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A 46-year-old male enrollee has requested reimbursement for the gastrointestinal (GI) effects comprehensive profile stool testing performed on 1/10/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
already had an endoscopic work-up documenting that he does not have colitis. | Upheld | Experimental | Summary Reviewer 1
A 46-year-old male enrollee has requested reimbursement for the gastrointestinal (GI) effects comprehensive profile stool testing performed on 1/10/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that the GI effects comprehensive profile stool testing performed on 1/10/16 was not likely to be more effective for this patient than other available options. Recommendations for the evaluation and management of irritable bowel syndrome do not support the approach prescribed for this patient. For example, a fecal calprotectin is part of the battery of tests included in the comprehensive stool analysis. This test would be potentially useful if the patient was undergoing an initial work-up. However, he already had an endoscopic work-up documenting that he does not have colitis. Given the above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 66-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Expression Assay provided on 10/12/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 3
A 66-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Expression Assay provided on 10/12/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the DecisionDx-Melanoma Gene Assay tests the tissue genetics of the melanoma to help stratify whether a melanoma is high risk for metastasis. The DecisionDx-Melanoma Gene Assay has shown some accuracy in thin melanomas. However, there is a lack of scientific evidence permitting conclusions concerning the effect of this test on health outcomes. The test is not considered routine standard of care and is not recommended by the National Comprehensive Cancer Network (NCCN) guidelines. Overall, there is a lack of published data to support its routine use. Since this test has not been demonstrated to provide a benefit more than established tests, the DecisionDx-Melanoma Gene Assay provided on 10/12/17 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 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 64-year-old female enrollee has requested reimbursement and prospective authorization and coverage for proton beam radiation. 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 64-year-old female enrollee has requested reimbursement and prospective authorization and coverage for proton beam radiation. 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 Proton beam radiation was not and is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The use of proton therapy is an accepted radiation technology that has proven efficacy and tolerability. For multiple myeloma, low doses are used to achieve palliation. IMRT and/or proton therapy can allow for better dose conformality of complex shaped targets. However, there is a lack of support for the use of proton therapy over IMRT when delivering such low doses. In this case, the actual radiation planning records are not provided, but the dose exposure of the right eye with IMRT is a mean of 23 Gy and the maximum dose recorded for all other structures are less than 12 Gy with IMRT. Based on the documentation submitted for review both IMRT and proton beam appear to result in excellent coverage of the tumor with similar toxicity risks. Proton therapy will almost always reduce dose to surrounding normal tissues. Simply demonstrating that proton therapy reduces the dose to some normal tissues does not necessarily demonstrate that it is superior to IMRT. Thus, proton therapy is not likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy. 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.
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A 62-year-old male enrollee has requested reimbursement for the Life Vest provided on 1/20/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees paroxysmal atrial flutter and atrial fibrillation with rapid ventricular response. | Upheld | Experimental | Summary Reviewer 3
A 62-year-old male enrollee has requested reimbursement for the Life Vest provided on 1/20/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees paroxysmal atrial flutter and atrial fibrillation with rapid ventricular response. The physician reviewer found that an increase in the risk of sudden cardiac death, and a potential benefit from implantable cardioverter defibrillator (ICD) implantation, has long been recognized in patients with LV dysfunction related to underlying ischemic heart disease. An increase in sudden cardiac death risk and potential benefit from an ICD has also been demonstrated in patients with a non-ischemic cardiomyopathy (Chung, et al; Epstein, et al). The Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial compared ICD implantation with standard medical therapy to standard medical therapy alone for primary prevention of sudden cardiac death in patients with a non-ischemic cardiomyopathy, non-sustained ventricular tachycardia, and LV ejection fraction of 35% of less. The authors reported findings toward mortality benefit in patients who received an ICD, regardless of duration since diagnosis. This patient was found to have a LV ejection fraction of less than 35%. Thus, the use of the Life Vest provided on 1/20/14 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the device at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 64-year-old male enrollee has requested reimbursement for inpatient stay performed on 1/13/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
this patient presented after a fall from a ladder. He was diagnosed with bilateral radial nondisplaced fractures that did not require surgical treatment. He was treated conservatively with oral pain medications and splinting and discharged home the same day with plans for outpatient follow-up.
, the patient was admitted in stable condition and could have been treated at | Upheld | Medical Necessity | Summary Reviewer
A 64-year-old male enrollee has requested reimbursement for inpatient stay performed on 1/13/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this patient presented after a fall from a ladder. He was diagnosed with bilateral radial nondisplaced fractures that did not require surgical treatment. He was treated conservatively with oral pain medications and splinting and discharged home the same day with plans for outpatient follow-up. The inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patients signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting, when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. His pain was well-controlled, and he did not have exacerbations of chronic medical problems. Therefore, the inpatient stay provided on 1/13/18 was not medically necessary for the treatment of this patient. | 1 |
patient is a 33-year-old female with a history of asthma, allergic rhinitis, aspirin allergy, and recurrent nasal polyps despite treatment with multiple nasal sprays. The patient has requested authorization and coverage for Dupixent.
. This patient has persistent nasal polyposis after nasal surgeries two years ago, and she has had recurrent rhinosinusitis despite treatment with intranasal corticosteroids such as Flonase, Nasonex and XHance. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 33-year-old female with a history of asthma, allergic rhinitis, aspirin allergy, and recurrent nasal polyps despite treatment with multiple nasal sprays. The patient has requested authorization and coverage for Dupixent. The physician reviewer found that Dupixent is a U.S. Food and Drug Administration (FDA) approved medication for adults with chronic rhinosinusitis with nasal polyposis, and the only approved therapy shown to shrink nasal polyp size and also improve the signs and symptoms of the associated chronic rhinosinusitis. This patient has persistent nasal polyposis after nasal surgeries two years ago, and she has had recurrent rhinosinusitis despite treatment with intranasal corticosteroids such as Flonase, Nasonex and XHance. The likely culprit of the recurrence of polyps is related to her aspirin allergy, as a condition called Samteras triad. It is a chronic condition called aspirin-exacerbated respiratory disease (AERD). The nasal polyps tent to recur despite standard treatment, such as the ones the patient has tried. The current medical evidence supports the requested medication in this clinical setting. Therefore, Dupixent is medically necessary. | 1 |
A 36-year-old male enrollee has requested authorization and coverage for implantation of hypoglossal nerve stimulator. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees sleep apnea. | Overturned | Experimental | Summary Reviewer 1
A 36-year-old male enrollee has requested authorization and coverage for implantation of hypoglossal nerve stimulator. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees sleep apnea. The physician reviewer found that While there is some support in the medical literature for the requested procedure, there is a lack of independent data establishing the superior efficacy of this treatment in this clinical setting. A review of the literature indicates that hypoglossal nerve stimulation for treatment of OSA may show beneficial outcomes with minimal adverse effect. However, there are a lack of studies that directly compare outcomes of hypoglossal nerve stimulation to current standard therapies. As such, the implantation with hypoglossal nerve stimulator is not likely to be more beneficial than standard available therapy for treatment of this patient. Therefore, for the reasons stated 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 29-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 2/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. | Upheld | Experimental | Summary Reviewer 2
A 29-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 2/25/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that this patient demonstrated clinical response at the time of Anser IFX testing. 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. While there have been testimonials, there are few well-controlled clinical trials to confirm that use of the Anser IFX 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. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. 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. In sum, Anser IFX testing performed on 2/25/16 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 40-year-old female enrollee has requested reimbursement for Anser ADA diagnostic testing performed on 2/18/15. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition.
. This patient was symptomatic with diarrhea and Anser ADA assay was performed to rule out antibodies to Humira, and | Overturned | Experimental | Summary Reviewer 1
A 40-year-old female enrollee has requested reimbursement for Anser ADA diagnostic testing performed on 2/18/15. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees medical condition. The physician reviewer found that based upon the medical records provided, the Anser ADA assay on 2/18/15 likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. This patient was symptomatic with diarrhea and Anser ADA assay was performed to rule out antibodies to Humira, and ensure therapeutic levels of the drug in an attempt to optimize therapy. Therapeutic drug monitoring (TDM) is the clinical practice of measuring drug concentrations or metabolites to attain a targeted concentration in a patient's bloodstream, thereby optimizing individual dosage regimens. Maximizing the efficacy of therapies for inflammatory bowel disease (IBD), while minimizing their toxicity remains the principal objective in developing management strategies for IBD patients. Recognition of the factors influencing therapeutic response allows providers to individualize dosing regimens to meet this objective. In order to optimize IBD therapy, it is critical that prescribers understand that standard dosing is insufficient for most patients, given the interindividual variability relating to response and tolerability. Moreover, the Anser ADA diagnostic test is considered safe and effective in optimizing therapy in patients with Crohns disease that are being treated with anti-tumor necrosis factor (TNF) agents such as Humira. The study by Li and colleagues noted a significant correlation between serum ADA levels and remission in patients with Crohns disease. Therefore, incorporation of Anser ADA diagnostic testing into clinical practice may allow providers to optimize treatment by maintaining effective drug concentrations over time. For the reasons provided, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than other modalities. 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 male enrollee has requested reimbursement for the DecisionDx-Melanoma assay provided on 2/14/17. 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 3
A 49-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma assay provided on 2/14/17. 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 the DecisionDx-Melanoma assay tests the tissue genetics of the melanoma to help stratify whether a melanoma is high risk for metastasis. The DecisionDx test has shown some impressive accuracy in thin melanomas like this patients tumor. However, there is a lack of scientific evidence permitting conclusions concerning the effect of this test on health outcomes. The test is not considered routine standard of care and is not recommended by the National Comprehensive Cancer Network (NCCN) guidelines. The test has not been demonstrated to provide a beneficial effect on health outcomes. Overall, there is not enough published data to support its routine use. Since this test has not been demonstrated to provide a greater benefit beyond that anticipated with established tests, the DecisionDx-Melanoma assay provided on 2/14/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 60-year-old female enrollee has requested authorization and coverage for a heart monitor (implantable ambulatory event monitor). The Health Plan has denied this request indicating that the requested device is considered investigational for treatment of the enrollees syncopal episodes.
. The patient has been extensively evaluated with two Zio Patch event monitoring periods in 2016 and 2017,
current syncope. In addition the patient has a structurally normal heart as well as a negative electrophysiologic study which failed to | Overturned | Experimental | Summary Reviewer 2
A 60-year-old female enrollee has requested authorization and coverage for a heart monitor (implantable ambulatory event monitor). The Health Plan has denied this request indicating that the requested device is considered investigational for treatment of the enrollees syncopal episodes. The physician reviewer found the request for a LINQ device is likely to be more beneficial for the treatment of the patients medical condition than any available standard therapy. The patient has been extensively evaluated with two Zio Patch event monitoring periods in 2016 and 2017, neither of these studies demonstrated an etiology for recurrent syncope. In addition the patient has a structurally normal heart as well as a negative electrophysiologic study which failed to demonstrate inducible arrhythmias or periods of high grade atrioventicular block. In light of these facts other than an implanted loop recorder there is no other diagnostic modality that would likely be more helpful. As such, request for a heart monitor (implantable ambulatory event monitor) 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 device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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SERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION] | Overturned | Experimental | Summary Reviewer 1
[INSERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION] The physician reviewer found that as noted in the current medical literature, transanal hemorrhoidal dearterialization has been shown to have equivalent or superior outcomes when compared to standard available procedures. Ratto and colleagues concluded that transanal hemorrhoidal dearterialization appears to be a very effective minimally invasive option to treat hemorrhoids and can be performed in a day-surgery setting. Similar findings were reported by Sohn and colleagues. The records indicate this patients symptoms did not adequately respond to rubber band ligation or conservative measures. Given these findings, 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.
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A 61-year-old male enrollee has requested authorization and coverage for positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 61-year-old male enrollee has requested authorization and coverage for positron emission tomography (PET) scan. The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the requested services in this clinical setting. Damle and colleagues noted that 18-F-fluoride positron emission tomography/computed tomography (PET/CT) is the most reliable method to rule out bone metastases in cases where there is a high index of suspicion. The authors noted that PET/CT has the potential to replace the (99m) Tc-MDP bone scan for the detection of bone metastases. In sum, the requested PET scan is likely to be of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the requested services are 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 58-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Plan has denied this request indicating that the requested procedure is considered investigational for the enrollees gastroesophageal reflux disease (GERD).
The patients pH recording demonstrated normal DeMeester scores (off acid blocker therapy) and her video esophagram did not show active reflux. | Upheld | Experimental | Summary Reviewer 2
A 58-year-old female enrollee has requested authorization and coverage for the LINX procedure. The Health Plan has denied this request indicating that the requested procedure is considered investigational for the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found the appropriate patient selection is crucial before anti-reflux procedures. In prelude to surgical intervention for GERD, it is critical to document the presence of abnormal distal esophageal acid exposure, especially when anti-reflux surgery is considered, and reflux-related symptoms should be severe enough to outweigh the potential side effects of fundoplication. Each testing modality has a specific role in the diagnosis and workup of GERD, and no single test alone can provide the entire clinical picture. Results of testing are combined to document the presence and extent of the disease and assist in planning the operative approach. Currently, upper endoscopy, barium esophagram, pH testing, and manometry are required for preoperative workup for antireflux surgery (Jobe, et al). In this case, the patient has undergone much of this pre-operative assessment but clinically significant reflux has not been demonstrated. In addition, the value of the LINX device in this clinical setting is uncertain. The patients pH recording demonstrated normal DeMeester scores (off acid blocker therapy) and her video esophagram did not show active reflux. Further, her infrequent reflux events proved poorly correlative with chest symptoms, thus, her ongoing symptoms cannot be considered medically refractory to acid blocker drugs. Also, implantation of the LINX device must be approached with caution given the patients documented complaint of dysphagia and demonstrated hang-up of a barium pill on esophagram. All told, the request for LINX procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 60-year-old male. The patient has requested reimbursement for magnetic
resonance (e.g., proton) imaging (MRI), spinal canal and contents, cervical; without contrast
Notes dated 8/15/22 reported a normal neurological examination, and an examination of the
cervical spine showed normal range of motion with tenderness only at the | Upheld | Medical Necessity | Summary Reviewer
The patient is a 60-year-old male. The patient has requested reimbursement for magnetic
resonance (e.g., proton) imaging (MRI), spinal canal and contents, cervical; without contrast
material on 8/15/22. The physician reviewer found that at issue is whether the MRI (e.g., proton),
spinal canal and contents, cervical; without contrast material on 8/15/22, was medically
necessary for the evaluation of this patient. The submitted documentation does not support the
medical necessity of the service at issue. The treatment for chronic musculoskeletal pain,
including benign neck pain with or without radicular symptoms, includes patient education, self-
care, independent exercise, remaining active, basic topical thermal modalities for palliation, and
common analgesics, if warranted, for palliation. Childress and colleagues note that in the initial
evaluation and management of neck pain, diagnostic tools such as imaging have variable utility.
