Answer:
The patient is a 28-year-old male who presented to his provider on 9/2/22. The patient has
requested reimbursement for magnetic resonance (e.g. proton) imaging, any joint of lower
extremity, without contrast material, on 9/21/22. The Health insurer has denied this request and
reported that the services at issue were not medically necessary for the evaluation of this patient.

Answer:
In this case, the patient had left ankle and right knee pain for
years that did not respond to conservative treatment. Notes dated 9/2/22 reported left posterior
tibial tendon tenderness and a positive Tinels sign, suggesting impingement. Subsequent MRI
imaging of the ankle did not show structural issues. The patient reported that the MRIs resulted
in a diagnosis of Tarsal Tunnel syndrome and referral for EMG. An EMG was conducted by a
neurologist that confirmed the diagnosis. Notes dated 9/2/22 also reported severe right knee
medial joint line tenderness and patellofemoral pain. MRI of the right knee revealed a deep root
tear of the meniscus requiring arthroscopy.

Context:
Summary Reviewer

The patient is a 28-year-old male who presented to his provider on 9/2/22. The patient has
requested reimbursement for magnetic resonance (e.g. proton) imaging, any joint of lower
extremity, without contrast material, on 9/21/22. The Health insurer has denied this request and
reported that the services at issue were not medically necessary for the evaluation of this patient.
The physician reviewer found that the submitted documentation supports the medical necessity
of a portion of the services at issue. In this case, the patient had left ankle and right knee pain for
years that did not respond to conservative treatment. Notes dated 9/2/22 reported left posterior
tibial tendon tenderness and a positive Tinels sign, suggesting impingement. Subsequent MRI
imaging of the ankle did not show structural issues. The patient reported that the MRIs resulted
in a diagnosis of Tarsal Tunnel syndrome and referral for EMG. An EMG was conducted by a
neurologist that confirmed the diagnosis. Notes dated 9/2/22 also reported severe right knee
medial joint line tenderness and patellofemoral pain. MRI of the right knee revealed a deep root
tear of the meniscus requiring arthroscopy. While the American College of Radiology (ACR) notes
that MRI is usually not appropriate in the setting of chronic ankle or knee pain without prior x-
rays, given this patients multi-year history of prolonged and unexplained ankle and knee pain,
the services at issue were medically indicated. Therefore, magnetic resonance imaging of the
right knee and the left ankle were medically necessary for the evaluation of this patient.

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


Answer:
The parent of a 13-year-old female enrollee has requested reimbursement for needle
electromyography (EMG) of anal or urethral sphincter, any technique; needle
electromyography, each extremity; and electroencephalogram performed on 6/10/20. The
Health Insurer has denied this request and reported that the services at issue were
investigational for the treatment of the enrollees medical condition.

Answer:
This
patient was being treated for adolescent idiopathic scoliosis. She underwent a thoracoscopic
anterior spinal tethering.

Context:
Summary Reviewer 1

The parent of a 13-year-old female enrollee has requested reimbursement for needle
electromyography (EMG) of anal or urethral sphincter, any technique; needle
electromyography, each extremity; and electroencephalogram performed on 6/10/20. The
Health Insurer has denied this request and reported that the services at issue were
investigational for the treatment of the enrollees medical condition. The physician reviewer
found that the medical evidence supports the services at issue in this clinical setting. This
patient was being treated for adolescent idiopathic scoliosis. She underwent a thoracoscopic
anterior spinal tethering. This procedure involved a high risk of significant complications. The
use of electromyographical monitoring has been found beneficial to help prevent further injury
during this procedure. Therefore, needle electromyography (EMG) of anal or urethral sphincter,
any technique; needle electromyography, each extremity; and electroencephalogram
performed on 6/10/20 was likely to have been more beneficial than any available standard
therapy.

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


Answer: The parent of a two-year-old male enrollee has requested reimbursement for FirstStepDX Plus chromosomal microarray analysis.  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 3

The parent of a two-year-old male enrollee has requested reimbursement for FirstStepDX Plus chromosomal microarray analysis.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found that CMA is increasingly utilized for genetic testing of individuals with unexplained developmental delay/intellectual disability, autism spectrum disorders, or multiple congenital anomalies.  CMA offers a much higher diagnostic yield for genetic testing of patients with unexplained developmental delay/intellectual disability, autism spectrum disorder, or multiple congenital anomalies than the previous standard testing with G-banded karyotype, primarily because of its higher sensitivity for submicroscopic deletions and duplications.  Available evidence strongly supports the use of CMA in place of G-banded karyotyping as the first-tier cytogenetic diagnostic test for patients with developmental delay/intellectual disability, autism spectrum disorders, or multiple congenital anomalies.  Given that the standard of care is now CMA, the FirstStepDx Plus chromosomal microarray was likely to have been of greater benefit than other methods of evaluation.  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: A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.

Context:
Summary Reviewer 1

A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested services in this clinical setting. The medical evidence does not support the use of intravenous, intramuscular, or subcutaneous immune globulin as a treatment to prevent recurrent spontaneous abortion in pregnant women. The American College of Obstetricians and Gynecologists does not support the requested services for the treatment of this patient. The use of intravenous immune globulin for pregnancy loss prevention has not been demonstrated by large scale, prospective clinical trials to have superior outcomes compared to existing therapies. Therefore, immune globulin injection (Gamunex-C), 500 mg is not likely to be of greater benefit than other treatment options.

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


Answer: A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.

Answer: This patients provider seeks to treat her recurrent pregnancy loss thought to be of autoimmune nature with intravenous immune globulin (IVIG).

Context:
Summary Reviewer 2

A 43-year-old female enrollee has requested authorization and coverage for immune globulin injection 500 mg (Gamunex-C). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is limited high-quality data on the management of recurrent pregnancy loss. Currently, therapeutic recommendations are largely based upon clinical experience and data from observational studies. This patients provider seeks to treat her recurrent pregnancy loss thought to be of autoimmune nature with intravenous immune globulin (IVIG). The studies cited by the provider are observational and pre-date current systematic reviews. Systematic reviews have consistently found no beneficial effect of immunotherapy for treatment of recurrent pregnancy loss. Wong and colleagues performed a systematic review of 20 trials of high-quality. The authors noted that immunotherapy did not result in a statistically significant improvement in live births compared to untreated controls. Treatment with intravenous immune globulin was included in this study. In sum, immune globulin injection (Gamunex-C), 500 mg is not likely to be superior over other available treatment options.

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


Answer: A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis.

Context:
Summary Reviewer 3

A 63-year-old female has requested reimbursement for Anser ADA testing provided on 4/25/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees ulcerative colitis. The physician reviewer found there is insufficient medical evidence to support the effectiveness of Anser ADA compared with conventional courses of action in the management of ulcerative colitis. Patients being treated with adalimumab may experience loss of response, but the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature. These small studies demonstrated, at best, correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect.  Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking.  Therefore, the clinical literature has not established the superior efficacy of Anser ADA testing performed on 4/25/16.  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 patient is a 19-year-old female with short stature, congenital heart disease, multiple minor malformations, and borderline intellectual disability. A specific diagnosis could not be recognized.  Chromosomal microarray was performed to investigate the etiology of the patients medical issues, in order to direct the patients medical care more specifically. The patient has requested reimbursement for FirstStepDX Plus test rendered on 4/14/17. The Health Insurer has denied reimbursement and reported the services at issue were investigational for the evaluation of the patients medical condition.

