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A 19-year-old female enrollee has requested reimbursement for electromyography (EMG) and electroencephalogram (EEG) monitoring during spine surgery performed on 12/05/19. 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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Overturned
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Experimental
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Summary Reviewer 1
A 19-year-old female enrollee has requested reimbursement for electromyography (EMG) and electroencephalogram (EEG) monitoring during spine surgery performed on 12/05/19. 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 intraoperative neurophysiologic monitoring is the standard of care for intraoperative detection of emerging iatrogenic complications of scoliosis surgery, and to prevent its progression and to possibly reverse it by making adjustments during surgery. The monitoring needs to be total, as in this case. Combined sensory and motor evoked potentials monitoring must be regarded as the least neurophysiological standard for intraoperative detection of emerging spinal cord injury during corrective spinal deformity surgery. Early detection affords the surgical team an opportunity to perform rapid intervention to prevent injury progression or possibly to reverse impending neurologic sequelae. Iatrogenic spinal cord injury is the most feared complication of scoliosis surgery. Based on the medical evidence, the monitoring in this case was medically appropriate. Therefore, EMG and EEG monitoring during spine surgery performed on 12/05/19 was likely to have been more beneficial than other available standard therapy.
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A 54-year-old female enrollee has requested reimbursement for the shingles vaccine performed on 2/06/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of rheumatoid arthritis.
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Upheld
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Experimental
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Summary Reviewer 1
A 54-year-old female enrollee has requested reimbursement for the shingles vaccine performed on 2/06/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of rheumatoid arthritis. The physician reviewer found the herpes zoster vaccine is recommended for people age 60 years and older by the Centers for Disease Control. Patients with a diagnosis of rheumatoid arthritis who are on methotrexate, steroids, azathioprine or 6-mercaptopurine or are expected to receive high level immunosuppressive therapy are eligible to receive the vaccine if they are greater than 50 years of age. This patient does not qualify under these criteria. The diagnosis of rheumatoid arthritis or lichen planus in itself is not an indication for vaccination. In sum, the shingles vaccine performed on 2/06/17 was not likely to have been superior over other treatment options in this patients case. 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 46-year-old female enrollee has requested reimbursement for Botox injections provided on 7/8/15 and 11/6/15. The Health Insurer has denied this request indicating that the services at issue 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 2
A 46-year-old female enrollee has requested reimbursement for Botox injections provided on 7/8/15 and 11/6/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of documentation provided for review regarding the nature and character of the patients headaches. Per the current medical literature, the following drugs are known to be effective in the prophylactic treatment of headaches antiepileptic drugs, antidepressants, beta-blockers, calcium channel antagonists, serotonin antagonists, botulinum neurotoxins, [nonsteroidal anti-inflammatory drugs] NSAIDs, and others (including riboflavin, magnesium, and Petasites) (Silberstein, et al). A meta-analysis by Jackson and colleagues noted that, single trials found no differences between botulinum toxin A and amitriptyline. Based on these findings, it cannot be concluded that the Botox injections performed were more effective than other standard therapies for the patients condition.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.
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A 52-year-old male enrollee has requested reimbursement for proton beam therapy provided from October through December 2016. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees nasopharyngeal carcinoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 52-year-old male enrollee has requested reimbursement for proton beam therapy provided from October through December 2016. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees nasopharyngeal carcinoma. The physician reviewer found that currently, there is insufficient data to suggest the superior efficacy of proton beam therapy in this clinical setting. At this time, further data through prospective clinical trials is needed regarding cases in which the target is the primary volume located near critical structures. Whether or not proton therapy (in general) affords any benefit over conventional radiation therapy is a controversial issue with quite disparate opinions among experts in the field. The medical literature suggests that the benefit from proton beam therapy is primarily in the head and neck cancers in which the target directly abuts critical structures like skull base tumors. There are preliminary dosimetric studies, which suggest that proton beam therapy may be better at sparing pharyngeal constrictor muscles spinal cord, parotid glands, larynx, and brainstem. However, the issue of whether dose reduction to any of these structures beyond what intensity modulated radiation therapy (IMRT) can achieve, is still undecided. For most head and neck cancers, IMRT should be able to readily spare the salivary glands, pharyngeal constrictors, spinal cord, brainstem, mandible and other normal tissues. The medical evidence for sinonasal tumors is encouraging, but further data is needed. As such, proton beam therapy provided from October through December 2016 was not likely to have been superior to IMRT or other standard modalities for evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/10/16. 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 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/10/16. 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 2/10/16 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 documentation submitted for review and 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.
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A 19-year-old female enrollee has requested reimbursement for mental health inpatient services provided from 3/23/15 through 8/24/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
prompt readmission. The patient was reported to be isolative, hallucinating and picking at her self-inflicted wounds. Her medications were not yet optimized and her disposition was uncertain. Thereafter, the patient struggled with apprehension, anxiety, depression, auditory hallucinations and suicidal ideation. By late-April, a trend of sustained mood improvement began to emerge. On 4/22/15, her mood was okay with no behavioral dysregulation or skin picking. It was the first day she was described as pleasant rather than depressed. On 4/24/15, the patient was less irritable and not as angry. She was consolidating the notion of conservatorship, taking her medication without issue and participating in all unit activities. In the days that followed she was described as bright and playful. On 4/20/15, placement was pending, suggestive that the illness burden was
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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 inpatient services provided from 3/23/15 through 8/24/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found considering this patients formidable psychiatric history, significant affective symptoms with psychosis, suicidality and drug use, a conservative hospitalization was reasonably expected to improve her condition and prevent a more serious episode of illness. However, based on the medical records, services at the acute level of care were only necessary through 5/9/15. Discharge on 3/22/15 would have been premature and more than likely would have resulted in undue morbidity and prompt readmission. The patient was reported to be isolative, hallucinating and picking at her self-inflicted wounds. Her medications were not yet optimized and her disposition was uncertain. Thereafter, the patient struggled with apprehension, anxiety, depression, auditory hallucinations and suicidal ideation. By late-April, a trend of sustained mood improvement began to emerge. On 4/22/15, her mood was okay with no behavioral dysregulation or skin picking. It was the first day she was described as pleasant rather than depressed. On 4/24/15, the patient was less irritable and not as angry. She was consolidating the notion of conservatorship, taking her medication without issue and participating in all unit activities. In the days that followed she was described as bright and playful. On 4/20/15, placement was pending, suggestive that the illness burden was approaching appropriateness for an alternative setting. By 5/9/15, the prolonged disposition process had declared itself as the primary source of the patients frustration and apprehension. She was eating well and sleeping well, and maintaining her activities of daily living. She had unimpaired cognitive faculties. Her mood was euthymic. She had not been suicidal or psychotic in nearly three weeks, while her depression had lifted as well. She was adherent with medications which were well tolerated. Although the patients chronicity warranted ongoing treatment, she was no longer suffering from an acute psychiatric syndrome. Based on the documentation provided, safe, appropriate and adequate treatment could have reasonably been conducted at a less restrictive setting, such as a residential treatment facility, as of 5/10/15. Thus, mental health inpatient services provided from 3/23/15 through 5/9/15 were medically necessary, 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 65-year-old male has requested reimbursement for gene testing performed on 12/09/15. The Health Insurer has denied this request indicating that the services at issue were 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 2
A 65-year-old male has requested reimbursement for gene testing performed on 12/09/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found this patient has a low risk prostate cancer and likely has a significant life expectancy. The medical evidence supports Oncotype DX prostate cancer testing post-biopsy for patients with very-low-risk and low-risk prostate cancer at diagnosis with 10 to 20 years life expectancy. In this clinical setting, the services at issue were likely to be more beneficial than not performing the test and pursuing aggressive 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.
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patient is a 65-year-old male with a history of melanoma involving the right axillae. He has a history of a melanoma in the chest in 2016.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 65-year-old male with a history of melanoma involving the right axillae. He has a history of a melanoma in the chest in 2016. The physician reviewer found that the National Comprehensive Cancer Network guidelines recommend that patients with metastatic melanoma have tissue sent to ascertain alterations in BRAF, and in the appropriate clinical setting, KIT from either biopsy of the metastasis (preferred) or archival material, if the patient is being considered for targeted therapy. Consideration of broader genomic profiling is recommended if the test results might guide future treatment decisions or eligibility for participation in a clinical trial. Given the patients advanced disease, molecular profiling was medically indicated. Therefore, targeted genomic sequence analysis, DNA 324 genes (0037U) performed on 2/20/19 was medically necessary for the evaluation of this patient.
| 1 |
A 35-year-old female enrollee has requested authorization and coverage for surgical jaw reconstruction. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.
The patient presents with a class II malocclusion and has been recommended to undergo orthodontic appliances and double jaw surgery.
the patient does not have evidence of significant disfigurement from her malocclusion and overjet.
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Upheld
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Medical Necessity
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Summary Reviewer
A 35-year-old female enrollee has requested authorization and coverage for surgical jaw reconstruction. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that the medical necessity for the requested surgical jaw reconstruction has not been established in this clinical setting. The patient presents with a class II malocclusion and has been recommended to undergo orthodontic appliances and double jaw surgery. However, a clear functional deficit related to this malocclusion that has failed reasonable conservative management and would likely improve with complex surgical intervention has not been adequately defined in the medical documentation. The patient complains of discomfort and intermittent pain. However, it is not clear from the requesting surgeon that this is from the malocclusion and that this would likely improve with surgical correction, as he states that this may or may not improve with jaw repositioning and correction of her occlusion. In addition, based on the photographs, the patient does not have evidence of significant disfigurement from her malocclusion and overjet. Therefore, the requested procedures are not considered medically necessary, as there is not a well-defined functional impairment that would likely improve with surgical intervention. Moreover, based on the photographs submitted for review, the patient does not have evidence of significant deformity to warrant surgical correction on a reconstructive basis.
Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 59-year-old male enrollee has requested reimbursement for testosterone injections provided from 4/25/16 through 6/6/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees low testosterone.
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Overturned
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Medical Necessity
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Summary Reviewer
A 59-year-old male enrollee has requested reimbursement for testosterone injections provided from 4/25/16 through 6/6/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees low testosterone. The physician reviewer found that this patient has low testosterone levels. Based on current medical literature, the low level and the patients symptoms were adequate to justify the three intramuscular testosterone injections. Intramuscular therapy is one way of replacing testosterone in hypogonadal men (Morley; Shoskes, et al). While topical gel therapy is preferred by most providers and patients over intramuscular injections, the latter is a standard therapeutic means of replacing testosterone in patients with low testosterone. All told, the testosterone injections provided from 4/25/16 through 6/6/16 were medically necessary for treatment of this patients low testosterone. Based on the foregoing discussions, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
A 57-year-old female enrollee has requested reimbursement for comprehensive cancer genomic panel provided on 5/9/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectal carcinoma.
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Overturned
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Experimental
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Summary Reviewer 2
A 57-year-old female enrollee has requested reimbursement for comprehensive cancer genomic panel provided on 5/9/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees rectal carcinoma. The physician reviewer found that FoundationOne testing offers a comprehensive panel of molecular genetic markers on an individual patients tumor with the hopes of identifying markers than can help guide therapy decision making. Per the National Comprehensive Cancer Network (NCCN) guidelines, KRAS, NRAS, and BRAF mutations, and microsatellite instability (MSI) markers may provide some guide toward possible treatment options. There is currently a phase II clinical trial underway that is evaluating the efficacy of genetic molecular testing to guide individual therapy (Benson, et al). Thus, the KRAS, NRAS, BRAF, MLH1, MSH2, MSH6 and PSM2 portions of the testing performed on 5/9/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy, while the remainder of the testing 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, a portion of 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 partially overturned.
| 1 |
The patient is a 62-year-old male who presented with complaints of severe low back pain. Past surgical history was positive for L4/5 and L5/S1 laminectomy.
this patient presents with persistent severe mechanical back pain. Functional limitations
in activities of daily living. Clinical examination findings have documented pain with lumbar flexion and extension. He is neurologically intact. He is status post prior laminectomies at the L4/5 and L5/S1 levels. There is imaging evidence of degenerative disc disease at L4/5 and L5/S1. There is radiographic evidence of 4 mm spondylolisthesis at L4/5. He has failed to improve with conservative treatment, including activity modification, medications, and physical 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 presented with complaints of severe low back pain. Past surgical history was positive for L4/5 and L5/S1 laminectomy. The physician reviewer found that this patient presents with persistent severe mechanical back pain. Functional limitations are noted in activities of daily living. Clinical examination findings have documented pain with lumbar flexion and extension. He is neurologically intact. He is status post prior laminectomies at the L4/5 and L5/S1 levels. There is imaging evidence of degenerative disc disease at L4/5 and L5/S1. There is radiographic evidence of 4 mm spondylolisthesis at L4/5. He has failed to improve with conservative treatment, including activity modification, medications, and physical therapy. Evidence-based peer-reviewed literature supports the use of lumbar fusion for patients with severe degenerative disc disease and spondylolisthesis. Given the patientas significant mechanical pain, failed conservative treatment, imaging findings of reportedly severe degenerative disc disease at L4/5 and L5/S1, prior lumbar laminectomy at both levels, and spondylolisthesis at L5/S1, the request for lumbar fusion surgery is supported to improve pain and restore function. Therefore, the requested lower back fusion is medically necessary for the treatment of this patient.
| 1 |
A 62-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer.
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Overturned
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Experimental
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Summary Reviewer 2
A 62-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that Tomosynthesis was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography, the American College of Radiology (ACR) urged the technique be removed from the investigational category due to the advantages this new tomographic technique brings to radiologists interpreting mammograms. This technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to this patient than had her exam been done with two-dimensional imaging alone. Accordingly, the breast tomosynthesis that was performed on 8/9/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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 |
The parent of a 14-year-old male enrollee has requested authorization and coverage for Norditropin Flexpro 15 mg/1.5. 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 was already between the 5th and 10th percentile before starting treatment. His growth velocity had already started to improve before the start of growth hormone therapy, suggesting that he might have constitutional delay of growth and puberty, and ultimately started to have pubertal growth spurt.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 14-year-old male enrollee has requested authorization and coverage for Norditropin Flexpro 15 mg/1.5. 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. This patient was already between the 5th and 10th percentile before starting treatment. His growth velocity had already started to improve before the start of growth hormone therapy, suggesting that he might have constitutional delay of growth and puberty, and ultimately started to have pubertal growth spurt. There is no clear documentation of Tanner staging for the patient. It seems there was period of slow growth in 2019, which could be due to pre-pubertal slow down, which is a normal physiological phenomenon. His height/growth potential was always maintained, as the predicted adult height has been either in range or above the range of his target height. Therefore, Norditropin FlexPro 15 mg/1.5 is not medically necessary for the treatment of this patient.
| 1 |
A 35-year-old male enrollee has requested authorization and coverage for jaw surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 35-year-old male enrollee has requested authorization and coverage for jaw surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the medical literature documents mixed results in attempting to correct moderate to severe obstructive sleep apnea with jaw surgery. The surgical goal is to advance the jaws to increase the size of the pharyngeal airway space. It was stated that a mandibular repositioning appliance, found to be effective in treatment of mild obstructive sleep, was not an option due to the patients orthodontic treatment. These appliances work on the premise that advancement of the mandible will cause a resultant increase in the pharyngeal space by moving soft tissue obstruction, thus opening the airway. It is thus counterintuitive that a setback of the mandible as prescribed would allow effective treatment of the obstructive sleep apnea as the movement of the jaw is opposite to that of the mandibular advancement appliance. All told, the requested jaw surgery is not medically indicated for the treatment of this patient. Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
The patient is a 39-year-old male with persistent PLA2R titer and persistent nephrotic syndrome. The records indicate that the patient previously responded to anti CD-20 therapy with rituximab. The patient has requested authorization and coverage for obinutuzumab (Gazyva) injections. The Health Insurer has denied this request indicating that the requested medication is considered investigational.
