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A 59-year-old male enrollee has requested reimbursement for gene testing performed on 3/9/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 59-year-old male enrollee has requested reimbursement for gene testing performed on 3/9/15. The Health Plan has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that while a FNA biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15 % of FNA biopsy results are considered to be indeterminate (Alexander, et al). Until recently, the only way to establish whether the nodule was in fact thyroid cancer was via surgical excision even though the majority of the cases turn out to be benign (Miller, et al). The Afirma Thyroid FNA Analysis utilizes a gene expression classifier in order to help determine the likelihood of malignancy of nodules with indeterminate cytology on FNA biopsy, thereby decreasing the need for unnecessary surgeries. Because it is very sensitive and has a high negative predictive value, a negative Afirma result is rather suggestive of a benign nodule and can therefore preclude such surgical procedures (Duick et al). For the reasons provided above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 58-year-old female enrollee has requested authorization and coverage for breast magnetic resonance imaging (MRI). The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollee, who is status post breast implant placement.
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Upheld
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Medical Necessity
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Summary Reviewer
A 58-year-old female enrollee has requested authorization and coverage for breast magnetic resonance imaging (MRI). The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollee, who is status post breast implant placement. The physician reviewer found that according to the American College of Radiology appropriateness criteria, in a patient with average risk for breast cancer, or less than 15% lifetime risk, mammography or breast tomosynthesis is the appropriate screening examination regardless of the presence of breast implants. In the absence of additional risk factors, MRI is not indicated in this setting. There are specific mammographic techniques that are utilized, such as the Eklund maneuver, to displace the implant away from the breast tissue during mammography for better visualization of the breast tissue. If implant rupture is a concern, then non-contrast MRI would be indicated to evaluate for implant integrity. Alternatively, if the patient has implant rupture with free silicone in the breast, this could obscure findings on mammography, and contrast enhanced MRI may be indicated. However, there is no indication of either of these scenarios in the clinical records. In this case, breast MRI is not indicated for breast cancer screening. Specialized techniques exist for mammographic visualization of the breast tissue in the augmented breast. Thus, the requested breast MRI is not medically necessary for the evaluation of this patient. Therefore, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
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The parent of a 10-year-old male enrollee has requested reimbursement for the functional neuromuscular electrical stimulator-arms therapy system provided on 4/16/20. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a 10-year-old male enrollee has requested reimbursement for the functional neuromuscular electrical stimulator-arms therapy system provided on 4/16/20. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the superior efficacy of the device at issue in this clinical setting. Murphy and colleagues noted, Following the acute phase of acute flaccid myelitis (AFM), patients typically have substantial residual disability and unique long-term rehabilitation needs." Per the authors, Patients engaged in multimodal rehabilitation can achieve functional improvements for years even after recovery of motor strength plateaus. The authors describe that potential long-term sequelae from AFM include musculoskeletal problems and psychological sequelae, such as anxiety and depression. Melicosta and colleagues reported on the rehabilitation outcomes of a cohort of 31 children with AFM who received Activity Based Restorative Therapy (ABRT), including functional electrical stimulation. The authors concluded, Children with flaccid paralysis due to AFM undergoing structured, comprehensive rehabilitation interventions, even when these are initiated long after paralysis onset, can make significant neurologic and functional gains. Recovery of function and prevention of comorbidities are the main therapeutic targets for interventions in this population. Therefore, the functional neuromuscular electrical stimulator-arms therapy system provided on 4/16/20 was likely to have been more beneficial than any available standard therapy.
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A 63-year-old female enrollee has requested authorization and coverage for rizatriptan tablets 5 mg, 12 tablets per copayment every 30 days. The Health Insurer has denied this request and reported that the requested medication quantity is not medically necessary for the treatment of the enrollees medical condition.
This patient has been diagnosed with migraine headaches. She has tried other forms of therapy, including Topamax, gabapentin, nortriptyline, Lexapro, Wellbutrin, and Geodon.
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Overturned
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Medical Necessity
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Summary Reviewer
A 63-year-old female enrollee has requested authorization and coverage for rizatriptan tablets 5 mg, 12 tablets per copayment every 30 days. The Health Insurer has denied this request and reported that the requested medication quantity 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 quantity. This patient has been diagnosed with migraine headaches. She has tried other forms of therapy, including Topamax, gabapentin, nortriptyline, Lexapro, Wellbutrin, and Geodon. Rizatriptan is a medication that can be prescribed such that a patient may not take more than 30 mg in a 24-hour period. The dosage provided by the provider appears to be appropriate to treat three to four migraine attacks per month. This is consistent with the current standard of care. Therefore, rizatriptan tablets 5 mg, 12 tablets per copayment every 30 days is medically necessary for the treatment of this patient.
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A 55-year-old female enrollee has requested authorization and coverage for botulinum toxin type A (Botox) treatment and ongoing treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
In this case, the patient presents with a long history of migraine headaches dating to childhood. The records indicate that before starting Botox she had a baseline headache frequency of 16 to 24 per month, which
of chronic migraine. In addition, the patient has had a marked improvement documented with Botox treatments for more than 10 years.
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Overturned
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Experimental
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Summary Reviewer 2
A 55-year-old female enrollee has requested authorization and coverage for botulinum toxin type A (Botox) treatment and ongoing treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that ongoing Botox treatment is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In this case, the patient presents with a long history of migraine headaches dating to childhood. The records indicate that before starting Botox she had a baseline headache frequency of 16 to 24 per month, which is consistent with the diagnosis of chronic migraine. In addition, the patient has had a marked improvement documented with Botox treatments for more than 10 years. In sum, Botox treatment for chronic migraine is indicated for this patient and ongoing treatments are 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 36-year-old female enrollee has requested reimbursement for infliximab antibody testing performed on 3/30/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees medical condition.
In this case, the patient had a recent flare-up while being treated with Remicade and the infl
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Upheld
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Experimental
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Summary Reviewer 3
A 36-year-old female enrollee has requested reimbursement for infliximab antibody testing performed on 3/30/15. 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 infliximab antibody testing performed on 3/30/15 was likely to be more effective for this patient than other available treatment options. Maximizing the efficacy of therapies for inflammatory bowel disease such as ulcerative colitis, while minimizing their toxicity remains the principal objective in developing management strategies. The loss of response to infliximab can be due to sub-therapeutic infliximab levels or the presence of antibodies to infliximab and performing this assay can be very useful in the management of the patients who are being treated with infliximab. In this case, the patient had a recent flare-up while being treated with Remicade and the infliximab antibody testing performed was indicated to assist with managing treatment strategies. 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 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.
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Upheld
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Experimental
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Summary Reviewer 3
A 62-year-old male enrollee has requested 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 the use of food-specific IgG level testing has not been shown to improve health outcomes at long-term follow-up. There is data suggesting that this testing does not predict true food hypersensitivity, and may actually be a marker of earlier development of food tolerance. Food-specific IgG tests typically yield multiple positive results and may represent a normal immune response to foods (Beyer and Teuber). Thus, food-specific IgG should not be used as a tool to diagnose food allergy and the positive foods should not be eliminated from the diet based upon results of these tests (Lemon-Mule, et al; Savilahti, et al). The standard evaluation of food allergy consists of blood IgE level for foods and skin testing. IgE immunoassays are in vitro assays used to identify food-specific IgE in the serum. Immunoassays have demonstrated very high positive predictive accuracy for several of the major food allergens including egg, milk, peanut, tree nuts, and fish that correspond to a positive predictive accuracy of 95%. Skin testing for food-specific IgE is used in the diagnosis of IgE-mediated food allergies. A positive skin test to a particular food indicates the possibility that the patient has true allergy to that food. A negative skin test result indicates the absence of an IgE-mediated allergy upon subsequent challenge with a 90 to 95% predictive accuracy. In conclusion, the IgG food laboratory testing performed on 2/10/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard of care.Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 63-year-old male enrollee has requested reimbursement for Guardant360 liquid biopsy test performed on 9/14/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 63-year-old male enrollee has requested reimbursement for Guardant360 liquid biopsy test performed on 9/14/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that Guardant assay is a multigene assay that looks at cell-free DNA in the blood, presumably shed by cancer cells. In certain situations, where tissue biopsy is not feasible or safe, it can be used instead of a tissue biopsy assay. The hope with this and other similar assays is that they will identify a molecular target at which a therapeutic drug can be aimed to produce a clinically beneficial outcome. Thus far, however, the assay has not been shown to yield reliable and clinically useful results. A randomized study by Le Tourneau and colleagues did not demonstrate advantage to treating based on such an assay versus conventional judgment. Therefore, Guardant360 liquid biopsy test performed on 9/14/20 was not likely to have been more beneficial than other methods of evaluating this patient.
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A 40-year-old female enrollee has requested reimbursement for CPT code 31299 performed on 12/22/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.
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Overturned
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Experimental
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Summary Reviewer 3
A 40-year-old female enrollee has requested reimbursement for CPT code 31299 performed on 12/22/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is sufficient support for the service at issue in this clinical setting. This patient had already failed optimal medical therapy. The alternative treatment, surgical neurectomy, is well-known to be associated with increased adverse events and complications. There is sufficient evidence in the peer-reviewed literature to support the safety, efficacy, and long-term outcome in the treatment of chronic rhinitis with cryotherapeutic ablation of the posterior nasal nerves utilizing the ClariFix device.
A multicenter, prospective, single-arm clinical study by Ow and colleagues showed that cryotherapy significantly and clinically improves rhinitis symptoms and quality of life with outcomes that are durable through 24 months after treatment. The prospective multicenter study by Chang and colleagues demonstrated the Reflective Total Nasal Symptom Score (rTNSS) significantly improved over pretreatment baseline at 1 month, 3 months, 6 months, and 9 months post-procedure. Gerka Stuyt and colleagues performed a prospective single-arm trial at multiple locations within a large health maintenance organization of patients with chronic rhinitis that failed medical therapy and were treated with in-office cryoablation of the posterior nasal nerve (PNN). The authors noted that the Total Nasal Symptom Score (TNSS) 12-hour symptom score significantly improved at 30 days, at 90 days and at one-year post treatment. Therefore, CPT code 31299 performed on 12/22/20 was likely to have been more beneficial than other available standard therapy.
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A 40-year-old male enrollee has requested reimbursement for acupuncture services (CPT code 97810) provided from 8/13/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees abdominal pain.
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Upheld
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Experimental
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Summary Reviewer 2
A 40-year-old male enrollee has requested reimbursement for acupuncture services (CPT code 97810) provided from 8/13/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees abdominal pain. The physician reviewer found the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is a lack of objective measurable evidence of functional gain and/or improvement. There are a lack of clinical references to objective functional improvement during the dates in dispute. In sum, the records lacked sufficient evidence supporting treatment with acupuncture 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 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 male enrollee has requested reimbursement for platelet-rich plasma injections provided from 7/14/17 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 3
A 59-year-old male enrollee has requested reimbursement for platelet-rich plasma injections provided from 7/14/17 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that there is limited reliable clinical evidence to guide the use of platelet-rich plasma injections. Transient side effects, such as post-injection swelling and pain, short duration nausea and dizziness, have been reported in up to 20% of recipients. Side effects appear to be more common with multiple injection protocols. Long-term benefits of platelet-rich plasma have not been demonstrated yet in the knee. Short-term benefits, lasting from six months to over a year, include functional improvement and pain relief. Such effects have been demonstrated primarily in patients under age 50 with mild to moderate osteoarthritis or recalcitrant patella tendinopathy. There is lack of high quality studies regarding platelet-rich plasma injections in the sacroiliac joint or thumb carpometacarpal joints. The effects of platelet-rich plasma on knee osteoarthritis are quite mixed, and the research is not high quality. The majority of published data suggests better symptomatic relief with early osteoarthritis. Kon and colleagues performed a study of platelet-rich plasma injections in patients with early arthritis comparing the effectiveness of platelet-rich plasma with that of both low- and high-molecular-weight hyaluronic acid injections. The authors concluded that platelet-rich plasma is promising for less severe early arthritis for patients under 50 years of age, but not for more severe osteoarthritis, especially in older patients. Filardo and colleagues compared platelet-rich plasma injections to hyaluronic acid injections in a 192 patient randomized controlled trial where three weekly injections were followed for 12 months. Significantly more post-injection swelling and pain was seen in the platelet-rich plasma group, with no significant differences in outcome. The authors concluded that platelet-rich plasma should not be preferred to viscosupplementation. In this case, the patient was treated with platelet-rich plasma injections to his thumb carpometacarpal joints, knees and sacroiliac joint for the presumed diagnosis of osteoarthritis, although the records did not clearly define the indication. The current medical evidence does not support this treatment modality in this setting. The patient is over the age of 50, and the submitted records do not include radiology reports which grade the degree of osteoarthritis, if present. Thus, platelet-rich plasma injections provided from 7/14/17 forward were not and are not likely to be of greater benefit than other treatment alternatives. 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 52-year-old female enrollee has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 52-year-old female enrollee has requested authorization and coverage for proton beam therapy. 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 currently, there is a lack of strong prospective clinical data in the medical literature to suggest that treatment with proton beam radiation offers a clinical benefit compared to conventional radiation therapy techniques for esophageal tumors. In the majority of cases, the standard approach to treat this malignancy is with standard photon techniques using intensity modulated radiation therapy (IMRT). The comparison dosimetry was reviewed, and the major dose metrics for the normal structures are being met with the standard photon plan. Consensus group guidelines do not support the use of proton beam therapy in this setting. Also, there is a lack of level I evidence to support the use of proton beam therapy for the treatment of esophageal cancer. Thus, proton beam therapy is not likely to be more beneficial than other available treatment options.
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A 61-year-old female enrollee has requested reimbursement for Collagen Type 1 C-telopeptide blood test that was performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees post-menopausal osteoporosis.
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Overturned
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Experimental
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Summary Reviewer 1
A 61-year-old female enrollee has requested reimbursement for Collagen Type 1 C-telopeptide blood test that was performed on 11/21/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees post-menopausal osteoporosis. The physician reviewer found osteoporosis is a condition of thinning of the bones which leads to increased risk of fracture. It is defined by the World Health Organization (WHO) as a bone mineral density of 2.5 standard deviations or more below the mean peak bone mass (average of young, healthy adults) as measured by dual-energy X-ray absorptiometry. Bone mineral density (BMD) assessment, via DEXA, is still the criterion standard for evaluation and diagnosis of osteoporosis. However, because changes in bone mass and density in response to antiresorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover, (proteins and peptides, referred to as biochemical bone markers, that are released as a consequence of the physiological action of osteoblasts and osteoclasts) may be a useful adjunct in monitoring of osteoporotic patients treated with antiresorptive agents (Eastell et al). Medical evidence suggests that biochemical markers could be useful in making therapeutic decisions because, in general, the higher the bone remodeling and bone loss rates, the greater the concentration of bone biochemical markers in blood or urine (Chestnut et al). For this reason, the Centers for Medicare and Medicaid Services (CMS) has established a national policy for reimbursement of collagen crosslink testing including indications such as identifying individuals with elevated bone resorption, who have osteoporosis in whom response to treatment is being monitored and predicting response to Food and Drug Administration approved antiresorptive therapy in postmenopausal women. In sum, the disputed testing was clinically appropriate and indicated for evaluation of the patients medical condition.
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 57-year-old female enrollee has requested reimbursement for code 81599 (DecisionDx-Melanoma) testing provided on 1/29/19. 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.
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Upheld
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Medical Necessity
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Summary Reviewer
A 57-year-old female enrollee has requested reimbursement for code 81599 (DecisionDx-Melanoma) testing provided on 1/29/19. 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 this patient has 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 are no definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, code 81599 (DecisionDx-Melanoma) testing provided on 1/29/19 was not medically necessary for the evaluation of this patient.
