Answer: The parent of a four-year-old male enrollee has requested reimbursement for chromosomal microarray testing provided on 11/12/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.

Context:
Summary Reviewer 1

The parent of a four-year-old male enrollee has requested reimbursement for chromosomal microarray testing provided on 11/12/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the clinical utility of chromosomal microarray (CMA) is well-established, and is now considered first-line genetic testing for individuals with developmental delays and autism spectrum disorders. It is important to note that CMA technology has been shown to provide clinically actionable information. Research continues to support the use of CMA testing in the evaluation of developmental delays and autism spectrum disorders. Recent evidence-based international guidelines promote the use of CMA as a first-tier investigation for global developmental delay if no etiological indicators from history and examination are found. The higher sensitivity that it has for identifying submicroscopic deletions and duplications (than standard karyotyping methods) and better definition of the breakpoints and size of imbalances all make CMA a suitable first-line test. Therefore, chromosomal microarray testing provided on 11/12/18 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: A 20-year-old male enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation therapy from 6/30/16 forward.  The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.

Context:
Summary Reviewer

A 20-year-old male enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation therapy from 6/30/16 forward.  The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions.  The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue.  Documents critical to the review, such as a psychiatric assessment, interpretative summary, serial progress notes, longitudinal history of the illness burden and outcomes of specific evidence-based psychotherapies and non-pharmacologic interventions, were not presented.  The information provided, including the patients lengthy course of treatment with mood stabilizing and antipsychotic medications and poor tolerability of antidepressants, strongly suggests bipolar depression rather than a unilateral mood disorder and does not detail the influence of the patients psychiatric comorbid conditions.  Considering transcranial magnetic stimulation is indicated for the acute phase treatment of major depressive disorder at this time, and the safety and effectiveness of transcranial magnetic stimulation therapy has not been established for other psychiatric disorders, the medical necessity of the services at issue cannot be established.  All told, transcranial magnetic stimulation therapy from 6/30/16 forward was not and is not medically indicated for the treatment of this patient.  Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. 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 2

A 64-year-old female has requested reimbursement for DecisionDx-Melanoma assay provided on 3/21/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha.  The data on the DecisionDx-Melanoma assay has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. In sum, DecisionDx-Melanoma assay provided on 3/21/18 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: The parent of a 13-year-old male enrollee has requested authorization and coverage for Cimzia loading dose 400 mg (two injections), then 200 mg subcutaneous every two weeks, three applications. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who has been diagnosed with inflammatory bowel disease, psoriasis and juvenile ankylosing spondylitis.

Context:
Summary Reviewer

The parent of a 13-year-old male enrollee has requested authorization and coverage for Cimzia loading dose 400 mg (two injections), then 200 mg subcutaneous every two weeks, three applications. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who has been diagnosed with inflammatory bowel disease, psoriasis and juvenile ankylosing spondylitis. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication in this clinical setting. Cimzia is an anti-tumor necrosis factor medication which is indicated for the treatment of psoriasis, inflammatory bowel disease and ankylosing spondylitis/sacroiliitis. These diseases are the same in children and adults and respond to therapy similarly. Currently, there is an active trial being conducted, the Pediatric Arthritis Study of Certolizumab Pegol (PASCAL). This is a phase 3, multicenter, open-label study to assess the pharmacokinetics, safety, and efficacy of certolizumab pegol (Cimzia) in children and adolescents with moderately to severely active polyarticular-course juvenile idiopathic arthritis. In this patients case, Cimzia is a medically appropriate treatment option. Thus, Cimzia loading dose 400 mg (two injections), then 200 mg subcutaneous every two weeks, three applications are medically necessary for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer: An 80-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire airway stimulation. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.

Answer: This patient has

Answer: failed CPAP therapy and is not an optimal candidate for oral appliance therapy due to the severity of his obstructive sleep apnea.

Context:
Summary Reviewer 2

An 80-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire airway stimulation. 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 there is sufficient support for the requested services in this clinical setting. This patient has already failed CPAP therapy and is not an optimal candidate for oral appliance therapy due to the severity of his obstructive sleep apnea. Multiple studies have demonstrated that hypoglossal nerve stimulation or Inspire airway stimulation improves health for people with obstructive sleep apnea with clinically significant decreases in observed mean apnea-hypopnea index and improvements in quality of life. The American Academy of Otolaryngology-Head and Neck Surgery considers aupper airway stimulation via the hypoglossal nerve for the treatment of adult obstructive sleep apnea syndrome to be a safe and effective second-line treatment of moderate to severe obstructive sleep apnea in patients who are intolerant or unable to achieve benefit with positive pressure therapy.a All told, hypoglossal nerve stimulation or Inspire airway stimulation is likely to be more beneficial than any available standard therapy.

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


Answer: A 45-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain.

Context:
Summary Reviewer 3

A 45-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation of the knee. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees knee pain. The physician reviewer found that surgical implantation of healthy cartilage cells (autologous chondrocyte implantation) is an alternative option for the treatment of large articular cartilage defects. Autologous chondrocyte implantation is primarily used to treat full-thickness cartilaginous defects of the distal femur by arthroscopically extracting healthy chondrocyte cells from the patients knee, culturing the cells, and implanting them back into an articular defect via an open surgical procedure. In general, autologous chondrocyte implantation is recommended as a second-line surgical option either after failure of initial arthroscopic repair or when a full-thickness articular cartilage defect is very large (2.5 cm2 or greater).  Autologous chondrocyte implantation should also be avoided in obese patients who have been shown to have no sustained improvement at two years. Worse outcomes have been reported in females with autologous chondrocyte implantation, especially in patients with patellar defects. Weak evidence has suggested some success with patellar autologous chondrocyte implantation, which remains off-label, but quality randomized controlled trials are lacking. In this patients case, the records noted a bipolar chondral lesion of the patellofemoral joint, which is a contraindication for autologous chondrocyte implantation. The failure rate of this procedure is high in this location. Thus, autologous chondrocyte implantation of the knee is not likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 21-year-old female enrollee has requested authorization and coverage for Octagam infusions. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition.

Answer: This patient has been treated with a variety of modalities, including beta-blocker therapy, fludrocortisone and pyridostigmine, but has some persistent symptomatology.

Context:
Summary Reviewer 1

A 21-year-old female enrollee has requested authorization and coverage for Octagam infusions. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the treatment of autonomic neuropathy can often involve multidisciplinary strategies, both from cardiovascular medicine as well as neurology. This patient has been treated with a variety of modalities, including beta-blocker therapy, fludrocortisone and pyridostigmine, but has some persistent symptomatology. There is the additional factor that there may be comorbidities to suggest autoimmune disorder as well. However, the use of intravenous immunoglobulin to treat autonomic dysfunction remains investigational. The study by Schofield is retrospective and only included 38 patients. There is a lack of support for the requested medication in this clinical setting. Therefore, Octagam infusions are not likely to be more beneficial than any available standard therapy.

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


Answer: A 47-year-old female enrollee has requested reimbursement and prospective authorization and coverage for pertuzumab injections from 8/18/15 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition.