Early MRI imaging is not known to improve outcomes in this clinical setting and may lead to an
overemphasis in invasive procedures and surgery that are ultimately not clinically beneficial. In
this case, the records did not document red flags in the patients history or examination such
as symptoms or signs suspicious for infection, abscess, bleeding, or tumor, that would indicate
advanced imaging of the cervical spine without an appropriate trial of conservative therapy.
Notes dated 8/15/22 reported a normal neurological examination, and an examination of the
cervical spine showed normal range of motion with tenderness only at the level of the
musculature surrounding the neck and upper back, consistent with myofascial pain and possible
radiculitis. The provider recommended physical therapy and did not note a plan for cervical spine
MRI. In this case, given that the patients clinical history and examination did not suggest
pathology that necessitated interventions beyond observation and conservative care, and as the
records did not document a trial of appropriate conservative management prior to the imaging
study in question, the service at issue was not medically indicated. Therefore, MRI (e.g., proton),
spinal canal and contents, cervical; without contrast material on 8/15/22, was not medically
necessary for the evaluation of this patient.
| 1 |
A 22-year-old male enrollee has requested reimbursement for residential mental health treatment for adults provided from 1/14/19 through 2/08/19. 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 22-year-old male enrollee has requested reimbursement for residential mental health treatment for adults provided from 1/14/19 through 2/08/19. 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 ideation with any active intent or plan and no history of suicidality. With regards to functional status, the records support a score of 2 due to overall good functional level in treatment but consideration of functional problems, including withdrawing from school when in the community and using substances. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to overall medical stability and history of psychotic symptoms that appear under adequate control. With regards to level of stress of the recovery environment, the records support a score of 2 due to a stable living environment. In terms of level of support of the recovery environment, the records support a score of 2 due to an overall supportive recovery environment. In terms of treatment and recovery history, the records support a score of 3 due to some motivation for treatment but no past significant substance use treatment mentioned in the records. With regards to engagement and recovery status, the records support a score of 2 due to cooperation in treatment. Thus, the patient has a composite score of 14. This score correlates with low-intensity community-based services. Therefore, residential mental health treatment for adults provided from 1/14/19 through 2/08/19 was not medically necessary for the treatment of this patient. | 0 |
The parent of a 15-year-old male enrollee has requested authorization and coverage for Humatrope 24 mg cartridge, 2.2 mg injected. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
inches). Additionally, the patient grew 2.6 cm from June 2018 to January 2019 before starting growth hormone therapy. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 15-year-old male enrollee has requested authorization and coverage for Humatrope 24 mg cartridge, 2.2 mg injected. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient does not have a known hypothalamic-pituitary defect or a known deficiency of at least one pituitary hormone (other than growth hormone), which would allow the diagnosis of growth hormone deficiency without growth hormone (GH) stimulation testing. In addition, this patient does not have a medical condition for which growth hormone is strongly recommended, such as small for gestational age with failed catch-up growth. Based on this patients normal laboratory results and delayed bone age, the most likely diagnosis is idiopathic short stature. The 2008 consensus guidelines on idiopathic short stature describe a height Z score of -2 to -3 as the range to consider growth hormone therapy. Although this patients height Z score was -2.3 standard deviations below the mean at the time of growth hormone initiation, the predicted adult height of 67 to 68 inches is concordant with his mean parental height (68.75 inches). Additionally, the patient grew 2.6 cm from June 2018 to January 2019 before starting growth hormone therapy. Based on the records, the response to growth hormone therapy is likely secondary to a pubertal growth spurt. Therefore, Humatrope 24 mg cartridge 2.2 mg cartridge is not medically necessary for the treatment of this patient. | 1 |
The patient is a 63-year-old female with a history of breast cancer. The patient has requested reimbursement for acute hospital admission from 6/04/21 through 6/06/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
In this case, the patient had three rib fractures but was admitted in stable condition with minimal pain. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 63-year-old female with a history of breast cancer. The patient has requested reimbursement for acute hospital admission from 6/04/21 through 6/06/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that outpatient management with oral analgesic medication and incentive spirometry is reasonable for rib fractures involving less than three ribs. The patient is at increased risk for complications, such as flail chest, pneumonia, pulmonary contusions or respiratory failure, when there are three or more ribs fractured. There is an increased risk of complications in individuals who are older than 65 years. The presence of six or more rib fractures increases the risk for serious complications. Pain control, pulmonary hygiene and mobility are the goals of care for individuals with severe rib fractures. The submitted documentation fails to demonstrate the medical necessity of the services at issue. 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 had three rib fractures but was admitted in stable condition with minimal pain. The objective data supported that she was stable. While close monitoring was appropriate, she could have been treated at a lower level of care. Therefore, acute hospital admission from 6/04/21 through 6/06/21 was not medically necessary for the treatment of this patient.
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A 41-year-old female enrollee has requested reimbursement for a dopamine transporter single-photon emission computed tomography (DAT-SPECT) scan performed on 9/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of tremor. | Overturned | Experimental | Summary Reviewer 2
A 41-year-old female enrollee has requested reimbursement for a dopamine transporter single-photon emission computed tomography (DAT-SPECT) scan performed on 9/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who has a history of tremor. The physician reviewer found that while a DAT-SPECT study is not indicated for all patients with a hand tremor, it has been shown to be useful in cases where the diagnosis of essential tremor and Parkinsons disease are both being considered and cannot be differentiated based on clinical grounds. In this patients case, her provider suspected a possible essential tremor (or other tremor disorder). It is imperative to provide a definitive diagnosis as treatment for essential tremor and Parkinsons disease are quite different, and the treatments for Parkinsons disease can have significant side effects. In this particular case, the patients diagnosis was confirmed using this study and the patient was able to be appropriately counseled. Therefore, DAT-SPECT scan performed on 9/17/15 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 17-year-old female with migraine headaches, postural orthostatic tachycardia syndrome, and significantly elevated lactate. Her headaches have been treated with several medications, with some reduction in pain, but she continues to miss school for the associated symptoms of nausea and dizziness. Her provider suspected a mitochondrial disorder and ordered mitochondrial DNA sequencing. The Health Insurer has denied reimbursement for genetic testing (mitochondrial genome sequencing) performed on 12/31/16. Per the Health Insurer, the services at issue were investigational for the evaluation of this patient. | Overturned | Experimental | Summary Reviewer 1
The patient is a 17-year-old female with migraine headaches, postural orthostatic tachycardia syndrome, and significantly elevated lactate. Her headaches have been treated with several medications, with some reduction in pain, but she continues to miss school for the associated symptoms of nausea and dizziness. Her provider suspected a mitochondrial disorder and ordered mitochondrial DNA sequencing. The Health Insurer has denied reimbursement for genetic testing (mitochondrial genome sequencing) performed on 12/31/16. Per the Health Insurer, 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. Mitochondrial disorders are challenging to diagnose because they can present at any age, have a wide spectrum of clinical symptoms, and are often insidious in onset. Because energy production is a need of all tissues, mitochondrial disease can present with virtually any symptom. While there are some well-described mitochondrial syndromes, many patients with mitochondrial disease do not fall neatly into one of the described syndromes. The advent of mitochondrial genome sequencing and whole exome sequencing have obviated the need for invasive testing, such as muscle biopsy. Patients with mitochondrial disease need comprehensive multidisciplinary care, optimally through a mitochondrial specialty center. There are consensus-based guidelines for treatment and surveillance of these multisystem disorders. In order to determine whether these recommendations should be applied to the patient, a diagnostic evaluation is needed to determine whether a mitochondrial disorder is responsible for the patients symptoms. Mitochondrial genome sequencing is an integral part of such a diagnostic evaluation, and is standard of care for the evaluation of mitochondrial disorders. Therefore, genetic testing (mitochondrial genome sequencing) performed on 12/31/16 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 60-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 7/8/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 7/8/16. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the digital breast tomosynthesis performed on 7/8/16 was likely to be more beneficial for evaluation of the patients medical condition than available standard modalities. Ciatto and colleagues investigated the effect of integrated two-dimensional (2D) and three-dimensional (3D) mammography in the breast cancer screening population. The authors found that Integrated 2D and 3D mammography improves breast cancer detection and has the potential to reduce false positive recalls. Based on the support in the medical literature, the use of breast tomosynthesis was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 66-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Expression Assay provided on 10/12/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 2
A 66-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Gene Expression Assay provided on 10/12/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the National Comprehensive Cancer Network (NCCN) guidelines indicate that genetic testing such as the DecisionDx-Melanoma Gene Assay should not be used outside of a clinical trial setting. The use of this type of testing is not considered to be standard of care in the evaluation of this patients melanoma. Moreover, the DecisionDx-Melanoma Gene Assay was not expected to impact the treatment or outcome of this patients melanoma. All told, the DecisionDx-Melanoma Gene Expression Assay provided on 10/12/17 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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The parent of a 13-year-old male enrollee has requested authorization and coverage for Genotropin 12 mg cartridge. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
This patient has a very low growth velocity of 2.75 cm per year. He has a poor height prediction of less than 160 | Overturned | Medical Necessity | Summary Reviewer
The parent of a 13-year-old male enrollee has requested authorization and coverage for Genotropin 12 mg cartridge. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the U.S. Food and Drug Administration (FDA) has approved the use of growth hormone therapy for idiopathic short stature or non-growth hormone-deficient short stature, defined as height standard deviation less than or equal to -2.25 or less than or equal to 1.2nd percentile for age and gender and who are considered unlikely to reach a normal adult height. In 2016, the Pediatric Endocrine Society came out with guidelines and recommendations for growth hormone use and indicated the decision to treat in idiopathic short stature should be made on case-by-case basis. The guidelines also suggested a follow-up assessment of benefit in height standard deviation and psychosocial impact 12 months after growth hormone initiation and dose optimization. This patient has a very low growth velocity of 2.75 cm per year. He has a poor height prediction of less than 160 cm, which is below the -2.25 standard deviation for the U.S. adult male population. Based on the records, this patient meets the criteria for idiopathic short stature and meets the FDA criteria for treatment with growth hormone therapy. Therefore, Genotropin 12 mg cartridge is medically necessary for the treatment of this patient. | 1 |
The parent of a 17-year-old female enrollee has requested reimbursement for intensive outpatient services provided from 3/01/18 through 6/30/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
The patient had deterioration in expected level of functioning in relationships with peers, adults and
The patient did not have medical problems and had apparent active substance use. | Overturned | Medical Necessity | Summary Reviewer
The parent of a 17-year-old female enrollee has requested reimbursement for intensive outpatient services provided from 3/01/18 through 6/30/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. In terms of risk of harm, the records support a score of 2 due to the patients history of recent ideation and hospitalization. With regards to functional status, the records support a score of 2. The patient had deterioration in expected level of functioning in relationships with peers, adults and family. In terms of comorbidity, the records support a score of 2. The patient did not have medical problems and had apparent active substance use. With regards to level of stress of the recovery environment, the records support a score of 3. The patient has problematic issues with family relationships. In terms of level of support of the recovery environment, the records support a score of 2. The patients family actively participated in treatment. However, their relationship was strained. With regards to resiliency and treatment history, the records support a score of 3 due to recent minimal progress in the intensive outpatient program. In terms of acceptance and engagement, the records support a score of 3. The patient participated, but appeared ambivalent. In terms of acceptance and engagement of the parent, the records support a score of 2. The parents worked actively and constructively with clinicians. Thus, the patient has a composite score of 19. The score correlates with intensive outpatient services. Therefore, intensive outpatient services provided from 3/01/18 through 6/30/18 were medically necessary for the treatment of this patient. | 1 |
The patient is a 61-year-old female with cutaneous melanoma on the left ear. A pathology report revealed non-ulcerating malignant melanoma extending to a depth of 2.65 mm, stage pT3A. The DecisionDx melanoma assay report dated 6/30/14 noted findings of a Class 2 molecular signature associated with a high risk metastatic disease within five years. The patient has requested reimbursement for the DecisionDx melanoma assay provided on 6/30/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. | Upheld | Experimental | Summary Reviewer 3
The patient is a 61-year-old female with cutaneous melanoma on the left ear. A pathology report revealed non-ulcerating malignant melanoma extending to a depth of 2.65 mm, stage pT3A. The DecisionDx melanoma assay report dated 6/30/14 noted findings of a Class 2 molecular signature associated with a high risk metastatic disease within five years. The patient has requested reimbursement for the DecisionDx melanoma assay provided on 6/30/14. The Health Insurer has denied this request indicating that the testing at issue was considered investigational. Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages 0-IV. While the majority of clinical stage I patients will be disease-free at five years, some stage I patients will develop advanced disease. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin examinations and clinical examination. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. DecisionDx melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 consistent with a low risk of metastasis or Class 2 suggestive of a high risk of metastasis. One peer-reviewed publication indicated that there was a statistically significant association of a Class 1 signature by DecisionDx melanoma assay for primary dermal melanoma (PDM), whereas cutaneous metastatic melanoma (CMM) were more frequently Class 2 (Sidiropoulos, et al). The authors concluded that the melanoma prognostic assay may be a useful tool for distinguishing PDM from CMM. According to the results of analysis of this patients melanoma performed with DecisionDx melanoma assay, the tumor was classified as Class 2 with a high risk of near-term (within five years) metastatic disease. Therefore, DecisionDx melanoma signature may be an independent predictor of metastasis risk. Identification of the increased risk of recurrence of melanoma in this patient helped establishing appropriate follow-up plan to improve the outcome in this particular patient. All told, the DecisionDx melanoma assay performed on 6/30/14 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 55-year-old female enrollee has requested reimbursement for gene test (molecular profiling) performed on 2/18/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of lung cancer.T | Overturned | Experimental | Summary Reviewer 1
A 55-year-old female enrollee has requested reimbursement for gene test (molecular profiling) performed on 2/18/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of lung cancer.The physician reviewer found there is some support for a portion of the services at issue in this clinical setting. Specifically, testing for the T790M mutation was beneficial. Genomic testing, using the Guardant360 test, interrogates more than 72 genes while all that is required. However, the National Comprehensive Cancer Network (NCCN) guidelines note that for patients with known EGFR mutation, testing for the T790M EGFR mutation is recommended. As such, in this patients case, there was a clinical benefit from testing for the T790M mutation and for the portions of the panel. Prospective randomized clinical trials are needed that compare the strategy of targeted treatment based on panel results with standard of care. There is a lack of published trials that demonstrate the clinical utility of this genomic testing. The available literature on its clinical utility consists of a small number of uncontrolled studies, and nonrandomized controlled trials that use imperfect comparators. This evidence is not sufficient to make conclusions on clinical utility. In addition, there is potential for harm if ineffective therapy is provided based on test results because there may be adverse effects of therapy in absence of a benefit. As a result, the use of expanded mutation panel testing for targeted treatment in cancer is considered investigational and should only be conducted in the setting of a clinical trial. All told, a portion of the gene test (molecular profiling) performed on 2/18/16 was likely to have been more effective than the available standard therapy for the evaluation of this patients medical condition. Based upon the information set forth above, a portion of the services 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 partially overturned.
