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A 39-year-old male enrollee has requested reimbursement for chiropractic treatment provided from 4/20/15 through 7/24/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
A 39-year-old male enrollee has requested reimbursement for chiropractic treatment provided from 4/20/15 through 7/24/15. 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 review I am board certified in chiropractic orthopedics and I am actively practicing. I am an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition. In addition, I hold a current certification by a recognized American medical specialty board in the area or areas appropriate to the treatment under review. I have no history of disciplinary action or sanctions against my license.
| 0 |
The parent of a 15-year-old male enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 5/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that the patient is a 15-year-old male with Crohns disease. The patient presented with bloody diarrhea and the presence of perianal fistulous disease. Colonoscopy revealed discontinuous ulcers in the rectum and sigmoid. After initially starting Flagyl, the patient ultimately was placed on Remicade. He experienced healing of the fistulas with resolution of hematochezia. The patients parent has requested reimbursement for Prometheus Anser IFX testing performed on 5/13/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient.
The patient appeared to be responding, and there is no mention of an infusion-related adverse event. | Upheld | Experimental | Summary Reviewer 2
The parent of a 15-year-old male enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 5/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that the patient is a 15-year-old male with Crohns disease. The patient presented with bloody diarrhea and the presence of perianal fistulous disease. Colonoscopy revealed discontinuous ulcers in the rectum and sigmoid. After initially starting Flagyl, the patient ultimately was placed on Remicade. He experienced healing of the fistulas with resolution of hematochezia. The patients parent has requested reimbursement for Prometheus Anser IFX testing performed on 5/13/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient. The current medical evidence has not established the superior efficacy of the services at issue in this clinical setting. The patient appeared to be responding, and there is no mention of an infusion-related adverse event. Antibodies in low titer can be transient and not of biologic significance. The provider increased the dose based on the testing. There is a lack of prospective, controlled data showing that this leads to improved outcomes. In summary, while targeted dosing of biologics may be an attractive concept, there is a lack of data demonstrating that this approach actually benefits patients. Thus, Prometheus Anser IFX testing performed on 5/13/16 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 45-year-old male enrollee has requested authorization and coverage for powered upper extremity range of motion assist device, elbow, wrist, hand and finger. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 1
A 45-year-old male enrollee has requested authorization and coverage for powered upper extremity range of motion assist device, elbow, wrist, hand and finger. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the standard of rehabilitative care in the setting of central nervous system pathology such as stroke resulting in severe functional impairments is to directly address these impairments and optimize overall function, as well as to mitigate the risks of health complications. Depending on the impairments specific to a case, increased independence can be achieved using equipment, such as assistive speech technology, adaptive utensils, nonskid plates, gait/mobility implements, wheelchairs, and other adaptive equipment and accessibility/environmental modifications, if/when appropriate. When there are limits to function despite exhausting more direct interventions, or when efficiency or safety call require it, caregivers may be called upon to otherwise meet a personas functional needs.There is no proven role of the MyoPro elbow-wrist-hand-finger orthosis in stroke management or rehabilitation. The proposed device does not replace the role of conventional (i.e., passive, light and custom-fitted) orthoses, which can be employed as needed to manage the effects of tone, to reinforce therapeutic positioning, and to enhance functionality when applicable. The device in question is not expected to practically assist a user in self-care tasks such as grooming, bathing, dressing, or other tasks requiring dextrous upper extremity use. Given the weight, bulk, and delayed responses effectuated by the device in question, adoption of the device for regular functional use on a long-term basis is not expected to be likely.
There are, moreover, potential adverse sequelae and safety issues related to this device, including the potential to cause or exacerbate edema, skin injuries, musculoskeletal injuries or pain, including hemiplegic shoulder pain. Hemiplegic shoulder pain, in particular, is highly prevalent following stroke, affecting up to 50% of this population. Its etiology is multifactorial, but glenohumeral subluxation is an important factor. Risk factors for shoulder subluxation and hemiplegic shoulder pain include increased levels of weakness, i.e., shoulder muscles that are too weak to adequately support the weight of the upper limb against gravity. The device in question can add approximately 50% to the weight of an arm, which would increase the risk of subluxation and hemiplegic shoulder pain.
In addition, the safety of using this device while standing or walking in persons who have impaired lower limb strength and balance due to stroke with hemiparesis is unclear. Falls could be potentially precipitated in device users with unexpected disturbances in their center of gravity that cannot be adequately compensated for while using the heavy device due to stroke-related impairments in balance and the hemiparetic trunk and lower limb.
There are, overall, no functional benefits that would be expected from the use of this device. There are potential risks of injury associated with use of this device, as discussed above. There is a lack of proven health benefits associated with the use of this device. The available scientific evidence related to the type of orthotic device in question is limited to preclinical work and anecdotal literature. The requested device is not likely to be more beneficial for treatment of the patientas medical condition than any available standard treatment and rehabilitation for chronic functional impairment following severe stroke, which would include the devices and supportive care discussed above. Therefore, the requested powered upper extremity range of motion assist device, elbow, wrist, hand and finger is not likely to be more beneficial than other methods of evaluating this patient.
| 1 |
A 54-year-old male enrollee has requested authorization and coverage for Gilotrif (afatinib dimaleate tablet 40 mg). The Health Insurer indicates that the requested medication is investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied coverage for the requested medication.
| Overturned | Experimental | Summary Reviewer 2
A 54-year-old male enrollee has requested authorization and coverage for Gilotrif (afatinib dimaleate tablet 40 mg). The Health Insurer indicates that the requested medication is investigational for the treatment of the enrollees medical condition. Therefore, the Health Insurer has denied coverage for the requested medication.
At issue is whether the requested medication is likely to be more beneficial for treatment of the enrollees condition than any available standard therapy. The physician reviewer found that the therapy of advanced non-small cell lung cancer has been revolutionized by the finding of EGFR mutations in adenocarcinomas. Even if stage IV disease is present, therapy targeted to EGFR with erlotinib results in prolonged survival when compared with standard chemotherapy regimens. The mutational landscape of non-small cell lung cancer has significantly expanded in recent years to encompass gain of function in multiple oncogenes with major prognostic and therapeutic consequences. This patient has a rare EGFR gene rearrangement. The approach to a rare EGFR gene rearrangement is comparable to the presence of an EGFR mutation. Within the National Comprehensive Cancer Network guidelines, EGFR mutations discovered during first-line systemic therapy or those discovered prior to first-line systemic therapy should be treated with afatinib. This is a category 1 recommendation. Therefore, Gilotrif (afatinib dimaleate tablet 40 mg) is likely to be more beneficial than other available standard therapy.
| 1 |
A 56-year-old female enrollee has requested reimbursement for Oncotype DX colon cancer assay completed on 8/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. | Overturned | Experimental | Summary Reviewer 3
A 56-year-old female enrollee has requested reimbursement for Oncotype DX colon cancer assay completed on 8/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that there is some evidence to consider adjuvant treatment for those stage II patients with T4 disease, obstructing lesions, and other biomarkers. The Oncotype DX colon cancer assay uses a reverse transcriptase-polymerase chain reaction assay for 12 genes in an algorithm that can be used to predict recurrence. The medical evidence for the test is sufficient to allow its use to estimate the risk of recurrence for stage II patients when incorporated with other tests, such as standard pathology and microsatellite instability testing. This patient has been diagnosed with stage II cancer. Thus, Oncotype DX colon cancer assay performed on 8/19/15 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 3
A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The National Comprehensive Cancer Network guidelines indicate that genetic testing such as the DecisionDx-Melanoma testing should not be used outside of a clinical trial setting. The use of this type of testing is not considered to be standard of care in the treatment of this patients melanoma. This testing is not expected to impact the treatment or outcome of this patients melanoma. Thus, DecisionDx-Melanoma testing performed on 2/20/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
The patient is a 62-year-old female with a history of invasive urothelial carcinoma, high grade T4NxMx (y2aN2) status post right inguinal node biopsy on 6/29/17. Pathology was consistent with metastatic urothelial cancer, high grade with plasmacytoid features. Treatment included neoadjuvant chemotherapy with four cycles of cisplatin and gemcitabine and cystectomy. FoundationOne gene testing was performed on 8/15/16. The patient has requested reimbursement for the FoundationOne gene test provided on 8/15/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. This patient underwent molecular profiling with FoundationOne testing on 8/15/16 shortly after initial diagnosis and prior to receiving first-line therapy. | Upheld | Experimental | Summary Reviewer 2
The patient is a 62-year-old female with a history of invasive urothelial carcinoma, high grade T4NxMx (y2aN2) status post right inguinal node biopsy on 6/29/17. Pathology was consistent with metastatic urothelial cancer, high grade with plasmacytoid features. Treatment included neoadjuvant chemotherapy with four cycles of cisplatin and gemcitabine and cystectomy. FoundationOne gene testing was performed on 8/15/16. The patient has requested reimbursement for the FoundationOne gene test provided on 8/15/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. This patient underwent molecular profiling with FoundationOne testing on 8/15/16 shortly after initial diagnosis and prior to receiving first-line therapy. As noted in the current peer-reviewed medical literature, molecular profiling is not considered the standard of care for the treatment of urothelial cancer. Moreover, in this case, the FoundationOne testing was performed when several first- and second-line therapies were available. Molecular testing to guide therapy is the ongoing subject of several active clinical trials. All told, the FoundationOne gene test provided on 8/15/16 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 36-year-old female enrollee has requested authorization and coverage for peripheral nerve stimulator (implant of neuroelectrodes (G4555)). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees paraclavicular and neck pain.
this right handed patient has chronic refractory neuropathic pain of her right neck and right shoulder. She has failed use of a SCS as treatment for her pain as well as other standard treatment modalities.
. She has been offered a peripheral nerve stimulator trial. | Overturned | Experimental | Summary Reviewer 1
A 36-year-old female enrollee has requested authorization and coverage for peripheral nerve stimulator (implant of neuroelectrodes (G4555)). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees paraclavicular and neck pain. The physician reviewer found that this right handed patient has chronic refractory neuropathic pain of her right neck and right shoulder. She has failed use of a SCS as treatment for her pain as well as other standard treatment modalities. According to the American Academy of Neurology (AAN) guidelines, SCS is used to treat neuropathic pain, and is considered to be a surgery of last resort when all other treatment options have failed. She has been offered a peripheral nerve stimulator trial. Peripheral nerve stimulation has been shown to be safe and effective (Petersen and Slavin). Since she has failed use of the SCS, the peripheral nerve stimulator is the only available modality to treat her current pain (Al-Jehani and Jacques). Thus, the requested peripheral nerve stimulator (implant of neuroelectrodes (G4555)) is likely to be more beneficial for this patient than any available standard treatment. Based upon the information set forth above, I have determined 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 |
The patient is a 34-year-old male who was admitted to a residential treatment center (RTC) on
7/7/22. The patient has requested reimbursement for RTC from 7/26/22 through 8/4/22. The Health
Insurer has denied this request and reported that the services at issue were not medically necessary
for the treatment of this patient.
For dimension 1, the patient underwent withdrawal
management for opioid withdrawal earlier in his treatment stay. He declined MAT. The patients
withdrawal needs were safely managed in a Level 3.5 setting. For dimension 2, the patient had no
significant medical problems. The | Overturned | Medical Necessity | Summary Reviewer
The patient is a 34-year-old male who was admitted to a residential treatment center (RTC) on
7/7/22. The patient has requested reimbursement for RTC from 7/26/22 through 8/4/22. The Health
Insurer has denied this request and reported that the services at issue were not medically necessary
for the treatment of this patient. This denial is the subject of this appeal and determination.
The physician reviewer found that per American Society of Addiction Medicine (ASAM) criteria,
this patient met Level 3.5 criteria for RTC services from 7/26/22 through 8/4/22. ASAM criteria
focuses on six dimensions to determine the appropriate level of care, which includes: (1)
intoxication and withdrawal potential; (2) biomedical conditions; (3) emotional, behavioral and
cognitive conditions; (4) readiness to change; (5) relapse, continued use, or continued problem
potential; and (6) recovery environment. For dimension 1, the patient underwent withdrawal
management for opioid withdrawal earlier in his treatment stay. He declined MAT. The patients
withdrawal needs were safely managed in a Level 3.5 setting. For dimension 2, the patient had no
significant medical problems. The patients biomedical problems, if any, were stable and did not
require 24-hour medical or nurse monitoring. For dimension 3, the patient was diagnosed with
PTSD and MDD. He reported using fentanyl to manage depression about a knee injury and his
inability to participate in activities that he had previously enjoyed. He reported symptoms of
depression. He reported using 0.5 grams of fentanyl for two years. He had crashed his motorcycle
while seeking fentanyl and had an overdose on fentanyl. He reported continued use despite formal
detoxification and RTC stays. The patients mental status was stable enough to permit
participation, he demonstrated a repeated inability to control his impulses to use substances, and
he was in imminent danger of relapse with attendant likelihood of harm to self. The resulting level
of dysfunction was of such severity that it precluded participation in treatment in the absence of
24-hour support and structure of a Level 3.5 program. For dimension 4, the patient was admitted
voluntarily for treatment after crashing his motorcycle while seeking fentanyl. He reported using
fentanyl for two years after relapsing in 2019, due to knee injury, following five years of sobriety.
The patient minimized the severity of his addiction and denied a need for MAT. The patient
required structured therapy and a 24-hour programmatic milieu to promote treatment progress and
recovery, because due to the intensity and chronicity of the addictive disorder, he had limited
insight and little awareness of the need for continuing care or the existence of his substance use
and need for treatment, and thus had limited readiness to change. For dimension 5, the patient had
been in a relapse for over two years after using opiate medication for a knee injury. He reported
using 0.5 grams of fentanyl daily. He had an overdose and a serious motorcycle accident while
using. He viewed pain as his primary reason for relapse and had not been able to identify other
relapse triggers. He declined MAT. The patient did not recognize relapse triggers and lacked
insight into the benefits of continuing care and was therefore not committed to treatment. His
continued substance use posed an imminent danger of harm to self or others in the absence of 24-
hour monitoring and structured support. For dimension 6, the patient was unable to cope without
using substances on a daily basis since 2019 and had been unable to work throughout this time due
to his addiction. He had been in a relapse for years, using substances alone in the home
environment. He was developing a plan to move to Arizona and continue treatment there with his
mothers assistance. The patient was unable to cope, for even limited periods of time, outside of
24-hour care. He required staff monitoring to learn to cope with problems before being transferred safely to a less intensive setting. Given these findings, the patient met the six ASAM criteria for
RTC services provided from 7/26/22 through 8/4/22. Accordingly, the RTC from 7/26/22 through
8/4/22 was medically necessary for treatment of this patient.
| 1 |
A 25-year-old male enrollee has requested reimbursement for quantitative EEG (brain mapping) performed from 7/02/20 through 8/25/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeAaas medical condition. | Upheld | Experimental | Summary Reviewer 1
A 25-year-old male enrollee has requested reimbursement for quantitative EEG (brain mapping) performed from 7/02/20 through 8/25/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeAaas medical condition. The physician reviewer found that in a 2017 review of the evidence base for neurofeedback and biofeedback for mood and anxiety disorders, Banerjee and Argaez concluded the following, AaAFive relevant RCTs (randomized controlled trials). . . comparing NF (neurofeedback) or BF (biofeedback) with other psychological treatments or no treatments for managing patients with posttraumatic stress disorder (PTSD), generalized anxiety disorder (GAD) or major depressive disorder (MDD) were identified. Of these five RCTs, two RCTs...were on NF provided by health professionals, and three RCTsAaAwere on BF provided by health professionals. No relevant studies on the clinical effectiveness of biofeedback using home equipment for treatment of PTSD, GAD, or depression without continued support from health professionals were identified. No relevant evidence-based guidelines regarding the use of NF or BF for the treatment of PTSD, GAD, or depression were identifiedAaAFor patients with MDD, one RCT found that patients who received heart rate variability biofeedback (HRV-BF) in addition to psychotherapy showed significant improvements in symptoms after treatment, while significant improvements were not achieved with psychotherapy alone. Findings need to be interpreted in the light of the limitations (such as small sample size, limited number of relevant studies, lack of randomization details, lack of reporting of adverse event, and lack of long-term data).AaA The paucity of data to support the use of EEG neurofeedback/biofeedback for depression is reflected in the fact that this treatment is not mentioned in recent depression guidelines.
