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text stringlengths 60 2.6k	decision stringclasses 2 values	appeal_type stringclasses 8 values	full_text stringlengths 206 13.1k	sufficiency_id int64 0 1
A 53-year-old female enrollee has requested authorization and coverage for foam sclerosant/endovenous ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.	Overturned	Experimental	Summary Reviewer 1 A 53-year-old female enrollee has requested authorization and coverage for foam sclerosant/endovenous ablation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports a portion of the requested services. The records noted a plan for a large number of procedures, each performed on isolated days. No medical reason for performing each procedure on isolated days is documented. These procedures have been requested without documentation of a plan to reassess the patient after initial procedures. However, there is documentation of symptomatology that is impacting this patients daily activities despite the use of compression stockings. There is documentation of truncal superficial venous reflux as well as absence of deep vein thrombosis in the presence of palpable pedal pulses. Therefore, the documentation supports bilateral greater saphenous vein ablation and one session of sclerotherapy per leg, although the truncal ablation and sclerotherapy for each leg should be performed on the same day. The records support a total of two days of service (one day for each leg). Anything performed after the first of service for each leg would require clear documentation of failure of the approved procedures to improve symptomatology with documentation of continued activity limiting symptoms despite the regular use of compression stockings. In sum, bilateral greater saphenous vein ablation and one session of sclerotherapy per leg are likely to be superior over other available treatment options.	0
A 22-year-old male enrollee has requested reimbursement for surgical treatment of femoroacetabular impingement syndrome performed on 12/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees hip pain. gen and colleagues reported that a cohort of 86 competitive baseball players undergoing femoroacetabular impingement surgery had 88% return-to-sport rate. In this case, the patient had insidious onset of symptoms for greater than six months prior to surgical treatment. There is documented	Overturned	Experimental	Summary Reviewer 2 A 22-year-old male enrollee has requested reimbursement for surgical treatment of femoroacetabular impingement syndrome performed on 12/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees hip pain. The physician reviewer found that femoral and/or acetabular bone can develop rough edges or an irregular shape, which can subsequently impinge against the bone and soft tissues, causing tendon/labral/capsular damage. It has been theorized that by shaving and contouring the bony prominences, surgeons might protect patients from further injury and prevent additional arthritic progression. Short-term results showed that individuals with greater than 2 mm of joint space might expect some improvement in pain and function after hip arthroscopy for femoroacetabular impingement. Degen and colleagues reported that a cohort of 86 competitive baseball players undergoing femoroacetabular impingement surgery had 88% return-to-sport rate. In this case, the patient had insidious onset of symptoms for greater than six months prior to surgical treatment. There is documented evidence of a failed conservative management program to include intraarticular corticosteroid injection, activity modification and a formal course of physical therapy. The records documents well-preserved joint space and radiographic findings consistent with femoroacetabular impingement. While the literature is lacking high-quality randomized controlled trials, there is a propensity of studies consistently demonstrating benefit in this clinical setting (young age, no advanced degenerative changes on imaging and classic physical examination findings with corroborating imaging). Except for hip arthroplasty, which should be the option of last resort in a patient of this age, there was a lack of other reasonable treatment interventions which have been shown to be efficacious. There is sufficient support for the services at issue in this patients case. In sum, surgical treatment of femoroacetabular impingement syndrome performed on 12/23/15 was likely to have been more effective than other treatment alternatives. 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 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.	Upheld	Experimental	Summary Reviewer 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. The physician reviewer found that Homocysteine testing is not recommended as part of the investigation for pregnancy loss. In order to initiate an investigation for pregnancy loss, there should be a demonstration of recurrence. This patient has not had recurrent pregnancy loss. Even in the case of recurrent pregnancy loss, checking the level of homocysteine is not recommended. There is no clinical utility to this evaluation. All woman are advised to take adequate folate in the form of diet or supplement. The homocysteine level would not impact this recommendation. Therefore, homocysteine testing provided on 6/05/18 and 7/16/18 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 52-year-old male requested authorization and coverage for hypoglossal stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea.	Upheld	Experimental	Summary Reviewer 3 A 52-year-old male requested authorization and coverage for hypoglossal stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that there are multiple references supporting the efficacy of hypoglossal stimulator in this clinical setting. However, further studies comparing this intervention with conventional therapies are needed to definitively evaluate outcomes (Certal et al). In this patients case, there is a lack of records that indicates other procedures have been tried and failed. The provider does suggest that the patient would meet clinical criteria for consideration of hypoglossal nerve stimulator therapy for improvement of the symptoms of snoring and apnea. However, the records do not indicate that this patient has undergone other methods of management. Specifically, other surgical procedures have not been attempted such as improvement of the nasal airway with turbinate reduction and possible nasal septal reconstruction. These methods have not been shown to improve sleep apnea, but can improve tolerance to nasal CPAP therapy. Additionally, the patient may be a candidate for other traditional oropharyngeal surgery such as uvulopalatopharyngoplasty with tonsillectomy which may improve this patients symptoms. In summary, hypoglossal stimulator is not likely to be more effective than conventional therapies for treatment of this patients medical condition.Therefore, for the reasons stated above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.	1
