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The patient is a 58-year-old male with chronic hepatitis C virus, genotype 1b. The documentation submitted for review indicates he has early stage disease. Fibrospect II testing on 2/13/14 revealed a Metavir score of F0-F1. The patients provider recommends treatment with Viekira Pak. Thus, the patient is requesting authorization and coverage for Viekira Pak. The Health Insurer has denied the requested medication as not medically necessary.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 58-year-old male with chronic hepatitis C virus, genotype 1b. The documentation submitted for review indicates he has early stage disease. Fibrospect II testing on 2/13/14 revealed a Metavir score of F0-F1. The patients provider recommends treatment with Viekira Pak. Thus, the patient is requesting authorization and coverage for Viekira Pak. The Health Insurer has denied the requested medication as not medically necessary. The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the requested medication. According to the American Association for the Study of Liver Diseases (AASLD) recommendations for treating hepatitis C, Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Denying treatment for patients with early stage hepatitis C is not supported by the peer-reviewed literature. Thus, the recommendation is not deny patients treatment if they have early stage disease, but to provide treatment to avoid complications from advanced disease, including liver failure and extrahepatic complications. AASLD/IDSA guidelines recommend Viekira Pak, a daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) plus twice-daily dosed dasabuvir (250 mg) for 12 weeks for treatment-naive patients with HCV genotype 1 infection. For the reasons provided, 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 residential mental health treatment services provided from 5/9/15 through 8/7/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder, and parent-child relational problem.
which was assessed as an attempt to manipulate the staff. The patient was able to contract for safety and no additional intervention occurred.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 15-year-old male enrollee has requested reimbursement for residential mental health treatment services provided from 5/9/15 through 8/7/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder, and parent-child relational problem.
The physician reviewer found that the documentation provided for review does not support the medical necessity of residential mental health treatment services provided from 5/9/15 through 8/7/15. There is no evidence that treatment in a less restrictive setting would have been ineffective to manage the patient, since this had not been given an adequate trial. Similarly, there is a lack of objective evidence that continuation with a lesser intensity of care could not have provided improvement or prevention of deterioration. The patients level of symptomatology did not justify residential services. No suicidal ideations or homicidal ideations had been documented, but in one incident, which was assessed as an attempt to manipulate the staff. The patient was able to contract for safety and no additional intervention occurred. Further, continued residential services, especially at the highly intensive levels that were used, may have led to service dependency, which would be an adverse outcome. Therefore, this patient would have been more appropriately managed at a less restrictive, less intrusive intensity of services, such as outpatient care. For these reasons, the residential mental health treatment services provided from 5/9/15 through 8/7/15 were not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/29/15. 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 the medical literature supports the services at issue in this clinical setting. Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues reported that integrated two-dimensional and three-dimensional mammography improve breast cancer detection and has the potential to reduce false positive recalls. In sum, the literature supports the use of breast tomosynthesis over conventional mammogram due to improved cancer detection rate. Therefore, breast tomosynthesis performed on 7/29/15 was likely to have been of greater benefit than other modalities. 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 60-year-old female enrollee has requested reimbursement for DecisionDX Melanoma gene expression assay performed on 12/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 60-year-old female enrollee has requested reimbursement for DecisionDX Melanoma gene expression assay performed on 12/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found the prognosis of cutaneous melanoma has classically been determined by the staging system as documented by Balch and colleagues. Mitotic index has also been thought to add a bit more to the prognostics. By Balch tables, this patients melanoma would be classified as a T1a melanoma, or stage 1A. By these determinations, this patient has an excellent prognosis. DecisionDX is a study of 31 genes in the melanoma cells. It then classifies that particular melanoma as either Class 1 (with a 97% disease free rate at five years) versus Class 2 (with a 31% disease free rate at five years). The study by Gerami and colleagues reported on 217 cases with good correlation between prognosis and DecisionDx classification, in patients undergoing sentinel node biopsy. However, it is not clear as yet how DecisionDx data compares to the ten year data of the Balch determinations, and whether it can be used to make clinical practice decisions. This is the issue presented in this patient with her pathologic findings and excellent prognosis. Moreover, National Comprehensive Cancer Network (NCCN) guidelines recognize that there is interest in these newer genetic profiles, but as yet only in the context of a clinical trial. In sum, DecisionDX melanoma gene expression assay performed on 12/23/15 was not likely be of greater clinical benefit than standard tests for the evaluation of this patient. Based on the information 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 37-year-old female enrollee has requested reimbursement for the Afirma thyroid fine needle aspiration (FNA) analysis provided on 1/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pituitary tumor and elevated prolactin.
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Overturned
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Experimental
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Summary Reviewer 1
A 37-year-old female enrollee has requested reimbursement for the Afirma thyroid fine needle aspiration (FNA) analysis provided on 1/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees pituitary tumor and elevated prolactin. The physician reviewer found that
the National Comprehensive Cancer Network (NCCN) indicated that genetic profiling for atypia of unknown significance is a category 2b recommendation. In the medical literature, Duick and colleagues reported that obtaining a gene expression classifier in patients with cytologically indeterminate nodules is associated with a striking reduction in the rate of diagnostic thyroidectomy. Thus, in conjunction with peer-reviewed literature, the Afirma thyroid analysis performed on 1/15/15 was likely to have been more beneficial for thorough evaluation of this patients condition than any available testing.
Based upon the information set forth above, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 32-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 asthma.
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Overturned
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Experimental
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Summary Reviewer 2
A 32-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 asthma. The physician reviewer found that the current medical literature supports the use of bronchial thermoplasty in patients with severe persistent asthma that has not responded to adequate trials of medical therapy. The use of bronchial thermoplasty in well selected patients has resulted in reduced exacerbations, fewer emergency department visits, and improved quality of life. All told, the scientific data supports the safety and effectiveness of the requested bronchial thermoplasty as likely to be more beneficial for this patients medical condition than treatment with any available standard therapy. Based upon the information set forth above, I have determined 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 51-year-old female enrollee has requested authorization and coverage for the LINX reflux management system lower esophageal sphincter augmentation. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).
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Upheld
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Experimental
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Summary Reviewer 3
A 51-year-old female enrollee has requested authorization and coverage for the LINX reflux management system lower esophageal sphincter augmentation. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that the U.S. Food and Drug Administration (FDA) approved the LINX reflux management system for lower esophageal sphincter (LES) augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including those patients with mild to moderate GERD and a hiatal hernia less than 3 cm. This patient meets these criteria. A recent study comparing the LINX procedure with laparoscopic fundoplication found that GERD patients had similar control of reflux symptoms after both LINX and fundoplication. The inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms (Reynolds, et al). Given these findings, the requested LINX reflux management system lower esophageal sphincter augmentation 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 service is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of a 15-year-old female enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 1/29/18 through 12/05/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
. The patient not actively suicidal, but she had a history of suicidal ideation. In terms of functional status, the records
2. The patient had some issues with level of function due to chronic mental illness, but overall showed appropriate daily functioning including school progress in treatment and prior to treatment at the residential treatment center.
did not have active medical problems and did not have a recent history of substance use.
patients parents are involved in treatment on a regular basis and appeared to understand her needs.
that the patient had response to her stay in the residential treatment center prior to her readmission for the disputed dates of service. She was
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 15-year-old female enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 1/29/18 through 12/05/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based instrument such as American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) assists in determining necessary level of care for children. With regards to risk of harm, the records support a score of 2. The patient not actively suicidal, but she had a history of suicidal ideation. In terms of functional status, the records support a score of 2. The patient had some issues with level of function due to chronic mental illness, but overall showed appropriate daily functioning including school progress in treatment and prior to treatment at the residential treatment center. In terms of comorbidity, the records support a score of 1. The patient did not have active medical problems and did not have a recent history of substance use. In terms of level of stress of the recovery environment, the records support a score of 2. The progress notes document that her relationship and family sessions were productive and were not adversarial. With regards to level of support of the recovery environment, the records support a score of 2. The patients parents are involved in treatment on a regular basis and appeared to understand her needs. In terms of resiliency and treatment history, the records support a score of 3. It appears that the patient had response to her stay in the residential treatment center prior to her readmission for the disputed dates of service. She was participating in therapy programming and was not displaying seriously disruptive behaviors on a regular basis. It was noted that she had intermittent behavioral issues, but these were infrequent in nature. With regards to acceptance and engagement of the patient, the records support a score of 2. The patient participated in therapy actively. In terms of acceptance and engagement of the parent, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Thus, the patient has a composite score of 16. This score correlated with outpatient services. In sum, residential mental health treatment for children and adolescents provided from 1/29/18 through 12/05/18 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 68-year-old female who underwent a right total hip replacement on 1/08/18. She underwent physical therapy postoperatively. She had hip pain, as well as low back pain. As of 3/13/18, she was doing yoga and walking one to two miles daily. She had active right hip flexion to 112 degrees and active right hip abduction to 40 degrees. Strength was fair to fair minus in the hips bilaterally. Strength at the hips was symmetric. Strength at the knees was intact bilaterally. As of 4/26/18, she was noted to have 3/5 hip abduction strength. On 5/01/18, she was noted to have ridden her bike for 15 to 20 minutes over the prior weekend, without problems. Therapies continued, which included soft tissue massage, stretching and therapeutic exercises. The patient has requested reimbursement for CPT codes 97530-59, 97110 and 97140 provided on 5/03/18, 5/08/18 and 5/10/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 68-year-old female who underwent a right total hip replacement on 1/08/18. She underwent physical therapy postoperatively. She had hip pain, as well as low back pain. As of 3/13/18, she was doing yoga and walking one to two miles daily. She had active right hip flexion to 112 degrees and active right hip abduction to 40 degrees. Strength was fair to fair minus in the hips bilaterally. Strength at the hips was symmetric. Strength at the knees was intact bilaterally. As of 4/26/18, she was noted to have 3/5 hip abduction strength. On 5/01/18, she was noted to have ridden her bike for 15 to 20 minutes over the prior weekend, without problems. Therapies continued, which included soft tissue massage, stretching and therapeutic exercises. The patient has requested reimbursement for CPT codes 97530-59, 97110 and 97140 provided on 5/03/18, 5/08/18 and 5/10/18. 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 submitted documentation fails to demonstrate the medical necessity of the services at issue. The literature related to optimal rehabilitation and exercise following total hip arthroplasty have been reported to be limited with respect to trial and data quality. Di Monaco and Castiglioni reported that favorable outcomes in the early postoperative phase were due to ergometer cycling and maximal strength training, while late (greater than eight weeks postoperative) phase advantages were due to weight-bearing exercises. Their conclusion was that there was insufficient evidence to design an evidence-based exercise protocol after total hip replacement, with sparse data to support specific exercises to add beyond the usual mobility-related training. Lowe and colleagues concluded in a review that, physiotherapy exercise after discharge following total hip replacement may potentially benefit patients in terms of function, walking and muscle strengthening, but the evidence was insufficient to determine that physiotherapy after hospital discharge was indeed an effective intervention. The overall quantity, quality and diversity of the available literature precluded meta-analyses. Walsh and colleagues noted that there was strong evidence to support exercise to improve pain, function and quality of life in the setting of lower limb osteoarthritis, but limited evidence to support the use of commonly utilized physiotherapy interventions. Per the authors, studies that investigate packages of care required further investigation. In this case, the patient underwent a right total hip replacement on 1/08/18. As of March 2018, she was doing yoga and walking one to two miles daily. As of April 2018, she was able to ride a bicycle for 15 to 20 minutes without problems. Although she continued to have symptoms, range of motion deficits and strength deficits in her lower limbs, there were no indications that she could not have continued an exercise program on her own in order to improve her function. There was no need for ongoing formal exercise and manual therapy. The physical therapy services in question were not medically necessary per the available clinical documentation and the medical literature. Thus, CPT codes 97530-59, 97110 and 97140 provided on 5/03/18, 5/08/18 and 5/10/18 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old male has requested authorization and coverage for cervical artificial disc replacement. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 57-year-old male has requested authorization and coverage for cervical artificial disc replacement. 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 sufficient support for the requested services in this patients case. A review of the current literature pertaining to artificial disc replacement adjacent to a fused level indicates results superior to anterior cervical discectomy and fusion. In particular, due to preservation of the motion, adjacent segment disease may be minimized. The current medical evidence supports the recommended cervical artificial disc replacement in this clinical setting. Therefore, the requested cervical artificial disc replacement 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.
| 1 |
The patient is a 32-year-old male who has a past history that includes attention deficit/hyperactivity disorder. The patient has requested reimbursement for air wing transport provided on 1/12/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
In this case, the patient sustained a severe, acute traumatic brain injury due to a skateboarding-related fall. His course was complicated by seizures. He had persistent cognitive and safety-related impairments. He was eventually stabilized sufficiently from a medical
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 32-year-old male who has a past history that includes attention deficit/hyperactivity disorder. The patient has requested reimbursement for air wing transport provided on 1/12/21. 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 functional impairments due to traumatically acquired brain insults can be profound, particularly in the setting of severe injuries and in the setting of intracerebral hemorrhage. Traumatic brain injury, notably, is a major cause of disability in adults. While there is some natural recovery following acute traumatic brain injury, the impairments associated with this condition, nevertheless, are also generally amenable, at least in part, to various rehabilitation interventions.
