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The parent of an eight-year-old male enrollee has requested reimbursement for FirstStep Dx Plus testing performed on 5/28/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the treatment of the enrollees autism spectrum disorder (ASD). | Overturned | Experimental | Summary Reviewer 2
The parent of an eight-year-old male enrollee has requested reimbursement for FirstStep Dx Plus testing performed on 5/28/14. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for the treatment of the enrollees autism spectrum disorder (ASD). The physician reviewer found the FirstStep Dx Plus testing performed on 5/28/14 was likely to be more effective for this patient with autism than other available treatment options. CMA testing is the first-line genetic testing when there are findings suggesting an underlying genetic etiology. The medical literature demonstrates that this test has become an important and mainstream tool in the practice of clinical genetics. The study by Henderson and colleagues retrospectively reviewed the medical records of patients who had abnormal chromosomal microarray findings reported per laboratory over a three-year period and quantified the management recommendations made in response to these results. The authors concluded that These results empirically demonstrate the clinical utility of chromosomal microarray by providing evidence that management was directly affected for the majority of patients in our cohort with abnormal chromosomal microarray findings. Based on the support in the medical literature, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 54-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. | Overturned | Medical Necessity | Summary Reviewer
A 54-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication in this clinical setting. According to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with life expectancy less than 12 months due to non-liver-related comorbid conditions. It is advantageous to treat patients before they progress to F3 or F4 fibrosis. Based on published evidence of safety and efficacy in the medical literature, Harvoni is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 68-year-old female insured has requested reimbursement for a Guardant360 CDx test provided
on 1/19/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insured's metastatic non-small cell lung cancer.
this patient was recently diagnosed with advanced non-small
cell lung cancer. | Overturned | Experimental | Summary Reviewer 1
A 68-year-old female insured has requested reimbursement for a Guardant360 CDx test provided
on 1/19/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insured's metastatic non-small cell lung cancer.
The physician reviewer found that this patient was recently diagnosed with advanced non-small
cell lung cancer. The mutational landscape of non-small cell lung cancer has significantly
expanded in the past few years to encompass gain of function in multiple oncogenes with major
prognostic and therapeutic implications (Rolfo, et al.). This patients genetic testing was for
mutually exclusive somatic driver mutations, which is consistent with the standard of care.
Typically, KRAS, TP53, and BRAF are included in these panels and have been shown to be
informative in treatment planning. Primary tumor tissue by next-generation sequencing is the
preferred method for identifying actionable driver mutations. The patients requisition form stated
that primary tumor sampling was not feasible. For these reasons, the Guardant360 CDx test
provided on 1/19/22 was likely to be more beneficial for the evaluation of the patients condition
than any available standard therapy.
| 1 |
A 52-year-old female enrollee has requested reimbursement for colorectal cancer screening; stool-based DNA and fecal occult hemoglobin performed on 9/16/15. 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 2
A 52-year-old female enrollee has requested reimbursement for colorectal cancer screening; stool-based DNA and fecal occult hemoglobin performed on 9/16/15. 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 that the Conventional assessment of colorectal cancer (CRC) risk largely involves detection of non-dysplastic adenomatous polyps. The efficacy of computed tomography (CT) colonography, of the Cologuard assay, and of detection of occult blood in stool is traditionally compared against the gold standard optical colonoscopy. Cologuard is a stool DNA test that includes molecular assays for DNA mutation and methylation biomarkers (KRAS mutations, NDRG4, and BMP3 methylation) and a non-DNA immunochemical assay for human hemoglobin. However, Cologuard and ColonSentry demonstrate inadequate sensitivity to detect precancerous lesions which is the point of colon cancer screening. Despite that the patients migraines with conventional testing, the stool-based DNA and fecal occult hemoglobin performed 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 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 58-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Plan has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees severe and persistent asthma.
In this patients case, he is on a very aggressive regimen of bronchodilators along with antihistamines and Xolair. | Overturned | Medical Necessity | Summary Reviewer
A 58-year-old male enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Plan has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees severe and persistent asthma. The physician reviewer found the current medical evidence supports the requested services in this clinical setting. Initial trials of bronchial thermoplasty have demonstrated improved symptom control after the procedure was completed. Cox and colleagues examined 112 subjects with moderate to severe asthma, and the authors noted that bronchial thermoplasty resulted in improved asthma control. Pavord and colleagues examined the safety of thermoplasty and found short-term worsening in symptoms, but evidence of improved long-term control of asthma. Castro and colleagues compared thermoplasty with a sham procedure and followed the patients for 12 months as well. The authors found that the thermoplasty group had fewer exacerbations and improved quality of life when compared to the sham group. In this patients case, he is on a very aggressive regimen of bronchodilators along with antihistamines and Xolair. There is little left in the standard armamentarium to control his refractory symptoms. All told, the requested bronchial thermoplasty is medically indicated for the treatment of this patient. Therefore, the requested services are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 49-year-old female enrollee has requested authorization and coverage for insulin infusion pump. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes, type I.
The patient has diabetes, type I and has managed her diabetes well in the past with insulin pump therapy. However, the tubeless OmniPod pump has malfunctioned and she has developed allergic reactions to its adhesive, preventing the pump from staying in place. Therefore, the patient is being administered suboptimal doses of insulin. Her hemoglobin A1c has gone up from 7
. The patients provider has requested a replacement, because the OmniPod is no longer working for this patient.
The records document that this patient has not responded well to her current OmniPod system and she has had adverse effects.
The patient has attempted to work with this pump, unsuccessfully. | Overturned | Medical Necessity | Summary Reviewer
A 49-year-old female enrollee has requested authorization and coverage for insulin infusion pump. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees diabetes, type I. The physician reviewer found that there is sufficient support in the medical literature for the requested device in this clinical setting. The patient has diabetes, type I and has managed her diabetes well in the past with insulin pump therapy. However, the tubeless OmniPod pump has malfunctioned and she has developed allergic reactions to its adhesive, preventing the pump from staying in place. Therefore, the patient is being administered suboptimal doses of insulin. Her hemoglobin A1c has gone up from 7 to 8.1 percent, which goes against the goals of diabetes management (2017- Standards of Medical Care in Diabetes). The patients provider has requested a replacement, because the OmniPod is no longer working for this patient. The need to work with the patient is written in the guidelines by the American Diabetes Association and the American Association of Clinical Endocrinologists. The records document that this patient has not responded well to her current OmniPod system and she has had adverse effects. While skin hypersensitivity to adhesives or cannulas at the insertion site is not common, it is an issue that occurs in some patients and addressed in the literature. In this patients case, staying on the OmniPod system is no longer effective and safe. The patient has attempted to work with this pump, unsuccessfully. All told, the requested insulin infusion pump is medically necessary for the management of this patients diabetes.Therefore, for all the reasons stated above, the requested device is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 49-year-old male enrollee has requested reimbursement for residential substance use disorders treatment provided from 3/27/17 through 4/22/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
The patient had been engaged in hospital based care or supervised detoxification services since 3/05/17. He was frightened by his most recent alcohol withdrawal syndrome and motivated for recovery. He had no alcohol cravings. He had a supportive girlfriend who insisted on sobriety which contributed to an environment conducive to recovery. He had not been active in chemical dependency treatment during the episode of illness. His mental status examination had no concerning entries. He had a chronic limp but no medical or psychiatric conditions that would | Upheld | Medical Necessity | Summary Reviewer
A 49-year-old male enrollee has requested reimbursement for residential substance use disorders treatment provided from 3/27/17 through 4/22/17. 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 fails to demonstrate the medical necessity of the services at issue. Modern psychiatric practice favors treatment in the community as outcome measures and therapeutic gains are optimized in this environment. The records do not demonstrate that comprehensive, evidence-based services provided a less restrictive treatment setting would have been insufficient or inadequate. The patient had been engaged in hospital based care or supervised detoxification services since 3/05/17. He was frightened by his most recent alcohol withdrawal syndrome and motivated for recovery. He had no alcohol cravings. He had a supportive girlfriend who insisted on sobriety which contributed to an environment conducive to recovery. He had not been active in chemical dependency treatment during the episode of illness. His mental status examination had no concerning entries. He had a chronic limp but no medical or psychiatric conditions that would warrant a residential placement. All told, residential substance use disorders treatment provided from 3/27/17 through 4/22/17 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 46-year-old female insured has requested authorization and coverage for lymphedema surgery
and two inpatient bed days. The Health Insurer has denied this request indicating that the requested
services are considered investigational for treatment of the insureds lymphedema. | Overturned | Experimental | Summary Reviewer 3
A 46-year-old female insured has requested authorization and coverage for lymphedema surgery
and two inpatient bed days. The Health Insurer has denied this request indicating that the requested
services are considered investigational for treatment of the insureds lymphedema.
The physician reviewer found that an exhaustive review of the current medical literature pertaining
for microsurgical treatment of lymphedema reveals that this procedure has been performed for
many years with a high degree of success. Basta and colleagues published a meta-analysis of 27
studies with 91% of patients showing improvement of their symptoms in their lymphovenous
microsurgery and tissue transplantation. The patient has tried multiple nonsurgical interventions
without substantial improvement. Given the rigorous scientific review lymphedema surgeries with
demonstrated success, the requested lymphedema surgery is likely to provide the patient with an
improved health outcome when compared to standard therapies. For these reasons, the requested
lymphedema surgery and two inpatient bed days is likely to be more beneficial for treatment of
the patients medical condition than any available standard therapy.
| 1 |
A 29-year-old female enrollee has requested reimbursement for allergen specific immunoglobulin G (IgG) (RAST/ELISA) for routine allergy testing performed on 3/22/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 29-year-old female enrollee has requested reimbursement for allergen specific immunoglobulin G (IgG) (RAST/ELISA) for routine allergy testing performed on 3/22/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. Food-specific immunoglobulin G (IgG) level does not predict true food hypersensitivity and may actually be a marker of earlier development of food tolerance. Food-specific IgG tests typically yield multiple positive results and may represent a normal immune response to foods. Thus, food-specific IgG should not be used as a tool to diagnose food allergy, and the positive food should not be eliminated from the diet based upon results of these tests. The standard evaluation of food allergy consists of blood immunoglobulin E (IgE) level for foods and skin testing. IgE immunoassays are in vitro assays used to identify food-specific IgE in the serum. Immunoassays have demonstrated very high positive predictive accuracy in children for several of the major food allergens. Values have been established for egg, milk, peanut, tree nuts, and fish that correspond to a positive predictive accuracy of 95 percent. Skin testing for food-specific IgE is used in the diagnosis of IgE-mediated food allergies. A positive skin test to a particular food indicates the possibility that the patient has true allergy to that food. A negative skin test result indicates the absence of an IgE-mediated allergy upon subsequent challenge with a 90 to 95 percent predictive accuracy. Therefore, allergen specific immunoglobulin G (IgG) (RAST/ELISA) for routine allergy testing performed on 3/22/19 was not likely to have been more beneficial than other methods of evaluating this patient.
| 1 |
A 48-year-old male enrollee has requested authorization and coverage for intravenous immune globulin (IVIG). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees specific antibody dysfunction.
, the patient is not on an antihistamine for his elevated IgE and there is no
allergic component to his symptoms. The patient has not been vaccinated with the conjugate pneumococc | Upheld | Medical Necessity | Summary Reviewer
A 48-year-old male enrollee has requested authorization and coverage for intravenous immune globulin (IVIG). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees specific antibody dysfunction. The physician reviewer found the treatment of specific antibody deficiency with replacement immunoglobulin remains controversial. Most experts recommend treatment which includes immunization with conjugated pneumococcal vaccine (Prevnar 7 or 13), aggressive treatment of other conditions predisposing to recurrent sinopulmonary infections, increased vigilance and appropriate antibiotic therapy for infections, prophylactic antibiotics and IVIG. Replacement IGIV is an option for patients with proven recurrent infections that persist after immunizing with conjugate vaccines and appropriate antibiotic treatment (Cohn, et al.). However, studies have demonstrated that prophylactic antibiotic therapy may be as effective as replacement immunoglobulin (Gelfand, et al). In this case, the patient is not on an antihistamine for his elevated IgE and there is no evaluation of his most likely allergic component to his symptoms. The patient has not been vaccinated with the conjugate pneumococcal vaccines. There is also no documentation of a trial of prophylactic antibiotics. Moreover, IVIG is a pooled blood product and there are significant risks involved in the administration of IVIG including thrombosis, renal dysfunction, acute failure and infection. The documentation does not support that IVIG is safe and effective for the patient. In addition, there is no documentation other therapies used and failed such as aggressive allergic rhinitis treatment, vaccinated with conjugate pneumococcal vaccine or trial of prophylactic antibiotics in the patient. Therefore, the request for IVIG is not medically necessary in this clinical setting. For the reasons provided, 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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A 39-year-old male enrollee has requested reimbursement for Anser IFX testing provided on 4/23/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.T | Upheld | Experimental | Summary Reviewer 2
A 39-year-old male enrollee has requested reimbursement for Anser IFX testing provided on 4/23/14. 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 there is a lack of support for the services at issue in this clinical setting. Some evidence exists that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well-controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. The clinical utility of measuring drug antibody concentrations has not been established, and it has not been established how patient management would change based on test results. In addition, there are technical factors relating to the use of different assay methods across studies. It has not yet been established whether the use of threshold levels aid in the discrimination of treatment response, nor has the optimal timing of when to measure antibody levels been established. Therefore, Anser IFX testing performed on 4/23/14 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 35-year-old female has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 9/15/16 through 4/17/17. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees major depressive disorder. | Upheld | Experimental | Summary Reviewer 1
A 35-year-old female has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 9/15/16 through 4/17/17. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees major depressive disorder. The physician reviewer found that on the information provided, it appears that the TMS is being used for maintenance or continuation purposes, which is consistent with an investigational application. A typical course of TMS consists of 30 to 40 sessions spanning four to six weeks. For patients who respond well to TMS, clinical improvement is usually maintained with psychotherapy and psychotropic medication. Although small studies are demonstrating good tolerability and clinical efficacy of TMS therapy for treatment courses lasting years at a time, according to the summary of TMS treatment recommendations authored by Perera and colleagues, The standard parameter setprovided clinical benefit in treatment courses up to six weeks in duration. Controlled studies of longer duration, acute treatment courses or using alternative treatment parameters are not established. In other words, at this time there is a lack of well-designed and adequately-powered controlled studies showing the benefit of longer courses of TMS therapy. Therefore, the superior efficacy of maintenance TMS therapy as compared to other available standard therapy, such as ongoing pharmacotherapy, psychotherapy and electroconvulsive therapy, has not been established. Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 52-year-old male requested authorization and coverage for hypoglossal stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. | Upheld | Experimental | Summary Reviewer 2
A 52-year-old male requested authorization and coverage for hypoglossal stimulator. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that obstructive sleep apnea (OSA) is an increasingly prevalent clinical problem with significant effects on both personal and public health. CPAP has demonstrated excellent efficacy and low morbidity with long term adherence rates approach 50%. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. After decades of trials demonstrating proof of concept of hypoglossal nerve stimulation in animal and human subjects, the three and four year results of a large multicenter, prospective trial were published in January 2016 and February 2017. The STAR trial demonstrated that hypoglossal nerve stimulation led to significant improvements in objective and subjective measurements of the severity of OSA. This trial has demonstrated the hypoglossal nerve stimulator to be safe and effective in a small subset of patients with OSA who have failed CPAP. This patient meets the criteria. He has failed CPAP, which is the gold standard treatment for OSA. All told, implantation with a hypoglossal stimulator is likely to be more beneficial than the standard options available for treatment of this patients medical condition.Therefore, for the reasons stated above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
patient is a 55-year-old male with a long history of chronic headaches. He has seen neurologists in the past and more recently has been given the diagnosis of chronic migraine and occipital neuralgia. In a letter dated 8/23/17, the patient outlined his previous treatment with various preventive medications and stated that he is currently taking 8 to 10 Excedrin tablets per day. He reportedly responded to occipital nerve blocks in the past. The patient requested authorization and coverage for CPT codes 64722, 64772 and 64910. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. | Upheld | Medical Necessity | Summary
The patient is a 55-year-old male with a long history of chronic headaches. He has seen neurologists in the past and more recently has been given the diagnosis of chronic migraine and occipital neuralgia. In a letter dated 8/23/17, the patient outlined his previous treatment with various preventive medications and stated that he is currently taking 8 to 10 Excedrin tablets per day. He reportedly responded to occipital nerve blocks in the past. The patient requested authorization and coverage for CPT codes 64722, 64772 and 64910. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The submitted documentation fails to demonstrate the medical necessity of the requested services. There are several publications regarding the use of decompression or neurolysis of the occipital nerves for the treatment of intractable headache. Many of these studies have demonstrated high success rates relative to headache reduction. However, there is a lack of studies performed using randomized studies and/or sham procedures to demonstrate efficacy greater than placebo. Accordingly, the requested services are not considered to be a standard of care and are an unproven treatment at this point. All told, CPT codes 64722, 64772 and 64910 are not medically necessary in this patients case. 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 64-year-old male with a medical history including migraine headaches, hypertension, coronary artery disease and benign prostatic hypertrophy, who presented to the emergency department with complaints of a severe headache with chills. He had recently been admitted to the hospital from 10/08/19 through 10/10/19 with a diagnosis of a viral infection with severe headaches.
