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1
A 47-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition.
Overturned
Medical Necessity
Summary Reviewer A 47-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. 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, treatment-naive genotype 1 patients should be treated with Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials. All told, the requested medication Harvoni is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
The parent of a 15-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure, Anser IFX assay testing (CPT code 84999) performed on 11/17/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease.
Overturned
Experimental
Summary Reviewer 2 The parent of a 15-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure, Anser IFX assay testing (CPT code 84999) performed on 11/17/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the unlisted chemistry procedure, Anser IFX assay testing (CPT code 84999) performed on 11/17/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The testing at issue is standard for patients treated with infliximab. The information received from Anser IFX assay testing may lead to a shortened interval or increased dose or possibly change of medication. In addition, Anser IFX assay testing indicates whether serum levels of the drug are in the range to be beneficial and effective or if the patient has antibodies that could potentially lead to a reaction or failure to respond. Anser IFX assay testing results can help guide the provider in dosing or may lead them to discontinue the drug if the patient is not likely to benefit from the medication. This can also prevent the patient from having a flare and prevent potential side effects. All told, the testing at issue 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.
0
A 50-year-old male enrollee has requested reimbursement for MRI of the pelvis without and without dye performed on 7/24/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. this case, the patient had clinically suspected prostate cancer given his elevated PSA and strong family history.
Overturned
Medical Necessity
Summary Reviewer A 50-year-old male enrollee has requested reimbursement for MRI of the pelvis without and without dye performed on 7/24/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the clinical model for the approach to diagnosing prostate cancer is quickly moving towards the use of MRI targeted biopsy. The medical evidence indicates the superiority of this modality compared to traditional biopsy, resulting in a decrease in the number of false negative results, improved tumor characterization and localization, as well as better treatment planning. According to the American College of Radiology appropriateness criteria in the setting of clinically suspected prostate cancer in a patient without history of prior biopsy, MRI with subsequent targeted biopsy is considered usually appropriate. In this case, the patient had clinically suspected prostate cancer given his elevated PSA and strong family history. Therefore, MRI prior to prostate biopsy was indicated. Therefore, MRI of the pelvis with and without dye performed on 7/24/18 was medically necessary for the evaluation of this patient.
1
A 23-year-old male enrollee requested authorization and coverage for E1399 (functional electrical stimulation cycle ergometer). The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrollees medical condition. that this patient has a history of a spinal cord injury at the C7 level. The records document associated spasms in the lower extremities and elbow pain. The patients provider has recommended use of a functional electrical stimulation (FES) cycle ergometer for this patients physical rehabilitation following spinal cord injury.
Upheld
Experimental
Summary Reviewer 2 A 23-year-old male enrollee requested authorization and coverage for E1399 (functional electrical stimulation cycle ergometer). The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has a history of a spinal cord injury at the C7 level. The records document associated spasms in the lower extremities and elbow pain. The patients provider has recommended use of a functional electrical stimulation (FES) cycle ergometer for this patients physical rehabilitation following spinal cord injury. Kressler and colleagues assessed the use of home-based functional electrical stimulation cycle ergometers. The authors noted the key findings of this study are that usage frequency of home-based FES cycling is below recommended levels for weekly use and caloric expenditure is below the recommended levels for the majority of persons with spinal cord injuryOverall, we find that users of home-based FES cycling are below authoritative standards for overall health maintenance. Ralston and colleagues noted there were no clear effects of FES cycling on urine output, swelling and spasticity even though all point estimates of treatment effects favored FES cycling and participants perceived therapeutic effects. There is a lack of clinical research demonstrating significant benefit of FES units as an adjunct treatment for spinal cord injury. In sum, E1399 (functional electrical stimulation cycle ergometer) is not likely to be more beneficial than other treatment options.
1
A 28-year-old female enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees persistent asthma and shortness of breath. Her computed tomography (CT) scan showed diffuse mild bronchial wall thickening but no bronchiectasis
Overturned
Experimental
Summary Reviewer 2 A 28-year-old female enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees persistent asthma and shortness of breath. The physician reviewer found that this patient meets the established criteria for bronchial thermoplasty based on age, pulmonary function, severity of condition and treatment program. Her computed tomography (CT) scan showed diffuse mild bronchial wall thickening but no bronchiectasis which would contraindicate bronchial thermoplasty. Bronchial thermoplasty is a newer treatment for severe asthma, now included in GINA (Global Initiative for Asthma) guidelines. The American College of Chest Physicians also considers bronchial thermoplasty an important treatment option for adult patients with severe asthma who continue to be symptomatic despite maximal medical treatment. Wechsler and colleagues showed bronchial thermoplasty is an effective and safe therapy with reductions in exacerbations lasting to at least five years. While some studies have shown short-term increase in asthma morbidity, long lasting improvement appears to be the most common outcome. Consistent with this support, the requested bronchial thermoplasty is likely to provide this patient with greater benefits than any available standard therapy. Based upon the information set forth above, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 4/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 1 A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 4/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is some support for the services at issue in this clinical setting. Singh and colleagues discussed therapeutic drug monitoring (TDM) in children and young adults with inflammatory bowel disease (IBD). According to the paper by Singh and colleagues, The clinical value of TDM [therapeutic drug monitoring] is increasingly being recognized, with the growing body of evidence linking serum anti-TNF drug and ADA concentrations to clinical outcomes in IBD. The knowledge of these results provides insight into the etiology of loss of response and enables therapy to be optimized for an individual patient. Per the submitted documentation, Prometheus IFX testing performed on 4/29/15 was likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
0
patient is a 59-year-old female who self-palpated a right breast mass in January 2020. The patient has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
Upheld
Medical Necessity
Summary Reviewer The patient is a 59-year-old female who self-palpated a right breast mass in January 2020. The patient has requested authorization and coverage for proton beam therapy. 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 guidelines do not endorse the routine use of proton therapy in the treatment of breast cancer. There is a lack of data to suggest that proton therapy would be beneficial in this case or that it would be associated with less side effects than standard treatment with photons. The standard treatment in this case would be with chemotherapy followed by surgery followed by radiation with photons. Furthermore, consensus group guidelines do not support the use of proton therapy in this setting. In the vast majority of cases, intensity modulated radiation or 3D conformal techniques with photons is able to achieve an acceptable cardiac and lung dose. Also, there is a lack of level I evidence to support the use of proton beam therapy for the treatment of breast cancer. Therefore, proton beam therapy is not medically necessary for the treatment of this patient.
1
A 42-year-old female enrollee has requested authorization and coverage for total disc replacement. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. this patient has a history of anterior cervical discectomy and fusion at C6-7 and adjacent level degenerative disc disease with radiculopathy at C5-6 and C4-5. She has tried and failed conservative treatment, and her provider has requested total disc replacement at these levels.
Upheld
Experimental
Summary Reviewer 3 A 42-year-old female enrollee has requested authorization and coverage for total disc replacement. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has a history of anterior cervical discectomy and fusion at C6-7 and adjacent level degenerative disc disease with radiculopathy at C5-6 and C4-5. She has tried and failed conservative treatment, and her provider has requested total disc replacement at these levels. Hybrid surgery in the cervical spine may lead to better neck disability index recovery, less postoperative neck pain, faster cervical range of motion recovery, and less adjacent segment disease. There is support for the requested services in this clinical setting. Thus, the requested total disc replacement is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.
1
A 68-year-old female enrollee has requested authorization and coverage for iStent placement (times two). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
Overturned
Experimental
Summary Reviewer 3 A 68-year-old female enrollee has requested authorization and coverage for iStent placement (times two). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the current medical evidence supports the requested iStent placement (times two) in this clinical setting. The peer-reviewed has demonstrated the superior efficacy of the requested services in this patients case. Studies reviewed indicate that this procedure is a safe and effective modality for achieving better glaucoma control after cataract surgery. Thus, iStent placement (times two) is likely to be more effective 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.
0
A 46-year-old male enrollee has requested reimbursement for the gastrointestinal (GI) effects comprehensive profile stool testing performed on 1/10/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 2 A 46-year-old male enrollee has requested reimbursement for the gastrointestinal (GI) effects comprehensive profile stool testing performed on 1/10/16. 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 based on the documentation submitted for review, the GI effects comprehensive profile stool testing was not likely to be more beneficial for evaluation of the patients medical condition than standard testing. Specifically, the polymerase chain reaction (PCR) assessment of enteric pathogens and the ova and parasite components of the comprehensive profile stool testing were duplicative to studies the patient reports were already performed. In addition, the calprotectin assay was not indicated since colitis had already been ruled out by previous colonoscopy and computed tomography (CT) imaging. As such, the GI effects comprehensive profile stool testing was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
0
A 56-year-old female enrollee has requested reimbursement for the hip surgery (CPT codes 29914 and 29915) provided on 6/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees right hip impingement syndrome. This patient presented with a three year history of hip pain that had severely worsened six months prior to initial examination. The pain interfered with her work duties and activities of daily living. Clinical examination findings were consistent with femoroacetabular impingement syndrome. She failed over six months of conservative treatment including activity modification, chiropractic care, ice, and anti-inflammatory medications.
Overturned
Experimental
Summary Reviewer 2 A 56-year-old female enrollee has requested reimbursement for the hip surgery (CPT codes 29914 and 29915) provided on 6/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees right hip impingement syndrome. The physician reviewer found that in the peer-reviewed medical literature, Hellman and colleagues reviewed five approaches for surgical management of femoroacetabular impingement syndrome, including arthroscopy. The authors reported that when nonsurgical treatment methods fail, surgical options were recommended, but there was no long-term outcome data to support one method over another. Harris and colleagues concluded that the outcomes of operative treatment of femoroacetabular impingement are significantly better than nonsurgical management. This patient presented with a three year history of hip pain that had severely worsened six months prior to initial examination. The pain interfered with her work duties and activities of daily living. Clinical examination findings were consistent with femoroacetabular impingement syndrome. She failed over six months of conservative treatment including activity modification, chiropractic care, ice, and anti-inflammatory medications. There were no significant degenerative findings of the right hip. Therefore, the right hip arthroscopy with femoroplasty and acetabuloplasty (CPT codes 29914 and 29915) performed on 6/17/16 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 services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 41-year-old male enrollee has requested authorization and coverage for rituximab injections 100 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees pretibial myxedema.
Upheld
Medical Necessity
Summary Reviewer A 41-year-old male enrollee has requested authorization and coverage for rituximab injections 100 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees pretibial myxedema. The physician reviewer found that the use of rituximab for ocular related findings associated with Graves disease is supported by peer-reviewed medical literature. However, there is a paucity of large, controlled studies demonstrating the safety and efficacy of rituximab for treatment of pretibial myxedema (Heyes, et al; Ferreira-Hermosillo, et al). As this patient does not have any documented ocular related findings associated with Graves disease, the requested rituximab injections 100 mg are 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 male enrollee has requested authorization and coverage for Acthar Gel. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees sarcoidosis.
Upheld
Experimental
Summary Reviewer 2 A 46-year-old male enrollee has requested authorization and coverage for Acthar Gel. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees sarcoidosis. The physician reviewer found that Gerke explains that treatment of sarcoidosis involves the use of corticosteroids and conventional immunosuppression with medications such as methotrexate, azathioprine, leflunomide, and mycophenolate. Baughman and colleagues note, The biologic agents, especially monoclonal anti-tumor necrosis factor (anti-TNF) antibodies, have proved effective in patients who have failed other treatments. While Acthar Gel is FDA-approved for the treatment of symptomatic sarcoidosis, in this clinical setting, current medical literature does not support its use as superior to multiple other treatment options that have been proven to be effective for the treatment of sarcoidosis. Therefore, Acthar Gel is not likely to be more beneficial for treatment of the patients condition than any available standard therapy.
1
patient is a 22-year-old female with a history of persistent depressive disorder, social anxiety disorder, emerging post-traumatic stress disorder (PTSD), and emerging borderline personality disordered traits. The patient has requested reimbursement for the adult mental health RTC services provided from 6/1/21 through 9/13/21. The Health Insurer has denied the services at issue as not medically necessary. the patient was at serious risk of harm (score 4) due to continued suicidal ideation and self-injurious behavior throughout her RTC stay. The patients behavior culminated in discharge from RTC when she was hospitalized with active suicidal ideation, walking along the side of the highway with thoughts of jumping in traffic, and continued self-injurious behavior.
Overturned
Medical Necessity
Summary The patient is a 22-year-old female with a history of persistent depressive disorder, social anxiety disorder, emerging post-traumatic stress disorder (PTSD), and emerging borderline personality disordered traits. The patient has requested reimbursement for the adult mental health RTC services provided from 6/1/21 through 9/13/21. The Health Insurer has denied the services at issue as not medically necessary. This denial is the subject of this appeal and determination. The physician reviewer found that the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery environment (a. stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score is then used to determine the level of care needed. Applying the LOCUS framework, the patient met the criteria for RTC services provided from 6/1/21 through 9/13/21. For dimension 1, the patient was at serious risk of harm (score 4) due to continued suicidal ideation and self-injurious behavior throughout her RTC stay. The patients behavior culminated in discharge from RTC when she was hospitalized with active suicidal ideation, walking along the side of the highway with thoughts of jumping in traffic, and continued self-injurious behavior. Current suicidal or homicidal ideation with expressed intentions and/or past history of carrying out such behavior but without means for carrying out the behavior. For dimension 2, the patient demonstrated serious functional impairment (score 4) since she has been unable to attend school or work due to severe symptoms. The patient had consistently conflictual relations with both staff and other patients, became dysregulated even while in treatment, and acted with impulsive and aggressive behaviors. Overall, the patient showed a serious decrease in the quality of interpersonal interactions with consistently conflictual or otherwise disrupted relations with others, which may include impulsive, aggressive or abusive behaviors. For dimension 3, the patient has significant co-morbidities (score 3) considering her significant substance use prior to entering RTC. The patients learning disorder made it difficult for her to learn new skills while in treatment. The patient also was found to have fecal impaction and constipation when she complained of abdominal pain toward the end of her RTC admission. The records document ongoing or episodic substance use occurring despite negative consequences with significant or potentially significant negative impact on the course of any co-occurring psychiatric disorder. For dimension 4A, the patients recovery environment was moderately stressful (score 3) given the patients significant discord and difficulties in all of her relationships due to her inability to communicate effectively and with conflict. There is evidence of significant discord or difficulties in family or other important relationships or alienation from social interaction. For dimension 4B, the patients recovery environment provided limited support (score 3). The records indicate that the patient relied heavily on her parents for support despite her conflictual exchanges with them. A few supportive resources exist in current environment and may be capable of providing some help if needed. For dimension 5, the patient showed poor response to treatment and recovery management (score 4). The provider noted that the patient was hospitalized psychiatrically leading up to her RTC stay, attempted treatment at intensive outpatient program (IOP) and in various outpatient treatment settings. Even within RTC setting, the patient was unable to achieve remission of symptoms. Thus, previous or current treatment has not achieved complete remission of symptoms or optimal control of symptoms even with intensive and/or repeated exposure. For dimension 6, the patient has exhibited minimal engagement and recovery (score 4). The records noted that the patient showed great difficulty accepting any responsibility for recovery and had consistently conflictual relationships with treatment providers. Overall, the patient did not accept any responsibility for recovery or felt powerless to do so. These findings give the patient a composite score of 25, which is consistent with medically monitored residence-based services or RTC. Additionally, the patient scores of 4 in risk of harm and functional status support placement in RTC. Additionally, in terms of length of stay, the patient meets criteria for level 5B moderate intensity intermediate stay residential treatment programs due to significant disturbance in interpersonal skills as well as serious impairment in expected role functioning at home, school and work. For these reasons, the adult mental health RTC services provided from 6/1/21 through 9/13/21 were medically necessary for treatment of this patient.
1
A 44-year-old female enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees sacroiliac joint pain.
