off for six months. The patient has requested reimbursement for opium tincture 10 mg/mL provided on 2/18/20. The Health Insurer has denied this request and reported that the medication at issue was not medically necessary for the treatment of this patient. The physician reviewer found that the use of opium tincture is supported as medically necessary for the treatment of this patientas incontinence and diarrhea. American Society of Colon and Rectal Surgeons guidelines for the treatment of fecal incontinence state that medical management should be first-line therapy, and opioids result in decreased intestinal motility, decreased intestinal secretion, and increased absorption. Opiates are recommended as safe and effective for the treatment of chronic diarrhea. The patient has been stabilized on opium tincture for several years. She has attempted several medical alternatives and has undergone sacral nerve stimulator. There is sufficient support for the requested medication in this setting. Therefore, opium tincture 10 mg/mL provided on 2/18/20 was medically necessary for the treatment of this patient.
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The patient is a 63-year-old female who presented to her provider on 4/30/20. The patient has requested authorization and coverage for surgery of the left shoulder. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
. In this case, there is a history of pain, failed conservative treatment, large osteophytes on the MRI scan, clinical evidence of localized tenderness over the acromioclavicular joint, and evidence of
Additionally, she also has failed conservative management of anterior shoulder impingement for six months and there is evidence of a type 2 acromion and narrowed supraspinatus outlet.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 63-year-old female who presented to her provider on 4/30/20. The patient has requested authorization and coverage for surgery of the left shoulder. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that Osteoarthritis of the acromioclavicular joint is a frequent cause of shoulder pain and can result in significant disability. Although the treatment is usually conservative, surgery may be necessary if conservative treatment is not effective and there is documented severe pathology and the pain source can be confirmed. In this case, there is a history of pain, failed conservative treatment, large osteophytes on the MRI scan, clinical evidence of localized tenderness over the acromioclavicular joint, and evidence of a type 2 acromion with impingement syndrome. Conservative treatment for impingement syndrome has also not been effective. This patient meets the criteria for surgical management of the persistent acromioclavicular joint arthritis. Additionally, she also has failed conservative management of anterior shoulder impingement for six months and there is evidence of a type 2 acromion and narrowed supraspinatus outlet. Therefore, the requested surgery of the left shoulder is medically necessary for the treatment of this patient.
| 1 |
A 49-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 1/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease.
the records indicate this patient was on Humira but appeared to be non-responsive.
this case, the patient was found to have detectable levels and no antibodies and was switched to Remicade.
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Upheld
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Experimental
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Summary Reviewer 3
A 49-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 1/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that the records indicate this patient was on Humira but appeared to be non-responsive. Determining therapeutic levels with the Anser ADA test with no antibodies can provide a valuable medical guide to the treating provider. As noted in the medical literature, the Anser ADA test measures the Humira blood level and detects antibodies to Humira (Ordas, et al). A patient with detectable levels and no antibodies will likely require a change in treatment management in order to control their disease, as the test potentially implies an escape phenomenon to Humira (Afif, et al). Patients with undetectable levels and low/no antibodies are under-dosed and a higher dose will be needed to achieve remission and control of disease (Baert, et al). Patients with a low level and detectable antibodies have a low drug level due to the development of antibodies. In this case, the patient was found to have detectable levels and no antibodies and was switched to Remicade. In this clinical setting, the use of the Anser ADA test performed on 1/11/16 was likely to have been more beneficial for evaluation and treatment of this patients Crohns disease than standard available testing. Based upon the information set forth above, the testing 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 52-year-old male enrollee has requested reimbursement for proton beam therapy provided from October through December 2016. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees nasopharyngeal carcinoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 52-year-old male enrollee has requested reimbursement for proton beam therapy provided from October through December 2016. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees nasopharyngeal carcinoma. The physician reviewer found that there is a lack of clinical data in the medical literature to suggest that treatment with proton beam radiation offers a superior clinical benefit when compared to conventional radiation therapy techniques for tumors of the head and neck area. In the majority of cases, the standard approach to treat this malignancy is with standard photon techniques using intensity modulated radiation therapy (IMRT). A recent comparative analysis found no significant difference in symptom burden in the acute and chronic phases of treatment with proton therapy was compared to photon therapy for head and neck cancer (Sio). Also, the ASTRO emerging technology committee report on proton beam therapy specifically states that there is insufficient data to recommend proton beam therapy for routine head and neck radiation therapy outside of clinical trials (Allen, et al). The comparative planning was reviewed and showed no clinically significant benefit with treatment with proton therapy over standard photon techniques as all standard dose metrics are met with the photon plan. In sum, the proton beam therapy provided from October through December 2016 were not likely to have been more efficacious than the standard options available to evaluate this patient. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 54-year-old male has requested reimbursement for genetic testing performed on 2/04/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer.T
