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A 66-year-old male enrollee has requested authorization and coverage for Dupixent 300 mg/2 mL, quantity of four every 30 days. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees asthma.
ma with persistent airflow obstruction. On 6/05/18, he was noted to have improved and even borderline obstruction in the pre-bronchodilator pulmonary function tests. The plan was to continue the current medications which included Singulair,
the patient had borderline obstruction and did not have oral corticosteroid-dependent asthma. | Upheld | Medical Necessity | Summary Reviewer
A 66-year-old male enrollee has requested authorization and coverage for Dupixent 300 mg/2 mL, quantity of four every 30 days. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees asthma. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. Dupixent is U.S. Food and Drug Administration (FDA) approved for the treatment of moderate to severe eosinophilic asthma and atopic dermatitis. The patient does not have a diagnosis of atopic dermatitis. Although the records noted severe asthma eosinophilic phenotype, the documentation does not include a recent complete blood count showing peripheral blood eosinophils greater than 150 cells/uL in the last 12 months. The most recent documentation does not support that he has a diagnosis of oral corticosteroid-dependent asthma with persistent airflow obstruction. On 6/05/18, he was noted to have improved and even borderline obstruction in the pre-bronchodilator pulmonary function tests. The plan was to continue the current medications which included Singulair, Zyflo and Symbicort. The records do not support the requested medication in this clinical setting. As of 6/05/18, the patient had borderline obstruction and did not have oral corticosteroid-dependent asthma. Furthermore, there is no documentation in the last year of a complete blood count with significant eosinophilia. Thus, Dupixent 300 mg/2 mL, quantity of four every 30 days is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 55-year-old male enrollee has requested reimbursement for FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18. 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
that the patient is reported to have had abnormal liver enzyme tests. | Upheld | Experimental | Summary Reviewer 2
A 55-year-old male enrollee has requested reimbursement for FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18. 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 patient is reported to have had abnormal liver enzyme tests. The use of FibroTest has support in current medical literature for the evaluation of and for liver disease. The alternative, liver biopsy, is invasive, with risks including bleeding, bowel perforation, and bile duct injury. It is subject to interoperator variability and sampling error. Therefore, both initial and then if needed, long-term and repeated clinical monitoring, can more safely and effectively be done with serum markers such as FibroTest rather than repeated biopsies. Over the long-term, chronic liver disease can evolve into cirrhosis, which requires specific therapy and monitoring for complications. Therefore, identification of cirrhosis with a test such as FibroTest is important to prevent complications of unidentified cirrhosis or liver disease. For these reasons, FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18 was likely to have been more beneficial than other available standard therapy.
| 1 |
A 57-year-old male 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 severe, persistent asthma.
patients provider states that the patient has a progressive decrease in the quality of | Upheld | Experimental | Summary Reviewer 3
A 57-year-old male 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 severe, persistent asthma. The physician reviewer found that Bronchial thermoplasty is a procedure that uses a bronchoscope probe/catheter to provide thermal energy to the smooth muscle of the airway. There are three bronchoscopic procedures. The first treats the right lower lobe, the second the left lower lobe and the third bronchoscopic procedure is for both upper lobes. Thomson and colleagues reported on the safety of the procedure but noted that there was no difference in forced expiratory volume in one second (FEV-1), emergency department visits, or hospital admissions between the bronchial thermoplasty group and the control group. This patients provider states that the patient has a progressive decrease in the quality of life. However, there is no documentation that the use bronchial thermoplasty would improve the long-term functional outcome of the patients condition. Thus, the requested bronchial thermoplasty is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 29-year-old female with a diagnosis of juvenile onset hypophosphatasia (HPP). The patient has requested authorization and coverage for Strensiq 80 mg/0.8 ml vial. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 29-year-old female with a diagnosis of juvenile onset hypophosphatasia (HPP). The patient has requested authorization and coverage for Strensiq 80 mg/0.8 ml vial. 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 the clinical, genetics and laboratory findings of this patient are supportive of the diagnosis of HPP. Since Strensiq is the only U.S. Food and Drug Administration (FDA) approved medication that replaces deficient alkaline phosphatase and allows the patient to improve bone mineralization, which results in lower risk for further fractures, pain in the bones, muscles and chronic pain, the patient should benefit from a trial of this medication. In an open-label prospective study which included patients with perinatal-, infantile-, or juvenile-onset hypophosphatasia, enzyme replacement therapy (Strensiq) was associated with improved overall survival, ventilator-free survival, growth, and bone mineralization. A recent study that included adults showed that therapy with Strensiq was safe and provided benefit to patients, with improvements in gross motor function, muscle strength, and patient-reported functional disability over five years of treatment. Therefore, Strensiq 80 mg/0.8 ml vial is medically necessary for the treatment of this patient.
| 1 |
A 55-year-old female enrollee has requested reimbursement for inpatient hospital services provided from 3/01/18 through 3/02/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who reported chest tightness and dyspnea.
This patient presented with unforeseen symptoms possibly due to coronary ischemia associated with an abnormal electrocardiogram and normal initial troponin value. | Upheld | Medical Necessity | Summary Reviewer
A 55-year-old female enrollee has requested reimbursement for inpatient hospital services provided from 3/01/18 through 3/02/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who reported chest tightness and dyspnea. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient presented with unforeseen symptoms possibly due to coronary ischemia associated with an abnormal electrocardiogram and normal initial troponin value. In this circumstance, a period of overnight observation without hospital admission is reasonable and appropriate to confirm no evidence of myocardial infarction with serial troponins prior to discharge. Since the patient was clinically stable after initial evaluation, with an anticipated length of stay of less than 48 hours or less than two midnights, hospital admission was not medically necessary. Based on the records, an observational level of stay would have been safe and effective. Thus, inpatient hospital services provided from 3/01/18 through 3/02/18 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 |
patient is a 62-year-old female with a history of right foot pain and metatarsalgia of the right foot.
The records available for review indicate that the patient had been experiencing pain in her foot and
cramping of her toes for several years.
this patient presented
with right foot pain for several years. The patient tried and failed conservative treatment measures such
as local cortisone injections and off-loading arch supports. An ultrasound revealed a significant
intermetatarsal neuroma and a plantar plate tear at the second MPJ. | Overturned | Medical Necessity | Summary
The patient is a 62-year-old female with a history of right foot pain and metatarsalgia of the right foot.
The records available for review indicate that the patient had been experiencing pain in her foot and
cramping of her toes for several years. The physician reviewer found that at issue is whether the
osteotomy (CPT 28308) performed on 1/20/22 was medically necessary for the treatment of this
patient.The current medical literature recommends an osteotomy with double screw fixation combined
with plantar plate repair for the treatment of patients with a plantar plate tear and associated second
MPJ metatarsalgia (Klein and Weil). The records available for review indicate that this patient presented
with right foot pain for several years. The patient tried and failed conservative treatment measures such
as local cortisone injections and off-loading arch supports. An ultrasound revealed a significant
intermetatarsal neuroma and a plantar plate tear at the second MPJ. The current medical literature
supports the use of an osteotomy to treat this patients foot pain after the failure of conservative
measures. All told, the osteotomy (CPT 28308) performed on 1/20/22 was medically necessary for the
treatment of this patient. | 1 |
The patient is a 57-year-old female who presented to urgent care on 7/12/18 for evaluation of left medial knee pain and swelling. Radiographs were obtained, reportedly demonstrating mild osteoarthritis, although no
. The patient had a follow-up office visit on 7/31/18. On this date, the provider recommended physical therapy and the use of a knee brace. On 9/20/18, the patient reported mild improvement in symptoms after utilizing a knee brace, with little benefit from physical therapy. The patient has requested coverage for magnetic resonance imaging (MRI) of the left knee. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the evaluation of this patient. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 57-year-old female who presented to urgent care on 7/12/18 for evaluation of left medial knee pain and swelling. Radiographs were obtained, reportedly demonstrating mild osteoarthritis, although no formal interpretation is available. The patient had a follow-up office visit on 7/31/18. On this date, the provider recommended physical therapy and the use of a knee brace. On 9/20/18, the patient reported mild improvement in symptoms after utilizing a knee brace, with little benefit from physical therapy. The patient has requested coverage for magnetic resonance imaging (MRI) of the left knee. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the evaluation of this patient. The submitted documentation fails to demonstrate the medical necessity of the requested services. The best initial imaging examination for the evaluation of chronic knee pain in an adult is radiographs. In the setting of osteoarthritis diagnosed by initial radiographs, MRI may be indicated in follow-up if the patients symptoms are not explained by the radiographic findings. According to the American College of Radiology appropriateness criteria for the evaluation of chronic knee pain in an adult with initial radiographs demonstrating degenerative changes, MRI may be appropriate as the next imaging examination. In this patients case, radiographs were reportedly obtained at an urgent care visit, although there was no formal radiological interpretation. Interpretation, presumably by the urgent care provider, reported mild osteoarthritis. In this patients case, a formal interpretation of the patients radiographs is necessary. The preliminary report issued by an urgent care physician may differ from an official report from a radiologist, possibly changing management. Thus, the requested MRI of the left knee is not medically necessary for the evaluation of this patient. Therefore, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 54-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees prostate cancer. | Upheld | Medical Necessity | Summary Reviewer
A 54-year-old male enrollee has requested authorization and coverage for proton beam radiation therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees prostate cancer. The physician reviewer found that currently, there is insufficient clinical data to discern whether treatment with proton beam radiation therapy offers a clinical benefit compared to conventional radiation therapy techniques in the treatment of prostate cancer. Sheets and colleagues evaluated the comparative effectiveness of intensity-modulated radiation therapy (IMRT), proton beam radiation therapy, and conformal radiation therapy for prostate cancer. In the comparison between IMRT and proton beam radiation therapy, IMRT patients had a lower rate of gastrointestinal morbidity. There were no other significant differences regarding toxicities between IMRT and proton therapy. The National Comprehensive Cancer Network guidelines indicate that no clear benefit of proton beam radiation therapy has been demonstrated over standard treatment with photons and IMRT technique. Therefore, the requested proton beam radiation therapy is not medically necessary for the treatment of this patient. Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
The patient is a 27-year-old transgender female who is seeking facial feminization surgery. The Health Insurer has denied authorization and coverage for transfeminine facial contouring. Per the Health Insurer, the requested services | Overturned | Medical Necessity | Summary Reviewer
The patient is a 27-year-old transgender female who is seeking facial feminization surgery. The Health Insurer has denied authorization and coverage for transfeminine facial contouring. Per the Health Insurer, the requested services are not medically necessary for the treatment of the patient. The physician reviewer found that the current medical evidence supports the requested services in this clinical setting. The purpose of medically necessary facial feminization surgery is to relieve gender dysphoria. Ainsworth and Spiegel demonstrated that facial feminization surgery, like genital surgery, aimproved mental health-related quality of life.a World Professional Association for Transgender Health (WPATH) stated, aNon-genital surgical proceduresanotably facial feminization surgeryaare often of greater practical significance in the patientas daily life than reconstruction of the genitals.a The authors noted, aThese reconstructive procedures are not optional in any meaningful sense, but are understood to be medically necessary for the treatment of the diagnosed condition.a Therefore, the requested transfeminine facial contouring is medically necessary for the treatment of this patient. | 1 |
A 21-year-old female enrollee has requested authorization and coverage for placement of a cardiovascular defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee who has a family history of early repolarization syndrome (ERS) and an episode of syncope. The physician
The patient is a 21-year-old female who presented to her provider for syncope and ventricular tachycardia. Genetic testing has shown homozygous for genetic abnormality. Family history is positive for syncope due to cardiac arrhythmia and other family members also have implanted defibrillators. The patients diagnosis is early repolarization syndrome (ERS). Implantable cardiac defibrillator (ICD) was recommended by the treating provider. The Health Insurer denied the requested device as investigational/experimental for treatment of this patient.
However, this patient has been symptomatic with syncope and has the documented genetic abnormality. | Overturned | Experimental | Summary Reviewer 3
A 21-year-old female enrollee has requested authorization and coverage for placement of a cardiovascular defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee who has a family history of early repolarization syndrome (ERS) and an episode of syncope. The physician reviewer found The patient is a 21-year-old female who presented to her provider for syncope and ventricular tachycardia. Genetic testing has shown homozygous for genetic abnormality. Family history is positive for syncope due to cardiac arrhythmia and other family members also have implanted defibrillators. The patients diagnosis is early repolarization syndrome (ERS). Implantable cardiac defibrillator (ICD) was recommended by the treating provider. The Health Insurer denied the requested device as investigational/experimental for treatment of this patient. The diagnosis of ERS is an uncommon diagnosis with some uncertainty in the recommended treatment. However, this patient has been symptomatic with syncope and has the documented genetic abnormality. The most recent guidelines from American College of Cardiology and the European Society of Cardiology do not directly make treatment recommendations for this diagnosis. However, ICD is recommended for individuals with long QT syndrome and cardiac syncope, and this condition of ERS is very similar. Majida and colleagues noted that electrophysiological studies (EP studies) do not help differentiate individuals who are at higher risk of sudden death within this diagnosis group, so further EP study would not be helpful. With the documented genetic abnormality, the family history and the symptoms, the requested cardiovascular defibrillator is likely to be more efficacious than the standard treatment available for the treatment of this patient. Therefore, for the reasons stated above, the cardiovascular defibrillator 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 12-year-old male enrollee has requested authorization and coverage for Omnitrope growth hormone therapy. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
In this patients case, his height is close to the 50th percentile, and he has demonstrated catch-up growth. The growth velocity of 7.3 cm per year is normal. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 12-year-old male enrollee has requested authorization and coverage for Omnitrope growth hormone therapy. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. The current medical evidence supports growth hormone therapy for children born small for gestational age, which is defined as birth weight or length two or more standard deviations below the mean for gestational age, who fail to manifest catch-up growth by two years of age, defined as height two or more standard deviations below the mean for age and sex. In this patients case, his height is close to the 50th percentile, and he has demonstrated catch-up growth. The growth velocity of 7.3 cm per year is normal. His predicted adult height is 59, which is the 50th percentile for a male in the United States. The predicted adult height is within two standard deviations of the mid-parental height of 72.1 inches. This patient does not meet the criteria for growth hormone treatment. Therefore, Omnitrope is not medically necessary for the treatment of this patient. | 1 |
The patient is a 43-year-old female with major depressive disorder. Per the records, she sustained hypoxic brain damage after an overdose on medications. She has tried multiple medications for the treatment of her major depressive disorder. The records noted prior treatment with electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS). The clinical notes document a history of abuse, insomnia and chronic pain. The patient has requested authorization and coverage for CPT 64568 (implantation of vagus nerve neurostimulator electrode). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient.