Context:
Summary Reviewer 1

A 47-year-old female enrollee has requested reimbursement and prospective authorization and coverage for pertuzumab injections from 8/18/15 forward. The Health Insurer has denied this request indicating that the services at issue were and are considered investigational for treatment of the enrollees medical condition. The physician reviewer found pertuzumab is a monoclonal antibody that targets HER2 positive breast cancer cells, similar to, but not exactly in the same way as trastuzumab.  In metastatic breast cancer, when used in combination with chemotherapy and trastuzumab, pertuzumab yields superior progression-free survival compared to treatment with Taxotere-Herceptin without pertuzumab.  Combining pertuzumab with Herceptin and chemotherapy also appears to be superior to the combination without pertuzumab in the neoadjuvant situation.  However, there is a lack of data to support the use of combining pertuzumab with trastuzumab in the adjuvant setting.  Therefore, the superior efficacy of pertuzumab injections from 8/18/15 forward has not been established.  Based upon the information set forth above, the services at issue were not and are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 51-year-old female enrollee has requested authorization and coverage for the LINX reflux management system lower esophageal sphincter augmentation. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).

Context:
Summary Reviewer 2

A 51-year-old female enrollee has requested authorization and coverage for the LINX reflux management system lower esophageal sphincter augmentation. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that overall, there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than standard surgical anti-reflux procedures. One evidence review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Another best-evidence review concluded that long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval (Bauer, et al). Additionally, LINX more than surgical fundoplication is associated with severe dysphagia requiring endoscopic intervention (Sheu, et al). The currently available peer-reviewed literature does not support the conclusion that LINX is more likely to be beneficial in this case than standard treatment including surgical fundoplication (Sheu, et al). Further, the American College of Gastroenterology (ACG) guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). For these reasons, the requested LINX reflux management system lower esophageal sphincter augmentation is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested service is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer:
The patient is a 60-year-old female with a history of class 1 obesity complicated by dyslipidemia. The
records available for review indicate that the patient had a body mass index (BMI) over 30 kg/m2 prior
to beginning treatment with Wegovy.

Answer:
the issue is whether the
requested Wegovy solution auto-injector 0.25 mg/0.5 mL is medically necessary for the treatment of
this patient.

Answer:
In
this case, the patient has a history of class 1 obesity complicated by dyslipidemia. The records reflect
that the patient has attempted treatment with diet management and exercise without significant
benefit. Per the provider, the patient has contraindications or intolerances to several weight loss
medications.

Answer:
the patient has demonstrated prior weight loss success with
Wegovy.

Context:
Summary
The patient is a 60-year-old female with a history of class 1 obesity complicated by dyslipidemia. The
records available for review indicate that the patient had a body mass index (BMI) over 30 kg/m2 prior
to beginning treatment with Wegovy. The physician reviewer found that the issue is whether the
requested Wegovy solution auto-injector 0.25 mg/0.5 mL is medically necessary for the treatment of
this patient. According to Gadde and colleagues, while lifestyle modification is recommended as the
cornerstone of obesity management, many patients do not achieve long-lasting benefits due to difficulty
with adherence as well as physiological and neurohormonal adaptation of the body in response to
weight loss. There are multiple pharmacologic therapies available for weight management. Wegovy is a
member of a class of medications known as glucagon-like peptide 1 (GLP-1) analogs. As noted in the
medical literature, GLP-1 analogs have been shown to improve glycemic control, reduce body weight,
and decrease cardiovascular risk (Knudsen and Lau). Studies have demonstrated Wegovys ability to
promote weight loss via reduced appetite and energy intake and delayed gastric emptying (Cornell). In
this case, the patient has a history of class 1 obesity complicated by dyslipidemia. The records reflect
that the patient has attempted treatment with diet management and exercise without significant
benefit. Per the provider, the patient has contraindications or intolerances to several weight loss
medications. Wegovy has been shown to effectively promote weight loss for patients in conjunction
with diet and exercise. Furthermore, the patient has demonstrated prior weight loss success with
Wegovy. All told, the requested Wegovy solution auto-injector 0.25 mg/0.5 mL is medically necessary
for the treatment of this patient.

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


Answer:
The patient is a 52-year-old female who presented to her provider on 3/17/22. The patient reported
pain in her left knee that she rated at an eight out of a scale of ten. The patient has requested
reimbursement for Synvisc from 6/15/22 through 6/29/22. The Health Insurer has denied this
request and reported that the services at issue were not medically necessary.

Answer:
In this case, the
patient reported pain at a level of eight out of ten that did not respond to a corticosteroid injection
on 3/17/22. The patient had tried and failed other conservative treatments.

Context:
Summary Reviewer
The patient is a 52-year-old female who presented to her provider on 3/17/22. The patient reported
pain in her left knee that she rated at an eight out of a scale of ten. The patient has requested
reimbursement for Synvisc from 6/15/22 through 6/29/22. The Health Insurer has denied this
request and reported that the services at issue were not medically necessary. This denial is the
subject  of  this  appeal  and  determination.  The  physician  reviewer  found  that  the  submitted
documentation supports the medical necessity of the services at issue. Per the medical literature,
although viscosupplementation may relieve knee pain in some individuals with osteoarthritis, it is
not known as to which individuals will benefit. The current evidence is limited, and guidelines
from organizations such as the American Academy of Orthopedic Surgeons indicate that the
evidence  is  not  conclusive.  In  light  of  the  foregoing,  viscosupplementation  can  only  be
recommended in individuals with a history of lasting benefit from prior injections, and in carefully
selected cases where everything else has been tried, and the options are limited. In this case, the
patient reported pain at a level of eight out of ten that did not respond to a corticosteroid injection
on 3/17/22. The patient had tried and failed other conservative treatments. Given the patients
limited options and based on the current medical literature, the services at issue were medically
indicated. Therefore, Synvisc from 6/15/22 through 6/29/22 was medically necessary for the
treatment of this patient.

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


Answer:
A 30-year-old female enrollee has requested reimbursement for ultrasound and reading of the
ultrasound on 8/2/22. The Health Insurer has denied this request and reported that the service at
issue  was  investigational  for  the  evaluation  of  the  enrollees  pregnancy.

Answer:
In this case, notes dated 6/2/22
reported a body mass index of 28 kg/m2, the demise of a dichorionic twin at seven weeks, and the
finding of a uterine synechia.

Context:
Summary Reviewer 1

A 30-year-old female enrollee has requested reimbursement for ultrasound and reading of the
ultrasound on 8/2/22. The Health Insurer has denied this request and reported that the service at
issue  was  investigational  for  the  evaluation  of  the  enrollees  pregnancy.
The physician reviewer found that American Institute of Ultrasound Medicine (AIUM) notes that
detailed obstetric ultrasound examination is not intended to be the routine ultrasound examination
performed for all pregnancies. Rather, the AIUM notes that it is an indication-driven examination
performed for a known or suspected fetal anatomic abnormality, known fetal growth disorder,
genetic abnormality, or increased risk for a fetal anatomic or genetic abnormality or placenta
accreta spectrum. The Society for Maternal-Fetal Medicine (SMFM) notes that the performance
of the detailed fetal anatomic examination should be rare outside referral practices with special
expertise in the identification and diagnosis of fetal anomalies. In this case, notes dated 6/2/22
reported a body mass index of 28 kg/m2, the demise of a dichorionic twin at seven weeks, and the
finding of a uterine synechia. However, these are not indications that the more detailed fetal
ultrasound  at  issue  was  likely  to  be  beneficial  than  standard,  routine  ultrasound  screening
Therefore, ultrasound and reading of the ultrasound on 8/2/22 was not likely to have been more
beneficial for evaluation of the patients condition than any available standard therapy.

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


Answer: A 31-year-old female enrollee has requested authorization and coverage for exome sequence analysis (gene panel testing). The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition.