Context:
Summary Reviewer 2

The patient is a 19-year-old female with short stature, congenital heart disease, multiple minor malformations, and borderline intellectual disability. A specific diagnosis could not be recognized.  Chromosomal microarray was performed to investigate the etiology of the patients medical issues, in order to direct the patients medical care more specifically. The patient has requested reimbursement for FirstStepDX Plus test rendered on 4/14/17. The Health Insurer has denied reimbursement and reported the services at issue were investigational for the evaluation of the patients medical condition.  Array-based comparative genomic hybridization (CGH, or chromosomal microarray) has become standard of care to evaluate children with developmental delay, intellectual disability, autism spectrum disorders or multiple congenital anomalies.  Formerly, it was a diagnostic test that was employed when the first-line investigation of karyotype (chromosome analysis) returned normal; however, currently it is considered a first-line investigation.  The yield of this test is approximately 8 to 17% and varies with the degree of cognitive impairment, the presence of dysmorphic features, and the presence of congenital anomalies. The cited references indicate that this test has become an important and mainstream tool in the practice of clinical genetics.  As early as 2007, its utility had been convincingly demonstrated, such that experts in the field were recommending its inclusion in the evaluation of any child with intellectual disability.  More recently, its clinical utility has been confirmed in a study by Henderson and colleagues where 12.7% of patients meeting referral criteria had a pathogenic copy number variant identified on microarray, and that half of those results influenced management (including pharmacological treatment, cancer-related screening or exclusion of screening, identifying contraindications, and referrals for further evaluation).  Medical literature has shown that microarray results affect clinical management, at rates, which are similar to other genetic testing. Given the potential to influence management, microarray is an appropriate test to perform in this clinical scenario. Accordingly, the FirstStepDX Plus test rendered on 4/14/17 was likely to have been more effective for the evaluation of this patients medical condition than the other available modalities.  Therefore, for the reasons stated above, the services at issue were likely to have been 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 59-year-old female with listed diagnoses of inflammatory polyarthropathy, osteoarthritis and fibromyalgia. She has been treated with multiple medications, including prednisone, sulfasalazine, Humira, ibuprofen and Toradol.

Answer: This patient reports pain in her back, hands and feet, as well as multiple soft tissue areas. She has been treated with multiple medications to date, all of which have either resulted in side effects or a lack of response.

Context:
Summary Reviewer

The patient is a 59-year-old female with listed diagnoses of inflammatory polyarthropathy, osteoarthritis and fibromyalgia. She has been treated with multiple medications, including prednisone, sulfasalazine, Humira, ibuprofen and Toradol. The physician reviewer found that the submitted documentation fails to support the medical necessity of the requested medication in this clinical setting. This patient reports pain in her back, hands and feet, as well as multiple soft tissue areas. She has been treated with multiple medications to date, all of which have either resulted in side effects or a lack of response. The available medical records do not document objective findings to support the presence of an inflammatory arthritis. There is no documentation of synovitis on physical examination, nor is there documentation of radiologic studies with findings consistent with inflammatory disease. On the basis of this lack of documentation, the requested medication is not medically indicated. Additionally, there is a lack of evidence
supporting the use of H.P. Acthar Gel in fibromyalgia. Therefore, H.P. Acthar 80 unit/mL Gel is not medically necessary for the treatment of this patient.

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


Answer: An 18-year-old male enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 11/16/17 through 1/04/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.

Answer: The medical records indicate that the patient was not actively suicidal at any time, although he had recent passive suicidal ideation without intent to harm himself.

Answer: The patient has had some issues with level of function that were sporadic nature. He showed intact activities of daily living.

Answer: The patient does not have active medical problems or substance use.

Answer: There was no indication of an unsafe home environment.

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

Answer: the patient has had minimal prior treatment and was cooperative in the residential treatment center program at issue.

Answer: The patient actively participated in therapy on admission.

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

Context:
Summary Reviewer

An 18-year-old male enrollee has requested reimbursement for residential mental health treatment for children and adolescents provided from 11/16/17 through 1/04/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that 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 at any time, although he had recent passive suicidal ideation without intent to harm himself. With regards to functional status, the records support a score of 2. The patient has had some issues with level of function that were sporadic nature. He showed intact activities of daily living. In terms of comorbidity, the records support a score of 1. The patient does not have active medical problems or substance use. With regards to level of stress of the recovery environment, the records support a score of 2. There was no indication of an unsafe home environment. In terms of 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. With regards to resiliency and treatment history, the records support a score of 3. It appears that the patient has had minimal prior treatment and was cooperative in the residential treatment center program at issue. In terms of acceptance and engagement, the records support a score of 2. The patient actively participated in therapy on admission. With regards to 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 16.  This score correlates with intensive outpatient services. Therefore, residential mental health treatment for children and adolescents provided from 11/16/17 through 1/04/18 was not medically necessary for the treatment of this patient.

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


Answer: The parent of a 16-month-old female enrollee has requested authorization and coverage for hourly pediatric nursing, 12 hours per day, seven days per week (S9123). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition.

Answer: this

Answer: patient has a number of problems as a result of, and in addition to, her cloacal abnormalities, chronic kidney disease, and prematurity.

Answer: With the introduction of skilled nursing services, she has had no further significant urinary tract infections requiring parenteral antibiotics and hospitalization. She has been able to attend preschool to aid in her development and help her to catch up to her peers. The patients mother is the primary caregiver and has significantly modified her schedule in order to provide for the patients custodial needs. She does not have the necessary expertise

Answer: to provide for the patients skilled medical needs, including ostomy care and prevention of urinary tract infections.

Context:
Summary Reviewer

The parent of a 16-month-old female enrollee has requested authorization and coverage for hourly pediatric nursing, 12 hours per day, seven days per week (S9123). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that this medically fragile patient has a number of problems as a result of, and in addition to, her cloacal abnormalities, chronic kidney disease, and prematurity. The most important issue for her at this time, prior to completion of her reconstructive surgeries, is prevention of urinary tract infection and preservation of renal function. With the introduction of skilled nursing services, she has had no further significant urinary tract infections requiring parenteral antibiotics and hospitalization. She has been able to attend preschool to aid in her development and help her to catch up to her peers. The patients mother is the primary caregiver and has significantly modified her schedule in order to provide for the patients custodial needs. She does not have the necessary expertise, however, to provide for the patients skilled medical needs, including ostomy care and prevention of urinary tract infections. The requested skilled nursing services 12 hours daily 7 days per week are essential to this patients current health as well as to the future success of her reconstructive surgeries. Therefore, the requested hourly pediatric nursing, 12 hours per day, seven days per week (S9123), is medically necessary for the treatment of this patient.

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


Answer: A 59-year-old enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.

Context:
Summary Reviewer 3

A 59-year-old enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 4/20/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found the staging and classification of cutaneous melanoma has classically been described by Balch. Mitotic index has been thought to add a bit to the statistics. DecisionDx-Melanoma testing is an assay of 31 genes in the cells of an individualas melanoma cells. It then classifies that melanoma based on the five-year risk of metastasis. It is not known how the five-year DecisionDx-Melanoma testing data compares to the 10-year Balch data. Additionally, it is not clear if the DecisionDx-Melanoma classification can be used to make therapeutic decisions, such as whether to do a sentinel node and/or give adjuvant therapy. Therefore, DecisionDx-Melanoma testing performed on 4/20/20 was not likely to have been more beneficial than other available methods of evaluating this patient.

