Answer: An enrollee has requested authorization and coverage for Stelara.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Stelara. Current medical literature supports the use of Stelara in this case. Stelara is U.S. Food and Drug Administration (FDA) approved for Crohns disease. One large randomized controlled trial demonstrated safety and efficacy for induction and maintenance of remission in patients with moderate-to-severe Crohns disease that was resistant to anti-tumor necrosis factor (TNF) therapy. Another study showed a 73% response in patients with anti-TNF-resistant Crohns disease, and 80% of responders maintained remission for one year. A recent study demonstrated that a majority of patients who have failed an anti-TNF medication achieve and maintain response with Stelara. In this patient with primary nonresponse to anti-TNF medication (Humira), a medication with an alternative mechanism of action, such as Stelara, is more appropriate to control disease and to prevent further complications. For these reasons, Stelara is medically necessary for the treatment of this patients Crohns disease.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Orthovisc injection (hyaluronan) for treatment of knee pain due to osteoarthritis.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Orthovisc injection (hyaluronan) for treatment of knee pain due to osteoarthritis. The current literature continues to support the use of viscosupplementation for osteoarthritis of the knees. Researchers have noted that medical guidelines recommend intra-articular hyaluronic acid for management of knee osteoarthritis as second-line treatment in patients who remain symptomatic despite use of non-steroidal anti-inflammatory drugs. This recommendation is based upon accumulating evidence that intra-articular hyaluronic acid provides a significant benefit in knee osteoarthritis. There is good evidence that intra-articular hyaluronic acid injections reduce pain and increase function in knee osteoarthritis, and the benefits are long-lasting as compared with intra-articular corticosteroids. Evidence from real-life studies of repeat courses of intra-articular hyaluronic acid demonstrates an improvement in pain or function lasting up to 40 months (12 months after the last injection cycle), a reduction in use of concomitant analgesia by up to 50%, and suggests that there may be a delay in the need for total knee replacement (TKR) of around 2 years. The clinical benefit of intraarticular hyaluronic acid on knee osteoarthritis may be 2-fold: (i) mechanical viscosupplementation of the joint (allowing lubrication and shock absorption); and (ii) the re-establishment of joint homeostasis through induction of endogenous hyaluronic acid production, which continues long after the exogenous injection has left the joint. In addition, other researchers have conducted a systematic review of overlapping meta-analyses comparing viscosupplementation with other non-operative treatment modalities for knee osteoarthritis. This review shows that the current highest level of evidence suggests that intra-articular hyaluronic acid is a viable option for knee osteoarthritis. Its use results in improvements in knee pain and function that can persist for up to 26 weeks. Viscosupplementation has a good safety profile, and its use should be considered in patients with knee osteoarthritis. As such, the requested services are medically necessary.Final Result: The reviewer determined that the requested services are medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for interferon alfa 2b injections.

Context: Nature of Statutory Criteria/Case Summary:  An enrollee has requested authorization and coverage for interferon alfa 2b injections. The submitted documentation supports the medical necessity of the requested medication. A large case series of 127 patients by researchers demonstrated an overall 54% response rate with a mean 9 degree improvement in curvature in all patients. The study concluded that intralesional therapy with interferon alfa 2b continues to be a viable treatment option for Peyronies disease with data consistently showing improvements in disease characteristics. The current medical evidence supports intralesional interferon alfa 2b for nonoperative treatment of Peyronies disease. Therefore, interferon alfa 2b injections is medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in urology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: The parent of an enrollee has requested authorization and coverage for intravenous immunoglobulin (IVIG).

Context: Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for intravenous immunoglobulin (IVIG). Central to the idea of PANDAS is the concept that after Group A beta-hemolytic streptococcal (GABHS) infection, antibodies are generated that cross-react with antigens present in the basal ganglia and related structures. This in turn causes pathologic derangement of poly-synaptic pathways that subserve both cognitive, emotional and motor functions frequently associated with obsessive compulsive disorder and other neuropsychiatric disorders. In the medical literature, researchers reported on a clinical trial that showed no difference between IVIG and placebo in the blinded phase for pediatric patients with a purported diagnosis of PANDAS. All told, the current medical literature does not support the requested IVIG as medically necessary for treatment of this patients medical condition. Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in pediatrics and neurology with special qualification in child neurology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Xeljanz 5 mg tablet.

Answer: In this case, the patient has seronegative rheumatoid arthritis, Sjogren's syndrome and a positive ANA. The submitted documentation demonstrates the patient has failed methotrexate and hydroxychloroquine.

Answer: the patient has previously done well with Xeljanz with no evidence of synovitis.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Xeljanz 5 mg tablet. Review of the submitted evidence demonstrates that the requested Xeljanz 5 mg tablet is medically necessary for treatment of the patients medical condition. In this case, the patient has seronegative rheumatoid arthritis, Sjogren's syndrome and a positive ANA. The submitted documentation demonstrates the patient has failed methotrexate and hydroxychloroquine. Further, there is evidence the patient has previously done well with Xeljanz with no evidence of synovitis. Given the patients history of positive ANA, a tumor necrosis factor inhibitor (TNFi) such as Enbrel or Humira would not be recommended. Therefore, the requested Xeljanz 5 mg tablet is medically necessary.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in rheumatology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: A patient has requested authorization and coverage for Lyrica. The Health Plan has denied this request on the basis that the requested medication is not medically necessary for treatment of the enrollee's foot pain.

Answer: The patient presents with traumatic neuropathy with motor involvement. The submitted records reveal the patient has EMG-confirmed peroneal neuropathy (sensorimotor). He has a history of treatment with gabapentin. Gabapentin is contraindicated in this patient as it caused mental confusion, which is a known side effect of the drug.

Context: Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Lyrica. The Health Plan has denied this request on the basis that the requested medication is not medically necessary for treatment of the enrollee's foot pain. Review of the submitted documentation supports the medical necessity of Lyrica in this clinical setting. The patient presents with traumatic neuropathy with motor involvement. The submitted records reveal the patient has EMG-confirmed peroneal neuropathy (sensorimotor). He has a history of treatment with gabapentin. Gabapentin is contraindicated in this patient as it caused mental confusion, which is a known side effect of the drug. As such, gabapentin is not appropriate for this patient due to well recognized neurologic side effects. Lyrica has been approved by the U.S. Food and Drug Administration for treatment of neuropathic pain. As such, the requested medication is medically reasonable and necessary for treatment of this patients medical condition.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer is board certified in pain medicine and anesthesiology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Depend brand adult diapers.