Context:
Summary Reviewer 1

A 31-year-old female enrollee has requested authorization and coverage for exome sequence analysis (gene panel testing). The Health Insurer has denied this request indicating that the requested services are considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is a lack of support for the requested services in this patients case.  The records do not demonstrate that a specific genetic condition is suspected by the requesting provider.  In the absence of a proposed diagnosis, there is insufficient evidence that this testing will change management or improve health for this patient.   In addition, given the early state of this technology, the implications of many genetic mutations are not currently known.  For these reasons, the requested services are not likely to be more efficacious than other methods of evaluating this patient.  Based upon the information set forth above, the requested services are 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 42-year-old female enrollee has requested reimbursement for DecisionDx Melanoma testing (84999) performed on 1/23/17. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cutaneous melanoma.

Context:
Summary Reviewer 2

A 42-year-old female enrollee has requested reimbursement for DecisionDx Melanoma testing (84999) performed on 1/23/17. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Although DecisionDx Melanoma may be an independent predictor of metastasis risk, there is a lack of peer-reviewed published studies confirming this hypothesis. For this reason, the DecisionDx Melanoma testing (CPT code 84999) performed on 1/23/17 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: The parent of a 17-year-old male enrollee has requested reimbursement for residential treatment provided from 2/06/13 through 5/03/13. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.

Answer: In this case, the patient was struggling with the developmental stage of identity formation which was complicated by a formidable anxiety and affective burden coupled with an underdeveloped sense of self and substance use which fueled dysphoria and parent-child disharmony.

Context:
Summary Reviewer

The parent of a 17-year-old male enrollee has requested reimbursement for residential treatment provided from 2/06/13 through 5/03/13. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue.  In this case, the patient was struggling with the developmental stage of identity formation which was complicated by a formidable anxiety and affective burden coupled with an underdeveloped sense of self and substance use which fueled dysphoria and parent-child disharmony.  The documentation provided does not support the medical necessity of the services at issue during the disputed timeframe.  It appears as though the patient and his family had not pursued evidence-based treatments in a less restrictive setting during the episode of illness.  Such interventions include, but are not limited to, school-based services, psychotherapy, chemical dependency counseling, family therapy, parent training and pharmacotherapy.  Additionally, the medical records did not include a psychiatric evaluation, psychosocial assessment, history and physical examination, or integrated summary justifying the necessity of the placement as opposed to a lower level of care.  The discharge summary, psychological evaluation and initial treatment plan did not describe behaviors, symptomatologies, or treatment interventions that would typically require a 24-hour supervised setting.  In sum, the documentation submitted for review did not suggest that a less restrictive setting would have been insufficient.  All told, residential treatment provided from 2/06/13 through 5/03/13 was not medically necessary for the treatment of this patient.  Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 30-year-old female enrollee has requested reimbursement for gene expression profiling performed on 6/29/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees malignant melanoma.

Context:
Summary Reviewer 2

A 30-year-old female enrollee has requested reimbursement for gene expression profiling performed on 6/29/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found the Decision Dx melanoma assay examines genes for certain markers and then the lesion can be further stratified to tell if it is high risk for metastasis. This test has shown some accuracy in thin melanomas. However, the patients treatment would not likely change based on the results of the exam. There is a lack of medical literature to support its use in patients with thin melanomas to effect health outcomes. Given the lack of published data to support the use of gene expression profiling, the testing performed on 6/29/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the 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 32-year-old male enrollee has requested authorization and coverage for Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 ml and Gamunex-C. The Health Insurer has denied this request and reported that the medication at issue is investigational for the treatment of the enrollees medical condition.

Answer: There has been a diagnosis of peripheral motor polyneuropathy. Medical records from his neurologist describes muscular atrophy and weakness, diminished distal reflexes, and no upper motor neuron signs. Headaches and autonomic dysfunction are also described. He has had treatment with Radicava, which is indicated for treatment of amyotrophic lateral sclerosis.

Context:
Summary Reviewer 3

A 32-year-old male enrollee has requested authorization and coverage for Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 ml and Gamunex-C. The Health Insurer has denied this request and reported that the medication at issue is investigational for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the requested medication. There has been a diagnosis of peripheral motor polyneuropathy. Medical records from his neurologist describes muscular atrophy and weakness, diminished distal reflexes, and no upper motor neuron signs. Headaches and autonomic dysfunction are also described. He has had treatment with Radicava, which is indicated for treatment of amyotrophic lateral sclerosis. The notes do not include electromyography/nerve conduction velocity studies or autoimmune studies. Based on the available records, the diagnosis is unclear. While motor neuropathy is commonly treated with intravenous immune globulin, there is a lack of evidence that intravenous immune globulin would be helpful for amyotrophic lateral sclerosis. Without a more distinct diagnosis, it is not possible to state that intravenous immune globulin is likely to be more effective than other therapies. Thus, Gammagard liquid (immune globulin (human) IV or subcutaneous solution 5 gm/50 mL) and Gamunex-C is not likely to be more beneficial than other treatment options.

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


Answer: The patient is a 36year-old female with a history of low back and right lower extremity pain due to a disc herniation at L4-5.  The patient has requested reimbursement for anterior interbody fusion with cage lumbar disc L4-5 performed on 4/23/21 and two days of inpatient hospitalization. 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: This patient has requested reimbursement for the surgery and two days of inpatient hospitalization.

Context:
Summary Reviewer

The patient is a 36year-old female with a history of low back and right lower extremity pain due to a disc herniation at L4-5.  The patient has requested reimbursement for anterior interbody fusion with cage lumbar disc L4-5 performed on 4/23/21 and two days of inpatient hospitalization. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that there is sufficient support for the services at issue in this clinical setting. Phan and colleagues performed a meta-analysis of seven studies, including 181 patients who underwent anterior lumbar discectomy and fusion after primary discectomy had resulted in a recurrence of low back and leg pain, as in this patients case. The authors noted that there are certain advantages to the anterior approach. Repeat posterior approach for recurrent herniations may result in trauma to the spinal nerves and paraspinal muscles that is avoided in the anterior approach. Furthermore, the authors noted that the exposure allows for a comprehensive discectomy. In these 181 patients, there was significant improvement in the Oswestry Disability Index and Visual Analogue Scale (VAS) back and leg pain scores. The average length of hospital stay was 5.28 days. This patient has requested reimbursement for the surgery and two days of inpatient hospitalization. The authors concluded that anterior lumbar interbody fusion is a feasible approach for the treatment of recurrent lumbar disc herniations and demonstrates good results, with minimal complications. As such, in the presence of a recurrent herniation with chronic low back and leg pain, and failure of conservative treatment, the services at issue were medically indicated. Therefore, the anterior interbody fusion with cage lumbar disc L4-5 performed on 4/23/21 and two days of inpatient hospitalization were medically necessary for the treatment of this patient.

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


Answer: The parent of a 13-year-old male enrollee has requested authorization and coverage for Humatrope 24 mg cartridge. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.

Answer: This patient had a low annual growth velocity which indicated abnormal growth. His estimated adult height gradually declined to 66 inches

Answer: His estimated adult height is below his genetic potential of 71.6 inches. Per the records, he failed growth hormone stimulation testing with a peak less than 10ng/mL

Context:
Summary Reviewer

The parent of a 13-year-old male enrollee has requested authorization and coverage for Humatrope 24 mg cartridge. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested medication in this clinical setting. This patient had a low annual growth velocity which indicated abnormal growth. His estimated adult height gradually declined to 66 inches, which indicates poor growth. His estimated adult height is below his genetic potential of 71.6 inches. Per the records, he failed growth hormone stimulation testing with a peak less than 10ng/mL, which indicates growth hormone deficiency in the setting of poor growth. Therefore, Humatrope 24 mg cartridge is medically necessary for the treatment of this patient.