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The parent of an eight-year-old male enrollee has requested reimbursement for services by JNK Assessments provided from 9/13/17 through 11/27/17. 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.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of an eight-year-old male enrollee has requested reimbursement for services by JNK Assessments provided from 9/13/17 through 11/27/17. 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 Colenbrander and colleagues noted that early identification of dyslexia is crucial to ensure that children are able to maximize their educational potential. DuPaul and colleagues described that comprehensive intervention services for students with comorbid attention deficit/hyperactivity disorder and learning disability will require empirically supported treatment strategies that address both disorders and that are implemented across school and home settings. Hebert and colleagues described that children with dyslexia often have related writing difficulties. The authors found evidence of effective remedial and compensatory intervention strategies in spelling, transcription, executive function, and working memory. The medical evidence supports the services at issue in this clinical setting. Therefore, JNK Assessments provided from 9/13/17 through 11/27/17 were medically necessary for the evaluation of this patient.
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A 23-year-old female enrollee has requested authorization and coverage for FirstStep Plus Cytogenomic Constitutional (Genome-Wide) Microarray Analysis. The Health Insurer has denied this request indicating that the requested services are investigational for the evaluation of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 1
A 23-year-old female enrollee has requested authorization and coverage for FirstStep Plus Cytogenomic Constitutional (Genome-Wide) Microarray Analysis. The Health Insurer has denied this request indicating that the requested services are investigational for the evaluation of the enrollees medical condition. The physician reviewer found arraybased comparative genomic hybridization has become standard of care to investigate children with developmental delay, intellectual disability, autism spectrum disorders or congenital anomalies. Until recently, it was a diagnostic test that was employed when the first-line investigation of karyotype (chromosome analysis) returned normal. Over the last five years, it has emerged as a first-line investigation. This test has become an important and mainstream tool in the practice of clinical genetics. Data have now emerged showing that actionable findings from chromosomal microarray justify its use. All told, the requested services are likely to be of greater benefit than other methods of 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.
| 0 |
A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 4/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 23-year-old female enrollee has requested reimbursement for Prometheus Anser IFX testing performed on 4/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the testing in dispute was ordered to direct the use of infliximab in this patient with Crohns disease. However, the use of this testing to direct subsequent management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. In sum, Prometheus Anser IFX testing performed on 4/29/15 was not likely to have been of greater benefit than other methods of evaluation. 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 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/31/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
The patient is a 62-year-old female who had a screening mammogram including tomosynthesis on 3/31/16. The patient relayed a complaint of a palpable breast mass. The report noted no evidence of breast cancer. The Health Insurer has denied reimbursement for digital breast tomosynthesis performed on 3/31/16. Per the Health Insurer, the service at issue was investigational for the evaluation of this patient.
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Overturned
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Experimental
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Summary Reviewer 3
A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/31/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found The patient is a 62-year-old female who had a screening mammogram including tomosynthesis on 3/31/16. The patient relayed a complaint of a palpable breast mass. The report noted no evidence of breast cancer. The Health Insurer has denied reimbursement for digital breast tomosynthesis performed on 3/31/16. Per the Health Insurer, the service at issue was investigational for the evaluation of this patient.
There is sufficient support for digital breast tomosynthesis for the evaluation of this patient. The medical studies have shown that the addition of three dimensional digital breast tomosynthesis (DBT) reduces false positive results and increases cancer detection when compared to two dimensional full field digital mammography alone. Three dimensional DBT allows better characterization of possible masses, spiculation, and architectural distortion. In sum, there is sufficient evidence supporting the use of tomosynthesis for this patients routine breast cancer screening. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned
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A 44-year-old male enrollee has requested authorization and coverage for lumbar spinal fusion. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees lower back pain.
presents with persistent and worsening low back pain radiating into both lower extremities. He reported difficulty with functional mobility due to right lower extremity numbness and weakness.
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Upheld
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Medical Necessity
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Summary Reviewer
A 44-year-old male enrollee has requested authorization and coverage for lumbar spinal fusion. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees lower back pain. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the procedure at issue. Resnick and colleagues recommend surgery for spinal stenosis for patients who do not improve with conservative treatment. Numerous studies have demonstrated the role of surgical decompression in this patient population; however, few have investigated the utility of fusion in patients without underlying instability. The inclusion of fusion is recommended for patients with demonstrated spinal instability or the likelihood of iatrogenic instability (Resnick et al). Fusion may be supported for segmental instability (objectively demonstrable) including excessive motion, as in isthmic or degenerative spondylolisthesis, surgically induced segmental instability and mechanical intervertebral collapse of the motion segment and advanced degenerative changes after surgical discectomy. Pre-operative clinical surgical indications require completion of all physical therapy and manual therapy interventions, x-rays demonstrating spinal instability, spine pathology limited to two levels, and psychosocial screening with confounding issues addressed. Ghogawala and colleagues reported that the results of recent studies suggest that a patient's pretreatment psychological state is a major independent variable that affects the ability to detect change in functional outcome. In this patients case, the above-noted evidence-based medical guidelines and peer-reviewed criteria have not been met. This patient presents with persistent and worsening low back pain radiating into both lower extremities. He reported difficulty with functional mobility due to right lower extremity numbness and weakness. There are no clinical findings of nerve root compromise correlated with imaging evidence of degenerative disc disease at L4/5 and L5/S1. Discography is of limited diagnostic value. There is no radiographic evidence of spondylolisthesis or spinal segmental instability on flexion and extension x-rays. There is no imaging evidence of significant facet arthropathy supporting the need for wide decompression that would result in temporary intraoperative instability and necessitate fusion. There is no evidence of a psychosocial assessment. Therefore, the requested lumbar spinal fusion is not considered medically necessary for the treatment of this patients medical condition. Based on the submitted documentation and per accepted clinical guidelines, the requested procedure is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 62-year-old female enrollee has requested reimbursement for corrective footwear provided on 4/09/19. The Health Insurer has denied this request and reported that the equipment at issue was not medically necessary for the treatment of the enrollees medical condition.
tibial tendon dysfunction and associated stage I flexible flat foot deformity. The patient also has associated pain and gait abnormality. Posterior tibialis
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Overturned
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Medical Necessity
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Summary Reviewer
A 62-year-old female enrollee has requested reimbursement for corrective footwear provided on 4/09/19. The Health Insurer has denied this request and reported that the equipment at issue was not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the records document posterior tibial tendon dysfunction and associated stage I flexible flat foot deformity. The patient also has associated pain and gait abnormality. Posterior tibialis tendon dysfunction is an acquired defect that affects 10% of the geriatric population, particularly women. The cause is degenerative changes. There are four primary stages of posterior tibialis tendon with subcategorizations that range from mild to severe. Orthotics and corrective shoes are generally used for stage I and stage II cases, along with nonsteroidal anti-inflammatory drugs (NSAIDs). In this case, the deformity was stage I flexible flatfoot. Therefore, the use of corrective footwear and orthotics was appropriate. Stage III and stage IV deformities require surgery. Thus, corrective footwear provided on 4/09/19 was medically necessary for the treatment of this patient.
| 1 |
The patient is a 49-year-old female with a history of ex pleomorphic adenoma of her right lacrimal gland. The patient has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 49-year-old female with a history of ex pleomorphic adenoma of her right lacrimal gland. The patient has requested authorization and coverage for proton beam therapy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that this case was previously reviewed, and additional documentation was submitted for reconsideration. The additional documentation includes a letter from the provider and a photon/proton plan comparison. Based on the provided photon/proton plan comparison, the requested proton beam therapy is medically indicated. The photon-based plan results in excessive and potentially dangerous radiation exposure to the patientas right optic nerve and cornea, which will place the patient at an unnecessarily high risk for right eye pain and blindness. The proton radiation therapy plan is able to significantly reduce the exposure to these right eye structures, and accomplish known treatment planning objectives. The additional records demonstrate that the patient cannot be treated safely and effectively with photon-based radiation therapy. Therefore, proton beam therapy is medically necessary for the treatment of this patient.
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A 78-year-old female enrollee has requested reimbursement for emergency health services (99285) provided on 2/28/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.
. The patient presented on 2/28/17 with abdominal pain that commenced suddenly that morning and was associated with vomiting and increasing abdominal distention. She had a history of an abdominal aortic aneurysm, putting her at risk for dissection. Patients with aortic aneurysms
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Overturned
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Medical Necessity
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Summary Reviewer
A 78-year-old female enrollee has requested reimbursement for emergency health services (99285) provided on 2/28/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found that at issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. Review of the submitted documentation demonstrates that a prudent layperson would have sought immediate medical attention on the date in question. The patient presented on 2/28/17 with abdominal pain that commenced suddenly that morning and was associated with vomiting and increasing abdominal distention. She had a history of an abdominal aortic aneurysm, putting her at risk for dissection. Patients with aortic aneurysms are cautioned to seek immediate medical attention for the sudden onset of abdominal pain. This patients symptoms of worsening abdominal pain with vomiting meets the prudent layperson criteria for an emergency medical condition. Moreover, CPT code 99285 corresponds to an emergency department visit of high severity where there is an immediate threat to life or physiologic function. The code includes a complete history, physical examination, and decision-making of high complexity. In this case, the medical records support CPT code 99285 level of care. This patient is an elderly female with a history of an abdominal aortic aneurysm as well as a prior abdominal surgery. The history of abdominal aortic aneurysm in a patient with abdominal pain requires thorough and detailed history, examination and imaging. This ruled out an aortic dissection, but revealed a small bowel obstruction. This is a life-threatening emergency, necessitating fluid resuscitation and gastric decompression as well as surgical consultation. Therefore, the care and treatment of this patient meets all three components of a CPT code 99285. Thus, the emergency health services (99285) provided on 2/28/17 met prudent layperson criteria for emergency care.
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A representative of a deceased female enrollee has requested reimbursement for inpatient admission in South Korea from 1/1/12 through 1/1/13. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who was diagnosed with leptomeningeal hemangioblastoma.T
. The patient has had a longstanding diagnosis of hemangioblastoma and the records show that there was an acute worsening of the disease from May 2011 through June 2011.
a document dated 5/12/16, a treating provider from South Korea noted
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Medical Necessity
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Summary Reviewer
A representative of a deceased female enrollee has requested reimbursement for inpatient admission in South Korea from 1/1/12 through 1/1/13. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who was diagnosed with leptomeningeal hemangioblastoma.The physician reviewer found that the submitted documentation supports the medical necessity for the services at issue in this clinical setting. There are detailed medical records that document the progression of this patients medical condition which support inpatient admission in South Korea. Moreover, the medical records prior to the hospital admission in South Korea confirm disease progression. The patient has had a longstanding diagnosis of hemangioblastoma and the records show that there was an acute worsening of the disease from May 2011 through June 2011. According to standard practice, the hospital admission rendered in South Korea was medically appropriate due to the acute urgent worsening and progression of her disease. In a document dated 5/12/16, a treating provider from South Korea noted increased extent of leptomeningeal metastasis in the cerebellum, brainstem, and present in both cerebral hemisphere surface, and spinal cord surface. Thus, inpatient admission in South Korea from 1/1/12 through 1/1/13 was medically indicated in this case. Therefore, for the reasons state above, the services at issue were medically necessary for treatment of this patients medical condition. The Health Insurers denial should be overturned.
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A year-old female enrollee has requested reimbursement for collagen crosslink testing provided on 4/17/19. 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 was on bisphosphonate therapy for six years and is currently on a drug holiday. Her provider is monitoring her bone turnover markers so that she
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Experimental
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Summary Reviewer 2
A year-old female enrollee has requested reimbursement for collagen crosslink testing provided on 4/17/19. 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 sufficient support for the services at issue in this clinical setting. Bone turnover marker assays measure collagen breakdown products released from osteoclasts and osteoblasts during the process of bone resorption and formation. Bone turnover markers are useful for monitoring osteoporosis treatment. This patient was on bisphosphonate therapy for six years and is currently on a drug holiday. Her provider is monitoring her bone turnover markers so that she can decide the timing of restarting antiresorptive therapy, if needed in the future. The services at issue were medically appropriate in this clinical setting. In sum, collagen crosslink testing provided on 4/17/19 was likely to have been more beneficial than other methods of evaluating this patient.
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A 57-year-old male enrollee has requested authorization and coverage for Praluent. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees coronary artery disease status post drug eluting stent (DES) placement.
has severe multi-vessel coronary artery disease. He is currently being treated with ezetimibe, but his LDL cholesterol is still not at goal. His most recent LDL cholesterol was 91, which is over the target range of less than 70. He was intolerant of both simvastatin and pravastatin due to muscle pain and fatigue. Thus, he
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Overturned
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Medical Necessity
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Summary Reviewer
A 57-year-old male enrollee has requested authorization and coverage for Praluent. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees coronary artery disease status post drug eluting stent (DES) placement. The physician reviewer found that the documentation provided for review establishes that this patient has severe multi-vessel coronary artery disease. He is currently being treated with ezetimibe, but his LDL cholesterol is still not at goal. His most recent LDL cholesterol was 91, which is over the target range of less than 70. He was intolerant of both simvastatin and pravastatin due to muscle pain and fatigue. Thus, he meets all of the criteria for treatment with Praluent. The use of Praluent in this instance is clinically indicated and is supported by published guidelines from the American College of Cardiology (ACC) and American Heart Association (AHA) (Grundy, et al; Rosenson, et al). Given this support, the requested Praluent is medically necessary for treatment of this patients severe, multi-vessel coronary artery disease. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 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 records dated
10/30/20 documented 100% surface area of affected scalp. Her prior treatment included squaric
acid, Rogaine, and intralesional Kenalog injections. Per the records, this patient has failed typical
first-line and second-line therapies.
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Overturned
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Experimental
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Summary Reviewer 3
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 the medical evidence supports the requested medication in this clinical setting. The records dated
10/30/20 documented 100% surface area of affected scalp. Her prior treatment included squaric
acid, Rogaine, and intralesional Kenalog injections. Per the records, this patient has failed typical
first-line and second-line therapies. Based on the medical literature, a JAK inhibitor would be the
next ideal choice for therapy. Therefore, Xeljanz is likely to be more beneficial than other available
standard therapy.
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The parent of a 16-year-old female enrollee has requested authorization and coverage for Rituxan. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition.
n patients with juvenile idiopathic arthritis (JIA) and polyarthritis and moderate or high disease activity receiving a first tumor necrosis factor inhibitor (TNFi) (w
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Upheld
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Experimental
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Summary Reviewer 1
The parent of a 16-year-old female enrollee has requested authorization and coverage for Rituxan. 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 current medical evidence has not established the superior efficacy of the requested medication in this patientas case. Ringold and colleagues noted, aIn patients with juvenile idiopathic arthritis (JIA) and polyarthritis and moderate or high disease activity receiving a first tumor necrosis factor inhibitor (TNFi) (with or without disease-modifying antirheumatic drug (DMARD)), switching to a non-TNFi biologic (tocilizumab or abatacept) is conditionally recommended over switching to a second TNFi.a The authors also noted, aA second TNFi may be appropriate for patients who had a good initial response to their first TNFi (i.e., secondary failure), particularly failure due to the presence of suspected or measured antidrug antibodies to the first TNFi.a Furthermore, the authors also noted, aIn patients with JIA and polyarthritis and moderate or high disease activity despite a second biologic, using a TNFi, abatacept, or tocilizumab (depending upon prior biologics received) is conditionally recommended over rituximab. In this case, the medical record does not indicate that the patient utilized non-TNFi biologics, such as tocilizumab and abatacept, or a second TNFi after failing Humira therapy. All such options would be in keeping with the 2019 guideline. These options are recommended prior to rituximab therapy. Data on the use of rituximab in JIA is very limited. In addition, the patientas provider planned to combine Humira with rituximab as indicated in the 5/19/20 office visit note. Data supporting the efficacy and safety of such combination therapy for JIA appears scarce and is not supported by the medical literature. Rituximab prescribing information states there is limited data available on the safety of the use of rituximab with other biologic agents or DMARDs other than methotrexate. Therefore, Rituxan is not likely to be more beneficial than other available standard therapy.