at the time of admission, the patient was hemodynamically stable and afebrile with normal oxygen saturations on room air. The physical examination did not show any neurological deficits or altered mental status. His blood pressure had normalized with treatment in the emergency department. The laboratory studies did not show any active infection, | Upheld | Medical Necessity | Summary Reviewer
The patient is a 64-year-old male with a medical history including migraine headaches, hypertension, coronary artery disease and benign prostatic hypertrophy, who presented to the emergency department with complaints of a severe headache with chills. He had recently been admitted to the hospital from 10/08/19 through 10/10/19 with a diagnosis of a viral infection with severe headaches. The physician reviewer found that at the time of admission, the patient was hemodynamically stable and afebrile with normal oxygen saturations on room air. The physical examination did not show any neurological deficits or altered mental status. His blood pressure had normalized with treatment in the emergency department. The laboratory studies did not show any active infection, significant electrolyte disturbance or end organ damage. Imaging was negative for acute disease or injury. There was no need for urgent procedures or surgical intervention. The inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patientas 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. Therefore, acute inpatient services at the step-down level of care from 10/11/19 through 10/13/19 was not medically necessary for the treatment of this patient. | 1 |
A 53-year-old male enrollee has requested authorization and coverage for placement of a hypoglossal nerve stimulation device. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 53-year-old male enrollee has requested authorization and coverage for placement of a hypoglossal nerve stimulation device. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested device. A review of the literature indicates that hypoglossal nerve stimulation for treatment of obstructive sleep apnea can show positive and beneficial outcomes with minimal adverse effect in select patients. However, further independent outcomes data, especially regarding long-term effects, are needed. The medical necessity of hypoglossal nerve stimulation has not been demonstrated, as there is a lack of data to date to support its efficacy in the longer term. All told, the requested placement of a hypoglossal nerve stimulation device is not medically indicated for the treatment of this patient. Therefore, the requested device is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 56-year-old female enrollee has requested reimbursement for the Foundation One genetic testing provided on 1/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees recurrent ovarian cancer. | Upheld | Experimental | Summary Reviewer 1
A 56-year-old female enrollee has requested reimbursement for the Foundation One genetic testing provided on 1/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees recurrent ovarian cancer. The physician reviewer found that the Foundation One assay tests for the presence of a wide array of molecular markers that have been demonstrated to be of relevance in the pathogenesis of various cancers. Screening for the presence of these markers in a tumor may provide information relevant to the selection of potentially active therapeutic agents. Several commercially available assays are currently available which provide similar information. This methodology is promising, but with few exceptions, the level of evidence supporting clinical decision-making using genomic profiling is at present not of sufficient quality and maturity to inform current standards of care (Doroshow). According to the National Comprehensive Cancer Network (NCCN) guidelines, genomic profiling is not mentioned, and is not considered a standard of care. A recent review from Kohn similarly asserted that, tumor profiling done for therapeutic guidance is currently premature, save BRCA1 and BRCA2 mutation testing, and when done, should rely on validated ovarian cancer-specific treatment data. All told, the Foundation One genetic testing performed on 1/12/15 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.
| 1 |
The parent of a 15-year-old male enrollee has requested reimbursement for quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative,
, performed on 12/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 1
The parent of a 15-year-old male enrollee has requested reimbursement for quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified, performed on 12/10/19. 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 therapeutic drug level monitoring has become an essential procedure in the management of inflammatory bowel disease. Measuring the drug level and the presence of antibodies can help the treating provider differentiate between primary treatment failures versus insufficient dosing. It can also allow dosing titration and adjustments. The clinical practice guidelines adopted by the American College of Gastroenterology (ACG) support the use of therapeutic drug monitoring in the management of patients with inflammatory bowel disease. There is sufficient scientific evidence supporting the benefit of biologics drug level measurement. Per Singh and Dubinsky, aTherapeutic drug monitoring allows for optimized, individualized dosing and improved care for inflammatory bowel disease patients of all ages.a Raimundo Fernandes and colleagues published a prospective study showing that proactive therapeutic drug level monitoring is associated with fewer surgeries and higher rates of mucosal healing than conventional non-therapeutic drug level monitoring-based management. Therefore, quantification of therapeutic drug, not elsewhere specified and immunoassay for analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise specified, performed on 12/10/19 was likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 49-year-old male enrollee has requested reimbursement for CPT 83516 (Immunoassay, nonantibody) performed on 7/20/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.
this patient has type 2 diabetes. The assay ordered was an immunoassay for analyte other than infectious | Upheld | Experimental | Summary Reviewer 3
A 49-year-old male enrollee has requested reimbursement for CPT 83516 (Immunoassay, nonantibody) performed on 7/20/19. 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 this patient has type 2 diabetes. The assay ordered was an immunoassay for analyte other than infectious agent antibody or infectious agent antigen. The diagnosis code used for testing was for type 2 diabetes. In this case, there is no documentation that would support the need for the services at issue. There is no documented relationship between type 2 diabetes and the testing at issue. Furthermore, monitoring of control of type 2 diabetes is with hemoglobin A1C. There is no documentation that the patient had symptoms that would be concerning for poorly controlled diabetes mellitus or any complications with the diabetes. Thus, CPT 83516 performed on 7/20/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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The patient is a 44-year-old female with a history multiple malignancies, including breast cancer. Per the records, she had an abnormal uterine ultrasound. She has a significant family history, including a sister with non-Hodgkins lymphoma, a sister with thyroid cancer, two cousins with thyroid cancer, and a mother with thyroid cancer. The history was suggestive of a familial predisposition of cancer which prompted testing using the MyRisk panel. The patient has requested reimbursement for gene testing performed on 11/28/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. This patients family history is suggestive of a breast/ovarian cancer syndrome. | Overturned | Experimental | Summary Reviewer 3
The patient is a 44-year-old female with a history multiple malignancies, including breast cancer. Per the records, she had an abnormal uterine ultrasound. She has a significant family history, including a sister with non-Hodgkins lymphoma, a sister with thyroid cancer, two cousins with thyroid cancer, and a mother with thyroid cancer. The history was suggestive of a familial predisposition of cancer which prompted testing using the MyRisk panel. The patient has requested reimbursement for gene testing performed on 11/28/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. This patients family history is suggestive of a breast/ovarian cancer syndrome. BRCA1 mutation can increase risk for breast, ovarian, cervical, uterine, pancreatic, gastric, and prostate cancers. BRCA2 mutations can increase risk for breast, ovarian, gallbladder, bile duct, prostate, pancreatic, and gastric cancers. In the event the BRCA tests were negative, there is still a possibility of hereditary predisposition from another gene defect. There are guidelines in place that evaluate the occurrence of Lynch syndrome or hereditary nonpolyposis colorectal cancer (HNPCC) tumors in families. The most common extracolonic cancer in Lynch syndrome is endometrial cancer followed, in no particular order, by ovarian, gastric, renal, small intestine, pancreas, hepatobiliary, and ureteral. In this patients case, the MyRisk panel was appropriate since the current clinical situation may be caused by several potential cancer-causing genes. Thus, genetic testing performed on 11/28/16 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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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. | Upheld | Experimental | Summary Reviewer 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 reviewer found that the records noted complaints of gastric pain and chronic diarrhea in the setting of acute on chronic pancreatitis of uncertain etiology. There is a lack of medical literature supporting the use of FibroTest in this setting. When liver biopsy is undesired, FibroScan demonstrates greater accuracy, sensitivity, and specificity for predicting and discriminating minimal or no fibrosis from extensive fibrosis, as well as in correlating treatment response in patients with chronic hepatitis C infection. By comparison, serum testing combines a2-macroglobulin, haptoglobin, ?-glutamyl transpeptidase, apolipoprotein A1, alanine transaminase, and total bilirubin into a proprietary algorithm for fibrosis and inflammatory activity. The large prospective cohort study of patients with chronic hepatitis C by Patel and colleagues showed validation of the diagnostic utility of serum markers in relation to biopsy. In summary, serum and/or imaging noninvasive tests can be used for prediction of at least moderate-stage disease in a global cohort of patients with chronic hepatitis C, including the potential of high accuracy compared against liver biopsy. However, this patient does not have hepatitis C, and the appropriateness of FibroTest in this case is not support by available records. Therefore, FibroTest-ActiTest/HCV-Fibrosure test performed on 8/07/18 was not likely to have been more beneficial than other available standard therapy.
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A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 12/03/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has been diagnosed with osteoporosis. | Overturned | Experimental | Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 12/03/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has been diagnosed with osteoporosis. The physician reviewer found that there is a lack of support for the services at issue in this patients case. The value of monitoring therapy with the use of biochemical markers of bone turnover to aid in clinical decision making is controversial. This test can be variable and subject to timing and dietary intake, and there is a lack of assay standardization. In this clinical setting, dual-energy x-ray absorptiometry (DEXA) scanning would have been appropriate to monitor therapy. Thus, laboratory testing (collagen crosslink testing) performed on 12/03/16 was not likely to have been more effective than standard 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 26-year-old female enrollee has requested reimbursement for DecisionDx testing performed on 4/28/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 1
A 26-year-old female enrollee has requested reimbursement for DecisionDx testing performed on 4/28/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that per National Comprehensive Cancer Network (NCCN) guidelines, adjuvant immunotherapy is indicated for stage III disease and is not governed by results of molecular profiling. Further, there is a paucity of randomized prospective controlled trials demonstrating the results from DecisionDx have improved treatment decisions and outcomes. Accordingly, the DecisionDx testing performed on 4/28/17 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 64-year-old female enrollee has requested reimbursement for the Decision DX Melanoma assay performed on 6/16/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 64-year-old female enrollee has requested reimbursement for the Decision DX Melanoma assay performed on 6/16/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that 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 suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha (Balch, et al). Currently, tshere is a lack of data in the medical literature supporting the use of Decision DX test in this clinical setting. Moreover, there is a lack of support in the peer-reviewed literature demonstrating how best to incorporate Decision DX testing into the treatment algorithm beyond standard staging techniques. Given the lack of support in the medical literature, the Decision DX Melanoma assay performed on 6/16/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 70-year-old male enrollee has requested authorization and coverage for DecisionDx-Melanoma testing performed on 10/28/16. 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 1
A 70-year-old male enrollee has requested authorization and coverage for DecisionDx-Melanoma testing performed on 10/28/16. 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 there is a lack of support in the medical literature for the services at issue in this patients case. DecisionDx-Melanoma assay claims to determine risk of recurrence for early melanoma as in this patient. However, there is a lack of data to support using adjuvant therapy in similar patients based on risk of recurrence. Adjuvant therapy is based on stage and not on the risk of recurrence as determined by this test. Moreover, the literature does not support a therapeutic advantage of this test over the standard options since this test is not designed to change or alter therapy nor alter surveillance regardless of risk. Furthermore, prospective randomized data for determination of recurrence is lacking in this test. All told, DecisionDx-Melanoma gene expression test performed on 10/28/16 was not likely to have been superior over other methods of evaluating 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.
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A 40-year-old female enrollee has requested reimbursement for the Decision Dx test and specimen handling provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 2
A 40-year-old female enrollee has requested reimbursement for the Decision Dx test and specimen handling provided on 11/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha (Balch, et al). There is a paucity of data on the Decision Dx test to be incorporated into the treatment algorithm beyond standard staging techniques. Accordingly, the Decision Dx test and specimen handling provided on 11/23/15 were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 33-year-old female enrollee has requested reimbursement for the unlisted chemistry procedure (Decision Dx testing) provided on 10/30/15. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees cutaneous melanoma. | Upheld | Medical Necessity | Summary Reviewer
A 33-year-old female enrollee has requested reimbursement for the unlisted chemistry procedure (Decision Dx testing) provided on 10/30/15. The Health Insurer has denied this request indicating that the testing at issue was not medically necessary for evaluation of the enrollees cutaneous melanoma. The physician reviewer found the unlisted chemistry procedure (Decision Dx testing) provided on 10/30/15 was not medically necessary for evaluation of the patients medical condition. Decision Dx testing was developed from ocular melanoma samples and it has not been established in the peer-reviewed literature that this data applies to cutaneous melanoma as well. Use of this testing is not considered the standard of care. The National Comprehensive Cancer Network (NCCN) guidelines recommend that Decision Dx testing should not be performed outside of a clinical trial setting. Based on the lack of support in the peer-reviewed literature and national guidelines, the testing at issue has not been established as medically necessary for evaluation of the patients melanoma. Therefore, the testing at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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A 38-year-old female enrollee has requested reimbursement and prospective authorization and coverage for substance use residential rehabilitation from 11/14/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.