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Upheld
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Experimental
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Summary Reviewer 2
A 54-year-old male has requested reimbursement for genetic testing performed on 2/04/16. 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 that Foundation One testing offers a comprehensive panel of molecular genetic markers on an individuals tumor with the hopes of identifying markers than can help guide therapy decision making. Per the National Comprehensive Cancer Network guidelines, it has not been determined if molecular markers are useful in treatment determination (predictive markers) and prognosis other than KRAS, NRAS, and BRAF mutations. There is currently a phase II clinical trial underway that is evaluating the efficacy of genetic molecular testing to guide individual therapy. Per the medical evidence, Foundation One testing was unlikely to be more beneficial than any available standard therapy such as testing the tumor for standard markers, such as KRAS, NRAS, and BRAF. All told, genetic testing performed on 2/04/16 was not likely to have been superior over 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 |
A 54-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the right hip. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition.
he has very severe osteoarthritis of the hip. He has no subtle abnormalities.
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Upheld
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Medical Necessity
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Summary Reviewer
A 54-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the right hip. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found that considering the patients relatively young age and lack of previous trauma, and further considering the severe long-standing deformity and radiographic findings, the records suggest that the underlying problem is a hip dysplasia. Most commonly, a hip dysplasia is a congenital or developmental deformity or misalignment of the hip leading to chronic arthritis. There is a role for MRI in the evaluation of hip problems. Generally, the evaluation of hip pain will begin with plain x-rays. For hip dysplasia, plain x-rays will often be sufficient, as the displacement will often be readily apparent. CT scans are often employed as well to confirm the plain x-ray findings. There are various entities, however, that can only be imaged by magnetic resonance scanning. Conditions such as labral tears, ligamentous injuries, and subtle osteochondral lesions are only demonstrable with MRI. Early stage subtle avascular necrosis can also be optimally imaged with MRI. However, in this patients case, he has very severe osteoarthritis of the hip. He has no subtle abnormalities. MRI would be expected to confirm the obvious arthritic change. All told, the requested MRI of the right hip is not medically indicated for the evaluation of this patient. Therefore, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 58-year-old male with a history of uveal melanoma. A tumor sample was submitted for genetic testing with the DecisionDx-UM analysis. The patient has requested reimbursement for the DecisionDx-UM test provided on 8/14/17. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 58-year-old male with a history of uveal melanoma. A tumor sample was submitted for genetic testing with the DecisionDx-UM analysis. The patient has requested reimbursement for the DecisionDx-UM test provided on 8/14/17. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary. DecisionDx-UM is a test that analyzes the genetic profile of a uveal melanoma tumor sample to determine its risk for metastasis. The DecisionDx-UM test stratifies a tumor to low risk and high risk for metastasis. Based on the available medical literature, the DecisionDx-UM is now considered within the standard of care for patients with uveal melanoma. Clinically, it helps determine how intensely a patient needs to be monitored for metastasis. Given these findings, the DecisionDx-UM test provided on 8/14/17 was medically necessary for evaluation of this patients uveal melanoma. Based on the foregoing discussion, the testing at issue was medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 45-year-old female enrollee has requested reimbursement for the Decision Dx melanoma test performed on 4/4/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 45-year-old female enrollee has requested reimbursement for the Decision Dx melanoma test performed on 4/4/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. The physician reviewer found the Decision Dx melanoma test performed on 4/4/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The patients tissue underwent Decision Dx testing where the genes are examined for certain markers and then the lesion can be further stratified to tell if there is high risk for metastasis. The treatment of this patient would not change based on the results of the. The test is not considered standard of care. There is a lack of peer-reviewed literature to support its use in the care of patients with thin melanomas to effect health outcomes. In sum, there is a lack of published data to support its use in this clinical setting. Therefore, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 35-year-old female enrollee has requested reimbursement for homocysteine testing provided on 6/05/18 and 7/16/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who had a history of miscarriage.