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


Answer: The patient is a 44-year-old female who presented to the emergency department on 10/13/19 with complaints of abdominal pain status post dirt bike accident. At the time of presentation, her vital signs were stable, with a heart rate of 112 and normal oxygen saturations on room air.

Answer: in this case, the patient was admitted in stable condition. Her pain was controlled with oral pain medications.

Answer: Her vital signs were stable

Context:
Summary Reviewer

The patient is a 44-year-old female who presented to the emergency department on 10/13/19 with complaints of abdominal pain status post dirt bike accident. At the time of presentation, her vital signs were stable, with a heart rate of 112 and normal oxygen saturations on room air. The physician reviewer found that in this case, the patient was admitted in stable condition. Her pain was controlled with oral pain medications. She did not require any urgent surgery or procedures. Her vital signs were stable, and there was no evidence of hemodynamic instability or active bleeding. The inpatient admission was not medically necessary for this patient. Inpatient care is necessary when the patients signs and symptoms and general medical condition can only be managed safely in an acute inpatient setting,
when the patient requires diagnostic studies in an inpatient setting, or if it is medically necessary for the patient to remain in the acute inpatient setting. In this case, the patient was admitted in stable condition and could have been treated at a lower level of care. Therefore, inpatient admission provided from 10/13/19 through 10/14/19 was not medically necessary for the treatment of this patient.

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


Answer: A 48-year-old female enrollee has requested reimbursement for laparoscopic gastric sleeve (CPT 43775) performed on 12/17/15.  The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees morbid obesity.

Answer: This patient is an adult with morbid obesity.  Per the records, her body mass index was greater than 40 kg/m2 (it was 44.9 kg/m2). The patient documented prior dietary efforts and completed a multidisciplinary evaluation

Context:
Summary Reviewer

A 48-year-old female enrollee has requested reimbursement for laparoscopic gastric sleeve (CPT 43775) performed on 12/17/15.  The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees morbid obesity. The physician reviewer found the submitted documentation supports the medical necessity of the services at issue.  This patient is an adult with morbid obesity.  Per the records, her body mass index was greater than 40 kg/m2 (it was 44.9 kg/m2). The patient documented prior dietary efforts and completed a multidisciplinary evaluation that did not reveal any obvious medical, dietary or behavioral barriers to surgery. The patient met standard nationally accepted criteria for bariatric surgery.  The current medical evidence supports the services at issue in this clinical setting.  All told, laparoscopic gastric sleeve performed on 12/17/15 was medically indicated for the treatment of this patient.  Therefore, the services at issue were 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: An 18-year-old female enrollee has requested reimbursement for mental health residential treatment from 7/17/17 through 9/16/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.

Answer: The medical records indicate that the patient was not actively suicidal. The progress notes indicate that the patient was not engaging in self-harm behaviors or expressing suicidal ideation. She did have a history of suicidal ideation and attempts.

Answer: The patient has had some issues with level of functioning, but the progress notes indicate significant improvement after a period of deterioration as evidenced by appropriate activities of daily living and grooming.

Answer: The patient did not have active medical problems and reported a history of mild cannabis use issues.

Answer: The patient was noted to have interpersonal conflict with the family as a focus of treatment.

Answer: the progress notes document that her family therapy sessions were productive and not adversarial.

Answer: The patients parents were involved in treatment on a regular basis.

Answer: The patient had good response to a short period in the residential treatment center prior to the disputed dates. Her presentation during the disputed timeframe indicates that she was cooperative in treatment. She had a history of residential treatment in the past

Answer: The patient participated in therapy actively and was able to develop a positive relationship with clinicians.

Answer: The parents worked actively and constructively with clinicians on a regular basis.

Context:
Summary Reviewer

An 18-year-old female enrollee has requested reimbursement for mental health residential treatment from 7/17/17 through 9/16/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the American Academy of Child and Adolescent Psychiatry and the American Association of Community Psychiatrists Child and Adolescent Level of Care Utilization System (CALOCUS) provides a reliable framework for determining the appropriate level of care for adolescents needing mental health treatment. In terms of risk of harm, the records support a score of 2. The medical records indicate that the patient was not actively suicidal. The progress notes indicate that the patient was not engaging in self-harm behaviors or expressing suicidal ideation. She did have a history of suicidal ideation and attempts. In terms of functional status, the records support a score of 2. The patient has had some issues with level of functioning, but the progress notes indicate significant improvement after a period of deterioration as evidenced by appropriate activities of daily living and grooming. With regards to comorbidity, the records support a score of 2. The patient did not have active medical problems and reported a history of mild cannabis use issues.  She did not describe continued cravings, and there was no documentation of withdrawal symptoms from substances. In terms of level of stress of the recovery environment, the records support a score of 2. The patient was noted to have interpersonal conflict with the family as a focus of treatment. However, the progress notes document that her family therapy sessions were productive and not adversarial. With regards to level of support of the recovery environment, the records support a score of 2. The patients parents were involved in treatment on a regular basis. In terms of resiliency and treatment history, the records support a score of 3. The patient had good response to a short period in the residential treatment center prior to the disputed dates. Her presentation during the disputed timeframe indicates that she was cooperative in treatment. She had a history of residential treatment in the past, and it is not clear that her symptoms resolved with past treatment efforts. With regards to acceptance and engagement of the patient, the records support a score of 2. The patient participated in therapy actively and was able to develop a positive relationship with clinicians. In terms of acceptance and engagement of the parent, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Thus, the patient had a composite score of 17. This score correlates intensive outpatient services. Therefore, mental health residential treatment provided from 7/17/17 through 9/16/17 was not medically necessary for the treatment of this patient.

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


Answer: A 56-year-old male enrollee has requested authorization and coverage for proton treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees tumor of the hypopharynx.

Context:
Summary Reviewer 2

A 56-year-old male enrollee has requested authorization and coverage for proton treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees tumor of the hypopharynx. The physician reviewer found Currently, that there is a lack of clinical data in the medical literature to indicate the superior efficacy of the requested services when compared to conventional treatment options. In the majority of cases, the standard approach to treat this malignancy is with standard photon techniques using intensity modulated radiation therapy (IMRT).  A recent comparative analysis by Sio and colleagues found no significant difference in symptom burden in the acute and chronic phases of treatment with proton therapy compared to photon therapy for head and neck cancer. Also, the ASTRO emerging technology committee report on proton therapy specifically states that there is insufficient data to recommend proton beam therapy for routine head and neck radiation therapy outside of clinical trials, (Allen, et al). Moreover, there is a lack of level I evidence to support the use of proton therapy for the treatment of head and neck cancer.  The patients previous history of treatment with radioactive iodine does not preclude the use of standard treatment with photons. Therefore, proton therapy is not likely to be more effective than standard therapy in the treatment of this patients medical condition. 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 33-year-old female enrollee has requested reimbursement for 91037-26 (esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation) performed on 7/29/21. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.

Answer: in this case, the patient had severe dysphagia with an inability to tolerate solid food intake and a hiatal hernia, with upper gastrointestinal series showing reflux. Hernia repair surgery was being contemplated before the endoscopy with pH study.