. On 1/29/18, the progress notes indicated that the patient was experiencing paranoia. These progress notes indicate that the patient was diagnosed with major depressive disorder with psychosis. | Upheld | Experimental | Summary Reviewer 3
The patient is a 43-year-old female with major depressive disorder. Per the records, she sustained hypoxic brain damage after an overdose on medications. She has tried multiple medications for the treatment of her major depressive disorder. The records noted prior treatment with electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS). The clinical notes document a history of abuse, insomnia and chronic pain. The patient has requested authorization and coverage for CPT 64568 (implantation of vagus nerve neurostimulator electrode). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient. The current medical evidence does not support the requested services in this patients case. On 1/29/18, the progress notes indicated that the patient was experiencing paranoia. These progress notes indicate that the patient was diagnosed with major depressive disorder with psychosis. There is a lack of support for the requested services for patients with psychosis. It is not clear whether the patient received evidence-based forms of psychotherapy for her major depressive disorder, which are the standard of care. The literature has limited support for the use of vagus nerve stimulation in unipolar depression. Thus, CPT 64568 (implantation of vagus nerve neurostimulator electrode) is not likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of a 13-year-old female enrollee has requested reimbursement for needle
electromyography (EMG) of anal or urethral sphincter, any technique; needle electromyography,
each extremity; and electroencephalogram performed on 6/10/20. The Health Insurer has denied
this request and reported that the services at issue were investigational for the treatment of the
enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
The parent of a 13-year-old female enrollee has requested reimbursement for needle
electromyography (EMG) of anal or urethral sphincter, any technique; needle electromyography,
each extremity; and electroencephalogram performed on 6/10/20. The Health Insurer has denied
this request and reported that the services at issue were investigational for the treatment of the
enrollees medical condition. The physician reviewer found that there is sufficient support for the
services at issue in this clinical setting. In the article by Levin and colleagues, intraoperative neural
monitoring for pediatric scoliosis correction is described as the standard of care. Buckwalter and
colleagues noted that not only does intraoperative neural monitoring identify complications in a
relatively high proportion of patients, but it also allows for corrective action to prevent
permanent neurologic injury. The neuromonitoring was standard of care in this patients case.
Therefore, needle electromyography (EMG) of anal or urethral sphincter, any technique; needle
electromyography, each extremity; and electroencephalogram performed on 6/10/20 was likely
to have been more beneficial than any available standard therapy.
| 1 |
A 37-year-old female enrollee has requested authorization and coverage for Remicade injections 100 mg. 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. | Overturned | Medical Necessity | Summary Reviewer
A 37-year-old female enrollee has requested authorization and coverage for Remicade injections 100 mg. 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 moderate to severe Crohns disease based on extensive (orofacial and bowel) involvement. Per American Gastroenterological Association guidelines for therapy of moderate to severe Crohns disease, immunosuppressants such as azathioprine, 6-mercaptopurine, and methotrexate are not recommended as primary monotherapy, and tumor necrosis factor (TNF) inhibitors such as Remicade are recommended. American College of Gastroenterology guidelines also do not recommend immunosuppressants or methotrexate as primary monotherapy for the induction of remission of Crohns disease. In this case, the patient is unlikely to respond to conventional alternatives such as immunosuppressants, corticosteroids, and 5-aminosalicylate therapy, and she is at risk for additional Crohns disease complications such as fistula, stricture, hospitalization, and the need for surgery if induction and maintenance of remission is not effective. Therefore, Remicade injections 100 mg are medically necessary for the treatment of this patient. | 0 |
A 48-year-old female has requested reimbursement for genotyping for CYP2D6 polymorphism performed on 7/10/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 48-year-old female has requested reimbursement for genotyping for CYP2D6 polymorphism performed on 7/10/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the patients with hormone receptor positive breast cancer usually receive some pharmacologic therapy to inhibit the estrogen induced growth of the cancer. The interventions differ for patients that are premenopausal and postmenopausal. Tamoxifen is the preferred agent in premenopausal women whereas aromatase inhibitors are preferred in postmenopausal patients. There is sufficient support for the services at issue in this clinical setting. Saladores and colleagues performed a study of 587 premenopausal women and analyzed CYP2D6 genotypes and found that increased CYP2D6 activity correlated with improved disease-free survival. In the event that tamoxifen was not a suitable anti-estrogen therapy for this patient, there were alternatives. Based on the current medical literature, CYP2D6 genotyping is supported especially in premenopausal patients. Thus, genotyping for CYP2D6 polymorphism performed on 7/10/14 was likely to have been more efficacious than other options for evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned. | 1 |
A 36-year-old male enrollee has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request indicating that the device at issue was considered investigational for evaluation of the enrollee, who reported palpitations. The physician reviewer found that the patient is a 36-year-old male with a history of hypertension and diabetes. The records noted a history of intermittent palpitations. An echocardiogram performed on 11/20/17 revealed normal left ventricular systolic function. A 30-day event monitor reported one episode of atrial fibrillation lasting 30 seconds which was associated with palpitations. Anticoagulation was not started at that time. An implantable loop recorder was placed on 12/28/17 to help determine burden of atrial fibrillation in order to help guide treatment. The patient has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request and reported that the device at issue was investigational for the evaluation of this patient. In this case, the records documented palpitations which were | Upheld | Experimental | Summary Reviewer 3
A 36-year-old male enrollee has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request indicating that the device at issue was considered investigational for evaluation of the enrollee, who reported palpitations. The physician reviewer found that the patient is a 36-year-old male with a history of hypertension and diabetes. The records noted a history of intermittent palpitations. An echocardiogram performed on 11/20/17 revealed normal left ventricular systolic function. A 30-day event monitor reported one episode of atrial fibrillation lasting 30 seconds which was associated with palpitations. Anticoagulation was not started at that time. An implantable loop recorder was placed on 12/28/17 to help determine burden of atrial fibrillation in order to help guide treatment. The patient has requested reimbursement for an implantable ambulatory event monitor provided on 12/28/17. The Health Insurer has denied this request and reported that the device at issue was investigational for the evaluation of this patient. In this case, the records documented palpitations which were determined to be due to atrial fibrillation by external event monitoring. In this circumstance, if further monitoring for recurrent atrial fibrillation were thought to be necessary, then additional external event monitors that are either patient activated or auto-triggered should be sufficient as an initial step in identifying atrial fibrillation. There is no documentation to indicate the patient is unable to manage external monitoring devices or that these have been tried and failed. In this setting, recurrent atrial fibrillation could be adequately identified using a combination of symptoms and additional external event monitors, if needed. The implantation of a loop recorder in this circumstance has not been demonstrated to improve cardiac outcome and is not recommended in current guidelines. Thus, the implantable ambulatory event monitor provided on 12/28/17 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the device at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing for bacterial vaginosis provided on 5/09/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing for bacterial vaginosis provided on 5/09/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that Polymerase chain reaction (PCR) testing has been compared to traditional clinical testing for vaginitis. The literature supports the use of PCR testing because it has resulted in significantly higher sensitivity and negative predictive value than clinician diagnosis or in clinic testing. The test may also be superior for detecting more than one cause for vaginitis. PCR testing is a means of accurate detection that allows for appropriate treatment, and it is commonly used test in clinical practice. The records noted that the patient presented for a postpartum examination. During the postpartum period, it is especially difficult to make an accurate diagnosis of vaginal complaints. Missing an infection could lead to a serious postpartum complication. Thus, PCR testing for bacterial vaginosis performed on 5/09/19 was likely to have been more beneficial than other methods of evaluating this patient.
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A 64-year-old male enrollee has requested authorization and coverage for cetuximab (Erbitux) to be given in conjunction with FOLFIRI. The Health Insurer has denied this request and reported that the requested medication regimen is investigational for the treatment of the enrollees medical condition.
this patient has a very poor prognosis disease, a gastroesophageal junction cancer with regional metastases and progression on standard multi-agent chemotherapy. His tumor was submitted for mutational analysis. | Overturned | Experimental | Summary Reviewer 2
A 64-year-old male enrollee has requested authorization and coverage for cetuximab (Erbitux) to be given in conjunction with FOLFIRI. The Health Insurer has denied this request and reported that the requested medication regimen is investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has a very poor prognosis disease, a gastroesophageal junction cancer with regional metastases and progression on standard multi-agent chemotherapy. His tumor was submitted for mutational analysis. Recently, it has become important to identify mutations that may be amenable to targeted therapy. Von Hoff and colleagues performed a pilot study of 86 patients, and the progression-free survival on regimen selected by molecular profiling was compared to progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. In this case, the analysis revealed marked amplification of the EGFR gene. The EGFRs have multiple oncogenic roles in gastroesophageal junction tumors. In this patients case, the oncologist has recommended FOLFIRI in combination with cetuximab. There is significant evidence that cetuximab can lead to a durable response in patients with EGFR amplification. Therefore, cetuximab (Erbitux) to be given in conjunction with FOLFIRI is likely to be more beneficial than any available standard therapy.
| 1 |
A 32-year-old female enrollee has requested reimbursement for laboratory testing performed on 6/26/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 32-year-old female enrollee has requested reimbursement for laboratory testing performed on 6/26/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that when performing thrombophilia screening, while the probability of a positive assay is higher in patients with a history of thrombus, the information provided does not help to inform future management. Various professional organizations have published guidelines indicating that routine thrombophilia screening in patients presenting with thrombosis should not be performed. In this
case, results of the thrombophilia screen is not likely to justify an evidence-based modification of this patients management. Furthermore, the consulting provider indicated that the deep vein thrombosis was considered to be a provoked event. The medical evidence does not support thrombophilia screening in this setting. In sum, laboratory testing performed on 6/26/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
The patient is a 66-year-old male with history of bilateral greater saphenous vein (GSV) ablations. Despite the continued use of medical grade compression stockings for more than five months, he remains symptomatic with tired, heavy, achy legs and associated skin changes. He has no active skin ulcers. Ultrasound on 6/13/17 demonstrated prior bilateral GSV ablations, pathologic reflux in both short saphenous veins and refluxing tributaries, and pathologic reflux in both calf perforator veins. The patient has requested authorization and coverage for endovenous vein ablation. The Health Insurer has denied this request indicating that the requested services are considered investigational. The patient meets the criteria for the ablation of the short saphenous vein and the ultrasound guided sclerotherapy. The
tion is 4.5 mm. This patients left small saphenous vein is 7.5 mm with pathologic reflux, and the right small saphenous vein is 4.2 mm with pathologic reflux. | Upheld | Experimental | Summary Reviewer 3
The patient is a 66-year-old male with history of bilateral greater saphenous vein (GSV) ablations. Despite the continued use of medical grade compression stockings for more than five months, he remains symptomatic with tired, heavy, achy legs and associated skin changes. He has no active skin ulcers. Ultrasound on 6/13/17 demonstrated prior bilateral GSV ablations, pathologic reflux in both short saphenous veins and refluxing tributaries, and pathologic reflux in both calf perforator veins. The patient has requested authorization and coverage for endovenous vein ablation. The Health Insurer has denied this request indicating that the requested services are considered investigational. The patient meets the criteria for the ablation of the short saphenous vein and the ultrasound guided sclerotherapy. The current medical literature indicates that the recommended size for ablation is 4.5 mm. This patients left small saphenous vein is 7.5 mm with pathologic reflux, and the right small saphenous vein is 4.2 mm with pathologic reflux. Ultrasound guided sclerotherapy is appropriate for the tributaries on the basis of size and reflux criteria, after the small saphenous veins are ablated. However, there is a lack of peer-reviewed literature supporting better outcomes with ablations of refluxing perforators compared to other therapies. These can be treated by ultrasound guided sclerotherapy, after the short saphenous vein ablations. Thus, the small saphenous vein ablations are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy while the perforator ablations are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, a portion of 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 partially overturned.
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The parent of a 17-year-old male enrollee has requested reimbursement for wilderness therapy program provided from 7/11/16 through 9/21/16 and from 11/3/16 through 12/27/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health condition.
Prior to this patients initial admission to the wilderness therapy program on 7/11/16, the patient was noted to have worsening depressive and anxiety symptoms, difficulty with completing activities of daily living, and suicidal ideation. He was socially withdrawn, refusing to attend school, and aggressive towards family members. | Upheld | Experimental | Summary Reviewer 2
The parent of a 17-year-old male enrollee has requested reimbursement for wilderness therapy program provided from 7/11/16 through 9/21/16 and from 11/3/16 through 12/27/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees behavioral health condition. The physician reviewer found that there is some evidence in the medical literature that wilderness therapy is as effective as traditional psychotherapy. Prior to this patients initial admission to the wilderness therapy program on 7/11/16, the patient was noted to have worsening depressive and anxiety symptoms, difficulty with completing activities of daily living, and suicidal ideation. He was socially withdrawn, refusing to attend school, and aggressive towards family members. There are several published studies supporting the use of wilderness therapy in the adolescent population. Therefore, based on the support in the medical literature, the wilderness therapy program provided from 7/11/16 through 9/21/16 and from 11/3/16 through 12/27/16 was likely to have been of greater benefit than the available standard methods of treating this patients medical condition. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of a seven-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis (ABA) therapy, in excess of 35 hours per week provided from 5/10/16 through 11/8/16. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder.
