Answer: A 35-year-old female has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 9/15/16 through 4/17/17.  The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees major depressive disorder.

Context:
Summary Reviewer 1

A 35-year-old female has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 9/15/16 through 4/17/17.  The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees major depressive disorder. The physician reviewer found that on the information provided, it appears that the TMS is being used for maintenance or continuation purposes, which is consistent with an investigational application.  A typical course of TMS consists of 30 to 40 sessions spanning four to six weeks.  For patients who respond well to TMS, clinical improvement is usually maintained with psychotherapy and psychotropic medication.  Although small studies are demonstrating good tolerability and clinical efficacy of TMS therapy for treatment courses lasting years at a time, according to the summary of TMS treatment recommendations authored by Perera and colleagues, The standard parameter setprovided clinical benefit in treatment courses up to six weeks in duration. Controlled studies of longer duration, acute treatment courses or using alternative treatment parameters are not established.  In other words, at this time there is a lack of well-designed and adequately-powered controlled studies showing the benefit of longer courses of TMS therapy.  Therefore, the superior efficacy of maintenance TMS therapy as compared to other available standard therapy, such as ongoing pharmacotherapy, psychotherapy and electroconvulsive therapy, has not been established.  Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 35-year-old female has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 9/15/16 through 4/17/17.  The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees major depressive disorder.

Answer: this patient received 36 treatments prior to the Health Insurers denial.

Answer: in this case, the patient did show an initial response to TMS treatment.   The records indicate that the patients symptoms had improved during the initial TMS treatment period.

Context:
Summary Reviewer 3

A 35-year-old female has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation provided from 9/15/16 through 4/17/17.  The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees major depressive disorder. The physician reviewer found this patient received 36 treatments prior to the Health Insurers denial.  At this time, the literature on TMS is not clear on whether maintenance treatment is an evidence-based treatment.  The literature indicates that continued treatment can and should occur if an initial response to TMS is not apparent.  However, in this case, the patient did show an initial response to TMS treatment.   The records indicate that the patients symptoms had improved during the initial TMS treatment period.  Since the patient showed benefit from acute/initial TMS treatments and given the lack of evidence for maintenance TMS treatments, the superior effectiveness of the services at issue has not been established.  Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 32-year-old female enrollee has requested authorization and coverage for Enbrel. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees ankylosing spondylitis.

Answer: the patient does not have systematic lupus erythematosus, rather she carries a low titer double stranded deoxyribonucleic acid (dsdna) antibody which is being monitored.

Context:
Summary Reviewer 2

A 32-year-old female enrollee has requested authorization and coverage for Enbrel. The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees ankylosing spondylitis. The physician reviewer found that Enbrel is appropriate for this patients diagnosis of ankylosing spondylitis. However, if the patient does have systematic lupus erythematosus, than it is not suggested to use Enbrel or other anti-tumor necrosis factor (TNF) agents as these drugs can trigger lupus. Given the presentation in the records, the patient does not have systematic lupus erythematosus, rather she carries a low titer double stranded deoxyribonucleic acid (dsdna) antibody which is being monitored. Thus, the requested Enbrel is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 54-year-old female enrollee has requested reimbursement for the shingles vaccine performed on 2/06/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of rheumatoid arthritis.

Answer: In this case, the patient has multiple skin conditions including lichen planus, herpes simplex virus, and atopy, and she has been diagnosed with rheumatoid arthritis.

Context:
Summary Reviewer 2

A 54-year-old female enrollee has requested reimbursement for the shingles vaccine performed on 2/06/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has a history of rheumatoid arthritis. The physician reviewer found the varicella-zoster virus causes two clinically distinct forms of infection.  Herpes zoster is related to reactivation of varicella-zoster virus infection and is characterized by a painful, unilateral vesicular eruption in a dermatomal distribution. The herpes zoster vaccination can decrease the risk of developing herpes zoster and post-herpetic neuralgia associated with infection.  The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of all patients 60 years of age or older, including patients who report a previous episode of zoster and patients with chronic medical conditions (such as chronic renal failure, diabetes mellitus, rheumatoid arthritis, chronic pulmonary disease), unless those conditions are contraindications. In clinical practice, the vaccine is recommended for patients between 50 and 59 who are receiving low-level immunosuppressive therapy or are expected to receive high-level immunosuppressive therapy or for patients that would have difficulty tolerating a zoster infection. In this case, the patient has multiple skin conditions including lichen planus, herpes simplex virus, and atopy, and she has been diagnosed with rheumatoid arthritis. Rheumatoid arthritis is treated with immunosuppressive medications that would leave the patient vulnerable to infections. Given this patients rheumatoid arthritis and skin conditions, it was appropriate to vaccinate this patient. Therefore, the shingles vaccine performed on 2/06/17 was likely to have been of greater benefit than other treatment options. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 22-year-old male enrollee has requested reimbursement for (81229) cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities on 3/16/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health condition.

Context:
Summary Reviewer 2

A 22-year-old male enrollee has requested reimbursement for (81229) cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and single nucleotide polymorphism (SNP) variants for chromosomal abnormalities on 3/16/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found that there is a lack of evidence based literature that show the efficacy of genetic testing in evaluating patients  diagnosed with bipolar disorders or ADHD. There is very limited clinical justification, based on substantial medical research, to endorse genetic screening tests prior to attempting another medication for treatment of ADHD, bipolar disorder, or personality disorders.  Specifically, the standard of care for treatment of these disorders would be to continue to trial or prescribe stimulant medication. This method of prescribing medication would produce similar outcomes when compared to awaiting genetic testing results in this patients case.  In sum, cytogenomic constitutional (genome-wide) microarray analysis; interrogation of genomic regions for copy number and SNP variants for chromosomal abnormalities administered on 3/16/16 were not likely to have been more effective than the standard options available for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: The patient is a 28-year-old female with a history of severe persistent eosinophilic asthma. She has requested authorization and coverage for Fasenra Pen.

Answer: The submitted documentation indicates that the patient has severe persistent asthma and has required several courses of oral steroids for uncontrolled asthma symptoms. The patient has been using Symbicort and Breztri, and she continues to have episodes of asthma flare-ups. Her blood eosinophil count in end of August 2021 was greater than 150 cell/ml. The provider attested that she will continue to use inhaled corticosteroids Symbicort in conjunction with Fasenra therapy.

Context:
Summary Reviewer

The patient is a 28-year-old female with a history of severe persistent eosinophilic asthma. She has requested authorization and coverage for Fasenra Pen. The physician reviewer found that Benralizumab (Fasenra) is a cytotoxic monoclonal antibody directed against IL-5 receptor alpha that is approved by the U.S. Food and Drug Administration (FDA) as add-on therapy in patients with severe asthma and an eosinophilic phenotype. The submitted documentation indicates that the patient has severe persistent asthma and has required several courses of oral steroids for uncontrolled asthma symptoms. The patient has been using Symbicort and Breztri, and she continues to have episodes of asthma flare-ups. Her blood eosinophil count in end of August 2021 was greater than 150 cell/ml. The provider attested that she will continue to use inhaled corticosteroids Symbicort in conjunction with Fasenra therapy. There is sufficient support for the requested medication in this clinical setting. Therefore, the requested Fasenra Pen is medically necessary for the treatment of this patient.