Context:
Summary Reviewer 1

A 33-year-old female enrollee has requested reimbursement for 91037-26 (esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation) performed on 7/29/21. 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 in this case, the patient had severe dysphagia with an inability to tolerate solid food intake and a hiatal hernia, with upper gastrointestinal series showing reflux. Hernia repair surgery was being contemplated before the endoscopy with pH study. This is consistent with current medical literature, which recommends a pH study to evaluate esophageal motility before undergoing such a surgery. Additionally, dysphagia in the setting of dilated and angulated esophagus can be suggestive of achalasia, and warrants evaluation with impedance and with esophagogastroduodenoscopy. Furthermore, esophagogastroduodenoscopy is recommended for the evaluation of dysphagia. Therefore, 91037-26 (esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation) performed on 7/29/21 was likely to have been more beneficial than any available standard therapy.

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


Answer: A 60-year-old female enrollee has requested reimbursement for DecisionDX Melanoma gene expression assay performed on 12/23/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma.

Context:
Summary Reviewer 3

A 60-year-old female enrollee has requested reimbursement for DecisionDX Melanoma gene expression assay performed on 12/23/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found there is a lack of high-grade scientific data to support the superior efficacy of the services at issue in this clinical setting. The DecisionDX Melanoma gene expression assay has not been clinically shown to add to the current standard of care for the evaluation of malignant melanoma. Therefore, the DecisionDX Melanoma gene expression assay performed on 12/23/15 was not likely to be more effective than standard treatment for the evaluation of this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer:
The parent of a seven-year-old female enrollee has requested authorization and coverage for
Xeljanz 5 mg tablet. The Health Insurer has denied this request and reported that the requested
medication is investigational for the treatment of the enrollees alopecia.

Context:
Summary Reviewer 1

The parent of a seven-year-old female enrollee has requested authorization and coverage for
Xeljanz 5 mg tablet. The Health Insurer has denied this request and reported that the requested
medication is investigational for the treatment of the enrollees alopecia. The physician reviewer
found that the U.S. Food and Drug Administration (FDA) approves the use of one Janus kinase
(JAK) inhibitor, Olumiant (generic name baricitinib), for the treatment of adult patients with
severe alopecia areata. Pediatric-onset alopecia areata, including alopecia universalis, tends to
be more severe and carries a worse prognosis than adult-onset disease. While there are no FDA
approved treatments for alopecia areata in pediatric patients, current medical literature supports
the use of oral JAK inhibitors, such as Xeljanz, as resulting in an improvement of Severity of
Alopecia Tool (SALT) scores. Kennedy Crispin and colleagues report that tofacitinib is a safe and
effective treatment for severe alopecia areata. Toussi and colleagues note that alopecia areata
has substantial psychosocial impact on patients and results in reduced health-related quality of
life, which should be addressed as an active part of treatment. In this case, given the patients
response to Xeljanz, including hair regrowth and improvement of psychiatric comorbidities, the
requested medication is likely to be more beneficial than the several other treatments that she
has already tried and failed. Therefore, Xeljanz 5 mg tablet is 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: The patient is a 57-year-old male with a history of oligometastatic adenocarcinoma of his prostate gland. The patient has requested authorization and coverage for intensity modulated radiation therapy image-guided radiation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.

Context:
Summary Reviewer

The patient is a 57-year-old male with a history of oligometastatic adenocarcinoma of his prostate gland. The patient has requested authorization and coverage for intensity modulated radiation therapy image-guided radiation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that the requested services are standard of care in this clinical setting. High-quality clinical outcomes published in the peer-reviewed medical literature have proven that aggressive consolidation of oligometastatic prostate cancer is associated with a significant improvement in chances for long-term survival. The high-quality prospective trial by Parker and colleagues supports such a benefit, as definitive radiotherapy improved failure-free survival. IMRT is widely employed nationwide for similar patients in this setting. Therefore, intensity modulated radiation therapy image-guided radiation is medically necessary for the treatment of this patient.

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


Answer: A 51-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.

Answer: This patient presents with a history of chronic severe right ankle pain and swelling. Significant functional limitations are noted that interfere with activities of daily living. There is imaging evidence of a very large cystic osteochondral lesion of the right talus. She has failed long-term conservative management as well as operative intervention. She is not a candidate for microfracture surgery due to the size of the lesion.

Context:
Summary Reviewer 2

A 51-year-old female enrollee has requested authorization and coverage for autologous chondrocyte implantation. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that current evidence-based medical literature supports the use of autologous chondrocyte implantation as a first-line treatment option for large articular cartilage defects. The literature supports treatment with bone marrow stimulation for lesions of smaller sizes, whereas treatment with autologous osteochondral transplantation may be utilized for larger or cystic lesions. The literature indicates that autologous chondrocyte implantation of the talus yields improvement in all parameters tested, with enduring long-term results in patients who have failed previous surgery for osteochondral lesions of the talus. This patient presents with a history of chronic severe right ankle pain and swelling. Significant functional limitations are noted that interfere with activities of daily living. There is imaging evidence of a very large cystic osteochondral lesion of the right talus. She has failed long-term conservative management as well as operative intervention. She is not a candidate for microfracture surgery due to the size of the lesion. Current evidence-based medical literature supports the use of autologous chondrocyte implantation in this clinical setting as a salvage procedure. In sum, autologous chondrocyte implantation is likely to be more beneficial than other treatment options.

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


Answer: A 55-year-old female enrollee has requested reimbursement for cervical spine surgery performed on 7/25/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees neck pain and tingling in the upper extremities.

Answer: This patient presented with persistent and worsening neck pain radiating down the left upper extremity, with tingling and weakness, and progressive right upper extremity symptoms. Associated symptoms included clumsiness and inability to grasp and hold objects. She was no longer able to work. Clinical examination findings evidenced C6 and C7 myotomal weakness

Answer: evidence of long-term reasonable and/or comprehensive nonoperative treatment protocol trial and failure has been submitted.

Context:
Summary Reviewer

A 55-year-old female enrollee has requested reimbursement for cervical spine surgery performed on 7/25/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees neck pain and tingling in the upper extremities.The physician reviewer found there is sufficient support for the services at issue in this clinical setting. Davis and colleagues performed a prospective, randomized, controlled, multicenter clinical trial on two-level symptomatic degenerative disc disease. Their findings supported the use of cervical arthroplasty at two contiguous levels and demonstrated advantages over two-level anterior cervical discectomy and fusion. The U.S. Food and Drug Administration has approved the use of artificial disc replacement for skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or neurologic deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging: herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes) and/or visible loss of disc height compared with adjacent levels. This patient presented with persistent and worsening neck pain radiating down the left upper extremity, with tingling and weakness, and progressive right upper extremity symptoms. Associated symptoms included clumsiness and inability to grasp and hold objects. She was no longer able to work. Clinical examination findings evidenced C6 and C7 myotomal weakness consistent with imaging evidence of nerve root compromise at the C5-C6 level and bilateral neural foraminal stenosis at the C6-C7 level. Detailed evidence of long-term reasonable and/or comprehensive nonoperative treatment protocol trial and failure has been submitted. Evidence-based criteria were met to establish the medical necessity of this surgical intervention. Therefore, the cervical spine surgery performed on 7/25/17 was medically necessary for the treatment of this patient. Therefore, the services at issue were 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 patient is a 51-year-old female who had a vaginal delivery in 2004 complicated by grade 4 episiotomy and Clostridium difficile on and off for six months. The patient has requested reimbursement for opium tincture 10 mg/mL provided on 2/18/20. The Health Insurer has denied this request and reported that the medication at issue was not medically necessary for the treatment of this patient.