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Upheld
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Experimental
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Summary Reviewer 3
A 35-year-old female enrollee has requested reimbursement for homocysteine testing provided on 6/05/18 and 7/16/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who had a history of miscarriage. The physician reviewer found that the current medical evidence does not support the services at issue in this patients case. Recurrent miscarriage is defined as three or more consecutive miscarriages. In this patients case, the records document one miscarriage. Even if she had such a history, this testing is not recommended. According to the American College of Obstetricians and Gynecologists Practice Bulletin Number 197, 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 of venous thromboembolism, screening with either MTHFR mutation analyses or fasting homocysteine levels is not recommended. The American College of Obstetricians and Gynecologists does not recommend homocysteine testing in non-pregnant or pregnant women. Thus, homocysteine testing provided on 6/05/18 and 7/16/18 was not likely to have been of greater efficacy 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.
| 0 |
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx TM
comprehensive genomic profiling test performed on 1/26/21. The Health Insurer has denied this
request and reported that the services at issue were investigational for the evaluation of the
enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx TM
comprehensive genomic profiling test performed on 1/26/21. 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 a lack of support for the
services at issue in this clinical setting. The hope is that the FoundationOne assay will identify a
target that would indicate a useful treatment drug. At this time, there is a lack of evidence that
therapy guided by such assays is likely to be superior to therapy guided by the literature and
experience. A randomized study by Le Tourneau and colleagues did not indicate that genome
driven therapy was superior to conventional therapy. Marquart and colleagues indicated that the
percentage of patients who benefit from assay directed therapy is actually quite low. The use of
the FoundationOne assay was not likely to have been of clinical benefit. Therefore,
FoundationOne CDx TM comprehensive genomic profiling test performed on 1/26/21 was not
likely to have been more beneficial than any available standard therapy.
| 0 |
A 24-year-old male enrollee has requested reimbursement for substance use residential treatment center services from 1/21/16 through 2/4/16. 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.
Upon admission, the patient was experiencing mild post-acute withdrawal symptoms. By 1/21/16, he was not a danger to himself or others. He was medically and psychiatrically stable.
. He was motivated as evidenced by his active engagement in all aspects of his treatment. The patient was working on relapse prevention and completion of assignments. He was developing insight and coping mechanisms. He was on anti-craving medication. No new problems had arisen and there was no evidence
that returning him to his environment would lead to destabilization. His family was supportive and participating in his recovery.
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Upheld
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Medical Necessity
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Summary Reviewer
A 24-year-old male enrollee has requested reimbursement for substance use residential treatment center services from 1/21/16 through 2/4/16. 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 there is a lack of support for the services at issue in this clinical setting. Upon admission, the patient was experiencing mild post-acute withdrawal symptoms. By 1/21/16, he was not a danger to himself or others. He was medically and psychiatrically stable. There were no emotional, behavioral, cognitive, or impulsive symptoms that would warrant residential level of care. He was motivated as evidenced by his active engagement in all aspects of his treatment. The patient was working on relapse prevention and completion of assignments. He was developing insight and coping mechanisms. He was on anti-craving medication. No new problems had arisen and there was no evidence to indicate that returning him to his environment would lead to destabilization. His family was supportive and participating in his recovery. Although he continued to struggle with his desire to drink and use, further treatment to further solidify coping skills did not require the structured environment of a residential setting. By 1/21/16, he could have been stepped down to a lower level of care. As such, the residential treatment center services from 1/21/16 through 2/4/16 were not medically necessary. 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 |
The patient is a 66-year-old male who presented with anterior mediastinal mass measuring 3.6 cm
mass with calcifications. On 7/10/20, he underwent a computed tomography (CT) guided biopsy
of the mass which revealed no evidence of malignancy with benign thymic tissue.