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


Answer: A 25-year-old male enrollee has requested reimbursement for substance abuse residential treatment services provided from 7/22/17 through 8/3/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance and alcohol abuse.

Answer: the patients post-acute withdrawal symptoms were not severe in nature. He was not a danger to himself or others, nor was he aggressive.

Answer: He was motivated and working the program. He was cooperative and participating in his treatment plan.

Answer: the patient continued to require further treatment to develop and solidify coping skills

Context:
Summary Reviewer

A 25-year-old male enrollee has requested reimbursement for substance abuse residential treatment services provided from 7/22/17 through 8/3/17. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees polysubstance and alcohol abuse. The physician reviewer found that the patients post-acute withdrawal symptoms were not severe in nature. He was not a danger to himself or others, nor was he aggressive. There were no emotional, behavioral, cognitive, or impulsive symptoms that would warrant residential level of care. He had no comorbid medical conditions and he was psychiatrically stable. His medications could have been managed in an ambulatory setting. There was no evidence of a high degree of impulsivity, agitation, depression, mania, hallucinations, or any other significant symptom that would interfere with his care. He was motivated and working the program. He was cooperative and participating in his treatment plan. Although the patient continued to require further treatment to develop and solidify coping skills, this did not require the residential structure. No new problems had arisen and there was no evidence to indicate that returning him to his environment would lead to destabilization. Thus, as of 7/22/17, the patient no longer met the criteria for residential level of care. Accordingly, the substance abuse residential treatment services provided from 7/22/17 through 8/3/17 were not medically necessary for treatment of the patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition.

Answer: in this case, the patient has already been treated with eight different antidepressants, with at least three different pharmacodynamic strategies, and has not had a good response.

Context:
Summary Reviewer 1

A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The medical literature suggests that continued research is still necessary to develop clear guidelines for the usage of pharmacogenetics testing. Therefore, pharmacogenetics testing is not considered the standard treatment. However, in this case, the patient has already been treated with eight different antidepressants, with at least three different pharmacodynamic strategies, and has not had a good response. Given that she has failed the standard treatments that are available, the pharmacogenetics testing was medically reasonable in this clinical setting. The genetic testing has the potential to guide the providers decisions to medications that will be better tolerated and more effective. Therefore, the gene testing performed on 8/11/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition.

Context:
Summary Reviewer 3

A 32-year-old female enrollee has requested reimbursement for the gene testing performed on 8/11/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees behavioral health condition. The physician reviewer found that despite its promise, pharmacogenetics is not yet ready for mainstream clinical application. The American Psychiatric Association (APA) does not endorse such testing in its current clinical practice guidelines. In this case, the documentation submitted for review failed to show the patients longitudinal illness burden and extent of impairment at the time of testing, including family history, psychosocial stressors, substance use disorders and medical comorbidities. In addition, there was no mention of prior interventions used to treat panic, depression and excessive worry. Without the review of the specific type, setting and duration of psychotherapies, or, the selection, dosing and length of previous psychotropic medication trials, it cannot be inferred that the patient had exhausted standard treatments available to treat her condition. In sum, considering the relevant peer-reviewed literature and current practice standards, it is not possible to assert with any degree of confidence that the disputed gene test yielded information that significantly influenced treatment decisions, improved the patients condition, prevented a more serious episode of illness or reduced morbidity. Thus, the gene testing performed on 8/11/16 was not likely to be more beneficial for treatment of the enrollees medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: The patient is a 20-year-old male with significant daytime frequency every hour and nocturia every four to six hours. The patient reportedly also has insomnia. The patient has tried pelvic floor muscle rehabilitation as well as multiple medications including oxybutynin, Vesicare, and Myrbetriq. The patient experienced side effects and no substantial improvement in his symptoms with these therapies. The patient is currently on desmopressin with some improvement. The patient has requested reimbursement for percutaneous tibial nerve stimulation (PTNS) provided on 10/16/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational. It was suggested that this patient undergo treatment with PTNS therapy for significant urinary frequency. The records document treatment failure with multimodal primary and secondary treatments for his condition. He does not wish to proceed with sacral neuromodulation or Botox injections.

Context:
Summary Reviewer 3

The patient is a 20-year-old male with significant daytime frequency every hour and nocturia every four to six hours. The patient reportedly also has insomnia. The patient has tried pelvic floor muscle rehabilitation as well as multiple medications including oxybutynin, Vesicare, and Myrbetriq. The patient experienced side effects and no substantial improvement in his symptoms with these therapies. The patient is currently on desmopressin with some improvement. The patient has requested reimbursement for percutaneous tibial nerve stimulation (PTNS) provided on 10/16/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational. It was suggested that this patient undergo treatment with PTNS therapy for significant urinary frequency. The records document treatment failure with multimodal primary and secondary treatments for his condition. He does not wish to proceed with sacral neuromodulation or Botox injections. As noted in the medical literature, PTNS is performed as a salvage procedure. For these reasons, the PTNS provided on 10/16/17 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.

Context:
Summary Reviewer 1

A 66-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index has also been thought to add a bit to these statistics. There are two important decision points in the treatment of cutaneous melanoma. The first is
whether or not to do sentinel node; the pathology alone here strongly indicates that the procedure should be done. The second issue is that of whether adjuvant therapy should be given. Coupling the initial pathology, along with the results of the sentinel node, would give enough information to make the decision about adjuvant therapy.
DecisionDx-Melanoma testing is a study of 31 genes in an individualas melanoma cells. It then classifies that particular melanoma based on the five-year risk of metastasis. Gerami reported on 217 cases and found good correlation between DecisionDx-Melanoma testing prediction and prognosis in patients undergoing sentinel node biopsy. However, it is not clear how the DecisionDx-Melanoma testing five-year data compares to the ten-year Balch data. Most importantly, it is not known if it can be used to make therapeutic decisions beyond those that can be made on the pathologic data. Therefore, DecisionDx-Melanoma testing performed on 5/17/19 was not likely to have been more beneficial than other available standard therapy.

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


Answer: A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease.

Context:
Summary Reviewer 1

A 60-year-old male enrollee has requested reimbursement for the fecal calprotectin testing performed on 11/17/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for evaluation of the enrollees Crohns disease.   The physician reviewer found calprotectin is a small calcium-binding protein and is a member of the S100 family of zinc-binding proteins found primarily in neutrophils. Any disturbance to the mucosal architecture due to the inflammatory process, results in leakage of neutrophils, and hence, calprotectin, into the lumen and its subsequent excretion in feces. Studies have demonstrated that of patients with Crohns in remission, only a small percentage had a significant within-individual variability for calprotectin concentrations over three samples suggesting that measurements are reliable (Walsham and Sherwood; Schoepfer, et al; Sipponen, et al). Given this support, the fecal calprotectin testing performed on 11/17/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: The parent of an 11-year-old female enrollee has requested reimbursement for the FirstStep PLUS test provided on 11/23/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees severe attention deficit hyperactivity disorder (ADHD) and developmental delays.