Answer: The patient has been stabilized on opium tincture for several years. She has attempted several medical alternatives and has undergone sacral nerve stimulator.

Context:
Summary Reviewer

The patient is a 51-year-old female who had a vaginal delivery in 2004 complicated by grade 4 episiotomy and Clostridium difficile on and off for six months. The patient has requested reimbursement for opium tincture 10 mg/mL provided on 2/18/20. The Health Insurer has denied this request and reported that the medication at issue was not medically necessary for the treatment of this patient. The physician reviewer found that the use of opium tincture is supported as medically necessary for the treatment of this patientas incontinence and diarrhea. American Society of Colon and Rectal Surgeons guidelines for the treatment of fecal incontinence state that medical management should be first-line therapy, and opioids result in decreased intestinal motility, decreased intestinal secretion, and increased absorption. Opiates are recommended as safe and effective for the treatment of chronic diarrhea. The patient has been stabilized on opium tincture for several years. She has attempted several medical alternatives and has undergone sacral nerve stimulator. There is sufficient support for the requested medication in this setting. Therefore, opium tincture 10 mg/mL provided on 2/18/20 was medically necessary for the treatment of this patient.

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


Answer: A 54-year-old female enrollee has requested reimbursement for left and right eye refraction surgery performed on 9/19/16 and 10/07/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollee, who has a history of blurred vision.

Answer: The records show that the patient did have symptomatic cataracts

Context:
Summary Reviewer

A 54-year-old female enrollee has requested reimbursement for left and right eye refraction surgery performed on 9/19/16 and 10/07/16. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollee, who has a history of blurred vision. The physician reviewer found that the submitted submitted documentation supports the medical necessity of a portion of the services at issue. The records show that the patient did have symptomatic cataracts requiring surgery. The Health Insurers argument that the surgery was purely for refractive reasons was not substantiated upon reviewing the medical records. Thus, the portion of surgeries to treat cataract was medically necessary. The additional treatments of femtosecond laser and multifocal intraocular lens were for the purpose of refractive treatment and were not medically necessary. Therefore, a portion of the services at issue was 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 32-year-old female enrollee has requested reimbursement for laboratory testing performed on 6/26/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.

Context:
Summary Reviewer 2

A 32-year-old female enrollee has requested reimbursement for laboratory testing performed on 6/26/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that when performing thrombophilia screening, while the probability of a positive assay is higher in patients with a history of thrombus, the information provided does not help to inform future management. Various professional organizations have published guidelines indicating that routine thrombophilia screening in patients presenting with thrombosis should not be performed. In this
case, results of the thrombophilia screen is not likely to justify an evidence-based modification of this patients management. Furthermore, the consulting provider indicated that the deep vein thrombosis was considered to be a provoked event. The medical evidence does not support thrombophilia screening in this setting. In sum, laboratory testing performed on 6/26/19 was not likely to have been more beneficial than other methods of evaluating this patient.

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


Answer:
A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy.
The  Health  Insurer  has  denied  this  request  and  reported  that  the  requested  service  is
investigational for the treatment of the enrollees prostate cancer.

Context:
Summary Reviewer 3

A 62-year-old male enrollee has requested authorization and coverage for proton beam therapy.
The  Health  Insurer  has  denied  this  request  and  reported  that  the  requested  service  is
investigational for the treatment of the enrollees prostate cancer. The physician reviewer found
that in this clinical setting, the only justified use for proton therapy would be in a clinical trial.
Standard radiation therapy for prostate cancer is with x-ray IMRT radiation therapy, which has
been shown to carry no long-term significant side effects. There is a lack of evidence in current
medical literature showing improvement in terms of local control of the prostate cancer or for a
survival benefit with the use of proton therapy. The NCCN guidelines note that photon or proton
EBRT are both effective at achieving highly conformal radiotherapy with acceptable and similar
biochemical control and long-term side effect profiles. Takeda and colleagues reported a very
low  rate  of  grade  3  urine  toxicity,  which  is  not  life-threatening  and  does  not  require
hospitalization, in patients with prostate cancer treated with IMRT and no in stances of grade 4
toxicity. In a study regarding 15-year outcomes data for 301 patients with prostate cancer treated
with x-ray IMRT, Weg and colleagues observed grade 3 gastrointestinal toxicity in three patients
and no instances of grade 4 toxicity. The Radiation Therapy Oncology Group (RTOG) protocol
notes that the small bowel can tolerate a maximum dose of 50 Gy, which is more than the typical
dosage of 45 Gy in 2 gray equivalent dosage for EBRT treatment of elective lymph nodes for
prostate cancer. In this case, the patient reported concern regarding the potential impact of ADT
due to his history of hypogonadism. In this clinical setting, the NCCN recommends brachytherapy
and EBRT, noting that ADT is only optional in this setting. Therefore, proton beam therapy 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: The patient is a 39-year-old female who underwent genetic testing during pregnancy.  Specifically, she underwent testing for the SMARCA4 gene mutation. The patient had a prior affected child with the SMARCA4 gene mutation leading to the child having Coffin-Siris syndrome. She has requested reimbursement for SMARCA4 gene mutation and chromosome testing performed on 8/14/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.

Context:
Summary Reviewer 3

The patient is a 39-year-old female who underwent genetic testing during pregnancy.  Specifically, she underwent testing for the SMARCA4 gene mutation. The patient had a prior affected child with the SMARCA4 gene mutation leading to the child having Coffin-Siris syndrome. She has requested reimbursement for SMARCA4 gene mutation and chromosome testing performed on 8/14/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.  There is sufficient support for the services at issue in this clinical setting. Per the records, there is a higher chance than the general population that the fetus may have the gene mutation SMARCA4 leading to Coffin-Siris syndrome.  Since this patient already had a severely affected offspring, the information from this testing was important in making important medical decisions regarding the pregnancy. Thus, SMARCA4 gene mutation and chromosome testing performed on 8/14/17 were likely to be of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: The patient is a 49-year-old male with a history of acute trauma to the thigh resulting in a thigh compartment syndrome. He underwent an emergency fasciotomy; however, the submitted documentation indicates the treating surgeon was not familiar with post-surgical care. The record noted a 14-inch draining skin incision. The patient was transported by air ambulance from Florida to Dallas, Texas. The patient has requested reimbursement for air ambulance services provided on 11/25/17. The Health Plan has denied this request and reported that the services at issue were not medically necessary.

Answer: the record had noted that the patients vital signs were stable

Answer: The patient had a 14-inch long draining wound and the submitted documentation indicates the initial surgeon was not familiar with current fasciotomy wound closure techniques.

Answer: The patient could not utilize public transportation due to the need for maximum assistance with ambulation. His ambulation was limited to use of bathroom only with assistance. He required dressing changes by medical personnel with sterile precautions as needed to keep wound clean during transport.

