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A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata.
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Overturned
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Experimental
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Summary Reviewer 2
A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata. The physician reviewer found that Alopecia areata is autoimmune in nature and brings psychological manifestations as well as physical. The use of Xeljanz has shown some promise, with better results than any other available standard treatment, other than maybe long-term oral steroids, which are limited by their side effects. In this clinical setting, Xeljanz is likely to offer this patient the safest option to treat her ongoing disease. In sum, Xeljanz 5 mg are likely to be of greater benefit than other treatment modalities. 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.
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A 58-year-old male enrollee has requested authorization and coverage for right shoulder surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
The patient has a history of right shoulder pain associated with an isolated SLAP tear. Non-operative treatment has been tried and failed. The provider is requesting arthroscopy and biceps tenodesis. Cvetanovich and colleagues performed a retrospective query from years 2007 to 2016 for the management of isolated SLAP tears.
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Overturned
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Medical Necessity
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Summary Reviewer
A 58-year-old male enrollee has requested authorization and coverage for right shoulder surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested services in this clinical setting. The patient has a history of right shoulder pain associated with an isolated SLAP tear. Non-operative treatment has been tried and failed. The provider is requesting arthroscopy and biceps tenodesis. Cvetanovich and colleagues performed a retrospective query from years 2007 to 2016 for the management of isolated SLAP tears. The treatments compared included debridement, SLAP repair, open or arthroscopic biceps tenodesis, and SLAP repair combined with biceps tenodesis. The analysis revealed that surgical treatment of isolated SLAP tears in the United States has shifted from 2007 to 2016, with an increase in the frequency of biceps tenodesis and decrease in the frequency of SLAP repair, particularly in patients older than 40 years. A review of the surgical results indicates that biceps tenotomy or tenodesis yields good results in this age group. The article by Fourman and colleagues noted that surgical repair of type VIII SLAP tears in the young athletes led to significant improvements in stability, pain, range of motion, and outcome scores at midterm follow-up, except in throwers in whom the results were not as good. These findings suggest that type VIII SLAP tears should be repaired in young athletes because outcomes do improve. However, in this patients age group, biceps tenotomy or tenodesis remains the procedure of choice. Therefore, the requested right shoulder surgery is medically necessary for the treatment of this patient.
| 1 |
A 29-year-old male enrollee has requested authorization and coverage for Subsys. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 29-year-old male enrollee has requested authorization and coverage for Subsys. 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 this clinical setting. The requested medication is appropriate for breakthrough cancer pain relief. While the patient does have documented chronic pain, he does not have a diagnosis of cancer. The medical evidence does not support Subsys for the treatment of this patients condition. Therefore, Subsys is not likely to be more efficacious 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.
| 0 |
A 50-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 8/19/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees thin melanoma.
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Upheld
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Experimental
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Summary Reviewer 3
A 50-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 8/19/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees thin melanoma. The physician reviewer found that melanoma staging is characterized by the American Joint Committee on Cancer (AJCC). While the majority of clinical stage I patients will be disease-free at five years, some stage I patients will develop advanced disease. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin exams and clinical examination. The DecisionDx melanoma gene expression profile (GEP) test is an expression assay designed to predict distant metastasis in stage I and stage II melanoma patients. DecisionDx melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as class 1 consistent with a low risk of metastasis or class 2 suggestive of a high risk of metastasis. One peer-reviewed publication indicated that there was a statistically significant association of a class 1 signature by DecisionDx melanoma assay for primary dermal melanoma (PDM), whereas cutaneous metastatic melanoma (CMM) were more frequently class 2 (Sidiropoulos, et al). The authors concluded that the melanoma prognostic assay may be a useful tool for distinguishing PDM from CMM. However, there is a lack of peer-reviewed published studies confirming improved health outcomes with use of this assay over standard testing. Thus, the DecisionDx melanoma assay provided on 8/19/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 50-year-old female enrollee has requested authorization and coverage for ultrasound ablation. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees uterine fibroids.
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Upheld
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Experimental
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Summary Reviewer 1
A 50-year-old female enrollee has requested authorization and coverage for ultrasound ablation. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees uterine fibroids. The physician reviewer found the request for ultrasound ablation is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Although there is some medical literature that suggests MR-guided high intensity focused ultrasound is a promising technique, there is a lack of peer-reviewed literature that shows increased effectiveness of this technique compared to other currently available minimally invasive techniques, such as uterine fibroid embolization. In addition, there is a lack of documentation provided that indicates that patient would not be a suitable candidate for uterine fibroid embolization or other traditional standard of care treatments. For these reasons, the requested procedure 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 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 41-year-old male has requested reimbursement for a wearable cardioverter defibrillator. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees non-ischemic cardiomyopathy.
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Upheld
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Experimental
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Summary Reviewer 3
A 41-year-old male has requested reimbursement for a wearable cardioverter defibrillator. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees non-ischemic cardiomyopathy. The physician reviewer found the medical records fail to demonstrate the superior efficacy of the device at issue in this clinical setting. In this circumstance, there is potential for recovery of left ventricular function over time with medical therapy, and there was no documented 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 a period of time greater than 90 days where continued left ventricular dysfunction (ejection fraction less than or equal to 35%) is documented to persist despite of appropriate treatment. A prophylactic defibrillator, either wearable or implantable, before this time has not been demonstrated to improve outcome. At this time, prophylactic wearable external defibrillator would be indicated only if accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed, needed to be significantly delayed (due to infection, for example) or required explantation. Per the current evidence, the wearable cardioverter defibrillator was not likely to have been of greater benefit than other treatment options. Based upon the information set forth above, 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.
| 1 |
The parent of a 14-year-old male enrollee has requested authorization and coverage for the ReWalk Exoskeletal Device durable medical equipment (DME). The Health Insurer has denied this request indicating that the requested equipment is investigational for treatment of the enrollees T8 incomplete spinal cord injury due to spinal tumor.
Asselin and colleagues reported that paraplegic patients were able to ambulate efficiently using the powered exoskeleton for overground ambulation, providing the potential for functional gain and improved fitness. The clinical documentation submitted for review indicated the patient had a spinal cord injury due to a cancerous tumor. The patients cancer was in remission. The patient was in a wheelchair. The patient had reduced lung capacity. The patient had a successful trial of the unit with an improved ability to ambulate and to transfer from one position to
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a 14-year-old male enrollee has requested authorization and coverage for the ReWalk Exoskeletal Device durable medical equipment (DME). The Health Insurer has denied this request indicating that the requested equipment is investigational for treatment of the enrollees T8 incomplete spinal cord injury due to spinal tumor. The physician reviewer found the current peer-reviewed medical literature supports the requested ReWalk Exoskeletal Device as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Miller and colleagues noted that, powered exoskeletons allow patients with spinal cord injury to safely ambulate in real-world settings at a physical activity intensity conducive to prolonged use and known to yield health benefits. Asselin and colleagues reported that paraplegic patients were able to ambulate efficiently using the powered exoskeleton for overground ambulation, providing the potential for functional gain and improved fitness. The clinical documentation submitted for review indicated the patient had a spinal cord injury due to a cancerous tumor. The patients cancer was in remission. The patient was in a wheelchair. The patient had reduced lung capacity. The patient had a successful trial of the unit with an improved ability to ambulate and to transfer from one position to another. The peer-reviewed literature indicates that exoskeletons such as the ReWalk device may allow patients to ambulate with a normal velocity and may assist the patient to have improved fitness. An upright posture may also permit this patient to have an increase lung capacity, whereas, continual sitting in a wheelchair has led to decreased lung capacity. According to the support in the medical literature as well as this patients performance with a trial with the requested device, the ReWalk Exoskeletal Device 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 equipment 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 patient is a 34-year-old male who has been diagnosed with ulcerative colitis. The patient has requested authorization and coverage for Simponi 100 mg every 21 days. The Health Insurer has denied this request and reported that the requested medication regimen is not medically necessary for the treatment of this patient.
In this case, the patient has failed the standard dose of Simponi, with symptoms of active disease, and elevated fecal calprotectin.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 34-year-old male who has been diagnosed with ulcerative colitis. The patient has requested authorization and coverage for Simponi 100 mg every 21 days. The Health Insurer has denied this request and reported that the requested medication regimen is not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication regimen. The randomized PURSUIT study showed that Simponi serum concentrations are proportional to dose, and higher Simponi concentration was associated with improved clinical outcomes. Studies have shown that dose escalation can recover response to therapy in a significant fraction of patients. One study showed recovery of response in 71% of ulcerative colitis patients undergoing Simponi dose escalation, and another demonstrated improvement in half of patients (Taxonera and Rodriguez, et al; Taxonera and Iborra, et al). In this case, the patient has failed the standard dose of Simponi, with symptoms of active disease, and elevated fecal calprotectin. Dose escalation can recover response and prevent complications, such as disease flare, hospitalization, toxic megacolon, and dysplasia with risk of colorectal cancer. Therefore, Simponi 100 mg every 21 days is medically necessary for the treatment of this patient.
| 1 |
A 43-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/14/18. The Health Insurer has denied this request indicating that the services at issue were 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 43-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/14/18. 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 prognosis of cutaneous melanoma is classically evaluated by the staging system spelled out by Balch. Mitotic rate may add to these statistics. DecisionDx-Melanoma testing is a 31-gene panel of 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 DecisionDx-Melanoma classification and prognosis, in patients who had had sentinel node biopsy. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch statistics. Most importantly, it is not clear if DecisionDx-Melanoma testing can be used to make clinical decisions. Therefore, DecisionDx-Melanoma testing performed on 2/14/18 was not 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 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 26-year-old female enrollee has requested reimbursement for mental health partial hospitalization provided from 1/23/19 through 1/25/19. 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.
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Upheld
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Medical Necessity
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Summary Reviewer
A 26-year-old female enrollee has requested reimbursement for mental health partial hospitalization provided from 1/23/19 through 1/25/19. 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. With regards to risk of harm, the records support a score of 1 due to a lack of current suicidal ideation and no self-harming behaviors. In terms of functional status, the records support a score of 2 due to an overall good functional level with appropriate activities of daily living. With regards to medical, addictive and psychiatric comorbidity, the records support a score of 2 due to overall medical stability, no chronic medical issues and no active substance use. In terms of level of stress of the recovery environment, the records support a score of 2 due to no mention of a stressful recovery environment. With regards to level of support of the recovery environment, the records support a score of 2 due to family support and availability of treatment resources. In terms of 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. With regards to engagement and recovery status, the records support a score of 2 due to cooperation in treatment and insight into her need for treatment. Therefore, the patient has a composite score of 13. This score correlates with low intensity community-based services. In sum, this patients presentation did not meet criteria for partial hospitalization program level of care during the disputed timeframe. Thus, mental health partial hospitalization services provided from 1/23/19 through 1/25/19 were not medically necessary for the treatment of this patient.
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patient is a 55-year-old female who has been diagnosed with cervical dystonia. The patient
has requested authorization and coverage for J0585, Botox 200 unit vial and service code 64615
x 4 che
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 55-year-old female who has been diagnosed with cervical dystonia. The patient
has requested authorization and coverage for J0585, Botox 200 unit vial and service code 64615
x 4 chemodenervation. The physician reviewer found that the submitted documentation
supports the medical necessity of the requested services. Cervical dystonia is one of the most
common adult-onset focal dystonias. It is a movement disorder with symptoms of neck posturing,
tremor, and/or pain. Although mostly considered benign, cervical dystonia can lead to significant
disability. The treatment of choice for cervical dystonia is botulinum toxin injections, which are
administered into neck muscles to cause denervation and relaxation of the abnormal neck
posture. There is sufficient support for the requested services in this setting. Therefore, J0585,
Botox 200 unit vial and service code 64615 x 4 chemodenervation are medically necessary for the
treatment of this patient.
| 1 |
The parent of a two-year-old female enrollee has requested reimbursement for chromosomal microarray (CMA, CPT code 81229) testing 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 enrollee, who has had a history of breath holding episodes that have increased in it severity.
, she has a history of seizure like activity following breath holding spells
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a two-year-old female enrollee has requested reimbursement for chromosomal microarray (CMA, CPT code 81229) testing 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 enrollee, who has had a history of breath holding episodes that have increased in it severity. The physician reviewer found that the use of chromosomal microarray testing now plays a central role in the evaluation and diagnosis of children with global developmental delay, cognitive delay, and autism spectrum disorders. In a recent consensus article by Miller and colleagues, the following statement was made: available evidence strongly supports the use of CMA in place of G-banded karyotyping as the first-tier cytogenetic diagnostic test for patients with DD/ID (developmental delay/intellectual disability), ASD, or MCA. Further, our recommendation based on current evidence is to offer CMA as the first-tier genetic test, in place of G-banded karyotype, for patients with unexplained DD/ID, ASD, or MCA. In this patients case, she has a history of seizure like activity following breath holding spells that were increasing in frequency despite treatment with antiepileptic medications. However, the submitted records do not raise a concern of autism or global developmental delay. Moreover, there was no physical examination evidence of dysmorphic features. Based on the current literature, chromosomal microarray (CMA, CPT code 81229) testing performed on 1/26/16 was not likely to yield a diagnosis above and beyond what has been noted clinically. Therefore, the services at issue was not likely to have been more effective than other standard options available in the evaluation of this patients medical condition. Based upon the information set forth above, the requested 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 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 10/21/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue is considered investigational for treatment 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.
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Overturned
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Experimental
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Summary Reviewer 3
A 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 10/21/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue is considered investigational for treatment 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 as 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. A routine mammogram would have been sufficient for screening purposes. 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. Thus, in this clinical setting, the use of the digital 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. 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 20-year-old male enrollee has requested authorization and coverage for inpatient admission for lidocaine infusions for seven days. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees orthostatic headache.
In this case, the patient was diagnosed with chronic headache of migraine type with positional component.
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Upheld
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Experimental
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Summary Reviewer 3
A 20-year-old male enrollee has requested authorization and coverage for inpatient admission for lidocaine infusions for seven days. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees orthostatic headache. The physician reviewer found the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is a lack of support in the medical literature for the requested services in this clinical setting. In this case, the patient was diagnosed with chronic headache of migraine type with positional component. There is a lack of controlled studies supporting the safety and efficacy for lidocaine infusions for treatment of the patients medical condition. 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 |
A 30-year-old female enrollee has requested reimbursement for Prometheus Anser ADA (84999) provided on 10/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees inflammatory bowel disease (IBD).