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Upheld
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Experimental
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Summary Reviewer 3
The patient is a 39-year-old male with persistent PLA2R titer and persistent nephrotic syndrome. The records indicate that the patient previously responded to anti CD-20 therapy with rituximab. The patient has requested authorization and coverage for obinutuzumab (Gazyva) injections. The Health Insurer has denied this request indicating that the requested medication is considered investigational. Gazyva is not supported as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Currently, there is a lack of clinical trials showing that Gazyva is effective for treatment of membranous glomerulonephritis. In addition, rituximab has been demonstrated to more efficiently deplete CD-20 and is likely beneficial in this patient. Thus, the requested obinutuzumab (Gazyva) injections are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old female enrollee has requested reimbursement for Afirma Thyroid FNA Analysis performed on 12/4/14. 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 in this case, the patient presented with a thyroid nodule with suspicious features.
the specimen was sent to Afirma Thyroid FNA Analysis, which was consistent with a benign finding.
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Overturned
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Experimental
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Summary Reviewer 2
A 57-year-old female enrollee has requested reimbursement for Afirma Thyroid FNA Analysis performed on 12/4/14. 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 in this case, the patient presented with a thyroid nodule with suspicious features. In this clinical setting the risk of malignancy may be as high as 70-90% (Haugen, et al). The cytopathology was consistent with atypia of undetermined significance (AUS), therefore, the specimen was sent to Afirma Thyroid FNA Analysis, which was consistent with a benign finding. The Bethesda System recommends a second fine needle aspiration (FNA) when the cytopathology is consistent with AUS. The 2015 American Thyroid Associations guidelines indicate that for nodules with AUS cytology, after consideration of worrisome clinical and sonographic features, investigations such as repeat FNA or molecular testing may be used to supplement malignancy risk assessment in lieu of proceeding directly with a strategy of either surveillance or diagnostic surgery. FNA with molecular testing is considered standard of care in this clinical setting. Proceeding directly to the Afirma Thyroid FNA Analysis prevented a second biopsy and or diagnostic thyroidectomy with its possible complications. All told, the Afirma Thyroid FNA Analysis performed on 12/4/14 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, 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 57-year-old male enrollee has requested reimbursement for automated nerve conduction testing performed on 10/20/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 57-year-old male enrollee has requested reimbursement for automated nerve conduction testing performed on 10/20/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found that the automated nerve conduction studies in dispute performed during surgery are not supported in the peer-reviewed literature. Intraoperative monitoring utilizing automated nerve conduction testing on peripheral nerves during surgery was not indicated. There is a lack of support in the medical literature supporting nerve conduction velocity monitoring on peripheral nerves during cervical spine surgery. As such, the automated intraoperative nerve conduction studies were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The patient is a 27-year-old male who was admitted for hospitalization on 8/13/21 after
presenting with progressively worsening abdominal pain with vomiting. The patient has
requested reimbursement for inpatient admission (hospital treatment services) from 8/13/21
through 8/15/21.
In this case, the patient was hemodynamically stable and
afebrile at admission. After treatment in the emergency department, the patients symptoms of
pain and vomiting improved. The records did not indicate that the patient required any urgent
procedures or surgical intervention. He did not have any significant electrolyte disturbances. He
was treated with a nasogastric tube for a short time but able to tolerate oral nutrition shortly
after admission. His symptoms
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 27-year-old male who was admitted for hospitalization on 8/13/21 after
presenting with progressively worsening abdominal pain with vomiting. The patient has
requested reimbursement for inpatient admission (hospital treatment services) from 8/13/21
through 8/15/21. The physician reviewer found that at issue is whether inpatient admission
(hospital treatment services) from 8/13/21 through 8/15/21 was medically necessary for the
treatment of this patient. The submitted documentation does not support the medical necessity
of the services at issue. Inpatient care may be necessary when a patients signs, symptoms, and
general medical condition can only be managed safely in an acute inpatient setting, when a
patient requires diagnostic studies in an inpatient setting, or when it is necessary for the patient
to remain in an acute inpatient setting. In this case, the patient was hemodynamically stable and
afebrile at admission. After treatment in the emergency department, the patients symptoms of
pain and vomiting improved. The records did not indicate that the patient required any urgent
procedures or surgical intervention. He did not have any significant electrolyte disturbances. He
was treated with a nasogastric tube for a short time but able to tolerate oral nutrition shortly
after admission. His symptoms improved quickly with treatment and he did not have
complications. Given that this patient was in stable condition at admission and could have been
treated at a lower level of care, the services at issue were not medically indicated. Therefore,
inpatient admission (hospital treatment services) from 8/13/21 through 8/15/21 was not
medically necessary for the treatment of this patient.
| 1 |
A 50-year-old female enrollee has requested authorization and coverage for Balversa 4 mg
tablets (two tablets per day). The Health Insurer has denied this request indicating that the
requested medication is considered investigational for treatment of the insureds urothelial
carcinoma.
The patients recent CT scan showed mixed response with
some new growth in the lungs.
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Overturned
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Experimental
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Summary Reviewer 3
A 50-year-old female enrollee has requested authorization and coverage for Balversa 4 mg
tablets (two tablets per day). The Health Insurer has denied this request indicating that the
requested medication is considered investigational for treatment of the insureds urothelial
carcinoma. The physician reviewer found that molecular testing in patients with metastatic non-
small cell lung cancer has helped develop significant advances in therapy options for patients
with improved patient health outcomes. Medical therapies such as Tagrisso are FDA approved
for the treatment of patients with EGFR mutations. At this time, no FGFR inhibitor, such as
Balversa, is approved for non-small cell lung cancer, but trials are ongoing. In addition, there is a
lack of support from societal guidelines to include FGFR directed therapy in the management of
non-small cell lung cancer. The patients recent improvement in CEA may be the result of Y90
therapy, which was completed in 2022. The patients recent CT scan showed mixed response with
some new growth in the lungs. Therefore, the requested Balversa 4 mg tablets (two tablets per
day) is not likely to be more beneficial for treatment of the patients medical condition than any
available standard therapy.
| 1 |
patient is a 53-year-old female with a history of unilateral primary osteoarthritis of the right
hip and associated severe right hip pain. The provider recommended treatment with an
arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty),
with or without autograft
the patient presents
with a history of unilateral primary osteoarthritis of the right hip and associated right hip pain,
stiffness, and tenderness.
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Upheld
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Medical Necessity
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Summary
The patient is a 53-year-old female with a history of unilateral primary osteoarthritis of the right
hip and associated severe right hip pain. The provider recommended treatment with an
arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty),
with or without autograft or allograft, and associated bed day. The physician reviewer found that
at issue is whether the requested arthroplasty, acetabular and proximal femoral prosthetic
replacement (total hip arthroplasty), with or without autograft or allograft, and associated bed
day are medically necessary for the treatment of this patient. According to Rahm and colleagues,
A total hip arthroplasty is indicated in end-stage hip osteoarthritis with a high degree of
persistent suffering when conservative treatment has failed. In this case, the patient presents
with a history of unilateral primary osteoarthritis of the right hip and associated right hip pain,
stiffness, and tenderness. However, there is a lack of documentation of a formal diagnostic
imaging study to corroborate that the patients hip osteoarthritis is at relative end-stage.
Therefore, the requested arthroplasty, acetabular and proximal femoral prosthetic replacement
(total hip arthroplasty), with or without autograft or allograft, and associated bed day are not
medically necessary for the treatment of this patient.
| 1 |
A 59-year-old female enrollee has requested authorization and coverage for heart surgery to correct the heart valve using a catheter (transcatheter valve repair). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
including prior extensive mantle irradiation with resulting scarring, restrictive lung disease, and a calcified porcelain aorta.
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Overturned
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Experimental
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Summary Reviewer 1
A 59-year-old female enrollee has requested authorization and coverage for heart surgery to correct the heart valve using a catheter (transcatheter valve repair). 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 this patient has multiple comorbidities which make her high risk for open chest surgery, including prior extensive mantle irradiation with resulting scarring, restrictive lung disease, and a calcified porcelain aorta. There is ongoing published data supporting the safety and efficacy of transcatheter aortic valve replacement, especially in high risk or inoperable patients who require valve replacement. This patient fits into a very high risk category for open heart surgery, and this has been documented in her surgical consultations. Therefore, the requested services are likely to be of greater benefit than standard available therapy, which in this case is open heart surgery. Thus, the requested heart surgery to correct the heart valve using a catheter (transcatheter valve repair) is likely to be more effective than other treatment options.
| 1 |
A 58-year-old female enrollee has requested reimbursement for the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage lung adenocarcinoma.
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Overturned
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Experimental
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Summary Reviewer 2
A 58-year-old female enrollee has requested reimbursement for the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees stage lung adenocarcinoma. The physician reviewer found that Guardant360 testing offers a comprehensive panel of molecular genetic markers on an individual patients tumor in an attempt to identify markers than can help guide therapy decision making. Per the National Comprehensive Cancer Network (NCCN) guidelines, it has not been determined if molecular markers are useful in treatment determination other than EGFR, ALK, ROS-1, PDL1, MET, RET, ERBB2, and BRAF. There is currently a phase II clinical trial underway that is evaluating the efficacy of broad genetic molecular testing to guide individual therapy (Masters, et al). In this case, the metastases were noted to be difficult to biopsy, which supports the additional genetic testing with Guardant360 for EGFR, ALK, ROS-1, PDL1, MET, RET, ERBB2, and BRAF. For these reasons, the EGFR, ALK, ROS-1, PDL1, MET, RET, ERBB2, and BRAF portions of the blood test (Guardant360 biopsy-free tumor sequencing test) performed on 12/8/17 were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy, while the remainder of the testing performed on 12/8/17 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, a portion of 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 partially overturned.
| 1 |
The patient is an eight-year-old male with a medical history of congenital torticollis, gastroesophageal reflux disease, and neurofibromatosis, type I. The patientas parent has requested reimbursement for inpatient level of care provided from 5/12/21 through 5/13/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is an eight-year-old male with a medical history of congenital torticollis, gastroesophageal reflux disease, and neurofibromatosis, type I. The patientas parent has requested reimbursement for inpatient level of care provided from 5/12/21 through 5/13/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. Acute appendicitis is one of the most common sources of acute abdominal pain in children, particularly for those between 4 and 15 years of age. While the classic presentation is that of periumbilical abdominal pain that localizes to the right lower quadrant, with anorexia and fever, there are many exceptions to this presentation. Fever may or may not be present, and pain may not yet be localized early in the course of appendicitis. Physical examination findings typically include signs and symptoms of peritonitis with localization to the right lower quadrant, but this is dependent on the intra-abdominal location of the appendix. While most patients have an elevated white blood cell count, a normal value does not rule out appendicitis. Diagnostic studies include abdominal ultrasound and abdominal computed tomography (CT) scan. The usual findings on CT include an enlarged, edematous appendix, with fat stranding in the right lower quadrant indicative of adjacent inflammation. In the absence of classical findings, with up to 50% of children presenting with an atypical history, the differential diagnosis is quite broad. Management of early acute appendicitis includes intravenous fluids, antibiotics, and pain medication. Appendectomy typically occurs within the first 12-24 hours after diagnosis. Perforation can occur, and results in a much more complicated course. The outpatient laparoscopic procedure is reserved for patients with uncomplicated appendicitis. In this patientas case, given the free fluid in the pelvis, it was not completely clear if this patient had a ruptured appendicitis or not. Second, there was evidence of peritoneal abscess upon laparoscopic investigation. Patients such as this must be monitored closely postoperatively because just as often as not, the abscess fluid re-accumulates and they require additional surgical procedures, or at the very least interventional radiology placement of pigtail catheters to drain. This patient had complicated appendicitis secondary to abscess formation as well as concern for rupture. Consistent with both care guidelines and the standard of care, acute inpatient admission was medically necessary and appropriate. Therefore, inpatient level of care provided from 5/12/21 through 5/13/21 was medically necessary for the treatment of this patient.
| 1 |
A 49-year-old male enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 5/29/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 49-year-old male enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 5/29/14. 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 has not demonstrated the superior efficacy of the services at issue. Clinical validation has shown that recurrence scores are prognostic for survival, recurrence and disease-free survival, but are not predictive of response to adjuvant therapy. Thus, there is a lack of support for the services at issue to predict response to chemotherapy. At this time, the services at issue are not standard of care. In sum, Oncotype DX Colon Cancer Assay performed on 5/29/14 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 61-year-old male enrollee has requested reimbursement for surgical services (atrial fibrillation ablation) performed on 7/10/13. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees recurrent symptomatic atrial fibrillation.
, the patient presented with symptomatic paroxysmal atrial fibrillation in spite of a prior remote ablation in 2011 and suppressive antiarrhythmic medication trials. Since the patient continued to
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Overturned
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Experimental
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Summary Reviewer 2
A 61-year-old male enrollee has requested reimbursement for surgical services (atrial fibrillation ablation) performed on 7/10/13. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees recurrent symptomatic atrial fibrillation. The physician reviewer found the surgical services performed on 7/10/13 were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based on the documentation submitted for review, the patient presented with symptomatic paroxysmal atrial fibrillation in spite of a prior remote ablation in 2011 and suppressive antiarrhythmic medication trials. Since the patient continued to have significant symptoms in spite of attempts at rate control and rhythm control a second atrial fibrillation ablation procedure in this clinical setting was reasonable and medically appropriate and considered the standard of care in the medical community. The highest success in preventing atrial fibrillation with ablation is in those patients with paroxysmal (as opposed to persistent) atrial fibrillation (January, et al). Also, cryoablation has favorable results compared to radiofrequency ablation (Packer, et al). Given that the repeat ablation procedure performed on 7/10/13 was clinically indicated to relieve symptoms and is the standard of care in the medical community, the surgical services 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 31-year-old female enrollee has requested reimbursement for evaluation of arterial inflow and
venous outflow of abdomen, retroperitoneum, scrotal contents and/or pelvic organs and
detailed fetal ultrasound, fetal doppler echocardiography and umbilical artery doppler
velocimetry on 3/11/22 and 5/10/22. The Health Insurer has denied this request and reported
that the services at issue were investigational for the evaluation of the enrollees high risk
pregnancy.
