Answer: A 43-year-old male enrollee has requested reimbursement for a continuous positive airway pressure (CPAP) device provided on 2/9/15. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees medical condition.

Answer: The patient noted he was not using CPAP because of seasonal allergies.

Context:
Summary Reviewer

A 43-year-old male enrollee has requested reimbursement for a continuous positive airway pressure (CPAP) device provided on 2/9/15. The Health Insurer has denied this request indicating that the device at issue was not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that the clinical indication for CPAP device includes the requirement of documentation that the patient is compliant and is utilizing the CPAP device for at least four hours a night for at least 70% of the nights for a 30 day period. The patient noted he was not using CPAP because of seasonal allergies. There is a lack of documentation demonstrating that the patient utilized the device at issue for a 30 day period. Given the lack of documentation demonstrating compliance, CPAP was not medically necessary for treatment of the patients medical condition. Given the above reasons, the device at issue was 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 male enrollee has requested authorization and coverage for inpatient care. The Health Insurer has denied this request indicating that the requested service is not medically necessary for treatment of the enrollees surgical procedure.

Context:
Summary Reviewer

A 51-year-old male enrollee has requested authorization and coverage for inpatient care. The Health Insurer has denied this request indicating that the requested service is not medically necessary for treatment of the enrollees surgical procedure. The physician reviewer found that infection of a penile implant can cause complications from scarring after the penile implant is removed. Although a few studies with a small numbers of patients have shown that penile implants can be done in an outpatient setting, most providers prefer to continue preoperative antibiotics for at least 24 hours. The American Urological Associations (AUA) guideline for management of erectile dysfunction states, These antibiotics are administered before the incision is made and usually are continued for 24 to 48 hours postoperatively. The AUA best practice statement for antimicrobial prophylaxis in urologic surgery states, Although there are no [randomized controlled trials] RCTs regarding antimicrobial prophylaxis for insertion of penile prostheses, meta-analyses of mesh hernia repair 100 and orthopedic surgery 101 confirm that antimicrobial prophylaxis is beneficial when foreign material is implanted. A prolonged course of antimicrobials has been used by many practitioners following penile prosthesis insertion, but evidence from the orthopedic literature suggests that prophylaxis for 24 hours or less is adequate. In this case, there is a lack of documentation to support the medical necessity for inpatient care. Most patients who undergo penile prosthesis implantation can be discharged within 24 hours of presentation. The patient can be provided with perioperative antibiotics while on observation status without the need for inpatient stay. As such, the request for inpatient admission is not medically necessary for treatment of the patients medical condition. Therefore, the requested service is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 63-year-old male enrollee has requested reimbursement for the wearable cardioverter defibrillator provided on 11/5/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.

Answer: In this case, the patient was at a significant risk from sudden cardiac death. He benefited from risk reduction with the wearable cardioverter defibrillator provided on 11/5/14.

Answer: This patient was at risk for sudden cardiac death while awaiting improvement in left ventricular systolic function prior to consideration of a permanent ICD.

Context:
Summary Reviewer 1

A 63-year-old male enrollee has requested reimbursement for the wearable cardioverter defibrillator provided on 11/5/14. 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 services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. In this case, the patient was at a significant risk from sudden cardiac death. He benefited from risk reduction with the wearable cardioverter defibrillator provided on 11/5/14. An increase in the risk of sudden cardiac death, and a potential benefit from implantable cardioverter defibrillator (ICD) implantation, has long been recognized in patients with left ventricular dysfunction related to underlying ischemic heart disease. This patient was at risk for sudden cardiac death while awaiting improvement in left ventricular systolic function prior to consideration of a permanent ICD. Given the above, the wearable cardioverter defibrillator provided on 11/5/14 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 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: The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment provided from 6/16/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition

Answer: the documentation notes he has access to a private school, tutors, and therapists.

Answer: he has shown poor resiliency and poor response to treatment.

Answer: he has shown an obstructive engagement, as he was ambivalent, avoidant or distrustful in his relationship with clinicians and other care providers.

Answer: his parents showed

Answer: acceptance and engagement in his treatment.

Context:
Summary Reviewer

The parent of a 17-year-old male enrollee has requested reimbursement and prospective authorization and coverage for psychiatric residential treatment provided from 6/16/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health condition The physician reviewer found that the residential treatment provided from 6/16/16 forward was not and is not medically necessary for treatment of the patients medical condition. Per the Child and Adolescent Level of Care Utilization System (CALOCUS), the patient qualifies for Level Four, intensive integrated services without 24-hour psychiatric monitoring. Specifically, this level of care would include placements such as group homes or foster care. This level qualifies him for treatment by a child psychiatrist and nurse as well as individual and family therapy. Support services should also be provided. Specifically, in Dimension I, risk of harm, he scores as some risk of harm. Dimension II, functional status, he qualifies as serious functional impairment. Dimension III, co-morbidity developmental, medical, substance use and psychiatric, he qualifies as major co-morbidity. In Dimension IV, recovery environment, he scores as minimally stressful environment as his material needs are met without significant cause for concern. He also has a highly supportive environment, as the documentation notes he has access to a private school, tutors, and therapists. In Dimension V, resiliency and treatment history, he has shown poor resiliency and poor response to treatment. In Dimension VI, treatment acceptance and engagement, he has shown an obstructive engagement, as he was ambivalent, avoidant or distrustful in his relationship with clinicians and other care providers. However, his parents showed an optimal acceptance and engagement in his treatment. Given the above, the RTC level of care as of 6/16/16 was not and is not medically necessary for treatment of the patients medical condition.Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer:
A 35-year-old female enrollee has requested reimbursement for colorectal cancer screening
using chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22. The
Health Insurer has denied this request and reported that the services at issue were investigational
for the evaluation of the enrollees medical condition.

