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A 36-year-old male enrollee has requested reimbursement for air ambulance transport provided on 2/12/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
. The patient was receiving adequate care at the initial location in California.
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Upheld
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Medical Necessity
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Summary Reviewer
A 36-year-old male enrollee has requested reimbursement for air ambulance transport provided on 2/12/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to establish the medical necessity of the services at issue. Based on the medical records submitted for review, there is no medical reason for the patients transfer. The patient was receiving adequate care at the initial location in California. The promise of successful weaning off mechanical ventilation does not warrant the risks for transferring a patient such a long distance. In some case, patients are better off on the ventilator. In this case, there is no evidence that this patient, who has been on a ventilator since 2011 was weanable. All told, the air ambulance transport provided on 2/12/14 was not medically necessary for treatment of the patients medical condition.Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 19-year-old female enrollee has requested reimbursement for mental health residential treatment provided from 8/1/13 through 9/26/13. 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 patient presents with multiple diagnoses including depressive disorder, autism spectrum disorder, attention-deficit/hyperactivity disorder and substance abuse.
Almost half of children with these problems had suicide ideation or attempts. The patient had recently been hospitalized due to an overdose of Xanax.
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Overturned
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Medical Necessity
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Summary Reviewer
A 19-year-old female enrollee has requested reimbursement for mental health residential treatment provided from 8/1/13 through 9/26/13. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that the mental health residential treatment provided from 8/1/13 through 9/26/13 were medically necessary for treatment of the patients medical condition. The documentation submitted for review supports the residential placement. The patient presents with multiple diagnoses including depressive disorder, autism spectrum disorder, attention-deficit/hyperactivity disorder and substance abuse. According to Mayes and colleagues Comorbid psychological problems most highly predictive of ideation or attempts were depression, behavior problems, and teased. Almost half of children with these problems had suicide ideation or attempts. The patient had recently been hospitalized due to an overdose of Xanax. The treatment at issue was medically necessary to assist the patient with handling life stressors in the context of autism spectrum disorder. Thus, the residential mental health services at issue were medically necessary for treatment of the patients behavioral health condition. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 51-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 5/23/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who reported bilateral breast tenderness.
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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 reimbursement for breast tomosynthesis performed on 5/23/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who reported bilateral breast tenderness. 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, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. There is a lack of support for breast tomosynthesis in patients case. Generally, bilateral breast tenderness is an unlikely presenting symptom for breast cancer. In addition, she did not have particularly dense breasts, and her mammogram was unchanged when compared to a prior mammogram. Breast tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality, especially when there has been no change when compared to prior mammograms. Thus, breast tomosynthesis performed on 5/23/16 was not likely to have been of greater benefit than other available modalities. Based upon the information set forth above, the service 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 40-year-old female enrollee has requested authorization and coverage for spinal fusion. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who has been diagnosed with lateral recess stenosis at L4-5 and severe foraminal stenosis at L5-S1.
. This patient presents with persistent worsening low back pain radiating into the left lower extremity to the calf consistent with a left L5 radiculopathy.
findings were consistent with imaging evidence of lateral recess stenosis at L4-5 and severe foraminal stenosis at L5-S1. There is radiographic evidence of spondylolisthesis at L4-5 exaggerated in extension and reduced in flexion. The treating provider has planned complete facetectomy and foraminotomy to achieve adequate nerve root decompressi
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Overturned
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Medical Necessity
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Summary Reviewer
A 40-year-old female enrollee has requested authorization and coverage for spinal fusion. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who has been diagnosed with lateral recess stenosis at L4-5 and severe foraminal stenosis at L5-S1. The physician reviewer found there is sufficient support for the requested services in this patients case. Evidence-based medical guidelines support lumbar fusion in the setting of degenerative spondylolisthesis with symptomatic radiculopathy or spinal stenosis when nonoperative treatment has failed. Lumbar fusion is also supported in the setting of wide decompression with anticipated intraoperative instability. This patient presents with persistent worsening low back pain radiating into the left lower extremity to the calf consistent with a left L5 radiculopathy. Significant functional difficulty is documented in ambulation and activities of daily living. Detailed evidence of a comprehensive nonoperative treatment protocol trial and failure has been submitted. Clinical examination findings were consistent with imaging evidence of lateral recess stenosis at L4-5 and severe foraminal stenosis at L5-S1. There is radiographic evidence of spondylolisthesis at L4-5 exaggerated in extension and reduced in flexion. The treating provider has planned complete facetectomy and foraminotomy to achieve adequate nerve root decompression which would result in temporary intraoperative instability and necessitate fusion. Thus, the requested spinal fusion is medically indicated 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 41-year-old female enrollee has requested reimbursement for monitored anesthesia care (MAC) services provided on 2/12/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees risk for colon cancer.
this patient has a history of extreme anxiety and panic attacks.
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Overturned
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Medical Necessity
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Summary Reviewer
A 41-year-old female enrollee has requested reimbursement for monitored anesthesia care (MAC) services provided on 2/12/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees risk for colon cancer. The physician reviewer found that The American Society of Anesthesiologist (ASA) noted that MAC with sedation may be necessary to improve patient cooperation, decreased movement, and reduce discomfort during endoscopy procedures in patients with significant psychiatric disorders, cognitive dysfunction and movement disorders. The ASA also noted that MAC is necessary for patients in situations of extreme procedure anxiety. The records indicate that this patient has a history of extreme anxiety and panic attacks. Thus, the MAC services were appropriate and medically necessary during the colonoscopy performed on 2/12/15 for evaluation of this patients medical condition. Based on the foregoing discussion, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The parent of a 16-year-old male insured has requested reimbursement for a laboratory test
performed on 2/10/23. The Health Insurer has denied this request indicating that the services at
issue were considered investigational for the evaluation of the insureds Chrons disease.
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Overturned
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Experimental
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Summary Reviewer 3 The parent of a 16-year-old male insured has requested reimbursement for a laboratory test
performed on 2/10/23. The Health Insurer has denied this request indicating that the services at
issue were considered investigational for the evaluation of the insureds Chrons disease.
The physician reviewer found that according to Cheifetz and colleagues, When infliximab de-
escalation (dose reduction) is considered in patients in remission, proactive TDM both before and
after de-escalation should be performed. In this case, the patients Inflectra dosage was reduced.
Evaluating Inflectra drug levels and antibody levels both before and after changing dose is the
standard of care for this patient. For this reason, the laboratory test performed on 2/10/23 was
likely to have been more beneficial for the evaluation of the patients condition than any available
standard therapy.
| 0 |
A 20-year-old female enrollee has requested authorization and coverage for arthroscopy of the knee. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who has a history of knee pain.
anterior cruciate ligament reconstruction. This patient presents with persistent right knee pain and stiffness nearly three years status post anterior cruciate ligament reconstruction for complete rupture.
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Overturned
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Medical Necessity
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Summary Reviewer
A 20-year-old female enrollee has requested authorization and coverage for arthroscopy of the knee. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who has a history of knee pain. The physician reviewer found that the peer reviewed literature supports arthroscopy debridement of cyclops lesions, lysis of adhesions and manipulation under anesthesia of the knee to restore full knee extension when loss of full extension and painful stiffness persist, despite aggressive rehabilitation following anterior cruciate ligament reconstruction. This patient presents with persistent right knee pain and stiffness nearly three years status post anterior cruciate ligament reconstruction for complete rupture. The submitted documentation supports the patients loss of full extension. There is documented pain consistent with imaging evidence of synovitis, intercondylar notch scar tissue, and possible cyclops lesion. Evidence of long-term reasonable and/or comprehensive non-operative treatment protocol trial and failure has been submitted. As such, the requested services are medically necessary for treatment of this patients medical condition. Therefore, based on the reasons stated above, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 61-year-old male with benign prostatic hyperplasia (BPH) and American Urological Association (AUA) symptom score of 20. The patient underwent UroLift on 10/18/16 to relieve obstructive symptoms. The patient has requested reimbursement for the UroLift procedure provided on 10/18/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational.
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 61-year-old male with benign prostatic hyperplasia (BPH) and American Urological Association (AUA) symptom score of 20. The patient underwent UroLift on 10/18/16 to relieve obstructive symptoms. The patient has requested reimbursement for the UroLift procedure provided on 10/18/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational. Currently, there is a lack of peer-reviewed medical literature or clinical guidelines that support the utility of UroLift with standard available treatment options. As noted by Chung and Woo, UroLift appears to be a well tolerated and effective minimally invasive treatment for lower urinary tract symptoms due to BPH in men who wish to preserve sexual function or who are not suitable for invasive surgery. Further studies will confirm the currently mixed results regarding intraprostatic botulinum toxin or ethanol injections. Thus, additional investigation is appropriate to confirm these initial results. For these reasons, the UroLift procedure provided on 10/18/16 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service 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 50-year-old male has requested reimbursement for Anser IFX testing performed on 4/15/15. 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 3
A 50-year-old male has requested reimbursement for Anser IFX testing performed on 4/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the Anser IFX test was ordered to direct the use of Remicade in this patient with Crohns disease. However, the use of Anser IFX to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Based on the clinical literature, the Anser IFX testing performed on 4/15/15 was not likely to be more beneficial for treatment of the patients medical condition than standard management. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 64-year-old female enrollee has requested placement of permanent sacral nerve stimulator performed on 12/09/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees fecal incontinence.
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Overturned
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Experimental
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Summary Reviewer 2
A 64-year-old female enrollee has requested placement of permanent sacral nerve stimulator performed on 12/09/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees fecal incontinence. The physician reviewer found there is sufficient support for the services at issue in this patients case. According to the American Society of Colon and Rectal Surgeons guideline for the treatment of fecal incontinence, sacral neuromodulation may be considered as a first-line surgical option for incontinent patients with and without sphincter defects. The treatment consistently demonstrates reduction in frequency of incontinence episodes in studies. In this patients case, the permanent sacral nerve stimulator provided on 12/09/14 was likely to have been of greater benefit than other treatment options. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 54-year-old female with a history of non-allergic rhinitis, previously diagnosed
nasal septal deviation, asthma and recurrent acute sinusitis. The patient has requested
authorization and coverage for computed tomography (CT) scan of the sinuses.
This patient also has
progressive sinus disease that has affected her ability to smell and does
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 54-year-old female with a history of non-allergic rhinitis, previously diagnosed
nasal septal deviation, asthma and recurrent acute sinusitis. The patient has requested
authorization and coverage for computed tomography (CT) scan of the sinuses. The physician
reviewer found that the current medical literature supports the requested CT scan of the sinuses
in this case. The American Academy of Allergy, Asthma and Immunology (AAAAI) Practice
Parameters for the management of sinusitis discusses that if a patient fails antibiotics and other
adjunctive measures such as inflammation control with systemic steroids, nasal sprays
(azelastine and fluticasone) and Singulair, a sinus CT would be indicated. This patient also has
progressive sinus disease that has affected her ability to smell and does not have positive skin
testing to indicate that allergies would be the main driving factor for her recurrent inflammation.
She also does have documented septal deviation which could contribute to her rhinitis and
sinusitis. In addition, the Rhinitis 2020 AAAAI practice parameter update does consider symptoms
including facial pain, pressure, decreased sense of smell and post-nasal drainage to be an
indication for sinus CT. Therefore, the requested CT scan of the sinuses is medically necessary for
the evaluation of this patient.
| 1 |
A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 1/19/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 42-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 1/19/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the breast tomosynthesis performed on 1/19/16 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. Ciatto and colleagues investigated the effect of integrated two dimensional (2D) and three dimensional (3D) mammography in the breast cancer screening population. The authors found that Integrated 2D and 3D mammography improves breast cancer detection and has the potential to reduce false positive recalls. Based on the support in the medical literature, the use of breast tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 57-year-old male enrollee has requested reimbursement for automated nerve conduction testing during anterior cervical discectomy and fusion performed on 10/20/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
during multiple level anterior cervical discectomy and fusion in the presence of myelopathy.
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Overturned
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Medical Necessity
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Summary Reviewer
A 57-year-old male enrollee has requested reimbursement for automated nerve conduction testing during anterior cervical discectomy and fusion performed on 10/20/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the patient underwent intraoperative neurophysiological monitoring during multiple level anterior cervical discectomy and fusion in the presence of myelopathy. Intraoperative neurophysiological monitoring during surgery is recommended when such procedures have a risk of significant complications that can be detected and prevented through use of neurophysiological monitoring. Intraoperative monitoring of somatosensory evoked potentials and transcranial electrical motor evoked potentials in procedures that involve the spinal cord itself can predict adverse surgical outcomes in complex cases. However, the evidence-based guidelines do not recommend intraoperative electromyography (EMG) and nerve conduction velocity monitoring on peripheral nerves during cervical spine surgery. An abnormal EMG response during the surgical procedure may or may not be associated with a clinically significant injury (Resnick, et al). Therefore, intraoperative electromyography is not recommended. In sum, intraoperative EMG and nerve conduction velocity monitoring on peripheral nerves during surgery is not recommended. In sum, the somatosensory and motor evoked potentials were medically necessary; however, the intraoperative electromyography and neuromuscular junction testing has not been substantiated. Therefore, a portion of the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
A 60-year-old female enrollee has requested authorization and coverage for bronchoscopic thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees moderate to severe persistent asthma.
This patient has undergone a thorough evaluation and is on an aggressive regimen. However, her symptoms have persisted despite her current medical therapy and she has continuously required systemic steroids.