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Upheld
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Experimental
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Summary Reviewer 3
A 31-year-old female enrollee has requested reimbursement for evaluation of arterial inflow and
venous outflow of abdomen, retroperitoneum, scrotal contents and/or pelvic organs and
detailed fetal ultrasound, fetal doppler echocardiography and umbilical artery doppler
velocimetry on 3/11/22 and 5/10/22. The Health Insurer has denied this request and reported
that the services at issue were investigational for the evaluation of the enrollees high risk
pregnancy. The physician reviewer found that Uterine artery Dopplers and fetal
echocardiography on 3/11/22 at 12 weeks of gestation were not likely to be more beneficial for
the evaluation of the patients medical condition than standard, routine ultrasounds for fetal
growth and development and prenatal care. Uterine artery Doppler screening of high-risk women
such as women with a history of chronic hypertension or preeclampsia, prior fetal growth
restriction, or stillbirth, with singleton gestations may identify those at substantially increased
risk for adverse pregnancy outcomes. Abnormal testing in these women could potentially lead to
increased surveillance, including earlier and more frequent assessment of fetal growth and
maternal clinical condition, and interventions that might improve clinical outcomes. Normal
Doppler studies could potentially lead to a reduction in such testing and interventions. However,
further study is needed to determine which high-risk conditions are amenable to such screening,
what testing regimen is optimal for a normal or abnormal test in these women, and what
interventions based on these findings will improve pregnancy outcomes. Currently, there is a lack
of evidence supporting routine screening with uterine artery Doppler in any particular group of
patients. Assessment of uterine artery flow in second trimester has yielded more consistent
results than in the first trimester, with performance at 18 to 20 weeks' gestation being a
reasonable approach and some evidence that repeating the tests at 24 to 26 weeks may add
further benefit. In this case, 12 weeks was the wrong gestational age to perform a uterine
Doppler assessment. The ACOG notes regarding antepartum fetal surveillance that there is no evidence that umbilical artery Doppler velocimetry provides information about fetal well-being
in a fetus with normal growth. Similarly, 12 weeks was not the correct gestational age for a fetal
echocardiogram nor was there a clinical indication for this study. The American Institute of
Ultrasound in Medicine (AIUM) notes that fetal echocardiography is commonly performed
between 18 and 22 weeks gestational age, although some cardiac structures may be better
visualized before or after this period. The AIUM further notes that indications for fetal
echocardiogram include pre-gestational, not gestational, diabetes, a condition that the patient
would not have been diagnosed at 12 weeks. Regarding the umbilical artery Doppler and
biophysical profile done on 5/10/22 at 21 weeks, both these tests of fetal well-being are usually
performed in the third trimester. The ACOG notes that initiating antepartum fetal testing at 32
weeks of gestation or later is appropriate for most at-risk patients. Additionally, umbilical artery
Doppler studies are a technique of fetal surveillance for growth-restricted fetuses, based on the
observation that flow velocity waveforms in the umbilical artery of normally growing fetuses
differ from those of growth-restricted fetuses. In this case, the records did not document that
the patients fetus was growth restricted. Therefore, evaluation of arterial inflow and venous
outflow of abdomen, retroperitoneum, scrotal contents and/or pelvic organs and detailed fetal
ultrasound, fetal doppler echocardiography and umbilical artery doppler velocimetry on 3/11/22
and 5/10/22 was not likely to have been more beneficial for evaluation of the patients condition
than any available standard therapy.
| 1 |
A 20-year-old male enrollee has requested reimbursement for the Anser IFX testing provided on 10/26/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease status post resection. The physician reviewer found that the patient has had Crohns disease that necessitated bowel resection. The records indicate the patients ileitis has also been complicated by Clostridium difficile and abscess. The patients symptoms remained active and it was unclear whether it would be Crohns disease from undertreatment or antibody
. Hence, an Anser IFX test was sent to help determine such. In this case, there is concern as the disease is advanced and the patient had already failed several regimen and flared on all.
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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 reimbursement for the Anser IFX testing provided on 10/26/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease status post resection. The physician reviewer found that the patient has had Crohns disease that necessitated bowel resection. The records indicate the patients ileitis has also been complicated by Clostridium difficile and abscess. The patients symptoms remained active and it was unclear whether it would be Crohns disease from undertreatment or antibody development versus other complicating factors. Hence, an Anser IFX test was sent to help determine such. In this case, there is concern as the disease is advanced and the patient had already failed several regimen and flared on all. The concern between total loss of response, low antibody level to the biologic, or a completely different diagnosis such as inflammatory bowel disease entails different and drastic measures varying from surgery, change or increase in dose of biologic, to symptomatic adjunct treatment in case of inflammatory bowel disease. Therapeutic levels and lack of antibodies may point the provider toward a different drug versus another etiology. It follows, that testing for antibodies identifies the subset of patients who will benefit from an increased dose, instead of doing such blindly and risking unnecessary potentially risky outcomes and adverse effects. Conversely, missing a sub-therapeutic Remicade level suggests progression of the disease, which could be avoided by dose adjustment as guided by the Anser IFX assay. Moreover, it has been shown that checking for such antibodies helps optimize clinical response by helping achieve a more optimal drug concentration. For these reasons, the Anser IFX testing provided on 10/26/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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 44-year-old female enrollee has requested reimbursement for Prometheus testing performed on 4/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 44-year-old female enrollee has requested reimbursement for Prometheus testing performed on 4/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence has not demonstrated the superior effectiveness of the services at issue. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of adalimumab or the presence of adalimumab antibodies may have an adverse effect on the clinical outcome of a patients response to treatment. However, while there have been testimonials, there are few well-controlled clinical trials to confirm that the testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. In sum, the services at issue were not likely to have been of greater benefit than other methods of evaluating this patient. In sum, the services at issue were not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The patient is a 41-year-old male with chronic migraine. On 10/16/17, Botox injections were provided. He reported 15 headaches per month lasting more than four hours associated with migraine symptoms at the start of treatment. 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.
. This patient reports that he experiences 15 headache days per month.
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Overturned
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Experimental
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Summary Reviewer 1
The patient is a 41-year-old male with chronic migraine. On 10/16/17, Botox injections were provided. He reported 15 headaches per month lasting more than four hours associated with migraine symptoms at the start of treatment. 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 use of Botox is indicated for the treatment of chronic headaches in individuals who have at least 14 headache days per month. This patient reports that he experiences 15 headache days per month. Furthermore, Botox has been approved by the U.S. Food and Drug Administration for the treatment of migraines. Therefore, Botox injections provided on 10/16/17 and 1/08/18 were likely to be more effective 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 52-year-old female with a reported history of chronic back pain dating back to 2005.The patient has requested authorization and coverage for cervical spine MRI and thoracic spine MRI. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of this patient.
. For the thoracic spine MRI, the records noted that the patient had a T3-4 radiculopathy. Conceivably, she could have a compression fracture or focal arthritic change.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 52-year-old female with a reported history of chronic back pain dating back to 2005.The patient has requested authorization and coverage for cervical spine MRI and thoracic spine MRI. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of this patient. The physician reviewer found that there are two studies currently under question. The first is an MRI of the cervical spine. In the medical records, there is no mention of any signs or symptoms pointing to the neck. In view of this, there is no indication for any imaging of the cervical spine. For the thoracic spine MRI, the records noted that the patient had a T3-4 radiculopathy. Conceivably, she could have a compression fracture or focal arthritic change. Remotely, she could even have a significant lesion, such as a severe fracture or even a mass. While the likelihood of these possibilities is low, an MRI is the best means to pick up a focal abnormality. The presence of radiculopathy is also considered a legitimate indication for an MRI. In conclusion, there is no indication for a cervical spine MRI. However, the thoracic spine MRI could help in management, Therefore, the requested thoracic spine MRI is medically necessary for the evaluation of this patient.
| 1 |
A 42-year-old female enrollee has requested reimbursement for reduction mammaplasty performed on 12/03/15. 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 patient had chronic pain of the neck, back, and shoulders, as well as the breasts. Her examination was consistent with significant asymmetric macromastia. Conservative management included nonsteroidal anti-inflammatory medications. Her degree of resection was consistent with a significant breast reduction. The patients symptoms had significantly impacted her activities of daily living.
these findings. The records document a functional problem that was directly related to her significant macromastia.
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Overturned
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Medical Necessity
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Summary Reviewer
A 42-year-old female enrollee has requested reimbursement for reduction mammaplasty performed on 12/03/15. 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 submitted documentation supports the medical necessity of the services at issue. The patient had chronic pain of the neck, back, and shoulders, as well as the breasts. Her examination was consistent with significant asymmetric macromastia. Conservative management included nonsteroidal anti-inflammatory medications. Her degree of resection was consistent with a significant breast reduction. The patients symptoms had significantly impacted her activities of daily living. Multiple medical evaluations provided confirmatory evidence of these findings. The records document a functional problem that was directly related to her significant macromastia. Breast reduction is a well-known procedure that directly addresses this functional deficit. All told, reduction mammaplasty performed on 12/03/15 was medically indicated for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
patient is a 40-year-old female who was evaluated with a lactulose breath test on 7/31/19. The patient has requested authorization and coverage for Xifaxan. The Health Insurer has denied the request and reported that the requested medication is not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 40-year-old female who was evaluated with a lactulose breath test on 7/31/19. The patient has requested authorization and coverage for Xifaxan. The Health Insurer has denied the request and reported that the requested medication is not medically necessary for the treatment of this patient. The physician reviewer found that the current medical evidence supports the requested medication in this clinical setting. This patient has small intestinal bacterial overgrowth. Xifaxan has proven highly effective in small intestinal bacterial overgrowth for eradication of bacteria and symptom relief. This medication had greater effectiveness with fewer side effects than antibiotic alternatives such as metronidazole, neomycin, fluoroquinolones, and penicillins. Results are sustained for several weeks after treatment. Therefore, Xifaxan is medically necessary for the treatment of this patient.
| 1 |
A 64-year-old female enrollee has requested reimbursement and prospective authorization and coverage for proton beam radiation. The Health Insurer has denied this request indicating that the services at issue were and 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 2
A 64-year-old female enrollee has requested reimbursement and prospective authorization and coverage for proton beam radiation. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition. The physician reviewer found based on the submitted documentation, proton beam radiation is not likely to be more beneficial in this clinical scenario when compared with conventional treatment such as photon-based intensity modulated radiation therapy (IMRT). The theoretical advantage of proton therapy is that it has a Bragg beak, resulting in less dose to surrounding normal tissue and a lower integral dose (Shin, et al). The main use of proton therapy in the orbital region is in treating uveal melanomas too large for brachytherapy, where it has an accepted benefit over photons (Weber, et al). In the setting of a myelomatous orbital lesion, however, data is lacking due to the rarity of such a clinical scenario. As appropriate, the treating provider has submitted comparison plan data between protons and photon IMRT. While the doses to normal tissue are lower with protons versus IMRT, the IMRT doses are still well below accepted thresholds of toxicity. In other words, the protons are superior dosimetrically as would be expected, but there is unlikely to be any actually clinical benefit, as IMRT is already not expected to lead to any significant side effect. Based on the above, there is not expected to be any clinical benefit of using proton therapy over photon-based IMRT. As such, proton beam radiation was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The parent of an 11-year-old female enrollee has requested authorization and coverage for gene testing. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of an 11-year-old female enrollee has requested authorization and coverage for gene testing. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patient is an ideal candidate for whole exome sequencing, given her multisystem disease, with short stature, intellectual disability, and renal anomalies (both structural and functional). These multisystem findings increase the likelihood of an underlying single gene disorder which can be identified by whole exome sequencing. The identification of a specific diagnosis in this patient may provide guidance for treatment of her renal anomalies and electrolyte abnormalities. A unifying diagnosis may also provide insight into helpful treatments for growth failure. Thus, the requested gene testing is likely to be superior over 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 |
A 39-year-old female enrollee has requested authorization and coverage for cervical transection
and avulsion of extraspinal nerve. The Health Insurer has denied this request and reported that
the requested services are investigational for the treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 39-year-old female enrollee has requested authorization and coverage for cervical transection
and avulsion of extraspinal nerve. The Health Insurer has denied this request and reported that
the requested services are investigational for the treatment of the enrollees medical condition.
The physician reviewer found that the submitted records fail to demonstrate the superior efficacy
of the requested services in this patients case. The records do not document behavior therapy
despite significant research to support its use. Moreover, the research that is being listed by the
requesting provider to support the procedure for the neck pain is a pilot study for the lumbar
spine doing an endoscopic rhizotomy not a cervical transection and avulsion of extraspinal nerve.
A review of the difference between studies is warranted. Leon and colleagues noted, The choice
of the intervention for a pilot study should be based on theory, mechanism of action, a case
series, or animal studies that justify a rationale for therapeutic effect...Despite the convention,
pilot studies do not provide useful information regarding the population effect size because the
estimates are quite crude owing to the small sample sizes. Basing a decision to proceed or
terminate evaluation of a particular intervention on pilot data is perilous because there is a very
good chance that the decision will be derived from false positive or false negative results. Per
the authors, A pilot study is not a hypothesis testing study and therefore safety and efficacy are
not evaluated...In summary, pilot studies are a necessary first step in exploring novel
interventions and novel applications of interventions. Nothing submitted shows that cervical transection and avulsion of extraspinal nerve has undergone the rigors of scientific research to
move it from investigational research to standard of care. Nevertheless, all other treatments for
neck pain have not been exhausted. Therefore, cervical transection and avulsion of extraspinal
nerve is not likely to be more beneficial than any available standard therapy.
| 1 |
A 55-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 11/2/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 55-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 11/2/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the breast tomosynthesis performed on 11/2/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. There is sufficient support in the peer-reviewed literature for the services at issue in the routine screening population. According to the study by Ciatto and colleagues, the addition of breast tomosynthesis reduces false positives and increases cancer detection when compared to two-dimensional mammography alone. Moreover, Detection rates, including those for invasive and in situ cancers, were 6.1 per 1000 examinations for mammography alone and 8.0 per 1000 examinations for mammography plus tomosynthesis (Skaane, et al). Given the support above, the breast tomosynthesis performed on 11/2/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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 20-year-old male enrollee has requested reimbursement for the human T-lymphotropic virus (HTLV) testing performed on 4/25/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees sperm prior to banking.