Upheld
Experimental
Summary Reviewer 2 A 44-year-old female enrollee has requested authorization and coverage for sacroiliac joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees sacroiliac joint pain. The physician reviewer found that the sacroiliac joint degeneration is a common cause of chronic low back pain which is underdiagnosed. Minimally invasive fusion procedures have demonstrated successful pain relief for these patients. Recent medical literature has documented two-year follow-up of these procedures demonstrating meaningful clinical improvement and maintained pain relief as well as evidence of a solid fusion on imaging studies. In the absence of evidence of neural compression on the magnetic resonance imaging (MRI) scan and in the presence of clinical findings of sacroiliac pain which is relieved by injecting the sacroiliac joint, the requested procedure of sacroiliac fusion using the minimally invasive technique is likely to be beneficial in this case. As such, the requested sacroiliac joint fusion is likely to be of greater benefit than other treatment options. 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 62-year-old male enrollee has requested reimbursement for the RT300 functional electrical stimulator (FES) cycle provided on 2/10/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees quadriplegia.
Upheld
Experimental
Summary Reviewer 2 A 62-year-old male enrollee has requested reimbursement for the RT300 functional electrical stimulator (FES) cycle provided on 2/10/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees quadriplegia. The physician reviewer found that currently, there is a paucity of proven significant health or functional benefits of exogenous neurostimulation therapy of paralyzed muscles using FES cycle ergometry for use in this clinical setting. There have been a number of case reports and series providing some preliminary data suggesting possible benefits, but larger studies designed to evaluate the actual clinical efficacy of passive exercise such as FES cycle ergometry in the setting of spinal cord injury are lacking. While repeated bouts of exogenous neurostimulation of paralyzed muscle may potentially retard or reverse muscle atrophy in paralyzed muscle, there is no proven significant health or functional benefit of this achievement in patients with spinal cord injury because the muscle tissue that is gained or spared does not protect against pressure ulcers or provide any other clinically or functionally relevant benefit. Passive cycling may be an option to provide passive range of motion therapy to prevent contractures or mitigate spasticity, but this is considered a custodial use of the device (Reichenfelser, et al). The other purported benefits of passive cycling have not been sufficiently investigated to allow conclusions related to clinically relevant outcomes. To date, the limited available data provide mixed results regarding health measures. Given that the RT300 FES cycle is not active exercise and not an appropriate substitute for active exercise, its use in this patients care was not indicated. Thus, the RT300 FES cycle provided on 2/10/16 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 equipment 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 30-year-old female enrollee has requested reimbursement for Prometheus Anser ADA (84999) provided on 10/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees inflammatory bowel disease (IBD). This patients level was in the normal range despite the fact that he was having an active flare/progression of disease,
Upheld
Experimental
Summary Reviewer 2 A 30-year-old female enrollee has requested reimbursement for Prometheus Anser ADA (84999) provided on 10/14/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees inflammatory bowel disease (IBD). The physician reviewer found that monitoring patients on adalimumab with measurement of adalimumab levels and antibodies to adalimumab continues to be an area of interest in the inflammatory bowel disease community. In general, adalimumab levels correlate inversely with disease activity. However, there is a lack controlled data which has identified the optimal drug level and so, the issue remains speculative. This patients level was in the normal range despite the fact that he was having an active flare/progression of disease, highlighting the limitation of the test. Using the Anser ADA, one can set up a hypothetical table categorizing drug levels as high or low and antibody levels as high or low. In theory, one could use this table to determine whether to dose increase or switch to a biologic agent with a different mechanism of action. However, this hypothetical benefit is not supported by high quality medical evidence. In sum, Prometheus Anser ADA (84999) provided on 10/14/15 was not likely to have been more effective than other modalities in the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
The patient is a 15-year-old female diagnosed with major depressive disorder, recurrent, severe, alcohol use disorder, severe, and self-harm. The patient was admitted to intensive outpatient program (IOP) treatment on 1/19/17. The clinical record documents discord between the patient and her family. During the course of treatment, the patient has described herself as a mediator between her parents. An entry on 2/8/17 reveals that she was allowed to go on a trip with her father from 2/9/17 until 2/13/19, while in IOP. On 4/10/17, the patient reported less suicidal ideation but continued mood symptoms thus Prozac was increased from 20 mg daily for 30 mg daily with a plan to reassess in five weeks. Also on 4/10/17, she indicated in group that she does not express her anger in adaptive ways and she acknowledged that she wanted to learn more adaptive strategies. Her parent has requested reimbursement and prospective authorization and coverage for mental health IOP services from 4/10/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary.
Upheld
Medical Necessity
Summary Reviewer The patient is a 15-year-old female diagnosed with major depressive disorder, recurrent, severe, alcohol use disorder, severe, and self-harm. The patient was admitted to intensive outpatient program (IOP) treatment on 1/19/17. The clinical record documents discord between the patient and her family. During the course of treatment, the patient has described herself as a mediator between her parents. An entry on 2/8/17 reveals that she was allowed to go on a trip with her father from 2/9/17 until 2/13/19, while in IOP. On 4/10/17, the patient reported less suicidal ideation but continued mood symptoms thus Prozac was increased from 20 mg daily for 30 mg daily with a plan to reassess in five weeks. Also on 4/10/17, she indicated in group that she does not express her anger in adaptive ways and she acknowledged that she wanted to learn more adaptive strategies. Her parent has requested reimbursement and prospective authorization and coverage for mental health IOP services from 4/10/17 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary. The additional information provided has been reviewed. On 5/24/17, an entry indicates that clients and parents attended a multifamily group. However, there is no indication the session focused on the specific issues and needs of this patient. Progress notes from other group encounters are similarly not specific to this patients needs and do not tailor care to the diagnoses and circumstances of the patient. Individual outpatient therapy and focused parent-child intervention in a less restrictive environment is likely to be more effective. More specific and focused treatment could be provided in a less restrictive setting. Accordingly, the IOP services provided from 4/10/17 forward were not and are not medically necessary for treatment of this patients behavioral health issues. Based on the foregoing discussion, 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.
1
The parent of an eight-year-old male enrollee has requested reimbursement for FirstStep Dx Plus testing performed on 5/28/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the treatment of the enrollees autism spectrum disorder (ASD). . He carries the dual diagnoses of autism and ADD, which also suggests a multi-factorial genetic etiology.
Overturned
Experimental
Summary Reviewer 3 The parent of an eight-year-old male enrollee has requested reimbursement for FirstStep Dx Plus testing performed on 5/28/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the treatment of the enrollees autism spectrum disorder (ASD). The physician reviewer found the clinical literature supports CMA as a primary screening test for autistic children (Miller, et al; Manning and Hudgins). The article by McGrew and colleagues concluded that CMA should be the clinical standard in all specialties for first tier genetic testing in ASD. In addition, this patient has additional factors to validate the need for the CMA testing. He carries the dual diagnoses of autism and ADD, which also suggests a multi-factorial genetic etiology. CMA is a routine part of the evaluation of an autistic child, whether or not the child is intellectually disabled or if dysmorphic features are noted (Miller, et al). In sum, the testing at issue 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 48-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/12/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
Upheld
Experimental
Summary Reviewer 2 A 48-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/12/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that this patient has an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the services at issue were unlikely to have altered treatment and surveillance recommendations. In sum, DecisionDx-Melanoma testing performed on 12/12/17 was not likely to have been of greater benefit than other available methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 28-year-old female enrollee has requested reimbursement for CPT code 92025 (computerized corneal topography, unilateral or bilateral, with interpretation and report) provided on 6/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. This patient has been treated with topical lubricants, medication, and punctual plugs.
Upheld
Experimental
Summary Reviewer 3 A 28-year-old female enrollee has requested reimbursement for CPT code 92025 (computerized corneal topography, unilateral or bilateral, with interpretation and report) provided on 6/02/15. 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 the submitted documentation fails to demonstrate the superior effectiveness of the services at issue. Dry eye syndrome is a chronic, multi-factorial problem. This patient has been treated with topical lubricants, medication, and punctual plugs. Corneal topography is a method of measuring the three-dimensional shape of the cornea. It is useful for evaluating structural abnormalities of the cornea. While dry eye syndrome can cause interference with corneal topography, dry eye syndrome is not related to the three-dimensional shape of the cornea, and cannot be meaningfully evaluated by corneal topography. In sum, the superior efficacy of the services at issue has not been established. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
Overturned
Experimental
Summary Reviewer 3 A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation. 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 that while endovenous ablation of the greater saphenous vein has been extensively evaluated in the treatment of varicose veins, little is known about the efficacy in the treatment of accessory saphenous veins. Furthermore, patterns of recurrence of varicose veins after greater saphenous vein treatment is usually new reflux in the accessory saphenous vein and there is little evidence available to guide optimal therapy, in contrast to greater saphenous vein interventions. Therefore, given the absence of evidence for the efficacy of endovenous ablation of accessory saphenous veins after surgical therapy of greater saphenous vein incompetence, the superior effectiveness of the requested services has not been established. 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.
0
A 48-year-old female enrollee has requested authorization and coverage for implantation of Strattice. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees abdominal hernia.
Overturned
Experimental
Summary Reviewer 2 A 48-year-old female enrollee has requested authorization and coverage for implantation of Strattice. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees abdominal hernia. The physician reviewer found that based on peer reviewed medical literature, Strattice is an effective product for treatment of abdominal wall hernias and is available in a size appropriate for the patients condition. Strattice is a non crosslinked decellularized porcine xenograft which is comparable to Alloderm, a decellularized human allograft. Patel and colleagues (2011) reported a study of 78 complex patients with component separation abdominal ventral hernia repair with Strattice reinforcement. There was 12% exposure rate, but all patients went on to complete healing without explantation. They concluded that Strattice is an effective adjunct to abdominal wall reconstruction (AWR) when used as reinforcement in component separation ventral hernia repair. Patel and colleagues (2013), in a review of 41 patients with complex AWR and Strattice underlay from 2007-2010, state that all patients achieved abdominal wall closure with no recurrent hernias or need for Strattice removal. They concluded that patients with multiple comorbidities at intermediate risk of postoperative complications can achieve successful, safe AWR with Strattice. All told, implantation of Strattice is likely to be more effective than the standard options available for treatment of this patients medical condition. Therefore, for the reasons stated above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 40-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral, on 8/26/21. The Health Insurer has denied this request and reported that the service at issue was investigational for the treatment of the enrollees bilateral eustachian tube dysfunction.
Overturned
Experimental
Summary Reviewer 3 A 40-year-old male enrollee has requested reimbursement for nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral, on 8/26/21. The Health Insurer has denied this request and reported that the service at issue was investigational for the treatment of the enrollees bilateral eustachian tube dysfunction. The physician reviewer found that there are limited treatments for eustachian tube dysfunction, including medical management, myringotomy and tube placement, and more recently, eustachian tube balloon dilation. Tucci and colleagues report, At this time, additional randomized controlled trials with longer follow-up are still necessary to establish a higher level of evidence for balloon dilation of the eustachian tube efficacy. The authors further noted a lack of consensus regarding the overall short-term or long- term effectiveness of Eustachian tube balloon dilation. Froehlich and colleagues note, Eustachian tube balloon dilation appears to be associated with improvement in subjective and objective treatment outcome metrics at three to 12 months after dilation. However, the authors noted that only 50.5% of patients had improved tympanograms and 55.4% had normal otoscopy examinations in the long term. In a randomized controlled trial comparing balloon dilation to medical management that evaluated patients ETDQ-7 scores at six weeks and at 12 months, Meyer and colleagues reported that balloon dilation was a safe and effective treatment. However, this trial included only 31 patients treated with balloon dilation and 29 patients as control. There are a lack of studies comparing balloon dilation to myringotomy tube placement. In this setting, clinical evidence in published current medical literature is insufficient to show that eustachian tube balloon dilation is more effective for the treatment of eustachian tube dysfunction than standard treatment with medical management or with myringotomy and tube placement. Therefore, nasopharyngoscopy, surgical, with dilation of eustachian tube (i.e. balloon dilation); bilateral, on 8/26/21, was not likely to have been more beneficial for treatment of the patients condition than any available standard therapy.
1
A 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. 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 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. 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 that a commercial gene expression profile test (DecisionDX-Melanoma) has been developed in patients with stage I and II cutaneous melanoma. However, there are no definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials according to published data available. Per the National Comprehensive Cancer Network (NCCN) guidelines, 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 SLNB) is not recommended outside of a clinical study (trial). In sum, gene testing performed on 12/28/15, was not likely to have been more beneficial than any available standard of care in evaluating this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
The parent of a 16-year-old female enrollee has requested reimbursement for residential treatment services provided from 8/26/15 through 12/31/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The patient could have been treated in a lower level of care from 10/19/17 through 10/25/17. On 10/17/17, the patient weighed 120.40 pounds and was 102% of her IBW. The patient had exceeded her ideal body weight of 118 pounds. The patient was engaged during her therapy sessions and she completed 98% of her meal plans over the week. She continued to struggle with anxiety and depression but she reported to staff on many occasions that she felt that the RTC level of care was excessively restrictive for her and she had a desire to be discharged. The patient did not report any suicidal ideation or homicidal ideation. The patient was medically stable. By 10/19/17, she no longer required 24 hour supervision.
Upheld
Medical Necessity
Summary Reviewer The parent of a 16-year-old female enrollee has requested reimbursement for residential treatment services provided from 8/26/15 through 12/31/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue in this clinical setting. The patient could have been treated in a lower level of care from 10/19/17 through 10/25/17. On 10/17/17, the patient weighed 120.40 pounds and was 102% of her IBW. The patient had exceeded her ideal body weight of 118 pounds. The patient was engaged during her therapy sessions and she completed 98% of her meal plans over the week. She continued to struggle with anxiety and depression but she reported to staff on many occasions that she felt that the RTC level of care was excessively restrictive for her and she had a desire to be discharged. The patient did not report any suicidal ideation or homicidal ideation. The patient was medically stable. By 10/19/17, she no longer required 24 hour supervision. It is standard of care to treat patients in the least restrictive environment possible. This patient continued to require treatment for her eating disorder but her treatment could have been accomplished at a less restrictive environment. Accordingly, the eating disorder RTC services from 10/19/17 through 10/25/17 were not medically necessary for the treatment of this patients medical condition. Based upon the information set forth above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
1
A 42-year-old female enrollee has requested authorization and coverage for Trokendi XR. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees migraine headaches.
Overturned
Medical Necessity
Summary Reviewer A 42-year-old female enrollee has requested authorization and coverage for Trokendi XR. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees migraine headaches. The physician reviewer found that there is sufficient support in the medical literature and in the submitted documentation for the requested medication. Trokendi XR is an extended release version of topiramate. Its pharmacokinetic studies indicate smoother exposure, and less variation of blood levels compared to the immediate release formulation. Studies indicate better tolerability, fewer side effects, and better patient acceptance. Clinical notes in this case also indicate that the patients tolerability has been better at comparable doses. A review of topiramate studies in migraines treated with extended release topiramate support a clinically meaningful benefit of extended release topiramate versus immediate release topiramate in terms of significantly fewer cognitive effects, improved adherence, and overall better outcomes of migraine prophylaxis with topiramate. Based on the clinical notes, she has done better with Trokendi then the generic, immediate release. Trokendi XR is U.S. Food and Drug Administration approved and indicated for migraine prevention. While it has the same active ingredient as generic topiramate, it is not therapeutically equivalent as evidenced by studies as well as in this patient. All told, Trokendi XR is medically necessary for treatment of this patients medical condition.Therefore, for the reasons stated above, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
patient is a 14-year-old transgender male with a psychiatric history of major depressive disorder, generalized anxiety disorder, attention-deficit/hyperactivity disorder (ADHD), gender dysphoria, reactive attachment disorder, factitious disorder, unspecified neurodevelopmental disorder with difficulty in social functioning, parent-child relational problem, and academic or educational problem. The patients parent has requested reimbursement for the mental health RTC services provided from 9/7/21 through 9/24/21. The Health Insurer has denied the services that issue is not medically necessary.