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Overturned
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Medical Necessity
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Summary Reviewer
A 60-year-old female enrollee has requested authorization and coverage for bronchoscopic thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees moderate to severe persistent asthma. The physician reviewer found that currently, the three initial trials of bronchial thermoplasty have demonstrated improved symptom control after the procedure was completed. Cox and colleagues reported that patients with moderate to severe asthma demonstrated improved control at one-year follow-up following treatment with bronchial thermoplasty. Further, Pavord and colleagues found short-term worsening in symptoms, but evidence of improved long-term control of asthma with the procedure. Finally, the Castro and colleagues compared bronchial thermoplasty with a sham procedure and followed the patients for one year. The authors noted that the thermoplasty group had fewer exacerbations and improved quality of life when compared to the sham group. Overall, the data supports the short- and long-term benefits of bronchial thermoplasty for well selected patients. This patient has undergone a thorough evaluation and is on an aggressive regimen. However, her symptoms have persisted despite her current medical therapy and she has continuously required systemic steroids. Given these findings, the requested bronchoscopic thermoplasty is supported as medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested procedure is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 65-year-old male enrollee has requested authorization and coverage for PET (CPT code 78813) scan. The Health Insurer has denied this request indicating that the requested testing considered investigational for evaluation of the enrollees prostate cancer.
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Overturned
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Experimental
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Summary Reviewer 3
A 65-year-old male enrollee has requested authorization and coverage for PET (CPT code 78813) scan. The Health Insurer has denied this request indicating that the requested testing considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that a recent trial assessed the impact of PET (Axumin) scans on patients with a biochemical recurrence. It found that 61.2% of patients had a change in management as a result of the scan and the trial was stopped early. Of the changes, 40% required a change in radiation fields, and 35% underwent systemic therapy instead of radiotherapy (ASCO GU 2018). Recent medical literature have come to similar conclusions that PET scans can affect treatment after a prostatectomy (Wallitt, et al; Jani, et al). As such, PET (CPT code 78813) scan is likely to be of greater benefit when compared to the available conventional modalities for the management of this patients medical condition. Therefore, for the reasons stated above, the requested services are 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 68-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/03/18 and 10/16/18. The Health Insurer has denied this request and reported that the service at issue were 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 68-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/03/18 and 10/16/18. The Health Insurer has denied this request and reported that the service at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that this patient had several early stage melanomas. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. 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. Therefore, DecisionDx-Melanoma testing provided on 10/03/18 and 10/16/18 was not medically necessary for the evaluation of this patient.
| 0 |
A 48-year-old female enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 4/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer.
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Overturned
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Experimental
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Summary Reviewer 1
A 48-year-old female enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 4/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. It has been established that adjuvant chemotherapy is of benefit to patients with stage III (node positive) colon cancer. It is much more controversial as to its value in stage II colon cancer, as in this patients case. Most oncologists have made this decision based on specific pathologic features, such as a poorly differentiated histology, lymphovascular invasion, or presentation with obstruction or perforation. Another approach is with the use of genetic panels. The Oncotype DX Colon Cancer Assay is a 12-gene panel that predicts the risk of recurrence of the cancer in both stage II and III colon cancer. This assay appears to predict the risk of recurrence with accuracy beyond what could be predicted from these usual pathologic features. The medical evidence supports the use of Oncotype DX Colon Cancer Assay in assessing the potential value of adjuvant chemotherapy. Therefore, Oncotype DX Colon Cancer Assay performed on 4/28/16 was likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 48-year-old female enrollee has requested reimbursement for genetic testing performed on 5/25/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees breast cancer.
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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 genetic testing performed on 5/25/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees breast cancer. The physician reviewer found that understanding the molecular drivers of cancer progression and metastases is an area of ongoing and active research, predominantly driven by the goal of identifying specific genomic aberrations that may ultimately result in individualized cancer treatment. In addition to likely providing prognostic information, the value of next generation sequencing (NGS) to predict candidates for specific mutation-driven treatment holds promise, but is not yet ready for routine clinical use. Although the ability to decipher genomic aberrations in individual breast cancers to the single nucleotide resolution is now possible, there is a lack of data to show that this information can guide treatment decisions for patients with metastatic breast cancer. The use of NGS, such as with FoundationOne testing, continues to be the subject of ongoing clinical trials, and use outside of a clinical trial at this time is not reasonable or medically necessary. In addition, this patient still has treatment options available to her, such as TDM-1. Thus, genetic testing performed on 5/25/17 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 62-year-old female enrollee has requested reimbursement for FoundationOne CDx test performed on 12/31/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 62-year-old female enrollee has requested reimbursement for FoundationOne CDx test performed on 12/31/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition. The physician reviewer found that the The therapy of advanced NSCLC has been revolutionized by the finding of EGFR mutations in certain adenocarcinomas. Even if stage IV disease is present, therapy targeted to EGFR with erlotinib results in prolonged survival when compared with standard chemotherapy regimens. The mutational landscape of NSCLC has significantly expanded in recent years to encompass gain of function in multiple oncogenes with major prognostic and therapeutic consequences. It is generally accepted that the panel of mutations that was analyzed in the patient in question is for mutually exclusive somatic driver mutations. Patients on targeted therapy may develop resistance to erlotinib and this too may be appreciated at the genetic level by recognition of new mutations or amplifications in parallel signal transduction pathways. BRAF mutations may suggest alternative targeted therapies that may be better than those selected empirically. There is sufficient support for the services at issue in this clinical setting. Therefore, FoundationOne CDx test performed on 12/31/19 was likely to have been more beneficial than other available standard therapy.
| 0 |
A 60-year-old male enrollee has requested reimbursement for CPT 81529, which is an oncology
(cutaneous melanoma, mRNA, gene expression profiling by real-time RT-PCR of 31 genes (28
content and three housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm
reported as recurrence risk including likelihood of sentinel lymph node metastasis, on 3/8/22.
The Health Insurer has denied this request and reported that the service at issue was
investigational for the evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 3
A 60-year-old male enrollee has requested reimbursement for CPT 81529, which is an oncology
(cutaneous melanoma, mRNA, gene expression profiling by real-time RT-PCR of 31 genes (28
content and three housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm
reported as recurrence risk including likelihood of sentinel lymph node metastasis, on 3/8/22.
The Health Insurer has denied this request and reported that the service at issue was
investigational for the evaluation of the enrollees melanoma. The physician reviewer found that
the American Academy of Dermatologys clinical guidelines for melanoma note that routine
molecular testing, including GEP, for prognostication is discouraged until better use criteria are
defined. The guidelines further note that the application of molecular information for clinical
management, such as informing on sentinel lymph node eligibility, follow-up, and/or therapeutic
choices, is not recommended outside of a clinical study or trial. The NCCN guidelines on
cutaneous melanoma note that the use of GEP testing according to specific American Joint
Committee on Cancer (AJCC)-8 melanoma staging, before or after sentinel lymph node biopsy,
requires further prospective investigation in large, contemporary data sets of unselected
patients, and that prognostic GEP testing to differentiate melanomas at low versus high risk for
metastasis should not replace pathologic staging procedures. The NCCN further notes that there
is a low probability of metastasis in stage I melanoma and a higher proportion of false-positive
results, and that GEP testing should not guide clinical decision-making in this subgroup. Therefore, CPT 81529, which is an oncology (cutaneous melanoma, mRNA, gene expression
profiling by real-time RT-PCR of 31 genes (28 content and three housekeeping), utilizing formalin-
fixed paraffin-embedded tissue, algorithm reported as recurrence risk including likelihood of
sentinel lymph node metastasis, on 3/8/22, was not likely to have been more beneficial for
evaluation of the patients condition than any available standard therapy.
| 1 |
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 1
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 choroidal melanoma is a relatively rare tumor which has consequences on both vision and lifespan. Metastatic disease prediction has been difficult and little data has been available to providers to educate the patient and to aid in the type and frequency of tests to order to follow the disease. With the DecisionDX assay the provider has a tool at their disposal to help predict the likelihood of metastatic disease and accordingly prescribe adjuvant therapy. The DecisionDX also helps provide a feasible schedule for the frequency of metastatic disease testing via laboratory and imaging studies. 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.
| 0 |
The patient is a 61-year-old male with a history of hypothyroidism on escalating doses of levothyroxine. The patient has requested reimbursement for the ultrasound of the soft tissues of head and neck performed on 1/12/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 61-year-old male with a history of hypothyroidism on escalating doses of levothyroxine. The patient has requested reimbursement for the ultrasound of the soft tissues of head and neck performed on 1/12/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that Hypothyroidism affects up to 5% of the general population, with a further estimated 5% being undiagnosed. Hypothyroidism is diagnosed biochemically, being overt primary hypothyroidism defined as serum thyroid stimulating hormone (TSH) concentrations above and thyroxine concentrations below the normal reference range. Although studies have demonstrated that patients diagnosed with hyperthyroidism, thyroiditis, goiter, and adenoma had significantly elevated risks of differentiated thyroid cancer, there does not appear to be an association between a history of hypothyroidism and risk of thyroid cancer. Thyroid ultrasonography is not indicated as part of routine workup of hypothyroidism. Therefore, the ultrasound of the soft tissues of head and neck performed on 1/12/21 was not medically necessary for the evaluation of this patient.
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The patient is a five-year-old male who has been diagnosed with disorder of dysregulated anger and aggression of early childhood, combined, proactive and reactive aggression. The patientas parent has requested reimbursement for intensive outpatient mental health treatment for children and adolescents provided from 7/15/19 through 7/31/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
The patient had a significant risk of harm, due to impulsivity, self-harm, and aggression.
The patient had moderate functional impairment, due to conflict with parents and other adults as well as peers, and recent expulsion from school. Gains were
The patient had a mildly stressful environment, due to expulsion from school.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a five-year-old male who has been diagnosed with disorder of dysregulated anger and aggression of early childhood, combined, proactive and reactive aggression. The patientas parent has requested reimbursement for intensive outpatient mental health treatment for children and adolescents provided from 7/15/19 through 7/31/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the Child and Adolescent Level of Care Utilization System (CALOCUS) provides a framework for determining the clinically appropriate level of care for a child or adolescent in mental health treatment. In terms of risk of harm, the records support a score of 3. The patient had a significant risk of harm, due to impulsivity, self-harm, and aggression. With regard to functional status, the records support a score of 3. The patient had moderate functional impairment, due to conflict with parents and other adults as well as peers, and recent expulsion from school. Gains were made in the context of a structured setting. In terms of comorbidity, the records support a score of 1. There were no developmental or medical issues. With regard to level of stress of the recovery environment, the records support a score of 2. The patient had a mildly stressful environment, due to expulsion from school. In terms of environmental support, the records support a score of 2 due to his parentsa attempts to participate in treatment, with some struggles to manage the patientas behavior and medications at home. In terms of resiliency and treatment history, the records support a score of 4. The records indicate poor resiliency and/or response to treatment, due to a lack of response to previous intensive treatment, and his current turmoil and difficulty making progress toward developmentally appropriate behaviors. With regard to treatment and acceptance of the parents, the records support a score of 2 due to their participation in treatment. Thus, the patient had a total score of 17. This recommended level of care is high-intensity community-based services. An intensive outpatient program, such as the one the patient was attending, is consistent with this level of care. Furthermore, a program specializing in young children was needed for the patient. Therefore, intensive outpatient mental health treatment for children and adolescents provided from 7/15/19 through 7/31/19 was medically necessary for the treatment of this patient.
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A 58-year-old female enrollee has requested reimbursement for MammaPrint testing performed on 1/21/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the evaluation of the enrollees breast cancer.
In this case, the patient was provided with adjuvant chemotherapy based on her high risk MammaPrint profile.
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Upheld
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Experimental
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Summary Reviewer 3
A 58-year-old female enrollee has requested reimbursement for MammaPrint testing performed on 1/21/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the evaluation of the enrollees breast cancer. The physician reviewer found there are several established biomarkers that are prognostically valuable in breast cancer. These include the presence of estrogen or progesterone receptors, HER2 amplification, as well as proliferative index, and histologic grade. Newer technologies such as gene expression such as the MammaPrint may also classify tumors to basal-like or luminal-type of disease. MammaPrint is U.S. Food and Drug Administration (FDA) approved and has been validated in different clinical trials. In this case, the patient was provided with adjuvant chemotherapy based on her high risk MammaPrint profile. Based on available medical evidence and medical literature, MammaPrint was likely to be more beneficial for evaluation of the patients medical condition than other modalities. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 36-year-old female enrollee has requested reimbursement for Botox injections received on 10/14/14. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition.
the patient has chronic migraine. In addition, the patient has failed at least two classes of preventive agents.
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Overturned
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Experimental
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Summary Reviewer 1
A 36-year-old female enrollee has requested reimbursement for Botox injections received on 10/14/14. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition. The physician reviewer found review of the submitted documentation and relevant literature supports the use of Botox injections in this clinical setting. The documentation submitted for review documents the patient has chronic migraine. In addition, the patient has failed at least two classes of preventive agents. Botox is standard therapy for treatment of chronic migraine, and has been shown to be as effective or more effective, than medications available to treat chronic migraine. In addition, Botox is U.S. Food and Drug Administration (FDA) approved for the treatment of chronic migraine. For the reasons provided, the Botox injections at issue were 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 services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/17/19. 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 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 very novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma testing performed on 5/17/19 was not likely to have been more beneficial than other available standard therapy.
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A 61-year-old female enrollee has requested authorization and coverage for 64568 and 0466T. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
She has moderate obstructive sleep apnea. The documentation notes that the patient is intolerant to continuous positive airway pressure therapy.
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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 authorization and coverage for 64568 and 0466T. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested services in this patients case. She has moderate obstructive sleep apnea. The documentation notes that the patient is intolerant to continuous positive airway pressure therapy. The records do not clearly establish that the patient is not a candidate for oral appliance therapy. Mild to moderate obstructive sleep apnea has been shown to be responsive to oral appliance therapy. Thus, 64568 and 0466T are not likely to be more beneficial than other treatment options.