Formal rehabilitation in a setting that is appropriate for the patientas level of dysfunction and clinical needs is the standard of care for this condition. Options for setting of care following the acute hospitalization include long-term acute care hospitals, acute inpatient rehabilitation facilities and skilled nursing facilities. Treatment centers around efforts to improve function, foster neurological recovery, mitigate risk of complications, advise on appropriate durable medical equipment, train family members/caregivers, and aid in the transition back to the community when feasible. There may be a limit, however, to the benefits of intensive rehabilitation to promote recovery significantly greater than natural recovery. The evidence base for rehabilitation following traumatic brain injury remains limited, particularly with respect to promoting function. In this case, the patient sustained a severe, acute traumatic brain injury due to a skateboarding-related fall. His course was complicated by seizures. He had persistent cognitive and safety-related impairments. He was eventually stabilized sufficiently from a medical standpoint for rehabilitation-focused care. Due to these deficits, he did require inpatient rehabilitation services. There was, however, no medical necessity of a transfer of the patient by air ambulance from the acute hospital in his residential state of Florida to a rehabilitation facility in the state of Georgia. The patientas acute hospital was in Delray Beach, Florida. This acute hospital has an acute inpatient rehabilitation facility on its own campus (Pinecrest Rehabilitation Hospital), which is Commission on Accreditation of Rehabilitation Facilities (CARF) accredited for both brain and spinal cord injury inpatient rehabilitation. There are also multiple other acute inpatient rehabilitation facilities in that region that are easily accessible by ground ambulance. The acute hospital in Delray Beach, Florida for instance, is about 55 miles away from Miami, Florida, which is a very large metropolitan area with multiple acute inpatient rehabilitation facilities that can manage brain injury rehabilitation (e.g., Mount Sinai Medical Center [Miami Beach, Florida] and Encompass Health Rehabilitation Hospital of Miami [Miami, Florida]). The transfer of the patient by air ambulance from Florida to Georgia for inpatient rehabilitation was elective, non-emergent and not medically necessary. Therefore, air wing transport provided on 1/12/21 was not medically necessary for the treatment of this patient.
| 1 |
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 11/27/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for FoundationOne CDx testing performed on 11/27/20. 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 FoundationOne assay is one of many multi-genomic assays used in the hope of identifying a target at which a specific chemotherapeutic agent can be aimed. Thus far, there is a lack of convincing evidence that choosing an agent by such an assay is reliably beneficial or better than choosing an agent in more conventional ways. A randomized study by Le Tourneau failed to demonstrate benefit from such use of an assay-directed therapy. The percentage of patients who will benefit from such an approach appears to be quite small. One use of Foundation One assay is to identify tumors that are microsatellite unstable, and/or with high tumor mutational burden. Such tumors are sensitive to treatment with Keytruda. In this case, there was a previous FoundationOne assay in 2015 that indeed did identify the tumor cells as fitting into this category. There was no need to repeat the FoundationOne assay in 2020. Therefore, FoundationOne CDx testing performed on 11/27/20 was not likely to be more beneficial than other available standard therapy.
| 0 |
The patient is a 23-year-old female with a history of limited cutaneous systemic sclerosis, Raynauds phenomenon, mild skin tightness, arthritis and gastrointestinal disease. Per the provider, the patient has been treated with sildenafil since 2010 with good results. On 11/20/17, she presented for follow-up. She was to have repeat pulmonary function testing given her worsening shortening of breath and follow-up with subspecialty providers. She continued to have mild depigmentation in her anterior shins, increased dilated blood vessels at the medial ankle, Raynauds at fingers and cold feet. The patients therapies included hydroxychloroquine, methotrexate, pantoprazole, calcium/vitamin D, inhalers and sildenafil. Examination demonstrated mild sclerodactyly, dilated purple ankle vessels at the left ankle, right fourth finger periungual dilation, light tan ill-defined patches on both shins, and multiple blue dilated vessels on left lateral thigh. The plan is
hematology consultation for possible iron infusion. Prior treatment has included nifedipine, Imuran, methotrexate, Rituximab, and Dynacirc without improvement, as well as minocycline. Pulmonary function testing on 12/31/14 showed restrictive chest wall disease, with potential airway disease and an increase in resistance. Echocardiogram on 6/29/16 showed a normal left and right ventricle and systolic function, with no significant change from previous study on 6/26/15. The
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 23-year-old female with a history of limited cutaneous systemic sclerosis, Raynauds phenomenon, mild skin tightness, arthritis and gastrointestinal disease. Per the provider, the patient has been treated with sildenafil since 2010 with good results. On 11/20/17, she presented for follow-up. She was to have repeat pulmonary function testing given her worsening shortening of breath and follow-up with subspecialty providers. She continued to have mild depigmentation in her anterior shins, increased dilated blood vessels at the medial ankle, Raynauds at fingers and cold feet. The patients therapies included hydroxychloroquine, methotrexate, pantoprazole, calcium/vitamin D, inhalers and sildenafil. Examination demonstrated mild sclerodactyly, dilated purple ankle vessels at the left ankle, right fourth finger periungual dilation, light tan ill-defined patches on both shins, and multiple blue dilated vessels on left lateral thigh. The plan is to increase sildenafil to, follow-up with gastroenterology, continue Plaquenil, and consider hematology consultation for possible iron infusion. Prior treatment has included nifedipine, Imuran, methotrexate, Rituximab, and Dynacirc without improvement, as well as minocycline. Pulmonary function testing on 12/31/14 showed restrictive chest wall disease, with potential airway disease and an increase in resistance. Echocardiogram on 6/29/16 showed a normal left and right ventricle and systolic function, with no significant change from previous study on 6/26/15. The patient has requested authorization and coverage for sildenafil 20 mg tablets. The Health Insurer has denied this request indicating that the requested medication is not medically necessary. For the treatment of secondary Raynauds phenomenon, the treatment of choice is a calcium channel blocker. Second-line treatment is typically a phosphodiesterase inhibitor (PDE-5). Roustit and colleagues concluded that PDE-5 inhibitors appear to have significant but moderate efficacy in secondary Raynauds phenomenon. Thompson and colleagues reported that PDE-5 medications are able to reduce episodes by 0.5/day which is comparable to calcium channel blockers (CCB) reduction by 0.6/day. In this case, the patient has failed multiple medications to include methotrexate, Imuran, CCB, Dynacirc, and Rituximab. The medical records demonstrate response with sildenafil. All told, the requested sildenafil 20 mg tablets is supported as medically necessary for treatment of this patients medical condition. 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 patient is a 43-year-old male with a history of bilateral squamous cell carcinoma of his oropharynx, cT3N0M0 stage II left tonsillar cancer and cT1N0M0 stage I right tonsillar cancer. 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.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 43-year-old male with a history of bilateral squamous cell carcinoma of his oropharynx, cT3N0M0 stage II left tonsillar cancer and cT1N0M0 stage I right tonsillar cancer. 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 the submitted documentation supports the medical necessity of the requested services. It is appropriate to spare the more superficial parotid gland, while maintaining coverage of the deep parotid/level II nodal region, as the treating provider has demonstrated in the plan comparison. The provider has shown that the use of photon-based intensity modulated radiation therapy would be associated with an excessive risk for parotid gland injury, resulting in xerostomia that would put the patient at an unacceptable risk for complications, such as swallowing dysfunction and dental caries. The proton radiation plan was able to significantly reduce the parotid exposure to within known safe tolerance limits, thereby minimizing this risk for high-grade radiation-induced morbidity. Proton radiation is supported by the American Society for Radiation Oncology (ASTRO) Model Policy and National Comprehensive Cancer Network guidelines in this setting, as the provider has shown that photon-based radiotherapy cannot be delivered with adequate safety/precision. Therefore, the requested proton beam radiation therapy is medically necessary for the treatment of this patient.
| 1 |
A 62-year-old female enrollee has requested reimbursement for the ThyGenX Thyroid Oncogene Panel testing provided on 11/18/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees thyroid nodule.
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Overturned
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Experimental
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Summary Reviewer 2
A 62-year-old female enrollee has requested reimbursement for the ThyGenX Thyroid Oncogene Panel testing provided on 11/18/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees thyroid nodule. The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). The ThyGenX analyzes a panel of DNA mutations and RNA translocation fusion markers to assess the risk of malignancy with good negative and positive predictive value thereby obviating the need for unnecessary surgery. Currently, there is adequate data supporting the ThyGenX Thyroid Oncogene Panel testing provided on 11/18/15 as 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 54-year-old male enrollee has requested reimbursement for high-intensity focused ultrasound (HIFU) performed on 6/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer.
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Upheld
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Experimental
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Summary Reviewer 3
A 54-year-old male enrollee has requested reimbursement for high-intensity focused ultrasound (HIFU) performed on 6/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that HIFU for prostate cancer is relatively new procedure. The U.S. Food and Drug Administration (FDA) has approved this procedure to be safe for treatment of prostate ablation. However, there is no specific indication for treatment of prostate cancer. The safety and efficacy of this treatment is currently being evaluated. The medical evidence has not demonstrated that this form of treatment is superior to conventional treatment options. Thus, HIFU provided on 6/28/16 was not likely to have been superior over other treatment modalities. 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 52-year-old female enrollee has requested authorization and coverage for matrix-assisted autologous chondrocyte implantation (MACI) procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain.
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Overturned
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Experimental
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Summary Reviewer 1
A 52-year-old female enrollee has requested authorization and coverage for matrix-assisted autologous chondrocyte implantation (MACI) procedure. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain. The physician reviewer found that there is a lack of support for the requested services in this clinical setting. In this case, the requested MACI procedure is not recommended or supported by high-quality literature for this patients condition. This procedure is not indicated for lesions involving the patellar cartilage or for bipolar patellofemoral lesions. Additionally, this procedure is not indicated in the presence of patellofemoral malalignment. There is lack of data to support the efficacy of MACI in these clinical situations, which have all been documented as being present based on the submitted operative report. Thus, the requested MACI procedure is not likely to be superior over other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 42-year-old female enrollee requested authorization and coverage for CPT 58674 (Acessa procedure - laparoscopic radiofrequency ablation). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
id, a conductive needle array punctures the fibroid and transmits radiofrequency energy, which causes coagulative necrosis.
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Overturned
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Experimental
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Summary Reviewer 1
A 42-year-old female enrollee requested authorization and coverage for CPT 58674 (Acessa procedure - laparoscopic radiofrequency ablation). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the desired procedure is a minimally invasive radiofrequency ablation treatment that reduces fibroid-related symptoms by reducing fibroid volume. The procedure is performed through a laparoscopic approach. Alternative standard therapy to the procedure includes more aggressive interventions, such as hysterectomy or myomectomy. Interventional radiology embolization procedures are only successful in a certain patient population with fibroids in specific locations. The procedure is done as an outpatient basis, with return to normal activity within approximately one week. Using ultrasound guidance to identify the fibroid, a conductive needle array punctures the fibroid and transmits radiofrequency energy, which causes coagulative necrosis. An ultrasound probe is used to monitor the tissue effect until the bulk of the fibroid is treated. Over subsequent months, fibroids are reabsorbed, with a decrease in fibroid volume and a resultant reduction in fibroid-related symptoms. This is directed therapy and allows for treatment in the proper candidate within a minimally invasive surgical approach. The medical evidence supports the requested services in this clinical setting. Therefore, CPT 58674 (Acessa procedure - laparoscopic radiofrequency ablation) is likely to be more beneficial than any available standard therapy.
| 1 |
A 37-year-old male enrollee has requested reimbursement and prospective authorization and coverage for assay for calprotectin fecal laboratory performed on 10/28/16 and ongoing. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease.
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Upheld
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Experimental
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Summary Reviewer 1
A 37-year-old male enrollee has requested reimbursement and prospective authorization and coverage for assay for calprotectin fecal laboratory performed on 10/28/16 and ongoing. The Health Plan 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 role of fecal calprotectin has been extensively studied in many areas of inflammatory bowel disease (IBD) patients management. There is emerging evidence that fecal calprotectin is a useful surrogate marker of inflammation in the post-operative setting, as it correlates with the presence and severity of endoscopic recurrence according to Rutgeerts score and can predict the subsequent clinical recurrence and response to therapy in CD patients. There is sufficient medical literature showing the usefulness of following fecal calprotectin levels serially. All told, the assay for calprotectin fecal laboratory performed on 10/28/16 and ongoing was and is 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 and is 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 23-year-old female enrollee has requested reimbursement for intraoperative monitoring on
7/25/22. The Health Insurer has denied this request and reported that the service at issue was
investigational for the treatment of the enrollees spastic quadriparesis secondary to cerebral palsy
and spastic dislocation of the right hip.
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Overturned
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Experimental
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Summary Reviewer 2
A 23-year-old female enrollee has requested reimbursement for intraoperative monitoring on
7/25/22. The Health Insurer has denied this request and reported that the service at issue was
investigational for the treatment of the enrollees spastic quadriparesis secondary to cerebral palsy
and spastic dislocation of the right hip. The physician reviewer found that in a review of the
intraoperative monitoring records of 40 hip periacetabular osteotomies, Novais and colleagues
found that abnormal recording alerts notified the surgeon in six cases, allowing the surgeon to alter
the surgical plan and take steps to avert serious permanent sciatic nerve injury. In a case series of
10 patients, Overzet and colleagues identified changes in 36% of the cases, due to leg lengthening
procedures, that allowed the surgeon to take corrective procedures to avoid permanent injury. In a
systematic review, Murena and colleagues concluded, There is general agreement in recognizing
a role for intraoperative nerve monitoring to define the critical maneuvers, positions or pathologies
that could lead to sciatic nerve intraoperative damage. In this clinical setting, given the complex
nature of this patients severe hip deformity and osteotomy, the service at issue was likely to have
provided more benefit for this patient than standard care. Therefore, intraoperative monitoring on
7/25/22 was likely to have been more beneficial for treatment of the patients condition than any
available standard therapy.
| 1 |
A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye.
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Overturned
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Experimental
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Summary Reviewer 2
A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye. The physician reviewer found that there is a lack of evidence-based medical studies that support the superiority of DecisionDX assay over standard testing options for the evaluation of uveal melanoma in this clinical setting. While there are some studies that show genomic testing can lead to more frequent evaluations for metastasis, there is still is no approved adjuvant therapy for the treatment of uveal melanoma. Moreover, it has not been shown to predict response to adjuvant therapy. In summary, the DecisionDX uveal melanoma multigene assay performed on 4/10/15 was not likely to have led to greater benefit for the evaluation of this patient than other standard treatment options. Based upon the information set forth above, the service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 42-year-old female enrollee has requested authorization and coverage for disc fusion. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
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Overturned
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Medical Necessity
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Summary Reviewer
A 42-year-old female enrollee has requested authorization and coverage for disc fusion. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. Anterior lumbar interbody fusion is associated with higher fusion rates compared with posterolateral lumbar fusion in patients with degenerative changes of the lumbar spine, including those with instability. There is moderate evidence that for lumbar degenerative disc disease without instability, a standalone anterior lumbar interbody fusion has better clinical outcomes than the anterior lumbar interbody fusion plus instrumented open posterior lumbar fusion. With regard to the type of interbody spacer used, frozen allograft is associated with lower pseudarthrosis rates compared with freeze-dried allograft. Based on these guidelines, the requested anterior lumbar interbody fusion procedure is likely to be beneficial for this patients severely symptomatic degenerative disc disease with a 4 mm protrusion at L5-S1 that did not respond to nonoperative treatment. Therefore, the requested 63077, 22558 and 22845 are medically necessary for the treatment of this patient.
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A 46-year-old female enrollee has requested reimbursement for CPT code 84999 performed on 1/12/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 46-year-old female enrollee has requested reimbursement for CPT code 84999 performed on 1/12/17. 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 the DecisionDx-Melanoma testing has been developed in patients with stage I and II cutaneous melanoma. However, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. 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 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 genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. In sum, CPT code 84999 performed on 1/12/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 57-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 11/24/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.
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Overturned
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Experimental
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Summary Reviewer 3
A 57-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 11/24/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. In this patients case, her breast tissue was extremely dense. While one could make the argument that her mammogram has not changed since the last study, it is specifically those patients who have dense breasts that can benefit most from breast tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Thus, breast tomosynthesis performed on 11/24/15 was likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 27-year-old female insured has requested authorization and coverage for Besremi 500 mcg/mL
syringe. A review of the record indicates the insured is currently pregnant and has a history of
essential thrombocythemia. The Health Insurer indicates the requested treatment is considered
investigational for the treatment of the insureds medical condition. Therefore, the Health Insurer
has denied coverage for the requested treatment.