Overturned
Medical Necessity
Summary The patient is a 14-year-old transgender male with a psychiatric history of major depressive disorder, generalized anxiety disorder, attention-deficit/hyperactivity disorder (ADHD), gender dysphoria, reactive attachment disorder, factitious disorder, unspecified neurodevelopmental disorder with difficulty in social functioning, parent-child relational problem, and academic or educational problem. The patients parent has requested reimbursement for the mental health RTC services provided from 9/7/21 through 9/24/21. The Health Insurer has denied the services that issue is not medically necessary. 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 RTC services provided from 9/7/21 through 9/24/21. For dimension 1, the patient was at serious risk of harm (score 4) due to a history of attempting suicide at least twice and engaging in self-injurious behaviors. The patient endorsed longstanding suicidal ideation. The patient has demonstrated physical aggression toward their mother. While hospitalized shortly before their admission to RTC, the patient required restraints on an almost daily basis to prevent them from self-harming. During the period under review, the patient engaged in self-harm and was physically aggressive toward others. The patient demonstrated current suicidal or homicidal ideation with either clear, expressed intentions and/or past history of carrying out such behavior. The patient expressed ambivalence about carrying out the safety plan and/or their familys ability to carry out the safety plan was compromised. For dimension 2, the patient demonstrated serious functional impairment (score 4) given their longstanding problems with hygiene and struggles with intermittent bowel and bladder incontinence. The provider noted that the patient exhibited odd behaviors including growling at staff and acting like an animal. The patient was noted to lack any ability to use coping skills. The patient engaged in dietary restrictions while hospitalized and showed difficulty expressing their needs to staff. During the period under review, the patient engaged in disruptive and unsafe behaviors including physical aggression toward staff. The patients participation in school during this time was inconsistent. The patient showed a consistent failure to age and/or appropriate to age and/or developmental level. Per the provider, the patient showed serious deterioration of interpersonal interactions with consistent conflict or otherwise disrupted interactions with others, which may have included impulsive or abusive behaviors. For dimension 3, the patient has significant co-occurrences (score 3) considering their diagnosis of ADHD, which is a neurodevelopmental disability. The patient also has insomnia. Anxiety and depression can cause insomnia and conversely, insomnia and lack of sleep can exacerbate anxiety and depressive symptoms. Thus, medical conditions were present that may have adversely affected, or been adversely affected by, the presenting condition. For dimension 4A, the patients recovery environment was moderately stressful (score 3). Per the provider, the patient is adopted and has a conflictual relationship with their adoptive mother. The patient has maintained contact with their biological mother and half-siblings on an annual basis. Overall, the role expectations appear to exceed the patients capacity given their age, status, and developmental level. For dimension 4B, the patients recovery environment was supportive (score 2). The provider noted that the patients mother participated in the patients treatment. The patients mother appeared to be supportive as evidenced by her advocacy for the patient. The patients family was willing and able to participate in treatment if requested to do so and had the capacity to affect needed changes. For dimension 5, the patient demonstrated poor resiliency and response to services (score 4) since previous treatment has not achieved remission of symptoms or optimal control of symptoms even with intensive and/or repeated exposure to interventions. The records indicate that prior treatment has included outpatient psychotherapy, psychiatric treatment including psychotropic medications, RTC, and two inpatient psychiatric hospitalizations. The provider charted that the patient has a long history of complex and refractory behavioral health conditions that have required intensive and specialized care. For dimension 6, the patient showed minimal engagement in services (score 4). The providers described the patient as unmotivated to participate in treatment and lacked the ability to use coping skills. During the period under review, the patient was unresponsive to the staff at times and was unable to process precipitating factors or triggers leading to unsafe behaviors. The patient was also noted to claim they did not remember their episodes of emotion dysregulation. The patient demonstrated a difficult and unproductive relationship with clinicians and other care providers. These findings give the patient a composite score of 24, which is consistent with Level 5 medically monitored residence-based services. Furthermore, per CALOCUS-CASII, the patients score of 4 for risk of harm and functional status co-occurrence also supports treatment with Level 5 medically monitored residence-based services. For these reasons, the requested RTC services provided from 9/7/21 through 9/24/21 were medically necessary for the treatment of this patient.
1
A 32-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1b.
Overturned
Medical Necessity
Summary Reviewer A 32-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees chronic hepatitis C virus genotype 1b. The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C virus, regardless of fibrosis, should be treated except those with a life expectancy of less than 12 months due to non-liver-related comorbid conditions. In addition, treatment naive patients are recommended to be treated with Harvoni for 12 weeks. These recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage. Moreover, it is beneficial to treat patients with hepatitis C before they progress to F3 or F4 fibrosis. For these reasons, the requested treatment with Harvoni is supported as medically necessary for treatment of this patients hepatitis C virus infection. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
The parent of a 17-year-old female enrollee has requested reimbursement for psychiatric residential treatment center services provided from 7/17/18 through 9/13/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. . The medical records indicate that the patient was not actively suicidal. She did engage in some self-harm behavior prior to her treatment. In terms of functional status, the records 3. The patient had issues with level of functioning due to mental illness in the past. She had been missing school due to her anxiety and withdrew from school in March 2018. During the initial portion of treatment, it was noted that she would at times go a few days between showers.
Upheld
Medical Necessity
Summary Reviewer The parent of a 17-year-old female enrollee has requested reimbursement for psychiatric residential treatment center services provided from 7/17/18 through 9/13/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. In terms of risk of harm, the records support a score of 2. The medical records indicate that the patient was not actively suicidal. She did engage in some self-harm behavior prior to her treatment. In terms of functional status, the records support a score of 3. The patient had issues with level of functioning due to mental illness in the past. She had been missing school due to her anxiety and withdrew from school in March 2018. During the initial portion of treatment, it was noted that she would at times go a few days between showers. With regards to comorbidity, the records support a score of 1. The patient did not have active medical problems or substance use that affected primary psychiatric issues. In terms of level of stress of the recovery environment, the records support a score of 2. There was no indication of an unsafe home environment. In terms of level of support of the recovery environment, the records support a score of 2. The patients family was actively involved in treatment on a regular basis. With regards to resiliency and treatment history, the records support a score of 3. She showed engagement with providers, and previous treatment had not been successful in optimal relief of symptoms. In terms of acceptance and engagement of the patient, the records support a score of 2. The patient was hesitant to participate in treatment after admission for a brief timeframe. Overall, she was cooperative in treatment. With regards to acceptance and engagement of the parents, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Therefore, the patient has a composite score of 17. This score correlates with intensive outpatient services. Therefore, psychiatric residential treatment center services provided from 7/17/18 through 9/13/18 were not medically necessary for the treatment of this patient.
1
The parent of a five-year-old male enrollee has requested reimbursement for immunoglobulin G (IgG) food testing performed on 9/27/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 1 The parent of a five-year-old male enrollee has requested reimbursement for immunoglobulin G (IgG) food testing performed on 9/27/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the current standard of care for treatment of food allergy is avoidance of the food allergen and treatment of anaphylaxis with auto- injectable epinephrine. However, this standard of care leaves much to be desired given the difficulty to maintain this practice, and the possibility of accidental ingestions with consequences. While many food allergy treatments, including oral immunotherapy, have been considered investigational by professional allergy societies and other key stakeholders, the Allergenic Products Advisory Committee of the Food and Drug Administration (FDA) has voted to support approval of a standardized oral immunotherapy (OIT) product for peanut allergy. Oral immunotherapy refers to feeding an allergic individual an increasing amount of an allergen with the goal of increasing the threshold that triggers a reaction. For example, an individual who is allergic to peanuts may be given very small amounts of peanut protein that would not trigger a reaction. This small amount is gradually increased in the allergists office or a clinical research setting over a period of months. The goal of therapy is to raise the threshold that may trigger a reaction and provide the allergic individual protection against accidental ingestion of the allergen. Efficacy in clinical trials has typically been defined by induction of a desensitized state. Desensitization refers to the improvement in food challenge outcomes after therapy and relies on ongoing exposure to the allergen. Peanut, eggs and milk oral immunotherapy have been shown to desensitize approximately 60 to 80% of patients studied. However, there are many important questions about oral immunotherapy that require ongoing study. The precise degree of protection is a topic of active investigation. The length of treatment and doses used have varied in published studies. Therefore, the best dose to give for any particular allergen is unknown. IgG4 testing is not approved for the diagnosis of food allergies. However, per the letter dated 2/08/22, the provider noted that the testing was recommended in order to monitor therapeutic efficacy of the tolerance induction program, a type of oral immunotherapy. Studies have shown the efficacy of environmental allergen immunotherapy not only by their decrease in specific IgE but also in their increase in specific IgG4 blocking antibody. Specifically concerning foods, Burton and colleagues showed that injection of specific egg IgG4 to mice facilitated tolerance to eggs. Therefore, researchers may use specific food IgG4 antibody levels to monitor the efficacy of oral immunotherapy. More importantly, recent studies have confirmed not only the use of repeat baseline and during treatment skin prick test and serum allergen specific IgE (sIgE) but also specific food IgG4 to monitor oral immunotherapy efficacy. Therefore, IgG food testing performed on 9/27/21 was likely to have been more beneficial than any available standard therapy.
0
A 45-year-old male enrollee has requested authorization and coverage for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. that the patients are exposed to particulate debris. This particulate debris consisting of abrasive wear and adhesive contact wear between the components of the device
Upheld
Experimental
Summary Reviewer 2 A 45-year-old male enrollee has requested authorization and coverage for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollees low back pain. The physician reviewer found the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. After implantation of metal and metal methylmethacrylate devices in the knee and hip, it has been demonstrated that the patients are exposed to particulate debris. This particulate debris consisting of abrasive wear and adhesive contact wear between the components of the device elicit a chronic inflammatory reaction including a giant cell tissue response. The effect of this exposure may vary from patient to patient but all patients will be exposed to the consequences of wear. Moreover, fusion at the L5-S1 level is not likely to effectively eliminate chronic inflammation with pro-inflammatory cytokines mediating the patients ongoing experience of lumbosacral regional pain. The extent of neural foraminal stenosis at L5-S1 is minimal based on two separate MRI studies performed. The clinical examination does not demonstrate motor deficits or sensory pattern changes beyond pain changes, and there is no definite evidence for spinal nerve root compromise. In this clinical setting, ongoing conservative management and continued observation is likely be more beneficial than surgical treatment plans. Accordingly, the request for hybrid artificial disc replacement at L4-5 and fusion at L5-S1 (CPT codes 22558, 22851, 22585, 22845, 20930, 63090, 63091 and 77003) are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
patient is a 23-year-old female who presented to her provider on 4/27/22. The patient has requested reimbursement for air ambulance transport on 5/6/22. . In this case, the patient had an extremely low body mass index with hyponatremia, hypotension, and renal dysfunction due to severe anorexia nervosa. In the course of air ambulance transfer, the patient required numerous intravenous medications including Ativan, Zofran, and Fentanyl due to anxiety, nausea, and abdominal pain. The patient had non- epileptiform seizure activity just prior to the flight and enroute to the receiving hospital. She continued to be hypotensive throughout the flight and required continuous cardiac monitoring.
Overturned
Medical Necessity
Summary Reviewer The patient is a 23-year-old female who presented to her provider on 4/27/22. The patient has requested reimbursement for air ambulance transport on 5/6/22. The physician reviewer found that at issue is whether air ambulance transport on 5/6/22 was medically necessary for the treatment of this patient. The submitted documentation supports the medical necessity of the service at issue. In this case, the patient had an extremely low body mass index with hyponatremia, hypotension, and renal dysfunction due to severe anorexia nervosa. In the course of air ambulance transfer, the patient required numerous intravenous medications including Ativan, Zofran, and Fentanyl due to anxiety, nausea, and abdominal pain. The patient had non- epileptiform seizure activity just prior to the flight and enroute to the receiving hospital. She continued to be hypotensive throughout the flight and required continuous cardiac monitoring. Given the significant morbidity and mortality associated with medical ramifications of severe malnutrition and anorexia nervosa, and this patients clearly compromised medical state leading up to the transfer to specialized care and enroute, the service at issue was medically indicated to safely transfer the patient. Therefore, air ambulance transport on 5/6/22 was medically necessary for the treatment of this patient.
1
A 59-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier assay performed on 10/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule.
Overturned
Experimental
Summary Reviewer 2 A 59-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier assay performed on 10/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule. The physician reviewer found the medical evidence supports the services at issue in this clinical setting. Genetic testing is generally considered standard protocol on all fine needle aspirations performed on thyroid nodules. There is sufficient literature demonstrating that this testing can be performed to avoid needless surgeries. In this case, the results helped guide future management. In sum, Afirma Gene Expression Classifier assay performed on 10/12/15 was likely to have been more efficacious than other modalities for 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 20-year-old male enrollee has requested reimbursement for wilderness program services provided from 7/12/18 through 10/08/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. . He had failed lower levels of treatment to include psychiatric outpatient treatment (medication and therapy) following his inpatient admission in June 2018. In terms of readiness to change, the patient initially had limited insight for need for treatment but relented due to his parents continued requests and his deteriorating condition prior to admission. He had demonstrated a known resistance to being controlled. His perspectives
Overturned
Medical Necessity
Summary Reviewer A 20-year-old male enrollee has requested reimbursement for wilderness program services provided from 7/12/18 through 10/08/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that with regard to acute intoxication or withdrawal potential, there were no known signs of symptoms of withdrawal upon admission. However, the risk of protracted withdrawal symptoms, such as heightened anxiety, depression, leading to suicidal ideation warranted close monitoring and structure. In terms of biomedical conditions, the records noted a history of traumatic brain injury. As noted above, there are concerns regarding co-occurring traumatic brain injury and substance use disorder and the increased morbidity and mortality of continued substance use in patients with a known traumatic brain injury. With regard to emotional, behavioral, cognitive conditions, his mental status was sufficient to permit participation. Despite limitations placed on the patient by his parents, his behavior continued to escalate to the point that he was at high risk of harm to self or others if his substance use and related behaviors were not curtailed. He had failed lower levels of treatment to include psychiatric outpatient treatment (medication management and therapy) following his inpatient admission in June 2018. In terms of readiness to change, the patient initially had limited insight for need for treatment but relented due to his parents continued requests and his deteriorating condition prior to admission. He had demonstrated a known resistance to being controlled. His perspectives impaired his ability to make care decisions, as evidenced by his impulsive behaviors. With regard to relapse, continued use, or continued problem potential, the patient had risk-taking behavior that was escalating to the point of aggression and not responding to parental limits, leading to a prior inpatient psychiatric admission. However, after discharge from the hospital, little change occurred. His maladaptive behaviors, such as need for immediate gratification, poor judgment, limited coping skills and low frustration tolerance, placed him at imminent danger of relapse if not in a structured setting that provided tools for improved coping and living a sober lifestyle. In terms of recovery environment, the home setting (with his parents) was not conducive to continued recovery. Therefore, wilderness program services provided from 7/12/18 through 10/08/18 were medically necessary for the treatment of this patient.
1
A 32-year-old female enrollee has requested reimbursement for bilateral breast magnetic resonance imaging (MRI) performed on 1/28/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who tested positive for BRCA1 mutation.
Overturned
Experimental
Summary Reviewer 1 A 32-year-old female enrollee has requested reimbursement for bilateral breast magnetic resonance imaging (MRI) performed on 1/28/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who tested positive for BRCA1 mutation. The physician reviewer found that the limitations of mammography in the detection of breast cancer in patients with dense tissue have been well-documented. In patients with BRCA1 mutation, there is a markedly elevated lifetime risk of breast cancer exceeding 75%. MRI has been shown to be far superior to mammography in the detection of breast cancer. The medical evidence supports the services at issue in this clinical setting. Therefore, bilateral breast MRI performed on 1/28/18 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 32-year-old male enrollee has requested reimbursement for gene testing performed on 3/12/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 3 A 32-year-old male enrollee has requested reimbursement for gene testing performed on 3/12/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that 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 the DecisionDx-Melanoma assay 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. Thus, gene testing performed on 3/12/19 was not likely to have been more beneficial than other methods of evaluating this patient.
0
patient is a 64-year-old female with a longstanding history of eczema. The patient has requested authorization and coverage for Dupixent. This patient has chronic recalcitrant eczema which has failed topical treatment.