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A 42-year-old male enrollee has requested reimbursement for decompression procedure performed on 10/5/15. The Health Insurer has denied this request indicating that the procedure at issue is considered investigational for treatment of the enrollees occipital neuralgia.
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Upheld
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Experimental
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Summary Reviewer 1
A 42-year-old male enrollee has requested reimbursement for decompression procedure performed on 10/5/15. The Health Insurer has denied this request indicating that the procedure at issue is considered investigational for treatment of the enrollees occipital neuralgia. The physician reviewer found that the decompression procedure (neurolysis) performed on 10/5/15 was likely to be more beneficial for treatment of the patients occipital neuralgia than any available standard therapy. There is some medical literature supporting the use of neurolysis for the treatment of occipital neuralgia. Although there is a lack of data demonstrating superior results with the neurolysis, several studies have shown good results for treatment of the occipital neuralgia. In this case, the patient presented with intractable occipital neuralgia and treatment with neurolysis 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 procedure 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 68-year-old male requested authorization and coverage for UroLift procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees benign prostatic hyperplasia (BPH).T
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Overturned
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Experimental
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Summary Reviewer 3
A 68-year-old male requested authorization and coverage for UroLift procedure. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees benign prostatic hyperplasia (BPH).The physician reviewer found that UroLift has been approved by the U.S. Food and Drug Administration and is considered a treatment option by the American Urologic Association Residency Education program on BPH management. This treatment option is most beneficial in men who wish to avoid retrograde ejaculation, increased risk of bleeding and retention, which are normally found in prostatic vaporization, or transurethral electro-resection of the prostate (TURP). A recent publication has reported the five year follow up of a pivotal trial of UroLift with equal efficacy and lower complications compared to historical TURP analogous data. Accordingly, UroLift is likely to be more efficacious than other alternatives for treatment of this patients symptoms.
Therefore, for the reasons stated above, the requested procedure is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 34-year-old male enrollee has requested reimbursement for the chiropractic services provided from 5/17/14 through 7/5/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees neck pain, upper back pain and shoulder pain.
that this patient had significant improvement in neck disability index and functional upper extremity index with chiropractic treatment provided from 5/17/14 through 7/5/14. The patient was returned to functional status after this course of chiropractic care.
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Overturned
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Medical Necessity
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Summary Reviewer
A 34-year-old male enrollee has requested reimbursement for the chiropractic services provided from 5/17/14 through 7/5/14. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees neck pain, upper back pain and shoulder pain. The physician reviewer found the records demonstrate that this patient had significant improvement in neck disability index and functional upper extremity index with chiropractic treatment provided from 5/17/14 through 7/5/14. The patient was returned to functional status after this course of chiropractic care. According to current medical research, manual therapy is a favorable treatment option for patients with neck pain compared with physical therapy or continued care by a general practitioner. With the objective improvement, the chiropractic treatment sessions provided on 5/17/14, 5/19/14, 7/2/14, and 7/5/14 were appropriate and provided substantial improvement in this patients functional status. Thus, the chiropractic services provided from 5/17/14 through 7/5/14 were medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The parent of a 10-year-old female enrollee has requested authorization and coverage for Nutropin growth hormone (GH) therapy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature and ulcerative colitis.
has extreme short stature with an adult height prediction that is less than 59 inches,
poor weight gain, her ulcerative colitis is currently inactive, she is not receiving steroid medications that can impair growth, and her weight for her height is
underlying ulcerative colitis is under control, yet she continues to have a poor growth velocity and has a very short adult height prediction.
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Overturned
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Medical Necessity
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Summary Reviewer
The parent of a 10-year-old female enrollee has requested authorization and coverage for Nutropin growth hormone (GH) therapy. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees short stature and ulcerative colitis. The physician reviewer found that the records provided for review demonstrate that this patient has extreme short stature with an adult height prediction that is less than 59 inches, which is short enough to meet U.S. Food and Drug Administration (FDA) criteria for a trial of GH therapy for idiopathic short stature. Although some of the patients growth failure may be attributed to underlying ulcerative colitis, poor nutritional intake, and poor weight gain, her ulcerative colitis is currently inactive, she is not receiving steroid medications that can impair growth, and her weight for her height is appropriate. Her normal ESR, iron studies, and complete blood count are evidence that her underlying ulcerative colitis is under control, yet she continues to have a poor growth velocity and has a very short adult height prediction. According to Pediatric Endocrinology Society guidelines, a trial of GH therapy should be approved for children with otherwise unexplained short stature who pass GH stimulation tests but who meet most of the following criteria: (1) height more than 2.25 SDs below the mean for age or more than two SDs below the mid-parental height percentile; (2) growth velocity less than 25th percentile for bone age; (3) bone age more than two SDs below the mean for age; (4) low serum IGF-1 and/or IGFBP-3; and/or (5) other clinical features suggestive of GH deficiency. This patient meets most of these criteria. Thus, GH therapy is indicated to improve her height potential. Accordingly, the requested Nutropin GH therapy is supported as medically necessary for treatment of this patients short stature. Based on these findings, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The parent of a one-year-old female enrollee has requested authorization and coverage for a whole
genome test. The Health Insurer has denied this request and reported that the requested service is
investigational for the enrollees of the enrollees ataxia. The Health Insurer indicated that the
requested service is investigational for the evaluation of the enrollees medical condition.
Therefore, the Health Insurer has denied coverage for the requested service.
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Upheld
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Experimental
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Summary Reviewer 2
The parent of a one-year-old female enrollee has requested authorization and coverage for a whole
genome test. The Health Insurer has denied this request and reported that the requested service is
investigational for the enrollees of the enrollees ataxia. The Health Insurer indicated that the
requested service is investigational for the evaluation of the enrollees medical condition.
Therefore, the Health Insurer has denied coverage for the requested service. At issue is whether a
whole genome test is likely to be more beneficial for evaluation of the enrollee's condition than
any available standard therapy. The physician reviewer found that while whole genome sequencing
may be effective at finding a diagnosis in complex patients in whom other genetic tests are
negative, there are alternative, simpler tests addressing ataxia telangiectasia. In this clinical setting,
ATM gene testing would have a 90% yield. In this case, the requested service is too big of a test
and does not justify the risk of unknown variants. The records did not note the rationale behind the
urgency of the requested rapid whole genome sequencing test and how this may affect the patients
management. Therefore, a whole genome test is not likely to be more beneficial for evaluation of
the patients condition than any available standard therapy.
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The parent of an eight-year-old male enrollee has requested authorization and coverage for Exondys 51. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees Duchenne muscular dystrophy.
The patient has been on Exondys 51 on a clinical trial since 2015. His DMD
excursions, developing muscle cramps and fatigue with exercise.
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Overturned
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Experimental
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Summary Reviewer 2
The parent of an eight-year-old male enrollee has requested authorization and coverage for Exondys 51. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees Duchenne muscular dystrophy. The physician reviewer found that there is sufficient support for the requested medication in this patients case. All other treatments for DMD are palliative, whereas Exondys 51 is disease-modifying. The patient has been on Exondys 51 on a clinical trial since 2015. His DMD disease trajectory is very different from that of his affected peers, who by the patients age, typically need to use a stroller for community excursions, developing muscle cramps and fatigue with exercise. In September 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval for eteplirsen (Exondys 51), a drug that acts to promote dystrophin production by restoring the translational reading frame of DMD through specific skipping of exon 51 in defective gene variants. Eteplirsen is applicable for approximately 14% of patients with DMD mutations. Most treatments currently available for DMD are palliative, aimed at prolonging the ability to walk, improving breathing and cardiac function. Treatment with corticosteroids has been found to be the most effective option for patients, resulting in improved muscle strength, prolongation of the ability to walk, and better pulmonary function. However, corticosteroids only delay disease progression, and treatment is associated with significant side effects, including weight gain, osteoporosis and cataracts. In this patients case, the requested medication is likely to be superior over other treatment options. In sum, Exondys 51 is likely to be more efficacious than other treatment modalities. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is an 18-year-old male with a past psychiatric history of major depressive disorder, generalized anxiety disorder, attention deficit/hyperactivity disorder, unspecified trauma and stressor-related disorder, and cannabis use disorder. The patient has requested reimbursement for residential treatment services provided from 7/01/20 through 6/04/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
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Upheld
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Medical Necessity
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Summary Reviewer
The patient is an 18-year-old male with a past psychiatric history of major depressive disorder, generalized anxiety disorder, attention deficit/hyperactivity disorder, unspecified trauma and stressor-related disorder, and cannabis use disorder. The patient has requested reimbursement for residential treatment services provided from 7/01/20 through 6/04/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the American Academy of Child and Adolescent Psychiatry (AACAP) and American Association for Community Psychiatry (AACP) have unified the Child and Adolescent Level of Care Utilization System (CALOCUS) and the Child and Adolescent Service Intensity Instrument (CASII) into a single instrument, the Child and Adolescent Level of Care/Service Intensity Utilization System (CALOCUS-CASII). This instrument is a standardized tool used to determine the intensity of services needed for children and adolescents, 6-18 years of age, presenting with psychiatric, substance use, medical and/or developmental concerns. Using CALOCUS-CASII, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) co-occurrence of developmental, medical, substance use and psychiatric conditions; (4) recovery environment (a. stressors and b. supports); (5) resiliency and response to services; and (6) engagement. The composite score is then used to determine the level of care needed. Applying the CALOCUS-CASII framework, this patient did not meet the criteria for residential treatment services provided from 7/01/20 through 6/04/21. For dimension 1, the records support a score of 3. This dimension assesses potential for harm to self or others, or having harm inflicted upon them. The patient has a history of threatening suicide and has attempted suicide in the past. He has a history of impulsive behaviors. During his stay in residential treatment, he had intermittent suicidal ideation and self-harm thoughts. He did not exhibit any unsafe behaviors during residential treatment. This is most consistent with significant risk of harm. For dimension 2, the records support a score of 3. This dimension assesses the degree to which a patient is able to fulfill responsibilities within developmental constraints. Prior to admission to residential treatment, the patient was refusing to go to school, using drugs regularly, had engaged in an act of arson, stole his motheras credit card and engaged in property destruction. During the period under review, the patient was attending school and completing schoolwork. He was not using substances, and he was getting along with peers and staff. This is most consistent with moderate functional impairment, as the recent gains/stabilization in functioning have been achieved while participating in a structured and protected treatment environment. For dimension 3, the records support a score of 3. This dimension assesses the co-existence of disorders across four domains (psychiatric, substance use, medical or developmental) that may complicate the course of treatment. The patient has a history of depression, anxiety, attention deficit/hyperactivity disorder and substance use issues. His psychiatric symptoms, neurodevelopmental symptoms, and substance use clearly impaired his functioning prior to admission. During the period under review, the patient had been abstinent from substances for greater than four months, and his psychiatric symptoms had improved. For recovery environment dimension 4A, the records support a score of 3. This dimension assesses the stressors in the environment, social circumstances, and interpersonal relationships. The patientas environment appears to be moderately stressful as role expectations appear to exceed the patientas capacity, given his age and developmental level. For recovery environment dimension 4B, the records support a score of 2. This dimension assesses the presence of family and social support to augment the recovery environment. The patientas parents are supportive of the patient and are willing and able to participate in treatment. For dimension 5, the records support a score of 4. This dimension assesses how past experiences with treatment and recovery might indicate how the patient might respond in the future. Previous experience in treatment at a low level of intensity has not been successful in relief of symptoms or optimal control of symptoms. The patient was engaged in outpatient therapy, received psychiatric care including medication management, was hospitalized once on an inpatient psychiatric unit, and spent over three months a therapeutic wilderness program. Records indicate that developmental pressures and life changes have created episodes of turmoil/distress for patient, indicative of poor resiliency. For dimension 6, the records support a score of 2. The child and adolescent sub-dimension assesses ability to form therapeutic relationship within developmental constraints. According to records, the patient engaged constructively and well in treatment. He was open about the reasons for his placement in treatment. These findings give the patient a composite score of 20, which is consistent with Level 4, Medically Monitored Community-Based Services. For this reason, residential treatment services provided from 7/01/20 through 6/04/21 were not medically necessary for the treatment of this patient.
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The parent of a 14-year-old male enrollee has requested authorization and coverage for the ReWalk Exoskeletal Device durable medical equipment (DME). The Health Insurer has denied this request indicating that the requested equipment is investigational for treatment of the enrollees T8 incomplete spinal cord injury due to spinal tumor.
Both his rehabilitation provider and his physical therapist state that he has mastered the system and can ambulate when fitted with the exoskeleton.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 14-year-old male enrollee has requested authorization and coverage for the ReWalk Exoskeletal Device durable medical equipment (DME). The Health Insurer has denied this request indicating that the requested equipment is investigational for treatment of the enrollees T8 incomplete spinal cord injury due to spinal tumor. The physician reviewer found the ReWalk exoskeleton relies on arm strength to maintain balance and posture with bilateral Canadian crutches. This patients level of cord dysfunction at T8 is significantly below the intervention of his arms and his skills as a pianist would imply significant arm dexterity. Both his rehabilitation provider and his physical therapist state that he has mastered the system and can ambulate when fitted with the exoskeleton. In the medical literature, Goemaere and colleagues noted concern that non-standing paraplegics will lose bone density. Kunkel and colleagues reported improved bone density with standing and as well as reduction in contractures. Jain and colleagues found that there is a significant impact with standing in the emotional well-being of a paraplegic. Further, White and Hayes found success with use of the ReWalk system in their studies. Moreover, the U.S. Food and Drug Administration (FDA) approved the ReWalk system as a medical device in 2014 for use in this clinical setting. Given this support, the requested ReWalk Exoskeletal Device DME is likely to provide this patient with an improved health outcome beyond that anticipated with standard available alternatives. Based upon the information set forth above, the requested equipment 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 58-year-old male enrollee has requested reimbursement for therapeutic phlebotomy from
1/6/21 through 1/26/21. The Health Insurer has denied this request and reported that the service
at issue was investigational for the treatment of the enrollees hereditary hemochromatosis.
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Overturned
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Experimental
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Summary Reviewer 1
A 58-year-old male enrollee has requested reimbursement for therapeutic phlebotomy from
1/6/21 through 1/26/21. The Health Insurer has denied this request and reported that the service
at issue was investigational for the treatment of the enrollees hereditary hemochromatosis. The
physician reviewer found that in this case, the patient meets criteria for hereditary
hemochromatosis. Kowdley and colleagues report that phlebotomy remains the mainstay of
therapy for hereditary hemochromatosis. The American College of Gastroenterology
recommends that phlebotomy be used as the first-line treatment in patients diagnosed with
hereditary hemochromatosis, as determined by C282Y homozygosity or C282Y/H63D compound
heterozygosity. The guidelines further recommend against chelation as the first-line therapy for
hereditary hemochromatosis, given the effectiveness of phlebotomy, the associated side effects
of chelation including hepatic and renal toxicity, and the relatively small sample size of clinical
trials supporting chelation. However, the guidelines note that iron chelation may be used in the
treatment of hereditary hemochromatosis for the patient who is intolerant or refractory to
phlebotomy or when phlebotomy has the potential for harm, such as in patients with severe
anemia or congestive heart failure. Phlebotomy in fit patients with biochemical or clinical
evidence of iron overload is proven to improve overall survival and reduce end organ damage,
such as by cirrhosis or heart failure, due to iron overload. In the maintenance of
hemochromatosis, phlebotomy is also recommended as needed to keep serum ferritin below 50-
100 ug/L. Intolerance of phlebotomy, such as congestive heart failure with unstable
hemodynamics, may be an indication for alternative therapies such as erythocytapheresis or iron
chelation therapy. There are three chelating agents currently approved by the U.S. Food and Drug
Administration (FDA) for the treatment of secondary iron overload, but none that are approved
for primary iron overload and hereditary hemochromatosis. Deferoxamine has been approved
for the treatment of secondary iron overload in thalassemia, with adverse effects including
retinopathy and auditory toxicity. Deferiprone is an oral chelator which is approved for the
treatment in transfusion-dependent patients with thalassemia when chelation with
deferoxamine is inadequate, with significant side effects including neutropenia and
agranulocytosis. Deferasirox, the most recently approved oral chelator, has side effects including
gastrointestinal upset, rash, aminotransferase elevation, and renal toxicity, which can occur in
more than 10% of all patients. In this clinical setting, phlebotomy is considered standard
treatment and is likely to be superior to other treatments such as erythocytapheresis or iron
chelation therapy. Therefore, therapeutic phlebotomy from 1/6/21 through 1/26/21 was likely
to have been more beneficial for treatment of the enrollee's condition than any available
standard therapy.
| 1 |
A 39-year-old male enrollee has requested reimbursement for the sleep study performed on 3/30/17. The Health Insurer has denied this request indicating that the service at issue was not medically necessary for evaluation of the enrollees obstructive sleep apnea (OSA).