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Overturned
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Experimental
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Summary Reviewer 3
A 27-year-old female insured has requested authorization and coverage for Besremi 500 mcg/mL
syringe. A review of the record indicates the insured is currently pregnant and has a history of
essential thrombocythemia. The Health Insurer indicates the requested treatment is considered
investigational for the treatment of the insureds medical condition. Therefore, the Health Insurer
has denied coverage for the requested treatment. This denial is the subject of this appeal and
determination. The physician reviewer found that the use of aspirin and interferon has been
associated with increased numbers of live births without significant maternal or fetal adverse
effects, according to current data from the peer-reviewed medical literature. One meta-analysis
and review of the literature included 767 patients and 1,210 pregnancies from 22 studies on patients
with myeloproliferative neoplasms, most of whom had essential thrombocythemia (Maze, et al.).
The authors found that moderate-quality evidence suggests that aspirin or interferon is associated
with higher odds of live birth in pregnant women with myeloproliferative disorder. Although
Pegasys and Besremi are both pegylated interferon (peginterferon) alfa-2a, Besremi is better
tolerated with fewer injections and it has been shown to be safe during pregnancy. All told, the
requested Besremi 500 mcg/mL syringe is likely to be more beneficial for the treatment of the
patients medical condition than any available standard therapy.
| 1 |
The parent of a nine-year-old female enrollee has requested authorization and coverage for chromosomal microarray analysis. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition.
The patient has previously had a microarray, but the results
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a nine-year-old female enrollee has requested authorization and coverage for chromosomal microarray analysis. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found that Microarray is a first-line test in the evaluation of children with intellectual disability/developmental delay, autism spectrum disorder, or multiple congenital anomalies. This patient falls into a category of patient for whom microarray is recommended as a first line investigation. Microarray technology has evolved over the years, initially being done using bacterial artificial chromosomes (BAC) and now being done with oligonucleotides and single nucleotide polymorphisms. The patient has previously had a microarray, but the results were not provided and the details of the methodology used are not given. In order to determine if a chromosomal microarray analysis is superior to what was done previously, a comparison of the methodologies is needed. Additionally, it is noted that the initial microarray showed a maternally-inherited chromosome 16 deletion which was interpreted as nonsignificant. Interpretation of a chromosomal microarray finding may change over time as new information regarding significance of copy number variations becomes available (Palmer, et al). Therefore, the appropriate next step is to have this patients prior microarray results reviewed by a clinical geneticist who can re-evaluate the medical literature associated with the chromosome 16 deletion to determine if there has been a change in interpretation of pathogenicity, and decide, based on this information and comparing the methodology of the previous microarray and the proposed new testing, whether a new study is needed. Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 75-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 5/26/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 75-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 5/26/21. 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 use of gene expression profiling (GEP) testing according to specific
American Joint cancer Committee (AJCC) melanoma stage requires further prospective
investigation in large, contemporary datasets of unselected patients. Prognostic GEP testing to
differentiate melanomas at low versus high risk for metastasis should not replace pathologic
staging procedures. Moreover, since there is a low probability of metastasis in early stage
melanoma and a higher proportion of false-positive results, GEP testing should not guide clinical
decision-making in this subgroup. It remains unclear where these GEP platforms provide clinically
actionable prognostic information when used in addition to or in comparison with known
clinicopathologic factors or multivariate nomograms that incorporate patient sex, age, tumor
location and thickness, ulceration, mitotic rate, lymphovascular invasion, and sentinel lymph
node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up
schedules has not been established. Therefore, DecisionDx-Melanoma testing performed on
5/26/21 was not likely to have been more beneficial than any available standard therapy.
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A 35-year-old male enrollee has requested authorization and coverage for bariatric surgery and one day inpatient admission. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees morbid obesity.
This patient is an adult that is morbidly obese with a BMI of 52 kg/m2. The patient has failed dietary efforts including more than six months of supervised weight loss. The patient completed a comprehensive multidisciplinary evaluation that did not reveal any obvious dietary, psychological or medical barriers to surgery. The patient has no correctable causes of obesity and has demonstrated ongoing reliable participation in preparatory program. The provider as included an att
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Overturned
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Medical Necessity
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Summary Reviewer
A 35-year-old male enrollee has requested authorization and coverage for bariatric surgery and one day inpatient admission. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees morbid obesity. The physician reviewer found that this patient meets all nationally accepted criteria for bariatric surgery including the American Society for Metabolic and Bariatric Surgery. This patient is an adult that is morbidly obese with a BMI of 52 kg/m2. The patient has failed dietary efforts including more than six months of supervised weight loss. The patient completed a comprehensive multidisciplinary evaluation that did not reveal any obvious dietary, psychological or medical barriers to surgery. The patient has no correctable causes of obesity and has demonstrated ongoing reliable participation in preparatory program. The provider as included an attestation regarding compliance to a long-term program with diet, multidisciplinary program, lifestyle changes and follow-up. Given these findings, the requested bariatric surgery and one day inpatient admission are supported as medically necessary for treatment of this patients medical condition. Based on the foregoing, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 51-year-old female has requested reimbursement for genetic testing performed on 4/13/18. 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 patient is a 51-year-old female who was diagnosed with melanoma of the right medial distal pretibial region. Pathology report from 6/06/16 showed a malignant melanoma, superficial spreading type, Clarks level IV. There was no ulceration, necrosis or regression. DecisionDx-Melanoma testing was performed on 4/13/18. The patient has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. This patient had an early stage melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 51-year-old female has requested reimbursement for genetic testing performed on 4/13/18. 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 patient is a 51-year-old female who was diagnosed with melanoma of the right medial distal pretibial region. Pathology report from 6/06/16 showed a malignant melanoma, superficial spreading type, Clarks level IV. There was no ulceration, necrosis or regression. DecisionDx-Melanoma testing was performed on 4/13/18. The patient has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. 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. Therefore, genetic testing performed on 4/13/18 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 38-year-old male enrollee has requested reimbursement for polymerase chain reaction testing for gastrointestinal pathogen panel performed on 12/16/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 38-year-old male enrollee has requested reimbursement for polymerase chain reaction testing for gastrointestinal pathogen panel performed on 12/16/19. 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 most cases of acute diarrhea are due to infections and are self-limited. The major causes of acute infectious diarrhea include viruses, bacteria, and protozoa. For most patients who do not have severe illness or high-risk comorbidities, it is reasonable to continue expectant management for several days without microbiologic stool testing (e.g. polymerase chain reaction multiplex molecular panel tests). Per the Infectious Diseases Society of America (IDSA) guidelines, immediate testing is indicated with severe disease defined as follows: profuse watery diarrhea with signs of hypovolemia; passage of greater than six unformed stools per 24 hours; severe abdominal pain; need for hospitalization; other signs or symptoms concerning for inflammatory diarrhea; bloody diarrhea; passage of many small volume stools containing blood and mucus; temperature greater than or equal to 38.5AoC (101.3AoF). In this case, the submitted records do not document the severity and duration of symptoms. The clinical notes provided do not support that the patient met criteria for the services at issue. Therefore, polymerase chain reaction testing for gastrointestinal pathogen panel performed on 12/16/19 was not likely to have been more beneficial than other available methods of evaluating this patient.
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A 26-year-old male enrollee has requested authorization and coverage for Xyrem. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
The interpreting sleep physician explained that the patient met the criteria in the first four naps.
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Overturned
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Medical Necessity
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Summary Reviewer
A 26-year-old male enrollee has requested authorization and coverage for Xyrem. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the patients history of excessive daytime sleepiness and the MSLT with normal polysomnography are consistent with the narcolepsy diagnosis. The interpreting sleep physician explained that the patient met the criteria in the first four naps. It is usually acceptable not to conduct the fifth nap if the first four naps are consistent with the diagnosis. Thus, the records confirm the diagnosis of narcolepsy. In this patients case, it appears as if a stimulant alone is not enough to control the patients symptoms. Untreated or undertreated narcolepsy can lead to accidents. Therefore, Xyrem is medically necessary for the treatment of this patient.
| 1 |
The patient is a 63-year-old male who was evaluated with DecisionDx-Melanoma testing on 5/13/19. Pathology from 4/10/19 from a left forearm biopsy showed melanoma, Clarks level II, 0.36 mm thickness.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 63-year-old male who was evaluated with DecisionDx-Melanoma testing on 5/13/19. Pathology from 4/10/19 from a left forearm biopsy showed melanoma, Clarks level II, 0.36 mm thickness. The physician reviewer found that this patient had an early stage melanoma. Per the National Comprehensive Cancer Network guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to help differentiate benign from malignant neoplasms, or to help distinguish melanomas at low-risk versus high-risk for metastasis, routine genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, tumor biomarker or gene expression classifier test performed on 5/13/19 was not medically necessary for the evaluation of this patient.
| 1 |
A 20-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 8/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 20-year-old female enrollee has requested reimbursement for polymerase chain reaction testing performed on 8/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the medical evidence has not demonstrated the superior efficacy of vaginitis panel testing using polymerase chain reaction technology. Although these methods have high sensitivity and specificity, including a shorter turn-around time than culture, the testing offers no proven benefit over standard culture in symptomatic women. Furthermore, there is a lack of evidence on the clinical utility and impact of polymerase chain reaction testing for vaginitis. There is a lack of studies showing that this testing leads to better patient management decisions or better health outcomes. Studies of diagnostic accuracy alone are inadequate, especially because most symptomatic women can be diagnosed with a standard work-up and/or a trial of empiric therapy. Thus, polymerase chain reaction testing performed on 8/14/18 was not likely to have been superior over other methods of evaluating this patient.
| 0 |
A 55-year-old female enrollee has requested authorization and coverage for corticotropin (Acthar Gel). The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records document refractory rheumatoid arthritis and type 2 diabetes. She has tried and failed multiple medications, including nonsteroidal anti-inflammatory drugs (NSAIDs), high-dose intravenous corticosteroids, methotrexate, Enbrel, Arava, Plaquenil, Rituxan, Actemra, Xeljanz, Cimzia, Humira, Orencia, Imuran, Simponi, and Remicade. She has failed multiple tumor necrosis factor inhibitors and multiple biologic agents and continues to have active rheumatoid arthritis.
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Upheld
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Experimental
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Summary Reviewer 2
A 55-year-old female enrollee has requested authorization and coverage for corticotropin (Acthar Gel). The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the records document refractory rheumatoid arthritis and type 2 diabetes. She has tried and failed multiple medications, including nonsteroidal anti-inflammatory drugs (NSAIDs), high-dose intravenous corticosteroids, methotrexate, Enbrel, Arava, Plaquenil, Rituxan, Actemra, Xeljanz, Cimzia, Humira, Orencia, Imuran, Simponi, and Remicade. She has failed multiple tumor necrosis factor inhibitors and multiple biologic agents and continues to have active rheumatoid arthritis. In this case, the use of Acthar Gel would not be considered off-label, as Acthar Gel is approved for short-term use in rheumatological conditions, and this request is for six to eight weeks of therapy. She would need to be bridged to another medication. Short-term use would be consistent with current labeling and as a bridge to more definitive therapy. In sum, corticotropin (Acthar Gel) is likely to be more beneficial than other treatment options.
| 1 |
A 66-year-old male enrollee has requested authorization and coverage for Praluent. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee who has been diagnosed with hyperlipidemia and cardiovascular disease.
Based on the records, the patient has been diagnosed with hyperlipidemia and documented coronary disease.
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Upheld
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Medical Necessity
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Summary Reviewer
A 66-year-old male enrollee has requested authorization and coverage for Praluent. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee who has been diagnosed with hyperlipidemia and cardiovascular disease. The physician reviewer found that the documentation provided does not support the requested medication in this clinical setting. Based on the records, the patient has been diagnosed with hyperlipidemia and documented coronary disease. In this setting, medical therapy is indicated to achieve a goal reduction in LDL cholesterol to less than 70 mg/dl according to current guidelines. Since this was documented to be achieved with Vytorin 10/80 alone, the medical necessity for the addition of a proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitor, such as Praluent, is not supported by the documentation. PCSK9 inhibitors are approved for patients with familial hyperlipidemia or documented atherosclerotic heart disease who require additional lowering of LDL-cholesterol. The medical literature suggests that additional LDL lowering on top of that achieved with Vytorin is not medically necessary since the LDL cholesterol was already less than 70 mg/dl without the addition of a PCSK9 inhibitor. Accordingly, Praluent is not medically necessary for the treatment of this patients medical condition. Therefore, based on the above, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 46-year-old female enrollee has requested authorization and coverage for CPT 19316 performed on 10/24/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
This patient had evidence of significant symptomatic macromastia, and she had failed conservative management. Based on the documentation provided, she was a candidate for bilateral breast reduction based on non-resolving functional impairment. She underwent this procedure on 10/24/18. The operative note was
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Upheld
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Medical Necessity
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Summary Reviewer
A 46-year-old female enrollee has requested authorization and coverage for CPT 19316 performed on 10/24/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient had evidence of significant symptomatic macromastia, and she had failed conservative management. Based on the documentation provided, she was a candidate for bilateral breast reduction based on non-resolving functional impairment. She underwent this procedure on 10/24/18. The operative note was consistent with a standard breast reduction and not solely a mastopexy. Generally, standard breast reductions include a breast lift as an integral part of the procedure and would not be considered a separate procedure. Based on the documentation provided, this patient underwent a bilateral breast reduction and not solely a mastopexy. An additional mastopexy would not be considered as a separate procedure, but an integral portion to the breast reduction. Therefore, the Health Insurers denial was appropriate. Thus, mastopexy (CPT 19316) performed on 10/24/18 was not medically necessary for the treatment of this patient.
| 1 |
patient is a 23-year-old female with a history of depression. She has undergone pharmacological management of her depression since 2019.
This patient has failed over four different agents of two different classes. She has failed CBT,
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 23-year-old female with a history of depression. She has undergone pharmacological management of her depression since 2019. Medication trials have included Prozac, Wellbutrin, venlafaxine, Zoloft, Lamictal and Ability. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. Given the severity of her symptoms and functional impairment, TMS is medically indicated. Currently, TMS is indicated for the acute phase of major depression. This patient has failed over four different agents of two different classes. She has failed CBT, which is an evidence-based psychotherapy for major depressive disorder. The TMS Society Consensus Review recommends TMS for the acute phase of severe depression, which she is currently experiencing. Therefore, TMS is medically necessary for the treatment of this patient.
| 1 |
The patient is a 61-year-old female with a diagnosis of melanoma measuring 2.65 mm in depth. Her provider submitted a tissue sample for molecular genetic testing with the DecisionDx to determine the risk of metastasis for this tumor. The patient has requested reimbursement for the DecisionDx melanoma assay provided on 6/30/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational.