. In this patients case, Anser ADA was ordered to direct the management of the patients Crohns disease.
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Upheld
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Experimental
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Summary Reviewer 3
A 30-year-old female enrollee has requested reimbursement for Prometheus Anser ADA (84999) provided on 10/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees inflammatory bowel disease (IBD). The physician reviewer found that there is a lack of support in the medical literature as to the superior efficacy of the services at issue in this clinical setting. In this patients case, Anser ADA was ordered to direct the management of the patients Crohns disease. However, the use of Anser ADA has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. The effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with Humira (adalimumab) may experience loss of response, but the appropriate method for determination of the cause for loss of response is unclear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature (Karmiris, et al; Imaeda, et al; Lichtenstein, et al). These small studies demonstrated, at best, correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect. Karmiris and colleagues found no direct relationship between trough serum adalimumab concentration or anti-adalimumab antibody and short-term treatment efficacy. Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. The available data does not allow final conclusions about the relevance of anti-adalimumab antibodies to the clinical efficacy of adalimumab. A study by Yanai and Hanauer concluded that prospective controlled trials are direly needed to investigate the optimal tailored management in individual patients who lose response. As such, the clinical literature does not support the superior efficacy of Prometheus Anser ADA diagnostic test performed on 10/14/15 over standard options in the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been 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 45-year-old male diagnosed with amyotrophic lateral sclerosis (ALS). In October 2013 the patient presented with onset of symptoms that started about a year before. The occupational therapy evaluation performed in June 2017 indicates he is maximum assistance to total assistance for many of his activities of daily living (ADLs) including toileting, eating, and bathing. The patient is no longer ambulatory, and needs moderate to maximum assistance with transfers. The patient shows no significant respiratory compromise or bulbar symptoms. The patient has requested authorization and coverage for edaravone (Radicava). The Health Insurer has denied this request as investigational. According to the documentation submitted for review, the patient presents with late stage ALS with marked disability and sparing of respiratory and bulbar function. He initially had slow progression but has had much more rapid progression over the past year and has minimal upper limb function, and is non-ambulatory.
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Overturned
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Experimental
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Summary Reviewer 2
The patient is a 45-year-old male diagnosed with amyotrophic lateral sclerosis (ALS). In October 2013 the patient presented with onset of symptoms that started about a year before. The occupational therapy evaluation performed in June 2017 indicates he is maximum assistance to total assistance for many of his activities of daily living (ADLs) including toileting, eating, and bathing. The patient is no longer ambulatory, and needs moderate to maximum assistance with transfers. The patient shows no significant respiratory compromise or bulbar symptoms. The patient has requested authorization and coverage for edaravone (Radicava). The Health Insurer has denied this request as investigational. According to the documentation submitted for review, the patient presents with late stage ALS with marked disability and sparing of respiratory and bulbar function. He initially had slow progression but has had much more rapid progression over the past year and has minimal upper limb function, and is non-ambulatory. A phase III study showed efficacy in a selective group of patients with early disease and mild-to-moderate disability (Abe, et al). However, the phase III study was designed to maximize the likelihood of a clinical response, so the criteria for entry were skewed to take those patients who were most likely to benefit, and they did benefit. Given that the patient has already been treated with riluzole and a lack of other potential therapeutic options, treatment with Radicava is likely to be beneficial for treatment of the patients ALS than any available standard therapy. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 20-year-old male enrollee has requested reimbursement for substance use disorder partial hospitalization program (PHP) services provided from 10/3/17 through 10/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
himself or others, and he was not aggressive or violent. His post-a
He was medically and psychiatrically stable. He remained in partial denial about his problem with alcohol.
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Upheld
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Medical Necessity
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Summary Reviewer
A 20-year-old male enrollee has requested reimbursement for substance use disorder partial hospitalization program (PHP) services provided from 10/3/17 through 10/6/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the substance use PHP services provided from 10/3/17 through 10/6/17 were not medically necessary for treatment of the patients medical condition. According to the documentation submitted for review, the patient was not a danger to himself or others, and he was not aggressive or violent. His post-acute withdrawal symptoms were not reported. There were no significant emotional, behavioral, or cognitive symptoms that would warrant continued PHP level of care. There was no high degree of impulsivity, agitation, depression, mania, hallucinations, or any other significant symptom that would have prevented stepping him down to a lower level of care. He was medically and psychiatrically stable. He remained in partial denial about his problem with alcohol. There was no documentation of significant progress, change in medications, and change in treatment plan, or mental status examinations. He had support systems in place. The source of his anxiety and depression were not clear and did not appear to be addressed in the PHP treatments. Thus, the patients continued recovery efforts, and development of coping skills could have been accomplished in IOP level of care or outpatient. He was working on issues in DBT/CBT groups, which could have been provided on an outpatient basis. As such, the services at issue were 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 22-year-old female enrollee has requested reimbursement for the blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the patient is a 22-year-old female with Crohns disease and ileocolonic disease with a stenotic ileocecal valve. The patient also has a history of perianal disease. The patient is maintained on infliximab monotherapy. On 3/2/16, the patient reported feeling well. However, her fecal calprotectin was elevated at 288 and recent magnetic resonance enterography demonstrated increasing disease activity. There was concern that the patients infliximab levels were inadequate. The patient underwent Prometheus Anser IFX on 4/26/16 and results demonstrated detectable levels of infliximab (8.7) and undetectable levels of antibody. The patient has requested reimbursement for blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request
that the patient has good trough level of infliximab and no antibodies. However, the patient has active disease so the decision was made to
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Upheld
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Experimental
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Summary Reviewer 2
A 22-year-old female enrollee has requested reimbursement for the blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the patient is a 22-year-old female with Crohns disease and ileocolonic disease with a stenotic ileocecal valve. The patient also has a history of perianal disease. The patient is maintained on infliximab monotherapy. On 3/2/16, the patient reported feeling well. However, her fecal calprotectin was elevated at 288 and recent magnetic resonance enterography demonstrated increasing disease activity. There was concern that the patients infliximab levels were inadequate. The patient underwent Prometheus Anser IFX on 4/26/16 and results demonstrated detectable levels of infliximab (8.7) and undetectable levels of antibody. The patient has requested reimbursement for blood testing (Prometheus Anser IFX) performed on 4/26/16. The Health Insurer has denied this request as investigational. This case highlights exactly why infliximab level measurement is often not helpful clinically and there is very low evidence for its use to guide clinical management. The records demonstrate that the patient has good trough level of infliximab and no antibodies. However, the patient has active disease so the decision was made to increase the dose of infliximab. In this clinical setting, even without Prometheus Anser IFX testing the same clinical decision would have been made. For the reasons provided, the blood testing (Prometheus Anser IFX) performed on 4/26/16 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 73-year-old male enrollee has requested reimbursement for targeted genomic sequence analysis performed on 5/30/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 73-year-old male enrollee has requested reimbursement for targeted genomic sequence analysis performed on 5/30/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that molecular diagnostic studies in non-small cell lung cancer are considered a standard of care. Numerous gene alterations have been identified that impact therapy selection. The National Comprehensive Cancer Network guidelines strongly advise 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 non-small cell lung cancer. 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. Molecular profiling was medically appropriate in this patients case. Therefore, targeted genomic sequence analysis performed on 5/30/19 was medically necessary for the evaluation of this patient.
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The parent of a 16-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) testing performed on 4/26/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for the enrollees dysmorphic facies and postural and kinetic tremor.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 16-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) testing performed on 4/26/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for the enrollees dysmorphic facies and postural and kinetic tremor. The physician reviewer found the array-based CGH, also known as CMA, has become standard of care to evaluate children with developmental delay, intellectual disability, autism spectrum disorders or multiple congenital anomalies. Until recently, it was a diagnostic test that was employed when the first-line investigation of karyotype returned normal. Subsequently, CGH has emerged as a first-line investigation. The yield of this test is estimated to be 8-17% and varies with the degree of cognitive impairment, the presence of dysmorphic features, and the presence of congenital anomalies. More recently, data have shown that actionable findings from chromosomal microarray justify its use (Coulter, et al). Based on the support in the peer-reviewed literature, the CGH testing performed on 4/26/16 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 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.
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A 70-year-old male enrollee has requested authorization and coverage for DecisionDx-Melanoma testing performed on 10/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 70-year-old male enrollee has requested authorization and coverage for DecisionDx-Melanoma testing performed on 10/28/16. 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 that a commercial gene expression profile test (DecisionDx-Melanoma) has been developed in patients with stage I and II cutaneous melanoma. However, 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 according to published data available. The National Comprehensive Cancer Network has not recommended its use in this clinical setting. At this time, DecisionDx-Melanoma does not appear likely to be of greater benefit than the available standard therapy. As such, DecisionDx-Melanoma gene expression test performed on 10/28/16 was not likely to have been more effective than the other methods for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been 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 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 10/21/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue is considered investigational for treatment 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 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 10/21/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue is considered investigational for treatment 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 to the usual two dimensional protocol 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 10/21/15 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.
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An 18-year-old male enrollee has requested reimbursement for outdoor behavioral health
services provided from 11/03/20 through 12/31/20. The Health Insurer has denied this request
and reported that the services at issue were investigational for the treatment of the enrollees
medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
An 18-year-old male enrollee has requested reimbursement for outdoor behavioral health
services provided from 11/03/20 through 12/31/20. The Health Insurer has denied this request
and reported that the services at issue were investigational for the treatment of the enrollees
medical condition. The physician reviewer found that Bowen and colleagues noted that
wilderness therapy is adventure therapy that offers a prevention, early intervention, and
treatment modality for people with behavioral, psychological, and psychosocial issues. It can
appeal to youth-at-risk who are often less responsive to traditional psychotherapeutic
interventions. Overall, this study concluded, For participants in clinical ranges pre-program,
there was a large, statistically significant reduction in depressive symptomology, and large to very
large, statistically significant improvements in behavioral and emotional functioning. These
changes were retained at the three-month follow-up. These findings indicate that wilderness
adventure therapy is as effective as traditional psychotherapy techniques for clinically
symptomatic people. In general, wilderness therapy has been considered residential level of
care, with components of therapy frequency and intensity that qualify it as such; however, there is a wide range of wilderness therapy programs with varying degrees of evidence-based practice
within each one. Overall, this patients multiple conditions appear to have required
comprehensive trauma informed cognitive behavioral therapy and dialectical behavioral therapy
modalities and significant psychiatric management. There is limited evidence available showing
that outdoor behavioral health services are superior to these evidence-based treatments.
Therefore, outdoor behavioral health services provided from 11/03/20 through 12/31/20 was
not likely to have been more beneficial than any available standard therapy.
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A 51-year-old male enrollee has requested authorization and coverage for Xiaflex. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition.
This patient has severe erectile dysfunction and Peyronies disease.
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Upheld
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Medical Necessity
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Summary Reviewer
A 51-year-old male enrollee has requested authorization and coverage for Xiaflex. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient has severe erectile dysfunction and Peyronies disease. The standard of care for treatment in this situation is insertion of penile implant with or without adjunct surgery for correction of curvature if needed intraoperatively. Although Xiaflex has been shown to be effective in treatment of patient with Peyronies disease with intact sexual function, the value of Xiaflex in patients with Peyronies disease and coexisting severe erectile dysfunction has not been scientifically proven. Hence, Xiaflex is not medically indicated for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 51-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) performed on 3/18/19. 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 2
A 51-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) performed on 3/18/19. 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 PCR testing has been compared to traditional clinical testing for vaginitis. The literature supports the use of PCR testing due to significantly higher sensitivity and negative predictive value than clinician diagnosis or in clinic testing. PCR testing has been shown to be superior for detecting more than one cause for vaginitis. PCR testing is commonly used test in clinical practice. In this case, the postoperative period is especially difficult to make an accurate diagnosis of vaginal complaints. Missing an infection could lead to a serious complication, Thus, PCR testing performed on 3/18/19 was likely to have been more beneficial than other methods of evaluating this patient.
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A 22-year-old female enrollee has requested reimbursement for mastopexy and reduction mammoplasty performed on 12/16/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees breast asymmetry.
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Overturned
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Medical Necessity
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Summary Reviewer
A 22-year-old female enrollee has requested reimbursement for mastopexy and reduction mammoplasty performed on 12/16/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees breast asymmetry. The physician reviewer found that as noted by the American Society of Plastic and Reconstructive Surgeons (ASPRS), breast deformities unrelated to cancer treatment occur in both men and women and may present either bilaterally or unilaterally. These deformities result from congenital anomalies, trauma, disease, or mal-development. Because breast deformities often result in abnormally asymmetrical breasts, surgery of the contralateral breast, as well as the affected breast, may be required to achieve asymmetry. Tuberous breast deformity is a well-defined type of congenital breast deformity and treatment for correction is considered reconstructive surgery. Breast reduction of the contralateral side and mastopexy of the affected side are recognized forms of surgical treatment for this condition. It is common in breast reconstruction to perform surgery on the contralateral side for the purpose of symmetry. The medical literature, as well as this patients clinical documentation and photographs, demonstrate the patient had a severe congenital deformity which was abnormal. Reconstructive surgery in this clinical setting was indicated to improve function and also to restore a more normal appearance. Consistent with these findings, the mastopexy and reduction mammoplasty performed on 12/16/14 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.
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A 49-year-old female enrollee has requested authorization and coverage for hysterectomy. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees symptomatic fibroids.
In this patients case, she has pain and heavy bleeding that continue to interfere with her quality of life.
This patient has already had a myomectomy and her symptoms are worsening.
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Overturned
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Medical Necessity
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Summary Reviewer
A 49-year-old female enrollee has requested authorization and coverage for hysterectomy. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees symptomatic fibroids. The physician reviewer found that there is support in the medical literature for the medical necessity of the requested procedure in this clinical setting. In this patients case, she has pain and heavy bleeding that continue to interfere with her quality of life. There are a number of surgical and non-surgical management options for symptomatic fibroids. This patient has already had a myomectomy and her symptoms are worsening. She is not a good candidate for estrogen containing medications, as she is a smoker. In this patients case, the literature supports the hysterectomy as a treatment modality for symptomatic fibroids. Accordingly, hysterectomy is medically necessary for the treatment of this patient. 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.