In a 2017 overview of the use of biofeedback and neurofeedback in traumatic brain injury, Gray concluded the following, AaANeurofeedback, a type of biofeedback, shows promise in initial research studying its efficacy for treatment of symptoms of TBI. Biofeedback may provide a more concrete, structured approach that might appeal to some populations and/or personality types than others, although the cost of the treatment and equipment, along with the potential for some computer-based interventions to exacerbate symptoms in patients with TBI, may need to be weighed against the potential benefits. Although more research, including blinded randomized controlled trials, is needed on the use of biofeedbackAaaand neurofeedback in particular for TBIAaathe literature suggests that this approach shows promise for treating some symptoms of TBI with this modality. With further advances occurring in technology, including at-home use of neurofeedback devices, preliminary data from the pilot study suggests that survivors of TBI could benefit from improved motivation for treatment and some reduction of symptoms related to attention, mood, and mindfulness with the addition of neurofeedback to mindfulness meditation training. Additional research is needed on the use of neurofeedback, including at-home devices, with veteran populations with brain injuries and should screen for comorbid conditions such as PTSD.AaA
In this case, the patient has a history of anxiety, depression, suicidal ideation, panic attacks, and multiple reported traumatic brain injuries. A review of the literature reveals that there is insufficient data to support quantitative EEG/brain mapping as an effective diagnostic tool or treatment for these conditions. Quantitative EEG/brain mapping is not listed in recent depression guidelines. Therefore, quantitative EEG (brain mapping) performed from 7/02/20 through 8/25/20 was not likely to have been more beneficial than other available standard therapy.
| 0 |
A 37-year-old male enrollee has requested authorization and coverage for Afinitor 5 mg one tablet daily. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees anaplastic ependymoma.
document that this is a patient with refractory ependymoma. The treating provider has recommended treatment with Afinitor. | Upheld | Medical Necessity | Summary Reviewer
A 37-year-old male enrollee has requested authorization and coverage for Afinitor 5 mg one tablet daily. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees anaplastic ependymoma. The physician reviewer found that the records provided for review document that this is a patient with refractory ependymoma. The treating provider has recommended treatment with Afinitor. However, there is a lack of peer-reviewed medical literature supporting the effectiveness of Afinitor in this clinical setting. The available data on the use of Afinitor in patients with ependymoma is not single agent use data. In addition, the available reports are phase 1 data. Moreover, the National Comprehensive Cancer Network (NCCN) guidelines do not include Afinitor as an active agent in the treatment of ependymoma. All told, Afinitor may subject a patient to significant toxicities, which suggests its use should not be performed outside of a clinical trial. Accordingly, the requested Afinitor 5 mg, one tablet daily, is not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 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. | Upheld | Experimental | Summary Reviewer 3
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 review of the submitted documentation and relevant literature fails to support the use of Botox injections in this clinical setting. The documentation submitted for review fails to adequately detail the patients headache symptoms to determine if she has migraine, or cervicogenic headache due to chronic neck issues. There is a lack of documentation to confirm a diagnosis of migraine or chronic migraine. Moreover, the medical literature indicates that Botox is not effective for episodic migraine or cervicogenic headache. In sum, based on the documentation submitted, the Botox injections provided on 7/8/15 and 11/6/15 were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 56-year-old male enrollee has requested reimbursement for DecisionDx Melanoma testing performed on 11/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 56-year-old male enrollee has requested reimbursement for DecisionDx Melanoma testing performed on 11/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node biopsy. There has been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, DecisionDx-Melanoma testing performed on 11/14/18 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 61-year-old female enrollee has requested authorization and coverage for home health aide services eight (8) hours per day three (3) days per week (Monday, Wednesday, Friday). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees hemorrhagic stroke with left-sided hemiparesis.
. This patient has left-sided hemiparesis and sustained a fall resulting in left radial/ulnar fracture which will require surgery. She remains at risk for subsequent falls and requires assistance with all activities of daily living. | Overturned | Medical Necessity | Summary Reviewer
A 61-year-old female enrollee has requested authorization and coverage for home health aide services eight (8) hours per day three (3) days per week (Monday, Wednesday, Friday). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees hemorrhagic stroke with left-sided hemiparesis. The physician reviewer found that per the reviewed literature, a providers orders for services in the plan of care must specify the medical treatments to be furnished as well as the type of home health discipline that will furnish the services and at what frequency the services will be provided. This patients documentation states that the provider noted that health aide services eight hours per day three days per week (Monday, Wednesday, Friday) are medically necessary and reasonable given the patients deficits and complex medical history. This patient has left-sided hemiparesis and sustained a fall resulting in left radial/ulnar fracture which will require surgery. She remains at risk for subsequent falls and requires assistance with all activities of daily living. Given these findings, the requested home health aide services eight (8) hours per day three (3) days per week (Monday, Wednesday, Friday) are supported as medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 57-year-old 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.
in this case, the patient underwent a multilevel cervical discectomy and fusion procedure with instrumentation. Intrao | Upheld | Experimental | Summary Reviewer 2
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 in this case, the patient underwent a multilevel cervical discectomy and fusion procedure with instrumentation. Intraoperative neurophysiologic monitoring was performed during the procedure to include automated nerve conduction testing. There is a lack of large volume, long-term peer-reviewed outcome studies to support the use of this testing. According to the technological review, Morse concluded that the diagnostic accuracy of NC-stat (automated nerve conduction testing) is not yet demonstrated in the scientific literature to be equivalent to traditional or gold-standard testing methods. Moreover, the study by Schmidt and colleagues concluded that the automated device accurately recorded raw data, but the interpretations provided were overly sensitive and lacked the specificity necessary for a screening or diagnostic examination. Therefore, the automated nerve conduction testing performed on 10/20/15 have not been established as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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 |
The patient is a 65-year-old male who has been diagnosed with prostate cancer. The records noted that he has castrate resistant prostate cancer status post systemic therapy using docetaxel, followed by enzalutamide and cabazitaxel. The disease has now progressed and the treating provider ordered a Guardant360 molecular test, which identified a MET proto-oncogene mutation. The treating provider stated that there are preclinical models
. The patient has requested authorization and coverage for Cabometyx (cabozantinib) 60 mg #30/30. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of this patients medical condition. | Upheld | Experimental | Summary Reviewer 2
The patient is a 65-year-old male who has been diagnosed with prostate cancer. The records noted that he has castrate resistant prostate cancer status post systemic therapy using docetaxel, followed by enzalutamide and cabazitaxel. The disease has now progressed and the treating provider ordered a Guardant360 molecular test, which identified a MET proto-oncogene mutation. The treating provider stated that there are preclinical models suggesting that MET proto-oncogene mutations are a good target for cabozantinib. The patient has requested authorization and coverage for Cabometyx (cabozantinib) 60 mg #30/30. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of this patients medical condition. There is a lack of peer reviewed literature to support the requested medication in this clinical setting. As stated by the treating provider, there are preclinical models for potential activity in MET mutations. As such, the use of this therapy, outside of a well conducted clinical trial, is potentially harmful and may not generate meaningful conclusions. In sum, Cabometyx (cabozantinib) 60 mg #30/30 is not likely to be more effective than the available options for treatment of this patients medical condition. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a 12-year-old male enrollee has requested authorization and coverage for Remicade 400 mg for two weeks and then once monthly for one year. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees juvenile dermatomyositis (JDMS). | Overturned | Experimental | Summary Reviewer 3
The parent of a 12-year-old male enrollee has requested authorization and coverage for Remicade 400 mg for two weeks and then once monthly for one year. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees juvenile dermatomyositis (JDMS). The physician reviewer found the requested services are 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 has juvenile dermatomyositis which is moderate to severe and a biologic such as Remicade (infliximab) would likely be beneficial for this patient. Moreover, infliximab has been shown to be safe and effective in children with juvenile dermatomyositis. Riley and colleagues assessed the response of five refractory juvenile dermatomyositis patients to infliximab. The authors reported Improvements in all five patients as shown by positive changes in physician visual analogue scale (VAS), Childhood Myositis Assessment Score (CMAS), Childhood Health Assessment Questionnaire (CHAQ), joint range of movement and, in some, regression of calcinosis and skin signs. There were no major side effects observed with addition of infliximab to the therapeutic regime. For the reasons provided, 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 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. | Overturned | Experimental | Summary Reviewer 3
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 the submitted documentation supports a portion of the services at issue. Specifically, interlaminar epidural steroid injections were likely to have been more beneficial than other treatment options. However, there is a lack of support for transforaminal selective nerve root blocks. The description of these blocks in the operative reports indicates that these blocks were directed towards treating the facet joint pain, which is not the standard approach to the performance of medial branch blocks. The approach and the quantity of medication utilized would likely result in treating much more than just the medial branches, making this non-diagnostic for facet joint syndrome. Even if the medial branch blocks were done in the standard, generally-accepted fashion, combining them with an epidural steroid injection that contained 5cc of bupivacaine and steroid, would make it impossible to differentiate the results of the various injections, thus making the medial branch blocks non-diagnostic. The primary goal of medial branch blocks is to determine whether radiofrequency ablation of the nerves is likely to result in relief of facet joint pain by demonstrating substantial temporary relief of the low back pain. Therefore, interlaminar epidural steroid injections (62311) were likely to have been more beneficial than other treatment modalities. However, the superior efficacy of the remainder of the services at issue has not been established.
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A 45-year-old female enrollee has requested reimbursement for FoundationOne gene testing performed on 3/26/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees adenosarcoma of the cervix.
this patient, she has exhausted conventional therapies, has a rare cancer and maintains a good functional status. | Overturned | Experimental | Summary Reviewer 2
A 45-year-old female enrollee has requested reimbursement for FoundationOne gene testing performed on 3/26/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees adenosarcoma of the cervix. The physician reviewer found the services at issue were likely more effective than any standard tests available for treatment of this patients uterine adenosarcoma. Uterine adenosarcomas are rare and generally treated similar to other endometrial stromal tumors. The prognosis is poor once it metastasizes. For patients with recurrent uterine adenosarcoma, there are few data to guide management. However, in this patient, she has exhausted conventional therapies, has a rare cancer and maintains a good functional status. The medical literature supports molecular testing, such as with FoundationOne, to assist in identifying potential markers to help guide 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.
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The patient is a 15-year-old male with a past psychiatric history of disruptive mood dysregulation disorder, major depressive disorder, and cannabis use disorder. He was admitted to a partial hospitalization program for the treatment of mood dysregulation characterized by anger dyscontrol and physical aggression, mood symptoms, including amotivation, poor concentration, and distractibility, a decline in functioning characterized by failure to attend school for over two months, and ongoing substance use.
The patient has a history of suicidal ideation, mood dysregulation, anger dyscontrol, physical aggression, and property destruction. The patient also struggles with impulse control. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 15-year-old male with a past psychiatric history of disruptive mood dysregulation disorder, major depressive disorder, and cannabis use disorder. He was admitted to a partial hospitalization program for the treatment of mood dysregulation characterized by anger dyscontrol and physical aggression, mood symptoms, including amotivation, poor concentration, and distractibility, a decline in functioning characterized by failure to attend school for over two months, and ongoing substance use. The physician reviewer found that the Child and Adolescent Level of Care Utilization System (CALOCUS) provides a framework for determining the clinically appropriate level of care for a child or adolescent in mental health treatment. Using CALOCUS, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score helps determine the level of care needed.
With regard to 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 suicidal ideation, mood dysregulation, anger dyscontrol, physical aggression, and property destruction. The patient also struggles with impulse control. During the period under review, patient did not exhibit aggression or report suicidal ideation. Given the patientas history, there is some risk of harm.
In terms of function, the records support a score of 2. This dimension assesses the degree to which a person is able to fulfill responsibilities within developmental constraints. During the period under review, the patient exhibited some mild functional impairment in that he continued to struggle with poor frustration tolerance. However, records indicate that he completed routine hygiene, attended and participated (mostly) in groups, and ate regular meals. This is most consistent with mild functional impairment.
With regard to comorbidity, 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 has significant comorbidity as evidenced by a mood disorder and substance use disorder.
In terms of level of stress of the recovery environment, the records support a score of 4. This dimension assesses the stressors in the environment, social circumstances, and interpersonal relationships. The patientas recovery environment appears to be highly stressful. His father died by suicide after his parents separated and were in the midst of a divorce. He does not have a close relationship with his stepfather. The patient also reports a history of abuse.
With regard to level of support of 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. Records provided for the period under review provide limited information regarding environmental support. It appears that the family has engaged in family therapy, which suggests some level of parental involvement and support, but records also intimate problems in the relationship between the patient and his stepfather.
In terms of treatment and recovery history, 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. The patientas previous treatment has included intensive outpatient treatment, which failed to achieve provide optimal control of symptoms. This suggests moderate resiliency and/or response to treatment.
With regard to engagement of the patient, the records support a score of 3. The records indicate that the patient was engaged, cooperative, and participatory during the period under review. However, records also note during this time the patient struggled to accept responsibility for his actions and blamed others. At other times, he was distracted, exhibited poor frustration tolerance, minimized his cannabis use, and engaged in ablack and white thinking.a This suggests incomplete engagement.
Thus, the patient has a composite score of 20, which is consistent with Level 4 Medically Monitored Community Based Services. Therefore, partial hospitalization program services provided from 6/27/20 through 6/29/20 were medically necessary for the treatment of this patient.
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A 39-year-old male enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees gastroesophageal reflux disease (GERD).
44 patients who underwent a laparoscopic surgical procedure for placement of the LINX System around | Upheld | Experimental | Summary Reviewer 3
A 39-year-old male enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found LINX Reflux Management System is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Lipham and colleagues performed a multicenter, prospective, single-arm study that included 44 patients who underwent a laparoscopic surgical procedure for placement of the LINX System around the gastroesophageal junction. The authors demonstrated efficacy up to four years in the reduction of the amount of pathologic esophageal acid exposure. The authors concluded that the magnetic device decreased exposure to esophageal acid, improved reflux symptoms, and allowed cessation of proton-pump inhibitors in the majority of patients. Additionally, the requested procedure is approved by the U.S. Food and Drug Administration (FDA). Based on the support in the medical literature cited above, the requested procedure is likely to 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 19-year-old female enrollee has requested reimbursement for a Papanicolaou (Pap) smear
performed on 1/03/22. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition.
This patient was seen by her provider at 19 years of age, and a Pap smear was
performed. | Upheld | Experimental | Summary Reviewer 2
A 19-year-old female enrollee has requested reimbursement for a Papanicolaou (Pap) smear
performed on 1/03/22. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. The physician
reviewer found that the current medical evidence does not supports the services at issue in this
clinical setting. This patient was seen by her provider at 19 years of age, and a Pap smear was
performed. Pap smear in women under the age of 21 for routine screening is not indicated per
multiple professional organizational opinions. It is not more beneficial for this patient to have a
Pap smear than the standard treatment of waiting to screen for cervical cancer at age 21.
Therefore, the Pap smear performed on 1/03/22 was not likely to have been more beneficial for
evaluation of the patient than any available standard therapy.
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A 43-year-old female enrollee has requested authorization and coverage for right sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. | Upheld | Experimental | Summary Reviewer 2
A 43-year-old female enrollee has requested authorization and coverage for right sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. The physician reviewer found that SI joint fusion has not been demonstrated in the peer-reviewed medical literature to provide superior health outcomes for treatment of low back pain. Overall, long-term outcomes and complications remain unknown. There is a lack of evidence of SI joint instability, fracture, or tumor. This patients records do not support a clinical justification for SI joint fusion. Thus, the requested right SI joint fusion is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 63-year-old male enrollee has requested authorization and coverage for stereotactic body radiotherapy (SBRT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees liver cancer.