Answer: the patient is requesting a specific brand of adult briefs or incontinence pads.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Depend brand adult diapers. The submitted documentation fails to demonstrate the medical necessity of the requested equipment. There are several types of urinary incontinence, and there is significant overlap in the conditions that cause urinary leakage. The risks for urinary incontinence increase with age, female gender, decrease in estrogen levels at menopause, obesity, smoking, chronic constipation, neurologic disorders and diabetes mellitus.  The diagnosis is mainly based on history and examination. The treatment depends on the etiology of the incontinence. Initial treatment includes lifestyle modifications and pelvic floor muscle exercises for all patients with urinary incontinence (stress, urgency, or mixed), along with bladder training in women with urgency incontinence. Patients often use incontinence pads when leaking is not controlled by medications or surgical treatments.  In this case, the patient is requesting a specific brand of adult briefs or incontinence pads. However, there is no medical documentation to support that she has had a significant adverse reaction to the pads that are provided by her Health Plan. Therefore, the requested Depend brand adult diapers are not medically necessary for the treatment of this patient. Final Result: The reviewer determined that the requested equipment is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in internal medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: A patient has requested authorization and coverage for Saxenda. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patients obesity.

Context: Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Saxenda. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the patients obesity. The submitted documentation does not support the medical necessity of the requested medication. Saxenda is approved for the treatment of obesity. It is used in adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index greater than 30 kg/m2 or greater than 27 kg/m2 in the presence of at least one weight-related comorbid condition, including hypertension, type II diabetes mellitus, and/or dyslipidemia. Initial management of individuals who would benefit from weight loss is a comprehensive lifestyle intervention consisting of a combination of diet, exercise, and behavioral modification. Per the medical evidence, patients who would benefit from weight loss should receive counseling on diet, exercise, and goals for weight loss. When a patient with an initial body mass index greater than 30 kg/m2 or a body mass index of 27 kg/m2 with comorbidities, such as hypertension or diabetes mellitus, has failed to achieve weight loss goals through diet and exercise alone, a pharmacologic therapy is suggested. In this case, the documentation does not support that the patient has failed treatment with counseling, calorie restriction, and increased physical activity to achieve weight loss goals. Additionally, the requested non-formulary drug, Saxenda, would not be more effective than the Health Plans formulary drugs, phentermine, benzphetamine, diethylpropion, and phendimetrazine.  There is a lack of studies that demonstrate that Saxenda is more effective than the listed formulary drugs. Therefore, Saxenda is not medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in internal medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: The parent of a male enrollee has requested authorization and coverage for immunotherapy with nivolumab (Opdivo). The Health Plan has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees grade IV glioblastoma.

Context: Nature of Statutory Criteria/Case Summary: The parent of a male enrollee has requested authorization and coverage for immunotherapy with nivolumab (Opdivo). The Health Plan has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees grade IV glioblastoma. Although multiple trials are testing various forms of immunotherapy in patients with glioblastoma, published data remain limited. In a phase I trial investigating the safety of monotherapy or combination therapy with two checkpoint inhibitors, 40 patients received either Opdivo with or without ipilimumab. Overall, monotherapy with Opdivo was better tolerated than combination therapy. However, the authors concluded that further studies are needed to help select patients most likely to respond to checkpoint inhibitor immunotherapy. Available standard therapies include retreatment with temozolomide and low-intensity alternating electric fields, which have more data to support them than Opdivo in this clinical setting. Accordingly, the requested Opdivo is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.One reviewer found that Opdivo is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: Two of the three reviewers determined that the requested medication is not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications:  One reviewer is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. One Reviewer is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing.  One Reviewer is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing.  All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for platelet-rich plasma injections (CPT 0232T).

Answer: this patient presented with a history of chronic bilateral knee pain. There was imaging evidence of bilateral lateral meniscus tears. Prior hyaluronic acid injections had provided two years of good relief.

Answer: The procedure report documented bilateral knee platelet-rich plasma injections were performed for the diagnoses of bilateral meniscal tears and knee pain.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for platelet-rich plasma injections (CPT 0232T). Findings:  Two of the three physician reviewers found this patient presented with a history of chronic bilateral knee pain. There was imaging evidence of bilateral lateral meniscus tears. Prior hyaluronic acid injections had provided two years of good relief. Detailed evidence of a recent, reasonable and/or comprehensive nonoperative treatment protocol trial and failure was not submitted. The procedure report documented bilateral knee platelet-rich plasma injections were performed for the diagnoses of bilateral meniscal tears and knee pain. There is an absence of large well-designed clinical studies to support the safety and efficacy of platelet-rich plasma in knee meniscal and cartilage disorders. The use of platelet-rich plasma injections is not supported in this clinical setting. In this patients case, the evidence does not support the use of platelet-rich plasma injections over other conservative treatment options. In sum, platelet-rich plasma injections were not likely to have been more effective than other treatment modalities. Final Result: The reviewers determined that the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in orthopedic surgery and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for stroller repairs for treatment of the enrollees cerebral palsy.

Answer: The patient is quadriplegic and has cerebral palsy.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for stroller repairs for treatment of the enrollees cerebral palsy.  Findings:  The physician reviewer found that the patients stroller is the primary source of mobility that the patient uses. The patient is quadriplegic and has cerebral palsy. Thus, the use of the stroller is mandatory for proper transport of the patient for activities of daily living (ADLs) and for routine daily travel. Based on the review of the current medical literature, the stroller repairs provided were medically necessary for treatment of this patients medical condition. Final Result: The reviewer determined that the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in neurology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: this patient has been diagnosed with Lyme disease

Answer: An enrollee has requested authorization and coverage for additional ceftriaxone sodium injection (HCPCS-J0696) with accompanying supplies and home infusion nursing visits (CPT 99601). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollee who has a history of neurologic disorder.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for additional ceftriaxone sodium injection (HCPCS-J0696) with accompanying supplies and home infusion nursing visits (CPT 99601). The Health Plan has denied this request indicating that the requested services are considered investigational for treatment of the enrollee who has a history of neurologic disorder. Findings:  The documentation provided does not support the superior efficacy of the requested services. While there is documentation that this patient has been diagnosed with Lyme disease, the available records do not substantiate conclusively the presence of Lyme disease or any other infection in this patient.  However, even if the records support the diagnosis of Lyme disease in this patient, peer reviewed literature supports treatment for no more than four weeks with any antibiotics. This patients request is for intravenous ceftriaxone for a period in excess of four weeks. Based on the documentation provided as well as the medical literature, additional ceftriaxone sodium injection (HCPCS-J0696) with accompanying supplies and home infusion nursing visits (CPT 99601) is not likely to be of greater benefit when compared to the available standard duration for treatment of this patients medical condition. Final Result: All three reviewers determined that the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications:  Two reviewers are board certified in internal medicine with sub-specialty certification in infectious disease and is actively practicing. One reviewer is board certified in internal medicine with expertise in Lyme disease. All three reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: A patient has requested authorization and coverage for testosterone injections.