Context:
Summary Reviewer 1

The parent of an 11-year-old female enrollee has requested reimbursement for the FirstStep PLUS test provided on 11/23/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees severe attention deficit hyperactivity disorder (ADHD) and developmental delays. The physician reviewer found that the clinical utility of CMA is well established, and is now considered first-line genetic tests for patients with developmental delays and autism spectrum disorders according to the American Academy of Pediatrics, the American College of Medical Genetics, the American College of Neurology and the Child Neurology Society (Schaefer, et al; Moeschler, et al; Shevell, et al; Shen, et al). In a study by Coulter and colleagues, a retrospective chart review of CMA testing was performed on patients with developmental delay, intellectual disability, autism spectrum disorders and congenital anomalies. Findings in this study demonstrated that CMA results influenced medical care by in the majority of patients by precipitating medical referrals, diagnostic imaging, or specific laboratory testing, supporting the use of CMA as a clinically useful diagnostic test. It is for these reasons, that the FirstStep PLUS test provided on 11/23/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 38-year-old male enrollee has requested reimbursement for the homocysteine testing provided on 9/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees anemia.

Answer: the patient is a 38-year old male with unexplained anemia.

Context:
Summary Reviewer 3

A 38-year-old male enrollee has requested reimbursement for the homocysteine testing provided on 9/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees anemia. The physician reviewer found that based on the records provided, the patient is a 38-year old male with unexplained anemia. Although elevated homocysteine levels have been associated with anemia, an elevated homocysteine level does not point to a specific cause of the anemia (den Elzen, et al). Moreover there is a lack of clinical trials that demonstrate outcome improvement with treatment targeted at reducing homocysteine levels (Lonn; Toole, et al). Likewise, even though results of homocysteine levels may be abnormal and considered independent risk markers for coronary disease, there is a paucity of scientific data demonstrating outcome benefits by treating routinely obtained abnormal results. Thus, the homocysteine testing provided on 9/5/14 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer:
A 68-year-old female insured has requested reimbursement for a Guardant360 CDx test provided
on 1/19/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insured's metastatic non-small cell lung cancer.

Context:
Summary Reviewer 2
A 68-year-old female insured has requested reimbursement for a Guardant360 CDx test provided
on 1/19/22. The Health Insurer has denied this request indicating that the services at issue were
considered investigational for evaluation of the insured's metastatic non-small cell lung cancer.
The physician reviewer found that the integration of next-generation sequencing (NGS) testing
into the routine management of stage IV non-small cell lung cancer demonstrates a marked
increase  in  the  detection  of  therapeutically  targetable  mutations  and  improved  delivery  of
molecularly guided therapy. The National Comprehensive Cancer Network (NCCN) guidelines
recommend liquid or plasma NGS if the patient has insufficient tissue from the tumor, or if
expedited results are necessary. A repeat biopsy can delay care and lead to unnecessary procedures.
In this case, the provider noted that the patient had insufficient tissue for full NGS testing.
Therefore, the Guardant360 CDx test provided on 1/19/22 was likely to be more beneficial for the
evaluation of the patients condition than any available standard therapy.

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


Answer: A 25-year-old transgender male enrollee has requested authorization and coverage for total hysterectomy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.

Answer: The Health Insurer noted that the requested services are not medically necessary because he needs to be living as male for two years and on hormones for one year before surgery.

Context:
Summary Reviewer

A 25-year-old transgender male enrollee has requested authorization and coverage for total hysterectomy. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested services. The Health Insurer noted that the requested services are not medically necessary because he needs to be living as male for two years and on hormones for one year before surgery. World Professional Association for Transgender Health (WPATH) has no requirements for social transition before hysterectomy. There is a one year requirement before reconstructive genital surgery, such as phalloplasty or metoidioplasty, but not for hysterectomy. Per WPATH, social transition is not required before hysterectomy. WPATH recommends one year of hormones before hysterectomy, unless this is not clinically indicated. The decision that this is clinically indicated before one year lies with the patients treatment team, which recommends the surgery. WPATH lists 12 continuous months of hormone therapy as appropriate to the patients gender goals (unless hormones are not clinically indicated for the individual). This provides flexibility for the treatment team to decide on the appropriate hormone treatment regimen before hysterectomy. WPATH noted that hysterectomy is one of the medically necessary treatments for gender dysphoria. There is sufficient support for the requested services in this clinical setting. Therefore, the requested hysterectomy is medically necessary for the treatment of this patient.

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


Answer: A 25-year-old female enrollee has requested authorization and coverage for surgery to remove the uterus (laparoscopic or laparoscopic assisted vaginal hysterectomy). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.

Answer: This patient has undergone a thorough evaluation, with no distinct etiology found.

Answer: In this case, the patient has failed medical management options, including oral contraceptive pills and a short trial of Mirena intrauterine device, which she was unable to tolerate. She is not a candidate for tranexamic acid, given her prolonged bleeding pattern (greater than five days per month) and is not a candidate for endometrial ablation given her age and high risk of failure. The patient desires definitive management hysterectomy.

Answer: she has completed childbearing status-post bilateral salpingectomy

Context:
Summary Reviewer

A 25-year-old female enrollee has requested authorization and coverage for surgery to remove the uterus (laparoscopic or laparoscopic assisted vaginal hysterectomy). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that abnormal uterine bleeding is a common gynecologic problem. Prolonged uterine bleeding can result in anemia and interfere with daily activities, as in this case. Abnormal uterine bleeding encompasses a heterogeneous group of conditions with diverse etiologies. Diagnosing the etiology of the abnormal uterine bleeding involves a thorough history, physical examination, imaging, and endometrial sampling. This patient has undergone a thorough evaluation, with no distinct etiology found. Initial management usually consists of progestin-based treatments, including combination oral contraceptive pills, the 52 mg levonorgestrel-releasing intrauterine device, and tranexamic acid. Surgical treatment options include endometrial ablation for patients who desire uterine sparing or definitive treatment with hysterectomy for patient who have completed childbearing.  In this case, the patient has failed medical management options, including oral contraceptive pills and a short trial of Mirena intrauterine device, which she was unable to tolerate. She is not a candidate for tranexamic acid, given her prolonged bleeding pattern (greater than five days per month) and is not a candidate for endometrial ablation given her age and high risk of failure. The patient desires definitive management hysterectomy. Given that she has completed childbearing status-post bilateral salpingectomy, a hysterectomy is appropriate for this patient. Therefore, surgery to remove the uterus (laparoscopic or laparoscopic assisted vaginal hysterectomy) is medically necessary for the treatment of this patient.

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


Answer: A 38-year-old male enrollee has requested reimbursement for genetic testing performed on 5/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.

Answer: In this patients case

Answer: this test was done as a follow-up of an indeterminate result.