. The provider has stated his intention of
treating to 70 Gy.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 66-year-old male who presented with anterior mediastinal mass measuring 3.6 cm
mass with calcifications. On 7/10/20, he underwent a computed tomography (CT) guided biopsy
of the mass which revealed no evidence of malignancy with benign thymic tissue. The physician reviewer found that the Current National Comprehensive Cancer Network (NCCN) guidelines state that thymoma should
be treated in 60-70 Gy in 1.8 Gy to 2 Gy fraction sizes. The provider has stated his intention of
treating to 70 Gy. Thus, only 35 fractions are considered medically necessary, which would treat
the patient with 2 Gy per day. There is no benefit to treating this tumor at 1.8 Gy per day which
would prolong the entire treatment course by four fractions. In cases of patients requiring doses of
70 Gy to the mediastinum or chest, it is typically standard to treat in 2 Gy fraction sizes. There is
a lack of medical literature to suggest that treatment with 1.8 Gy per day over 2.0 Gy per day is
associated with improved toxicities or improved outcomes. Consensus group guidelines also
support use of 35 fractions in this setting. Therefore, an additional four fractions (treatment
sessions) of IMRT is not medically necessary for the treatment of this patient.
| 1 |
The patient is a 58-year-old female with osteoporosis of the spine demonstrated on a recent dual-energy x-ray absorptiometry (DEXA). She also has history of hypothyroidism, hypercholesterolemia and breast cancer that has been treated with letrozole. Her provider has recommended Prolia. The patient has requested authorization and coverage for Prolia injection. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
medication. This patient has osteoporosis of the spine. Her risk factors include postmenopausal status, treatment with letrozole, an aromatase inhibitor, and vitamin D deficiency. This patient needs to initiate osteoporosis therapy. This patient is on Synthroid, thyroid hormone replacement, which she must take on an empty stomach. This requirement
requirement to take alendronate on an empty stomach as well.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 58-year-old female with osteoporosis of the spine demonstrated on a recent dual-energy x-ray absorptiometry (DEXA). She also has history of hypothyroidism, hypercholesterolemia and breast cancer that has been treated with letrozole. Her provider has recommended Prolia. The patient has requested authorization and coverage for Prolia injection. 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. This patient has osteoporosis of the spine. Her risk factors include postmenopausal status, treatment with letrozole, an aromatase inhibitor, and vitamin D deficiency. This patient needs to initiate osteoporosis therapy. This patient is on Synthroid, thyroid hormone replacement, which she must take on an empty stomach. This requirement will be affected by the requirement to take alendronate on an empty stomach as well. Additionally, zoledronic acid is frequently associated with a flu-like syndrome post injection, whereas Prolia has rare side effects. Per the medical evidence, Prolia has a better outcome in prevention of spinal fractures as compared to oral bisphosphonates. There is sufficient support for the requested medication in this clinical setting. Thus, the requested Prolia injection 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 |
A 51-year-old female enrollee has requested authorization and coverage for Vemlidy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis B virus.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 51-year-old female enrollee has requested authorization and coverage for Vemlidy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis B virus. The physician reviewer found that according to the American Association or the Study of Liver Disease (AASLD) guidelines for treatment of hepatitis B, tenofovir is the first-line recommended therapy for the treatment of hepatitis B (Terrault, et al). Per AASLD guidelines, the goal of therapy is long term viral suppression, unless there is clear seroconversion, when applicable, and long-term undetectable viral DNA. In addition, the Vemlidy formulation of tenofovir is effective for hepatitis B and associated with fewer adverse effects, including osteopenia compared to Viread (Grant, et al). For these reasons, Vemlidy is supported as medically necessary for the treatment of the patients hepatitis B infection.
For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old female enrollee has requested reimbursement for air and ground ambulance transportation services provided on 4/1/17. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees stage IV squamous cell carcinoma with significant functional decline.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 59-year-old female enrollee has requested reimbursement for air and ground ambulance transportation services provided on 4/1/17. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees stage IV squamous cell carcinoma with significant functional decline. The physician reviewer found the air and ground ambulance transportation services provided on 4/1/17 were not medically necessary for treatment of the patients medical condition. There is a lack of support in the peer-reviewed medical literature for the services at issue in this clinical setting. In this case, hospice services were available for the patient in California. The request for air and ground transportation to New Jersey to be closer to family support was not medically necessary for treatment of the patients medical condition. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 49-year-old female enrollee has requested reimbursement for polymerase
chain reaction (PCR) testing performed on 4/29/19. The Health Insurer has
denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 49-year-old female enrollee has requested reimbursement for polymerase
chain reaction (PCR) testing performed on 4/29/19. 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 for a patient who presents with
symptoms of abnormal vaginal discharge, an examination of the vaginal
discharge including microscopic evidence of infection can lead to a
definitive diagnosis. In the case where microscopy is not available,
commercial diagnostic testing methods, including PCR testing, are used
for confirming the clinical suspicion of bacterial vaginosis, vaginal
candidiasis, or trichomonas vaginitis. Furthermore, PCR testing be
can
utilized for detecting both gonorrhea and chlamydia. Microscopy is no
longer widely available in clinic settings, and practices are now relying
on this testing to diagnose and treat vaginitis. Current studies reported
sensitivities and specificities of over 96 percent for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis. Therefore, PCR testing
performed on 4/29/19 was likely to have been more beneficial than any
available standard therapy.