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A 47-year-old female enrollee has requested reimbursement for proton beam therapy provided on 5/20/19 through 7/12/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 47-year-old female enrollee has requested reimbursement for proton beam therapy provided on 5/20/19 through 7/12/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the services at issue. There is currently insufficient high quality clinical outcomes reported in the peer-reviewed medical literature to allow one to make definitive conclusions regarding the relative safety and efficacy of proton radiation for rectal cancer, as compared to standard of care photon-based radiotherapy. This patient could have been treated safely and effectively with photon-based radiotherapy. Therefore, proton beam therapy provided from 5/20/19 through 7/12/19 was not likely to have been more beneficial than other available treatment options.
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A 67-year-old male enrollee has requested authorization and coverage for Praluent Pen injections. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees diabetes, dyspnea, and a positive coronary calcium score.
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Upheld
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Medical Necessity
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Summary Reviewer
A 67-year-old male enrollee has requested authorization and coverage for Praluent Pen injections. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees diabetes, dyspnea, and a positive coronary calcium score. The physician reviewer found that the U.S. Food and Drug Administration (FDA) has approved Praluent as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol. However, this patients documented level of cholesterol is not high enough to suspect familial heterozygous hypercholesterolemia, which is diagnosed with LDL over 190. In addition, there is no evidence of clinical atherosclerotic cardiovascular disease (CAD). There are coronary calcifications on CT scan but a normal stress nuclear imaging study, showing no ischemia. Since there is no documented contraindication to treatment with Repatha, which has been authorized by the Health Insurer, the requested Praluent Pen injections are not supported as medically necessary for treatment of this patients hyperlipidemia. Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 61-year-old female enrollee has requested authorization and coverage for endoscopic anti-reflux procedure (LINX). The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).
patient has GERD as based on pH recording when off Nexium. However, while it appears on pH testing her symptom correlation with reflux was limited, she has reportedly benefited to a significant degree from acid suppression treatment. Her record documents that symptoms worsened off proton pump inhibitor therapy.
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Upheld
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Experimental
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Summary Reviewer 2
A 61-year-old female enrollee has requested authorization and coverage for endoscopic anti-reflux procedure (LINX). The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that the documentation provided supports that this patient has GERD as based on pH recording when off Nexium. However, while it appears on pH testing her symptom correlation with reflux was limited, she has reportedly benefited to a significant degree from acid suppression treatment. Her record documents that symptoms worsened off proton pump inhibitor therapy. As such, she cannot be considered medically refractory to acid blocker drugs. In addition, implantation of LINX in this patients setting must be approached with caution given her documented intestinal metaplasia on esophageal biopsy. Moreover, there is a lack of medical studies in the setting of Barretts esophagus. Accordingly, the requested endoscopic anti-reflux procedure (LINX) is not likely to be more efficacious than the standard methods of treating this patients medical condition.
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.
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A 48-year-old female enrollee has requested authorization and coverage for implantation of Strattice. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees abdominal hernia.
that the patient has a large area of abdominal wall weakness.
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Overturned
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Experimental
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Summary Reviewer 3
A 48-year-old female enrollee has requested authorization and coverage for implantation of Strattice. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees abdominal hernia. The physician reviewer found that the patient has a large area of abdominal wall weakness. Component separation (CS) reinforced with Strattice or porcine acellular dermal matrix (PADM) has shown favorable results for ventral hernia repair. Per a study by Richmond and colleagues, CS/PADM reinforcement should be strongly considered for the repair of significant midline ventral hernia defects. According to another recent study by Richmond and colleagues, Biologic materials have made it such that ventral hernias can be safely repaired after bowel surgery without increased risk of complications. Finally, a study by Huntington and colleagues note, In 223 ventral hernia repair performed with biologic mesh at a tertiary care institution, Strattice, a porcine acellular dermal mesh, had significantly lower odds of hernia recurrence compared with AlloMax, FlexHD, and XenMatrix. Choice of biologic mesh affects long-term postoperative outcomes in ventral hernia repair. The medical studies show that use of Strattice may decrease recurrence and increase the likelihood of a successful repair. This patient has documented failure with synthetic mesh. As such, the medical literature as well as this patients failure with other options support the use of Strattice in this clinical setting. Accordingly, Strattice is likely to be a more effective treatment option than the available standard alternatives for this patient.Therefore, for the reasons stated 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.
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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.
has tried multiple therapies for myasthenia gravis, including multiple immunomodulators. He has been hospitalized due to exacerbation. These events
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Overturned
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Experimental
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Summary Reviewer 3
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 this patient has tried multiple therapies for myasthenia gravis, including multiple immunomodulators. He has been hospitalized due to exacerbation. These events have potential morbidity associated with them. In this case, intravenous immune globulin treatment on periodic basis helps the patient avoid hospitalization. Thus, intravenous immune globulin is likely to be more efficacious than other treatment options. 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.
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The parent of a 14-year-old female enrollee has requested reimbursement for subtalar arthroereisis provided on 12/11/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral moderate-to-severe pes planus.
in this case, the patient presented with chronic foot and leg pain due to collapsed arches that was unresolved with conservative care.
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Upheld
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Experimental
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Summary Reviewer 3
The parent of a 14-year-old female enrollee has requested reimbursement for subtalar arthroereisis provided on 12/11/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral moderate-to-severe pes planus. The physician reviewer found that in this case, the patient presented with chronic foot and leg pain due to collapsed arches that was unresolved with conservative care. The procedure has been performed by different methods in various patient populations with reports of positive outcomes in well selected patients. Schon noted the procedure had promise, while Needleman reported 78% clinical improvement, despite high complication rates. Thus, the procedure is reserved for patients who have exhausted conservative treatments. Since this patients records demonstrate that she failed all reasonable conservative therapies prior to surgical intervention, the subtalar arthroereisis performed on 12/11/14 was likely to be more beneficial than standard available modalities. Based upon the information set forth above, I have determined 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.
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The patient is a 14-year-old male with moderately severe Crohnas disease associated with poor growth, diarrhea, nocturnal stooling, fatigue, and perianal disease with fissures and tags. The patientas parent has requested authorization and coverage for Inflectra procedure code Q5103 starting dose 7.5 mg/kg and treatment at a hospital affiliated infusion center. The Health Insurer has denied this request and reported that the requested medication and services are 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 14-year-old male with moderately severe Crohnas disease associated with poor growth, diarrhea, nocturnal stooling, fatigue, and perianal disease with fissures and tags. The patientas parent has requested authorization and coverage for Inflectra procedure code Q5103 starting dose 7.5 mg/kg and treatment at a hospital affiliated infusion center. The Health Insurer has denied this request and reported that the requested medication and services are not medically necessary for the treatment of this patient. The physician reviewer found that adequate trough concentrations of infliximab during the induction phase are associated with better outcomes in both adults and children with Crohnas disease. Unfortunately, sub-therapeutic infliximab levels are common, leading to a need to measure drug concentrations carefully at the end of the induction period. Alternate dosing strategies have also been considered. At this time, there have not been head-to-head trials comparing standard (5 mg/kg/dose) to higher-dose infliximab induction regimen. However, pharmacokinetic modeling studies have identified factors associated with lower trough levels. The recent study by Xiong and colleagues found predictors of sub-therapeutic infliximab exposure to include age less than 10 years, ESR greater than 30 mm/h, weight less than 30 kg, and neutrophil CD64 activity ratio greater than 6. This patient meets one of these parameters (ESR), although his neutrophil CD64 activity ratio, which is not a standard clinical measurement, is not known. European consensus guidelines state that factors indicating higher dosing are similar, including extensive disease and low serum albumin levels, which are not present in this patient. Considering his clinical picture, higher dose infliximab induction is not indicated. The patientas provider has requested that induction doses be given in a hospital-based infusion center, and the Health Insurer has already agreed to cover the first two inductions at that location. Data on outcomes for children receiving infliximab infusions at non-hospital-based infusion centers are limited, although the practice has been described in the pediatric gastrointestinal literature. In the paper by Gupta and colleagues, over 40% of patients receiving infliximab infusions were not deemed to be appropriate candidates for non-hospital-based infusions by their medical providers. This patient does not have any obvious disqualifications for home infusion (e.g. poor vascular access). It is possible that such a characteristic will be identified during the first two infusions, in which case the question can be reconsidered. In the meantime, transition to home or independent infusion center infusions would be expected to be appropriate, for the third induction dose and maintenance dosing, assuming that the home health agency or infusion center is able to provide pediatric-trained staff. In sum, Inflectra procedure code Q5103 starting dose 7.5 mg/kg and treatment at a hospital affiliated infusion center are not medically necessary for the treatment of this patient.
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A 32-year-old female enrollee has requested reimbursement for laboratory testing performed on 6/26/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
this patient has a history of a left lower extremity deep vein thrombosis felt to be provoked in the setting of trauma, for which she was placed in an orthopedic boot, and travel.
. This patient is young and had a venous thromboembolic event,
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Overturned
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Experimental
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Summary Reviewer 1
A 32-year-old female enrollee has requested reimbursement for laboratory testing performed on 6/26/19. 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 this patient has a history of a left lower extremity deep vein thrombosis felt to be provoked in the setting of trauma, for which she was placed in an orthopedic boot, and travel. There is no family history of blood clots. Most experts recommend testing for all five inherited thrombophilias (protein S, C, and antithrombin deficiencies, factor V Leiden and prothrombin gene mutation) and antiphospholipid syndrome in those who are younger than 45 years of age. In an analysis by Weingarz and colleagues of unselected patients with venous thromboembolic event and a median age of 43 years, at least one thrombophilic disorder was identified in half of the cohort. This patient is young and had a venous thromboembolic event, and although provoked, meets criteria for more intense testing. Therefore, laboratory testing performed on 6/26/19 was likely to have been more beneficial than other methods of evaluating this patient.
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A 54-year-old female enrollee has requested reimbursement for acute inpatient psychiatric treatment from 11/18/16 through 12/4/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions
On 11/17/16, although the patient continued to endorse depression and anxiety, her suicidal ideation was passive in nature and there was no intent. She denied homicidal ideation. She was no longer a danger to herself, and she was not a danger to others. She was cognitively intact. She was able to care for herself and adequately perform activities of daily living. She was not gravely disabled. Beyond that date, she continued to report depression, anxiety, poor sleep, somatic preoccupation, and preoccupation with family finances. These states appear to be her baseline. The record notes that her medication changes were tolerated well and were
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Upheld
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Medical Necessity
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Summary Reviewer
A 54-year-old female enrollee has requested reimbursement for acute inpatient psychiatric treatment from 11/18/16 through 12/4/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions The physician reviewer found that there is a lack of support for the medical necessity of the services at issue in this clinical setting. On 11/17/16, although the patient continued to endorse depression and anxiety, her suicidal ideation was passive in nature and there was no intent. She denied homicidal ideation. She was no longer a danger to herself, and she was not a danger to others. She was cognitively intact. She was able to care for herself and adequately perform activities of daily living. She was not gravely disabled. Beyond that date, she continued to report depression, anxiety, poor sleep, somatic preoccupation, and preoccupation with family finances. These states appear to be her baseline. The record notes that her medication changes were tolerated well and were not of a complicated nature that required inpatient level of care. She was participating in therapies and groups offered. It should be noted that dialectic behavior therapy is typically an outpatient modality. The issues this patient was working on, emotional regulation, improvement of mood, decrease feelings of being overwhelmed, increase structure, identification of triggers of suicidal thoughts, and building coping skills, could have continued in PHP. Based on the documentation, this patient could have been stepped down on 11/18/16. As such, inpatient psychiatric services from 11/18/16 through 12/4/16 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 |
A 54-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 2/5/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 3
A 54-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 2/5/16. 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 do not support the DecisionDx testing for use outside of the clinical trial setting. Moreover, there is a lack of peer-reviewed medical literature demonstrating that the results of the DecisionDx testing would change the recommended therapy or long-term outcomes. Consequently, the DecisionDx melanoma assay provided on 2/5/16 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 63-year-old female who has requested reimbursement for harvest auto stem cells provided on 1/28/19 and 1/29/19. She has a history of multiple myeloma.
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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 has requested reimbursement for harvest auto stem cells provided on 1/28/19 and 1/29/19. She has a history of multiple myeloma. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. Autologous stem cell transplantation is considered a standard of care in the treatment of multiple myeloma with a good response after primary therapy. This approach is supported by the National Comprehensive Cancer Network (NCCN) guidelines. Stem cell collection from the patient after stimulation of the bone marrow to produce increased stem cells is also standard. Therefore, harvest auto stem cells provided on 1/28/19 and 1/29/19 were medically necessary for the treatment of this patient.
| 1 |
An 18-year-old male enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 11/16/17 through 1/04/18. 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 medical records indicate that the patient was not actively suicidal at any time, although he had recent passive suicidal ideation without intent to harm himself.
. The patient has had some issues with level of function that were sporadic nature. He showed intact activities of daily living.
the patient has had minimal prior treatment and was cooperative in the residential treatment center program at issue.