Context:
Summary Reviewer 2

A 38-year-old male enrollee has requested reimbursement for genetic testing performed on 5/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that molecular testing has emerged as a promising method for clarifying the gray area of indeterminate thyroid fine needle aspirations, with the aim of reducing the overtreatment of benign nodules and increasing the preoperative detection of malignant nodules that should be treated by a single surgery (total thyroidectomy) rather than a two-step procedure. When molecular testing informs patient management, it should be further integrated with clinical findings and ultrasonographic results. As additional information accumulates to further refine these integrated approaches to patient management, the genetic information provided by molecular tests is expected to increasingly individualize the management of patients with thyroid nodules and cancer. In this patients case, a second thyroid biopsy was not necessary because this test was done as a follow-up of an indeterminate result. A benign result by the ThyGenX/ThyraMIR test has a significant negative predictive value. The medical evidence supports the services at issue in this clinical setting. All told, genetic testing performed on 5/31/18 was likely to have been more beneficial than other methods of evaluating this patient.

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


Answer: The patient is a 42-year-old female who is requesting reimbursement for fetal chromosomal analysis via cell-free DNA. The records document advanced maternal age and history of prior miscarriages.

Context:
Summary Reviewer

The patient is a 42-year-old female who is requesting reimbursement for fetal chromosomal analysis via cell-free DNA. The records document advanced maternal age and history of prior miscarriages. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. Noninvasive prenatal screening by cell-free DNA is increasingly becoming accepted as an appropriate method for first trimester aneuploidy screening. Noninvasive prenatal screening is a sensitive screen for aneuploidy, is more sensitive than sequential screening, but does not require the invasive procedure of chorionic villus sampling or amniocentesis. This is the case for both younger women and for women of advanced maternal age. This test is less invasive, with less risk to the pregnancy. Therefore, fetal chromosomal microdeletions genomic sequence analysis (81422) performed on 7/09/19 was medically necessary for the evaluation of this patient.

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


Answer: A 50-year-old female enrollee has requested authorization and coverage for minimally invasive sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.

Answer: the patient has chronic left sacroiliac dysfunction and pain that interferes with activities of daily living.

Context:
Summary Reviewer 1

A 50-year-old female enrollee has requested authorization and coverage for minimally invasive sacroiliac joint fusion. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the patient has chronic left sacroiliac dysfunction and pain that interferes with activities of daily living. The selected procedure of minimally invasive sacroiliac fusion using the triangular titanium implant is a relatively popular procedure, with 88 percent fusion rate and documented excellent results at five-year follow-up. Minimally invasive sacroiliac joint fusion has become an increasingly popular and accepted surgical option for chronic sacroiliac joint dysfunction, a common cause of unremitting chronic low back/buttock pain. Minimally invasive sacroiliac joint surgery has been proven to be a safe and effective procedure, with a high fusion rate, a good safety profile and significant improvements in pain severity and disability reported through 12 months post-procedure. A five-year follow-up showed continued excellent clinical responses in patients with sacroiliac joint pain treated with sacroiliac joint fusion using triangular titanium implants along with a high rate of joint fusion. Therefore, the requested minimally invasive sacroiliac joint fusion is likely to be more beneficial than any available standard therapy.

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


Answer: The parent of a 12-year-old male enrollee has requested authorization and coverage for Humatrope 12 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency.

Answer: The patient has experienced a deceleration in growth velocity from the 40th percentile to fifth percentile between 2-11 years of age. IGF-1 level was low, and provocative GH testing results were poor.

Answer: He had a good response to one year of therapy without adverse effects

Context:
Summary Reviewer

The parent of a 12-year-old male enrollee has requested authorization and coverage for Humatrope 12 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency. The physician reviewer found the requested medication is medically necessary for treatment of the patients medical condition. The patient has experienced a deceleration in growth velocity from the 40th percentile to fifth percentile between 2-11 years of age. IGF-1 level was low, and provocative GH testing results were poor. Based on auxological and biochemical criteria, the patient meets generally established guidelines for GH treatment. He had a good response to one year of therapy without adverse effects, and continuation of GH therapy is medically necessary until epiphyseal fusion. Withdrawal of therapy at the age of expected puberty may result in irreversible impairment in height potential. As such, Humatrope 12 mg cartridge has been established as medically necessary for treatment of the patients medical condition. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer: The parent of a seven-year-old male enrollee has requested authorization and coverage for Saizen 8.8 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency.

Answer: his adult predicted height, based on the bone age and height assessment in March 2015, is approximately 66.5 inches

Answer: His growth factors are normal

Answer: The patient underwent provocative testing with serial GH levels assayed for a period of three hours after the baseline measurement

Context:
Summary Reviewer

The parent of a seven-year-old male enrollee has requested authorization and coverage for Saizen 8.8 mg cartridge. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees growth hormone deficiency. The physician reviewer found the submitted documentation fails to establish the medical necessity of the requested medication. According to the documentation submitted for review, the patients height is not more than 2 SDS below the mean for age and gender, and his adult predicted height, based on the bone age and height assessment in March 2015, is approximately 66.5 inches, appropriate for his genetic potential. His growth factors are normal, he does not have any known morphological abnormalities of his pituitary gland, and there is no documentation of abnormal growth velocity for age. The delayed bone age is most consistent with a diagnosis of constitutional delay rather than GH deficiency. The patient underwent provocative testing with serial GH levels assayed for a period of three hours after the baseline measurement, but it is not clear from the results provided that two separate provocative tests were performed, with serial measurements of GH levels for 2-3 hours after each test independently. Although the U.S. Food and Drug Administration (FDA) has approved GH therapy for children with intrauterine growth retardation/small for gestational age with failure to catch-up in height, this patients height is not below the 3rd percentile on the growth curve, and thus he would not meet criteria for failure to catch- up in height. In addition, his adult height prediction is not short enough to qualify for GH on the basis of the FDA-approved idiopathic short stature indication. For the reasons provided, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/31/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.

Answer: This patient is a 62-year-old female who had a bilateral screening mammogram with tomosynthesis on 3/31/16. The patient reported a positive family history of breast cancer in her maternal grandmother, and in her maternal and paternal aunts. The patient presented for a breast screening examination on 3/31/16. The patients breast was noted with scattered fibroglandular densities in the right breast. The ultrasound showed small cysts. The Health Insurer has denied the tomosynthesis portion of the exam.

Context:
Summary Reviewer 2

A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 3/31/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found This patient is a 62-year-old female who had a bilateral screening mammogram with tomosynthesis on 3/31/16. The patient reported a positive family history of breast cancer in her maternal grandmother, and in her maternal and paternal aunts. The patient presented for a breast screening examination on 3/31/16. The patients breast was noted with scattered fibroglandular densities in the right breast. The ultrasound showed small cysts. The Health Insurer has denied the tomosynthesis portion of the exam. The patient has appealed the denial and this denial is the subject of this appeal and determination.
The medical literature supports breast tomosynthesis in this clinical setting.  Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues state that integrated two dimensional and three dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Thus the literature supports the use of digital breast tomosynthesis over conventional mammogram due to improved cancer detection rate.  In sum, digital breast tomosynthesis performed on 3/31/16 was likely to have been superior to other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/02/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic.