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


Answer: The patient is a 26-year-old female with a history of an intensive care unit admission for alcoholic ketoacidosis. She had a history of depression and anxiety with poor compliance with medication.

Answer: the patient had several episodes of withdrawal and experienced alcoholic ketoacidosis, alcohol hepatocyte injury, macrocytic anemia and physical withdrawal. After discharge from the inpatient hospital, she was stable enough to receive further medical detoxification at the level 3.5 residential treatment level of care.

Answer: the patientas medical problems

Answer: were stable enough to be treated at the 3.5 level of care.

Answer: the patient had a history of anxiety and depression and had difficulty complying with medication on an outpatient basis.

Answer: the patient was ambivalent about residential treatment and thought it was ajust what her family wanteda, showing low insight and poor judgment and supporting the need for further structured treatment to enhance her willingness to change.

Answer: the patient had tried stopping on her own several times and had developed serious medical problems

Answer: the patientas family works in the wine business and she would have been exposed to continuous use had she been discharged to her motheras home. The patient had no support for sobriety at her home in Colorado.

Context:
Summary Reviewer

The patient is a 26-year-old female with a history of an intensive care unit admission for alcoholic ketoacidosis. She had a history of depression and anxiety with poor compliance with medication. The physician reviewer found that based on the records, this patient met American Society of Addiction Medicine (ASAM) criteria for sub-acute substance abuse rehabilitation (ASAM 3.5) provided from 6/20/21 through 7/18/21. The ASAM criteria focuses on six dimensions to determine the appropriate level of care.

For dimension 1, acute intoxication or withdrawal potential, the patient had several episodes of withdrawal and experienced alcoholic ketoacidosis, alcohol hepatocyte injury, macrocytic anemia and physical withdrawal. After discharge from the inpatient hospital, she was stable enough to receive further medical detoxification at the level 3.5 residential treatment level of care.

For dimension 2, biomedical conditions, the patientas medical problems as cited in dimension 1 were stable enough to be treated at the 3.5 level of care.

For dimension 3, emotional, behavioral, or cognitive conditions, the patient had a history of anxiety and depression and had difficulty complying with medication on an outpatient basis. Her co-occurring anxiety and depression and need for supervision of medications meets ASAM 3.5 level of care criteria.

For dimension 4, readiness to change, the patient was ambivalent about residential treatment and thought it was ajust what her family wanteda, showing low insight and poor judgment and supporting the need for further structured treatment to enhance her willingness to change.

For dimension 5, relapse, continued use, continued problem potential, the patient had tried stopping on her own several times and had developed serious medical problems which could worsen and be potentially fatal outside of a structured 24-hour monitored treatment setting.

For dimension 6, recovery environment, the patientas family works in the wine business and she would have been exposed to continuous use had she been discharged to her motheras home. The patient had no support for sobriety at her home in Colorado. She met 3.5 level of care on dimension 6.

Accordingly, sub-acute substance abuse rehabilitation (ASAM 3.5) provided from 6/20/21 through 7/18/21 was medically necessary for the treatment of this patient

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


Answer: A 57-year-old male enrollee has requested reimbursement for automated nerve conduction testing performed on 10/20/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.

Context:
Summary Reviewer 3

A 57-year-old male enrollee has requested reimbursement for automated nerve conduction testing performed on 10/20/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found that the automated nerve conduction studies in dispute performed during surgery are not supported in the peer-reviewed literature. Intraoperative monitoring utilizing automated nerve conduction testing on peripheral nerves during surgery was not indicated. There is a lack of support in the medical literature supporting nerve conduction velocity monitoring on peripheral nerves during cervical spine surgery. As such, the automated intraoperative nerve conduction studies were 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 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 59-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/30/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination.

Context:
Summary Reviewer 2

A 59-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 8/30/16.  The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who presented for a breast examination.  The physician reviewer found that the medical literature supports breast tomosynthesis in this clinical setting.  Per Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues state that integrated two dimensional and three dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Thus, the literature supports the use of digital breast tomosynthesis over conventional mammogram due to improved cancer detection rate.  In sum, digital breast tomosynthesis performed on 8/30/16 was likely to have been superior to other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 54-year-old female enrollee has requested reimbursement for acute hospital stay from 12/30/17 through 2/11/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.

Context:
Summary Reviewer

A 54-year-old female enrollee has requested reimbursement for acute hospital stay from 12/30/17 through 2/11/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. 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. At the time of admission, the records did not document that she required frequent treatment with intravenous analgesic medication. The documentation did not indicate an emergent need for surgical intervention. The current medical evidence does not support the services at issue in this clinical setting. Therefore, acute hospital stay provided from 12/30/17 through 2/11/18 was not medically necessary for the treatment of this patient.

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


Answer:
The patient is a 26-year-old male with a history of suspected multiple sclerosis (MS). In an effort
to treat the patients flare and as maintenance therapy for suspected MS, the provider has
recommended treatment with intravenous immunoglobulin (IVIG) therapy with Gamunex-C. The
Health Insurer has denied the requested treatment as not medically necessary for the treatment
of the patients medical condition.

Answer: the patient experienced an exacerbation of symptoms from suspected MS.

Context:
Summary Reviewer

The patient is a 26-year-old male with a history of suspected multiple sclerosis (MS). In an effort
to treat the patients flare and as maintenance therapy for suspected MS, the provider has
recommended treatment with intravenous immunoglobulin (IVIG) therapy with Gamunex-C. The
Health Insurer has denied the requested treatment as not medically necessary for the treatment
of the patients medical condition. The physician reviewer found that the records provided for
review indicate that the patient experienced an exacerbation of symptoms from suspected MS.
For patients who experience an acute MS exacerbation that results in neurologic symptoms and
increased disability or impairments in vision, strength, or cerebellar function, a short course of
high-dose glucocorticoid therapy is recommended (Olek, et al.). If the patient has a poor response
to treatment with high-dose glucocorticoids, treatment with plasma exchange is considered for
the next line of therapy. Other options for a second treatment course after a poor response to
initial high-dose glucocorticoid therapy include adrenocorticotropic hormone (ACTH), a second
cycle of high-dose glucocorticoid therapy, or immunoadsorption. There is a paucity of high-
quality medical studies demonstrating that IVIG therapy is an effective treatment option for
patients who experience an exacerbation of symptoms from suspected MS. A small number of
limited medical studies have demonstrated that IVIG therapy may be used for patients with
relapsing-remitting MS who do not tolerate or have contraindications to approved therapies
(Bayry, et al.). In this case, a diagnosis of relapsing-remitting MS has not been established for the
patient. The records indicate that the patient experienced an acute exacerbation of symptoms
from suspected MS. Based on the current medical literature, IVIG therapy is not recommended
as a treatment option for patients with acute exacerbations of symptoms from suspected MS.
Therefore, the requested Gamunex-C is not medically necessary for the treatment of this patient.

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


Answer: A 55-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 5/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.