A 50-year-old female enrollee has requested authorization and coverage for Aimovig. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. this patient has a history of migraines. She has already been on several nonspecific oral preventives for migraines. In this patients case, she reported that she experiences five to six migraines per month. addition, the Health Insurer noted that the patient was started on Aimovig 140 mg.	Overturned	Medical Necessity	Summary Reviewer A 50-year-old female enrollee has requested authorization and coverage for Aimovig. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient has a history of migraines. She has already been on several nonspecific oral preventives for migraines. The medical evidence support the use of Aimovig for the preventive management of migraines in adults. Per American Headache Society guidelines, prevention is warranted for people with three migraine days monthly. In this patients case, she reported that she experiences five to six migraines per month. Guidelines also noted that individuals who fail greater than two prior preventives are appropriate for calcitonin gene-related peptide (CGRP) therapies. She meets this guidance. In addition, the Health Insurer noted that the patient was started on Aimovig 140 mg. Review of the data regarding Aimovig reveals that this is a more effective dose than 70 mg. It is appropriate to start patients on what is likely to be most effective as a standard part of clinical care. Therefore, Aimovig (erenumab-aooe subcutaneous solution auto-injector 140 mg/mL) is medically necessary for the treatment of this patient.	1
A 52-year-old female enrollee has requested reimbursement for gene testing (unlisted multianalyte assay with algorithmic analysis) performed on 12/21/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.	Upheld	Experimental	Summary Reviewer 2 A 52-year-old female enrollee has requested reimbursement for gene testing (unlisted multianalyte assay with algorithmic analysis) performed on 12/21/18. 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 this patient has an early stage melanoma. Per the National Comprehensive Cancer Network guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. All told, gene testing (unlisted multianalyte assay with algorithmic analysis) performed on 12/21/18 was not likely to have been more beneficial than other methods of evaluating this patient.	0
A 58-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Assay testing provided on 4/24/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.	Overturned	Experimental	Summary Reviewer 3 A 58-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Assay testing provided on 4/24/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the National Comprehensive Cancer Network (NCCN) guidelines indicate that genetic testing such as the DecisionDx-Melanoma Gene Assay should not be used outside of a clinical trial setting. The use of this type of testing is not considered to be standard of care in the evaluation of this patients melanoma. Moreover, the DecisionDx-Melanoma Gene Assay is not expected to impact the treatment or outcome of this patients melanoma. All told, the DecisionDx-Melanoma Gene Assay provided on 4/24/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.	1
The patient is a 47-year-old female who has requested authorization and coverage for Neulasta. She underwent chemotherapy for breast cancer. The patient has requested authorization and coverage for Neulasta. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.	Overturned	Medical Necessity	Summary Reviewer The patient is a 47-year-old female who has requested authorization and coverage for Neulasta. She underwent chemotherapy for breast cancer. The patient has requested authorization and coverage for Neulasta. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the current medical evidence supports the requested medication in this clinical setting. Neulasta has been approved by the U.S. Food and Drug Administration to decrease the incidence of infection (as manifested by febrile neutropenia) in patients with non-myeloid malignancies receiving myelosuppressive cancer chemotherapy associated with a clinically significant incidence of febrile neutropenia. The combination of Adriamycin and cyclophosphamide carries a high risk of neutropenic fever. The standard of care is administration in a dose dense fashion every two weeks with growth factor support with Neulasta. Therefore, Neulasta is medically necessary for the treatment of this patient.	1
A 51-year-old female enrollee has requested reimbursement for hyaluronan knee injections performed on 12/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees osteoarthritis.	Overturned	Medical Necessity	Summary Reviewer A 51-year-old female enrollee has requested reimbursement for hyaluronan knee injections performed on 12/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees osteoarthritis. The physician reviewer found that there is adequate evidence that intraarticular hyaluronic acid injections reduce pain and increase function in knee osteoarthritis, and the benefits are long-lasting as compared with intraarticular corticosteroids. Maheu and colleagues conducted a systematic review of overlapping meta-analyses comparing viscosupplementation with other non-operative treatment modalities for knee osteoarthritis. The authors reported that the current highest level of evidence suggests that intraarticular hyaluronic acid is a viable option for patients with knee osteoarthritis which results in improvements in knee pain and function that can persist for up to 26 weeks. Viscosupplementation has a good safety profile, and its use should be considered in patients with knee osteoarthritis. All told, the hyaluronan knee injections performed on 12/6/17 were medically necessary for treatment of this patients medical condition. Based on the foregoing, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.	1
A 47-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 8/26/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.	Upheld	Experimental	Summary Reviewer 1 A 47-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 8/26/21. 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 the use of 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. Commercially available GEPs, such as DecisionDx-Melanoma testing, are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, 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, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Various (mostly retrospective) studies of prognostic GEP testing suggest its role as an independent predictor of worse outcome, although not superior to Breslow thickness or sentinel lymph node status. It remains unclear whether this GEP profile is reliably predictive of outcome 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. Therefore, DecisionDx-Melanoma testing performed on 8/26/21 was not likely to have been more beneficial than any available standard therapy.	0