Overturned
Medical Necessity
Summary Reviewer The patient is a 64-year-old female with a longstanding history of eczema. The patient has requested authorization and coverage for Dupixent. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. This patient has chronic recalcitrant eczema which has failed topical treatment. Dupilumab has been approved by the U.S. Food and Drug Administration (FDA) for patients with atopic eczema that warrants systemic treatment. This medication has been demonstrated to be safe and effective in this clinical setting. Therefore, Dupixent is medically necessary for the treatment of this patient.
1
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 12/18/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
Overturned
Experimental
Summary Reviewer 2 A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 12/18/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this patients case. The addition of digital breast tomosynthesis to screening mammography reduces false positives and increases cancer detection when compared to two-dimensional mammography alone. Breast tomosynthesis allows for separation of structures to differentiate architectural distortion from masses and overlapping fibroglandular tissue (asymmetries). The medical literature supports the use of breast tomosynthesis in the routine screening population. Therefore, digital breast tomosynthesis performed on 12/18/15 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 33-year-old female enrollee has requested reimbursement for fecal lactoferrin testing performed on 12/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition. the patient had gastrointestinal symptoms, such as mucus in her stool, which
Upheld
Experimental
Summary Reviewer 2 A 33-year-old female enrollee has requested reimbursement for fecal lactoferrin testing performed on 12/06/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition. The physician reviewer found that the patient had gastrointestinal symptoms, such as mucus in her stool, which could be consistent with irritable bowel syndrome, or with inflammatory bowel disease (CrohnAaas disease or ulcerative colitis). The American College of Gastroenterology guidelines for the management of CrohnAaas disease support the use of fecal calprotectin testing, stating that when there are symptoms concerning for active CrohnAaas disease, AaAFecal calprotectin and fecal lactoferrin measurements may have an adjunctive role in monitoring disease activityAaA and AaAstudies have shown that both fecal lactoferrin and fecal calprotectin are sensitive markers of disease activity and correlate with a number of the endoscopic activity indicesAaA Lactoferrin testing is a highly sensitive, low-risk test to assess for inflammatory bowel disease. Therefore, fecal lactoferrin testing performed on 12/06/19 was likely to have been more beneficial than any available standard therapy.
1
A 33-year-old female enrollee has requested reimbursement for homocysteine testing, Factor V Leiden genetic testing and methylenetetrahydrofolate reductase (MTHFR) performed on 8/7/15. The Health Insurer has denied this request indicating that the services at were considered investigational for evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 2 A 33-year-old female enrollee has requested reimbursement for homocysteine testing, Factor V Leiden genetic testing and methylenetetrahydrofolate reductase (MTHFR) performed on 8/7/15. The Health Insurer has denied this request indicating that the services at were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that according to the medical records the patient has undergone one pregnancy loss. The American Society for Reproductive Medicine, in its Practice Committee Opinion, defines recurrent pregnancy loss as the occurrence of two or more miscarriages. Therefore the patient does not meet the standard of care definition of recurrent pregnancy loss. The American Society for Reproductive Medicine, in its practice committee opinion states Screening for inherited thrombophilias (specifically, Factor V Leiden and the prothrombin gene mutations, protein C, protein S, and antithrombin deficiencies) may be clinically justified when a patient has a personal history of venous thromboembolism in the setting of a non-recurrent risk factor (such as surgery) or a first-degree relative with a known or suspected high-risk thrombophilia. Although an association between hereditary thrombophilias and fetal loss has been suggested, prospective cohort studies have failed to confirm this. Routine testing of women with recurrent pregnancy loss for inherited thrombophilias is not currently recommended. There is no evidence that the patient has a personal or family history of a thrombophilia. Therefore there is a lack of support for the Factor V Leiden testing or any other tests for inherited thrombophilias. In addition, there is a lack of support in the peer-reviewed literature that a significant association of MTHFR and recurrent miscarriage exists. Therefore, MTHFR testing is not within the standard of care and was not likely to be more beneficial for evaluation of the enrollees medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
The patient is a 41-year-old male who was involved in a motor vehicle accident in 2002, which resulted in a left brachial plexus injury. There has been residual severe left arm weakness distal to the shoulder despite extensive treatment including nerve transfers in 2003 and 2005, static orthoses and physical therapy. He has been effectively one handed functionally. A myoelectric elbow-wrist-hand orthosis has been of the sound contralateral upper limb from overuse syndrome. The patient has requested authorization and coverage for MyoPro device. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of this patients medical condition.
Upheld
Experimental
Summary Reviewer 1 The patient is a 41-year-old male who was involved in a motor vehicle accident in 2002, which resulted in a left brachial plexus injury. There has been residual severe left arm weakness distal to the shoulder despite extensive treatment including nerve transfers in 2003 and 2005, static orthoses and physical therapy. He has been effectively one handed functionally. A myoelectric elbow-wrist-hand orthosis has been recommended for promotion of bimanual activities and protection of the sound contralateral upper limb from overuse syndrome. The patient has requested authorization and coverage for MyoPro device. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of this patients medical condition. The medical literature regarding the potential benefit from this type of device is limited to preclinical work, developmental work and small anecdotal reports. The requested device is not yet proven to provide functional improvements that could not be achieved through standard occupational therapy interventions with static orthoses and durable medical device used for assisting with self care and other activities. It is not well known whether users will adopt the device for regular functional use in the long term or if the device itself causes injuries with long term use (e.g., at the shoulder due to the equipments weight). Current commercially available iterations of this type of device remain heavy, bulky, difficult to wear, and difficult to use on a practical basis. Further study is required to determine its efficacy and safety when compared to standard means of treatment. As such, the requested device is not reasonably expected to favorably affect this patients clinical or functional outcomes. Therefore, the MyoPro device is not likely to be more effective than the standard therapies available for the treatment of this patients medical condition. Based upon the information set forth above, the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 35-year-old female enrollee has requested reimbursement for colorectal cancer screening using chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. . The patient has had a colon polyp (of the serrated type) in the past, and
Overturned
Experimental
Summary Reviewer 1 A 35-year-old female enrollee has requested reimbursement for colorectal cancer screening using chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that as noted by Marion and colleagues, chromoendoscopy is supported as superior to alternatives for localization of dysplasia in randomized trials. Per American Society for Gastrointestinal Endoscopy (ASGE) guidelines for inflammatory bowel disease, chromoendoscopy allows better characterization of visible lesions as endoscopically resectable or unresectable, and chromoendoscopy with targeted biopsies is the preferred surveillance technique to maximize dysplasia detection. Per American Gastroenterological Association guidelines, Dye spray chromoendoscopy...should be considered in all persons with colonic inflammatory bowel disease undergoing surveillance colonoscopy, particularly if a standard definition endoscope is used or if there is a history of dysplasia. The patient has had a colon polyp (of the serrated type) in the past, and aside from that, warrants surveillance biopsies for dysplasia given the diagnosis of ulcerative colitis. Per the guidelines cited above, surveillance colonoscopies should be performed using chromoendoscopy when possible. Therefore, colorectal cancer screening using chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22 was likely to have been more beneficial than any available standard therapy.
1
The parent of a 16-year-old male insured has requested reimbursement for a laboratory test performed on 2/10/23. The Health Insurer has denied this request indicating that the services at issue were considered investigational for the evaluation of the insureds Chrons disease.
Overturned
Experimental
Summary Reviewer 2 The parent of a 16-year-old male insured has requested reimbursement for a laboratory test performed on 2/10/23. The Health Insurer has denied this request indicating that the services at issue were considered investigational for the evaluation of the insureds Chrons disease. The physician reviewer found that the use of infliximab trough levels and antibodies have become standard in clinical practice to determine if infliximab dosing is appropriate and whether a patient has lost, or is likely to lose, responsiveness to treatment due to the formation of antibodies to infliximab. These lab tests lead to adjustments in treatment, as low serum drug troughs and elevated antibody levels are predictive and explanatory of disease flare. Routine monitoring of asymptomatic patients is now being done to prevent flares by ensuring appropriate drug levels. According to Hyams and colleagues, It is clear that whether monotherapy or combination biologic therapy is used, we are now in the age where monitoring drug and antibody levels should be considered standard of care. Although the use of proactive versus reactive monitoring remains in question, measurement of infliximab levels and antibodies is considered the standard of care. In this case, the lab testing was performed in response to a dosage change and was thus appropriate. All told, the laboratory test performed on 2/10/23 was likely to have been more beneficial for the evaluation of the patients condition than any available standard therapy.
0
The patient is a 49-year-old transgender female who is seeking facial feminization surgery. Her primary care provider, surgeon, and psychologist all In this case, the patient has been diagnosed with gender dysphoria.
Overturned
Medical Necessity
Summary Reviewer The patient is a 49-year-old transgender female who is seeking facial feminization surgery. Her primary care provider, surgeon, and psychologist all assert that facial feminization surgery is a medically necessary treatment for her gender dysphoria. The physician reviewer found that facial feminization surgery is medically necessary for some patients as a treatment for gender dysphoria. Ainsworth and Spiegel demonstrated that facial feminization surgery, like genital surgery, aimproved mental health-related quality of life.a The World Professional Association for Transgender Health (WPATH) position statement notes, aNon-genital surgical proceduresa notably facial feminization surgeryaare often of greater practical significance in the patientas daily life than reconstruction of the genitalsaThese reconstructive procedures are not optional in any meaningful sense, but are understood to be medically necessary for the treatment of the diagnosed condition.a In this case, the patient has been diagnosed with gender dysphoria. The medical evidence supports the requested services in this clinical setting. Therefore, the requested facial feminization surgery is medically necessary for the treatment of this patient.
1
The patient is a 58-year-old female who has been diagnosed with multiple sclerosis and type 1 diabetes. The patient has requested authorization and coverage for Acthar (corticotropin injectable gel 80 U/ml). 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 58-year-old female who has been diagnosed with multiple sclerosis and type 1 diabetes. The patient has requested authorization and coverage for Acthar (corticotropin injectable gel 80 U/ml). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that standard therapy for acute exacerbations of multiple sclerosis has been high-dose corticosteroid therapy. Adrenocorticotropic hormone (ACTH, Acthar Gel) is also approved by the U.S. Food and Drug Administration (FDA) for the treatment of exacerbations of multiple sclerosis in adults. Other therapies include plasmapharesis and intravenous immunoglobulin (IVIG). Plasmapharesis is generally reserved for treatment of relapses that are severe or refractory to treatment with high-dose corticosteroids or ACTH. IVIG is sometimes used in patients for whom high-dose corticosteroids are contraindicated or not tolerated, but there is a lack of consistent evidence for its use in relapse management. Ross and colleagues noted, aAdrenocorticotropic hormone gel, as previously noted, may be considered as an alternative treatment of multiple sclerosis relapses. In our experience, reasons for using adrenocorticotropic hormone include a lack of benefit established with corticosteroids, inability to tolerate corticosteroids or adverse effects, and poor intravenous access. Its efficacy has been studied in several published investigations, and treatment outcomes may be comparable to those seen with corticosteroids.a In a randomized, open-label, crossover study, Bell and colleagues evaluated 18 patients with multiple sclerosis treated with subcutaneous Acthar Gel and intravenous methylprednisolone. Preliminary results suggest that fewer drug-related adverse effects occurred with Acthar Gel than intravenous methylprednisolone for treatment of multiple sclerosis exacerbations. In this case, the patient has multiple sclerosis and is seeking approval for Acthar Gel for treatment of acute exacerbations. Acthar Gel is currently an FDA approved therapy for multiple sclerosis exacerbations, and the studies noted above report less adverse effects with Acthar Gel and comparable efficacy and treatment outcomes compared with intravenous corticosteroid therapy. Clinically, Acthar Gel has been effective for the patient and she has not experienced any significant side effects with Acthar Gel. Therefore, Acthar (corticotropin injectable gel 80 U/ml) is medically necessary for the treatment of this patient.
1
The patient is a 61-year-old female who was diagnosed with advanced stage serous ovarian cancer at surgery in 2008. The surgery was followed by six cycles of cisplatin and Taxol. She had recurrence and was treated with a variety of chemotherapeutic agents, including carboplatin, Avastin, Gemzar, Doxil, and Topotecan. She also had been treated on a clinical trial with olaparib. The patient has requested reimbursement for blood testing performed on 3/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational.
Overturned
Experimental
Summary Reviewer 3 The patient is a 61-year-old female who was diagnosed with advanced stage serous ovarian cancer at surgery in 2008. The surgery was followed by six cycles of cisplatin and Taxol. She had recurrence and was treated with a variety of chemotherapeutic agents, including carboplatin, Avastin, Gemzar, Doxil, and Topotecan. She also had been treated on a clinical trial with olaparib. The patient has requested reimbursement for blood testing performed on 3/16/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. FoundationOne is a molecular assay that explores the mutations of an individual patients cancer cells. The goal of the assay is to identify a specific mutation or target which could guide the provider as to which chemotherapeutic agent would be useful. However, there is a paucity of evidence that the FoundationOne assay adds to decision making ability, or yields a result that is reliably clinically beneficial. There are non-randomized studies exploring the value of molecular profiling, but the results have not been convincing as to the efficacy of such an approach to treatment (Von Hoff, et al). A randomized trial did not demonstrate a significant clinical benefit from choosing therapy based on molecular targets versus by the providers clinical judgment (LeTourneau, et al). Currently, the data suggests that finding a mutation does not support treatment directed at that target to produce a clinically meaningful response. All told, the blood testing performed on 3/16/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 27-year-old female enrollee has requested authorization and coverage for proton beam therapy for six weeks. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees breast cancer.
Upheld
Experimental
Summary Reviewer 2 A 27-year-old female enrollee has requested authorization and coverage for proton beam therapy for six weeks. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees breast cancer. The physician reviewer found that there is a lack of clinical data in the medical literature to suggest that treatment with proton beam radiation offers a superior clinical benefit when compared to conventional radiation therapy techniques for breast cancer. The standard techniques to use in this clinical setting are with three-dimensional conformal or intensity modulated radiation therapy with photons instead of protons. Consensus group guidelines do not support the use of proton therapy in this setting (National Comprehensive Cancer Network Guidelines). Also, there is a lack of level I evidence to support the use of proton therapy for the treatment of breast cancer. There is a lack of clinical data to suggest that treatment with proton techniques will be able to improve the sparing of the skin, heart, and/or lungs compared to standard intensity modulated breast radiation with photon techniques. As such, proton beam therapy for six weeks is not likely to be more beneficial than other standard modalities for treatment of this patient. Therefore, for the reasons stated above, the requested services are not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 23-year-old female enrollee has requested reimbursement for genotype testing performed on 11/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health conditions. the documentation indicates that the patient has a history of mood and anxiety problems. She also reported a significant history of substance use. medication trials which the patient has attempted for her psychiatric conditions.
Upheld
Experimental
Summary Reviewer 3 A 23-year-old female enrollee has requested reimbursement for genotype testing performed on 11/10/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health conditions. The physician reviewer found that the documentation indicates that the patient has a history of mood and anxiety problems. She also reported a significant history of substance use. The submitted records do not indicate past medication trials which the patient has attempted for her psychiatric conditions. It appears that the patient has attempted non-medication treatment, such as psychotherapy, but details of this were not provided. It is not clear that the patient has had cognitive behavioral therapy for her major depressive disorder or generalized anxiety disorder diagnoses. It is not clear that the patient has tried other forms of psychotherapy that have been shown to be effective for her diagnoses. Cognitive behavioral therapy is a first-line treatment for the patients conditions. Thus, genotype testing performed on 11/10/17 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 47-year-old female enrollee has requested authorization and coverage for treprostinil (Orenitram) tablets. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees pulmonary arterial hypertension. with WHO functional class II-III symptoms. This patient has been diagnosed with PAH consistent with WHO Group 1, NYHA functional class III. The patient underwent reactive testing, which was consistent with the etiology of PAH. The patient underwent the appropriate testing and was considered to be a candidate for Orenitram.