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A 62-year-old male enrollee has requested reimbursement for services (Foundation One testing) performed on 2/07/19. 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 recurrent metastatic disease. He has been well managed so far and was | Overturned | Experimental | Summary Reviewer 3
A 62-year-old male enrollee has requested reimbursement for services (Foundation One testing) performed on 2/07/19. 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 recurrent metastatic disease. He has been well managed so far and was empirically tried on standard regimens. Since his tumor has progressed, referral for clinical trials is appropriate. This could be facilitated by mutational testing of the tumor. Some testing that may provide insight are KRAS, TP53, and BRAF, which are included in these panels. BRAF mutations may suggest alternative targeted therapies that may be better than those selected empirically. Von Hoff and colleagues performed a study of 86 patients. The progression-free survival on regimen selected by molecular profiling was compared to the progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has significant results for patients with stage IV tumors. In this patients case, the results from molecular profiling may offer a rational selection of the next regimen. Thus, services (Foundation One testing) performed on 2/07/19 were likely to have been more beneficial than other standard methods of evaluating this patient.
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A 28-year-old male enrollee has requested reimbursement for code L0456 provided on 1/13/16. The Health Insurer has denied this request and reported that the equipment at issue was not medically necessary for treatment of the enrollee, who had a history of neck pain, upper back pain, and shoulder pain.
the patient had a condition that required the use of a thoracolumbosacral orthosis.
the patient has an unstable bony spine (e.g., fracture or significant spondylolisthesis) or that he recently underwent destabilizing spinal surgery. The records indicate that the patient had neck and upper back pain following a twisting and falling injury while putting away holiday decorations. | Upheld | Medical Necessity | Summary Reviewer
A 28-year-old male enrollee has requested reimbursement for code L0456 provided on 1/13/16. The Health Insurer has denied this request and reported that the equipment at issue was not medically necessary for treatment of the enrollee, who had a history of neck pain, upper back pain, and shoulder pain. The physician reviewer found there are no indications in the records forwarded for review that the patient had a condition that required the use of a thoracolumbosacral orthosis. There are no indications in the records, for instance, that the patient has an unstable bony spine (e.g., fracture or significant spondylolisthesis) or that he recently underwent destabilizing spinal surgery. The records indicate that the patient had neck and upper back pain following a twisting and falling injury while putting away holiday decorations. A lumbosacral orthosis was not appropriate for this patients condition. There is a lack of objective evidence that it is an effective measure to treat any spinal condition in the absence of objective instability or postoperatively. There is a lack of high-grade published data that this type of intervention favorably impacts the natural history of sprain/strain/enthesopathic spinal conditions in a clinically meaningful manner. Clinically, they are generally considered contraindicated because they can promote core weakness, which is the opposite of appropriate treatment. All told, code L0456 provided on 1/13/16 was not medically necessary for the treatment of this patient. Therefore, the equipment at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 51-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 9/29/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 3
A 51-year-old female enrollee has requested reimbursement for Guardant360 testing performed on 9/29/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that understanding the molecular drivers of cancer progression and metastases is an area of ongoing and active research, predominantly driven by the goal of identifying specific genomic aberrations that may ultimately result in individualized cancer treatment. In addition to likely providing prognostic information, the value of next generation sequencing (NGS) to predict candidates for specific mutation-driven treatment holds promise. Patients with inflammatory and metastatic breast cancers benefit from NGS to identify markers that may indicate benefit from targeted treatment or clinical trials. The use of NGS, such as with Guardant360, is likely to be more effective than available standard therapy. Therefore, Guardant360 testing performed on 9/29/20 was likely to have been more beneficial than other available standard therapy.
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A 38-year-old male enrollee has requested authorization and coverage for sirolimus cream. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 1
A 38-year-old male enrollee has requested authorization and coverage for sirolimus cream. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is sufficient support for the requested medication in this clinical setting. Tuberous sclerosis is a rare genetic disease, and there are not enough patients to have double blind, placebo-controlled studies for the treatment of the associated facial angiofibromas. Topical rapamycin or sirolimus is considered standard of care for the treatment of these lesions. The International Tuberous Sclerosis Complex Consensus Statement also recommends the use of this medication for treatment of facial angiofibromas in tuberous sclerosis. Therefore, sirolimus cream is likely to be more beneficial than other available standard therapy.
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A 40-year-old male enrollee has requested reimbursement for therapeutic exercises and application modality infrared services (CPT 97026 and 97110) provided from 8/13/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees lower back pain.
this patient that underwent therapeutic exercises and infrared therapy for the | Upheld | Medical Necessity | Summary Reviewer
A 40-year-old male enrollee has requested reimbursement for therapeutic exercises and application modality infrared services (CPT 97026 and 97110) provided from 8/13/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees lower back pain. The physician reviewer found this patient that underwent therapeutic exercises and infrared therapy for the treatment of acute lower back pain. There is a lack of documentation demonstrating sustained, objective functional or ADL improvements obtained with therapeutic exercises and infrared therapy. In addition, there is a lack of support in the peer-reviewed literature for the services at issue in this clinical setting. Given the lack of support in the peer-reviewed literature and the documentation submitted for review, the therapeutic exercises and application modality infrared services (CPT 97026 and 97110) provided from 8/13/15 through 10/31/15 have not been established as medically necessary for treatment of the patients medical condition. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing for bacterial vaginosis provided on 5/09/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 36-year-old female enrollee has requested reimbursement for polymerase chain reaction testing for bacterial vaginosis provided on 5/09/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is insufficient support for vaginitis panel testing using polymerase chain reaction (PCR) technology. This testing offers no proven benefit over standard culture in symptomatic women. Furthermore, there is a lack of evidence on the clinical utility and impact of PCR testing for vaginitis. There is a lack of studies showing that this testing leads to better patient management decisions and/or better health outcomes. Studies of diagnostic accuracy alone are inadequate, especially because most symptomatic women can be diagnosed with a standard work-up and/or a trial of empiric therapy. Therefore, PCR testing for bacterial vaginosis performed on 5/09/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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The patient is a 63-year-old male with a history of urothelial cancer. He presented with gross hematuria when a large 17 cm soft tissue mass was found in the distal left ureter. He started with neoadjuvant chemotherapy with gemcitabine and cisplatin for four cycles with some response. A cystoscopy showed a T1 transitional cell carcinoma of the bladder. He underwent a transurethral resection. A left abdominal lymph node was sampled and was positive for metastatic disease. A sample of his tumor was sent to Foundation Medicine for FoundationOne mutational analysis. The patient is requesting reimbursement for the FoundationOne gene testing (CPT codes 81201, 81235 and 81321) performed on 5/4/16. The Health Insurer has denied this request as investigational. Metastatic bladder cancer has a poor prognosis.
In this case, the patient was tried on MVAC and his tumor showed a poor response. | Overturned | Experimental | Summary Reviewer 3
The patient is a 63-year-old male with a history of urothelial cancer. He presented with gross hematuria when a large 17 cm soft tissue mass was found in the distal left ureter. He started with neoadjuvant chemotherapy with gemcitabine and cisplatin for four cycles with some response. A cystoscopy showed a T1 transitional cell carcinoma of the bladder. He underwent a transurethral resection. A left abdominal lymph node was sampled and was positive for metastatic disease. A sample of his tumor was sent to Foundation Medicine for FoundationOne mutational analysis. The patient is requesting reimbursement for the FoundationOne gene testing (CPT codes 81201, 81235 and 81321) performed on 5/4/16. The Health Insurer has denied this request as investigational. Metastatic bladder cancer has a poor prognosis. One standard regimen for advanced bladder cancer is methotrexate, vincristine, doxorubicin, and cisplatin (MVAC). This regimen is toxic with many patients requiring hospitalization due to myelosuppression or mucositis. Therefore, not all patients are suitable. One regimen that stands out is that of gemcitabine/cisplatin which was equivalent to MVAC in one clinical trial. Some complete responses were seen with this regimen (von der Maase, et al). According to the National Cancer Institutes Physicians Data Query, gemcitabine/cisplatin is a reasonable alternative for those patients that may not tolerate MVAC. In this case, the patient was tried on MVAC and his tumor showed a poor response. A study by Von Hoff and colleagues of 86 patients where the progression-free survival on regimen selected by molecular profiling was compared to progression-free survival on the last chemotherapy regimen. The regimen selected by molecular profiling offered a 27% survival advantage. This trial has very significant results for patients with stage IV tumors. As such, the results from molecular profiling offer a rational selection of the next regimen. Therefore, the FoundationOne gene testing (CPT codes 81201, 81235 and 81321) performed on 5/4/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 61-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/02/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 61-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/02/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. This patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines states while there is interest in newer prognostic molecular techniques such as gene expression profiling to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. This test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy. Therefore, DecisionDx-Melanoma test performed on 10/02/18 was not medically necessary for the evaluation of this patient. | 0 |
A 60-year-old male enrollee has requested authorization and coverage for nerve stimulator implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
that this patient has obstructive sleep apnea. Drug-induced sleep endoscopy showed no concentric collapse at the palate or tongue base. The patient has not been able to tolerate continuous positive airway pressure (CPAP) therapy. The Inspire device has been | Overturned | Experimental | Summary Reviewer 1
A 60-year-old male enrollee has requested authorization and coverage for nerve stimulator implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has obstructive sleep apnea. Drug-induced sleep endoscopy showed no concentric collapse at the palate or tongue base. The patient has not been able to tolerate continuous positive airway pressure (CPAP) therapy. The Inspire device has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of obstructive sleep apnea. At this time, this patient is not a candidate for the Inspire device given his body mass index is greater than 32 and outside of FDA criteria. Very small studies have included patients with a body mass index greater than 32, but the number of the patients and data at this point in time is not adequate to consider standard. Therefore, the requested nerve stimulator implant is not likely to be superior over other treatment options.
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A 46-year-old female enrollee has requested reimbursement for Botox injections provided on 7/8/15 and 11/6/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees medical condition.
The patient has chronic migraine and has failed at least two medications from the same class. Moreover, the patient had reported benefit with Botox. | Upheld | Experimental | Summary Reviewer 1
A 46-year-old female enrollee has requested reimbursement for Botox injections provided on 7/8/15 and 11/6/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees medical condition. The physician reviewer found review of the submitted documentation and relevant literature supports the use of Botox injections in this clinical setting. The patient has chronic migraine and has failed at least two medications from the same class. Moreover, the patient had reported benefit with Botox. Botox is standard therapy for treatment of chronic migraine, and has been shown to be as effective or more effective, than medications available to treat chronic migraine. In addition, Botox is U.S. Food and Drug Administration (FDA) approved for the treatment of chronic migraine. For the reasons provided, the Botox injections at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 35-year-old female enrollee has requested reimbursement for NxGen MDx Universal panel and Harmony Prenatal test provided on 11/12/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for treatment of the enrollees pregnancy.]
, the patient had increased risk based on her age of 35 at the expected time of delivery. | Overturned | Experimental | Summary Reviewer 1
A 35-year-old female enrollee has requested reimbursement for NxGen MDx Universal panel and Harmony Prenatal test provided on 11/12/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for treatment of the enrollees pregnancy.] The physician reviewer found that the Harmony Prenatal cell-free DNA testing provided on 11/12/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Cell-free fetal DNA testing is an accepted approach to aneuploidy screening in high risk individuals (Devers, et al). In this case, the patient had increased risk based on her age of 35 at the expected time of delivery. However, the NxGen MDx Universal panel provided on 11/12/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Genetic carrier screening with NxGen MDx Universal panel is not recommended without a family history or ethnic background placing a patient at increased risk for the screened genetic disorders. According to Grody and colleagues, the standard of care for prenatal/preconception population carrier screening for common single-gene autosomal recessive disorders (such as cystic fibrosis and spinal muscular atrophy) and a panel of single-gene autosomal recessive conditions specifically for the Ashkenazi Jewish population. The patients records do not document a family history or ethnic background to support the NxGen MDx Universal panel. Based upon the information set forth above, a portion of 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 partially overturned.
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A 59-year-old male enrollee has requested authorization and coverage for deep brain stimulation.
The Health Insurer has denied this request and reported that the requested service is investigational
for the treatment of the enrollees Parkinsons disease.
the patient
is not newly diagnosed, has tried standard oral medication therapies with considerable
side-effects, had less favorable and escalating medication dosages
unwanted
side-effects following initial good response to medications, and has been on a medication regimen
for ten years. | Overturned | Experimental | Summary Reviewer 3
A 59-year-old male enrollee has requested authorization and coverage for deep brain stimulation.
The Health Insurer has denied this request and reported that the requested service is investigational
for the treatment of the enrollees Parkinsons disease. The physician reviewer found that the
standard therapies available for patients with Parkinsons disease depend on a number of factors
including whether the patient has been newly diagnosed, whether the patient has tried standard
medication therapies such as carbidopa/levodopa, what type of responses the patient demonstrates
to oral medication therapies, and the duration of treatment with medications. In this case the patient
is not newly diagnosed, has tried standard oral medication therapies with considerable and
intolerable side-effects, had less favorable and escalating medication dosages leading to unwanted
side-effects following initial good response to medications, and has been on a medication regimen
for ten years. In this clinical setting, DBS represents the only standard therapy option for this
patient following the trial and failure of standard oral medication therapies. Therefore, deep brain
stimulation is likely to be more beneficial for treatment of the patients condition than any available
standard therapy.
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The parent of a one-year-old male enrollee has requested authorization and coverage for Olumiant
1 mg tablet. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 1
The parent of a one-year-old male enrollee has requested authorization and coverage for Olumiant
1 mg tablet. The Health Insurer has denied this request and reported that the requested medication
is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the current medical evidence supports the requested medication in this clinical setting. Aicardi-
GoutiA res Syndrome (AGS) is recognized as a Type 1 interferonopathy, which leads to
autoimmune-mediated inflammation. Uncontrolled autoimmune inflammation results in a wide
range of disease manifestations with the central nervous system (CNS), in particular, being
affected. This is an important point to make, because any conventional FDA-approved medicine
that treats CNS disease, including all available antiepileptic medications, does not address the
underlying disease processes in AGS. In this patientas case, Olumiant therapy offers the chance
for a marked reduction in AGS-associated morbidity. Therefore, Olumiant 1 mg tablet is likely to
be more beneficial than other available standard therapy.
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A 47-year-old female enrollee has requested reimbursement for DecisionDX-UM assay performed on 5/09/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ocular melanoma. | Overturned | Experimental | Summary Reviewer 1
A 47-year-old female enrollee has requested reimbursement for DecisionDX-UM assay performed on 5/09/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ocular melanoma. The physician reviewer found that the DecisionDX is a study of 15 to 31 genes in a patients melanoma cells. It has been used to classify the individuals melanoma as having either a high or low risk of metastasis. It is controversial in cutaneous melanoma as to whether it has additional value when added to the usual pathologic prognostic factors. However, it is particularly useful in the analysis of uveal melanoma and has been validated in several studies. Specifically, a Class 1 category carries with it a less than 20% chance of metastasis, whereas Class 2 has a greater than 70% chance of metastasis. This testing has become a standard in many ocular cancer centers. Its clinical value lies in determining the need for intense surveillance, and possibly to assist in the decision as to adjuvant therapy. Therefore, DecisionDX-UM assay performed on 5/09/16 was likely to have been superior over 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 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.