Context:
Summary Reviewer 3

A 55-year-old female enrollee has requested reimbursement for DecisionDx-Melanoma testing provided on 5/29/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that 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 DecisionDx-Melanoma testing 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. Thus, DecisionDx-Melanoma testing provided on 5/29/19 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 64-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 8/14/19. 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 3

A 64-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing
performed on 8/14/19. 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 the staging and prognosis of cutaneous melanoma has classically been
determined by applying the system spelled out by Balch. Mitotic index may add a bit to these
statistics. DecisionDx-Melanoma testing is an assay of 31 genes in a particular melanoma. It then
places that particular melanoma into either Class 1 or 2, with somewhat different risks of
metastasis by five years. It is not clear how the five-year DecisionDx-Melanoma data compares
to the ten-year Balch data. Most importantly, it has not been shown that one can use the
DecisionDx-Melanoma data to make important clinical decisions, such as the need for sentinel
node biopsy or the use of adjuvant therapy. Therefore, DecisionDx-Melanoma testing performed
on 8/14/19 was not likely to have been more beneficial than any available standard therapy.

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


Answer: The parent of a 14-year-old male enrollee has requested authorization and coverage for applied behavioral analysis (ABA) services for 30 hours per week. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees autism spectrum disorder.

Answer: this patient is reported to be on the autism spectrum.

Context:
Summary Reviewer

The parent of a 14-year-old male enrollee has requested authorization and coverage for applied behavioral analysis (ABA) services for 30 hours per week. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees autism spectrum disorder. The physician reviewer found that this patient is reported to be on the autism spectrum. However, the records provided for review do not provide details regarding the frequency of challenging behaviors, nor his response to previous ABA therapy. Some of the goals being addressed in the proposed ABA therapy plan provided are more consistent with goals addressed with occupational or vocational therapy than directly addressing the patients autism spectrum disorder. These goals include completing chores and using utensils. In the medical literature, Orinstein and colleagues reviewed the intensity of ABA therapy required for optimal outcomes in children with autism spectrum disorder and found no correlation between the number of hours provided per week and outcomes. The authors noted that the age at which ABA therapy was started and duration of treatment was correlated with outcome. Luiselli and colleagues reached similar conclusions. Thus, the Health Insurers approval for 15 hours per week of direct ABA therapy is appropriate to address this patients current needs as documented in the records reviewed. Accordingly, the requested ABA services for 30 hours per week is not supported as medically necessary. Based on the foregoing discussion, the requested services 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 51-year-old female enrollee has requested authorization and coverage for Provigil 200 mg tablets, 60 tablets per 30 days. 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: The medical records indicate that the patient has a long history of hypersomnia. She has been evaluated by multiple specialists in order to maximize her medications. This patient has significant functional problems due to her hypersomnia as well as her bipolar disorder

Answer: Based on the records, the requested medication appears to be working well for her

Context:
Summary Reviewer

A 51-year-old female enrollee has requested authorization and coverage for Provigil 200 mg tablets, 60 tablets per 30 days. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. The medical records indicate that the patient has a long history of hypersomnia. She has been evaluated by multiple specialists in order to maximize her medications. This patient has significant functional problems due to her hypersomnia as well as her bipolar disorder, as referenced by her use of the antipsychotic medication Clozaril, which is typically reserved for recalcitrant illnesses. Based on the records, the requested medication appears to be working well for her, and discontinuation of the requested medication could have significant adverse results. Therefore, Provigil 200 mg tablets, 60 tablets per 30 days are medically necessary for the treatment of this patient.

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


Answer: The patient is a 68-year-old male who has requested reimbursement for DecisionDx-Melanoma testing. The patient has requested reimbursement for DecisionDx-Melanoma testing performed on 11/23/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.

Context:
Summary Reviewer

The patient is a 68-year-old male who has requested reimbursement for DecisionDx-Melanoma testing. The patient has requested reimbursement for DecisionDx-Melanoma testing performed on 11/23/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient. The physician reviewer found that the use of gene expression profiling (GEP) testing according to specific melanoma stage (either before or after sentinel lymph node biopsy) requires rather prospective investigation in large, contemporary datasets of unselected patients. Prognostic GEP testing to differentiate melanomas at low versus high risk for metastasis should not replace pathologic staging procedures. Moreover, since there is a low probability of metastasis in stage I melanoma and a higher proportion of false-positive result, GEP testing should not guide clinical decision making in this group. Commercially available GEPs, such as DecisionDx-Melanoma, are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear where these GEP platforms provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariate nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. It remains unclear whether this GEP profile is reliably predictive of outcome across the risk spectrum of melanoma. Prospective validation studies are required to more accurately define the clinical utility of molecular testing prior to widespread implementation of GEP for prognostication of cutaneous melanoma, and in particular, to determine its role in guiding surveillance imaging, sentinel lymph node biopsy, and adjuvant treatment decisions. Therefore, DecisionDx-Melanoma testing performed on 11/23/20 was not medically necessary for the evaluation of this patient.

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


Answer: A 38-year-old female enrollee has requested authorization and coverage for Tysabri.  The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition.

Answer: this patient has been diagnosed with relapsing-remitting multiple sclerosis.

Answer: She has been prescribed Tysabri

Answer: This patient did not tolerate Copaxone.

Context:
Summary Reviewer

A 38-year-old female enrollee has requested authorization and coverage for Tysabri.  The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees medical condition. The physician reviewer found this patient has been diagnosed with relapsing-remitting multiple sclerosis. Treatment is indicated to reduce attacks.  She has been prescribed Tysabri, and the current medical evidence supports the requested medication in this clinical setting.  Guidelines and clinical experience show reduction of relapse rates and progression, with generally favorable tolerability. Compliance with once monthly regimen is high.  This patient did not tolerate Copaxone.  There is sufficient support for the requested medication in this patients case.  All told, Tysabri is medically indicated for the treatment of this patient.  Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer: A 40-year-old male enrollee has requested reimbursement for acupuncture services (CPT code 97810) provided from 8/13/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees abdominal pain.

Context:
Summary Reviewer 2

A 40-year-old male enrollee has requested reimbursement for acupuncture services (CPT code 97810) provided from 8/13/15 through 10/31/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees abdominal pain. The physician reviewer found the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. There is a lack of objective measurable evidence of functional gain and/or improvement. There are a lack of clinical references to objective functional improvement during the dates in dispute. In sum, the records lacked sufficient evidence supporting treatment with acupuncture was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 45-year-old female enrollee has requested authorization and coverage for L-methylfolate. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who is homozygous for methylene tetrahydrofolate reductase (MTHFR) enzyme deficiency.

Answer: The patient has trialed many standard therapies for major depressive disorder, to no avail.

Answer: The patient has a genetic test that demonstrates a defective MTHFR gene which suggests L-methylfolate deficiency.

Context:
Summary Reviewer

A 45-year-old female enrollee has requested authorization and coverage for L-methylfolate. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who is homozygous for methylene tetrahydrofolate reductase (MTHFR) enzyme deficiency. The physician reviewer found there is sufficient support for the requested medication in this clinical setting.  Folic acid is vitamin B9.  It is converted to L-methylfolate, the active form of the vitamin in the body, by an enzyme, MTHFR.  If individuals lack the ability to convert folic acid, they may be prescribed synthetic L-methylfolate.  It is hypothesized that L-methylfolate may help the body create neurotransmitters such as serotonin, dopamine and norepinephrine, and thus may augment antidepressant medications for those struggling with treatment-resistant depression.  Despite the rather limited data, L-methylfolate is safe and reasonably expected to improve the patients condition in this case.  The patient has trialed many standard therapies for major depressive disorder, to no avail.  Thus, the affective illness can be characterized as treatment-resistant depression.  The patient has a genetic test that demonstrates a defective MTHFR gene which suggests L-methylfolate deficiency.  There are several well-designed studies that demonstrate the benefit of L-methylfolate augmentation.  Further, when considering the favorable safety profile, the potential benefits appear to outweigh the risks of treatment.  Finally, the patient is reportedly in remission on the combination of bupropion and L-methylfolate.  Thus, L-methylfolate is medically indicated for the treatment of this patient.  Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer: The parent of a 16-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health intensive outpatient program services from 5/21/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions.