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A 44-year-old female enrollee has requested authorization and coverage for the Intracept procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
involved 17 patients who were treated for refractory chronic low back pain.
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Overturned
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Experimental
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Summary Reviewer 3
A 44-year-old female enrollee has requested authorization and coverage for the Intracept procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is a sparse amount of published clinical data to support the use of this treatment modality. An industry sponsored trial by Becker and colleagues involved 17 patients who were treated for refractory chronic low back pain. The authors concluded, aAblation of the basivertebral nerve for the treatment of chronic lumbar back pain significantly improves patientsa self-reported outcome early in the follow-up period; the improvement persisted throughout the one-year study period.a Fischgrund and colleagues performed a multicenter randomized control trial involving 225 patients with refractory low back pain. The authors noted, aPatients treated with radiofrequency ablation of the basivertebral nerve for chronic low back pain exhibited significantly greater improvement in Oswestry Disability Index (ODI) at three months and a higher responder rate than sham treated controls.a While there is a small amount of supporting data which suggests some short-term patient reported outcomes with the Intracept procedure, some of this data is industry sponsored. The single randomized controlled trial demonstrates some potential short-term benefit, but is lacking long-term efficacy and safety data. Clinical conclusions on this procedureas safety and efficacy require longer-term safety and efficacy data prior to accepting it as standard of care. Thus, the requested Intracept procedure is not likely to be more beneficial than any available standard therapy.
| 1 |
An 18-year-old female enrollee has requested reimbursement for mental health residential treatment center (RTC) services provided from 2/4/15 through 4/24/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees bipolar disorder, parent-child relational problem, and cannabis abuse.
The patient did not have any suicidal or homicidal ideations, there was no evidence of psychosis, and she had no self-injurious impulses during the course of treatment documented.
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Upheld
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Medical Necessity
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Summary Reviewer
An 18-year-old female enrollee has requested reimbursement for mental health residential treatment center (RTC) services provided from 2/4/15 through 4/24/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees bipolar disorder, parent-child relational problem, and cannabis abuse. The physician reviewer found that based on the records provided for review, the criteria for RTC services from 2/4/15 through 4/24/15 have not been met. The patient did not have any suicidal or homicidal ideations, there was no evidence of psychosis, and she had no self-injurious impulses during the course of treatment documented. Additionally, no medication changes were made during the course of admission that required 24-hour supervision. The records suggest the patient could have been treated safely and effectively in a less intrusive, less invasive level of care such as outpatient medication management and outpatient therapy during this period of time. Accordingly, the RTC services provided from 2/4/15 through 4/24/15 were not medically necessary. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 19-year-old female who has been recognized to have a number of inherited disorders, including intellectual disability, multiple congenital anomalies including, coarctation of the aorta and small left ventricles unbalanced atrioventricular canal defect and short stature. The patient underwent genetic testing in order to obtain additional information and to best guide medical management of her care. The patient has requested reimbursement for FirstStepDX Plus test rendered on 4/14/17. The Health Insurer has denied the request for reimbursement. Per the Health Insurer, the services at issue were investigational.
in April 2017. The provider ordered testing to gather additional information that could affect the care and treatment of this patient.
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Overturned
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Experimental
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Summary Reviewer 3
The patient is a 19-year-old female who has been recognized to have a number of inherited disorders, including intellectual disability, multiple congenital anomalies including, coarctation of the aorta and small left ventricles unbalanced atrioventricular canal defect and short stature. The patient underwent genetic testing in order to obtain additional information and to best guide medical management of her care. The patient has requested reimbursement for FirstStepDX Plus test rendered on 4/14/17. The Health Insurer has denied the request for reimbursement. Per the Health Insurer, the services at issue were investigational. There is support in the medical literature for the efficacy of the tests performed in April 2017. The provider ordered testing to gather additional information that could affect the care and treatment of this patient. The records show that the patients clinical presentation is not specific to a well delineated syndrome and she has two or more major malformations. As such, targeted genetic testing is relevant as a rationale pursuit of information that could potentially alter treatment services. All told, the FirstStepDX Plus test rendered on 4/14/17 was likely to have been more efficacious for evaluating this patients medical condition when compared to other available standard options. Therefore, for the reasons stated above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 45-year-old male enrollee has requested reimbursement for ipilimumab and nivolumab provided on 6/11/19, 7/02/19, 7/23/19 and 8/13/19. The Health Insurer has denied this request and reported that the medications 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 3
A 45-year-old male enrollee has requested reimbursement for ipilimumab and nivolumab provided on 6/11/19, 7/02/19, 7/23/19 and 8/13/19. The Health Insurer has denied this request and reported that the medications at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for the medications at issue in this clinical setting. In patients with widespread metastatic renal cell cancer, this combination of immunotherapy drugs is superior to more standard therapy, and is currently the recommended treatment. The medullary variant is a rare variant, and there is less data concerning this type. Nonetheless, this combination was likely to have been more effective than other treatment alternatives. Thus, ipilimumab and nivolumab provided on 6/11/19, 7/02/19, 7/23/19 and 8/13/19 were likely to have been more beneficial than other available treatment options.
| 1 |
The patient is a 55-year-old female with a history of rheumatoid arthritis. On 8/18/16, she was being treated with methotrexate, prednisone and Xeljanz. Per the records, Xeljanz had improved her symptoms, but she was having more frequent outbreaks of herpes. During the past month, she had experienced pain in her right elbow, worse back pain, left ankle pain/stiffness and weight gain. The records noted that the patient has responded to Remicade in the past, although this was discontinued due to cost. The patients provider recommended retrying Remicade, but the provider reported concerns given the long period of abstinence. The provider recommended Prometheus Anser IFX testing. The Health Insurer has denied reimbursement for Prometheus Anser IFX testing performed on 8/19/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient.
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 55-year-old female with a history of rheumatoid arthritis. On 8/18/16, she was being treated with methotrexate, prednisone and Xeljanz. Per the records, Xeljanz had improved her symptoms, but she was having more frequent outbreaks of herpes. During the past month, she had experienced pain in her right elbow, worse back pain, left ankle pain/stiffness and weight gain. The records noted that the patient has responded to Remicade in the past, although this was discontinued due to cost. The patients provider recommended retrying Remicade, but the provider reported concerns given the long period of abstinence. The provider recommended Prometheus Anser IFX testing. The Health Insurer has denied reimbursement for Prometheus Anser IFX testing performed on 8/19/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient.
The anti-tumor necrosis factor agents have been noted to be associated with an increasing amount of autoantibodies resulting in an increased risk of infusion reactions, a reduced response to medications, and the need for increasing dose adjustments. Up to about 50% of patients treated with infliximab develop these antibodies, and those patients with high antibodies have been found to have a higher risk of infusion reactions. In this patients case, based on the records from 8/18/16, there was evidence of active rheumatoid arthritis and intolerance of Xeljanz. She has tolerated Remicade in the past, with no reactions, and other anti-tumor necrosis factor agents were stopped due to ineffectiveness or cost. There is a lack of evidence to support that Remicade would be ineffective or possibly harmful. Remicade was stopped in the past due to cost, not medical issues. At this time, the role of this testing is still being determined. As such, the medical records and the current medical literature fail to support that Prometheus Anser IFX testing performed on 8/19/16 was likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were 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 25-year-old female has requested authorization and coverage for intravenous ceftriaxone. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition.
This patient was diagnosed with neuroborreliosis per the submitted records.
. This patient has been treated with intravenous ceftriaxone for 28 days.
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Upheld
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Experimental
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Summary Reviewer 2
A 25-year-old female has requested authorization and coverage for intravenous ceftriaxone. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition. The physician reviewer found the medical evidence does not support the requested medication in this clinical setting. This patient was diagnosed with neuroborreliosis per the submitted records. Current Lyme disease guidelines and data indicated that ceftriaxone is recommended for 14 to 21 days. This patient has been treated with intravenous ceftriaxone for 28 days. In addition, doxycycline has been shown to be non-inferior to ceftriaxone in some studies. Moreover, atovaquone and azithromycin are standard treatment regimens for Babesia. For those reasons, the requested intravenous ceftriaxone is not likely to be of greater benefit than other available treatment alternatives. 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 |
An 81-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 7/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
An 81-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 7/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that he National Comprehensive Cancer Network (NCCN) guidelines define the low-risk group as patients with clinical stage T1 to T2a, Grade Group 1, and serum prostate specific antigen (PSA) level less than 10 ng/mL. If the patientas life expectancy is 10 years or more, initial treatment options include: 1) active surveillance (preferred); 2) external beam radiation therapy or brachytherapy; or 3) radical prostatectomy. Molecular tumor testing can be considered for these men for prognostic information independent of NCCN risk groups. Recommendations per the NCCN guidelines support coverage post-biopsy for NCCN very-low-, low-risk, and favorable intermediate-risk prostate cancer in patients with at least 10 years life expectancy who have not received treatment for prostate cancer and are candidates for active surveillance or definitive therapy. The records indicate that this patient underwent Oncotype DX Prostate testing in 2019 as well as on 7/23/20. There is a lack of support for the services performed on 7/23/20, as Oncotype DX Prostate testing is intended for use at initial diagnosis. Therefore, Oncotype DX Prostate testing performed on 7/23/20 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 64-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma gene expression profile testing performed on 7/23/18. 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.
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Upheld
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Medical Necessity
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Summary Reviewer
A 64-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma gene expression profile testing performed on 7/23/18. 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 the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. Therefore, DecisionDx-Melanoma gene expression profile testing performed on 7/23/18 was not medically necessary for the evaluation of this patient.
| 0 |
A 65-year-old male enrollee has requested reimbursement for polymerase chain reaction (PCR)
testing on 8/10/21. The Health Insurer has denied this request and reported that the service at
issue was investigational for the evaluation of the enrollees severe diarrhea.
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Upheld
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Experimental
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Summary Reviewer 2
A 65-year-old male enrollee has requested reimbursement for polymerase chain reaction (PCR)
testing on 8/10/21. The Health Insurer has denied this request and reported that the service at
issue was investigational for the evaluation of the enrollees severe diarrhea. The physician
reviewer found that in the setting of acute diarrhea in a non-toxic, healthy patient, standard
therapy consists of supportive care. Many of the organisms tested for, such as norovirus, cause
self-limited disease and have no treatment. Others cause self-limited disease and can be treated
with antibiotics, although antibiotics tend to delay clearance of the organism and may cause
immune-mediated side effects such as hemolytic uremic syndrome. Additionally, many of the
organisms tested for, such as entamoeba histolytica, are incredibly rare in North Americans
eating a normal diet such that testing for them does not make sense. In this clinical setting, the
PCR testing at issue, which involved testing for numerous gastrointestinal pathogens, was not
likely to be more beneficial than standard testing using routine cultures for pathogens including
E. coli subtype, or a PCR or enzyme immunoassay (EIA) test limited to determine the presence of
Clostridioides difficile. Therefore, PCR testing on 8/10/21 was not likely to have been more
beneficial for the evaluation of the patients condition than any available standard therapy.
| 0 |
The parent of a nine-year-old female enrollee has requested reimbursement and prospective authorization and coverage for 20 hours per week of applied behavioral analysis (ABA) therapy provided from 9/28/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a nine-year-old female enrollee has requested reimbursement and prospective authorization and coverage for 20 hours per week of applied behavioral analysis (ABA) therapy provided from 9/28/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder. The physician reviewer found that the request for 20 hours per week of ABA therapy provided from 9/28/17 forward was not and is not medically necessary for treatment of the patients autism spectrum disorder. According to the documentation submitted for review, the patient is documented as making progress with her goals. The Health Insurer authorized 16 hours per week of ABA therapy is medically appropriate and adequate in this clinical setting. In sum, there is a lack of clinical documentation supporting the request for 20 hours per week of direct ABA services for treatment of the patients autism spectrum disorder. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
A 27-year-old male enrollee has requested reimbursement for acute inpatient mental health treatment for adults provided from 4/25/16 through 6/5/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
On 4/24/16, the test results from the psychosis work-up had not yet returned. The patient remained guarded and isolative. He had no insight regarding his mental illness. Further, he was refusing psychotropic medication.