In this case, the patient has received ABA therapy since his diagnosis in 2014. ABA therapy has been effective for him, however he continues to have self-injurious behaviors that include tapping/hitting, elopement and tantrum. | Overturned | Medical Necessity | Summary Reviewer
The parent of a seven-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavioral analysis (ABA) therapy, in excess of 35 hours per week provided from 5/10/16 through 11/8/16. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder. The physician reviewer found in this clinical setting, ABA therapy in excess of 35 hours per week provided from 5/10/16 through 11/8/16 was and is medically necessary for treatment of the patients medical condition. ABA therapy is medically indicated for children diagnosed with autism. The review by Reichow and colleagues shows that ABA started at a younger age provides improvements in cognitive skills, adaptive skills and language skills. In this case, the patient has received ABA therapy since his diagnosis in 2014. ABA therapy has been effective for him, however he continues to have self-injurious behaviors that include tapping/hitting, elopement and tantrum. Therefore, ABA therapy in excess of 35 hours per week were and are medically necessary for treatment of the patients medical condition. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The patient is a 61-year-old female who underwent testing with the DecisionDx melanoma gene testing to assess the metastatic risk of the 2.65 mm Breslow depth melanoma identified on her left ear. 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. | Upheld | Experimental | Summary Reviewer 2
The patient is a 61-year-old female who underwent testing with the DecisionDx melanoma gene testing to assess the metastatic risk of the 2.65 mm Breslow depth melanoma identified on her left ear. 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 National Comprehensive Cancer Network (NCCN) guidelines indicate that genetic testing such at the DecisionDx Melanoma gene assay should not be used outside of clinical trials as its utility remains to be proven. Moreover, there is a paucity of data demonstrating that results of the DecisionDx assay results in treatment changes that improve health outcomes. Overall, the testing requested is not considered to be standard of care in the evaluation and treatment of melanoma. Accordingly, 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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A 54-year-old female enrollee has requested reimbursement for acute hospital stay from 12/30/17 through 2/11/18. 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.
In this case, the patient was admitted in stable condition and could have been treated at
she required frequent treatment with intravenous analgesic medication. | Upheld | Medical Necessity | Summary Reviewer
A 54-year-old female enrollee has requested reimbursement for acute hospital stay from 12/30/17 through 2/11/18. 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. The inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patients signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. At the time of admission, the records did not document that she required frequent treatment with intravenous analgesic medication. The documentation did not indicate an emergent need for surgical intervention. The current medical evidence does not support the services at issue in this clinical setting. Therefore, acute hospital stay provided from 12/30/17 through 2/11/18 was not medically necessary for the treatment of this patient. | 1 |
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/06/16. 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. | Overturned | Experimental | Summary Reviewer 3
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/06/16. 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 (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. There is sufficient support for the service at issue in this clinical setting. In this patients case, it was not unreasonable to perform surveillance mammography with the addition of tomosynthesis despite of the non-dense nature of her left breast, as there is an increased risk of developing a contralateral carcinoma. Thus, digital breast tomosynthesis performed on 7/06/16 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.
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A 64-year-old male enrollee has requested authorization and coverage for cetuximab (Erbitux) to be given in conjunction with FOLFIRI. The Health Insurer has denied this request and reported that the requested medication regimen is investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 64-year-old male enrollee has requested authorization and coverage for cetuximab (Erbitux) to be given in conjunction with FOLFIRI. The Health Insurer has denied this request and reported that the requested medication regimen is investigational for the treatment of the enrollees medical condition. The physician reviewer found that Erbitux (cetuximab) is a monoclonal antibody targeting EGFR. It has been approved in several types of cancer, usually when given with chemotherapy or radiation therapy. The literature as to its use in esophageal cancer does not demonstrate convincing evidence of its efficacy. The randomized trial by Suntharalingam and colleagues did not demonstrate benefit to cetuximab when added to chemoradiation therapy in localized disease. Huang and colleagues noted that cetuximab failed to significantly improve the overall survival and progression-free survival for patients with localized or metastatic esophageal cancer. Overall, there is a lack of convincing data to indicate the usefulness of cetuximab in esophageal cancer. Therefore, cetuximab (Erbitux) to be given in conjunction with FOLFIRI is not likely to be more beneficial than any available standard therapy.
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patient is a 55-year-old female who presented to the emergency room on 11/10/21 with a
history of a recent sinus infection treated with antibiotics. The patient has requested
reimbursement for a hospital stay from 11/10/21 through 11/12/21.
, patient may have had partially treated meningitis because
of the antibiotic therapy she had received for sinusitis and,
she may also have had a small parameningeal focus of infection related to her sinus
infection. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 55-year-old female who presented to the emergency room on 11/10/21 with a
history of a recent sinus infection treated with antibiotics. The patient has requested
reimbursement for a hospital stay from 11/10/21 through 11/12/21. The physician reviewer
found that the submitted documentation supports the medical necessity for the services at issue.
Acute inpatient care for a patient with suspected meningitis may be appropriate if the patient is
immunocompromised,has altered mental status, hemodynamic instability, or other factors like
those present in this case. In this case, patient may have had partially treated meningitis because
of the antibiotic therapy she had received for sinusitis and, although unlikely because of the CT
study, she may also have had a small parameningeal focus of infection related to her sinus
infection. The acute changes in cells, protein, and glucose may imitate the findings in non-
bacterial meningitis in both of these situations. Barring use of polymerase chain reaction (PCR)
testing or other rapid techniques to make a rapid etiologic diagnosis, the possibility of a partially
treated infection needed to be considered pending culture results. In this clinical setting,
inpatient care while these issues were evaluated was medically indicated. Therefore, the hospital
stay from 11/10/21 through 11/12/21 was medically necessary for the treatment of this patient. | 1 |
A 49-year-old male enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 5/29/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 49-year-old male enrollee has requested reimbursement for Oncotype DX Colon Cancer Assay performed on 5/29/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the use of 12-gene expression test (Oncotype DX Colon Cancer Assay) is unproven for predicting the likelihood of disease recurrence in patients with stage II colon cancer following surgery. There is a lack of prospective randomized solid phase II or III data to warrant its routine use. Until prospective randomized data is published, the superior efficacy of the services at issue cannot be 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.
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A 29-year-old female enrollee has requested reimbursement for human papilloma virus (HPV) testing performed on 9/29/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue.
The patient has a history of high-risk HPV genotype 16. She has not been consistent with her follow-up. | Overturned | Experimental | Summary Reviewer 1
A 29-year-old female enrollee has requested reimbursement for human papilloma virus (HPV) testing performed on 9/29/20. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrollees medical condition. Therefore, the Health Insurer has denied reimbursement for the services at issue. The physician reviewer found that the current medical evidence supports the services at issue in this clinical setting. The patient has a history of high-risk HPV genotype 16. She has not been consistent with her follow-up. Recent changes in the American Society of Colposcopy and Cervical Pathology (ASCCP) guidelines have moved to a risk-based assessment for the management of cervical cancer screening. HPV testing is the preferred manner of assessing risk. In this case, because data is missing, the guideline algorithm recommends clinical judgment. Therefore, HPV testing performed on 9/29/20 was likely to have been more beneficial for evaluation of the patients condition than any available standard therapy.
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A 57-year-old female enrollee has requested reimbursement for DecisionDX-melanoma gene expression test performed on 8/12/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees left cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 3
A 57-year-old female enrollee has requested reimbursement for DecisionDX-melanoma gene expression test performed on 8/12/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees left cutaneous melanoma. The physician reviewer found that the Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision but they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the DecisionDX test for melanoma has not made it part of routine analysis after sentinel lymph node biopsy. There is also a lack of consistency between various genes being used as biomarkers. As such, the test is very novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. This was also the consensus opinion of the National Comprehensive Cancer Network (NCCN) guidelines. All told, DecisionDX-melanoma gene expression test performed on 8/12/16 was not likely to have been superior over other methods of evaluating this patients medical condition.Therefore, for the reasons stated above, the service at issue was not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 29-year-old female enrollee has requested authorization and coverage for Otezla 30 mg tablets. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees psoriasis. | Overturned | Medical Necessity | Summary Reviewer
A 29-year-old female enrollee has requested authorization and coverage for Otezla 30 mg tablets. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees psoriasis. The physician reviewer found the patients diagnosis of chronic plaque psoriasis requires systemic treatment. Psoriasis is a chronic inflammatory skin disease. Traditional systemic therapies for psoriasis, including methotrexate and cyclosporine, have a well-documented array of toxicities, particularly end-organ toxicities. Over the past several years, the use of anti-tumor necrosis factor (TNF) biologic therapies for the treatment of moderate to severe psoriasis have been a major clinical and research focus. Despite several difficulties with documenting risks, some systemic treatments for psoriasis have been linked with an increased risk of selected cancers. On the other hand, Otezla does not increase the risk of malignancy, and it is approved by the U.S. Food and Drug Administration for treatment of psoriasis. Moreover, Otezla may be taken orally and is a therapeutic option for treatment of this patient. The physical limitations and risk of cancer/infection of injectable biologics, taken together with this patients family history of cancer, support Otezla for treatment of this patient. 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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A 39-year-old male enrollee has requested reimbursement for the surgery performed on 9/22/15. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational for treatment of the enrollees degenerative disc disease (DDD) with herniations. | Upheld | Experimental | Summary Reviewer 2
A 39-year-old male enrollee has requested reimbursement for the surgery performed on 9/22/15. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational for treatment of the enrollees degenerative disc disease (DDD) with herniations. The physician reviewer found the U.S. Food and Drug Administration (FDA) approval for the ProDisc-L total disc replacement states that this device is indicated for spinal arthroplasty in patients who are skeletally mature, have degenerative disc disease at one level in the lumbar spine from L3 to S1, have no more than grade 1 spondylolisthesis at the involved level, and have had no pain relief after at least six months of non-surgical treatment. The FDA indicates that this device should not be use in patients with isolated radicular compression syndromes, especially due to disc herniation. Yue and colleagues conducted a study 41 patients who underwent one-level versus two-level lumbar total disc replacement with five-year follow-up. The authors reported that the study was unable to identify statistical differences in all clinical and radiographical outcomes for patients who underwent one- and two-level ProDisc arthroplasty in a cohort from two centers. Delamarter and colleagues concluded, despite the relatively short duration of follow-up and design limitations, that two-level lumbar disc arthroplasty offers clinical advantages in terms of pain relief and functional recovery in comparison with arthrodesis. Longer-term follow-up is needed to determine the risks for implant wear and degenerative segment changes. Given the lack of peer-reviewed medical literature demonstrating superior health outcomes with total disc replacements with the ProDisc-L and Synthes devices, the surgery at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the surgery at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 56-year-old female enrollee has requested reimbursement for inpatient length of stay provided on 8/17/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
further surgery. The patient tolerated the procedure well and was deemed stable postoperatively. | Upheld | Medical Necessity | Summary Reviewer
A 56-year-old female enrollee has requested reimbursement for inpatient length of stay provided on 8/17/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that vaginal bleeding secondary to a post-coital vaginal laceration, if severe, is managed through operative repair. Repair of vaginal lacerations usually requires surgical intervention and is best performed in the operating room to obtain adequate exposure. Regional or general anesthesia may be needed due to pain and pressure from retraction or extensive suturing. In this case, the repair was uncomplicated, with no extension beyond the vagina requiring further surgery. The patient tolerated the procedure well and was deemed stable postoperatively. Typically, patients are able to be discharged following the surgery from the ambulatory surgical unit, in which case inpatient admission is not medically necessary. In this patients case, she did not have any unique clinical circumstances that required acute inpatient admission. She was hemodynamically stable throughout her course and could have discharged after monitoring in the postoperative recovery unit. This patient did not require acute inpatient admission and could have been discharged after an appropriate period of monitoring in the recovery unit. Therefore, inpatient length of stay provided on 8/17/19 was not medically necessary for the treatment of this patient. | 1 |
The parent of a three-year-old female enrollee has requested authorization and coverage for homocysteine, Factor V Leiden, and methylene tetrahydrofolate reductase (MTHFR), testing performed on 6/4/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee whose parent was diagnosed with idiopathic venous embolism and was positive for the MTHFR mutation and Factor V Leiden deficiency. | Upheld | Experimental | Summary Reviewer 3
The parent of a three-year-old female enrollee has requested authorization and coverage for homocysteine, Factor V Leiden, and methylene tetrahydrofolate reductase (MTHFR), testing performed on 6/4/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee whose parent was diagnosed with idiopathic venous embolism and was positive for the MTHFR mutation and Factor V Leiden deficiency. The physician reviewer found that While there is some support for the services at issue, the studies do not show that these tests have a clinical benefit to normal healthy children, as in this patients case. The majority of pediatric deep venous thromboembolisms occur in hospitalized children with underlying medical conditions, such as prematurity, cancer, congenital heart disease, and infection. Most have multiple risk factors, the single most common being the presence of a central venous catheter. Outcomes from testing in the pediatric population include these types of screening are only recommended when it may alter therapy or result in targeted thromboprophylaxis. These screening tests are used in certain patients, if indicated. However, in this patients case, she does not fall within the suggested clinical indications. Instead, the available literature appears to suggest that for generally healthy children, the best approach is to delay testing until children are older. As such, homocysteine, FVL, and MTHFR testing performed on 6/4/16 was not likely to have been more efficacious than standard therapies available for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 61-year-old male enrollee has requested authorization and coverage for radiofrequency ablation (code 50592). 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. | Upheld | Medical Necessity | Summary Reviewer
A 61-year-old male enrollee has requested authorization and coverage for radiofrequency ablation (code 50592). 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 fails to demonstrate the medical necessity of the requested services. The records document a small, localized, renal cell tumor, for which surgical resection is the standard of care (likely, in the form of partial nephrectomy). This is stated in the National Comprehensive Cancer Network guidelines, and is justified by much higher local recurrence rates for radiofrequency ablation or microwave ablation as compared with resection. Therefore, the more minimally invasive approaches, such as radiofrequency ablation and microwave ablation, are reserved for patients who would not tolerate surgery, either by virtue of being poor surgical candidates, or for patients in whom removal of a kidney or part of it may result in renal failure. There is a lack of support for the requested services in this clinical setting. Thus, radiofrequency ablation is not medically necessary for the treatment of this patient. | 0 |
A 51-year-old female enrollee has requested reimbursement for hyperthermia (77605 and 77600) provided from 11/03/15 through 12/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees breast cancer. | Upheld | Experimental | Summary Reviewer 1
A 51-year-old female enrollee has requested reimbursement for hyperthermia (77605 and 77600) provided from 11/03/15 through 12/15/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees breast cancer. The physician reviewer found the superior efficacy of the services at issue has not been established. Hyperthermia is generally reserved for treatment of recurrent breast cancer to the chest wall after mastectomy. Whether the addition of hyperthermia to conventional external beam radiation therapy is of clinical benefit is unknown. At least six randomized trials have compared radiation therapy with and without hyperthermia in the setting of measurable breast cancer where local therapy was indicated and surgery not feasible. Most have not been published, and the trials had a number of weaknesses, including the fact that at least two were stopped before reaching target accrual, the eligibility requirements of all of the trials varied markedly, and the primary endpoint was complete local response rather than survival. Per the medical evidence, hyperthermia (77605 and 77600) provided from 11/03/15 through 12/15/15 was not likely to have been more efficacious than other treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 32-year-old male with a history of thoracic spine pain and T11-12 degenerative disc disease. On 12/22/17, the patient was treated with a bilateral T11-12 epidural steroid injection. Per the records, this provided good, but temporary, relief. The enrollee was also treated with physical therapy, chiropractic care, and massage. The provider has recommended transformational lumbar interbody fusion (TLIF). The patient has requested coverage for spinal fusion surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for the treatment of this patient. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 32-year-old male with a history of thoracic spine pain and T11-12 degenerative disc disease. On 12/22/17, the patient was treated with a bilateral T11-12 epidural steroid injection. Per the records, this provided good, but temporary, relief. The enrollee was also treated with physical therapy, chiropractic care, and massage. The provider has recommended transformational lumbar interbody fusion (TLIF). The patient has requested coverage for spinal fusion surgery. The Health Insurer has denied this request indicating 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 submitted documentation fails to demonstrate the medical necessity of the requested services. The 2009 American Pain Society guidelines indicate that spinal fusion surgery is not better than intensive rehabilitation for pain associated with degenerative changes (non-radicular). Per the medical records submitted, the patient does not meet this standard. The patient does not have radicular disease with neurological deficits, and he does not have spinal instability, fracture or tumor. Thus, the requested spinal fusion surgery is not medically necessary for the treatment of this patient. Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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patient is a 31-year-old female who complains of back, shoulder, neck and rib pain. She has shoulder grooving.