The parent of a 17-year-old female enrollee has requested reimbursement for residential treatment services provided from 8/26/15 through 12/31/16. 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.	Upheld	Medical Necessity	Summary Reviewer The parent of a 17-year-old female enrollee has requested reimbursement for residential treatment services provided from 8/26/15 through 12/31/16. 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 the submitted documentation fails to demonstrate the medical necessity for the services at issue in this clinical setting. The Child and Adolescent Level of Care Utilization System (CALOCUS) is an accepted national standard for determining the appropriate level of care for children and adolescents. According to the CALOCUS criteria, this patients risk of harm is scored as a 3, significant risk of harm. The patient has a history of cutting, but she has not had any cutting since ninth grade. The parent had reported that the patient has had prior suicide attempts. The patient had been researching on the internet about suicide and wrote a suicide poem in January 2015. However, the RTC provider noted that she started having suicidal ideation in the 8th grade with the last reported suicidal ideation some time last year. It does not appear that she had presented suicidal ideations while at RTC. The patients functional status is scored a 3, moderate functional impairment. The patient graduated from a school that required accommodations due to learning impairments. The patient has some conflictual relationships with her family but is able to engage in interpersonal relationships. Recent gains in functioning have been achieved while participating in a structured setting. Her co-morbidity is assessed at a 3, significant co-morbidity. The patient has a co-morbidity of bipolar disorder, ADHD, learning disabilities, and emotional lability. Her environmental stress is scored a 3, moderately stressful environment. The patient has previously had frequent interpersonal conflicts with her parents. The patient has had prior physical altercations with her parents and have threatened to hurt her twin sister when she was younger. Her environmental support is a 2, supportive environment. The patient has supportive parents who are willing to participate in treatment if asked to do so. Her resiliency is scored a 2, positive response to treatment. The patient has documented improvement with the treatment she received at the wilderness program. Her acceptance and engagement is scored a 2, constructive. The patient is cooperative with treatment. The patient is able to develop a positive relationship with clinicians and care providers. At admission, the patient denied any suicidal or homicidal ideation. The patient reports that her mood had improved since discharging from the wilderness program. The provider felt that the patient was manic because the patient had rapid speech and grandiosity, but then stated that her mania was chronic and not cyclical suggesting it was tied with cognitive processing or personality development. It is noted that the patient was sleeping well and most notes document that the patient will speak rapidly. The provider reports that she her use of rapid speech as a way to accommodate deficits in her auditory memory. It appears there was uncertainty whether the patient was acutely manic at the time of admission or if this was the patients baseline way of communicating. This patients composite score using the CALOCUS criteria is 18. Based on these criteria, the patient would have met criteria for a less restrictive program like an intensive outpatient program (IOP). The patient had shown significant improvement since being discharged from the wilderness program. The records do not support an admission to a RTC level of treatment nor did the records support the length of treatment at a highly restrictive environment from 8/26/15-12/31/16. While this patient required treatment for her bipolar disorder and ADHD, this could have been provided in a less restrictive environment. Accordingly, the residential treatment services provided from 8/26/15 through 12/31/16 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.	0
The patient is a 46-year-old female with severe cervical spondylosis with progressive involvement of C5-6 and C6-7 levels and associated radiculopathy. The patient has requested reimbursement for cervical artificial discectomy performed on 4/13/17. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational.	Overturned	Experimental	Summary Reviewer 1 The patient is a 46-year-old female with severe cervical spondylosis with progressive involvement of C5-6 and C6-7 levels and associated radiculopathy. The patient has requested reimbursement for cervical artificial discectomy performed on 4/13/17. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational. Cervical disc arthroplasty has been approved by the US Food and Drug Administration (FDA) and has been demonstrated preserve some motion and provide decreased incidence of adjacent level disease when compared with anterior cervical discectomy and fusion. The need for revision surgery is also less than anterior cervical discectomy and fusion (Gao, et al; Wu, et al; Radcliff, et al). For these reasons, the cervical artificial discectomy performed on 4/13/17 was 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 surgery 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.	1
A 53-year-old female enrollee has requested authorization and coverage for a transcatheter aortic valve replacement (TAVR). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.	Upheld	Experimental	Summary Reviewer 1 A 53-year-old female enrollee has requested authorization and coverage for a transcatheter aortic valve replacement (TAVR). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that based on current guidelines, including the recent Partner 3 Trial, TAVR is considered superior to surgical aortic valve replacement (SAVR) in low risk patients with severe aortic stenosis. The one-year outcomes showed a significantly lower composite of death, stroke or re-hospitalization. However, as in prior TAVR trials, patients were excluded if they did not have severe aortic stenosis (a transvalvular gradient of at least 40 mmHg) and if the valve was bicuspid, as is the case with this who has a bicuspid valve and a gradient of only 26 mmHg. Therefore, the patient would not meet inclusion criteria in the relevant TAVR trials. Therefore, the requested TAVR is not likely to be more beneficial than other available standard therapy.	1
A 21-year-old female enrollee has requested reimbursement for partial hospitalization program level of care provided form 4/12/19 through 4/26/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.	Upheld	Medical Necessity	Summary Reviewer A 21-year-old female enrollee has requested reimbursement for partial hospitalization program level of care provided form 4/12/19 through 4/26/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based, objective instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. In terms of risk of harm, the records support a score of 1 due to a lack of current suicidal ideation and no self-harming behaviors. With regards to functional status, the records support a score of 2 due to an overall good functional level with appropriate activities of daily living. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to overall medical stability with controlled diabetes and no active substance use. With regards to level of stress of the recovery environment, the records support a score of 2 due to no mention of a stressful recovery environment. In terms of level of support of the recovery environment, the records support a score of 2 due to family support and availability of treatment resources. With regards to treatment and recovery history, the records support a score of 2 due to success in the treatment program with a good level of cooperation and stabilization of symptoms. In terms of engagement and recovery status, the records support a score of 2 due to cooperation in treatment and insight into her need for treatment. Thus, the patient has a composite score of 13. This score correlates with low intensity, community-based services. Therefore, the patient did not meet criteria for partial hospitalization program level of care during the disputed timeframe. In sum, partial hospitalization program level of care provided from 4/12/19 through 4/26/19 was not medically necessary for the treatment of this patient.	0