The patient presents with a single metastatic lesion in liver. | Overturned | Experimental | Summary Reviewer 3
A 63-year-old male enrollee has requested authorization and coverage for stereotactic body radiotherapy (SBRT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees liver cancer. The physician reviewer found SBRT is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The patient presents with a single metastatic lesion in liver. SBRT has been used to treat primary liver cancer as well as metastatic lesions in liver. There are several clinical published studies to support SBRT for such clinical conditions (Lee, et al). Moreover, the provider documents that the patient is not a candidate for radiofrequency ablation as the lesion is close to vessels. For the reasons provided, 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 61-year-old female enrollee has requested reimbursement for magnetic resonance imaging (MRI) of the head performed on 1/05/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees head pain and traumatic injury. | Upheld | Medical Necessity | Summary Reviewer
A 61-year-old female enrollee has requested reimbursement for magnetic resonance imaging (MRI) of the head performed on 1/05/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees head pain and traumatic injury. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. In this patients case, based on her age and symptoms, it would have been appropriate to perform cross-sectional imaging to exclude a significant brain injury. The American College of Radiology noted although non-contrast head CT is normal in the majority of patients with minor or mild acute closed head injury, it remains the primary modality for detecting clinically relevant brain injuries in this patient population. Though non-contrast head CT has a high negative predictive value in triaging patients, this does not mean that a patient with a negative head CT does not have traumatic brain injury, and neurologically abnormal patients should be followed closely despite a negative head CT. MRI is not indicated as the initial imaging modality in the setting of minor or mild acute closed head injury. However, it may have a role in follow-up imaging. Of note, a small fresh subdural hematoma can occasionally be missed on MRI scans. There is a lack of support for an MRI in this setting, and in a general medical practice, a CT scan is appropriate. Thus, MRI of the head performed on 1/05/18 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld. | 0 |
A 24-year-old female enrollee has requested reimbursement for intensive outpatient program services provided from 9/26/15 through 12/07/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
were intertwined with affective illness, psychosis and character pathology resulting in a complex episode of illness.
documentation provided, the patient remained ill and had not yet consolidated the
. During the disputed service, the patient was engaged in active treatment that included psychotherapy, nutritional counseling services, and psychiatric services including diagnostic evaluation and pharmacotherapy. Despite these interventions, the patient continued to struggle with eating disordered behavior, poor self-esteem, mood symptoms and psychosis. The record described an individual who had not optimized the skills needed to maintain weight and emotional stability in an outpatient based setting prior to the actual discharge date. The patient remained at elevated risk for undue morbidity | Overturned | Medical Necessity | Summary Reviewer
A 24-year-old female enrollee has requested reimbursement for intensive outpatient program services provided from 9/26/15 through 12/07/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. This patients eating disordered behaviors were intertwined with affective illness, psychosis and character pathology resulting in a complex episode of illness. Based on the documentation provided, the patient remained ill and had not yet consolidated the treatment gains necessary to succeed in a less restrictive setting. During the disputed service, the patient was engaged in active treatment that included psychotherapy, nutritional counseling services, and psychiatric services including diagnostic evaluation and pharmacotherapy. Despite these interventions, the patient continued to struggle with eating disordered behavior, poor self-esteem, mood symptoms and psychosis. The record described an individual who had not optimized the skills needed to maintain weight and emotional stability in an outpatient based setting prior to the actual discharge date. The patient remained at elevated risk for undue morbidity and admission to a higher level of care in the absence of intensive outpatient program level of care. The disputed care was reasonably expected to improve her condition and prevent a more serious illness. In sum, the intensive outpatient program services provided from 9/26/15 through 12/07/15 were 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.
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A 64-year-old female enrollee has requested reimbursement and prospective authorization and coverage for inpatient skilled nursing facility care from 2/16/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees medical condition.
On 2/14/16 and 2/15/16, she was requiring extensive assistance for her self-care. She was not ambulating. She had plateaued at requiring about moderate assistance for her transfers. There
. Overall, the patient had health issues and impairments which significantly increased the energy cost of her gait. These deficits severely limited her functional progress | Upheld | Medical Necessity | Summary Reviewer
A 64-year-old female enrollee has requested reimbursement and prospective authorization and coverage for inpatient skilled nursing facility care from 2/16/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. On 2/14/16 and 2/15/16, she was requiring extensive assistance for her self-care. She was not ambulating. She had plateaued at requiring about moderate assistance for her transfers. There is no documentation of any further, significant progress. Overall, the patient had health issues and impairments which significantly increased the energy cost of her gait. These deficits severely limited her functional progress with respect to self-care, transfers and ambulation. Further rehabilitative care as of 2/16/16 and forward could have been provided at a less intensive level of care such as a custodial facility, or home care with custodial level assistance and community-based rehabilitation. Given the patients substantial and chronic impairments and the limited gains achieved to date as of 2/16/16, it would not have been anticipated that she would have made further significant functional gains in a predictable and reasonable timeframe. All told, inpatient skilled nursing facility care from 2/16/16 forward was not and is not medically indicated for the treatment of this patient. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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The parent of a 16-year-old male enrollee has requested authorization and coverage for private duty nursing. The Health Insurer has denied this request and reported that the requested services are not medically necessary for treatment of the enrollee, who has been diagnosed with spinal muscular atrophy.
. He is at risk for aspiration with resultant pneumonia and skin breakdown. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 16-year-old male enrollee has requested authorization and coverage for private duty nursing. The Health Insurer has denied this request and reported that the requested services are not medically necessary for treatment of the enrollee, who has been diagnosed with spinal muscular atrophy. The physician reviewer found the submitted documentation supports the medical necessity of the requested services. Spinal muscular atrophy is an autosomal recessive progressive disorder with multiple phenotypic presentations. Children with this diagnosis are typically severely disabled and wheelchair-bound. Scoliosis and severe gastroesophageal reflux eventually occur, with risk for aspiration, pneumonia, and malnutrition. Intelligence is generally normal. This patient with spinal muscular atrophy has a number of skilled nursing needs as detailed above. He is at risk for aspiration with resultant pneumonia and skin breakdown. He requires aggressive respiratory care, including airway clearance to prevent pneumonia, close observation during feeding to prevent aspiration, and assistance with all aspects of daily living, including application of supplemental oxygen and administration of medications. Based on his current clinical situation, the requested private duty nursing is medically necessary. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 61-year-old female enrollee has requested reimbursement for the molecular profiling lab testing performed on 1/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic carcinoma of unknown primary site. | Upheld | Experimental | Summary Reviewer 1
A 61-year-old female enrollee has requested reimbursement for the molecular profiling lab testing performed on 1/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic carcinoma of unknown primary site. The physician reviewer found thatalthough it is important to determine the tissue of origin so that the proper therapy could be applied, in this case, there were numerous tests ordered piecemeal with no specific rationale. In retrospective studies, molecular profiling based on gene expression has been demonstrated to be highly accurate in determining the tissue of origin (Bender and Erlander). The Pathwork Tissue of Origin test is similar to the test provided in this case, but is strongly supported by a large multicenter clinical trial (Monzon, et al). All told, there was more conventional testing to adequately evaluate this patients CUP and the additional molecular profiling lab testing performed on 1/23/15 was not likely to be more beneficial for evaluation of the patients medical condition than any the available standard tests. Based upon the information set forth above, I have determined the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 46-year-old female who presented to her provider on 8/23/21. The examination
findings included that the patients sensation was grossly intact. The patient has requested
reimbursement for CPT 97016-GP application of vasopneumatic device provided on 9/08/21,
9/09/21, 9/13/21, 9/15/21, 9/20/21, 9/22/21, 9/28/21 and | Upheld | Medical Necessity | Summary Reviewer
The patient is a 46-year-old female who presented to her provider on 8/23/21. The examination
findings included that the patients sensation was grossly intact. The patient has requested
reimbursement for CPT 97016-GP application of vasopneumatic device provided on 9/08/21,
9/09/21, 9/13/21, 9/15/21, 9/20/21, 9/22/21, 9/28/21 and 9/29/21. The physician reviewer
found that the submitted documentation fails to demonstrate the medical necessity of the device
at issue. In a letter dated 8/23/21, the provider cited 33 studies. All journal articles cited were
reviewed. Additionally, an independent literature review was performed. Of the journal articles
provided for review, none discussed the use of vasopneumatic compression for complex regional
pain syndrome. Smart and colleagues recommended a multimodality approach to treat complex
regional pain syndrome. However, despite the numerous treatment options they discuss, they
do not discuss the use of vasopneumatic compression. Similarly, Harden and colleagues do not
mention vasopneumatic compression in the treatment of complex regional pain syndrome. There
is a lack of peer-reviewed published literature that has a control group demonstrating
improvement in complex regional pain syndrome when compared with standard treatment
options. Guidelines support a combination of medication, physical modalities, interventional, and
psychological treatment to address complex regional pain syndrome. There is a paucity of
literature support for the use of vasopneumatic compression for complex regional pain
syndrome. Furthermore, the documents provided indicated that the vasopneumatic
compression was intended to address edema and paresthesia, but neither of these were
identified in the records provided. Therefore, CPT 97016-GP application of vasopneumatic device
provided on 9/08/21, 9/09/21, 9/13/21, 9/15/21, 9/20/21, 9/22/21, 9/28/21 and 9/29/21 was
not medically necessary for the treatment of this patient.
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A 62-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator performed on 7/25/18, 8/25/18 and 9/25/18. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition.
of percutaneous coronary intervention with recent onset symptomatic non-ischemic cardiomyopathy. Catheterization showed a patent left anterior descending artery stent and left ventricular dysfunction out of proportion to his residual mild coronary artery disease, consistent with a new non-ischemic cardiomyopathy. His medical therapy was increased.
. The patient was at risk for malignant arrhythmia and sudden death while his ejection fraction was low. | Overturned | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator performed on 7/25/18, 8/25/18 and 9/25/18. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for the device at issue in this case. The records document a history of percutaneous coronary intervention with recent onset symptomatic non-ischemic cardiomyopathy. Catheterization showed a patent left anterior descending artery stent and left ventricular dysfunction out of proportion to his residual mild coronary artery disease, consistent with a new non-ischemic cardiomyopathy. His medical therapy was increased. There is some likelihood of recovery of left ventricular function in this instance over the initial three-month period with evidence-based medical therapy. Although implantable cardioverter defibrillators have been shown to be beneficial in both ischemic and non-ischemic cardiomyopathy, this patient did not meet criteria for implantable cardioverter defibrillator. The current medical evidence recommends a minimum of three months of evidence-based medical therapy of left ventricular dysfunction, and then reassessment of ejection fraction prior to consideration of implantable cardioverter defibrillator. The patient was at risk for malignant arrhythmia and sudden death while his ejection fraction was low. A wearable cardioverter defibrillator can provide temporary protection from sudden death due to arrhythmia in this patient population during this interim period. Therefore, the wearable cardioverter defibrillator provided on 7/25/18, 8/25/18 and 9/25/18 was likely to have been more effective than other treatment options.
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The patient is a 66-year-old male with a history of leg achiness, tightness, swelling, skin discoloration and heaviness for five years. His body mass index (BMI) is 39. The patient is documented as having worn compression stockings for more than five months without perceived benefit. An ultrasound report noted reflux in the bilateral short saphenous vein (SSV) and reflux in the bilateral medial distal calf perforator veins. The bilateral greater saphenous vein were noted to have been ablated. There was no evidence of deep vein thrombosis (DVT). The provider recommended radiofrequency ablation of bilateral SSV and bilateral medial distal calf perforator veins as well as ultrasound guided injections of varicose vein tributaries. The patient has requested authorization and coverage for endovenous vein ablation. The Health Insurer has denied this request indicating that the requested services are considered investigational. | Upheld | Experimental | Summary Reviewer 2
The patient is a 66-year-old male with a history of leg achiness, tightness, swelling, skin discoloration and heaviness for five years. His body mass index (BMI) is 39. The patient is documented as having worn compression stockings for more than five months without perceived benefit. An ultrasound report noted reflux in the bilateral short saphenous vein (SSV) and reflux in the bilateral medial distal calf perforator veins. The bilateral greater saphenous vein were noted to have been ablated. There was no evidence of deep vein thrombosis (DVT). The provider recommended radiofrequency ablation of bilateral SSV and bilateral medial distal calf perforator veins as well as ultrasound guided injections of varicose vein tributaries. The patient has requested authorization and coverage for endovenous vein ablation. The Health Insurer has denied this request indicating that the requested services are considered investigational. Consensus indications for radiofrequency ablation include venous diameter within 2-20 mm, reflux time of 0.5 or more seconds, and distance from the skin 5 or more mm, or subfascial location. There are insufficient level 1 or level 2 studies in the literature to demonstrate that radiofrequency ablation of perforators is appropriate and a lack of evidence to support perforator surgery in the absence of stage 5 and 6 chronic venous disease. Overall, the current guidelines do not support the requested endovenous vein ablation for treatment of this patients medical condition. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 56-year-old female enrollee has requested authorization and coverage for biliopancreatic bypass with duodenal switch (CPT code 43845). The Health Insurer has denied this request indicating that requested procedure is considered investigational for treatment of the enrollee, who has a history of morbid obesity and type 2 diabetes. | Upheld | Experimental | Summary Reviewer 2
A 56-year-old female enrollee has requested authorization and coverage for biliopancreatic bypass with duodenal switch (CPT code 43845). The Health Insurer has denied this request indicating that requested procedure is considered investigational for treatment of the enrollee, who has a history of morbid obesity and type 2 diabetes. The physician reviewer found that the documentation provided does not support the superior efficacy of the requested procedure in this clinical setting. It is not clear from the record whether this patient may benefit from conversion from sleeve gastrectomy to duodenal switch. The conversion cannot be determined without ensuring that this patient has been adequately evaluated and prepared for the different nutritional consequences ,including the need for fat soluble vitamins. The records provided do not document that this patient has been assessed behaviorally as to the increased potential risks related to re-operative surgery or that she has been deemed an appropriate candidate for the requested procedure. Both nutritional and psychological evaluations should be initiated. Therefore, biliopancreatic bypass with duodenal switch (CPT code 43845) is not likely to be superior to the available methods of treating this patients medical condition. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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patient is a 56-year-old female. The patient has requested authorization and coverage for
transcranial magnetic stimulation (TMS) treatment services. The Health Insurer has denied this
request and reported that the requested services are not medically necessary for the treatment of
this patient.
In this
case, the patient has tried and failed first-line medications including fluoxetine, sertraline, and
fluvoxamine, as well as clomipramine, a second-line agent. The patient has also tried and failed
duloxetine and escitalopram. From a therapy standpoint, the patient has failed CBT and exposure
therapy; both in combination with medications. The patient's | Overturned | Medical Necessity | Summary
The patient is a 56-year-old female. The patient has requested authorization and coverage for
transcranial magnetic stimulation (TMS) treatment services. The Health Insurer has denied this
request and reported that the requested services are not medically necessary for the treatment of
this patient. This denial is the subject of this appeal and determination. The physician reviewer found
that the submitted documentation supports the medical necessity of the requested services. In this
case, the patient has tried and failed first-line medications including fluoxetine, sertraline, and
fluvoxamine, as well as clomipramine, a second-line agent. The patient has also tried and failed
duloxetine and escitalopram. From a therapy standpoint, the patient has failed CBT and exposure
therapy; both in combination with medications. The patient's OCD symptoms are chronic, severe,
and resistant to treatment. Given that current medical literature supports the use of the TMS as an
evidence-based intervention for selected, treatment-resistant patients such as in this clinical setting,
the requested services are medically indicated. Therefore, TMS treatment services are medically
necessary for the treatment of this patient.