Answer: The patient has failed therapy with transdermal testosterone.

Context: Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for testosterone injections. The submitted documentation supports the medical necessity of the requested medication. Low testosterone can lead to complications such as reduced libido, erectile dysfunction, reduced muscle mass and strength, increased adiposity, osteoporosis, depressed mood and fatigue. For these reasons, many providers treat patients with hypogonadism when their testosterone level is less than 350 ng/dL. The general target level for testosterone ranges from 350 to 750 ng/dL, which is roughly the range for healthy, androgen-sufficient adult men. Testosterone levels should be monitored three to six months after initiation of treatment, in order to assure that the patients testosterone level is optimal, and the dose of testosterone replacement therapy should be adjusted accordingly. The patient has failed therapy with transdermal testosterone. The patient will benefit from intramuscular testosterone therapy. Therefore, the requested testosterone injections are medically necessary for this patient.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Zepatier 50-100 mg for 12 weeks.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Zepatier 50-100 mg for 12 weeks.Findings: According to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated, except those with limited life expectancy due to non-liver-related conditions. This recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment-naive genotype 1a patients should be treated with regimens including Zepatier for 12 weeks when NS5A resistance is not found and Zepatier with ribavirin for 16 weeks when NS5A resistance is present. However, the guidelines now state that lack of NS5A resistance testing in genotype 1a patients should not be an impediment to coverage, and recommend 12 weeks of Zepatier when NS5A resistance testing is not available. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, Zepatier 50-100 mg tablets daily for 12 weeks is medically necessary for this patient.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for gene panel testing.

Answer: The records document that this patient underwent screening for spinal muscular atrophy.

Answer: the submitted documentation indicates that CPT code 81401 is in dispute. This code represents a complete gene panel.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for gene panel testing. Findings:  Three physician reviewers found there is sufficient support for a portion of the services at issue. The American College of Obstetricians and Gynecologists recommends that providers offer screening for spinal muscular atrophy to all patients who are considering pregnancy or who are currently pregnant. The records document that this patient underwent screening for spinal muscular atrophy. Thus, the medical evidence supports this testing in this clinical setting. However, the submitted documentation indicates that CPT code 81401 is in dispute. This code represents a complete gene panel. The records did not provide further support for the remaining of the tests which were included in the gene panel testing. In sum, screening for spinal muscular atrophy was likely to have been of greater benefit than other methods of evaluating this patient. However, the superior efficacy of the remaining tests of the gene panel testing has not been established.Final Result: The reviewers determined that a portion of the services at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be partially overturned.Credentials/Qualifications: Physician reviewers 1, 2 and 3 are board certified in obstetrics and gynecology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Latuda prescription for treatment of the enrollees behavioral health condition.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Latuda prescription for treatment of the enrollees behavioral health condition. Findings:  The physician reviewer found that Lurasidone is an atypical, or second generation, antipsychotic medication initially approved for the treatment of schizophrenia. In mid-2013, lurasidone gained two additional indications, both for the treatment of bipolar illness, and is one of only three U.S. Food and Drug Administration (FDA) approved medications for bipolar depression.  The other two, quetiapine and olanzapine-fluoxetine combinations, are frequently associated with weight gain, glucose intolerance and dyslipidemia.  The medical evidence appears to indicate that lurasidone is associated with fewer metabolic side effects and less weight gain. The Health Plan suggested aripiprazole as an alternative.  However, the data supporting aripiprazole as a monotherapy or in conjunction with lamotrigine in the treatment of bipolar depression are weak when compared to lurasidone. Lurasidone is approved by FDA for this patients condition and is reasonably expected to improve the patients condition and to prevent a more serious episode of illness.  Therefore, Latuda is medically necessary for the treatment of this patients medical condition. Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for wireless capsule endoscopy for evaluation of the enrollees abdominal pain.

Answer: this patient has had symptoms and biopsy findings suggestive of possible Crohns disease.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for wireless capsule endoscopy for evaluation of the enrollees abdominal pain. Findings:  2/3 of the physician reviewers found that the physician reviewer found this patient has had symptoms and biopsy findings suggestive of possible Crohns disease. Capsule endoscopy is useful for the diagnosis of Crohns disease or determination of the extent of disease activity, and has been demonstrated to be superior to radiographic imaging tests such as small bowel follow through. Capsule endoscopy has proven superior to current forms of radiological testing of the small intestine in detecting the mucosal abnormalities of non-stricturing Crohns disease. Per the study by colleagues, the frequency of small intestinal Crohns disease activity found by capsule endoscopy in a consecutive series was approximately double that detected by computed tomography enteroclysis, leading to change in management in a significant number of patients. In this patients case, wireless capsule endoscopy was likely to have been more effective than other available modalities for evaluating this patient.  Final Result: 2/3 of the reviewers determined that the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for Prometheus Anser ADA diagnostic testing.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Prometheus Anser ADA diagnostic testing. Findings:  Three physician reviewers found that there is insufficient medical evidence to support the effectiveness of Prometheus Anser ADA diagnostic testing compared with conventional courses of action in the management ulcerative colitis. The published studies on the use of anti-adalimumab antibodies and serum levels are small, retrospective, and/or observational rather than controlled in nature, preventing firm conclusions about cause and effect. These small studies at best demonstrated correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect. It is possible that active disease results in low adalimumab levels due to loss of adalimumab, rather than low adalimumab levels resulting in loss of disease control. Additionally, controlled studies are lacking to show that use of the test results in improved long-term health outcomes for patients with ulcerative colitis compared with conventional management.  For these reasons, the superior effectiveness of Prometheus Anser ADA diagnostic testing performed has not been established. Final Result: 3 of 3 reviewers determined that the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: All three reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for magnetic resonance imaging (MRI).