The parent of a 16-year-old female enrollee has requested authorization and coverage for Rituxan. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition.	Upheld	Experimental	Summary Reviewer 3 The parent of a 16-year-old female enrollee has requested authorization and coverage for Rituxan. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the use of Rituxan in this case is not likely to be more beneficial than the available standard therapy. According to the 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis, biologic medications available to treat children with juvenile idiopathic arthritis include Actemra, Enbrel, Humira, and Orencia after failure of standard DMARD therapy. According to the Rituxan prescribing information, it is indicated for the treatment of rheumatoid arthritis in combination with methotrexate in adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies. This patient has failed a single biologic therapy according to the medical records. There are other options that are considered a standard of care in this case, including Orencia intravenous or subcutaneous, Actemra intravenous or subcutaneous, or Enbrel. These medications are indicated for juvenile idiopathic arthritis. There is no data available to suggest that this patient would respond more to Rituxan as opposed to the biologic medications that are approved for juvenile idiopathic arthritis. Thus, Rituxan is not likely to be more beneficial than other available standard therapy.	1
patient is a 50-year-old female with ZZ phenotype severe alpha-1-antitrypsin deficiency. The patient has requested authorization and coverage for Prolastin-C 1,000 mg/20 ml (J0256).	Upheld	Medical Necessity	Summary Reviewer The patient is a 50-year-old female with ZZ phenotype severe alpha-1-antitrypsin deficiency. The patient has requested authorization and coverage for Prolastin-C 1,000 mg/20 ml (J0256). The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. Prolastin-C augmentation treatment is not medically indicated because the patient does not have any evidence of airflow obstruction on pulmonary function testing. The GOLD guidelines cited below indicate that patients most likely to benefit from Prolastin-C should have a forced expiratory volume in one second (FEV1) between 35 to 65% of predicted. Therefore, Prolastin-C 1,000 mg/20 ml (J0256) is not medically necessary for the treatment of this patient.	1
A 60-year-old male enrollee has requested reimbursement for positron emission tomography (PET) performed on 3/08/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. this patient exhibited biochemical failure after treatment for prostate cancer as proven by steadily rising PSA levels. Routine imaging was	Overturned	Experimental	Summary Reviewer 1 A 60-year-old male enrollee has requested reimbursement for positron emission tomography (PET) performed on 3/08/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that this patient exhibited biochemical failure after treatment for prostate cancer as proven by steadily rising PSA levels. Routine imaging was unremarkable. In such cases, the use of a tracer to detect prostate cancer specific tissue is the current state of the art evaluation. This determination of site of recurrence is crucial in order to direct definitive treatment. Therefore, PET performed on 3/08/18 was 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 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 37-year-old female enrollee has requested authorization and coverage for lymphaticovenous anastomosis and intraoperative indocyanine green lymphatic mapping. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.	Overturned	Experimental	Summary Reviewer 1 A 37-year-old female enrollee has requested authorization and coverage for lymphaticovenous anastomosis and intraoperative indocyanine green lymphatic mapping. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the proposed procedure has been studied for over a decade, and the peer-reviewed literature supports the benefit of the procedure. Scaglioni and colleagues performed a systematic review of lymphovenous anastomosis for the treatment of lymphedema. The authors noted, aAlthough the studies included in this review showed great heterogeneity, lymphovenous anastomosis surgery revealed both objective and subjective improvements in most patients.a Thomas and colleagues noted, aThe findings suggest that the real impact of living with lymphedema is much more challenging than previously identified. The findings suggest that lymphovenous anastomosis can give a future of greater choice for some of its recipients, but further research should explore longer-term benefits. Lymphovenous anastomosis could offer hope to some people with lymphedema, but a realistic expectation is essential.a There is sufficient support for the requested services in this clinical setting. Therefore, lymphaticovenous anastomosis and intraoperative indocyanine green lymphatic mapping is likely to be more beneficial than other available standard therapy.	1
A 65-year-old female enrollee has requested authorization and coverage for Prolia. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.	Overturned	Medical Necessity	Summary Reviewer A 65-year-old female enrollee has requested authorization and coverage for Prolia. The Health Insurer has denied this request and reported that the requested medication is 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 requested medication. Fractures are the most dangerous aspect of osteoporosis and can lead to acute and chronic pain. A newer medication, denosumab (Prolia) is a fully human monoclonal antibody which has been approved for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and giant cell tumor of bone. Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or for patients who have failed or are intolerant to other available osteoporosis therapy. Therefore, Prolia is medically necessary for the treatment of this patient.	0
The patient is a three-year-old female who was transported by air ambulance from Childrens Hospital in Centennial, Colorado (CHCC) to Childrens Hospital in Millard, Nebraska (CHMC) on 6/30/15. The patient was born with a congenital diaphragmatic hernia on 1/29/15. She was intubated at birth. The patient underwent several surgeries. She remained with severe pulmonary hypertension. Multiple attempts to wean the child from the ventilator failed. It was determined that the patient no longer required the services of a level IV neonatal intensive care unit (NICU). The decision was made to transfer the patient to a level III NICU in Nebraska to be closer to her home. The ambulance was scheduled in advance on 6/29/15. The transport was initiated on 6/30/15, and no adverse events occurred during transport. The Health Insurer has denied reimbursement for air ambulance services provided on 6/30/15. Per the Health Insurer, the services at issue were not medically the patient was being transferred from a level IV NICU to a level III NICU, a	Upheld	Medical Necessity	Summary Reviewer The patient is a three-year-old female who was transported by air ambulance from Childrens Hospital in Centennial, Colorado (CHCC) to Childrens Hospital in Millard, Nebraska (CHMC) on 6/30/15. The patient was born with a congenital diaphragmatic hernia on 1/29/15. She was intubated at birth. The patient underwent several surgeries. She remained with severe pulmonary hypertension. Multiple attempts to wean the child from the ventilator failed. It was determined that the patient no longer required the services of a level IV neonatal intensive care unit (NICU). The decision was made to transfer the patient to a level III NICU in Nebraska to be closer to her home. The ambulance was scheduled in advance on 6/29/15. The transport was initiated on 6/30/15, and no adverse events occurred during transport. The Health Insurer has denied reimbursement for air ambulance services provided on 6/30/15. Per the Health Insurer, the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. Air ambulance services are considered medically necessary under certain circumstances. These circumstances include: the patients condition is such that any other means of transport would be medically contraindicated, the patients condition is such that the time necessary for transport by land poses a threat to the patients health, and the patient is transported to the nearest hospital with appropriate facilities for treatment. All of these criteria must be met in order for air ambulance transport to be medically necessary. In this case, the patient was being transferred from a level IV NICU to a level III NICU, a lower level of care. This transfer was planned in advance, not completed emergently. The patient was transferred to another state in order to be closer to home. There are other NICU facilities closer to CHCC than CHMC. All told, air ambulance services provided on 6/30/15 were 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
A 63-year-old female enrollee has requested reimbursement for unlisted laboratory services provided on 7/02/19 and 1/28/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.	Overturned	Experimental	Summary Reviewer 1 A 63-year-old female enrollee has requested reimbursement for unlisted laboratory services provided on 7/02/19 and 1/28/20. 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 ClonoSEQ assay is a very sensitive genetic assay that can detect very minimal numbers of residual myeloma cells. It is used often in clinical trial situations to determine the efficacy of treatment. Munshi and colleagues performed a meta-analysis, and the assay has been shown to correlate with both progression-free survival and overall survival. It is becoming more commonly used to accurately guide therapy. The National Comprehensive Cancer Network recommends its use. Therefore, unlisted laboratory services provided on 7/02/19 and 1/28/20 were likely to have been more beneficial than other methods of evaluating this patient.	0
A 64-year-old female enrollee has requested reimbursement for collagen crosslinks testing performed on 11/18/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis. In this case, the patient had recently started a new anabolic agent.	Overturned	Experimental	Summary Reviewer 3 A 64-year-old female enrollee has requested reimbursement for collagen crosslinks testing performed on 11/18/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis. The physician reviewer found that Biochemical markers provide a dynamic view of the remodeling process, which covers rate of turnover and pathogenesis, and should improve fracture risk prediction. Furthermore, biochemical markers can be used to monitor the short-term effects of therapy, and indicate if an excessive slowing of the remodeling process is occurring. Suppression of biochemical markers of bone turnover after three to six months of treatment and biochemical marker increases after one to three months of anabolic therapy have been predictive of greater bone mineral density responses and fracture risk reduction in large clinical trials. In this case, the patient had recently started a new anabolic agent. The information derived from collagen crosslinks can be used to determine whether the therapy is working and whether the patient is compliant with therapy. Thus, collagen crosslinks testing performed on 11/18/17 was likely to have been more effective 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
The patient is a 41-year-old male. Notes dated 10/27/21 reported that the patient presented to the hospital on 9/18/21 with acute hypoxemic respiratory failure and sepsis in the setting of COVID- 19 pneumonia. The patient has requested reimbursement for LTACH days from 11/11/21 through 11/13/21. The Health Insurer has denied this request and reported the services at issue were not medically necessary for the treatment of this patient. this case, the patient remained at a very high aspiration risk, highlighted by his witnessed aspiration event on 11/11/21. The LTACH screened the patient for transfer to a lower level of service, the skilled nursing facility (SNF) setting. he was transferred to SNF, the patient continued to receive medically necessary LTACH care, including aggressive mucous clearance and pulmonary hygiene. By 11/13/21, the patients providers had observed him for three days following tracheostomy tube removal and felt more comfortable transferring the patient to the SNF,	Overturned	Medical Necessity	Summary Reviewer The patient is a 41-year-old male. Notes dated 10/27/21 reported that the patient presented to the hospital on 9/18/21 with acute hypoxemic respiratory failure and sepsis in the setting of COVID- 19 pneumonia. The patient has requested reimbursement for LTACH days from 11/11/21 through 11/13/21. The Health Insurer has denied this request and reported 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 supports the medical necessity of the services at issue. In this case, the patient remained at a very high aspiration risk, highlighted by his witnessed aspiration event on 11/11/21. It is not uncommon for patients to fail tracheostomy decannulation in the LTACH setting, as they are at high risk for mucous impaction and aspiration in the days following decannulation. The LTACH screened the patient for transfer to a lower level of service, the skilled nursing facility (SNF) setting. Regardless of the timing of when the patient was accepted to the SNF versus when he was transferred to SNF, the patient continued to receive medically necessary LTACH care, including aggressive mucous clearance and pulmonary hygiene. By 11/13/21, the patients providers had observed him for three days following tracheostomy tube removal and felt more comfortable transferring the patient to the SNF, where less aggressive respiratory support would be available to the patient. Therefore, LTACH days from 11/11/21 through 11/13/21 were medically necessary for the treatment of this patient.	1
A 59-year-old female enrollee has requested reimbursement for the Veracyte Afirma genetic testing provided on 12/3/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule. as this patients initial biopsy report reported suspicious findings but the lesion was not malignant. provider direct treatment and the patient was able to avoid unnecessary surgery.	Overturned	Experimental	Summary Reviewer 3 A 59-year-old female enrollee has requested reimbursement for the Veracyte Afirma genetic testing provided on 12/3/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule. The physician reviewer found that as this patients initial biopsy report reported suspicious findings but the lesion was not malignant. This was a major determining factor in delineating further course of action. Genetic testing with the Veracyte Afirma was indicated in this case as standard protocol on the fine needle aspirate from this patients thyroid nodule. The findings helped the provider direct treatment and the patient was able to avoid unnecessary surgery. Given the current medical literature, the Veracyte Afirma genetic testing performed on 12/3/14 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.	1