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Upheld
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Experimental
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Summary Reviewer 1
The patient is a 61-year-old female with a diagnosis of melanoma measuring 2.65 mm in depth. Her provider submitted a tissue sample for molecular genetic testing with the DecisionDx to determine the risk of metastasis for this tumor. The patient has requested reimbursement for the DecisionDx melanoma assay provided on 6/30/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. The DecisionDx melanoma assay tests the tissue genetics of the melanoma to help stratify whether melanoma is high risk for metastasis. The DecisionDx test has shown some accuracy in melanomas. However, there is a lack of scientific evidence permitting conclusions concerning the effect of this test on health outcomes. The test is not considered routine standard of care and is not recommended by the National Comprehensive Cancer Network (NCCN) guidelines. Overall, there is not enough published data to support its routine use. Since this test has not been demonstrated to provide a benefit more than established tests, the DecisionDx melanoma assay provided on 6/30/14 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 12-year-old female enrollee has requested reimbursement for fecal calprotectin testing provided on 7/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a 12-year-old female enrollee has requested reimbursement for fecal calprotectin testing provided on 7/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that Fecal calprotectin is a noninvasive laboratory test which is frequently used in clinical practice to evaluate for the presence of intestinal inflammation. In addition to its utility in screening for inflammatory bowel disease, it also has utility in evaluating for flares or recurrent inflammation in the setting of known inflammatory bowel disease. This test can be particularly helpful in a situation where a patients symptoms may be due to another cause, to assess for presence of deep remission in a patient who is asymptomatic, and to evaluate for response to treatment in a patient with atypical or mild symptoms at diagnosis. Fecal calprotectin testing has become a standard measurement in the practice of pediatric gastroenterology, as it often allows the physician to avoid or defer a repeat colonoscopy on a child. All told, there is adequate peer-reviewed medical data demonstrating that the fecal calprotectin testing provided on 7/17/15 was likely to be more beneficial for evaluation of this patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 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.
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Upheld
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Experimental
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Summary Reviewer 3
A 56-year-old male enrollee has requested reimbursement for 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 the Cologuard test provided on 12/1/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Cologuard is U.S. Food and Drug Administration (FDA) approved to test for colon cancer, proved 92% sensitive for detection of colon cancer, and can detect most adenomas with high-grade dysplasia (Imperiale, et al). The limited evidence for Cologuard reports that 154 patients would have to be screened to find one cancer using colonoscopy, versus 166 patients using Cologuard, thus cancers may be missed by Cologuard (Imperiale, et al). Additionally, the evidence of the impact of this information on patient care or health outcomes is lacking. Although Cologuard is able to determine that cancer has already developed, it cannot detect or remove polyps or precancerous lesions. Health outcomes using Cologuard have not been compared over the long-term with other screening methods for colon cancer. In addition, there is a lack of consensus in clinical guidelines and peer-reviewed literature to support that Cologuard has a positive impact on health outcomes. Given the limited support in the peer-reviewed medical literature, Cologuard was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 43-year-old female enrollee has requested authorization and coverage for Contrave. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees morbid obesity.
this patient falls into a class III (high risk) obesity. She has not had success with diet or exercise, or with the weight loss medication Belviq. She also has multiple comorbidities such as hypertension, borderline diabetes, and obstructive sleep apnea (J
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Upheld
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Medical Necessity
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Summary Reviewer
A 43-year-old female enrollee has requested authorization and coverage for Contrave. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees morbid obesity. The physician reviewer found that there is support in the medical literature for the requested medication in this clinical setting. According to the documentation provided, this patient falls into a class III (high risk) obesity. She has not had success with diet or exercise, or with the weight loss medication Belviq. She also has multiple comorbidities such as hypertension, borderline diabetes, and obstructive sleep apnea (Jensen, et al). Contrave is U.S. Food and Drug Administration approved for chronic weight management in patients with BMI over 30 (package insert). Guidelines for pharmacological management of obesity released in 2015 by the Endocrine Society state that patients who have a history of being unable to successfully lose and maintain weight are candidates for weight loss medications (Apovian, et al). Specifically, pharmacotherapy is recommended in patients with BMI higher than 30 kg/m2 (or 27 if comorbidities are present). This patient had a BMI of 45.2 kg/m2 in May 2017. Studies have shown 8.2% weight loss at one year, with approximately 40% of patients losing more than 10% of their weight (Sherman, et al). For these reasons, the request for Contrave is supported as medically necessary for the treatment of the 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.
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The parent of a 14-year-old female enrollee has requested authorization and coverage for lidocaine injection 10 mg and associated inpatient stay. The Health Insurer has denied this request and reported that the requested services and requested medication is investigational for the treatment of the enrollees medical condition.
This patient has tried the new anti-calcitonin gene-related peptide medications, without improvement in her symptoms. She has had several inpatient admissions for infusions of different medications, including sodium valproate, dihydroergotamine, and Thorazine. She has also had multiple injections to the greater occipital nerve, without improvement in her symptoms.
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Overturned
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Experimental
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Summary Reviewer 2
The parent of a 14-year-old female enrollee has requested authorization and coverage for lidocaine injection 10 mg and associated inpatient stay. The Health Insurer has denied this request and reported that the requested services and requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for the requested services and requested medication in this clinical setting. A stepwise, exhaustive trial of numerous medications from different classes has been used for both migraine prophylaxis and acute abortive treatment. This patient has tried the new anti-calcitonin gene-related peptide medications, without improvement in her symptoms. She has had several inpatient admissions for infusions of different medications, including sodium valproate, dihydroergotamine, and Thorazine. She has also had multiple injections to the greater occipital nerve, without improvement in her symptoms. There are published studies supporting the use and efficacy of intravenous lidocaine in migraine and chronic daily headache. Due to the potential side effects of this medication, close monitoring in an intensive care unit is required. In sum, lidocaine injection 10 mg and associated inpatient stay are likely to be of greater benefit than other treatment options.
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A 58-year-old male enrollee has requested reimbursement for Oncotype DX Prostate Cancer Assay performed on 11/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer.
that the patient is a 58-year-old male with a history of elevated prostate-specific antigen level. On 10/18/17, pathology report noted prostatic adenocarcinoma, Gleason score 3+4=7. The tumor involved four of 12 cores. The patient has requested reimbursement for Oncotype DX Prostate Cancer Assay performed on 11/13/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.
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Overturned
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Experimental
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Summary Reviewer 3
A 58-year-old male enrollee has requested reimbursement for Oncotype DX Prostate Cancer Assay performed on 11/13/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that the patient is a 58-year-old male with a history of elevated prostate-specific antigen level. On 10/18/17, pathology report noted prostatic adenocarcinoma, Gleason score 3+4=7. The tumor involved four of 12 cores. The patient has requested reimbursement for Oncotype DX Prostate Cancer Assay performed on 11/13/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. The medical evidence has not established the superior effectiveness of the services at issue in this clinical setting. This testing has not been validated with prospective randomized clinical trials to change outcomes and impact survival or quality of life. There is a lack of support for the use of this molecular test to determine the appropriateness of observation or active surveillance. Thus, Oncotype DX Prostate Cancer Assay performed on 11/13/17 was not likely to be of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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patient is a 16-year-old male with idiopathic short stature. He presented to his endocrinologist at the age of 8 years 6 months with height at approximately the third percentile.
The above patient had a history of short stature with height being at 1.2 percentile and poor growth velocity. He has been treated with growth hormone therapy. His predicted adult height of 71.8 to 73.6
His current height is 64.8 inches and he is likely to achieve his mid-parental height.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 16-year-old male with idiopathic short stature. He presented to his endocrinologist at the age of 8 years 6 months with height at approximately the third percentile. The physician reviewer found that the submitted documentation does not support the medical necessity of the requested medication. Based on the bone age of 13 years, the calculated predicted adult height is 187 cm or 73.6 inches. Based on the bone age of 13.5 years, the calculated predicted adult height was 182.4 cm or 71.8 inches. These are based on values per Greulich and Pyle method. The U.S. Food and Drug Administration has approved the use of growth hormone therapy for idiopathic short stature or non-growth hormone-deficient short stature defined as height standard deviation less than or equal to -2.25 or less than or equal to 1.2nd percentile for age and gender. In 2016, Pediatric Endocrine Society came out with guidelines and recommendations for growth hormone use and noted that the decision to treat idiopathic short stature should be made on case-by-case basis. The above patient had a history of short stature with height being at 1.2 percentile and poor growth velocity. He has been treated with growth hormone therapy. His predicted adult height of 71.8 to 73.6 inches is higher than the 66.5 inches of mid-parental height by a good margin. His current height is 64.8 inches and he is likely to achieve his mid-parental height. At this point, continued growth hormone therapy is not medically necessary. Therefore, Norditropin Flexpro 10 mg/1.5 mL pen injector is not medically necessary for the treatment of this patient.
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The patient is a 21-year-old male with a history of gastroesophageal reflux disease (GERD). The patient has been treated with pantoprazole 40 mg. Multiple esophagogastroduodenoscopies performed in 2017 showed antral erythema and Z-line irregularity without esophagitis or Barretts. A video esophagram dated 8/22/17, proved unremarkable. A Bravo pH testing dated 8/18/17 was normal. The patient has requested authorization and coverage for the esophageal sphincter augmentation device (CPT code 43284). The Health Insurer has denied this request as investigational.
with acid exposure, whereas esophagitis was absent visually and histologically on three serial esophag
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Upheld
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Experimental
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Summary Reviewer 2
The patient is a 21-year-old male with a history of gastroesophageal reflux disease (GERD). The patient has been treated with pantoprazole 40 mg. Multiple esophagogastroduodenoscopies performed in 2017 showed antral erythema and Z-line irregularity without esophagitis or Barretts. A video esophagram dated 8/22/17, proved unremarkable. A Bravo pH testing dated 8/18/17 was normal. The patient has requested authorization and coverage for the esophageal sphincter augmentation device (CPT code 43284). The Health Insurer has denied this request as investigational. Based on the clinical documentation submitted for review, the esophageal sphincter augmentation device (CPT code 43284) is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In this case, testing showed a normal DeMeester score and zero symptom correlation with acid exposure, whereas esophagitis was absent visually and histologically on three serial esophagogastroduodenoscopies. LINX is indicated in GERD patients refractory to medical management. The patient does not have pathologic GERD, based on objective evidence provided. As such, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. I have determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Insurers denial should be uphel
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A 51-year-old female enrollee has requested reimbursement for air ambulance services provided on 11/29/16. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition status post subarachnoid hemorrhage.
In this case, the patient sustained a stroke and a facility in Washington did not accept her. She was transferred by air ambulance to Colorado for acute rehabilitation.
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Overturned
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Medical Necessity
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Summary Reviewer
A 51-year-old female enrollee has requested reimbursement for air ambulance services provided on 11/29/16. The Health Plan has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition status post subarachnoid hemorrhage. The physician reviewer found the air ambulance services provided on 11/29/16 were medically necessary for treatment of the patients medical condition. There is sufficient support in the peer-reviewed literature to support the services at issue in this clinical setting. Pollock and colleagues reviewed whether physical rehabilitation approaches are effective in recovery of function and mobility in patients with stroke, and to assess if any one physical rehabilitation approach is more effective than any other approach. The authors found that physical therapy improved recovery from stroke. In this case, the patient sustained a stroke and a facility in Washington did not accept her. She was transferred by air ambulance to Colorado for acute rehabilitation. The medical literature supports the therapies delivered at the Craig Hospital in Colorado which is the standard treatment approach for patients status post stroke. Given the patients medical condition, the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 40-year-old female enrollee has requested reimbursement for cytogenomic constitutional microarray analysis performed on 6/14/17. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees recurrent miscarriages.
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Overturned
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Medical Necessity
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Summary Reviewer
A 40-year-old female enrollee has requested reimbursement for cytogenomic constitutional microarray analysis performed on 6/14/17. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees recurrent miscarriages. The physician reviewer found that according to the American College of Obstetricians and Gynecologists (ACOG), approximately 50% of all causes of early pregnancy loss are due to fetal chromosomal abnormalities. For this reason, genetic testing is recommended, especially in women of advanced maternal age or following two or more miscarriages. Chromosomal microarray analysis is a method of measuring gains and losses of DNA throughout the human genome. This testing can identify chromosomal aneuploidy and other large changes in the structure of chromosomes that would otherwise be identified by standard karyotype analysis, as well as submicroscopic abnormalities that are too small to be detected by traditional modalities. Accordingly, the cytogenomic constitutional microarray analysis performed on 6/14/17 was medically necessary for evaluation of the patients medical condition. Based on the foregoing discussion, the testing at issue was medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
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A 64-year-old male enrollee has requested reimbursement for injection, immune globulin, Gammagard liquid, non-lyophilized, (e.g., liquid) 500 mg from 11/2/15 through 11/6/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees anti-GM1 polyneuropathy and Sjogrens syndrome.
. This patient has had sensory-motor polyneuropathy confirmed, and with associated autoimmune markers. He has tried and failed prednisone and medications for symptom management. IVIG has been administered with benefit, and he has had relapse when not treated. This patient was responsive to treatment with IVIG.
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Overturned
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Experimental
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Summary Reviewer 1
A 64-year-old male enrollee has requested reimbursement for injection, immune globulin, Gammagard liquid, non-lyophilized, (e.g., liquid) 500 mg from 11/2/15 through 11/6/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees anti-GM1 polyneuropathy and Sjogrens syndrome. The physician reviewer found the medical literature support the superior efficacy of the services at issue in this clinical setting. Polyneuropathy can be idiopathic or can be traced to specific etiologies. Dysimmune neuropathies, with antibodies to gangliosides GM1 and GD1a can present in an acute or a chronic fashion. Patwa and colleagues stated the following, IVIG is effective and should be offered in the long-term treatment of chronic inflammatory demyelinating polyneuropathy (Level A). This patient has had sensory-motor polyneuropathy confirmed, and with associated autoimmune markers. He has tried and failed prednisone and medications for symptom management. IVIG has been administered with benefit, and he has had relapse when not treated. This patient was responsive to treatment with IVIG. As such, injection, immune globulin, (Gammagard liquid), non-lyophilized, (e.g., liquid), 500 mg from 11/2/15 through 11/6/15 was shown to be more effective than standard therapy for treatment of this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 55-year-old male enrollee has requested reimbursement for CPT code 81479 provided on 12/21/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 55-year-old male enrollee has requested reimbursement for CPT code 81479 provided on 12/21/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. Retrospective studies have shown that molecular assays performed on prostate biopsy or radical prostatectomy specimens provide prognostic information independent of National Comprehensive Cancer Network risk groups. These include, but are not limited to, likelihood of biochemical progression after radical prostatectomy or external beam therapy, and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. Men with clinically localized disease may consider the use of tumor-based molecular assays. It is considered a standard of care in guiding treatment decision making. This patient with low risk disease meets criteria for testing. In sum, CPT code 81479 provided on 12/21/18 was likely to have been more beneficial than other methods of evaluating this patient.
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A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/14/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts.
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Overturned
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Experimental
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Summary Reviewer 2
A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/14/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts. The physician reviewer found that per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues state that integrated two dimensional and three dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Therefore, the medical literature supports the use of digital breast tomosynthesis over conventional mammogram due to improved cancer detection rate. As such, digital breast tomosynthesis performed on 7/14/16 was likely to have been superior to other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 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 patient has
metastatic disease involving the cervical and thoracic spine.