Answer: This patient has a PSA level in the 14 to 16 range and his PSA has been persistently elevated.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for magnetic resonance imaging (MRI). Findings:  The physician reviewer found that there is currently considerable debate about how best to screen for prostate cancer.  The fact that this patients PSA level is stable does not rule out prostate cancer. Prostate cancer is notoriously slow growing, and the lack of progressive elevation does not exclude a malignancy. In general, PSA levels under 4 are not considered abnormal, whereas levels over 4 are regarded as suspicious.  This patient has a PSA level in the 14 to 16 range and his PSA has been persistently elevated. There are many options for therapy (radical prostatectomy, observation and monitoring, brachytherapy, external bean radiation), with no single therapy clearly advantageous, and all therapies having significant risks of complication. Accordingly, MRI has become a common imaging procedure to better evaluate the prostate. The American College of Radiology (ACR) provides recommendations to help guide clinicians as to the most efficient and efficacious means to evaluate various clinical entities. In their publication concerning patients who are clinically suspected with prostate cancer and who has had a prior negative transrectal ultrasonography-guided biopsy, MRI is felt to be the most appropriate study to perform. They found that MRI is a useful adjunct for tumor localization in biopsy negative patients, as in this patients case. A study concurs with the ACR assessment, MRUS fusion biopsy provides improved detection of PCa in men with prior negative biopsies and elevated PSA values. Most cancers found were clinically significant.  This patient fits the ACR criteria and the medical literature. All told, MRI is medically necessary for the evaluation of this patients medical condition. Final Result: The reviewer determined that the requested services are medically necessary for evaluation of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in diagnostic radiology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Monovisc injection to the right knee for treatment of the enrollees knee pain.

Answer: This patient presents with chronic right knee pain with associated stiffness, swelling and weakness. Functional limitations were documented with stairs and prolonged sitting. Clinical examination findings were consistent with the diagnosis of medial compartment osteoarthritis. He has not obtained significant symptom relief with prior conservative treatment, including medications, activity modification, and physical therapy. The records noted that prior viscosupplementation injections had provided significant sustained relief. It was also noted that he was attempting to delay knee replacement surgery given his young age.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Monovisc injection to the right knee for treatment of the enrollees knee pain. Findings: The physician reviewer found there is sufficient support for the requested services in this clinical setting. This patient presents with chronic right knee pain with associated stiffness, swelling and weakness. Functional limitations were documented with stairs and prolonged sitting. Clinical examination findings were consistent with the diagnosis of medial compartment osteoarthritis. He has not obtained significant symptom relief with prior conservative treatment, including medications, activity modification, and physical therapy. The records noted that prior viscosupplementation injections had provided significant sustained relief. It was also noted that he was attempting to delay knee replacement surgery given his young age. The peer-reviewed literature supports the use of viscosupplementation injections for the treatment of pain in patients with osteoarthritis of the knee. Repeat viscosupplementation injections have been found to be safe and effective and allow for delay of knee replacement surgery. Therefore, the requested Monovisc injection to the right knee is medically necessary for the treatment of this patient.Final Result: The reviewer determined that the requested services are medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Danmar soft shell helmet for treatment of the enrollees seizure disorder.

Answer: In the past, the patient has tolerated a Danmar helmet well with reported reduction of head traumas during seizures.

Answer: The patient requires protection from potential risk of head trauma when her seizures occur.

Context: Nature of Statutory Criteria/Case Summary:An enrollee has requested authorization and coverage for Danmar soft shell helmet for treatment of the enrollees seizure disorder. Findings:  The physician reviewer found that the submitted documentation as well as the medical literature provide support for the requested equipment in this patients case. There is medical literature that documents the association between seizures and head injuries. Head trauma is a common occurrence in patients with intractable epilepsy.  The ramifications of this event can be reduced through the use of a helmet.  In this case, compliance and use of a standard bike helmet would be limited given the patients baseline strength. In the past, the patient has tolerated a Danmar helmet well with reported reduction of head traumas during seizures. To this end, it is reasonable for this patient to continue to use this type of helmet. The patient requires protection from potential risk of head trauma when her seizures occur. For these reasons, Danmar soft shell helmet is medically necessary for this patient. Final Result: The reviewer determined that the requested equipment is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in neurology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: The patient has requested authorization and coverage for hyaluronan (Orthovisc) injections in the left knee for treatment of the enrollees knee pain.

Answer: it is documented the patient has been treated with physical therapy, braces, Norco, and underwent corticosteroid injections.

Answer: the patient is not a reasonable candidate for repeat corticosteroid injections so close to the time of planned revision right knee arthroplasty which might increase risk of periprosthetic joint infection. Previously, the patient has experienced success with viscosupplementation.

Context: Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for hyaluronan (Orthovisc) injections in the left knee for treatment of the enrollees knee pain. Findings: The physician reviewer found that there is adequate evidence that intraarticular hyaluronic acid injections reduce pain and increase function in knee osteoarthritis, and the benefits are long-lasting as compared with intraarticular corticosteroids. Maheu and colleagues conducted a systematic review of overlapping meta-analyses comparing viscosupplementation with other non-operative treatment modalities for knee osteoarthritis. The authors reported that the current highest level of evidence suggests that intraarticular hyaluronic acid is a viable option for patients with knee osteoarthritis which results in improvements in knee pain and function that can persist for up to 26 weeks. Viscosupplementation has a good safety profile, and its use should be considered in patients with knee osteoarthritis. In this case, it is documented the patient has been treated with physical therapy, braces, Norco, and underwent corticosteroid injections. Moreover, the patient is not a reasonable candidate for repeat corticosteroid injections so close to the time of planned revision right knee arthroplasty which might increase risk of periprosthetic joint infection. Previously, the patient has experienced success with viscosupplementation. For these reasons, the requested hyaluronan (Orthovisc) injections in the left knee is supported as medically necessary for treatment of this patients medical condition. Final Result: The reviewer determined that the requested service is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in orthopedic surgery and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Vemlidy 25 mg tablets.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Vemlidy 25 mg tablets. Findings:  The physician reviewer found that : Guidelines for the treatment of hepatitis B from the American Association for the Study of Liver Disease (AASLD) recommend entecavir and tenofovir (Viread and Vemlidy) compared to the alternatives for the treatment of chronic hepatitis B. In comparison with tenofovir disoproxil fumarate (Viread), which the patient takes, the Vemlidy formulation of tenofovir is effective for hepatitis B, but is associated with fewer side effects, including decreased risk of osteopenia and renal disease. For this reason, the request for Vemlidy is medically necessary for the treatment of this patients chronic hepatitis B.Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for compound medication (progesterone micronized 100% powder)

Answer: In this case, the patient was of an advanced maternal age and attempted pregnancy via embryo transfer.