A 48-year-old female has requested reimbursement for procedure codes 84999 (DecisionDx-Melanoma) and 99000 performed on 1/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.	Upheld	Experimental	Summary Reviewer 3 A 48-year-old female has requested reimbursement for procedure codes 84999 (DecisionDx-Melanoma) and 99000 performed on 1/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76 to 1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggest 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 the DecisionDx-Melanoma test has not made it part of routine analysis after sentinel lymph node biopsy. There has 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, procedure codes 84999 (DecisionDx-Melanoma) and 99000 performed on 1/25/17 were not likely to have been more effective than other available methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.	0
A 62-year-old male enrollee has requested authorization and coverage for insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.	Overturned	Experimental	Summary Reviewer 3 A 62-year-old male enrollee has requested authorization and coverage for insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator. 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 submitted documentation supports the requested services in this clinical setting. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. Hypoglossal nerve stimulator has been demonstrated to be safe and effective in a small subset of patients with obstructive sleep apnea who have failed continuous positive airway pressure, have nonconcentric airway collapse, an apnea-hypopnea index between 20 and 50, and a body mass index less than 32. This procedure has been approved by the U.S. Food and Drug Administration. With a body mass index of 26.6, apnea-hypopnea index of 19.3 and nonconcentric airway collapse, this patient meets the criteria. He has failed continuous positive airway pressure therapy, which is the gold standard treatment for obstructive sleep apnea. Thus, insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator is likely to be of greater benefit than other treatment options.	1
A 44-year-old female enrollee has requested reimbursement for Prometheus testing performed on 4/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.	Upheld	Experimental	Summary Reviewer 1 A 44-year-old female enrollee has requested reimbursement for Prometheus testing performed on 4/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there are a number of reasons why patients can develop worsening symptoms while on maintenance therapy with a tumor necrosis factor inhibitor. The patients inflammatory pathway may have escaped the influence of tumor necrosis factor. The patient may have the presence of antibodies resulting in below therapeutic levels of the anti-tumor necrosis factor agent. The possibility of Clostridium difficile and other enteric infections also needs to be considered. However, measuring drug levels and their antibodies is problematic. The target drug level for any patient is unknown, and it is likely that the tissue level of drug rather than serum level is most important. Additionally, antibody detection is imprecise. Antibodies are often transient and may not be biologically meaningful in vivo. In sum, the services at issue were not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.	0
A 51-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Assay (CPT code 84999 - unlisted chemistry procedure) provided on 1/17/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.	Upheld	Experimental	Summary Reviewer 2 A 51-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Assay (CPT code 84999 - unlisted chemistry procedure) provided on 1/17/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the National Comprehensive Cancer Network (NCCN) guidelines indicate that genetic testing such as the DecisionDx-Melanoma Assay should not be used outside of a clinical trial setting. The use of this type of testing is not considered to be standard of care in the evaluation of this patients melanoma. Moreover, the DecisionDx-Melanoma Assay is not expected to impact the treatment or outcome of this patients melanoma. All told, the DecisionDx-Melanoma Assay provided on 1/17/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.	1
A 41-year-old male has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The medical records document gastroesophageal reflux disease as based on pH recording. However, it appears he has benefited	Upheld	Experimental	Summary Reviewer 2 A 41-year-old male has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the current medical evidence has not demonstrated the superior efficacy of the requested services in this patients case. The medical records document gastroesophageal reflux disease as based on pH recording. However, it appears he has benefited to a significant degree from acid suppression treatment, and as such cannot be considered medically refractory to acid blocker drugs. Also, implantation of LINX in this clinical setting must be approached with caution given his documented complaints of dysphagia and probable eosinophilic esophagitis. In sum, the requested LINX procedure is not likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.	1
patient is a 66-year-old male who has requested reimbursement for magnetic resonance imaging (MRI) of the pelvis performed on 11/08/21. The patient has requested reimbursement for MRI of the pelvis provided on 11/08/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. the patient had a normal PSA after antibiotic treatment and	Upheld	Medical Necessity	Summary Reviewer The patient is a 66-year-old male who has requested reimbursement for magnetic resonance imaging (MRI) of the pelvis performed on 11/08/21. The patient has requested reimbursement for MRI of the pelvis provided on 11/08/21. 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 the submitted documentation fails to demonstrate the medical necessity of the services at issue. Based on the clinical records, the patient had a normal PSA after antibiotic treatment and normal PSA density. Performing an MRI would not be considered a clinically appropriate or generally accepted standard for management of this patients medical condition. The current medical literature does not support utility of MRI in patients with a normal PSA and PSA density. Therefore, the MRI of the pelvis provided on 11/08/21 was not medically necessary for the evaluation of this patient.	1