| 0 |
The patient is a 60-year-old female who has a long history of migraines and facial pain. The patient has requested authorization and coverage for cervical spine MRI. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of this patient.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 60-year-old female who has a long history of migraines and facial pain. The patient has requested authorization and coverage for cervical spine MRI. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that headaches are a common clinical presentation and often present the patient and the medical practitioner with an issue of when to obtain imaging. Multiple organizations have tried to address this dilemma and have published guidelines. The American College of Radiology has published aAppropriateness Criteriaa for various clinical presentations in order to help guide the practitioner in the most efficacious use of imaging. One of these guidelines is titled aHeadachea, and it is divided into various clinical presentations. The one most closely applicable to this patient is Variant 6, aChronic headache. No new features. No neurologic deficit. Initial imaging.a In this variant, imaging is not recommended. Specifically, MRI is felt to be ausually not appropriatea. Evans and colleagues noted, aIt is not necessary to do neuroimaging in patients with headaches consistent with migraine who have a normal neurologic examination.a Holle and colleagues noted,
aUsually, neuroimaging is not required in patients with episodic migraine who present with typical headache features according to the classification of the International Headache Society (IHS)aand normal neurologic examination. A meta-analysis of studies with migraine patients showed that in cases with normal neurologic examination and a typical clinical presentation significant brain pathology was only detected in 0.18% of the patients. Therefore, neuroimaging is usually unnecessary in these patients.a There is a lack of support for the requested services in this clinical setting. Therefore, the requested cervical spine MRI is not medically necessary for the evaluation of this patient.
| 1 |
A 40-year-old female enrollee has requested authorization and coverage for thermal destruction
of intraosseous basivertebral nerve. The Health Insurer has denied this request indicating that
the requested services are considered investigational for treatment of the insureds spondylosis
without myelopathy or radiculopathy, lumbar region.
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Overturned
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Experimental
|
Summary Reviewer 2
A 40-year-old female enrollee has requested authorization and coverage for thermal destruction
of intraosseous basivertebral nerve. The Health Insurer has denied this request indicating that
the requested services are considered investigational for treatment of the insureds spondylosis
without myelopathy or radiculopathy, lumbar region. The physician reviewer found that when
Modic changes are present in the disc spaces, the vertebrogenic source is considered an etiology
of a patients chronic back pain. To address this issue, ablation of the basivertebral nerve has
been demonstrated to be a safe and effective procedure that is evidence-based for appropriately
selected candidates. One study noted that based on the U.S. Preventative Task Force (USPSTF)
criteria for grading evidence, basivertebral nerve ablation has Level A grade evidence with high
certainty that the net benefit is substantial in appropriately selected individuals (Sayed, et al.).
Furthermore, a prospective, randomized, multicenter study by Khalil and colleagues highlighted
that basivertebral nerve ablation led to significant improvement of pain and function at three- months in patients with chronic vertebrogenic related low back pain. In terms of long-term
results, Fischgrund and colleagues demonstrated basivertebral nerve ablation was associated
with sustained clinical improvements in pain and improvement in function at a mean of 6.4 years
following treatment. Standard therapies in this instance would be conservative care with physical
therapy, medications, and procedural interventions such as lumbar medial branch
radiofrequency ablation. On review of this patients records, she has failed to improve despite
adequate attempts at conservative therapies. Given these findings, the requested thermal
destruction of intraosseous basivertebral nerve is likely to be more beneficial for treatment of
the patients medical condition than any available standard therapy.