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Overturned
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Experimental
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Summary Reviewer 3
A 64-year-old female enrollee has requested 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 the Guardant360 test is a liquid biopsy that analyzes patient plasma for mutations in a panel of 70
genes. Von Hoff and colleagues performed a clinical study directly that compared the use of
targeted agents with conventional chemotherapy approaches. The study involved 86 patients, and
the progression-free survival (PFS) on regimen selected by molecular profiling was compared to
the PFS on the last chemotherapy regimen. The regimen selected by molecular profiling offered a
27% survival advantage. This trial has very significant results for patients with stage IV tumors.
In most instances of visceral disease or lymph node involvement, testing can be performed on the
excised tissue. However, in certain cases, such as bone metastases, the decalcification process
makes the material unsuitable for gene sequencing. Thus, liquid biopsy is specifically mentioned
in the National Comprehensive Cancer Network (NCCN) guidelines as an alternative approach
when the tissues are less accessible. The oncologistas progress notes indicate that the patient has
metastatic disease involving the cervical and thoracic spine. The anatomical locations are difficult
to directly sample without a significant invasive procedure with its own morbidities. Thus, the
patientas clinical situation fits the scenario outlined in the NCCN guidelines for performing the
Guardant360 test. Therefore, genetic testing performed on 1/27/20 was likely to have been more
beneficial than other available standard therapy.
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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.
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Overturned
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Experimental
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Summary Reviewer 3
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 Tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, by separating the various layers of breast tissue, one can better detect abnormalities. In this particular patient, while the presence of a nipple discharge is concerning, statistically it is more commonly either physiologic or secondary to a benign etiology. As noted by Patel and colleagues, the cause of nipple discharge is usually benign, so the primary goal of evaluation and management is separation of patients with pathologic causes of discharge from those with benign or physiologic causes. For this reason, tomosynthesis is warranted. This is especially true considering the heterogeneously dense nature of her breasts. It is specifically this type of patient with dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Accordingly, the digital breast tomosynthesis provided on 9/6/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 17-year-old male who has been diagnosed with autism spectrum disorder and an intellectual disability. The parent has requested reimbursement for ABA performed from 7/01/20 through 12/31/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is a 17-year-old male who has been diagnosed with autism spectrum disorder and an intellectual disability. The parent has requested reimbursement for ABA performed from 7/01/20 through 12/31/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. Papatola and Lustigas definition of medical necessity entails ahealth-care services that a provider, exercising a prudent clinical judgment, would provide to a patient for the purpose of evaluating, diagnosing, or treating an illness, injury, disease, or its symptoms and are (a) required to meet the essential health needs of the patient; (b) consistent with the diagnosis of the condition for which they are required; (c) consistent in type, frequency, and duration of treatment with scientifically based guidelines as determined by medical research; (d) required for purposes other than the convenience of the provider or the comfort of the patient; and (e) rendered in the least intensive setting that is appropriate for the delivery of health care.a This patientas request fails to meet criterion (a), as many of the goals are not linked to their autism diagnosis. Specifically, the goals of preparing food and washing dishes are tied to executive functioning, but it is unclear how exactly executive functioning is being measured and whether these specific tasks are improving executive functioning and/or ameliorating the symptoms of autism. Further, the insured fails to meet criterion (c), as many elements or missing from the treatment plan, which will be described in greater detail below. Both the Council of Autism Service Providers (CASP) and the ABA Coding Coalition outline the necessary elements of treatment plans. While the patientas treatment plan includes many of these items, several are missing, which makes it difficult to ascertain progress and necessity of the request. Specifically, the treatment authorization request fails to include dates of proposed mastery. Data on almost all goals (with the exception of minimal challenging behavior data), transition and discharge planning is lacking specific measurable criteria. The medical necessity of the goals are unclear, and there has been an overall lack of progress on most goals (at least how it can be interpreted from the lack of data provided) with no explanation of why. Given these missing elements, the lack of progress, and the emphasis on non-autism related goals, the request fails to meet medical necessity. Therefore, ABA performed from 7/01/20 through 12/31/20 was not medically necessary for the treatment of this patient.
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The parent of a 14-year-old male enrollee has requested reimbursement for psychological testing performed on 3/15/18. 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.
This patient had a previous diagnosis of attention deficit/hyperactivity disorder and had previous psychological testing prior to the disputed date of the requested testing. Per the records, he was benefiting from his current outpatient psychotherapy, and his behaviors have improved in school over the past year.
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Upheld
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Medical Necessity
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Summary Reviewer
The parent of a 14-year-old male enrollee has requested reimbursement for psychological testing performed on 3/15/18. 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 the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient had a previous diagnosis of attention deficit/hyperactivity disorder and had previous psychological testing prior to the disputed date of the requested testing. Per the records, he was benefiting from his current outpatient psychotherapy, and his behaviors have improved in school over the past year. The records do not indicate why the testing would need to be repeated in this patients case. The documentation does not indicate that the patient had a low general cognitive ability or other neurological deficits that would require further and more complex evaluation. The current standard of care for diagnosis of attention deficit/hyperactivity disorder is a full clinical evaluation. Attention deficit/hyperactivity disorder is a clinical diagnosis. The medical evidence does not support the services at issue in this clinical setting. Thus, psychological testing performed on 3/15/18 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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A 64-year-old male enrollee has requested reimbursement for a LifeVest provided from 6/2/14 through 9/2/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.
the patient is a 64-year-old male with a newly recognized non-ischemic cardiomyopathy and congestive heart failure.
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Upheld
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Medical Necessity
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Summary Reviewer
A 64-year-old male enrollee has requested reimbursement for a LifeVest provided from 6/2/14 through 9/2/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that based on the records provided for review, the patient is a 64-year-old male with a newly recognized non-ischemic cardiomyopathy and congestive heart failure. In this circumstance there is potential for recovery of left ventricular function over time with medical therapy and there was no indication for immediate placement of a defibrillator such as sustained or inducible ventricular tachycardia, syncope or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until a period of time (more than 90 days) where continued left ventricular dysfunction (ejection fraction is less than or equal to 35%) is documented to persist in spite of appropriate treatment (Russo, et al). A prophylactic defibrillator (wearable or implantable) before this time has not been demonstrated to improve outcome. Medical studies assessing efficacy of prophylactic defibrillators early after diagnosis of myocardial infarction and reduced ejection fraction less than or equal to 35% before ventricular function has had a chance to recover have not demonstrated improved outcome (Hohnloser, et al; Steinbeck, et al). Also, studies evaluating wearable defibrillators during periods of increased risk where criteria for implantable defibrillators have not yet been met are largely comprised of registry data without adequate control groups (Chung, et al). At this time prophylactic wearable external defibrillator would be indicated only if accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed, needed to be significantly delayed (due to infection, for example) or required explantation. For the reasons provided, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 48-year-old male enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees squamous cell carcinoma.
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Upheld
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Experimental
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Summary Reviewer 2
A 48-year-old male enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees squamous cell carcinoma. The physician reviewer found that there is a lack of clinical data in the medical literature to suggest that treatment with proton beam therapy offers a clinical benefit compared to conventional radiation therapy techniques for tumors of the head and neck area. In the majority of cases, the standard approach to treat this malignancy is with standard photon techniques using intensity modulated radiation therapy (IMRT). In this patients case, the comparative planning showed no clinically significant benefit with treatment with proton beam therapy over standard photon techniques, as all standard dose metrics are met with the photon plan. In sum, proton beam therapy is not likely to be more effective than other treatment alternatives in this patients case. 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 |
The parent of a 20-month-old female enrollee has requested authorization and coverage for Synagis. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.
plasia. This patient was born prematurely at 33 weeks twin gestation with a medical history significant for chronic lung disease, tracheoesophageal fistula complicated by esophageal tear and difficulty managing secretions. The records document severe gastroesophageal reflux disease and feeding intolerance requiring gastrostomy tube feedings. Because of her prematurity complicated by chronic lung disease, gastroesophageal reflux disease, and tracheoesophageal fistula, she is at risk for
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 20-month-old female enrollee has requested authorization and coverage for Synagis. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation supports the requested services in this clinical setting. Fauroux and colleagues noted increased respiratory morbidity in infant born less than 33 weeks gestation even in the absence of bronchopulmonary dysplasia. This patient was born prematurely at 33 weeks twin gestation with a medical history significant for chronic lung disease, tracheoesophageal fistula complicated by esophageal tear and difficulty managing secretions. The records document severe gastroesophageal reflux disease and feeding intolerance requiring gastrostomy tube feedings. Because of her prematurity complicated by chronic lung disease, gastroesophageal reflux disease, and tracheoesophageal fistula, she is at risk for severe respiratory syncytial virus disease. Therefore, Synagis is medically indicated for the treatment of this patient. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 60-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 3/29/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 60-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 3/29/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines indicate 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. The medical evidence does not support the services at issue in this clinical setting. Thus, DecisionDx-Melanoma testing performed on 3/29/18 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 57-year-old female enrollee has requested reimbursement for tumor necrosis factor antagonist testing performed on 4/04/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 57-year-old female enrollee has requested reimbursement for tumor necrosis factor antagonist testing performed on 4/04/15. 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 it is not standard of care to measure tumor necrosis factor drug levels and their antibodies in patients failing on a biologic. The Anser tests for both infliximab and adalimumab have been available for several years, and their role in clinical management continues to be defined. There is a lack of evidence from prospective controlled trials demonstrating superiority over standard clinical management. Patients with inflammatory bowel disease experience disease refractory symptoms for a number of reasons unrelated to tumor necrosis levels. All told, tumor necrosis factor antagonist testing performed on 4/04/15 was not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 61-year-old male enrollee has requested reimbursement for physical therapy services performed from 8/27/15 through 12/5/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of low back pain, knee pain and bilateral arm numbness.
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Upheld
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Experimental
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Summary Reviewer 1
A 61-year-old male enrollee has requested reimbursement for physical therapy services performed from 8/27/15 through 12/5/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of low back pain, knee pain and bilateral arm numbness. The physician reviewer found that the medical evidence has not demonstrated the superior efficacy of the services at issue in this clinical setting. Huang and colleagues noted that cupping therapy is promising for pain control and may improve the quality of life but the research shows that that cupping in the treatment of low back pain requires further research. In a meta-analysis by Yuan and colleagues, they were unable to draw definitive conclusions as to the superior efficacy of gua sha, and other forms of Chinese manipulations in treating disability associated with chronic neck pain or chronic back pain. In addition, their study could not substantiate the efficacy of tui na and moxibustion over other forms of therapy. Moreover, there was a lack of sustained, significant, objective, functional improvement or quantifiable response to the physical therapy services in this patients case. In sum, the physical therapy services provided between 8/27/15 and 12/5/15 were not likely to have been superior to other forms of therapy for the treatment of this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been 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 gene expression profiling performed on 6/29/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees malignant melanoma.
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Upheld
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Experimental
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Summary Reviewer 1
A 30-year-old female enrollee has requested reimbursement for gene expression profiling performed on 6/29/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found there is a lack of medical literature supporting the testing at issue in this clinical setting. According to the results of analysis of patients Decision Dx Melanoma testing, the tumor was classified as Class 1A with a low risk of near-term within five years, such as 96% metastasis free rate. According to the standard analysis of such risk, the lesions of 1-2 mm depth have a risk of 80-96% of recurrence. Therefore, the gene expression profiling performed on 6/29/16 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 19-year-old male who has been diagnosed with Crohnas disease. The patient has requested authorization and coverage for Stelara injections 90 mg/ml. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 19-year-old male who has been diagnosed with Crohnas disease. The patient has requested authorization and coverage for Stelara injections 90 mg/ml. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the current medical literature supports the use of Stelara in this case. Stelara has been approved by the U.S. Food and Drug Administration (FDA) for Crohnas disease. Sandborn and colleagues performed a large randomized controlled trial that demonstrated safety and efficacy for induction and maintenance of remission in patients with moderate-to-severe Crohnas disease that was resistant to anti-tumor necrosis factor (TNF) therapy. The study by Kopylov and colleagues showed a 73.7% response in patients with anti-TNF-resistant Crohnas disease, and 80% of responders maintained remission for six months. A significant majority of these patients were able to discontinue steroids. The mechanism of Stelara (ustekinumab) is entirely different than that of immunosuppressants and anti-TNF medications, which the patient has failed. A recent study by Wils and colleagues demonstrated that a significant majority of patients who have failed an anti-TNF medication achieve and maintain response with Stelara. American Gastroenterological Association guidelines for the treatment of Crohnas disease recommend ustekinumab in patients with failure of an anti-TNF medication such as Remicade. In this case, Stelara can control disease and prevent further complications (such as need for surgery) in this patient with severe disease, currently uncontrolled disease, and prior complications such as fistula. Guidelines do not recommend Humira before the use of Stelara, or Humira as safer or more effective than Stelara for the treatment of Crohnas disease. Therefore, Stelara injections 90 mg/ml are medically necessary for the treatment of this patient.
| 1 |
A 60-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees prostate cancer.
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Upheld
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Experimental
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Summary Reviewer 2
A 60-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees prostate cancer. The physician reviewer found that there are studies comparing photons and protons in radiation therapy. The emerging technology committee of the American Society for Radiation Oncology (ASTRO) published an evidence-based review of proton beam therapy, which concluded that, although proton therapy holds promise, there is insufficient evidence that it is superior or even comparable to photon radiotherapy. Although proton therapy is an option for prostate cancer, there is a lack of data demonstrating substantial benefits over intensity modulated radiation therapy (IMRT). For these reasons, the requested proton beam radiation therapy is not likely to be more beneficial for treatment of the patients medical condition than any available modality. Based upon the information set forth above, I have determined the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 63-year-old male enrollee has requested 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.
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Upheld
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Experimental
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Summary Reviewer 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. The physician reviewer found there is insufficient support in the peer-reviewed literature for the testing at issue in this clinical setting. According to the results of analysis of the patients melanoma performed with Decision Dx Melanoma, the tumor was classified as Class 1A with a low risk of near-term within five years metastatic disease, such as 96% metastasis free rate. According to the standard analysis of such risk, the lesions of 1-2 mm depth have a risk of 80-96%. Although the Decision Dx Melanoma signature may be an independent predictor of metastasis risk, there are a lack of peer-reviewed published studies confirming this hypothesis. All told, 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 |
A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 2/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of osteoporosis.
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Overturned
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Experimental
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Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 2/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of osteoporosis. The physician reviewer found that the current medical evidence has not established the superior efficacy of the services at issue. The value of monitoring therapy with the use of biochemical markers of bone turnover to aid in clinical decision is controversial. This testing can be variable and subject to timing and dietary intake. Additionally, there is a lack of assay standardization. Thus, laboratory testing (collagen crosslink testing) performed on 2/25/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 40-year-old male enrollee has requested reimbursement for emergency room services provided on 1/24/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found the patient is a 40-year-old male who presented to the emergency department on 1/24/17 with reports of back pain. He reported low back pain that had commenced two weeks prior. Carrying his daughter on his shoulders had worsened his discomfort. Ibuprofen, rest, and ice had not alleviated his pain. He denied any fever, numbness, tingling, or loss of bowel or bladder control. The patients vital signs included blood pressure of 131/92, respiratory rate of 18, and a temperature of 98.8 F. Mild discomfort in the lumbosacral region was noted without radiation or step-offs. He had a positive straight leg raising and antalgic gait. No obvious sensory or motor deficits were present. The record notes that the patient had good strength of his hip, knee, and ankle dorsi- and plantar flexion. Normal reflexes were present. An x-ray revealed mild degenerative changes with endplate spur formation at L3-4 and mild facet arthropathy at L4-5 and L5-S1. He was treated with intramuscular Toradol and Flexeril. The patient was assessed with back pain and discharged home with improved symptoms. The patient has requested reimbursement for emergency services provided on 1/24/17.