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Overturned
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Experimental
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Summary Reviewer 3
A 20-year-old male enrollee has requested reimbursement for the human T-lymphotropic virus (HTLV) testing performed on 4/25/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees sperm prior to banking. The physician reviewer found that sperm banking is regulated by the U.S. Food and Drug Administration (FDA). A committee opinion states that HTLV testing may be obtained at the discretion of the provider in the appropriate clinical setting. Although HTLV testing would benefit the recipient of the sperm and the embryo, the patient would not receive benefit. Thus, although the FDA recommends testing and the American Society Reproductive Medicine states it is optional, the HTLV testing in this circumstance 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.
| 0 |
The patient is a 38-year-old female who presented to her provider on 4/20/22. The records noted
that the patient had been diagnosed with adult onset Stills disease (AOSD) in 2017 following a
hospitalization due to fever, sore throat, arthralgias, myalgias, and rashes. The patient has
requested authorization and coverage for Actemra injection 162 mg/0.9 mL. The Health Insurer
has denied this request and reported that 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 38-year-old female who presented to her provider on 4/20/22. The records noted
that the patient had been diagnosed with adult onset Stills disease (AOSD) in 2017 following a
hospitalization due to fever, sore throat, arthralgias, myalgias, and rashes. The patient has
requested authorization and coverage for Actemra injection 162 mg/0.9 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. Adult onset Still's disease (AOSD) is a rare systemic inflammatory disorder
of unknown etiology, characterized by quotidian or doublequotidian spiking fevers with an
evanescent rash, arthritis, and multiorgan involvement. While its etiology is largely
unknown/idiopathic, it has recently been suggested that alterations in cytokine production have an
important pathophysiological role in AOSD. Treatment in AOSD has been exclusively empirical,
with data on treatment efficacy extrapolated from case reports and small scale retrospective
studies. High-dose glucocorticoids and nonsteroidal anti-inflammatory drugs (NSAIDs) are used
in initial treatment and for flares. The U.S. Food and Drug administration notes that Actemra
(generic name tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment:
rheumatoid arthritis in adult patients with moderately to severely active rheumatoid arthritis who
have had an inadequate response to one or more disease modifying anti-rheumatic drugs
(DMARDs); giant cell arteritis in adult patients; polyarticular juvenile idiopathic arthritis (PJIA)
in patients two years of age and older with active PJIA; systemic juvenile idiopathic arthritis (SJIA)
in patients two years of age and older with active SJIA; and cytokine release syndrome (CRS) in
adults and pediatric patients two years of age and older with chimeric antigen receptor T cell-
induced severe or life-threatening CRS. While there are no randomized clinical trials to
prospectively evaluate the efficacy/safety of tocilizumab in AOSD, multiple case series and
retrospective case reports support its use for the resolution of disease activity, ability to taper
steroids faster, and overall tolerability. Kr and colleagues report that tocilizumab is an effective
and well-tolerated treatment option for treatment resistant AOSD. Tang and colleagues report that
patients with AOSD refractory to high-dose corticosteroids and methotrexate may respond well to
tocilizumab treatment with a steroid-sparing effect and an acceptable safety profile. Reihl Crnogaj
and colleagues report that there is experience supporting subcutaneous tocilizumab as a promising
option for treatment of refractory AOSD patients. In this case, given current medical literature and
as the patient has been symptom-free, flare-free, and able to avoid taking glucocorticoids since
starting Actemra in December 2017, the requested medication is medically indicated. Therefore,
Actemra injection 162 mg/0.9 mL is medically necessary for the treatment of this patient.
| 1 |
A 23-year-old female enrollee has requested reimbursement for the E0835 - RR continuous passive motion exercise device provided on 9/28/16. The Health Insurer has denied this request indicating that the device at issue is considered investigational for treatment of the enrollees status post right knee surgery.
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Upheld
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Experimental
|
Summary Reviewer 1
A 23-year-old female enrollee has requested reimbursement for the E0835 - RR continuous passive motion exercise device provided on 9/28/16. The Health Insurer has denied this request indicating that the device at issue is considered investigational for treatment of the enrollees status post right knee surgery. The physician reviewer found the device at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Fazalare and colleagues concluded that clinical evidence to support the use of CPM following knee cartilage defect surgery was lacking. The authors noted there is a need for well-conducted, high-level evidence studies to address this void in the medical literature. Similarly, Karnes and colleagues concluded that there is a paucity of clinical evidence to support broad implementation of CPM following cartilage restoration procedures. In addition, Gatewood and colleagues concluded that CPM was not warranted in post-operative protocols following arthroscopic knee surgery because of its limited effectiveness in returning knee range of motion. In this case, there is a lack of documentation showing complex regional pain syndrome, significant arthrofibrosis or tendon fibrosis, or inability to participate in active physical therapy to support the use of a CPM device over standard therapy. Therefore, the CPM exercise device provided on 9/28/16 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy in this clinical setting. Based upon the information set forth above, the device at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 21-year-old male enrollee has requested reimbursement for corneal collagen crosslinking performed on 3/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees keratoconus.
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Overturned
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Experimental
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Summary Reviewer 2
A 21-year-old male enrollee has requested reimbursement for corneal collagen crosslinking performed on 3/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees keratoconus. The physician reviewer found that based on the patients vision loss and progression, corneal collagen crosslinking was the most appropriate and effective treatment available. The medical evidence shows corneal collagen crosslinking is a safe and effective procedure for stabilizing corneal ectasia and potentially delaying or preventing the need for full-thickness corneal transplant. In this clinical setting, there is a lack of treatment option available to slow or halt disease progression. Thus, corneal collagen crosslinking performed on 3/13/17 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 |
A 39-year-old male enrollee has requested authorization and coverage for autologous cultured chondrocyte and autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
this patient presents with chronic severe localized right knee pain and swelling.
daily living. He underwent right knee arthroscopy with chondroplasty of the medial femoral condyle, lateral femoral condyle, and trochlear groove on 1/25/18. Operative findings confirmed multiple full thickness chondral defects of the medial femoral condyle, lateral femoral condyle, and trochlear groove, approximately 2.25 cm2, 4 cm2, and 1.25 cm2 respectively. There were minimal degenerative changes in the surrounding articular cartilage, and intact and stable knee with normal joint spacing. He has failed long-term extensive conservative treatment.
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Overturned
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Experimental
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Summary Reviewer 1
A 39-year-old male enrollee has requested authorization and coverage for autologous cultured chondrocyte and autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient presents with chronic severe localized right knee pain and swelling. Functional limitations are noted in activities of daily living. He underwent right knee arthroscopy with chondroplasty of the medial femoral condyle, lateral femoral condyle, and trochlear groove on 1/25/18. Operative findings confirmed multiple full thickness chondral defects of the medial femoral condyle, lateral femoral condyle, and trochlear groove, approximately 2.25 cm2, 4 cm2, and 1.25 cm2 respectively. There were minimal degenerative changes in the surrounding articular cartilage, and intact and stable knee with normal joint spacing. He has failed long-term extensive conservative treatment. U.S. Food and Drug Administration (FDA) indications support the use of matrix autologous chondrocyte implantation (MACI) for the treatment of single or multiple symptomatic, full thickness cartilage defects of the knee. Current evidence-based medical literature supports the use of MACI as safe and effective, with better long-term outcomes as compared to microfracture surgery. In this case, the requested MACI would be supported for the treatment of this patients medical condition as safe and effective given his young age and multiple defects. Therefore, the requested autologous cultured chondrocyte and autologous chondrocyte implantation of the knee are likely to be more beneficial than other treatment options.
| 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.
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Upheld
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Experimental
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Summary Reviewer 3
A 52-year-old female enrollee has requested reimbursement for 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 the American College of Obstetrics and Gynecology (ACOG) and the Society of Gynecologic Oncologists (SGO) have addressed the issue of the application and use of tumor markers in the evaluation of a pelvic/adnexal mass. The guidelines suggest the evaluation of symptomatic patients should include physical examination, possible transvaginal ultrasonography, and measurement of levels of the serum tumor marker CA-125. The underlying goals of management are to help direct patients suspected of having ovarian cancer. These findings also help gynecologic surgeons to comprehensive surgical staging and cyto-reductive surgery. However, the ACOG and SGO guidelines do not support the addition of HE-4 in this clinical setting. The patients presentation warrants surgical intervention with a preoperative evaluation by gynecologic oncology and did not require additional testing with HE-4 prior to this referral. Thus, the ROMA test provided on 6/22/15 was not likely to have yielded further information relevant to this patients management beyond that anticipated with standard CA-125 testing and proper clinical examination. 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 62-year-old male enrollee has requested reimbursement for laboratory services provided on 9/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 62-year-old male enrollee has requested reimbursement for laboratory services provided on 9/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patient had an early stage melanoma with good prognostic features. 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. In sum, laboratory services provided on 9/06/18 were not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 19-year-old male enrollee has requested reimbursement for procedure codes 86671 x 2 and 86021 x 3 performed on 2/14/20. 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
|
Summary Reviewer 1
A 19-year-old male enrollee has requested reimbursement for procedure codes 86671 x 2 and 86021 x 3 performed on 2/14/20. 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 services at issue were antibody tests to specific serum proteins found in some patients with inflammatory bowel disease (IBD). The diagnosis of IBD is based on endoscopic, radiologic and histopathologic criteria. For several years, there has been a search for noninvasive markers that could replace part of this diagnostic process. Antibody markers, including microbial antibodies, autoantibodies and peptide antibodies, have been explored. At present, no single marker with qualities that are satisfactory for the diagnosis and treatment of IBD have been identified. The 2018 American College of Gastroenterology guidelines make the following statement: aSerologic markers of IBD - Routine use of serologic markers of IBD to establish the diagnosis of Crohn's disease is not indicated (
| 0 |
The patient is a 39-year-old male who is status post repair of left cleft lip and palate as a child. He does have a maxillofacial skeletal deformity and was evaluated by an oral surgeon and was found to have severe maxillary hypoplasia, mandibular hyperplasia, and missing tooth number 10 with an alveolar cleft in this area. His provider recommended orthognathic surgery with a Lefort 1 osteotomy, mandibular osteotomy and repair of his alveolar cleft. The patient has requested authorization and coverage for bone graft procedure; nasal, maxillary, or malar areas (includes obtaining graft) (CPT code 21210). The Health Insurer has denied this request indicating that the requested procedure is not medically necessary.
reports that the patient has a maxillofacial skeletal deformity that
The patient also has an alveolar cleft in the area of missing tooth number 10.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 39-year-old male who is status post repair of left cleft lip and palate as a child. He does have a maxillofacial skeletal deformity and was evaluated by an oral surgeon and was found to have severe maxillary hypoplasia, mandibular hyperplasia, and missing tooth number 10 with an alveolar cleft in this area. His provider recommended orthognathic surgery with a Lefort 1 osteotomy, mandibular osteotomy and repair of his alveolar cleft. The patient has requested authorization and coverage for bone graft procedure; nasal, maxillary, or malar areas (includes obtaining graft) (CPT code 21210). The Health Insurer has denied this request indicating that the requested procedure is not medically necessary. Applying the parameters of care outlined by the American Association of Oral and Maxillofacial Surgeons (AAOMS), the proposed surgery is supported as medically necessary for the treatment of this patients medical condition. The provider reports that the patient has a maxillofacial skeletal deformity that cannot be corrected with orthodontics. The proposed procedure will result in improved musculoskeletal and dento-osseous relationships and improvement in mastication. The patient also has an alveolar cleft in the area of missing tooth number 10. Alveolar grafting of this site is indicated and is separate from the Lefort 1 procedure. The goals of this procedure are to provide adequate bone stock for his adjacent teeth and future dental replacement if needed, to establish a nasal skeletal base, and more ideal architecture in the area. All told, the requested bone graft procedure; nasal, maxillary, or malar areas (includes obtaining graft) (CPT code 21210) is medically necessary. 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 64-year-old male enrollee has requested reimbursement for inpatient stay at telemetry level of care provided from 5/23/18 through 5/30/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
that at the time of admission, the patient had a low potassium and an elevated troponin level. He had multiple cardiac risk factors, including hypertension, diabetes mellitus, congestive heart failure and advanced renal disease.
/24/18. He did not have any chest pain or acute ischemia on admission,
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Overturned
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Medical Necessity
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Summary Reviewer
A 64-year-old male enrollee has requested reimbursement for inpatient stay at telemetry level of care provided from 5/23/18 through 5/30/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that at the time of admission, the patient had a low potassium and an elevated troponin level. He had multiple cardiac risk factors, including hypertension, diabetes mellitus, congestive heart failure and advanced renal disease. Given these risk factors and the severity of his infection and wounds, it was reasonable to admit him to a telemetry level of care for 24 hours. The initial 24 hours is sufficient time to check serial echocardiogram and cardiac enzymes and have a cardiology consultation. Furthermore, the potassium level was improved by 5/24/18. He did not have any chest pain or acute ischemia on admission, and after monitoring and serial enzymes/echocardiograms, he could have been treated at a lower level of care from 5/25/18 through 5/30/18. Therefore, inpatient stay at telemetry level of care provided from 5/23/18 through 5/24/18 was medically necessary for the treatment of this patient. The records fail to demonstrate the medical necessity of inpatient stay at telemetry level of care provided from 5/25/18 through 5/30/18.
| 1 |
A 57-year-old male enrollee has requested reimbursement for magnetic resonance imaging (MRI) (code 73721) performed on 12/22/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees knee pain.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 57-year-old male enrollee has requested reimbursement for magnetic resonance imaging (MRI) (code 73721) performed on 12/22/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees knee pain. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. MRI is the most optimal means to evaluate an internal derangement. Plain x-rays are of only limited value because the menisci and ligaments are not visible on plain x-rays. One can assess the degree of degenerative disease and whether there are any acute bony structural abnormalities, but this information is only of limited interest in this patient. The initial x-rays did not demonstrate a fracture, and whether or not he has degenerative change has no bearing. Some patients with no degenerative disease have grossly abnormal menisci, and conversely, there are patients who have gross degenerative joint disease but relatively intact menisci. In a typical patient without trauma, conservative management may be appropriate prior to considering an MRI. However, this patient had an acute traumatic event. Subsequently, the patients symptoms worsened to the point where he had difficulty bearing weight. In this patients case, there was an indication for subsequent cross-sectional imaging following trauma and a negative initial plain x-ray. In sum, considering the worsening symptoms, and the likelihood of associated ligamentous injuries, the MRI was the best means for further evaluation. Thus, MRI (code 73721) performed on 12/22/17 was medically necessary for the evaluation of this patient. Therefore, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
The patient is a 24-year-old male with a history of persistent depressive disorder and generalized anxiety disorder. The patient reported that he has been depressed since middle school. He reported that he was consuming alcohol as a coping method. The records indicate that he was anxious, depressed, and irritable. The patient was admitted to an intensive outpatient program and was treated with psychotherapy and psychopharmacology. The patient requested reimbursement for mental health intensive outpatient services provided from 8/11/16 through 12/31/16. 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 did have passive suicidal ideation. With regards to functional status, the records support a score of 3. The patient had moderate impairment. It appeared that the patient was unemployed.
The patient has no serious medical problems. However, he had been overusing alcohol. He reports having persistent depression since middle school.
The patient had a mildly stressful environment. He had pressure from his family regarding expectations to perform well in school.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 24-year-old male with a history of persistent depressive disorder and generalized anxiety disorder. The patient reported that he has been depressed since middle school. He reported that he was consuming alcohol as a coping method. The records indicate that he was anxious, depressed, and irritable. The patient was admitted to an intensive outpatient program and was treated with psychotherapy and psychopharmacology. The patient requested reimbursement for mental health intensive outpatient services provided from 8/11/16 through 12/31/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The Level of Care Utilization System (LOCUS) is an accepted, national standard for determining the appropriate level of care for adults. During the dates of service in dispute, in terms of risk of harm, the records support a score of 2. There was no documentation of prior suicide attempts or current suicidal or homicidal ideation. The patient did have passive suicidal ideation. With regards to functional status, the records support a score of 3. The patient had moderate impairment. It appeared that the patient was unemployed. In terms of medical/addictive/psychiatric comorbidity, the records support a score of 3. The patient has no serious medical problems. However, he had been overusing alcohol. He reports having persistent depression since middle school. With regards to recovery environment, the records support a score of 2. The patient had a mildly stressful environment. He had pressure from his family regarding expectations to perform well in school. In terms of level of support, the records support a score of 2. The patients parents were supportive of the patient. With regards to treatment history, the records support a score of 2. It does not appear that the patient participated in extensive outpatient treatment prior to the intensive outpatient program admission. In terms of engagement and recovery status, the records support a score of 2. The patient was attentive and engaged during treatment. The patient appeared motivated for change and was compliant with medication. Therefore, the records support a composite score of 16. Based on these criteria, the patient met criteria for routine outpatient services. The patient could have been treated through outpatient psychopharmacology and routine outpatient individual and group therapy. The patients alcohol use could have been treated through a sober living environment along with Alcoholics Anonymous groups. The patient continued to require treatment for his persistent depressive disorder and anxiety, but this could have been done in a less restrictive environment. Thus, mental health intensive outpatient services provided from 8/11/16 through 12/31/16 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 50-year-old female enrollee has requested reimbursement for Afirma gene testing performed on 7/22/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 50-year-old female enrollee has requested reimbursement for Afirma gene testing performed on 7/22/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Over the last few years gene testing analysis has become standard of care for analyzing thyroid nodules with a cytologic diagnosis of atypia of undetermined significance or follicular lesion of undetermined significance. This patient is precisely the type of patient that would benefit from this type of analysis. Therefore, the Afirma gene testing performed on 7/22/14 was likely to be more beneficial than other modalities. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 33-year-old female enrollee has requested reimbursement for gene testing (BRAF mutation analysis) provided on 11/19/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees papillary thyroid carcinoma.