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Upheld
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Medical Necessity
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Summary Reviewer
An 18-year-old male enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 11/16/17 through 1/04/18. 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 American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. In terms of risk of harm, the records support a score of 2. The medical records indicate that the patient was not actively suicidal at any time, although he had recent passive suicidal ideation without intent to harm himself. With regards to functional status, the records support a score of 2. The patient has had some issues with level of function that were sporadic nature. He showed intact activities of daily living. In terms of comorbidity, the records support a score of 1. The patient does not have active medical problems or substance use. With regards to level of stress of the recovery environment, the records support a score of 2. There was no indication of an unsafe home environment. In terms of level of support of the recovery environment, the records support a score of 2. The patients parents were involved in treatment on a regular basis. With regards to resiliency and treatment history, the records support a score of 3. It appears that the patient has had minimal prior treatment and was cooperative in the residential treatment center program at issue. In terms of acceptance and engagement, the records support a score of 2. The patient actively participated in therapy on admission. With regards to acceptance and engagement of the parent, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Thus, the patient had a composite score of 16. This score correlates with intensive outpatient services. Therefore, residential mental health treatment for children and adolescents provided from 11/16/17 through 1/04/18 was not medically necessary for the treatment of this patient.
| 1 |
The patient is a 39-year-old female with chronic paranoid schizophrenia. The patient has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment center care provided from 5/22/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 39-year-old female with chronic paranoid schizophrenia. The patient has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment center care provided from 5/22/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are 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 American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score is then used to determine the level of care needed. Applying the LOCUS framework, the patient met the criteria for psychiatric residential treatment provided from 5/22/19 onward. For dimension 1, risk of harm, the records support a score of 4. This dimension assesses potential for harm to self or others. Although the patient does not have suicidal or homicidal ideation, she does demonstrate a consistent clear compromise in her ability to care adequately for herself or to be adequately aware of her environment due to her chronic, impairing symptoms of schizophrenia. For dimension 2, function, the records support a score of 5. This dimension assesses the degree to which a person is able to fulfill social responsibilities, interacts with, maintain physical functioning and capacity for self-care. The patient demonstrates a severe impairment in functional status. She withdraws completely, spending days in her room without eating or taking care of her activities of daily living. The patient has complete withdrawal from social interactions and complete neglect of her personal hygiene and an inability to tend to her basic needs, such as food intake. For dimension 3, comorbidity, the records support a score of 5. This dimension assesses potential complications in the course of treatment due to acuity or disability related to co-occurring medical illness, substance use disorder, or psychiatric disorder. Prior to moving to the residence, the patient had neglected her physical state, gaining weight due to inactivity. The patient had neglected any medical appointments during that time as well. While at the current facility, she has been attending to medical appointments during which medical issues were identified, including hypertension, and in August 2019, papilledema was identified. Without the assistance of the residential staff, patients health might have suffered, but they got her to the emergency room for further evaluation and treatment. For Recovery Environment dimension 4A, stress, the records support a score of 4. This dimension assesses the stressors in the environment, social circumstances, and interpersonal relationships. Prior to moving to the residence, the patient was unable to provide for her physical and material well-being outside of a structured, residential facility.For Recovery Environment dimension 4B, support, the records support a score of 4. This dimension assesses the presence of family and social support to augment the recovery environment. Although the patients mother is her greatest advocate, she has a limited ability to provide all the support that the patient needs. For dimension 5, treatment and recovery history, the records support a score of 4. This dimension assesses how past experiences with treatment and recovery might indicate how the patient might respond in the future. The patient has had limited improvement in her ability to function in prior placements. For dimension 6, engagement, the records support a score of 5. This dimension assesses a persons understanding of their illness and treatment, and ability and willingness to engage in the treatment process. Prior to admission to the current residential program, the patient was completely isolated, guarded, paranoid and unable to engage in recovery due to her symptoms and lack of engagement. These findings give the patient a composite score of 31, which is consistent with medically monitored residence-based services. Per LOCUS, the patients scores of 4 for risk of harm and 5 for functional status also support treatment at Level 6 medically monitored residence-based services level of care. For these reasons, the patients psychiatric residential treatment provided from 5/22/19 onward was and is medically necessary. Additionally, based on the patients presentation and the LOCUS criteria, the patient meets criteria for medically managed residence-based services, level 6, but more specifically, since this is not an acute decompensation but a chronic lack of ability to function independently would qualify the patient for level 6B or medically managed extended care residential programs, which is a longer duration of treatment until the patient is stable enough to step down in intensity of care.
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A 66-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Expression Assay provided on 10/12/17. The Health Insurer 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 66-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Expression Assay provided on 10/12/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages 0-IV. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin examinations and clinical examination. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. However, there is a lack of peer-reviewed published studies confirming the role of DecisionDx-Melanoma Gene Assay in this clinical setting. All told, the DecisionDx-Melanoma Gene Assay performed on 10/12/17 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 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 44-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 7/28/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 44-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 7/28/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees melanoma. The physician
reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous
melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for
those with high depth of invasion, 0.76-1.0 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. This is also the consensus opinion of
the National Comprehensive Cancer Network guidelines. Therefore, DecisionDx-Melanoma
testing performed on 7/28/21 was not likely to have been more beneficial for evaluation of the
patients condition than any available standard therapy.
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A 61-year-old female enrollee has requested reimbursement for Collagen Type 1 C-telopeptide blood test that was performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees post-menopausal osteoporosis.
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Overturned
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Experimental
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Summary Reviewer 2
A 61-year-old female enrollee has requested reimbursement for Collagen Type 1 C-telopeptide blood test that was performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees post-menopausal osteoporosis. The physician reviewer found per the National Osteoporosis Foundation guidelines, biochemical markers of bone turnover may predict the following: risk of fracture independently of bone density in untreated patients; rapidity of bone loss in untreated patients; the extent of fracture risk reduction when repeated after 36 months of treatment with Food and Drug Administration (FDA) approved therapies; help determine adequacy of patient compliance and persistence with osteoporosis therapy; and help determine duration when and if medication should be restarted.In this patient, the biochemical marker of bone turnover Collagen Type 1 C-telopeptide, aids the physician in risk assessment and serves as an additional monitoring tool when treatment is initiated (Cosman et al and Burch et al). The change in biochemical markers can be seen sooner than the expected change in bone mineral density. The standard of care is to normally order this test as part of the assessment of patient compliance and effect of medication on bone turnover. It is widely used by endocrinologists and experts in osteoporosis management to assess the effect of therapy as delineated above. This test, Collagen Type 1 C-telopeptide, was appropriately ordered for this patient as part of her osteoporosis management.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.
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A 54-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 2/5/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 54-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 2/5/16. 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 DecisionDx melanoma assay tests the tissue genetics of the melanoma to help stratify whether a thin melanoma is high risk for metastasis. The DecisionDx test has shown some impressive accuracy in thin melanomas like this patients. However, there is a lack of scientific evidence permitting conclusions concerning the effect of this test on health outcomes. The test is not considered routine standard of care and is not recommended by the National Comprehensive Cancer Network (NCCN) guidelines. Further, there is a paucity of literature to support its use in the care of patients with thin melanomas to effect health outcomes. The test is currently not standard of care, has not been demonstrated to provide a beneficial effect on health outcomes, and is not recommended by the NCCN guidelines. Overall, there is not enough published data to support its routine use. There needs to be clinical trials to determine the utility of the results of the test. Since this test does not provide a benefit more than established tests on outcomes, the DecisionDx melanoma assay provided on 2/5/16 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 51-year-old male enrollee has requested reimbursement for DecisionDX testing provided on 10/6/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees uveal melanoma.
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Overturned
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Experimental
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Summary Reviewer 3
A 51-year-old male enrollee has requested reimbursement for DecisionDX testing provided on 10/6/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees uveal melanoma. The physician reviewer found there is convincing scientific evidence that genetic testing of uveal melanoma tumor can stratify the tumors into high and low risk for systemic metastasis (Field and Harbour). The key questions are whether having this information is needed for an individual patient and whether it alters the course of treatment. Currently, this test is part of the standard of care in these patients in this clinical setting (Shields and Shields). Given this support, the DecisionDX testing provided on 10/6/14 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.
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A 61-year-old female enrollee has requested authorization and coverage for endoscopic anti-reflux procedure (LINX). The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).
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Upheld
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Experimental
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Summary Reviewer 1
A 61-year-old female enrollee has requested authorization and coverage for endoscopic anti-reflux procedure (LINX). The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that there is sufficient support for the requested services in this patients case. The U.S. Food and Drug Administration has approved the LINX reflux management system for lower esophageal sphincter augmentation. Appropriate candidates for the procedure include patients with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD and a hiatal hernia less than 3 cm. This patient meets those specific criteria and in addition has a documented episode of aspiration pneumonia perhaps from a severe reflux event. As such, the medical evidence supports the efficacy of the requested procedure in this clinical setting. Accordingly, the requested endoscopic anti-reflux procedure (LINX) is likely to be more effective than the standard options for treatment of this patients medical condition. Therefore, for the reasons stated 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.
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A 55-year-old male enrollee has requested reimbursement for CPT code 81479 provided 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.
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Overturned
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Experimental
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Summary Reviewer 1
A 55-year-old male enrollee has requested reimbursement for CPT code 81479 provided 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 there currently are three major approaches to the management of localized prostate cancer. These include surgical prostatectomy, radiation therapy, or active surveillance with no specific treatment given. Recommendations as to these options are based on risk stratification, which is a process that takes into account patient factors, prostate-specific antigen level, clinical stage, Gleason grade, and the percent of involvement of the cores. Using this methodology, this patient falls into the very low risk category. Generally, active surveillance is recommended for such patients. Oncotype DX testing is an analysis of the expression of 12 genes in an individuals cancer cells. It then classifies that cancer into various risk categories of cancer progression. Such analyses appear useful in patients undergoing prostatectomy and in other risk categories. However, there is a lack of support for the use of this testing in patients in the very low risk category, such as this patient. Therefore, CPT code 81479 provided on 12/21/18 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 62-year-old male enrollee has requested reimbursement for laboratory services provided on 9/06/18. 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 62-year-old male enrollee has requested reimbursement for laboratory services provided on 9/06/18. 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 prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also 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 based on the five-year risk of metastasis. Berger and colleagues reported on its use in 156 cases, but there was insufficient follow-up to determine the actual value of the assay. It is not clear how the ten-year Balch data compares to the five-year DecisionDx-Melanoma data. Furthermore, it is not clear if the assay can be used to make clinical decisions. Therefore, laboratory services provided on 9/06/18 were not likely to have been more beneficial than other methods of evaluating this patient.
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A 49-year-old transgender female enrollee has requested reimbursement for breast augmentation provided on 3/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria.
This patient had well-documented gender dysphoria related to masculine features of her body. The records documented social anxiety and depression.
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Overturned
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Medical Necessity
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Summary Reviewer
A 49-year-old transgender female enrollee has requested reimbursement for breast augmentation provided on 3/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. This patient had well-documented gender dysphoria related to masculine features of her body. The records documented social anxiety and depression. Feminizing mammoplasty under these circumstances is medically necessary for the treatment of gender dysphoria. World Professional Association for Transgender Health (WPATH) criteria for surgery state that surgical procedures for patients with gender dysphoria may include augmentation mammoplasty, genital surgery and other interventions, such as facial feminization surgery, lipofilling and thyroid cartilage reduction. The current medical evidence supports the services at issue in this clinical setting. Therefore, breast augmentation provided on 3/26/18 was medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 44-year-old female enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees sacroiliac joint pain.
that this patient presents with chronic left sacroiliac joint pain following childbirth, and chronic low back and left leg pain and paresthesias. She has been diagnosed with left sacroiliac joint pain, sacroiliitis, and sacroiliac joint dysfunction. She has reportedly failed extensive conservative treatment options, including physical therapy, home exercise program, chiropractic care, bracing, and nonsteroidal anti-inflammatory drugs. On 4/05/18, left sacroiliac joint corticosteroid injection reduced pain from grade 6/10 to 4/10 (33%) for less than one week.
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Upheld
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Experimental
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Summary Reviewer 1
A 44-year-old female enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees sacroiliac joint pain. The physician reviewer found that this patient presents with chronic left sacroiliac joint pain following childbirth, and chronic low back and left leg pain and paresthesias. She has been diagnosed with left sacroiliac joint pain, sacroiliitis, and sacroiliac joint dysfunction. She has reportedly failed extensive conservative treatment options, including physical therapy, home exercise program, chiropractic care, bracing, and nonsteroidal anti-inflammatory drugs. On 4/05/18, left sacroiliac joint corticosteroid injection reduced pain from grade 6/10 to 4/10 (33%) for less than one week. There is no imaging study presented to evidence sacroiliac joint spondyloarthropathy, degenerative sacroiliitis, or sacroiliac joint disruption. Current evidence-based guidelines and literature support minimally invasive sacroiliac joint fusion for patients with sacroiliac joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruption. However, current evidence-based guidelines do not support sacroiliac joint fusion for mechanical low back pain, non-specific low back pain, sacroiliac joint disruption (in the absence of major pelvic fracture), degenerative sacroiliitis or sacroiliac joint osteoarthritis. In this case, there is no clear evidence of a condition for which sacroiliac joint fusion is supported. Additionally, diagnostic injection response does not meet the standards of at least 75% decrease in pain. Therefore, sacroiliac joint fusion is not likely to be superior over 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.
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A 35-year-old female enrollee has requested reimbursement for arthroscopy surgery provided on 11/21/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
found that this patient presented with chronic significant right hip pain with associated popping, clicking, and snapping, and repeated dislocations. Functional limitations were documented in activities of daily living. Clinical examination findings were consistent with radiographic evidence of femoroacetabular impingement and imaging findings of labral cartilaginous junctional delamination, confirmed at the time of arthroscopic examination. She had a history of bilateral hip dysplasia and no evidence of significant degenerative changes.
and failure was submitted. She underwent complex right hip arthroscopic surgery with acetabuloplasty, femoroplasty, labral cartilaginous junctional refixation after abrasion chondroplasty, microfracture, synovectomy and capsular plication on 11/21/18.
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Overturned
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Medical Necessity
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Summary Reviewer
A 35-year-old female enrollee has requested reimbursement for arthroscopy surgery provided on 11/21/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient presented with chronic significant right hip pain with associated popping, clicking, and snapping, and repeated dislocations. Functional limitations were documented in activities of daily living. Clinical examination findings were consistent with radiographic evidence of femoroacetabular impingement and imaging findings of labral cartilaginous junctional delamination, confirmed at the time of arthroscopic examination. She had a history of bilateral hip dysplasia and no evidence of significant degenerative changes. Detailed evidence of long-term comprehensive nonoperative treatment and failure was submitted. She underwent complex right hip arthroscopic surgery with acetabuloplasty, femoroplasty, labral cartilaginous junctional refixation after abrasion chondroplasty, microfracture, synovectomy and capsular plication on 11/21/18. Current evidence-based medical literature supports this surgical intervention in this clinical scenario. Therefore, the arthroscopic surgery provided on 11/21/18 was medically necessary for the treatment of this patient.
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A 46-year-old female enrollee has requested authorization and coverage for Epclusa. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for treatment of the enrollees hepatitis C.