Context:
Summary Reviewer 1

A 62-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/02/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic. The physician reviewer found the medical evidence supports the service at issue in this clinical setting.  Breast tomosynthesis provides advantages to radiologists interpreting mammograms.  This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and increase in overall diagnostic accuracy and detection of small cancers compared to two-dimensional imaging alone.  Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to the patient than had her examination been done with two-dimensional imaging alone.  Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 63-year-old male enrollee has requested reimbursement for CPT 64999 (unlisted procedure, nervous system, right wrist anterior and posterior interosseous neurectomy) performed on 6/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition.

Answer: this patient presented with chronic right wrist pain that interfered with his activities of daily living. He had a past medical history that included right distal radius fracture. Clinical examination findings were consistent with imaging evidence of right wrist post-traumatic arthritis of the radioscaphoid joint and STT joint with positive ulnar variance of 7.5 mm. He had failed to achieve sustained improvement with activity modification, medications, bracing and steroid injection. He underwent right wrist anterior and posterior interosseous neurectomies on 6/10/19 as an alternative to motion-limiting surgeries, including wrist fusion, proximal row carpectomy, and radioscapholunate arthrodesis.

Context:
Summary Reviewer 1

A 63-year-old male enrollee has requested reimbursement for CPT 64999 (unlisted procedure, nervous system, right wrist anterior and posterior interosseous neurectomy) performed on 6/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient presented with chronic right wrist pain that interfered with his activities of daily living. He had a past medical history that included right distal radius fracture. Clinical examination findings were consistent with imaging evidence of right wrist post-traumatic arthritis of the radioscaphoid joint and STT joint with positive ulnar variance of 7.5 mm. He had failed to achieve sustained improvement with activity modification, medications, bracing and steroid injection. He underwent right wrist anterior and posterior interosseous neurectomies on 6/10/19 as an alternative to motion-limiting surgeries, including wrist fusion, proximal row carpectomy, and radioscapholunate arthrodesis. Current evidence-based medical literature supports the use of anterior and/or posterior interosseous neurectomies for the treatment of chronic wrist pain and to delay or avoid wrist fusion/reconstruction surgeries. There is adequate literature support for the use of this procedure as salvage prior to fusion. He had failed reasonable and/or comprehensive conservative treatment, and no additional conservative treatment would have been reasonably expected to improve his medical condition. Therefore, CPT code 64999 (unlisted procedure, nervous system, right wrist anterior and posterior interosseous neurectomy) performed on 6/10/19 was likely to have been more beneficial for treatment of the patientas medical condition than any available standard therapy.

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


Answer: A 61-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with implant (Watchman device).  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.

Answer: The medical records document paroxysmal atrial fibrillation and a prior stroke with no documented significant bleeding complications on anticoagulation.

Context:
Summary Reviewer 1

A 61-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with implant (Watchman device).  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found there is a lack of support for the requested services in this clinical setting.  The medical records document paroxysmal atrial fibrillation and a prior stroke with no documented significant bleeding complications on anticoagulation.  In this circumstance, atrial fibrillation treatment options include continuation of anticoagulation while accepting an increased bleeding risk, discontinuing anticoagulation while accepting an increased thromboembolic risk or percutaneous left atrial appendage exclusion using a Watchman device.  The Watchman device has been demonstrated in one trial to be non-inferior compared with warfarin.  However, device placement has a high rate of significant complications due to pericardial effusion and procedural stroke related to thromboembolism or air embolization.  The Watchman device is not likely to be of greater benefit than other treatment options, especially in patients who are tolerating anticoagulation without significant bleeding side effects.  Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 59-year-old male enrollee has requested authorization and coverage for spinal cord stimulator. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrollees medical condition.

Context:
Summary Reviewer

A 59-year-old male enrollee has requested authorization and coverage for spinal cord stimulator. The Health Insurer has denied this request and reported that the requested device is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the medical evidence supports the requested device in this clinical setting. Wong and colleagues concluded that the option of spinal cord stimulation should be considered after conservative therapy has failed. They pointed to large randomized control studies which showed that high frequency forms of stimulation was effective for chronic low back pain. A systematic review and meta-analysis by Taylor and colleagues concluded that spinal cord stimulation is an effective pain relieving treatment for chronic low back and leg pain with or without a prior history of back surgery.  The mean level of pain relief across 74 studies was found to be 58% at an average follow-up of 24 months. All told, the requested spinal cord stimulator is medically necessary for the treatment of this patient.

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


Answer: A 38-year-old male enrollee has requested authorization and coverage for sirolimus cream. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition.

Context:
Summary Reviewer 1

A 38-year-old male enrollee has requested authorization and coverage for sirolimus cream. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is sufficient support for the requested medication in this clinical setting. Tuberous sclerosis is a rare genetic disease, and there are not enough patients to have double blind, placebo-controlled studies for the treatment of the associated facial angiofibromas. Topical rapamycin or sirolimus is considered standard of care for the treatment of these lesions.  The International Tuberous Sclerosis Complex Consensus Statement also recommends the use of this medication for treatment of facial angiofibromas in tuberous sclerosis. Therefore, sirolimus cream is likely to be more beneficial than other available standard therapy.

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


Answer: A 61-year-old female enrollee has requested reimbursement for the in-office surgical injections performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees lumbar spondylosis with arthropathy.

Answer: this patient has mild facet arthropathy as demonstrated on magnetic resonance imaging (MRI) as well as having discogenic radiculopathy.

Context:
Summary Reviewer 2

A 61-year-old female enrollee has requested reimbursement for the in-office surgical injections performed on 8/4/15. The Health Insurer has denied this request indicating that the services at issue are considered investigational for treatment of the enrollees lumbar spondylosis with arthropathy.   The physician reviewer found that the available records document that this patient has mild facet arthropathy as demonstrated on magnetic resonance imaging (MRI) as well as having discogenic radiculopathy. However, the medial branch blocks performed on 8/4/15 are not indicated in the presence of another clear cause of the patients low back and radicular pain. Further, the use of repeated diagnostic blocks absent a plan for radiofrequency neurolysis is not consistent with clinical practice guidelines. Thus, the in-office surgical injections performed on 8/4/15 were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 66-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure (84999) Prometheus Anser testing performed on 12/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease.

Context:
Summary Reviewer 1

A 66-year-old male enrollee has requested reimbursement for the unlisted chemistry procedure (84999) Prometheus Anser testing performed on 12/22/15. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease.  The physician reviewer found the concept of following drug levels when using tumor necrosis factor (TNF)-alpha antibodies to provide personalized dosing has been around for many years. Following drug levels can keep a patient at a target level which translates into a higher probability of clinical benefit. This concept is based primarily on retrospective data which has demonstrated that, in general, higher trough levels correlate directly, and the presence of antibody correlates indirectly, with clinical efficacy. Knowledge of the drug and antibody level would therefore assist the provider in the decision to increase a drugs dose or perhaps switch to another class of biologics. However, this approach has not been shown to be superior to making empiric changes. There is a lack of controlled data which have identified the optimal drug level. A recent trial demonstrated this approach had no impact on clinical efficacy compared to empiric dose titration (Steenholdt, et al). Therefore, the unlisted chemistry procedure (84999) Prometheus Anser testing performed on 12/22/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 47-year-old male enrollee has requested authorization and coverage for vestibular stenosis repair. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of nasal congestion and obstruction.