was being forged, the patient continued with the diagnostic work-up. Aside from a slightly elevated cholesterol level, his laboratory studies were unremarkable. On 5/4/16, the electroencephalogram finding was normal. On 5/6/16, the neuropsychology report was published while the magnetic resonance imaging (MRI) of the brain was normal. On 5/10/16, the patient elected to start an antipsychotic medication. On 5/13/16, the patient was described as reserved and polite and noted to have no side effect from the medication. On 5/17/16, the patient was slowly feeling better. On 5/19/16, the patient agreed to step-down to a
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Overturned
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Medical Necessity
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Summary Reviewer
A 27-year-old male enrollee has requested reimbursement for acute inpatient mental health treatment for adults provided from 4/25/16 through 6/5/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the clinical record does not support the medical necessity of service delivery at the acute inpatient level of care as of 5/20/16. On 4/24/16, the test results from the psychosis work-up had not yet returned. The patient remained guarded and isolative. He had no insight regarding his mental illness. Further, he was refusing psychotropic medication. The treatment team did provide thoughtful patient-centric care at a slow-pace to help build the rapport and trust necessary for meaningful therapeutic gains. For example, on 4/27/16, the psychologist did not confront the patients denial, rather the concepts of self-perception and idealism were introduced. As the therapeutic path was being forged, the patient continued with the diagnostic work-up. Aside from a slightly elevated cholesterol level, his laboratory studies were unremarkable. On 5/4/16, the electroencephalogram finding was normal. On 5/6/16, the neuropsychology report was published while the magnetic resonance imaging (MRI) of the brain was normal. On 5/10/16, the patient elected to start an antipsychotic medication. On 5/13/16, the patient was described as reserved and polite and noted to have no side effect from the medication. On 5/17/16, the patient was slowly feeling better. On 5/19/16, the patient agreed to step-down to a less restrictive setting and residential placement was recommended by the psychiatrist. In sum, the admission facilitated the completion of a thorough diagnostic assessment and improved the patients clinical condition. During the course of the admission, the patient had not voiced any new complaints or expressed any suicidal ideation, homicidal ideation or aggressive behavior. He was illogical at times, but neither disruptive nor disrespectful. Based on his past behaviors and the severity of his illness, a structured and supervised setting remained indicated to consolidate the therapeutic gains, but there was no indication that residential placement would have been unsafe or inadequate as of 5/20/16. Thus, the services at the acute inpatient level of care were medically necessary from 4/25/16 through 5/19/16, but not thereafter. Therefore, a portion of the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
A 23-year-old female enrollee has requested authorization and coverage for FirstStep Plus Cytogenomic Constitutional (Genome-Wide) Microarray Analysis. The Health Insurer has denied this request indicating that the requested services are 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 23-year-old female enrollee has requested authorization and coverage for FirstStep Plus Cytogenomic Constitutional (Genome-Wide) Microarray Analysis. The Health Insurer has denied this request indicating that the requested services are investigational for the evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. Chromosomal microarray testing is an appropriate first-line test for patients with non-syndromic developmental delay/intellectual disability, as well as patients with autism spectrum disorders. There are clear management implications that chromosomal microarray testing has provided for patients. In sum, FirstStep Plus Cytogenomic Constitutional (Genome-Wide) Microarray Analysis is likely to be of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
The patient is a 22-year-old male with a history of idiopathic scoliosis. He has had extensive chiropractic care from 10/13/15 through 7/4/16 for at least 36 visits. His diagnoses are cervical and thoracic sprain, rib sprain, and muscle spasm. His treatment includes chiropractic manipulation, traction, and electrical stimulation, as well as abdominal and low back exercises. Overall, his condition was unchanged and his pain was consistently at 2/10. The patient has requested reimbursement for the chiropractic services provided from 6/13/16 through 8/13/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary. The patient has a stable condition that shows no sign of improvement even with continuous extensive care.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 22-year-old male with a history of idiopathic scoliosis. He has had extensive chiropractic care from 10/13/15 through 7/4/16 for at least 36 visits. His diagnoses are cervical and thoracic sprain, rib sprain, and muscle spasm. His treatment includes chiropractic manipulation, traction, and electrical stimulation, as well as abdominal and low back exercises. Overall, his condition was unchanged and his pain was consistently at 2/10. The patient has requested reimbursement for the chiropractic services provided from 6/13/16 through 8/13/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary. The patient has a stable condition that shows no sign of improvement even with continuous extensive care. This is considered maintenance therapy and chiropractic is not superior to alternative forms of standard treatment. There is also no evidence that chiropractic care is useful in the treatment of idiopathic scoliosis. Therefore, the chiropractic treatments provided from 6/13/16 through 8/13/16 were not medically necessary.
Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 53-year-old female enrollee has requested reimbursement for the Foundation One genetic testing performed on 1/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees serous papillary carcinoma.
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Overturned
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Experimental
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Summary Reviewer 3
A 53-year-old female enrollee has requested reimbursement for the Foundation One genetic testing performed on 1/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees serous papillary carcinoma. The physician reviewer found that the utility of the Foundation One testing has not been demonstrated to improve patient outcomes as compared to standard testing. According to the National Comprehensive Cancer Network (NCCN), to demonstrate clinical utility of panel genetic testing such as Foundation One, prospective randomized clinical trials are needed that compare the strategy of targeted treatment based on panel results with standard of care. The available literature on clinical utility consists of a small number of uncontrolled studies, and non-randomized controlled trials that use imperfect comparators. This evidence is not sufficient to make any conclusions on clinical utility. As a result, the use of expanded mutation panel testing for targeted treatment in cancer should only be conducted in the setting of a clinical trial. For these reasons, the Foundation One test provided on 1/25/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 28-year-old female insured has requested authorization and coverage for intravenous (IV)
Gammagard. The Health Insurer has denied this request indicating that the requested treatment is
considered investigational for the treatment of the insured's refractory relapsing polychondritis.
azathioprine. The patient has experienced documented success with IVIG
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Overturned
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Experimental
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Summary Reviewer 2
A 28-year-old female insured has requested authorization and coverage for intravenous (IV)
Gammagard. The Health Insurer has denied this request indicating that the requested treatment is
considered investigational for the treatment of the insured's refractory relapsing polychondritis.
The physician reviewer found that the treatment of relapsing polychondritis is challenging and
often lifelong. Corticosteroids remain the mainstay of therapy options, but other
immunosuppressive agents and biologic agents may be used in combination or as alternatives if
corticosteroids are inefficacious (Mathian, et al.). The choice of alternative therapy depends on the
severity and location of the inflammation, as well as the patient's overall health and response to
previous treatments. The current medical literature has suggested IVIG as an alternative treatment
option for patients with relapsing polychondritis (Lekpa and Chevalier). IVIG is a preparation of
antibodies derived from human plasma which has been shown to have immunomodulatory and
anti-inflammatory effects. IVIG is typically administered every two to four weeks and is generally
well-tolerated, though the dose and frequency may be adjusted based on the patient's response. In
this case, the records available for review indicate that the patient has tried and failed treatment
with several standard therapies, including multiple courses of high-dose corticosteroids,
methotrexate, dapsone, adalimumab, infliximab, cyclosporine, abatacept, rituximab, and
azathioprine. The patient has experienced documented success with IVIG as a treatment modality.
Therefore, the requested IV Gammagard is likely to be more beneficial for the treatment of the
patients condition than any available standard therapy.
| 1 |
The patient is a 51-year-old male with heartburn, vomiting, dyspepsia but was taking no acid suppression medication at the time of his 2/20/15 visit to his provider. Evaluation has included esophageal manometry with impedance testing that suggested a hiatal hernia but showed no classic dysmotilities. An esophagogastroduodenoscopy (EGD) with biopsies supported mild reactive changes at the gastroesophageal junction, H. pylori-negative mild reactive gastropathy, and peptic duodenitis. A 24-hour pH test identified both acid and non-acid reflux events with good symptom correlation with heartburn, regurgitation, and vomiting episodes. The patient has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational. The
This patient has already undergone much of this pre-operative assessment which revealed relatively mild GERD, predominantly recumbent.
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Upheld
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Experimental
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Summary Reviewer 3
The patient is a 51-year-old male with heartburn, vomiting, dyspepsia but was taking no acid suppression medication at the time of his 2/20/15 visit to his provider. Evaluation has included esophageal manometry with impedance testing that suggested a hiatal hernia but showed no classic dysmotilities. An esophagogastroduodenoscopy (EGD) with biopsies supported mild reactive changes at the gastroesophageal junction, H. pylori-negative mild reactive gastropathy, and peptic duodenitis. A 24-hour pH test identified both acid and non-acid reflux events with good symptom correlation with heartburn, regurgitation, and vomiting episodes. The patient has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested procedure is considered investigational. The LINX device received U.S. Food and Drug Administration (FDA) approval for patients with diagnosed GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal medica_l therapy for the treatment of reflux. The FDA noted that appropriate patient selection is important and reflux-related symptoms should be severe enough to outweigh the potential side effects of fundoplication. Currently, upper endoscopy, barium esophagram, pH testing, and manometry are required for preoperative work-up for antireflux surgery. This patient has already undergone much of this pre-operative assessment which revealed relatively mild GERD, predominantly recumbent. However, the available records do not support ongoing use of acid suppression therapy, and as such is not considered medically refractory to acid blocker drugs. Accordingly, the requested LINX device 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 25-year-old male enrollee has requested authorization and coverage for Daklinza 60 mg and Sovaldi 400 mg for 12 weeks. The Health Insurer has denied this request indicating that the requested medications are 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 25-year-old male enrollee has requested authorization and coverage for Daklinza 60 mg and Sovaldi 400 mg for 12 weeks. The Health Insurer has denied this request indicating that the requested medications are not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found according to joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C should be treated except those with life expectancy less than 12 months due to non-liver-related conditions. In treatment-naive genotype 3 patients, the guidelines recommend therapy with Sovaldi and Daklinza for 12 weeks. All told, the requested Daklinza 60 mg and Sovaldi 400 mg for 12 weeks are medically indicated for the treatment of this patient. Therefore, the requested medications are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 43-year-old female enrollee has requested authorization and coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain.
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Overturned
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Experimental
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Summary Reviewer 1
A 43-year-old female enrollee has requested authorization and coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. The physician reviewer found that minimally invasive SI joint fusion has not been demonstrated to result in superior health outcomes for the treatment of back pain when compared to standard available treatment options. Further, this patients medical records do not show any evidence of SI joint instability, fracture, or tumor, thus the criteria for SI joint fusion are not met. This patient has chronic back pain after previous lumbar fusion surgery. The pain is likely degenerative in cause. For these reasons, the requested SI joint fusion 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 63-year-old male enrollee has requested authorization and coverage for Repatha SureClick. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
this patient has an intermediate 10-year cardiovascular risk of approximately 8.4%. He also has other risk factors
a family history of cardiovascular disease and a markedly elevated coronary calcium score. He is a candidate for statin therapy based on published guidelines. He has done lifestyle modification but has a documented intolerance to two statin medications. He was started on ezetimibe per guidelines. The patient had a moderate reduction in his LDL to 125, but this is still not at goal. In a patient with elevated risk and intolerance to multiple statin medications who is already on ezetimibe and is still not
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Overturned
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Medical Necessity
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Summary Reviewer
A 63-year-old male enrollee has requested authorization and coverage for Repatha SureClick. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient has an intermediate 10-year cardiovascular risk of approximately 8.4%. He also has other risk factors which increase his cardiovascular risk independent of those measured by the clinical cardiovascular calculator, including a family history of cardiovascular disease and a markedly elevated coronary calcium score. He is a candidate for statin therapy based on published guidelines. He has done lifestyle modification but has a documented intolerance to two statin medications. He was started on ezetimibe per guidelines. The patient had a moderate reduction in his LDL to 125, but this is still not at goal. In a patient with elevated risk and intolerance to multiple statin medications who is already on ezetimibe and is still not at LDL goal, the addition of the proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitor Repatha SureClick is reasonable and medically indicated to achieve the guideline directed LDL goal. Therefore, Repatha SureClick is medically necessary for the treatment of this patient.
| 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.
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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 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 compared to standard radiotherapy with photon-based intensity modulated radiation therapy, the benefit of proton therapy is that with its Bragg Peak, radiation dose is deposited more precisely on its target. This translates into a decrease in exposure of normal tissue in the low-dose to intermediate-dose range, but not in the high-dose range. Comparing dosimetric parameters, proton therapy will always appear superior to photon-based intensity modulated radiation therapy. However, this dosimetric benefit does not always translate into an actual clinical benefit to the patient. While there are several dosimetric studies evaluating proton therapy for rectal cancer, there is a lack of studies evaluating clinical benefit. In this case, the treating provider submitted a comparison dose-volume histogram of intensity modulated proton therapy versus photon therapy. However, the photon therapy was a three-dimensional conformal plan and not an intensity modulated radiation therapy plan. Thus, a true comparison of the benefit of protons versus photons cannot be made. In sum, 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.
| 0 |
patient is a 57-year-old male who presented to his provider on 1/20/22. The patient has
requested authorization and coverage for MRI cervical spine without contrast material.
In this case, the patient has symptoms
suggestive of left cervical radiculopathy with numbness on physical examination in the vicinity of
the left C3 dermatome.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 57-year-old male who presented to his provider on 1/20/22. The patient has
requested authorization and coverage for MRI cervical spine without contrast material. The
physician reviewer found that at issue is whether the requested MRI cervical spine without
contrast material is medically necessary for the evaluation of this patient. The submitted
documentation supports the medical necessity of the requested service. Kothari explains that
cervical radiculopathy is a clinical diagnosis that may result from a number of causes including
but not limited to degenerative disease, infection, inflammation, and tumor. Ancillary testing is
important in localization and in determining pathology in addition to the clinical evaluation.
Neuroimaging is indicated for most patients with a corresponding neurological deficit present on
examination and is currently the study of choice to assist in confirming a compressive
radiculopathy for diagnostic and treatment purposes. In this case, the patient has symptoms
suggestive of left cervical radiculopathy with numbness on physical examination in the vicinity of
the left C3 dermatome. In this clinical setting, an MRI of the cervical spine without contrast
medically indicated for the evaluation of suspected left C3-C4 radiculopathy. Therefore, MRI
cervical spine without contrast material is medically necessary for the evaluation of this patient.
| 1 |
A 32-year-old male enrollee has requested reimbursement for laboratory testing performed on 12/05/18. 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.