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Upheld
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Medical Necessity
|
Summary Reviewer
A 39-year-old male enrollee has requested reimbursement for the sleep study performed on 3/30/17. The Health Insurer has denied this request indicating that the service at issue was not medically necessary for evaluation of the enrollees obstructive sleep apnea (OSA). The physician reviewer found based on the medical literature and the presented clinical records submitted for review, the sleep study performed on 3/30/17 was not medically necessary for evaluation of the patients medical condition. In this case, the patient has no documentation demonstrating lung disease, heart disease or neuromuscular disease. There is no documentation of dementia or impairment. In sum, there is a lack of objective documentation provided for review that supports the medical necessity of a facility based sleep study. The sleep study could have been performed in a home setting. For the reasons provided, the sleep study performed on 3/30/17 was not medically necessary for evaluation of the patients medical condition. Therefore, the service at issue was not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.
| 0 |
A 62-year-old male enrollee has requested reimbursement for the RT300 functional electrical stimulator (FES) cycle provided on 2/10/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees quadriplegia.
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Upheld
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Experimental
|
Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for the RT300 functional electrical stimulator (FES) cycle provided on 2/10/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees quadriplegia. The physician reviewer found the RT300 FES cycle was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The RT300 cycle has not been demonstrated to prevent secondary long-term cardiovascular dysfunction or promote cardiac conditioning. In addition, the RT300 has not been proven to result in changes in muscle strength and volume that lead to clinically significant functional improvement in long-term patient outcomes. The RT300 FES cycle is not reasonably expected to reduce the long-term deficits secondary to this patients injury and assist the patient to maintain and achieve functional capacity in performing daily activities. Baldi and colleagues suggested that neuromuscular electrical stimulation may increase muscle mass in some spinal cord injury patients with disuse atrophy, however, the literature does not demonstrate that this leads to improved health outcomes such as reduced fracture risk from increased bone density. All told, the peer-reviewed medical literature does not support the RT300 FES cycle provided on 2/10/16 as likely to be more beneficial for treatment of this patients medical condition than standard available treatment options. Based upon the information set forth above, the equipment at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 52-year-old male enrollee has requested reimbursement for proton beam therapy provided from October through December 2016. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees nasopharyngeal carcinoma.
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Upheld
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Experimental
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Summary Reviewer 3
A 52-year-old male enrollee has requested reimbursement for proton beam therapy provided from October through December 2016. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees nasopharyngeal carcinoma. The physician reviewer found that based on review of available data, proton beam therapy in the treatment of nasopharyngeal carcinoma is superior to the standard alternatives available.
While there are no randomized trials evaluating the use of proton beam therapy for nasopharyngeal carcinomas, its Bragg Peak, proton beam therapy will always appear dosimetrically superior (Lewis 2016). For any given site, whether or not this dosimetric benefit translates into a clinical benefit is uncertain, but such a benefit exists for nasopharyngeal carcinoma. The treatment of skull-based tumors is a well-accepted use of proton therapy. It is the prototypical site used to demonstrate the ability of proton therapy to spare adjacent cranial nerves in a tight space to a high precision. The most common histology of skull-based tumors are chordomas and chondrosarcomas. According to the ASTRO Model Policy on Proton Beam Therapy, on the basis of [the above] medical necessity requirements and published clinical data, disease sites that frequently support the use of PBT include tumors that approach or are located at the base of skull, including but not limited to chordoma and chondrosarcomas. Due to the fact that the typical nasopharyngeal carcinoma radiation field includes the base of skull by definition (RTOG 0615), and that the dose required to treat nasopharyngeal cancer is higher than needed for a chordoma, proton therapy would also be beneficial for the treatment of nasopharyngeal cancer. Additionally, the optic nerves and chiasm are typically adjacent to the treatment volume for nasopharyngeal carcinoma. These structures typically limit the nasopharynx from receiving the full prescribed dose of radiotherapy, whereas proton beam therapy would allow full treatment of these areas. Based on the above, proton beam therapy provided from October through December 2016 was the superior modality for the treatment of this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to be more beneficial for treatment of this patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old female enrollee has requested authorization and coverage for Viekira Pak. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus (HCV).
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Overturned
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Medical Necessity
|
Summary Reviewer
A 59-year-old female enrollee has requested authorization and coverage for Viekira Pak. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus (HCV). The physician reviewer found that review of the submitted documentation establishes the medical necessity of the requested medication. According to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) recommendations for HCV treatment Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. AASLD/IDSA guidelines further adding that The goal of treatment of HCV-infected persons is to reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by an SVR. Additionally, the study by Ferenci and colleagues concluded that Twelve weeks of treatment with ABT-450/r-ombitasvir and dasabuvir without ribavirin was associated with high rates of sustained virologic response among previously untreated patients with HCV genotype 1 infection. Rates of virologic failure were higher without ribavirin than with ribavirin among patients with genotype 1a infection but not among those with genotype 1b infection. Therefore, based upon the peer reviewed literature cited above, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
The patient is a 42-year-old male who has requested authorization and coverage for Oxbryta 500
mg. The patient has requested authorization and coverage for Oxbryta 500 mg.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 42-year-old male who has requested authorization and coverage for Oxbryta 500
mg. The patient has requested authorization and coverage for Oxbryta 500 mg. The physician
reviewer found that the submitted documentation supports the requested medication in this
clinical setting. Voxelotor (Oxbryta) has been approved by the U.S. Food and Drug Administration
for the treatment of sickle cell disease in adults and pediatric patients who are four years of age
or older. Adakveo and Endari are used to decrease the incidence of vaso-occlusive events. This
patients main issue is fatigue. Voxelotor may be considered in patients whose morbidity is from
severe anemia (hemoglobin less than or equal to 6.5 g/dL), excessive fatigue, poor quality of life,
and decreased Clinical Global Impression of Change (CGI-C) score. The other drugs are not used
for fatigue. The use of the requested medication is supported by phase III clinical trials. Therefore,
Oxbryta 500 mg is medically necessary for the treatment of this patient.
| 1 |
A 60-year-old male enrollee has requested reimbursement for inpatient services (telemetry level of care) provided from 4/04/19 through 4/06/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician
that the patient had known coronary artery disease and multiple prior interventions. He was initially scheduled for elective catheterization when he presented to the outpatient office with low effort angina, and his medical regimen was appropriately adjusted at that time. However, in the subsequent days, he developed rest angina and was diagnosed with acute coronary syndrome.
Initially, the plan was for elective catheterization. However, the patients symptoms progressed rapidly, and he presented with an acute coronary syndrome in the setting of prior known severe coronary artery disease.
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Overturned
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Medical Necessity
|
Summary Reviewer
A 60-year-old male enrollee has requested reimbursement for inpatient services (telemetry level of care) provided from 4/04/19 through 4/06/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the patient had known coronary artery disease and multiple prior interventions. He was initially scheduled for elective catheterization when he presented to the outpatient office with low effort angina, and his medical regimen was appropriately adjusted at that time. However, in the subsequent days, he developed rest angina and was diagnosed with acute coronary syndrome. Patients presenting with rest angina and known complex coronary artery disease require hospitalization to rule out myocardial infarction, have cardiac telemetry monitoring and then are referred for cardiac catheterization and potential revascularization. Initially, the plan was for elective catheterization. However, the patients symptoms progressed rapidly, and he presented with an acute coronary syndrome in the setting of prior known severe coronary artery disease. Admission for acute coronary syndrome to rule out myocardial infarction, telemetry monitor, adjust his acute medical regimen and undergo subsequent catheterization and revascularization was medically appropriate and within the current standard of care. Therefore, inpatient services (telemetry level of care) provided from 4/04/19 through 4/06/19 were medically necessary for the treatment of this patient.
| 1 |
A 62-year-old male enrollee has requested reimbursement for gene testing for prostate cancer performed on 4/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition.
|
Overturned
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Experimental
|
Summary Reviewer 2
A 62-year-old male enrollee has requested reimbursement for gene testing for prostate cancer performed on 4/21/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found once prostate cancer is diagnosed in a pathologic specimen, risk stratification is performed by the analysis of certain features such as the grade of tumor and PSA level. This helps guide the most appropriate therapy for patients taking into account their age and co-morbidities because many patients will not require therapy and may be observed without any intervention. The important features to recognize are Gleason score and PSA but these are imperfect and better prognostic biomarkers are needed. There are no robust biomarkers that can predict which cancers should be observed and which should be aggressively treated by radiation or surgery. The Prolaris test is an analysis of expression of genes (Cuzick, et al, 2012). It has been extensively tested retrospectively on a large cohort of prostate cancer patients (Cuzick, et al, 2011). It was also applied on another cohort and found to be predictive of prostate cancer aggressiveness (Cuzick, et al, 2014). The provider in this case had a reasonable discussion with the patient regarding treatment options and the Prolaris data may assist him and the patient to determine with the best treatment option. As such, the gene testing for prostate cancer performed on 4/21/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 0 |
A 21-year-old male enrollee has requested authorization and coverage for LINX reflux management system. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.
|
Overturned
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Experimental
|
Summary Reviewer 2
A 21-year-old male enrollee has requested authorization and coverage for LINX reflux management system. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the current medical evidence supports the requested services in this clinical setting. LINX is a minimally invasive anti-reflux procedure that has been approved by the U.S. Food and Drug Administration. LINX has been shown to be as effective as surgery, and is less invasive. Additionally, LINX is potentially reversible, with less adverse effects. In sum, the requested LINX reflux management system is likely to be more efficacious 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.
| 0 |
A 59-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier assay performed on 10/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule.
|
Overturned
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Experimental
|
Summary Reviewer 3
A 59-year-old female enrollee has requested reimbursement for Afirma Gene Expression Classifier assay performed on 10/12/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees thyroid nodule. The physician reviewer found the medical evidence supports the services at issue in this clinical setting. The cytopathology of the thyroid nodule was consistent with follicular lesion of undetermined significance. The risk of malignancy is 5 to 15% in these nodules. The newest 2015 American Thyroid Association guidelines indicate that for nodules with follicular lesion of undetermined significance cytology, investigations such as repeat fine needle aspiration or molecular testing may be used to supplement malignancy risk assessment in lieu of proceeding directly with either surveillance or diagnostic surgery. In this patients case, the services at issue assisted with treatment planning. Thus, Afirma Gene Expression Classifier assay performed on 10/12/15 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 61-year-old female has requested authorization and coverage for 64568, 0466T and 95970. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that this patient has requested implantation of hypoglossal nerve stimulation for her symptoms of obstructive sleep apnea. She previously was treated with CPAP therapy, but the patient became intolerant to the use of this device. Sleep study reports documented increasing symptoms of obstructive sleep apnea with apnea-hypopnea
patient did have evidence of some degree of tongue base obstruction based on sleep endoscopy procedure.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 61-year-old female has requested authorization and coverage for 64568, 0466T and 95970. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees obstructive sleep apnea. The physician reviewer found that this patient has requested implantation of hypoglossal nerve stimulation for her symptoms of obstructive sleep apnea. She previously was treated with CPAP therapy, but the patient became intolerant to the use of this device. Sleep study reports documented increasing symptoms of obstructive sleep apnea with apnea-hypopnea index at the moderate level of obstructive sleep apnea syndrome. Hypoglossal nerve stimulation therapy has been proven by the U.S. Food and Drug Administration (FDA) to be an effective modality of treatment of obstructive sleep apnea in patients with tongue-based obstruction. This patient did have evidence of some degree of tongue base obstruction based on sleep endoscopy procedure. Although this patient meets some of the criteria for implantation of upper airway stimulation, she has not undergone other methods of management. Other surgical procedures have not been attempted, such as nasal turbinate reduction and/or nasal septal reconstruction. These methods have been shown to improve tolerance to nasal CPAP therapy. Additionally, the patient may be a candidate for other traditional oropharyngeal surgery, such as uvulopalatopharyngoplasty with tonsillectomy, which may improve symptoms. Therefore, the requested services (64568, 0466T and 95970) are not likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 23-year-old male enrollee requested authorization and coverage for E1399 (functional electrical stimulation cycle ergometer). The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrollees medical condition.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 23-year-old male enrollee requested authorization and coverage for E1399 (functional electrical stimulation cycle ergometer). The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the medical evidence has not established the superior efficacy of the requested device. There is a lack of proven significant health or functional benefit of exogenous neurostimulation therapy of paralyzed muscles using functional electrical stimulation cycle ergometry. There have been a number of small papers (case reports and series) published over the years providing some preliminary data suggesting possible benefits, but larger studies designed to evaluate the actual clinical efficacy of passive exercise such as functional electrical stimulation cycle ergometry in the setting of spinal cord injury have not been completed and published. While repeated bouts of exogenous neurostimulation of paralyzed muscle may potentially reverse muscle atrophy in paralyzed muscle, there is no significant health or functional benefit of this process in spinal cord injury because the muscle tissue that is gained or spared does not protect against pressure ulcers in a clinically relevant manner or provide other clinically or functionally relevant benefit. It does not obviate the need for pressure relief. Passive cycling may be an option to provide passive range of motion therapy, e.g., to prevent contractures or mitigate spasticity, but this can also be performed independently or with caregiver assistance in a custodial fashion. The other purported benefits of passive cycling, such as improving cardiovascular function and bone density, have not been sufficiently investigated to allow conclusions related to clinically relevant outcomes. To date, the limited data that are available provide mixed results regarding health measures. With respect to bone health after spinal cord injury, there are insufficient data regarding clinically relevant outcomes related to the efficacy of this device. Therefore, E1399 (functional electrical stimulation cycle ergometer) is not likely to be superior over other available treatment options.
| 0 |
A 31-year-old female enrollee has requested reimbursement for the collagen cross links, any method (CPT code 82523) provided on 1/10/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees left ankle pain status De Novo procedure for osteochondral lesion of the medial talar dome.
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Upheld
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Experimental
|
Summary Reviewer 2
A 31-year-old female enrollee has requested reimbursement for the collagen cross links, any method (CPT code 82523) provided on 1/10/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees left ankle pain status De Novo procedure for osteochondral lesion of the medial talar dome. The physician reviewer found that the use of collagen cross links and biochemical markers of bone turnover, are unproven and not considered part of the standard of care in this clinical setting. Other testing that was performed in this patients case should have been adequate to rule out a bone formation abnormality. As such, the collagen cross links, any method (CPT code 82523) provided on 1/10/17 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 service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 51-year-old female enrollee has requested reimbursement for the MammaPrint genetic test provided on 2/3/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees left breast carcinoma.
|
Upheld
|
Experimental
|
Summary Reviewer 3
A 51-year-old female enrollee has requested reimbursement for the MammaPrint genetic test provided on 2/3/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees left breast carcinoma. The physician reviewer found that early breast cancer that is hormone receptor positive can be treated with tamoxifen alone in postmenopausal women. In that instance, there is a 15% chance of recurrence. It is this 15% that needs adjuvant chemotherapy (Paik, et al). There are several established biomarkers that are prognostically valuable in breast cancer. These include the presence of estrogen or progesterone receptors, HER2 amplification, as well as proliferative index, and histologic grade. Newer technologies such as gene expression such as the MammaPrint may also classify tumors to basal-like or luminal-type of disease. Since the OncotypeDX test returned intermediate results that did not allow a definitive decision on adjuvant treatment, the MammaPrint genetic test provided on 2/3/16 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.
| 1 |
A 49-year-old female enrollee has requested reimbursement for endometrial ablation performed on 9/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.