. This patient had a low risk of harm, as she denied any suicidal thoughts or plans, but occasionally had transient suicidal thoughts. She had no prior suicide attempts. Per the records, the patient had some moderate impairment in her functional status. The documentation noted ongoing substance use despite negative consequences. She also has comorbid general anxiety disorder. The clinical notes indicates limited support. The patient has maintained partial recovery for moderate periods of time, but only with strong professional and peer support. Based upon the provided documentation, the patient appears to have had difficulties engaging in treatments at times. However, recently she appears to be more motivated for treatment as her family and job are in jeopardy due to the patients current substance use. | Upheld | Medical Necessity | Summary Reviewer
A 38-year-old female enrollee has requested reimbursement and prospective authorization and coverage for substance use residential rehabilitation from 11/14/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient had a low risk of harm, as she denied any suicidal thoughts or plans, but occasionally had transient suicidal thoughts. She had no prior suicide attempts. Per the records, the patient had some moderate impairment in her functional status. The documentation noted ongoing substance use despite negative consequences. She also has comorbid general anxiety disorder. The clinical notes indicates limited support. The patient has maintained partial recovery for moderate periods of time, but only with strong professional and peer support. Based upon the provided documentation, the patient appears to have had difficulties engaging in treatments at times. However, recently she appears to be more motivated for treatment as her family and job are in jeopardy due to the patients current substance use. Based on the American Association of Community Psychiatrists Level of Care Utilization System, the patient meets criteria for partial hospitalization program level of care. In sum, substance use residential rehabilitation from 11/14/16 forward was not and is not medically indicated for the treatment of this patient. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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The patient is a 47-year-old male with a medical history including obesity and hypertension. Per the records, he has been treated with Saxenda since March 2020. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 47-year-old male with a medical history including obesity and hypertension. Per the records, he has been treated with Saxenda since March 2020. The physician reviewer found that according to the U.S. Food and Drug Administration (FDA), Saxenda is approved as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, dyslipidemia). The initial management of individuals who would benefit from weight loss is a comprehensive lifestyle intervention: a combination of diet, exercise, and behavioral modification. All patients who would benefit from weight loss should receive counseling on diet, exercise, and goals for weight loss. When a patient with a BMI greater than 30kg/m2 or a BMI of 27-29.9 kg/m2 with comorbidities, such as hypertension or diabetes Mellitus, has failed to achieve weight loss goals through diet and exercise alone, a pharmacologic therapy
is suggested. In this case, the documentation does not support that the patient has failed treatment with counseling, calorie restriction and increased physical activity to achieve weight loss goals. Therefore, Saxenda pen injector 6 mg/mL is not medically necessary for the treatment of this patient. | 1 |
A 53-year-old female enrollee has requested reimbursement for the Foundation One genetic testing performed on 1/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees serous papillary carcinoma. | Overturned | Experimental | Summary Reviewer 2
A 53-year-old female enrollee has requested reimbursement for the Foundation One genetic testing performed on 1/25/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees serous papillary carcinoma. The physician reviewer found that serous papillary carcinoma is a malignant histologic sub-type uterine carcinoma that have a propensity to spread within the peritoneum or by lymphovascular invasion. Standard practice is to initiate systemic therapy with adjuvant intent if all macroscopic disease is removed or systemic with palliative intent if the provider is unable to remove all disease. Current guidelines suggest that there are a number of systemic therapy and hormone therapy options that can be considered. There is limited data regarding the benefit of subsequent treatment for patients who progress despite two prior regimens. Thus, tumor molecular assessment is the only effective means to assess the patients therapeutic options. For these reasons, the Foundation One genetic testing performed on 1/25/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 49-year-old female insured has requested authorization and coverage for thermal destruction of
intraosseous basivertebral nerve including all imaging guidance; first two vertebral bodies, lumbar
(CPT 64628). The insureds symptoms are having a significant impact on activities of daily living
such as household chores, leisure activities, sleeping, and work. Medications have included
acetaminophen, Celebrex, meloxicam, naproxen, and muscle relaxants. The Health Insurer
indicates the requested services are considered investigational for the treatment of the insureds
medical condition. Therefore, the Health Plan has denied coverage for the requested treatment. | Overturned | Experimental | Summary Reviewer 1
A 49-year-old female insured has requested authorization and coverage for thermal destruction of
intraosseous basivertebral nerve including all imaging guidance; first two vertebral bodies, lumbar
(CPT 64628). The insureds symptoms are having a significant impact on activities of daily living
such as household chores, leisure activities, sleeping, and work. Medications have included
acetaminophen, Celebrex, meloxicam, naproxen, and muscle relaxants. The Health Insurer
indicates the requested services are considered investigational for the treatment of the insureds
medical condition. Therefore, the Health Plan has denied coverage for the requested treatment.
This denial is the subject of this appeal and determination. The physician reviewer found that a
randomized controlled trial evaluating the effectiveness of intraosseous radiofrequency ablation of
the basivertebral nerve to standard care for the treatment of chronic low back pain in a specific
subgroup of patients suspected to have vertebrogenic-related symptomatology was conducted
(Khalil, et al.). The authors noted that there was a clear statistical superiority for all primary and
secondary patient-reported outcome measures in the radiofrequency ablation patients outcomes
compared with the standard of care. Moreover, Fischgrund and colleagues concluded that patients
with chronic low back pain who underwent treatment with radiofrequency ablation of the
basivertebral nerve reported clinically meaningful improvements in both Oswestry Disability
Index (ODI) and Visual Analog Scale (VAS) scores at two-year follow-up. The International
Society for the Advancement of Spine Surgery noted that basivertebral nerve ablation can be
beneficial for patients with chronic low back pain that has not improved despite at least six months
of non-surgical management and with Modic changes on at least one endplate on MRI (Lorio, et
al.). In this case, the patient has had a history of chronic low back pain that has persisted for several
years and has been refractory to multiple modes of standard care including physical therapy,
exercise, anti-inflammatory medications, and spine injections. Multiple randomized controlled
trials comparing basivertebral nerve ablation to the current standard of care support the procedure
as superior in improving pain scores and disability scores. For these reasons, the requested thermal
destruction of intraosseous basivertebral nerve including all imaging guidance; first two vertebral
bodies, lumbar (CPT 64628) is likely to be more beneficial for the treatment of the patients
medical condition than any available standard therapy.
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A 31-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/11/19. 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 2
A 31-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/11/19. 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 this patient had an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Newer prognostic molecular techniques should not replace standard staging procedures. There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. All told, DecisionDx-Melanoma testing performed on 12/11/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 35-year-old male enrollee has requested reimbursement for the osteogenesis stimulator provided on 11/30/16. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees right ankle pain. | Upheld | Medical Necessity | Summary Reviewer
A 35-year-old male enrollee has requested reimbursement for the osteogenesis stimulator provided on 11/30/16. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees right ankle pain. The physician reviewer found that as noted in the medical literature, an accessory navicular is the most common extra ossicle of the foot. In cases of failed nonsurgical treatment, excision of the ossicle has been demonstrated to be effective (Jegal, et al; Rietveld and Diemer). Similarly, Marcus and Kopp found that when conservative measures fail to relieve the symptoms of a painful accessory navicular, simple excision of the accessory navicular and anatomic repair of the posterior tibialis tendon is a successful intervention. In addition, there is a lack of scientific evidence supporting the efficacy of ultrasound stimulation for treatment of foot and ankle pain in this clinical setting. All told, the osteogenesis stimulatory provided on 11/30/16 was not medically necessary for treatment of this patients foot pain. Based on the foregoing discussion, the device at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 56-year-old male enrollee has requested reimbursement for the Cologuard test provided on 12/1/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees colon cancer. | Upheld | Experimental | Summary Reviewer 1
A 56-year-old male enrollee has requested reimbursement for the Cologuard test provided on 12/1/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that the Cologuard test provided on 12/1/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Colorectal neoplasms shed DNA in the stool from which the DNA can be isolated and tested for the presence of mutations and epigenetic changes acquired during carcinogenesis. Cologuard, which is a second generation stool DNA test combines stool DNA testing using a gene amplification technique to allow detection of low frequency mutations with increased sensitivity for advanced adenomas, for patterns of DNA methylation with testing for hemoglobin (Ahlquist, et al). Imperiale and colleagues compared stool DNA test with a fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. The authors found that the sensitivity for colorectal cancer of the stool DNA and FIT tests were 92.3% and 73.8% respectively. Given the support in the peer-reviewed literature, the testing at issue has 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 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 59-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/30/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination. | Overturned | Experimental | Summary Reviewer 1
A 59-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/30/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination. The physician reviewer found that there is evidence based support for the service at issue in this clinical setting. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and biopsies and an increase in detection of small cancers when compared to two dimensional imaging alone. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. Therefore, the addition of digital breast tomosynthesis, to the usual two dimensional protocol was likely to be more effective than had her examination been performed using two dimensional imaging alone. Based upon the information set forth above, the service at issue was likely to have been 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 49-year-old male enrollee has requested authorization and coverage for 0424T insertion
neurostimulator system for central sleep apnea. The Health Insurer has denied this request and
reported that the requested service is investigational for the treatment of the enrollees central
sleep apnea.
in this case, the patient has severe central sleep
apnea. Notes dated 6/18/22 reported an apnea-hypopnea index (AHI) of 35 with significant
daytime sleepiness. The patient was noted as being a highway maintenance worker, an
occupation posing high risk of injury to himself or others. The 0424T | Overturned | Experimental | Summary Reviewer 1
A 49-year-old male enrollee has requested authorization and coverage for 0424T insertion
neurostimulator system for central sleep apnea. The Health Insurer has denied this request and
reported that the requested service is investigational for the treatment of the enrollees central
sleep apnea. The physician reviewer found that in this case, the patient has severe central sleep
apnea. Notes dated 6/18/22 reported an apnea-hypopnea index (AHI) of 35 with significant
daytime sleepiness. The patient was noted as being a highway maintenance worker, an
occupation posing high risk of injury to himself or others. The 0424T phrenic neurostimulator
system is an implantable device that stimulates the diaphragm to contract, resulting in patients
breathing, and is an option in selected patients with symptomatic central sleep apnea intolerant
of CPAP or other standard therapies. While the device is approved by the U.S. Food and Drug
Administration, (FDA), there may be a need for additional studies on cardiovascular outcomes
and long-term safety in relation to other therapies for central sleep apnea. However, in this
clinical setting, as the records indicate that the patient is unable to tolerate standard therapy
with CPAP, biPAP, or ASV, the requested service is likely to be more beneficial for the patient
than any remaining, available therapies. Therefore, 0424T insertion neurostimulator system for
central sleep apnea is likely to be more beneficial for treatment of the patients condition than
any available standard therapy.
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A 29-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
this patient has only partially responded to medical therapy with acid suppressive medication. The LINX | Overturned | Experimental | Summary Reviewer 2
A 29-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient has only partially responded to medical therapy with acid suppressive medication. The LINX Reflux Management System has been shown to be superior to twice-daily proton pump inhibitor (PPI) therapy. Bell and colleagues noted that the LINX Reflux Management System normalized the total number of reflux episodes and acid exposure in 91 and 89 percent of patients, compared with 58 and 75 percent of those treated with twice-daily PPIs. The LINX Reflux Management System has been compared with laparoscopic Nissen fundoplication in several meta-analyses. Clinical control of reflux was comparable after the two procedures. In the study by Ganz and colleagues, the long-term safety and efficacy of the LINX prosthesis was evaluated in a prospective single-group trial of 100 patients with long-standing gastroesophageal reflux disease. At five years after LINX implantation, significantly fewer patients reported moderate or severe heartburn (12 versus 89 percent), moderate or severe regurgitation (1 versus 57 percent), bothersome gas-bloat (8 versus 52 percent), and daily PPI use (15 versus 100 percent). GERD-related quality of life was also better. There is sufficient support for the requested services in this clinical setting. Therefore, the requested LINX procedure is likely to be more beneficial than any available standard therapy.
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A 30-year-old female enrollee has requested reimbursement for knee orthosis provided on 1/04/19. The Health Insurer has denied this request and reported that the device at issue was not medically necessary for the treatment of the enrollees medical condition.
. This patient was diagnosed with right knee osteochondral dissecans defect of the medial femoral condyle and underwent cartilage repair surgery on 11/08/18. A postoperative prefabricated medial unloader brace was prescribed to unload the repaired cartilage defect as she resumed maximal functional activity. | Overturned | Medical Necessity | Summary Reviewer
A 30-year-old female enrollee has requested reimbursement for knee orthosis provided on 1/04/19. The Health Insurer has denied this request and reported that the device at issue was not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the device at issue in this patients case. The current evidence-based literature supports the use of unloader braces for patients with osteoarthritis of the knee to improve pain and physical function. This patient was diagnosed with right knee osteochondral dissecans defect of the medial femoral condyle and underwent cartilage repair surgery on 11/08/18. A postoperative prefabricated medial unloader brace was prescribed to unload the repaired cartilage defect as she resumed maximal functional activity. Evidence-based guidelines support knee bracing in this clinical setting, and the literature supports use for improved pain and physical function generally. Therefore, the knee orthosis provided on 1/04/19 was medically necessary for the treatment of this patient. | 1 |
The parent of a 16-year-old female enrollee has requested reimbursement for intra-operative
electromyography (EMG) monitoring and neuromuscular junction testing during spinal surgery
including anterior cervical procedures on 2/14/22. The Health Insurer has denied this request
indicating that the services at issue were investigational for the treatment of the enrollee.
. In this case, the patient was
diagnosed with adolescent idiopathic scoliosis and underwent corrective surgery with thorascopic
anterior spinal tethering. | Overturned | Experimental | Summary Reviewer 1
The parent of a 16-year-old female enrollee has requested reimbursement for intra-operative
electromyography (EMG) monitoring and neuromuscular junction testing during spinal surgery
including anterior cervical procedures on 2/14/22. The Health Insurer has denied this request
indicating that the services at issue were investigational for the treatment of the enrollee. The
physician reviewer found that adolescent idiopathic scoliosis is a condition that causes the spine
to curve in an S or C shape where the etiology is unknown. Symptoms include tilted, uneven
shoulders, the prominence of the ribs on one side, an uneven waistline, and one hip being higher
than the other, and may cause back pain and improper growth. In this case, the patient was
diagnosed with adolescent idiopathic scoliosis and underwent corrective surgery with thorascopic
anterior spinal tethering. Intraoperative EMG monitoring and neuromuscular junction testing is a
form of non-invasive intra-operative monitoring (NIOM) that is safe, well-known to improve
outcomes, and standard clinical practice during spinal surgery. Research demonstrates that
intraoperative EMG is necessary to assess the adequacy of nerve root decompression, detect nerve
root irritation, and improve the reliability of the placement of pedicle screws during spinal surgery.
Therefore, intra-operative EMG monitoring and neuromuscular junction testing during spinal
surgery including anterior cervical procedures on 2/14/22 was likely to have been more beneficial
for treatment of the patients condition than any available standard therapy.
| 1 |
A 46-year-old female enrollee has requested authorization and coverage for the Flexitouch pneumatic compression pump and leg garment. The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 46-year-old female enrollee has requested authorization and coverage for the Flexitouch pneumatic compression pump and leg garment. The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that the request for Flexitouch pneumatic compression pump and leg garment is not medically necessary for treatment of the patients medical condition. The documentation submitted for review does not document that she has failed a sustained trial of compression or documentation that she has failed treatment with a compression pump. Given the lack of documentation of conservative treatments, the requested equipment is not indicated. Therefore, the medical necessity for Flexitouch pneumatic compression pump and leg garment has not been established in this clinical setting. Therefore, the requested equipment is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 31-year-old transgender female enrollee has requested reimbursement for facial feminization surgeries (21139, 14041, 21122, 30420, 15839 and 31899) performed on 11/16/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria.
with a female gender. Her hairline does not show significant frontal bone prominence and her nose, chin, face and neck appear consistent with the female gender. There is a slight tracheal prominence but the | Upheld | Medical Necessity | Summary Reviewer
A 31-year-old transgender female enrollee has requested reimbursement for facial feminization surgeries (21139, 14041, 21122, 30420, 15839 and 31899) performed on 11/16/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees gender dysphoria. The physician reviewer found that based on the medical documentation provided including a review of the photographs, the services at issue were not medically necessary. Facial feminization and tracheal shave surgeries can help to approximate a more feminine appearance. However, in this patients case, the photographs show that her facial structure is consistent with a female gender. Her hairline does not show significant frontal bone prominence and her nose, chin, face and neck appear consistent with the female gender. There is a slight tracheal prominence but the photographs do not show evidence of a significantly prominent tracheal cartilage. In this case, the photographs do not show evidence of a masculine appearance of the brows, forehead, hairline, midface, and neck. These findings are relatively gender neutral and not atypical for a female. As such, this patient lacked evidence of abnormal facial structures for a female and her facial presentation is consistent within the spectrum of the female gender. Accordingly, the facial feminization surgeries (21139, 14041, 21122, 30420, 15839 and 31899) performed on 11/16/17 were not medically necessary for the treatment of this patient.