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Overturned
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Experimental
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Summary Reviewer 1
A 33-year-old female enrollee has requested reimbursement for gene testing (BRAF mutation analysis) provided on 11/19/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees papillary thyroid carcinoma. The physician reviewer found the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. There is insufficient support in the peer-reviewed medical literature for the testing at issue in this clinical setting. The National Comprehensive Cancer Network (NCCN) guidelines classify molecular profile testing as category 2B, based upon lower level evidence. Given the lack of sufficient support per national guidelines, the gene testing (BRAF mutation analysis) provided on 11/19/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 41-year-old female enrollee has requested authorization and coverage for Xeljanz. 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 been diagnosed with rheumatoid arthritis. In addition to having failed methotrexate, Orencia and Actemra, the patient also failed a reasonable trial of two anti-tumor necrosis factor agents, Cimzia and Enbrel.
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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 authorization and coverage for Xeljanz. 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 current medical evidence supports the requested medication in this clinical setting. This patient has been diagnosed with rheumatoid arthritis. In addition to having failed methotrexate, Orencia and Actemra, the patient also failed a reasonable trial of two anti-tumor necrosis factor agents, Cimzia and Enbrel. The current literature supports the use of a drug with a different mechanism of action than anti-tumor necrosis factor agents. Per Emory and colleagues, if more than one tumor necrosis factor (TNF) inhibitor provides inadequate responses and/or similar tolerability issues, switching to a different class of agent may provide a more effective option. Gottenberg and colleagues noted that among patients with rheumatoid arthritis previously treated with anti-TNF drugs but with inadequate primary response, a non-TNF biologic agent was more effective in achieving a good or moderate disease activity response at 24 weeks than was the second anti-TNF medication. Therefore, Xeljanz is medically necessary for the treatment of this patient.
| 1 |
A 63-year-old female enrollee has requested authorization and coverage for dental services. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the treatment of the enrollees dental condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 63-year-old female enrollee has requested authorization and coverage for dental services. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the treatment of the enrollees dental condition. The physician reviewer found that treatment for accidental injury is medically necessary when treatment is required due to accidental damage, with coverage for crowns when the service is the only clinically acceptable treatment alternative. Clinical records from prior to the accident and immediately following the accident do not demonstrate significant damage to the teeth, with the exception of the tooth fracture on number 7, which clinical records would indicate could be repaired successfully with a conventional bonded restoration. With a history of periodontal disease, the literature supports that even when treated and stabilized, mobility would be expected due to the loss of supporting alveolar bone. Aesthetic concerns include the existence of super eruption of tooth number 8 related to the patients history of periodontal disease, as well as rotations and malocclusion existing at the time of the accident. These findings would demonstrate that the treatment requested is, to a significant extent, to address structural and aesthetic issues related to existing periodontal disease and malocclusion and not in treatment of injury related to the patients fall, as the only substantial damage related to the fall was the incisal fracture of number 7 noted above. Therefore, the requested dental services are not medically necessary for the treatment of this patient.
| 0 |
A 52-year-old male enrollee has requested reimbursement for gene testing (gene expression profiling) performed on 10/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 52-year-old male enrollee has requested reimbursement for gene testing (gene expression profiling) performed on 10/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch, with some minor updates. Mitotic index has also been thought to add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based upon the risk of metastasis. Gerami reported on 217 cases, with good correlation between DecisionDx-Melanoma testing class and risk of recurrence in patients undergoing sentinel node biopsy. It is not clear how the five-year DecisionDx-Melanoma testing data compares to the ten-year Balch data. Most importantly, it is not clear that the DecisionDx-Melanoma testing assay can be used to make clinical decisions. In sum, gene testing (gene expression profiling) performed on 10/31/18 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 30-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 30-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees medical condition. The physician reviewer
found that available treatment options for alopecia areata are quite limited. This is especially
true for diffuse/multifocal involvement, where standard therapies such as topical steroids,
intralesional kenalog, contact immunotherapy and conventional immunosuppressants are often
less than satisfactory and associated with side effects. There is substantial clinical evidence to support the use of oral Janus kinase inhibitors such as tofacitinib for alopecia areata (including
from clinical trials). In one open label pilot study by Jabbari and colleagues, eight of 12 patients
demonstrated greater than 50% hair regrowth as measured by Severity in Alopecia Tool (SALT)
scoring. Liu and colleagues performed a retrospective study which consisted of patients age 18
years or older with alopecia areata with at least 40% scalp hair loss treated with tofacitinib. The
authors found that 77% achieved a clinical response. There have been minimal adverse effects
reported to date. Moreover, these results are better than what has been reported for contact
immunotherapy and systemic steroids (which have considerable short-term and long-term side
effects). Therefore, Xeljanz 5 mg tablet is likely to be more beneficial than any available standard
therapy.
| 1 |
A 60-year-old male enrollee has requested reimbursement for thoracic spine magnetic resonance imaging (MRI) performed on 6/27/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees thoracic pain.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 60-year-old male enrollee has requested reimbursement for thoracic spine magnetic resonance imaging (MRI) performed on 6/27/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees thoracic pain. The physician reviewer found that presently, there are no discrete guidelines for the management and evaluation of thoracic pain. The current practice guidelines are based upon the guidelines for low back pain. According the American College of Radiology appropriateness criteria for the evaluation of back pain, in a patient with sub-acute or chronic back pain who is a surgical candidate with persistent symptoms after four to six weeks of conservative management, MRI is considered usually appropriate. Imaging after conservative treatment could affect patient management if intervention is pursued. MRI can demonstrate disc disease and central canal stenosis among other findings, which may be the cause of the patients symptoms and may prompt intervention. First-line evaluation and treatment of back pain remains conservative, utilizing NSAIDS, physical therapy, as well as activity modification. If the patient is a candidate for intervention, and the pain persists despite four to six weeks of these measures, then MRI imaging may be appropriate. In this case, there is documentation of conservative evaluation and treatment for at least four weeks. Thus, MRI was appropriate as the next diagnostic step. In sum, thoracic spine MRI performed on 6/27/18 was medically necessary for the evaluation of this patient. Therefore, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 36-year-old female enrollee has requested reimbursement for AmnioMatrix or BioDMatrix injectable, 1 cc provided on 2/01/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who underwent open reduction and internal fixation.
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Upheld
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Experimental
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Summary Reviewer 2
A 36-year-old female enrollee has requested reimbursement for AmnioMatrix or BioDMatrix injectable, 1 cc provided on 2/01/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who underwent open reduction and internal fixation. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The medical evidence has not demonstrated that AmnioFix graft was likely to be more effective than any other available standard therapy. Further study is warranted to fully understand the efficacy of this treatment method. In sum, AmnioMatrix or BioDMatrix injectable, 1 cc provided on 2/01/18 was not likely to be of greater benefit than other available treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 21-year-old female enrollee has requested authorization and coverage for Octagam infusions. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition.
This patient has been treated with a variety of modalities, including beta-blocker therapy, fludrocortisone and pyridostigmine, but has some persistent symptomatology.
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Upheld
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Experimental
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Summary Reviewer 1
A 21-year-old female enrollee has requested authorization and coverage for Octagam infusions. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the treatment of autonomic neuropathy can often involve multidisciplinary strategies, both from cardiovascular medicine as well as neurology. This patient has been treated with a variety of modalities, including beta-blocker therapy, fludrocortisone and pyridostigmine, but has some persistent symptomatology. There is the additional factor that there may be comorbidities to suggest autoimmune disorder as well. However, the use of intravenous immunoglobulin to treat autonomic dysfunction remains investigational. The study by Schofield is retrospective and only included 38 patients. There is a lack of support for the requested medication in this clinical setting. Therefore, Octagam infusions are not likely to be more beneficial than any available standard therapy.
| 1 |
A 46-year-old female insured has requested authorization and coverage for lymphedema surgery
and two inpatient bed days. The Health Insurer has denied this request indicating that the requested
services are considered investigational for treatment of the insureds lymphedema.
Based
on the review of this case, the patient underwent evaluation and was diagnosed with lymphedema.
The patient has undergone surgery on the left side twice. She appears to have recovered well after
surgery and now seeks treatment for the other affected side.
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Experimental
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Summary Reviewer 2
A 46-year-old female insured has requested authorization and coverage for lymphedema surgery
and two inpatient bed days. The Health Insurer has denied this request indicating that the requested
services are considered investigational for treatment of the insureds lymphedema.
The physician reviewer found that lymphedema surgery has slowly improved over time and has
become more mainstream with the improvement in microsurgery techniques. With advances in
super-microsurgery as well as findings from breakthrough studies, the surgical treatment of
lymphedema has become widely accepted and is considered the gold standard for treatment of this
disease process (Chang, et al.; Schaverien, et al.). Once the diagnosis is confirmed with tests, such
as this patients evaluation with lymphoscintigraphy, treatment options include compression
garments and or surgery, which have been demonstrated to be effective modalities to help alleviate
symptoms in patients with lymphedema (Brown, et al.). Surgical options are based on the stage of
the disease. Lymphovenous bypass is a treatment option described for her stage of disease. Based
on the review of this case, the patient underwent evaluation and was diagnosed with lymphedema.
The patient has undergone surgery on the left side twice. She appears to have recovered well after
surgery and now seeks treatment for the other affected side. Given the patients history and the
current literature, the requested lymphedema surgery and a two day hospital stay is likely to be
significantly more beneficial for treatment of the patient than other available therapies. In addition,
she has proven by her own medical history that this treatment has been successful for her left leg.
All told, the requested lymphedema surgery and two inpatient bed days is likely to be more
beneficial for treatment of the patients medical condition than any available standard therapy.
| 1 |
A 22-year-old male has requested reimbursement for Prometheus Anser IFX testing performed on 8/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 22-year-old male has requested reimbursement for Prometheus Anser IFX testing performed on 8/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. With respect to maintenance of healing of perianal disease in Crohns disease, Remicade has the strongest evidence to support its use. Therefore, it is critical to identify whether the patient is developing antibodies or a sub-therapeutic levels of infliximab as discontinuation or an increase in dose may be necessary depending on the results. In sum, Prometheus Anser IFX testing performed on 8/30/15 was likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 54-year-old male enrollee has requested reimbursement for inpatient admission on 6/3/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees lower abdominal pain.
In this case, the patient was admitted in stable condition and could have been treated at an observational level of care. He was tolerating oral fluids and his pain was well controlled. The patient remained hemodynamically stable without a need for any urgent procedures.
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Upheld
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Medical Necessity
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Summary Reviewer
A 54-year-old male enrollee has requested reimbursement for inpatient admission on 6/3/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees lower abdominal pain. The physician reviewer found that impatient care is medically necessary when the patients signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. Outpatient observation admission is appropriate when the provider is unsure about the patients need for inpatient admission and requires time for short-term treatment, assessment, and reassessment in order to make that decision or the physician anticipates that the patients condition can be evaluated and treated within 24 hours and/or rapid improvement of the patients condition can be anticipated within 24 hours. In this case, the patient was admitted in stable condition and could have been treated at an observational level of care. He was tolerating oral fluids and his pain was well controlled. The patient remained hemodynamically stable without a need for any urgent procedures. Thus, the patient could have been treated at a lower level of care. As such, the inpatient admission on 6/3/16 was not medically necessary for treatment of the patients medical condition. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 42-year-old male enrollee has requested reimbursement for substance abuse treatment provided form 6/25/19 through 7/02/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
The records document longstanding heavy alcohol use which posed a serious danger to his liver and brain health. He reported a history of persisting anxiety and depression since age ten. The clinical notes documented poor insight and judgment, and he presented with no clear plan on how to change. The patient had multiple prior relapses, including a relapse just after his discharge from admission 10 days prior to the admission at issue. The records noted limited support, marital separation, and he associated with others who consumed alcohol.
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Overturned
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Medical Necessity
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Summary Reviewer
A 42-year-old male enrollee has requested reimbursement for substance abuse treatment provided form 6/25/19 through 7/02/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. Per the American Society of Addiction Medicine (ASAM) criteria, substance abuse residential treatment was medically necessary. The records document longstanding heavy alcohol use which posed a serious danger to his liver and brain health. He reported a history of persisting anxiety and depression since age ten. The clinical notes documented poor insight and judgment, and he presented with no clear plan on how to change. The patient had multiple prior relapses, including a relapse just after his discharge from admission 10 days prior to the admission at issue. The records noted limited support, marital separation, and he associated with others who consumed alcohol. Patients requires safe and stable living environments in order to develop their recovery skills. Given the severity of the patients illness, residential treatment was in accordance with generally accepted standards of medical practice and was clinically appropriate for the patients illness. Therefore, substance abuse residential treatment provided from 6/25/19 through 7/02/19 was medically necessary for the treatment of this patient.
| 1 |
A 44-year-old female enrollee has requested reimbursement for BRCA testing performed on 3/17/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk of cancer.