Context:
Summary Reviewer

The parent of a 16-year-old female enrollee has requested reimbursement and prospective authorization and coverage for mental health intensive outpatient program services from 5/21/19 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that the 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 given her reported history of physical abuse and poor social skills. In terms of functional status, the records support a score of 2 based on her history of the suspension from school and conflict in the home environment. In terms of comorbidity, the records support a score of 2 due to poor social skills and emotional expression for her chronological age without current medical illness. With regards to level of stress of the recovery environment, the records support a score of 3 due to the death of her ex-boyfriend prior to the start of treatment and her sisters car accident during treatment, as well as her sisters cannabis use. In terms of level of stress of the recovery environment, the records support a score of 3 due to the parent stating that she was giving up on parenting the patient in a family therapy session on 6/05/19. With regards to resiliency and treatment history, the records support a score of 3 due to having been in a residential treatment center for 17 months and continuing to decline in functioning since returning home. In terms of acceptance and engagement of the patient, the records support a score of 3 since the patient refused to speak in groups after 5/21/19. With regards to acceptance and engagement of the parent, the records support a score of 3 due to the parent stating in family therapy that she was done parenting the patient. Therefore, the patient has a composite score of 21. Mental health intensive outpatient program services were and are appropriate in this clinical setting. Thus, mental health intensive outpatient program services from 5/21/19 forward were and are medically necessary for the treatment of this patient.

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


Answer:
The patient is a 32-year-old female who presented to her provider on 8/31/21. The records noted
that the patient was 66.5 inches tall and weighed 296.6 pounds, with a body mass index (BMI) of
47.15 kg/m2. The patient has requested authorization and coverage for (1) Mounjaro 7.5 mg, (2)
Ozempic 2 mg, and (3) Rybelsus 7 mg. The Health Insurer has denied this request and reported
that the requested medications are not medically necessary for the treatment of this patient.

Context:
Summary
The patient is a 32-year-old female who presented to her provider on 8/31/21. The records noted
that the patient was 66.5 inches tall and weighed 296.6 pounds, with a body mass index (BMI) of
47.15 kg/m2. The patient has requested authorization and coverage for (1) Mounjaro 7.5 mg, (2)
Ozempic 2 mg, and (3) Rybelsus 7 mg. The Health Insurer has denied this request and reported
that the requested medications are not medically necessary for the treatment of this patient. This
denial is the subject of this appeal and determination. The physician reviewer found that the
submitted documentation does not support the medical necessity of the requested medications.
Prediabetes is defined as an elevated hemoglobin A1C in the range of 5.7% to 6.4%. Some
individuals with prediabetes may progress to developing diabetes mellitus. The American Diabetes
Association (ADA) guidelines on the prevention of type 2 diabetes recommend that individuals
with prediabetes undergo counseling on lifestyle changes including weight loss and routine
exercise. The ADA recommends that the only pharmacologic agent to be considered for use for
prediabetes is metformin for those at high risk for developing diabetes. Obesity is a disease
associated with many health risks, including type 2 diabetes mellitus, hypertension, dyslipidemia,
and coronary heart disease. Weight loss in  patients with obesity or who are overweight is
associated with a reduction in mortality. The American Association of Clinical Endocrinologists
guidelines for the medical care of patients with obesity notes that patients with obesity or who are
overweight  and  with  dyslipidemia  should  be  considered  for  treatment  with  a  weight-loss
medication combined with lifestyle therapy when necessary to achieve sufficient improvements in
lipids. The guidelines further note that for patients who struggle with weight loss and who would
receive health benefit from weight loss, management of medications that are contributing to weight
gain and the use of approved medications for chronic weight management along with lifestyle
changes are appropriate. Medications for weight loss are generally considered an option for
patients with a BMI over 27 kg/m2 with comorbidities such as diabetes or sleep apnea, or a BMI
over 30 kg/m2 without comorbidities. There are multiple medications approved by the U.S. Food
and  Drug Administration  (FDA)  for  the  treatment  of  obesity  including  orlistat,  naltrexone-
bupropion, lorcaserin, phentermine, phentermine with topiramate, liraglutide and semaglutide.
WIlding and colleagues note that semaglutide has demonstrated impressive efficacy in weight
reduction, along with improvement in blood sugars and cholesterol levels. Semaglutide is available
under the brand name Wegovy, Ozempic and Rybelsus. The FDA approves the use of Wegovy to
assist patients with obesity, or who are overweight with weight-related medical problems, to lose
weight when added to diet and exercise. The FDA approves the use of Ozempic and Rybelsus to
lower blood sugar levels in adults with type 2 diabetes, in addition to diet and exercise. The FDA
approves  the  use  of  tirzepatide  (Mounjaro),  a  unique  dual  glucagon-like  peptide-1  (GLP-
1)/glucagon receptor (GIP) agonist, for the treatment of type 2 diabetes.  In an open-label, parallel-
group, randomized, active-controlled trial examining the benefits on weight loss of tirzepatide
versuss semaglutide in over 1,800 patients with type 2 diabetes over 40 weeks, Frias and colleagues
concluded that reductions in body weight were greater with tirzepatide than with semaglutide.
While concurrent medications for weight loss may be appropriate for patients with a BMI over 27
kg/m2 with comorbidities, in this case, the patients most recent BMI is 25.8 kg/m2 and the patient
reports that her comorbidities of hypertension and hyperlipidemia have resolved. While published
studies support the use of Mounjaro, Ozempic, and Rybelsus as effective for weight loss, given
the lack of data available on their benefits over FDA approved medications for weight loss in
patients without diabetes or obesity, the requested medications are not medically indicated.  Therefore, (1) Mounjaro 7.5 mg, (2) Ozempic 2 mg, and (3) Rybelsus 7 mg are not medically
necessary for the treatment of this patient.

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


Answer: A 62-year-old female enrollee has requested reimbursement for genetic testing performed on 7/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation for the evaluation of the enrollees medical condition.

Context:
Summary Reviewer 2

A 62-year-old female enrollee has requested reimbursement for genetic testing performed on 7/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation for the evaluation of the enrollees medical condition. The physician reviewer found that the DecisionDx-Melanoma test is a clinically validated prognostic tool for patients with stage 1A disease, who are not recommended for sentinel node biopsy. Traditional clinical pathologic assessment for determination of prognosis based on tumor size, and histopathologic features as described in this patients biopsy report, underreport a significant percentage of stage 1 and 2 patients who subsequently present with recurrent disease and metastases with incurable melanoma. The DecisionDx-Melanoma test has been used as a standard method for prognosis assessment, based on multiple publications detailing the test utility in melanoma patients. The DecisionDx-Melanoma test is an independent predictor of risk. In sum, testing (DecisionDx-Melanoma Gene Assay) performed on 7/31/18 was likely to have been more beneficial than other methods of evaluating this patient.