Context:
Summary Reviewer

The patient is a 49-year-old male with a history of acute trauma to the thigh resulting in a thigh compartment syndrome. He underwent an emergency fasciotomy; however, the submitted documentation indicates the treating surgeon was not familiar with post-surgical care. The record noted a 14-inch draining skin incision. The patient was transported by air ambulance from Florida to Dallas, Texas. The patient has requested reimbursement for air ambulance services provided on 11/25/17. The Health Plan has denied this request and reported that the services at issue were not medically necessary. This denial is the subject of this appeal and determination.  There is sufficient support in the documentation and the medical literature for the medical necessity of the services at issue. Early fasciotomy is the gold standard of prevention and treatment of compartment syndrome; however, the resulting wounds may significantly increase morbidity. To address the challenge of timely and safe closure of fasciotomy wounds, numerous methods have been described. Thorough knowledge of available techniques and their comparative advantages is essential for their clinical implementation, careful selection of patients, management of possible complications, decreased morbidity, and hospital recovery time are also crucial for optimization of functional and aesthetic outcomes. The patient had a 14-inch long draining wound and the submitted documentation indicates the initial surgeon was not familiar with current fasciotomy wound closure techniques. Transfer by air ambulance to a tertiary care institution was needed in light of the 14-inch long draining open wound and the patients pain. There was an urgent need for wound management at a tertiary care center to prevent deep infection, facilitate healing, and prevent complications such as deep vein thrombosis. The patient could not utilize public transportation due to the need for maximum assistance with ambulation. His ambulation was limited to use of bathroom only with assistance. He required dressing changes by medical personnel with sterile precautions as needed to keep wound clean during transport. While the record had noted that the patients vital signs were stable, stable vitals do not mean a sudden change in vitals cannot take place at any moment due to bleeding from an open wound. The presence of emergency medical personnel was essential. Tertiary care in Dallas, Texas was chosen because it was near his home. His treatment in Orlando, Florida would have necessitated a prolonged stay for follow-up care and inability to use public transportation. As noted above, the surgeon in Florida was unfamiliar with vacuum assisted closure.  Vacuum assisted closure technique has one of the lowest complication rates. In sum, air ambulance services provided on 11/25/17 were medically necessary for treating this patients medical condition. Therefore, for the reasons stated above, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer: A 19-year-old male enrollee has requested reimbursement for 84999 performed on 10/17/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.

Answer: this patient had an early stage melanoma.

Context:
Summary Reviewer

A 19-year-old male enrollee has requested reimbursement for 84999 performed on 10/17/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that this patient had an early stage melanoma. The National Comprehensive Cancer Network guidelines states while there is interest in newer prognostic molecular techniques, such as gene expression profiling, to differentiate melanomas at low versus high risk for metastasis, routine prognostic genetic testing of primary cutaneous melanomas is not recommended outside of a clinical trial. Newer prognostic molecular techniques should not replace standard staging procedures.  In addition, there is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. Therefore, CPT 84999 performed on 10/17/18 was not medically necessary for the evaluation of this patient.

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


Answer: The patient is a 64-year-old male with a diagnosis of hypogonadism. His symptoms include decreased energy and libido, mood swings, sleepiness and changes in fat/muscles. His pre-treatment testosterone level was 208 in 2011. The patient has been treated with testosterone injections and Testopel. The patient is requesting reimbursement for Testopel implants provided on 1/21/16 and 5/26/16. The Health Insurer has denied this request as investigational.

Context:
Summary Reviewer 1

The patient is a 64-year-old male with a diagnosis of hypogonadism. His symptoms include decreased energy and libido, mood swings, sleepiness and changes in fat/muscles. His pre-treatment testosterone level was 208 in 2011. The patient has been treated with testosterone injections and Testopel. The patient is requesting reimbursement for Testopel implants provided on 1/21/16 and 5/26/16. The Health Insurer has denied this request as investigational. The use of Testopel is appropriate only for patients with an appropriate diagnosis of hypogonadism based on criteria recommended by national and international guidelines. Guidelines require measurement of two morning testosterone levels along with follicle-stimulating hormone/luteinizing hormone (FSH/LH) levels prior to initiation of therapy to identify the presence of and type of hypogonadism. In this case, the documentation submitted for review does not support that this was performed. In addition, patients who are on testosterone replacement should be monitored with laboratory work-up that includes testosterone, hematocrit, prostate-specific antigen (PSA), and lipid profile initially at frequent intervals and annually thereafter. Based on the clinical documentation submitted for review, the Testopel implants provided on 1/21/16 and 5/26/16 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 65-year-old female enrollee has requested reimbursement for autonomic nerve function testing performed on 3/26/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.

Context:
Summary Reviewer 1

A 65-year-old female enrollee has requested reimbursement for autonomic nerve function testing performed on 3/26/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is a lack of support for the services at issue in this clinical setting.  While autonomic testing can be useful in select cases where clear autonomic symptoms and findings have been documented, it should not be used in generic cases where a patient is noted to have pain.  In this case, the records do not clearly demonstrate marked autonomic findings or symptoms.  In the absence of this, autonomic testing has not been shown by clinical studies to statistically improve the management of patients.  The patient can be evaluated for treatable causes of peripheral neuropathies in the absence of the requested testing.  All told, autonomic nerve function testing performed on 3/26/15 was not likely to have been of greater benefit than other alternatives.  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 65-year-old female enrollee has requested reimbursement for autonomic nerve function testing performed on 3/26/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.

Answer: The patients history is not well-documented

Context:
Summary Reviewer 3

A 65-year-old female enrollee has requested reimbursement for autonomic nerve function testing performed on 3/26/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the superior efficacy of the services at issue has not been established.  The patients history is not well-documented and does not indicate features of neuropathy.  The examination was inadequate to discern if neuropathy was a realistic consideration. Electrodiagnostic test results were not submitted for review.  If small fiber neuropathy is within the differential, commonly such individuals would be assessed by a neurologist familiar with neuropathy, and undergo more detailed neurologic clinical examination.  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 51-year-old male enrollee has requested authorization and coverage for Octagam intravenous immune globulin (IVIG). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees bilateral upper extremity weakness and atrophy.

Answer: this patient developed progressive motor neuropathy

Answer: the patients condition is active and he is losing axons.

Context:
Summary Reviewer

A 51-year-old male enrollee has requested authorization and coverage for Octagam intravenous immune globulin (IVIG). The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees bilateral upper extremity weakness and atrophy.  The physician reviewer found the records provided for review demonstrate that this patient developed progressive motor neuropathy that could be related to a variant of lower motor neuron syndrome. However, a variant of chronic inflammatory demyelinating polyneuropathy (CIDP), multifocal motor neuropathy or inflammatory neuropathy cannot be excluded. Considering the fact that the disease is active and progressive, a short trial of IVIG as recommended by the provider is appropriate. If the patient has an inflammatory neuropathy, he may respond to IVIG. In addition, the patients condition is active and he is losing axons. Delaying IVIG treatment in inflammatory neuropathy may limit the patients response to immunotherapy. An IVIG trial may help support or exclude the diagnosis of CIDP variant. Given this support, the requested Octagam IVIG is supported as medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer: A 55-year-old male enrollee has requested authorization and coverage for heart surgery (93580, percutaneous transcatheter closure of heart defect). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees patent foramen ovale.