This patient was appropriately treated for infectious risks associated with monkey bites.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 32-year-old male enrollee has requested reimbursement for laboratory testing performed on 12/05/18. 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 the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient was appropriately treated for infectious risks associated with monkey bites. The standard references for management of travel-associated illness do not discuss risk of transmission of hepatitis from monkey bites. The medical literature does not indicate that monkey bites are a source of transmission for hepatitis viruses. The testing ordered after his return to the United States was not medically indicated. Therefore, laboratory testing performed on 12/05/18 was not medically necessary for the evaluation for the patient.
| 1 |
An 18-year-old male has requested reimbursement for Anser IFX testing performed on 7/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
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Upheld
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Experimental
|
Summary Reviewer 2
An 18-year-old male has requested reimbursement for Anser IFX testing performed on 7/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the current medical evidence has not demonstrated the superior efficacy of the services at issue. The use of Anser IFX testing to direct management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials of patients with Crohns disease. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have clear Remicade levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Although loss of response to infliximab is common, there were a lack of standard guidelines defining a therapeutic strategy at the time of testing. A systematic review by Yarur and colleagues noted that future prospective controlled studies are needed, especially considering that anti-tumor necrosis levels are influenced by several variables that can fluctuate over time and among individuals. In sum, Anser IFX testing performed on 7/09/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 38-year-old female enrollee has requested authorization and coverage for Humira 40 mg weekly. The Health Insurer has denied this request indicating that the requested medication dosage is considered investigational for treatment of the enrollees ulcerative colitis.
This patient has had uncontrolled disease on dosing every 14 days.
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Overturned
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Experimental
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Summary Reviewer 3
A 38-year-old female enrollee has requested authorization and coverage for Humira 40 mg weekly. The Health Insurer has denied this request indicating that the requested medication dosage is considered investigational for treatment of the enrollees ulcerative colitis. The physician reviewer found that there is sufficient support for the requested medication dosage in this clinical setting. This patient has had uncontrolled disease on dosing every 14 days. In the ULTRA 2 trial by Sandborn and colleagues, it was part of the protocol to change patients to weekly Humira if response was not adequate on Humira every two weeks. The trial advanced non-responders at week 8 to weekly therapy as well as week-8 responders. Both groups contained a fraction that responded to dosing frequency increase. Current guidelines recommend that when anti-tumor necrosis factor level is low, and anti-drug antibody is low or absent (as in this case), the drug dose should be increased. Staying on the dose of 40 mg every other week or changing to a different medication may result in disease flare, disease complications, and hospitalization. For these reasons, the request for Humira 40 mg weekly is likely to be of greater benefit than other available treatment options. Based upon the information set forth above, the requested medication dosage 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 35-year-old female enrollee has requested reimbursement for colorectal cancer screening
using chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22. The
Health Insurer has denied this request and reported that the services at issue were investigational
for the evaluation of the enrollees medical condition.
standard colonoscopy. During the
examination, the mucosa is inspected and biopsied in standard fashion. Subsequent to this, the
mucosa is sprayed with a vital dye that
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Overturned
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Experimental
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Summary Reviewer 2
A 35-year-old female enrollee has requested reimbursement for colorectal cancer screening
using chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22. 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
Chromoendoscopy is a well-accepted adjunct to colonoscopy to look for dysplasia in patients
with longstanding ulcerative colitis. Patients undergo a standard colonoscopy. During the
examination, the mucosa is inspected and biopsied in standard fashion. Subsequent to this, the
mucosa is sprayed with a vital dye that highlights subtle areas that may represent neoplasia.
These areas are biopsied separately. Chromoendoscopy has become the standard of care for
patients previously identified to have abnormal mucosa on a previous colonoscopy, such as this
patient. The medical evidence supports the services at issue in this setting. Therefore, colorectal
cancer screening using chromoendoscopy or narrowband imaging optical colonoscopy
performed on 1/25/22 was likely to have been more beneficial than any available standard
therapy.
| 1 |
A 62-year-old female enrollee has requested reimbursement for acute hospital admission to telemetry level of care from 9/24/18 through 9/25/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who had a history of chest pain.
cardiovascular physical examination, an unchanged electrocardiogram and
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Upheld
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Medical Necessity
|
Summary Reviewer
A 62-year-old female enrollee has requested reimbursement for acute hospital admission to telemetry level of care from 9/24/18 through 9/25/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who had a history of chest pain. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The records document some coronary risk, chest pain concerning for possible ischemia, a normal cardiovascular physical examination, an unchanged electrocardiogram and an initial negative evaluation in the emergency department. In this circumstance, it would have been reasonable to anticipate a hospital length of stay to require less than 48 hours or less than two midnights, and it would have been safe to manage the patient at an observational level of care as opposed to an inpatient admission. There was no documented hemodynamic instability or objective evidence of coronary ischemia or other acute medical condition to warrant an inpatient admission. Thus, acute hospital admission to telemetry level of care from 9/24/18 through 9/25/18 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 51-year-old female enrollee has requested authorization and coverage for Botox. The Health
Insurer has denied this request and reported that the requested service is investigational for the
treatment of the enrollee.
physical therapy, warm and cold compresses, and splinting with a dentist
prescribed occlusal devise.
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Upheld
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Experimental
|
Summary Reviewer 3
A 51-year-old female enrollee has requested authorization and coverage for Botox. The Health
Insurer has denied this request and reported that the requested service is investigational for the
treatment of the enrollee. The physician reviewer found that standard medical therapies for
temporomandibular joint disorder include NSAIDs, both enteral and topical, diet restriction, jaw
exercises including physical therapy, warm and cold compresses, and splinting with a dentist
prescribed occlusal devise. Gonzalez-Perez and colleagues note that the use of dry needling is
also becoming more common and has been shown to be safe and effective in the treatment of
temporomandibular joint disorder. As the use of Botox for the treatment of temporomandibular
joint disorder is not FDA approved, there is limited high quality data regarding its use and efficacy
for the treatment of temporomandibular joint disorder, and there is no standardization for its
administration in this clinical setting. In a randomized controlled trial comparing the efficacy of
dry needling and Botox in the treatment of temporomandibular joint disorder, Kutuc and
colleagues reported that at the end of six weeks, patients treated with dry needling reported
more pain relief on the visual analog scale (VAS), better improvement in jaw protrusion angles
on both sides, and better recovery of temporomandibular joint function than the patients treated
with Botox. In a randomized controlled trial comparing the efficacy of Botox to occlusal splinting
in the treatment of myofacial pain, Miotto and colleagues noted improvement in both treatment
arms but did not specify any statistically significant difference between the groups. In a
systematic review of the use of Botox in the treatment of temporomandibular joint disorder that
included an investigation of physical therapy versus Botox, Patel and colleagues found no
statistically significant difference between either treatment modality. Given the lack of evidence
supporting the use of Botox over other proven treatment modalities, while Botox is emerging as
a promising therapeutic option in the management of certain aspects of temporomandibular
joint disorder, the requested service is not likely to be more beneficial than other currently
available standard treatments for the treatment of this patient. Therefore, Botox is not likely to
be more beneficial for treatment of the patients condition than any available standard therapy.
| 1 |
The patient is an 11-year-old male who has been diagnosed with autism spectrum disorder and attention deficit/hyperactivity disorder (ADHD). The patientas parent has requested reimbursement for speech therapy provided from 3/13/19 through 6/12/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
The records indicate that the patient was performing at a range from the average
This patient was noted to score in the 97th percentile on the TOPL-2, which was in the superior range. He did not appear to require speech therapy to address deficits in pragmatic language. His pediatrician wrote a referral for speech therapy to address stuttering, but
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is an 11-year-old male who has been diagnosed with autism spectrum disorder and attention deficit/hyperactivity disorder (ADHD). The patientas parent has requested reimbursement for speech therapy provided from 3/13/19 through 6/12/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The records indicate that the patient was performing at a range from the average to very superior range in the speech areas of concern, including articulation and pragmatic speech. No short-term speech therapy goals were indicated. The American Speech-Hearing Association lists as one of its criteria for discharge from therapy awhen the communication disorder has been remediated or compensatory strategies have been successfully established.a One of the major areas of language difficulty in children with autism spectrum disorder is pragmatic language. This patient was noted to score in the 97th percentile on the TOPL-2, which was in the superior range. He did not appear to require speech therapy to address deficits in pragmatic language. His pediatrician wrote a referral for speech therapy to address stuttering, but there is no comment regarding stuttering being an issue in his speech therapy reports. Therefore, speech therapy provided from 3/13/19 through 6/12/19 was not medically necessary for the treatment of this patient.
| 1 |
The parent of a six-year-old male enrollee has requested authorization and coverage for growth hormone therapy. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
|
Upheld
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Medical Necessity
|
Summary Reviewer
The parent of a six-year-old male enrollee has requested authorization and coverage for growth hormone therapy. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. The records document linear growth around the fifth percentile. There is a lack of evidence of poor growth based on the growth chart. Growth hormone therapy is not indicated for a child that is growing well. The clinical notes indicate that this patients weight is at the first percentile. Poor nutrition can affect growth, and this patient may benefit from extra calories to improve growth. This patient has a relatively short genetic potential. However, growth hormone therapy is not indicated to treat short genetic potential. There is no indication of idiopathic short stature, as this patient is not growing below -2.25 standard deviations for age and sex. Thus, growth hormone therapy is not medically necessary for the treatment of this patient.
| 0 |
A 59-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan performed on 2/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees rigidity, lack of response to Sinemet trial, with suspected Parkinsons disease.
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Overturned
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Experimental
|
Summary Reviewer 1
A 59-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan performed on 2/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees rigidity, lack of response to Sinemet trial, with suspected Parkinsons disease. The physician reviewer found that in the medical literature, Suwijn and colleagues reported that Parkinsons disease (PD) is wrongly diagnosed in 6 to 25% of cases. To improve the accuracy of the clinical diagnosis, it is necessary to have a reliable and practical reference standard. Dopamine transporter single-photon emission computed tomography (DAT SPECT) imaging might have the potential (high diagnostic accuracy and practical to use) to act as reference standard in detecting nigrostriatal cell loss in patients with (early stage) parkinsonism. Kagi and colleagues found that the use of DAT SPECT can prove or exclude with high sensitivity nigrostriatal dysfunction in those cases and facilitates early and accurate diagnosis. Thus, the literature does support the use of DAT SPECT for the diagnosis of Parkinsons disease. Given this support, the SPECT scan performed on 2/17/15 was likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 56-year-old female enrollee has requested authorization and coverage for Repatha SureClick (evolocumab subcutaneous solution auto-injector 140 mg/mL). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hyperlipidemia.
. The patient has been intolerant of two statin medications and Zetia. Repatha (evolocumab
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 56-year-old female enrollee has requested authorization and coverage for Repatha SureClick (evolocumab subcutaneous solution auto-injector 140 mg/mL). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hyperlipidemia. The physician reviewer found that in this case, there is no documented heart disease and mildly elevated LDL level. The patient has been intolerant of two statin medications and Zetia. Repatha (evolocumab) is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor sufficiently studied only for patients with heterozygous familial hypercholesterolemia or for patients with documented atherosclerotic heart disease who require additional lowering of LDL-cholesterol. This patient does not fit any of those criteria. PCSK9 inhibitors have not been sufficiently studied in other patient populations, such as this patient with no documented cardiovascular disease and relatively mildly elevated lipid levels after lifestyle changes. Current guidelines that are endorsed by several national organizations do not recommend the use of PCSK9 inhibitors in this primary prevention setting. Thus, Repatha SureClick (evolocumab subcutaneous solution auto-injector 140 mg/mL) is not medically necessary 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.
| 1 |
A 57-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/27/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cutaneous melanoma.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 57-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/27/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the standard protocol for an intermediate thickness tumor such as in this case does not include a work-up with molecular genetic testing. Although DecisionDx-Melanoma testing has shown results in predicting risk of metastasis, there is no set change in treatment protocol based on the findings. Currently the standard of care includes wide local excision and a sentinel node biopsy and the decision to pursue medical treatment would be based on the results of these tests. There are no clinical studies at this time that show that the results of the molecular testing will make a difference in the treatment or morbidity or mortality of the patient. For the reasons provided, the DecisionDx-Melanoma testing performed on 10/27/16 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 49-year-old female enrollee has requested reimbursement for DecisionDX-Melanoma assay test performed on 6/30/14. The Health Insurer has denied this request indicating that the test at issue was not medically necessary for evaluation of the enrollees cutaneous melanoma.
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 49-year-old female enrollee has requested reimbursement for DecisionDX-Melanoma assay test performed on 6/30/14. The Health Insurer has denied this request indicating that the test at issue was not medically necessary for evaluation of the enrollees cutaneous melanoma. The physician reviewer found the prognosis of cutaneous melanoma has classically been determined by the staging system as documented by Balch and colleagues. Mitotic index has also been thought to add a bit more to the prognostics. By these determinations, this patient has an excellent prognosis. DecisionDX is a study of 31 genes in the melanoma cells. It then classifies that melanoma as either high or low risk for recurrence (Dillion et al). The National Comprehensive Cancer Network (NCCN) guidelines state there is interest in these newer genetic profiles, but only in the context of a clinical trial. Currently, medical studies are not clear as to how DecisionDX data compares to the 10 year data of the Balch determinations and whether it is useful in clinical practice for patients with a good prognosis, as is true in this patients case. In sum, this assay was not medically necessary in evaluating this patients likelihood of metastasis in cutaneous melanoma. Based on the information above, the test at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 73-year-old female who presented to her provider on 7/19/22. The records noted
statin intolerance, coronary artery disease, and an abnormal electron beam computed tomography
(EBCT) result. The patient has requested authorization and coverage for Repatha Sureclick
solution auto-injector 140 mg/mL. The Health Insurer has denied this request and reported that the
requested medication is not medically necessary for the treatment of this patient.