, this patient had heavy menstrual cycles and cramping. The patient no longer desired fertility. She trialed a course of hormonal management with oral contraceptives.
, the patient has not responded to medical treatment and opted to undergo ablation.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 49-year-old female enrollee has requested reimbursement for endometrial ablation performed on 9/23/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that an endometrial ablation is a minimally invasive technique used to destroy the uterine lining for the treatment of chronic menorrhagia/abnormal uterine bleeding. This technique is supported by peer-reviewed current medical literature in patients who no longer desire fertility and in whom a thorough work-up has been performed to rule-out other causes of abnormal uterine bleeding. This evaluation includes performing a pelvic ultrasound and an endometrial biopsy/dilation and curettage (D&C). Furthermore, the patient should have tried and failed medical management options (such as birth control pills) over a reasonable period of time. Alternative treatment options, including hormones (pills, intrauterine device) and surgery, should be discussed. Based on review of this case, this patient had heavy menstrual cycles and cramping. The patient no longer desired fertility. She trialed a course of hormonal management with oral contraceptives. Per the available documentation, the patient has not responded to medical treatment and opted to undergo ablation. However, given the available clinical documentation, there is no evidence to support that the patient underwent a complete work-up to rule out other causes of abnormal uterine bleeding with endometrial sampling prior to the ablation. Therefore, endometrial ablation performed on 9/23/20 was not likely to have been more beneficial than other available standard therapy.
| 1 |
A 53-year-old female enrollee has requested reimbursement for gene testing performed on 11/15/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.
|
Upheld
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Experimental
|
Summary Reviewer 1
A 53-year-old female enrollee has requested reimbursement for gene testing performed on 11/15/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may also add a bit more to these prognostic statistics. As per these criteria, this patients melanoma would be classified as a stage 1A, with an expected ten-year survival of at least 88%. DecisionDx is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either Class 1 (with a 90-96% five year distant metastasis-free survival) or Class 2 (with a 65-80% rate). Gerami and colleagues reported on 217 cases, with good correlation between prognosis and DecisionDx classification, in patients undergoing sentinel node sampling, which was not documented in this case. Berger and colleagues reported on 156 cases, but there was not sufficient follow-up to determine the actual value of the assay. It is not clear how the five-year DecisionDx data compares to the ten-year Balch data, and whether it can be used to make clinical decisions. This would be particularly at issue in this patient given her excellent prognosis. All told, gene testing performed on 11/15/16 was not likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 51-year-old female enrollee has requested reimbursement for chiropractic services provided on 5/19/16, 5/25/16, 6/02/16, 6/03/16, 6/06/16, 6/08/16, 6/10/16, 6/13/16, 6/20/16, 6/27/16, 7/01/16, 7/11/16, 7/18/16 and 7/21/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for treatment of the enrollees pain.
. The patient has had extensive chiropractic treatment. The records noted that diagnosis of subluxation complex of vertebral of the head region, which is not what the patient states that she is being treated for or improving from. The providers
|
Upheld
|
Medical Necessity
|
Summary Reviewer
A 51-year-old female enrollee has requested reimbursement for chiropractic services provided on 5/19/16, 5/25/16, 6/02/16, 6/03/16, 6/06/16, 6/08/16, 6/10/16, 6/13/16, 6/20/16, 6/27/16, 7/01/16, 7/11/16, 7/18/16 and 7/21/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for treatment of the enrollees pain. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue. The patient has had extensive chiropractic treatment. The records noted that diagnosis of subluxation complex of vertebral of the head region, which is not what the patient states that she is being treated for or improving from. The providers notes are almost the same from each visit, and there is no documented functional improvement. It is unclear how many visits were rendered under the diagnosis of subluxation complex of vertebral of the head region. The current medical evidence does not support the services at issue in this clinical setting. All told, chiropractic services provided on 5/19/16, 5/25/16, 6/02/16, 6/03/16, 6/06/16, 6/08/16, 6/10/16, 6/13/16, 6/20/16, 6/27/16, 7/01/16, 7/11/16, 7/18/16 and 7/21/16 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 53-year-old male enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition.
The records document that the patient has tried multiple prior therapies to assist in the management of severe sleep disorder. He has a long history of objective evidence of sleep apnea and meets criteria
However, this patient became intolerant of the use of this device. This patient
|
Overturned
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Experimental
|
Summary Reviewer 2
A 53-year-old male enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. The physician reviewer found in this patients case, the requested Inspire upper airway stimulation system is likely to be more efficacious than other treatment option. The records document that the patient has tried multiple prior therapies to assist in the management of severe sleep disorder. He has a long history of objective evidence of sleep apnea and meets criteria for management. Normal management of obstructive sleep apnea is with the use of CPAP therapy. However, this patient became intolerant of the use of this device. This patient meets the criteria established for the implantation of the requested device. Medical reports are now demonstrating the long-term effectiveness of this method of 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.
| 1 |
The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment center services provided from 2/27/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found this patient has significant impulse control problems, related to his diagnoses of autism, ADHD and cerebral dysrhythmia. He has little insight into the nature of his problems and only seems
others and even himself. The progress notes indicate that he still struggles with violent thoughts of raping women he encounters in his environment.
|
Overturned
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Medical Necessity
|
Summary Reviewer
The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health residential treatment center services provided from 2/27/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found this patient has significant impulse control problems, related to his diagnoses of autism, ADHD and cerebral dysrhythmia. He has little insight into the nature of his problems and only seems reluctantly to admit that he could cause significant harm to others and even himself. The progress notes indicate that he still struggles with violent thoughts of raping women he encounters in his environment. The documentation submitted for review indicates that his symptoms are quite severe. In addition, there are few facilities that have the experience and expertise to treat such an individual. It is unlikely that an outpatient or partial hospital program could meet his needs and also ensure the safety of others in the community. In sum, treatment in a 24-hour facility is clinically indicated for this patient. Therefore, the services at issue were and are medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 51-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Assay (CPT code 84999 - unlisted chemistry procedure) provided on 1/17/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma.
|
Upheld
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Experimental
|
Summary Reviewer 3
A 51-year-old male enrollee has requested reimbursement for the DecisionDx-Melanoma Assay (CPT code 84999 - unlisted chemistry procedure) provided on 1/17/17. 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 melanoma staging is characterized by the American Joint Committee on Cancer (AJCC) system that defines cutaneous melanoma stages 0-IV. 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 Assay 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. Therefore, DecisionDx-Melanoma Assay signature may be an independent predictor of metastasis risk. However, there is a lack of peer-reviewed published studies confirming this hypothesis. All told, the DecisionDx-Melanoma Assay performed on 1/17/17 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 |
The parent of a 12-year-old male enrollee has requested authorization and coverage for Remicade 400 mg for two weeks and then once monthly for one year. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees juvenile dermatomyositis (JDMS).
. This patient has JDMS and has been treated with numerous treatments, which have been either ineffective or partially effective. The patient was doing better while on IVIG, but developed headaches after the infusions, which is a common side effect. After stopping IVIG, the patient has become weaker with his creatine kinase (CK) levels increasing.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a 12-year-old male enrollee has requested authorization and coverage for Remicade 400 mg for two weeks and then once monthly for one year. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees juvenile dermatomyositis (JDMS). The physician reviewer found remicade is likely to be more effective for this patient than other available treatment options. This patient has JDMS and has been treated with numerous treatments, which have been either ineffective or partially effective. The patient was doing better while on IVIG, but developed headaches after the infusions, which is a common side effect. After stopping IVIG, the patient has become weaker with his creatine kinase (CK) levels increasing. The medical literature supports infliximab for the treatment of refractory myositis demonstrating beneficial effect with improved motor strength, decrease in fatigue, and a decrease in CK. Thus, infliximab is clinically indicated for this patient with JDMS and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 21-year-old male enrollee has requested authorization and coverage of Humira pen psoriasis-uveitis 40 mg/0.8 mL pen injector kit. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees plaque psoriasis.
with methotrexate as he drinks alcohol and may be trying to conceive a child.
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Overturned
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Medical Necessity
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Summary Reviewer
A 21-year-old male enrollee has requested authorization and coverage of Humira pen psoriasis-uveitis 40 mg/0.8 mL pen injector kit. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees plaque psoriasis.
The physician reviewer found that there is support in the medical literature for the requested medication in this clinical setting. The records indicate that this patient is a poor candidate for systemic treatments. He not a candidate for treatment with methotrexate as he drinks alcohol and may be trying to conceive a child. He should also avoid a systemic retinoid like Soriatane as he has elevated triglycerides and Soriatane has the side effect of raising triglyceride levels. Cyclosporine is not recommended since this patients medical condition is a chronic disease and there are long term risks with use of cyclosporine. On the other hand, Humira has been shown effective as a treatment option and it has strong safety ratings. Additionally per available data, Humira has better efficacy than methotrexate or cyclosporine in this clinical setting. According to the American Academy of Dermatology and the medical literature, Humira is a standard treatment option for treatment of chronic plaque psoriasis. Humira is also U.S. Food and Drug Administration approved. As such, Humira pen psoriasis-uveitis 40 mg/0.8 mL pen injector kit is medically necessary for the treatment of this patients medical condition. Therefore, based on the information noted above, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 55-year-old male enrollee has requested authorization and coverage for an electrical stimulation device. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition.
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Overturned
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Experimental
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Summary Reviewer 2
A 55-year-old male enrollee has requested authorization and coverage for an electrical stimulation device. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees medical condition. The physician reviewer found the current medical evidence supports the superior effectiveness of the requested device in this clinical setting. Optune is a type of alternating electric field therapy which is U.S. Food and Drug Administration (FDA) approved for recurrent/progressive disease in patients with glioblastoma multiforme. It is considered a standard of care based on a follow-up study showing prolonged progression free and overall survival. Consensus-based guidelines published by the National Comprehensive Cancer Network include alternating electric field therapy as a treatment option for patients with recurrent glioblastoma. 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.
| 0 |
A 46-year-old female enrollee has requested authorization and coverage for total disc arthroplasty (CPT 22858 and 22856). The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition.
disc disease. This patient presents with neck pain radiating into the right arm with weakness. Clinical examination findings are consistent with imaging evidence of neural compression and spondylosis at the C5-6 and C6-7 levels.
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Overturned
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Experimental
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Summary Reviewer 1
A 46-year-old female enrollee has requested authorization and coverage for total disc arthroplasty (CPT 22858 and 22856). The Health Insurer has denied this request indicating that the requested services are investigational for treatment of the enrollees medical condition. The physician reviewer found there is sufficient support for the requested services in this clinical setting. The evidence-based literature supports the use of two-level contiguous cervical artificial disc replacement as an option over anterior cervical discectomy and fusion for the treatment of symptomatic degenerative disc disease. This patient presents with neck pain radiating into the right arm with weakness. Clinical examination findings are consistent with imaging evidence of neural compression and spondylosis at the C5-6 and C6-7 levels. Per the medical records, a conservative nonoperative treatment has been tried and failed to provide sustained improvement. The use of two-level artificial disc replacement will allow for motion preservation, which would be sacrificed with the use of fusion. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 59-year-old female enrollee has requested reimbursement for HCMNext Reflex-Ambry genetic test performed on 10/2/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollee, who has a history of hypertrophic cardiomyopathy.
. The patient did not complain of lightheadedness or palpitations and had no other non-invasive evaluation prior to
While the patient has evidence of hypertrophic cardiomyopathy by echocardiography, the provider calculated a 2.09% five year risk of sudden cardiac death and opined that she was not a candidate for prophylactic implantable cardioverter defibrillator placement.
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Overturned
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Experimental
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Summary Reviewer 2
A 59-year-old female enrollee has requested reimbursement for HCMNext Reflex-Ambry genetic test performed on 10/2/17. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollee, who has a history of hypertrophic cardiomyopathy. The physician reviewer found that the documentation provided does not support the testing at issue was likely to have been more effective when compared to available standard methods of evaluating this patient. The patient did not complain of lightheadedness or palpitations and had no other non-invasive evaluation prior to genetic testing. There was no evidence provided that the genetic testing offered prognostic information. While the patient has evidence of hypertrophic cardiomyopathy by echocardiography, the provider calculated a 2.09% five year risk of sudden cardiac death and opined that she was not a candidate for prophylactic implantable cardioverter defibrillator placement. In spite of the positive results from the genetic testing for a pathogenic variant associated with a diagnosis of hypertrophic cardiomyopathy, the records provided for review do not support any change of the patients therapy based on these results. The patient was recommended for a one year follow up with the cardiologist provider which would indicate clinical stability. Accordingly, HCMNext Reflex-Ambry genetic testing performed on 10/2/17 was not likely to have been more beneficial than the standard evaluation techniques available for treating this patient.
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 male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 60-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 10/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add a bit to these statistics. DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. It is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear if the assay can be used to make clinical decisions. All told, DecisionDx-Melanoma testing performed on 10/10/19 was not likely to have been more beneficial than any available standard therapy.
| 0 |
A 62-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C.
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Overturned
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Medical Necessity
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Summary Reviewer
A 62-year-old female enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per the guidelines, non-cirrhotic genotype 1 patients who have failed peg-interferon and ribavirin should be treated with Harvoni for 12 weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C, genotype 1 regardless of fibrosis stage. For these reasons, Harvoni is medically indicated for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 55-year-old female enrollee has requested reimbursement for inpatient services provided on 4/03/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees palpitations.
the patient presented with complaints of tinnitus without any other neurologic complaints. She was hemodynamically stable, without any neurologic deficits on examination.
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Upheld
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Medical Necessity
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Summary Reviewer
A 55-year-old female enrollee has requested reimbursement for inpatient services provided on 4/03/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees palpitations. The physician reviewer found that the patient presented with complaints of tinnitus without any other neurologic complaints. She was hemodynamically stable, without any neurologic deficits on examination. 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. Thus, inpatient services provided on 4/03/17 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 70-year-old male enrollee has requested authorization and coverage for DecisionDx-Melanoma testing performed on 10/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.
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Upheld
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Experimental
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Summary Reviewer 3
A 70-year-old male enrollee has requested authorization and coverage for DecisionDx-Melanoma testing performed on 10/28/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the data on the DecisionDx test for melanoma is not 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. This was also the consensus opinion of the National Comprehensive Cancer Network (NCCN) guidelines. Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision but they suggest a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon alpha. In sum, DecisionDx-Melanoma testing performed on 10/28/16 was not likely to have been more effective than the available options for the evaluation of this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 38-year-old male who presented for a biopsychosocial assessment on 5/9/22.
The patient has requested reimbursement for Level 3.5 clinically managed high-intensity
residential services (adult criteria) from 5/25/22 through discharge.
For dimension 1, the patient underwent management for alcohol withdrawal
earlier in his treatment stay. The patients withdrawal needs were safely managed in a Level 3.5
setting. For dimension 2, the patient had hypertension, elevated transaminases, and a twenty
pound weight loss. The patients biomedical problems were stable and did not require 24-hour
medical or nurse monitoring. For dimension 3, the patient had symptoms of anxiety and
depression. He reported drinking 750 mL of whiskey daily. He had tried to reduce his drinking by
switching to seltzers, resulting in an alcohol withdrawal seizure in January 2022. The patient was
reluctant to remove alcohol from his home. The patients mental status was stable enough to
permit participation, he demonstrated a repeated inability to control his impulses to use
substances, and he was in imminent danger of relapse with attendant likelihood of harm to self.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 38-year-old male who presented for a biopsychosocial assessment on 5/9/22.