Answer: In this patients case, the provider recommended micronized progesterone suppositories, and there are no prescription suppositories currently manufactured by a pharmaceutical company.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for compound medication (progesterone micronized 100% powder) provided Findings:  The physician reviewer found that the physician reviewer found that progesterone supplementation is routinely used in assisted reproduction to increase pregnancy success rates.  In this case, the patient was of an advanced maternal age and attempted pregnancy via embryo transfer. As noted by a study, there is little doubt that endometrial receptivity plays a major role in the success or failure of embryo implantation after in vitro fertilization (IVF). To optimize endometrial receptivity, it is common practice to administer a progesterone supplement during the luteal phase. Thus, treating this patient with micronized progesterone was medically appropriate. In this patients case, the provider recommended micronized progesterone suppositories, and there are no prescription suppositories currently manufactured by a pharmaceutical company.  The medical evidence supports the medication at issue in this clinical setting. All told, compound medication (progesterone micronized 100% powder) provided during the dates of dispute was medically necessary for the treatment of this patient.Final Result: The reviewer determined that the medication at issue was medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in obstetrics and gynecology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for emergency medical services.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for emergency medical services. Findings:  The physician reviewer found that the medical services provided were not necessary for treatment of an emergency medical condition. The documentation submitted for review does not demonstrate evidence of an emergency medical condition. The medical records provided for review, fail to show past medical history addressing a mechanism of injury leading to the reported acute presentation or evidence of chronicity. In addition, there is no documentation of imaging to rule out underlying injury/pathology that would lead to the reported emergency presentation. Therefore, the services provided are not considered emergency medical services. Thus, the patient did not receive emergency medical services on the date of service at issue. Final Result: The reviewer determined that the patient did not receive emergency medical services on the date of service at issue. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in oriental medicine and chiropractic medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: The parent of an enrollee has requested reimbursement for the gene panel testing.

Context: Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested reimbursement for the gene panel testing. Findings:  The physician reviewer found that the gene panel testing performed was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Genotype testing for genetic polymorphisms to determine psychotropic drug metabolizer status holds promise for improving the treatment of individuals with autism spectrum disorder who could benefit from pharmacotherapy. However, at present time there are insufficient controlled, adequately powered published studies to support its general adaptation . Variables such as age, sex, precision of diagnosis and environmental influences have not been addressed in currently available published studies. For the reasons provided, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Final Result: All three of the reviewers determined that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers 1,2 & 3 are board certified in pediatrics and neurology with special qualification in child neurology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for Botox.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Botox. Findings:  The physician reviewer found that The Botox provided was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Although trials evaluating the effect of intrapyloric Botox injection on gastroparesis have been reported, there is no definitive agreement whether Botox can effectively relieve the symptoms and improve the results of gastric emptying study in patients with gastroparesis. Bai and colleagues performed a systemic review on intrapyloric Botox injection for gastroparesis. The authors concluded that there is no evidence to recommend Botox injection for the treatment of gastroparesis. Moreover, the American College of Gastroenterology clinical guideline on the management of gastroparesis states Second-line approaches include venting gastrostomy or feeding jejunostomy; intrapyloric botulinum toxin injection was not effective in randomized controlled trials. All told, the service at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Final Result: All three of the reviewers determined that the service at issue was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers are board certified in internal medicine with sub-specialty certification in gastroenterology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: The enrollee has requested reimbursement for residential treatment services for treatment of the enrollees substance abuse.

Answer: the patient was not in withdrawals as she had only used once and did not require detoxification. She was not a danger to herself or others and she was not gravely disabled.

Answer: She was not psychotic or manic and she was medically and psychiatrically stable.

Answer: She was cooperative and participated in her treatment plan. She had multiple prior treatments

Context: Nature of Statutory Criteria/Case Summary: The enrollee has requested reimbursement for residential treatment services for treatment of the enrollees substance abuse. Findings:  The physician reviewer found that the patient was not in withdrawals as she had only used once and did not require detoxification. She was not a danger to herself or others and she was not gravely disabled. There were no emotional, behavioral, cognitive, or impulsive symptoms that would warrant treatment at the residential treatment center (RTC) level of care. She was not psychotic or manic and she was medically and psychiatrically stable. Her medication regimen could have been managed in an ambulatory setting. She was cooperative and participated in her treatment plan. She had multiple prior treatments and therefore had a base of knowledge from which to continue to build her relapse prevention plan. Her difficulties with abuse and relapse were chronic in nature and did not require 24-hour monitoring in the absence of unstable medical or psychiatric conditions. She could have safely been treated in an ambulatory level of care, with the assistance of medically assisted treatment such as suboxone for opiate use disorder if deemed appropriate by her provider. Final Result: The reviewer determined that the services at issue were not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in psychiatry with sub-specialty certification in addiction psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: The parent of an enrollee has requested authorization and coverage for 16 hours per week of applied behavioral analysis (ABA) services.

Answer: The records submitted for review document that the patient has autism spectrum disorder and has received ABA therapy for five years . The patients ABA service provider has recommended parent training due to the barriers to the implementation of direct intervention services.