| 1 |
A 65-year-old male enrollee has requested reimbursement for collagen crosslink testing performed on 7/11/15. 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 3
A 65-year-old male enrollee has requested reimbursement for collagen crosslink testing performed on 7/11/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue. This patient has received Prolia. In this clinical setting, a dual-energy x-ray absorptiometry (DEXA) scan is appropriate to monitor therapy. The value of monitoring therapy with the use of biochemical markers of bone turnover is controversial. This is a test that can be variable and subject to timing, dietary intake and lack of assay standardization. In sum, collagen crosslink testing performed on 7/11/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 38-year-old male enrollee has requested authorization and coverage for chemotherapy administration into the peritoneal cavity via indwelling port or catheter (hyperthermic intraperitoneal chemotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
|
Upheld
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Experimental
|
Summary Reviewer 3
A 38-year-old male enrollee has requested authorization and coverage for chemotherapy administration into the peritoneal cavity via indwelling port or catheter (hyperthermic intraperitoneal chemotherapy. 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 sufficient support for the requested services in this clinical setting. Hyperthermic intraperitoneal chemotherapy has followed debulking surgery in many of the series that have been published with good results. In one randomized clinical trial by Verwaal and colleagues, cytoreduction followed by hyperthermic intraperitoneal chemotherapy improved survival in peritoneal carcinomatosis of colorectal origin. The results were the same after an eight-year follow-up report. In sum, the requested hyperthermic intraperitoneal chemotherapy is likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
An 18-year-old transgender female enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 11/19/17 through 3/08/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
score of 1. The medical records indicated that the patient was not actively suicidal.
The patient had some issues with level of function due to mental illness and relational issues, but overall showed appropriate daily functioning while in treatment.
The patient was noted to have strained relationship with family and indicated some mild stress at home.
The patient
had some outpatient mental health therapy prior to residential admission but continued to have symptoms of anxiety.
|
Upheld
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Medical Necessity
|
Summary Reviewer
An 18-year-old transgender female enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 11/19/17 through 3/08/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based instrument such as American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) assists in determining the necessary level of care for children. In terms of risk of harm, the records support a score of 1. The medical records indicated that the patient was not actively suicidal. With regards to functional status, the records support a score of 2. The patient had some issues with level of function due to mental illness and relational issues, but overall showed appropriate daily functioning while in treatment. In terms of comorbidity, the records support a score of 1. The patient did not have a history of active serious medical issues or substance use. In terms of level of stress of the recovery environment, the records support a score of 2. The patient was noted to have strained relationship with family and indicated some mild stress at home. With regards to level of support of the recovery environment, the records support a score of 2. The patients parents were involved in treatment. In terms of resiliency and treatment history, the records support a score of 3. The patient
had some outpatient mental health therapy prior to residential admission but continued to have symptoms of anxiety. With regards to acceptance and engagement of the patient, the records support a score of 2. The patient participated in therapy. In terms of acceptance and engagement of the parents, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Thus, the patient has a composite score of 15. This score correlates with outpatient services. Therefore, residential mental health treatment from 11/19/17 through 3/08/18 were not medically necessary for the treatment of this patient.
| 1 |
The parent of a nine-year-old female enrollee has requested reimbursement and prospective authorization and coverage for 33 hours per week of applied behavioral analysis (ABA) therapy provided from 5/18/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder (ASD).
|
Overturned
|
Medical Necessity
|
Summary Reviewer
The parent of a nine-year-old female enrollee has requested reimbursement and prospective authorization and coverage for 33 hours per week of applied behavioral analysis (ABA) therapy provided from 5/18/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder (ASD). The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the services at issue. ABA has been shown in the medical literature to be effective for children and preschoolers with autism spectrum disorders. Reichow and colleagues performed a review showing that early intensive behavioral intervention is effective to increase IQ, improve communication and adaptive skills. In addition, Mohammadzaheri and colleagues examined the use of ABA and pivotal response treatment in school age children with autism and disruptive behavior. The authors found these interventions to be very effective in decreasing maladaptive and disruptive behaviors even in school age children. Based on the documentation submitted for review, the patient presents with behaviors of pica and mouthing non-food items, which can be dangerous. The mouthing of non-food items can lead to infections and also to bezoar, impactions, and other events requiring surgical intervention. Furthermore, this patient has made slow progress with her current level of services in adaptive, communication and behavioral domains. Based on the documentation submitted for review a decrease in ABA hours is not indicated. Self-injury is primarily improved with communication skills. The research study by Richards and colleagues showed that the children with the worse self-injury had higher levels of autism symptoms and lower levels of communication skills. The most effective intervention for pica and to prevent surgical interventions is behavioral interventions. Based on the support in the peer-reviewed literature and the severity of the patients behaviors, the request for 33 hours per week of ABA was and is medically necessary for treatment of the patients medical condition.Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
A 64-year-old male enrollee has requested reimbursement for the LifeVest provided from 3/31/17 forward. The Health Insurer has denied this request indicating that the device at issue was and is considered investigational for treatment of the enrollees myocardial infarction and congestive heart failure.