Overturned
Medical Necessity
Summary Reviewer A 47-year-old female enrollee has requested authorization and coverage for treprostinil (Orenitram) tablets. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees pulmonary arterial hypertension. The physician reviewer found the U.S. Food and Drug Administration (FDA) indicates that Orenitram is a prostacyclin vasodilator indicated for treatment of PAH with WHO Group 1 to improve exercise capacity. The study that established effectiveness included predominately patients with WHO functional class II-III symptoms. This patient has been diagnosed with PAH consistent with WHO Group 1, NYHA functional class III. The patient underwent reactive testing, which was consistent with the etiology of PAH. The patient underwent the appropriate testing and was considered to be a candidate for Orenitram. All told, Orenitram is FDA approved for treatment of this patients medical condition and the literature supports the requested therapy for use in this clinical setting. Thus, the requested Orenitram is medically necessary for treatment of this patients PAH. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 37-year-old male enrollee has requested reimbursement for single-photon emission computed tomography (SPECT) imaging (CPT 78607) provided on 2/22/17 and 2/23/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees behavioral health conditions.
Upheld
Medical Necessity
Summary Reviewer A 37-year-old male enrollee has requested reimbursement for single-photon emission computed tomography (SPECT) imaging (CPT 78607) provided on 2/22/17 and 2/23/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees behavioral health conditions. The physician reviewer found that SPECT is a sophisticated nuclear medicine study that examines blood flow in the brain with the assistance of a radioactive tracer that is introduced to the patients body. Brain activity demands blood flow, so it is postulated that SPECT can provide information regarding hyperactive, suboptimal or normal functionality of specific brain structures and regions. Advances in neuroimaging techniques, such as SPECT, represent an exciting, and potentially useful, expansion of the collective knowledge base. However, the technology is still in its infancy, and meaningful correlation between clinical diagnoses and specific brain activity patterns does not yet exist. Additionally, the documentation did not indicate that first-line strategies for the treatment of mood and anxiety disorders had been exhausted. Further, it was noted that the patient had urges to associate with other women only when he drinks, but there was no discussion about the possibility of an alcohol use disorder or interventions to ameliorate that precipitating factor. In sum, considering the relevant peer-reviewed literature and current practice standards in the United States, at this point in time, SPECT is not a standard diagnostic intervention. Further, it has not been established that the disputed neuroimaging yielded information that significantly influenced treatment decisions, improved the patients condition, prevented a more serious episode of illness or reduced the psychiatric morbidity. Thus, SPECT imaging (CPT 78607) provided on 2/22/17 and 2/23/17 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
0
The patient is a 55-year-old male with a history of hearing loss and vertigo which has been responsive to prednisone. He was treated with Simponi injections in August 2017. The patient has requested authorization and coverage for Simponi 50 mg injections once per month for one year (J1602). The Health Insurer has denied this request indicating that the requested medication is considered investigational. The records indicate that this patient has autoimmune hearing loss. The patient has been treated with high dose prednisone as well as Atabrine.
Upheld
Experimental
Summary Reviewer 1 The patient is a 55-year-old male with a history of hearing loss and vertigo which has been responsive to prednisone. He was treated with Simponi injections in August 2017. The patient has requested authorization and coverage for Simponi 50 mg injections once per month for one year (J1602). The Health Insurer has denied this request indicating that the requested medication is considered investigational. The records indicate that this patient has autoimmune hearing loss. The patient has been treated with high dose prednisone as well as Atabrine. However, there is a paucity of peer-reviewed medical literature supporting the use of tumor necrosis factor (TNF) blockers for the treatment of autoimmune hearing loss (Derebery, et al; Van Wijk, et al). Thus, the requested Simponi 50 mg injections once per month for one year (J1602) are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
The parent of a 14-year-old female enrollee has requested reimbursement for acute psychiatric inpatient treatment provided from 4/15/19 through 5/03/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The records documented an extreme risk of harm, due to suicidal ideation with plan and recent self-harm. The patient had serious functional impairment due to conflict with parents and recent threats of self-harm. patient had a moderately stressful environment due to multiple school changes and recent trauma involving an online pedophile making threats to harm the patient and her family. The patient had a supportive environment due to her parents involvement in treatment and treatment planning. The patient had minimal response to recent treatment, including multiple hospitalizations and residential treatment.
Overturned
Medical Necessity
Summary Reviewer The parent of a 14-year-old female enrollee has requested reimbursement for acute psychiatric inpatient treatment provided from 4/15/19 through 5/03/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the Child and Adolescent Level of Care Utilization System (CALOCUS) provides a framework for determining the clinically appropriate level of care for a child or adolescent in mental health treatment. In terms of risk of harm, the records support a score of 5. The records documented an extreme risk of harm, due to suicidal ideation with plan and recent self-harm. With regard to functional status, the records support a score of 4. The patient had serious functional impairment due to conflict with parents and recent threats of self-harm. In terms of comorbidity, the records support a score of 1. There was no comorbidity, due to lack of substance abuse, medical concerns, or developmental concerns. With regard to stress of the recovery environment, the records support a score of 3. The patient had a moderately stressful environment due to multiple school changes and recent trauma involving an online pedophile making threats to harm the patient and her family. In terms of environmental support, the records support a score of 2. The patient had a supportive environment due to her parents involvement in treatment and treatment planning. With regard to resiliency and treatment history, the records support a score of 5. The patient had minimal response to recent treatment, including multiple hospitalizations and residential treatment. In terms of treatment acceptance and engagement, the records support a score of 4. The patient demonstrated initial resistance to participating in treatment. Thus, the patient has a total score of 24. Due to the extreme risk of harm, medically managed residence-based services were indicated. Furthermore, due to multiple recent treatment failures with shorter hospitalizations, an extended hospitalization incorporating an extended diagnostic assessment, intensive treatment and careful treatment planning was indicated for this high-risk patient. Therefore, acute psychiatric inpatient treatment provided from 4/15/19 through 5/03/19 was medically necessary for the treatment of this patient.
1
A 42-year-old female enrollee has requested authorization and coverage for destruction of intraosseous basivertebral nerve. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. a In this case, the patient has had a history of chronic low back pain that has persisted for several years, which has been ref
Overturned
Experimental
Summary Reviewer 3 A 42-year-old female enrollee has requested authorization and coverage for destruction of intraosseous basivertebral nerve. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that Fischgrund and colleagues performed a randomized controlled trial regarding the two-year clinical outcomes for chronic low back pain patients treated with radiofrequency ablation of the basivertebral nerve. The authors noted, aBasivertebral nerve ablation appears to be a safe, durable, minimally invasive treatment for the relief of chronic low back pain in a patient population that typically has few effective treatment options.a Lorio and colleagues concluded, aThe procedure is supported by level 1 evidence including two randomized controlled trials demonstrating a statistically significant decrease in pain and an improvement in function with outcomes sustained to at least 24 months in a limited number of studies.a In this case, the patient has had a history of chronic low back pain that has persisted for several years, which has been refractory to multiple modes of standard care. Based on the available medical records for review and the current studies, the requested services are likely to be superior over other treatment options. Thus, destruction of intraosseous basivertebral nerve is likely to be more beneficial than any available standard therapy.
1
A 63-year-old male enrollee has requested reimbursement for Decision Dx Assay testing performed on 7/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees melanoma.
Upheld
Experimental
Summary Reviewer 2 A 63-year-old male enrollee has requested reimbursement for Decision Dx Assay testing performed on 7/18/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees melanoma. The physician reviewer found the Decision Dx Assay tests the tissue genetics of the melanoma and can stratify whether a thin melanoma is high risk for metastasis or not. The patients provider recommended Decision Dx where the genes are examined for certain markers and then the lesion can be further stratified to tell if it is high risk for metastasis. This test has shown some accuracy in thin melanomas like this patients. However, the treatment of this patient would not change based on the results of the testing. Moreover, the testing at issue is not the standard of care. There is a lack of peer-reviewed literature to support its use in the care of patients with thin melanomas to effect health outcomes. Given the lack of support in the peer-reviewed literature, the Decision Dx Assay testing performed on 7/18/16 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
The patient is a 64-year-old female with a history of chronic right knee pain due to osteoarthritis. The patient has requested reimbursement for Hyaluronan injections provided on 11/05/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. . She had tried and failed other conservative treatments, including bracing and medication, with the alternative being a total knee arthroplasty.
Overturned
Medical Necessity
Summary Reviewer The patient is a 64-year-old female with a history of chronic right knee pain due to osteoarthritis. The patient has requested reimbursement for Hyaluronan injections provided on 11/05/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that an exhaustive review of the current medical literature pertaining to viscosupplementation reveals mixed results. Evidence from eight systematic reviews and six randomized controlled trials indicates that although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is not known as to which individuals will benefit. Different studies have tried mixing hyaluronic acid with corticosteroids, platelet-rich plasma, and other agents to make it more effective. The current evidence is limited, and guidelines from organizations such as the American Academy of Orthopedic Surgeons indicate that the evidence is not conclusive. In light of the foregoing, viscosupplementation can only be recommended in individuals with a history of lasting benefit from prior injections, and in carefully selected cases where everything else has been tried, and the options are limited. In this case, the patientas options were limited. She had tried and failed other conservative treatments, including bracing and medication, with the alternative being a total knee arthroplasty. Therefore, Hyaluronan injections provided on 11/05/20 were medically necessary for the treatment of this patient.
1
A 48-year-old female enrollee has requested reimbursement for laparoscopic gastric sleeve (CPT 43775) performed on 12/17/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees morbid obesity. This patient is an adult with morbid obesity. Per the records, her body mass index was greater than 40 kg/m2 (it was 44.9 kg/m2). The patient documented prior dietary efforts and completed a multidisciplinary evaluation that did not reveal any obvious medical, dietary or behavioral barriers to surgery. The patient
Overturned
Medical Necessity
Summary Reviewer A 48-year-old female enrollee has requested reimbursement for laparoscopic gastric sleeve (CPT 43775) performed on 12/17/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees morbid obesity. The physician reviewer found the submitted documentation supports the medical necessity of the services at issue. This patient is an adult with morbid obesity. Per the records, her body mass index was greater than 40 kg/m2 (it was 44.9 kg/m2). The patient documented prior dietary efforts and completed a multidisciplinary evaluation that did not reveal any obvious medical, dietary or behavioral barriers to surgery. The patient met standard nationally accepted criteria for bariatric surgery. The current medical evidence supports the services at issue in this clinical setting. All told, laparoscopic gastric sleeve performed on 12/17/15 was medically indicated for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 39-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 9/6/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees breast examination.
Overturned
Experimental
Summary Reviewer 2 A 39-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 9/6/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees breast examination. The physician reviewer found that in the peer-reviewed medical literature, Skaane and colleagues found that the addition of three-dimensional digital breast tomosynthesis to two-dimensional full field digital mammography resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Thus, although additional studies are needed to confirm these findings, there is adequate data to support the utility of three-dimensional digital breast tomosynthesis in this clinical setting. For these reasons, the breast tomosynthesis performed on 9/6/16 was likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 49-year-old female enrollee has requested reimbursement for Tempus xT gene panel performed on 3/16/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
Overturned
Experimental
Summary Reviewer 1 A 49-year-old female enrollee has requested reimbursement for Tempus xT gene panel performed on 3/16/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that individualized molecular tumor profiling holds the promise of enabling personalized selection of molecularly targeted treatment based on the specific genotype identified. Several platforms are available, including the Tempus gene panel. The National Comprehensive Cancer Network guidelines recommend tumor molecular testing prior to initiation of therapy for recurrent or persistent ovarian cancer, if not previously done. Molecular profiling is now considered a standard of care in patients with recurrent or persistent ovarian cancer. There is sufficient support for the services at issue in this clinical setting. Therefore, the Tempus xT gene panel performed on 3/16/20 was likely to have been more beneficial than any available standard therapy.
0
A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 12/03/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has been diagnosed with osteoporosis.
Overturned
Experimental
Summary Reviewer 1 A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 12/03/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has been diagnosed with osteoporosis. The physician reviewer found that bone mineral density (BMD) assessment, via dual-energy x-ray absorptiometry (DEXA) is still the criterion standard for evaluation and diagnosis of osteoporosis. However, because changes in bone mass and density in response to antiresorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover may be a useful adjunct in monitoring of osteoporotic patients treated with antiresorptive agents. The medical evidence suggests that biochemical markers could be useful in making therapeutic decisions because, in general, the higher the bone remodeling and bone loss rates, the greater the concentration of bone biochemical markers in blood or urine. There is sufficient support for the services at issue in this clinical setting. All told, laboratory testing (collagen crosslink testing) performed on 12/03/16 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.
0
A 68-year-old female enrollee has requested DecisionDX melanoma assay test performed on 6/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
Overturned
Experimental
Summary Reviewer 3 A 68-year-old female enrollee has requested DecisionDX melanoma assay test performed on 6/19/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found this patient has a rare disease, ocular melanoma, which has a poor prognosis once it metastasizes. However, knowledge of the propensity for metastasis directly affects surveillance of patients by computed tomography (CT) scan. The gene expression classifier DecisionDX defines two classes of ocular melanoma. Class I is associated with a low risk of metastasis and class 2 has a 50% risk at two years and 72% risk at five years. There is no other standard prognostic indicator that could serve as an alternative. Thus, the current medical evidence favors the use of this test in the postoperative surveillance of patients with ocular melanoma. In sum, the DecisionDX melanoma assay test was likely to have been of greater efficacy than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
0
A 28-year-old female enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees persistent asthma and shortness of breath. muscle of the airway. The tissue is heated to 65 degrees centigrade.
Overturned
Experimental
Summary Reviewer 3 A 28-year-old female enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees persistent asthma and shortness of breath. The physician reviewer found that bronchial thermoplasty is a procedure that uses a bronchoscope probe/catheter to provide thermal energy to the smooth muscle of the airway. The tissue is heated to 65 degrees centigrade. There are three bronchoscopic procedures. The first treats the right lower lobe, the second the left lower lobe, and the third bronchoscopic procedure is for both upper lobes. The procedures are scheduled three weeks apart. This patients provider states the patient has a progressive decrease in the quality of life, but there is a lack of documentation that the use bronchial thermoplasty would improve the long-term functional outcome of the patients condition. Thus, the requested bronchial thermoplasty is not likely to provide this patient with an improved health outcome when compared with standard alternatives. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
patient is a 33-year-old female who had preconception genetic carrier screening with her spouse.Both were found to be carriers of a cystic fibrosis (CF) gene mutation.
Overturned
Medical Necessity
Summary Reviewer The patient is a 33-year-old female who had preconception genetic carrier screening with her spouse.Both were found to be carriers of a cystic fibrosis (CF) gene mutation. The physician reviewer found that the basis of screening patients pre-conception for CF among other conditions is to provide actionable information to avoid having an affected child. This was done in this case, and provided the impetus to pursue what is currently the best option to avoid having a child with CF. In vitro fertilization with prenatal genetic screening essentially avoids the risk of having to terminate an affected pregnancy, or having a child with a serious lifelong and ultimately fatal condition. The American College of Obstetricians and Gynecologists (ACOG) Committee Opinion on pregnancy counseling notes, Couples at risk of having children with specific genetic diseases can be counseled about the disease inheritance and course and offered referral for potential interventions, such as preimplantation genetic testing. It recommends screening of all women who are planning a pregnancy for this reason. The ACOG Committee Opinion on Identification and Referral of Maternal Genetic Conditions in Pregnancy states, Patients with established causative mutations for a genetic condition, and who desire prenatal genetic testing, should be offered preimplantation genetic testing with in vitro fertilization by a reproductive endocrinologist. There is sufficient support for the requested services in this clinical setting. Therefore, the requested embryo transfer is medically necessary for the treatment of this patient.