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A 34-year-old female enrollee has requested reimbursement for emergency room services provided on 12/22/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found that this patient presented with low back pain described as spasms. Her pain was not sudden in onset, but had commenced three days prior. The patient had not sustained any recent trauma. She denied any systemic symptoms. The patient was not experiencing any acute neurologic deficit. | Upheld | Medical Necessity | Summary Reviewer
A 34-year-old female enrollee has requested reimbursement for emergency room services provided on 12/22/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found that this patient presented with low back pain described as spasms. Her pain was not sudden in onset, but had commenced three days prior. The patient had not sustained any recent trauma. She denied any systemic symptoms. The patient was not experiencing any acute neurologic deficit. Because this patients back pain was not acute in nature and was without any systemic symptoms or deficits, it does not meet prudent layperson criteria for an emergency. The patients symptoms on 12/22/17 did not meet prudent layperson criteria for emergency care. A prudent layperson in the patients circumstances would not reasonably expect the absence of emergency care to jeopardize his or her health. Therefore, the Health Insurers denial should be upheld. | 1 |
The parent of 10-year-old male enrollee has requested reimbursement for biofeedback treatment services provided from 3/05/18 through 5/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
The parent of 10-year-old male enrollee has requested reimbursement for biofeedback treatment services provided from 3/05/18 through 5/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this patients case. Biofeedback/neurofeedback is not generally recognized for the treatment of attention deficit/hyperactivity disorder. Holtmann and colleagues reported stringent meta-analysis of eight randomized controlled trials published in 2013 found that the effects were stronger for unblinded measures and three recent subsequently published well-controlled trials found no effects for the most blinded attention deficit/hyperactivity disorder outcome. Firmer conclusions must await upcoming evidence from larger controlled studies and future meta-analyses contrasting different forms of neurofeedback and different outcome measures. In a meta-analysis by Cortese and colleagues, the authors concluded that the evidence currently fails to support neurofeedback as an effective treatment for attention deficit/hyperactivity disorder. The authors noted future efforts should focus on implementing standard neurofeedback protocols, ensuring learning, and optimizing clinically relevant transfer. In sum, biofeedback treatment services provided from 3/05/18 through 5/14/18 was not likely to have been superior over other treatment options.
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A 50-year-old female enrollee has requested authorization and coverage for ultrasound ablation. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees uterine fibroids. | Upheld | Experimental | Summary Reviewer 2
A 50-year-old female enrollee has requested authorization and coverage for ultrasound ablation. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees uterine fibroids. The physician reviewer found the two most common symptoms of uterine fibroids are abnormal uterine bleeding and pelvic pressure. The most common kind of abnormal bleeding associated with leiomyomas is heavy or prolonged menstrual bleeding. Hysterectomy remains the most common surgical treatment for fibroids because it is the only definitive treatment that eliminates the possibility of recurrence. HIFU is a noninvasive approach uses high-intensity ultrasound waves directed into a focal volume of a leiomyoma. The ultrasound energy penetrates soft tissue and produces well-defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis. Although short-term studies show safety and efficacy, long-term studies are needed. There is a lack of well-designed clinical studies evaluating the safety and efficacy of HIFU using relevant outcome measures are lacking. Studies have generally lacked comparison to the currently accepted treatments of uterine myomas (Chittawar and Kamath). In addition, the published evidence regarding HIFU does not adequately address the potential for regrowth of treated myomas over time, especially beyond three years. In conclusion, given the lack of well-designed randomized controlled trials with adequate follow-up periods and appropriate outcome measure, ultrasound ablation has not been established as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 61-year-old male enrollee has requested authorization and coverage for Androgel. 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 patient has symptoms of hypogonadism and one test result available consistent with low testosterone level.
The patient is on Proscar, which is a medication for treatment of enlarged prostate and benign pros | Upheld | Medical Necessity | Summary Reviewer
A 61-year-old male enrollee has requested authorization and coverage for Androgel. 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 in this case, the patient has symptoms of hypogonadism and one test result available consistent with low testosterone level. The records do not document a second test confirming the low testosterone. The records do not document whether there was a diagnostic work-up for hypogonadism, such as determining whether it is primary or secondary. The records do not show whether this patient has been counseled regarding the possible side effects of testosterone replacement, or that he is being monitored. It is recommended that complete blood count, a prostate-specific antigen (PSA) level or a prostate examination be done prior to starting therapy and to monitor after initiation of testosterone. The patient is on Proscar, which is a medication for treatment of enlarged prostate and benign prostatic hyperplasia. It is well-documented that testosterone replacement might contribute to prostate cancer. Therefore, patients at risk for prostate cancer should avoid testosterone replacement therapy and should be evaluated by a urologist. Thus, Androgel is not medically necessary for the treatment of this patient. | 1 |
A 19-year-old male enrollee has requested reimbursement for residential treatment services provided from 11/13/14 through 12/22/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
anxiety agents, the patient was irritable and anxious with poor eye contact, limited insight and a blunted affect. He endorsed somatic delusions of having toxins in his body, which was likely an extension of his assertion that he had an eating disorder. He also complained of chronic headaches and gastrointestinal distress. During the disputed course of treatment, the patient demonstrated signs of clinical improvement and was engaged in active treatment. Regarding the former, the patient was described by nursing as anxious and isolative with ongoing bodily concerns and affective restriction. However, in mid-December 2014, the patient started to appear more positive, more relaxed and more social, which | Overturned | Medical Necessity | Summary Reviewer
A 19-year-old male enrollee has requested reimbursement for residential treatment services provided from 11/13/14 through 12/22/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found in this patients case, despite pharmacotherapy with antipsychotic and antianxiety agents, the patient was irritable and anxious with poor eye contact, limited insight and a blunted affect. He endorsed somatic delusions of having toxins in his body, which was likely an extension of his assertion that he had an eating disorder. He also complained of chronic headaches and gastrointestinal distress. During the disputed course of treatment, the patient demonstrated signs of clinical improvement and was engaged in active treatment. Regarding the former, the patient was described by nursing as anxious and isolative with ongoing bodily concerns and affective restriction. However, in mid-December 2014, the patient started to appear more positive, more relaxed and more social, which is consistent with the consolidation of treatment gains. In terms of treatment, the patient benefited from milieu, group, individual and family therapies on the unit. His diagnostic assessment, which had included multiple rule outs upon admission, was determined with far greater certainty. The services provided during the disputed timeframe were for active treatment and were reasonably expected to improve his condition and prevent a more serious episode of illness. Thus, residential treatment services provided from 11/13/14 through 12/22/14 were 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.
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A 63-year-old male enrollee has requested reimbursement for the Foundation One test performed on 3/13/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees metastatic poorly differentiated carcinoma. | Upheld | Experimental | Summary Reviewer 3
A 63-year-old male enrollee has requested reimbursement for the Foundation One test performed on 3/13/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees metastatic poorly differentiated carcinoma. The physician reviewer found that the Foundation One test analyzes 200 oncogenes and tumor suppressor genes for mutations by next generation sequencing. The results can assist providers in selecting treatment towards these mutations. Von Hoff and colleagues reported on a study of 86 patients where the progression free survival (PFS) on regimen selected by molecular profiling was compared to PFS on the last chemotherapy regimen. The authors found that the regimen selected by molecular profiling offered a 27% survival advantage. Two clinical trials compared cabozantinib to placebo and showed that the drug extended PFS, decreased opiate use in patients, treated soft tissue and bone lesions, and decreased markers of bone turnover (Smith, et al; Goodin and DiPaola). Given this support, the Foundation One test provided on 3/13/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 56-year-old female enrollee has requested reimbursement for Oncotype DX colon cancer assay completed on 8/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. | Overturned | Experimental | Summary Reviewer 1
A 56-year-old female enrollee has requested reimbursement for Oncotype DX colon cancer assay completed on 8/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that there is support in the medical literature for the services at issue in this clinical setting. Oncotype DX assay is a 12 gene panel that predicts the risk of recurrence in both stage II and III colon cancer (Yothers, et al; Yamanaka, et al). Moreover, a review by You and colleagues supported the use of Oncotype assay in the decision about adjuvant chemotherapy. Most oncologists make this decision based on specific pathologic and clinical features in an individual's situation. Among those features that predict for a higher risk of recurrence are poorly differentiated histology, lymphovascular invasion, presentation with obstruction or perforation, or a T4 tumor. Of these features, only the fact that there was perforation at the time of diagnosis is applicable in this patients case. This factor alone does suggest the possible need for adjuvant chemotherapy. This test is useful in a situation wherein there is an adverse feature (perforation), upon which to base the decision for chemotherapy. All told, the use of Oncotype DX colon cancer assay completed on 8/19/15 was likely to be more effective than the standard options for the evaluation of this patient. Therefore, for the reasons stated 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 63-year-old female enrollee has requested reimbursement for breast tomosynthesis (three-dimensional mammogram) performed on 10/31/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. | Overturned | Experimental | Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for breast tomosynthesis (three-dimensional mammogram) performed on 10/31/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that there is sufficient support for the service at issue in this patients case. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and increase in diagnostic accuracy and detection of small cancers compared to two-dimensional imaging alone. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had her examination been done with two-dimensional imaging alone. In sum, breast tomosynthesis (three-dimensional mammogram) performed on 10/31/16 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.
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A 56-year-old male enrollee has requested reimbursement for DecisionDX-Melanoma test performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma] | Upheld | Experimental | Summary Reviewer 2
A 56-year-old male enrollee has requested reimbursement for DecisionDX-Melanoma test performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma] The physician reviewer found the current standard of care, based on National Comprehensive Cancer Network Guidelines (NCCN) guidelines, uses the tumor node metastasis (TNM) cancer staging system to determine a recommendation for additional imaging tests or for additional treatment. The NCCN guidelines state that there is an interest in newer prognostic molecular techniques such as gene expression profiling to determine low versus high risk for metastases. However, routine baseline genetic testing of primary cutaneous melanoma is not recommended outside of a clinical trial. As such, in this patients case, the use of DecisionDX-Melanoma assay was not likely to be more effective than available standard staging systems for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 36-year-old female enrollee has requested authorization and coverage for Flex Walk System and multiaxial rotation unit for right leg. The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollees bilateral transtibial amputation. | Overturned | Medical Necessity | Summary Reviewer
A 36-year-old female enrollee has requested authorization and coverage for Flex Walk System and multiaxial rotation unit for right leg. The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollees bilateral transtibial amputation. The physician reviewer found that in this case, the patients functional condition is expected to increase by two categories with the addition of the new components. As noted by Armannsdottir and colleagues, following transfemoral amputation numerous changes in movement patterns during gait can occur. The authors reported that six weeks of individualized training with a microprocessor controlled prosthetic foot with active/inactive ankle dorsiflexion resulted in improved gait quality. The requested equipment is expected to allow complete independent function in all ambulatory environments. Given this support, the requested Flex Walk System and multiaxial rotation unit for right leg is supported as medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested equipment is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
The parent of a 17-year-old male enrollee has requested reimbursement for adolescent mental health residential treatment services with New Vision Wilderness, an out-of-state wilderness program, provided from 11/01/19 through 2/10/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.
. The patient had serious risk of harm, due to significant impulsivity, with poor judgment and insight, and this was significantly endangering to himself or others. He had been punching walls, hitting mother and transport team member. In terms of functional status, the records support a score of 4. The patient had serious functional impairment, due to serious deterioration of interpersonal interactions, with consistent conflict as well as sporadic school attendance.
. The patient had uncontrolled substance use that posed a serious threat to
The patient had a moderately stressful environment, due to estrangement from his father, conflict with his mother, and school difficulties.
The patients mother was involved in treatment and treatment planning. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement for adolescent mental health residential treatment services with New Vision Wilderness, an out-of-state wilderness program, provided from 11/01/19 through 2/10/20. 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 Child and Adolescent Level of Care Utilization System (CALOCUS) provides a framework for determining the clinically appropriate level of care for a child or adolescent in mental health treatment. With regard to risk of harm, the records support a score of 4. The patient had serious risk of harm, due to significant impulsivity, with poor judgment and insight, and this was significantly endangering to himself or others. He had been punching walls, hitting mother and transport team member. In terms of functional status, the records support a score of 4. The patient had serious functional impairment, due to serious deterioration of interpersonal interactions, with consistent conflict as well as sporadic school attendance. With regard to comorbidity, the records support a score of 4. The patient had uncontrolled substance use that posed a serious threat to health. In terms of level of environmental stress, the records support a score of 3. The patient had a moderately stressful environment, due to estrangement from his father, conflict with his mother, and school difficulties. With regard to level of support of the recovery environment, the records support a score of 2. The patients mother was involved in treatment and treatment planning. In terms of resiliency and treatment history, the records support a score of 3. The patient had a lack of improvement at lower levels of care, and refused to attend intensive outpatient program treatment. With regard to treatment acceptance and engagement, the records support a score of 3. The patient was incompletely engaged, due to minimization of the problems caused by his substance abuse, refusal to participate in intensive outpatient program, and initial resistance to being transported to the wilderness program. Therefore, the patient has a total score of 23. Due to serious risk of harm, the recommended level of care is medically monitored residence-based services. In this case, the therapeutic services offered at the wilderness program (individual and group therapy) are not different from those offered at other residential treatment programs. The fact that they took place in a wilderness milieu does not mean that they are not evidence-based. Therefore, adolescent mental health residential treatment services with New Vision Wilderness, an out-of-state wilderness program, provided from 11/01/19 through 2/10/20 were medically necessary for the treatment of this patient. | 1 |
The patient is a 44-year-old female who has a personal history of several malignancies including bilateral invasive lobular breast cancer at age 42, non-Hodgkins lymphoma in 1997, thyroid cancer in 1998, and a mucoepidermoid carcinoma of the trachea in 2009. Her family history is significant for a sister with thyroid cancer at age 34. The records noted a sister was diagnosed with non-Hodgkins lymphoma at 42. Her paternal grandmother was diagnosed with uterine cancer in her 60s, her mother was diagnosed with thyroid cancer at 66, two maternal cousins were diagnosed with thyroid cancer, and a maternal uncle was diagnosed with leukemia at age 18. The patient has requested reimbursement for gene testing performed on 11/28/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. This patient has an extensive personal history of cancer, including breast cancer before the age of 50 that was bilateral. Her family history is also suggestive of a familial genetic predisposition to thyroid cancer on the maternal side. | Overturned | Experimental | Summary Reviewer 1
The patient is a 44-year-old female who has a personal history of several malignancies including bilateral invasive lobular breast cancer at age 42, non-Hodgkins lymphoma in 1997, thyroid cancer in 1998, and a mucoepidermoid carcinoma of the trachea in 2009. Her family history is significant for a sister with thyroid cancer at age 34. The records noted a sister was diagnosed with non-Hodgkins lymphoma at 42. Her paternal grandmother was diagnosed with uterine cancer in her 60s, her mother was diagnosed with thyroid cancer at 66, two maternal cousins were diagnosed with thyroid cancer, and a maternal uncle was diagnosed with leukemia at age 18. The patient has requested reimbursement for gene testing performed on 11/28/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. This patient has an extensive personal history of cancer, including breast cancer before the age of 50 that was bilateral. Her family history is also suggestive of a familial genetic predisposition to thyroid cancer on the maternal side. More than one gene could explain the patients genetic risk of cancer. If a gene is identified, this could help guide prevention and treatment strategies. This patient meets criteria for BRCA1 and BRCA2 testing. The largest studies reporting on the outcomes of multigene testing indicate that among women tested in clinical settings, about 5 to 10 percent have a BRCA1 or BRCA2 mutation, and about 4 to 7 percent have a harmful mutation in another gene associated with high to moderate risks of breast and/or ovarian cancer, or a mutation in a newer gene that may also be associated with increased risks for these cancers. She also has a significant family history, and testing positive for a mutation would guide additional therapy, such as mastectomy or oophorectomy as well as how to manage her screening for another breast cancer or other cancer. The medical evidence supports the services at issue in this clinical setting. All told, gene testing performed on 11/28/16 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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An 18-year-old female enrollee has requested reimbursement for residential mental health treatment provided from 4/01/14 through 5/20/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
. She had no substance abuse problems. She was engaged and an active participant in the treatment process. She was independent in her activities of daily living, and there were no cognitive difficulties. Her parents were active participants in the family process. The patient did not require 24-hour supervision in the restricted setting of residential. | Upheld | Medical Necessity | Summary Reviewer
An 18-year-old female enrollee has requested reimbursement for residential mental health treatment provided from 4/01/14 through 5/20/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found there is a lack of support for the services at issue in this patients case. She had no substance abuse problems. She was engaged and an active participant in the treatment process. She was independent in her activities of daily living, and there were no cognitive difficulties. Her parents were active participants in the family process. The patient did not require 24-hour supervision in the restricted setting of residential. Although she required treatment, her medication management and other treatment could have been conducted at a lower level of care. There was no documentation as to the patients response to medications or assessment for side effects. There was no comprehensive intake, history and physical, or initial psychiatric evaluation. Overall, the documentation was inadequate to support the medical necessity for 24-hour supervised care in a residential setting. In sum, residential mental health treatment provided from 4/01/14 through 5/20/15 were not medically indicated 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.