does not have a personal history of cancer, is not identified as being from a high risk ethnic group such as Ashkenazi Jewish and has identified one second or later degree relatives on both sides of the family that are over the age of 50. A third relative is
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Upheld
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Experimental
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Summary Reviewer 2
A 44-year-old female enrollee has requested reimbursement for BRCA testing performed on 3/17/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees risk of cancer. The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. This patient does not meet established guidelines for testing for BRCA mutations (Robson, et al). She does not have a personal history of cancer, is not identified as being from a high risk ethnic group such as Ashkenazi Jewish and has identified one second or later degree relatives on both sides of the family that are over the age of 50. A third relative is mentioned but no information is provided. In this clinical setting, pre-test counseling would likely be more beneficial than BRCA testing with a genetic risk assessment based on personal and family history. Therefore, the BRCA testing performed on 3/17/16 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 29-year-old female enrollee has requested reimbursement for allergen specific immunoglobulin G (IgG) (RAST/ELISA) for routine allergy testing performed on 3/22/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 29-year-old female enrollee has requested reimbursement for allergen specific immunoglobulin G (IgG) (RAST/ELISA) for routine allergy testing performed on 3/22/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that multiple evidence based studies have demonstrated that immunoglobulin G (IgG) testing to foods is an unproven method of testing for food intolerances as well as food allergy. IgG antibodies are proteins produced by the immune system in response to exposure to external triggers, like pollens, foods or insect venoms. Their presence reflects exposure to these triggers, not disease that results from exposure. IgG antibodies to food are commonly detectable in healthy adult patients and children, whether food-related symptoms are present or not. There is a lack of credible evidence indicating that measuring IgG antibodies is useful for diagnosing food allergy or intolerance, or that IgG antibodies cause symptoms. The only exception is that gliadin IgG antibodies can be used to monitor the success of avoiding gluten in people with proven celiac disease. Testing for allergen specific IgG is not a recommended method of evaluating and treating a patient for suspected food allergy or food intolerance. Thus, allergen specific immunoglobulin G (IgG) (RAST/ELISA) for routine allergy testing performed on 3/22/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/02/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
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Overturned
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Experimental
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Summary Reviewer 3
A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/02/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that the current medical evidence supports the service at issue in this patients case. Per 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. Thus, digital breast tomosynthesis performed on 9/02/16 was likely to have been more efficacious than other methods of evaluating this patient. 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 55-year-old male enrollee has requested reimbursement for epidural injections of corticosteroid preparations (e.g., Depo-Medrol) with or without added anesthetic agents on 2/02/16 and 2/18/16. 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 this patient underwent multiple epidural steroid injections at four lumbar spine levels. At the L2-3 level, an interlaminar injection was performed followed by bilateral transforaminal injections at L3-4, L4-5 and L5-S1
, the provider performed a lumbar epidural steroid injection at L2-3, despite
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Overturned
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Experimental
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Summary Reviewer 1
A 55-year-old male enrollee has requested reimbursement for epidural injections of corticosteroid preparations (e.g., Depo-Medrol) with or without added anesthetic agents on 2/02/16 and 2/18/16. 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 this patient underwent multiple epidural steroid injections at four lumbar spine levels. At the L2-3 level, an interlaminar injection was performed followed by bilateral transforaminal injections at L3-4, L4-5 and L5-S1. A prospective study by Choi and colleagues evaluated the role of epidural steroid injections to treat low back pain. The authors found that epidural steroid injections can decrease the pain and disability in the majority of patients with moderate disability for up to one year. They recommended epidural steroid injection as a first-line treatment in patients with moderate disability. A systemic review and meta-analysis by Manchikanti and colleagues concluded that epidural corticosteroid injections for radiculopathy or spinal stenosis with sodium chloride solution or bupivacaine were shown to be ineffective. Lidocaine alone or lidocaine in conjunction with steroids were significantly effective. In this case, the provider performed a lumbar epidural steroid injection at L2-3, despite a lack of pathology seen at this level. There were no findings of disc herniation, spinal canal narrowing, or neural foraminal narrowing. The physical examination did not report findings consistent with focal neurological deficits at this level. As such, there was no rationale for performing this injection at this level. The other issue is that the interlaminar injection done at L2-3 is expected to spread to levels above and below the level of the injection. In this case, the injection would spread to the L3-4 and possibly L4-5 levels, so there was no medical rationale to perform additional injections at these levels, which is what was done in this case. While epidural steroid injections do have evidence to support their use in lumbar stenosis and lumbar radiculopathy, which this patient has, there is a lack of evidence in the medical literature to support performing two different types of epidural steroid injections on the same patient on the same day. The standard of care is to perform one type of injection at the level of the spine where the symptoms are expected to be coming from. There is also a lack of evidence to support performance of the injections at lumbar levels where there is no evidence of pathology. The interventional therapy provided in this case is not consistent with current standards of practice. There is a lack of support in the peer-reviewed literature for combining interlaminar and transforaminal epidural steroid injections on the same day in the same area of the spine. Therefore, epidural injections of corticosteroid preparations (e.g., Depo-Medrol) with or without added anesthetic agents on 2/02/16 and 2/18/16 were not likely to have been more beneficial than other treatment options.
| 1 |
A 57-year-old female enrollee has requested reimbursement for the DecisionDx-Melanoma Assay provided on 7/20/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 57-year-old female enrollee has requested reimbursement for the DecisionDx-Melanoma Assay provided on 7/20/18. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that there is a lack of support for the services at issue in this patients case. DecisionDx-Melanoma Assay is a gene expression profile test which was designed to predict distant metastasis in stage I and stage II melanoma patients. DecisionDx-Melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 (i.e., low risk of metastasis) or Class 2 (i.e., high risk of metastasis). At this time, the medical evidence has not demonstrated the superior efficacy of the services at issue. There is a lack of peer-reviewed published studies demonstrating that the DecisionDx-Melanoma Assay is superior over other modalities in this clinical setting. Therefore, DecisionDx-Melanoma Assay performed on 7/20/18 was not likely to have been more effective than other methods of evaluating this patient.
| 1 |
A 31-year-old female has requested reimbursement for lab tests that measure the levels of
medication, adalimumab (ADA) performed on 8/1/22. The Health Insurer has denied this request
indicating that the testing at issue was considered investigational for evaluation of the insureds
ulcerative colitis.
.). The records indicate that this patient
was on ADA for the treatment of ulcerative colitis. The patient reportedly demonstrated ongoing
symptoms of active ulcerative colitis, and showed a markedly elevated C-reactive protein, which
are accepted markers for uncontrolled ulcerative colitis (Rubin, et al.). Given the
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Overturned
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Experimental
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Summary Reviewer 1
A 31-year-old female has requested reimbursement for lab tests that measure the levels of
medication, adalimumab (ADA) performed on 8/1/22. The Health Insurer has denied this request
indicating that the testing at issue was considered investigational for evaluation of the insureds
ulcerative colitis. The physician reviewer found that the use of testing for the assessment of this
patients adalimumab (ADA) drug level and anti-ADA antibody level is supported by the current
guidelines from the American Gastroenterological Association (AGA) and American College of
Gastroenterology (ACG) (Feuerstein, et al.; Rubin, et al.). The records indicate that this patient
was on ADA for the treatment of ulcerative colitis. The patient reportedly demonstrated ongoing
symptoms of active ulcerative colitis, and showed a markedly elevated C-reactive protein, which
are accepted markers for uncontrolled ulcerative colitis (Rubin, et al.). Given the patients elevated
C-reactive protein and ongoing symptoms, which are consistent with active or uncontrolled
ulcerative colitis, the patient was at risk for complications of ulcerative colitis. According to the
AGA, In adults with active inflammatory bowel disease treated with anti-tumor necrosis factor
agents, the AGA suggests reactive therapeutic drug monitoring to guide treatment changes
(Feuerstein, et al.). According to the AGA guidelines, drug concentration and anti-drug antibody
levels should be checked if there is a loss of response to an anti-tumor necrosis factor (TNF)
medication, such as ADA, with a subsequent change in management. Per the ACG guidelines,
The patient with nonresponse or loss of response to therapy should be assessed with therapeutic
drug monitoring to identify the reason for lack of response and whether to optimize the existing
therapy or to select an alternate therapy (Rubin, et al.; Roda, et al.; Irving and Gesce.). Assessment
of whether the patients ADA dose should have been increased or changed to an alternative therapy
was appropriate per the ACG and AGA guidelines. For these reasons, the lab tests that measure
the levels of medication, adalimumab (ADA) performed on 8/1/22 were likely to be more
beneficial for evaluation of the patients medical condition than any available standard therapy.
| 1 |
The patient is a 62-year-old male with hyperlipidemia, diabetes and coronary artery disease including prior stent placement. There is documented intolerance to several -statins and Zetia. A clinic note dated 10/3/16 documents a low density lipoprotein (LDL) cholesterol of 99 mg/dl while taking pravastatin 80 mg per day. The patient has requested authorization and coverage for Repatha. The Health Insurer has denied this request as not medically necessary indicating the patient must first try the formulary alternative Praluent. Based on the records provided the patient is a 62-year-old male with known coronary disease, intolerance to several statins and Zetia, as well as suboptimal
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 62-year-old male with hyperlipidemia, diabetes and coronary artery disease including prior stent placement. There is documented intolerance to several -statins and Zetia. A clinic note dated 10/3/16 documents a low density lipoprotein (LDL) cholesterol of 99 mg/dl while taking pravastatin 80 mg per day. The patient has requested authorization and coverage for Repatha. The Health Insurer has denied this request as not medically necessary indicating the patient must first try the formulary alternative Praluent. Based on the records provided the patient is a 62-year-old male with known coronary disease, intolerance to several statins and Zetia, as well as suboptimal LDL control on maximum tolerated pravastatin dose. In this circumstance PSCK9 inhibitors have been shown to be safe, effective at further reducing LDL levels and result in improved cardiac outcomes. Repatha and Praluent have been demonstrated to be effective in this clinical setting, however there is a lack of controlled trials comparing the relative efficacy of these two medications (Sabatine, et al; Robinson, et al). The use of Repatha over Praluent is not clinically indicated, given that there is no documented intolerance or contraindication to the formulary preferred PCSK9 inhibitor. For the reasons provided, the request for Repatha is not medically necessary for treatment of the patients medical condition. For the reasons provided, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 46-year-old female with a three-year history of chronic neck pain radiating to the bilateral upper extremity with numbness in both hands and feet. A 3/30/17 cervical spine magnetic resonance imaging (MRI) impression documented straightening of the normal cervical lordotic curve. At C5-6, there was subacute reactive marrow beneath the left endplates, 1-2 mm retrolisthesis, 2 mm broad-based disc bulge with no impingement, lateral disc osteophytic spurring, greater on the left, and mild to moderate left neuroforaminal narrowing. At C6-7, there was a 1-2 mm central disc protrusion, and minimal right uncovertebral hypertrophic changes but no significant stenosis. The 3/22/17 provider noted that the patient was seen for follow-up. She underwent facet blocks from C5-7 three times and did well each time, but her symptoms recurred. X-rays showed greater collapse in the C5-6 level than when she was first evaluated, as well as C6-7 intervertebral collapse. She was not responding to conservative management any longer. A 3/22/17 cervical spine x-ray report documented loss of disc height at C5-6, and mild motion on flexion/extension views from C2-3 through C4-5. A 4/13/17 operative report indicated that anterior cervical discectomies were performed at C5-6 and C6-7 with insertion of the intervertebral disc replacement prosthesis C5-6 and C7. The patient has requested reimbursement for cervica
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Overturned
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Experimental
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Summary Reviewer 2
The patient is a 46-year-old female with a three-year history of chronic neck pain radiating to the bilateral upper extremity with numbness in both hands and feet. A 3/30/17 cervical spine magnetic resonance imaging (MRI) impression documented straightening of the normal cervical lordotic curve. At C5-6, there was subacute reactive marrow beneath the left endplates, 1-2 mm retrolisthesis, 2 mm broad-based disc bulge with no impingement, lateral disc osteophytic spurring, greater on the left, and mild to moderate left neuroforaminal narrowing. At C6-7, there was a 1-2 mm central disc protrusion, and minimal right uncovertebral hypertrophic changes but no significant stenosis. The 3/22/17 provider noted that the patient was seen for follow-up. She underwent facet blocks from C5-7 three times and did well each time, but her symptoms recurred. X-rays showed greater collapse in the C5-6 level than when she was first evaluated, as well as C6-7 intervertebral collapse. She was not responding to conservative management any longer. A 3/22/17 cervical spine x-ray report documented loss of disc height at C5-6, and mild motion on flexion/extension views from C2-3 through C4-5. A 4/13/17 operative report indicated that anterior cervical discectomies were performed at C5-6 and C6-7 with insertion of the intervertebral disc replacement prosthesis C5-6 and C7. The patient has requested reimbursement for cervical artificial discectomy performed on 4/13/17. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational. In the peer-reviewed medical literature, Davis and colleagues performed a prospective, randomized, controlled multicenter clinical trial on two-level symptomatic degenerative disc disease. The authors found that use of cervical arthroplasty at two contiguous levels provided advantages over two-level anterior cervical discectomy and fusion. Coric and colleagues reported that the use of anterior cervical surgery for contiguous two-level pathology as safe and effective. The authors concluded that total disc replacement was superior to anterior cervical discectomy and fusion for the treatment of two-level contiguous pathology at five years. Moreover, the US Food and Drug Administration (FDA) has approved the use of the Mobi-C and Prestige discs for well selected patients who have failed conservative treatment. This patient met the FDA and evidence based medical criteria for the two level artificial disc replacement performed on 4/13/17. Therefore, the cervical artificial discectomy performed on 4/13/17 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the surgery at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 45-year-old female enrollee has requested authorization and coverage for Tazorac 0.1% cream. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found this patient has been diagnosed with keratosis pilaris, and she has been stably treated with Tazorac for greater than 10 years.
. She has already tried and failed the typical preparations, but had success with Tazorac, a retinoid cream.
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Overturned
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Medical Necessity
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Summary Reviewer
A 45-year-old female enrollee has requested authorization and coverage for Tazorac 0.1% cream. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found this patient has been diagnosed with keratosis pilaris, and she has been stably treated with Tazorac for greater than 10 years. Keratosis pilaris is a common genetic condition resulting in build-up of the outer layer of skin at hair follicles, typically on the upper arms, thighs, buttocks and occasionally cheeks. Treatment is most successful with keratolytic agents, including ammonium lactate, urea and salicylic acid preparations, or retinoid creams. She has already tried and failed the typical preparations, but had success with Tazorac, a retinoid cream. The request for coverage of this medication should be continued, as she has been treated successfully and stably for years with this medication and there is a lack of alternatives. All told, Tazorac 0.1% cream is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 56-year-old male with a ventricular fibrillation cardiac arrest with anterior myocardial infarction. He was resuscitated and referred for percutaneous coronary intervention of left anterior descending artery with drug eluting stent. The patient subsequently had recurrent ventricular fibrillation requiring both lidocaine and amiodarone load to control. He was referred for repeat catheterization which showed distal narrowing of stented segment of left anterior descending artery which was treated with angioplasty and a severe non-culprit lesion in right coronary artery was treated with stenting as well. The patient has requested reimbursement for wearable cardioverter defibrillator. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of this patient. There
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 56-year-old male with a ventricular fibrillation cardiac arrest with anterior myocardial infarction. He was resuscitated and referred for percutaneous coronary intervention of left anterior descending artery with drug eluting stent. The patient subsequently had recurrent ventricular fibrillation requiring both lidocaine and amiodarone load to control. He was referred for repeat catheterization which showed distal narrowing of stented segment of left anterior descending artery which was treated with angioplasty and a severe non-culprit lesion in right coronary artery was treated with stenting as well. The patient has requested reimbursement for wearable cardioverter defibrillator. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of this patient. There is sufficient support for the device at issue in this clinical setting. Given the recurrent episodes, the requirement for multiple anti-arrhythmic medications and the predisposition to life-threatening rhythm disturbances with ischemia, he remained at high risk for sudden death if he were to have early stent thrombosis and/or recurrent ischemia. In the period where medical management and subsequent reassessment of left ventricular function needs to occur (first three months post infarction), the use of an external defibrillator vest is reasonable in the event of another episode of ventricular fibrillation and sudden cardiac death to deliver immediate counter shock therapy. At three months, left ventricular ejection fraction can be reassessed by echocardiogram, along with any further ongoing ventricular rhythm disturbances by Holter monitoring, and a decision about the need for long-term automatic implantable cardioverter defibrillator therapy can be made at that time. In the interim, an external defibrillator vest was a reasonable interim solution to protect against sudden cardiac death. Therefore, the wearable cardioverter defibrillator was likely to have been more effective than other treatment options. Based upon the information set forth above, the device at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 63-year-old male enrollee has requested reimbursement for monitored anesthesia care provided on 10/21/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
request is for reimbursement for monitored anesthesia care during routine screening colonoscopy with polypectomy.