The patient has requested reimbursement for Level 3.5 clinically managed high-intensity
residential services (adult criteria) from 5/25/22 through discharge. The physician reviewer found
that Per American Society of Addiction Medicine (ASAM) criteria, this patient met Level 3.5
criteria for RTC services from 5/25/22 through discharge. ASAM criteria focuses on six dimensions
to determine the appropriate level of care, which includes: (1) intoxication and withdrawal
potential; (2) biomedical conditions; (3) emotional, behavioral and cognitive conditions; (4)
readiness to change; (5) relapse, continued use, or continued problem potential; and (6) recovery
environment. For dimension 1, the patient underwent management for alcohol withdrawal
earlier in his treatment stay. The patients withdrawal needs were safely managed in a Level 3.5
setting. For dimension 2, the patient had hypertension, elevated transaminases, and a twenty
pound weight loss. The patients biomedical problems were stable and did not require 24-hour
medical or nurse monitoring. For dimension 3, the patient had symptoms of anxiety and
depression. He reported drinking 750 mL of whiskey daily. He had tried to reduce his drinking by
switching to seltzers, resulting in an alcohol withdrawal seizure in January 2022. The patient was
reluctant to remove alcohol from his home. The patients mental status was stable enough to
permit participation, he demonstrated a repeated inability to control his impulses to use
substances, and he was in imminent danger of relapse with attendant likelihood of harm to self.
The resulting level of dysfunction was of such severity that it precluded participation in treatment
in the absence of 24-hour support and structure of a Level 3.5 program. For dimension 4, the
patient was admitted voluntarily for treatment after being unable to reduce or stop drinking on
his own and having an alcohol withdrawal seizure in January 2022. He reported problematic
drinking for the past four years and drinking 750 mL of whiskey daily. The patient appeared
ambivalent about his need for treatment as he did not want to remove alcohol from his house.
Due to the intensity and chronicity of the addictive disorder, the patient had limited insight and
little awareness of the need for continuing care or the existence of his substance use and need
for treatment, and thus had limited readiness to change. For dimension 5, this was the patient's
first attempt at treatment. He reported drinking 750 mL of whiskey daily. He was assessed as not
having the skills to manage his urges to drink alcohol and was resistant to fully removing alcohol
from the house. His drinking was so severe that he had an alcohol withdrawal seizure in January
2022. The patient did not recognize relapse triggers and lacked insight into the benefits of
continuing care and was therefore not committed to treatment. His continued alcohol use posed
an imminent danger of harm to self or others in the absence of 24-hour monitoring and
structured support. For dimension 6, the patient lived with his wife, who was a social drinker. He
was reluctant to remove alcohol from the home. He consistently drank alcohol heavily when in
his home environment. The patient was unable to cope, for even limited periods of time, outside
of 24-hour care and required monitoring to learn to cope with problems before being transferred
safely to a less intensive setting. Given these findings, the patient met the six ASAM criteria for RTC services provided from 5/25/22 through discharge. Accordingly, Level 3.5 clinically managed
high-intensity residential services (adult criteria) from 5/25/22 through discharge were medically
necessary for treatment of this patient.
| 1 |
A 45-year-old male enrollee has requested has requested reimbursement for the testosterone pellet (Testopel) 75 mg received on 12/18/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees hypogonadism.
In this case, the patient was unable to remain on topical testosterone therapy, and he has derived benefit from treatment with Testo
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Overturned
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Medical Necessity
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Summary Reviewer
A 45-year-old male enrollee has requested has requested reimbursement for the testosterone pellet (Testopel) 75 mg received on 12/18/15. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees hypogonadism. The physician reviewer found that low testosterone can lead to such complications as reduced libido/erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis/low bone mass, depressed mood and fatigue (Dandona and Rosenberg). For these reasons, many providers treat patients with hypogonadism when their testosterone level is less than 350 ng/dL (Nieschlag, et al). The general target level for testosterone ranges from 350 to 750 ng/dL, which is approximately the range for healthy, androgen-sufficient adult men. Testosterone levels should be monitored for three to six months after initiation of treatment in order to assure that the patients testosterone level is optimal and the dose of testosterone replacement therapy should be adjusted accordingly (Rivas, et al). Testopel, which measures 3 mm by 9 mm, is an implantable testosterone pellet containing crystalline testosterone which are implanted under the skin and slowly release testosterone over the course of three to six months. Benefits include relatively long duration of action and reduced risk of exposure to other individuals via skin contact (Margo and Winn). In this case, the patient was unable to remain on topical testosterone therapy, and he has derived benefit from treatment with Testopel 75 mg. Therefore, the Testopel 75 mg received on 12/18/15 has been established as medically necessary for treatment of the patients medical condition. Therefore, the medication at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 49-year-old male enrollee has requested reimbursement for a positron emission tomography (PET) scan performed on 6/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
, a CT scan was obtained which demonstrated what was described as bulky adenopathy in the retroperitoneum, mesentery, and supraclavicular regions.
providers proceeded with a bone marrow aspiration which was
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Overturned
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Experimental
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Summary Reviewer 2
A 49-year-old male enrollee has requested reimbursement for a positron emission tomography (PET) scan performed on 6/30/17. 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 that very limited clinical information has been submitted concerning this patient. For some reason, a CT scan was obtained which demonstrated what was described as bulky adenopathy in the retroperitoneum, mesentery, and supraclavicular regions. Lymphadenopathy is a common clinical presentation, and the first role of the provider is to determine whether this represents a significant systemic disease or whether the lymphadenopathy is likely due to a local inflammatory (and likely self-limited) reaction. But when one has evidence of multisite bulky adenopathy, it can be assumed that this represents a significant illness. The next step is to differentiate between benign and malignant processes. In this patients case, considering the likely diagnosis of lymphoma, his providers proceeded with a bone marrow aspiration which was negative. One critical issue is to decide on a node to biopsy that is both accessible as well as likely demonstrating an answer. It is in this situation where PET scanning is the most optimal next step. By demonstrating metabolic activity, the provider can safely pick the most suspicious node to sample. In this case, obtaining a PET/CT scan was warranted, and is the typical common means to proceed in patients with this presentation. In sum, PET scan performed on 6/30/17 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
A 45-year-old male enrollee has requested authorization and coverage for Xyrem. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
. This patient was diagnosed with narcolepsy in 2015 by a multiple sleep latency test (MSLT), which was preceded by an overnight polysomnography sleep study.
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Upheld
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Medical Necessity
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Summary Reviewer
A 45-year-old male enrollee has requested authorization and coverage for Xyrem. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient was diagnosed with narcolepsy in 2015 by a multiple sleep latency test (MSLT), which was preceded by an overnight polysomnography sleep study. After reviewing the result of the sleep study and MSLT, these studies were inconclusive and technically inadequate. The patient slept only 228 minutes, while at least 360 minutes is required per American Academy of Sleep Medicine guidelines to have adequate MSLT test results. In addition, the MSLT showed an average sleep latency of 9 minutes and 48 seconds, while the guidelines for positive MSLT is less than 8 minutes. The results from his sleep studies cannot be considered adequate to support the diagnosis of narcolepsy. Xyrem is indicated to treat appropriately diagnosed narcolepsy patients with or without cataplexy if there is contraindication or poor response to other medications. There is a lack of support for the requested medication in this clinical setting. Therefore, Xyrem is not medically necessary for the treatment of this patient.
| 1 |
A 20-year-old male enrollee has requested reimbursement for residential treatment, partial hospitalization program services and intensive outpatient program services provided from 3/6/15 through 5/3/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
review, the patient presented to residential treatment on 3/6/15 with mild. He was not a danger to himself or others.
. He was psychiatrically stable. Although his liver function tests were elevated, he was medically stable. He participated in the program and was motivated. He did not require 24-hour monitoring at residential level of care.
The patient no longer had PAWS and he was not at risk to himself or others. He was counseled regarding the need to monitor his liver function tests and liver health. His overall mood was euthymic. As of 3/25/1
of 4/17/15, he had a sponsor, and he was actively attending meetings/groups, and was employed. He was highly motivated. His mother was participating in family sessions.
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Upheld
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Medical Necessity
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Summary Reviewer
A 20-year-old male enrollee has requested reimbursement for residential treatment, partial hospitalization program services and intensive outpatient program services provided from 3/6/15 through 5/3/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that the services at issue were not medically indicated for this patient during the dates in dispute. According to the documentation submitted for review, the patient presented to residential treatment on 3/6/15 with mild. He was not a danger to himself or others. There were no emotional, behavioral, or cognitive barriers requiring residential treatment. He was psychiatrically stable. Although his liver function tests were elevated, he was medically stable. He participated in the program and was motivated. He did not require 24-hour monitoring at residential level of care. As of 3/25/15, partial hospitalization program services were not clinically indicated. The patient no longer had PAWS and he was not at risk to himself or others. He was counseled regarding the need to monitor his liver function tests and liver health. His overall mood was euthymic. As of 3/25/15 he could have been stepped down to a lower level of care. Further, the intensive outpatient program services were not indicated for this patient. As of 4/17/15, he had a sponsor, and he was actively attending meetings/groups, and was employed. He was highly motivated. His mother was participating in family sessions. There were no emotional, behavioral, or cognitive barriers to treatment at a lower level of care. Therefore, the residential treatment, partial hospitalization program services and intensive outpatient program services provided from 3/6/15 through 5/3/15 were not medically necessary. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
patient is 62-year-old male with a history of major depressive disorder, generalized anxiety
disorder, cannabis use disorder, alcohol use disorder, hypothyroidism, and hypertension.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is 62-year-old male with a history of major depressive disorder, generalized anxiety
disorder, cannabis use disorder, alcohol use disorder, hypothyroidism, and hypertension. The
physician reviewer found that The American Association of Community Psychiatrists Level of Care
Utilization System (LOCUS) provides a reliable framework for determining the appropriate level
of care for adults needing mental health treatment. Using LOCUS, providers score patients on a
scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk
of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery
environment (a. stressors and b. supports); (5) treatment and recovery history; and (6)
engagement. The composite score is then used to determine the level of care needed. Applying
the LOCUS framework, the patient meets the criteria for RTC services provided from 12/15/22
through 12/18/22. For dimension 1, the patient was at a moderate risk of harm (score 3), due to
having no history of suicide attempts, but a history of daily suicidal ideation. The records
document the patient being in extreme distress as well as a history of excessive use of substances
resulting in potentially harmful behaviors. For dimension 2, the patient demonstrated serious
functional impairment (score 4). The providers records document a significant withdrawal and
avoidance of almost all social interaction. The patient was unable to work due to his symptoms.
Additionally, the patient had estrangement from his family and significant withdrawal and
isolation from almost all social interactions. For dimension 3, the patient had significant co-
morbidity (score 3). The patient had significant substance use with detrimental effects, which has
been temporarily arrested through detoxification and now RTC. The patient has also had
diagnoses of hypothyroidism and hypertension, which can influence his depressive symptoms
and may require significant medical monitoring. For dimension 4A, the patients recovery
environment was highly stressful (score 4). The providers records note that the patient
experienced difficulty avoiding exposure to active users and other pressures to partake in alcohol
or drug use. The patient is estranged from his family and was living with a friend who uses
substances daily. For dimension 4B, the patients recovery environment was minimally
supportive (score 4). The provider notes report very few actual or potential sources of support
were available. The patient had no social support other than his roommate. For dimension 5, this
patient has exhibited poor response to treatment and recovery management (score 4). The
providers records document that previous treatment had not achieved complete remission of
symptoms or optimal control of symptoms even with intensive and/or repeated exposure. The
patient had been previously hospitalized for mental health reasons and had completed RTC in
the past. The patient had been in detoxification six times during the last several years without
remission of his symptoms. For dimension 6, the patient has shown limited engagement and
recovery (score 3). The patient was actively engaged in treatment but lacked confidence to
change despite intentions to do so because of his past inability to change. These findings give the
patient a composite score of 25, which is consistent with medically monitored residence-based
services. Further, a score of 4 in level of functioning requires treatment at this higher level of care
(RTC). Additionally, in terms of length of stay, the patient meets criteria for level 5B: moderate
intensity intermediate stay residential treatment programs with length of stay up to 60 days due
to serious impairment in expected role functioning in work, school and home. Moreover, the RTC services are in accordance with the generally accepted standards of mental health and substance
use disorder care, clinically appropriate in terms of type, frequency, extent, site, and duration,
and not primarily for the convenience of the patient or provider. For these reasons, RTC services
at A Better Life Recovery provided from 12/15/22 through 12/18/22 were medically necessary
for treatment of this patient.
| 1 |
A 29-year-old male enrollee has requested authorization and coverage for implant of neuroelectrodes (InterStim, under fluoroscopy guidance). The Health Insurer has denied this request indicating that the requested service is not medically necessary for treatment of the enrollees neurogenic bladder.
The patient has a sensation of incomplete emptying. However, he has never catheterized for urinary retention and the post-void residual was normal at 64 cc on 7/23/15. The urodynamic study reportedly had an elevated post void residual but
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Upheld
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Medical Necessity
|
Summary Reviewer
A 29-year-old male enrollee has requested authorization and coverage for implant of neuroelectrodes (InterStim, under fluoroscopy guidance). The Health Insurer has denied this request indicating that the requested service is not medically necessary for treatment of the enrollees neurogenic bladder. The physician reviewer found this patients provider has recommended placement of InterStim for treatment of non-obstructive urinary retention. However, the diagnosis of non-obstructive urinary retention is not supported by the documentation provided for review in this case. The patient has a sensation of incomplete emptying. However, he has never catheterized for urinary retention and the post-void residual was normal at 64 cc on 7/23/15. The urodynamic study reportedly had an elevated post void residual but the study is not available for review. The study also shows detrusor hyperreflexia which can explain nocturia and frequent small voids. This patients symptoms would be best treated by an anticholinergic medication. In addition, it is unclear if the elevated post void residual reported on the urodynamic study is from poor detrusor contraction, detrusor sphincter dyssynergia, or bladder outlet obstruction. This information would only be available from a pressure flow study which is not available for review. Thus, the diagnosis of non-obstructive urinary retention cannot be justified and the requested implant of neuroelectrodes (InterStim, under fluoroscopy guidance) is not supported as medically necessary. Based on the foregoing discussion, the requested service is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
The parent of a four-year-old female enrollee has requested reimbursement for chromosomal microarray (CMA) genetic testing performed on 9/16/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation the enrollees developmental delays.
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Overturned
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Experimental
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Summary Reviewer 1
The parent of a four-year-old female enrollee has requested reimbursement for chromosomal microarray (CMA) genetic testing performed on 9/16/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation the enrollees developmental delays. The physician reviewer found that chromosomal microarray genetic testing has become standard of care to evaluate children with developmental disabilities. Henderson and colleagues retrospectively reviewed the medical records of patients who had abnormal chromosomal microarray findings over a three-year period and quantified the management recommendations made in response to these results. The authors concluded that their results empirically demonstrate the clinical utility of chromosomal microarray by providing evidence that management was directly affected for the majority of patients in our cohort with abnormal chromosomal microarray findings. Similarly, Riggs and colleagues reported that 7% of microarray results impact clinical management, a rate which is similar to other genetic tests. Given the support in the peer-reviewed literature, the chromosomal microarray genetic testing performed on 9/16/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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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.
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Experimental
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Summary Reviewer 3
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 Tomosynthesis was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography, the American College of Radiology (ACR) urged the technique be removed from the investigational category in 2014 due to the advantages this new tomographic technique brings to radiologists interpreting mammograms. This technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to this patient than had her exam been done with two-dimensional imaging alone. Accordingly, the breast tomosynthesis that was performed on 7/29/16 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 service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 23-year-old male enrollee has requested reimbursement and prospective authorization and coverage for substance abuse partial hospitalization program (PHP) services provided from 5/28/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees opiate dependence and depression.T
As documented in this patients case notes, he has poor coping skills, is impulsive, has low self-esteem, and demonstrates a pattern of being unable to abstain from drugs and alcohol as evidenced by multiple treatment episodes.