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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 records document cerebral palsy and constipation refractory to medical management. The patient has tried several medications and cleanouts, without success. | Overturned | Experimental | Summary Reviewer 2
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 there is sufficient support for the requested services in this clinical setting. The records document cerebral palsy and constipation refractory to medical management. The patient has tried several medications and cleanouts, without success. This treatment is commonly used in motility centers for children with difficulty stooling due to problems relaxing the muscles. Studies have shown that it can be safe and effective for constipation that is difficult to treat. Therefore, J0585 - Botox 100 units are likely to be more beneficial than any available standard therapy.
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A 59-year-old male has requested authorization and coverage for CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease. | Upheld | Experimental | Summary Reviewer 3
A 59-year-old male has requested authorization and coverage for CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease. The physician reviewer found that appropriate patient selection is crucial before anti-reflux procedures. Transoral incisionless fundoplication has shown durable response for a select population of gastroesophageal reflux disease patients. However, the severity of this patients esophageal dysmotility disqualifies him as an ideal candidate for the proposed transoral incisionless fundoplication procedure. As such, CPT 43210 (transoral incisionless fundoplication procedure utilizing the EsoPhyx device) is not likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 10-month-old female enrollee has requested authorization and coverage for lansoprazole. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition.
This patient has been diagnosed with gastroesophageal reflux disease. On 1/07/19, while the patient was on lansoprazole, the provider suggested a trial of hypoallergenic formula. The provider also recommended gastroenterology evaluation. On 2/15/19, the records noted that that the patient was intolerant of the hypoallergenic formula. | Upheld | Experimental | Summary Reviewer 2
The parent of a 10-month-old female enrollee has requested authorization and coverage for lansoprazole. 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 that there is a lack of support for the requested medication in this clinical setting. This patient has been diagnosed with gastroesophageal reflux disease. On 1/07/19, while the patient was on lansoprazole, the provider suggested a trial of hypoallergenic formula. The provider also recommended gastroenterology evaluation. On 2/15/19, the records noted that that the patient was intolerant of the hypoallergenic formula. However, the records do not provide additional details regarding the symptoms of intolerance. Proton pump inhibitor therapy is recommended in infants only when there are findings of erosive esophagitis or in the presence of certain anatomic abnormalities (such as repaired tracheoesophageal fistula/esophageal atresia). Given that esophagitis was not documented in this case, lansoprazole is not likely to be more effective than other treatment options.
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A 61-year-old female enrollee has requested authorization and coverage for a series of left knee Synvisc One injections. The Health Plan has denied this request and reported that the requested services are not medically necessary for treatment of the enrollees osteoarthritis.
This patient presents with chronic left knee pain with intermittent swelling, grinding, and instability. She is status post ACL reconstruction. She reports functional difficulty interfering with her work ability. She had failed reasonable conservative treatment, including medications, corticosteroid injections and physical therapy. Criteria | Upheld | Medical Necessity | Summary Reviewer
A 61-year-old female enrollee has requested authorization and coverage for a series of left knee Synvisc One injections. The Health Plan has denied this request and reported that the requested services are not medically necessary for treatment of the enrollees osteoarthritis. The physician reviewer found that current evidence-based guidelines recommend hyaluronic acid injections in the knee as a possible option for patients with osteoarthritis who have not responded adequately to recommended conservative treatments for at least three months, including failure to adequately respond to aspiration and injection of intra-articular steroids. Guidelines support hyaluronic acid injections to potentially delay total knee replacement for patients with pain that interferes with functional activities. Guidelines state that there is no maximum amount of injections established by high quality scientific evidence, nor is one type of viscosupplementation supported over another. This patient presents with chronic left knee pain with intermittent swelling, grinding, and instability. She is status post ACL reconstruction. She reports functional difficulty interfering with her work ability. She had failed reasonable conservative treatment, including medications, corticosteroid injections and physical therapy. Criteria have been met for the use of viscosupplementation for this patients medical condition. However, current evidence-based guidelines and peer-reviewed literature indicate that there is a general lack of reliable evidence that any specific brand is superior to others. There is no compelling rationale presented to support the medical necessity of Synvisc One as the initial viscosupplementation agent. Therefore, the requested series of left knee Synvisc One injections is not medically necessary 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. | 1 |
The patient is a 54-year-old female who presented to her provider on 10/12/21 for evaluation
of chronic neck pain. The patient has requested reimbursement for code 01936-QZ 20 units
anesthesia for percutaneous image guided procedures on the spine and spinal cord performed
on 11/04/21.
the patient was required to undergo a cervical transforaminal
epidural steroid injection as per recommendations of her neurosurgeon. She has confirmed
needle phobia and anxiety that required previous anesthetic care during those procedures.
Furthermore, | Overturned | Medical Necessity | Summary Reviewer
The patient is a 54-year-old female who presented to her provider on 10/12/21 for evaluation
of chronic neck pain. The patient has requested reimbursement for code 01936-QZ 20 units
anesthesia for percutaneous image guided procedures on the spine and spinal cord performed
on 11/04/21. The physician reviewer found that the 2019 American Society of Interventional
Pain Physicians (ASIPP) guidelines on procedural sedation state, Given that patients
undergoing pain procedures typically are anxious and in pain, mild to moderate sedation is
acceptable for many patients. The authors went on to further state, "Deeper sedation should
only be undertaken in the presence of anesthesia providers and for patients who have high
anxiety, complex pharmacotherapy, or a low pain threshold when undergoing more painful
interventional pain procedures. In special cases, the risk of patient movement during a
procedure resulting in potential inadvertent injury may justify a deeper anesthetic state. The
2016 American Society of Anesthesiologists (ASA) Statement on Anesthetic Care During
Interventional Pain Procedures for Adults states, Patient anxiety and/or medical comorbidities
may be an indication for moderate (conscious) sedation or anesthesia care team services. In
addition, procedures that require the patient to remain motionless for a prolonged period of
time and/or remain in a painful position may require moderate sedation or anesthesia care
team services. In this case, the patient was required to undergo a cervical transforaminal
epidural steroid injection as per recommendations of her neurosurgeon. She has confirmed
needle phobia and anxiety that required previous anesthetic care during those procedures.
Furthermore, the cervical transforaminal injection inherently carries a great deal of risk of
intravascular injection, nerve root injury, seizure, stroke and paralysis. Based on the presence of
pre-existing anxiety, needle phobia, and danger associated with movement in this procedure,
the anesthesia used for the procedure was medically necessary. Therefore, code 01936-QZ 20
units anesthesia for percutaneous image guided procedures on the spine and spinal cord
performed on 11/04/21 was medically necessary for the treatment of this patient.
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A 20-year-old male enrollee has requested authorization and coverage for chondrocyte implantation with Denovo. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
The patient is skeletally mature and he has had localized knee pain for greater than six months. The lesion present appears to be discreet and single and does not include evidence for a kissing lesion. | Upheld | Experimental | Summary Reviewer 1
A 20-year-old male enrollee has requested authorization and coverage for chondrocyte implantation with Denovo. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation supports the superior efficacy of the requested services. The patient is skeletally mature and he has had localized knee pain for greater than six months. The lesion present appears to be discreet and single and does not include evidence for a kissing lesion. No systemic arthritic conditions have been diagnosed. When nonsurgical treatment has become ineffective for patellofemoral osteoarthritis, other procedures are appropriate. Depending upon the specific findings for a given patient, these procedures may include soft tissue realignment either through lateral release or tubercle transfer and/or autologous chondrocyte implantation for focal cartilage defects. The specific combination of realignment procedures and cartilage resurfacing procedures depend upon the clinical problems presented to the surgeon. While additional lesions including trochlear lesions may not necessarily rule out cartilage transplantation, this patient does not have a trochlear lesion by either direct inspection on arthroscopy or indirect visualization through MRI. This increases the likelihood that a satisfactory clinical result will be obtained. Given this patients young age, if the lesion is not addressed then there will be progressive deterioration of the patellofemoral joint. All told, the requested chondrocyte implantation with Denovo is likely to be more efficacious than other treatment alternatives. 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.
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A 49-year-old female enrollee has requested authorization and coverage for Ubrelvy. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
this patient has a history of chronic migraine, and she has failed traditional migraine treatments. The provider notes that the patient had modest benefit with the use of triptan medications. | Overturned | Medical Necessity | Summary Reviewer
A 49-year-old female enrollee has requested authorization and coverage for Ubrelvy. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient has a history of chronic migraine, and she has failed traditional migraine treatments. The provider notes that the patient had modest benefit with the use of triptan medications. The current method of treating intractable migraine headaches, especially during acute attacks, is the use of medications with various mechanisms of action. Since triptans are somewhat effective for this patient, the use of a calcitonin gene-related peptide (CGRP) antagonist such as Ubrelvy is likely to provide added benefit, since there is a different mechanism of action. There is sufficient support for the requested medication in this clinical setting. Therefore, Ubrelvy is medically necessary for the treatment of this patient. | 1 |
The parent of a 16-year-old female enrollee has requested reimbursement for mental health inpatient treatment provided from 11/24/15 through 11/30/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
On 11/24/15, the patients Zoloft and Abilify dosages were increased, as she was still depressed. Furthermore, she had been placed on one to one staffing because of self-abusing. The records reflect that the patient was still unstable.
the patients recent history of decompensation after stepping down for only a few days to PHP | Overturned | Medical Necessity | Summary Reviewer
The parent of a 16-year-old female enrollee has requested reimbursement for mental health inpatient treatment provided from 11/24/15 through 11/30/15. 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 the submitted documentation demonstrates the medical necessity of the services at issue.
On 11/24/15, the patients Zoloft and Abilify dosages were increased, as she was still depressed. Furthermore, she had been placed on one to one staffing because of self-abusing. The records reflect that the patient was still unstable. The submitted documentation supports the continuation of this patients inpatient treatment in order to stabilize her prior to discharge. In addition, the patients recent history of decompensation after stepping down for only a few days to PHP further increased the likelihood of a relapse if she were discharged from acute care prematurely. All told, the services at issue were medically prudent and necessary in the treatment of the patients behavioral health condition. The Health Insurers denial should be overturned.
| 1 |
patient is a 66-year-old female with a history of spondylolisthesis of the lumbar region, lumbar
post-laminectomy syndrome, lumbar radiculitis, and lumbar degenerative disc disease. The patient
has requested arthrodesis of the SI joint, percutaneous, or minimally invasive, for the treatment of
her back pain. The Health Insurer has denied the requested service as not medically necessary for
the treatment of the patients medical condition.
the patients CT scan on 9/29/22 did demonstrate mild bilateral SI joint degenerative
changes, | Upheld | Medical Necessity | Summary
The patient is a 66-year-old female with a history of spondylolisthesis of the lumbar region, lumbar
post-laminectomy syndrome, lumbar radiculitis, and lumbar degenerative disc disease. The patient
has requested arthrodesis of the SI joint, percutaneous, or minimally invasive, for the treatment of
her back pain. The Health Insurer has denied the requested service as not medically necessary for
the treatment of the patients medical condition. This denial is the subject of this appeal and
determination. The physician reviewer found that the records provided for review fail to
corroborate a diagnosis of SI joint pain for this patient. According to Lorio and colleagues, SI
joint pain diagnosis is typically accomplished via a clinical diagnostic algorithm involving history,
physical exam, diagnostic block, and ruling out other pain contributors. Patients with SI joint pain
typically report pain in the buttock(s), with possible radiation into the groin or upper legs.
Although the patients CT scan on 9/29/22 did demonstrate mild bilateral SI joint degenerative
changes, Lorio and colleagues further noted that, No specific imaging modality has demonstrated
acceptable sensitivity and specificity in the diagnosis of noninflammatory, nontraumatic SI joint
pain, including plain radiographs, CT, magnetic resonance imaging, and radionucleotide studies.
In this case, multiple other plausible pain generators, including at the lumbosacral spine, are
evident. Furthermore, per Shamrock and colleagues, Minimally invasive SI joint fusion is a
relatively safe procedure but is not without certain risks. Further work must be done to optimize
the procedure's complication profile. The records provided for review indicate that this patient
presents with ongoing low back pain and a history of spondylolisthesis of the lumbar region,
lumbar post-laminectomy syndrome, lumbar radiculitis, and lumbar degenerative disc disease.
However, there is a lack of documentation reporting a diagnosis of SI joint pain for this patient.
Overall, there is limited medical literature indicating that arthrodesis of the SI joint, percutaneous
or minimally invasive is an effective and/or safe treatment for the patients pathology. For these
reasons, the requested arthrodesis, SI joint, percutaneous, or minimally invasive (CPT 27279 RT)
is not medically necessary for the treatment of this patient.
| 1 |
A 49-year-old female has requested authorization and coverage for 22857 [total disc
arthroplasty (artificial disc), two-day inpatient stay]. The Health Insurer has
denied this request and reported that the requested services are investigational for
the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 49-year-old female has requested authorization and coverage for 22857 [total disc
arthroplasty (artificial disc), two-day inpatient stay]. 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 U.S. Food and Drug Administration (FDA) approves the use of ProDisc-L total disc
replacement for treatment of up to two consecutive lumbar spinal sections (levels)
from L3-S1. Indications for this device include: patients who are skeletally mature
with no spinal growth remaining; patients who have a condition in which pain is
caused by wear-and-tear on a spinal disc, such as degenerative disc disease, at one
or two consecutive levels in the lumbar spine from L3-S1; patients with no more than
25% of the affected vertebral disc having slipped forward out of the proper position
(grade 1 spondylolisthesis); and patients who have no relief from pain after at
least six months of non-surgical treatment. The FDA notes that contraindications
include infection at the implant location or elsewhere; osteopenia or osteoporosis
with a T-score bone density measurement of the less than -1.0; narrowing of the
lumbar bones that puts pressure on the spinal cord and nerves; allergy or
sensitivity to the implant materials such as cobalt, chromium, molybdenum,
polyethylene, titanium; compression syndromes due to herniated disc; stress fracture
in the lumbar spine; an affected vertebral endplate that is smaller than 34.5 mm
when measured form the middle of the disc to the side of the disc and/or 27 mm when
measured from the front of the disc to the back of the disc; current or past damage
to the affected disc; and spondylolisthesis that is greater than Grade1.