Answer: This patient has lateral nasal wall collapse from lower lateral cartilage weakness.

Context:
Summary Reviewer 2

A 47-year-old male enrollee has requested authorization and coverage for vestibular stenosis repair. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of nasal congestion and obstruction. The physician reviewer found that there is sufficient support for the requested services in this case. This patient has lateral nasal wall collapse from lower lateral cartilage weakness. The images appear to show significant collapse. The Latera implant is a U.S. Food and Drug Administration (FDA) approved device which has been used successfully for lateral nasal wall collapse. In sum, vestibular stenosis repair is likely to be more effective than other treatment options. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 46-year-old male enrollee has requested reimbursement for emergency services provided on 7/2/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.

Answer: the patient is a 46-year-old male who was evaluated in the emergency department at 14:31 on 7/2/17 with complaints of chest discomfort that had persisted for a couple of weeks. His pain was intermittent, and radiated to his left arm and jaw. He described his pain as heaviness and pressure that was moderate in intensity. His pain was accompanied by shortness of breath and diaphoresis. He had experienced tingling to the left face. The patient indicated that he initially thought his symptoms were due to discontinuing temazepam, but his symptoms had persisted. The patients medical history is significant for diabetes. His family history includes coronary artery disease. Differential diagnoses considered included unstable angina, pulmonary embolism, and atypical chest pain. The patients heart sounds were regular, normal perfusion was present and lungs were clear with unlabored respirations. An electrocardiogram (EKG) did not reveal any acute ischemia. A chest x-ray was negative for acute disease. Laboratory data was significant for an elevated D-dimer and a normal Troponin. A computed tomography (CT) angiogram of the chest did not show any evidence of pulmonary embolism. The patient was medicated with oral aspirin and sublingual nitroglycerin. He was admitted to observation unit on telemetry. The patient has requested reimbursement for emergency services provided on 7/2/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.

Context:
Summary Reviewer

A 46-year-old male enrollee has requested reimbursement for emergency services provided on 7/2/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found the patient is a 46-year-old male who was evaluated in the emergency department at 14:31 on 7/2/17 with complaints of chest discomfort that had persisted for a couple of weeks. His pain was intermittent, and radiated to his left arm and jaw. He described his pain as heaviness and pressure that was moderate in intensity. His pain was accompanied by shortness of breath and diaphoresis. He had experienced tingling to the left face. The patient indicated that he initially thought his symptoms were due to discontinuing temazepam, but his symptoms had persisted. The patients medical history is significant for diabetes. His family history includes coronary artery disease. Differential diagnoses considered included unstable angina, pulmonary embolism, and atypical chest pain. The patients heart sounds were regular, normal perfusion was present and lungs were clear with unlabored respirations. An electrocardiogram (EKG) did not reveal any acute ischemia. A chest x-ray was negative for acute disease. Laboratory data was significant for an elevated D-dimer and a normal Troponin. A computed tomography (CT) angiogram of the chest did not show any evidence of pulmonary embolism. The patient was medicated with oral aspirin and sublingual nitroglycerin. He was admitted to observation unit on telemetry. The patient has requested reimbursement for emergency services provided on 7/2/17. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.At issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part.The patients symptoms on 7/2/17 did meet the prudent layperson criteria for emergency care. A prudent layperson in the patients circumstances would reasonably expect the absence of emergency care to jeopardize his or her health. This patient presented to the emergency department after experiencing intermittent chest pain for a few weeks. Symptoms of paresthesia with an elevated D-dimer made pulmonary embolism a consideration. His symptoms were classic for acute coronary syndrome as they were described as intermittent, radiating to his arm and jaw, and associated with shortness of breath and diaphoresis. In addition, the patients significant risk factors for coronary artery disease included diabetes, obesity, and a family history of coronary artery disease. These factors, combined with the patients age, would generate a history, EKG, age, risk factors and initial troponin (HEART) score of 4. Admission is recommended for such patients as a score of 4 is associated with a 12-16% risk of an adverse cardiac event. A patient who experiences intermittent chest pain with significant cardiac risk factors meets prudent layperson criteria for an emergency. Thus, the services provided on 7/2/17 were for treatment of an emergency medical condition.

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


Answer:
The patient is a 42-year-old female with a history of treatment resistant, recurrent major
depressive disorder. The patient has requested reimbursement and prospective authorization
and coverage for adult mental health transcranial magnetic stimulation provided from 10/15/21
forward.

Answer:
This  patient  had  also  tried  electroconvulsive  therapy.  She  completed  five
treatments but could not tolerate the confusion and headaches.

Answer:
she was evaluated
by a psychiatrist who recommended transcranial magnetic stimulation at this point in her
treatment.

Context:
Summary Reviewer

The patient is a 42-year-old female with a history of treatment resistant, recurrent major
depressive disorder. The patient has requested reimbursement and prospective authorization
and coverage for adult mental health transcranial magnetic stimulation provided from 10/15/21
forward. The physician reviewer found that per the medical literature, transcranial magnetic
stimulation is indicated for severe, recurrent major depressive disorder that has not responded
to traditional medication and psychotherapy treatment.  This patient qualifies for the diagnosis
of treatment refractory depression given her two failed antidepressant trials in addition to
psychotherapy.  This  patient  had  also  tried  electroconvulsive  therapy.  She  completed  five
treatments but could not tolerate the confusion and headaches.  Additionally, she was evaluated
by a psychiatrist who recommended transcranial magnetic stimulation at this point in her
treatment. Based on the records, transcranial magnetic stimulation was the appropriate next
step  in  treatment  for  this  patient.  Therefore,  adult  mental  health  transcranial  magnetic
stimulation provided from 10/15/21 forward was and is medically necessary for the treatment of
this patient.

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


Answer: A 65-year-old male enrollee has requested authorization and coverage for Rytary. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees Parkinsons disease.

Answer: The patient has not been placed on extended release formulations of carbidopa/levodopa.

Context:
Summary Reviewer

A 65-year-old male enrollee has requested authorization and coverage for Rytary. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees Parkinsons disease. The physician reviewer found that the submitted documentation fails to support the medical necessity for the requested medication. While Rytary is a medication that is commonly used for the treatment of patients with Parkinsons disease, it is prescribed after the patient has tried and failed extended release formulations. The documentation provided do not demonstrate that this has been administered in this patient.  The patient has not been placed on extended release formulations of carbidopa/levodopa. As such, it would be appropriate for the patient to try the extended release formulations prior to being started on Rytary. Accordingly, Rytary is not currently medically necessary for treatment of this patient.  Therefore, for the reasons stated above, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 49-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 3/15/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who underwent a breast screening evaluation.

Context:
Summary Reviewer 1

A 49-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 3/15/17. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who underwent a breast screening evaluation. The physician reviewer found that breast tomosynthesis provides advantages to radiologists interpreting mammograms, especially in patients with dense tissue such as this patient. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion, resulting in a decrease in callbacks and overall increase in diagnostic accuracy compared to two-dimensional imaging alone. The medical evidence supports the service at issue in this clinical setting. All told, breast tomosynthesis performed on 3/15/17 was likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: The patient is a 16-month-old male who was born by Cesarean section at 32 weeks 3 days gestation. The patientas parent has requested reimbursement for occupational and speech therapy services provided from 7/24/20 through 8/20/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.