This patient has lateral nasal wall collapse from lower lateral cartilage weakness. The images appear to show significant collapse. The Latera implant is a U.S | Upheld | Experimental | Summary Reviewer 2
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 there is sufficient support for the requested services in this case. This patient has lateral nasal wall collapse from lower lateral cartilage weakness. The images appear to show significant collapse. The Latera implant is a U.S. Food and Drug Administration (FDA) approved device which has been used successfully for lateral nasal wall collapse. In sum, vestibular stenosis repair is likely to be more effective than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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An 18-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment provided from 2/20/20 through 3/05/20. 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 behavioral health conditions.
the patient being age 18, due to her developmental level, dependence on her family, and family involvement in her care. In addition, the residential treatment center she attended was a treatment center designed for adolescents.
The patient had a serious risk of harm, due to two prior serious suicide attempts, and a recent pattern of excessive substance use.
. The patient had serious functional impairment due to conflict with her family and refusal to leave the house prior to admission to the
The patient had a mildly stressful environment due to expectations for performance at home or school
The patient had a supportive environment due to her parents active participation in treatment. | Overturned | Medical Necessity | Summary Reviewer
An 18-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment provided from 2/20/20 through 3/05/20. 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 behavioral health conditions. The physician reviewer found that the Child and Adolescent Level of Care Utilization System (CALOCUS) provides a framework for determining the clinically appropriate level of care for a child or adolescent in mental health treatment. In this case, CALOCUS, rather than the adult Level of Care Utilization System (LOCUS) was used, despite the patient being age 18, due to her developmental level, dependence on her family, and family involvement in her care. In addition, the residential treatment center she attended was a treatment center designed for adolescents. With regard to risk of harm, the records support a score of 4. The patient had a serious risk of harm, due to two prior serious suicide attempts, and a recent pattern of excessive substance use. In terms of functional impairment, the records support a score of 4. The patient had serious functional impairment due to conflict with her family and refusal to leave the house prior to admission to the residential treatment center. With regard to comorbidity, the records support a score of 4. The patient had uncontrolled substance use. In terms of level of stress of the recovery environment, the records support a score of 2. The patient had a mildly stressful environment due to expectations for performance at home or school that create discomfort. With regard to environmental support, the records support a score of 2. The patient had a supportive environment due to her parents active participation in treatment. In terms of resiliency and response to treatment, the records support a score of 4. The patient had poor resiliency and/or response to treatment. With regard to treatment acceptance and engagement, the records support a score of 2. The patient actively participated in treatment and was motivated for change. Thus, the patient has a composite score of 22. Due to her risk of harm, the patient qualified for medically monitored residence-based services. The combination of depression, anxiety, past suicidality, family conflict, and substance use, as well as lack of response to prior outpatient treatment, placed the patient at high risk. Therefore, mental health residential treatment provided from 2/20/20 through 3/05/20 was medically necessary for the treatment of this patient. | 1 |
A 28-year-old male enrollee has requested reimbursement for Prometheus Anser ADA diagnostic test performed on 12/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
This patients level was in the normal range despite the fact that he was having an active flare/progression of disease, | Upheld | Experimental | Summary Reviewer 1
A 28-year-old male enrollee has requested reimbursement for Prometheus Anser ADA diagnostic test performed on 12/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
The physician reviewer found that monitoring patients on adalimumab with measurement of adalimumab levels and antibodies to adalimumab continues to be an area of interest in the inflammatory bowel disease community. In general, adalimumab levels correlate inversely with disease activity. However, there is a lack controlled data which has identified the optimal drug level and so, the issue remains speculative. This patients level was in the normal range despite the fact that he was having an active flare/progression of disease, highlighting the limitation of the test. Using the Anser ADA, one can set up a hypothetical table categorizing drug levels as high or low and antibody levels as high or low. In theory, one could use this table to determine whether to dose increase or switch to a biologic agent with a different mechanism of action. Unfortunately, this hypothetical benefit is not supported by high quality medical evidence. In sum, Prometheus Anser ADA diagnostic test performed on 12/30/15 was not likely to be more effective than standard options of therapy, like empiric dose titration. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 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 3
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 current medical literature does not demonstrate that advanced lipoprotein
testing adds significant actionable information to what is already known from a basic fasting lipid
profile. There is a lack of randomized trials showing that therapies to correct any novel
lipoprotein abnormalities, such as lipoprotein(a), have any effect on cardiovascular outcomes
such as myocardial infarction, stroke, or death. In this clinical setting, there is insufficient
evidence to support the use of the service at issue. 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 27-year-old female enrollee has requested authorization and coverage for E1399 durable
medical equipment RT300 FES arm therapy system. The Health Insurer has denied this request
and reported that the requested device is investigational for the treatment of the enrollees
medical condition.
There is documented improvement in the patients
function with the RT300 FES therapy system. | Upheld | Experimental | Summary Reviewer 3
A 27-year-old female enrollee has requested authorization and coverage for E1399 durable
medical equipment RT300 FES arm therapy system. The Health Insurer has denied this request
and reported that the requested device is investigational for the treatment of the enrollees
medical condition. The physician reviewer found that there is support for the requested device
in this clinical setting. Zheng and colleagues demonstrated significant shortened time of
improving upper extremity function in early-phase stroke in the treatment group compared to
the control group. Shimodozono and colleagues conducted a randomized controlled pilot study
that demonstrated neuromuscular electrical stimulation demonstrated greater improvement
compared to a conventional arm rehabilitation program for post-stroke hemiplegia. There are
many significant health consequences that can occur with untreated spastic hemiplegia and the
neurodeficits described by the patients provider, including severe spasticity with contracture.
Avoiding this issue will take daily treatment. There is documented improvement in the patients
function with the RT300 FES therapy system. The documentation indicates that occupational
therapy without functional electrical stimulation was most likely inadequate. Therefore, the
requested for E1399 durable medical equipment RT300 FES arm therapy system is likely to be
more beneficial than any available standard therapy. | 1 |
A 33-year-old female enrollee has requested reimbursement for the assistant at surgery for the pelvic examination under anesthesia and the laparoscopic aspiration of a cavity or cyst with biopsy performed on 3/15/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant neoplasm peritoneum and retroperitoneum. | Upheld | Medical Necessity | Summary Reviewer
A 33-year-old female enrollee has requested reimbursement for the assistant at surgery for the pelvic examination under anesthesia and the laparoscopic aspiration of a cavity or cyst with biopsy performed on 3/15/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollees malignant neoplasm peritoneum and retroperitoneum. The physician reviewer found that based on the available records, there is a lack of documentation to establish the requirement for the services of the assistant at surgery during the procedure performed on 3/15/18. This procedure is the standard, recommended procedure for evaluation of a patient in this clinical setting. The operation was staffed by an attending surgeon, a resident, and a physician assistant. However, there is no documentation regarding the procedure was complex and required an assistant at surgery. The records do not report which portions of the case which were staffed by the resident or the physician assistant. All told, the assistant at surgery for the pelvic examination under anesthesia and the laparoscopic aspiration of a cavity or cyst with biopsy performed on 3/15/18 was not medically necessary for evaluation of this patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 52-year-old male enrollee has requested authorization and coverage for Vascepa. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
This patient has established coronary artery disease and is at significantly higher cardiovascular event risk at his age due to his elevated calcium score. He has been maximized previously for his hyperlipidemia and hypertriglyceridemia with diet, high dose statin medication and Lovaza, with marked improvement in his lipid profile. | Overturned | Medical Necessity | Summary Reviewer
A 52-year-old male enrollee has requested authorization and coverage for Vascepa. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. This patient has established coronary artery disease and is at significantly higher cardiovascular event risk at his age due to his elevated calcium score. He has been maximized previously for his hyperlipidemia and hypertriglyceridemia with diet, high dose statin medication and Lovaza, with marked improvement in his lipid profile. Although eicosapentaenoic acids have been shown to possibly have effects on cardiovascular risk previously, the most recent data specifically on the preparation Lovaza, while effective at lowering triglyceride level, has not been shown to affect cardiovascular risk or freedom from cardiovascular events in the recent ASCEND trial. Most recently, the specific icosapent ethyl preparation, Vascepa, has been shown to lower both triglyceride levels and decrease cardiovascular events in high risk patients with either known coronary artery disease or diabetes mellitus. Given that this patient is already on triglyceride lowering therapy and has known established coronary artery disease, it is appropriate that he be on lipid lowering therapy that has been clinically shown to decrease his cardiovascular risk. Vascepa is medically indicated in this specific, high-risk clinical circumstance. Therefore, Vascepa is medically necessary for the treatment of this patient. | 1 |
A 64-year-old female enrollee has requested reimbursement for FoundationOne test performed on 1/19/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. | Upheld | Experimental | Summary Reviewer 3
A 64-year-old female enrollee has requested reimbursement for FoundationOne test performed on 1/19/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees colon cancer. The physician reviewer found that the medical literature has not established if molecular markers are useful in treatment determination as predictive markers and prognosis other than for KRAS, NRAS, and BRAF mutation testing and microsatellite instability (MSI) or mismatch repair (MMR) testing. This is supported by both the National Comprehensive Cancer Network (NCCN) guidelines and American Society of Clinical Oncology (ASCO). Although preliminary data from some clinical studies have fueled excitement about the value and utility of these studies, their execution has also provoked many questions about the best way to approach complicating factors such as tumor heterogeneity and the choice of which genetic mutations to target. To date it is unclear if molecular profiling is beneficial in identifying potential targets for treatment or if targets are identified whether or not targeted treatment is beneficial. In this patients case, there were other chemotherapy options available for adjuvant therapy including treatment with irinotecan. All told, the use of FoundationOne testing on 1/19/17 was not likely to have been of greater benefit than any other available standard therapy for evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 62-year-old male enrollee has requested reimbursement for the Life Vest provided on 1/20/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees paroxysmal atrial flutter and atrial fibrillation with rapid ventricular response.
records provided, the patient has newly recognized severely depressed LV ejection fraction due to a non-ischemic cardiomyopathy possibly tachycardia mediated. | Upheld | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for the Life Vest provided on 1/20/14. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees paroxysmal atrial flutter and atrial fibrillation with rapid ventricular response. The physician reviewer found that based on the records provided, the patient has newly recognized severely depressed LV ejection fraction due to a non-ischemic cardiomyopathy possibly tachycardia mediated. In this circumstance, there is potential for recovery of LV function with medical therapy and atrial flutter ablation. Thus, there was no indication for immediate placement of a defibrillator such as sustained or inducible ventricular tachycardia, syncope or aborted sudden cardiac arrest. Placement of a prophylactic defibrillator is not recommended until at least 90 days have elapsed with continued LV dysfunction with an ejection fraction 35% or less is documented to persist in spite of appropriate treatment (Russo, et al). A prophylactic defibrillator (wearable or implantable) before this time has passed has not been demonstrated to improve outcome (Hohnloser, et al). At this time, prophylactic wearable external defibrillator would be indicated only if accepted criteria for an implantable defibrillator were met and an implantable defibrillator could not be placed, needed to be significantly delayed or required explantation. For these reasons, the use of the Life Vest provided on 1/20/14 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the device at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 53-year-old female enrollee has requested authorization and coverage for a transcatheter aortic valve replacement (TAVR). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 3
A 53-year-old female enrollee has requested authorization and coverage for a transcatheter aortic valve replacement (TAVR). 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 submitted documentation fails to demonstrate the superior efficacy of the requested services. TAVR is indicated for patients with symptomatic severe aortic valve stenosis and either intermediate or high surgical risk for open aortic valve replacement surgery. This patient would be considered low surgical risk by the information provided. Although recent data has evaluated lower risk patients for TAVR, they have generally excluded patients with bicuspid aortic valves such as with this patient, they required higher baseline gradients for eligibility compared to this patient, and there is no long-term follow-up beyond one year. Therefore, the requested TAVR is not likely to be more beneficial than other available standard therapy.
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A 38-year-old male enrollee has requested reimbursement for Truvada 200/300 mg, 30 tablets for 30 days, provided on 10/03/17. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollee, who had a potential exposure to human immunodeficiency virus (HIV).
. The records document that the patient was exposed to HIV infected blood. | Overturned | Medical Necessity | Summary Reviewer
A 38-year-old male enrollee has requested reimbursement for Truvada 200/300 mg, 30 tablets for 30 days, provided on 10/03/17. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollee, who had a potential exposure to human immunodeficiency virus (HIV). The physician reviewer found that the current medical evidence supports a portion of the medication at issue. The records document that the patient was exposed to HIV infected blood. Recommendations from Centers for Disease Control and Prevention and the U.S. Public Health Service note 28 days of treatment is recommended in this setting. Thus, Truvada 200/300 mg, 28 tablets was medically indicated. There is a lack of support for the quantity provided in this patients case. In sum, Truvada 200/300 mg, 28 tablets, was medically necessary for the treatment of this patient. Therefore, a portion of the medication at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned. | 1 |
An 18-year-old female enrollee has requested reimbursement for the gene testing performed on 9/1/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. | Upheld | Experimental | Summary Reviewer 3
An 18-year-old female enrollee has requested reimbursement for the gene testing performed on 9/1/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees major depressive disorder. The physician reviewer found that in general, the practice of pharmacogenetics, or the tailoring of a medication regimen based on an individual patients genetic organization, may become a valuable tool in the treatment armamentarium for those plagued with psychiatric illness. However, despite its promise, pharmacogenetics is not yet ready for routine clinical application as the relatively small, short-term studies to date have not been replicated on a larger scale. In addition, the American Psychiatric Association (APA) did not endorse such testing per current clinical practice guidelines. In this case, there was no clinical data provided to support genetic testing. Notably absent was the documentation of the longitudinal illness burden and extent of impairment at the time, family history, developmental history, social history, psychosocial stressors and medical comorbidities. In sum, considering the relevant peer-reviewed literature and current practice standards, it is not possible to assert with any degree of confidence that the disputed gene test yielded information that significantly influenced treatment decisions, improved the patients condition, prevented a more serious episode of illness or reduced morbidity. Thus, the genetic testing performed on 9/1/16 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.
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A 56-year-old female enrollee has requested reimbursement for a blood test performed on 11/24/18. 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 female enrollee has requested reimbursement for a blood test performed on 11/24/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is a lack of support for the services at issue in this clinical setting. The choice of test used to diagnose Helicobacter pylori depends on whether a patient requires an upper endoscopy for evaluation of symptoms or surveillance. Endoscopy is not indicated solely for the purpose of establishing Helicobacter pylori status. In patients who do not require endoscopic evaluation, initial diagnosis of Helicobacter pylori should be made with a test for active infection (stool antigen or urea breath test). The urea breath test and stool antigen assay both have high sensitivity and specificity for identifying active Helicobacter pylori infection. Serology has low sensitivity and specificity for Helicobacter pylori and cannot differentiate between active and past infection. Therefore, the blood test performed on 11/24/18 was not likely to have been more effective than other methods of evaluating this patient.