Answer:
The patient has had a colon polyp (of the serrated type) in the
past, and

Answer:
the diagnosis of
ulcerative colitis.

Context:
Summary Reviewer 1

A 35-year-old female enrollee has requested reimbursement for colorectal cancer screening
using chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22. 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 as noted
by  Marion  and  colleagues,  chromoendoscopy  is  supported  as  superior  to  alternatives  for
localization  of  dysplasia  in  randomized  trials.  Per  American  Society  for  Gastrointestinal
Endoscopy (ASGE) guidelines for inflammatory bowel disease, chromoendoscopy allows better
characterization  of  visible  lesions  as  endoscopically  resectable  or  unresectable,  and
chromoendoscopy with targeted biopsies is the preferred surveillance technique to maximize
dysplasia  detection.  Per  American  Gastroenterological  Association  guidelines,  Dye  spray
chromoendoscopy...should be considered in all persons with colonic inflammatory bowel disease
undergoing surveillance colonoscopy, particularly if a standard definition endoscope is used or if
there is a history of dysplasia. The patient has had a colon polyp (of the serrated type) in the
past, and aside from that, warrants surveillance biopsies for dysplasia given the diagnosis of
ulcerative colitis. Per the guidelines cited above, surveillance colonoscopies should be performed
using  chromoendoscopy  when  possible.  Therefore,  colorectal  cancer  screening  using
chromoendoscopy or narrowband imaging optical colonoscopy performed on 1/25/22 was likely
to have been more beneficial than any available standard therapy.

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


Answer: A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.

Context:
Summary Reviewer 3

A 58-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76 to 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 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, the superior effectiveness of DecisionDx-Melanoma testing performed on 1/03/17 and transfer of the laboratory specimen has not been established in this patients case. 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 61-year-old male with persistent, symptomatic atrial fibrillation with multiple
hospital visits for chemical cardioversion. The patient has requested authorization and coverage
for hybrid convergent ablation treatment of atrial fibrillation (CPT 33266).

Context:
Summary Reviewer

The patient is a 61-year-old male with persistent, symptomatic atrial fibrillation with multiple
hospital visits for chemical cardioversion. The patient has requested authorization and coverage
for hybrid convergent ablation treatment of atrial fibrillation (CPT 33266). The physician reviewer
found  that  the  hybrid  convergent  procedure  has  superior  effectiveness  compared  with
endocardial-only ablation in patients with advanced atrial fibrillation. This was demonstrated in
the CONVERGE trial, a multicenter, randomized clinical trial which also showed a significantly
higher number of patients in the hybrid convergent arm remaining free from cardioversion at 18
months follow-up. This was also associated with an acceptable safety profile. The cumulative
experience with the convergent procedure is now greater than 10,000 patients to date and has
an established position in managing atrial fibrillation. Therefore, hybrid convergent ablation
treatment of atrial fibrillation (CPT 33266) is medically necessary for treatment of the patients
medical condition.

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


Answer: The parent of a 16-year-old female enrollee has requested authorization and coverage for Rituxan. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition.

Answer: This patient has failed a

Answer: biologic therapy according to the medical records.

Context:
Summary Reviewer 3

The parent of a 16-year-old female enrollee has requested authorization and coverage for Rituxan. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the use of Rituxan in this case is not likely to be more beneficial than the available standard therapy. According to the 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis, biologic medications available to treat children with juvenile idiopathic arthritis include Actemra, Enbrel, Humira, and Orencia after failure of standard DMARD therapy. According to the Rituxan prescribing information, it is indicated for the treatment of rheumatoid arthritis in combination with methotrexate in adult patients with moderately-to-severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies. This patient has failed a single biologic therapy according to the medical records. There are other options that are considered a standard of care in this case, including Orencia intravenous or subcutaneous, Actemra intravenous or subcutaneous, or Enbrel. These medications are indicated for juvenile idiopathic arthritis.  There is no data available to suggest that this patient would respond more to Rituxan as opposed to the biologic medications that are approved for juvenile idiopathic arthritis. Thus, Rituxan is not likely to be more beneficial than other available standard therapy.

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


Answer: The patient is a nine-year-old female. The patient has requested reimbursement for neuropsychological testing performed from 1/18/20 through 8/13/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of this patient.

Answer: Neuropsychological testing indicated that the patient had a complex combination of ADHD combined subtype, non-verbal learning disorders in math and reading, dysgraphia/dyspraxia, and dysthymia with symptoms of anxiety and depression. The patientas symptoms were interfering with her social, academic and family functioning. She was noted to be at risk of social isolation, peer rejection and bullying.