Therefore, for the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The patient is a 49-year-old male with a history of acute trauma to the thigh resulting in a thigh compartment syndrome. He underwent an emergency fasciotomy; however, the submitted documentation indicates the treating surgeon was not familiar with post-surgical care. The record noted a 14-inch draining skin incision. The patient was transported by air ambulance from Florida to Dallas, Texas. The patient has requested reimbursement for air ambulance services provided on 11/25/17. The Health Plan has denied this request and reported that the services at issue were not medically necessary.
patient could not utilize public transportation due to the need for maximum assistance with ambulation. His ambulation was limited to use of bathroom only with assistance. He required dressing changes by medical personnel with sterile precautions as needed to keep wound clean during transport. While the record had noted that the patients vital signs were stable, stable vitals do
place at any moment due to bleeding from an open wound. The presence of emergency medical personnel was essential. Tertiary care in Dallas, Texas was chosen because it was near his home. His treatment in Orlando, Florida would have necessitated a prolonged stay for follow-up care and inability to use public transportation. As | Overturned | Medical Necessity | Summary Reviewer
The patient is a 49-year-old male with a history of acute trauma to the thigh resulting in a thigh compartment syndrome. He underwent an emergency fasciotomy; however, the submitted documentation indicates the treating surgeon was not familiar with post-surgical care. The record noted a 14-inch draining skin incision. The patient was transported by air ambulance from Florida to Dallas, Texas. The patient has requested reimbursement for air ambulance services provided on 11/25/17. The Health Plan has denied this request and reported that the services at issue were not medically necessary. This denial is the subject of this appeal and determination. There is sufficient support in the documentation and the medical literature for the medical necessity of the services at issue. Early fasciotomy is the gold standard of prevention and treatment of compartment syndrome; however, the resulting wounds may significantly increase morbidity. To address the challenge of timely and safe closure of fasciotomy wounds, numerous methods have been described. Thorough knowledge of available techniques and their comparative advantages is essential for their clinical implementation, careful selection of patients, management of possible complications, decreased morbidity, and hospital recovery time are also crucial for optimization of functional and aesthetic outcomes. The patient had a 14-inch long draining wound and the submitted documentation indicates the initial surgeon was not familiar with current fasciotomy wound closure techniques. Transfer by air ambulance to a tertiary care institution was needed in light of the 14-inch long draining open wound and the patients pain. There was an urgent need for wound management at a tertiary care center to prevent deep infection, facilitate healing, and prevent complications such as deep vein thrombosis. The patient could not utilize public transportation due to the need for maximum assistance with ambulation. His ambulation was limited to use of bathroom only with assistance. He required dressing changes by medical personnel with sterile precautions as needed to keep wound clean during transport. While the record had noted that the patients vital signs were stable, stable vitals do not mean a sudden change in vitals cannot take place at any moment due to bleeding from an open wound. The presence of emergency medical personnel was essential. Tertiary care in Dallas, Texas was chosen because it was near his home. His treatment in Orlando, Florida would have necessitated a prolonged stay for follow-up care and inability to use public transportation. As noted above, the surgeon in Florida was unfamiliar with vacuum assisted closure. Vacuum assisted closure technique has one of the lowest complication rates. In sum, air ambulance services provided on 11/25/17 were medically necessary for treating this patients medical condition. Therefore, for the reasons stated above, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 60-year-old female enrollee has requested reimbursement for methylenetetrahydrofolate reductase (MTHFR) and nerve conduction velocity (NCV) studies provided on 9/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Hashimotos thyroiditis. | Overturned | Experimental | Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for methylenetetrahydrofolate reductase (MTHFR) and nerve conduction velocity (NCV) studies provided on 9/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Hashimotos thyroiditis. The physician reviewer found that based on current medical guidelines, the MTHFR and NCV testing performed on 9/22/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Neither of these tests are integral to the management and treatment of the patients hypothyroidism. While patients with hypothyroidism may experience neuropathy and muscle complaints, a NCV test is generally not indicated to diagnose or treat this condition. MTHFR testing has no role in the treatment of patients with hypothyroidism and Hashimotos thyroiditis. Recent data indicates that there is a lack of evidence for this type of testing in this clinical setting. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a seven-year-old male. He has been diagnosed with mixed receptive/expressive speech disorder, phonological disorder and severe apraxia of speech. The patientas parent has requested reimbursement for speech therapy provided from 1/01/19 through 12/30/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
The patient has mixed receptive/expressive speech disorder, phonological disorder and severe apraxia of speech. His speech and language impairment is severely impeding his ability to communicate with his family, peers and teachers. He has been documented as consistently attending therapy sessions, and to be making progress towards goals, with new goals subsequently being introduced by the therapist. | Overturned | Medical Necessity | Summary Reviewer
The patient is a seven-year-old male. He has been diagnosed with mixed receptive/expressive speech disorder, phonological disorder and severe apraxia of speech. The patientas parent has requested reimbursement for speech therapy provided from 1/01/19 through 12/30/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the submitted documentation supports the services at issue in this clinical setting. The patient has mixed receptive/expressive speech disorder, phonological disorder and severe apraxia of speech. His speech and language impairment is severely impeding his ability to communicate with his family, peers and teachers. He has been documented as consistently attending therapy sessions, and to be making progress towards goals, with new goals subsequently being introduced by the therapist. Law and colleagues performed a review on speech and language therapy interventions for children with primary speech and language delay or disorder. The authors noted, aOverall there is a positive effect of speech and language therapy interventions for children with expressive phonological and expressive vocabulary difficulties. The evidence for expressive syntax difficulties is more mixed, and there is a need for further research to investigate intervention for receptive language difficulties.a Liu and colleagues noted, aThe ability to communicate effectively with others is central to childrenas development. Delays or disruptions due to isolated expressive language delay, articulation errors, multiple sound production errors with motor planning deficits, or mixed expressive and receptive language delay, often bring widespread consequences.a Capone Singleton noted that late talking in children who do not receive professional intervention places them at risk for lifelong disability. OaHare and Bremner emphasize the need for comprehensive speech and language assessment, and speech therapy, for children with speech and language difficulty. Therefore, speech therapy provided from 1/01/19 through 12/30/20 was medically necessary for the treatment of this patient.
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A 44-year-old male enrollee has requested authorization and coverage for Testim. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees testicular hypofunction.
iposity, osteoporosis/low bone mass, depressed mood and fatigue
This patient has a history of hypogonadism, with documentation of low serum testosterone including levels of 275, 283, 300 ng/dL. | Overturned | Medical Necessity | Summary Reviewer
A 44-year-old male enrollee has requested authorization and coverage for Testim. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees testicular hypofunction.
The physician reviewer found that low testosterone can lead to such complications as reduced libido/erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis/low bone mass, depressed mood and fatigue (Dandona and Rosenberg). For these reasons, many providers treat patients with hypogonadism when a patients testosterone level is less than 350 ng/dL (Nieschlag, et al). The general target level for testosterone ranges from 350 to 750 ng/dL, in androgen-sufficient adult men. Testosterone levels should be monitored three to six months after initiation of treatment in order to assure that the patients testosterone level is optimal and the dose of testosterone replacement therapy should be adjusted accordingly (Rivas, et al). This patient has a history of hypogonadism, with documentation of low serum testosterone including levels of 275, 283, 300 ng/dL. Thus, the requested Testim is supported as medically necessary for treatment of this patients hypogonadism. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 54-year-old male enrollee has requested reimbursement for air ambulance services provided on 5/12/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees brain tumor with mass effect and parenchymal hemorrhage. | Upheld | Medical Necessity | Summary Reviewer
A 54-year-old male enrollee has requested reimbursement for air ambulance services provided on 5/12/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees brain tumor with mass effect and parenchymal hemorrhage. The physician reviewer found the review of the submitted documentation and relevant literature fails to demonstrate the medical necessity for the services at issue. Pituitary apoplexy is considered an acute neurosurgical life threatening, emergency (Post et al; Briet et al; Vanderpump, et al). The potential for acute hemorrhage, acute pituitary collapse with adrenal insufficiency, and blindness requires emergency care and treatment (Muthukumar, et al; Nawar, et al; Rajasekaran, et al). Not all hospitals have the combination of neurosurgical with transsphenoidal abilities/endocrinologic/ophthalmologic and intensive care facilities. These services are a must for proper care of pituitary apoplexy (Rajasekaran, et al). In this clinical setting, UCSF was a closer facility with these capabilities than UCSD. Therefore, the ambulance services provided on 5/12/14 was not medically necessary in this patients case. For the reasons provided, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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The patient is a 61-year-old male with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms. Associated symptoms include nocturia, slow stream, and incomplete emptying. Prior failed therapy includes uroxatral. The patient has requested reimbursement for the UroLift procedure provided on 10/18/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational. | Upheld | Experimental | Summary Reviewer 3
The patient is a 61-year-old male with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms. Associated symptoms include nocturia, slow stream, and incomplete emptying. Prior failed therapy includes uroxatral. The patient has requested reimbursement for the UroLift procedure provided on 10/18/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational. The prostatic urethral lift (PUL) system is a novel, minimally invasive approach to treating BPH that lifts or holds the enlarged prostate tissue out of the way of the urethra. Recent clinical trials including prospective sham controlled randomized studies have shown that the UroLift System treatment is safe and effective in relieving lower urinary tract symptoms due to BPH without significantly compromising sexual function. Compared with standard available options, PUL is minimally invasive procedure without a requirement of general anesthesia with a potentially shorter operative time. A recent prospective, randomized, multinational study compared the outcome of PUL to transurethral resection of the prostate (TURP) and concluded that participants who underwent the PUL procedure responded significantly better than those who underwent TURP as therapy for BPH with regard to important aspects of quality of life (Snksen, et al). All told, the UroLift procedure provided on 10/18/16 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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 |
The patient is a 15-year-old male who has been diagnosed with mixed receptive-expressive language disorder, cognitive communication deficit and other speech disturbances. The patientas parent has requested reimbursement and prospective authorization and coverage for speech therapy provided from 1/10/21 through 12/31/21.
This patient has been receiving speech therapy from two therapists. One therapist, Anna Vagin, PhD, coordinates a weekly group speech therapy session, facilitating the development of the patientas social language skills in a group setting. He is functioning below age-level in his communication skills. As such, he is at risk of being socially excluded and bullied,
Brooke Gonterman, M.D., CCC-SLP was working on school assignments with the | Overturned | Medical Necessity | Summary Reviewer
The patient is a 15-year-old male who has been diagnosed with mixed receptive-expressive language disorder, cognitive communication deficit and other speech disturbances. The patientas parent has requested reimbursement and prospective authorization and coverage for speech therapy provided from 1/10/21 through 12/31/21. The physician reviewer found that the submitted documentation supports the medical necessity of a portion of the services at issue. This patient has been receiving speech therapy from two therapists. One therapist, Anna Vagin, PhD, coordinates a weekly group speech therapy session, facilitating the development of the patientas social language skills in a group setting. He is functioning below age-level in his communication skills. As such, he is at risk of being socially excluded and bullied, which may increase his risk of mental health problems unless he continues to receive medically necessary speech therapy to address improving his communication skills with his peers. His scores on the Comprehensive Assessment of Spoken Language (CASL-2) were very low. Ebbels and colleagues describe the effectiveness of speech and language therapy for older children with language disorders. The therapy provided by the second therapist, Brooke Gonterman, M.D., CCC-SLP, appears to be primarily educational in nature. Brooke Gonterman, M.D., CCC-SLP was working on school assignments with the patient, which appears educational rather than medically necessary in nature. As such, it does not appear to be medically necessary, and could be addressed in the school setting. Therefore, speech therapy services provided by Anna Vagin, PhD were and are medically necessary. Speech therapy services provided by Brooke Gonterman, M.D., CCC-SLP were not and are not medically necessary. | 1 |
The patient is a 61-year-old female with a history of sarcoma. Per the records, positron emission tomography (PET) scan showed a thyroid nodule. A biopsy was consistent with atypia of undetermined significance. Therefore, the specimen was sent for genetic testing. The patient has requested reimbursement for the gene test provided on 12/21/16. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of this patient. | Overturned | Experimental | Summary Reviewer 2
The patient is a 61-year-old female with a history of sarcoma. Per the records, positron emission tomography (PET) scan showed a thyroid nodule. A biopsy was consistent with atypia of undetermined significance. Therefore, the specimen was sent for genetic testing. The patient has requested reimbursement for the gene test provided on 12/21/16. The Health Insurer has denied this request indicating that the services at issue were investigational for the evaluation of this patient. There is sufficient support for the services at issue in this clinical setting. In this patients case, pathology was consistent with atypia of undetermined significance. The submission to genetic studies was appropriately done in this case, because it was important for medical decision making. The results of this testing were important to determine whether to perform thyroidectomy or not, and the extent of surgery. With a benign result, surgery may be avoided. The test is in vitro, which confers no physical risk to the patient. The sample is obtained at the same time of the fine needle aspiration biopsy, and no additional procedure is needed. In sum, gene test provided on 12/21/16 was likely to have been of greater benefit than other available modalities for evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 43-year-old female with major depressive disorder. She reports insomnia and chronic pain. She has a history of a prior suicide attempt. The patient has been treated with a myriad of medications. She has also been treated with electroconvulsive therapy (ECT) and an incomplete trial of transcranial magnetic stimulation (TMS). 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. | Upheld | Experimental | Summary Reviewer 2
The patient is a 43-year-old female with major depressive disorder. She reports insomnia and chronic pain. She has a history of a prior suicide attempt. The patient has been treated with a myriad of medications. She has also been treated with electroconvulsive therapy (ECT) and an incomplete trial of transcranial magnetic stimulation (TMS). 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 submitted documentation fails to demonstrate the superior efficacy of the requested services. While a myriad of medications are listed, the doses and durations are not provided. Therefore, the adequacy of her medication trials cannot be established. It cannot be determined that she is a true medication non-responder based on the information provided. Based on the records, the patient may be a candidate for a recurrent trial of ECT, which is community standard. Vagus nerve stimulation is a longer term and less effective treatment than either ECT or TMS. All told, CPT 64568 (implantation of vagus nerve neurostimulator electrode) is not likely to be more efficacious than other available 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 54-year-old female enrollee has requested reimbursement for advanced lipoprotein testing
performed on 4/15/22. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 54-year-old female enrollee has requested reimbursement for advanced lipoprotein testing
performed on 4/15/22. The Health Insurer has denied this request and reported that the services
at issue were investigational for the evaluation of the enrollees medical condition. The physician
reviewer found that in this case, the American College of Cardiology calculated ten-year coronary
artery disease risk score is in the low-risk range for this patient. Patients with high-sensitivity C-
reactive protein (hs-CRP) levels less than two do not have an increased risk of disease associated
with elevated lipoprotein(a). There is a lack of data in current medical literature demonstrating
that the lowering of lipoprotein(a) in patients other than in those at high traditional
cardiovascular risk is beneficial. While lipoprotein(a) testing may be reasonable in adults to aid
in the clinician-patient discussion about whether to prescribe a statin in those aged 40 to 75 with
borderline ten-year atherosclerotic cardiovascular disease risk, to identify a possible cause for a
less-than-anticipated low-density lipoprotein cholesterol lowering, to use in cascade screening
of family members with severe hypercholesterolemia, and to identify those at risk for progressive
atherosclerotic cardiovascular disease, the submitted records did not demonstrate that this
patient met any of these risk factors. The patient does not have a documented family history of
premature coronary artery disease and has normal lipoprotein levels. Therefore, advanced
lipoprotein testing performed on 4/15/22 was not likely to have been more beneficial for
evaluation of the patients condition than any available standard therapy.
| 0 |
A 57-year-old male enrollee has requested reimbursement for CPT 43210 esophagogastroduodenoscopy with transoral incisionless fundoplication performed on 4/23/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.