Answer: The patient was born prematurely, at 32 weeks 3 days gestation. He spent four weeks in the NICU, and required a feeding tube. He has documented developmental delays, including gross motor delays, apraxia, poor emotional regulation, and feeding difficulties.

Context:
Summary Reviewer

The patient is a 16-month-old male who was born by Cesarean section at 32 weeks 3 days gestation. The patientas parent has requested reimbursement for occupational and speech therapy services provided from 7/24/20 through 8/20/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that the submitted documentation supports the medical necessity of the services at issue. The patient was born prematurely, at 32 weeks 3 days gestation. He spent four weeks in the NICU, and required a feeding tube. He has documented developmental delays, including gross motor delays, apraxia, poor emotional regulation, and feeding difficulties. Spittle and colleagues compared the effectiveness of early developmental intervention program provided post hospital discharge to prevent motor or cognitive impairment in preterm infants versus standard medical follow-up of preterm infants at infancy, preschool age, school age, and adulthood. The authors noted, aInfants born preterm are at increased risk of developing cognitive and motor impairment compared with infants born at term. Early developmental interventions have been provided in the clinical setting with the aim of improving overall functional outcomes for these infants.a Spittle and colleagues noted, aEarly intervention programs for preterm infants have a positive influence on cognitive and motor outcomes during infancy, with cognitive benefits persisting into preschool age.a Woodward and colleagues stated that infants born before 34 weeks of gestation have three times the risk of impairments in multiple developmental domains compared with term infants. Bui reported, aPreterm children should be screened regularly for developmental delay, and parents of preterm infants should be counseled about the options of early intervention programs, and their potential positive impact on development.a In an article describing the importance of physical, occupational and speech therapy for infants born prematurely, Orton and colleagues noted, aThe developmental allied health team, consisting of physical therapy, occupational therapy, and speech pathology, is crucial in early evaluation of gross motor, fine motor, feeding, and language development. Surveillance of neurodevelopment in the first year of life is essential to ensure early detection of specific developmental delays and impairments, and to ensure timely referral for early intervention. Early intervention is not only important in optimizing long-term outcomes for the child, but it also plays an important role in enhancing the parent-child relationship and parental well-being.a The medical evidence supports the services at issue in this clinical setting. Therefore, occupational and speech therapy services provided from 7/24/20 through 8/20/20 were medically necessary for the treatment of this patient.

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


Answer: A 31-year-old male enrollee has requested authorization and coverage for anastrozole 1 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition.

Answer: This patient is being treated for testicular hypodysfunction with testosterone and human chorionic gonadotropin.  The laboratory studies from November 2015 and February 2016 show normal or high values of testosterone.

Context:
Summary Reviewer

A 31-year-old male enrollee has requested authorization and coverage for anastrozole 1 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the requested medication.  This patient is being treated for testicular hypodysfunction with testosterone and human chorionic gonadotropin.  The laboratory studies from November 2015 and February 2016 show normal or high values of testosterone.  For men who are hypogonadal, as evidenced by clinical symptoms and signs consistent with androgen deficiency and a subnormal morning serum testosterone concentration on three separate occasions, testosterone replacement therapy is recommended. The approved uses for anastrozole 1 mg include first-line treatment of locally-advanced or metastatic breast cancer (hormone receptor-positive or unknown) in postmenopausal women, adjuvant treatment of early hormone receptor-positive breast cancer in postmenopausal women or treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.  In this case, the patient does not have an approved indication for the use of anastrozole.  Furthermore, this medication is not recommended for the use of testicular hypofunction.  The documentation supports that the patient has had improved symptoms while taking testosterone and human chorionic gonadotropin.  Thus, the requested anastrozole 1 mg is not medically indicated for the treatment of this patient.  Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 55-year-old female enrollee has requested authorization and coverage for LINX Reflux Management System (code 43284) and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.

Context:
Summary Reviewer 1

A 55-year-old female enrollee has requested authorization and coverage for LINX Reflux Management System (code 43284) and one inpatient bed day. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the U.S. Food and Drug Administration has approved the LINX Reflux Management System for lower esophageal sphincter augmentation. Eligible patients for the procedure include those with inadequate symptom control with acid suppression therapy, including patients with mild to moderate gastroesophageal reflux disease and a hiatal hernia less than 3 cm. This patient meets those specific criteria. The device is a ring made up of a series of magnets that have sufficient attraction to increase the lower esophageal sphincter closure pressure, but allow for food passage with swallowing. Based upon a prospective study by Lipham and colleagues that included 44 patients, the mean total percent time that pH was less than 4 was reduced from 11.9 percent at baseline to 3.8 percent at three years. A recent study comparing the LINX procedure with laparoscopic fundoplication was performed by Reynolds and colleagues. The authors found that gastroesophageal reflux disease patients had similar control of reflux symptoms after both LINX and fundoplication. The inabilities to belch and vomit were significantly fewer with LINX, along with a significantly lower incidence of severe gas-bloat symptoms. Therefore, the LINX Reflux Management System (code 43284) and one inpatient day are likely to be superior over other treatment options.

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


Answer: A 54-year-old female enrollee has requested authorization and coverage for surgery to treat her heart rhythm. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of paroxysmal (AF) atrial fibrillation.

Answer: the patient has a history of persistent AF and has required cardioversions. She is now on antiarrhythmic drug therapy with dronedarone.

Answer: In this patients case, the provider reported that the patient has symptomatic paroxysmal AF despite antiarrhythmic drug therapy. Thus, catheter ablation of atrial fibrillation was offered.

Context:
Summary Reviewer 3

A 54-year-old female enrollee has requested authorization and coverage for surgery to treat her heart rhythm. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollee, who has a history of paroxysmal (AF) atrial fibrillation. The physician reviewer found that the patient has a history of persistent AF and has required cardioversions. She is now on antiarrhythmic drug therapy with dronedarone.  According to the guidelines endorsed by the American College of Cardiology, American Heart Association and the Heart Rhythm Society, catheter ablation of atrial fibrillation in this patient would be recommended, AF catheter ablation is useful for symptomatic paroxysmal AF refractory or intolerant to at least one class I or III antiarrhythmic medication when a rhythm-control strategy is desired. In this patients case, the provider reported that the patient has symptomatic paroxysmal AF despite antiarrhythmic drug therapy. Thus, catheter ablation of atrial fibrillation was offered. In sum, the requested surgery to treat her heart rhythm is likely to be more effective than the standard options available for the treatment of this patients medical condition. Therefore, for the reasons stated above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 63-year-old female enrollee has requested reimbursement and prospective authorization and coverage for physical therapy provided from 8/17/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees medical condition.

Answer: according to the documentation submitted for review, the patient had post-operative disability after foot surgery and physical therapy was prescribed to improve function. The patient made improvement in physical therapy through 8/19/15.

Answer: the patient did not show further improvement.