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Upheld
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Medical Necessity
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Summary Reviewer
A 40-year-old male enrollee has requested reimbursement for emergency room services provided on 1/24/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found the patient is a 40-year-old male who presented to the emergency department on 1/24/17 with reports of back pain. He reported low back pain that had commenced two weeks prior. Carrying his daughter on his shoulders had worsened his discomfort. Ibuprofen, rest, and ice had not alleviated his pain. He denied any fever, numbness, tingling, or loss of bowel or bladder control. The patients vital signs included blood pressure of 131/92, respiratory rate of 18, and a temperature of 98.8 F. Mild discomfort in the lumbosacral region was noted without radiation or step-offs. He had a positive straight leg raising and antalgic gait. No obvious sensory or motor deficits were present. The record notes that the patient had good strength of his hip, knee, and ankle dorsi- and plantar flexion. Normal reflexes were present. An x-ray revealed mild degenerative changes with endplate spur formation at L3-4 and mild facet arthropathy at L4-5 and L5-S1. He was treated with intramuscular Toradol and Flexeril. The patient was assessed with back pain and discharged home with improved symptoms. The patient has requested reimbursement for emergency services provided on 1/24/17. At issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. Review of the submitted documentation demonstrates that a prudent layperson would not have sought immediate medical attention on the date in question. Upon review of the submitted medical records, the patient presented with back pain that had commenced two weeks prior. He had not suffered any trauma. He denied any neurologic symptoms. The patient was afebrile with normal vital signs. He had normal motor strength and no sensory deficits. Given that the patients symptoms were not acute in onset or severe, and he had not suffered any trauma, his symptoms do not meet prudent layperson criteria for an emergency medical condition. In sum, the patient was not suffering from a serious medical condition that was likely to place the patients health in serious jeopardy, cause serious impairment to body functions or cause serious dysfunction to a body organ or part. Thus, the services provided on 1/24/17 did not meet prudent layperson criteria for emergency care.
| 1 |
The patient is a 51-year-old female. An operative report dated 4/28/22 reported that the patient
underwent transanal excision of circumferential rectal mass with recto-anal anastomosis for treatment
of a circumferential tubulovillous adenoma.
the patient was relatively young, at 51 years of age, without
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Upheld
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Medical Necessity
|
Summary Reviewer
The patient is a 51-year-old female. An operative report dated 4/28/22 reported that the patient
underwent transanal excision of circumferential rectal mass with recto-anal anastomosis for treatment
of a circumferential tubulovillous adenoma. The physician reviewer found that the issue is whether
inpatient admission from 4/28/22 to 4/29/22 was medically necessary for the treatment of this patient.
The submitted documentation does not support the medical necessity of the services at issue. In this
case, the records showed that the patient was relatively young, at 51 years of age, without severe
comorbidities or complications after surgery. Given that, the additional care, such as pain control and
Foley catheter placement, could have been provided at a lower level of care such as in observation.
Accordingly, the services at issue were not medically necessary for the treatment of this patient.
Therefore, inpatient admission from 4/28/22 to 4/29/22 was not medically necessary for the treatment
of this patient.
| 1 |
A 35-year-old female has requested reimbursement for Oncotype Dx Colon Cancer Assay provided on 11/16/18. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 35-year-old female has requested reimbursement for Oncotype Dx Colon Cancer Assay provided on 11/16/18. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that many experts consider chemotherapy versus avoiding the toxicities of chemotherapy in such a young patient. There is a lack of consensus from expert groups as to which, if any, patients with stage II disease should receive adjuvant chemotherapy. In the study by Venook and colleagues, the recurrence score (RS) appeared to be most discerning for patients with T3 tumors that were proficient for MMR enzymes, in whom the pre-specified low-RS and high-RS groups had average five-year recurrence risks of 13 and 21 percent, respectively. Forty-four percent of patients with T3N0 pMMR tumors fell into the low-RS category and, thus, may have been spared from receiving chemotherapy. There is some support for the services at issue in this patients case. In sum, Oncotype DX Colon Cancer Assay performed on 11/16/18 was likely to have been more effective than other methods of evaluating this patient.
| 1 |
A 65-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 6/13/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who has a history of breast cancer.
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Overturned
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Experimental
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Summary Reviewer 3
A 65-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 6/13/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who has a history of breast cancer. The physician reviewer found that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. Another advantage of tomosynthesis is better delineation and characterization of breast masses. In very recent years, there have been several studies that have supported the use of breast tomosynthesis as a more accurate study than routine screening mammography. Skaane and colleagues noted the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Friedewald and colleagues noted that the addition of tomosynthesis to digital mammography was associated with a decrease in recall rate and an increase in cancer detection rate. In this patients case, given her recent history of breast cancer, performing her surveillance with breast tomosynthesis was appropriate. Thus, breast tomosynthesis performed on 6/13/17 was likely to have been superior over other available modalities for evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old female enrollee has requested has requested reimbursement for physical therapy treatment provided from 12/1/14 through 12/30/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees hip pain, wrist pain, spinal stenosis and shoulder pain.
The patient underwent physical therapy for an extended period of time without adequate support for the medical necessity of these interventions. She had more than 20 physical therapy sessions for her lumbar stenosis and patellofemoral pain by 12/1/14.
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Upheld
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Medical Necessity
|
Summary Reviewer
A 59-year-old female enrollee has requested has requested reimbursement for physical therapy treatment provided from 12/1/14 through 12/30/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees hip pain, wrist pain, spinal stenosis and shoulder pain. The physician reviewer found that physical therapy is a widely used treatment for lumbar spine pathology and patellofemoral pain. The duration and frequency of treatment are not adequately addressed in the medical literature. Delitto and colleagues indicate that there is benefit to therapeutic exercise tailored to the patients condition. In this case, the patient received documented therapeutic benefit through the first 13 sessions of physical therapy. However, the documentation submitted for review does not show a need for continued skilled services as of 12/1/14. The patient underwent physical therapy for an extended period of time without adequate support for the medical necessity of these interventions. She had more than 20 physical therapy sessions for her lumbar stenosis and patellofemoral pain by 12/1/14. Additional skilled treatment for these conditions was not medically necessary. In addition, the patient had wrist and shoulder pain in 2015 but the physical therapy notes do not show these issues being systematically evaluated and treated. The physical therapy sessions provided for her wrist and shoulder pain were not medically necessary. As such, physical therapy treatment provided from 12/1/14 through 12/30/15 has not been established as medically necessary for treatment of the patients medical condition. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 56-year-old male enrollee has requested authorization and coverage for proton treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees tumor of the hypopharynx.
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Upheld
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Experimental
|
Summary Reviewer 3
A 56-year-old male enrollee has requested authorization and coverage for proton treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees tumor of the hypopharynx. The physician reviewer found that in this clinical setting, there is a lack of published literature that compares clinical outcomes of proton beam radiotherapy to standard photon techniques. Consensus group guidelines do not support the use of proton therapy in this setting. Currently, proton therapy for head and neck cancer is being evaluated in National Cancer Institute sponsored trials. However, there is currently insufficient clinical data to discern whether treatment with proton beam radiation offers a clinical benefit beyond conventional radiation therapy. As such, proton therapy is not likely to be superior to the standard options available for treatment of this patients medical condition. Therefore, 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 66-year-old female enrollee has requested authorization and coverage for Lantus. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees diabetes.
The patient was placed on Levemir and Basaglar to control her diabetes. She had side effects and failure to respond properly to Levemir and Basaglar. The alternative Levemir insulin and the biosimilar insulin Basaglar did not provide her with similar benefit to Lantus and were
The patient tried Levemir and Basaglar with poor response. In this patients case, the
managing her diabetes. The patient was well controlled on Lantus.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 66-year-old female enrollee has requested authorization and coverage for Lantus. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees diabetes. The physician reviewer found that there is sufficient support in the medical literature for the requested medication in this clinical setting. The patient was placed on Levemir and Basaglar to control her diabetes. She had side effects and failure to respond properly to Levemir and Basaglar. The alternative Levemir insulin and the biosimilar insulin Basaglar did not provide her with similar benefit to Lantus and were associated to poor control. It is important to note that Lantus is not interchangeable with Levemir. Levemir is a different insulin analog and has a different pharmacokinetic profile. Usually, patients on Levemir require twice a day dose and larger doses, to mimic the effect of Lantus (Wallace, et al). The patient tried Levemir and Basaglar with poor response. In this patients case, the alternative insulins were not effective in managing her diabetes. The patient was well controlled on Lantus. Accordingly, treatment with Lantus has been demonstrated as medically necessary.
Therefore, as stated above, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 27-year-old male enrollee has requested reimbursement for the pneumatic compressor or deep vein thrombosis (DVT) system provided from 4/5/16 through 5/4/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees left knee with patellar tendon rupture, anterior cruciate ligament (ACL) rupture, medial cruciate ligament (MCL) injury and medial meniscus injury.
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Overturned
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Experimental
|
Summary Reviewer 3
A 27-year-old male enrollee has requested reimbursement for the pneumatic compressor or deep vein thrombosis (DVT) system provided from 4/5/16 through 5/4/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees left knee with patellar tendon rupture, anterior cruciate ligament (ACL) rupture, medial cruciate ligament (MCL) injury and medial meniscus injury. The physician reviewer found that the use of intermittent pneumatic compression in this case was supported by the high risk for DVT as a result of the prolonged disability, obesity, and history of smoking. In addition, dynamic intermittent compression combined with cryotherapy decreases analgesic drug requirements after ACL reconstruction and improves the postoperative recovery of range of knee motion. Murgier and Cassard reported that the use of intermittent pneumatic compression combined with cryotherapy after ACL reconstruction resulted in decreased pain, inflammation, and need for narcotics after surgery in addition to the mechanical DVT prophylaxis. Waterman and colleagues found that the efficacy of combined cryotherapy and dynamic compression compared to cryotherapy alone demonstrates the advantage of using this combination after ACL reconstruction. In light of the foregoing, the use of intermittent pneumatic compression or DVT system provided from 4/5/16 through 5/4/16 was reasonable, appropriate, and better than any other available standard treatment. Based upon the information set forth above, the equipment at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
An 18-year-old female enrollee has requested reimbursement for residential treatment provided from 9/11/19 through 9/15/19. 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.
4. The patient failed to achieve full weight restoration and she had primary amenorrhea.
The patient had a mildly stressful recovery environment, due to conflict with her parents regarding her eating, as well as the disruptions to her social and educational activities caused by her need for
The patient was incompletely engaged, due to her minimization of the seriousness
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Overturned
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Medical Necessity
|
Summary Reviewer
An 18-year-old female enrollee has requested reimbursement for residential treatment provided from 9/11/19 through 9/15/19. 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 4 due to signs of consistent deficits in ability to care for self, as evidenced by the patients continued restriction of food intake, leading to lack of desired weight gain. With regard to functional impairment, the records support a score of 3. The patient had moderate functional impairment. In terms of comorbidity, the records support a score of 4. The patient failed to achieve full weight restoration and she had primary amenorrhea. With regard to level of stress of the recovery environment, the records support a score of 2. The patient had a mildly stressful recovery environment, due to conflict with her parents regarding her eating, as well as the disruptions to her social and educational activities caused by her need for intensive treatment. In terms of level of support of the recovery environment, the records support a score of 2 due to the parents active participation in treatment. With regard to resiliency and treatment history, the records support a score of 4 due to persistence of disordered eating despite extensive prior treatment exposure at various levels of care. In terms of treatment acceptant and engagement of the patient, the records support a score of 3. The patient was incompletely engaged, due to her minimization of the seriousness of her disordered eating and her struggles to comply with her food plan. Therefore, the records support a total score of 22. Due to serious risk of harm, the recommended level of care is level five medically monitored residence-based services. Therefore, residential treatment provided from 9/11/19 through 9/15/19 was medically necessary for the treatment of this patient.
| 1 |
patient is a 49-year-old female with a history of progressive asymmetric sensorineural hearing
loss (ASNHL) seeking approval for a right-sided cochlear implant (CI). The patient was first
diagnosed with hearing loss in 2014 and started wearing conventional hearing aids in 2015. The
Health Insurer has denied the requested services as not medically necessary for treatment of the
patients medical condition.
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Overturned
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Medical Necessity
|
Summary
The patient is a 49-year-old female with a history of progressive asymmetric sensorineural hearing
loss (ASNHL) seeking approval for a right-sided cochlear implant (CI). The patient was first
diagnosed with hearing loss in 2014 and started wearing conventional hearing aids in 2015. The
Health Insurer has denied the requested services 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 Cochlear implants have traditionally been used to treat bilateral
sensorineural hearing loss in the presence of normal cochlear anatomy when conventional
amplification techniques do not provide adequate hearing rehabilitation. Needle electromyography
and continuous intraoperative neurophysiology monitoring of the right ear are both to be
performed along with the right CI in order to decrease risk of injury to the seventh cranial nerve.
These techniques are an adjunct to the CI placement procedure and are required to safely implant
the device. The benefits of treating unilateral hearing loss (UHL) and single-sided deafness (SSD)
with cochlear implants have been established in recent medical literature (Zeitler and Dorman).
Patients with UHL/SSD experience difficulty with speech comprehension in both quiet and
competing noise environments, sound localization, and severe ipsilateral tinnitus. In a study
investigating the effects of CI on sound localization and speech comprehension in competing noise
environments in patients with UHL/SSD. Zeitler and colleagues found that speech comprehension
and sound localization improved significantly, with some patients achieving localization in the
95th percentile of normal hearing patients. A second study by Zeitler and colleagues demonstrated
that CI provided significant improvement in tinnitus in young patients with SSD. In 2019, the U.S.
Food and Drug Administration (FDA) approved unilateral CI placement in patients five years of
age and older. Finally, in 2022, the American Cochlear Implant Task Force determined that CI is
an effective treatment option for patients with unilateral hearing loss and single sided deafness.
The FDAs specific criteria for the requested Cochlear Nucleus 7 indicates that it is recommended
for adults with moderate to profound sensorineural hearing loss and limited benefit from
conventional amplification defined as preoperative word (sentence) comprehension less than or
equal to 50% in the ear to be implanted and less than or equal to 60% in the opposite ear. The
patient continued to experience hearing difficulties despite the use of hearing aids. A hearing test
performed on 8/10/22 demonstrated a significant decline in her word comprehension in the right
ear. A review of the record indicates word recognition scores of 12% on the right ear, 44% on the
left ear and 24% binaurally. Therefore, the requested cochlear device, implantation, needle
electromyography, and continuous intraoperative neurophysiology monitoring in the right ear are
medically necessary for treatment of the patient.
| 1 |
The parent of a 14-year-old male enrollee has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment center services provided from 7/12/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition.