A 65-year-old male enrollee has requested reimbursement for gene testing provided on 9/26/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.	Upheld	Experimental	Summary Reviewer 1 A 65-year-old male enrollee has requested reimbursement for gene testing provided on 9/26/18. 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 prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has been thought to add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either class 1 or 2, with class 2 melanomas having a significantly higher rate of recurrence than class 1. Gerami reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma class, in patients who have undergone sentinel node biopsy. Berger reported on 156 cases, but there was insufficient follow-up to determine the real value of the assay. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear if the DecisionDx-Melanoma assay can be used to make clinical decisions. Therefore, gene testing provided on 9/26/18 was not likely to have been superior over other methods of evaluating this patient.	0
A 45-year-old male enrollee has requested authorization and coverage for powered upper extremity range of motion assist device, elbow, wrist, hand and finger. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition.	Upheld	Experimental	Summary Reviewer 2 A 45-year-old male enrollee has requested authorization and coverage for powered upper extremity range of motion assist device, elbow, wrist, hand and finger. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is a lack of support for the requested device in this clinical setting. There is insufficient evidence in the literature that the MyoPro Orthosis will improve the long-term outcomes for this patient, improve his hemiparetic arm function, or be safe for long term use. There is insufficient evidence in the literature that this device will increase his participation in bimanual activities. Winstein and colleagues reviewed the various treatments of motor dysfunction after a stroke. The authors noted that a Cochrane review found that upper limb robotic therapy provided some benefit with regard to activities of daily living and arm function, but not arm muscle strength. The guidelines indicate that these studies were noted to have numerous limitations. These limitations include the variation within the trials with regard to duration and amount of training, the specific devices used, and patient populations studied limit the interpretation of these results. McCabe and colleagues performed a small study that was retrospective with inconsistent timing of testing and limited interpretation. The authors discussed the feasibility and clinical experience of using myoelectric orthosis in rehabilitation of chronic stroke patients. The study used a small patient group and indicated that additional studies are warranted to determine the effectiveness of these methods in the clinical setting. Additional controlled studies of the MyoPro Orthosis for upper extremity paralysis after a stroke are needed with larger patient groups, consistent improvements of relevant outcome functional measures, and long-term follow-up. Therefore, the requested powered upper extremity range of motion assist device, elbow, wrist, hand and finger is not likely to be more beneficial than other methods of evaluating this patient.	1
A 38-year-old male enrollee has requested authorization and coverage for a cardioverter defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee, who has cardiac sarcoidosis. this patient has a history of cardiac sarcoidosis and symptomatic 2:1 atrioventricular block in need of pacemaker placement.	Overturned	Experimental	Summary Reviewer 2 A 38-year-old male enrollee has requested authorization and coverage for a cardioverter defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee, who has cardiac sarcoidosis. The physician reviewer found that this patient has a history of cardiac sarcoidosis and symptomatic 2:1 atrioventricular block in need of pacemaker placement. In this circumstance of cardiac sarcoidosis and ejection fraction greater than 35% with an indication for pacemaker placement, it is reasonable to implant a defibrillator if meaningful survival of greater than one year is expected. Some patients with cardiac sarcoidosis with normal ejection fraction and no heart failure symptoms have high arrhythmic event rates, especially when late gadolinium enhancement is identified on cardiac MRI or abnormal findings are seen on cardiac PET imaging, such as this patient. The medical evidence supports the requested device in this case. Therefore, the requested cardioverter defibrillator is likely to be of greater benefit than other treatment options. 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.	1
A 55-year-old male has requested reimbursement for high-intensity focused ultrasound performed on 8/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer.	Upheld	Experimental	Summary Reviewer 2 A 55-year-old male has requested reimbursement for high-intensity focused ultrasound performed on 8/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that high-intensity focused ultrasound is an evolving technology in the prostate cancer treatment armamentarium. While the minimally invasive nature makes high-intensity focused ultrasound ablation a readily accessible tool, its role in initial therapy of moderate risk disease as monotherapy shows no benefit and potential risk over standard treatment protocols at this time. In sum, high-intensity focused ultrasound performed on 8/14/17 was not likely to have been of greater benefit than other 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 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 patient did not have dense breasts, she did not have a mass, there were no palpable lumps, and she did not have suspicious calcifications.	Overturned	Experimental	Summary Reviewer 3 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 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, by separating the various layers of breast tissue, one can better detect abnormalities. However, in this particular patient, there were no problems to be resolved, the patient did not have dense breasts, she did not have a mass, there were no palpable lumps, and she did not have suspicious calcifications. Thus, a routine mammogram would have been sufficient for evaluation of the patients risk for breast cancer. 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 prior mammograms. Given these findings, the breast tomosynthesis performed on 3/11/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard imaging technique. Based upon the information set forth above, the diagnostic procedure 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 58-year-old male enrollee has requested authorization and coverage for intravenous immune globulin. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees myasthenia gravis. In this case, the patient developed severe myasthenia gravis that failed to respond to several immunosuppressive drugs. The patient has been stable while on intravenous immunoglobulin.	Overturned	Experimental	Summary Reviewer 2 A 58-year-old male enrollee has requested authorization and coverage for intravenous immune globulin. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees myasthenia gravis. The physician reviewer found that there is sufficient support for the requested medication in this clinical setting. There are several reports of non-controlled studies which demonstrated a benefit from the use of intravenous immune globulin in some patients with myasthenia gravis as a maintenance therapy. In this case, the patient developed severe myasthenia gravis that failed to respond to several immunosuppressive drugs. The patient has been stable while on intravenous immunoglobulin. In sum, intravenous immune globulin is likely to be superior over other treatment options in this patients case. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.	1