; upper back, neck, and shoulder pain; backache, unspecified; thoracic kyphosis, acquired; shoulder grooving from bra straps; upper extremity paresthesia due to brachial plexus compression syndrome secondary to the weight of the breasts being transferred to the shoulder strap area; headache; and congenital breast deformity.
This patient reports back, shoulder and neck pain, with shoulder grooving documented on physical examination. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 31-year-old female who complains of back, shoulder, neck and rib pain. She has shoulder grooving. The physician reviewer found that the American Society of Plastic Surgeons (ASPS) states that reduction mammaplasty authorization should be based on documentation of the severity of the symptoms of macromastia and impact on health-related quality of life with at least two of the following signs: chronic breast pain due to weight of the breasts; intertrigo unresponsive to medical management; upper back, neck, and shoulder pain; backache, unspecified; thoracic kyphosis, acquired; shoulder grooving from bra straps; upper extremity paresthesia due to brachial plexus compression syndrome secondary to the weight of the breasts being transferred to the shoulder strap area; headache; and congenital breast deformity.
This patient reports back, shoulder and neck pain, with shoulder grooving documented on physical examination. There is no report of chronic breast pain due to weight of the breasts, intertrigo unresponsive to medical management, thoracic kyphosis, upper extremity paresthesia, headache, or congenital breast deformity. Because there are at least two quality of life signs, the requested service would be considered medically necessary according to ASPS criteria.
The American Society of Plastic Surgeons (ASPS) has indicated the decision to perform reduction mammaplasty should be based on the patientas symptoms and a surgeonas assessment of the likelihood of benefit as opposed to the amount (weight) of breast tissue to be removed. It has been indicated by others, however, that the ASPS position is largely based on observational studies, which are un-blinded, lack randomized control groups and have potential for selection bias, and expert opinion. The more common and accepted guidelines use a measurement of body surface area and weight removed to determine medical necessity.
The gold standard for this determination is the study by Schnur and colleagues. This article does not establish a defined lower weight for breast resection; it establishes a range. According to the article, 351 grams would be the lower 22nd percentile of weight resection for a BSA of 1.67, with 224 grams being the lower 5th percentile of weight of resection with a BSA of 1.67. According to the article, aif the womanas data plot above the 22nd percentile, her motivation is purely medical. If her data plot below the 5th percentile, her motivation is purely cosmetic. If her data plot between the two lines, her motivation is mixed and must be looked at individually.a
In this patient, the proposed resection of approximately 338 grams per breast is essentially at the 22nd percentile of 351 grams per breast at a BSA of 1.67 and would qualify the procedure as medically necessary according to weight. Combining this determination of medical necessity based on weight with the determination of medical necessity based on ASPS criteria, the requested service of bilateral reduction mammaplasty would be considered medically necessary for this patient.
The California reconstructive surgery statute requires health insurers to cover reconstructive surgeries, defined as surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) To improve function; (2) To create a normal appearance, to the extent possible.
This patient complains of back, shoulder and neck pain with rib pain. She has shoulder grooving from the weight of her breasts on her bra straps. She has taken muscle relaxers and anti-inflammatory drugs, without relief. She has tried many sessions of physical therapy for upper back pain and has undergone chiropractic treatment without relief. She has breast hypertrophy, which is a developmental abnormality. She has a functional disability from pain, and breast reduction surgery would be to improve function. The California reconstructive surgery statute applies, and breast reduction surgery would constitute reconstructive surgery as defined by the California reconstructive surgery statute.
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The parent of a 13-year-old male enrollee has requested reimbursement for balloon sinus ostial dilation performed on 10/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees chronic sinus problems.
This patient had chronic sinusitis. He underwent the standard of care treatment, which is adenoidectomy. | Overturned | Experimental | Summary Reviewer 1
The parent of a 13-year-old male enrollee has requested reimbursement for balloon sinus ostial dilation performed on 10/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees chronic sinus problems. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. This patient had chronic sinusitis. He underwent the standard of care treatment, which is adenoidectomy. A balloon sinuplasty procedure is a clinically effective procedure for pediatric patients suffering from chronic sinusitis. This has been proven in multiple trials. All told, balloon sinus ostial dilation performed on 10/28/15 was likely to have been superior over other treatment options. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 60-year-old female enrollee has requested reimbursement for the emergency department services provided at Hoag Hospital on 12/1/16. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.
. The patient was directed to go to the emergency department by her primary care provider to rule out diverticulitis. She was evaluated and found to have diverticulitis, was offered admission, and declined. She was prescribed oral antibiotics. The medical
. The patient then left and went to the second emergency department. There she received one dose of intravenous antibiotics and was discharged. | Overturned | Medical Necessity | Summary Reviewer
A 60-year-old female enrollee has requested reimbursement for the emergency department services provided at Hoag Hospital on 12/1/16. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found that 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. The patients symptoms on 12/1/16 did meet prudent layperson criteria for emergency care. A prudent layperson in the patients circumstances would reasonably expect the absence of emergency care to jeopardize his or her health. The patient was directed to go to the emergency department by her primary care provider to rule out diverticulitis. She was evaluated and found to have diverticulitis, was offered admission, and declined. She was prescribed oral antibiotics. The medical records support a comprehensive history and medical decision making of high complexity to support CPT code 99285. The patient then left and went to the second emergency department. There she received one dose of intravenous antibiotics and was discharged. All told, the emergency department services provided at Hoag Hospital on 12/1/16 were required on an emergent basis and include comprehensive history and medical decision making of high complexity to support CPT code 99285. Therefore, the Health Insurers denial should be overturned. | 1 |
The parent of a seven-year-old female enrollee has requested reimbursement for tonsillectomy and adenoidectomy performed on 9/25/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees sleep disordered breathing, recurrent tonsillitis, and adenotonsillar hypertrophy.
This patient had clinically evident obstructive sleep apnea and growth failure as well as recurrent infections. | Overturned | Medical Necessity | Summary Reviewer
The parent of a seven-year-old female enrollee has requested reimbursement for tonsillectomy and adenoidectomy performed on 9/25/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees sleep disordered breathing, recurrent tonsillitis, and adenotonsillar hypertrophy. The physician reviewer found that removal of tonsils and adenoids is a safe, effective surgical method to resolve breathing obstruction, throat infections and manage recurrent childhood ear disease. Tonsillectomy is performed commonly in combination with adenoidectomy, and has demonstrated efficacy as the primary treatment option for most children with obstructive sleep apnea syndrome. The medical literature suggests that obstructive sleep apnea syndrome is a risk factor for growth failure in children. A significant number of children with obstructive sleep apnea concurrent with growth failure are noted to benefit from tonsillectomy and adenoidectomy to recover and normalize their growth rate. This patient had clinically evident obstructive sleep apnea and growth failure as well as recurrent infections. Therefore, the tonsillectomy and adenoidectomy performed on 9/25/17 were medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 37-year-old female enrollee has requested authorization and coverage for escitalopram three tablets 20 mg daily. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees behavioral health condition. | Overturned | Medical Necessity | Summary Reviewer
A 37-year-old female enrollee has requested authorization and coverage for escitalopram three tablets 20 mg daily. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found the United States Food and Drug Administration (FDA) provides medication dose recommendations based on scientific data. The interpretation and application of these recommendations falls upon providers working directly with the patient population. This process allows for consideration of additional factors, such as provider experience, emerging treatment trends and clinical issues unique to individual cases, in the delivery of evidence-based, patient-centric care. As such, systematic medication titration is a core element of the art of medical practice and a key component to patient-centered care. Escitalopram is a potent and highly selective serotonin reuptake inhibitor (SSRI) that acts by binding directly to the serotonin transporter. Like other SSRI medications, escitalopram is a trusted intervention in the treatment armamentarium for those suffering from OCD. Providers have long recognized that the treatment of OCD often requires supra-therapeutic SSRI dosing. This practice is supported by the American Psychiatric Association (APA) clinical practice guideline for OCD which supports the occasionally prescribed maximum dose of escitalopram is 60 mg per day. Considering the medical records, community standards, endorsement from the APA and the peer-reviewed literature base, escitalopram 60 mg daily represents a safe, appropriate treatment consistent with good medical practice. The requested medication is reasonably expected to improve the patients condition and prevent a more serious episode of illness. As such, the requested escitalopram three tablets 20 mg daily are medically necessary for treatment of the patients behavioral health condition. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 55-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 11/2/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 55-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 11/2/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the American College of Radiology (ACR) has recommended tomosynthesis be removed from the investigational category due to the advantages it affords radiologists in interpreting mammograms. This tomographic method allows radiologists to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in biopsies, decrease in callbacks and increase in detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional (2D) imaging protocol was likely of greater benefit to the patient than 2D imaging alone. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 60-year-old male. An echocardiography report dated 10/13/21 reported severe
apical hypertrophy, reduced strain, and an apical aneurysm. The patient has requested
reimbursement for a S-ICD subcutaneous cardioverter defibrillator from 12/9/21 through
12/10/21. The Health Insurer has denied this request and reported the service at issue was not
medically necessary for the evaluation of this patient. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 60-year-old male. An echocardiography report dated 10/13/21 reported severe
apical hypertrophy, reduced strain, and an apical aneurysm. The patient has requested
reimbursement for a S-ICD subcutaneous cardioverter defibrillator from 12/9/21 through
12/10/21. The Health Insurer has denied this request and reported the service at issue was not
medically necessary for the evaluation of this patient. This denial is the subject of this appeal and
determination. The physician reviewer found that the submitted documentation does not support the
medical necessity of the service at issue. In the setting of primary prevention implantable
cardioverter defibrillator (ICD) placement, the usual indications for a subcutaneous defibrillator
over a transvenous defibrillator include inadequate vascular access, anticipated multiple venous
access procedures (for example, in the case of a patient with young age), previous cardiac infection,
increased risk of infection, and existence of right-sided artificial heart valves that preclude
transvenous lead placement. In this case, none of these indications are documented in the records
provided and there is report of ventricular tachycardia that would not be able to be terminated by
tachypacing, if needed, if a subcutaneous device were placed. Therefore, S-ICD subcutaneous
cardioverter defibrillator from 12/9/21 through 12/10/21 was not medically necessary for the
treatment of this patient.
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A 23-year-old male enrollee has requested authorization and coverage for orthognathic surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees mandibular prognathism, maxillary hypoplasia and class II malocclusion. | Overturned | Medical Necessity | Summary Reviewer
A 23-year-old male enrollee has requested authorization and coverage for orthognathic surgery. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees mandibular prognathism, maxillary hypoplasia and class II malocclusion. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. This patient has a maxillofacial skeletal deformity that cannot be corrected with orthodontics alone. The requested services are likely to result in improved musculoskeletal and dento-osseous relationships and improvement in mastication. The anterior segmental osteotomy will maximize the patients outcome. The medical evidence supports the requested services in this clinical setting. Thus, the requested orthognathic surgery is medically necessary 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 38-year-old female enrollee has requested authorization and coverage for Tysabri. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found this patient has been diagnosed with relapsing-remitting multiple sclerosis. Treatment is indicated to reduce attacks. She has been prescribed Tysabri, and the current medical | Overturned | Medical Necessity | Summary Reviewer
A 38-year-old female enrollee has requested authorization and coverage for Tysabri. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found this patient has been diagnosed with relapsing-remitting multiple sclerosis. Treatment is indicated to reduce attacks. She has been prescribed Tysabri, and the current medical evidence supports the requested medication in this clinical setting. Guidelines and clinical experience show reduction of relapse rates and progression, with generally favorable tolerability. Compliance with once monthly regimen is high. This patient did not tolerate Copaxone. There is sufficient support for the requested medication in this patients case. All told, Tysabri is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The patient is a 26-year-old male who presented to his provider on 1/28/22 with diagnoses of
recurrent, severe major depressive disorder, generalized anxiety disorder, and insomnia. The
patient has requested reimbursement for adult mental health transcranial magnetic stimulation
from 1/31/22 through 3/28/22. The Health Insurer has denied this request and reported that the
services at issue were not medically necessary for the treatment of this patient.