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The parent of an 11-year-old female enrollee has requested reimbursement for the FirstStep PLUS test provided on 11/23/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees severe attention deficit hyperactivity disorder (ADHD) and developmental delays. | Overturned | Experimental | Summary Reviewer 2
The parent of an 11-year-old female enrollee has requested reimbursement for the FirstStep PLUS test provided on 11/23/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees severe attention deficit hyperactivity disorder (ADHD) and developmental delays. The physician reviewer found that array-based comparative genomic hybridization or chromosomal microarray (CMA) has become the standard of care to evaluate children with developmental delay, intellectual disability, autism spectrum disorders or congenital anomalies. This patient meets the criteria established for CMA use given the documentation of intellectual disability. In addition, the patients positive family history provides additional support for this testing. In the medical literature, Henderson and colleagues reported that 12.7% of patients meeting referral criteria had a pathogenic copy number variant identified on microarray, and that half of those results influenced management including pharmacological treatment, cancer-related screening or exclusion of screening, identifying contraindications, and referrals for further evaluation. Riggs and colleagues demonstrated that 7% of microarray results impact clinical management, a rate which is similar to other genetic tests. Data have now emerged showing that actionable findings from CMA justify its use. All told, the FirstStep PLUS test provided on 11/23/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 29-year-old female enrollee has requested reimbursement and prospective authorization and coverage for OxyContin 20 mg three times per day from 2/9/18 forward. The Health Insurer has denied this request indicating that the medication dosage at issue was not and is not medically necessary for treatment of the enrollee who has been assessed with chronic pain syndrome. | Upheld | Medical Necessity | Summary Reviewer
A 29-year-old female enrollee has requested reimbursement and prospective authorization and coverage for OxyContin 20 mg three times per day from 2/9/18 forward. The Health Insurer has denied this request indicating that the medication dosage at issue was not and is not medically necessary for treatment of the enrollee who has been assessed with chronic pain syndrome. The physician reviewer found that the medical literature states that dose escalation is not a long-term plan but a short-term plan for the treatment of tolerance. In the documentation available for review, there were no objective treatment goals for pain and function noted for the requested medication. In addition, several requirements for opioid prescribing have not been documented to be performed. Therefore, the need to use them as the primary medication treatment strategy for pain has not been established (Chou, et al). The Centers for Disease Control and Prevention (CDC) states that when starting opioid therapy for chronic pain, providers should prescribe immediate release opioids instead of extended release/long-acting (ER/LA) opioids. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, and should carefully reassess evidence of individual benefits and risks when considering increasing dosage to 50 or more morphine milligram equivalents (MME) per day, and should avoid increasing dosage to 90 or more MME per day or carefully justify a decision to titrate dosage to 90 or more MME per day. In this case, the patient was recently taking 135 MME per day. However, there is no submitted evidence based rationale given by the provider to support the potential long-term consequences with the continual increase in opioids. Risk and benefit analysis must be performed to justify the requested level of 90 MME per day. It is also reasonable to consider alternatives to opioids. Moreover, pure mu agonists are not considered evidence based treatments for fibromyalgia and the adverse effects of opioids in fibromyalgia patients are unknown. In addition, the submitted records do not mention the completion of behavior therapy despite much research to support its use. For all of these reasons, reimbursement and prospective authorization and coverage for OxyContin 20 mg three times per day from 2/9/18 forward has not been demonstrated as medically necessary for treatment of the patients medical condition. Therefore, based on the reasons stated above, the medication dosage at issue was not and is not medically necessary for the treatment of this patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 51-year-old female has requested reimbursement for destruction by neurolytic agent (CPT codes 64635 and 64636) performed on 12/02/13 and 12/23/13. 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 records indicate that the patient underwent cooled radiofrequency lesioning. | Overturned | Experimental | Summary Reviewer 1
A 51-year-old female has requested reimbursement for destruction by neurolytic agent (CPT codes 64635 and 64636) performed on 12/02/13 and 12/23/13. 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 records indicate that the patient underwent cooled radiofrequency lesioning. Of note, cooled radiofrequency lesioning is a newer technology that does not have the same peer-reviewed evidence of duration and efficacy as conventional radiofrequency lesioning. Although the current literature on cooled radiofrequency lesioning is promising, more extensive studies need to be conducted against the standard approach. Therefore, the services at issue performed on 12/02/13 and 12/23/13 were not likely to be of greater benefit than other treatment alternatives. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 16-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) testing performed on 4/26/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for the enrollees dysmorphic facies and postural and kinetic tremor. | Overturned | Experimental | Summary Reviewer 2
The parent of a 16-year-old male enrollee has requested reimbursement for the comparative genomic hybridization (CGH) testing performed on 4/26/16. The Health Plan has denied this request indicating that the testing at issue was considered investigational for the enrollees dysmorphic facies and postural and kinetic tremor. The physician reviewer found that CGH, also referred to as CMA, is a well-established first-line genetic test for individuals with developmental delays and autism spectrum disorders according to the American Academy of Pediatrics (AAP), the American College of Medical Genetics (ACMG), the American College of Neurology (AAN) and the Child Neurology Society (CNS) (Schaefer et al; Moeschler et al; Shevell, et al; Shen et al). CMA technology has been shown to provide clinically actionable information. In this case, the patient presented with kinetic tremor. The clinical utility of CMA in the evaluation of seizure concerns is also well established. Olson and colleagues evaluated 805 patients with epilepsy/seizures using CMA technology. The authors found that in at least 40 cases (5%), the epilepsy phenotype was explained by a [copy number variant] CNV, including 29 patients with epilepsy-associated syndromes and 11 with likely disease-associated CNVs involving epilepsy genes or hotspots. Copy number abnormalities were found to play an important role in patients with epilepsy. The authors concluded that because the diagnostic yield of CMA for epilepsy patients is similar to the yield in autism spectrum disorders and in prenatal diagnosis, for which published guidelines recommend testing with CMA, we recommend the implementation of CMA in the evaluation of unexplained epilepsy. For these reasons, CGH testing performed on 4/26/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 41-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/02/15. 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 41-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.The physician reviewer found the current medical evidence does not support the services at issue in this clinical setting. 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 has 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. Limited retrospective evidence describes changes in management after measurement to anti-drug antibodies, but does not compare these management changes to those made in the absence of anti-drug antibody measurement. 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. In sum, Anser IFX testing performed on 4/02/15 was not likely to have been superior over other modalities for 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 56-year-old male enrollee has requested reimbursement for inpatient hospital stay provided from 6/23/18 through 6/25/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
The patient was injured in an accident and presented to the emergency department with shortness of breath and chest/rib pain. He denied loss of consciousness, and the initial imaging did not show any acute central nervous system bleeding. He was treated in the emergency department with intravenous fluids and pain medications. At the time of admission, his vital signs were stable with normal oxygen saturation. Imaging showed a fractured rib without any significant complications. | Upheld | Medical Necessity | Summary Reviewer
A 56-year-old male enrollee has requested reimbursement for inpatient hospital stay provided from 6/23/18 through 6/25/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient was injured in an accident and presented to the emergency department with shortness of breath and chest/rib pain. He denied loss of consciousness, and the initial imaging did not show any acute central nervous system bleeding. He was treated in the emergency department with intravenous fluids and pain medications. At the time of admission, his vital signs were stable with normal oxygen saturation. Imaging showed a fractured rib without any significant complications. The inpatient admission was not medically necessary for this patient. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Therefore, inpatient hospital stay from 6/23/18 through 6/25/18 was not medically necessary for the treatment of this patient. | 1 |
A 64-year-old female has requested reimbursement for vedolizumab infusions provided on 5/03/19 and 6/28/19. The Health Insurer has denied this request and reported that the medication at issue was investigational for the treatment of the enrollees medical condition.
. The patient was previously treated with Humira, but had side effects, including hair loss. The patient was started on vedolizumab and received infusions on 5/03/19 and 6/28/19. | Overturned | Experimental | Summary Reviewer 2
A 64-year-old female has requested reimbursement for vedolizumab infusions provided on 5/03/19 and 6/28/19. The Health Insurer has denied this request and reported that the medication at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that this patient has been diagnosed with ulcerative colitis. The U.S. Food and Drug Administration has approved vedolizumab for induction of remission and maintenance of remission in moderate to severe ulcerative colitis. The patient was previously treated with Humira, but had side effects, including hair loss. The patient was started on vedolizumab and received infusions on 5/03/19 and 6/28/19. In this patients case, there are no progress notes or other information from the provider documenting that vedolizumab was working. There is insufficient documentation of benefit for the continued use of this medication. All told, vedolizumab infusions provided on 5/03/19 and 6/28/19 were not likely to have been more beneficial than other methods of evaluating this patient.
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A 62-year-old female enrollee has requested authorization and coverage for Xeljanz.A review of the record indicates that the enrollee has been diagnosed with alopecia areata. In an
undated letter, the provider reported that the enrollee has tried squaric acid, Rogaine, and
intralesional Kenalog injections.The Health Insurer indicates that the requested medication is investigational for the evaluation of
the enrolleeas medical condition. Therefore, the Health Insurer has denied coverage for the
requested medication. | Overturned | Experimental | Summary Reviewer 1
A 62-year-old female enrollee has requested authorization and coverage for Xeljanz.A review of the record indicates that the enrollee has been diagnosed with alopecia areata. In an
undated letter, the provider reported that the enrollee has tried squaric acid, Rogaine, and
intralesional Kenalog injections.The Health Insurer indicates that the requested medication is investigational for the evaluation of
the enrolleeas medical condition. Therefore, the Health Insurer has denied coverage for the
requested medication. The physician reviewer found that available treatment options for alopecia areata (AA) are limited. This is especially true for diffuse
involvement, where standard therapies such as topical steroids, intralesional kenalog, contact
immunotherapy and conventional immunosuppressants (systemic steroids, methotrexate and
cyclosporine) are more often than not less than satisfactory and associated with side effects.
Although there is no significant data yet from randomized clinical trials (which are currently
underway), there is substantial clinical evidence to support the use of oral JAK kinase inhibitors
such as tofacitinib for alopecia areata. In an open label pilot study by Jabbari and colleagues, eight
out of 12 patients demonstrated greater than 50% hair regrowth as measured by Severity in
Alopecia Tool (SALT) scoring. Liu and colleagues performed a retrospective study which
consisted of patients age 18 years or older with AA with at least 40% scalp hair loss treated with
tofacitinib. The authors found that 77% achieved a clinical response, and 58% of patients had a
greater than 50% change in SALT score. There have been minimal adverse effects reported to date.
Moreover, these results are better than what has been reported for contact immunotherapy and
systemic steroids. Therefore, Xeljanz is likely to be more beneficial than other available standard
therapy.
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The patient is a 34-year-old male. X-rays of the lumbar spine dated 4/22/22 reported findings of
mild upper lumbar scoliosis centered at L2 and convex to the left, with otherwise normal alignment
and no malalignment provoked by flexion or extension. The patient has requested authorization
and coverage for single-level lumbar fusion. The Health Insurer has denied this request and
reported that the requested service is not medically necessary for the treatment of this patient.
lumbar
spondylosis. The patient reported ongoing low back pain that is interfering with his ability to
tenderness to
palpation over the lumbar spine. The records | Upheld | Medical Necessity | Summary
The patient is a 34-year-old male. X-rays of the lumbar spine dated 4/22/22 reported findings of
mild upper lumbar scoliosis centered at L2 and convex to the left, with otherwise normal alignment
and no malalignment provoked by flexion or extension. The patient has requested authorization
and coverage for single-level lumbar fusion. The Health Insurer has denied this request and
reported that the requested service 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 does not support the medical necessity of the requested service. Bydon
and colleagues note, A trial of conservative therapy may be considered for patients with low-
grade spondylolisthesis presenting with radiculopathy and/or pseudoclaudication. These options
may include physical therapy, epidural steroid injection, and pain medications. If unresolved,
surgical options may include decompression alone or decompression and fusion. Chan and
colleagues report, Patients with symptomatic lumbar spondylolisthesis may first be treated with
conservative management strategies including, but not limited to, non-narcotic and narcotic pain
medications, epidural steroid injections, transforaminal injections, and physical therapy. For well-
selected patients who fail conservative management strategies, surgical management is
appropriate. Resnick and colleagues explain, As a result of the decompression, the inherent
instability associated with the spondylolisthesis may progress and lead to further misalignment
that results in pain or recurrence of neurological complaints. Under these circumstances, lumbar
fusion is considered appropriate to stabilize the spine and prevent delayed deterioration. In this
case, the patient is a 34-year-old male with back pain, lumbar radiculopathy, and lumbar
spondylosis. The patient reported ongoing low back pain that is interfering with his ability to return
to work that he rated at a five as of 2/24/23. An examination revealed moderate tenderness to
palpation over the lumbar spine. The records noted that the patient was neurologically intact.
However, the submitted records did not include detailed documentation regarding a trial and
failure of recent, reasonable, comprehensive, less invasive conservative care measures, as
recommended prior to surgery in current medical literature. Dynamic flexion/extension films did
not corroborate instability at the requested surgical level of L5-S1, and there was no detailed
documentation regarding potential impending/inevitable temporary intra-operative instability.
Therefore, single-level lumbar fusion is not medically necessary for the treatment of this patient.