Buttner-Janz and colleagues report, With respect to safety, there was good
agreement in the literature to exclude patients with osteopenia/osteoporosis or
fracture. Risk of injury to vascular structures due to the anterior approach was
often addressed by excluding patients with previous abdominal surgery in the area of
disc pathology or increased age. The literature was very consistent on the primary
indication for total disc replacement being painful disc degeneration unresponsive
to at least 6 months of nonoperative care. Literature investigating the impact of
previous spine surgery was mixed; however, prior surgery was not necessarily a contra-indication, provided the patient otherwise met selection criteria. The
literature was mixed on setting a minimum preoperative disc height as a selection
criterion. There were no publications investigating whether some patients are
better/worse candidates for specific total disc replacement designs. Based on the
literature a proposal for patient selection criteria is offered. In a follow-up at
the five-year mark of 236 patients who underwent either ProDisc-L total disc
replacement or fusions, Zigler and colleagues noted that the total disc replacement
group had significantly better improvement on some scales, and while total disc
replacement patients avoid the stiffness of fusion and are more satisfied than
fusion patients, both fusion and total disc replacement were reasonable surgical
options in this specific patient population. In this case, the patient presented to
her provider on 7/14/21 with back and primarily left lower extremity pain for
several years. The patient rated her pain at seven out of ten and reported having
tried and failed multiple epidural injections and therapy without improvement. The
patient reported having to change her professional activities as an occupational
therapist to accommodate her pain. On examination, the patient had mild limited
range of motion of her lumbar spine. A review of MRI scans from 5/28/21 reported at
the L4-5 level severe disk height loss and mild narrowing of the exiting neural
foramen, without evidence of clear instability. X-rays showed L4-5 degenerative disc
disease with coronal angulation, and mid-lumber mild scoliosis of approximately ten
degrees at the L1 and L2 levels. Computed tomography (CT) of the lumbar spine on
7/23/21 reported the following at L4-5: severe disc height loss which is worse on
the left with associated endplate sclerosis and lateral spurring, an eccentric disc
bulge to the left without high-grade spinal canal stenosis, mild bilateral facet
arthropathy along with lateral spurring and bulging results in moderate-to-severe
left and moderate right neural foraminal stenosis. The records noted multiple levels
of pathology, including thoracolumbar levoscoliosis of 21 degrees from T12-L1
through L3-4. There are multiple additional levels of degenerative disc
abnormalities. The submitted records did not include detailed documentation
regarding the epidural steroid injections that had been tried and failed including
the dates, the levels, and the respective benefit with those injections. However,
regardless of the respective benefit, or lack thereof, with lumber epidural steroid
injections, there are multiple plausible alternative pain generators. In this
clinical setting, there is a lack of published, large-scale, long-term peer-reviewed
medical literature showing that the requested service is an effective and safe
treatment for the noted pathology. Therefore, 22857 [total disc arthroplasty
(artificial disc), two-day inpatient stay] is not likely to be more beneficial for
treatment of the patient's condition than any available standard therapy.
| 1 |
A 53-year-old female enrollee has requested reimbursement for gene testing performed to gauge risk for thyroid cancer on 2/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees follicular lesion of undetermined significance. | Overturned | Experimental | Summary Reviewer 1
A 53-year-old female enrollee has requested reimbursement for gene testing performed to gauge risk for thyroid cancer on 2/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees follicular lesion of undetermined significance. The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). The Afirma Thyroid FNA Analysis utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures (Duick, et al). For these reasons, the gene testing performed to gauge risk for thyroid cancer on 2/16/17 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 55-year-old male enrollee has requested authorization and coverage for an electrical stimulation device. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 55-year-old male enrollee has requested authorization and coverage for an electrical stimulation device. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. The physician reviewer found the use of alternating electrical fields via Novocure device is a relatively new type of therapy used in the treatment of brain tumors. This technique involves the use of a helmet which delivers low-intensity alternating electric fields. It was approved for use by the U.S. Food and Drug Administration for the treatment of glioblastoma in 2011. In the study by Stupp and colleagues, 237 patients with recurrent glioblastoma were randomized to either chemotherapy or electrical field therapy. There was no difference seen in overall survival between the chemotherapy group and the electrical field group. However, there was noted to be significantly less toxicity in the electrical field group. All told, the requested device is likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 53-year-old female enrollee has requested authorization and coverage for PET scan (78816). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 53-year-old female enrollee has requested authorization and coverage for PET scan (78816). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested services in this clinical setting. The avidity of fluorodeoxyglucose (FDG) uptake can be helpful in differentiating between benign and malignant solid nodules. Given the resolution limitations of PET, tracer avidity cannot be reliably assessed for nodules with solid components measuring less than 8 mm. The nodules on this patient are 6 mm and below. Thus, the requested PET scan is unlikely to be of utility. Therefore, that PET/CT scan of the whole body with CT scan attenuation (78816) is not medically necessary for the evaluation of this patient. | 0 |
A 30-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 6/16/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease.
The patient demonstrated a clinical and radiographic improvement and was tolerating therapy without problems. | Upheld | Experimental | Summary Reviewer 1
A 30-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 6/16/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the Prometheus Anser IFX diagnostic testing performed on 6/16/14 was not likely to be more effective for this patient than other available treatment options. There is a lack of controlled data supporting the testing for antibodies or adalimumab levels in this clinical setting. The patient demonstrated a clinical and radiographic improvement and was tolerating therapy without problems. There were no infusion reactions or other indications of the development of human anti-chimeric antibodies. Given the lack of support in the peer-reviewed literature, the testing at issue was not likely to be more beneficial than other modalities. Based upon the information set forth above, the testing 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 52-year-old female enrollee has requested reimbursement for the Decision Dx melanoma assay provided on 11/18/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees malignant melanoma. | Upheld | Experimental | Summary Reviewer 3
A 52-year-old female enrollee has requested reimbursement for the Decision Dx melanoma assay provided on 11/18/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found that cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion. Metastases to regional lymph nodes may be amenable to excision but they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha (Balch, et al). Currently, there is a paucity of scientific data on the Decision Dx test for melanoma. As such, the test is novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. For these reasons, the Decision Dx melanoma assay provided on 11/18/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
patient is a 67-year-old male who presented in 2021 with a prostate-specific antigen (PSA)
level of 5.64. The patient has requested authorization and coverage for proton beam therapy. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 67-year-old male who presented in 2021 with a prostate-specific antigen (PSA)
level of 5.64. The patient has requested authorization and coverage for proton beam therapy.
The physician reviewer found that the submitted documentation fails to demonstrate the
medical necessity of the requested services. There is a lack of strong medical evidence to
suggest that treatment with proton beam therapy is associated with a clinical benefit compared
to standard treatment. Currently, there is insufficient clinical data to discern whether treatment
with proton beam radiation offers a clinical benefit compared to conventional radiation therapy
techniques in the treatment of prostate cancer. Vapiwala and colleagues performed a recent
multi-institutional analysis of 1,850 patients with low or intermediate risk prostate cancer. The
authors compared groups receiving hypofractionated radiation proton therapy and intensity
modulated radiation therapy with photons. This analysis found no significant difference in
gastrointestinal or genitourinary toxicities between the two treatments. Furthermore, it found
no difference in disease control between the two modalities. The American Society of Radiation
Oncology (ASTRO) Model Policy stated, Proton beam therapy for primary treatment of
prostate cancer should only be performed within the context of a prospective clinical trial or
registry. At the present time, ASTRO believes the comparative efficacy evidence of proton
beam therapy with other prostate cancer treatments is still being developed, and thus the role
of proton beam therapy for localized prostate cancer within the current availability of
treatment options remains unclear. The National Comprehensive Cancer Network guidelines
endorse the position statement by ASTRO and state that no clear benefit of proton beam
therapy has been demonstrated over standard treatment with photons and intensity
modulated radiation therapy technique. Therefore, proton beam therapy is not medically
necessary for the treatment of this patient.
| 1 |
An 18-year-old female enrollee has requested reimbursement for psychiatric residential treatment provided from 2/17/20 through 3/01/20. 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.
There was a serious risk of harm, due to suicidal ideation with a recent history of overdose, and the patients stated inability to keep herself safe at home. Additionally, there was recent excessive substance use. In terms of functional status, the records
3. The patient had moderate functional impairment, due to conflict with her mother and declining grades.
The patient has significant comorbidity, due to alcohol abuse, post-traumatic stress disorder, and depression as well as a recent concussion.
The patient had a moderately stressful environment due to sexual assault and a recent change in school. | Overturned | Medical Necessity | Summary Reviewer
An 18-year-old female enrollee has requested reimbursement for psychiatric residential treatment provided from 2/17/20 through 3/01/20. 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 with regard to risk of harm, the records support a score of 4. There was a serious risk of harm, due to suicidal ideation with a recent history of overdose, and the patients stated inability to keep herself safe at home. Additionally, there was recent excessive substance use. In terms of functional status, the records support a score of 3. The patient had moderate functional impairment, due to conflict with her mother and declining grades. With regard to comorbidity, the records support a score of 3. The patient has significant comorbidity, due to alcohol abuse, post-traumatic stress disorder, and depression as well as a recent concussion. In terms of level of stress of the recovery environment, the records support a score of 3. The patient had a moderately stressful environment due to sexual assault and a recent change in school. With regard to level of environmental support, the records support a score of 2. Her parents participated in treatment. In terms of resiliency and treatment history, the records support a score of 4. The patient had poor resiliency and/or response to treatment, due to continued symptoms despite outpatient treatment, inpatient hospitalization, and partial hospitalization program and intensive outpatient program treatment. With regard to acceptance and engagement, the records support a score of 2. The patient had initial difficulty being open and honest with treatment providers about the extent of her symptoms. Thus, the patient has a composite score of 21. This score supports medically monitored residence-based services, due to serious risk of self-harm and environmental stress. The submitted documentation supports the services at issue in this clinical setting. Therefore, psychiatric residential treatment provided from 2/17/20 through 3/01/20 was medically necessary for the treatment of this patient. | 1 |
A 53-year-old female enrollee has requested reimbursement for gene testing performed on 7/5/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees bilateral thyroid nodules. | Overturned | Experimental | Summary Reviewer 1
A 53-year-old female enrollee has requested reimbursement for gene testing performed on 7/5/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees bilateral thyroid nodules. The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only method to establish whether the nodule was thyroid cancer was via surgical excision even though the majority of the cases are benign (Miller, et al). The Afirma Thyroid FNA Analysis utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures (Duick, et al). Therefore, gene testing performed on 7/5/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of a 14-year-old male enrollee has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment center services provided from 9/19/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition.
. The medical records show that the patient is aggressive, irritable, critical of others, agitated, rude and argues with peers and staff.
his behavior. On 9/22/16, the individual therapy note stated that he presented agitated, critical of others and defensive. He blamed others and was dismissive of feedback. The therapist noted that his struggle with negative self-talk exacerbates his impulsive and disrespectful behaviors. On 9/26/16 the group therapy note stated that the patient struggles with accepting feedback about his behaviors and suggestions of he could improve. The patient argues and becomes defensive, particularly with his disrespect for female staff members was addressed. On 10/2/16, the notes indicate the he continued to be agitated and argued with staff and peers. He continues to be agitated and angry, and becomes unable to be directed and aggressive. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 14-year-old male enrollee has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment center services provided from 9/19/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the residential treatment center services provided from 9/19/16 forward were and are medically necessary for treatment of the patients medical condition. The medical records show that the patient is aggressive, irritable, critical of others, agitated, rude and argues with peers and staff. There are significant gaps in his ability to modulate his behavior. On 9/22/16, the individual therapy note stated that he presented agitated, critical of others and defensive. He blamed others and was dismissive of feedback. The therapist noted that his struggle with negative self-talk exacerbates his impulsive and disrespectful behaviors. On 9/26/16 the group therapy note stated that the patient struggles with accepting feedback about his behaviors and suggestions of he could improve. The patient argues and becomes defensive, particularly with his disrespect for female staff members was addressed. On 10/2/16, the notes indicate the he continued to be agitated and argued with staff and peers. He continues to be agitated and angry, and becomes unable to be directed and aggressive. Based on the documentation submitted for review, the patient requires the structure and 24-hour setting of continued residential treatment center services in order to allow learned gains to become established prior to discharge to a lower level of care. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 48-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 1/20/17. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees right breast lump and discharge from the nipple. | Upheld | Medical Necessity | Summary Reviewer
A 48-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 1/20/17. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary for evaluation of the enrollees right breast lump and discharge from the nipple. The physician reviewer found that Tomosynthesis was approved for clinical use by the U.S. Food and Drug Administration (FDA) in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of mammography, the American College of Radiology (ACR) has urged the technique be removed from the investigational category in 2014 due to the advantage it provides radiologists interpreting mammograms especially in women with dense tissue. This tomographic method often allows the reader to separate dense glandular elements from underlying mass and architectural distortions resulting in a decrease in callbacks and increase in overall diagnostic accuracy. However, the standard of practice for radiology does not yet require tomosynthesis on all mammography cases. Thus, the use of digital breast tomosynthesis performed on 1/20/17 was not medically necessary for evaluation of this patients right breast lump and discharge. Based on the foregoing discussion, the diagnostic procedure at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 16-year-old male with a past psychiatric history of major depressive disorder and
unspecified anxiety disorder. The patients parent has requested reimbursement for partial
hospitalization program services provided from 2/10/22 through 2/23/22. The Health Insurer has
denied this request and reported that the services at issue were not medically necessary for the
treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 16-year-old male with a past psychiatric history of major depressive disorder and
unspecified anxiety disorder. The patients parent has requested reimbursement for partial
hospitalization program services provided from 2/10/22 through 2/23/22. The Health Insurer has
denied this request and reported that the services at issue were not medically necessary for the
treatment of this patient. This denial is the subject of this appeal and determination. The physician
reviewer found that the 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 PHP level of care
services provided from 2/10/22 through 2/23/22. For dimension 1, risk of harm, the records support
a score of 3. This dimension assesses potential for harm to self or others, or having harm inflicted
upon them. During the period under review, the patient reported increasing suicidal ideation but
denied plan or intent. He has attempted suicide once by overdose. The patients risk of harm was
significant. For dimension 2, functional status, the records support a score of 3. This dimension
assesses the degree to which a patient is able to fulfill responsibilities within developmental
constraints. The patient has a history of overwhelming anxiety and frequent panic attacks. He
continues to endorse times of very high depression. He is noted to have extreme dysregulation.
Recent gains in functioning have been achieved only while participating in the highly treatment
setting. 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 has asthma and is under the care of a pulmonologist. His
asthma symptoms can mimic anxiety and panic, and anxiety/panic can worsen symptoms of
asthma. For dimension 4A, level of stress of 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 is isolated. His coping skills appear minimal, and he is
often overwhelmed by anxiety. He is falling behind in school. For dimensional 4B, level of support
in the recovery environment dimension, 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 his primary source of support but the patient struggles to utilize this support as
evidenced by his reluctance/failure to disclose to parents when he is feeling suicidal. For dimension
5, resiliency and response to services, the records support a score of 4. This dimension assesses
how past experiences with treatment and recovery might indicate how the patient might respond
in the future. Prior treatment has included outpatient therapy and numerous psychotropic
medications. Furthermore, the patient exhibits frequent evidence of innate vulnerability under
stress and difficulty resuming progress toward expected developmental level. For dimension 6, engagement of the patient, the records support a score of 3. The child and adolescent sub-
dimension assesses the ability to form therapeutic relationships within developmental constraints.