the patient presents status post acute myocardial infarction leading to a reduction in left ventricular ejection fraction to 20-25%.
|
Upheld
|
Medical Necessity
|
Summary Reviewer 2
A 64-year-old male enrollee has requested reimbursement for the LifeVest provided from 3/31/17 forward. The Health Insurer has denied this request indicating that the device at issue was and is considered investigational for treatment of the enrollees myocardial infarction and congestive heart failure. The physician reviewer found that based on the records provided, the patient presents status post acute myocardial infarction leading to a reduction in left ventricular ejection fraction to 20-25%. In this circumstance, there is potential for recovery of left ventricular function over time with medical therapy and there was no indication for immediate placement of a defibrillator such as sustained or inducible ventricular tachycardia, syncope or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until approximately 90 days have elapsed where continued left ventricular dysfunction with an ejection fraction of 35% or less is documented to persist in spite of appropriate treatment (Russo, et al). A prophylactic defibrillator before this time has not been demonstrated to improve outcome (Hohnloser, et al; Steinbeck, et al). Also, studies evaluating wearable defibrillators during periods of increased risk where criteria for implantable defibrillators have not yet been met are largely comprised of registry data without adequate control groups (Chung, et al). At this time, a prophylactic wearable external defibrillator would be indicated only if accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed, needed to be significantly delayed or required explantation. Thus, in this clinical setting, the LifeVest provided from 3/31/17 forward was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the device at issue was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 60-year-old female enrollee has requested reimbursement for the gene test (gene expression profiling) CPT 84999 performed on 12/29/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees melanoma.
|
Upheld
|
Experimental
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Summary Reviewer 2
A 60-year-old female enrollee has requested reimbursement for the gene test (gene expression profiling) CPT 84999 performed on 12/29/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that in this clinical setting, the standard protocol for an intermediate thickness tumor does not include a work-up with molecular genetic testing. Although gene expression testing has shown some impressive results in predicting risk of metastasis, there is no set change in treatment protocol based on the findings. The standard of care in this clinical setting would be a wide local excision and a sentinel node biopsy and the decision to pursue medical treatment would be based on the results of these tests. There are no clinical studies at this time that show that the results of the molecular testing will make a difference in the treatment of the patient. As such, the gene test (gene expression profiling) CPT 84999 performed on 12/29/16 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.
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A 22-year-old male enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation (TMS) provided from 9/21/16 forward. The Health Insurer has denied this request indicating that the service at issue was not and is not medically necessary for treatment of the enrollees major depressive disorder.
In this case, the patient has had multiple relapses. He had trialed many medications and psychotherapies with no improvement. He had responded well to TMS maintenance therapy and the treatment was recommended by his treating clinical providers.
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Overturned
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Medical Necessity
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Summary Reviewer
A 22-year-old male enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation (TMS) provided from 9/21/16 forward. The Health Insurer has denied this request indicating that the service at issue was not and is not medically necessary for treatment of the enrollees major depressive disorder. The physician reviewer found in this case, continued TMS was and is medically necessary for treatment of the patients medical condition. The Clinical TMS Society recommends considering continuation or maintenance TMS therapy when other established methods of maintenance antidepressant therapy fail to provide a satisfactory sustained pattern of clinical benefit or a patient has a history of frequent relapse (Perera, et al). In addition, several naturalistic studies have demonstrated good tolerability and clinical efficacy of TMS therapy for treatment courses at long-term follow-up (Dunner, et al; Janicak, et al). In this case, the patient has had multiple relapses. He had trialed many medications and psychotherapies with no improvement. He had responded well to TMS maintenance therapy and the treatment was recommended by his treating clinical providers. Thus, it is reasonably expected that the patient will continue to benefit from TMS sessions. Further, there is no evidence suggesting that ongoing TMS would be unsafe. Based on the medical literature, TMS sessions not to exceed two per week for a period of six months and then clinical re-evaluation is appropriate. As such, TMS provided from 9/21/16 forward was and is medically necessary for treatment of the patients major depressive disorder. Therefore, the service at issue was and is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 57-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 12/17/15 and 1/12/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk for breast cancer.