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Overturned
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Medical Necessity
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Summary Reviewer
A 23-year-old male enrollee has requested reimbursement and prospective authorization and coverage for substance abuse partial hospitalization program (PHP) services provided from 5/28/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees opiate dependence and depression.The physician reviewer found that the American Psychiatric Association (APA) treatment guidelines recommend that PHP treatment is indicated for patients who do not meet the clinical criteria for hospitalization but whose lives and social interactions have come to focus predominantly on substance uselack sufficient social and vocational skills and drug-free social supports to maintain abstinence in an outpatient setting. As documented in this patients case notes, he has poor coping skills, is impulsive, has low self-esteem, and demonstrates a pattern of being unable to abstain from drugs and alcohol as evidenced by multiple treatment episodes. Consistent with the American Society of Addiction Medicine (ASAM) criteria, he requires safe and stable living environments in order to develop recovery skills, and the services at the PHP level of care are thus appropriate. All told, the PHP services provided from 5/28/15 forward were and are medically necessary for treatment of this patients medical condition.Therefore, the Health Insurer's denial should be overturned.
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A 43-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/2/16. 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 patient did not have dense breasts, she did not have a mass, there were no palpable lumps, and she did not have suspicious calcifications.
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Experimental
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Summary Reviewer 3
A 43-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/2/16. 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 tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, by separating the various layers of breast tissue, one can better detect abnormalities. However, in this particular patient, there were no problems to be resolved since the patient did not have dense breasts, she did not have a mass, there were no palpable lumps, and she did not have suspicious calcifications. As the 2D images were most likely reconstructed from the primary tomosynthesis acquisition, a routine mammogram would have been sufficient. 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 a prior mammogram from eight years earlier, and especially when there is considerable fatty change. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 9/2/16 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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A 63-year-old male enrollee has requested reimbursement for CPT 64999 (unlisted procedure, nervous system, right wrist anterior and posterior interosseous neurectomy) performed on 6/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.
this patient had significant right osteoarthritis following wrist fracture 20 years ago.
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Experimental
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Summary Reviewer 2
A 63-year-old male enrollee has requested reimbursement for CPT 64999 (unlisted procedure, nervous system, right wrist anterior and posterior interosseous neurectomy) performed on 6/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient had significant right osteoarthritis following wrist fracture 20 years ago. A review of the medical literature shows that the requested procedure does have a moderate amount of good quality literature to support efficacy in patients who are otherwise only candidates for wrist fusion surgery. The submitted records do demonstrate that the patient has failed an appropriate course of conservative management. There is sufficient support for the services at issue in this clinical setting. Therefore, CPT code 64999 (unlisted procedure, nervous system, right wrist anterior and posterior interosseous neurectomy) performed on 6/10/19 was likely to have been more beneficial for treatment of the patientas medical condition than any available standard therapy.
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A 33-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/30/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 33-year-old female enrollee has requested reimbursement for Anser IFX testing performed on 4/30/15. 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 submitted medical records fail to demonstrate the superior effectiveness of the services at issue. 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. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. The reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well controlled clinical trials to confirm that use of the Anser testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment. 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 4/30/15 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 28-year-old female enrollee has requested reimbursement for CPT code 92025 (computerized corneal topography, unilateral or bilateral, with interpretation and report) provided on 6/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 2
A 28-year-old female enrollee has requested reimbursement for CPT code 92025 (computerized corneal topography, unilateral or bilateral, with interpretation and report) provided on 6/02/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found the current medical evidence does not support the services at issue in this patients case. Corneal topography provides a map of the cornea. It is most often used to determine if there is any sign of ectasia. While there can be corneal abnormalities in patients with dry eyes, the use of topography purely for the management of the dry eyes is not considered standard of care. Likewise, since the patient could see 20/20 and the refraction showed low astigmatism, the suspicion for corneal ectasia is very low. Therefore, based on the medical records provided, the services at issue were not likely to have been of greater benefit than other treatment options. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 32-year-old female enrollee has requested reimbursement for the laboratory testing provided on 6/6/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees miscarriage.
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Upheld
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Experimental
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Summary Reviewer 3
A 32-year-old female enrollee has requested reimbursement for the laboratory testing provided on 6/6/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees miscarriage. The physician reviewer found that the laboratory studies that were ordered for this patient have not been recommended by American College of Obstetricians and Gynecologists (ACOG) as beneficial for patients who have had first trimester pregnancy loss. Further, the use of anticoagulation, aspirin, or both has not been shown to reduce the risk of early pregnancy loss in women with thrombophilias. Since there is no effective treatment associated with identification of abnormalities in these laboratory studies, there is no benefit to the patient in obtaining the studies. Thus, the laboratory testing provided on 6/6/16 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 62-year-old female enrollee has requested reimbursement for ChemoFX assay performed on 5/08/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Upheld
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Experimental
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Summary Reviewer 1
A 62-year-old female enrollee has requested reimbursement for ChemoFX assay performed on 5/08/15. 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 ChemoFx is an attempt to determine the likelihood of a specific chemotherapeutic agent being effective in a patient, by testing the growth of an individuals cancer in an environment of various agents in vitro. The hope is that drugs to which the cancer cells will respond to in vitro will then be clinically useful in that patient. Such personalized selection would then spare the patient the toxicity of drugs that would not be useful. There have been many such assays developed over the years. As yet, none has convincingly demonstrated that selecting the specific chemotherapeutic regimen under the guidance of this assay has given the patient a significantly better survival, when compared to selecting a regimen based on known clinical studies and standards. At this time, the evidence is insufficient to use the information from these assays to supplement standard of care chemotherapy decisions. All told, ChemoFx assay performed on 5/08/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 48-year-old female enrollee has requested reimbursement for the lab testing provided on 11/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees migraines, mild memory impairment, and prior syncope.
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Upheld
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Experimental
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Summary Reviewer 1
A 48-year-old female enrollee has requested reimbursement for the lab testing provided on 11/28/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees migraines, mild memory impairment, and prior syncope. The physician reviewer found that there is a lack of conclusive evidence of a linkage between migraines and homocysteine levels (Lippi, et al). Further, the current guidelines from the American Heart Association and American Stroke Association do not support the performance of this testing (Goldstein, et al). In addition, the current practice guidelines from the American College of Medical Genetics (ACMG) do not support the performance of testing for MTHFR (Hickey, et al). With regard to Factor V Leiden, Grody and colleagues report that the ACMG does not recommend random screening of the general population for factor V Leiden. Routine testing is also not recommended for patients with a personal or family history of arterial thrombotic disorders (e.g., acute coronary syndromes or stroke) except for the special situation of myocardial infarction in young female smokers. In this case, there was no reported family history noted of a hypercoagulable condition. Nor does the patient have a history of a thrombus or other similar condition. Given that the patient did not present with a condition related to a coagulable disorder the need for testing for Factor V Leiden is not supported in the records provided for review. All told, the lab testing provided on 11/28/16 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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The parent of an 11-year-old male enrollee has requested authorization and coverage for Epidiolex Solution (cannabidiol). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees intractable epilepsy.
This patient has medically refractory epilepsy, having been tried on multiple anticonvulsant medications without obtaining seizure control. He has structural brain abnormalities that increase his risk of having intractable epilepsy. Silvestro and
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Medical Necessity
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Summary Reviewer
The parent of an 11-year-old male enrollee has requested authorization and coverage for Epidiolex Solution (cannabidiol). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees intractable epilepsy. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. This patient has medically refractory epilepsy, having been tried on multiple anticonvulsant medications without obtaining seizure control. He has structural brain abnormalities that increase his risk of having intractable epilepsy. Silvestro and colleagues noted, Cannabidiol (CBD) is one of the cannabinoids with non-psychotropic action, extracted from Cannabis sativa. CBD is a terpenophenol and it has received a great scientific interest thanks to its medical applications. This compound showed efficacy as anti-seizure, antipsychotic, neuroprotective, antidepressant and anxiolytic. The neuroprotective activity appears linked to its excellent anti-inflammatory and antioxidant properties. The authors stated, The results of scientific studies obtained so far for the use of CBD in clinical applications could represent hope for patients who are resistant to all conventional anti-epileptic drugs. Epidiolex has been demonstrated to be an effective long-term treatment option in Lennox-Gastaut syndrome and Dravet syndrome, two forms of intractable generalized epilepsy syndromes in children, and is approved by the U.S. Food and Drug Administration (FDA) for those conditions. The drug does not have biological specificity for these two conditions, however. OConnell and colleagues noted that open-label studies with 100mg/ml CBD (Epidiolex, GW Pharmaceuticals) have provided additional evidence of its efficacy along with an adequate safety profile (including certain drug interactions) in children and young adults with a spectrum of treatment resistant epilepsies. There is sufficient support for the requested medication in this clinical setting. Therefore, Epidiolex solution (cannabidiol) is medically necessary for the treatment of this patient.
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A 56-year-old female enrollee has requested reimbursement for gene test (Breast Cancer Index) performed on 1/6/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who had a history of breast cancer.
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Upheld
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Experimental
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Summary Reviewer 3
A 56-year-old female enrollee has requested reimbursement for gene test (Breast Cancer Index) performed on 1/6/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who had a history of breast cancer. The physician reviewer found that the Breast Cancer Index test was investigational for the evaluation of this patient. Randomized prospective clinical trials showing progression free survival or overall survival benefit using this test are lacking. As such, recommending this test remains provocative and debatable. The results from the test showed very low risk for recurrence. The adjuvant hormonal therapy was based on stage at diagnosis and hormonal status. Accordingly, the gene test (Breast Cancer Index) performed on 1/6/17 was not likely to have been superior over the other methods of evaluating this patients medical condition.
Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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patient is a 31-year-old male who was admitted to a residential treatment center on 12/22/21
and presented for an admission assessment. The patient has requested reimbursement for ASAM
Level 3.5, clinically managed high-intensity residential services (adult criteria), from 12/29/21
through 12/31/21. The Health Insurer has denied this request and reported that the services at issue
were not medically necessary for the treatment of this patient.
. The patient was admitted to the residential treatment center following
detoxification. The patients withdrawal needs were
had no acute medical problems during
his treatment and did not require 24-hour medical or nurse monitoring.
. The patient reported a history of PTSD. The patient was not on any
psychotropic medications when he entered the facility and did not endorse suicidal or homicidal
ideation, psychosis,
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Upheld
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Medical Necessity
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Summary
The patient is a 31-year-old male who was admitted to a residential treatment center on 12/22/21
and presented for an admission assessment. The patient has requested reimbursement for ASAM
Level 3.5, clinically managed high-intensity residential services (adult criteria), from 12/29/21
through 12/31/21. 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 per American Society of Addiction
Medicine (ASAM) criteria, this patient did not meet Level 3.5 criteria for RTC services from
12/29/21 through 12/31/21. ASAM criteria focuses on six dimensions to determine the appropriate
level of care, which includes: (1) intoxication and withdrawal potential; (2) biomedical conditions;
(3) emotional, behavioral and cognitive conditions; (4) readiness to change; (5) relapse, continued
use, or continued problem potential; and (6) recovery environment. For dimension 1, the records
support a score of 0. The patient was admitted to the residential treatment center following
detoxification. The patients withdrawal needs were safely managed in a Level 3.5 setting. For
dimension 2, the records support a score of 0. The patient had no acute medical problems during
his treatment and did not require 24-hour medical or nurse monitoring. For dimension 3, the
records support a score of 1. The patient reported a history of PTSD. The patient was not on any
psychotropic medications when he entered the facility and did not endorse suicidal or homicidal
ideation, psychosis, major depression, panic attacks, severe anxiety, or mania during the period in
question. This criterion was not met. For dimension 4, the records support a score of 1. The records
showed that the patient participated in individual treatment, equine therapy, 12-step work, and
group sessions. He reported that he was working on his mental health. This criterion was not met.
For dimension 5, the records support a score of 2. The records noted two prior residential treatment
center attempts. The patients first attempt was at age 15, resulting in a relapse when the patient
went to college. The second attempt was in 2018 and the patient relapsed six years later. The
patient reported that the relapse was due to loneliness. The patient was able to stay clean and sober
for six years and relearned relapse-prevention tools while at the facility. The records reflected that
the patient worked hard on recovery and was willing to step down to sober living to continue with
a sober network and supports. This criterion was not met. For dimension 6, the records support a
score of 1. The patient reported good family support and the patient agreed to step down to sober
living to continue receiving support. He was aware of the sober network in his community and
was not returning to an unsafe home or environment. This criterion was not met. Given these
findings, the patient did not meet the six ASAM criteria for RTC services provided from 12/29/21
through 12/31/21. Therefore, ASAM Level 3.5, clinically managed high-intensity residential
services (adult criteria), from 12/29/21 through 12/31/21, were not medically necessary for the
treatment of this patient.
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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.
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Overturned
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Experimental
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Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for 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 there is sufficient support for the services at issue in this clinical setting. The prognosis of patients with recurrent or metastatic head and neck squamous cell cancer is generally poor. Treatment options include single-agent therapy and combination regimens using either conventional cytotoxic chemotherapy and/or molecularly targeted agents combined with best supportive care. Conventional cytotoxic drugs, checkpoint inhibitor immunotherapy, and molecularly targeted compounds have activity in metastatic and recurrent head and neck cancer. The National Comprehensive Cancer Network indicates that the best management of any patient with cancer is in a clinical trial. Molecular profiling can help identify available therapies (such as immunotherapy) or potential for clinical trials. Therefore, 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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The parent of a 14-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 10/7/14. The Health Insurer has denied this request indicating that the testing at issue was investigational for evaluation of the enrollees Crohns disease.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a 14-year-old male enrollee has requested reimbursement for Prometheus Anser IFX diagnostic testing performed on 10/7/14. 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 medical literature indicates that measurement of infliximab levels and anti-infliximab (anti-chimeric) antibodies produces actionable data (Afif, et al; Yanai and Hanauer). Change of dose or drug based on these results improves response to treatment, as measured by clinical response. The study by Hoekman and colleagues demonstrates that lower infliximab troughs are associated with elevated markers of mucosal inflammation in children. Paul and colleagues demonstrate prospectively that an increase in infliximab levels leads to a decrease in those same markers. Moreover, infliximab levels and antibodies allow the providers to adjust or change biologic therapy with some objective determinants. The utility of this approach is indicated in the article by Huang and colleagues who demonstrate that knowledge of infliximab trough levels frequently leads to a change in treatment course. An alternative is to sequentially increase dose and decrease dosing frequency of infliximab, then empirically change to another medication, typically adalimumab. However, this clinical approach can be lengthy and prolong a patients symptoms as well as the likelihood of an intercurrent hospital admission. In sum, the medical literature supports the use of infliximab levels and antibody measurements in the setting of inadequate clinical response to treatment, as well as for monitoring effectiveness of dose escalation. Therefore, the Prometheus Anser IFX testing 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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The parent of a six-year-old male insured has requested reimbursement for Coronavirus COVID-
19 (SARS-CoV-2) respiratory panel performed on 11/8/22. The Health Plan has denied this request
indicating that the requested services are considered investigational for evaluation of the insureds
respiratory illness with concern for SARS-CoV-2 infection.
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Overturned
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Experimental
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Summary Reviewer 3
The parent of a six-year-old male insured has requested reimbursement for Coronavirus COVID-
19 (SARS-CoV-2) respiratory panel performed on 11/8/22. The Health Plan has denied this request
indicating that the requested services are considered investigational for evaluation of the insureds
respiratory illness with concern for SARS-CoV-2 infection. The physician reviewer found that on
review of the current medical literature, the BioFire 2.1 Respiratory Panel was appropriate for use
in this patients clinical setting. The accurate diagnosis of COVID is essential for infection control
and prevention. When a patients household has immunosuppressed or elderly patients, an accurate
diagnosis is needed for quarantine. Also, this information is helpful to monitor for multisystem
inflammatory syndrome (MIS-C), which is a potential complication of COVID in pediatric patients
that can manifest four to six weeks after the initial COVID infection (Kabeerdoss, et al.). Proper
diagnosis helps create a timeline for monitoring pediatric patients for the constellation of
symptoms associated with MIS-C. For these reasons, the Coronavirus COVID-19 (SARS-CoV-2)
respiratory panel performed on 11/8/22 was likely to be more beneficial for evaluation of the
patients medical condition than any available standard therapy.