Context: Nature of Statutory Criteria/Case Summary: The parent of an enrollee has requested authorization and coverage for 16 hours per week of applied behavioral analysis (ABA) services. Findings:  The physician reviewer found that the request for ABA therapy is not medically necessary for treatment of the patients medical condition. The records submitted for review document that the patient has autism spectrum disorder and has received ABA therapy for five years . The patients ABA service provider has recommended parent training due to the barriers to the implementation of direct intervention services. The providers recommendation for caregiver training to occur prior to consideration of re-introduction of direct intervention services is medically reasonable and appropriate in this clinical setting. As such, the request for 16 hours per week of ABA services is not clinically indicated for this patient.  Final Result: The reviewer determined that the requested services are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld.Credentials/Qualifications: The reviewer is board certified in pediatrics with sub-specialty certification in developmental-behavioral pediatrics and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement and prospective authorization and coverage for residential treatment center services for treatment of the enrollees behavioral health condition.

Answer: the patients abuse of opiates, benzodiazepines and cannabinoids use was impairing his daily routine and contributed to significant impairment across multiple domains of functionality. The patient was unable to sustain employment and lost his apartment.  His motor vehicle license had been revoked due to substance use.  He was prescribed psychotropic medications including an atypical antipsychotic. This patient had reportedly tried buprenorphine prior to the episode of care, although the documentation did not specify if it was obtained illicitly or by prescription. Upon presentation, the patient was malnourished, circumstantial, anxious, agitated and depressed.  He endorsed symptoms consistent with a withdrawal syndrome.

Answer: However, the patient had positive support from this patients family and a recent three and half year history of sobriety. The patient also has prior success with community programming.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for residential treatment center services for treatment of the enrollees behavioral health condition. Findings:  The physician reviewer found that the patients abuse of opiates, benzodiazepines and cannabinoids use was impairing his daily routine and contributed to significant impairment across multiple domains of functionality. The patient was unable to sustain employment and lost his apartment.  His motor vehicle license had been revoked due to substance use.  He was prescribed psychotropic medications including an atypical antipsychotic. This patient had reportedly tried buprenorphine prior to the episode of care, although the documentation did not specify if it was obtained illicitly or by prescription. Upon presentation, the patient was malnourished, circumstantial, anxious, agitated and depressed.  He endorsed symptoms consistent with a withdrawal syndrome.  Finally, despite outpatient services and a brief residential stay during the episode of illness, the patient was unable to maintain sobriety in his environment.  The patient was clinically unstable and had not consolidated the treatment gains necessary to succeed in the outpatient setting and promptly would have relapsed in a community based setting if he was not admitted that day. However, the patient had positive support from this patients family and a recent three and half year history of sobriety. The patient also has prior success with community programming. The documentation supports that 2 weeks of services were medically necessary.  The two weeks of treatment would have been reasonably expected to improve this patients condition and prevent a more serious episode of illness while fulfilling the initial projected length of stay and providing a total of four weeks of residential treatment, which would be a duration of care consistent with community standards. For these reasons, a portion of the residential treatment center services was medically necessary for treatment of this patients medical condition. Specifically, the residential treatment center services for 2 weeks were medically necessary, but not thereafter. Final Result: The reviewer determined that the services at issue was medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned. Credentials/Qualifications: The reviewer is board certified in psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement and prospective authorization and coverage for skilled nursing care provided.

Answer: According to the documentation submitted for review, the patient has function deficits due to a brain tumor (glioblastoma).

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for skilled nursing care provided. Findings:  The physician reviewer found that skilled nursing care provided was not and is not medically necessary for treatment of the patients medical condition. According to the documentation submitted for review, the patient has function deficits due to a brain tumor (glioblastoma). There is a lack of peer-reviewed literature supporting rehabilitation in this clinical setting. Roberts and colleagues studied intensive rehabilitation for glioblastoma, finding that there was functional benefit but not survival benefit. In this case, the patient has received an adequate trial of skilled nursing care level of care without functional benefit. Thus, the medical documentation provided does not support the medical necessity for continued skilled nursing level of care.Final Result: The reviewer determined that the services at issue were not and are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in physical medicine and rehabilitation and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Divigel 1 mg/gram (0.1%) gel packet for treatment of the enrollees menopausal symptoms.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Divigel 1 mg/gram (0.1%) gel packet for treatment of the enrollees menopausal symptoms.  Findings:  The physician reviewer found that according to a study, Once a decision has been made to treat a postmenopausal woman with estrogen, consideration should be given to the type of estrogen and the route by which it is to be given, as well as the need for progestin and the most appropriate progestin regimen. Estrogen is available in many forms: oral, transdermal, topical gels and lotions. The potency and therefore the doses of these estrogen preparations differ, but they differ little in efficacy. The documentation provided for review does not show that the patient has tried any of the Health Plans formulary alternatives. In addition, various patches may use different adhesives, so one might be tolerated when another was not. An oral option eliminate the possibility of skin reactions. Final Result: The reviewer determined that the requested medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in obstetrics and gynecology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage of Epclusa for 12 weeks for treatment of the enrollees hepatitis C virus.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage of Epclusa for 12 weeks for treatment of the enrollees hepatitis C virus.Findings:  The physician reviewer found that according to joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with life expectancy less than 12 months due to non-liver-related conditions. This applies regardless of fibrosis stage, and advanced fibrosis is not required for treatment. Per the guidelines, Epclusa is recommended as first line therapy for treatment naive genotype 2 patients, based on clinical trials including ASTRAL-1 and ASTRAL-2, which showed a 99% cure rate and superiority to Sovaldi with ribavirin. Final Result: The reviewer determined that the requested medication regimen is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for the residential treatment center (RTC) level of care services for treatment of the enrollees opiate use disorder.

Answer: this patients post-acute withdrawal symptoms were not described other than his cravings and moods.

Answer: He continuously expressed that he lacked interest in pursuing sobriety and relapse prevention. He was discharged on Suboxone

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the residential treatment center (RTC) level of care services for treatment of the enrollees opiate use disorder. Findings:  The physician reviewer found that this patients post-acute withdrawal symptoms were not described other than his cravings and moods. There was no evidence that he was a danger to self or others. He was cognitively intact, and his level of emotional and behavioral issues were not severe enough to warrant ongoing RTC services. He demonstrated inappropriate behavior in group therapy. However, he was not manic, psychotic, or agitated. He was medically stable. He continuously expressed that he lacked interest in pursuing sobriety and relapse prevention. He was discharged on Suboxone, of which the management did not require the RTC setting. Given the patients lack of motivation and distinct, well-defined, and verbalized intent to resume drinking and use cannabis, the RTC services were not medically necessary for treatment of the patients medical condition. Final Result: The reviewer determined that the services at issue were not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in psychiatry with sub-specialty certification in addiction medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement and prospective authorization and coverage for partial hospitalization program (PHP) services provided for treatment of the enrollees behavioral health condition.