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Overturned
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Medical Necessity
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Summary Reviewer
A 46-year-old female enrollee has requested authorization and coverage for Epclusa. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found that according to 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 life expectancy less than 12 months due to non-liver-related conditions. This applies regardless of fibrosis stage, and advanced fibrosis is not required for treatment. Per the guidelines, Epclusa is recommended as first-line therapy for treatment-naive, genotype 2 patients, based on clinical trials which showed a 99% cure rate and superiority to Sovaldi with ribavirin. A delay in treatment may result in decreased survival. All told, Epclusa is medically necessary in this patients case. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 46-year-old female with a history of right hip pain. The patients hip pain has not responded to conservative treatment in addition to revision arthroscopic labral debridement, iliopsoas bursectomy, synovectomy, lysis of adhesions, and capsular release. The patient has requested authorization and coverage for AmnioFix injection. The Health Insurer has denied this request indicating that the requested service is considered investigational.
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 46-year-old female with a history of right hip pain. The patients hip pain has not responded to conservative treatment in addition to revision arthroscopic labral debridement, iliopsoas bursectomy, synovectomy, lysis of adhesions, and capsular release. The patient has requested authorization and coverage for AmnioFix injection. The Health Insurer has denied this request indicating that the requested service is considered investigational. While intraarticular stem cell injections for osteoarthritis have been evaluated in clinical trials, it is not currently a standard treatment for hip osteoarthritis. In addition, there is a lack of data regarding the clinical safety including the risk of complications after surgery, compatibility of donor stem cells, and long-term effectiveness. There is an insufficient amount of clinical data demonstrating superiority of amniotic fluid injections when compared with pharmacological treatments for osteoarthritis. Given the adverse biomechanical nature of a dysplastic hip, injections of amniotic stem cells, or stem cells of any derivative, are not likely to provide any lasting relief. Thus, the requested AmnioFix injection 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 requested service 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 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 1
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 array-based comparative genomic hybridization has become standard of care to investigate children with developmental delay, intellectual disability, autism spectrum disorders or congenital anomalies. Until recently, it was a diagnostic test that was employed when the first-line investigation of karyotype (chromosome analysis) returned normal; over the last several years it has emerged as a first-line investigation. This test has become an important and mainstream tool in the practice of clinical genetics. Its diagnostic utility had been convincingly demonstrated. Data have now emerged showing that actionable findings from chromosomal microarray justify its use. In sum, FirstStepDX Plus chromosomal microarray analysis 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.
| 0 |
A 47-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).
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Upheld
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Experimental
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Summary Reviewer 2
A 47-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).The physician reviewer found that there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than Nissen fundoplication or other surgical anti-reflux procedures. One evidence review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Similarly, a best-evidence review concluded that long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). In addition, adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval (Bauer, et al). Additionally, LINX more than surgical fundoplication is associated with severe dysphagia requiring endoscopic intervention (Sheu, et al). The currently available peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment such as surgical fundoplication (Sheu, et al; Ganz). The American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). For these reasons, the request for the LINX procedure 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 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 54-year-old male enrollee has requested reimbursement for radiofrequency neurolysis performed on 4/08/16. The Health Insurer has denied this request indicating that the services at issue were 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 1
A 54-year-old male enrollee has requested reimbursement for radiofrequency neurolysis performed on 4/08/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. In the documentation available for review, the providers plan is to perform a medial branch block first. Furthermore, the physical examination does not demonstrate any pain coming from the left side. It is unclear why a left side medial branch block or radiofrequency ablation would be done when physical examination does not corroborate pain coming from this area. Based on the submitted documentation, it is possible the patient would have experienced the same relief from a steroid injection alone without also having the increased risk from the radiofrequency ablation. There is a lack of support for the services at issue in this patients case. All told, radiofrequency neurolysis performed on 4/08/16 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.
| 0 |
The patient is a 36-year-old male with a history of posterior scleritis. The patient has requested
authorization and coverage for Acthar Gel.
This patient has also been treated with
methotrexate, and his scleritis is still not controlled.
Therefore, his provider has recommended that the patient be started
on the last line of treatment, Acthar Gel. This patient has already demonstrated good clinical
response to this medication in the past, with
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 36-year-old male with a history of posterior scleritis. The patient has requested
authorization and coverage for Acthar Gel. The physician reviewer found that Scleritis is
inflammation of the sclera, the wall of the eye, and is frequently associated with the
rheumatologic/autoimmune spectrum of diseases. It generally presents with significant pain and
can result in severe vision-threatening problems if left untreated. The first line of treatment for
uveitis is nonsteroidal anti-inflammatory drugs (NSAIDs). The second line of treatment is steroids.
Unfortunately, treatment with these agents is not without the risk of side effects such as
glaucoma and cataracts, as well as serious systemic side effects. This patient has failed to respond
to both. If the scleritis cannot be controlled adequately and safely with steroids, the third line of
treatment is a disease modifying antirheumatic drugs (DMARD), such as methotrexate. DMARDs
likewise carry the risk of serious side effects. This patient has also been treated with
methotrexate, and his scleritis is still not controlled. When steroids and DMARDs are unable to
control the disease process, then the patient is advanced to the fourth line of agents, which
includes use of a tumor necrosis factor inhibitor, such as Remicade (infliximab) or Humira
(adalimumab). Unfortunately, this patients disease has not been controlled even with the
addition of adalimumab. Therefore, his provider has recommended that the patient be started
on the last line of treatment, Acthar Gel. This patient has already demonstrated good clinical
response to this medication in the past, with resolution of symptoms and without intolerable
side effects. Although Acthar Gel is not an appropriate treatment for uveitis when used as a first
or second line treatment, this is not the case with this patient. This patient has been treated with
every class of medication other than Acthar Gel, and his uveitis is still not under control, despite
a level of treatment that has already resulted in serious side effects. He requires additional
treatment in an attempt to bring his scleritis under control. Additionally, he has already
demonstrated prior resolution on Acthar Gel. There is sufficient support for the requested
medication in this clinical setting. Therefore, Acthar Gel is medically necessary for the treatment
of this patient.
| 1 |
The patient is a 24-year-old male who presented to the emergency room on 5/21/22 with severe
right-sided lower back pain and one concerning episode of bloody emesis. The patient has
requested reimbursement for an inpatient stay from 5/21/22 through 5/23/22. 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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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 24-year-old male who presented to the emergency room on 5/21/22 with severe
right-sided lower back pain and one concerning episode of bloody emesis. The patient has
requested reimbursement for an inpatient stay from 5/21/22 through 5/23/22. 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 supports the medical necessity of the services at
issue. Antiphospholipid syndrome is a multisystem disease characterized by arterial, venous, or
microvascular thromboses. Denas and colleagues note that patients with antiphospholipid
syndrome are at increased risk for developing coronary artery disease resulting from coronary
thromboembolism, accelerated atherosclerosis leading to a plaque rupture, or microvascular
thrombosis. While not all troponin elevations are a result of acute coronary syndromes, all troponin
elevations are abnormal and in the absence of clinical evidence of ischemia, a search for an
alternative cause of myocardial necrosis is recommended. Several of these causes require urgent
medical evaluation, as does an ischemic evaluation in the setting of elevated troponin levels.
Myocarditis is one such cause, especially given its highly variable presentation, and was on the
differential in the evaluation of this patients elevated troponin levels. In this case, the patient was
at a particularly high risk for thromboses secondary to his antiphospholipid syndrome at the time
of admission due to the cessation of anticoagulation in preparation for a dental procedure. In this
clinical setting, given the timing of the patients presentation with stopping anticoagulation and an
otherwise unexplained troponin elevation, the services at issue were medically indicated to
evaluate for both ischemic and non-ischemic potentially life-threatening etiologies. Therefore, the
inpatient stay from 5/21/22 through 5/23/22 was medically necessary for the treatment of this
patient.
| 1 |
A 56-year-old male enrollee has requested reimbursement for the anesthesia service provided on 9/7/16. The Health Insurer has denied this request indicating that the service at issue was not medically necessary for evaluation of the enrollees risk for colon cancer and polypectomy.
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Upheld
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Medical Necessity
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Summary Reviewer
A 56-year-old male enrollee has requested reimbursement for the anesthesia service provided on 9/7/16. The Health Insurer has denied this request indicating that the service at issue was not medically necessary for evaluation of the enrollees risk for colon cancer and polypectomy. The physician reviewer found that the patient has an ASA preoperative physical status classification score of 1. Intravenous sedation performed by a non-anesthesiologist and non-certified registered nurse anesthetist is well supported in both clinical practice and in the research given a low preoperative physical status classification score (Heuss, et al; Trummel; Redondo-Cerezo, et al). While the billing office stated the patient failed moderate sedation, this prior failure of moderate sedation is not reflected in either the clinical records provided for review. All told, the anesthesia service provided on 9/7/16, was not medically necessary for evaluation of the patients medical condition. Based on the foregoing discussion, the service at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
The patient is a 58-year-old female with gastroesophageal reflux disease (GERD). Computed tomography (CT) scan of the abdomen on 3/14/17 showed mild wall thickening of the distal esophagus and a small hiatal hernia. Esophagogastroduodenoscopy (EGD) on 7/11/17 showed and irregular squamocolumnar junction at 40 cm, 1 cm hiatal hernia, scattered erosions in the gastric body and antrum, and normal appearing duodenal bulb and second portion of the duodenum. Biopsies showed acute and chronic inflammation at the gastroesophageal junction, Barretts esophagus, and minimal chronic gastritis. Esophagram on 9/19/17 showed normal esophageal peristalsis, no ulceration or stricture, and episodes of gastroesophageal reflux. EGD on 9/26/17 showed a normal-appearing esophagus, a Hill Grade 2 lower esophageal valve, and mild gastritis. Bravo pH study on 9/26/17 showed an elevated DeMeester score of 39.7, consistent with increased acid exposure. Per the providers note dated 10/9/17, the patient had a partial response to proton pump inhibitor therapy. The patient has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational.
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 58-year-old female with gastroesophageal reflux disease (GERD). Computed tomography (CT) scan of the abdomen on 3/14/17 showed mild wall thickening of the distal esophagus and a small hiatal hernia. Esophagogastroduodenoscopy (EGD) on 7/11/17 showed and irregular squamocolumnar junction at 40 cm, 1 cm hiatal hernia, scattered erosions in the gastric body and antrum, and normal appearing duodenal bulb and second portion of the duodenum. Biopsies showed acute and chronic inflammation at the gastroesophageal junction, Barretts esophagus, and minimal chronic gastritis. Esophagram on 9/19/17 showed normal esophageal peristalsis, no ulceration or stricture, and episodes of gastroesophageal reflux. EGD on 9/26/17 showed a normal-appearing esophagus, a Hill Grade 2 lower esophageal valve, and mild gastritis. Bravo pH study on 9/26/17 showed an elevated DeMeester score of 39.7, consistent with increased acid exposure. Per the providers note dated 10/9/17, the patient had a partial response to proton pump inhibitor therapy. The patient has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational. Overall, there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than standard surgical anti-reflux procedures. One evidence review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Another best-evidence review concluded that long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval (Bauer, et al). Additionally, LINX more than surgical fundoplication is associated with severe dysphagia requiring endoscopic intervention (Sheu, et al). Further, the American College of Gastroenterology (ACG) guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). For these reasons, the requested LINX 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 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 62-year-old female enrollee has requested reimbursement for the DecisionDx melanoma gene expression assay provided on 7/29/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 62-year-old female enrollee has requested reimbursement for the DecisionDx melanoma gene expression assay provided on 7/29/15. 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 currently, the National Comprehensive Cancer Network (NCCN) guidelines indicate that genetic testing such as the DecisionDx melanoma assay should be reserved for use only in a clinical trial setting. Peer-reviewed medical literature has not demonstrated that the DecisionDx melanoma assay changes treatment options or outcomes. Consequently, the DecisionDx melanoma gene expression assay provided on 7/29/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
patient is a 61-year-old female with prior instrumented lumbar fusion. The patient has
requested authorization and coverage for percutaneous or minimally invasive sacroiliac joint
arthrodesis.
response to diagnostic SI joint injections. In this case, the patient has clear
degenerative changes of the sacroiliac joint with positive temporary response to injection, pain
noted by a Fortin sign, and 5/5 provocative SI joint tests on exam.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 61-year-old female with prior instrumented lumbar fusion. The patient has
requested authorization and coverage for percutaneous or minimally invasive sacroiliac joint
arthrodesis. The physician reviewer found the current medical evidence supports the requested
services in this clinical setting. Sturesson and colleagues noted significant improvement with
surgical treatment for chronic sacroiliac joint mediated pain with minimally invasive fusion over
continued conservative management. Martin and colleagues noted, Minimally invasive
sacroiliac joint fusion provides clinically significant improvement in pain scores and disability in
most patients, across multiple studies and implant manufacturers. In addition, Martin and
colleagues noted, The authors of this manuscript recommend that in order to be candidates
for an MIS SI joint fusion, patients have at least 3 of 5 positive provocative exam maneuvers,
report pain consistent with that coming from the SI joint with a positive Fortin finger sign, and
have a positive response to diagnostic SI joint injections. In this case, the patient has clear
degenerative changes of the sacroiliac joint with positive temporary response to injection, pain
noted by a Fortin sign, and 5/5 provocative SI joint tests on exam. The requested services are
likely to decrease pain and increase function. Therefore, the requested percutaneous or
minimally invasive sacroiliac joint arthrodesis is medically necessary for the treatment of this
patient.
| 1 |
A 24-year-old male enrollee has requested reimbursement for services provided from 5/10/15 through 8/05/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health conditions.