. In this case, the patient presents with impulsivity, poor decision making and anger outbursts which make him volatile and a potential danger to others. In addition, his behavior is of a nature that his family is unsafe around him. The
. The patient was described as being agitated and frustrated and argumentative. On 8/19/16, the individual therapy note documents that he had been argumentative consistently throughout the day. He angrily teased a peer several times and aggressively argued with staff and peers. The patient lacks the coping skills
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 14-year-old male enrollee has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment center services provided from 7/12/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the psychiatric residential treatment center services provided from 7/12/16 forward were and are medically necessary for treatment of the patients medical condition. In this case, the patient presents with impulsivity, poor decision making and anger outbursts which make him volatile and a potential danger to others. In addition, his behavior is of a nature that his family is unsafe around him. The documentation submitted for review demonstrates that multiple facetime family sessions did not go well. The patient was described as being agitated and frustrated and argumentative. On 8/19/16, the individual therapy note documents that he had been argumentative consistently throughout the day. He angrily teased a peer several times and aggressively argued with staff and peers. The patient lacks the coping skills needed for limit setting and disappointment. Given the above, residential treatment center services have been established as medically necessary for treatment of the patients behavioral health condition. Moreover, the treatment at issue is reasonably expected to improve the patients 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 51-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 1/18/21. 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
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Experimental
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Summary Reviewer 3
A 51-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 1/18/21. 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 Melanoma is a cancer that is curable in its earliest stages. Cutaneous
melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for
those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be
amenable to excision but this suggests a high risk for the development of metastatic disease in
the future. Such patients may be observed or treated with interferon-alpha. The data on
DecisionDx-Melanoma testing has not made it part of routine analysis after sentinel lymph node
biopsy. There has also been some lack of consistency between various genes being used as
biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the
treatment algorithm beyond standard staging techniques. Therefore, DecisionDx-Melanoma
testing performed on 1/18/21 was not likely to have been more beneficial than other available
methods of evaluating this patient.
| 0 |
A 56-year-old male enrollee has requested reimbursement for transcranial magnetic stimulation (TMS) treatment provided on 8/2/16, 8/4/16, and 8/9/16. 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.
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Overturned
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Medical Necessity
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Summary Reviewer
A 56-year-old male enrollee has requested reimbursement for transcranial magnetic stimulation (TMS) treatment provided on 8/2/16, 8/4/16, and 8/9/16. 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 there is sufficient support for the services at issue in this clinical setting. TMS is a novel, non-invasive, neuro-stimulatory intervention endorsed by the American Psychiatric Association for the treatment of acute phase depression in the adult population. A typical treatment course of TMS consists of 30-40 sessions spanning four to six weeks. Tapering of the therapy is clinically recommended. Per Perera and colleagues, Once a determination of maximum benefit is made, the TMS treatments should be tapered for the patient. A typical taper occurs over the course of two through three weeks and may consist of as many as six sessions. Thus, the services in dispute were reasonably expected to both improve the patients condition and consolidate the efficacy of the therapy. The duration of service and number of sessions were consistent with community practice standards, in this patients case. The therapy itself was safe and appropriate for the treatment of this patients behavioral health condition. All told, TMS treatments provided on 8/2/16, 8/4/16 and 8/9/16 were medically necessary. Therefore, for the reasons stated above, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
A 50-year-old female enrollee has requested authorization and coverage for minimally invasive sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 50-year-old female enrollee has requested authorization and coverage for minimally invasive sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the International Society for Advancement of Spine Surgery (ISASS) policy statement for minimally invasive sacroiliac joint fusion provides specific indications for surgery. In addition to such specific criteria, it is noted, aAdditional or alternative diagnoses that could be responsible for the patientas ongoing pain or disability have been clearly considered, investigated and ruled out.a In this patientas case, there are potential alternate and/or additional contributing diagnoses. The three clinical reports are significantly varied regarding subjective and objective findings documented. For example, on 9/18/20, the documented findings suggested multiple alternate pain generators, plausibly inclusive of the thoracolumbosacral regions of the spine itself. There were multiple denoted subjective and examination findings in the 9/18/20 report that were not significantly discussed and/or completely ruled out as significant plausible pain generators in the subsequent clinical reports. The medical literature at large does not exclusively rely on injection results as being 100% diagnostic of sacroiliac joint(s) as the clear pain generator, in isolation. Nor are the denoted sacroiliac joint injection results dispositive for a definitive surgical indication, again when considered within the realm of the entirety of records reviewed. Furthermore, multiple other plausible pain generators including at the lumbosacral spine are evident. Therefore, the requested minimally invasive sacroiliac joint fusion is not likely to be more beneficial than any available standard therapy.
| 1 |
The parent of a 10-month-old female enrollee has requested reimbursement for a cranial remolding orthosis provided on 7/19/17. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees severe brachycephaly.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 10-month-old female enrollee has requested reimbursement for a cranial remolding orthosis provided on 7/19/17. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees severe brachycephaly. The physician reviewer found that since the back to sleep approach was recommended by the American Academy of Pediatrics in 1994, there has been an increase in the incidence of positional plagiocephaly in infants (Trachtenberg, et al). One review of 15 studies on the treatment of positional plagiocephaly in infants and concluded that there is a fairly substantive body of nonrandomized evidence that demonstrates more significant and faster improvement of cranial shape in infants with positional plagiocephaly treated with a helmet in comparison with conservative therapy, especially if the deformity is severe, provided that helmet therapy is applied during the appropriate period of infancy (Tamber, et al). The authors also noted that in general, infants with a more severe presenting deformity and infants who are helmeted early in infancy tend to have more significant correction (and even normalization) of head shape. Roby and colleagues evaluated 1045 teenagers born after the introduction of the back to sleep recommendation and found persistent plagiocephaly in only 1.1% and brachycephaly in 1%, compared with the estimates of 20-48% incidence in infants, suggesting that positional plagiocephaly may self-correct over time. Given that the Congress of Neurological Surgeons recommends cranial orthosis treatment for infants with persistent moderate to severe plagiocephaly after a course of conservative treatment, the DOC Band device at issue was indicated for treatment of this patients medical condition (Tamber, et al). A trial of repositioning had occurred, and she was documented as having severe brachycephaly with a cephalic index of 101.5, which was more than six standard deviations from the mean. Thus, the cranial remolding orthosis provided on 7/19/17 was medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the device at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 62-year-old male enrollee has requested authorization and coverage for sacroiliac joint (SI) fusion/percutaneous spine fusion. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees SI joint disorder.
chronic pain. The patient has had an L4-S1 fusion and has had procedures above the levels of fusion but
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Upheld
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Experimental
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Summary Reviewer 3
A 62-year-old male enrollee has requested authorization and coverage for sacroiliac joint (SI) fusion/percutaneous spine fusion. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees SI joint disorder. The physician reviewer found that the submitted documentation fails to demonstrate the efficacy of the sacroiliac fusion, over any standard therapy. The case specific reasons reference a documented clinical syndrome of complex regional pain syndrome with multiple pain generators contributing to the patient's experience of chronic pain. The patient has had an L4-S1 fusion and has had procedures above the levels of fusion but those procedures do not rule out the likelihood of continuing chronic pain from adjacent segment disorder above the levels of fusion. The issue of pain originating at the sacroiliac joint remains controversial, both in general and in patients such as this patient. In the study by Rupert and colleagues, it is pointed out that there are no definitive historical, physical or radiological features that can definitely establish a diagnosis of sacroiliac joint pain. In this specific patient, local anesthetic injection sometimes used in an effort to localize the sacroiliac joint as a pain generator gave only a short-term relief of symptoms. The reliance of local anesthetic injection in the sacroiliac joint to establish that joint as the prime pain generator is susceptible to placebo effect. The statement of a positive benefit from local steroid injection to the sacroiliac joint is not sufficient to provide evidence for likely benefit through the proposed sacroiliac fusion. In summary, it is not likely to be beneficial for this patient to undergo sacroiliac fusion for treatment of his chronic pain. For the reasons set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a 13-year-old female enrollee has requested reimbursement for the neurological evaluation and testing performed from 3/17/17 to 5/24/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees delays in gross motor, fine motor, language, and daily functioning skills.
. The patient has previously been diagnosed with global developmental delay, microcephaly and ADHD combined subtype. She has been noted to have learning difficulties on previous educational psychological testing performed through the school district. The neuropsychological testing addressed her learning difficulties and ADHD, and predominantly educational difficulties rather than a medical condition.
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Upheld
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Medical Necessity
|
Summary Reviewer
The parent of a 13-year-old female enrollee has requested reimbursement for the neurological evaluation and testing performed from 3/17/17 to 5/24/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees delays in gross motor, fine motor, language, and daily functioning skills. The physician reviewer found that based on the available documentation, the neuropsychological testing provided from 3/17/17 through 5/24/17 was not medically necessary for evaluation of this patients medical condition. The patient has previously been diagnosed with global developmental delay, microcephaly and ADHD combined subtype. She has been noted to have learning difficulties on previous educational psychological testing performed through the school district. The neuropsychological testing addressed her learning difficulties and ADHD, and predominantly educational difficulties rather than a medical condition. In the medical literature, Palumbo and Lynch described the utility of neuropsychological testing in addressing learning disabilities in adolescents. Pham and Riviere outlined how neuropsychological testing in children with ADHD allows implementation of assistance in an educational setting. All told, the documentation does not support the medical necessity of the neurological evaluation and testing performed from 3/17/17 to 5/24/17 for evaluation of this patients medical condition. Based on the foregoing discussion, 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 35-year-old male with a lengthy history of mood/psychotic episodes and amphetamine use disorder. He was admitted to the residential treatment center due to symptoms of hallucinations, thought disorganization, racing thoughts, and pressured speech.
to care for himself even in the structured residential treatment center environment due to his manic symptoms. He had a history of dangerous actions due to his manic symptoms.
patient has been unable to complete community college courses or hold a job for longer than one month.
but mandated by probation to live in a recovery house. He has historically been unable to remain in recovery houses
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 35-year-old male with a lengthy history of mood/psychotic episodes and amphetamine use disorder. He was admitted to the residential treatment center due to symptoms of hallucinations, thought disorganization, racing thoughts, and pressured speech. The physician reviewer found that the American Association of Community Psychiatrists Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) is a beneficial tool in determining the appropriate level of care. In terms of risk of harm, the records support a score of 3, due to the evidence of self-neglect and inability to care for himself even in the structured residential treatment center environment due to his manic symptoms. He had a history of dangerous actions due to his manic symptoms. With regard to functional status, the records support a score of 4. This patient has been unable to complete community college courses or hold a job for longer than one month. In terms of comorbidity, the records support a score of 4 due to the presence of disabling psychiatric symptoms that interact with and impair his ability to recover from his substance use disorders. With regard to level of stress of the recovery, the records support a score of 4. He is technically homeless but mandated by probation to live in a recovery house. He has historically been unable to remain in recovery houses longer than days to weeks due to relapse of manic and psychotic symptoms. In terms of level of support of the recovery environment, the records support a score of 3. His only natural supports would be his parents, and the patient does not reliably include them. He has not had cohesive professional supports outside of the residential treatment center. With regard to acceptance and engagement, the records support a score of 4. He has had significant treatment exposure but has been unable to achieve complete remission of optimal control of symptoms even with repeated exposure. Attempts to maintain gains attained in intensive treatment have had limited success. Therefore, the patient has a composite score of 22. In this case, the patients functional status and comorbidity were both scored as 4, which would support the residential treatment center placement. Thus, psychiatric residential center treatment provided from 12/30/19 through 1/17/20 was medically necessary for the treatment of this patient.
| 1 |
A 54-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.
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Upheld
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Experimental
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Summary Reviewer 2
A 54-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. The physician reviewer found the most important considerations in the use of bronchial thermoplasty are the proper selection of patients and ensuring an experienced qualified provider is performing the procedure. Bronchial thermoplasty has adequate data on long-term safety and effectiveness in patients with asthma in terms of demonstrating improvement in symptoms and reduction in exacerbations. On the basis of daily symptoms, frequent rescue medication use, interference with daily activities and frequent exacerbations, this patient meets criteria for severe persistent asthma. However, there is not adequate information provided to determine two important considerations in the treatment of asthma. First, the records do not document that alternate diagnoses have been ruled out. The appearance of infiltrates and adenopathy on the computed tomography (CT) may indicate a secondary cause of wheezing. Secondly, there was not information provided to exclude other asthma therapies such as omalizumab or mepolizumab based on IgE levels or eosinophil counts. All told, there is a lack of documentation supporting the requested bronchial thermoplasty as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a 12-year-old male enrollee has requested authorization and coverage for functional electrical stimulation RT300 therapy system. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees incomplete paraplegia.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a 12-year-old male enrollee has requested authorization and coverage for functional electrical stimulation RT300 therapy system. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees incomplete paraplegia. The physician reviewer found the requested device is likely to be more effective than other options for treating this patient. There have been a number of studies reporting the benefits and utility of functional electrical stimulation cycling in patients with spinal cord injury. The study by Johnson and colleagues demonstrated that cycling with functional electrical stimulation led to gains in oxygen uptake when compared to passive cycling alone. Per the submitted documentation, the patient has demonstrated good response to initial trials with the requested device. Based on the literature, his clinical history, and his response to a trial evaluation, the requested functional electrical stimulation RT300 therapy system is likely to be more effective than other treatment modalities. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/10/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
that this patient had an early stage melanoma followed by a node positive recurrence. DecisionDx-Melanoma testing was performed on the recurrent tumor.