.8% and esophagitis healed in 86% and 71% had stopped proton pump inhibitor; at five | Upheld | Experimental | Summary Reviewer 1
A 57-year-old male enrollee has requested reimbursement for CPT 43210 esophagogastroduodenoscopy with transoral incisionless fundoplication performed on 4/23/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the efficacy of transoral incisionless fundoplication (TIF) using the EsophyX device has been studied in randomized controlled trials. However, the conclusions are contradictory. A non-blinded multicenter randomized crossover study (TEMPO) showed improvement in regurgitation in 97% of TIF patients versus 50% of proton pump inhibitor patients at six months, with similar normalization in esophageal acid exposure; at three years, after all control patients had TIF, total esophageal pH less than 4 time improved from 10.5% to 7.8% and esophagitis healed in 86% and 71% had stopped proton pump inhibitor; at five years, 86% reported resolution of regurgitation, 80% reported resolution of atypical symptoms, and 34% remained on proton pump inhibitor. One large randomized trial by Witteman and colleagues included 60 patients and found no improvement in esophageal acid exposure compared with baseline at 12 months; normalization of pH was accomplished in only 29% (less than the proton pump inhibitor group) in conjunction with deteriorated valve appearances at endoscopy and resumption of proton pump inhibitors in 61%. The study concluded that no long-term objective reflux control was achieved. A recent systematic review and meta-analysis by McCarty and colleagues concluded, aFuture controlled trials are needed to directly compare efficacy, long-term durability, and safety between TIF and Nissen fundoplication.a Another recent systematic review and meta-analysis by Huang and colleagues concluded, aLong-term results showed decreased efficacy with time. Patients often resume proton pump inhibitors at reduced doses in the near future.a The current medical literature has not definitively established that TIF will be able to control acid reflux over the long-term, especially in comparison with conventional methods, such as Nissen fundoplication. The 2013 American College of Gastroenterology guidelines for treatment of gastroesophageal reflux disease noted, aThe usage of current endoscopic therapy or TIF cannot be recommended as an alternative to medical or traditional surgical therapy (moderate level of evidence).a In 2013, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) reported that numerous published series have reported significant adverse events and that there is a lack of sham-controlled trials comparing TIF with anti-reflux surgery. SAGES concluded, aFurther studies are required to define optimal techniques and most appropriate patient selection criteria, and to further evaluate device and technique safety.a These conclusions are bolstered by recent reports of severe adverse events during the procedure and the need for surgery to revise ineffective TIF. Therefore, CPT 43210 esophagogastroduodenoscopy with transoral incisionless fundoplication performed on 4/23/21 was not likely to have been more beneficial than other available standard therapy.
| 1 |
A 29-year-old male enrollee has requested authorization and coverage for Subsys. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 29-year-old male enrollee has requested authorization and coverage for Subsys. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees medical condition. The physician reviewer found the current standard of care for chronic pain is treatment in a multidisciplinary practice to include physical therapy, massage therapy, behavioral therapy, and injections to help reduce pain. Baron and McDonald reported that high-dose and short-acting opiates may contribute to pain sensitization via opioid-induced hyperalgesia, decreasing patient pain threshold and potentially masking resolution of a preexisting pain condition. Long-term opiates are more likely to cause adverse outcomes. Ballantyne and Mao reported that prolonged use of high-dose, opiates might induce tolerance and abnormal pain sensitivity. All told, the requested medication Subsys is not likely to be of greater benefit than other treatment options. 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.
| 0 |
The parent of a 15-year-old male enrollee has requested reimbursement for CPT code 95165, professional services for the suppression and provision of antigens for allergen immunotherapy from 2/10/15 through 2/12/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
The parent of a 15-year-old male enrollee has requested reimbursement for CPT code 95165, professional services for the suppression and provision of antigens for allergen immunotherapy from 2/10/15 through 2/12/15. The Health Insurer has denied this request indicating that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the services at issue in this clinical setting. Allergen immunotherapy is a long-term treatment that decreases symptoms for many people with allergic rhinitis, allergic asthma, conjunctivitis or stinging insect allergy. Allergy shots decrease sensitivity to allergens and often lead to lasting relief of allergy symptoms even after treatment is stopped. Indications for allergen immunotherapy include allergic asthma and rhinitis, conjunctivitis, as well as venom-induced anaphylaxis. In this patients case, the records do not support the services at issue. Without a diagnosis of asthma, rhinitis, conjunctivitis or anaphylaxis, the services at issue cannot be recommended. In sum, CPT code 95165, professional services for the suppression and provision of antigens for allergen immunotherapy from 2/10/15 through 2/12/15 were not likely to have been of greater benefit 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.
| 0 |
The patient is a 63-year-old female with a diagnosis of hereditary angioedema and monoclonal gammopathy of unknown significance (MGUS). Provider records indicate that patient has ongoing angioedema with up to three attacks per month. Hereditary angioedema (HAE) attacks have responded well to Firazyr,
two to three hours following an attack. The provider has recommended tranexamic acid 650 mg tablets/120 tablets for a 30 day supply (two tablets, twice per day, with 11 refills).
. The patient has requested authorization and coverage for tranexamic acid 650 mg tablets/120 tablets for a 30 day supply (two tablets, twice per day, with 11 refills). The Health Insurer has denied this request indicating that the requested medication dosage is not medically | Overturned | Medical Necessity | Summary Reviewer
The patient is a 63-year-old female with a diagnosis of hereditary angioedema and monoclonal gammopathy of unknown significance (MGUS). Provider records indicate that patient has ongoing angioedema with up to three attacks per month. Hereditary angioedema (HAE) attacks have responded well to Firazyr, which is used as on demand therapy, but recovery time is prolonged up to two to three hours following an attack. The provider has recommended tranexamic acid 650 mg tablets/120 tablets for a 30 day supply (two tablets, twice per day, with 11 refills). The provider states that this specific dosage will be used as ongoing prophylactic therapy, and a trial of tranexamic acid has previously shown effectiveness for this patient. The patient has requested authorization and coverage for tranexamic acid 650 mg tablets/120 tablets for a 30 day supply (two tablets, twice per day, with 11 refills). The Health Insurer has denied this request indicating that the requested medication dosage is not medically necessary. Given this patients medical condition, the requested dosage of tranexamic acid meets the criteria for medical necessity to provide long-term prophylaxis for the treatment of hereditary angioedema. There is sufficient evidence to support the long-term prophylactic dosing of tranexamic acid at 650 mg twice daily, which would necessitate the quantity of 120 tablets for a 30 day supply. According to the current evidence-based literature, this dosing amount is within the standard of care for the use of tranexamic acid for the long-term prophylactic treatment of hereditary angioedema. Accordingly, the requested tranexamic acid 650 mg tablets/120 tablets for a 30 day supply (two tablets, twice per day, with 11 refills) is medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication dosage is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 28-year-old female enrollee has requested reimbursement for CPT code 92025 (computerized corneal topography, unilateral or bilateral, with interpretation and report) provided on 6/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
. The medical records document keratitis sicca and eyelid cellulitis. The records indicate that the patient had ongoing ancillary testing with topography and tear osmolarity for management of dry eyes. | Upheld | Experimental | Summary Reviewer 1
A 28-year-old female enrollee has requested reimbursement for CPT code 92025 (computerized corneal topography, unilateral or bilateral, with interpretation and report) provided on 6/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the services at issue in this patients case. The medical records document keratitis sicca and eyelid cellulitis. The records indicate that the patient had ongoing ancillary testing with topography and tear osmolarity for management of dry eyes. The current medical evidence suggests that tear osmolarity is appropriate to determine the effectiveness of dry eye treatments and progress. However, serial corneal topography is not. In sum, the services at issue were not likely to have been of greater benefit 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 |
The patient is a 62-year-old male who presented to his provider on 9/12/22. The patient has
requested authorization and coverage for stereotactic body radiation therapy. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 62-year-old male who presented to his provider on 9/12/22. The patient has
requested authorization and coverage for stereotactic body radiation therapy. The physician
reviewer found that at issue is whether the requested stereotactic body radiation therapy is
medically necessary for the treatment of this patient. The submitted documentation supports
the medical necessity of the requested service. Historically, the management of metastatic
tumors was focused on systemic therapies such as chemotherapy. The advent of newer
molecular sequencing techniques and targeted therapies has allowed clinicians to provide very
tailored systemic therapies to metastatic cancer patients. Patients who respond well to these
targeted systemic therapies demonstrate very good disease response throughout most of their
body. However, it is still common for certain localized metastatic tumor deposits to continue to
grow despite good overall disease control in the rest of the body, as is the case in this patient.
This disease state is referred to as oligometastatic disease and the role of stereotactic body
radiation therapy (SBRT) in this setting is a very active area of research. There is strong evidence
showing improved overall survival and progression-free survival with the addition of SBRT to
systemic therapies in an oligometastatic setting. SBRT technique allows for higher doses to be
delivered with greater precision, allowing for very high local control when treating localized
lesions. SBRT also allows for very rapid radiation dose falloff outside of the treated lesion,
meaning less exposure to surrounding normal tissues and resulting in less normal organ toxicity.
Navarria and colleagues report that SBRT has promising results in terms of local control, survival,
and toxicity. There are very few grade 3 or higher toxicities seen with the administration of SBRT
to the thoracic area and lung. This improved toxicity profile is only achievable with SBRT
technique and not with standard radiation techniques. Further improvements in targeted
systemic therapy will require equal improvements in local disease control. The clinical implication
of oligometastatic disease is that cure or long-term survival can be achieved for this subset of
patients with metastatic disease, so minimizing treatment toxicity is critical. In this case, the
patient had a previous course of radiation therapy to the adjacent chest wall. It is not uncommon
for patients with oligometastatic cancers to undergo several courses of local radiation therapy as
their oligometastatic state evolves over time. SBRT allows for very high ablative radiation doses
to be delivered to small areas of disease while avoiding previously irradiated tissue. Some of the
toxicities of overlapping reirradiation include chronic ulcers, fibrosis, rib fracture, and chronic
pain. Each of these toxicities may be debilitating, so it is critical to utilize highly focused radiation
techniques. In this case, as the records note that the patient already had a wedge resection of
the lung, reducing his functional lung capacity, it is critical to spare normal lung volume from
excess radiation exposure. In this clinical setting, given this patients previously irradiated
adjacent chest wall and history of lung resection, the requested service is medically indicated.
Therefore, stereotactic body radiation therapy is medically necessary for the treatment of this
patient. | 1 |
The patient is a 62-year-old female with invasive urothelial carcinoma status post chemotherapy using Gem/Cisplatin followed by a radical cystectomy revealing a high grade T4NxMx yP2aypN2. The patient subsequently developed a right inguinal lymph node on 6/29/17 with pathology consistent with metastatic urothelial cancer, multiple retroperitoneal lymph nodes were subsequently documented and the patient was started on pembrolizumab. FoundationOne testing on 8/15/16 revealed multiple genomic alterations. The patient has requested reimbursement for the FoundationOne gene test provided on 8/15/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. | Upheld | Experimental | Summary Reviewer 1
The patient is a 62-year-old female with invasive urothelial carcinoma status post chemotherapy using Gem/Cisplatin followed by a radical cystectomy revealing a high grade T4NxMx yP2aypN2. The patient subsequently developed a right inguinal lymph node on 6/29/17 with pathology consistent with metastatic urothelial cancer, multiple retroperitoneal lymph nodes were subsequently documented and the patient was started on pembrolizumab. FoundationOne testing on 8/15/16 revealed multiple genomic alterations. The patient has requested reimbursement for the FoundationOne gene test provided on 8/15/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. In the peer-reviewed medical literature, FoundationOne testing has not been demonstrated to improve patient outcomes as compared to standard testing. According to the National Comprehensive Cancer Network (NCCN), to demonstrate clinical utility of panel genetic testing such as FoundationOne, prospective randomized clinical trials are needed that compare the strategy of targeted treatment based on panel results with standard of care. The available literature consists of a small number of uncontrolled studies, and non-randomized controlled trials that use imperfect comparators. This evidence is insufficient to support the use of FoundationOne in lieu of standard testing. As a result, the use of expanded mutation panel testing for targeted treatment in cancer should only be conducted in the setting of a clinical trial. For these reasons, the FoundationOne test provided on 8/15/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 63-year-old male with a diagnosis of benign prostatic hyperplasia (BPH). Associated symptoms include frequency, dysuria, intermittent difficulty in urinary flow, and an elevated prostate-specific antigen (PSA) of 10. A computed tomography (CT) scan of the abdomen and pelvis dated 8/21/17 showed a large prostate, thick bladder with calculi, intermittent hematuria, large calcifications, and left low pole stone and bladder stone. On 8/24/17, he underwent a prostate biopsy and a cystolitholapaxy, which revealed an enlarged prostate with a volume of 45 mL, biopsy was negative, and the bladder was moderate to severely trabeculated with multiple saccules and small diverticula with a stone of 1.5 x 2.5 cm. The patient has requested authorization and coverage for a prostatic urethral lift implant. The Health Insurer has denied this request indicating that the requested surgical procedure is considered investigational. | Overturned | Experimental | Summary Reviewer 1
The patient is a 63-year-old male with a diagnosis of benign prostatic hyperplasia (BPH). Associated symptoms include frequency, dysuria, intermittent difficulty in urinary flow, and an elevated prostate-specific antigen (PSA) of 10. A computed tomography (CT) scan of the abdomen and pelvis dated 8/21/17 showed a large prostate, thick bladder with calculi, intermittent hematuria, large calcifications, and left low pole stone and bladder stone. On 8/24/17, he underwent a prostate biopsy and a cystolitholapaxy, which revealed an enlarged prostate with a volume of 45 mL, biopsy was negative, and the bladder was moderate to severely trabeculated with multiple saccules and small diverticula with a stone of 1.5 x 2.5 cm. The patient has requested authorization and coverage for a prostatic urethral lift implant. The Health Insurer has denied this request indicating that the requested surgical procedure is considered investigational. The prostatic UroLift system is a minimally invasive approach to treating BPH that lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. Recent clinical trials including prospective sham controlled randomized studies have shown that the UroLift system treatment is safe and effective in relieving lower urinary tract symptoms due to BPH without significantly compromising sexual function. Compared with standard available alternatives, the prostatic UroLift system is minimally invasive procedure without a requirement of general anesthesia and with a potentially shorter operative time. All told, the requested prostatic urethral lift implant 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 procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a 55-year-old female who presented to her provider on 1/3/22. The records noted
generalized abdominal pain, along with fibromyalgia, chronic low back pain, and migraines. The
patient has requested authorization and coverage for Oxycontin (oxycodone HCL tablet ER 12
hour deter 40 mg). The Health Plan has denied this request and reported the requested
medication is not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 55-year-old female who presented to her provider on 1/3/22. The records noted
generalized abdominal pain, along with fibromyalgia, chronic low back pain, and migraines. The
patient has requested authorization and coverage for Oxycontin (oxycodone HCL tablet ER 12
hour deter 40 mg). The Health Plan has denied this request and reported the requested
medication is not medically necessary for the treatment of this patient. This denial is the subject
of this appeal and determination. The physician reviewer found that the submitted documentation
supports the medical necessity of the requested medication. On determining when to initiate or
continue opioids for chronic pain, Dowell and colleagues report, Nonpharmacologic therapy
and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider
opioid therapy only if expected benefits for both pain and function are anticipated to outweigh
risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy
and nonopioid pharmacologic therapy, as appropriate. The authors further note, Before starting
opioid therapy for chronic pain, clinicians should establish treatment goals with all patients,
including realistic goals for pain and function, and should consider how opioid therapy will be
discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if
there is clinically meaningful improvement in pain and function that outweighs risks to patient
safety. The Federation of State Medical Boards (FSMB) recommends prescribers use opioid
therapy for chronic pain that is not cancer-related, or part of palliative care or end-of-life care,
only when non-opioid and non-pharmacological options have not been effective. Maintain opioid
dosage as low as possible and continue only if clear and objective outcomes are being met.
Manchikanti and colleagues advise that providers establish appropriate physical diagnosis and
psychological diagnosis if available, consider appropriate imaging, physical diagnosis, and
psychological status to collaborate with subjective complaints, and establish medical necessity
based on the average moderate-to-severe pain and/or disability. In this case, the patient has
chronic pain involving multiple areas, particularly in the abdomen and back. The patient is
currently receiving specialty care from gastroenterology and neurology for pain management.
She has been stable on Oxycontin with adequate pain control, prescribed by the same provider,
without irregular urine toxicology screens, and with CURES reports consistent with therapy. The
records did not document evidence of adverse drug reactions or aberrant behavior identified.