1
The parent of a 13-year-old male enrollee has requested reimbursement for balloon sinus ostial dilation performed on 10/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees chronic sinus problems. . Chronic rhinosinusitis was documented in this patient. There was documentation that he was treated with maximal medical therapy prior to the computed tomography (CT) scan. He has been treated with multiple courses of antibiotics and with adenoidectomy, which is the first-l
Overturned
Experimental
Summary Reviewer 2 The parent of a 13-year-old male enrollee has requested reimbursement for balloon sinus ostial dilation performed on 10/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees chronic sinus problems. The physician reviewer found there is sufficient support for the services at issue in this patients case. The indication for balloon sinuplasty is chronic sinusitis refractory to maximal medical treatment. Chronic rhinosinusitis was documented in this patient. There was documentation that he was treated with maximal medical therapy prior to the computed tomography (CT) scan. He has been treated with multiple courses of antibiotics and with adenoidectomy, which is the first-line treatment for sinusitis in pediatric patients. Balloon sinuplasty is an effective therapy for chronic sinusitis patients and for pediatric patients. In sum, balloon sinus ostial dilation performed on 10/28/15 was likely to have been more efficacious than other treatment options. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
The patient is a 38-year-old female with a history of chronic left hip pain in the groin related to CAM type femoroacetabular impingement, with a small pincer and associated tear of the anterior-superior labrum. The patient has requested reimbursement for hip arthroscopy performed on 12/03/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. included arthroscopic surgery on her left hip consisting of acetabular rim trimming, repair of the labral tear, femoral osteochondroplasty, and capsular plication. The operative report describes the deformity that was corrected. Physical therapy was not helping at three months, and surgery was
Overturned
Medical Necessity
Summary Reviewer The patient is a 38-year-old female with a history of chronic left hip pain in the groin related to CAM type femoroacetabular impingement, with a small pincer and associated tear of the anterior-superior labrum. The patient has requested reimbursement for hip arthroscopy performed on 12/03/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. Femoroacetabular impingement is a common condition among young adults. Griffin and colleagues compared physical therapy and surgery for management of this condition. Among 348 participants, 171 participants were treated with hip arthroscopy and 177 were treated with hip physical therapy. Both treatments improved the quality of life. However, hip arthroscopy resulted in greater improvement than physical therapy. In this patientas case, the procedures performed at the time of hip arthroscopy were appropriate and are known to be beneficial. These included arthroscopic surgery on her left hip consisting of acetabular rim trimming, repair of the labral tear, femoral osteochondroplasty, and capsular plication. The operative report describes the deformity that was corrected. Physical therapy was not helping at three months, and surgery was medically indicated. Therefore, hip arthroscopy performed on 12/03/19 was medically necessary for the treatment of this patient.
1
A 64-year-old female enrollee has requested reimbursement for genetic testing performed on 1/27/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
Overturned
Experimental
Summary Reviewer 1 A 64-year-old female enrollee has requested reimbursement for genetic testing performed on 1/27/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that Guardant360 is a multigene assay done from circulating DNA in blood. It is capable of reliably detecting tumor-related genetic mutations and molecular abnormalities. The issue is whether such an assay can direct therapy to a clinically beneficial and reliable degree. Thus far, there has been a lack of convincing evidence that the Guardant360 assay is likely to be clinically beneficial in the treatment of breast cancer. Finding a mutation does not guarantee that a treatment directed at that atargeta will be successful. The likelihood of benefit from using therapy based on genomic assay is small. Therefore, genetic testing performed on 1/27/20 was not likely to have been more beneficial than other available standard therapy.
0
patient is a 27-year-old female with a history of lymphedema of the right lower extremity. The patient developed lymphedema of the right lower extremity in 2017, which spread to her calf and thigh by 2018. The provider recommended treatment with lymphaticovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) surgeries with inpatient hospital stay. The Health Insurer has denied the requested inpatient hospital stay associated with the approved LVA as not medically , the patient has a history of lymphedema of the right lower extremity and has been recommended treatment with LVA and VLNT surgeries. The records document that the patient has failed to improve despite treatment with SAPL of the right lower extremity, compression garments, and ablation procedures.
Overturned
Medical Necessity
Summary The patient is a 27-year-old female with a history of lymphedema of the right lower extremity. The patient developed lymphedema of the right lower extremity in 2017, which spread to her calf and thigh by 2018. The provider recommended treatment with lymphaticovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) surgeries with inpatient hospital stay. The Health Insurer has denied the requested inpatient hospital stay associated with the approved LVA as not medically necessary for treatment of the patients medical condition. This denial is the subject of this appeal and determination. The physician reviewer found that the current medical literature supports the use of LVA for treatment of patients with lymphedema. While LVA requires less hospitalization than VLNT, there is a lack of medical literature suggesting outpatient treatment is adequate for patients undergoing treatment with LVA. In a study by Cha and colleagues involving patients with advanced lymphedema that underwent LVA, the authors noted that, The patients were discharged on postoperative day 3 or 4, and they received education on proper compression therapy at discharge. In another study, Gallagher and colleagues reported that, The complication rate of LVA is low. These procedures can often be performed under local anesthesia, and there is minimal length of stay. In this case, the patient has a history of lymphedema of the right lower extremity and has been recommended treatment with LVA and VLNT surgeries. The records document that the patient has failed to improve despite treatment with SAPL of the right lower extremity, compression garments, and ablation procedures. Based on the medical literature, the requested inpatient hospital stay associated with approved LVA surgery is 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 3 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 standard of care for major depressive disorder involves treatment with different classes of antidepressants, such as selective serotonin reuptake inhibitors, serotoninAaanorepinephrine reuptake inhibitors, bupropion, mirtazapine or newer generation antidepressants. After a patient fails antidepressant trials from multiple classes, the standard of care is to then add an adjunctive medication, such as aripiprazole, quetiapine, risperidone, or lithium. This patient tried only one antidepressant. Psychotherapy (specifically cognitive behavioral therapy) is also highly recommended as a first-line treatment for depression as well as anxiety disorder, as well as the combination of pharmacotherapy and psychotherapy. There is no documentation provided that the patient failed psychotherapy. Given that there is no documentation (Patient Health Questionnaire 9 other other rating scores) of the patientAaas improvement before and after neurofeedback treatment, and this treatment has very little evidence showing benefit in this specific condition (major depression), standard therapy (adjunctive medications, CBT, other psychotherapy, ECT) should have been tried. 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 56-year-old male enrollee has requested reimbursement for the Cologuard test provided 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 colon cancer.
Upheld
Experimental
Summary Reviewer 2 A 56-year-old male enrollee has requested reimbursement for the Cologuard test provided 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 colon cancer. The physician reviewer found that conventional assessment of colorectal cancer risk largely involves detection of non-dysplastic adenomatous polyps. Cologuard is a stool DNA test that includes molecular assays for DNA mutation and methylation biomarkers (KRAS mutations, NDRG4, and BMP3 methylation) and a non-DNA immunochemical assay for human hemoglobin (e.g. FIT). Given the low sensitivity of Cologuard in detecting adenomas, the assay is not likely to be more beneficial for evaluation of the patients medical condition than the gold standard colonoscopy. Further, the records submitted for review do not support that the patient is contraindicated to more effective screening strategies. 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 35-year-old female enrollee has requested reimbursement for the three-dimensional (3D) mammogram provided on 10/31/16. The Health Insurer has denied this request indicating that the service at issue is considered investigational for evaluation of the enrollees risk of breast cancer.
Overturned
Experimental
Summary Reviewer 1 A 35-year-old female enrollee has requested reimbursement for the three-dimensional (3D) mammogram provided on 10/31/16. The Health Insurer has denied this request indicating that the service at issue is considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found that the 3D mammogram provided on 10/31/16 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. Ciatto and colleagues investigated the effect of integrated two dimensional (2D) and 3D mammography in the breast cancer screening population. The authors found that Integrated 2D and 3D mammography improves breast cancer detection and has the potential to reduce false positive recalls. Based on the documentation submitted for review and medical literature cited above, 3D mammogram was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
The patient is a 13-year-old who was admitted to a residential treatment center following hospitalization for depression, suicidality, and self-harm. The patients parent has requested reimbursement for residential treatment center services provided from 4/26/21 through 6/15/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
Overturned
Medical Necessity
Summary Reviewer The patient is a 13-year-old who was admitted to a residential treatment center following hospitalization for depression, suicidality, and self-harm. The patients parent has requested reimbursement for residential treatment center services provided from 4/26/21 through 6/15/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the 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, this patient met the criteria for residential treatment center services provided from 4/26/21 through 6/15/21. With regard to dimension I, risk of harm, the records support a score of 4. Just prior to 4/26/21 admission to the residential treatment center, the patient was taken to the emergency department on 4/12/21 after overdosing on blood pressure pills, Tylenol, and ibuprofen, with indications of ongoing suicidal ideation. The patient also was self-harming via superficial scratches. The patient has demonstrated a long history of reactivity and poor impulse control, with gender identity struggles, placing the patient at risk for suicide during this time period. With regard to dimension II, functional status, the records support a score of 4. The patient has had serious deterioration of interpersonal interactions with consistent conflict or otherwise disrupted interactions with others, including impulsive and abusive behaviors. The patient appeared to be oppositional, irritable, anxious and depressed, with poor communication patterns with their mother. The records documented a poor ability to accept boundaries. In terms of dimension III, co-occurrence of conditions: developmental, medical, substance use and psychiatric, the records support a score of 3. The patient demonstrated significant psychiatric signs and symptoms that persisted chronically and appeared to be moderately to severely debilitating, adversely affecting their ability to be safe in the community. The patient was also diagnosed with generalized anxiety disorder and gender dysphoria. With regard to dimension IV, sub-scale level of stress of the recovery environment, the records support a score of 3. The patient has been in an open adoption, with ongoing concerns around attachment issues and conflicts with their adoptive mother. The patients mother appears to have challenges with managing the degree of anxious distress that the patient has exhibited over the years. With regard to dimension IV, sub-scale level of support of the recovery environment, the records support a score of 3. Overall, the patients mother seems to have had had limited ability to respond appropriately to the patients developmental needs and/or problems or is ambivalent toward meeting these needs or addressing these problems. In terms of dimension V, resiliency and response to services, the records support a score of 4. The patient has demonstrated frequent evidence of innate vulnerability under stress and difficulty resuming progress toward the expected developmental level. Despite the familys efforts to assist, the patient has struggled chronically with mood and behavioral issues. While at the residential treatment center, the patient continued to demonstrate struggles with implementing positive change, continuing to endorse anxiety, poor sleep, and challenges with taking responsibility. In terms of dimension VI, engagement in services, the records support a score of 3. It appears as if the patient tended to have ambivalent and distrustful relationships with clinicians and other care providers and at times reported not feeling validated by their therapist or mother. The patient appeared to have a number of treatment interfering behaviors, with challenges in following through with agreed upon expectations. Thus, the patient has a composite score of 24. This score supports Medically Monitored Intensive Integrated Services. Therefore, residential treatment center services provided from 4/26/21 through 6/15/21 were medically necessary for the treatment of this patient.
1
A 63-year-old female enrollee has requested reimbursement for advanced lipoprotein testing performed on 10/19/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
Upheld
Experimental
Summary Reviewer 2 A 63-year-old female enrollee has requested reimbursement for advanced lipoprotein testing performed on 10/19/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the current medical evidence has not established the superior effectiveness of the services at issue. Lipoprotein particles, which carry cholesterol and triglycerides, are comprised in part of apolipoproteins. Although some have proposed that the measurement of lipoproteins or apolipoproteins may be useful in some patients, the 2010 American College of Cardiology Foundation/American Heart Association guideline for assessment of cardiovascular risk in asymptomatic adults does not recommend the use of these tests for cardiovascular risk assessment in asymptomatic adults. Therefore, advanced lipoprotein testing performed on 10/19/20 was not likely to have been more beneficial than other available standard methods of evaluation.
0
A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/31/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The patient is a 62-year-old asymptomatic female who was evaluated with screening mammogram and digital breast tomosynthesis on 3/31/16. The patient reported a positive family history for breast cancer. The patient also felt a lump in her right breast. She had bilateral mammography including breast tomosynthesis which revealed vague density requiring further ultrasound evaluation. The studies showed no mass. The patient has requested reimbursement for the breast tomosynthesis portion of her examination. The Health Insurer has denied reimbursement for digital breast tomosynthesis performed on 3/31/16. Per the Health Insurer, the service at issue was investigational for the evaluation of this patient.
Overturned
Experimental
Summary Reviewer 1 A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/31/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found The patient is a 62-year-old asymptomatic female who was evaluated with screening mammogram and digital breast tomosynthesis on 3/31/16. The patient reported a positive family history for breast cancer. The patient also felt a lump in her right breast. She had bilateral mammography including breast tomosynthesis which revealed vague density requiring further ultrasound evaluation. The studies showed no mass. The patient has requested reimbursement for the breast tomosynthesis portion of her examination. The Health Insurer has denied reimbursement for digital breast tomosynthesis performed on 3/31/16. Per the Health Insurer, the service at issue was investigational for the evaluation of this patient. There is evidenced base support for the service at issue in this clinical setting. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and biopsies and an increase in detection of small cancers when compared to two dimensional imaging alone. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. Therefore, the addition of digital breast tomosynthesis to the usual two dimensional protocol was likely to be more effective than had her examination been performed using two dimensional imaging alone. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
1
A 50-year-old female enrollee has requested reimbursement for laboratory services (82306) provided on 6/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollee, who has a history of anxiety, depression, insomnia and attention deficit disorder. This patient has a history of depression, anxiety, attention deficit disorder and insomnia. the patient has had cognitive behavioral therapy (CBT) for her major depressive disorder or anxiety disorder diagnoses.
Upheld
Medical Necessity
Summary Reviewer A 50-year-old female enrollee has requested reimbursement for laboratory services (82306) provided on 6/26/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollee, who has a history of anxiety, depression, insomnia and attention deficit disorder. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient has a history of depression, anxiety, attention deficit disorder and insomnia. The psychiatric literature does not support the use of testing for vitamin D or supplementation of vitamin D for psychiatric conditions. It is not clear that the patient has had cognitive behavioral therapy (CBT) for her major depressive disorder or anxiety disorder diagnoses. It is not clear that the patient has tried other forms of psychotherapy that have been shown to be effective for her diagnoses. CBT is a first-line treatment for the patients conditions. Vitamin D testing was not an evidence-based treatment approach in this patients case. All told, laboratory services (82306) provided on 6/26/18 were 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.
1
patient is a 43-year-old male who has been diagnosed with generalized anxiety disorder with panic attacks. In a letter dated 1/07/19, the patient reported that he was experiencing a panic attack when he asked his colleague to call 911. the patient believed that he may have been experiencing a myocardial infarction due to his symptoms. He requested an immediate emergency evaluation due to his symptoms, including loss of feeling in his extremities.
Overturned
Medical Necessity
Summary Reviewer The patient is a 43-year-old male who has been diagnosed with generalized anxiety disorder with panic attacks. In a letter dated 1/07/19, the patient reported that he was experiencing a panic attack when he asked his colleague to call 911. The physician reviewer found that per the submitted documentation, the patient believed that he may have been experiencing a myocardial infarction due to his symptoms. He requested an immediate emergency evaluation due to his symptoms, including loss of feeling in his extremities. Based on the records, a prudent layperson would have sought immediate medical attention if given a similar symptom presentation. The medical literature indicates that patients who have anxiety or panic attacks often have physical symptoms that may mimic a serious medical problem, such as a myocardial infarction. Emergency medical evaluation would be requested and desired by a prudent layperson who believed they were experiencing a myocardial infarction. Therefore, A0998 (ambulance response and treatment, no transport) provided on 10/27/18 were emergency services.
1
A 21-year-old female enrollee has requested reimbursement for knee arthroscopy synovectomy performed on 12/20/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. . This patient presented on 12/20/17 with recalcitrant right knee pain and prominent medial synovial plica. She had failed to improve despite conservative treatment. She underwent right knee arthroscopy with medial synovial plicectomy excision, debridement and synovectomy on 12/20/17.
Overturned
Experimental
Summary Reviewer 1 A 21-year-old female enrollee has requested reimbursement for knee arthroscopy synovectomy performed on 12/20/17. 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 Schindler concluded that arthroscopic excision of the entire plical fold becomes indicated in recalcitrant cases and once a plica has undergone irrevocable morphological changes. The procedure carries low morbidity, and results are universally good, especially if the plica is the sole pathology. Hufeland and colleagues concluded that arthroscopic resection of a symptomatic medial plica provides excellent clinical results in young patients. This patient presented on 12/20/17 with recalcitrant right knee pain and prominent medial synovial plica. She had failed to improve despite conservative treatment. She underwent right knee arthroscopy with medial synovial plicectomy excision, debridement and synovectomy on 12/20/17. Current evidence-based medical guidelines support arthroscopic surgical intervention in this clinical scenario for synovial plica resection/synovectomy. Increased synovial hypertrophy is typically associated with multicompartmental pathology, as in this case. Therefore, knee arthroscopy synovectomy performed on 12/20/17 was likely to have been more beneficial than other treatment options.