At times, the patient has required prompting and encouragement to engage in groups. His
participation in groups is inconsistent. This is indicative of limited engagement. These findings
give the patient a composite score of 22, which is consistent with Level 4 Medically Monitored
Community Based Services. Therefore, PHP level of care services provided from 2/10/22 through
2/23/22 were medically necessary for treatment of this patient.
| 1 |
A 39-year-old male enrollee has requested reimbursement for the Factor V Leiden genetic testing and homocysteine testing provided on 3/23/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees superficial vein thrombophlebitis. | Overturned | Experimental | Summary Reviewer 2
A 39-year-old male enrollee has requested reimbursement for the Factor V Leiden genetic testing and homocysteine testing provided on 3/23/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees superficial vein thrombophlebitis. The physician reviewer found that there is extensive literature supporting the testing that was done in this case. The Factor V mutation also known as Factor V Leiden has the potential to induce hypercoagulopathy in certain circumstances. Importantly, the Prothrombin G20210A mutation adds to this risk such that compound heterozygous patients can have increased odds of developing deep vein thrombosis (Emmerich, et al). Similarly, patients with hyperhomocysteinemia and Factor V Leiden are at increased risk for deep vein thrombosis (Ridker, et al). The most common genetic cause for hyperhomocysteinemia is the thermolabile variant of the methylenetetrahydrofolate reductase (MTHFR) enzyme. This is due to homozygosity for the TT genotype at codon 677 (Kluijtmans, et al). If this patient was found to be a carrier of multiple mutations predisposing to thrombosis, then a recurrent thrombotic event could be prevented with medical therapy and activity modification. For these reasons, the Factor V Leiden genetic testing and homocysteine testing provided on 3/23/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 50-year-old female enrollee has requested reimbursement for CPT codes 84999 (unlisted chemistry procedure, Oncotype DX colon cancer assay) and 88342 (immunohistochemistry of immunohistochemistry, per specimen, initial single antibody stain procedure) performed on 6/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. | Overturned | Experimental | Summary Reviewer 3
A 50-year-old female enrollee has requested reimbursement for CPT codes 84999 (unlisted chemistry procedure, Oncotype DX colon cancer assay) and 88342 (immunohistochemistry of immunohistochemistry, per specimen, initial single antibody stain procedure) performed on 6/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found is sufficient support for the services at issue in this clinical setting. The medical evidence shows that adjuvant chemotherapy confers a survival advantage for patients with stage III colorectal cancer, but not for those with stage II disease. Meta-analyses have not shown any survival advantage for 5-FU/leucovorin treatment in stage II patients. The reasons for this conclusion are complex. Stage II patients do well after surgery alone so that the magnitude of the survival benefit conferred by adjuvant chemotherapy is small; and, randomized clinical trials to date have had too few stage II patients to discern a statistically significant advantage. Therefore, subset analyses to identify those patients with prognostic features that may predict for chemotherapy benefit have been analyzed. For example, oncologists consider adjuvant treatment for those stage II patients with T4 disease, obstructing lesions, and other biomarkers. The Oncotype DX colon cancer assay has been validated independently as being an excellent prognostic indicator. The medical evidence for the test is sufficient to allow its use to estimate the risk of recurrence for stage II patients when incorporated with other tests such as standard pathology and microsatellite instability testing. Thus, CPT codes 84999 and 88342 performed on 6/17/16 were likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 64-year-old female enrollee has requested reimbursement for the Decision DX Melanoma assay performed on 6/16/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 64-year-old female enrollee has requested reimbursement for the Decision DX Melanoma assay performed on 6/16/15. 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 review of the submitted documentation and relevant literature fails to support the services at issue in this clinical setting. This patient has a Stage I melanoma. There is a lack of support in the peer reviewed literature demonstrating the use of gene expression profiling would change the management of treatment for patients with Stage I melanoma. National Comprehensive Cancer Network (NCCN) guidelines state While there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate benign from malignant neoplasms, or melanomas at low versus high risk for metastasis, routine (baseline) genetic testing of primary cutaneous melanomas (before or following [sentinel lymph node biopsy] SLNB) is not recommended outside of a clinical study (trial). Based on the lack of support in the peer-reviewed literature, the Decision DX Melanoma assay performed on 6/16/15 was not likely to be more beneficial for evaluation of the patients medical condition than other modalities. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 61-year-old female enrollee has requested reimbursement for Collagen Type 1 C-telopeptide blood test that was performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees post-menopausal osteoporosis.T | Overturned | Experimental | Summary Reviewer 3
A 61-year-old female enrollee has requested reimbursement for Collagen Type 1 C-telopeptide blood test that was performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees post-menopausal osteoporosis.The physician reviewer found this patient has failed several therapies. Rather than watching her BMD decline further into the osteoporotic range, it was reasonable to utilize the Collagen Type 1 C-telopeptide to assess for adequate suppression of bone resorption in between Dexa scans. Consistent with the above-cited literature, the use of this test was likely to be more beneficial than any other available mechanisms of monitoring therapy in between the patients Dexa scans. Given the proven clinical utility of the Collagen Type 1 C-telopeptide in this setting, the use of the test was medically appropriate in this patients case. 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 63-year-old female enrollee has requested reimbursement for ExoSym kinetic orthosis for right knee provided on 9/12/16. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees right knee pain.
this patient has chronic subjective instability and knee pain following a remote ACL reconstruction of the right knee. | Upheld | Experimental | Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for ExoSym kinetic orthosis for right knee provided on 9/12/16. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees right knee pain. The physician reviewer found that this patient has chronic subjective instability and knee pain following a remote ACL reconstruction of the right knee. There are some associated degenerative changes in the lateral compartment. A posterolateral reconstruction was not substantially beneficial. In this clinical setting, a custom orthosis equipped with dynamic tensioning system can lower the strain on the meniscus, limits tibial rotation, and help protect the ACL graft, as well as reduce pain and subjective instability. Accordingly, the ExoSym kinetic orthosis for right knee provided on 9/12/16 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 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 |
The parent of a 14-year-old male enrollee has requested reimbursement and prospective authorization and coverage for residential treatment program services provided from 1/21/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition.
The treatment record indicates that this patient has severe, chronic difficulties that have recently presented significant difficulty both for him, his family and those around him. This patient is receiving a fairly high level of therapeutic interventions and is responding positively to these interventions. The treatment plan and psychiatric note document that the patient is improving and benefiting from his treatment. However, he still has significant problems and continues to require intensive treatment at the residential level of care. This patient has a history of repeated aggression that has the potential to cause serious injury to others, and he has potential for serious risk of harm to his family if he were not removed from home during his treatment. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 14-year-old male enrollee has requested reimbursement and prospective authorization and coverage for residential treatment program services provided from 1/21/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the submitted documentation supports the medical necessity of the services at issue. The treatment record indicates that this patient has severe, chronic difficulties that have recently presented significant difficulty both for him, his family and those around him. This patient is receiving a fairly high level of therapeutic interventions and is responding positively to these interventions. The treatment plan and psychiatric note document that the patient is improving and benefiting from his treatment. However, he still has significant problems and continues to require intensive treatment at the residential level of care. This patient has a history of repeated aggression that has the potential to cause serious injury to others, and he has potential for serious risk of harm to his family if he were not removed from home during his treatment. All told, residential treatment program services provided from 1/21/16 forward were and are medically indicated for the treatment of this patient. Therefore, the requested services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 51-year-old female enrollee has requested authorization and coverage for 64628 thermal
destruction of intraosseous basivertebral nerve. The Health Insurer has denied this request and
reported that the requested service is investigational for the treatment of the enrollees low back
pain. | Overturned | Experimental | Summary Reviewer 1
A 51-year-old female enrollee has requested authorization and coverage for 64628 thermal
destruction of intraosseous basivertebral nerve. The Health Insurer has denied this request and
reported that the requested service is investigational for the treatment of the enrollees low back
pain. At issue is whether 64628 thermal destruction of intraosseous basivertebral nerve is likely
to be more beneficial for treatment of the enrollee's condition than any available standard therapy.
The physician reviewer found that in a single-arm metanalysis to provide an estimate of the
effectiveness of basivertebral nerve radiofrequency ablation to treat vertebrogenic low back pain,
Conger and colleagues noted a rate of 65% and 64% for equal or greater than 50% pain relief at
six and 12 months, respectively. The authors further noted that rates of a 15-point or greater
Oswestry Disability Index (ODI) score improvement were 75% and 75% at six and 12 months,
respectively. The authors concluded that there is moderate-quality evidence that basivertebral
nerve radiofrequency ablation effectively reduces pain and disability in most patients with
vertebrogenic low back pain. Sayed and colleagues report in best practice guidelines that the
application of basivertebral nerve ablation for patients suffering from vertebrogenic low back pain
is grounded in a solid foundation of both pre-clinical and clinical evidence. The authors further
report that the United States Preventative Task Force (USPSTF) gives basivertebral nerve ablation
a Level A grade, with high certainty that the net benefit is substantial in appropriately selected
individuals. Fischgrund and colleagues found a reduction of visual analogue scale (VAS) pain
score, an improvement in ODI scores, and complete pain resolution for 34% of patients at 6.4 years
following treatment of chronic low back pain with basivertebral nerve ablation as compared to
sham therapy. Therefore, 64628 thermal destruction of intraosseous basivertebral nerve is likely
to be more beneficial for treatment of the patients condition than any available standard therapy.
| 1 |
A 48-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 10/15/20. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
This patient had already had a panel assay (Caris) from a tissue sample. | Upheld | Experimental | Summary Reviewer 3
A 48-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 10/15/20. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that Guardant Assay is a multigene assay done on the DNA found in blood, presumably shed by cancer cells. In many cancer situations, such as in non-small cell lung carcinoma, it is important to ascertain a variety of mutations, as each may have treatment implications. Generally, it is preferable to assay these genomic changes from a tissue biopsy. However, if this is not feasible or safe, serum based assays are acceptable. This patient had already had a panel assay (Caris) from a tissue sample. In this case, it appears as if Guardant360 was being used to determine if there was cancer recurrence. The medical evidence does not support the services at issue in this setting. If the assay is being used to select a specific treatment, the chances of this being beneficial is very low. Therefore, Guardant360 testing performed on 10/15/20 was not likely to have been more beneficial than other available standard therapy.
| 1 |
An 18-year-old female enrollee has requested authorization and coverage for transcranial magnetic stimulation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
An 18-year-old female enrollee has requested authorization and coverage for transcranial magnetic stimulation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that transcranial magnetic stimulation has been approved by the U.S. Food and Drug Administration (FDA) for use in individuals with major depressive disorder who have not had a satisfactory response to at least one antidepressant trial in the current episode of illness. Furthermore, the FDA has approved transcranial magnetic stimulation for adults with no distinction being made that the adult must be 21 and older, not 18 and older. In this case, the patient has met the criteria for transcranial magnetic stimulation established in current psychiatry guidelines. Therefore, transcranial magnetic stimulation is medically necessary for the treatment of this patient. | 0 |
A 63-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. | Overturned | Medical Necessity | Summary Reviewer
A 63-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per the guidelines, cirrhotic genotype 1 patients who have failed PEG-interferon and ribavirin patients should be treated with Harvoni for 24 weeks. These guideline recommendations are based on multiple randomized clinical trials. Studies have shown decreased survival with delayed treatment (Jezequel, et al). All told, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 53-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/25/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination. | Overturned | Experimental | Summary Reviewer 3
A 53-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/25/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination. The physician reviewer found that Breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. However, in this patients case, there were no problems to be resolved. The patient did not have dense breasts, a mass, palpable lumps, or suspicious calcifications. In this clinical setting, a routine mammogram would have been sufficient. Digital breast tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality. Therefore, breast tomosynthesis performed on 7/25/16 was not likely to have been of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 49-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
The records document chronic left knee pain due to a history of chondral defects in the patellofemoral joint. | Overturned | Medical Necessity | Summary Reviewer
A 49-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The records document chronic left knee pain due to a history of chondral defects in the patellofemoral joint. Focal chondral defects are common in the patellofemoral joint, are difficult to treat and can significantly impair the quality of life of the affected individuals. The autologous chondrocytes implantation technique has been used and perfected over 20 years with the current U.S. Food and Drug Administration (FDA) approved third generation technique called matrix-induced autologous chondrocyte implantation.
The study by Niemeyer and colleagues included a total of 6,425 patients who fulfilled the inclusion criteria, 6,273 who were treated with microfracture and 152 who were treated with matrix-induced autologous chondrocyte implantation. In the two years after treatment, 1,271 patients in the microfracture group needed a reoperation, compared with 19 in the matrix-induced autologous chondrocyte implantation group. According to Welch and colleagues, recent evidence suggests that autologous chondrocyte implantation should be considered as a first-line treatment option in select patients. Autologous chondrocyte implantation is an effective means for cartilage restoration. Therefore, the requested autologous chondrocyte implantation 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. | Upheld | Experimental | Summary Reviewer 3
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 there is a lack of medical literature supporting use of continuous passive motion exercise device following ligamentous reconstruction for patellar instability. In addition, there is limited medical literature supporting continuous passive motion exercise following any knee surgery. Moreover, the use of continuous passive motion status post total knee arthroplasty does not have clinically significant effects on active knee flexion range of motion, pain, function or quality of life to justify its routine use (Harvey, et al). Given the lack of support in the peer-reviewed literature, the E0835 - RR continuous passive motion 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. 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 63-year-old male enrollee has requested reimbursement for the prostate ablation performed on 10/24/17. The Health Insurer has denied this request indicating that the procedure at issue was not medically necessary for treatment of the enrollees prostate cancer. | Upheld | Medical Necessity | Summary Reviewer
A 63-year-old male enrollee has requested reimbursement for the prostate ablation performed on 10/24/17. The Health Insurer has denied this request indicating that the procedure at issue was not medically necessary for treatment of the enrollees prostate cancer. The physician reviewer found that HIFU consists of focused ultrasound waves, emitted from a transducer, that cause tissue damage by mechanical and thermal effects as well as by cavitation. The goal of HIFU is to heat malignant tissues above 65C so that they are destroyed by coagulative necrosis. HIFU has been increasingly been used for treatment of localized prostate cancer over the last decade. However, there is a paucity of controlled trials available for analysis, and currently no long-term survival data are available. In addition, the National comprehensive Cancer Network (NCCN) guideline indicates that HIFU warrants further study, but has not been demonstrated to result in long-term improved health outcomes. Moreover, the National Cancer Institute does not list HIFU as one of the seven standard treatments for treatment of prostate cancer. Furthermore, the American Urological Association (AUA), American Society of Radiation Oncology (ASTRO), and SUO guideline report that providers should inform low-risk prostate cancer patients who are considering focal therapy or high intensity focused ultrasound (HIFU) that these interventions are not standard care options because comparative outcome evidence is lacking. All told, the prostate ablation performed on 10/24/17 was not medically necessary for treatment of this patients prostate cancer. Based on the foregoing discussion, the procedure at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 38-year-old male enrollee has requested reimbursement for a second full-night polysomnography to titrate continuous positive airway pressure performed on 11/12/14. The Health Plan has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition.
This patient had clinically significant obstructive sleep apnea that was documented within two hours of the start of the sleep study on 9/24/14. | Upheld | Medical Necessity | Summary Reviewer
A 38-year-old male enrollee has requested reimbursement for a second full-night polysomnography to titrate continuous positive airway pressure performed on 11/12/14. The Health Plan has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient had clinically significant obstructive sleep apnea that was documented within two hours of the start of the sleep study on 9/24/14. Thus, a split night study with continuous positive airway pressure titration during the same study would have been appropriate. The purpose of a continuous positive airway pressure titration study is to document the optimal setting of continuous positive airway pressure for patients who meet criteria for continuous positive airway pressure treatment. The continuous positive airway pressure titration study on 11/12/14 did not result in an optimal continuous positive airway pressure setting, and the result of that study was placement on an auto-titrate continuous positive airway pressure machine within an interval. There is a lack of support for the services at issue in this clinical setting. All told, the second full-night polysomnography to titrate continuous positive airway pressure performed on 11/12/14 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 49-year-old female enrollee has requested reimbursement and prospective authorization coverage for transcranial magnetic stimulation (TMS) treatments provided from 9/20/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees major depressive disorder.
this patient has a unilateral mood disorder complicated by PTSD, marital discord, and a | Overturned | Medical Necessity | Summary Reviewer
A 49-year-old female enrollee has requested reimbursement and prospective authorization coverage for transcranial magnetic stimulation (TMS) treatments provided from 9/20/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees major depressive disorder. The physician reviewer found that TMS is a non-invasive brain stimulating procedure utilized in the treatment of major depressive disorder. TMS tends to be well tolerated with fewer barriers than electroconvulsive therapy. The American Psychiatric Association (APA) endorses TMS for the acute phase treatment of major depressive disorder after failure of at least one antidepressant trial. Although bipolar disorder is diagnosed in the medical record prior to the psychiatric assessment from 12/7/16, the records submitted for review fail to show evidence of mania or hypomania. Based on the records submitted, this patient has a unilateral mood disorder complicated by PTSD, marital discord, and a pathological personality organization which is steeped in psychodynamic theory. This would explain the refractoriness to bipolar treatments and the chronicity of symptoms with persistent negative schemas, impaired self-perception and recurrent patterns of maladaptive behavior. The medical record supports the presence of an acute-on-chronic depressive episode in context of major depressive disorder. Although TMS is not indicated for PTSD, its co-occurrence is not a contraindication to the therapy. Considering the clinical documentation, endorsement from the APA and the expanding peer-reviewed literature base, TMS represents a safe, appropriate treatment consistent with good medical practice. Further, since this patient responded well to the therapy in the past, it is reasonably expected that another course of TMS will improve her condition and prevent a more serious episode of illness. In sum, the TMS provided from 9/20/16 forward was and is medically necessary for treatment of the patients behavioral health condition. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old female enrollee has requested authorization and coverage for peroral endoscopic myotomy (POEM) and associated inpatient admission. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees esophageal achalasia.