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A 59-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination.
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Overturned
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Experimental
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Summary Reviewer 2
A 59-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/9/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination. The physician reviewer found that the medical literature supports breast tomosynthesis in this clinical setting. Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues state that integrated two dimensional and three dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Thus, the literature supports the use of digital breast tomosynthesis over conventional mammogram due to improved cancer detection rate. In sum, digital breast tomosynthesis performed on 8/9/16 was likely to have been superior to other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is a 15-year-old male who was admitted to a residential treatment center on 2/15/23
and presented for a biopsychosocial assessment. The patients parent has requested
reimbursement for mental health residential treatment from 2/15/23 through 4/26/23. The
Health Insurer has denied this request and reported that the services at issue were not medically
necessary for the treatment of this patient.
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Overturned
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Medical Necessity
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Summary Reviewer
The patient is a 15-year-old male who was admitted to a residential treatment center on 2/15/23
and presented for a biopsychosocial assessment. The patients parent has requested
reimbursement for mental health residential treatment from 2/15/23 through 4/26/23. The
Health Insurer has denied this request and reported that the services at issue were not medically
necessary for the treatment of this patient. The physician reviewer found that the American
Academy of Child and Adolescent Psychiatry (AACAP) and American Association for Community
Psychiatry (AACP) have unified the Child and Adolescent Level of Care Utilization System
(CALOCUS) and the Child and Adolescent Service Intensity Instrument (CASII) into a single
instrument, the Child and Adolescent Level of Care/Service Intensity Utilization System
(CALOCUS-CASII). This instrument is a standardized tool used to determine the intensity of
services needed for children and adolescents, 6-18 years of age, presenting with psychiatric,
substance use, medical and/or developmental concerns. Using CALOCUS-CASII, providers score
patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions
include: (1) risk of harm; (2) functional status; (3) co-occurrence of developmental, medical,
substance use and psychiatric conditions; (4) recovery environment (a. stressors and b. supports);
(5) resiliency and response to services; and (6) engagement. The composite score is then used to
determine the level of care needed. Applying the CALOCUS-CASII framework, this patient met
the criteria for RTC services. With regard to risk of harm, the records support a score of 4. The
patient had a serious risk of harm, due to a history of suicidal ideation, self-harm, and two suicide
attempts. The patient reported that his last incident of self-harm occurred two weeks prior to
admission. He denied suicidal ideation at the time of admission and throughout his stay in RTC.
The records noted a history of aggression, property destruction, and running away from home.
The patient had a history of significant and regular substance use. During the period under
review, the patient engaged in self-harm, was involved in a verbal altercation with a peer, and
inhaled cleaning products with the intention of getting high. The patient exhibited a clear and
persistent inability, given his developmental stage, to maintain physical safety and/or to use the
environment for safety. The patient exhibited significant impulsivity and physical aggression. In
terms of functional status, the records support a score of 4. The documentation noted serious
functional impairment as the patient was not attending school due to his mental health and
behavioral issues. He had been suspended and then expelled for fighting and truancy. The patient
struggled to focus when subjects were not easy for him. The records noted that the patient
struggled to speak to staff respectfully and had difficulty managing his frustration and anger,
getting upset and yelling. He required frequent redirection due to his poor boundaries and
impulsive behaviors. The records noted that lying, sneaky behavior, boundary crossing, and poor
impulse control continued to be problems for the patient during the period under review. With
regard to comorbidity, the records support a score of 3. The patient had significant comorbidity,
due to the presence of a neurodevelopmental disorder, ADHD, and a substance use disorder. The
patients use of substances adversely affected his mood and anxiety. The patients poor impulse
control secondary to ADHD likely contributed to his substance use. In terms of the level of stress
of the recovery environment, the records support a score of 3. The patient had a moderately
stressful environment. The patients biological mother was deceased. He had a conflictual relationship with his father and stepmother and left their home in the fall of 2022 due to his
behavior. The patient was living with his uncle but was no longer welcome to return due to his
behaviors. His father is described as volatile, verbally aggressive, and inattentive/disengaged at
times. The records noted that the patient was to be discharged to live with his aunt in another
state. With regard to the level of support of the recovery environment, the records support a
score of 2 as the patient reported that his peer group used substances. His family, including
extended family members, appeared supportive. In terms of resiliency and treatment history, the
records support a score of 4. The patient had poor resiliency and/or response to services as prior
treatment has included outpatient psychotherapy and psychiatric care including multiple
psychotropic medications, psychiatric residential treatment centers, and several inpatient
psychiatric hospitalizations. Previous treatment has not achieved complete remission of
symptoms or optimal control of symptoms and the patient demonstrates frequent evidence of
innate vulnerability under stress and difficulty resuming progress toward the expected
developmental level. With regard to treatment acceptance and engagement, the records support
a score of 4. The patient engaged in ongoing disrespectful behavior towards staff. The patient
appeared superficial, minimized his problems, and underreported his symptoms to his
psychiatrist, generally answering questions in a positive manner. The patient did not appear to
accept age-appropriate responsibility for his role in the development, perpetuation, and
consequences of his problems. Thus, the patient has a total score of 24. The records support a 4
in terms of functional status and risk of harm. In this case, the recommended level of care is
medically monitored residence-based services. With the functional impairment and elevated risk
of harm noted, the patient meets CALOCUS 5b extended stay criteria. This is consistent with the
level of care that the patient received at the residential treatment center. Therefore, mental
health residential treatment from 2/15/23 through 4/26/23 was medically necessary for the
treatment of this patient.
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patient is a 71-year-old female with osteoporosis. Per the records, she has tried alendronate twice. The first time she tried alendronate was in 2010, causing neck pain and headaches.
In this case, the patient has tried an oral bisphosphonate (alendronate) twice, which in both instances was associated to systemic side effect.
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Overturned
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Medical Necessity
|
Summary Reviewer
The patient is a 71-year-old female with osteoporosis. Per the records, she has tried alendronate twice. The first time she tried alendronate was in 2010, causing neck pain and headaches. The physician reviewer found that the submitted documentation supports the requested medication in this clinical setting. In this case, the patient has osteoporosis, and the recommendation is to treat it in order to decrease the patients risk of fracture and subsequent morbidity. Prolia (denosumab) has been approved by the U.S. Food and Drug Administration for the treatment of osteoporosis in postmenopausal women at high risk of fracture. Denosumab has been approved for first-line therapy for osteoporosis and prevention of fractures. In this case, the patient has tried an oral bisphosphonate (alendronate) twice, which in both instances was associated to systemic side effect. Therefore, J0897 (Prolia, 60 mg/ml syringe, 60 mg injected every six months for one year) is medically necessary for the treatment of this patient.
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A 47-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.
He has an apnea-hypopnea index of 21.1 and is unable to tolerate continuous positive airway pressure therapy.
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Overturned
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Experimental
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Summary Reviewer 3
A 47-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested services in this patients case. He has an apnea-hypopnea index of 21.1 and is unable to tolerate continuous positive airway pressure therapy. This patient meets clinical criteria for consideration of surgical management of his obstructive sleep apnea symptoms. Clinical studies of the use of hypoglossal nerve stimulation suggest that patients with a body mass index less than 32 benefit from this device. This patient meets this criteria, as his body mass index is 28.19. Thus, hypoglossal nerve stimulation or Inspire Upper Airway Stimulation System is likely to be more efficacious than other treatment options.
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A 45-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Gamunex-C from 7/01/21 forward. The Health Insurer has denied this request and reported that the medication at issue was and is investigational for the treatment of the enrolleeas medical condition.
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Overturned
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Experimental
|
Summary Reviewer 3
A 45-year-old female enrollee has requested reimbursement and prospective authorization and coverage for Gamunex-C from 7/01/21 forward. The Health Insurer has denied this request and reported that the medication at issue was and is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the polyneuropathies involve widespread damage to the bodyas peripheral nerves. Small fiber polyneuropathy (SFPN), also known as small fiber neuropathy, refers to those polyneuropathies that preferentially affect peripheral neurons with the thinnest axons. Small fiber neurons multifunctionality explains why SFPN increases risk of multiple symptoms. The most common are chronic widespread pain and/or itch, postural hypotension and/or tachycardia (POTS), nausea, constipation and/or diarrhea, disordered sweating, followed by urological and sexual dysfunction. Many studies have shown that autoimmunity and inflammation play a great role in SFPN. Treatments for these involve high dose steroids, IVIG or plasma exchange. Steroids carry significant side effects. Therefore, over the years, IVIG has been assuming a more important role. Cessation of the IVIG treatment in this patient could be detrimental to her health and quality of life. Therefore, Gamunex-C from 7/01/21 forward was and is likely to be more beneficial for the treatment of this patient than any available standard therapy.
| 0 |
A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
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Overturned
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Experimental
|
Summary Reviewer 3
A 56-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/29/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found 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, the original mammogram performed on 7/21/15 was done as a screening study, so that it is not unreasonable for the images to have been interpreted after the patient left the facility. To recall the patient for additional images once a suspicious abnormality is detected is typical and appropriate. However, it is not reasonable to repeat another tomosynthesis after only eight days. While the first breast tomosynthesis was warranted due to the heterogeneously dense nature of her breasts and the asymmetry, the records do not establish the need for the second breast tomosynthesis. Therefore, the breast tomosynthesis performed on 7/29/15 was not likely to have been more effective than other methods of evaluation. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 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.
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Overturned
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Experimental
|
Summary Reviewer 1
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 DAT-SPECT scanning has high sensitivity and specificity relative to differentiation between Parkinsons disease and other forms of tremor. However, it does not well correlate with treatment options which would depend upon the results of this testing. The diagnosis of essential tremor had been well-established in this case based on the response to propranolol with very little documented evidence of a parkinsonian syndrome. Accordingly, the DAT-SPECT scan performed on 9/17/15 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 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.
This patient has failed continuous positive airway pressure (CPAP) therapy. He has attempted to use an oral appliance, with limited success.
|
Overturned
|
Experimental
|
Summary Reviewer 2
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 there is sufficient support for the requested services in this clinical setting. This patient has failed continuous positive airway pressure (CPAP) therapy. He has attempted to use an oral appliance, with limited success. The medical evidence supports the requested services for patients who have failed CPAP therapy. Withrow and colleagues noted that apnea-hypopnea index (AHI) reduction and therapy usage were found to be somewhat higher among patients who were 65 years of age or older, and surgical complications with upper airway stimulation were low. In sum, the requested nerve stimulator implant is likely to be more effective than other treatment options.
| 1 |
A 58-year-old male enrollee has requested authorization and coverage for proton beam radiation
therapy (PBT). The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees locally advanced esophagus cancer.
|
Overturned
|
Experimental
|
Summary Reviewer 3
A 58-year-old male enrollee has requested authorization and coverage for proton beam radiation
therapy (PBT). The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees locally advanced esophagus cancer. The physician
reviewer found that PBT is likely to be more beneficial for treatment of the patients condition than any
available standard therapy.
| 1 |
The parent of a 14-year-old female enrollee has requested reimbursement for subtalar arthroereisis provided on 12/11/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral moderate-to-severe pes planus.
|
Upheld
|
Experimental
|
Summary Reviewer 2
The parent of a 14-year-old female enrollee has requested reimbursement for subtalar arthroereisis provided on 12/11/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees bilateral moderate-to-severe pes planus. The physician reviewer found that review of the current peer-reviewed medical literature does not provide adequate support for the safety and effectiveness of subtalar arthroereisis for the treatment of bilateral flatfoot. Moreover, there is a lack of indication for this procedure in this patients records. As this procedure has not been proven in the medical literature as safe and effective for the treatment of this patients medical condition, the subtalar arthroereisis performed on 12/11/14 was not likely to have been more beneficial for treatment of this patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were 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 34-year-old female enrollee has requested authorization and coverage for BRCA testing. The Health Insurer has denied this request indicating that the requested testing is considered investigational for evaluation of the enrollees risk of breast cancer.
guidelines as she has a second degree relative diagnosed with breast cancer at age 45. In addition, she has no living affected relatives
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Overturned
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Experimental
|
Summary Reviewer 1
A 34-year-old female enrollee has requested authorization and coverage for BRCA testing. The Health Insurer has denied this request indicating that the requested testing is considered investigational for evaluation of the enrollees risk of breast cancer. The physician reviewer found the requested testing is likely to be more effective for this patient than other available treatment options. In this case, the patient meets the National Comprehensive Cancer Network (NCCN) guidelines as she has a second degree relative diagnosed with breast cancer at age 45. In addition, she has no living affected relatives who can be tested. Therefore, BRCA genetic testing is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested testing is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
| 1 |
The parent of a 17-year-old female enrollee has reimbursement for psychiatric residential treatment from 10/06/18 through 10/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.
medical records indicate that the patient was not actively suicidal anytime during the disputed timeframe at the residential treatment center.
. The patient has had some issues with level of function, but the progress notes indicate significant improvement after a period of deterioration.
The patient did not have active medical problems, and her psychiatric symptoms were minimal and under control.
|
Upheld
|
Medical Necessity
|
Summary Reviewer
The parent of a 17-year-old female enrollee has reimbursement for psychiatric residential treatment from 10/06/18 through 10/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that in cases such as this, an evidence-based instrument such as American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) assists in determining necessary level of care for children. With regards to risk of harm, the records support a score of 1. The medical records indicate that the patient was not actively suicidal anytime during the disputed timeframe at the residential treatment center. In terms of functional status, the records support a score of 2. The patient has had some issues with level of function, but the progress notes indicate significant improvement after a period of deterioration. With regards to comorbidity, the records support a score of 2. The patient did not have active medical problems, and her psychiatric symptoms were minimal and under control. In terms of level of stress of the recovery environment, the records support a score of 2. The records noted a positive recovery environment and a stable housing situation. With regards to level of support of the recovery environment, the records support a score of 2. The patients parents were involved in treatment. In terms of resiliency and treatment history, the records support a score of 3. The records documented good response to a short period in the residential treatment center prior to the disputed dates of service. With regards to acceptance and engagement of the patient, the records support a score of 3. The patient participated in therapy actively, and her insight and judgment were noted to be good throughout treatment. In terms of acceptance and engagement of the parent, the records supported a score of 2. The parents worked actively and constructively with clinicians. Thus, the patient has a composite score of 17. This score correlates intensive outpatient services. In sum, psychiatric residential treatment from 10/06/18 through 10/20/18 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 60-year-old female enrollee has requested authorization and coverage for Botox. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees chronic migraine headaches
|
Upheld
|
Experimental
|
Summary Reviewer 1
A 60-year-old female enrollee has requested authorization and coverage for Botox. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees chronic migraine headaches The physician reviewer found that the submitted documentation fails to support the superior efficacy of the requested medication in this clinical setting. The available medical records indicate treatment with Botox but do not demonstrate or quantitate the specific degree of any benefit. The records provided do not specifically delineate or quantitate the frequency of the headaches in terms of days per month. The records describe a duration of two and a half months but does not describe any specific headache frequency decrease, headache intensity decrease or otherwise demonstrate any analgesic use reduction. There was no presentation of a headache diary. Moreover, there were no other mechanism demonstrating headaches lasting four or more hours per day within 15 days or more per month. As such, the effectiveness of Botox for treatment of this patient has not been demonstrated. Therefore, for the reasons stated above, the requested medication is not likely to be more beneficial for treatment of this patients medical condition than any available standard therapy. The Health Insurers denial should be upheld. AND FINDINGS]
| 1 |
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