1
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.
Upheld
Experimental
Summary Reviewer 3 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 Lansoprazole may be indicated in select cases, such as patients with esophagitis and postoperative esophageal dysmotility. The article by Hassall and colleagues noted the presumed safety and efficacy of proton pump inhibitor therapy in this age-group, but this was in the setting of defined esophagitis. It is difficult to label an infant as having an acid-related disease based on clinical assessment alone. The trend has shifted away from routine use of prolonged acid suppression in otherwise healthy infants. There may be a role for empiric use in the setting of feeding aversions or poor weight gain, but neither of those situations were demonstrated here. Thus, lansoprazole is not likely to be superior over other treatment options.
1
A 54-year-old female enrollee requested authorization and coverage for arthrodesis sacroiliac joint percutaneous. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees bilateral sacroiliitis.
Overturned
Experimental
Summary Reviewer 1 A 54-year-old female enrollee requested authorization and coverage for arthrodesis sacroiliac joint percutaneous. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees bilateral sacroiliitis. The physician reviewer found Evidence based medical guidelines support SI joint fusion (either open or percutaneous) on a case by case basis as a last line of therapy for the following conditions, with ongoing symptoms, corroborating physical examination findings and imaging, and after failure of non-operative treatment: SI joint infection, tumor, disabling pain due to sacroiliitis due to spondyloarthropathy, sacroiliac pain due to severe traumatic injury, and in conjunction with multisegmental spinal constructs. The International Society for Advancement of Spine Surgery (ISASS) policy statement for minimally invasive sacroiliac joint fusion provides specific indications for surgery. The ISASS criteria include significant sacroiliac joint pain or significant limitations in activities of daily living because of sacroiliac joint pain; sacroiliac joint pain confirmed by at least three positive sacroiliac joint provocative tests; confirmation of the sacroiliac joint as a pain generator with at least 75% decrease in pain following fluoroscopically guided diagnostic intra-articular sacroiliac joint block in the immediate post-injection period; failure to respond to at least six months of non-surgical treatment including medications, rest, physical therapy, and sacroiliac joint steroid injection or rhizotomy; and, additional or alternative diagnoses that could be responsible for the patients ongoing pain or disability have been clearly considered, investigated and ruled-out. This patient presents with persistent and unremitting bilateral SI joint pain, right greater than left. Significant functional difficulty has been documented in activities of daily living. She reported an onset of pain relative to a fall from counter height onto her buttocks in August 2015. There is evidence of long term conservative treatment including medications, activity modification, SI joint injections, and physical therapy without sustained improvement. Clinical examination findings have documented bilateral SI joint tenderness with at least three positive sacroiliac provocative tests. Bilateral SI joint injections have been documented with 75-80% short term pain relief. In this patients case, current evidence based medical guideline and peer-reviewed surgical indications for SI joint fusion have been met. All told, arthrodesis sacroiliac joint percutaneous is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested 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 49-year-old female enrollee has requested reimbursement for Guardant360 CDx testing performed on 3/22/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
Upheld
Experimental
Summary Reviewer 1 A 49-year-old female enrollee has requested reimbursement for Guardant360 CDx testing performed on 3/22/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that inoperable advanced pancreatic cancer is an incurable disease, but chemotherapy can prolong survival. The genetic mutations that are present can provide prognostic significance and can help direct therapy. Mutational analysis is also part of the algorithms that are included within the National Comprehensive Cancer Network (NCCN) guidelines, but this is restricted to testing on the primary tumor samples. According to the NCCN guidelines, aGermline testing is recommended for any patient with confirmed pancreatic cancer, using comprehensive gene panels for hereditary cancer syndromes. Genetic counseling is recommended for patients who test positive for a pathogenic mutation or for patients with a positive family history of cancer, especially pancreatic cancer, regardless of mutation status.a According to the NCCN guidelines, aTesting on tumor tissue was preferred; however, cell-free DNA testing can be considered if tumor tissue testing is not feasible.a The NCCN guidelines goes on to say, aData are not available to show that earlier treatment of recurrences, following detection by increased tumor marker levels or CT scan, leads to better patient outcomes.a The Guardant360 test is a liquid biopsy that analyzes patient plasma for mutations in a panel of 70 genes. In this case, Guardant360 CDx testing was not done to analyze mutational analysis of an existing recurrence or an existing mass. Instead, it was performed to look for recurrence. This is not a medically appropriate use of the test. Therefore, Guardant360 CDx testing performed on 3/22/21 was not likely to have been more beneficial for evaluation of the patientas condition than any available standard therapy.
0
A 46-year-old male enrollee has requested authorization and coverage for an oral appliance. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees mild obstructive sleep apnea. The patient has been diagnosed with mild obstructive sleep apnea. Per the records, treatment with CPAP was initially recommended.
Overturned
Medical Necessity
Summary Reviewer A 46-year-old male enrollee has requested authorization and coverage for an oral appliance. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees mild obstructive sleep apnea. The physician reviewer found that the submitted documentation supports the medical necessity of the requested device. The patient has been diagnosed with mild obstructive sleep apnea. Per the records, treatment with CPAP was initially recommended. The clinical notes indicate that the patient is unable to tolerate CPAP therapy. For patients who are unable to tolerate CPAP therapy, treatment with an oral appliance has been shown to improve symptoms of obstructive sleep apnea. The medical evidence supports the requested device in this clinical setting. Thus, the requested oral appliance is medically necessary for the treatment of this patient. Therefore, the requested device 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 female enrollee has requested reimbursement and prospective authorization and coverage for eating disorder residential treatment center (RTC) services provided from 2/19/18 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 eating disorder. The physician reviewer found that the records provided for review document that this patient presented for admission from another facility with a low BMI. The patients prior care was not adequate to stabilize her weight loss such that she had lost 20 pounds in two months while in treatment. During the beginning of her stay, the patient continued to have difficulty with gaining weight and completing her meals. She required staff supervision and one-to-one care in order to finish her meals. She also required supplementation with liquid dietary supplements and order to maintain her calorie requirements. She was noted to be depressed, withdrawn and minimally interactive with staff and peers. As her treatment has progressed, she has gained weight, but some of her mood symptoms have not resolved.
Overturned
Medical Necessity
Summary Reviewer The parent of a 17-year-old female enrollee has requested reimbursement and prospective authorization and coverage for eating disorder residential treatment center (RTC) services provided from 2/19/18 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 eating disorder. The physician reviewer found that the records provided for review document that this patient presented for admission from another facility with a low BMI. The patients prior care was not adequate to stabilize her weight loss such that she had lost 20 pounds in two months while in treatment. During the beginning of her stay, the patient continued to have difficulty with gaining weight and completing her meals. She required staff supervision and one-to-one care in order to finish her meals. She also required supplementation with liquid dietary supplements and order to maintain her calorie requirements. She was noted to be depressed, withdrawn and minimally interactive with staff and peers. As her treatment has progressed, she has gained weight, but some of her mood symptoms have not resolved. Give this patients history, it is unlikely that less restrictive treatments would be effective for her eating disorder treatment. In the medical literature, Mehler noted that anorexia nervosa is a psychiatric disorder characterized by abnormal eating behaviors that results in weight loss and has serious potential medical consequences. Due to this patients history of mood symptoms, self-harm, suicide attempts, and severe eating disorder behaviors, the eating disorder residential treatment center services provided from 2/19/18 forward were and are medically necessary. Based on the foregoing discussion, 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 50-year-old male enrollee has requested authorization and coverage for Vemlidy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis B. A review of the record indicates the enrollee has a history of hepatitis B. On 5/9/17, the enrollee was noted to have hepatitis B complicated by cirrhosis. The record indicates the enrollee has been treated with Viread 300 mg daily. At that time, the provider recommended treatment with Vemlidy which has a better renal and bone safety profile than Viread.
Overturned
Medical Necessity
Summary Reviewer A 50-year-old male enrollee has requested authorization and coverage for Vemlidy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis B. A review of the record indicates the enrollee has a history of hepatitis B. On 5/9/17, the enrollee was noted to have hepatitis B complicated by cirrhosis. The record indicates the enrollee has been treated with Viread 300 mg daily. At that time, the provider recommended treatment with Vemlidy which has a better renal and bone safety profile than Viread. The Health Insurer indicates the requested medication is not medically necessary for treatment of the enrollees medical condition. At issue is whether the requested medication is medically necessary for treatment of the enrollees medical condition.I have determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Insurers denial should be overturned.
1
The parent of a 12-year-old female enrollee has requested authorization and coverage for surgery (ApiFix procedure). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. this patient was diagnosed with scoliosis when she was nine years old. At the time, her curve was only 10 degrees. Recently, the patient has had a growth spurt. Despite bracing, the curve has grown. The patient and her family are requesting a growth friendly modulation surgical approach and would like to avoid permanent fusion.
Overturned
Experimental
Summary Reviewer 3 The parent of a 12-year-old female enrollee has requested authorization and coverage for surgery (ApiFix procedure). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. At issue is whether the requested services are likely to be more beneficial for treatment of the enrollees condition than any available standard therapy. The physician reviewer found that this patient was diagnosed with scoliosis when she was nine years old. At the time, her curve was only 10 degrees. Recently, the patient has had a growth spurt. Despite bracing, the curve has grown. The patient and her family are requesting a growth friendly modulation surgical approach and would like to avoid permanent fusion. The current medical evidence supports the requested services in this clinical setting. The ApiFix procedure is backed by nine years of clinical experience. There is substantial clinical experience and evidence now showing the validity and its efficacy in adolescent idiopathic scoliosis. Therefore, the requested surgery (ApiFix procedure) is likely to be more beneficial than other available standard therapy.
1
The parent of a five-year-old male enrollee has requested reimbursement for immunoglobulin G (IgG) food testing performed on 9/27/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 2 The parent of a five-year-old male enrollee has requested reimbursement for immunoglobulin G (IgG) food testing performed on 9/27/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that food-specific IgG level does not predict food hypersensitivity and may actually be a marker of earlier development of tolerance. Food- specific IgG tests typically yield multiple positive results and may represent a normal immune response to food. In one study, children with atopic dermatitis and egg and/or milk allergy who had higher levels of IgG4 to milk and egg proteins were more likely to be tolerant to these foods by 4.5 years of age compared with children with lower IgG4 levels. In another study, resolution of cows milk allergy was associated with increasing IgG4 level. In addition, IgG4 increased in patients who successfully underwent oral immunotherapy for milk or peanut allergy. Therefore, food-specific IgG should not be used as a tool to diagnose food allergy, and the positive food should not be eliminated from the diet based upon results of these tests. Use of food-specific IgG level does not predict true food hypersensitivity. The standard evaluation of food allergy consists of blood immunoglobulin E (IgE) level for foods and skin testing. IgE immunoassays are in vitro assays used to identify food-specific IgE in the serum. These tests are widely available. Immunoassays have demonstrated very high positive predictive accuracy in children for several of the major food allergens. Values have been established for egg, milk, peanut, tree nuts, and fish that correspond to a positive predictive accuracy of 95 percent. Skin testing for food-specific IgE is used in the diagnosis of IgE-mediated food allergies. A positive skin test to a particular food indicates the possibility that the patient has a true allergy to that food. A negative skin test result indicates the absence of an IgE-mediated allergy upon subsequent challenge with a 90 to 95 percent predictive accuracy. Therefore, IgG food testing performed on 9/27/21 was not likely to have been more beneficial than any available standard therapy.
0
A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. 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 1 A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by the applying the staging system spelled out by Balch. Mitotic index may add to these statistics. DecisionDx-Melanoma assay is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based on the risk of metastasis over five years. Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma assay classification, in patients undergoing sentinel lymph node biopsy. At this time, it is not clear how the five-year data from DecisionDx-Melanoma assay compares to the ten-year data from Balch. It is also not clear if one can use the assay to make clinical decisions. Therefore, DecisionDx-Melanoma assay provided on 3/21/18 was not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 61-year-old female enrollee has requested reimbursement for the office visits provided on 5/20/16, 8/25/16, and 11/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees hypothyroidism, Hashimotos thyroiditis, menopause syndrome, and iron deficiency anemia.
Overturned
Experimental
Summary Reviewer 3 A 61-year-old female enrollee has requested reimbursement for the office visits provided on 5/20/16, 8/25/16, and 11/17/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees hypothyroidism, Hashimotos thyroiditis, menopause syndrome, and iron deficiency anemia. The physician reviewer found that meta-analysis of randomized clinical trials shows no advantage of T4 and T3 combination therapy over T4 monotherapy (Grozinsky-Glasberg, et al). This patients records do not include documentation of trial and failure or contraindication to the available formulary alternatives for management of hypothyroidism (Jonklaas, et al). Due to lack of clinical documentation, detailed physical examination findings, history of present illness, and clinical documentation to support an indication of specialty services, the office visits provided on 5/20/16, 8/25/16, and 11/17/16 were not likely to be more beneficial for evaluation of the patients medical condition than any available standard services. 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 63-year-old female enrollee has requested reimbursement of liquid CDx laboratory testing by FoundationOne on 4/29/22. The Health Insurer has denied this request and reported that the service at issue was investigational for the evaluation of the enrollees lung cancer. notes dated 7/27/22 reported that the patient underwent a repeat biopsy on 4/12/22 by EBUS to confirm recurrent disease.
Overturned
Experimental
Summary Reviewer 3 A 63-year-old female enrollee has requested reimbursement of liquid CDx laboratory testing by FoundationOne on 4/29/22. The Health Insurer has denied this request and reported that the service at issue was investigational for the evaluation of the enrollees lung cancer. At issue is whether CDx laboratory testing by FoundationOne on 4/29/22 was likely to have been more beneficial for evaluation of the enrollee's condition than any available standard therapy. The physician reviewer found that Metastatic adenocarcinoma of the lung is an incurable disease, but many advances have been made with targeted therapies to help extend survival. Multiple guidelines including by the NCCN, College of American Pathologists (CAP), American Society of Clinical Oncology (ASCO), and European Society for Medical Oncology (ESMO), recommend testing for mutations such as epidermal growth factor receptor (EGFR), KRAS, anaplastic lymphoma kinase (ALK), and c-ros oncogene (ROS1) on tumor samples to help direct therapy options. If patients are not fit for biopsy, or if the tissue sample is insufficient for testing, then cell-free testing may help identify mutations. Cell-free tests, such as the FoundationOne CDx liquid test at issue, are very specific but not as sensitive as tissue testing for mutations and are not a substitute when appropriate tissue can be obtained. In this case, notes dated 7/27/22 reported that the patient underwent a repeat biopsy on 4/12/22 by EBUS to confirm recurrent disease. Molecular testing and FoundationOne CDx liquid testing were requested from this sample at the same time. In this clinical setting, given that the tissue sample is considered more sensitive/specific than liquid biopsy and is the standard for diagnostic management, the service at issue was not likely to have been more beneficial than the standard management. Therefore, CDx laboratory testing by FoundationOne on 4/29/22 was not likely to have been more beneficial for evaluation of the patients condition than any available standard therapy.
1
A 55-year-old female enrollee has requested authorization and coverage for Cambia 50 mg powder packet. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees migraine without aura. graine. This patients provider states that the patient is unable to use tablets due to nausea.