In this case, the records
document that the patient has coronary artery disease, has been unable to tolerate multiple statins,
has a high LDL level, and an abnormal EBCT result.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 73-year-old female who presented to her provider on 7/19/22. The records noted
statin intolerance, coronary artery disease, and an abnormal electron beam computed tomography
(EBCT) result. The patient has requested authorization and coverage for Repatha Sureclick
solution auto-injector 140 mg/mL. The Health Insurer has denied this request and reported that the
requested medication is not medically necessary for the treatment of this patient. This denial is the
subject of this appeal and determination. The physician reviewer found that the submitted
documentation supports the medical necessity of the requested medication. In this case, the records
document that the patient has coronary artery disease, has been unable to tolerate multiple statins,
has a high LDL level, and an abnormal EBCT result. In addition, according to Nissen and
colleagues, this medication has been successfully used in statin intolerant patients. In this clinical
setting, current medical literature supports the use of the requested medication. Therefore, Repatha
Sureclick solution auto-injector 140 mg/mL is medically necessary for the treatment of this patient.
| 1 |
A 58-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 not medically necessary for treatment of the enrollees gastroesophageal reflux disease (GERD), dysphagia and hiatal hernia.
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Upheld
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Medical Necessity
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Summary Reviewer
A 58-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 not medically necessary for treatment of the enrollees gastroesophageal reflux disease (GERD), dysphagia and hiatal hernia. The physician reviewer found that there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other standard surgical anti-reflux procedures in the treatment of patients with GERD. 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 evidence review found that further studies are required to determine its long-term outcomes and its relative efficacy as compared to other established treatments (Loh, et al). Adverse events, such as erosion through the esophagus, have been reported since U.S. Food and Drug Administration (FDA) approval (Bauer, et al). One peer-reviewed study reported that there are 11 cases of endoscopically-confirmed LINX erosion through the esophagus in the FDA Adverse Events database (Bielefeldt). Additionally, LINX has been 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 beneficial in this case than standard treatment including surgical fundoplication (Sheu, et al). The American College of Gastroenterology guidelines for the management of GERD also state that more evidence is needed before LINX can be recommended (Katz, et al). Based on current literature and clinical guidelines, the requested LINX procedure is not supported as medically necessary for the treatment of the patients medical condition. Based on the foregoing discussion, the requested procedure is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health partial hospitalization program (PHP) services from 2/20/16 and forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition.
records the patient was no longer a threat to himself as of 2/20/16 and he was not a danger to others. There was no evidence of psychosis or mania. He was able to perform his active daily living (ADL) and he was cognitively intact. He had made progress and was able to exert control over his behavior to an extent that a lower level of care would have been appropriate and indicated. The patients family was actively engaged and supportive. He did
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health partial hospitalization program (PHP) services from 2/20/16 and forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. According to the records the patient was no longer a threat to himself as of 2/20/16 and he was not a danger to others. There was no evidence of psychosis or mania. He was able to perform his active daily living (ADL) and he was cognitively intact. He had made progress and was able to exert control over his behavior to an extent that a lower level of care would have been appropriate and indicated. The patients family was actively engaged and supportive. He did not have coexistent medical or acute substance abuse issues that would have interfered with treatment at a lower level of care. The patients symptoms and behavior were no longer of an acuity requiring PHP level of care. For these reasons, the services at issue were not and are not medically necessary in the treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 41-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 11/06/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.T
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Overturned
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Medical Necessity
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Summary Reviewer 2
A 41-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 11/06/15. 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 current medical evidence supports the services at issue in this patients case. Breast tomosynthesis has been demonstrated to be of particular benefit in women with extremely dense and heterogeneously dense tissue. The tomographic nature of this technique often allows radiologists to separate dense underlying glandular elements from architectural distortion/mass resulting in a decrease in callbacks and increase in detection of small cancers. For these reasons, the addition of breast tomosynthesis to the usual two-dimensional protocol was likely of more benefit to this patient than if she had two-dimensional imaging alone. 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 40-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/08/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
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Overturned
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Experimental
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Summary Reviewer 1
A 40-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/08/16. 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 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 this 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 61-year-old female enrollee has requested reimbursement for the in-office surgical injections performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees lumbar spondylosis with arthropathy.
on magnetic resonance imaging (MRI) as well as having discogenic radiculopathy.
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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 reimbursement for the in-office surgical injections performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees lumbar spondylosis with arthropathy. The physician reviewer found that the available records document that this patient has mild facet arthropathy as demonstrated on magnetic resonance imaging (MRI) as well as having discogenic radiculopathy. However, the medial branch blocks performed on 8/4/15 are not indicated in the presence of another clear cause of the patients low back and radicular pain. Further, the use of repeated diagnostic blocks absent a plan for radiofrequency neurolysis is not consistent with clinical practice guidelines. Thus, the in-office surgical injections performed on 8/4/15 were 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 services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
patient is a 27-year-old female with a history of severe adolescent idiopathic scoliosis with
trunk rotation asymmetry, trunk shift, and associated pain. The patient was diagnosed with
scoliosis at 13 years of age. The provider has recommended treatment with surgical correction of
the patients scoliosis. The Health Insurer has denied the requested surgery as not medically
necessary for the treatment of the patients medical condition.
In this case, the patient
has a history of severe scoliosis with a Cobb angle of 66 degrees as measured from the superior
endplate at T8 to the
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Overturned
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Medical Necessity
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Summary
The patient is a 27-year-old female with a history of severe adolescent idiopathic scoliosis with
trunk rotation asymmetry, trunk shift, and associated pain. The patient was diagnosed with
scoliosis at 13 years of age. The provider has recommended treatment with surgical correction of
the patients scoliosis. The Health Insurer has denied the requested surgery as not medically
necessary for the treatment of the patients medical condition. This denial is the subject of this
appeal and determination. The physician reviewer found that the records provided for review
indicate that the patient has a history of severe adolescent idiopathic scoliosis. According to Kuznia
and colleagues, Patients with severe scoliosis (Cobb angle of 40 degrees or more) may have
physical pain, cosmetic deformity, psychosocial distress, or, rarely, pulmonary disorders. The
authors note that surgical correction of scoliosis should be reserved for severe cases, while
conservative treatment may be effective for mild to moderate scoliosis. Per Yang and colleagues,
Surgical management of adolescent idiopathic scoliosis can be performed using standard
posterior spinal fusion or with a posterior minimally invasive approach. The benefits of the
requested surgical procedure are further corroborated by Nishida and colleagues, who concluded
that, Posterior correction and fusion surgery have improved preoperative asymmetric global
rotational kinematics of trunk and pelvis in transverse plane to symmetric postoperatively in
adolescent idiopathic scoliosis patients with thoracic single major curve. In this case, the patient
has a history of severe scoliosis with a Cobb angle of 66 degrees as measured from the superior
endplate at T8 to the inferior endplate at L2. There is a lack of additional imaging demonstrating
any other significant spinal deficits that could be contributing to the patients pain. The patient has
undergone physical therapy without adequate benefit. The peer-reviewed literature supports that
conservative treatment is not as effective as surgical correction in severe cases of scoliosis.
Without surgical correction, the patients severe curve is likely to progress and further affect her
pulmonary function. Moreover, an initial perioperative hospital stay is indicated and supported for
lumbar fusion procedures as recommended for this patient. For these reasons, the requested
arthrodesis, anterior, for spinal deformity with or without cast, and anterior instrumentation with
an inpatient stay are medically necessary for the treatment of the patient.
| 1 |
patient is a 62-year-old male who was diagnosed with Eustachian tube dilatory dysfunction and significant middle ear pressure. The patient has requested reimbursement for endoscopic balloon dilation of the Eustachian tube performed on 12/04/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
The patient has a history of ear plugging due to chronic Eustachian tube dysfunction and has been unresponsive to medical therapy.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 62-year-old male who was diagnosed with Eustachian tube dilatory dysfunction and significant middle ear pressure. The patient has requested reimbursement for endoscopic balloon dilation of the Eustachian tube performed on 12/04/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The patient has a history of ear plugging due to chronic Eustachian tube dysfunction and has been unresponsive to medical therapy. Balloon Eustachian tuboplasty has been approved by the U.S. Food and Drug Administration. This procedure has been demonstrated to be effective in a randomized clinical trial with one-year follow-up. There is sufficient support for the services at issue in this patientas case. Therefore, endoscopic balloon dilation of the Eustachian tube performed on 12/04/20 was medically necessary for the treatment of this patient.
| 1 |
A 42-year-old female enrollee has requested reimbursement for DecisionDx Melanoma testing (84999) performed on 1/23/17. The Health Insurer has denied this request indicating that the testing at issue is 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 42-year-old female enrollee has requested reimbursement for DecisionDx Melanoma testing (84999) performed on 1/23/17. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the National Comprehensive Cancer Network guidelines indicate that genetic testing such as the DecisionDx Melanoma assay should not be used outside of a clinical trial setting. The use of DecisionDx Melanoma testing is not considered to be standard of care in the treatment of the patients melanoma. Thus, its usage is not expected to impact the treatment or outcome of the patients melanoma. All told, the DecisionDx Melanoma testing (CPT code 84999) performed on 1/23/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
patient is a 52-year-old female with a history of Graves disease and post-COVID symptoms
including fatigue, brain fog, and varying degrees of shortness of breath. The patient underwent
flow cytometry on 2/23/23 as workup for her long COVID symptoms. The Health Insurer has
denied the services at issue as not medically necessary for the evaluation of the patients medical
condition.
patient underwent flow cytometry on 2/23/23
as workup for her post-COVID conditions.
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Upheld
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Medical Necessity
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Summary
The patient is a 52-year-old female with a history of Graves disease and post-COVID symptoms
including fatigue, brain fog, and varying degrees of shortness of breath. The patient underwent
flow cytometry on 2/23/23 as workup for her long COVID symptoms. The Health Insurer has
denied the services at issue as not medically necessary for the evaluation of the patients medical
condition. This denial is the subject of this appeal and determination. The physician reviewer found
that the records provided for review reflect that this patient underwent flow cytometry on 2/23/23
as workup for her post-COVID conditions. No laboratory test can definitively distinguish post-
COVID conditions from other conditions with similar symptomatologies but different etiologies.
The use of flow cytometry to assess cell surface markers and cytokine expression in patients with
long COVID is being investigated in research settings to elucidate the pathophysiology of
inflammation in the setting of long COVID. However, there are no existing clinical applications
of flow cytometry results for patients with long COVID. Inflammatory markers are generally not
recommended for the workup of patients with suspected or confirmed long COVID. Therefore, the
laboratory services flow cytometry performed on 2/23/23 were not medically necessary for the
evaluation of the patient.
| 1 |
A 63-year-old female enrollee has requested authorization and coverage for LINX Reflux Management System, CPT code 43284. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
This patient has gastroesophageal reflux disease based on pH recordings.
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Upheld
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Experimental
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Summary Reviewer 1
A 63-year-old female enrollee has requested authorization and coverage for LINX Reflux Management System, CPT code 43284. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the LINX device has been approved for patients with diagnosed gastroesophageal reflux disease as defined by abnormal pH testing, and who continue to have chronic gastroesophageal reflux disease symptoms despite maximal medical therapy for the treatment of reflux. Appropriate patient selection is crucial before anti-reflux procedures. This patient has gastroesophageal reflux disease based on pH recordings. Aside for situations of diet indiscretion, the patient reports appropriate benefit from acid suppression treatment, and accordingly, she cannot be considered medically refractory to acid blocker drugs. In this patients case, implantation of the LINX device must be approached with caution, particularly since there are documented complaints of difficulty swallowing and a normal lower esophageal sphincter anatomy and function that does not warrant augmentation. As such, LINX cannot be considered more beneficial for treatment of the patients condition than appropriate diet and lifestyle modification in combination with her presently effective acid suppression medications. Therefore, the LINX Reflux Management System (CPT 43284) is not likely to be more effective than other treatment options.
| 1 |
A 39-year-old female has requested reimbursement for Anser ADA testing performed on 6/25/15. 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 1
A 39-year-old female has requested reimbursement for Anser ADA testing performed on 6/25/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. There is insufficient evidence to support the use of Anser ADA testing. Studies performed thus far have included retrospective cohorts or have employed an observational design. There is a need for randomized controlled trials of tumor necrosis factor level and antibody driven care versus standard of care. Therefore, Anser ADA testing performed on 6/25/15 was not likely to have been superior over 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 |
The patient is a 20-year-old female who sustained severe injuries with a Glasgow Coma Score
(GCS) of 6 from a motor vehicle versus cyclist accident on 5/2/23. The provider noted that the
patients pulse was 100 beats per minute on the date of transport. The patient has requested
reimbursement for the air and ground ambulance services provided on 6/23/22.
review document that this patient sustained TBI,
SDH, SAH, complex pelvic fractures, and an open tibia fracture in a motor vehicle versus bicycle
accident on 6/23/22.
The provider recommended transfer for the patient to undergo
neurological rehabilitation from an intensive multidisciplinary approach to maximize functional
independence. The records document that the patient had a pulse of 100 beats per minute on
the day of transport, which could have represented ongoing or recurrent internal hemorrhage.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 20-year-old female who sustained severe injuries with a Glasgow Coma Score
(GCS) of 6 from a motor vehicle versus cyclist accident on 5/2/23. The provider noted that the
patients pulse was 100 beats per minute on the date of transport. The patient has requested
reimbursement for the air and ground ambulance services provided on 6/23/22. The physician
reviewer found that the records provided for review document that this patient sustained TBI,
SDH, SAH, complex pelvic fractures, and an open tibia fracture in a motor vehicle versus bicycle
accident on 6/23/22. Based on review of the level of injuries sustained, including internal
hemorrhage and brain injury, this patient would have warranted air transport in order to
expedite the transfer. The provider recommended transfer for the patient to undergo
neurological rehabilitation from an intensive multidisciplinary approach to maximize functional
independence. The records document that the patient had a pulse of 100 beats per minute on
the day of transport, which could have represented ongoing or recurrent internal hemorrhage.