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Upheld
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Experimental
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Summary Reviewer 2
A 24-year-old male enrollee has requested reimbursement for services provided from 5/10/15 through 8/05/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health conditions. The physician reviewer found the reason for entry into a wilderness program is unclear. There is no admitting history or intake, and the records do not document that he was seen by a physician of any specialty. There is no prior psychiatric history. It is unknown if other treatment modalities were attempted in the past at lower levels of care and what those outcomes were. Mental status examinations were not performed and response to medications does not appear to have been assessed. In sum, the records do not establish that services provided from 5/10/15 through 8/05/15 were likely to have been more efficacious than other treatment alternatives. 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.
| 0 |
A 65-year-old female enrollee has requested reimbursement for autonomic nerve function testing performed on 3/26/15. 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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Upheld
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Experimental
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Summary Reviewer 2
A 65-year-old female enrollee has requested reimbursement for autonomic nerve function testing performed on 3/26/15. 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 medical records provided for review do not indicate focal neurologic disturbance in regards to motor, sensory, reflex, coordination, gait or cranial nerve or cognitive function. The clinical notes do not document by history the presence of any issue of labile blood pressure, orthostatic hypotension, or passing out episodes. There is no indication of neuropathic pain being reported in terms of having hypersensitivity or allodynia. Autonomic nervous system testing is useful for evaluation of autonomic nervous system when there are autonomic nervous system related symptoms. The available medical records provided for review does not support the presence of subjective symptoms consistent with autonomic nervous system abnormality or indicate objective findings on physical examination of autonomic nervous system dysfunction. Therefore, autonomic nerve function testing performed on 3/26/15 was not 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 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 37-year-old male enrollee has requested reimbursement for laboratory testing performed on
6/05/20. 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 2
A 37-year-old male enrollee has requested reimbursement for laboratory testing performed on
6/05/20. 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 Cutaneous T-cell lymphoma affects the skin and tends to transform and spread.
Oncogenic microRNAs are stable epigenetic inhibitors often deregulated in the tumor and
detectable as biomarkers in non-cellular fractions of peripheral blood. The tumor-specific
expression of miR-155, miR-203, and miR-205 was shown to correctly diagnose cutaneous T-cell
lymphoma. The studies demonstrate that these microRNAs can be used as plasma biomarkers
for clinical cutaneous T-cell lymphoma monitoring. Quantitation of the selected microRNAs in
plasma of the patient was a specific and straightforward approach for evaluating his cutaneous
T-cell lymphoma activity. Therefore, laboratory testing performed on 6/05/20 was likely to have
been more beneficial than any available standard therapy.
| 0 |
A 63-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 3/08/19. 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 2
A 63-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 3/08/19. 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. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is unknown if the DecisionDx-Melanoma assay can be used to make clinical decisions. Thus, DecisionDx-Melanoma testing provided on 3/08/19 was not likely to have been more beneficial than any available standard therapy.
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A 28-year-old male enrollee has requested reimbursement for sTMS mini device provided on 8/06/18. The Health Insurer has denied this request and reported that the device at issue was not medically necessary for the treatment of the enrollees medical condition.
This patient has both episodic acute and chronic migraine. Although he has not responded
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Upheld
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Medical Necessity
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Summary Reviewer
A 28-year-old male enrollee has requested reimbursement for sTMS mini device provided on 8/06/18. The Health Insurer has denied this request and reported that the device at issue was not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that migraine is a disorder which affects approximately twelve percent of the population. Its severity varies from patient to patient from a benign to a severe debilitating disease state. This patient has both episodic acute and chronic migraine. Although he has not responded well to Pamelor as well as triptan medications for migraine therapy, there are several other options with good evidence of effectiveness that the patient had not tried and failed in both preventative and abortive categories. While sTMS mini device has shown some effectiveness in migraine, there is a lack of evidence to suggest it is more effective than other established therapies, many of which the patient has not tried. Per the medical evidence, sTMS may be appropriate for patients who respond poorly, cannot tolerate, or have contraindications to pharmacotherapy. At this time, there is a lack of support for the device at issue in this clinical setting. Therefore, sTMS mini device provided on 8/06/18 was not medically necessary for the treatment of this patient.
| 1 |
A 35-year-old female enrollee has requested reimbursement for (CPT code 86343) leukocyte histamine release test (LHR) dated on 10/20/15. The Health Insurer has denied this request indicating that the requested procedure are considered investigational for treatment of the enrollees chronic idiopathic urticariaT
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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 (CPT code 86343) leukocyte histamine release test (LHR) dated on 10/20/15. The Health Insurer has denied this request indicating that the requested procedure are considered investigational for treatment of the enrollees chronic idiopathic urticariaThe physician reviewer found that there is a lack of support in the medical literature for LHR test in a clinical setting for the evaluation of chronic idiopathic urticarial (CIU). There is some utility of the LHR test as a research tool. Current evidence does not support routine clinical use of autologous serum skin testing or for LHR/basophil histamine responsiveness for the diagnosis of CIU. Chronic urticaria index is a test which consists of basophil (leukocyte) histamine release assay. If the test is positive (index greater than 10), the patient may have chronic autoimmune urticaria. The test is nonspecific. It measures only histamine release from the patients cells and compares it to a normal control. It does not measure antibodies or autoantibodies. Patients with a chronic form of urticaria with a positive functional anti-FceR test result likely have an autoimmune basis for their disease. A positive result does not indicate which autoantibody is present. This LHR test is usually combined with thyroid function, antithyroid microsomal titers, and peroxidase antibody titers. The result is reported as an index value. The reference range for a healthy non-CU population is less than 10. Values greater than or equal to 10 indicate that donor basophils were stimulated by patient serum to release histamine. The larger the value, the more histamine released. The CU index test (basophil histamine release test, AKA, Leukocyte histamine release test) has not been approved or cleared by the U.S. Food and Drug Administration. Although commercial assays are now available, the utility of testing for basophil histamine release and autoantibodies to the high-affinity IgE receptor or autoantibodies to IgE have not been established. Whether detection of basophil histamine release or autoantibodies identifies a clinically unique population or will lead to a change in management is also currently unclear. The American Academy of Allergy and Immunology guidelines for this test indicate it is primarily used in a research setting. All told, (CPT code 86343) leukocyte histamine release test (LHR) that was rendered on 10/20/15 was not likely to be more effective than the available standard methods of evaluating this patient. 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 |
A 61-year-old female enrollee has requested reimbursement of collagen crosslinking test (CPT 82523) performed on 9/07/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 61-year-old female enrollee has requested reimbursement of collagen crosslinking test (CPT 82523) performed on 9/07/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the superior efficacy of the services at issue. Reginster and colleagues noted that there are consistent data showing that short-term changes in biochemical markers of bone turnover may be significant predictors of future changes in bone mineral density or fracture reduction, hence suggesting that bone turnover markers play a significant role in the monitoring of anti-osteoporosis therapy. The use of markers of bone turnover is standard practice among endocrinologists and other specialists in osteoporosis. It is used as a guide to monitor compliance and efficacy of treatment. It also helps to identify non-responders that require additional work-up for other causes of osteoporosis. Thus, collagen crosslinking test (CPT 82523) performed on 9/07/18 was likely to have been more effective than other methods of evaluating this patient.
| 0 |
A 34-year-old male enrollee has requested authorization and coverage for computed tomography (CT) of the abdomen and CT of the chest (74178 and 71270). The Health Insurer has denied this request and reported that the requested services are not medically necessary 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
A 34-year-old male enrollee has requested authorization and coverage for computed tomography (CT) of the abdomen and CT of the chest (74178 and 71270). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that there is agreement by the National Comprehensive Cancer Network, which noted, A PET-CT scan should be performed to confirm complete remission (CR). Patients in CR should receive clinical follow-up with a history and physical examination and laboratory studies (e.g., complete blood cell count, comprehensive metabolic panel, lactate dehydrogenase level) every three to six months for five years and then yearly or as clinically indicated. Imaging studies (CT scan) should be performed no more often than every six months for two years after the completion of treatment, and then only as clinically indicated. Considering these many studies and advising bodies, the requested services are not medically indicated. Therefore, CT of the abdomen and CT of the chest (74178 and 71270) are not medically necessary for the evaluation of this patient.
| 0 |
A 30-year-old female enrollee has requested reimbursement for ultrasound and reading of the
ultrasound on 8/2/22. The Health Insurer has denied this request and reported that the service at
issue was investigational for the evaluation of the enrollees pregnancy.
In this case, notes dated 6/2/22
reported a body mass index of 28 kg/m2, the demise of a dichorionic twin at seven weeks, and the
finding of a uterine synechia.
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Overturned
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Medical Necessity
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Summary Reviewer 1
A 30-year-old female enrollee has requested reimbursement for ultrasound and reading of the
ultrasound on 8/2/22. The Health Insurer has denied this request and reported that the service at
issue was investigational for the evaluation of the enrollees pregnancy.
The physician reviewer found that American Institute of Ultrasound Medicine (AIUM) notes that
detailed obstetric ultrasound examination is not intended to be the routine ultrasound examination
performed for all pregnancies. Rather, the AIUM notes that it is an indication-driven examination
performed for a known or suspected fetal anatomic abnormality, known fetal growth disorder,
genetic abnormality, or increased risk for a fetal anatomic or genetic abnormality or placenta
accreta spectrum. The Society for Maternal-Fetal Medicine (SMFM) notes that the performance
of the detailed fetal anatomic examination should be rare outside referral practices with special
expertise in the identification and diagnosis of fetal anomalies. In this case, notes dated 6/2/22
reported a body mass index of 28 kg/m2, the demise of a dichorionic twin at seven weeks, and the
finding of a uterine synechia. However, these are not indications that the more detailed fetal
ultrasound at issue was likely to be beneficial than standard, routine ultrasound screening
Therefore, ultrasound and reading of the ultrasound on 8/2/22 was not likely to have been more
beneficial for evaluation of the patients condition than any available standard therapy.
| 1 |
A 36-year-old female enrollee has requested reimbursement for gene testing (MaterniT21 Plus) performed on 2/03/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pregnancy.
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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 gene testing (MaterniT21 Plus) performed on 2/03/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pregnancy. The physician reviewer found the methods for fetal aneuploidy detection involve either invasive technique that place the fetus at risk or non-invasive prenatal testing which uses cell free fetal DNA from the plasma of pregnant women. Cell free fetal DNA testing is an option that can be used as a primary screening test in women at an increased risk of aneuploidy. However, the accuracy of screening for aneuploidy is limited in multiple gestation pregnancies. The data regarding the performance of cell free DNA screening in two gestations are limited. Thus, gene testing (MaterniT21 Plus) performed on 2/03/15 was not 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 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 67-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees bilateral sacroiliac joint pain status post revision lumbar surgery.
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Upheld
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Experimental
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Summary Reviewer 2
A 67-year-old male enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees bilateral sacroiliac joint pain status post revision lumbar surgery. The physician reviewer found that the medical records indicate that the patient has had previous lumbar fusion surgery. Currently, there is a lack of documentation of sacroiliac joint instability, fracture, or tumor. For this reason, the criteria for sacroiliac joint fusion have not been met. Further, long-term outcomes and complications are not well-defined for use in this clinical setting. Given these findings, the requested sacroiliac joint fusion 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 service 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 29-year-old female enrollee has requested authorization and coverage for compound medication of sirolimus cream 1%. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has Klippel Trenaunay syndrome.
The documentation noted venous malformations associated with bleeding and lymphatic drainage. She has had treatment previously with laser, interferon and sclerotherapy, without improvement.
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Overturned
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Experimental
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Summary Reviewer 2
A 29-year-old female enrollee has requested authorization and coverage for compound medication of sirolimus cream 1%. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollee, who has Klippel Trenaunay syndrome. The physician reviewer found that the current medical evidence supports the requested medication in this patients case. The documentation noted venous malformations associated with bleeding and lymphatic drainage. She has had treatment previously with laser, interferon and sclerotherapy, without improvement. There is evidence in the medical literature indicating that sirolimus, both topical and oral, is effective for these symptomatic vascular lesions. This patient has a rare condition, and there is a lack of other treatment alternatives available. In sum, compound medication of sirolimus cream 1% is likely to be superior over other treatment options. 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 |
A 48-year-old female enrollee has requested reimbursement for residential substance use disorders treatment provided from 5/4/15 through 5/19/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
on 4/24/15. Laboratory analysis revealed mild elevation of hepatic enzymes and a slightly elevated mean corpuscular volume on 4/26/15.
ergies, the patient had an unremarkable physical examination on 4/27/15. The presence of depression, and
In addition, the patient participated in therapeutic programming which helped erode her treatment ambivalence. On 5/4/15, she had a willingness to participate fully in treatment. Finally, the patient had a safe residence. Her family was described as supportive. She identified two close friendships during her psychosocial assessment. She was motivated
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Upheld
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Medical Necessity
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Summary Reviewer
A 48-year-old female enrollee has requested reimbursement for residential substance use disorders treatment provided from 5/4/15 through 5/19/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found due to the lengthy history of drinking and increased yet inconsistent reports of consumption, a residentially based detoxification and preliminary introduction to chemical dependency treatment was safe, appropriate and consistent with good medical practice. However, the clinical documentation does not demonstrate the medical necessity of treatment in a 24-hour supervised setting as of 5/4/15. There is no evidence of the emergence of any late alcohol withdrawal symptomatologies. It appears that benzodiazepine medication, a common treatment for alcohol withdrawal, was last administered on 4/24/15. Laboratory analysis revealed mild elevation of hepatic enzymes and a slightly elevated mean corpuscular volume on 4/26/15. Such findings of transaminitis and macrocytosis are not uncommon in drinkers and often resolve rather promptly with sobriety, which is what occurred in this case. Despite the diagnoses of gastroesophageal reflux disease and seasonal/environmental allergies, the patient had an unremarkable physical examination on 4/27/15. The presence of depression, and anxiety dating back to childhood, were significant but not generating a psychiatric syndrome that warranted treatment in a residential setting. In addition, the patient participated in therapeutic programming which helped erode her treatment ambivalence. On 5/4/15, she had a willingness to participate fully in treatment. Finally, the patient had a safe residence. Her family was described as supportive. She identified two close friendships during her psychosocial assessment. She was motivated for care. Despite the diagnoses of depression anxiety, the patient had no safety concerns. She had no prior history of chemical dependency treatment in a less restrictive setting such as anti-craving medication, community programming, outpatient specialty care, intensive outpatient services or partial hospitalization. There was no evidence to suggest that a less restrictive treatment setting would have been insufficient. Thus, the residential rehabilitation services at issue were 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 26-year-old male enrollee has requested reimbursement for cervical discography injection provided on 6/25/20. The Health Insurer indicates that the services at issue were investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue.