In this case, the patient is status post orthotopic liver transplant which was complicated by biliary leak. The patient is | Overturned | Experimental | Summary Reviewer 1
A 60-year-old female enrollee has requested authorization and coverage for peroral endoscopic myotomy (POEM) and associated inpatient admission. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees esophageal achalasia. The physician reviewer found that POEM is a U.S. Food and Drug Administration (FDA) approved treatment for achalasia. In this case, the patient is status post orthotopic liver transplant which was complicated by biliary leak. The patient is not a candidate for surgical treatment. Given the patients severe achalasia and lack of surgical option, POEM is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. For the reasons provided, the request for POEM and associated inpatient admission 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 |
The patient is a 31-year-old female who presented to her provider on 7/15/22 with a flare of truncal
and facial acne vulgaris. The patient has requested authorization and coverage for Azelex 20%
cream. The Health Insurer has denied this request and reported that the requested medication is
not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 31-year-old female who presented to her provider on 7/15/22 with a flare of truncal
and facial acne vulgaris. The patient has requested authorization and coverage for Azelex 20%
cream. 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. There are limited treatments available to control
acne vulgaris during pregnancy or in patients trying to conceive. Most common topical treatments
are either contraindicated in pregnancy, such as retinoids, or do not have data to support their safe
usage in pregnancy. Kong and Tey recommend the use of topical medications as first-line
treatment for acne vulgaris in pregnant and lactating women, including antibiotics, such as
erythromycin and clindamycin, and azelaic acid. Prescription azelaic acid is available in different
concentrations such as a 15% gel or a 20% cream. There is a lack of head-to-head trials showing
a clear superiority of using a higher concentration of azelaic acid in a 20% cream versus a 15% gel
or vice versa. Given that either formulation is a safe and effective treatment in this specific subset
of patients, the requested medication is reasonable. Therefore, Azelex 20% cream is medically
necessary for the treatment of this patient.
| 1 |
The patient is a 20-year-old female who has been diagnosed with posttraumatic stress disorder,
major depressive disorder, generalized anxiety disorder, and alcohol use disorder.The
patient has requested reimbursement for mental health residential treatment provided from 3/22/20
through 5/22/20. The Health Insurer has denied this request and reported that the services at issue
were not medically necessary for the treatment of this patient.T | Overturned | Medical Necessity | Summary Reviewer
The patient is a 20-year-old female who has been diagnosed with posttraumatic stress disorder,
major depressive disorder, generalized anxiety disorder, and alcohol use disorder.The
patient has requested reimbursement for mental health residential treatment provided from 3/22/20
through 5/22/20. The Health Insurer has denied this request and reported that the services at issue
were not medically necessary for the treatment of this patient.The physician reviewer found the mental health residential
treatment provided from 3/22/20 through 5/22/20 was medically necessary for the treatment of this
patient. | 1 |
A 64-year-old female enrollee has requested authorization and coverage for implantation of a nerve stimulator. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees moderate obstructive sleep apnea (OSA). | Upheld | Experimental | Summary Reviewer 2
A 64-year-old female enrollee has requested authorization and coverage for implantation of a nerve stimulator. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees moderate obstructive sleep apnea (OSA). The physician reviewer found that in the peer-reviewed medical literature, Certal and colleagues noted that, that hypoglossal nerve stimulation therapy may be considered in selected patients with OSA who fail medical treatment. Further studies comparing hypoglossal nerve stimulation with conventional therapies are needed to definitively evaluate outcomes. In this clinical case, the patient meets some of the criteria for implantation of upper airway stimulation to improve the symptoms. However, the patient has not undergone standard methods of management including improvement of the nasal airway with turbinate reduction and possible nasal septal reconstruction. Although the standard methods have not been shown to improve OSA, they can improve tolerance to nasal CPAP therapy. Additionally, the patient did not present any other physical examination information to decide whether other surgery such as uvulopalatopharyngoplasty or maxillary-mandibular advancement could offer any additional improvement of the symptoms. Accordingly, the requested implantation of a nerve stimulator is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested service is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
patient is a 38-year-old male who has been found to be at risk for human immunodeficiency virus (HIV) by his clinical team. The patient has requested authorization and coverage for Descovy 200 mg-25 mg tablets. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
the patientas reaction to Truvada. This patient reported significant nausea, diarrhea and insomnia while on Truvada. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 38-year-old male who has been found to be at risk for human immunodeficiency virus (HIV) by his clinical team. The patient has requested authorization and coverage for Descovy 200 mg-25 mg tablets. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. In this patientas case, Descovy is medically indicated, given the patientas reaction to Truvada. This patient reported significant nausea, diarrhea and insomnia while on Truvada. Descovy has been approved by the U.S. Food and Drug Administration for HIV prophylaxis in patients at risk. There is sufficient support for the requested medication in this clinical setting. Therefore, Descovy 200 mg-25 mg tablets are medically necessary for the treatment of this patient.
| 1 |
A 63-year-old female enrollee has requested reimbursement for ExoSym kinetic orthosis for right knee provided on 9/12/16. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees right knee pain.
4 arthritic knees. The patients records document that she has exhausted all measures of conservative treatment. | Upheld | Experimental | Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for ExoSym kinetic orthosis for right knee provided on 9/12/16. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees right knee pain. The physician reviewer found that there is a paucity of high level clinical trials supporting the use of ExoSym kinetic orthosis in treatment of grade 4 arthritic knees. The patients records document that she has exhausted all measures of conservative treatment. In this clinical setting, knee replacement surgery would be indicated. ExoSym kinetic orthosis is not likely to be more beneficial than available standard treatment including total knee arthroplasty. Thus, the ExoSym kinetic orthosis for right knee provided on 9/12/16 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 device at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 64-year old female with a history of hypertension, hyperlipidemia and hypothyroidisms. There is reported intolerance to generic beta blocker medication and generic losartan (Cozaar). The patient reported dizziness and headache. The patient has requested authorization and coverage for the brand medication Cozaar. The Health Insurer denied this request and reported that the requested brand medication is not medically necessary for the treatment of the patients medical condition.
Based on the records provided, the patient has been diagnosed with hypertension and she reported side effects to some medications.
record notes that losartan was started six weeks prior to the reported dizziness and | Upheld | Medical Necessity | Summary Reviewer
The patient is a 64-year old female with a history of hypertension, hyperlipidemia and hypothyroidisms. There is reported intolerance to generic beta blocker medication and generic losartan (Cozaar). The patient reported dizziness and headache. The patient has requested authorization and coverage for the brand medication Cozaar. The Health Insurer denied this request and reported that the requested brand medication is not medically necessary for the treatment of the patients medical condition. This denial is the subject of this appeal and determination. There is a lack of support in the documentation provided for the medical necessity of the requested brand name medication. Based on the records provided, the patient has been diagnosed with hypertension and she reported side effects to some medications. However, the symptoms of headaches and dizziness, in the absence of hypotension, are uncommon side effects to generic losartan medication. In addition, there is a lack of temporal association between the start of the losartan and the symptom onset. The record notes that losartan was started six weeks prior to the reported dizziness and headaches making a causal relationship unlikely. The documentation provided does not demonstrate a significant intolerance to the generic losartan medication. Moreover, there are additional formulary medications that have not been documented as trialed if a true intolerance to losartan medication were to be demonstrated. In sum, Cozaar has not been demonstrated as medically necessary for treatment of this patients medical condition. Therefore, based on the above, 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 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 12/16/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 12/16/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for vaginitis panel testing using polymerase chain reaction technology in this patients case. Although these methods have high sensitivity and specificity and a shorter turn-around time than culture, polymerase chain reaction testing offers no proven benefit over standard culture in symptomatic women. Furthermore, there is a lack of evidence on the clinical utility and impact of polymerase chain reaction testing for vaginitis. There is a lack of studies showing that polymerase chain reaction testing leads to better patient management decisions and/or better health outcomes. Studies of diagnostic accuracy alone are inadequate, especially because most symptomatic women can be diagnosed with a standard workup and/or a trial of empiric therapy. Thus, polymerase chain reaction testing performed on 12/16/18 was not likely to have been more effective than other methods of evaluating this patient.
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A 34-year-old female enrollee has requested authorization and coverage for transcranial magnetic stimulation (TMS). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees major depressive disorder.
In this case, the patient started TMS therapy in early July 2017 and had already utilized this additional timeframe by 10/5/17. Further, on 8/24/17, the patients Patient Health Questionnaire (PHQ-9) score plateaued after treatment 22 at which time the patient was noted to be feeling better. On 9/18/17, the patients mood was much improved. She was doing better and rated her depression a 1 out of 10. At that time, the patients diagnosis was major depressive disorder, in full remission. | Upheld | Medical Necessity | Summary Reviewer
A 34-year-old female enrollee has requested authorization and coverage for transcranial magnetic stimulation (TMS). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees major depressive disorder. The physician reviewer found that the requested TMS therapy is not medically necessary for treatment of the patients major depressive disorder. TMS is endorsed by the American Psychiatric Association for the treatment of acute phase depression in the adult population. A typical treatment course of TMS consists of 30 to 40 sessions spanning four to six weeks. According to Perera and colleagues, the standard regimen is treatment courses up to six weeks in duration. The authors stated that Controlled studies of longer duration, acute treatment courses or using alternative treatment parameters are not established. The authors suggest that an extended treatment course of one to two weeks may be appropriate for patients who experience only partial improvement and the clinician believes that a clear plateau of benefit has not been obtained. In this case, the patient started TMS therapy in early July 2017 and had already utilized this additional timeframe by 10/5/17. Further, on 8/24/17, the patients Patient Health Questionnaire (PHQ-9) score plateaued after treatment 22 at which time the patient was noted to be feeling better. On 9/18/17, the patients mood was much improved. She was doing better and rated her depression a 1 out of 10. At that time, the patients diagnosis was major depressive disorder, in full remission. Given the lack of adequately powered, controlled studies showing the benefit of longer courses of TMS therapy, the request for additional TMS services have not been established as medically necessary for treatment of the patients medical condition. Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 28-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 12/1/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
The patient was not experiencing failure of the anti-tumor necrosis factor agent as the patient was reported to be doing well with Humira. | Upheld | Experimental | Summary Reviewer 1
A 28-year-old female enrollee has requested reimbursement for the Anser ADA testing performed on 12/1/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the Anser ADA testing performed on 12/1/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based on the documentation submitted for review, there is a lack of clinical indication for the testing at issue. The patient was not experiencing failure of the anti-tumor necrosis factor agent as the patient was reported to be doing well with Humira. Given the above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 21-year-old female has requested reimbursement for Anser IFX testing performed on 8/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. | Upheld | Experimental | Summary Reviewer 3
A 21-year-old female has requested reimbursement for Anser IFX testing performed on 8/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found the management of ulcerative colitis using Anser IFX testing has not been standardized, and standardized recommendations for management based on test results (change to a different medication versus increase in dose) have not been formed. The use of Anser IFX testing to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in high-quality controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold drug levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Although loss of response to infliximab is common, there was a lack of standard guidelines defining a therapeutic strategy at the time of testing. Per the clinical literature, Anser IFX testing performed on 8/17/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 54-year-old male enrollee has requested reimbursement for DecisionDx melanoma test performed on 11/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented with a mole on his left upper back. | Upheld | Experimental | Summary Reviewer 3
A 54-year-old male enrollee has requested reimbursement for DecisionDx melanoma test performed on 11/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee who presented with a mole on his left upper back. The physician reviewer found that cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision but they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the DecisionDx test for melanoma has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. This was also the consensus opinion of the National Comprehensive Cancer Network (NCCN) guidelines. In sum, DecisionDx melanoma gene expression test performed on 11/9/16 was not likely to have been more beneficial than the standard treatment options for evaluating this patients medical condition. Therefore, for the reasons stated above, the service at issue was not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 12/28/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 12/28/15. 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 12/28/15 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. The American College of Radiology (ACR) has urged the tomosynthesis be removed from the investigational category due to the advantages this tomographic technique provides radiologists interpreting mammograms. This technique often allows the radiologist to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and increase in detection of small cancers. For this reason the addition of tomosynthesis to the usual two-dimensional (2D) protocol was likely of more benefit for the patient than had her mammogram been done using 2D technique only. 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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The parent of a 16-year-old female enrollee has requested authorization and coverage for ceftriaxone sodium injection. The Health Insurer has denied this request indicating that the requested medication is at investigational for the treatment of the enrollees Lyme disease.
The patient presents with a diagnosis of chronic Lyme disease and is requesting an extended intravenous therapy with ceftriaxone. | Upheld | Experimental | Summary Reviewer 3
The parent of a 16-year-old female enrollee has requested authorization and coverage for ceftriaxone sodium injection. The Health Insurer has denied this request indicating that the requested medication is at investigational for the treatment of the enrollees Lyme disease. The physician reviewer found the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The patient presents with a diagnosis of chronic Lyme disease and is requesting an extended intravenous therapy with ceftriaxone. However, per the documentation submitted for review, the patients symptoms are not consistent with Lyme disease and there are no abnormal physical exam findings. In addition, the there was no Western blot submitted or Centers for Disease Control and Prevention criteria based immune assay for Borrelia burgdorferi. Moreover, the studies in the peer-reviewed literature have not supported the use of long term or extended therapy for the treatment of Lyme disease beyond four weeks. Thus, infusion medication with ceftriaxone is not likely to be more beneficial treatment than standard medical therapy in this clinical setting. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld. | 1 |
The patient is a 62-year-old male who has been diagnosed with melanoma of at least 1.0 mm Breslow depth on the left parietal scalp. The provider sent a sample tissue for testing to assess metastatic risk. The patient has requested reimbursement for the DecisionDx-Melanoma test (84999) performed on 1/12/17. The Health Insurer denied reimbursement and reported that the services at issue were considered investigational for the evaluation of this patients medical condition. | Upheld | Experimental | Summary Reviewer 3
The patient is a 62-year-old male who has been diagnosed with melanoma of at least 1.0 mm Breslow depth on the left parietal scalp. The provider sent a sample tissue for testing to assess metastatic risk. The patient has requested reimbursement for the DecisionDx-Melanoma test (84999) performed on 1/12/17. The Health Insurer denied reimbursement and reported that the services at issue were considered investigational for the evaluation of this patients medical condition. The National Comprehensive Cancer Network guidelines indicate that genetic testing such as the DecisionDx-Melanoma gene assay should not be used outside of a clinical trial setting as it is considered to be investigational. The use of this type of testing is not considered to be standard of care in this clinical setting. Thus, its use is not expected to affect the treatment of this patients melanoma. As such, the results from DecisionDx-Melanoma test (84999) performed on 1/12/17 was not likely to have been superior over the other standard treatment options for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 60-year-old male enrollee has requested authorization and coverage for Korlym 300 mg tablet. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees recurrent meningioma.
, the patient has received the standard of care and the tumor has progressed. | Overturned | Medical Necessity | Summary Reviewer
A 60-year-old male enrollee has requested authorization and coverage for Korlym 300 mg tablet. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees recurrent meningioma. The physician reviewer found that on the presented clinical records submitted for review, Korlym 300 mg tablet is medically necessary for treatment of the patients medical condition. Meningiomas are brain tumors arising from the dura mater of the brain. Radiation therapy after complete surgical resection is the standard of care for atypical meningiomas. Systemic therapy is indicated for patients in whom surgical resection is not possible and those with high grade disease. The medical evidence to support various chemotherapy agents comprises of observational studies (Newton). Since the disease is uncommon, there is a lack of rigorously designed randomized clinical trials confirming the use of chemotherapy. In this case, the patient has received the standard of care and the tumor has progressed. Radiation has been exhausted as a therapy systemic therapy must be tried. Small phase II trials have confirmed responses to Korlym treatment as well (Grunberg, et al; Touat, et al). Treatment with Korlym is more targeted since many meningiomas express progesterone receptors. Therefore, the use of Korlym 300 mg is appropriate and medically necessary and supported by the current medical literature for treatment of this patients recurrent meningioma. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
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