Given the extent and severity of the patients injuries, transport by any other means such as
ground ambulance for the entire transfer would have placed the patients long-term health at
risk. Moreover, the use of air and ground transport for this patient was consistent with the
recommendations from the Centers for Disease Control and Prevention (CDC). Therefore, the air
and ground ambulance services provided on 6/23/22 were medically necessary for treatment of
this patient.
| 1 |
A 51-year-old male has requested reimbursement for gene expression profiling performed on 5/14/17. 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 51-year-old male has requested reimbursement for gene expression profiling performed on 5/14/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add a bit more 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 risk of metastasis. Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients undergoing sentinel node biopsy. However, it is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year data of Balch. Most importantly, it is unclear whether DecisionDx-Melanoma data can be used to make clinical decisions. Therefore, gene expression profiling performed on 5/14/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 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 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 physician reviewer found in the peer-reviewed medical literature, Skaane and colleagues found that the addition of three-dimensional digital breast tomosynthesis to two-dimensional full field digital mammography resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Thus, although additional studies are needed to confirm these findings, there is adequate data to support the utility of three-dimensional digital breast tomosynthesis in this clinical setting. For these reasons, the breast tomosynthesis performed on 10/21/15 was likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old female enrollee has requested reimbursement for gene tests performed on 6/09/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees non-small cell lung cancer.
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Overturned
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Experimental
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Summary Reviewer 2
A 60-year-old female enrollee has requested reimbursement for gene tests performed on 6/09/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees non-small cell lung cancer. The physician reviewer found that molecular diagnostic studies in non-small cell lung cancer (NSCLC) are considered a standard of care. Numerous gene alterations have been identified that impact therapy selection. The National Comprehensive Cancer Network strongly advises broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with 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. In sum, gene tests performed on 6/09/16 were likely to be more beneficial than other methods of evaluating this patient. Based upon the information set forth above, the services at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 53-year-old male enrollee has requested authorization and coverage for transcranial magnetic stimulation (TMS). The Health Insurer has denied this request indicating that the requested service is not medically necessary for treatment of the enrollees major depressive disorder.
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Overturned
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Medical Necessity
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Summary Reviewer
A 53-year-old male enrollee has requested authorization and coverage for transcranial magnetic stimulation (TMS). The Health Insurer has denied this request indicating that the requested service is not medically necessary for treatment of the enrollees major depressive disorder. The physician reviewer found that TMS is a non-invasive brain stimulating procedure utilized in the treatment of major depressive disorder. The procedure is well tolerated with fewer barriers and side effects than electroconvulsive therapy. TMS is U.S. Food and Drug Administration (FDA) approved and supported by the American Psychiatric Association (APA) for the acute phase treatment of major depressive disorder after failure of at least one antidepressant trial. Further, the APA made no mention of pre-requisite psychotherapy. Thus, the standard of care does not require a certain course of psychotherapy prior to TMS. In this case, the patient remains symptomatic despite first-line medications and psychotherapy. Considering the medical records, endorsement from the APA and the expanding peer-reviewed literature base, TMS represents a safe, appropriate treatment consistent with good medical practice that is reasonably expected to improve the patients condition and prevent a more serious episode of illness. As such, the requested TMS is medically necessary for treatment of the patients major depressive disorder. Therefore, the requested service is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 41-year-old male with a diagnosis of chronic migraine. He has been on multiple antidepressant medications. The patient has also been treated with amlodipine and topiramate. A headache diary confirms the presence of chronic daily headache. The patient has requested reimbursement for Botox injections provided on 10/16/17 and 1/08/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of this patient.
patients records support the diagnosis of chronic migraine. He has already been on several preventive agents.
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Overturned
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Experimental
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Summary Reviewer 3
The patient is a 41-year-old male with a diagnosis of chronic migraine. He has been on multiple antidepressant medications. The patient has also been treated with amlodipine and topiramate. A headache diary confirms the presence of chronic daily headache. The patient has requested reimbursement for Botox injections provided on 10/16/17 and 1/08/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of this patient. The medical evidence supports the services at issue in this clinical setting. This patients records support the diagnosis of chronic migraine. He has already been on several preventive agents. Botox injections was appropriate in this patients case. Thus, Botox injections provided on 10/16/17 and 1/08/18 were likely to have been of greater benefit than other treatment options. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 68-year-old female enrollee has requested reimbursement for human epididymis protein 4 (HE4) testing performed on 9/20/18. 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 68-year-old female enrollee has requested reimbursement for human epididymis protein 4 (HE4) testing performed on 9/20/18. 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 human epididymis protein 4 (HE4) is a blood tumor marker that is often used in the management of ovarian carcinoma. There has been interest in applying HE4 in the management of endometrial cancer, particularly the endometrioid variant, as seen in this patients case. In 2019, Li and colleagues demonstrated that HE4 is superior to CA-125 in the detection of endometrial cancer. In 2015, Li and colleagues demonstrated that the level of HE4 correlates with prognosis. Plotti and colleagues reviewed 49 articles relevant to this issue, and the authors reported that HE4 was promising in endometrioid endometrial cancer. Therefore, HE4 testing performed on 9/20/18 was likely to have been of greater benefit than other methods of evaluating this patient.
| 0 |
A 56-year-old female enrollee has requested reimbursement for the three-dimensional (3D) mammogram (breast tomosynthesis) provided on 1/9/17. The Health Insurer has denied this request indicating that the service at issue is considered investigational for evaluation of the enrollees risk of 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 three-dimensional (3D) mammogram (breast tomosynthesis) provided on 1/9/17. The Health Insurer has denied this request indicating that the service at issue is considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found there is a lack of peer-reviewed literature that supports the use of breast tomosynthesis compared to currently available techniques. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in the peer-reviewed literature as superior to currently available standard medical therapies. Accordingly, the 3D mammogram (breast tomosynthesis) provided on 1/9/17 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 service 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 54-year-old male who was transported via air ambulance on 10/11/20. The patient has requested reimbursement for air ambulance transportation provided on 10/11/20.
individual is transported to the nearest hospital with appropriate facilities for treatment; and there
. This patient was struck by the door of his own vehicle as it rolled from a neutral position, dragging him approximately 25 feet before the rear of the vehicle struck a tree. The patient sustained multiple bilateral rib fractures with bilateral pneumothoraces and a liver laceration, from which he could have exsanguinated.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 54-year-old male who was transported via air ambulance on 10/11/20. The patient has requested reimbursement for air ambulance transportation provided on 10/11/20. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. In order to be medically necessary, specific criteria must be met. These criteria include the following: the individualas condition must be such any form of transportation other than ambulance would be medically contraindicated; the individualas condition is such that time needed to transport by ground poses a threat to the patientas survival; the individual is transported to the nearest hospital with appropriate facilities for treatment; and there is a medical condition that is life-threatening. This patient was struck by the door of his own vehicle as it rolled from a neutral position, dragging him approximately 25 feet before the rear of the vehicle struck a tree. The patient sustained multiple bilateral rib fractures with bilateral pneumothoraces and a liver laceration, from which he could have exsanguinated. Based on the mechanism of injury, and the time needed for ground transport, air ambulance services were medically necessary in this case. Therefore, air ambulance transportation provided on 10/11/20 was medically necessary for the treatment of this patient.
| 1 |
A 53-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 3/11/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees risk for breast cancer.
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Overturned
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Experimental
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Summary Reviewer 1
A 53-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 3/11/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that in the peer-reviewed medical literature, Skaane and colleagues found that the addition of three dimensional digital breast tomosynthesis to two dimensional full field digital mammography resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Thus, although additional studies are needed to confirm these findings, there is adequate data to support the utility of three dimensional digital breast tomosynthesis in this clinical setting. For these reasons, the breast tomosynthesis performed on 3/11/16 was likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 64-year-old female enrollee has requested placement of permanent sacral nerve stimulator performed on 12/09/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees fecal incontinence.
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Overturned
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Experimental
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Summary Reviewer 3
A 64-year-old female enrollee has requested placement of permanent sacral nerve stimulator performed on 12/09/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees fecal incontinence. The physician reviewer found in this patients case, the submitted records fail to establish the superior effectiveness of the services at issue. The clinical records did not provide details regarding what treatments had been tried and failed for her condition. Although the use of sacral nerve stimulation appears to hold promise in many patients with fecal incontinence, the records were insufficient to support the services at issue in this case. Thus, the permanent sacral nerve stimulator provided on 12/09/14 was not likely to be of greater benefit than other available options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 20-year-old male enrollee has requested authorization and coverage for chondrocyte implantation with Denovo. The Health Insurer has denied this request indicating that the requested services are 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 3
A 20-year-old male enrollee has requested authorization and coverage for chondrocyte implantation with Denovo. 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 per Vasiliadis and Wasiak, treatments for managing articular cartilage defects of the knee, including drilling and abrasion arthroplasty, are not always effective. An alternative is autologous chondrocyte implantation. The authors reviewed 431 cases in 6 trials. The authors noted that additional good quality randomized controlled trials with long-term functional outcomes are required to draw conclusions on the use of autologous chondrocyte implantation for treating full thickness articular cartilage defects in the knee. Farr and colleagues noted the need for prospective, randomized controlled studies to refine the indications and contraindications for the requested services. Thus, chondrocyte implantation with Denovo is not likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 24-year-old male enrollee has requested reimbursement for an implantable interstitial
glucose sensor on 1/7/22. The Health Insurer has denied this request and reported that the
device at issue was investigational for the treatment of the enrollees type 1 diabetes.
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Upheld
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Experimental
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Summary Reviewer 3
A 24-year-old male enrollee has requested reimbursement for an implantable interstitial
glucose sensor on 1/7/22. The Health Insurer has denied this request and reported that the
device at issue was investigational for the treatment of the enrollees type 1 diabetes. The
physician reviewer found that blood glucose monitoring is essential to diabetes management.
Options for blood glucose monitoring include self-monitoring of blood sugars (SMBG) with
fingersticks and use of a glucometer or via use of a rtCGM or isCGM. As compared with SMBG,
rtCGM and isCGM technology have been shown to improve glycemic control in patients with
type 1 and type 2 diabetes mellitus. The American Diabetes Association Professional Practice
Committee notes, Real-time continuous glucose monitoring or intermittently scanned
continuous glucose monitoring should be offered for diabetes management in adults with
diabetes on multiple daily injections or continuous subcutaneous insulin infusion who are
capable of using devices safely (either by themselves or with a caregiver). There are several
available CGMS including the Eversense CGMS. Historical data from the system can be used
nonadjunctively to replace SMBG for making diabetes treatment decisions, although it requires
two fingersticks daily with SMBG for calibration. There is a lack of guidance advocating use of
one type of CGM over another and mixed data on the benefits of one CGM over another. Jafri
and colleagues evaluated 23 adults with type 1 diabetes over six weeks comparing the
Eversense, DexCom G5, and FreeStyle Libre Pro. The authors found that the Eversense achieved
the lowest overall mean absolute relative difference (MARD) in glucose values. However, in an
evaluation of 11 patients with type 1 diabetes who initially were at home and on day three,
moved to a monitored setting for four days, Boscari and colleagues reported the DexCom G5
was more accurate in monitoring blood sugars than the Eversense. The authors noted that during the period of intense monitoring, the DexCom G5 showed overall smaller MARD than
the Eversense, concluding that the DexCom 5 was more accurate than the Eversense for
glucose monitoring. While CGM devices are widely popular as a means of monitoring blood
sugars for the management of diabetes and are beneficial in improving glycemic control, there
is a lack of data in current medical literature evaluating all types of CGMs available and small
trials have shown contradictory results. In this clinical setting, an implantable interstitial glucose
sensor was not likely to have been more beneficial for treatment of the patients medical
condition than any available standard therapy such as with rtCGM and/or isCGM. Therefore, an
implantable interstitial glucose sensor on 1/7/22 was not likely to have been more beneficial
for treatment of the patients condition than any available standard therapy
| 1 |
The patient is a 63-year-old male with an elevated prostate-specific antigen (PSA) of 10. A computed tomography (CT) scan of the abdomen and pelvis dated 8/21/17 showed a large prostate, thick bladder with calculi, intermittent hematuria, large calcifications, and left low pole bladder stone of 1.5 cm. On 8/24/17, a transrectal ultrasound and magnetic resonance imaging (MRI) of the prostate, guided needle placement, prostate biopsy, and a cystolitholapaxy revealed the prostate was enlarged with a volume of 45 mL, biopsy was negative, and the bladder was moderate to severely trabeculated with multiple saccules and small diverticula with a stone of 1.5 x 2.5 cm. In a progress note dated 11/27/17, the provider reported that the patients PSA was above 10 and recommended the Uroflow procedure. The patient has requested authorization and coverage for a prostatic urethral lift implant. The Health Insurer has denied this request indicating that the requested surgical procedure is considered investigational. The UroLi
their sexual function. However, this patient was treated for irritative urinary
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Overturned
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Experimental
|
Summary Reviewer 3
The patient is a 63-year-old male with an elevated prostate-specific antigen (PSA) of 10. A computed tomography (CT) scan of the abdomen and pelvis dated 8/21/17 showed a large prostate, thick bladder with calculi, intermittent hematuria, large calcifications, and left low pole bladder stone of 1.5 cm. On 8/24/17, a transrectal ultrasound and magnetic resonance imaging (MRI) of the prostate, guided needle placement, prostate biopsy, and a cystolitholapaxy revealed the prostate was enlarged with a volume of 45 mL, biopsy was negative, and the bladder was moderate to severely trabeculated with multiple saccules and small diverticula with a stone of 1.5 x 2.5 cm. In a progress note dated 11/27/17, the provider reported that the patients PSA was above 10 and recommended the Uroflow procedure. The patient has requested authorization and coverage for a prostatic urethral lift implant. The Health Insurer has denied this request indicating that the requested surgical procedure is considered investigational. The UroLift procedure has been shown to be successful in treating symptomatic benign prostatic hyperplasia (BPH) without adversely affecting a patients quality of life. Based on the current literature, the prostatic urethral lift can be considered as an option for symptomatic BPH patients with small or medium size prostates defined as 80 mL or less without median lobe enlargement, who failed or are intolerant to medical therapy and wish to preserve their sexual function. However, this patient was treated for irritative urinary symptoms related to bladder stone. His symptoms have markedly improved after removal of the bladder stone and are controlled while on medication. Therefore, the requested prostatic urethral lift implant 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 |
The patient is a 61-year-old female. In a letter dated 9/19/22, the provider reported that the patient
has post-menopausal osteoporosis and scoliosis, with a T-score of -3.0 at the hip. The patient has
requested authorization and coverage for teriparatide (FORTEO) injection pen, inject 20 mcg
under skin. The Health Plan has denied this request and reported the requested medication is not
medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 61-year-old female. In a letter dated 9/19/22, the provider reported that the patient
has post-menopausal osteoporosis and scoliosis, with a T-score of -3.0 at the hip. The patient has
requested authorization and coverage for teriparatide (FORTEO) injection pen, inject 20 mcg
under skin. The Health Plan has denied this request and reported the requested medication is not
medically necessary for the treatment of this patient. This denial is the subject of this appeal and
determination. The physician reviewer found that the submitted documentation supports the medical
necessity of the requested medication. Khosla and Hofbauer state, Osteoporosis is an enormous
and growing public health problem. Once considered an inevitable consequence of ageing, it is
now eminently preventable and treatable. While anti-resorptive drugs, especially
bisphosphonates, have traditionally been considered the treatment of choice, Li and colleagues
report that pro-formative anabolic drugs, such as Forteo, have attracted wide attention in recent
years. The authors further note that randomized controlled trials show a higher efficacy in the
reduced incidence of vertebral and non-vertebral fractures with the use of teriparatide (brand name
Forteo) than bisphosphonates such as risedronate. Forteo influences both cartilaginous and
mineralized callus formation in the fracture healing process, in contrast to other agents such as
Prolia and Tymlos, which do not increase rates of bony fusion. Therefore, teriparatide (FORTEO)
injection pen, inject 20 mcg under skin, is medically necessary for the treatment of this patient.