In this case, the patient has treatment refractory depression, having failed more than three
antidepressant trials in addition to psychotherapy. An evaluation by a psychiatrist resulted in a
recommendation of transcranial magnetic stimulation. The patient was in an episode of recurrent,
severe major depressive disorder. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 26-year-old male who presented to his provider on 1/28/22 with diagnoses of
recurrent, severe major depressive disorder, generalized anxiety disorder, and insomnia. The
patient has requested reimbursement for adult mental health transcranial magnetic stimulation
from 1/31/22 through 3/28/22. The Health Insurer has denied this request and reported that the
services at issue were not medically necessary for the treatment of this patient. The physician
reviewer found that the submitted documentation supports the medical necessity of the services
at issue. McClintock and colleagues note that there is an abundance of data pertaining to the safety
and efficacy of transcranial magnetic stimulation for individuals with major depressive disorder.
In this case, the patient has treatment refractory depression, having failed more than three
antidepressant trials in addition to psychotherapy. An evaluation by a psychiatrist resulted in a
recommendation of transcranial magnetic stimulation. The patient was in an episode of recurrent,
severe major depressive disorder. Given the patients lack of response to traditional medication
and psychotherapy treatment, transcranial magnetic stimulation was the appropriate next step in
the decision-making algorithm for treatment refractory depression. Therefore, adult mental health
transcranial magnetic stimulation from 1/31/22 through 3/28/22 were medically necessary for the
treatment of this patient.
| 1 |
A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition. | Upheld | Experimental | Summary Reviewer 2
A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found that according to Kirchheiner and colleagues there is still considerable controversy on whether adjustment of dosage driven by genetic information may improve therapeutic efficacy, and/or adverse events is prevented, to an extent of any practical importance in clinical practice. The documentation provided for review does not indicate specific medication doses used, length of medication trials or combinations of medications tried and failed. The record indicates that the testing was performed due to medication failures. However, there is a lack of documentation provided as to whether the patient has been treated with psychotherapy or cognitive behavioral therapy (CBT). CBT is a first-line treatment for the generalized anxiety disorder. In sum, the documentation provided for review does not demonstrate that the patient has failed medication trials of adequate dose and duration or that the patient has tried or failed evidence based psychotherapy trials. As such, the gene testing performed on 8/11/16 has not been established 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 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 63-year-old male enrollee has requested reimbursement for Guardant360 liquid biopsy test performed on 9/14/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 63-year-old male enrollee has requested reimbursement for Guardant360 liquid biopsy test performed on 9/14/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that pancreatic cancer has notably been a difficult cancer to treat. With the emergence of new agents to treat pancreatic cancer, particularly biologics, clinical trial strategies incorporating principles of molecular biology and new imaging methods as well as results from preclinical studies are important. Per the National Comprehensive Cancer Network guidelines, tumor/somatic gene profiling is recommended for patients with locally advanced/metastatic disease who are candidates for anti-cancer therapy to identify uncommon mutations. Molecular profiling or next-generation sequencing can help identify available therapies and identify clinical trials. It can also evaluate for microsatellite instability, mismatch repair and tumor mutational burden status to determine eligibility for immunotherapy. Therefore, Guardant360 liquid biopsy test performed on 9/14/20 was likely to have been more beneficial than other methods of evaluating this patient.
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A 48-year-old female has requested reimbursement for procedure codes 84999 (DecisionDx-Melanoma) and 99000 performed on 1/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 2
A 48-year-old female has requested reimbursement for procedure codes 84999 (DecisionDx-Melanoma) and 99000 performed on 1/25/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit more to these determinations. As per the Balch criteria, this patients melanoma would be considered a T1a, or stage 1A melanoma, with an expected ten-year survival in excess of 88%. DecisionDx-Melanoma assay is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either Class 1 (with a five-year distant metastasis free rate of greater 90%) or Class 2 (65-80%). Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx classification, in patients undergoing sentinel node sampling. The records do not document that this patient had sentinel node biopsy. It is not clear how the five-year DecisionDx data compares to the ten-year Balch data, and, most importantly, whether it can be used to make clinical decisions. That would be particularly true in this patient given her excellent prognosis. In sum, procedure codes 84999 (DecisionDx-Melanoma) and 99000 performed on 1/25/17 were not likely to have been of greater benefit than other available modalities 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 male enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 8/17/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 2
A 57-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 8/17/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add to these statistics. DecisionDx-Melanoma is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either class 1 (with a 90 to 92% distant disease free survival at five years), or class 2 (with a 65 to 80% rate). Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx-Melanoma classification, in patients undergoing sentinel node sampling. However, it is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear whether the assay can be used to make treatment decisions. Therefore, DecisionDx-Melanoma test performed on 8/17/17 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.
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A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 4/12/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 4/12/18. 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 has an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the services at issue were not likely to have altered treatment and surveillance recommendations. In sum, DecisionDx-Melanoma assay performed on 4/12/18 was not likely to have been more effective than other methods of evaluating this patient.
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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.
The provider has performed a photon/proton comparison plan which showed | Upheld | Experimental | Summary Reviewer 3
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 the submitted documentation fails to demonstrate the superior efficacy of the requested services. There is insufficient high-quality clinical outcomes reported in the peer-reviewed medical literature demonstrating that the requested services are safer or more effective as compared to standard of care photon radiation. The provider has performed a photon/proton comparison plan which showed that the photon plan could be delivered safely. There was a slight reduction in exposure to several normal tissues, but it remains unknown as to whether this would translate into a clinically meaningful benefit. Thus, proton beam therapy is not likely to be more effective than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 57-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 12/28/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees melanoma. | Upheld | Medical Necessity | Summary Reviewer
A 57-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma assay performed on 12/28/17. 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 there is a lack of support for the services at issue in this clinical setting. This patient has an early stage melanoma. The National Comprehensive Cancer Network guidelines state while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. The results of the DecisionDx-Melanoma assay were not likely to have altered treatment and surveillance recommendations. Thus, DecisionDx-Melanoma assay performed on 12/28/17 was not medically necessary for the evaluation of the enrollees medical condition. 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 65-year-old female enrollee has requested authorization and coverage for Venclexta (venetoclax) 100 mg, five tablets daily #150. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees multiple myeloma. | Upheld | Experimental | Summary Reviewer 3
A 65-year-old female enrollee has requested authorization and coverage for Venclexta (venetoclax) 100 mg, five tablets daily #150. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees multiple myeloma. The physician reviewer found that multiple myeloma is a plasma cell neoplasm that extends widely with many systemic complications including anemia, hypercalcemia, bony lytic lesions, and renal failure. Multi-agent chemotherapy is the mainstay of treatment and this is frequently consolidated with autologous hematopoietic stem cell transplant. Overall, it is common for patients to transition from many different agents and lines of therapy. Bortezomib is oftentimes used in newly diagnosed patients and patients with relapsed disease (Kastritis, et al; Reece, et al; Venner, et al). Daratumumab is a monoclonal antibody directed against CD38 that was approved by the U.S. Food and Drug Administration (FDA) for treatment of myeloma in those patients who have progressed on proteasome inhibitor or immunomodulatory agents. A recent phase III, randomized clinical trials showed that daratumumab with bortezomib and dexamethasone had increased overall response rate and improved progression free survival compared with bortezomib and dexamethasone (Palumbo, et al). Given this support, the requested Venclexta (venetoclax) 100 mg, five tablets daily #150 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 medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 61-year-old female enrollee has requested reimbursement for the molecular profiling lab testing performed on 1/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic carcinoma of unknown primary site. | Upheld | Experimental | Summary Reviewer 2
A 61-year-old female enrollee has requested reimbursement for the molecular profiling lab testing performed on 1/23/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic carcinoma of unknown primary site. The physician reviewer found that in the peer-reviewed medical literature, Weiss and colleagues noted that their study demonstrated a role for molecular studies in carcinoma of unknown primary, although the precise clinical indication requires further study. The current National Comprehensive Cancer Network (NCCN) guidelines state the clinical benefit of molecular assays remains to be determined. Finally, this patients records suggest the presence of a signet ring carcinoma of gastrointestinal origin, for which standard treatment is FOLFOX or FOLFIRI. Given these findings, the molecular profiling lab testing performed on 1/23/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 58-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Plan has denied this request indicating that the requested procedure is considered investigational for the enrollees gastroesophageal reflux disease (GERD). | Upheld | Experimental | Summary Reviewer 3
A 58-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Plan has denied this request indicating that the requested procedure is considered investigational for the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found there is a lack of randomized controlled trials comparing Linx with Nissen fundoplication or other standard surgical anti-reflux procedures. According to Sheu and Rattner the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined. In addition, Loh and colleagues concluded that further studies are required to determine its long term outcomes and its relative efficacy as compared to other established treatments, Adverse events, such as erosion through the esophagus, have been reported since U.S. Food and Drug Administration (FDA) approval (Bauer, et al). The currently available peer-reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial in this case than standard treatment, such as surgical fundoplication. Based on current literature and clinical guidelines, LINX is not likely to be more beneficial for treatment of the enrollees 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 29-year-old female enrollee has requested reimbursement for the Anser ADA test provided on 10/13/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. | Upheld | Experimental | Summary Reviewer 1
A 29-year-old female enrollee has requested reimbursement for the Anser ADA test provided on 10/13/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that in this patients case, the Anser ADA test was ordered to determine the etiology for possible loss of response to Humira and to direct management of the patients ulcerative colitis. Overall, the effectiveness of the Anser ADA compared to conventional courses of evaluation remains unproven. Patients being treated with adalimumab may experience loss of response. However, the appropriate method for determination of the cause for loss of response remains uncertain. The available published clinical studies on the use of these serum levels are small and retrospective or observational in nature (Karmiris, et al; Roblin, et al). Prospective controlled trials demonstrating the effectiveness of anti-adalimumab antibody testing and serum level testing as part of the clinical management strategy are lacking. For these reasons, the Anser ADA test provided on 10/13/14 was not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were 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 59-year-old male enrollee has requested reimbursement for advanced lipoprotein testing provided on 3/11/16. The Health Plan has denied this request indicating that the service at issue was considered investigational for the enrollees hypertension. | Upheld | Experimental | Summary Reviewer 1
A 59-year-old male enrollee has requested reimbursement for advanced lipoprotein testing provided on 3/11/16. The Health Plan has denied this request indicating that the service at issue was considered investigational for the enrollees hypertension. The physician reviewer found the advanced lipoprotein testing provided on 3/11/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Advanced lipoprotein analysis has not been approved in the current guidelines from the American College of Cardiology (ACC). The ACC guidelines recommend use of standard risk factors and standard lipid panels in managing cardiovascular risk. The ACC has also moved away from treating to target lipid values and favor a simpler approach to provide standard doses of moderate strength statins to patients at increased risk, based on outcome studies. This recommendation is based on consensus by experts who have reviewed the current literature. Therefore, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 36-year-old female enrollee has requested authorization and coverage for peripheral nerve stimulator (implant of neuroelectrodes (G4555)). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees paraclavicular and neck pain. | Overturned | Experimental | Summary Reviewer 3
A 36-year-old female enrollee has requested authorization and coverage for peripheral nerve stimulator (implant of neuroelectrodes (G4555)). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees paraclavicular and neck pain. The physician reviewer found that currently, there is a paucity of clinical data on peripheral nerve stimulation. Further, there is a lack of an indication for the peripheral nerve stimulation requested in this patients case. Considering the previous poor response to surgical interventions, which included thoracic outlet syndrome decompression as well as spinal cord stimulation, the recommended peripheral nerve stimulation does not appear to be superior to other modalities of treatments available. All told, the requested peripheral nerve stimulator (implant of neuroelectrodes (G4555)) is not likely to provide this patient with an improved health outcome beyond that anticipated with standard available alternatives. 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 the wearable cardioverter defibrillator provided on 11/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 63-year-old male enrollee has requested reimbursement for the wearable cardioverter defibrillator provided on 11/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found that 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 (>90 days) where continued left ventricular dysfunction (ejection fraction = 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. A 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. In sum, the wearable defibrillator has not yet been demonstrated by existing scientific literature as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 24-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 7/06/21. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 24-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 7/06/21. 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 Committee on Cancer (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 stage I (T1)
melanoma and a higher proportion of false-positive results, GEP testing should not guide clinical
decision-making in this subgroup. The current medical evidence has not established the superior
efficacy of the services at issue in this clinical setting. Therefore, DecisionDx-Melanoma testing
performed on 7/06/21 was not likely to have been more beneficial than any available standard
therapy.
| 0 |
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. | Overturned | Experimental | Summary Reviewer 2
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 minimally invasive therapies to treat symptoms of uterine myomas can be effective alternatives to major surgery. Such modalities include pharmacologic agents, uterine artery embolization, magnetic resonance-guided focused ultrasound, and laparoscopic radiofrequency ablation, known as the Acessa procedure. Acessa is used to treat women with symptomatic myomas and was approved by the U.S. Food and Drug Administration in 2012. Brucker and colleagues compared the mean hospital discharge times and perioperative outcomes for radiofrequency volumetric thermal ablation of fibroids and laparoscopic myomectomy. The authors noted, Radiofrequency volumetric thermal ablation resulted in the treatment of more fibroids, a significantly shorter hospital stay, and less intraoperative blood loss than laparoscopic myomectomy. Lin and colleagues performed a meta-analysis of eight studies. The authors assessed the short-term and long-term symptom relief and quality of life improvement, procedure-related adverse event rate, reintervention rate, and days missed from work after laparoscopic radiofrequency ablation. The authors noted, All subscales of quality of life improved significantly, and most of the changes remained stable in long-term follow-up. In conclusion, laparoscopic radiofrequency ablation therapy Acessa is an efficacious way to treat small-sized and nonpedunculated symptomatic uterine fibroids, providing stable long-term symptom relief and quality of life improvement. Therefore, CPT 58674 (Acessa procedure - laparoscopic radiofrequency ablation) is likely to be more beneficial than any available standard therapy.
| 0 |
A 43-year-old female enrollee has requested authorization and coverage for left arthroscopy, hip surgical with femoroplasty (treatment of cam lesion), left arthroscopy, hip surgical with acetabuloplasty (treatment of pincer lesion). The Health Insurer has denied this request and reported that the requested services are not medically necessary for treatment of the enrollees hip pain.