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Upheld
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Experimental
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Summary Reviewer 2
A 26-year-old male enrollee has requested reimbursement for cervical discography injection provided on 6/25/20. The Health Insurer indicates that the services at issue were investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. The physician reviewer found that neck pain in patients with clinical evidence of radiculopathy or myelopathy can be easily localized by clinical, electrodiagnostic, and imaging evidence and treated by anterior cervical surgery. Cervical discography is indicated when the pain is discogenic, but the imaging studies do not show a herniation or localized cervical spondylosis. Discography can localize the pain source by distinguishing between the painful, symptomatic discs from the asymptomatic non-painful discs. Discogenic neck pain alone without evidence of cervical disc herniation or cervical spondylosis constitutes a significant percentage of patients with chronic neck pain who are resistant to conservative treatment, as in this case. For patients who continue to have refractory neck pain and fail to respond to conservative treatment, anterior cervical fusion surgery or artificial cervical disc replacement may be a better choice, and preoperative cervical discography can guarantee that the pain source will be addressed, resulting in an excellent surgical result. Therefore, cervical discography injection provided on 6/25/20 was likely to have been more beneficial than other available standard therapy.
| 0 |
A 54-year-old male has requested reimbursement for Anser VDZ test provided on 7/17/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.
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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 Anser VDZ test provided on 7/17/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that Entyvio (vedolizumab) is a humanized monoclonal antibody. This medication is specifically indicated for adults with moderately to severely active ulcerative colitis or Crohns disease who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid. Entyvio is indicated to induce and maintain clinical response/clinical remission, achieve corticosteroid-free remission and improve the endoscopic appearance of the mucosa. Contemporary literature supports that vedolizumab response, and its long-term effectiveness, are not based on drug-antibody titers, but on clinical factors. At this time, it has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. In this patients case, he was not experiencing significant gastrointestinal symptomatology at the time of the testing. In sum, the records fail to establish the superior efficacy of the Anser VDZ test provided on 7/17/17. 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 |
The parent of a 14-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 10/7/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease.
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a 14-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 10/7/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the testing at issue was likely to be more effective for this patient than other available treatment options. Monitoring of both serum drug levels of infliximab as well as antibodies to infliximab have been recognized as crucial elements in maintaining long-term success and has been shown to improve the health of patients by preserving response to infliximab. A study by Gisbert and Panes noted cumulative loss of response to infliximab in approximately 13% of patients per year. In this case, a question was raised regarding whether the patients clinical symptoms were suggestive of loss of response to infliximab or some other cause, and subsequent notation reveals that the results of the test were interpreted to the benefit of the patient by leaving the pre-test dosing schedule unchanged. In this clinical setting, drug level monitoring 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 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 62-year-old male enrollee has requested reimbursement for the Life Vest provided on 1/20/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees paroxysmal atrial flutter and atrial fibrillation with rapid ventricular response.
has a newly diagnosed non-ischemic cardiomyopathy, possibly tachycardia-induced, due to rapidly
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Upheld
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Experimental
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Summary Reviewer 2
A 62-year-old male enrollee has requested reimbursement for the Life Vest provided on 1/20/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees paroxysmal atrial flutter and atrial fibrillation with rapid ventricular response. The physician reviewer found that the Life Vest wearable defibrillator is a U.S. Food and Drug Administration (FDA) approved device for prevention of sudden cardiac death for patients at increased risk for life threatening arrhythmias, ventricular tachycardia and ventricular fibrillation. However, the efficacy of the Life Vest for specific groups of patients is still being determined. For patients with acute heart failure, such as the patient in this case, the usefulness of the device is still being evaluated (Klein, et al). Zishiri and colleagues reported data that support the use of the Life Vest wearable defibrillator in the post-myocardial infarction phase, or immediately post-revascularization after myocardial infarction, which is not the case for this patient. Moreover, this patient does not meet current indications for an implantable cardioverter defibrillator, which may support an indication for the Life Vest. He has a newly diagnosed non-ischemic cardiomyopathy, possibly tachycardia-induced, due to rapidly conducted atrial flutter. All told, the current peer-reviewed medical literature does not indicate the Life Vest provided to this patient on 1/20/14 was likely to have been 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.
| 1 |
A 55-year-old female enrollee has requested authorization and coverage for bariatric surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees morbid obesity.
The patient has a body mass index which is greater than 35 kg/m2. Specifically, the records documented a body mass index of 60.53 kg/m2. The patient has more than one comorbid condition related to obesity. The patient has completed a multidisciplinary evaluation that did not reveal any obvious dietary or behavioral barriers. Medical clearance,
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Overturned
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Medical Necessity
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Summary Reviewer
A 55-year-old female enrollee has requested authorization and coverage for bariatric surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees morbid obesity. The physician reviewer found that submitted documentation supports the medical necessity of the requested services in this patients case. This patient meets the standard criteria for bariatric surgery, including the American Society for Metabolic and Bariatric Surgery criteria. The patient has a body mass index which is greater than 35 kg/m2. Specifically, the records documented a body mass index of 60.53 kg/m2. The patient has more than one comorbid condition related to obesity. The patient has completed a multidisciplinary evaluation that did not reveal any obvious dietary or behavioral barriers. Medical clearance, support and attestation of prior failed weight loss efforts were provided. The medical evidence supports the requested services in this clinical setting. Thus, the requested bariatric 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.
| 1 |
A 56-year-old male enrollee has requested reimbursement for an endoskeletal left transtibial prosthesis provided on 1/03/19. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient has requested reimbursement for a microprocessor controlled foot/ankle.
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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 an endoskeletal left transtibial prosthesis provided on 1/03/19. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient has requested reimbursement for a microprocessor controlled foot/ankle. There are many studies that discuss the use of a microprocessor controlled foot/ankle. Many of the studies described some improvement in physiologic/kinematic parameters, such as residual knee moment, increased stance phase dorsiflexion, and vertical ground reaction forces. However, these studies did not identify how these improvements translated into real world functional benefit, such as improved walking endurance, reduction in falls/instability, or reduction in skin friction/breakdown on the residual limb. The physiologic/kinematic benefits do not always correlate with clinical improvement. Hahn and colleagues noted, aWhile the perception of benefits regarding the negotiation of uneven terrain and slopes is very high, the correlation to product preference is moderate.a Users identified 80-90% improvement with walking on uneven ground, ascending, and descending ramps. However, only 40% of users preferred the microprocessor controlled foot. As such, it can be difficult to extrapolate findings regarding isolated physiologic/kinematic benefits to patient preference, let alone extrapolating that data to sustained functional improvement. As another example, many of the studies focused on an isolated point in time intervention in a gait lab or other clinical setting. As such, these studies had participants perform tasks in a clinical setting and did not evaluate whether the use of this device in a real world home setting would offer similar functional gains. Patients frequently have unexpected responses to adaptive equipment, as evidenced by a study by Lamers and colleagues. This study demonstrated that despite the microprocessor-controlled ankle behaving similarly for each user, there were marked differences in individual responses. The authors noted, aFor instance, two users switched from a forefoot landing pattern with the microprocessor-controlled ankle locked at neutral angle to rearfoot landing when the microprocessor-controlled ankle adapted to the slope, while two maintained a forefoot and three maintained a rearfoot landing pattern across conditions.a As such, it can be difficult to extrapolate benefits from a clinical setting to the real world day-to-day environment. Thus, the endoskeletal left transtibial prosthesis provided on 1/03/19 was not likely to have been more beneficial than other available treatment options.
| 1 |
A 64-year-old male insured has requested reimbursement for laboratory testing performed on
5/13/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds acute deep vein thrombosis (DVT).
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Upheld
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Experimental
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Summary Reviewer 3
A 64-year-old male insured has requested reimbursement for laboratory testing performed on
5/13/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds acute deep vein thrombosis (DVT). The
physician reviewer found that currently recommended indications for thrombophilia testing
include idiopathic or recurrent venous thromboembolism, a first episode of venous
thromboembolism at before 40 years of age, a family history of venous thromboembolism,
venous thrombosis in an unusual vascular territory, and neonatal purpura fulminans or warfarin-
induced skin necrosis (Nakashima and Rogers). As noted in the medical literature, when two or
more of these thrombosis characteristics are present, thrombophilia testing should be
considered. In this patients case, the patient meets only one of the requirements in that he has
a possible idiopathic unprovoked deep vein thrombosis. However, in the absence of a family
history concerning for a familial hypercoagulable state, Factor V Leiden mutation and
prothrombin G20210A gene mutations were highly unlikely to be detected. Given these findings,
the laboratory testing performed on 5/13/22 was not likely to be more beneficial for evaluation
of the patients medical condition than any available standard therapy.
| 1 |
A 40-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with
dilation of eustachian tube (i.e. balloon dilation); bilateral, on 8/26/21. The Health Insurer has
denied this request and reported that the service at issue was investigational for the treatment of
the enrollees bilateral eustachian tube dysfunction.
. In this case, notes dated 8/26/21 reported that the patient had previously failed intranasal
corticosteroid therapy, and tympanostomy tube placement had resulted in various adverse side
effects.
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Overturned
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Experimental
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Summary Reviewer 2
A 40-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with
dilation of eustachian tube (i.e. balloon dilation); bilateral, on 8/26/21. The Health Insurer has
denied this request and reported that the service at issue was investigational for the treatment of
the enrollees bilateral eustachian tube dysfunction. The physician reviewer found that based on
available clinical documentation, the service at issue was likely to have been more beneficial in
managing the patients eustachian tube dysfunction, as compared to other available standard
therapies. In this case, notes dated 8/26/21 reported that the patient had previously failed intranasal
corticosteroid therapy, and tympanostomy tube placement had resulted in various adverse side
effects. In a meta-analysis of studies regarding medical management for eustachian tube
dysfunction, Mehta and colleagues found that intranasal corticosteroids were not efficacious,
improving only 11% to 18% of chronic cases. In a meta-analysis of eustachian tube balloon dilation outcomes, including data from two randomized controlled trials comparing it to medical therapy,
Froehlich and colleagues found improvement in subjective symptoms and objective clinical
metrics after eustachian tube balloon dilation lasting up to 12 months. Therefore,
nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral, on
8/26/21, was likely to have been more beneficial for treatment of the patients condition than any
available standard therapy.
| 1 |
A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/06/16. 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
|
Summary Reviewer 1
A 47-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/06/16. 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 breast tomosynthesis provides advantages to radiologists interpreting mammograms, especially in women with dense tissue. 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 diagnostic accuracy and detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of tomosynthesis to the usual two-dimensional protocol 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 51-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records document a large osteochondral defect of the talus.
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Overturned
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Experimental
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Summary Reviewer 3
A 51-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records document a large osteochondral defect of the talus. Osteochondral lesions of the talus are difficult to treat because of the absence of healing reaction in damaged articular cartilage. Matrix-induced autologous chondrocyte implantation has been shown to be an effective method for treating cartilage lesions that fail to heal with the usual procedures, such as debridement and microfracture. The study by Kreulen and colleagues assessed the seven-year clinical follow-up data of matrix induced autologous chondrocyte implantation and demonstrated successful long-term healing. Ng and colleagues noted that autologous chondrocyte implantation and matrix-associated autologous chondrocyte implantation have shown promising results in osteochondral defects of the talus. This patients treatment options are limited. Thus, autologous chondrocyte implantation is likely to be more beneficial than other treatment options.
| 1 |
A 21-year-old male enrollee has requested reimbursement for corneal collagen crosslinking performed on 9/04/18. The Health Insurer has denied this request and reported that the services at issue were 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 2
A 21-year-old male enrollee has requested reimbursement for corneal collagen crosslinking performed on 9/04/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that based on the patients vision loss and progression, corneal collagen crosslinking was the most appropriate and effective treatment available. The medical evidence has demonstrated that corneal collagen crosslinking is a safe and effective procedure for stabilizing corneal ectasia and potentially delaying or preventing the need for full-thickness corneal transplant. Furthermore, there was a lack of treatment options available to slow or halt disease progression. In sum, corneal collagen crosslinking performed on 9/04/18 was likely to have been of greater benefit than other treatment options.
| 0 |
A 20-year-old female enrollee has requested reimbursement for Anser IFX diagnostic test performed on 2/8/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees chronic ulcerative pancolitis.T
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Upheld
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Experimental
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Summary Reviewer 3
A 20-year-old female enrollee has requested reimbursement for Anser IFX diagnostic test performed on 2/8/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees chronic ulcerative pancolitis.The physician reviewer found that management of ulcerative colitis using Anser IFX has not been standardized, and standardized recommendations for management based on test results (change to a different medication versus increase in dose) have not been formed (Kornbluth, et al). The use of Anser IFX to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in high-quality controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to Remicade (infliximab), nor have threshold drug levels been established (Steenholdt, et al). Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response (Vande Casteele, et al; Nanda, et al). A recent study by Adedokun and colleagues concluded that prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies. One study, with some patients undergoing dose intensification following initial non-response, showed no difference in serum levels of infliximab between patients who responded to dose intensification versus those who did not (Pariente, et al). Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing (Vande Casteele, et al). A systematic review reported that future prospective controlled studies are needed, especially considering anti-TNF levels are influenced by several variables that can fluctuate over time and among individuals (Yarur, et al). Therefore, there is a lack of support in the clinical literature as to the superiority of Anser IFX testing performed on 2/8/16 when compared to other treatment options for the evaluation of this patients medical condition. Based upon the information set forth above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 52-year-old male enrollee has requested reimbursement for ExoDx Prostate/ExosomeDx
Prostate (Intelliscore) performed on 12/23/20. 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 2
A 52-year-old male enrollee has requested reimbursement for ExoDx Prostate/ExosomeDx
Prostate (Intelliscore) performed on 12/23/20. 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 several ancillary tests have been developed
to better define a patient in need of an initial biopsy or repeat biopsy. ExoDx Prostate
(IntelliScore) is a non-invasive, urinary 3-gene expression test in which the results of the assay
are adjunctive to the ordering providers clinical judgment and work-up of the patient in the
determination of whether a prostate biopsy is necessary. The ExoDx Prostate (IntelliScore) was
clinically validated to discriminate patients with higher grade prostate cancer from those with
more indolent lower grade cancer and benign disease. For this reason, it may be useful in deciding
whether a patient would benefit from a prostate biopsy. National Comprehensive Cancer
Network (NCCN) guidelines recommend ExoDx testing for some men as an option prior to
invasive prostate biopsy in order to further risk stratify them. In this case, the services at issue
were appropriate to assist in better delineating this patients risk for prostate cancer. Therefore,
ExoDx Prostate/ExosomeDx Prostate (Intelliscore) performed on 12/23/20 was likely to have
been more beneficial than any available standard therapy.
| 1 |
A 48-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health outpatient treatment, two times per week, from 1/15/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions.