Given that this patient is being treated in a manner consistent with current medical literature, the
requested medication is medically indicated. Therefore, Oxycontin (oxycodone HCL tablet ER
12 hour deter 40 mg) is medically necessary for the treatment of this patient. | 1 |
A 31-year-old male enrollee has requested reimbursement for the home sleep study provided from 9/20/15 through 9/22/15. 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 patient had a normal Epworth Sleepiness score and thus did not have daytime hypersomnia.
In addition, he was not overweight or obese. There was no witnessed apnea. | Upheld | Medical Necessity | Summary Reviewer
A 31-year-old male enrollee has requested reimbursement for the home sleep study provided from 9/20/15 through 9/22/15. 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 that review of the submitted documentation and relevant literature fails to demonstrate the medical necessity of the services at issue. There was no clinical indication for the home sleep study for this patient. The patient had a normal Epworth Sleepiness score and thus did not have daytime hypersomnia. Hypersomnia is the cornerstone for a diagnosis of clinically significant sleep apnea. In addition, he was not overweight or obese. There was no witnessed apnea. There was no documented elevated Mallampati score. Moreover, snoring is not an indication for a sleep study. For the reasons stated, the home sleep study provided from 9/20/15 through 9/22/15 was not medically necessary for evaluation of the patients medical condition. Given the above reasons, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
INSERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION] | Overturned | Experimental | Summary Reviewer 2
[INSERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION] The physician reviewer found that the American Society of Colon and Rectal Surgeons guideline for the management of hemorrhoids describes Doppler guided hemorrhoidectomy as an effective surgical intervention for patients that have failed medical management and office-based procedures (Davis, et al). In the peer-reviewed medical literature, Ratto and colleagues performed a multicenter trial of transarterial hemorrhoidal dearterialization performed in 803 patients with symptomatic grade II, III, or IV hemorrhoids. The authors noted that the overall success rate was 91%, with recurrence in 9%. Based on these results, the authors concluded that transarterial hemorrhoidal dearterialization is a safe and effective treatment for patients with symptomatic grade II, III, or IV hemorrhoids. As this patients grade III internal hemorrhoids have not been responsive to conservative medical management or rubber band ligation, the Doppler guided transanal hemorrhoidal dearterialization provided on 11/20/17 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The patient is a nine-year-old female with no significant past medical history with early puberty and short stature. The patientas parent has requested authorization and coverage for Norditropin Flexpro 10 mg/1.5. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
In this case, the patient has growth hormone deficiency diagnosed after growth hormone stimulation testing. She is growing with a borderline low growth velocity of around 5 cm per year. | Overturned | Medical Necessity | Summary Reviewer
The patient is a nine-year-old female with no significant past medical history with early puberty and short stature. The patientas parent has requested authorization and coverage for Norditropin Flexpro 10 mg/1.5. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The physician reviewer found that in clinical practice, growth hormone therapy is considered if the predicted adult height is below the normal range. This corresponds to an adult height less than 63 inches (160 cm) for males and less than 59 inches (150 cm) for females. This is also one of the recommendations given by the U.S. Food and Drug Administration (FDA) when deciding to treat idiopathic short stature. Grimberg and colleagues recommended growth hormone therapy to normalize adult height and avoid extreme shortness in children and adolescents with growth hormone deficiency for potential benefits associated with quality of life, physical health and psychosocial wellbeing. In this case, the patient has growth hormone deficiency diagnosed after growth hormone stimulation testing. She is growing with a borderline low growth velocity of around 5 cm per year. The patientas predicted adult height is more than two standard deviations below the mid-parental height of 65.25 inches. As the predicted adult height is below the normal standard deviation range for a female in the United States, growth hormone therapy is indicated. Therefore, Norditropin Flexpro 10 mg/1.5 is medically necessary for the treatment of this patient.
| 1 |
A 57-year-old female enrollee has requested authorization and coverage for the injectable medication Euflexxa. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees knee pain.
This patient presents with chronic bilateral knee pain with limited function. Clinical examination findings are consistent with bilateral knee osteoarthritis in the medial and patellofemoral compartments. She has failed to adequately respond to conservative treatment, including activity modification, nonsteroidal anti-inflammatory drugs, ice, and physical therapy. She has undergone prior Euflexxa injections, with reported pain relief and functional restoration. | Overturned | Medical Necessity | Summary Reviewer
A 57-year-old female enrollee has requested authorization and coverage for the injectable medication Euflexxa. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees knee pain. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. Bannuru and colleagues concluded that hyaluronic acid was the best pharmacologic intervention for knee osteoarthritis in their meta-analysis of 137 studies with 33,243 participants. Hyaluronic acid was found to be better than injected placebo or injected corticosteroids. Campbell and colleagues conducted a systematic review of overlapping meta-analyses comparing intra-articular hyaluronic acid with other nonoperative treatment modalities for knee osteoarthritis. The authors reported that the current highest level of evidence suggests that intra-articular hyaluronic acid is a viable option for knee osteoarthritis. This patient presents with chronic bilateral knee pain with limited function. Clinical examination findings are consistent with bilateral knee osteoarthritis in the medial and patellofemoral compartments. She has failed to adequately respond to conservative treatment, including activity modification, nonsteroidal anti-inflammatory drugs, ice, and physical therapy. She has undergone prior Euflexxa injections, with reported pain relief and functional restoration. The peer-reviewed literature supports the use of viscosupplementation injections for the treatment of pain in patients with osteoarthritis of the knee. Repeat viscosupplementation injections have been found to be safe and effective and allow for delay of knee replacement surgery. Thus, the injectable medication Euflexxa is 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 53-year-old female enrollee has requested reimbursement for PathFinder TG testing (84999) performed on 7/30/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 53-year-old female enrollee has requested reimbursement for PathFinder TG testing (84999) performed on 7/30/14. 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 differential diagnosis of pancreatic cysts includes pseudocysts, simple cysts, and cystic neoplasms. The latter category represents cancer and requires aggressive surgical resection. Discriminating between benign and neoplastic lesions is complicated, and current technology is limited. Esophagogastroduodenoscopy and esophageal ultrasound are important for surveillance, but clinical observation is not definitive. Pathology is required. An endosonogram combined with tumor marker analysis on sampled cystic fluid can add to the sensitivity of diagnosing neoplastic disease, but it does not to the degree necessary to determine which patients require surgery. There is sufficient support for the services at issue in this clinical setting. The current standard approach of fluid cytology is inadequate to determine the management in every patient. In this patients case, PathFinder TG testing performed on 7/30/14 was likely to have been of greater benefit 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.
| 0 |
A 41-year-old male enrollee has requested authorization and coverage for the LINX device. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 41-year-old male enrollee has requested authorization and coverage for the LINX device. 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 the request services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Although, the LINX reflux management system is U.S. Food and Drug (FDA) approved it has not been demonstrated to be superior to optimal medical therapy or a standard reflux operation in controlled trials. The evidence to date has been derived from open label studies which have used patients as their own controls. In addition, dysphagia is a common adverse side effect of the procedure and can lead to long term dissatisfaction from the patient's perspective. Therefore, the patients request for the LINX device 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.
| 0 |
A 50-year-old female enrollee has requested authorization and coverage for minimally invasive sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.
the patient has chronic left sacroiliac dysfunction and pain that interferes with activities of daily living. | Upheld | Experimental | Summary Reviewer 1
A 50-year-old female enrollee has requested authorization and coverage for minimally invasive sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the patient has chronic left sacroiliac dysfunction and pain that interferes with activities of daily living. The selected procedure of minimally invasive sacroiliac fusion using the triangular titanium implant is a relatively popular procedure, with 88 percent fusion rate and documented excellent results at five-year follow-up. Minimally invasive sacroiliac joint fusion has become an increasingly popular and accepted surgical option for chronic sacroiliac joint dysfunction, a common cause of unremitting chronic low back/buttock pain. Minimally invasive sacroiliac joint surgery has been proven to be a safe and effective procedure, with a high fusion rate, a good safety profile and significant improvements in pain severity and disability reported through 12 months post-procedure. A five-year follow-up showed continued excellent clinical responses in patients with sacroiliac joint pain treated with sacroiliac joint fusion using triangular titanium implants along with a high rate of joint fusion. Therefore, the requested minimally invasive sacroiliac joint fusion is likely to be more beneficial than any available standard therapy.
| 1 |
A 51-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 7/13/15. 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 51-year-old female enrollee has requested reimbursement for the breast tomosynthesis provided on 7/13/15. 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 there is sufficient support in the medical literature for the services at issue in this clinical setting. The addition of tomosynthesis allows better characterization of possible masses, spiculation, and architectural distortion. Moreover, the services in dispute prevented additional magnification views. For the reasons provided, the services at issue were 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 30-year-old female enrollee has requested authorization and coverage for cervical total disc replacement surgery and one day inpatient services. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees neck pain. | Upheld | Experimental | Summary Reviewer 3
A 30-year-old female enrollee has requested authorization and coverage for cervical total disc replacement surgery and one day inpatient services. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees neck pain. The physician reviewer found that recent literature suggests that total disc replacement may provide well selected patients with superior health outcomes as compared to anterior cervical discectomy and fusion for one- and two-level degenerative disc disease. Bae and colleagues compared outcomes in a prospective randomized, U.S. Food and Drug Administration (FDA) investigational device exemption clinical trial. The authors reported that at four-year follow-up, each group demonstrated improvement in clinical outcome measures and a comparable safety profile. Davis and colleagues reviewed total disc replacement as surgical treatment of degenerative disc disease at one or two contiguous levels of the cervical spine and found similar outcomes when compared with anterior cervical discectomy with fusion (ACDF). Given this patients clinical findings and complaints, she is likely to obtain greater benefit from the requested cervical total disc replacement surgery and one day inpatient services than treatment with standard alternatives. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 47-year-old female enrollee has requested reimbursement and prospective authorization and coverage for pertuzumab injections from 8/18/15 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 47-year-old female enrollee has requested reimbursement and prospective authorization and coverage for pertuzumab injections from 8/18/15 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition. The physician reviewer found pertuzumab is a monoclonal antibody that targets HER2 positive breast cancer cells, similar to, but not exactly in the same way as trastuzumab. In metastatic breast cancer, when used in combination with chemotherapy and trastuzumab, pertuzumab yields superior progression-free survival compared to treatment with Taxotere-Herceptin without pertuzumab. Combining pertuzumab with Herceptin and chemotherapy also appears to be superior to the combination without pertuzumab in the neoadjuvant situation. However, there is a lack of data to support the use of combining pertuzumab with trastuzumab in the adjuvant setting. Therefore, the superior efficacy of pertuzumab injections from 8/18/15 forward has not been established. Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 30-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 30-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg tablet.
The Health Insurer has denied this request and reported that the requested medication is
investigational for the treatment of the enrollees medical condition. The physician reviewer
found that there are no FDA approved medications for the treatment of alopecia areata.
Commonly used treatments have included off-label use of steroids and steroid sparing drugs like
methotrexate as well as topical agents and topical immunotherapy with squaric acid (which
cannot be use for practical reasons on the eyelids). There are many Janus kinase inhibitors
currently in phase 3 trials and many more patients that are using this treatment off-label with
good success for this disease. There is sufficient support for the requested medication in this
clinical setting. Therefore, Xeljanz 5 mg tablet is likely to be more beneficial than any available
standard therapy.
| 1 |
The parent of a 12-year-old male enrollee has requested authorization and coverage for Humatrope 12 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency.
The patient has experienced a deceleration in growth velocity from the 40th percentile to fifth percentile between 2-11 years of age. IGF-1 level was low, and
. He had a good response to one year of therapy without adverse effects, and | Overturned | Medical Necessity | Summary Reviewer
The parent of a 12-year-old male enrollee has requested authorization and coverage for Humatrope 12 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency. The physician reviewer found the requested medication is medically necessary for treatment of the patients medical condition. The patient has experienced a deceleration in growth velocity from the 40th percentile to fifth percentile between 2-11 years of age. IGF-1 level was low, and provocative GH testing results were poor. Based on auxological and biochemical criteria, the patient meets generally established guidelines for GH treatment. He had a good response to one year of therapy without adverse effects, and continuation of GH therapy is medically necessary until epiphyseal fusion. Withdrawal of therapy at the age of expected puberty may result in irreversible impairment in height potential. As such, Humatrope 12 mg cartridge has been established as medically necessary for treatment of the patients medical condition. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 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. | Upheld | Experimental | Summary Reviewer 3
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 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 they suggest a high-risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. There is little data on the services at issue in this clinical setting. The test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, Decision DX Melanoma Assay performed on 12/16/15 was not likely to be more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The parent of an 11-year-old male enrollee has requested reimbursement for the Prometheus Anser IFX test performed on 7/16/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis. | Overturned | Experimental | Summary Reviewer 3
The parent of an 11-year-old male enrollee has requested reimbursement for the Prometheus Anser IFX test performed on 7/16/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found that in the current peer-reviewed medical literature, Yanai and Hanauer concluded that although the incorporation of the measurement of trough levels and anti-drug antibodies may be helpful in this clinical setting, prospective controlled trials are direly needed to investigate the optimal tailored management in individual patients who lose response. The testing for trough IFX levels and antibodies are appropriate and within the accepted standard of practice now in patients treated with IFX. The Anser IFX testing in this patients case was non-trough. All told, the mid treatment Anser IFX lab test performed on 7/16/14 was not likely to be more beneficial for evaluation of this patients ulcerative colitis than any available standard testing. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 26-year-old male enrollee has requested reimbursement for the substance use residential treatment services provided from 11/11/14 through 11/19/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse.
this patient was not at imminent risk for withdrawals. He was not suicidal or homicidal and he was not aggressive towards others. He did not show self-harm behaviors. He was cognitively intact and able to perform activities of daily living. He was medically and psychiatrically stable. He was motivated and a willing participant in his recovery. While he remained at risk for relapse, he had improved | Upheld | Medical Necessity | Summary Reviewer
A 26-year-old male enrollee has requested reimbursement for the substance use residential treatment services provided from 11/11/14 through 11/19/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse. The physician reviewer found that the records indicate that this patient was not at imminent risk for withdrawals. He was not suicidal or homicidal and he was not aggressive towards others. He did not show self-harm behaviors. He was cognitively intact and able to perform activities of daily living. He was medically and psychiatrically stable. He was motivated and a willing participant in his recovery. While he remained at risk for relapse, he had improved and treatment could have been managed at a lower level of care. By 11/11/14, he no longer required 24-hour supervision and could have been stepped down to a lower level of care such as intensive outpatient. For these reasons, the substance use residential treatment services provided from 11/11/14 through 11/19/14 were not medically necessary for treatment of this patients medical condition. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 62-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer.
In this case, the patient presented with heterogeneously dense breasts. | Overturned | Experimental | Summary Reviewer 3
A 62-year-old female enrollee has requested reimbursement for the breast tomosynthesis performed on 4/23/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found according to Helvie, The Achilles heel of screening mammography is the detection of cancer in women with radiographic dense breasts. While nearly all cancers will be apparent in fatty breasts, only half will be visible in extremely dense breast. This results, at least in large part, from the masking or camouflaging of noncalcified cancers by surrounding dense tissue. The author further states that breast tomosynthesis has the potential to change conventional mammographic screening and diagnostic imaging with possible improvements in cancer detection, decreased callbacks, and fewer false positive biopsies. In this case, the patient presented with heterogeneously dense breasts. Given the dense nature of the patients breasts, the breast tomosynthesis performed on 4/23/15 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned. | 1 |
A 67-year-old male enrollee has requested reimbursement for gene testing performed on 4/19/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic renal cell carcinoma. | Upheld | Experimental | Summary Reviewer 2
A 67-year-old male enrollee has requested reimbursement for gene testing performed on 4/19/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees metastatic renal cell carcinoma. The physician reviewer found the National Comprehensive Cancer Network guidelines list numerous first-line and second-line treatment options for clear cell kidney cancer (renal cell cancer.) These include temsirolimus and everolimus. None of them require genetic testing. The discussion section of the guidelines do not mention the use of next generation sequencing such as FoundationOne testing. There is a proposed clinical trial evaluating next generation sequencing that will include kidney cancer patients. It is not yet accruing patients. At this time, there is a lack of data to support that gene testing performed on 4/19/16 was likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 14-year-old male enrollee has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment center (RTC) services provided from 11/7/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD) and anxiety.