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Upheld
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Medical Necessity
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Summary Reviewer
A 63-year-old male enrollee has requested reimbursement for monitored anesthesia care provided on 10/21/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient does not have any documented significant disease history. The request is for reimbursement for monitored anesthesia care during routine screening colonoscopy with polypectomy. According to the American Society of Anesthesiologists guideline for anesthesia care during endoscopic procedures, monitored anesthesia care is warranted in prolonged or painful procedures such as complex polyp resections, endoscopic retrograde cholangiopancreatography or other biliary procedures, endoscopic dilation, or endoscopic resection. Additionally, the guidelines state that monitored anesthesia care is more likely necessary in patients with a failed history of moderate sedation for the procedure or psychological impediments to cooperation. The provided records do not support any of these criteria, or other criteria in the literature, such as difficult intubation, airway obstruction, allergies to sedation medications, chronic alcohol or illicit drug use resulting in increased tolerance to sedation medications, age greater than 70, pregnancy, increased aspiration risk, American Society of Anesthesiologists class III or higher, or morbid obesity. According to the most recent guidelines from the American Society for Gastrointestinal Endoscopy, during endoscopic procedures (unlike surgery) consciousness during the procedure is acceptable and is the goal during most procedures, and monitored anesthesia care is recommended for prolonged procedures requiring deep sedation, previously anticipated intolerance to standard sedatives, American Society of Anesthesiologists class IV or V, or risk for airway obstruction due to anatomic variant. For these reasons, the submitted records do not support the medical necessity of monitored anesthesia care in this case. Therefore, monitored anesthesia care provided on 10/21/19 was not medically necessary for the treatment of this patient.
| 0 |
The patient is a 59-year-old female who was diagnosed with a cutaneous melanoma on her left chest wall in February 2016. At that time, she was found to have a non-ulcerating melanoma with Breslow thickness of 1.28 mm, Clark level IV. The patient has requested reimbursement for gene testing performed on 5/12/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.
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Upheld
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Experimental
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Summary Reviewer 2
The patient is a 59-year-old female who was diagnosed with a cutaneous melanoma on her left chest wall in February 2016. At that time, she was found to have a non-ulcerating melanoma with Breslow thickness of 1.28 mm, Clark level IV. The patient has requested reimbursement for gene testing performed on 5/12/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. The prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit more to these statistics. DecisionDx-Melanoma assay is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based upon the risk of metastasis. Gerami reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification in patients undergoing sentinel node sampling. However, it is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year data of Balch. Most importantly, it is not clear if the assay can be used to make clinical decisions. Thus, gene testing performed on 5/12/16 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a nine-year-old transgender male enrollee has requested authorization and coverage for Supprelin LA KIT 50 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees gender dysphoria.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a nine-year-old transgender male enrollee has requested authorization and coverage for Supprelin LA KIT 50 mg. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees gender dysphoria. The physician reviewer found that blocking pubertal development has rapidly become more widely available and is now part of the clinical management guidelines for adolescents in addition to cross sex hormones and surgery (at older ages) as this leads to improved psychological functioning of transgender adolescents. Per standards of care, by the Endocrine Society guidelines and World Professional Association of Transgender guidelines, puberty suppression is indicated in early puberty if desired by the minor in order to prevent irreversible physical changes including breast development in transgender males. Puberty suppression also will likely help decrease self-harm in this vulnerable population as menstruation and breast development in a transgender boy is very emotionally difficult as their body is growing more incongruent to their identity. Thus, gonadotropin-releasing hormone analogs are safe and a reversible medical intervention that should be used to relieve distress that gender dysphoric adolescents experience when their secondary sex characteristics develop. Accordingly, Supprelin LA KIT 50 mg is likely to be more effective than other available treatment options for the treatment of this patients medical condition.Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of a four-year-old male enrollee has requested authorization and coverage for Botox 100 units. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a four-year-old male enrollee has requested authorization and coverage for Botox 100 units. 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 Botox injections have been successfully used for children with constipation due to Hirschsprung disease or anal achalasia. They are now being used in some centers for the management of refractory functional constipation. In this case, anorectal manometry has not yet been performed to assess for anal achalasia or non-relaxing internal anal sphincter, which, if present, would provide a clearer indication for Botox injection. Even in the absence of anal achalasia, refractory functional constipation which has not responded to medical therapy, and which otherwise would be treated with more invasive surgical procedures such as cecostomy, would support the use of Botox. However, based on the clinical data provided, there was still some question as to whether senna would be an effective intervention, as well as whether milk of magnesia would be tolerated by the patient. There is also a mention of the use of enemas and suppositories in the past, but no indication as to why they could not be used more aggressively prior to moving forward with anal sphincter Botox injection. Therefore, in the absence of known anal achalasia, and in light of the possibility that other medical treatments might still be effective, the superior efficacy of the requested services over standard treatments has not been established. Therefore, J0585 - Botox 100 units are not likely to be more beneficial than any available standard therapy.
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A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/02/16. 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 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/02/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that there is sufficient support for the service at issue in this clinical setting. Breast tomosynthesis provides advantages to radiologists interpreting mammograms, especially in women with very 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 compared to two-dimensional imaging alone. Thus, the addition of breast tomosynthesis to the usual two-dimensional mammographic protocol was likely of greater benefit to the patient than had her mammogram 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 40-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/9/16. The Health Insurer has denied this request indicating that the service 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 40-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that tomosynthesis was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography, the American College of Radiology (ACR) urged the technique be removed from the investigational category in 2014 due to the advantages this new tomographic technique brings to radiologists interpreting mammograms. This technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to this patient than had her exam been done with two-dimensional imaging alone. Accordingly, the breast tomosynthesis that was performed on 9/9/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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 48-year-old male enrollee has requested authorization and coverage for cervical artificial discectomy and second level cervical discectomy. 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 2
A 48-year-old male enrollee has requested authorization and coverage for cervical artificial discectomy and second level cervical discectomy. 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 thatthe requested cervical artificial discectomy and second level cervical discectomy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Two level total disc arthroplasty has become accepted by the neurological community to be superior to a two level anterior cervical discectomy and fusion (ACDF) especially in younger patients, such as in this case. There is a growing body of evidence in the peer-reviewed literature that demonstrates two level total disc replacement is associated with a lesser incidence of adjacent level disease than a two level anterior cervical fusion. Given, the above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested reimbursement for Oncotype DX prostate cancer assay (CPT code 84999) testing provided on 4/11/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees elevated prostate-specific antigen (PSA).
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Overturned
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Experimental
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Summary Reviewer 3
A 60-year-old male enrollee has requested reimbursement for Oncotype DX prostate cancer assay (CPT code 84999) testing provided on 4/11/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees elevated prostate-specific antigen (PSA). The physician reviewer found that the Oncotype DX prostate cancer assay (CPT 84999) testing performed on 4/11/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. This patient underwent genomic testing to help in clinical decision making. In this case, given the patients Gleason score of 6, PSA, and volume of cancer detected, current guidelines without genomic testing place this patient at low risk. In conclusion genomic testing 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 61-year-old female enrollee has requested authorization and coverage for breath hydrogen/methane test (91065). The Health Insurer has denied this request and reported that the requested services are 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 3
A 61-year-old female enrollee has requested authorization and coverage for breath hydrogen/methane test (91065). The Health Insurer has denied this request and reported that the requested services are investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patient presented with abdominal pain and gas after antibiotic use, potentially consistent with small intestinal bacterial overgrowth, although accurate and definitive diagnosis can be challenging. Hydrogen breath testing is the most widely available and widely used diagnostic test for small intestinal bacterial overgrowth. Testing for both hydrogen and methane increases the sensitivity of the breath test, and is a considerable improvement over hydrogen testing alone. Antibiotics are necessary for treatment if the results are positive, so confirmation of small intestinal bacterial overgrowth with breath testing can allow avoidance of unnecessary antibiotic use. Thus, breath hydrogen/methane test (91065) is likely to be more efficacious than other methods of evaluating this patient.
| 0 |
A 34-year-old male enrollee has requested authorization and coverage for Bicillin L-A. The Health Insurer has denied this request indicating that the requested medication is 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 3
A 34-year-old male enrollee has requested authorization and coverage for Bicillin L-A. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found Bicillin is a long acting form of penicillin G which generates protracted low levels of penicillin in the blood and has been used primarily for the treatment and prevention of streptococcal infections. It has also been used in the therapy of syphilis and related spirochetal infections. However, there is a lack of published medical literature that supports the use of this drug in the treatment of Lyme disease. Moreover, it is not a recommended therapy per the Infectious Diseases Society of America guidelines (Wormser, et al). Therefore, the use of Bicillin L-A 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 medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 55-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 1/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 55-year-old male enrollee has requested reimbursement for Oncotype DX Prostate testing performed on 1/24/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features, such as the grade of tumor and prostate-specific antigen (PSA) level. This helps guide the most appropriate therapy for patients taking into account their age and comorbidities, because many patients will not require therapy (i.e., surgery or radiation) and may be followed closely instead. Oncotype DX Prostate testing is a gene expression analysis of target genes in the biopsy specimen that generates a genomic prostate score. The current prognostic features are inadequate to make firm recommendations regarding active surveillance to patients. Oncotype DX Prostate testing is an appropriate test in this context. The National Comprehensive Cancer Network guidelines also suggest the use of this test to better stratify such patients with localized disease. Thus, Oncotype DX Prostate testing performed on 1/24/19 was likely to have been more beneficial than any available standard therapy.
| 1 |
A 25-year-old male enrollee has requested authorization and coverage for Stelara injections. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee who has a history of hidradenitis suppurativa.
, the provider noted that the patient is doing well on the Stelara injections.
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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 Stelara injections. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee who has a history of hidradenitis suppurativa. The physician reviewer found that there is support in the medical literature for the requested medication in this clinical setting. HS is a painful and debilitating disease that affects physical and emotional health of patients. The apocrine glands become diseased. There are only a few U.S. Food and Drug Administration approved medications for the treatment of HS. The evidences show that most patients have recalcitrant disease even with surgery and medical treatment. Recently, the pathophysiology of HS is thought to be immunologically influenced and the IL12/23 pathway is implicated in HS based on small studies demonstrating expression of IL12/23 in macrophages infiltrating HS lesioned skin and infiltration of the HS dermis by IL17 producing T-helper cells. Several small case reports of patients experiencing improvement in disease have been published with Stelara (ustekinumab), which blocks IL12/23. The submitted documentation indicates that this patient has failed numerous standard therapies. Smoking and obesity are known to increase disease activity, so smoking cessation would be important for this patient. However, the provider noted that the patient is doing well on the Stelara injections. This patient meets the criteria for the administration of this medication. Accordingly, Stelara injections have been demonstrated as medically necessary for treatment of this patients medical condition. Therefore, based on the information noted above, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 43-year-old male enrollee has requested reimbursement for the left eye corneal collagen cross-linking provided on 7/21/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees progressive keratoconus.
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Overturned
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Experimental
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Summary Reviewer 3
A 43-year-old male enrollee has requested reimbursement for the left eye corneal collagen cross-linking provided on 7/21/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees progressive keratoconus. The physician reviewer found that Collagen cross-linking was recently approved in the U.S. as a treatment for progressive keratoconus (Jeng, et al; Sykakis, et al). In this case, while the records state that there was progression in the left eye, there is a lack of evidence consisting of topography, manifest refraction, and pachymetry provided for the review. Therefore, since none of the historic results of the objective tests that demonstrate the progression have been provided, the left eye corneal collagen cross-linking provided on 7/21/16 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 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 41-year-old male enrollee has requested authorization and coverage for a spine procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 41-year-old male enrollee has requested authorization and coverage for a spine 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 the medical literature supported the Intracept procedure in this setting. The current modalities for these patients is either fusion or artificial disc replacement. Intracept procedure offers a far less invasive outpatient procedure, avoiding either fusion and or artificial disc replacement, while maintaining the structural integrity of the spine. Based on evidence-based literature, patients have been shown to have significant improvements in pain following the Intracept procedure. Therefore, the requested spine procedure is likely to be more beneficial for the treatment of the patientas medical condition than any available standard therapy.
| 0 |
A 60-year-old female enrollee has requested reimbursement for genomic analysis performed on 6/15/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ovarian 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 genomic analysis performed on 6/15/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ovarian cancer. The physician reviewer found that the current medical evidence supports a portion of the services at issue. FoundationOne testing offers a comprehensive panel of molecular genetic markers on an individuals tumor with the hopes of identifying markers than can help guide therapy decision making. It has not been determined if molecular markers are useful in treatment determination (predictive markers). There is currently a phase II clinical trial underway that is evaluating the efficacy of genetic molecular testing to guide individual therapy. Patients who are microsatellite instable (MSI) can be treated with Keytruda. In this patients case, there is support for MLH1, MSH2, MSH6 and PMS2 testing. However, the superior efficacy of the remaining of the services at issue has not been established. Based upon the information set forth above, a portion of 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 partially overturned.
| 0 |
A 42-year-old female enrollee has requested reimbursement for emergency room and related services provided on 4/10/15. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.
medical records, the patient presented with a sudden onset low back and flank pain, nausea, and dizziness.
pyelonephritis, herniated disc, and ovarian torsion. The patient attempted to treat her condition with ibuprofen at home. When that failed, she sought emergency medical evaluation.
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Overturned
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Medical Necessity
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Summary Reviewer
A 42-year-old female enrollee has requested reimbursement for emergency room and related services provided on 4/10/15. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found that the issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition on the date in dispute. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. Review of the submitted documentation demonstrates that a prudent layperson would have sought immediate medical attention on the date in question. Upon review of the submitted medical records, the patient presented with a sudden onset low back and flank pain, nausea, and dizziness. There are many serious medical conditions which may cause similar intense symptoms. These range from acute ureterolithiasis, aortic dissection, appendicitis, perforated viscous, pyelonephritis, herniated disc, and ovarian torsion. The patient attempted to treat her condition with ibuprofen at home. When that failed, she sought emergency medical evaluation. The etiology of the patients pain was unclear to the emergency physician and a thorough evaluation was performed to determine the cause of the symptoms. In sum, a prudent layperson would have sought medical attention on the date of service in question because the absence of immediate medical attention could reasonably be expected to result in placing the patients health in serious jeopardy. All told, the services provided on 4/10/15 met prudent layperson criteria for emergency care.
| 1 |
A 68-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/06/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 68-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/06/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines indicate that 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 trial. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, DecisionDx-Melanoma testing performed on 12/06/17 was not likely to have been superior over other methods of evaluating this patient.
| 0 |
A 45-year-old female enrollee has requested reimbursement for Privigen (intravenous immune globulin or IVIG) from 10/10/16 through 4/10/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees relapsing remitting multiple sclerosis.
The patient has been diagnosed with relapsing remitting multiple sclerosis. While she has tried two interferons, Copaxone and Tecfidera, for primary disease modification, there
patient has not tried. The patient has the option of considering other medications such as Tecfidera, Tysabri, and Zinbryta prior to considering the use of Privigen.