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


Answer: A 61-year-old female enrollee has requested reimbursement of collagen crosslinking test (CPT 82523) performed on 9/07/18. 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 2

A 61-year-old female enrollee has requested reimbursement of collagen crosslinking test (CPT 82523) performed on 9/07/18. 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 bone turnover marker assays measure collagen breakdown products released from osteoclasts and osteoblasts during the process of bone resorption and formation. Measurement of bone turnover markers is complicated by large random within-patient variability, biologic variability (age, gender, body mass index, circadian, and menstrual variation), and poor standardization of most assays. Uncertainties over its clinical use can be in part resolved by adopting international reference standards, which do not exist at this time. Guideline committees typically recommend against routine use of bone turnover markers, due to the limitations of measuring and interpreting bone turnover markers in individual patients. There is a lack of prospective trials to define the most optimal approach for incorporating bone turnover markers into the management of patients with osteoporosis. In sum, collagen crosslinking test (CPT 82523) performed on 9/07/18 was not likely to have been of greater benefit than other methods of evaluating this patient.

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


Answer: The parent of a 15-year-old female enrollee has requested reimbursement for mental health inpatient treatment services provided from 8/25/16 through 8/26/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees eating disorder.

Answer: In records dated 8/25/16, the patients weight was 141.2 pounds and 117.7% of her ideal body weight and she was compliant with her meal plan.

Context:
Summary Reviewer

The parent of a 15-year-old female enrollee has requested reimbursement for mental health inpatient treatment services provided from 8/25/16 through 8/26/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees eating disorder. The physician reviewer found that applying the guidelines from the American Psychiatric Association (APA), the mental health inpatient treatment services provided from 8/25/16 through 8/26/16 were not medically necessary for treatment of this patients eating disorder. In records dated 8/25/16, the patients weight was 141.2 pounds and 117.7% of her ideal body weight and she was compliant with her meal plan. Thus, the patient did not require 24-hour supervision in a highly restricted setting in a mental health treatment environment to manage her anorexia and depression safely and adequately. All told, the mental health inpatient treatment services provided from 8/25/16 through 8/26/16 were not medically necessary. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 55-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus.

Context:
Summary Reviewer

A 55-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons. Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions. In addition, AASLD/IDSA treatment guidelines recommend Harvoni for 12 weeks for treatment-naive patients with HCV genotype 1 infection. Therefore, based on national guidelines Harvoni is medically necessary in this clinical setting.For the reasons provided, 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 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye.

Context:
Summary Reviewer 1

A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye. The physician reviewer found that DecisionDx assay is a study of 15-31 genes in an individuals melanoma cells. It has been used to classify the individuals melanoma as having either a high or low risk of metastasis. It is controversial in cutaneous melanoma as to whether it has additional value when added to the usual pathologic prognostic factors. However, there are medical studies that show the effectiveness of this assay in the analysis of prognosis for uveal melanoma (Onken, et al (2010); Onken et al (2012)). This assay is also within the guidelines of the American Joint Cancer Commission. Specifically, a class 1 category carries with it a less than 20% chance for metastasis, whereas class 2 has a greater than 70% risk of metastasis. This assay has become a standard in many ocular cancer centers and is no longer considered investigational. Its clinical value lies in determining the need for intense surveillance, and possibly to assist in the decision as to adjuvant therapy. Overall, the DecisionDX uveal melanoma multigene assay performed on 4/10/15 was likely to have been more effective than available standard modality for the evaluation of this patient. Based upon the information set forth above, the services at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned

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


Answer: A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye.

Answer: This patient has

Answer: ocular melanoma.

Context:
Summary Reviewer 3
A 58-year-old female enrollee has requested reimbursement for the DecisionDX uveal melanoma (UM) multigene assay performed on 4/10/15. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees intraocular choroidal melanoma of the left eye. The physician reviewer found that the service at issue was likely to be more effective than other methods of evaluating this patient. This patient has a rare disease, ocular melanoma.  However, knowledge of the propensity for metastasis directly affects surveillance of patients by computed tomography scan. Along these lines, there are clinical studies that support the use of gene expression classifier DecisionDX uveal melanoma. This assay defines two classes of ocular melanoma. Class 1 is associated with a low risk of metastasis and class 2 has a 50% risk at two years and 72% risk at five years. Currently, there is no other standard prognostic indicator that could serve as an alternative. Thus, the current medical evidence favors the use of this test in the post-operative surveillance of patients with ocular melanoma. As such, the DecisionDX uveal melanoma multigene assay performed on 4/10/15 was likely to be superior over other available methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: The patient is a 30-year-old male with a history of gynecomastia. Therefore, the patient has requested authorization and coverage for suction assisted lipectomy, trunk (CPT 15877) and mastectomy, simple complete (CPT 19303). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.

Answer: On 5/09/20, the provider noted, aThe bilateral breasts demonstrate Simon Grade IIa gynecomastia. There are tender subareolar masses bilaterally measuring approximately 2 cm x 3 cm x 3 cm.a He also reported that the patient adesires surgical excision of gynecomastia in addition to potential suction lipectomy.

Answer: In this case, photographs demonstrate chest enlargement that significantly exceeds the 2 cm x 3 cm x 3 cm size of the glandular tissue, so that the chest enlargement constitutes mixed gynecomastia, with a mixture of both true glandular gynecomastia and fatty tissue constituting pseudogynecomastia.

Context:
Summary Reviewer

The patient is a 30-year-old male with a history of gynecomastia. Therefore, the patient has requested authorization and coverage for suction assisted lipectomy, trunk (CPT 15877) and mastectomy, simple complete (CPT 19303). 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 case was previously reviewed, and additional documentation was submitted for reconsideration. Additional medical information received for review included an email from the provider indicating that a surgical facility charges for liposuction for time and supplies, and there would still be a charge even if he charged no professional fee.  On 5/09/20, the provider noted, aThe bilateral breasts demonstrate Simon Grade IIa gynecomastia. There are tender subareolar masses bilaterally measuring approximately 2 cm x 3 cm x 3 cm.a He also reported that the patient adesires surgical excision of gynecomastia in addition to potential suction lipectomy.a The American Society of Plastic Surgeons reports the following gynecomastia scale adapted from the McKinney and Simon, Hoffman and Kohn scales: grade I a small breast enlargement with localized button of tissue that is concentrated around the areola; grade II - moderate breast enlargement exceeding areola boundaries with edges that are indistinct from the chest; grade III -moderate breast enlargement exceeding areola boundaries with edges that are distinct from the chest with skin redundancy present; grade IV - marked breast enlargement with skin redundancy and feminization of the breast. In this case, photographs demonstrate chest enlargement that significantly exceeds the 2 cm x 3 cm x 3 cm size of the glandular tissue, so that the chest enlargement constitutes mixed gynecomastia, with a mixture of both true glandular gynecomastia and fatty tissue constituting pseudogynecomastia. There is no change in determination that liposuction is an optional surgical technique that can be used during gynecomastia surgery and is not a separate surgical procedure for the patient for treatment of gynecomastia. Liposuction of the chest area well beyond the limited area of the gynecomastia excision can be performed for improved cosmetic appearance, particularly when the gynecomastia is mixed and there is some degree of pseudogynecomastia present. Liposuction for that purpose would be cosmetic and not medically necessary. Thus, suction assisted lipectomy trunk (CPT 15877) is not medically necessary as a separately billed procedure. CPT 19303 is not medically necessary because it applies to a mastectomy in a woman. In sum, suction assisted lipectomy, trunk (CPT 15877) and mastectomy, simple complete (CPT 19303) are not medically necessary for the treatment of this patient. The Health Insurer has approved the appropriate CPT code in this case (CPT code 19300).