As noted by the CALOCUS, the patient was at some risk of harm due to episodic outbursts but is not having active suicidal ideation or other behaviors or thoughts. In addition, the patients functional status is moderate, the patient has had minimal school disruption and is able to complete activities of daily living in an age appropriate manner. Further, the patient does not have active serious medical problems and although he has issues with family relationships, he has a stable housing situation if accepted home. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 14-year-old male enrollee has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment center (RTC) services provided from 11/7/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD) and anxiety. The physician reviewer found that based on current guidelines including the Child and Adolescent Level of Care Utilization System (CALOCUS), the RTC services provided from 11/7/16 forward were not and are not medically necessary for treatment of this patients medical condition. As noted by the CALOCUS, the patient was at some risk of harm due to episodic outbursts but is not having active suicidal ideation or other behaviors or thoughts. In addition, the patients functional status is moderate, the patient has had minimal school disruption and is able to complete activities of daily living in an age appropriate manner. Further, the patient does not have active serious medical problems and although he has issues with family relationships, he has a stable housing situation if accepted home. The patients resiliency and treatment history is moderate due to minimal positive treatment response in the past and the patient participates actively in therapy but has poor insight and is obstructive at times. Overall, this patients presentation supports treatment in a less restrictive setting such as intensive outpatient program (IOP). It appears that the patient has sufficiently stabilized to allow transition to a less restrictive setting. The majority of the patients current issues are due to continued oppositional behaviors and the patient has made progress related to his treatment goals. The patients goals are similar to those that would occur on an outpatient basis. Accordingly, the medical records do not support the medical necessity of the RTC services provided from 11/7/16 forward for treatment of this patients behavioral issues. Based on the available documentation, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 53-year-old female enrollee has requested authorization and coverage for durable medical equipment (Flexitouch pneumatic compression pump and leg garment). The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollees lymphedema of the left leg.
review, the patient has been treated with CDT and use of a Medi550 Class 4 (49.0 mmHg) compression garment. However, the patient has not failed treatment with a single chamber non programmable pump which | Upheld | Medical Necessity | Summary Reviewer
A 53-year-old female enrollee has requested authorization and coverage for durable medical equipment (Flexitouch pneumatic compression pump and leg garment). The Health Insurer has denied this request indicating that the requested equipment is not medically necessary for treatment of the enrollees lymphedema of the left leg. The physician reviewer found the review of the submitted documentation and relevant literature fails to demonstrate the medical necessity for the requested equipment. According to Oremus and colleagues there are several conservative (non-pharmacologic, nonsurgical) treatments that exist for secondary lymphedema, however the optimal treatment is unknown. Oremus and colleagues examined the effectiveness of conservative treatments for secondary lymphedema, as well as harms related to these treatments. The authors concluded The literature contains no evidence to suggest the most effective treatment for secondary lymphedema. According to the documentation submitted for review, the patient has been treated with CDT and use of a Medi550 Class 4 (49.0 mmHg) compression garment. However, the patient has not failed treatment with a single chamber non programmable pump which is the next of treatment for the patients medical condition. For the reasons provided, the requested equipment is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 37-year-old male enrollee has requested reimbursement for laboratory testing performed on
6/05/20. 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 patient had noticed a skin lesion in 2018 and was diagnosed
with mycosis fungoides stage IB in 2018 at UC Irvine; he was originally diagnosed with mycosis
fungoides at age 22 in China. On the examination of 4/16/20, he was noted to have patchy
erythema by his provider, who was unsure if this represented underlying cutaneous lymphoma
versus other process. As he had lost insurance, biopsy was deferred. On subsequent examination
on 6/04/20, he again had patchy erythema and had biopsies taken and blood taken for ClonoSeq
ID (T-cell receptor analysis). Biopsy results from 6/04/20 were consistent with mycosis fungoides
of the skin. T-cell clonality studies from the skin showed dominant TCR beta and TCR gamma
sequences, | Overturned | Experimental | Summary Reviewer 3
A 37-year-old male enrollee has requested reimbursement for laboratory testing performed on
6/05/20. 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 for primary cutaneous lymphoma (including mycosis fungoides), the most recent
NCCN guidelines state that T-cell receptor analysis is useful to support the diagnosis of mycosis
fungoides and to distinguish mycosis fungoides from other inflammatory dermatoses. In
addition, demonstration of identical clones in the skin, blood, and/or lymph nodes may be helpful
both for diagnosis and differentiating mycosis fungoides and Sezary syndrome from benign
inflammatory skin diseases, and blood testing is useful to identify blood involvement, which is
critical for staging purposes. The patient had noticed a skin lesion in 2018 and was diagnosed
with mycosis fungoides stage IB in 2018 at UC Irvine; he was originally diagnosed with mycosis
fungoides at age 22 in China. On the examination of 4/16/20, he was noted to have patchy
erythema by his provider, who was unsure if this represented underlying cutaneous lymphoma
versus other process. As he had lost insurance, biopsy was deferred. On subsequent examination
on 6/04/20, he again had patchy erythema and had biopsies taken and blood taken for ClonoSeq
ID (T-cell receptor analysis). Biopsy results from 6/04/20 were consistent with mycosis fungoides
of the skin. T-cell clonality studies from the skin showed dominant TCR beta and TCR gamma
sequences, providing support for a clonal process. NCCN guidelines for mycosis fungoides
highlight the importance of identifying TCR clones in skin and blood for staging purposes (in this
case to ensure that the staging had remained the same versus changed for the patient with
known history of mycosis fungoides). Therefore, laboratory testing performed on 6/05/20 was
likely to have been more beneficial than any available standard therapy.
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A 21-year-old female enrollee has requested reimbursement for adult mental health residential treatment center services provided from 3/12/19 through 12/20/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollee, who has been diagnosed with borderline personality disorder and substance use disorder, in remission.
. The patient had a moderate risk as she had periods of extreme distress and a history of suicidal ideation. She also had excessive usage of substances that resulted in harmful behaviors in the past.
3. The patient had moderate impairment as she had been recently conflicted, withdrawn and alienated in most of her relationships. She had significant deterioration in ability to fulfill responsibilities and obligations to school, self and family. She had severe deficits in interpersonal relationships, ability to engage in socially constructive activities and to maintain responsibilities.
The patient had significant addictive comorbidity. There was recent substance abuse that had clearly detrimental effects, which has been temporarily arrested through the use of a highly structured setting. | Upheld | Medical Necessity | Summary Reviewer
A 21-year-old female enrollee has requested reimbursement for adult mental health residential treatment center services provided from 3/12/19 through 12/20/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollee, who has been diagnosed with borderline personality disorder and substance use disorder, in remission. The physician reviewer found that the Level of Care Utilization System for Psychiatric and Addiction Services (LOCUS) provides a framework for determining the appropriate level of care in patients with mental health treatment needs. With regard to risk of harm, the records support a score of 3. The patient had a moderate risk as she had periods of extreme distress and a history of suicidal ideation. She also had excessive usage of substances that resulted in harmful behaviors in the past. In terms of functional status, the records support a score of 3. The patient had moderate impairment as she had been recently conflicted, withdrawn and alienated in most of her relationships. She had significant deterioration in ability to fulfill responsibilities and obligations to school, self and family. She had severe deficits in interpersonal relationships, ability to engage in socially constructive activities and to maintain responsibilities. Recent gains were achieved while participating in treatment in a structured setting. With regard to medical and addictive comorbidity, the records support a score of 3. The patient had significant addictive comorbidity. There was recent substance abuse that had clearly detrimental effects, which has been temporarily arrested through the use of a highly structured setting. In terms of level of stress of the recovery environment, the records support a score of 3. The patient had a moderately stressful environment due to significant discord or difficulties in family milieu due to recent death of grandparents, and conflict between mother and patient. She had recently failed out of college. She perceived tremendous pressure to perform scholastically that surpassed her ability to meet obligations in an adequate manner. With regard to level of support of the recovery environment, the records support a score of 3. The patient had limited support. She was refusing to see her outpatient psychiatrist and therapist for the 2 months preceding the crisis. She did have support from her family. In terms of treatment and recovery history, the records support a score of 3. The patient had a moderate response to treatment and recovery management. Her current treatment had not achieved complete control of symptoms or optimal control of symptoms. Previous treatment exposures were marked by minimal motivation. The partial recovery has only been maintained with strong professional support in a structured setting. With regard to engagement and recovery status, the records support a score of 3. The patient had limited engagement and recovery. She has had variability and uncertainty in acceptance and understanding of illness. She at times lacked confidence to change despite intentions to do so. She had a fluctuating ability to accept responsibility for recovery. Thus, the patient has a composite score of 21, which indicates that medically monitored non-residential services would be the medically necessary level of care. Services included in this level of care would typically be described as partial hospital programs or as assertive community treatment programs. Intensive treatment should be provided at least 5 days per week and include individual, group, and family therapy depending on the patient's needs. Therefore, the records do not support the medical necessity of residential level of care during the dates of service at issue. Thus, adult mental health residential treatment center services provided from 3/12/19 through 12/20/19 were not medically necessary for the treatment of this patient. | 1 |
The parent of a seven-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavior analysis (ABA) (36 hours of 97153 and 6 hours of 97155) provided from 3/03/20 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees medical condition. | Overturned | Medical Necessity | Summary Reviewer
The parent of a seven-year-old male enrollee has requested reimbursement and prospective authorization and coverage for applied behavior analysis (ABA) (36 hours of 97153 and 6 hours of 97155) provided from 3/03/20 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the patient meets all medical necessity criteria defined by Papatola and Lustig. The authors noted that medical necessity is defined as health-care services that a provider, exercising a prudent clinical judgment, would provide to a patient for the purpose of evaluating, diagnosing, or treating an illness, injury, disease, or its symptoms and are (a) required to meet the essential health needs of the patient; (b) consistent with the diagnosis of the condition for which they are required; (c) consistent in type, frequency, and duration of treatment with scientifically based guidelines as determined by medical research; (d) required for purposes other than the convenience of the provider or the comfort of the patient; and (e) rendered in the least intensive setting that is appropriate for the delivery of health care. The Health Insurer has indicated that the services at issue were not and are not medically necessary because they are educational in nature. While the services are provided in an educational setting (which the BACB encourages), the patient is working on goals related to his autism diagnosis, not goals that are intended to improve their academic performance. These goals include maladaptive behavior, receptive/expressive language, pragmatic language, social skills, self-help, and safety, all of which are associated with autism spectrum disorder. All of the goals highlight developing independence in association with the patients specific autism symptoms. Therefore, ABA services (36 hours of 97153 and 6 hours of 97155) provided from 3/03/20 forward were and are medically necessary for the treatment of this patient. | 0 |
A 60-year-old male has requested reimbursement for gene testing provided on 11/07/17. 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 1
A 60-year-old male has requested reimbursement for gene testing provided on 11/07/17. 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 the staging system spelled out by Balch. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either class 1 or class 2 based on the risk of metastasis. 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 if DecisionDx-Melanoma assay can be used to make clinical decisions. Therefore, gene testing provided on 11/07/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 28-year-old female enrollee has requested reimbursement for mental health residential treatment provided from 10/18/18 through 2/12/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. | Upheld | Medical Necessity | Summary Reviewer
A 28-year-old female enrollee has requested reimbursement for mental health residential treatment provided from 10/18/18 through 2/12/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based, objective instrument such as the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) is indispensable in determining necessary and appropriate level of care for adults. In terms of risk of harm, the records support a score of 1 due to a lack of current suicidal or homicidal ideation or self-harm. With regards to functional status, the records support a score of 2 due to some difficulty meeting obligations and disruptions in usual activities. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to stable medical issues and no active substance use. With regards to level of stress of the recovery environment, the records support a score of 2 due to recent move back in with parents. In terms of level of support of the recovery environment, the records support a score of 2 due to positive relationship with family overall and parents ability to aid her. With regards to treatment and recovery history, the records support a score of 3 due to no significant recent intensive forms of treatment prior to her residential admission and unclear response to prior treatment. In terms of engagement and recovery status, the records support a score of 3 due to variability in cooperation in treatment and limited insight into the need for treatment. The patient has a composite score of 15. This score of correlates with high intensity community-based services. Therefore, residential treatment was not medically indicated. Thus, mental health residential treatment provided from 10/18/18 through 2/12/19 was not medically necessary for the treatment of this patient. | 0 |
The patient is a 49-year-old female who developed shoulder pain and left leg atrophy. The patient has requested authorization and coverage for Rituxan (rituximab intravenous solution 500 mg/50 mL). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient.
The patient was diagnosed with an inflammatory neuropathy for which Rituximab was requested after intolerance to IVIG. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 49-year-old female who developed shoulder pain and left leg atrophy. The patient has requested authorization and coverage for Rituxan (rituximab intravenous solution 500 mg/50 mL). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. The patient was diagnosed with an inflammatory neuropathy for which Rituximab was requested after intolerance to IVIG. Rituximab is a reasonable alternative in this case. The medical literature includes several studies and reports that support the efficacy of Rituximab in CIDP and CIDP variants. Therefore, Rituxan (rituximab intravenous solution 500 mg/50 mL) is medically necessary for the treatment of this patient. | 1 |
A 70-year-old female enrollee has requested reimbursement for radiofrequency ablation of the right side performed on 5/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees varicose veins.T | Overturned | Experimental | Summary Reviewer 3
A 70-year-old female enrollee has requested reimbursement for radiofrequency ablation of the right side performed on 5/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees varicose veins.The physician reviewer found the medical evidence supports the services at issue in this patients case. The medical literature suggests that treatment of the anterior accessory vein can lead to favorable hemodynamic changes in the treatment of venous insufficiency. Providers may use endovascular techniques to treat an anterior accessory saphenous vein if it is straight enough to accept a treatment catheter. There are also providers who use Varithena for these procedures because the foam is able to travel in the branch if it is tortuous. The literature supports the use of ablation for treatment of the refluxing anterior accessory saphenous vein. Thus, radiofrequency ablation of the right side performed on 5/25/16 was likely to have been of greater benefit than other treatment methods. 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 17-year-old male enrollee has requested reimbursement for intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found the patient presents for cognitive dysfunction and fatigue of long-standing duration. The records do not include a positive IgG antibody titer. The patient has had multiple courses of antibiotics, without lasting and significant improvement. | Upheld | Experimental | Summary Reviewer 1
The parent of a 17-year-old male enrollee has requested reimbursement for intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found the patient presents for cognitive dysfunction and fatigue of long-standing duration. The records do not include a positive IgG antibody titer. The patient has had multiple courses of antibiotics, without lasting and significant improvement. The diagnosis of late stage Lyme disease has not been established. The treatment of late stage Lyme disease is a four-week course of intravenous antibiotic. Prolonged courses or repeat courses have not been shown to be efficacious. All told, intravenous treatment with antibiotics for Lyme disease from August 2015 through November 2015 was not likely to have been of greater benefit 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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A 47-year-old female enrollee has requested authorization and coverage for L5-S1 decompression with lumbar fusion, possible transforaminal lumbar interbody fusion (TLIF) and associated three inpatient days. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees back pain. | Overturned | Medical Necessity | Summary Reviewer
A 47-year-old female enrollee has requested authorization and coverage for L5-S1 decompression with lumbar fusion, possible transforaminal lumbar interbody fusion (TLIF) and associated three inpatient days. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees back pain. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. A review of the literature indicates moderate evidence of good outcomes from standalone lumbar fusions for chronic pain with or without instability. In this case, there is evidence of severe chronic low back pain associated with disc space collapse at L5-S1 and degenerative retrolisthesis. There is also evidence of facet arthritis and moderate bilateral neural foraminal narrowing and some displacement of the left S1 nerve root. As such, decompression combined with a fusion procedure is medically necessary. The medical evidence supports the requested services in this clinical setting. Therefore, L5-S1 decompression with lumbar fusion, possible transforaminal lumbar interbody fusion (TLIF) and associated three inpatient days 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 |
A 52-year-old transgender female enrollee has requested reimbursement for CPT codes 67900, 20926, 21121, 40799, 30410, 21172 and 30520 performed on 10/15/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
The records document that the patient has a history of gender dysphoria. | Overturned | Medical Necessity | Summary Reviewer
A 52-year-old transgender female enrollee has requested reimbursement for CPT codes 67900, 20926, 21121, 40799, 30410, 21172 and 30520 performed on 10/15/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The records document that the patient has a history of gender dysphoria. The World Professional Association for Transgender Health (WPATH) position statement notes, non-genital surgical procedures...notably facial feminization surgeryare often of greater practical significance in the patients daily life than reconstruction of the genitals. Ainsworth and Spiegel reported that facial feminization surgery, like genital surgery improved mental health-related quality of life. There is sufficient support for the services at issue in this clinical setting. Therefore, CPT codes 67900, 20926, 21121, 40799, 30410, 21172 and 30520 performed on 10/15/19 were medically necessary for the treatment of this patient. | 1 |
A 42-year-old female enrollee has requested authorization and coverage for anterior cervical discectomy and fusion surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.