In this case, the patient presents with an approximate one-year history of constant and progressively worsening left hip and groin pain. Significant functional limitations are noted in activities of daily living. Clinical examination findings have been consistent with radiographic and imaging evidence of a left hip femoroacetabular impingement with cam and pincer lesions. She has failed over six months of conservative treatment, including activity modification, anti-inflammatory medications, and physical therapy. X-rays findings document no signs of joint space | Overturned | Medical Necessity | Summary Reviewer
A 43-year-old female enrollee has requested authorization and coverage for left arthroscopy, hip surgical with femoroplasty (treatment of cam lesion), left arthroscopy, hip surgical with acetabuloplasty (treatment of pincer lesion). The Health Insurer has denied this request and reported that the requested services are not medically necessary for treatment of the enrollees hip pain. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services in this clinical setting. Harris and colleagues concluded that the outcomes of operative treatment of femoroacetabular impingement are significantly better than nonsurgical management. Surgical treatment significantly improves outcomes, with no consistent significant differences exhibited between open and arthroscopic techniques. In this case, the patient presents with an approximate one-year history of constant and progressively worsening left hip and groin pain. Significant functional limitations are noted in activities of daily living. Clinical examination findings have been consistent with radiographic and imaging evidence of a left hip femoroacetabular impingement with cam and pincer lesions. She has failed over six months of conservative treatment, including activity modification, anti-inflammatory medications, and physical therapy. X-rays findings document no signs of joint space narrowing, and are reportedly consistent with Tonnis grade 0. Current evidence-based medical guidelines and peer-reviewed literature support surgical management of femoroacetabular impingement syndrome when non-surgical treatment methods fail and specific criteria have been met. The medical evidence supports the requested services in this clinical setting. All told, the requested left arthroscopy, hip surgical with femoroplasty (treatment of cam lesion), left arthroscopy, hip surgical with acetabuloplasty (treatment of pincer lesion) are medically necessary 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 |
The patient is a 64-year-old female who was diagnosed with rectal cancer in 2016. This patient has localized (T3N0M0) squamous cell cancer of the rectum. The patients provider sent a sample tissue for molecular testing which was initiated on 2/28/17. The patient has requested reimbursement for CarisMI profile testing services performed on 3/10/17. The Health Insurer denied this request as investigational for the evaluation of this patients medical condition. | Upheld | Experimental | Summary Reviewer 3
The patient is a 64-year-old female who was diagnosed with rectal cancer in 2016. This patient has localized (T3N0M0) squamous cell cancer of the rectum. The patients provider sent a sample tissue for molecular testing which was initiated on 2/28/17. The patient has requested reimbursement for CarisMI profile testing services performed on 3/10/17. The Health Insurer denied this request as investigational for the evaluation of this patients medical condition. Molecular profiling, also known as next generation sequencing (NGS) is not considered a standard of care for the treatment of recurrent or locally progressive anal carcinoma. Its use is not endorsed by the National Network Cancer guidelines. Immunotherapy is used for salvage therapy and studies show a benefit from both nivolumab and pembrolizumab. PD-L1 overexpression should not be used to select patients for treatments targeting the PD-1 pathway as studies have shown benefit even in those with no expression. NGS would not have been more beneficial for treatment decision making for this patient. As such, CarisMI profile testing services performed on 3/10/17 was not likely to have been of greater benefit than any available standard of care. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 6/11/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 6/11/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the breast tomosynthesis at issue was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. Ciatto and colleagues investigated the effect of integrated two-dimensional (2D) and three-dimensional (3D) mammography in the breast cancer screening population. The authors found that Integrated 2D and 3D mammography improves breast cancer detection and has the potential to reduce false positive recalls. Thus, the literature does support the use of breast tomosynthesis over conventional mammogram due to improved cancer detection rate. Additionally in this case, the tomographic images were particularly helpful in resolving the left breast asymmetry as normal tissues, which was the lesion in question. Based on the support in the medical literature and the clinical documentation submitted for review, the use of breast tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 61-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with implant (Watchman device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.T | Overturned | Experimental | Summary Reviewer 3
A 61-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with implant (Watchman device). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.The physician reviewer found the submitted documentation supports the requested services in this clinical setting. The left atrial appendage occlusion device (Watchman) has been approved to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation, who are at increased risk for stroke and are recommended for anticoagulation therapy. There is sufficient support for the requested services in this patients case. Many patients with atrial fibrillation take warfarin or other blood thinning medicines to prevent a stroke caused by a blood clot in the brain. However, warfarin can increase the risk of bleeding anywhere in the body. If bleeding happens in the brain, this can also cause a stroke. In this patients case, the requested percutaneous transcatheter closure of the left atrial appendage with implant (Watchman device) is likely to be more effective than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old female enrollee has requested authorization and coverage for Prolia (denosumab) injections. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees osteoporosis. | Overturned | Medical Necessity | Summary Reviewer
A 59-year-old female enrollee has requested authorization and coverage for Prolia (denosumab) injections. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees osteoporosis. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. Osteoporosis is an increasingly widespread condition. Fractures are the most dangerous aspect of osteoporosis. Fractures can lead to acute and chronic pain. A newer medication, denosumab (Prolia), is a fully human monoclonal antibody which has been approved for the treatment of osteoporosis, treatment-induced bone loss, bone metastases, multiple myeloma, and giant cell tumor of bone. Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. This patient is unable to tolerate Reclast therapy. The requested medication is medically appropriate in this clinical setting. Thus, Prolia (denosumab) injections are medically necessary for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 57-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/01/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 57-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/01/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the service 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 noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Therefore, digital breast tomosynthesis performed on 9/01/16 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 34-year-old female enrollee has requested authorization and coverage for BRCA testing. The Health Insurer has denied this request indicating that the requested testing is considered investigational for evaluation of the enrollees risk of breast cancer.
has more than two relatives on the same side of the family with breast cancer. | Overturned | Experimental | Summary Reviewer 2
A 34-year-old female enrollee has requested authorization and coverage for BRCA testing. The Health Insurer has denied this request indicating that the requested testing is considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found the request for BRCA genetic testing is likely to be more effective for this patient than other available treatment options. The patient meets National Comprehensive Cancer Network (NCCN) guidelines for BRCA testing given that she has more than two relatives on the same side of the family with breast cancer. If she were to harbor a BRCA mutation then prophylactic surgeries or heightened screening could be pursued to lower her risk of breast and/or cervical cancer. As such, BRCA genetic testing is clinically indicated and 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 requested testing 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 50-year-old female enrollee has requested reimbursement for the injection of periurethral bulking agent provided on 12/19/14. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees recurrent stress urinary incontinence and intrinsic urethral sphincter deficiency. | Overturned | Experimental | Summary Reviewer 2
A 50-year-old female enrollee has requested reimbursement for the injection of periurethral bulking agent provided on 12/19/14. The Health Insurer has denied this request indicating that the service at issue was considered investigational for treatment of the enrollees recurrent stress urinary incontinence and intrinsic urethral sphincter deficiency. The physician reviewer found that the injection of coaptite for urinary stress incontinence is an acceptable treatment for urinary stress incontinence in well selected patients. The procedure can be performed under local anesthesia and there is usually an immediate improvement in the patients stress incontinence. Although there are other viable treatment options, this procedure is likely to be more beneficial. Thus, the injection of periurethral bulking agent provided on 12/19/14 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 34-year-old female enrollee has requested reimbursement for genetic testing for fragile X syndrome (CPT code 81423) provided on 6/28/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees pregnancy. | Upheld | Experimental | Summary Reviewer 3
A 34-year-old female enrollee has requested reimbursement for genetic testing for fragile X syndrome (CPT code 81423) provided on 6/28/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees pregnancy. The physician reviewer found that the American College of Obstetricians and Gynecologists (ACOG) recommends that all patients be screened for cystic fibrosis and SMA. However, the ACOG states that fragile X testing is only indicated for patients with a family history of fragile X-related disorders or intellectual disability suggestive of fragile X syndrome and who are considering pregnancy or are currently pregnant or if a woman has unexplained ovarian insufficiency or failure or an elevated follicle-stimulating hormone level before age 40 years, fragile X carrier screening is recommended to determine whether she has an FMR1. Based on these guidelines, the genetic testing for fragile X syndrome (CPT code 81423) provided on 6/28/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 68-year-old female enrollee has requested reimbursement for carbon dioxide laser surgery (Mona Lisa Touch Laser) provided on 9/12/17 and 11/3/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees vulvar atrophy. | Upheld | Experimental | Summary Reviewer 1
A 68-year-old female enrollee has requested reimbursement for carbon dioxide laser surgery (Mona Lisa Touch Laser) provided on 9/12/17 and 11/3/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees vulvar atrophy. The physician reviewer found Vulvovaginal atrophy with symptomatic vaginal dryness and dyspareunia is treated with non-hormonal vaginal moisturizers and lubricants as first-line treatment. If these therapies do not provide adequate symptom relief, estrogen therapy is used. Laser treatment is available for potential treatment of vulvovaginal atrophy with urinary incontinence, as in this case. The Mona Lisa laser technology, as used in this case, delivers carbon dioxide laser energy to the vaginal wall tissue with multiple treatment sessions over a specific period of time. Current literature supports that laser therapy is promising. However, laser devices have not been approved by the U.S. Food and Administration for the treatment of vulvovaginal atrophy. Further, the American College of Obstetricians and Gynecologists has advised that although initial observational data indicate potential utility, additional data from randomized trials are needed to further assess the efficacy and safety of this procedure in treating vulvovaginal atrophy, particularly for long-term benefit. Therefore, the carbon dioxide laser surgery (Mona Lisa Touch Laser) provided on 9/12/17 and 11/3/17 were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old male enrollee has requested reimbursement for testing for liver disease provided on 6/11/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for testing for liver disease provided on 6/11/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that FibroTest and FibroSure are identical proprietary tests marketed under different names in Europe and America, respectively. ActiTest is a modification of FibroTest. The tests have primarily been studied in patients with hepatitis B and C. FibroTest involves assessment of alpha-2-macroglobulin, alpha-2-globulin, gamma globulin, apolipoprotein A1, and total bilirubin. It also takes into account the patients age and sex. Results from the individual assays are combined and are used to classify patients having mild fibrosis (F0 to F1), significant fibrosis (F2 to F4), or an indeterminate stage of fibrosis. The sensitivity for detection of significant fibrosis is approximately 60 to 75 percent, and the specificity is approximately 80 to 90 percent. In clinical practice, the services at issue are used routinely in patients with hepatitis B. Therefore, testing for liver disease (FibroTest-ActiTest/HCV-FibroSure) provided on 6/11/19 was likely to have been more beneficial than other methods of evaluating this patient.
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A 32-year-old female enrollee has requested authorization and coverage for Enbrel. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees ankylosing spondylitis. | Overturned | Experimental | Summary Reviewer 1
A 32-year-old female enrollee has requested authorization and coverage for Enbrel. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees ankylosing spondylitis. The physician reviewer found that Enbrel is an anti-tumor necrosis factor (TNF) medication used to treat inflammatory arthritis. The available medical records do not contain documentation of active arthritis. There is a lack of evidence of synovitis on physical examination and there is no record of symptomatology consistent with inflammatory lower back pain or inflammatory peripheral joint disease. There is no radiographic documentation of inflammatory arthritis of the spine or peripheral joints. On the basis of this lack of documentation, the request for Enbrel is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 46-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 46-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. 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 Inspire device was approved by the US Food and Drug Administration for the treatment of moderate to severe obstructive sleep apnea refractory to continuous positive airway pressure (CPAP). However, a meta-analysis by Kompelli and colleagues found that contemporary
hypoglossal nerve stimulation research consisted of single-arm clinical trials and case series, with a high likelihood of publication bias and a lack of comparative trials of hypoglossal nerve stimulation versus existing alternatives, such as upper airway surgery. They concluded, aHypoglossal nerve stimulation may not be the definitive choice for second line therapya for obstructive sleep apnea. A meta-analysis by He and colleagues evaluated the effectiveness of uvulopalatopharyngoplasty and its modifications for obstructive sleep apnea, demonstrating improved objective and subjective outcomes for at least 34 months after uvulopalatopharyngoplasty. The authors reported that uvulopalatopharyngoplasty and its modification are an effective surgical method for adult patients with obstructive sleep apnea both short-term and long-term after the surgery. Overall, there is insufficient high-quality, peer-reviewed evidence to support the use of hypoglossal nerve stimulation over other available therapies. Therefore, hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System is not likely to be more beneficial than other available standard therapy.
| 1 |
patient is a 60-year-old female with a history of class 1 obesity complicated by dyslipidemia. The
records available for review indicate that the patient had a body mass index (BMI) over 30 kg/m2 prior
to beginning treatment with Wegovy.