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Upheld
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Medical Necessity
|
Summary Reviewer 2
A 59-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/10/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that this patient had an early stage melanoma followed by a node positive recurrence. DecisionDx-Melanoma testing was performed on the recurrent tumor. Per the National Comprehensive Cancer Network guidelines, while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. The role of DecisionDx-Melanoma testing for recurrent node positive disease has not been established. In sum, DecisionDx-Melanoma testing performed on 5/10/18 was not likely to have been of greater benefit than other methods of evaluating this patient.
| 1 |
A 65-year-old male enrollee has requested authorization and coverage for Repatha SureClick 140 mg/mL auto-injector. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
for coronary artery disease and a strong family history of coronary artery disease. His 10-year risk of sy
In addition, he has known moderate coronary artery disease on cardiac catheterization, particularly calcified ostial disease of the right coronary artery. He requires aggressive risk factor modification and is making lifestyle changes. In addition, he has a history of intolerance to multiple statin medications. The patient has known established coronary artery disease and elevated 10-year risk of symptomatic disease, which
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Overturned
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Medical Necessity
|
Summary Reviewer
A 65-year-old male enrollee has requested authorization and coverage for Repatha SureClick 140 mg/mL auto-injector. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient has multiple risk factors for coronary artery disease and a strong family history of coronary artery disease. His 10-year risk of symptomatic cardiovascular disease is 15%, placing him in the intermediate risk category. In addition, he has known moderate coronary artery disease on cardiac catheterization, particularly calcified ostial disease of the right coronary artery. He requires aggressive risk factor modification and is making lifestyle changes. In addition, he has a history of intolerance to multiple statin medications. The patient has known established coronary artery disease and elevated 10-year risk of symptomatic disease, which could be brought down significantly with optimal risk factor management. The current evidence supports proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in this clinical setting. Therefore, Repatha SureClick 140 mg/mL auto-injector is medically necessary for the treatment of this patient.
| 1 |
A 61-year-old female enrollee has requested authorization and coverage for breath hydrogen/methane test (91065). The Health Insurer has denied this request and reported that the requested services are investigational for the evaluation of the enrollees medical condition.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 61-year-old female enrollee has requested authorization and coverage for breath hydrogen/methane test (91065). The Health Insurer has denied this request and reported that the requested services are investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested services in this patients. In the setting of blood in the stool of a 61-year-old patient, a colonoscopy is typically warranted. The submitted records do not document that this study was performed. The clinical notes do not support that breath testing for small intestinal bacterial overgrowth is likely to be more beneficial for the evaluation of this patient than colonoscopy. If the patient has small intestinal bacterial overgrowth, options in lieu of breath testing could include empiric trials of Xifaxan and/or probiotics. Therefore, breath hydrogen/methane test (91065) is not likely to be superior over other available methods of evaluating this patient.
| 0 |
The parent of a 10-year-old female enrollee has requested authorization and coverage for Humatrope 24 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature. A review of the record indicates the enrollee has a history of short stature. Per the provider, the enrollees height dramatically improved at the time she started human growth hormone in November 2014. Since starting growth hormone and catching up her growth, the enrollees development and confidence have improved. Prior to treatment, the enrollees growth chart showed she was in the 1.2 percentile which is 2.25 standard deviations below average. The records note the enrollee has a mid-parental height (MPH) of 5 feet 5.5 inches, and was more than two standard deviations below her mid-parental height. The
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Overturned
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Medical Necessity
|
Summary Reviewer
The parent of a 10-year-old female enrollee has requested authorization and coverage for Humatrope 24 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature. A review of the record indicates the enrollee has a history of short stature. Per the provider, the enrollees height dramatically improved at the time she started human growth hormone in November 2014. Since starting growth hormone and catching up her growth, the enrollees development and confidence have improved. Prior to treatment, the enrollees growth chart showed she was in the 1.2 percentile which is 2.25 standard deviations below average. The records note the enrollee has a mid-parental height (MPH) of 5 feet 5.5 inches, and was more than two standard deviations below her mid-parental height. The Health Insurer indicates the requested medication is not medically necessary for treatment of the enrollees medical condition. At issue in this case 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 patient is a 36-year-old male with a history of heartburn and postprandial symptoms. The patients symptoms have reportedly been incompletely improved with proton pump inhibitor (PPI) therapy, or with ranitidine in combination with sucralfate. Per charting dated 1/27/16, an upper endoscopy demonstrated irregular Z-line, small hiatal hernia and chronic carditis. An esophageal manometry demonstrated normal motility with low lower esophageal sphincter (LES) pressures and minimal hiatal hernia. A 24-hour pH impedance off of PPI demonstrated a DeMeester score of 10.9 with symptom association probability (SAP) of 76%. The provider notes that the patient does not seem to have nocturnal reflux. On 3/7/16, ambulatory pH monitoring off acid blockers showed a composite DeMeester score of 30.1 with good symptom correlation with heartburn. An esophagogastroduodencoscopy (EGD) on 3/7/16 showed a histologically unremarkable upper gastrointestinal (GI) tract to the duodenum. The patient has requested authorization and coverage for transoral incisionless fundoplication (TIF) with EsophyX device. The Health Insurer has denied this request as investigational.
|
Upheld
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Experimental
|
Summary Reviewer 2
The patient is a 36-year-old male with a history of heartburn and postprandial symptoms. The patients symptoms have reportedly been incompletely improved with proton pump inhibitor (PPI) therapy, or with ranitidine in combination with sucralfate. Per charting dated 1/27/16, an upper endoscopy demonstrated irregular Z-line, small hiatal hernia and chronic carditis. An esophageal manometry demonstrated normal motility with low lower esophageal sphincter (LES) pressures and minimal hiatal hernia. A 24-hour pH impedance off of PPI demonstrated a DeMeester score of 10.9 with symptom association probability (SAP) of 76%. The provider notes that the patient does not seem to have nocturnal reflux. On 3/7/16, ambulatory pH monitoring off acid blockers showed a composite DeMeester score of 30.1 with good symptom correlation with heartburn. An esophagogastroduodencoscopy (EGD) on 3/7/16 showed a histologically unremarkable upper gastrointestinal (GI) tract to the duodenum. The patient has requested authorization and coverage for transoral incisionless fundoplication (TIF) with EsophyX device. The Health Insurer has denied this request as investigational. The request for TIF with EsophyX device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In this case, the patients acid reflux has been documented by pH testing, but the studies were performed off of acid suppression therapy. There is a lack of documentation provided to support that the patients reflux is refractory to optimally-dosed conventional acid suppression, nor that he has endoscopically-confirmed significant esophageal injury secondary to gastroesophageal reflux disease (GERD). Therefore, the request for TIF with EsophyX device procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 51-year-old male has requested reimbursement for gene expression profiling performed on 5/04/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
|
Upheld
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Experimental
|
Summary Reviewer 3
A 51-year-old male has requested reimbursement for gene expression profiling performed on 5/04/17. 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 (NCCN) guidelines states that while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of this testing was not likely to have altered treatment and surveillance recommendations. In sum, the superior effectiveness of gene expression profiling performed on 5/04/17 has not been established. 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 33-year-old female enrollee has requested reimbursement for gene testing (BRAF mutation analysis) provided on 11/19/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees papillary thyroid carcinoma.
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Overturned
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Experimental
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Summary Reviewer 3
A 33-year-old female enrollee has requested reimbursement for gene testing (BRAF mutation analysis) provided on 11/19/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees papillary thyroid carcinoma. The physician reviewer found the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Papillary thyroid cancer is a frequent histologic subtype of thyroid cancer. The genetics can be complex and the BRAF mutations are frequent. This is notable since the presence of the mutation provides significant prognostic information (Fraser, et al; Lee, et al; Kim, et al). The medical literature supports a role for BRAF mutational testing in this clinical setting. Accordingly, the gene testing (BRAF mutation analysis) provided on 11/19/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 62-year-old male enrollee has requested reimbursement for homocysteine, Factor V Leiden and methylenetetrahydrofolate reductase (MTHFR) testing provided on 4/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees right lower extremity deep vein thrombosis (DVT).
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Overturned
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Experimental
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Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for homocysteine, Factor V Leiden and methylenetetrahydrofolate reductase (MTHFR) testing provided on 4/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees right lower extremity deep vein thrombosis (DVT). The physician reviewer found the DVT and pulmonary embolism may be caused by hereditary thrombophilias. Information regarding the increased risk is important especially in situations of prolonged immobility such as surgery, long car trips, or long airplane flights. These complications may be prevented by appropriate interventions and the avoidance of estrogens, which are prothrombic. The Prothrombin (F2) G20210A mutation increases risk of DVT about three-fold, but nearly 20-fold in compound heterozygous patients with Factor V Leiden (Emmerich, et al; Koeleman, et al). Similarly, patients with hyperhomocysteinemia and Factor V Leiden are at greatly increased risk for DVT (Ridker, et al). The most common genetic cause for hyperhomocysteinemia is the thermolabile variant of the MTHFR enzyme. This is due to homozygosity for the TT genotype at codon 677 (Kluijtmans, et al). Given that appropriate interventions should be taken if mutations are identified, the homocysteine testing, Factor V Leiden and MTHFR provided on 4/28/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 44-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 7/28/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees melanoma.
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Upheld
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Experimental
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Summary Reviewer 3
A 44-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 7/28/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees melanoma. The physician
reviewer found that the pathology from the left upper back shows a T1a cutaneous melanoma.
Gene expression profile (GEP) testing, such as DecisionDx-Melanoma testing, can assist in
differentiating a precancerous lesion from melanoma and also help risk stratify for cancer
recurrence, although it is unclear if this performs better than standard methods such as
histopathologic features and sentinel lymph node biopsy. Further, National Comprehensive
Cancer Network guidelines do not recommend routine laboratory testing or imaging for stage IA
disease, after full wide excision of the melanoma, so surveillance would not be altered in this
case. Therefore, DecisionDx-Melanoma testing performed on 7/28/21 was not likely to have been
more beneficial for evaluation of the patients condition than any available standard therapy.
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A 31-year-old female enrollee has requested authorization and coverage for exome sequence analysis (gene panel testing). The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 31-year-old female enrollee has requested authorization and coverage for exome sequence analysis (gene panel testing). The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is a lack of support for the requested services in this patients case. The records do not demonstrate that a specific genetic condition is suspected by the requesting provider. In the absence of a proposed diagnosis, there is insufficient evidence that this testing will change management or improve health for this patient. In addition, given the early state of this technology, the implications of many genetic mutations are not currently known. For these reasons, the requested services are not likely to be more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the requested services are not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 61-year-old male enrollee has requested reimbursement for physical therapy services performed from 8/27/15 through 12/5/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of low back pain, knee pain and bilateral arm numbness.
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Upheld
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Experimental
|
Summary Reviewer 3
A 61-year-old male enrollee has requested reimbursement for physical therapy services performed from 8/27/15 through 12/5/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of low back pain, knee pain and bilateral arm numbness. The physician reviewer found that there is a lack of medical studies to show the efficacy of the services at issue in this clinical setting. A review by Yuan and colleagues provided some evidence to show that acupuncture, acupressure, and cupping could be efficacious but they could not draw definite conclusions. Their study consisted of over seventy five randomized controlled trials with over 11,000 patients evaluated. Another study also showed cupping could be promising for pain control and improvement of quality of life, and minimizes the potential risks of treatment (Huang, et al). However, further studies were recommended in order to analyze the potential role of cupping therapy in the treatment of low back pain. In a study by Arguisuelas and colleagues, they could not determine if myofascial treatment showed any clinical significance. In addition, this patient has had extensive treatment of acupuncture with ancillary therapies but the records do not indicate a clear improvement of functional benefit. Although the services at issue show some promise as treatment modalities for pain, more studies are recommended. As such, the physical therapy services provided between 8/27/15 and 12/5/15 were not likely to have been more effective than the available standard treatment options for this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 70-year-old female enrollee has requested reimbursement for an intermittent limb compression device provided from 10/13/16 through 10/28/16. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees right knee pain.
that the patient underwent arthroscopic surgery for osteoarthritis of the right knee including degenerative meniscal tears and chondromalacia on 10/13/16.
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Upheld
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Medical Necessity
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Summary Reviewer
A 70-year-old female enrollee has requested reimbursement for an intermittent limb compression device provided from 10/13/16 through 10/28/16. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees right knee pain. The physician reviewer found that the patient underwent arthroscopic surgery for osteoarthritis of the right knee including degenerative meniscal tears and chondromalacia on 10/13/16. There is no prior history of thromboembolism. The recent medical literature suggests that the incidence of symptomatic venous thromboembolism after arthroscopic knee surgery is very low and therefore the guidelines do not recommend intermittent pneumatic compression or pharmacotherapy postoperatively (Mauck, et al). The guidelines from the American College of Chest Physicians and American Academy of Orthopedic Surgeons agree that routine prophylaxis to prevent symptomatic venous thromboembolism is not needed for patients undergoing outpatient knee arthroscopy (Falck-Ytter, et al). For these reasons, the intermittent pneumatic compression provided from 10/13/16 through 10/28/16 was not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the device at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 63-year-old female enrollee has requested reimbursement for the Prolia injection performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition.
. In this case, the patient tried a bisphosphonate and was intolerant of this according to the records provided. In addition, she has osteoporosis with a documented T-score of -2.6.
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Overturned
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Experimental
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Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for the Prolia injection performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were investigational for treatment of the enrollees medical condition. The physician reviewer found the Prolia injection performed on 11/21/14 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is data to support use of Prolia in this clinical setting. Denosumab has been associated with a reduction in the risk of vertebral, non-vertebral, and hip fractures in women with osteoporosis (Cummings, et al). In this case, the patient tried a bisphosphonate and was intolerant of this according to the records provided. In addition, she has osteoporosis with a documented T-score of -2.6. All told, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 31-year-old female who was transported from Sharp Memorial Hospital to Sharp Mesa Vista Hospital on 4/28/19. She had arrived at Sharp Memorial Hospital for attempted overdose.
that this patient presented with suicidal ideation and was diagnosed with psychosis.
|
Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 31-year-old female who was transported from Sharp Memorial Hospital to Sharp Mesa Vista Hospital on 4/28/19. She had arrived at Sharp Memorial Hospital for attempted overdose. The physician reviewer found that this patient presented with suicidal ideation and was diagnosed with psychosis. The reason for transport is listed as psychiatric monitoring. Transportation of mental health patients between facilities by emergency medical services personnel poses a unique risk to both patients and their providers. Standard of care is to transport all such patients by basic ambulance. Special handling with the use of restraints could be required during transport to prevent self-injury by the patient as well as injury to transport staff. Emergency medical technicians (EMTs) possess the requisite training to apply restraints. Therefore, EMT attendance is required for such transports. There is sufficient support for the services at issue in this clinical setting. Therefore, non-emergent ambulance services provided on 4/28/19 were medically necessary for the treatment of this patient.
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A 60-year-old female enrollee has requested reimbursement for inpatient services provided from 6/21/17 through 6/26/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees non-ST-elevation myocardial infarction.
that this patient presented with a non-ST segment myocardial infarction on 6/19/17, and she was treated with medication including intravenous heparin.
the patient was on intravenous heparin for at least part of the day on 6/21/17, she could not have been safely discharged on that day.
|
Overturned
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Medical Necessity
|
Summary Reviewer
A 60-year-old female enrollee has requested reimbursement for inpatient services provided from 6/21/17 through 6/26/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees non-ST-elevation myocardial infarction. The physician reviewer found that this patient presented with a non-ST segment myocardial infarction on 6/19/17, and she was treated with medication including intravenous heparin. In this setting, it is standard of practice to treat with intravenous heparin for 48 to 72 hours. Since the patient was on intravenous heparin for at least part of the day on 6/21/17, she could not have been safely discharged on that day. However, since she remained clinically stable without recurrent chest discomfort or other evidence of ongoing ischemia on 6/22/17, about 24 hours after heparin was discontinued, it would have been medically safe to discharge the patient on this date, to return for coronary bypass surgery once dental abscess and nickel allergy had been sufficiently evaluated and treated. The records do not support the medical necessity for continued inpatient care beyond 6/22/17. All told, inpatient services provided from 6/21/17 through 6/22/17 were medically necessary for the treatment of this patient, but not thereafter. Therefore, a portion of the services at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.
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