Answer: The patient has a history of three suicide attempts. She attempted to overdose on beta blockers and slit her wrists. All these attempts were made when the patient was intoxicated. When the patient is sober, she does not have suicidal ideation and loves life and wants to live. As the patient was sober and did not have any suicidal ideation or homicidal ideation.

Answer: When the patient has relapsed from sobriety, she is unable to work and has to take time off to recover. The patient is currently employed. The patients recent gains in sobriety have been achieved while participating in treatment in structured settings.

Answer: The patient has a significant co-morbidity of alcohol use disorder, anxiety, and depression. The patient also has a history of pancreatitis and cirrhosis of her liver. The patient has a history of utilizing alcohol despite negative consequences. The patient has a history of driving under the influence and was recently cited for public intoxication.

Answer: The patient is financially stable and has family and friends that are supportive.

Answer: The patient has supportive family and friends.

Answer: Previous treatment had allowed the patient to obtain six months of sobriety.

Answer: The patient is cooperative and compliant with treatment. The patient is noted to be highly motivated for sobriety.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for partial hospitalization program (PHP) services provided for treatment of the enrollees behavioral health condition. Based on the Level of Care Utilization System (LOCUS) criteria,  the patient met criteria for treatment in a less restrictive environment. The patients risk of harm score is three (3), moderate risk of harm. The patient has a history of three suicide attempts. She attempted to overdose on beta blockers and slit her wrists. All these attempts were made when the patient was intoxicated. When the patient is sober, she does not have suicidal ideation and loves life and wants to live. As the patient was sober and did not have any suicidal ideation or homicidal ideation. The patients functional status score is three (3), moderate impairment, When the patient has relapsed from sobriety, she is unable to work and has to take time off to recover. The patient is currently employed. The patients recent gains in sobriety have been achieved while participating in treatment in structured settings. The patients medical, addictive and psychiatric co-morbidity score is three (3), significant co-morbidity. The patient has a significant co-morbidity of alcohol use disorder, anxiety, and depression. The patient also has a history of pancreatitis and cirrhosis of her liver. The patient has a history of utilizing alcohol despite negative consequences. The patient has a history of driving under the influence and was recently cited for public intoxication. The patients recovery environment score is two (2), mildly stressful environment. The patient is financially stable and has family and friends that are supportive. The patients level of support score is two (2), supportive environment. The patient has supportive family and friends. The patients treatment history score is three (3), equivocal response to treatment and recovery. Previous treatment had allowed the patient to obtain six months of sobriety. The patients engagement and recovery status score is two (2), positive engagement and recovery. The patient is cooperative and compliant with treatment. The patient is noted to be highly motivated for sobriety. Based on these criteria, the patient has a total score of 18, which would meet criteria for treatment in a less restrictive environment, such as an intensive outpatient program (IOP). Although the patient continues to need treatment for her alcohol use disorder, the patient improved enough to be treated in a less restrictive environment. Therefore, the PHP services provided was not and is not medically necessary for treatment of the patients medical condition. Final Result: The reviewer determined that the services at issue were not and are not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: The reviewer is board certified in psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for the genomic analysis for evaluation of the enrollees recurrent breast cancer.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for the genomic analysis for evaluation of the enrollees recurrent breast cancer. Findings:  2/3 of the physician reviewers found that there is a lack of support in the medical literature for the services at issue in this clinical setting. FoundationOne is a molecular assay that explores the mutations of an individuals cancer cells. The hope is that the assay will identify a specific mutation or target, which could inform the clinician as to which chemotherapeutic drug would be useful. However, there is a lack of convincing evidence that the assay adds to the decision making ability of the clinician, nor yields a result that is reliably clinically beneficial. There are a variety of nonrandomized studies exploring the value of molecular profiling but none of which have been convincing as to the efficacy of these analyses. While colleagues noted these ongoing studies, they also expressed serious limitations of such studies. This viewpoint was also expressed in an editorial by West in 2016. Moreover, a randomized trial by colleagues did not demonstrate a significant clinical benefit from choosing therapy based on molecular targets versus the oncologists clinical judgment. Finding a mutation does not guarantee that a treatment directed at the mutation will produce a clinically meaningful response. In this patients case, the decision was to proceed with advanced hormonal therapy, which was not based on the FoundationOne assay. Therefore, the genomic analysis provided was not likely to have been superior over the standard options available for the evaluation of this patients medical condition. Final Result: 2/3 of the reviewers determined that the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement and prospective authorization and coverage for residential treatment center (RTC) level of care services for treatment of the enrollees polysubstance abuse.

Answer: the patient was admitted in active withdrawal with an elevated COWS score

Answer: Although not suicidal, homicidal, or self-harming, she rated depression and anxiety as 10, and isolation as five to six