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Upheld
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Medical Necessity
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Summary Reviewer
A 45-year-old female enrollee has requested reimbursement for Privigen (intravenous immune globulin or IVIG) from 10/10/16 through 4/10/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees relapsing remitting multiple sclerosis. The physician reviewer found that the documentation provided does not support the medical necessity of the services at issue in this clinical setting. The patient has been diagnosed with relapsing remitting multiple sclerosis. While she has tried two interferons, Copaxone and Tecfidera, for primary disease modification, there are currently numerous other medications that are available for the treatment of relapsing remitting multiple sclerosis which this patient has not tried. The patient has the option of considering other medications such as Tecfidera, Tysabri, and Zinbryta prior to considering the use of Privigen. Moreover, Privigen is not U.S. Food and Drug Administration approved disease modifying agent for the treatment for RRMS. Therefore, for the reasons stated above, Privigen (intravenous immune globulin or IVIG) is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 68-year-old female enrollee has requested DecisionDX melanoma assay test performed on 6/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 68-year-old female enrollee has requested DecisionDX melanoma assay test performed on 6/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this clinical setting. The DecisionDx melanoma assay test is considered a standard of care for determining if adjuvant therapy is needed to treat patients with uveal melanoma. Using samples of primary uveal melanomas obtained by fine needle biopsy, tumors are classified as having low (class 1) or high (class 2) metastatic potential, depending on the expression of 15 genes. In sum, the DecisionDX melanoma assay test 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.
| 0 |
The patient is a 39-year-old female whose history is significant for having a child with Coffin-Siris syndrome with a mutation noted in SMARCA4. She has requested reimbursement for SMARCA4 gene mutation and chromosome testing performed on 8/14/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. Given the patients age and prior affected child,
. The patient then underwent cell-free fetal DNA testing for fetal aneuploidy.
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Overturned
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Experimental
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Summary Reviewer 1
The patient is a 39-year-old female whose history is significant for having a child with Coffin-Siris syndrome with a mutation noted in SMARCA4. She has requested reimbursement for SMARCA4 gene mutation and chromosome testing performed on 8/14/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. Given the patients age and prior affected child, testing for both fetal aneuploidy and the known gene mutation were medically appropriate. While the initial plan was to perform testing with chorionic villus sampling, the procedure did not yield adequate villi for testing. The patient then underwent cell-free fetal DNA testing for fetal aneuploidy. This was medically indicated since the American College of Obstetricians and Gynecologists and the Society for Maternal Fetal Medicine recommend cell-free DNA testing as a screening option for women at increased risk of fetal aneuploidy. Due to the patients age, the aneuploidy risk for this patient warranted cell-free DNA testing for aneuploidy. Since this test would not address the recurrence risk of the SMARCA4 mutation in the current pregnancy, the patient then underwent amniocentesis. While the testing for the SMARCA4 gene mutation in the amniotic fluid was medically indicated, there was no medical indication to perform a karyotype on the amniotic fluid, as the cell-free fetal DNA was normal. In sum, the testing for SMARCA4 gene mutation was likely to have been more effective than other methods of evaluating this patient, but the superior efficacy of the chromosome testing on 8/14/17 has not been established. Based upon the information set forth above, a portion of 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 partially overturned.
| 1 |
The parent of a 13-year-old female enrollee has requested reimbursement for needle
electromyography (EMG) of anal or urethral sphincter, any technique; needle
electromyography, each extremity; and electroencephalogram performed on 6/10/20. The
Health Insurer has denied this request and reported that the services at issue were
investigational for the treatment of the enrollees medical condition.
This
patient was being treated for adolescent idiopathic scoliosis. She underwent a thoracoscopic
anterior spinal tethering.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 13-year-old female enrollee has requested reimbursement for needle
electromyography (EMG) of anal or urethral sphincter, any technique; needle
electromyography, each extremity; and electroencephalogram performed on 6/10/20. The
Health Insurer has denied this request and reported that the services at issue were
investigational for the treatment of the enrollees medical condition. The physician reviewer
found that the medical evidence supports the services at issue in this clinical setting. This
patient was being treated for adolescent idiopathic scoliosis. She underwent a thoracoscopic
anterior spinal tethering. This procedure involved a high risk of significant complications. The
use of electromyographical monitoring has been found beneficial to help prevent further injury
during this procedure. Therefore, needle electromyography (EMG) of anal or urethral sphincter,
any technique; needle electromyography, each extremity; and electroencephalogram
performed on 6/10/20 was likely to have been more beneficial than any available standard
therapy.
| 1 |
The parent of a 14-year-old female enrollee has requested reimbursement for acute psychiatric inpatient treatment provided from 10/19/18 through 11/02/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
records indicated that the patient had issues with role performance due to psychiatric symptoms.
The patient participated in therapy and followed the meal plan as directed.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 14-year-old female enrollee has requested reimbursement for acute psychiatric inpatient treatment provided from 10/19/18 through 11/02/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that cases such as this, an evidence-based instrument such as American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) assists in determining necessary level of care for children. As of 10/24/18, with regards to risk of harm, the records support a score of 2 due to a lack of a history of suicidal ideation but behaviors, including refusal to eat, which could cause self-harm, even unintentionally. In terms of functional status, the records support a score of 3. The records indicated that the patient had issues with role performance due to psychiatric symptoms. With regards to medical, addictive and psychiatric comorbidity, the records support a score of 2. In terms of level of stress of the recovery environment, the records support a score of 2. The patient had a stable living environment. With regards to resiliency and treatment history, the records support a score of 3. There was no clear evidence of long-term treatment outcomes. In terms of acceptance and engagement of the patient, the records support a score of 2. The patient participated in therapy and followed the meal plan as directed. With regards to acceptance and engagement of the parent, the records support a score of 2. The patients parents worked actively and constructively with clinicians. Thus, the patient had a composite score of 16. This score correlates with intensive outpatient services. Thus, acute psychiatric inpatient treatment provided from 10/19/18 through 10/24/18 was medically necessary for the treatment of this patient. The submitted documentation fails to demonstrate the medical necessity of the remaining dates of services at issue. Therefore, a portion of the services at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
| 1 |
A 66-year-old female enrollee has requested reimbursement for the computed tomography (CT) of the chest with contrast and CT of the abdomen and pelvis with contrast provided on 10/19/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees uterine cancer.
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Overturned
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Medical Necessity
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Summary Reviewer
A 66-year-old female enrollee has requested reimbursement for the computed tomography (CT) of the chest with contrast and CT of the abdomen and pelvis with contrast provided on 10/19/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees uterine cancer. The physician reviewer found that the National Comprehensive Cancer Network (NCCN) guidelines support the preoperative use of CT of the chest, abdomen and pelvis for evaluation of possible metastases in patients with serous uterine cancer. In addition, the use of CT scans every six months for a course of two years are suggested per NCCN guidelines. The evaluation is designed to detect distant or local metastatic disease at the earliest possible stage in order to provide optimal treatment. All told, the CT of the chest with contrast and CT of the abdomen and pelvis with contrast provided on 10/19/17 were medically necessary 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.
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A 52-year-old male enrollee has requested authorization and coverage for Otezla. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for treatment of the enrollees plaque psoriasis.
that this patient has a history of chronic plaque psoriasis. Per the records, he has tried and failed treatment with topical steroids.
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Upheld
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Medical Necessity
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Summary Reviewer
A 52-year-old male enrollee has requested authorization and coverage for Otezla. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for treatment of the enrollees plaque psoriasis. The physician reviewer found that this patient has a history of chronic plaque psoriasis. Per the records, he has tried and failed treatment with topical steroids. However, there is no medical documentation of a contraindication, intolerance or adverse effect to using the preferred agents, including methotrexate, acitretin, Enbrel, Humira, Stelara or Remicade. In this patients case, the provider noted that disease-modifying antirheumatic drugs are contraindicated due to high blood pressure. However, disease-modifying antirheumatic drugs are contraindicated in the instances of liver disease and certain liver infections (such as hepatitis B or C), not high blood pressure. The patients provider noted that biologic agents have been avoided due to coronary artery disease. However, biologic agents are contraindicated in the setting of congestive heart failure, not coronary artery disease. The conditions reported for this patient do not represent contraindications to the use of the preferred formulary agents. As there are other effective, preferred agents offered for the treatment of the patients chronic plaque psoriasis, the requested medication Otezla 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.
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A 53-year-old female enrollee has requested reimbursement for clinical chemistry test (84999) performed on 10/01/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.
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Upheld
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Medical Necessity
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Summary Reviewer
A 53-year-old female enrollee has requested reimbursement for clinical chemistry test (84999) performed on 10/01/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that this patient had an early stage melanoma. Per the National Comprehensive Cancer Network guidelines, while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. 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, clinical chemistry test (84999) performed on 10/01/18 was not medically necessary for the evaluation of this patient.
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The patient is a 16-year-old male with a past psychiatric history of attention deficit/hyperactivity
disorder, combined presentation, major depressive disorder, single episode, mild, cannabis use
disorder, moderate or severe, opioid use disorder, moderate or severe, and sedative, hypnotic,
anxiolytic use disorder, mild. The patients parent has requested reimbursement for adolescent
substance use disorder IOP single case agreement for services provided from 2/10/22 through
3/14/22.
for the patient to have been seen by the provider 417 Recovery which
is out of network for his plan.
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 16-year-old male with a past psychiatric history of attention deficit/hyperactivity
disorder, combined presentation, major depressive disorder, single episode, mild, cannabis use
disorder, moderate or severe, opioid use disorder, moderate or severe, and sedative, hypnotic,
anxiolytic use disorder, mild. The patients parent has requested reimbursement for adolescent
substance use disorder IOP single case agreement for services provided from 2/10/22 through
3/14/22. The physician reviewer found that at issue is whether adolescent substance use disorder
intensive outpatient program services provided from 2/10/22 through 3/14/22 were medically
necessary for the treatment of the patients medical condition. Please specify whether or not it
was medically necessary for the patient to have been seen by the provider 417 Recovery which
is out of network for his plan. The American Academy of Child and Adolescent Psychiatry (AACAP)
and American Association for Community Psychiatry (AACP) have unified the Child and
Adolescent Level of Care Utilization System (CALOCUS) and the Child and Adolescent Service
Intensity Instrument (CASII) into a single instrument, the Child and Adolescent Level of
Care/Service Intensity Utilization System (CALOCUS-CASII). This instrument is a standardized tool
used to determine the intensity of services needed for children and adolescents, 6-18 years of
age, presenting with psychiatric, substance use, medical and/or developmental concerns. Using
CALOCUS-CASII, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating
System. The six dimensions include: (1) risk of harm; (2) functional status; (3) co-occurrence of
developmental, medical, substance use and psychiatric conditions; (4) recovery environment (a.
stressors and b. supports); (5) resiliency and response to services; and (6) engagement. The
composite score is then used to determine the level of care needed. Applying the CALOCUS-CASII
framework, the patient met the criteria for the IOP services provided from 2/10/22 through
3/14/22. For dimension 1, risk of harm, the records support a score of 2. This dimension assesses
potential for harm to self or others, or having harm inflicted upon them. The patient has a history
of polysubstance use and recently relapsed on cocaine, alcohol, and cannabis. He has a history
of cutting himself while under the influence of drugs. He denied a history of suicide attempts. For
dimension 2, functional status, the records support a score of 2. This dimension assesses the
degree to which a patient is able to fulfill responsibilities within developmental constraints. The
patient has struggled to stop using cannabis and nicotine while in treatment. Recent gains in
functioning appear to have occurred while the patient was participating in treatment. He is
attending school and maintaining good grades. For dimension 3, co-occurring developmental,
medical, substance use and psychiatric conditions, the records support a score of 3. This
dimension assesses the co-existence of disorders across four domains (psychiatric, substance
use, medical or developmental) that may complicate the course of treatment. The patient
struggles with both mental health and substance use issues. He continues to experience cravings
to use drugs and has had positive urine drug tests while in treatment. His substance use has been
(mostly) arrested due to use of highly structured setting. For dimension 4A, level of stress in the
recovery environment, the records support a score of 3. This dimension assesses the stressors in
the environment, social circumstances, and interpersonal relationships. The patient continues to
be exposed to substance use as he continues to associate with friends who use drugs. The patient
describes his home environment as pretty chaotic. For dimension 4B, level of support in the
recovery environment, the records support a score of 3. This dimension assesses the presence of family and social support to augment the recovery environment. The patients parents are
supportive. However, the patients friend group continues to use substances and the patient
finds it difficult to distance himself from this friend group. The patient is also noted to have
difficulty reaching out to friends and family for support. For dimension 5, resiliency and response
to services, the records support a score of 3. This dimension assesses how past experiences with
treatment and recovery might indicate how the patient might respond in the future. Prior
treatment has included individual and family therapy, two intensive outpatient programs, a
partial hospital program, and a brief stay in residential treatment. Overall, he has exhibited
moderate or equivocal resiliency and/or response to treatment. For dimension 6, engagement of
the child or adolescent, the records support a score of 3. The child and adolescent sub-dimension
assesses ability to form therapeutic relationship within developmental constraints. Although the
patient was engaged in treatment, he struggled with being honest with therapists and parents.
Concerns about his honesty and willingness were noted. These findings give the patient a
composite score of 19, which is consistent with Level 3 High Intensity Community Based Services.
Therefore, intensive outpatient program services provided from 2/10/22 through 3/14/22 were
medically necessary. However, the medical records fail to demonstrate the medical necessity of
services provided by the provider 417 Recovery which is out of network for his plan. Although
it may be preferable for the patient to receive treatment at a program known to him and where
he is known, appropriate treatment could be provided by any appropriately licensed treatment
facility specializing in adolescent substance use disorders. Therefore, it was not medically
necessary for the patient to have been seen by the provider 417 Recovery which is out of
network for his plan. Thus, an adolescent substance use disorder intensive outpatient program
single case agreement for services provided from 2/10/22 through 3/14/22 was not medically
necessary for the treatment of this patient.
| 1 |
A 60-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 8/04/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
. However, she had a questionable area of developing new architectural distortion in one breast.
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Overturned
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Experimental
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Summary Reviewer 1
A 60-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 8/04/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that the Breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. In this patients case, her breasts were not described as particularly dense. However, she had a questionable area of developing new architectural distortion in one breast. In this setting, breast tomosynthesis is valuable in separating out overlapping structures and possibly demonstrating an otherwise occult mass. Thus, breast tomosynthesis performed on 8/04/16 was likely to have been of greater benefit than other methods of evaluating this patient. 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 62-year-old male enrollee has requested reimbursement for services (Foundation One testing) performed on 2/07/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
|
Overturned
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Experimental
|
Summary Reviewer 2
A 62-year-old male enrollee has requested reimbursement for services (Foundation One testing) performed on 2/07/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that Foundation One is a molecular assay that explores the mutations of an individuals cancer cells. The hope is that the assay will identify a specific mutation or target that could guide the clinician as to which chemotherapeutic drug would be useful. However, at this time, there is a lack of convincing evidence that the assay adds to the decision making ability or yields as result that is clinically useful in a significant number of patients. A randomized study by Le Tourneau and colleagues did not demonstrate a significant clinical benefit from choosing therapy based on molecular targets versus by the oncologists clinical judgment. In sum, services (Foundation One testing) performed on 2/07/19 were not likely to have been more beneficial than other standard methods of evaluating this patient.
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