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The patient is a 65-year-old male who presented on 2/13/17 with continued right knee pain. The patient reported mixed results with platelet-rich plasma injections and viscosupplements did not help. He reported that the corticosteroid injection helped but the effect was somewhat transient. He reported pain along the anterior aspect. Right knee examination documented some patellar tilt, range of motion 2-130 degrees with some tightness and tenderness at extremes, and not a lot of increase in his Q-angle. X-rays of his knees demonstrated some arthrosis in the patellofemoral region, but not a lot of wear in the tibiofemoral aspects. Magnetic resonance imaging (MRI) was reviewed and demonstrated edema along the lateral trochlear area in combination with some arthrosis from the patellofemoral perspective. He was status post partial meniscectomy. The treatment plan included arthroscopic evaluation of his knee with lateral release and debridement. The patient did not want a knee replacement. The provider noted that to assist in his post-operative recovery and rehabilitation and mitigate post-operative complications associated with prolonged prescription pain | Upheld | Medical Necessity | Summary Reviewer
The patient is a 65-year-old male who presented on 2/13/17 with continued right knee pain. The patient reported mixed results with platelet-rich plasma injections and viscosupplements did not help. He reported that the corticosteroid injection helped but the effect was somewhat transient. He reported pain along the anterior aspect. Right knee examination documented some patellar tilt, range of motion 2-130 degrees with some tightness and tenderness at extremes, and not a lot of increase in his Q-angle. X-rays of his knees demonstrated some arthrosis in the patellofemoral region, but not a lot of wear in the tibiofemoral aspects. Magnetic resonance imaging (MRI) was reviewed and demonstrated edema along the lateral trochlear area in combination with some arthrosis from the patellofemoral perspective. He was status post partial meniscectomy. The treatment plan included arthroscopic evaluation of his knee with lateral release and debridement. The patient did not want a knee replacement. The provider noted that to assist in his post-operative recovery and rehabilitation and mitigate post-operative complications associated with prolonged prescription pain medication and/or non-ambulation/non-weight bearing such as increased risk of deep vein thrombosis (DVT) formation, he would prescribe durable medical equipment to reduce pain, swelling, edema, mitigate the risk of DVT, and improve his range of motion and strength. The patient underwent right knee arthroscopy with debridement and lateral release on 2/22/17. There were no post-operative notes available for review. The medical records indicate that an intermittent limb compression device was provided from 2/22/17 through 3/8/17. The record indicates that the patients medical history includes hypertension and skin basal/squamous cancer. His medications included Lisinopril, fish oil, and chondroitin glucosamine. The patient has requested reimbursement for an intermittent limb compression device rental (E0676) provided from 2/22/17 through 3/8/17. The Health Insurer has denied this request as not medically necessary. The medical literature recommend identifying subjects who are at a high risk of developing venous thrombosis and providing prophylactic measures such as consideration for anticoagulation therapy. Jobin and colleagues state that patients with moderate to high risk of venous thromboembolism should have pharmacologic prophylaxis, unless contraindicated. If pharmacologic therapy is contraindicated, then mechanical prophylaxis with intermittent pneumatic compression is recommended. In this case, the patients medical history was positive for hypertension. He underwent right knee arthroscopic debridement and lateral release on 2/22/17. An intermittent pneumatic compression device was ordered for post-operative use to reduce pain, swelling, and edema, mitigate the risk of DVT, and improve his range of motion and strength. The patients risk factors were documented to include the patients age, length of surgery, arthroscopic surgery, and restricted mobility. However, there is no documentation that anticoagulation therapy would be contraindicated, or standard compression stockings were insufficient, to warrant the use of mechanical prophylaxis following arthroscopic knee surgery. The medical records submitted for review fail to support the medical necessity of the device at issue in this case. Therefore, based on evidence-based literature, the intermittent limb compression device rental provided from 2/22/17 through 3/8/17 was not medically necessary for treatment of the patients medical condition. Therefore, the device at issue was not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 32-year-old male enrollee has requested reimbursement for gene testing (DecisionDx-Melanoma testing) performed on 1/23/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 32-year-old male enrollee has requested reimbursement for gene testing (DecisionDx-Melanoma testing) performed on 1/23/19. 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 an early stage melanoma. The National Comprehensive Cancer Network guidelines indicate that while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical study. Newer prognostic molecular techniques should not replace standard staging procedures. In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma. This test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. In sum, gene testing (DecisionDx-Melanoma testing) performed on 1/23/19 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 72-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene
expression profile assay performed on 8/30/19. The Health Insurer has denied this request and
reported that the services at issue were investigational for the evaluation of the enrollees
medical condition. | Upheld | Experimental | Summary Reviewer 3
A 72-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma gene
expression profile assay performed on 8/30/19. The Health Insurer has denied this request and
reported that the services at issue were investigational for the evaluation of the enrollees
medical condition. The physician reviewer found that Melanoma is a cancer that is curable in its
earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling
of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to
regional lymph nodes may be amenable to excision, but this suggests a high risk for the
development of metastatic disease in the future. Such patients may be observed or treated
with interferon-alpha. The data on the DecisionDx-Melanoma gene expression profile assay has
not made it part of routine analysis after sentinel lymph node biopsy. There has also been some
lack of consistency between various genes being used as biomarkers. As such, the test is novel,
and it is unclear how best to incorporate it into the treatment algorithm beyond standard
staging techniques. Therefore, DecisionDx-Melanoma gene expression profile assay performed
on 8/30/19 was not likely to have been more beneficial than any available standard therapy.
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patient is a 30-year-old male who presented to his provider on 9/20/22. The patient has
requested authorization and coverage for pantoprazole sodium tablet DR 20 mg twice daily. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 30-year-old male who presented to his provider on 9/20/22. The patient has
requested authorization and coverage for pantoprazole sodium tablet DR 20 mg twice daily. The
physician reviewer found that the submitted documentation does not support the medical
necessity of the requested medication regimen. There is a lack of well-designed, randomized
controlled trials supporting the requested dosing frequency as safe and effective for treatment
of this patients condition. In this case, the records do not indicate that the patient has
gastrointestinal bleeding of the esophagus, ulcerogenic disease, stricture, narrowing of the
esophagus, or Barrett's esophagus that may warrant such dosing. While a Prior Authorization
Request Form for Prescription Drugs reported that the patient had tried treatment with
omeprazole, it does not appear that the patient has tried and failed other proton pump inhibitors
such as lansoprazole, rabeprazole, and dexlansoprazole within the respective class and at dosing
frequencies approved by the U.S. Food and Drug Administration (FDA). Therefore, pantoprazole
sodium tablet DR 20 mg twice daily is not medically necessary for the treatment of this patient. | 1 |
The patient is a 60-year-old female with a history of progressively worsening left-sided low back pain radiating to the left buttock and down the left anterolateral thigh associated with paresthesias in the thigh. The patient has requested coverage for left side injections. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 60-year-old female with a history of progressively worsening left-sided low back pain radiating to the left buttock and down the left anterolateral thigh associated with paresthesias in the thigh. The patient has requested coverage for left side injections. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that lumbar epidural steroid injections under fluoroscopic guidance are commonly used for treatment of low back and lower extremity radicular pain. As noted in the articles referenced here, these procedures are safe and effective. The commonly used approaches for the epidural steroid injections include the interlaminar and transforaminal. These lumbar epidural injections have been used extensively to treat radicular pain and paresthesias, as in this case. Among interlaminar and transforaminal, the transforaminal epidural injections are more widely used for treatment of lumbar and lower extremity pain. The potential advantages of transforaminal over interlaminar include more targeted delivery of the injectate steroid to the site of the nerve root compressive pathology, thereby reducing the swelling, inflammation, and nerve root compression with associated pain relief. Facet joint injections are also useful in cases of facetogenic pain, although not for radicular pain. If the provider feels the necessity to use both, in light of the degenerative changes noted on x-rays, facet injections should also be useful. Therefore, the requested left side injections are medically necessary for the treatment of this patient. | 1 |
A 38-year-old female enrollee has requested reimbursement for oral device/appliance provided on 11/27/17. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollee, who has been diagnosed with sleep disordered breathing, periodic limb movement disorder, and insomnia with sleep apnea.
The patient was noted to have a diagnosis of obstructive sleep apnea. She opted for an oral appliance as a first-line therapy for her condition. | Overturned | Medical Necessity | Summary Reviewer
A 38-year-old female enrollee has requested reimbursement for oral device/appliance provided on 11/27/17. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollee, who has been diagnosed with sleep disordered breathing, periodic limb movement disorder, and insomnia with sleep apnea. The physician reviewer found that the submitted documentation supports the medical necessity of the device at issue. The patient was noted to have a diagnosis of obstructive sleep apnea. She opted for an oral appliance as a first-line therapy for her condition. The published joint practice guidelines of the American Academy of Sleep Medicine (AASM) and American Academy of Dental Sleep Medicine (AADSM) noted we recommend that sleep physicians consider prescription of oral appliances, rather than no treatment, for adult patients with obstructive sleep apnea who are intolerant of CPAP therapy or prefer alternate therapy. Okuno and colleagues performed a systematic review and meta-analysis of five studies assessing the effectiveness of an oral appliance for the treatment of obstructive sleep apnea. The authors found that an oral appliance decreased the apnea-hypopnea index as compared with a sham device. In this setting, given that a diagnosis of obstructive sleep apnea has been established, the use of an oral appliance was medically appropriate. Thus, the oral device/appliance provided on 11/27/17 was medically necessary for the treatment of this patient. Therefore, the device at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned. | 1 |
A 46-year-old female enrollee has requested authorization and coverage for fentanyl citrate lozenge on a handle 200 mcg. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
in this case, the patient has chronic pain involving several areas, which is complicated by hereditary angioedema,
. The patient has multiple drug allergies to several opioid medications, which
anaphylaxis. Per the submitted documentation, she has been stable on her current regiment of fentanyl lozenges and patches without further episodes of angioedema or hospitalizations. Her provider has indicated that adequate pain control is an important component to managing her hereditary angioedema. The patient has not demonstrated any irregular behavior and has been functional with the high-dose opioid therapy. | Overturned | Medical Necessity | Summary Reviewer
A 46-year-old female enrollee has requested authorization and coverage for fentanyl citrate lozenge on a handle 200 mcg. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that in this case, the patient has chronic pain involving several areas, which is complicated by hereditary angioedema, a life-threatening condition that can be precipitated by triggers, including pain. The patient has multiple drug allergies to several opioid medications, which range in severity from hives to life-threatening anaphylaxis. Per the submitted documentation, she has been stable on her current regiment of fentanyl lozenges and patches without further episodes of angioedema or hospitalizations. Her provider has indicated that adequate pain control is an important component to managing her hereditary angioedema. The patient has not demonstrated any irregular behavior and has been functional with the high-dose opioid therapy. There is sufficient support for the requested medication in this clinical setting. Therefore, fentanyl citrate lozenge on a handle 200 mcg is medically necessary for the treatment of this patient.
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A 53-year-old female enrollee has requested authorization and coverage for vascularized lymph node transfer (VLNT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
, the patient has a diagnosis of chronic left lower extremity lymphedema that severely affects her function with ambulation and activities of daily living. Her condition is noted to have been partially corrected with suction-assisted lipectomy, but she still had significant lymphedema of the lower part of her leg. She continued with prescribed non-operative management of compression therapy, which has not controlled her condition. | Overturned | Experimental | Summary Reviewer 1
A 53-year-old female enrollee has requested authorization and coverage for vascularized lymph node transfer (VLNT). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found according to the documentation submitted for review, the patient has a diagnosis of chronic left lower extremity lymphedema that severely affects her function with ambulation and activities of daily living. Her condition is noted to have been partially corrected with suction-assisted lipectomy, but she still had significant lymphedema of the lower part of her leg. She continued with prescribed non-operative management of compression therapy, which has not controlled her condition. Thus, standard recommended therapy has been exhausted and has not been successful. VLNT is a well-recognized form of treatment for lymphedema that has failed conservative management. According to Cheng and colleagues (2013) Vascularized groin lymph node flap transfer using the wrist or elbow as a recipient site is an efficacious approach to treating postmastectomy upper limb lymphedema. Additional peer-reviewed references as cited above document the use of vascularized lymph node transfer as a surgical procedure that is appropriate for the treatment of lymphedema and has a reasonable chance in improving the patients condition. In addition, VLNT is consistent with standards of good medical practice after failure of conservative management which has been well-documented in this case. In addition, there is no evidence that VLNT is being performed for personal comfort or convenience. Given the above, VLNT is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/02/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. | Overturned | Experimental | Summary Reviewer 3
A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/02/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found that breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. In this patients case, there were no problems to be resolved. The patient did not have dense breasts, a mass, palpable lumps, or suspicious calcifications. A routine mammogram would have been sufficient in this clinical setting. Breast tomosynthesis has not been shown to provide significant increased value in patients who do not have dense tissue that could obscure an abnormality, especially when there has been no change when compared to multiple prior mammograms. Thus, digital breast tomosynthesis performed on 8/02/16 was not likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 48-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 11/25/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for purposes of the enrollees breast cancer screening. | Overturned | Experimental | Summary Reviewer 3
A 48-year-old female enrollee has requested reimbursement for a breast tomosynthesis that was performed on 11/25/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for purposes of the enrollees breast cancer screening. The physician reviewer found breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts (Helvie). In this particular patient, she has dense breasts. While one could make the argument that her mammogram has not changed since the prior studies, it is specifically those patients who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. In this clinical setting, where the patient presents with dense breast tissues, the tomosynthesis was likely to be more beneficial as a screening tool than standard modalities including breast sonography. 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 19-year-old male enrollee has requested reimbursement for partial hospitalization program level of care provided from 1/18/18 through 1/22/18 and 2/01/18 through 2/06/18 and intensive outpatient program services provided from 3/21/18 through 3/26/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health condition.
This patient had a significant risk of harm, due to two prior suicide attempts in the past year, as well as impulsivity.
The patient had moderate functional impairment, due to recent gains in a structured treatment setting, and inconsistent ability to participate in program and | Overturned | Medical Necessity | Summary Reviewer
A 19-year-old male enrollee has requested reimbursement for partial hospitalization program level of care provided from 1/18/18 through 1/22/18 and 2/01/18 through 2/06/18 and intensive outpatient program services provided from 3/21/18 through 3/26/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health condition. The physician reviewer found that the American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. In terms of risk of harm, the records support a score of 3. This patient had a significant risk of harm, due to two prior suicide attempts in the past year, as well as impulsivity. With regards to functional status, the records support a score of 3. The patient had moderate functional impairment, due to recent gains in a structured treatment setting, and inconsistent ability to participate in program and adhere to rules. In terms of comorbidity, the records support a score of 3 due to post-concussive syndrome as well as substance abuse, anxiety, and attention deficit/hyperactivity disorder. With regards to stress of the recovery environment, the records support a score of 1. The patients environment was minimally stressful, due to absence of recent losses or difficulties. In terms of level of environmental support, the records support a score of 2. The records documented active participation of parents in treatment with occasional conflict between parents. With regards to resiliency and treatment history, the records support a score of 4 due to lack of progress despite multiple attempts at intensive treatment. Also, the patient had two prior suicide attempts within the past year while participating in intensive outpatient treatment. In terms of acceptance and engagement of the patient, the records support a score of 3 due to inconsistent participation in the treatment program. With regards to acceptance and engagement of the parent, the records support a score of 2 due to cooperation with the treatment plan. Therefore, the patient has a composite score of 21. This is consistent with intensive integrated services without 24-hour psychiatric monitoring. This level of care can encompass partial hospitalization or intensive outpatient care, which are the levels of service in dispute. Given the patients two prior suicide attempts in the past year while participating in intensive outpatient care, a level of service lower than this would have place him at significant risk of self-harm. Also, it is important to note that at the end of the period of services at issue, the patient did not transition to a lower level of care. Instead, he was transferred to a higher level of care (inpatient psychiatric unit) due to concerns about risk to himself, peers, and staff at his current program. Therefore, partial hospitalization program level of care provided from 1/18/18 through 1/22/18 and 2/01/18 through 2/06/18 and intensive outpatient program services provided from 3/21/18 through 3/26/18 were medically necessary for the treatment of this patient. | 1 |
A 30-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 6/16/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. | Upheld | Experimental | Summary Reviewer 2
A 30-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 6/16/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease. The physician reviewer found the Prometheus Anser ADA test is a quantitative measurement of serum adalimumab and anti-ADA antibodies. There are few well controlled clinical trials to confirm that use of the Anser ADA test leads to improved patient outcomes or quality of life as opposed to the standard method of treatment (Steenholdt, et al; Nanda, et al). Moreover, it has not 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, such as in this case. For the reasons provided, the Prometheus Anser ADA diagnostic testing performed on 6/16/14 was not more beneficial for treatment of the patients medical condition than conventional treatment strategies. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 25-year-old male enrollee has requested reimbursement for corneal crosslinking provided on 8/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician
that the patient was diagnosed with keratoconus in April 2013. On 5/13/14, his best corrected visual acuity was 20/40 in both eyes with manifest refraction. | Overturned | Experimental | Summary Reviewer 3
A 25-year-old male enrollee has requested reimbursement for corneal crosslinking provided on 8/06/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrollees medical condition. The physician reviewer found that the patient was diagnosed with keratoconus in April 2013. On 5/13/14, his best corrected visual acuity was 20/40 in both eyes with manifest refraction. Corneal cross-linking has been approved by the U.S. Food and Drug Administration for keratoconus and post-refractive ectasia. The primary purpose of cross-linking is to halt the progression of corneal thinning and stiffen the cornea. Prior to this treatment, patients with keratoconus who failed medical treatment (glasses and contact lenses) and whose disease continued to progress would undergo surgical management with corneal transplantation. Although better designed randomized control trials and long-term data are still underway, there is mounting evidence of the benefit of this treatment in younger patients with keratoconus and evidence of disease progression. In this case, the records do not clearly document that this patient has evidence of progressive keratoconus as indicated by increasing keratometry values, change in best corrected visual acuity, contact lens intolerance, and corneal pachymetry measurements. Therefore, the superior efficacy of the services at issue has not been established. Thus, corneal cross-linking provided on 8/06/18 was not likely to have been more beneficial than other available treatment options.