In
this case, the patient has a history of class 1 obesity complicated by dyslipidemia. The records reflect
that the patient has attempted treatment with diet management and exercise without significant
benefit. Per the provider, the patient has contraindications or intolerances to several weight loss
medications.
Furthermore, the patient has demonstrated prior weight loss success with
Weg | Overturned | Medical Necessity | Summary
The patient is a 60-year-old female with a history of class 1 obesity complicated by dyslipidemia. The
records available for review indicate that the patient had a body mass index (BMI) over 30 kg/m2 prior
to beginning treatment with Wegovy. The physician reviewer found that the issue is whether the
requested Wegovy solution auto-injector 0.25 mg/0.5 mL is medically necessary for the treatment of
this patient. According to Gadde and colleagues, while lifestyle modification is recommended as the
cornerstone of obesity management, many patients do not achieve long-lasting benefits due to difficulty
with adherence as well as physiological and neurohormonal adaptation of the body in response to
weight loss. There are multiple pharmacologic therapies available for weight management. Wegovy is a
member of a class of medications known as glucagon-like peptide 1 (GLP-1) analogs. As noted in the
medical literature, GLP-1 analogs have been shown to improve glycemic control, reduce body weight,
and decrease cardiovascular risk (Knudsen and Lau). Studies have demonstrated Wegovys ability to
promote weight loss via reduced appetite and energy intake and delayed gastric emptying (Cornell). In
this case, the patient has a history of class 1 obesity complicated by dyslipidemia. The records reflect
that the patient has attempted treatment with diet management and exercise without significant
benefit. Per the provider, the patient has contraindications or intolerances to several weight loss
medications. Wegovy has been shown to effectively promote weight loss for patients in conjunction
with diet and exercise. Furthermore, the patient has demonstrated prior weight loss success with
Wegovy. All told, the requested Wegovy solution auto-injector 0.25 mg/0.5 mL is medically necessary
for the treatment of this patient. | 1 |
A 72-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene
expression profile assay performed on 8/30/19. The Health Insurer has denied this request and
reported that the services at issue were investigational for the evaluation of the enrollees
medical condition. | Upheld | Experimental | Summary Reviewer 1
A 72-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene
expression profile assay performed on 8/30/19. The Health Insurer has denied this request and
reported that the services at issue were investigational for the evaluation of the enrollees
medical condition. The physician reviewer found that the use of gene expression profiling (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 stage
I melanoma and a higher proportion of false-positive result, GEP testing should not guide
clinical decision making in this group. Commercially available GEPs, such as DecisionDx
melanoma are marketed as being able to classify cutaneous melanoma into separate categories
based on risk of metastasis. However, 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. Various (mostly retrospective) studies of
prognostic GEP testing suggest its role as an independent predictor of worse outcome, although
not superior to Breslow thickness or sentinel lymph node status. It remains unclear whether
this GEP profile is reliably predictive of outcome across the risk spectrum of melanoma.
Prospective validation studies are required to more accurately define the clinical utility of
molecular testing prior to widespread implementation of GEP for prognostication of cutaneous
melanoma, and in particular to determine its role in guiding surveillance imaging, sentinel
lymph node biopsy, and adjuvant treatment decisions. Therefore, DecisionDx-Melanoma gene
expression profile assay performed on 8/30/19 was not likely to have been more beneficial
than any available standard therapy.
| 1 |
A 74-year-old male enrollee has requested reimbursement for laboratory testing provided on
10/12/20. The Health Insurer has denied this request and reported that the services at issue
were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 74-year-old male enrollee has requested reimbursement for laboratory testing provided on
10/12/20. The Health Insurer has denied this request and reported that the services at issue
were investigational for the evaluation of the enrollees medical condition. The physician
reviewer found that this patient has a rare disease, ocular melanoma. Ocular melanomas that
have metastasized are markedly resistant to standard chemotherapy regimens. However,
knowledge of the risk for metastasis directly affects surveillance of patients by computed
tomography (CT) scan. The DecisionDX-UM test analyzes gene expression and has been shown
to be highly informative for prognosticating metastatic risk. This gene expression classifier is
discussed in the Physicians Data Query of the National Cancer Institute and the National
Comprehensive Cancer Network guidelines on uveal melanoma. There is no other standard
prognostic indicator that could serve as an alternative. Therefore, laboratory testing provided
on 10/12/20 was likely to have been more beneficial than any available standard therapy.
| 0 |
A 39-year-old male enrollee has requested authorization and coverage for Stelara (ustekinumab). The Health Insurer has denied this request indicating that the requested medication is investigational for treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 39-year-old male enrollee has requested authorization and coverage for Stelara (ustekinumab). The Health Insurer has denied this request indicating that the requested medication is investigational for treatment of the enrollees medical condition. The physician reviewer found that Stelara (ustekinumab) is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. A large randomized controlled trial demonstrated safety and efficacy for induction and maintenance of remission in patients with moderate-severe Crohns disease that was resistant to anti-tumor necrosis factor (TNF) therapy (such as Remicade and Humira), which applies to this case (Sandborn, et al). Another study showed a 73% response in patients with anti-TNF-resistant Crohns disease, and 80% of responders maintained remission for one year (Kopylov, et al). A significant majority of these patients were able to discontinue steroids. The mechanism of Stelara (ustekinumab) is entirely different than that of anti-TNF medications, which the patient has failed (Tuskey and Behm). A recent study demonstrated that a significant majority of patients who have failed an anti-TNF medication are able to achieve and maintain response with Stelara (Wils, et al). In sum, the clinical literature supports the use of Stelara in this case given the patients treatment failure of anti-TNF therapy. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/21/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/21/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. Breast tomosynthesis allows radiologists to separate dense glandular elements from underlying mass/architectural distortion. This has resulted in a decrease in callbacks and increase in detection of small cancers. In this patients case, the detection of the abnormality in the right breast resulted in an ultimate diagnosis of breast cancer. Therefore, the addition of breast tomosynthesis to two-dimensional imaging likely was of more benefit to the patient than had she undergone two-dimensional digital mammogram alone. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 64-year-old male enrollee has requested reimbursement for PET scan performed on 8/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
The records document that the patient was diagnosed with a hepatic flexure malignancy. On 7/27/18, computed tomography (CT) scan of the abdomen and pelvis was performed.
In this patients case, he already had a staging laparotomy and CT scan, with no evidence of spread of disease. | Overturned | Experimental | Summary Reviewer 2
A 64-year-old male enrollee has requested reimbursement for PET scan performed on 8/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found taht the submitted documentation fails to demonstrate the superior efficacy of the services at issue. The records document that the patient was diagnosed with a hepatic flexure malignancy. On 7/27/18, computed tomography (CT) scan of the abdomen and pelvis was performed. While the use of positron emission tomography/computed tomography (PET/CT) scanning is becoming increasingly common in the work-up of malignancies, the current data does not support its routine use in staging colon cancer. In this patients case, he already had a staging laparotomy and CT scan, with no evidence of spread of disease. PET scanning was not indicated in this clinical setting. In sum, PET scan performed on 8/31/18 was not likely to have been superior over other methods of evaluating this patient.
| 1 |
The patient is a 60-year-old female who has been diagnosed with major depressive disorder, recurrent, moderate.The patient has requested authorization and coverage for brand name Wellbutrin 150 mg, brand name Wellbutrin 300 mg and brand name Prozac 20 mg. The Health Insurer has denied this request and reported that the requested medications are not medically necessary for the treatment of this patient.T
. She has tried generics in the past and reports that she could not tolerate the | Overturned | Medical Necessity | Summary Reviewer
The patient is a 60-year-old female who has been diagnosed with major depressive disorder, recurrent, moderate.The patient has requested authorization and coverage for brand name Wellbutrin 150 mg, brand name Wellbutrin 300 mg and brand name Prozac 20 mg. The Health Insurer has denied this request and reported that the requested medications are not medically necessary for the treatment of this patient.The physician reviewer found that given this patients stability, it is within the standard of care to maintain her on brand name medications as she poses a risk of decompensation should she be switched to generics. She has tried generics in the past and reports that she could not tolerate the fillers in the medications and that the generics were not effective in treating her depression. Some studies have demonstrated that brand name medications exhibited more protective effects on psychiatric hospitalization for depressive patients, and that the efficacy of generics versus brand name is not equal. Several different companies may make the same generic drug, but they might use different filler ingredients, and this they may have slightly different rates of absorption or cause different side effects. With somewhat older antidepressants, such as fluoxetine (Prozac), several different manufacturers make the generic antidepressants, each using different non-active ingredients. Thus, each generic brand may have slightly different effects. The current medical evidence supports the requested medications in this clinical setting. Therefore, brand name Wellbutrin 150 mg, brand name Wellbutrin 300 mg and brand name Prozac 20 mg are medically necessary for the treatment of this patient. | 1 |
A 49-year-old male enrollee has requested authorization and coverage for intraosseous
basivertebral nerve ablation. The Health Insurer has denied this request and reported that the
requested service is investigational for the treatment of the enrollees chronic low back pain. | Overturned | Experimental | Summary Reviewer 3
A 49-year-old male enrollee has requested authorization and coverage for intraosseous
basivertebral nerve ablation. The Health Insurer has denied this request and reported that the
requested service is investigational for the treatment of the enrollees chronic low back pain. At
issue is whether intraosseous basivertebral nerve ablation is likely to be more beneficial for
treatment of the enrollee's condition than any available standard therapy. The physician reviewer
found that chronic low back pain is a debilitating condition. When Modic changes are present in
the disc spaces, a vertebrogenic cause of back pain is considered an etiology of chronic back pain.
The main source of innervation for the vertebral body are the basivertebral nerves. Ablation of the
basivertebral nerve is a safe and effective procedure that is evidence based for appropriately
selected candidates. Becker and colleagues note that the ablation of the basivertebral nerve for the
treatment of chronic lumbar back pain significantly improves patients self-reported outcome early
in the follow-up period, with improvement persisting throughout the one-year study period.
Fischgrund and colleagues report that basivertebral nerve represents a potential minimally invasive
treatment for the relief of chronic low back pain. In this this case, other interventional procedures
targeting different etiologies of back pain have not provided benefit. Therefore, basivertebral nerve
ablation is likely to be more beneficial for treating this patients vertebrogenic back pain than other
treatments already tried. Therefore, intraosseous basivertebral nerve ablation is likely to be more
beneficial for treatment of the patients condition than any available standard therapy.
| 1 |
A 48-year-old female enrollee has requested reimbursement for electroretinography performed on 8/17/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
In this case, the patient has a history of diabetes and retinopathy with abnormal fundus appearance consistent with non-proliferative diabetic retinopathy. | Upheld | Experimental | Summary Reviewer 1
A 48-year-old female enrollee has requested reimbursement for electroretinography performed on 8/17/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the use of multifocal electroretinography to diagnose this patients condition. In this case, the patient has a history of diabetes and retinopathy with abnormal fundus appearance consistent with non-proliferative diabetic retinopathy. Electroretinography measures electrical responses of the retina from light stimulus. Different types of retinal cell and their functional state can be measured. It is most useful for the diagnosis of hereditary retinal and choroidal diseases and dystrophies. Studies show that it is useful in diagnosing disease that does not have significant visible markers, as well as diseases that are uncommon and have similar clinical appearances, but varying courses. Electroretinography can assess the functional status of the retina in different stages of retinopathy. There is evidence to suggest that it can detect damage from retinopathy before there are visible changes on examination. However, the utility of this in terms of diagnosis and treatment of diabetic retinopathy has yet to be established. Electroretinography testing is not the standard of care in this situation. The standard of care for the diagnosis of diabetic retinopathy is dilated fungus examination using slit-lamp biomicroscopy and indirect ophthalmoscopy. Therefore, electroretinography performed on 8/17/18 was not likely to have been superior over other methods of evaluating this patient.
| 1 |
A 55-year-old male insured has requested authorization and coverage for thermal destruction of
the intraosseous basivertebral nerve, including the first two vertebral bodies, lumbar or sacral,
Intracept procedure (CPT 64628). The Health Insurer has denied this request indicating that the
requested services are considered investigational for the treatment of the insureds chronic back
pain. The physician reviewer found that this patient presents with a history of chronic back pain.
The patients provider has recommended basivertebral nerve ablation with the Intracept
procedure,
patient complains of low back pain that has persisted for longer than six months and has not responded to conservative measures. He also has Modic changes noted on
the MRI at L5-S | Upheld | Experimental | Summary Reviewer 3
A 55-year-old male insured has requested authorization and coverage for thermal destruction of
the intraosseous basivertebral nerve, including the first two vertebral bodies, lumbar or sacral,
Intracept procedure (CPT 64628). The Health Insurer has denied this request indicating that the
requested services are considered investigational for the treatment of the insureds chronic back
pain. The physician reviewer found that this patient presents with a history of chronic back pain.
The patients provider has recommended basivertebral nerve ablation with the Intracept
procedure, which is a promising minimally invasive treatment option for patients with isolated
vertebrogenic pain. As noted in the medical literature, good therapeutic results can be achieved
through proper patient selection. The current peer-reviewed medical literature includes clinical
studies reporting on patients with isolated lumbar back pain as the chief complaint for treatment.
However, the current randomized controlled studies included patients with isolated lumbar back
pain as the chief complaint, with exclusion criteria specified in the studies in order to avoid
overlapping pain sources. Among these exclusions is the presence of other concomitant
symptoms or painful radiographic findings related to spine pathology that would overlap the
vertebrogenic pain pattern and would obscure the clinical presentation. Thus, making it difficult
to isolate vertebrogenic pain as the main problem to be treated. Patients with those findings
were excluded from the studies as it would not be guaranteed that the Intracept procedure can
be beneficial. This patient complains of low back pain that has persisted for longer than six months and has not responded to conservative measures. He also has Modic changes noted on
the MRI at L5-S1 which may point towards some vertebrogenic type pain origin. However, he
does have overlapping clinical symptoms and other imaging findings that are more significant
and potentially more pronounced sources of pain. The providers notes dated 2/15/23 state that
the patient has back pain, bilateral thigh numbness, and heaviness, which is improved with
flexing forward and is indicative of lumbar claudication due to spinal canal stenosis. This also
correlates with the MRI findings which showed L4-5 and L5-S1 ligamentum flavum hypertrophy
and stenosis both central and foraminal stenosis. Also noted was grade 1 anterolisthesis at L5-S1
with loss of disc space, facet arthropathy, and hypertrophic overgrowth. These findings represent
overlapping pain sources that have been considered exclusion criteria from the published studies
on the efficacy of the Intracept procedure. Furthermore, the epidural steroid injection that the
patient received on 12/15/22 provided relief for three weeks, further confirming that spinal
stenosis and ligamentum hypertrophy are likely the main causes of the patients symptoms.