Context:
Summary Reviewer

A 63-year-old female enrollee has requested reimbursement and prospective authorization and coverage for physical therapy provided from 8/17/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found according to the documentation submitted for review, the patient had post-operative disability after foot surgery and physical therapy was prescribed to improve function. The patient made improvement in physical therapy through 8/19/15. On that date further physical therapy was reasonable and medically necessary because the patient had continued deficits that are generally amenable to the care of a skilled physical therapist. Based on improvement up to 8/19/15, further improvement could be expected with skilled services. However, the patient did not show further improvement. As such, six additional physical therapy sessions after 8/19/15 were sufficient to show a plateau. After these six sessions, the patient could have been managed with a home exercise program. For the reasons provided, a portion of the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.

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


Answer: A 54-year-old male enrollee has requested authorization and coverage for apremilast (Otezla) 30 mg tablets. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees psoriatic arthritis.

Answer: the records indicate that this patient has failed two treatments with NSAIDs

Answer: the psoriasis

Answer: covers at least ten percent of his body surface area.

Context:
Summary Reviewer

A 54-year-old male enrollee has requested authorization and coverage for apremilast (Otezla) 30 mg tablets. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees psoriatic arthritis. The physician reviewer found that the documentation provided do not support the medical necessity for the requested medication in this clinical setting. While the records indicate that this patient has failed two treatments with NSAIDs, the records do not demonstrate that he has tried and failed nonpharmacological treatments (ultravioletlight therapy), disease-modifying antirheumatic drugs (DMARD) therapies, or anti-tumor necrosis factor (TNF) agents. There is also no documentation that he has tried the standard topical therapy to address the psoriasis that covers at least ten percent of his body surface area. While apremilast may represent a promising therapy for the treatment of psoriatic arthritis and psoriasis, the medication should be tried after failure of other standard forms of therapy. Per Zerilli, and Ocheretyaner, Additional long-term studies are needed to further elucidate its place in therapy. As such, the requested medication is not medically indicated for the treatment of this patient. Therefore, for the reasons stated above, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 60-year-old male has requested reimbursement for gene testing provided on 11/07/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.

Context:
Summary Reviewer 1

A 60-year-old male has requested reimbursement for gene testing provided on 11/07/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by the staging system spelled out by Balch. DecisionDx-Melanoma testing is a study of 31 genes in an individuals melanoma cells. It then classifies that particular melanoma as either class 1 or class 2 based on the risk of metastasis. However, it is not clear how the five-year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it is not clear if DecisionDx-Melanoma assay can be used to make clinical decisions. Therefore, gene testing provided on 11/07/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 68-year-old male enrollee has requested reimbursement for the positron emission tomography (PET) scan performed on 2/3/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue is considered investigational for evaluation of the enrollees cognitive impairments, neuropsychiatric symptoms and parkinsonian features.

Answer: In this case, MRI showed nonspecific atrophy. The EEG showed spike and slow wave discharges suggesting epilepsy. In addition, neuropsychology testing suggested frontotemporal dementia, and the examination showed Parkinsonian features. The patient presented with a subacute onset of progressive memory problems.

Context:
Summary Reviewer 1

A 68-year-old male enrollee has requested reimbursement for the positron emission tomography (PET) scan performed on 2/3/15. The Health Insurer has denied this request indicating that the diagnostic procedure at issue is considered investigational for evaluation of the enrollees cognitive impairments, neuropsychiatric symptoms and parkinsonian features.  The physician reviewer found that the PET scan performed on 2/3/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. PET is a standard procedure performed by providers when dementia is atypical, and most specifically to differentiate Alzheimers disease from frontotemporal dementia. This diagnostic procedure allows the patient and his family to better understand prognosis and treatment, and guide the treating provider to provide the best treatment. In this case, MRI showed nonspecific atrophy. The EEG showed spike and slow wave discharges suggesting epilepsy. In addition, neuropsychology testing suggested frontotemporal dementia, and the examination showed Parkinsonian features. The patient presented with a subacute onset of progressive memory problems. In this complex clinical setting, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 35-year-old female enrollee has requested reimbursement for (CPT code 86343) leukocyte histamine release test (LHR) dated on 10/20/15. The Health Insurer has denied this request indicating that the requested procedure are considered investigational for treatment of the enrollees chronic idiopathic urticaria

Context:
Summary Reviewer 2

A 35-year-old female enrollee has requested reimbursement for (CPT code 86343) leukocyte histamine release test (LHR) dated on 10/20/15. The Health Insurer has denied this request indicating that the requested procedure are considered investigational for treatment of the enrollees chronic idiopathic urticaria The physician reviewer found the clinical utility of LHR is not well established and there are currently no national Allergy and Immunology or Dermatology guidelines recommending routine use of this test. LHR is a test that consists of basophil histamine release assay.  This assay is used to detect anti-Fc-epsilon-RI-alpha antibodies. Some concerns with LHR is that there is evidence against a pathogenic role of autoantibodies to IgE or Fc-epsilon-RI and they are not specific to CU.  Anti-Fc-epsilon-RI-alpha antibodies have been identified in healthy normal people and those with other autoimmune diseases.  The level of these antibodies do not appear to change with the clinical disease activity. The presence of these antibodies do not appear to predict refractory disease. In this patients case, her symptoms are consistent with chronic idiopathic urticaria. Her evaluation to include LHR have all been negative.  As such, (CPT code 86343) leukocyte histamine release test (LHR) that was rendered on 10/20/15 was not likely to have been more effective than current standard therapy for evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 57-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/01/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition.

Context:
Summary Reviewer 3

A 57-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 9/01/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts.  In this patients case, her breasts were described as heterogeneously dense.  It is specifically those patients who have dense breasts that can benefit most from tomosynthesis.  The ability to separate out the overlapping structures better enables the possibility of demonstrating an otherwise occult tumor.  Thus, digital breast tomosynthesis performed on 9/01/16 was likely to have been more effective than other methods of evaluating this patient.  Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer:
A 58-year-old male enrollee has requested authorization and coverage for proton beam radiation
therapy (PBT). The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees locally advanced esophagus cancer.

Context:
Summary Reviewer 2

A 58-year-old male enrollee has requested authorization and coverage for proton beam radiation
therapy (PBT). The Health Insurer has denied this request and reported that the requested service is
investigational for the treatment of the enrollees locally advanced esophagus cancer. The physician
reviewer found that PBT is not likely to be more beneficial for treatment of the patients condition than
any available standard therapy.

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


Answer: A 48-year-old female has requested reimbursement for Anser IFX testing performed on 9/04/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns colitis.

Context:
Summary Reviewer 3

A 48-year-old female has requested reimbursement for Anser IFX testing performed on 9/04/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees Crohns colitis. The physician reviewer found the use of Anser IFX to direct management has not been clinically proven to improve patient clinical outcomes or alter patient management in controlled clinical trials of patients with Crohns disease.  The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have clear Remicade levels been established.  Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response.  Although loss of response to infliximab is common, there were a lack of standard guidelines defining a therapeutic strategy at the time of testing.  Based on the medical literature, Anser IFX testing performed on 9/04/15 was not likely to have been of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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