The records indicate that she is seeing a psychiatrist on a regular basis.
Per the records, this patient has a history of bipolar disorder and has had prior hospitalizations as well as suicidal ideation. At her appointment in February 2019, she was having suicidal ideation. Thus, she does need frequent therapy in order to help prevent possible suicide attempts as well as further inpatient acute admissions. The records
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Upheld
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Medical Necessity
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Summary Reviewer
A 48-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health outpatient treatment, two times per week, from 1/15/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that there is no description of the type of therapy. The records indicate that she is seeing a psychiatrist on a regular basis. The clinical progress notes from the psychiatrist do not recommend a specific interval for psychotherapy sessions. There are no other recommendations in the clinical records that specify frequency. Per the records, this patient has a history of bipolar disorder and has had prior hospitalizations as well as suicidal ideation. At her appointment in February 2019, she was having suicidal ideation. Thus, she does need frequent therapy in order to help prevent possible suicide attempts as well as further inpatient acute admissions. The records note emotional dysregulation and symptoms of bipolar disorder. Based on the records, the patient would likely benefit from therapy on a weekly basis. The literature indicates that psychotherapy is effective for the management of symptoms of bipolar disorder. Scott and colleagues noted that efficacy studies demonstrate that adjunctive psychological treatments for individuals with bipolar disorders reduce relapse risk. The literature does not specify the exact frequency of psychotherapy. Typically, the frequency is dictated by the symptom presentation of the patient. In this patients case, weekly outpatient services were and are medically necessary. Weekly therapy is a standard frequency in behavioral health treatment. There is no indication or clinical recommendation for twice weekly therapy. Therefore, mental health outpatient treatment, two times per week, from 1/15/19 forward was not and is not medically necessary for the treatment of this patient.
| 1 |
The patient is a 58-year-old male with prostate cancer. On 4/27/17, prostate biopsies were performed for a prostate-specific antigen (PSA) level of 5.1. Pathology report noted prostatic carcinoma, with highest Gleason score 3+3=6. Three cores were positive. The patient has requested reimbursement for Oncotype DX Prostate Assay performed on 9/29/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.
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Overturned
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Experimental
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Summary Reviewer 2
The patient is a 58-year-old male with prostate cancer. On 4/27/17, prostate biopsies were performed for a prostate-specific antigen (PSA) level of 5.1. Pathology report noted prostatic carcinoma, with highest Gleason score 3+3=6. Three cores were positive. The patient has requested reimbursement for Oncotype DX Prostate Assay performed on 9/29/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. National Comprehensive Cancer Network (NCCN) guidelines note that men who are status post biopsy with low or favorable intermediate-risk disease may consider the use of Oncotype DX Prostate Assay. Retrospective studies have shown that molecular assays performed on prostate biopsy or radical prostatectomy specimens provide prognostic information independent of NCCN risk groups. These include, but are not limited to, likelihood of biochemical progression after radical prostatectomy or external beam therapy, and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. Men with clinically localized disease may consider the use of tumor-based molecular assays. It is considered a standard of care in guiding treatment decision making. In sum, Oncotype DX Prostate Assay performed on 9/29/17 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 56-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 6/04/21. 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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Upheld
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Experimental
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Summary Reviewer 2
A 56-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 6/04/21. The Health Insurer has denied this request and reported that the services at
issue were investigational for the evaluation of the enrollees medical condition.
found that per the National Comprehensive Cancer Network guidelines, the recommended therapy
for stage IA cutaneous melanoma is history and physical and only imaging to evaluate certain signs
and symptoms. The recommended primary category 1A treatment is wide excision of the
melanoma. There is no indication for a gene expression assay to determine the primary course of
treatment as no sentinel lymph node biopsy is needed for stage IA cutaneous melanomas. Marchetti
and colleagues concluded, The prognostic ability of GEP tests among patients with localized
melanoma varied by AJCC stage and appeared to be poor at correctly identifying recurrence in
patients with stage I disease, suggesting limited potential for clinical utility in these patients.
Therefore, DecisionDx-Melanoma testing performed on 6/04/21 was not likely to have been more
beneficial than any available standard therapy.
| 0 |
patient is a 61-year-old female who has been diagnosed with amyotrophic lateral sclerosis. In a letter dated 12/03/19, the provider noted that the patient has significant arm and leg weakness.
This patient has been diagnosed with amyotrophic lateral sclerosis. She requires significant assistance with movement in bed, per the medical records. Due to poor mobility in bed, the patient is at high risk for decubitus ulcers. These ulcers
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 61-year-old female who has been diagnosed with amyotrophic lateral sclerosis. In a letter dated 12/03/19, the provider noted that the patient has significant arm and leg weakness. The physician reviewer found that the submitted documentation supports the medical necessity of the requested equipment. This patient has been diagnosed with amyotrophic lateral sclerosis. She requires significant assistance with movement in bed, per the medical records. Due to poor mobility in bed, the patient is at high risk for decubitus ulcers. These ulcers can lead to significant infections and can cause the patient to develop sepsis. The Freedom Bed will assist the patient in maintaining movement while in bed, thereby reducing the likelihood of developing decubitus ulcers. Therefore, the use of the Freedom Bed is indicated to reduce pain and risk of complications. Per Bromberg and colleagues, there is a specific timeline for the need for durable medical equipment for patients with amyotrophic lateral sclerosis. This includes the use of items similar to the Freedrom Bed. Therefore, the requested Freedom Bed is medically necessary for the treatment of this patient.
| 1 |
The patient is a 62-year-old male who had developed malignant melanoma on the skin of left parietal scalp above the ear, 1.0 mm in Breslow thickness. The DecisionDx-Melanoma gene assay performed on 1/12/17 revealed class 1A molecular signature associated with a low risk of recurrence within five years. The patient has requested reimbursement for the DecisionDx-Melanoma test (84999) performed on 1/12/17. The Health Insurer denied this request for reimbursement and noted that the services at issue were considered investigational for evaluation of this patient.
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Upheld
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Experimental
|
Summary Reviewer 1
The patient is a 62-year-old male who had developed malignant melanoma on the skin of left parietal scalp above the ear, 1.0 mm in Breslow thickness. The DecisionDx-Melanoma gene assay performed on 1/12/17 revealed class 1A molecular signature associated with a low risk of recurrence within five years. The patient has requested reimbursement for the DecisionDx-Melanoma test (84999) performed on 1/12/17. The Health Insurer denied this request for reimbursement and noted that the services at issue were considered investigational for evaluation of this patient. There is some support for the DecisionDx-Melanoma signature as an independent predictor of metastasis risk. However, there is a lack of peer reviewed published studies as to its superior efficacy when compared to other standard modalities. Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages 0-IV. DecisionDx-Melanoma assay assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as class 1, consistent with a low risk of metastasis, or class 2, suggestive of a high risk of metastasis. While the majority of clinical stage I patients will be disease free at five years, some stage I patients will develop advanced disease. According to the results of analysis of this patients melanoma performed with DecisionDx-Melanoma assay, the tumor was classified as class 1 with a low risk of near term (within five years) metastatic disease. In sum, while there is some support in the medical literature for the efficacy of the services at issue, DecisionDx-Melanoma test (84999) performed on 1/12/17 was not likely to have been of greater benefit than the available standard methods for the evaluation of patient. Therefore, for the reasons stated above, the services at issue were not likely to have been 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 54-year-old female with a family history of a sister who died from ovarian cancer, father with colon cancer, and grandmother with possible primary peritoneal cancer. The patient was noted to have a 1 cm ovarian cyst with no concerning features. Her uterus was noted to be normal. The patients evaluation included detailed genetic consultation and testing. The testing did not show any high risk mutations.
. The patient has requested authorization and coverage for hysterectomy. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary. The patient has elected to undergo a prophylactic hysterectomy and bilateral salpingo-oophorectomy due to her family history.
|
Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 54-year-old female with a family history of a sister who died from ovarian cancer, father with colon cancer, and grandmother with possible primary peritoneal cancer. The patient was noted to have a 1 cm ovarian cyst with no concerning features. Her uterus was noted to be normal. The patients evaluation included detailed genetic consultation and testing. The testing did not show any high risk mutations. As a result, the genetic counselor did not place the patient in a high risk category for gynecologic malignancies. The patient has requested authorization and coverage for hysterectomy. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary. The patient has elected to undergo a prophylactic hysterectomy and bilateral salpingo-oophorectomy due to her family history. However, genetic counseling and testing do not place her in a high risk category for epithelial ovarian cancer, fallopian tube cancer or uterine cancer. Current recommendations reserve risk reducing surgery for patients in the highest risk categories with genetic mutations such as BRCA1, BRCA 2 and Lynch syndrome. Based on the patients family history and genetic testing results, she does not have a strong clinical indication for surgical cancer prophylaxis. Accordingly, the requested hysterectomy is not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested surgery is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 25-year-old male enrollee has requested reimbursement for corneal crosslinking provided on 8/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
conus. This patient was diagnosed with keratoconus and reported increasing blurriness in both eyes. In this case, the patient has two major risk factors
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Overturned
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Experimental
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Summary Reviewer 2
A 25-year-old male enrollee has requested reimbursement for corneal crosslinking provided on 8/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that Corneal cross-linking has been approved as a treatment of progressive (unstable) keratoconus. This patient was diagnosed with keratoconus and reported increasing blurriness in both eyes. In this case, the patient has two major risk factors suggesting that his keratoconus is likely to progress. Given his young age, he is likely to progress. Second, by history, he reports that his vision has declined in the last two years. There is a lack of other treatment options in this clinical setting. In sum, corneal cross-linking provided on 8/06/18 was likely to have been more beneficial than other available treatment options.
| 1 |
A 63-year-old male enrollee has requested authorization and coverage for laparoscopy, surgical, esophagogastric fundoplasty (LINX). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
In this case, the patient has GERD based on pH recording. However, in this case, the patient has both a large hiatal hernia and Barretts esophagus.
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Upheld
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Experimental
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Summary Reviewer 3
A 63-year-old male enrollee has requested authorization and coverage for laparoscopy, surgical, esophagogastric fundoplasty (LINX). 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 according to Lipham and colleagues, Sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation. Moreover, according to the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in regards to the safety and effectiveness of LINX Reflux Management System, On the basis of the available evidence, the LINX device should be an option available to patients and providers for the management of medically refractory GERD. In this case, the patient has GERD based on pH recording. However, in this case, the patient has both a large hiatal hernia and Barretts esophagus. There is a lack of studies supporting the LINX device for patients with these conditions. As such, the requested services 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 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 53-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulator. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.
This patient has failed therapy for obstructive sleep apnea, including trials of conservative management and prior surgical intervention.
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Upheld
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Medical Necessity
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Summary Reviewer
A 53-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulator. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested services. This patient has failed therapy for obstructive sleep apnea, including trials of conservative management and prior surgical intervention. The case file for the re-review includes added data regarding the three years outcome results of the STAR trial. This was a study that was fully designed and funded through Inspire Medical. As noted by Certal and colleagues, further studies comparing hypoglossal nerve stimulation with conventional therapies are needed to definitively evaluate outcomes. All told, the requested hypoglossal nerve stimulator is not medically indicated for the treatment of this patient. Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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The parent of a 16-year-old female enrollee has requested authorization and coverage for ceftriaxone sodium injection. The Health Insurer has denied this request indicating that the requested medication is at investigational for the treatment of the enrollees Lyme disease.
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Upheld
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Experimental
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Summary Reviewer 2
The parent of a 16-year-old female enrollee has requested authorization and coverage for ceftriaxone sodium injection. The Health Insurer has denied this request indicating that the requested medication is at investigational for the treatment of the enrollees Lyme disease. The physician reviewer found the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The diagnosis of chronic Lyme disease is controversial. This is due to the inability of clinicians to consistently and reliably diagnose this disorder via laboratory testing. In addition, most accepted practice guidelines suggest the maximum length of antibiotic therapy for Lyme disease is four weeks. This is even for those individuals who have late disease with neurological complications. In multiple studies there has been no benefit shown in patients who have received antibiotics for greater than 28 days compared to those who have not. Moreover, long-term use of IV antibiotics carries significant risks including liver disease, anaphylaxis, and candidemia. The relation between CD8-CD57 cell counts/percentage and Lyme disease has been addressed sparsely in the medical literature despite anecdotal claims of these lymphocyte surface markers being an indicator of Lyme disease activity. Furthermore, the majority of patients who have epidemiological, clinical, and laboratory evidence of Lyme disease only require 13 days of therapy, usually oral. As such, the continued use of ceftriaxone sodium injection is not likely to be more beneficial treatment than standard medical therapy in this clinical setting. 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 parent of an 18-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 40 hours per week of applied behavioral analysis (ABA) therapy provided from 1/1/15 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).
However, the patient has already been treated with extensive ABA therapy and still continues to exhibit aggressive behavior. In addition, the patient was taken out of public school because of his aggression, which
This patient has a full scale IQ of 74 which would suggest he does have the intellect to learn from therapeutic sessions. However, his retention is limited and he has regressed to baseline at the completion of his prior ABA treatments.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of an 18-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 40 hours per week of applied behavioral analysis (ABA) therapy provided from 1/1/15 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 fails to demonstrate the medical necessity of the services at issue. A letter from the patients ABA provider recommends a number of goals designed to decrease the patients aggression. However, the patient has already been treated with extensive ABA therapy and still continues to exhibit aggressive behavior. In addition, the patient was taken out of public school because of his aggression, which may be problematic if therapy is attempted within a community setting. The additional tests and recommendations submitted for review do not support the medical necessity of the services at issue. This patient has a full scale IQ of 74 which would suggest he does have the intellect to learn from therapeutic sessions. However, his retention is limited and he has regressed to baseline at the completion of his prior ABA treatments. In addition, there is a lack of support in the medical literature for the additional testing performed. For the reasons provided, 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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A 57-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 11/24/15. 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 1
A 57-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 11/24/15. 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 breast tomosynthesis provides advantages to radiologists interpreting mammograms, especially in women with dense tissue. 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 and detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of breast tomosynthesis to the usual two-dimensional protocol 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.
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