The parent of a 13-year-old female enrollee has requested reimbursement for emergency medical services provided on 8/02/18. The Health Insurer has denied this request and reported that the services at issue were not required on an emergent basis. The physician reviewer found that this patient presented after a wick, which had been placed following abscess drainage, fell out. The patients mother was concerned that an abscess was re-developing. In most cases, following an incision and drainage of an uncomplicated skin abscess with a wick left in place, the patient is advised to return for packing removal. The patient presented on a Thursday morning. She had no fever or other sign of systemic infection. Her vital signs were normal. The infection had not suddenly worsened or spread.	Upheld	Medical Necessity	Summary Reviewer The parent of a 13-year-old female enrollee has requested reimbursement for emergency medical services provided on 8/02/18. The Health Insurer has denied this request and reported that the services at issue were not required on an emergent basis. The physician reviewer found that this patient presented after a wick, which had been placed following abscess drainage, fell out. The patients mother was concerned that an abscess was re-developing. In most cases, following an incision and drainage of an uncomplicated skin abscess with a wick left in place, the patient is advised to return for packing removal. The patient presented on a Thursday morning. She had no fever or other sign of systemic infection. Her vital signs were normal. The infection had not suddenly worsened or spread. Although the patient may have warranted medical attention, this care could safely have been provided on a non-emergent basis. A patient who has already undergone abscess incision and drainage with recurrent swelling at the site without fever does not meet prudent layperson criteria for an emergency. A prudent layperson in these circumstances would not reasonably expect the absence of emergency care to jeopardize ones health. Therefore, this patients symptoms on 8/02/18 did not meet prudent layperson criteria for emergency care.	1
A 45-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees asthma.	Upheld	Experimental	Summary Reviewer 3 A 45-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees asthma. The physician reviewer found that guidelines for asthma treatment recommend inhaled steroids as first line of therapy for patients with persistent asthma. The patients provider recommends bronchial thermoplasty because the patient has not been able to tolerate standard therapies to treat his medical condition. Moreover, per the records, inhaled steroids may trigger the patients depression. However, studies which demonstrate a link between depression and the use of inhaled steroids are lacking. The amount of steroids which gets into the circulation is very small, and it is unlikely to trigger depression. Also, there are methods to decrease intestinal absorption of inhaled steroids. In sum, this patient has not demonstrated that he has tried and failed standard medications recommended in the asthma guidelines. For these reasons, the requested procedure is not likely to be more efficacious for treatment of this patients medical condition than other alternatives. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.	1
A 44-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral on 7/6/21. The Health Insurer has denied this request and reported that the service at issue was investigational for the treatment of the enrollees bilateral chronic eustachian tube dysfunction.	Overturned	Experimental	Summary Reviewer 2 A 44-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral on 7/6/21. The Health Insurer has denied this request and reported that the service at issue was investigational for the treatment of the enrollees bilateral chronic eustachian tube dysfunction. The physician reviewer found that the standard medical therapies for the treatment of eustachian tube dysfunction include a trial of intranasal steroid therapy and/or oral glucocorticoids. The most widely accepted standard surgical treatment for eustachian tube dysfunction is myringotomy, with or without tube insertion, regarded as relatively safe and effective. While Poe and colleagues along with Meyer and colleagues appear to demonstrate a statistically significant benefit of balloon dilation of the eustachian tube over intranasal steroids and/or oral glucocorticoids, these studies were both limited by small patient pools, lack of blinding, loss to follow up, and a large enough degree of crossover of patients from the control arm to the treatment arm midway through the studies that neither study was able to compare the treatment and control groups at the final follow up. In a study of outcomes through 52 weeks, Anand and colleagues suggested that the beneficial effects of balloon dilation of the eustachian tube and medical management on tympanogram normalization and symptoms of subjects with refractory obstructive eustachian tube dysfunction demonstrated significant durability. There is less data available comparing balloon dilation of the eustachian tube with myringotomy, with or without tube insertion. In a cohort study comparing balloon dilation of the eustachian tube to balloon dilation of the eustachian tube along with adjunctive myringotomy with tube insertion, Chen and colleagues noted a statistically significant difference in post-operative hearing loss between the two groups, favoring balloon dilation of the eustachian tube along with tube placement, but did not identify a statistically significant difference in regards to overall cure rate or effectiveness. Thus, while current medical literature suggests that balloon dilation of the eustachian tube is more efficacious than the standard medical therapies of intranasal steroids and oral glucocorticoids in the management of eustachian tube dysfunction, there is a lack of similar data to suggest that it is a more effective treatment than myringotomy with or without tube placement. Therefore, nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral on 7/6/21 was not likely to have been more beneficial for treatment of the patients condition than any available standard therapy.	1
A 25-year-old female has requested authorization and coverage for intravenous ceftriaxone. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition. This patient has had no arthritis or heart block and has a normal neurological examination.	Upheld	Experimental	Summary Reviewer 3 A 25-year-old female has requested authorization and coverage for intravenous ceftriaxone. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the requested medication in patients case. There is a lack of evidence that this patient has Lyme disease. Late stage Lyme disease does occur, but involves the heart, joints or the central nervous system. This patient has had no arthritis or heart block and has a normal neurological examination. There is also no credible laboratory evidence she has Borrelia infection. Treatment with parenteral antibiotics is not supported by the information provided. Thus, intravenous ceftriaxone is not likely to be of greater benefit than other treatment options. 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