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A 32-year-old female enrollee has requested authorization and coverage for Gamunex-C. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrollees medical condition.
The patient has been diagnosed with autoimmune small fiber neuropathy. | Overturned | Experimental | Summary Reviewer 3
A 32-year-old female enrollee has requested authorization and coverage for Gamunex-C. 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 is support for the requested medication in this patients case. The patient has been diagnosed with autoimmune small fiber neuropathy. As noted by Schofield and Chemali, Intravenous immunoglobulin therapy is U.S. Food and Drug Administration (FDA) approved for the immune-mediated peripheral nerve disorders Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy. Immunoglobulin therapy has been used increasingly with significant efficacy in the treatment of patients with disabling autoimmune forms of dysautonomia, which are most often small fiber (autonomic and/or sensory) polyneuropathies. Intravenous immunoglobulin is used to treat a variety of autoimmune disorders, with a very good success rate. Thus, Gamunex-C is likely to be more beneficial than other available treatment options.
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A 54-year-old male enrollee has requested authorization and coverage for apremilast (Otezla) 30 mg tablets. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees psoriatic arthritis. | Upheld | Medical Necessity | Summary Reviewer
A 54-year-old male enrollee has requested authorization and coverage for apremilast (Otezla) 30 mg tablets. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees psoriatic arthritis. The physician reviewer found that the documentation provided do not support the medical necessity for the requested medication in this clinical setting. While the records indicate that this patient has failed two treatments with NSAIDs, the records do not demonstrate that he has tried and failed nonpharmacological treatments (ultravioletlight therapy), disease-modifying antirheumatic drugs (DMARD) therapies, or anti-tumor necrosis factor (TNF) agents. There is also no documentation that he has tried the standard topical therapy to address the psoriasis that covers at least ten percent of his body surface area. While apremilast may represent a promising therapy for the treatment of psoriatic arthritis and psoriasis, the medication should be tried after failure of other standard forms of therapy. Per Zerilli, and Ocheretyaner, Additional long-term studies are needed to further elucidate its place in therapy. As such, the requested medication is not medically indicated for the treatment of this patient. Therefore, for the reasons stated above, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 27-year-old female enrollee has requested reimbursement for genetic testing including methylenetetrahydrofolate reductase (MTHFR) gene analysis, common variants, and factor V Leiden mutation testing provided on 7/1/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for bleeding disorder. | Overturned | Experimental | Summary Reviewer 3
A 27-year-old female enrollee has requested reimbursement for genetic testing including methylenetetrahydrofolate reductase (MTHFR) gene analysis, common variants, and factor V Leiden mutation testing provided on 7/1/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees risk for bleeding disorder.
The physician reviewer found that the Pulmonary embolism (PE) and DVT may be caused by hereditary thrombophilias. The increased risk is worth knowing especially in situations of pregnancy, estrogen therapy, and prolonged immobility, such as surgery, long car trips, or long airplane flights. These complications may be prevented by appropriate interventions. There is strong medical evidence supporting factor V Leiden testing. There is a known interaction between estrogens and the mutation. Importantly, research indicates that the prothrombin G20210A mutation adds to this risk such that compound heterozygous patients can have up to 20 fold increased odds of developing DVT (Emmerich, et al). Accordingly, this patients case genetic testing including MTHFR gene analysis, common variants, and factor V Leiden mutation testing provided on 7/1/17 was likely to have been of greater benefit than the standard methods of evaluating this patients medical condition. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 57-year-old female enrollee has requested reimbursement for the gene test performed on 8/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 3
A 57-year-old female enrollee has requested reimbursement for the gene test performed on 8/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that there is a lack of medical studies to support the superior efficacy of this gene test in this patients case. The standard therapy for stage I malignant melanoma is surgical excision. The current body of medical research indicates that there is very little benefit from adjuvant therapy. The clinical trials have only looked at adjuvant therapy in lymph nodes positive for the disease. Regardless of the risk or recurrence determined by this test, the implications on therapeutic decisions cannot be validated by data and therefore, would not help direct therapy. Moreover, the gene test has not been shown to improve a patients health outcome over established alternatives. For these reasons, the gene test performed on 8/12/15 was not likely to have been more effective than available standard tests for the evaluation of this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 56-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Optune electrical stimulation device from 4/20/15 forward. The Health Insurer has denied this request indicating that the device at issue was not and is not medically necessary for treatment of the enrollees recurrent glioblastoma multiforme. | Overturned | Medical Necessity | Summary Reviewer
A 56-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Optune electrical stimulation device from 4/20/15 forward. The Health Insurer has denied this request indicating that the device at issue was not and is not medically necessary for treatment of the enrollees recurrent glioblastoma multiforme. The physician reviewer found The central nervous system tumors are classified by the World Health Organization (WHO) based on their proliferative potential, morphology, and molecular genetics and are conferred grades I-IV. Anaplastic astrocytomas and glioblastoma multiforme are high grade tumors that are best treated with resection, radiation therapy, and chemotherapy. This patient has exhausted all these options. In 2011, the U.S. Food and Drug Administration approved the NovoTTF-100A device, now known as the Optune electrical stimulation device, to deliver alternating electrical fields to treat recurrent glioblastoma multiforme. The approval was based on a randomized clinical study where 237 patients were treated with either NovoTTF versus best standard of care chemotherapy, including bevacizumab. There was no difference in overall survival between the two arms. The Optune electrical stimulation device is medically indicated for this patient who has exhausted standard treatment options. There is sufficient medical evidence to demonstrate the safety of this device. All told, Optune electrical stimulation device from 4/20/15 forward was and is medically indicated for the treatment of this patient. Therefore, the device at issue was and is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 62-year-old female enrollee has requested reimbursement for FoundationOne CDx test performed on 12/31/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 62-year-old female enrollee has requested reimbursement for FoundationOne CDx test performed on 12/31/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeAaas medical condition. The physician reviewer found that Molecular diagnostic studies in non-small cell lung cancer (NSCLC) are considered a standard of care. Numerous gene alterations have been identified that impact therapy selection. The National Comprehensive Cancer Network strongly advises broader molecular profiling with the goal of identifying rare driver mutations for which effective drugs may already be available, or to appropriately counsel patients regarding the availability of clinical trials. Broad molecular profiling is a key component of the improvement of care of patients with NSCLC. Testing of lung cancer specimens for these alterations is important for identification of potentially efficacious targeted therapies, as well as avoidance of therapies unlikely to provide clinical benefit. Therefore, FoundationOne CDx test performed on 12/31/19 was likely to have been more beneficial than other available standard therapy.
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A 62-year-old male enrollee has requested reimbursement for the IgG food sensitivity testing provided on 2/10/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees abdominal discomfort.T | Upheld | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for the IgG food sensitivity testing provided on 2/10/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees abdominal discomfort.The physician reviewer found in this case, the medical records fail to indicate any diagnosis consistent with an IgG mediated food allergy to support an indication for the testing at issue. The current National Institutes of Health National Institute of Allergy and Infectious Disease expert panel states that IgG food testing is not validated (Boyce, et al). The Joint Task Force on Practice Parameters for the Allergy and Immunology also state that IgG food testing is not validated (Sampson, et al). As such, IgG food testing is not considered the standard of care in this clinical setting (Sicherer and Teuber). Thus, the IgG food sensitivity testing performed on 2/10/16 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.
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A 19-year-old female enrollee has requested reimbursement for substance use partial hospitalization services provided form 10/08/18 through 10/11/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. | Upheld | Medical Necessity | Summary Reviewer
A 19-year-old female enrollee has requested reimbursement for substance use partial hospitalization services provided form 10/08/18 through 10/11/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees 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 ideation and no self-harming behaviors. With regards to functional status, the records support a score of 2 due to an overall good functional level with appropriate activities of daily living. In terms of medical, addictive and psychiatric comorbidity, the records support a score of 2 due to overall medical stability with stable psychiatric symptoms. With regards to level of stress of the recovery environment, the records support a score of 2 due to no mention of a stressful recovery environment. In terms of level of support of the recovery environment, the records support a score of 2 due to family support and availability of treatment resources. With regards to treatment and recovery history, the records support a score of 2 due to success in the treatment program with a good level of cooperation and stabilization of symptoms. In terms of engagement and recovery status, the records support a score of 2 due to cooperation in treatment and insight into her need for treatment. Thus, the patient has a composite score of 13. This score correlates with low intensity, community-based services. This patients presentation did not meet criteria for partial hospitalization program level of care. Therefore, substance use partial hospitalization that was provided from 10/08/18 through 10/11/18 was not medically necessary for the treatment of this patient. | 0 |
A 62-year-old male enrollee has requested authorization and coverage for sacroiliac joint (SI) fusion/percutaneous spine fusion. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees SI joint disorder.
. All patients had sacroiliac joint dysfunction confirmed by image guided intra-articular anesthetic sacroiliac joint injection and had failed non-operative treatment. | Upheld | Experimental | Summary Reviewer 2
A 62-year-old male enrollee has requested authorization and coverage for sacroiliac joint (SI) fusion/percutaneous spine fusion. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees SI joint disorder. The physician reviewer found that the selected procedure is a minimally invasive surgery which is more likely to be of benefit than any standard therapy for treatment of this patients SI dysfunction. The current medical literature pertaining to sacroiliac joint fusion demonstrates that surgical intervention for sacroiliac joint pain is beneficial in a subset of patients. Ledonio and colleagues studied 63 patients who underwent sacroiliac joint fusion with minimum one year follow-up. All patients had sacroiliac joint dysfunction confirmed by image guided intra-articular anesthetic sacroiliac joint injection and had failed non-operative treatment. The estimated blood loss, surgery time and length of stay favored the minimally invasive surgery sacroiliac fusion group. An article by Zaidi and colleagues demonstrates rates of excellent satisfaction determined by pain reduction, function, and quality of life ranged from 18%-100% with a mean of 54% in the open surgical cases and 56-100% with a mean of 84% in the minimally invasive surgery patients. The conclusion was that surgical intervention for sacroiliac joint pain was beneficial in a subset of patients. Although long-term results are still lacking, at this time there is sufficient data demonstrating that the requested sacroiliac joint fusion is likely to be more beneficial for treatment of the patients SI joint dysfunction than available standard modalities. In sum, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 62-year-old male enrollee has requested reimbursement for genetic testing performed on
9/29/20. The Health Insurer has denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for genetic testing performed on
9/29/20. The Health Insurer has denied this request and reported that the services at issue were
investigational for the evaluation of the enrollees medical condition. At issue is whether the
services at issue were likely to have been more beneficial for evaluation of the enrollee's condition
than any available standard therapy. The physician reviewer found that the submitted
documentation fails to demonstrate the superior efficacy of the services at issue. The initial
diagnosis of squamous cell carcinoma is soon followed by a determination of the risk for distant
metastasis or local recurrence. The various variables that figure into this determination involves
the tumor size and evidence for perineural or lymphovascular invasion. The clinical features that
figure into this include whether the lesion is recurrent or primary and is happening in the context
of immunosuppression. There are also histologic parameters of the primary lesion and the depth
of invasion that figure into the assessment of risk. The genetic analysis does not figure into the
current National Comprehensive Cancer Network guidelines or in current publications. Therefore,
the genetic testing performed on 9/29/20 was not likely to have been more beneficial than any
available standard therapy.
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A 58-year-old male enrollee has requested authorization and coverage for intravenous immune globulin. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees myasthenia gravis. | Overturned | Experimental | Summary Reviewer 1
A 58-year-old male enrollee has requested authorization and coverage for intravenous immune globulin. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees myasthenia gravis. The physician reviewer found that Myasthenia gravis affects the neuromuscular junction. Patients can have weakness of the ocular, limb, respiratory, and bulbar muscles. The nature of the pathogenesis (antibody mediated disease process) and the anatomical target can create clinical situations that are very diverse. Patients can have mild symptomatology with mild weakness or cosmetic changes to very severe life threatening clinical scenarios involving difficulty with breathing, ambulating, eating, and speaking. Treatment of myasthenia gravis is dependent on several factors including, but not limited to, the patients medical comorbidity, age, involvement of respiratory or bulbar muscles, progression, and severity. This patient has a form of myasthenia gravis that has been resistant to several therapies, including prednisone, plasmapharesis, azathioprine, mycophenolate mofetil, cyclosporine, and rituximab. Despite the significant number of medications the patient has failed, there are several therapeutic options that have shown to be effective in maintenance therapy for myasthenia gravis which have not been attempted, including tacrolimus, methotrexate, and cyclophosphamide. While intravenous immunoglobulin can be considered in severe refractory myasthenia gravis, there is a lack of evidence to suggest that intravenous immune globulin is more effective than these other agents which the patient has not tried. Therefore, intravenous immune globulin is not likely to be more effective 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.