Upheld
Medical Necessity
Summary Reviewer A 55-year-old female enrollee has requested authorization and coverage for Cambia 50 mg powder packet. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees migraine without aura. The physician reviewer found that Cambia is a powdered form of diclofenac which has been shown to be effective in treating acute migraine. This patients provider states that the patient is unable to use tablets due to nausea. However, Cambia must also be taken orally and is not a parenteral treatment. When nausea is present, then parenteral medication such as sumatriptan nasal spray, zolmitriptan nasal spray, sumatriptan injection, or use of an anti-nausea agent with antimigraine properties such as prochlorperazine are likely to be effective. Overall, the patients records do not document that the patient has used other approved standard therapies. Therefore, the requested Cambia 50 mg powder packet is not medically necessary for treatment of this patients medical condition. Based on the available documentation, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
1
A 72-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene expression profile assay performed on 8/30/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 2 A 72-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene expression profile assay performed on 8/30/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by the analysis of Balch. Mitotic index may add a bit to these statistics. DecisionDx-Melanoma gene expression profile assay is a 31-gene assay of an individuals melanoma cells. It then places that particular melanoma into either Class 1 or 2, with somewhat different risks of metastasis by five years. It is not clear how the five-year DecisionDx-Melanoma gene expression profile assay data compares to the ten-year Balch data. Most importantly, there is a lack of data to support using DecisionDx-Melanoma gene expression profile assay in making clinical decisions, such as the need for sentinel node biopsy and/or adjuvant therapy. Therefore, DecisionDx-Melanoma gene expression profile assay performed on 8/30/19 was not likely to have been more beneficial than any available standard therapy.
1
A 49-year-old female insured has requested authorization and coverage for thermal destruction of intraosseous basivertebral nerve including all imaging guidance; first two vertebral bodies, lumbar (CPT 64628). The insureds symptoms are having a significant impact on activities of daily living such as household chores, leisure activities, sleeping, and work. Medications have included acetaminophen, Celebrex, meloxicam, naproxen, and muscle relaxants. The Health Insurer indicates the requested services are considered investigational for the treatment of the insureds medical condition. Therefore, the Health Plan has denied coverage for the requested treatment.
Overturned
Experimental
Summary Reviewer 2 A 49-year-old female insured has requested authorization and coverage for thermal destruction of intraosseous basivertebral nerve including all imaging guidance; first two vertebral bodies, lumbar (CPT 64628). The insureds symptoms are having a significant impact on activities of daily living such as household chores, leisure activities, sleeping, and work. Medications have included acetaminophen, Celebrex, meloxicam, naproxen, and muscle relaxants. The Health Insurer indicates the requested services are considered investigational for the treatment of the insureds medical condition. Therefore, the Health Plan has denied coverage for the requested treatment. This denial is the subject of this appeal and determination. The physician reviewer found that overall, the data from the current peer-reviewed medical literature on basivertebral nerve ablation report long-term improvement in pain and function in well selected patients. One study from Fischgrund and colleagues reported that at two-year follow-up, patients treated with radiofrequency ablation of the basivertebral nerve for chronic low back pain exhibited sustained clinical benefits. The authors concluded that basivertebral nerve ablation is supported as a durable, minimally invasive treatment for the relief of chronic low back pain. In addition, Khalil and colleagues found that minimally invasive radiofrequency ablation of the basivertebral nerve ablation led to significant improvement of pain and function at three months in patients with chronic vertebrogenic related low back pain. As low back pain is known to arise from numerous etiologies, careful diagnosis and patient selection for those with vertebrogenic pain as the primary source of symptomatology is essential for optimal outcomes. Within the records available for review, there is documentation of chronic low back pain described as vertebrogenic pain. The treating provider has recommended thermal destruction of the intraosseous basivertebral nerve. The medical records indicate that the patient has tried and failed multiple conservative treatments including physical therapy, medial branch blocks, trigger point injections, lumbar facet injection, and medications such as acetaminophen, Celebrex, meloxicam, and naproxen. Based on the support in the medical literature, the requested thermal destruction of intraosseous basivertebral nerve including all imaging guidance; first two vertebral bodies, lumbar (CPT 64628) is likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy.
1
A 55-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 5/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
Upheld
Experimental
Summary Reviewer 1 A 55-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 5/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that particular melanoma based on the five-year risk of recurrence. Gerami reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma class, in patients undergoing sentinel node sampling. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear if the DecisionDx-Melanoma data can be used to make therapeutic decisions. National Comprehensive Cancer Network discusses the use of molecular assays in the treatment of cutaneous melanoma and does not currently recommend using the assay in other than clinical trial settings. Therefore, DecisionDx-Melanoma testing provided on 5/29/19 was not likely to have been more beneficial than other methods of evaluating this patient.
0
The parent of a three-year-old male enrollee has requested reimbursement and prospective authorization and coverage for nine additional weekly hours of applied behavioral analysis (ABA) therapy provided from 10/31/16 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 autism spectrum disorder. In this case, the patient is making slow, steady progress, but continues to have significantly problematic behaviors in the areas of social skills, social-emotional awareness and safety. He is a significant flight risk with several episodes of elopement. He continues to demonstrate impairment in several areas making it increasingly difficult for him to be successful in more generalized environments. The Health Plan has 22 hours of direct ABA therapy and
Overturned
Medical Necessity
Summary Reviewer The parent of a three-year-old male enrollee has requested reimbursement and prospective authorization and coverage for nine additional weekly hours of applied behavioral analysis (ABA) therapy provided from 10/31/16 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 autism spectrum disorder. The physician reviewer found in this clinical setting, nine additional weekly hours of ABA therapy provided from 10/31/16 forward were and are medically necessary for treatment of the patients medical condition. The study by Linstead and colleagues evaluated the relationship between ABA treatment intensity and treatment outcomes for individuals with autism spectrum disorder. The authors reported a strong relationship between treatment intensity and mastery of learning objectives, where higher treatment intensity predicted greater progress was demonstrated. In this case, the patient is making slow, steady progress, but continues to have significantly problematic behaviors in the areas of social skills, social-emotional awareness and safety. He is a significant flight risk with several episodes of elopement. He continues to demonstrate impairment in several areas making it increasingly difficult for him to be successful in more generalized environments. The Health Plan has 22 hours of direct ABA therapy and along with one hour per week of individual parent training and two hours of supervision per week, which is less than what is recommended for optimal response. Several studies have recommended 25 or more hours of direct weekly ABA to ensure optimal outcomes (Roane et al; Myers et al). The Behavior Analyst Certification Board states that typical comprehensive ABA programs range from 30-40 hours of treatment per week. Given the support cited above, nine additional weekly hours of ABA therapy provided from 10/31/16 forward has been established as medically necessary for treatment of the patients medical 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 48-year-old male enrollee has requested authorization and coverage for cervical artificial discectomy and second level cervical discectomy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
Upheld
Experimental
Summary Reviewer 3 A 48-year-old male enrollee has requested authorization and coverage for cervical artificial discectomy and second level cervical discectomy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that there is insufficient data to adequately assess the performance of total disc replacement. There is a lack of evidence that disc replacement reliably, reproducibly, and over long periods of time fulfills the three primary aims of clinical efficacy, continued motion, and few adjacent segment degenerative problems. Total disc replacement has been associated with a high rate of re-operations, and the potential problems that may occur with longer follow-up have not been fully documented. The standard procedure in this clinical setting is a two level anterior cervical discectomy and fusion. The proposed surgery 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 services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
1
A 19-year-old female enrollee has requested authorization and coverage for jaw surgery. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary for treatment of the enrollees facial pain, mastication and nasal obstruction. This patient has a maxillofacial skeletal deformity which has resulted in a functional deficit. The records noted that she has difficulty with mastication, speech and has associated facial pain.
Overturned
Medical Necessity
Summary Reviewer A 19-year-old female enrollee has requested authorization and coverage for jaw surgery. The Health Insurer has denied this request indicating that the requested surgery is not medically necessary for treatment of the enrollees facial pain, mastication and nasal obstruction. The physician reviewer found that the submitted documentation demonstrates the medical necessity for the requested surgery. This patient has a maxillofacial skeletal deformity which has resulted in a functional deficit. The records noted that she has difficulty with mastication, speech and has associated facial pain. Her medical condition cannot be corrected with conservative non-surgical therapy alone. Instead, this patient requires orthognathic surgery intervention to correct her maxillofacial skeletal deformity. Performance of this surgery is likely to result in improved musculoskeletal, dento-osseous and soft tissue relationships which will result in improved mastication and swallowing for the patient. The surgery has also been shown to improve the associated temporomandibular joint and associated muscular disorders. As such, the requested jaw surgery is medically necessary for the treatment of this patients medical condition. Therefore, for the reasons stated above, the requested surgery is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
1
A 64-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/1/16. 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 2 A 64-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/1/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the breast tomosynthesis performed on 2/1/16 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. Ciatto and colleagues investigated the effect of integrated two-dimensional (2D) and three-dimensional (3D) mammography in the breast cancer screening population. The authors found that Integrated 2D and 3D mammography improves breast cancer detection and has the potential to reduce false positive recalls. Based on the medical literature cited above, the use of breast tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
0
The patient is a 42-year-old female who has been treated for the following conditions: low back pain; other intervertebral disc degeneration, lumbosacral region; other intervertebral disc degeneration, lumbar region; radiculopathy, lumbar; other spondylosis, lumbar region; other intervertebral disc displacement, lumbar region. The patient has requested authorization and coverage for spinal surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. In addition, she is noted to be a daily tobacco user and notes she will quit nicotine;
Upheld
Medical Necessity
Summary Reviewer The patient is a 42-year-old female who has been treated for the following conditions: low back pain; other intervertebral disc degeneration, lumbosacral region; other intervertebral disc degeneration, lumbar region; radiculopathy, lumbar; other spondylosis, lumbar region; other intervertebral disc displacement, lumbar region. The patient has requested authorization and coverage for spinal surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that Bydon and colleagues noted, aA trial of conservative therapy may be considered for patients with low-grade spondylolisthesis presenting with radiculopathy and/or pseudoclaudication. These options may include physical therapy, epidural steroid injection, and pain medications. If unresolved, surgical options may include decompression alone or decompression and fusion.a Chan and colleagues stated, aPatients with symptomatic lumbar spondylolisthesis may first be treated with conservative management strategies including, but not limited to, non-narcotic and narcotic pain medications, epidural steroid injections, transforaminal injections, and physical therapy. For well-selected patients who fail conservative management strategies, surgical management is appropriate.a In this patientas case, detailed documentation is not evident regarding trial and failure of recent, reasonable and comprehensive less invasive conservative care measures prior to requested surgery to include (but not limited to) physical therapy measures. In addition, she is noted to be a daily tobacco user and notes she will quit nicotine; however, follow-up documentation does not indicate this has been completed. The provided imaging studies, including the dynamic x-rays from 8/10/21, do not corroborate movement/instability at the requested level, and detailed documentation is not evident regarding potential impending/inevitable temporary intraoperative instability. There is a lack of support for the requested services in this clinical setting. Therefore, the requested spinal surgery is not medically necessary for the treatment of this patient.
1
A 24-year-old female enrollee has requested authorization and coverage for lower esophageal myotomy, transoral (peroral endoscopic myotomy) (POEM) and one inpatient day. The Health Plan has denied this request indicating that the requested service is investigational for the treatment of the enrollees medical condition.
Overturned
Experimental
Summary Reviewer 2 A 24-year-old female enrollee has requested authorization and coverage for lower esophageal myotomy, transoral (peroral endoscopic myotomy) (POEM) and one inpatient day. The Health Plan has denied this request indicating that the requested service is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the efficacy and safety of POEM has been compared with that of laparoscopic Heller myotomy (LHM). In a randomized trial of 221 patients with all subtypes of achalasia, POEM and LHM with Dors fundoplication were equally successful in controlling symptoms at two years. Compared with LHM, POEM was associated with a lower rate of severe adverse events (2.7 versus 7.3 %). Schlottmann and colleagues performed a meta-analysis of over 7,000 patients with all 3 subtypes of achalasia in over 70 cohort studies. The authors noted that POEM was more effective than LHM in relieving dysphagia. Therefore, lower esophageal myotomy, transoral POEM and one inpatient day is likely to be more beneficial than any available standard therapy.
1
The patient is a 16-year-old male with a history of severe emotional and behavioral dysregulation, including property damage and conflicts. The records noted a history of school avoidance/refusal due to sleep deprivation, anhedonia and somatic complaints. The patientas parent has requested reimbursement for residential mental health treatment for children and adolescents provided from 10/02/19 through 4/24/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The patient has a history of significant physical and verbal aggression towards others as well as threats to harm himself. The records document a psychiatric hospitalization in April 2019 due to acute suicidality via plan to jump off an apartment terrace.
Overturned
Medical Necessity
Summary Reviewer The patient is a 16-year-old male with a history of severe emotional and behavioral dysregulation, including property damage and conflicts. The records noted a history of school avoidance/refusal due to sleep deprivation, anhedonia and somatic complaints. The patientas parent has requested reimbursement for residential mental health treatment for children and adolescents provided from 10/02/19 through 4/24/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that The 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. For dimension 1- Risk of Harm: This dimension assesses potential for harm to self or others, or having harm inflicted upon them. In this case, the records support a score of 4. The patient has a history of significant physical and verbal aggression towards others as well as threats to harm himself. The records document a psychiatric hospitalization in April 2019 due to acute suicidality via plan to jump off an apartment terrace. For dimension 2 a Function: This dimension assesses the degree to which a person is able to fulfill responsibilities for a given age level. In this case, the records support a score of 4. The patient has a history of severe school avoidance, conflicts with parents, frequent threats of self-harm, multiple depressive symptoms and suicidal ideation with poor impulse/frustration tolerance. For dimension 3 a Comorbidity: This dimension assesses the co-existence of disorders across four domains (psychiatric, substance use, medical or developmental) that may complicate the course of treatment. In this case, the records support a score of 3. The patient has significant comorbidities, including major depressive disorder, generalized anxiety disorder and parent-child relational problem. For Recovery Environment dimension 4A- Stress: This dimension assesses the stressors in the environment, social circumstances, and interpersonal relationships. In this case, the records support a score of 4. The patient appears to have had a stressful environment involving severe conflicts with his father and parental divorce. For Recovery Environment dimension 4B- Support: This dimension assesses the presence of family and social support to augment the recovery environment. The records support a score of 3. The patientas support is limited. His parents appear at a loss as to how to parent the patient and are overwhelmed. The records document multiple severe conflicts with his father. For dimension 5- Treatment and Recovery History: This dimension assesses success or failure to make use of treatment and natural support that fosters resilience. In this case, the records support a score of 4. The patient had a history of limited response to outpatient therapy and continued to decompensate while at home and in the community, with inability to attend school or maintain safety within the home. For dimension 6 a Engagement: With regard to engagement of the patient, the records support a score of 3. Per the notes, despite outpatient therapy and medication management, the patient had limited progress and insight. Thus, the patient has a composite score of 25, which is consistent with Level 5, residential level of care. The patientas scores of 4 in risk of harm criteria and functional status criteria also automatically qualify the patient for Level 5 services. This patient has consistently demonstrated multiple lagging skills in the social and emotional realms with inability to function safely outside of a highly structured setting. Therefore, residential mental health treatment for children and adolescents provided from 10/02/19 through 4/24/20 was medically necessary for the treatment of this patient.
1
A 45-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Gamunex-C from 7/01/21 forward. The Health Insurer has denied this request and reported that the medication at issue was and is investigational for the treatment of the enrolleeas medical condition.
Overturned
Experimental
Summary Reviewer 2 A 45-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Gamunex-C from 7/01/21 forward. The Health Insurer has denied this request and reported that the medication at issue was and is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is a lack of support for Gamunex-C in this clinical setting. Damages nerves causing neuropathy can cause a wide constellation of symptoms, as they are involved in both somatic and autonomic processes. Pain is a common complaint with neuropathies as well as other forms of paresthesia. Causes of neuropathies vary from diabetes, celiac disease, hepatitis, restless leg syndrome, neurotoxic drugs, paraneoplastic syndromes, Sjogrenas syndrome, and lupus, to name a few. While there is evidence to support the possibility of efficacy of IVIG in neuropathies, it is limited at best and studies call for further investigation into its use. Therefore, Gamunex-C from 7/01/21 forward was not and is not likely to be more beneficial for the treatment of this patient than any available standard therapy.
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A 43-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/14/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
Upheld
Experimental
Summary Reviewer 2 A 43-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 2/14/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. In sum, DecisionDx-Melanoma testing performed on 2/14/18 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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