Given that the published studies do not apply to this patients clinical setting with documentation
of multiple exclusion criteria, the requested Intracept procedure is not likely to yield a superior
health outcome when compared to standard available treatment modalities. Therefore, the
requested thermal destruction of the intraosseous basivertebral nerve, including the first two
vertebral bodies, lumbar or sacral, Intracept procedure (CPT 64628) is not likely to be more
beneficial for the treatment of the patients medical condition than any available standard
therapy. | 1 |
A 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 3
A 66-year-old female enrollee has requested authorization and coverage for gene testing provided on 12/28/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the 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 they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the DecisionDX test for melanoma has not been made a part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is very novel and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. This was also the consensus opinion of the National Comprehensive Cancer Network (NCCN) guidelines. Accordingly, the gene test performed on 12/28/15 was not likely to have been more effective than the standard methods of evaluating this patient.
Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
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).
this patient has GERD as based on pH recording and her disease progression to Barretts esophagus. | Upheld | Experimental | Summary Reviewer 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). The physician reviewer found that the records indicate that this patient has GERD as based on pH recording and her disease progression to Barretts esophagus. However, LINX is not indicated for patients with Barretts esophagus. Further, implantation of LINX in this patients case must be approached with caution given her documented esophageal dysmotility. As such, the LINX reflux management system lower esophageal sphincter augmentation is not likely to be more beneficial for treatment of this patients medical condition than standard GERD management treatment options. Based upon the information set forth above, the requested service is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 44-year-old female enrollee has requested reimbursement for positron emission tomography (PET) scan performed on 3/04/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
A 44-year-old female enrollee has requested reimbursement for positron emission tomography (PET) scan performed on 3/04/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting. Assessment of the response to treatment of metastases is crucial in daily oncological practice and clinical trials. For soft tissue metastases, this is done using CT scanning, magnetic resonance imaging (MRI) or PET scanning using validated response evaluation criteria. While PET/CT scanning may not be indicated when the recent CT scans or MRI scans are positive, this is less convincing when the recent CT or MRI scans are negative. In this patients case, the negative CT scans of the chest, abdomen, and pelvis were a reasonable indicator that the patient does not have metastatic disease. However, breast carcinoma often spreads to the bones, and the bones had not been specifically evaluated. PET/CT scans offer the ability to image the entire body as opposed to routine CT scans which must be directed to specific body regions. This patient is at a high-risk for developing metastatic disease, and a baseline PET/CT scan may help to further direct or continue what will be a second-line chemotherapy. All told, the PET scan performed on 3/04/16 was medically indicated for the evaluation of this patient. Therefore, the services at issue were medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.
| 0 |
A 51-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
talus. This patient presents with a history of chronic severe right ankle pain and swelling.
There is imaging evidence of a very large cystic osteochondral lesion of the right talus. She has failed long-term conservative management as well as operative intervention. She | Overturned | Experimental | Summary Reviewer 2
A 51-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that current evidence-based medical literature supports the use of autologous chondrocyte implantation as a first-line treatment option for large articular cartilage defects. The literature supports treatment with bone marrow stimulation for lesions of smaller sizes, whereas treatment with autologous osteochondral transplantation may be utilized for larger or cystic lesions. The literature indicates that autologous chondrocyte implantation of the talus yields improvement in all parameters tested, with enduring long-term results in patients who have failed previous surgery for osteochondral lesions of the talus. This patient presents with a history of chronic severe right ankle pain and swelling. Significant functional limitations are noted that interfere with activities of daily living. There is imaging evidence of a very large cystic osteochondral lesion of the right talus. She has failed long-term conservative management as well as operative intervention. She is not a candidate for microfracture surgery due to the size of the lesion. Current evidence-based medical literature supports the use of autologous chondrocyte implantation in this clinical setting as a salvage procedure. In sum, autologous chondrocyte implantation is likely to be more beneficial than other treatment options.
| 1 |
A 63-year-old male enrollee has requested authorization and coverage for laparoscopy, surgical, esophagogastric fundoplasty (LINX). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 63-year-old male enrollee has requested authorization and coverage for laparoscopy, surgical, esophagogastric fundoplasty (LINX). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the request services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The LINX Reflux Management System is for lower esophageal sphincter 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. Results from early studies at four years are encouraging. However, the requested procedure remains controversial as all studies to date have not included an appropriate control group. Additionally the bulk of the efficacy data is only from 1-3 years of follow-up. Therefore, the patients request for laparoscopy, surgical, esophagogastric fundoplasty (LINX) is not supported as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 55-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 5/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 3
A 55-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 5/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that 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. Thus, DecisionDx-Melanoma testing provided on 5/29/19 was not likely to have been more beneficial than other methods of evaluating this patient. | 0 |
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. | Upheld | Experimental | Summary Reviewer 2
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 the current medical evidence has not demonstrated the superior efficacy of the services at issue. At this time, there is a lack of data comparing the long-term results in a controlled or randomized protocol between HIFU and other standard treatments of prostate cancer, particularly in low stage and low grade disease where active surveillance is being used more commonly in patients. There is a lack of support for the services at issue in this patients case. In sum, HIFU provided on 6/28/16 was not likely to have been more efficacious than other treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
patient is a 22-year-old female who was diagnosed with narcolepsy type 1. The patient has
requested authorization and coverage for Wakix tablets 17.8 mg.
.
This patient was diagnosed with narcolepsy following adequate tests. The patients response to
previous treatment | Overturned | Medical Necessity | Summary Reviewer
The patient is a 22-year-old female who was diagnosed with narcolepsy type 1. The patient has
requested authorization and coverage for Wakix tablets 17.8 mg. The physician reviewer found
that the submitted documentation supports the medical necessity of the requested medication.
This patient was diagnosed with narcolepsy following adequate tests. The patients response to
previous treatment is well documented. Wakix has been approved by the U.S. Food and Drug
Administration (FDA) for the treatment of narcolepsy. Given the failure of other medications, the
requested medication is medically indicated. Therefore, Wakix tablets 17.8 mg are medically
necessary for the treatment of this patient.
| 1 |
A 30-year-old male enrollee has requested reimbursement for residential treatment provided from 5/05/18 through 5/08/18. 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.
Per the records, his polysubstance use was dominating his daily routine and contributing to significant impairment across multiple domains of functionality. He reported a family history and an early age of first use, both of which are associated with more severe cases of addictive illness. His substance use was undermining his educational pursuits and interpersonal functioning. The patient was negotiating emotional dysregulation, anxiety and depressive symptoms related to his substance use. Finally, the patient had attempted community-based programming, but was unable to maintain sobriety in his environment. Based on the records, the patient had not consolidated the treatment gains necessary to succeed in a less restrictive setting, and promptly would have relapsed, were he discharged to outpatient on 5/05/18. During the disputed timeframe, the patient was restless, on edge, moody, angry with himself and not sleeping well. However, he was actively engaged in therapeutic programming and | Overturned | Medical Necessity | Summary Reviewer
A 30-year-old male enrollee has requested reimbursement for residential treatment provided from 5/05/18 through 5/08/18. 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 the submitted documentation supports the services at issue in this patients case. Per the records, his polysubstance use was dominating his daily routine and contributing to significant impairment across multiple domains of functionality. He reported a family history and an early age of first use, both of which are associated with more severe cases of addictive illness. His substance use was undermining his educational pursuits and interpersonal functioning. The patient was negotiating emotional dysregulation, anxiety and depressive symptoms related to his substance use. Finally, the patient had attempted community-based programming, but was unable to maintain sobriety in his environment. Based on the records, the patient had not consolidated the treatment gains necessary to succeed in a less restrictive setting, and promptly would have relapsed, were he discharged to outpatient on 5/05/18. During the disputed timeframe, the patient was restless, on edge, moody, angry with himself and not sleeping well. However, he was actively engaged in therapeutic programming and furthering his recovery in a safe environment. The services and setting were safe, appropriate and consistent with good practice, while nine days of residential treatment would be considered an inadequate duration of care for an illness burden of this severity. Additionally, the services provided at the time were reasonably expected to improve his condition and prevent a more serious episode of illness. In sum, residential treatment provided from 5/05/18 through 5/08/18 was medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/10/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 58-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 2/10/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that tomosynthesis is a technique that was developed as a problem solving adjunct to routine mammography. In this case, the patient has dense breasts. It is specifically those patients who have 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. Given the support in the medical literature, the breast tomosynthesis performed on 2/10/16 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 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 41-year-old male enrollee has requested reimbursement for Decision DX Melanoma Assay performed on 12/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 1
A 41-year-old male enrollee has requested reimbursement for Decision DX Melanoma Assay performed on 12/16/15. 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 the submitted documentation fails to demonstrate the superior efficacy of the services at issue. Decision DX Melanoma Assay has been developed for 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, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy. 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 (baseline) genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. All told, Decision DX Melanoma Assay performed on 12/16/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 26-year-old female enrollee has requested reimbursement for myPath Melanoma test performed
on 12/30/21. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds melanoma.
. The lesion in question was biopsied on 11/29/21 and the pathology report of 12/14/21
described the clinicopathologic features of the lesion as a severely atypical compound melanocytic
neoplasm, favoring melanoma of 0.4 mm thickness. The provider | Upheld | Experimental | Summary Reviewer 1
A 26-year-old female enrollee has requested reimbursement for myPath Melanoma test performed
on 12/30/21. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insureds melanoma.
The physician reviewer found that for a melanocytic lesion of uncertain malignant potential,
current standard of care generally involves wide excision of the lesional site with appropriate
margins. The lesion in question was biopsied on 11/29/21 and the pathology report of 12/14/21
described the clinicopathologic features of the lesion as a severely atypical compound melanocytic
neoplasm, favoring melanoma of 0.4 mm thickness. The provider recommended further evaluation
with the myPath Melanoma gene expression test. Although the studies are less clear for patients
with severely atypical nevi, there are data to support re-excision with appropriate margins followed
by routine dermatologic surveillance (Soleymani, et al.). The most recent National Comprehensive
Cancer Network (NCCN) guidelines state that it is unclear whether gene expression profiling
platforms provide clinically actionable prognostic information when compared with known
clinicopathologic factors. In addition, the impact of these tests on treatment recommendations has
not been established. It also remains unclear whether gene expression profiling tests can reliably
predict outcome across the risk spectrum of cutaneous melanoma. The current consensus statement
by the Melanoma Prevention Working Group (MPWG) indicates that more evidence is needed to
support the use of gene expression profiling testing to inform recommendations about sentinel
lymph node biopsy, follow-up, or other adjuvant treatment (Grossman, et al.). Thus, the myPath
Melanoma test was unlikely to have added any significant benefit above the recommended
standard of care treatment with re-excision with appropriate margins. All told, the myPath
Melanoma test performed on 12/30/21 was not likely to be more beneficial for evaluation of the
patients medical condition than any available standard therapy.
| 1 |
A 31-year-old female enrollee has requested authorization and coverage for rituximab injection therapy. The Health Insurer has denied this request indicating that the requested therapy is considered investigational for treatment of the enrollees multiple sclerosis, relapsing-remitting.
the patient has failed multiple first line therapies for treatment of her medical condition. In addition, she has responded well to a prior treatment of rituximab and had no significant side effects with this medication. | Overturned | Experimental | Summary Reviewer 3
A 31-year-old female enrollee has requested authorization and coverage for rituximab injection therapy. The Health Insurer has denied this request indicating that the requested therapy is considered investigational for treatment of the enrollees multiple sclerosis, relapsing-remitting. The physician reviewer found that although rituximab should not be considered a first line therapy for patients with relapsing remitting MS, there is sufficient medical literature supporting its use, benefit, and safety in patients with refractory MS. In this particular case, the patient has failed multiple first line therapies for treatment of her medical condition. In addition, she has responded well to a prior treatment of rituximab and had no significant side effects with this medication. Undertreated MS can cause significant morbidity and potentially early mortality. As such, the use of rituximab in this particular case is medically reasonable. Based upon the information set forth above, the requested therapy is likely to be superior than any available standard therapy for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 57-year-old female enrollee has requested reimbursement for DecisionDX-melanoma gene expression test performed on 8/12/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees left cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 1
A 57-year-old female enrollee has requested reimbursement for DecisionDX-melanoma gene expression test performed on 8/12/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees left cutaneous melanoma. The physician reviewer found that the staging and prognosis of cutaneous malignant melanoma is classically determined by the system discussed by Balch and colleagues. There may be some further value in adding the mitotic rate to this system. By Balch staging, the melanoma would be classified as T2b and with the negative sentinel nodes, her stage would by IIA. This predicts for a 10 year survival of at least 64%. DecisionDX is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either Class 1 (with a greater than 90% disease free survival at five years), or Class 2 (with a less than 80% disease free survival at five years). Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDX classification, in patients undergoing sentinel node sampling. However, it is not clear how the five year DecisionDX data compares to the 10 year Balch data, and whether it can be used additionally to make clinical decisions. Berger and colleagues reported on 156 cases but there was not sufficient follow-up to determine the actual value of the test. The National Comprehensive Cancer Network (NCCN) guidelines state that there is interest in these types of assay but they can only be used in the context of a clinical trial. In sum, DecisionDX-melanoma gene expression test performed on 8/12/16 was not likely to have been more effective than the other options available in the evaluation of this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
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