| 1 |
A 44-year-old male enrollee has requested reimbursement for DecisionDX-Melanoma assay rendered on 2/1/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant melanoma.
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 44-year-old male enrollee has requested reimbursement for DecisionDX-Melanoma assay rendered on 2/1/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant melanoma. The physician reviewer found that the medical research indicates that melanoma is a cancer that is curable in its earliest stages. There is very little data on the DecisionDX test for melanoma. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision but they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. Castle Biosciences which developed and markets the test states that it has been validated prospectively. These data are not published and not available for review. As such, this test is very novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. This was also the consensus opinion of the National Comprehensive Cancer Network guidelines. In sum, DecisionDX-Melanoma assay rendered on 2/1/16 was not medically necessary for the evaluation of this patients cancer. Therefore, based on the stated reasons above, the services at issue were not medically necessary for evaluation of the patient. The Health Insurers denial should be upheld.
| 1 |
A 67-year-old male enrollee has requested reimbursement for clonoSEQ assay test performed on 9/13/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Overturned
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Experimental
|
Summary Reviewer 2
A 67-year-old male enrollee has requested reimbursement for clonoSEQ assay test performed on 9/13/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the current medical evidence has not established the superior efficacy of the services at issue. The assay has been shown to be useful in determining MRD in several types of hematologic malignancies. However, it has not been shown to be clinically beneficial in decision making for mantle cell lymphoma. The oncologist who saw him in September 2020 commented on a clinical trial looking at whether clonoSEQ would be useful in this situation, but there is no clear data yet as to its usefulness. Therefore, clonoSEQ assay test performed on 9/13/20 was not likely to have been more beneficial for the evaluation of the patient than any available standard therapy.
| 0 |
A 57-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1b.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 57-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1b. The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with life expectancy less than 12 months due to non-liver-related comorbid conditions. Patients who have failed treatment with peginterferon and ribavirin are recommended to be re-treated with daily Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). This patient should not be considered a failure of Sovaldi/ribavirin as he did not complete that therapy. Further, resistance to the medication due to prior use is not a concern. In the COSMOS trial, sofosbuvir resistance was not observed (Lawitz, et al). Based on published evidence of safety and efficacy in the published literature, and clinical guidelines, the requested treatment with Harvoni for 12 weeks is supported as medically necessary for treatment of this patients hepatitis C virus infection. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 74-year-old male enrollee has requested reimbursement for laboratory testing provided on
10/12/20. 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
|
Summary Reviewer 1
A 74-year-old male enrollee has requested reimbursement for laboratory testing provided on
10/12/20. 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 local treatment for primary uveal melanoma is effective in preventing local
recurrence in over 95 percent of cases, yet up to 50 percent of patients are at risk for
metastatic disease. The high risk of metastatic disease is thought to be due to a propensity for
early micrometastasis followed by a variable latency period prior to the emergence of overt
metastatic disease. Gene expression profiling (GEP) has been shown to be superior to
chromosomal markers, as well as clinical and histopathological prognostic factors, for defining
groups at high risk for the development of metastatic disease. Using primary uveal melanoma
samples obtained by fine needle biopsy, GEP classifies tumors as having low (class 1) or high
(class 2) metastatic potential depending on the expression of 12 discriminating genes and three
control genes. This profile test has been validated a prospective multicenter study and is a
standard of care and now recommended by the National Comprehensive Cancer Network
guidelines. Therefore, laboratory testing provided on 10/12/20 was likely to have been more
beneficial than any available standard therapy.
| 0 |
A 41-year-old female enrollee has requested reimbursement for a dopamine transporter single-photon emission computed tomography (DAT-SPECT) scan performed on 9/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of tremor.
The patient presented with tremor and posture elements that
|
Overturned
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Experimental
|
Summary Reviewer 3
A 41-year-old female enrollee has requested reimbursement for a dopamine transporter single-photon emission computed tomography (DAT-SPECT) scan performed on 9/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of tremor. The physician reviewer found that the current medical evidence supports the services at issue in this clinical setting. The patient presented with tremor and posture elements that raised question of a movement disorder condition. There is sufficient support for DAT-SPECT scan in this case, as it could help confirm a diagnosis and provide treatment guidance given the clinical diagnosis was not clear regarding the type of movement disorder. Thus, DAT-SPECT scan performed on 9/17/15 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 45-year-old male enrollee has requested authorization and coverage for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain.
In this case, the patient has multi-level degenerative disc disease confirmed on imaging.
|
Upheld
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Experimental
|
Summary Reviewer 3
A 45-year-old male enrollee has requested authorization and coverage for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. The physician reviewer found the request for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003) are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. According to the North American Spine Society guidelines, lumbar artificial disc replacement is indicated as an alternative to lumbar fusion for patients with discogenic low back pain with advanced single level disease. In this case, the patient has multi-level degenerative disc disease confirmed on imaging. As such, the requested services have not been established 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 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 52-year-old female enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 52-year-old female enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there are insufficient high quality clinical outcomes reported to allow one to make definitive conclusions regarding the relative safety and efficacy of proton beam radiation for the management of this patients esophageal cancer, as compared to standard of care photon-based radiotherapy. The American Society for Radiation Oncology (ASTRO) Model Policy for proton radiation does not support its use for thoracic malignancies (including esophageal cancer) outside the setting of a clinical trial. Proton beam radiation has the potential to reduce lower dose radiation exposure to surrounding normal tissues, but it remains to be seen as to whether such reduction in low dose is associated with clinically meaningful improvements in outcomes. Therefore, proton beam therapy is not likely to be more beneficial than other available treatment options.
| 0 |
A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 1/26/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
|
Overturned
|
Experimental
|
Summary Reviewer 1
A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 1/26/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this patients case. According to Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. In sum, breast tomosynthesis performed on 1/26/16 was likely to have been of greater benefit than other methods of evaluation. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 29-year-old female enrollee has requested reimbursement and prospective authorization and coverage for eating disorder residential treatment center services provided from 4/09/19 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.
|
Upheld
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Medical Necessity
|
Summary Reviewer
A 29-year-old female enrollee has requested reimbursement and prospective authorization and coverage for eating disorder residential treatment center services provided from 4/09/19 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 in cases such as this, an evidence-based, objective instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. In terms of risk of harm, the records support a score of 1 due to a lack of current suicidal ideation. With regards to functional status, the records support a score of 2 due to some difficulty meeting obligations but overall ability to maintain meaningful relationships. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to stable medical issues and no substance use. With regards to level of stress of the recovery environment, the records support a score of 2 due to some performance pressure at work and leave from work. In terms of level of support of the recovery environment, the records support a score of 2 due to positive relationship with family but some struggles with her relationship with her mother. With regards to treatment and recovery history, the records support a score of 3 due to successful recent residential treatment with significant weight gain but incomplete resolution of eating disorder symptoms. In terms of engagement and recovery status, the records support a score of 2 due to good cooperation in treatment and insight into the need for treatment. Thus, the patient has a composite score of 14. This score of correlates with a high intensity community-based services. Therefore, eating disorder residential treatment center services provided from 4/09/19 forward were not and are not medically necessary for the treatment of this patient.
| 0 |
A 52-year-old female enrollee has requested reimbursement for the risk of ovarian malignancy algorithm (ROMA) test provided on 6/22/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees irregular menstrual bleeding and ovarian cyst.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 52-year-old female enrollee has requested reimbursement for the risk of ovarian malignancy algorithm (ROMA) test provided on 6/22/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees irregular menstrual bleeding and ovarian cyst. The physician reviewer found that ovarian cancer screening includes evaluation of symptomatology, ultrasound and tumor marker levels to assess an individual patients risk. CA-125 is the gold standard tumor marker. Although new tests have been developed to predict a patients risk, the data is conflicting. Emerging literature recommends the ROMA test as a useful component in evaluating patients with ovarian/adnexal masses. The ROMA test is especially useful for its negative predictive value. Moore and colleagues noted that the ROMA test detected 94% of the women with an invasive epithelial ovarian cancer and 85% of the women with early-stage epithelial ovarian cancer in the initial validation trial. For this patient, a CA-125 of 36 in a perimenopausal female would likely be considered negative by most providers. However, the provider recommended a ROMA test for confirmation. In this clinical setting, repeating the CA-125 level alone without the addition of the HE-4 would have been sufficient to determine whether the patient was at an elevated risk for ovarian cancer. Thus, the ROMA test provided on 6/22/15 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 44-year-old male enrollee has requested authorization and coverage MRI of the left shoulder. 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.
In this case, the patient had radiographs, which were negative, followed by physical therapy. His pain has persisted. His provider suspects rotator cuff pathology.
|
Overturned
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Medical Necessity
|
Summary Reviewer
A 44-year-old male enrollee has requested authorization and coverage MRI of the left shoulder. 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 according to the American College of Radiology, the initial appropriate imaging study in the evaluation of atraumatic shoulder pain is radiography. Radiographs can evaluate for the presence of unsuspected fracture or dislocation, osteoarthritis or calcific tendinitis, among other pathology. If radiographs are negative or inconclusive, and rotator cuff pathology is suspected, then shoulder MRI is generally appropriate. MRI can accurately demonstrate rotator cuff tendinosis or full thickness tear as well as labral pathology. MRI can also aid in the diagnosis of extra-articular osseous or soft tissue findings that may contribute to shoulder impingement symptomatology. In this case, the patient had radiographs, which were negative, followed by physical therapy. His pain has persisted. His provider suspects rotator cuff pathology. The medical evidence supports the requested services in this clinical setting. Therefore, MRI of the left shoulder is medically necessary for the evaluation of this patient.
| 1 |
A 49-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma assay provided on 2/14/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
|
Upheld
|
Experimental
|
Summary Reviewer 1
A 49-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma assay provided on 2/14/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages 0-IV. 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 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. 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. 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. Therefore, DecisionDx-Melanoma signature may be an independent predictor of metastasis risk. However, there is a lack of peer-reviewed published studies confirming this hypothesis. Accordingly, the DecisionDx-Melanoma assay performed on 2/14/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 30-year-old female enrollee has requested authorization and coverage for Ocrevus injection, 300/10 mL. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees multiple sclerosis.
. The records document that the patient is unable to tolerate Copaxone.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 30-year-old female enrollee has requested authorization and coverage for Ocrevus injection, 300/10 mL. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees multiple sclerosis. The physician reviewer found that the submitted records fail to demonstrate the medical necessity of the requested medication. The records document that the patient is unable to tolerate Copaxone. Based on this patients side effect profile to Copaxone, Glatopa will cause similar side effect issues. The study by Kappos and colleagues compared Rebif to Ocrevus and demonstrated a relative reduction in new enhancing lesions achieved by Ocrevus. However, there is no evidence of superiority of Ocrevus compared to the Health Insurers alternative Gilenya in comparative studies. Since the proposed treatment has not been demonstrated to be superior to all of the offered preferred agents, the medical necessity of the requested medication has not been established. All told, Ocrevus injection, 300/10 mL is not medically necessary 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.
| 1 |
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