Context:
Summary Reviewer 2

A 55-year-old male enrollee has requested authorization and coverage for heart surgery (93580, percutaneous transcatheter closure of heart defect). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees patent foramen ovale. The physician reviewer found that the submitted records fails to demonstrate the superior efficacy of the requested services in this clinical setting. In this circumstance, while there is increasing evidence to suggest that patent foramen ovale device closure may more effective than medical therapy alone for select patients age 60 years or younger with a cryptogenic non-lacunar ischemic stroke who have a patent foramen ovale, the patients most likely to benefit are those with large right-to-left interatrial shunting and/or an associated atrial septal aneurysm, neither of which is documented in this patient. Based on the documentation, medical management with aspirin is most appropriate in this case. In sum, heart surgery (93580, percutaneous transcatheter closure of heart defect) is not likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: The patient is a 64-year-old female who presented to the neurosurgery clinic after being diagnosed with a right carotid occlusion and high-grade stenosis of the left carotid artery.  She has a history of several transient ischemic attacks with complaints of dizziness as well as headaches and blurry vision. The patient underwent left internal carotid artery angioplasty and stenting on 2/27/18.  The angiogram noted high-grade stenosis of the right vertebral artery is 70%, and a computed tomography (CT) perfusion revealed decreased blood flow to the right occipital lobe. During the postoperative examination, she continued with symptomatic dizziness, and the recommendation was made for right vertebral artery angioplasty with stenting.  The provider noted she is at increased risk for stroke should she become dehydrated or hypotensive given the carotid occlusion and stenosis of the right vertebral artery. The patient has requested coverage for vertebral artery angioplasty. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient.  This patient has been recommended to undergo a vertebral artery angioplasty due to vertebral artery occlusion.  The patient underwent left internal carotid artery angioplasty and stenting on 2/27/18 and was noted to have a follow-up on 3/06/18 where she indicated she was doing well. She did complain of one episode of dizziness.

Context:
Summary Reviewer 3

The patient is a 64-year-old female who presented to the neurosurgery clinic after being diagnosed with a right carotid occlusion and high-grade stenosis of the left carotid artery.  She has a history of several transient ischemic attacks with complaints of dizziness as well as headaches and blurry vision. The patient underwent left internal carotid artery angioplasty and stenting on 2/27/18.  The angiogram noted high-grade stenosis of the right vertebral artery is 70%, and a computed tomography (CT) perfusion revealed decreased blood flow to the right occipital lobe. During the postoperative examination, she continued with symptomatic dizziness, and the recommendation was made for right vertebral artery angioplasty with stenting.  The provider noted she is at increased risk for stroke should she become dehydrated or hypotensive given the carotid occlusion and stenosis of the right vertebral artery. The patient has requested coverage for vertebral artery angioplasty. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of this patient.  This patient has been recommended to undergo a vertebral artery angioplasty due to vertebral artery occlusion.  The patient underwent left internal carotid artery angioplasty and stenting on 2/27/18 and was noted to have a follow-up on 3/06/18 where she indicated she was doing well. She did complain of one episode of dizziness. While treatment with the requested surgical intervention may be appropriate in certain situations, it does not appear this patient is an appropriate candidate. There is lack of documentation indicating that the stenosis continues to make the patient symptomatic.  The follow-up note indicated the patient was doing well and only had one episode of dizziness.  Given the above, the requested vertebral artery angioplasty is not likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A  55-year-old female enrollee has requested reimbursement for DecisionDX-melanoma laboratory testing performed on 5/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees malignant melanoma.

Answer: this patient was staged as T1a, melanoma, with no mitoses seen.

Context: Summary Reviewer  A  55-year-old female enrollee has requested reimbursement for DecisionDX-melanoma laboratory testing performed on 5/13/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found that the staging and prognosis of cutaneous malignant melanoma is classically determined by the system spelled out by Balch and colleagues. There may be some further value in adding the mitotic rate to this system.  As per this system, this patient was staged as T1a, melanoma, with no mitoses seen. This would have an expected ten year survival of at least 88%.  There is no information in the records submitted as to whether she had sentinel node performed. DecisionDX, melanoma assay is a study of 31 genes in melanoma cells.  It then classifies that particular melanoma as either class 1 (with a 97% disease-free rate at five years) or class 2 (with a 31% disease free-rate at five years).  It is not clear how DecisionDX data compares to the ten year data of the Balch determinations, and whether it can be used to make clinical practice decisions.  This is particularly in question in this patients case given her pathologic findings and excellent prognosis.  All told, DecisionDX-melanoma laboratory testing performed on 5/13/16 was not likely to have been more effective than other modalities for evaluating 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 30-year-old male with a history of extensive physical and emotional abuse dating back to childhood and a history of alcohol as well as drug abuse. He was currently not working as a private basketball trainer due to COVID-19 and associated restrictions.

Answer: He has been involved in excessive use of substances. There was no suicidal or homicidal ideation.

Answer: The patient had relationship problems as a result of his drinking. His relationship with his girlfriend had suffered, and there was strain with his mother as well. He was motivated to achieve stability in these relationships and was engaged in family therapy.

Answer: He has insulin dependent diabetes mellitus. There was nothing in the notes to indicate that his blood sugars were unstable.

Answer: He was unable to work due to COVID-19 restrictions and was financially dependent on his mother.

Answer: The patientas mother participated in treatment.

Answer: The patient has had emotional problems since childhood and has struggled with substance use.

Answer: He had acceptance of his illness and was engaged in his treatment. He was motivated to get better.

Context:
Summary Reviewer

The patient is a 30-year-old male with a history of extensive physical and emotional abuse dating back to childhood and a history of alcohol as well as drug abuse. He was currently not working as a private basketball trainer due to COVID-19 and associated restrictions. The physician reviewer found that the American Association of Community Psychiatrists Level of Care Utilization System (LOCUS) provides a reliable framework for determining the appropriate level of care for adults needing mental health treatment. Using LOCUS, providers score patients on a scale of 1-5 using a six-pronged Dimensional Rating System. The six dimensions include: (1) risk of harm; (2) functional status; (3) medical, addictive and psychiatric comorbidity; (4) recovery environment (a.
stressors and b. supports); (5) treatment and recovery history; and (6) engagement. The composite score is then used to determine the level of care needed.
In terms of risk of harm, the records support a score of 3. He has been involved in excessive use of substances. There was no suicidal or homicidal ideation.
With regard to functional status, the records support a score of 3. The patient had relationship problems as a result of his drinking. His relationship with his girlfriend had suffered, and there was strain with his mother as well. He was motivated to achieve stability in these relationships and was engaged in family therapy.
In terms of comorbidity, the records support a score of 3. He has insulin dependent diabetes mellitus. There was nothing in the notes to indicate that his blood sugars were unstable.
With regard to level of stress of the recovery environment, the records support a score of 3. He was unable to work due to COVID-19 restrictions and was financially dependent on his mother.
In terms of level of support of the recovery environment, the records support a score of 2. The patientas mother participated in treatment.
With regard to resiliency and treatment history, the records support a score of 3. The patient has had emotional problems since childhood and has struggled with substance use.
In terms of engagement and recovery status, the records support a score of 2. He had acceptance of his illness and was engaged in his treatment. He was motivated to get better.
Thus, the records support a composite score of 19. Intensive outpatient program level of care was medically indicated. Therefore, intensive outpatient program services provided from 7/15/20 through 10/08/20 were medically necessary for the treatment of this patient.

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


Answer: A 51-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) performed on 3/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.

Answer: This patient reported itching and discharge.

Context:
Summary Reviewer 3

A 51-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) performed on 3/18/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that patients with vaginitis can be evaluated and treated with an examination, microscopy and/or cultures, depending on the patients symptoms and findings. This patient reported itching and discharge. The services performed in this patients case were clinically appropriate. Per the American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin number 215, Although microscopy with Amsel criteria and Gram staining with Nugent scoring remain the preferred methods and the most cost-effective way to diagnosis bacterial vaginosis, some newer commercially available diagnostic tests show promise for use in the clinical setting and may be considered when microscopy is unavailable. Per the medical evidence, this single-swab multiplex test may be a promising alternative to microscopy. Thus, PCR testing performed on 3/18/19 was likely to have been more beneficial than other methods of evaluating this patient.

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