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


Answer: A 64-year-old female enrollee has requested authorization and coverage for Harvoni for 24 weeks. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus.

Context:
Summary Reviewer

A 64-year-old female enrollee has requested authorization and coverage for Harvoni for 24 weeks. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found Harvoni for 24 weeks is medically necessary for treatment of the patients medical condition. In the ION-2 study, 440 HCV patients underwent randomization and were treated, 20% had cirrhosis and 79% had HCV genotype 1a infection. The rates of sustained virologic response were high in all treatment groups. There was a 99% (95% confidence interval (CI), (95 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir and 99% (95% CI, 95 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir and ribavirin (Afdhal, et al). The results of an abstract were presented at the American Association for the Study of Liver Diseases Liver Meeting. In this double-blind study, Bourliere and colleagues randomized 155 patients previously unable to achieve SVR after sequential treatment with a peginterferon and ribavirin regimen followed by a protease-inhibitor (PI), peginterferon  and ribavirin regimen, to undergo treatment with ledipasvir/sofosbuvir and ribavirin placebo for 24 weeks or matching placebo for 12 weeks, followed by ledipasvir/sofosbuvir and ribavirin for 12 weeks. Patients were stratified by HCV subtype and their responses to their most recent therapy. Of the 77 patients treated with ledipasvir/sofosbuvir and ribavirin for 12 weeks, 4% experienced relapse; compared with 3% of the 77 patients treated with ledipasvir/sofosbuvir for 24 weeks, for a 3% total incidence of relapse. Based on the peer-reviewed literature, Harvoni for 24 weeks is medically necessary in this clinical setting. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer:
The patient is a 20-year-old female who has been diagnosed with posttraumatic stress disorder,
major depressive disorder, generalized anxiety disorder, and alcohol use disorder.The
patient has requested reimbursement for mental health residential treatment provided from 3/22/20
through 5/22/20. The Health Insurer has denied this request and reported that the services at issue
were not medically necessary for the treatment of this patient.

Context:
Summary Reviewer

The patient is a 20-year-old female who has been diagnosed with posttraumatic stress disorder,
major depressive disorder, generalized anxiety disorder, and alcohol use disorder.The
patient has requested reimbursement for mental health residential treatment provided from 3/22/20
through 5/22/20. The Health Insurer has denied this request and reported that the services at issue
were not medically necessary for the treatment of this patient.The physician reviewer found the mental health residential
treatment provided from 3/22/20 through 5/22/20 was medically necessary for the treatment of this
patient.

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


Answer: A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.

Answer: the patient has already undergone great saphenous vein removal.  The reflux from the incompetent saphenofemoral junctions is now going down the accessory saphenous veins.  These veins are very large, and have free reflux.  They are essentially acting as refluxing greater saphenous veins.

Context:
Summary Reviewer 1

A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that in this case, the patient has already undergone great saphenous vein removal.  The reflux from the incompetent saphenofemoral junctions is now going down the accessory saphenous veins.  These veins are very large, and have free reflux.  They are essentially acting as refluxing greater saphenous veins. In the situation where these veins can be ablated, this treatment is standard of care.  All told, the requested ablation of varicose veins, right and left accessory ablation is likely to be of greater benefit than other treatment options.  Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.

Context:
Summary Reviewer 2
A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting.  Patients with anterior accessory saphenous vein reflux and patients with the great saphenous vein reflux demonstrate similar disease-specific features.  Following great saphenous veins ablation, persistent non-refluxing branches do not appear to have an adverse impact on clinical outcome two years after successful ablation of the great saphenous vein.  Although there is limited clinical data to recommend ablation of the non-axial veins, the published data suggest it is effective in selected patients.  There is evidence to support sclerotherapy in the treatment of accessory recurrent varicose veins following ablation.  Thus, ablation of varicose veins, right and left accessory ablation is likely to be more effective than other treatment options.  Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition.

Context:
Summary Reviewer 3

A 66-year-old female enrollee has requested authorization and coverage for ablation of varicose veins, right and left accessory ablation.  The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that while endovenous ablation of the greater saphenous vein has been extensively evaluated in the treatment of varicose veins, little is known about the efficacy in the treatment of accessory saphenous veins.  Furthermore, patterns of recurrence of varicose veins after greater saphenous vein treatment is usually new reflux in the accessory saphenous vein and there is little evidence available to guide optimal therapy, in contrast to greater saphenous vein interventions.  Therefore, given the absence of evidence for the efficacy of endovenous ablation of accessory saphenous veins after surgical therapy of greater saphenous vein incompetence, the superior effectiveness of the requested services has not been established.  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 parent of a 15-year-old male enrollee has requested reimbursement for mental health residential services provided from 1/10/18 through 4/20/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions.

Answer: On 12/29/17, the documentation noted that the patient had purchased knives and a taser gun.

Answer: these records are from admission.

Answer: The patient has demonstrated episodic failure to achieve expected levels of functioning in relationships with family and peers.

Answer: The patient did not have active medical problems or active substance use issues.

Answer: There is no indication of an unsafe home environment.

Answer: The patients family was actively involved in treatment on a regular basis.

Answer: It appears that the patients major depression symptoms were under good control with minimal signs or symptoms. He continued to have oppositional behaviors.

Answer: The patient was able to establish positive relationships with clinicians despite oppositional behaviors.

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

Context:
Summary Reviewer

The parent of a 15-year-old male enrollee has requested reimbursement for mental health residential services provided from 1/10/18 through 4/20/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees behavioral health conditions. The physician reviewer found that 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. On 12/29/17, the documentation noted that the patient had purchased knives and a taser gun. However, these records are from admission. The records for the disputed timeframe indicated evidence of low risk of harm. Additionally, this note had minimal objective evidence. This record does not document that violent acts or self-harm were committed. In terms of functional status, the records support a score of 2. The patient has demonstrated episodic failure to achieve expected levels of functioning in relationships with family and peers. With regards to comorbidity, the records support a score of 1. The patient did not have active medical problems or active substance use issues. In terms of level of stress of the recovery environment, the records support a score of 2. There is no indication of an unsafe home environment. With regards to level of support of the recovery environment, the records support a score of 2. The patients family was actively involved in treatment on a regular basis. In terms of resiliency and treatment history, the records support a score of 3. It appears that the patients major depression symptoms were under good control with minimal signs or symptoms. He continued to have oppositional behaviors. With regards to acceptance and engagement of the patient, the records support a score of 2. The patient was able to establish positive relationships with clinicians despite oppositional behaviors. In terms of acceptance and engagement of the parents, the records support a score of 2. The parents worked actively and constructively with clinicians on a regular basis. Thus, the patient has a composite score of 16. This score correlates with intensive outpatient services. Therefore, mental health residential services provided from 1/10/18 through 4/20/18 were not 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 emergency services provided on 1/26/16. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.

Answer: the patient presented for removal of scalp sutures due to a laceration nine days prior to her visit. She admitted to a lingering hangover feeling, but had no specific complaints of headache, vomiting, dizziness, blurry vision, or other symptoms of acute head injury. She denied any symptoms of wound infection.