The records document a history of neck pain and radicular paresthesias in the upper extremities, left greater than right, in the C6 distribution, and imaging
findings. Epidural steroid injections provided short-term relief. The provider has recommended an anterior cervical discectomy and fusion at C5-6. | Overturned | Medical Necessity | Summary Reviewer
A 42-year-old female enrollee has requested authorization and coverage for anterior cervical discectomy and fusion surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested services in this clinical setting. The records document a history of neck pain and radicular paresthesias in the upper extremities, left greater than right, in the C6 distribution, and imaging evidence corroborates the clinical findings. Epidural steroid injections provided short-term relief. The provider has recommended an anterior cervical discectomy and fusion at C5-6. Anterior cervical discectomy and fusion is one of the most common procedures performed in spine surgery. The indication is neck pain with a neurocompressive lesion, as in this case. It allows for a direct decompression of the spinal cord and the neural foramina. Various studies comparing anterior cervical discectomy and fusion with anterior plate fixation versus use of cages report superior surgical outcomes in anterior cervical discectomy and fusion procedures with anterior plate fixation and slightly better neck pain scores at last follow-up. There were no significant differences in the operative blood loss, clinical outcomes or rates of fusion between the two groups. The medical evidence supports the requested services in this patients case. Therefore, anterior cervical discectomy and fusion at C5-6 level is medically necessary for the treatment of this patient. | 1 |
A 56-year-old male enrollee has requested reimbursement for DecisionDx Melanoma testing performed on 11/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 56-year-old male enrollee has requested reimbursement for DecisionDx Melanoma testing performed on 11/14/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has been thought to add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami reported on 217 cases, with good correlation between DecisionDx-Melanoma testing class and prognosis in patients undergoing sentinel node biopsy. Berger reported on 156 cases, but there was not sufficient follow-up to determine the real value of the assay. It is not clear how the five-year DecisionDx-Melanoma testing date compares to the ten-year Balch data. Most importantly, it is unknown if it can be used to make clinical decisions. Therefore, DecisionDx-Melanoma testing performed on 11/14/18 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 47-year-old male enrollee has requested authorization and coverage for vestibular stenosis repair. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of nasal congestion and obstruction. | Upheld | Experimental | Summary Reviewer 3
A 47-year-old male enrollee has requested authorization and coverage for vestibular stenosis repair. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of nasal congestion and obstruction. The physician reviewer found that the Latera implant is an absorbable material specifically designed to support the lateral nasal wall collapse in selected patients. Currently, there is a lack of long-term objective data supporting the clinical advantage of the device, although there are some articles and anecdotal evidence that the device is useful. Stolovitsky and colleagues stated evidence for longer-term improvement in a prior cohort of patients examined at 12 and 24 months postoperatively provides hope that these results may be maintained for two years or more. Limitations of the study include a single arm study design with short-term follow-up. A randomized placebo control study design should be considered in the future. The current medical evidence has not demonstrated the superior efficacy of the requested services. Thus, vestibular stenosis repair 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.
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A 28-year-old female enrollee has requested reimbursement for computer-aided detection performed on 4/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has BRCA2 gene mutation. | Overturned | Experimental | Summary Reviewer 3
A 28-year-old female enrollee has requested reimbursement for computer-aided detection performed on 4/20/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has BRCA2 gene mutation. The physician reviewer found that contrast-enhanced breast MRI is approximately 90% sensitive for the detection of breast cancer in the high risk population, whereas ultrasound and mammography are approximately 38% sensitive individually in this population. Computer-aided detection is software that is used as part of the interpretation of the MRI, which helps to analyze the breast tissue and possible abnormalities. It is considered an integral part of the breast MRI examination. Screening contrast-enhanced breast MRI beginning at age 25 is recommended in women with BRCA gene mutations, their untested first degree relatives, and women with a lifetime risk of greater than 20%. MRI with mammography is recommended starting at age 30. This patient has a known BRCA2 gene mutation, which is considered one of the highest risk populations for breast cancer. In this setting, the medical evidence supports annual screening MRI examinations including computer-aided detection. Thus, computer-aided detection performed on 4/20/18 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 62-year-old male enrollee has requested reimbursement for homocysteine, Factor V Leiden and methylenetetrahydrofolate reductase (MTHFR) testing provided on 4/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees right lower extremity deep vein thrombosis (DVT).
In this case, the patient has de novo DVT without provocative factor per se, and is at high risk for pulmonary thromboembolism. | Overturned | Experimental | Summary Reviewer 2
A 62-year-old male enrollee has requested reimbursement for homocysteine, Factor V Leiden and methylenetetrahydrofolate reductase (MTHFR) testing provided on 4/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees right lower extremity deep vein thrombosis (DVT). The physician reviewer found the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Homocysteine testing is clinically indicated for idiopathic or recurrent venous thromboembolism. In this case, the patient has de novo DVT without provocative factor per se, and is at high risk for pulmonary thromboembolism. In addition, Factor V Leiden genetic testing was clinically indicated given the patients venous thrombosis with a family history of thrombotic disease. Moreover, there is growing evidence that MTHFR gene polymorphism testing has utility in this clinical setting. As such, the homocysteine, Factor V Leiden and MTHFR testing provided on 4/28/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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An 18-year-old male enrollee has requested reimbursement for outdoor behavioral health
services provided from 11/03/20 through 12/31/20. The Health Insurer has denied this request
and reported that the services at issue were investigational for the treatment of the enrollees
medical condition. | Upheld | Experimental | Summary Reviewer 3
An 18-year-old male enrollee has requested reimbursement for outdoor behavioral health
services provided from 11/03/20 through 12/31/20. 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 in a document outlining principles of care
for residential treatment, the American Academy of Child and Adolescent Psychiatry stated, The
best place for children and adolescents is at home with their families. A child or adolescent with
mental illness should be treated in the safest and least restrictive environment and needed
services should be wrapped-around to provide more intensive home or community-based
services. However, due to the severity of an individuals psychiatric illness, there are times when
a patients needs cannot be met in a community-based setting. The Child and Adolescent Service
Intensity Instrument (CASII; AACAP, 2007) defines level of service intensity by a combination of
variables: clinical services, support services, care environment, crisis stabilization and prevention
services. The Child and Adolescent Level of Care Service Intensity/Utilization System (CALOCUS-
CASII) provides a framework for determining the appropriate level of care for children and
adolescents in mental health treatment. CALOCUS-CASII also sets parameters for the clinical
services typically offered at each level of care. According to CALOCUS-CASII, Level Five: Medically
Monitored Intensive Integrated Services is the level assigned to most residential treatment
centers. Per CALOCUS-CASII, This level of service intensity refers to treatment in which the
essential element is the maintenance of a milieu in which the therapeutic needs of the child and
adolescent and family can be addressed intensively. CALOCUS-CASII guidelines state that
medical and psychiatric services should be available. Additionally, non-psychiatric clinical
services generally average 8-20 hours per client weekly. Per the clinical records provided, the
patient did not receive clinical services at this level of intensity while attending the outdoor
behavioral health program during the period under review. Furthermore, the clinical
documentation does not meet typical standards for residential care. There is no convincing
explanation offered as to why the patient could not have enrolled in a standard residential
treatment program instead of the outdoor behavioral health program. Additionally, there is no
indication that the patient received unique benefits from the outdoor behavioral health program
that he could not have received at a standard residential treatment facility. The discharge plan
for the outdoor behavioral health program included a recommendation for the patient to
transfer to a residential treatment program. Therefore, outdoor behavioral health services provided from 11/03/20 through 12/31/20 was not likely to have been more beneficial than any
available standard therapy. | 0 |
A 65-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 6/13/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who has a history of breast cancer. | Overturned | Experimental | Summary Reviewer 2
A 65-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 6/13/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who has a history of breast cancer. The physician reviewer found that digital mammography screening has been proven to decrease mortality related to breast cancer. Standard or two-dimensional mammography does have significant limitations, namely obscuration of cancers within areas of overlapping or dense tissue, as well as false positive recalls due to overlapping breast tissue, which must be confirmed with additional imaging. Digital breast tomosynthesis addresses both of these issues. The addition of breast tomosynthesis decreases the false positive recall rate by 15%. It does this by allowing the radiologist to scan through slices of breast tissue rather than seeing the breast tissue superimposed on itself. In sum, breast tomosynthesis performed on 6/13/17 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 |
patient is a 45-year-old female with attention deficit/hyperactivity disorder (ADHD). The
patient has requested authorization and coverage for brand name Adderall 20 mg tablets.
This patient was diagnosed with ADHD previously and has benefited
from treatment with Adderall.
Additionally, the patient has tried generic Adderall and had numerous adverse effects from that
formulation, which she did not experience from brand name Adderall. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 45-year-old female with attention deficit/hyperactivity disorder (ADHD). The
patient has requested authorization and coverage for brand name Adderall 20 mg tablets. The
physician reviewer found that the submitted documentation supports the medical necessity of
the requested medication. This patient was diagnosed with ADHD previously and has benefited
from treatment with Adderall. Given the patients lack of misuse of the stimulant and benefit in
her ADHD symptoms from this medication, there is support for the requested medication.
Additionally, the patient has tried generic Adderall and had numerous adverse effects from that
formulation, which she did not experience from brand name Adderall. This was reported in
medical records. Therefore, brand name Adderall 20 mg tablets are medically necessary for the
treatment of this patient. | 1 |
A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 12/03/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has been diagnosed with osteoporosis. | Overturned | Experimental | Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for laboratory testing (collagen crosslink testing) performed on 12/03/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has been diagnosed with osteoporosis. The physician reviewer found that markers of bone turnover, such as the collagen crosslinks, have been recognized by experts in osteoporosis as a tool to evaluate osteoporosis from diagnostic and therapeutic standpoints. There are multiple articles that show the value of this test with anabolic agents, such as Forteo, which is the medication that the patient is receiving. Antiresorptive agents decrease and anabolic agents increase the markers of bone turnover. These markers are useful to determine adherence and efficacy of therapy. This patient has received antiresorptive therapy in the past, so it is important to obtain a baseline of the markers of bone turnover. Subsequently, during therapy with Forteo, an anabolic agent, markers of bone turnover increase, and this elevation is associated to increases in bone density and therefore efficacy of therapy. Therefore, laboratory testing (collagen crosslink testing) performed on 12/03/16 was likely to have been more beneficial than any available standard test, and is an important component of monitoring therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
The parent of a 15-year-old male enrollee has requested reimbursement for intensive outpatient program (IOP) services provided from 4/28/16 through 7/8/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse.
The documentation indicates that this patient had not been in any type of behavioral health therapy for the three months prior to the disputed stay. Prior to that treatment, the patient was in talk therapy and there was no indication that the patient was receiving outpatient substance abuse treatment to address his substance use, anxiety, or oppositional behaviors. The psychiatric admission evaluation indicates the patient was cooperative and did not demonstrate any suicidal or homicidal ideation. His thoughts were logical and he did not have any cognitive issues that would have prevented participation in outpatient behavioral health therapy for substance abuse treatment. The patient appeared to make progress in treatment. He was cooperative, calm and engaged actively in the IOP. He was able to verbalize improvement in his relationships with family as well as his some of his target symptoms. In large, | Upheld | Medical Necessity | Summary Reviewer
The parent of a 15-year-old male enrollee has requested reimbursement for intensive outpatient program (IOP) services provided from 4/28/16 through 7/8/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance abuse. The physician reviewer found that outpatient treatment and least restrictive options are considered first-lines of care as referenced by The American Academy of Child and Adolescent Psychiatry (AACAP), which recommends that children and adolescents be treated in the least restrictive setting possible and to maintain and foster natural supports. The documentation indicates that this patient had not been in any type of behavioral health therapy for the three months prior to the disputed stay. Prior to that treatment, the patient was in talk therapy and there was no indication that the patient was receiving outpatient substance abuse treatment to address his substance use, anxiety, or oppositional behaviors. The psychiatric admission evaluation indicates the patient was cooperative and did not demonstrate any suicidal or homicidal ideation. His thoughts were logical and he did not have any cognitive issues that would have prevented participation in outpatient behavioral health therapy for substance abuse treatment. The patient appeared to make progress in treatment. He was cooperative, calm and engaged actively in the IOP. He was able to verbalize improvement in his relationships with family as well as his some of his target symptoms. In large, the treatment progress notes were extremely vague. Outpatient therapy for cannabis use has shown benefit as noted by Gates and colleagues, who noted that those receiving psychosocial intervention used cannabis on fewer days compared with those given inactive control. All told, the IOP services provided from 4/28/16 through 7/8/16 were not medically necessary for treatment of this patients behavioral health issues. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 22-year-old female enrollee has requested reimbursement for burn wound treatment provided on 1/10/19 (CPT 15273, 15274, 15277 and 15278). The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition.
This patient sustained 15% total body surface area second-degree and third-degree burns on the perineum and feet. She was initially managed with dressing changes. The burns developed a thick eschar, and it was felt they were not adequately being managed with dressing changes. On 1/10/19, she underwent debridement of the 15% total body surface area second-degree and third-degree burns of the perineum, bilateral thighs, bilateral lower legs and left foot, including all toes. The debrided burn wounds were then covered with Suprathel skin substitute. | Overturned | Experimental | Summary Reviewer 1
A 22-year-old female enrollee has requested reimbursement for burn wound treatment provided on 1/10/19 (CPT 15273, 15274, 15277 and 15278). The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the medical records support the superior efficacy of a portion of the services at issue. This patient sustained 15% total body surface area second-degree and third-degree burns on the perineum and feet. She was initially managed with dressing changes. The burns developed a thick eschar, and it was felt they were not adequately being managed with dressing changes. On 1/10/19, she underwent debridement of the 15% total body surface area second-degree and third-degree burns of the perineum, bilateral thighs, bilateral lower legs and left foot, including all toes. The debrided burn wounds were then covered with Suprathel skin substitute. Skin substitutes, such as Suprathel, offer the benefit of not requiring a host donor. Based on this benefit, skin substitutes offer benefits over traditional grafting strategies. The use of a skin substitute can also be used when there is uncertainty about the vascularity of the underlying wound bed and whether or not this would support the healing of a skin graft. The medical evidence supports the use of skin substitutes for partial thickness burns. In this patients case, Suprathel was used on both partial and full thickness burns. Therefore, the medical evidence supports the services at issue as it relates to the treatment of partial thickness burns. However, there is a lack of support for the services at issue for the treatment of this patients full thickness burns.
| 1 |
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