Answer: The patients self-care was lacking in her disheveled presentation and reported high levels of stress.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for residential treatment center (RTC) level of care services for treatment of the enrollees polysubstance abuse. Findings:  The physician reviewer found that the patient was admitted in active withdrawal with an elevated COWS score, which warranted admission. Although not suicidal, homicidal, or self-harming, she rated depression and anxiety as 10, and isolation as five to six, which also supported admission. The patients self-care was lacking in her disheveled presentation and reported high levels of stress. Thus, RTC was the best treatment option and was medically necessary. Treatment during these dates would afford the patient an opportunity to become more physically comfortable with less intense withdrawals, and increase the chances of compliance with medically assisted treatment with Subutex at a less restrictive level of care. However, RTC services after were not and are not medically necessary. For these reasons, RTC level of care services provided were medically necessary, but not thereafter. Final Result: The reviewer determined that a portion of the services at issue were medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned. Credentials/Qualifications: The reviewer is board certified in psychiatry with sub-specialty certification in child and addiction medicine and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for individual weekly psychotherapy for treatment of the enrollees depression and trauma.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for individual weekly psychotherapy for treatment of the enrollees depression and trauma. Findings:  The physician reviewer found that effective psychotherapy is a trusted intervention in the treatment armamentarium for patients afflicted with major depressive disorder. Current practice is focused on aggressive treatment of depression, particularly in the acute phase of the illness in which multiple sessions per week may be indicated, followed by less frequent services in the maintenance phase to foster patient autonomy and recovery. Individual psychotherapy is a standard treatment intervention of major depressive disorder, and a brief course of individual psychotherapy is warranted in this patients case. Such treatment could help build a therapeutic rapport by capitalizing on the principles of patient centricity, prepare the patient for a transition to the group setting and/or community programming, and facilitate additional evaluation for consideration of other treatments, such as cognitive behavioral therapy for pain, trauma-focused therapy or dialectical behavioral therapy. The American Psychiatric Association (APA) suggests that time-limited brief psychotherapies may mobilize many depressed patients to more rapid improvement. In addition, the provider should carefully and systematically monitor the patients response to treatment, which can be facilitated by the use of provider and patient rated scales at regular intervals. If eight weeks of treatment does not yield at least moderate improvement with 20% or greater diminution in symptoms, the provider should thoroughly review and reappraise the treatment plan. As such, a course of eight individual therapy appointments delivered once a week over a span of eight weeks with systematic monitoring and re-assessment of the patients clinical needs upon conclusion of the treatment episode would be safe, appropriate and reasonably expected to improve the patients condition and prevent a more serious episode of illness. Accordingly, a portion of the requested services are supported as medically necessary for treatment of this patients medical condition. Final Result: The reviewer determined that a portion of the requested services is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned. Credentials/Qualifications: The reviewer is board certified in psychiatry and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Zepatier 50/100 mg for treatment of the enrollees hepatitis C infection.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Zepatier 50/100 mg for treatment of the enrollees hepatitis C infection. Findings:  The physician reviewer found that According to the recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated (except those with limited life expectancy due to non-liver-related conditions). This recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment naive genotype 1b patients should be treated with regimens including or Zepatier for 12 weeks, based on clinical trial results showing a 99% cure rate regardless of NS5A resistance. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment. For these reasons, treatment with Zepatier 50/100 mg is medically necessary for the treatment of this patients hepatitis C infection.  Final Result: The reviewer determined that the requested medication is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested reimbursement for his Oncotype Dx Prostate Cancer Assay.

Answer: This patients prostate cancer was not newly diagnosed and the initial Oncotype was done in 2013.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for his Oncotype Dx Prostate Cancer Assay.  Findings:  Three physician reviewers found that while the Oncotype Dx Prostate Cancer Assay has the propensity to determine the risk of recurrence and sometimes change therapeutic intervention based on risk, there is currently a lack of well designed, controlled clinical trials to demonstrate an improvement in health outcomes based on its use.  The National Comprehensive Cancer Network guidelines lists Oncotype Dx for patients post biopsy for patients with very low risk and low risk prostate cancer who did not receive therapy and are candidates for surveillance or active therapy with a life expectancy of 10 years. This patients prostate cancer was not newly diagnosed and the initial Oncotype was done in 2013. This patients progression of the Gleason score over a period of three years from 6 to 7 was enough to demonstrate progression. Thus, the Oncotype Dx Prostate Cancer Assay provided did not add any additional information not provided by the clinical situation and was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Final Result: The reviewers determined that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: All three reviewers are board certified in internal medicine with sub-specialty certification in medical oncology and is actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for WalkAide for treatment of the enrollee, who has history of right foot drop, functional gait disorder, and pressure ulcer of the right foot.

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for WalkAide for treatment of the enrollee, who has history of right foot drop, functional gait disorder, and pressure ulcer of the right foot. Findings: Three physician reviewers found that the requested equipment is documented extensively in the medical literature as beneficial for central nervous system neurological injuries but not for peripheral nervous system pathology. While the provider stated that WalkAide will provide dorsiflexion assistance in this patients case, the current studies are lacking.  There is a lack of peer reviewed literature to support a rationale or mechanism by which the requested treatment would be effective or operational for a peripheral nervous system lesion as described in this patients case.  In sum, WalkAide is not likely to be more beneficial than the standard treatment options for this patient.Final Result: The three reviewers determined that the requested equipment is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.  Credentials/Qualifications: All three physician reviewers are board certified in physical medicine and rehabilitation and are actively practicing. The reviewer are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested LINX procedure (CPT code 0392T, laparoscopic anti-reflux surgery)for treatment of his gastroesophageal reflux disease (GERD).

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested LINX procedure (CPT code 0392T, laparoscopic anti-reflux surgery)for treatment of his gastroesophageal reflux disease (GERD). Findings:  Two physician reviewers found that the LINX device received U.S. Food and Drug Administration (FDA) premarketing approval for four years, effective 3/22/12. The approved indication was for patients with diagnosed GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal medical therapy for the treatment of reflux. As noted by in a study, sphincter augmentation with the LINX Reflux Management System provided long-term clinical benefits as demonstrated by reduced esophageal acid exposure, improved GERD-related quality of life, and cessation of dependence on PPIs, with minimal side effects. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation. This patients records support a diagnosis of GERD based on pH recording off PPI therapy, and per charted comments he has not optimally benefited from acid suppression treatment. Although symptomatic for many years, significantly he has not developed endoscopic evidence of esophagitis. From a symptomatic perspective, the patient may be considered medically refractory to acid blocker drugs. However, implantation of LINX in this patients clinical setting places him at significant risk for dysphagia post-LINX implantation given his known esophageal dysmotility. Final Result: The reviewers determined that the requested procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Reviewer 1, 2 and 3 are board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?


Answer: An enrollee has requested authorization and coverage for Epclusa 400-100 mg tablets for 12 weeks for treatment of the enrollees hepatitis C

Context: Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa 400-100 mg tablets for 12 weeks for treatment of the enrollees hepatitis C. Findings:  The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines recommend that all patients should be treated, regardless of fibrosis stage. The medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C, genotype 1 infection regardless of fibrosis stage. The guidelines recommend several medications, but Epclusa is the most appropriate therapy in this case based on NS5A resistance testing. AASLD/IDSA guidelines cite data showing reduced survival with delayed treatment.  Final Result: The reviewers determined that the requested medication regimen is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: The reviewer number is a board certified in internal medicine with sub-specialty certification in gastroenterology and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.

Question: What is the background context in this case summary?