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Overturned
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Experimental
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Summary Reviewer 3
A 57-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 12/17/15 and 1/12/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that there is a lack of peer-reviewed literature that supports the use of three dimensional breast tomosynthesis compared to currently available techniques, especially in a patient without an increased risk of breast cancer. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in the peer-reviewed medical literature. For these reasons, the breast tomosynthesis provided on 12/17/15 and 1/12/16 were 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.
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A 23-year-old female enrollee has requested reimbursement for the E0835 - RR continuous passive motion exercise device provided on 9/28/16. The Health Insurer has denied this request indicating that the device at issue is considered investigational for treatment of the enrollees status post right knee surgery.
. In this case, the patient presented with a chondral lesion of the medial facet of the patella and the lateral portion of the trochlea as well as an avulsion fracture
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Upheld
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Experimental
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Summary Reviewer 2
A 23-year-old female enrollee has requested reimbursement for the E0835 - RR continuous passive motion exercise device provided on 9/28/16. The Health Insurer has denied this request indicating that the device at issue is considered investigational for treatment of the enrollees status post right knee surgery. The physician reviewer found that although continuous passive motion is not routinely recommended, the device at issue was clinically indicated for this patient. In this case, the patient presented with a chondral lesion of the medial facet of the patella and the lateral portion of the trochlea as well as an avulsion fracture increasing the likelihood of postoperative arthrofibrosis and stiffness. Continuous passive motion devices have the potential to improve the histological content as well as the rate and volume of chondrogenesis in repair tissue following chondral injury. The use of continuous passive motion can improve the outcomes of cartilage restoration procedures. Furthermore, this patients need for medial patellofemoral ligament reconstruction was associated with additional articular damage as well as an avulsion fracture which would have likely increased the possibility of arthrofibrosis after surgery. As such, the use of the continuous passive motion device starting 9/28/16 was appropriate, reasonable, and likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the device at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 51-year-old female enrollee has requested reimbursement for continued inpatient stay from 7/02/19 through 7/15/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
The patient had an unstable pathologic cervical spine fracture of T1. She underwent the posterior decompression and stabilization procedure on 6/20/19. She underwent the anterior portion of the procedure on 7/16/19. The patient was hospitalized during the entire period from 6/19/19 through 7/25/19. During her stay, and up until the secondary stabilization procedure of 7/16/19, she had an unstable fracture.
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Overturned
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Medical Necessity
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Summary Reviewer
A 51-year-old female enrollee has requested reimbursement for continued inpatient stay from 7/02/19 through 7/15/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The patient had an unstable pathologic cervical spine fracture of T1. She underwent the posterior decompression and stabilization procedure on 6/20/19. She underwent the anterior portion of the procedure on 7/16/19. The patient was hospitalized during the entire period from 6/19/19 through 7/25/19. During her stay, and up until the secondary stabilization procedure of 7/16/19, she had an unstable fracture. It is for this reason that the patient remained in hospital. This was the safest and most expeditious way to maintain control of both the patients spine as well as her overall health. The medical evidence supports the services at issue in this clinical setting. Therefore, continued inpatient stay from 7/02/19 through 7/15/19 was medically necessary for the treatment of this patient.
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A 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 36-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 11/21/19. 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 may add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. Gerami reported on 217 cases, with good correlation between DecisionDx-Melanoma class and prognosis, in patients who had undergone sentinel node biopsy. There are two very important decisions to be made in the treatment of cutaneous melanoma. The first is whether to do a sentinel node biopsy. There is good acceptance that if the melanoma has a thickness of at 0.8 mm or more, sentinel node should be done. This applies in this case with a thickness of 1.05 mm. DecisionDx-Melanoma testing would not affect this decision. It is unknown whether this patient has had sentinel node done. The next important clinical decision is whether to give adjuvant therapy. For the most part, this is based on the result of sentinel node biopsy, with a positive node being an indication for such therapy. Again, DecisionDx-Melanoma testing has not been shown to be useful in this decision. Furthermore, it is not clear how the five-year DecisionDx-Melanoma testing data compares to the ten-year Balch data. The National Comprehensive Cancer Network does not recommend the use of genomic assays in this setting Therefore, DecisionDx-Melanoma testing performed on 11/21/19 was not likely to have been more beneficial than other available standard therapy.
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