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A 59-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan performed on 2/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees rigidity, lack of response to Sinemet trial, with suspected Parkinsons disease. | Overturned | Experimental | Summary Reviewer 2
A 59-year-old female enrollee has requested reimbursement for the single photon emission computed tomography (SPECT) scan performed on 2/17/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees rigidity, lack of response to Sinemet trial, with suspected Parkinsons disease. The physician reviewer found that in one study investigating the negative predictive value of imaging in questioned Parkinsons disease, Marek and colleagues found that in non-DAT avid patients, the likelihood of progressing on to Parkinsons disease is negligible (Marek, et al). This indicates a reasonable test to exclude Parkinsons disease in the presence of questionable symptomatology. In a large cohort from Ravina and colleagues, the authors noted a diagnostic and predictive benefit to early baseline DAT SPECT imaging in the outcomes of patients followed. Subsequent scans were less effective in guiding management, but initial baseline imaging was found predictive. In the case presented, an initial baseline DAT SPECT scan to establish the diagnosis in initial therapy resistant weakness and tremor is both efficient and prudent in establishing therapy and helping to curtail future debilitation. Given these findings, the SPECT scan performed on 2/17/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The parent of a 12-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intravenous immune globulin therapy. The Health Insurer has denied this request indicating that the services at issue were and are investigational for the treatment of the enrollees medical condition.T
. In this patients case, he had pre-existing autoimmune disease in the form of Hashimotos thyroiditis, and then developed acute symptoms associated with autoimmune encephalitis. He has an allergy to prednisone, and has thus far responded well to sequential administration of IVIG. His specialists have recommended a prolonged course of IVIG to prevent recurrence of this complication of his autoimmune disease. | Overturned | Experimental | Summary Reviewer 2
The parent of a 12-year-old male enrollee has requested reimbursement and prospective authorization and coverage for intravenous immune globulin therapy. The Health Insurer has denied this request indicating that the services at issue were and are investigational for the treatment of the enrollees medical condition.The physician reviewer found the medical literature supports the use of IVIG in patients with autoimmune encephalitis. In this patients case, he had pre-existing autoimmune disease in the form of Hashimotos thyroiditis, and then developed acute symptoms associated with autoimmune encephalitis. He has an allergy to prednisone, and has thus far responded well to sequential administration of IVIG. His specialists have recommended a prolonged course of IVIG to prevent recurrence of this complication of his autoimmune disease. Autoimmune encephalitis, or antibody-mediated encephalitis, affects children and adults, and is emerging as a more common cause of encephalopathy in these populations. Current treatment strategies involve removal of existing antibodies, in the form of intravenous immunoglobulins and plasmapheresis, as well as immunosuppression to decrease production of antibodies. The first-line therapy then includes IVIG, parenteral steroids, and plasmapheresis, with some potential additional benefit from second-line immunosuppressant therapies. For all these reasons, the services at issue were and are likely to be more beneficial for treatment of this patients autoimmune encephalitis than any available standard modality.For the reasons set forth above, the services at issue were and 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 64-year-old male enrollee has requested reimbursement for assay of vitamin D performed on 8/08/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollee, who has a history of hyperlipidemia. | Upheld | Medical Necessity | Summary Reviewer
A 64-year-old male enrollee has requested reimbursement for assay of vitamin D performed on 8/08/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for evaluation of the enrollee, who has a history of hyperlipidemia. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. The clinical manifestations of vitamin D deficiency depend upon the severity and duration of the deficiency. The majority of patients with moderate to mild vitamin D deficiency are asymptomatic. In the setting of severe vitamin D deficiency, there can be hypocalcemia which leads to bone disorders. Patient groups who are at risk for vitamin D insufficiency include those who have dark skin or are obese, those taking medications that accelerate the metabolism of vitamin D, hospitalized or institutionalized people or those who have limited effective sun exposure. Other people at high risk include those with osteoporosis or malabsorption, including inflammatory bowel disease and celiac disease. Screening of the general population is not recommended. In this case, the patient did not have chronic medical conditions that would cause vitamin D deficiency. Thus, assay of vitamin D performed on 8/08/18 was not medically necessary for the evaluation of this patient. Therefore, the services at issue were not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
The patient is a 13-year-old male who presented to his provider on 3/4/22. The patients parent
has requested authorization and coverage for Nutropin AQ Nusprin 10 injector. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 13-year-old male who presented to his provider on 3/4/22. The patients parent
has requested authorization and coverage for Nutropin AQ Nusprin 10 injector. The physician
reviewer found that at issue is whether Nutropin AQ Nusprin 10 injector is medically necessary
for the treatment of this patient. The submitted documentation does not support the medical
necessity of the requested medication. Somatotropin may be indicated for pediatric use for
specific conditions, including pediatric growth hormone deficiency so long as epiphyses, or
growth plates, remain open. Generally accepted diagnostic criteria define isolated growth
hormone deficiency as either growth velocity with a z-score below 2.0 standard deviation score
(SDS) or a height z-score below 2.25 SDS, along with subnormal response to two standard
growth hormone stimulation tests. In this case, the patients clinical presentation and course are
most consistent with normal variations of growth and development and with the familial pattern
of growth and development. The records do not document that this patient meets the generally
accepted indications for growth hormone therapy. The submitted records also did not discuss
brain magnetic resonance imaging (MRI), generally performed prior to initiation of somatotropin
in children and adolescents to exclude intracranial lesions, or direct measurements of parental
heights. Based on all of these factors, the medication is not indicated. Therefore, Nutropin AQ
Nusprin 10 injector is not medically necessary for the treatment of this patient.
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A 58-year-old female enrollee has requested reimbursement for the radiofrequency lesioning performed on 7/7/16 and 7/21/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees thoracic and lumbar degenerative disc disease and facet arthropathy. | Upheld | Medical Necessity | Summary Reviewer
A 58-year-old female enrollee has requested reimbursement for the radiofrequency lesioning performed on 7/7/16 and 7/21/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees thoracic and lumbar degenerative disc disease and facet arthropathy. The physician reviewer found that the literature states that a diagnostic medial branch block is supposed to be done prior to radiofrequency ablation and should include use of a pain diary for the day to verify when the local anesthetic wore off, using either solely lidocaine or bupivacaine, without sedation (Derby, et al). In the documentation available for review, the provider does not document a pain diary for the medial branch block done prior to the previous radiofrequency ablation. Further, the records do not document a steroid injection has been performed, which may provide the patient with identical relief without the increased risks associated with radiofrequency ablation (Manchikanti, et al). Finally, the medical records from the prior ablation are not submitted to demonstrate the patient obtained 50% relief, with increased functional benefit from baseline, and decrease in perceived pain from baseline. For these reasons, radiofrequency lesioning performed on 7/7/16 and 7/21/16, were not medically necessary for treatment of the patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 51-year-old female has requested reimbursement for human epididymis protein 4 (HE4) testing. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 51-year-old female has requested reimbursement for human epididymis protein 4 (HE4) testing. 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 evaluation of the symptomatic patient with pelvic/adnexal mass includes physical examination and may include transvaginal ultrasonography and measurement of levels of the serum tumor marker CA125. HE4 tumor markers are not recommended to help make the decision as to whether an adnexal mass represents a benign or malignant process. The results should not be used in the decision-making process of which patients should have additional surgical evaluation of an adnexal mass. Tumor marker panels have not been evaluated prospectively in large population-based studies and have not been proven to improve early detection and survival rates. In sum, HE4 testing performed on 11/20/15 was not likely to have been superior over other modalities for evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 51-year-old female has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
The physician reviewer found that the patient is a 51-year-old female who was diagnosed with a cutaneous melanoma in June 2016. At that time, she was found to have a superficial spreading melanoma, 0.8 mm in thickness, with no ulceration. DecisionDx-Melanoma testing was performed on 4/13/18. The patient has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. | Upheld | Experimental | Summary Reviewer 2
A 51-year-old female has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
The physician reviewer found that the patient is a 51-year-old female who was diagnosed with a cutaneous melanoma in June 2016. At that time, she was found to have a superficial spreading melanoma, 0.8 mm in thickness, with no ulceration. DecisionDx-Melanoma testing was performed on 4/13/18. The patient has requested reimbursement for genetic testing performed on 4/13/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. The prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add 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 and colleagues reported on 217 cases, with good correlation between DecisionDx-Melanoma classification and prognosis, in patients who had undergone sentinel node biopsy. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it not clear that the DecisionDx-Melanoma classification can be used to make clinical decisions. In sum, genetic testing performed on 4/13/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye. | Overturned | Experimental | Summary Reviewer 3
A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye. The physician reviewer found that the service at issue was likely to be more effective than other methods of evaluating this patient. This patient has a rare disease, ocular melanoma. However, knowledge of the propensity for metastasis directly affects surveillance of patients by computed tomography scan. Along these lines, there are clinical studies that support the use of gene expression classifier DecisionDX uveal melanoma. This assay defines two classes of ocular melanoma. Class 1 is associated with a low risk of metastasis and class 2 has a 50% risk at two years and 72% risk at five years. Currently, there is no other standard prognostic indicator that could serve as an alternative. Thus, the current medical evidence favors the use of this test in the post-operative surveillance of patients with ocular melanoma. As such, the DecisionDX uveal melanoma multigene assay performed on 4/10/15 was likely to be superior over other available methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 28-year-old male enrollee has requested reimbursement for Prometheus Anser ADA diagnostic test performed on 12/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
| Upheld | Experimental | Summary Reviewer 2
A 28-year-old male enrollee has requested reimbursement for Prometheus Anser ADA diagnostic test performed on 12/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns disease.
The physician reviewer found that the Anser ADA test assesses serum adalimumab (ADA) and anti-ADA antibodies. Some evidence exists that low serum levels of infliximab or adalimumab and/or the presence of antibodies to infliximab or adalimumab may play a role in primary or secondary response failures. However, 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. 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. While there have been testimonials, 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. Moreover, it has not been established how patient management would change based on test results. In sum, the Prometheus Anser ADA diagnostic test performed on 12/30/15 was not likely to have been more effective than other treatment modalities for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for the evaluation of this patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 39-year-old male enrollee has requested authorization and coverage for autologous cultured chondrocyte and autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
history of severe localized right knee pain. Upon failure of various conservative treatments, he underwent arthroscopic surgery of the right knee in January 2018 and was found to have multiple chondral defects of the medial and lateral femoral condyles and trochlear groove. The patient continues to experience localized severe pain and swelling in the knee. The provider has recommended autologous cultured chondrocyte implantation of the knee. | Overturned | Experimental | Summary Reviewer 2
A 39-year-old male enrollee has requested authorization and coverage for autologous cultured chondrocyte and autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that in this patients case, the records document a history of severe localized right knee pain. Upon failure of various conservative treatments, he underwent arthroscopic surgery of the right knee in January 2018 and was found to have multiple chondral defects of the medial and lateral femoral condyles and trochlear groove. The patient continues to experience localized severe pain and swelling in the knee. The provider has recommended autologous cultured chondrocyte implantation of the knee. Multiple chondral defects of the patellofemoral joint of the knee, as in this case, are common and can result in chronic pain and impair quality of life. The autologous chondrocyte implantation technique has evolved over the past 20 years and is associated with good to excellent mid-term and long-term results. The newest third-generation technique is matrix-induced autologous chondrocyte implantation. Physical examination and imaging is important to characterize the location and source of pain and identify associated injuries. In this case, arthroscopic evaluation has accurately localized the cartilage defects. Conservative measures have been exhausted. Therefore, surgical treatment is necessary to improve the quality of life. In sum, the requested autologous cultured chondrocyte and autologous chondrocyte implantation of the knee are likely to be more beneficial than other treatment options.
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A 19-year-old female enrollee has requested reimbursement for the Anser IFX test provided on 2/16/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees ulcerative colitis. | Upheld | Experimental | Summary Reviewer 2
A 19-year-old female enrollee has requested reimbursement for the Anser IFX test provided on 2/16/16. 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 this case, Anser IFX was ordered to determine infliximab level and whether antibodies to Remicade were present. Loss of response to infliximab can occur for many reasons, although there was not a clear loss of response to infliximab in this case (Mahadevan, et al). In addition, the presence of antibodies alone has not been proven to result in loss of response to infliximab or infusion reactions, nor have threshold levels been established (Steenholdt, et al). Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response (Vande Casteele, et al; Nanda, et al). One study, with some patients undergoing dose intensification following initial non-response, showed no difference in serum levels of infliximab between patients who responded to dose intensification versus those who did not (Pariente, et al). In summary, the current medical literature lacks high-quality controlled studies to define drug level or antibody level thresholds requiring action, compare clinical strategies based on those thresholds, and then definitively establish that use of Anser IFX improves outcome when used in those treatment pathways. Given these findings, the Anser IFX test provided on 2/16/16 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.
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A 29-year-old female enrollee has requested reimbursement for emergency services provided on 5/24/17. The Health Insurer has denied this request indicating the services at issue did not meet the prudent layperson criteria for treatment of an emergency medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 29-year-old female enrollee has requested reimbursement for emergency services provided on 5/24/17. The Health Insurer has denied this request indicating the services at issue did not meet the prudent layperson criteria for treatment of an emergency medical condition. The physician reviewer found at issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition on 5/24/17. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. In the medical literature, Martin and colleagues noted that, allergic contact dermatitis (ACD) is an inflammatory skin disease that affects about 20% of the adult general population. The authors reported that first-line treatment includes topical emollients and anti-inflammatory agents and avoidance of the culprit allergen. In this case, the medical records do not indicate that the patient developed any urgent or emergent symptoms, such as interference with breathing or rapid swelling of the face or lips. A prudent layperson would not have sought immediate medical attention for the patients cutaneous eruption. Thus, the services provided on 5/24/17 were not required for the treatment of an emergency medical condition. Based on the foregoing discussion, the services at issue were not required on an emergent basis. The Health Insurers denial should be upheld. | 0 |
A 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 7/29/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. | Overturned | Experimental | Summary Reviewer 1
A 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 7/29/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that there is a lack of peer-reviewed literature that supports the use of three-dimensional breast tomosynthesis compared to currently available techniques, especially in a patient without an increased risk of breast cancer. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in the peer-reviewed medical literature. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 7/29/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 36-year-old female who presented on 7/11/16. The records noted hormone imbalance. She was started on low dose birth control pills. The patient ultimately developed headaches on the birth control pills, which limited further use. On 11/07/16, the records noted major depressive disorder and generalized anxiety disorder. She was started on Viibryd. On 11/18/16, the records noted painful periods. On 12/30/16, endometrial ablation was performed. The Health Insurer has denied reimbursement for the services at issue. Per the Health Insurer, endometrial ablation was investigational for the treatment of this patient. | Upheld | Experimental | Summary Reviewer 1
The patient is a 36-year-old female who presented on 7/11/16. The records noted hormone imbalance. She was started on low dose birth control pills. The patient ultimately developed headaches on the birth control pills, which limited further use. On 11/07/16, the records noted major depressive disorder and generalized anxiety disorder. She was started on Viibryd. On 11/18/16, the records noted painful periods. On 12/30/16, endometrial ablation was performed. The Health Insurer has denied reimbursement for the services at issue. Per the Health Insurer, endometrial ablation was investigational for the treatment of this patient. The submitted documentation fails to demonstrate the superior efficacy of the services at issue. The submitted records do not include a complete blood count to attempt to document the anemia of heavy cycles. There is no documentation of sampling of the endometrium, such as endometrial biopsy or dilation and curettage (D&C). In this patients case, addressing her issues of mood disorders (which can have a strong effect on perception of pain) and offering a trial of medical management was reasonable. Although progesterone only may have worsened her mood disorders, but this would not be the case with Mirena. If the patient had a relatively normal complete blood count, she could have benefitted from the use of nonsteroidal anti-inflammatory drugs with or without progesterone. If the patient had contraindications to these management options, then an endometrial ablation may have been an appropriate next step. However, an endometrial biopsy should have been done before the ablative procedure was contemplated. Therefore, endometrial ablation was not likely to have been more effective than other available 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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