Answer: the patient was not experiencing the sudden onset of acute symptoms.

Context:
Summary Reviewer

A 54-year-old female enrollee has requested reimbursement for emergency services provided on 1/26/16. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found the issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. Review of the submitted documentation demonstrates that a prudent layperson would not have sought immediate medical attention on the date in question. Upon review of the submitted medical records, the patient presented for removal of scalp sutures due to a laceration nine days prior to her visit. She admitted to a lingering hangover feeling, but had no specific complaints of headache, vomiting, dizziness, blurry vision, or other symptoms of acute head injury. She denied any symptoms of wound infection. Moreover, the patient was not experiencing the sudden onset of acute symptoms. Based on the patients presenting complaints and symptoms, a prudent layperson in this circumstance would not reasonably believe she was suffering from a serious medical condition. In sum, the patient was not suffering from a serious medical condition that was likely to place the patients health in serious jeopardy, cause serious impairment to body functions or cause serious dysfunction to a body organ or part. Thus, the services provided on 1/26/16 did not meet prudent layperson criteria for emergency care.

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


Answer: The patient is a 57-year-old female with severe osteoporosis. As part of the work-up her endocrinologist ordered a parathyroid scan to rule out a parathyroid adenoma. The patient has requested authorization and coverage for parathyroid planar imaging. The Health Insurer has denied this request indicating that the requested diagnostic procedure is not medically necessary.

Answer: The laboratory tests performed on 10/26/17 show normal calcium, mid-normal intact PTH level at 36 and normal ionized calcium and phosphorus. The patients 25 vitamin D and 1, 5 vitamin D levels are normal, and urinary calcium is normal. In January 2018, the patient had two normal calcium levels and intact PTH.

Answer: this patient has severe osteoporosis

Context:
Summary Reviewer

The patient is a 57-year-old female with severe osteoporosis. As part of the work-up her endocrinologist ordered a parathyroid scan to rule out a parathyroid adenoma. The patient has requested authorization and coverage for parathyroid planar imaging. The Health Insurer has denied this request indicating that the requested diagnostic procedure is not medically necessary. The records provided for review indicate that this patient has severe osteoporosis and further evaluation for a parathyroid adenoma (primary hyperparathyroidism) is appropriate. However, the medical literature suggests that the diagnosis should be made with biochemical markers showing the combination of hypercalcemia and an elevated or inappropriately normal parathyroid hormone (PTH) level. Measured total serum calcium should be adjusted for albumin. If the corrected serum calcium is normal and PTH is elevated, serum ionized calcium should be measured, as primary hyperparathyroidism can present with an elevated ionized calcium despite a normal albumin-adjusted serum calcium (Khan, et al). The standards of care also indicate that parathyroid scan is appropriate when a decision to remove a parathyroid adenoma has been made (Khan, et al; Bilezikian, et al; Pallan, et al). Overall, parathyroid imaging is not a diagnostic procedure and is not advised unless surgical intervention is planned. The value of imaging rests with accurate identification of abnormal parathyroid tissue in order to assist in planning the appropriate parathyroid surgery (Khan, et al). In this case the diagnosis of primary hyperparathyroidism has not been established. The laboratory tests performed on 10/26/17 show normal calcium, mid-normal intact PTH level at 36 and normal ionized calcium and phosphorus. The patients 25 vitamin D and 1, 5 vitamin D levels are normal, and urinary calcium is normal. In January 2018, the patient had two normal calcium levels and intact PTH. As the patient does not have biochemical evidence of primary hyperparathyroidism, the requested parathyroid planar imaging is not medically necessary for evaluation of this patients medical condition.  Based on the foregoing discussion, the requested diagnostic procedure is not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer:
The patient is a 59-year-old male who presented with hematochezia in August 2021. The patient
has requested authorization and coverage for PET imaging with concurrent CT skull base to mid-
thigh.

Answer:
The original disease showed
significant FDG uptake. There were multiple sites of disease making the interpretation of follow-
up imaging very complex.

Context:
Summary Reviewer
The patient is a 59-year-old male who presented with hematochezia in August 2021. The patient
has requested authorization and coverage for PET imaging with concurrent CT skull base to mid-
thigh. The physician reviewer found that there is sufficient support for the requested services in
this clinical setting. According to the National Comprehensive Cancer Network (NCCN) guidelines,
PET/CT has a limited sensitivity but high specificity, and may be considered when there is an
equivocal finding. When hepatocellular carcinoma is detected by CT or magnetic resonance
imaging (MRI) and has increased metabolic activity on PET/CT, higher intralesional standardized
uptake value (SUV) is a marker of biologic aggressiveness and might predict less optimal response
to  locoregional  therapies.  Sensitivity  is  a  metric  for  the  screening  of  cancer,  but  for
discriminating responses, the specificity may be most relevant.  The original disease showed
significant FDG uptake. There were multiple sites of disease making the interpretation of follow-
up imaging very complex. The use PET/CT is medically necessary for further care. Therefore, the
requested PET imaging with concurrent CT skull base to mid-thigh is medically necessary for the
evaluation of this patient.

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


Answer: A 33-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) testing provided on 5/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of enlarged lymph nodes.

Context:
Summary Reviewer 1

A 33-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) testing provided on 5/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of enlarged lymph nodes. The physician reviewer found there is a lack of support in the medical literature for the services at issue in this clinical setting. The medical literature indicates that Epstein-Barr virus (EBV) is the main etiology of infectious mononucleosis syndrome associated with lymphadenopathy. The main methods of evaluation include PCR testing and testing by ELISA for the viral capsid antigen. Quantitative PCR testing may be indicated for the following EBV evaluations: EBV viral load, to monitor for EBV viral replication in hematopoietic stem cell and solid organ transplant recipients. More frequent testing is worth considering if the EBV load is rising. However, for standard risk individuals, as this patient, testing should be done only when they are suspected to have EBV infection. The submitted documentation does not support that this patient had a medical indication to have warranted the PCR testing. Accordingly, PCR testing provided on 5/30/17 was not likely to have been of greater benefit than the standard therapy available for evaluating this patients medical condition. Therefore, for the reasons stated above, the services at issue were not likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 33-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) testing provided on 5/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of enlarged lymph nodes.

Answer: the patient has had a history of enlarged lymph nodes of unknown etiology. She has had a biopsy and blood tests, which were all negative. She had a PCR test Epstein-Barr virus and other organisms.

Answer: The test results for this patient were normal but she continued to have large lymph nodes.

Context:
Summary Reviewer 2

A 33-year-old female enrollee has requested reimbursement for polymerase chain reaction (PCR) testing provided on 5/30/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee who has a history of enlarged lymph nodes. The physician reviewer found that the patient has had a history of enlarged lymph nodes of unknown etiology. She has had a biopsy and blood tests, which were all negative. She had a PCR test Epstein-Barr virus and other organisms. The common testing performed for lymphadenopathy can generally determine the cause of the lymphadenopathy. The test results for this patient were normal but she continued to have large lymph nodes. A PCR test to detect the cause of the lymphadenopathy is within the standard of care to evaluate uncommon etiologies of large lymph nodes such as in this patients case when all standard first step work up have been negative. As such, PCR testing provided on 5/30/17 was likely to have been more effective than the available standard techniques for the evaluation of this patients medical condition. Therefore, for the reasons stated above, the services at issue were likely to have been 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?