Context:
Summary Reviewer

The patient is a nine-year-old female. The patient has requested reimbursement for neuropsychological testing performed from 1/18/20 through 8/13/20. 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 submitted documentation supports the medical necessity of the services at issue. Neuropsychological testing indicated that the patient had a complex combination of ADHD combined subtype, non-verbal learning disorders in math and reading, dysgraphia/dyspraxia, and dysthymia with symptoms of anxiety and depression. The patientas symptoms were interfering with her social, academic and family functioning. She was noted to be at risk of social isolation, peer rejection and bullying. The neuropsychological testing and school evaluations that were performed were the only means by which the patientas complex combination of conditions could be clarified, and appropriate intervention instituted. Therefore, neuropsychological testing performed from 1/18/20 through 8/13/20 was medically necessary for the evaluation of this patient.

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


Answer: A 53-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/25/16.  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 53-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/25/16.  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 according to 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 noted 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 breast tomosynthesis over conventional mammogram due to improved cancer detection rate.  In sum, breast tomosynthesis performed on 7/25/16 was likely to have been more effective than other methods of evaluating this patient. Based upon the information set forth above, the service at issue was likely to 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 39-year-old female with a history of large breasts, low back pain, rheumatoid
arthritis, spinal stenosis, degenerative disease, and herniated disc. The patient underwent breast
reduction surgery on 9/12/22. The Health Insurer has denied the service at issue as not medically
necessary for the treatment of the patients medical condition.

Answer:
In this case, the patient has a
history of back and neck pain. The patient also presented with rheumatoid arthritis, spinal stenosis,
degenerative disc disease, and herniated disc.

Answer: The patient complained of intertrigo

Context:
Summary
The patient is a 39-year-old female with a history of large breasts, low back pain, rheumatoid
arthritis, spinal stenosis, degenerative disease, and herniated disc. The patient underwent breast
reduction surgery on 9/12/22. The Health Insurer has denied the service at issue as not medically
necessary for the treatment of the patients medical condition. This denial is the subject of this
appeal and determination. The physician reviewer found that the American Society of Plastic
Surgeons (ASPS) guidelines state that reduction mammaplasty should be performed based on
documentation of the severity of the symptoms of macromastia and its impact on health-related
quality of life. The guidelines indicate that reduction mammaplasty may be performed if at least
two of the following quality-of-life signs are present: chronic breast pain due to breast weight,
intertrigo unresponsive to medical management, upper back, neck, and shoulder pain, backache,
thoracic kyphosis, shoulder grooving from bra straps, upper extremity paresthesia due to brachial
plexus compression syndrome secondary to the weight of the breasts being transferred to the
shoulder strap area, headache, and congenital breast deformity. In this case, the patient has a
history of back and neck pain. The patient also presented with rheumatoid arthritis, spinal stenosis,
degenerative disc disease, and herniated disc. There is a lack of documentation of chronic breast
pain  due  to  weight  of  the  breasts,  thoracic  kyphosis,  shoulder  grooving,  upper  extremity
paresthesia, headache, or congenital breast deformity. The patient complained of intertrigo, but
there is a lack of documentation that the patients condition was unresponsive to adequate medical
management. Overall, there are fewer than two documented quality-of-life signs as defined by the
ASPS. Therefore, the breast reduction surgery performed on 9/12/22 was not medically necessary
for the treatment of this patient.

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


Answer: A 37-year-old female enrollee has requested authorization and coverage for an implanted electrical stimulator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees pain.

Context:
Summary Reviewer 1

A 37-year-old female enrollee has requested authorization and coverage for an implanted electrical stimulator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollees pain. The physician reviewer found that there is a lack of support for the requested device in this patients case. The records do not document a nonsteroidal anti-inflammatory drug trial. There is no surgical consultation that addresses the extruded disc in her neck. While there is literature supporting the use of cervical spinal cord stimulator for cervical radiculopathy, there are several available alternatives before embarking on spinal cord stimulation. Therefore, the implanted electrical stimulator is not likely to be more effective than other treatment options. Based upon the information set forth above, the requested device is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: The parent of a 10-month-old female enrollee has requested authorization and coverage for lansoprazole. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition.

Answer: This patient has been diagnosed with gastroesophageal reflux disease. On 1/07/19, while the patient was on lansoprazole, the provider suggested a trial of hypoallergenic formula. The provider also recommended gastroenterology evaluation. On 2/15/19, the records noted that that the patient was intolerant of the hypoallergenic formula.

Context:
Summary Reviewer 2

The parent of a 10-month-old female enrollee has requested authorization and coverage for lansoprazole. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested medication in this clinical setting. This patient has been diagnosed with gastroesophageal reflux disease. On 1/07/19, while the patient was on lansoprazole, the provider suggested a trial of hypoallergenic formula. The provider also recommended gastroenterology evaluation. On 2/15/19, the records noted that that the patient was intolerant of the hypoallergenic formula. However, the records do not provide additional details regarding the symptoms of intolerance. Proton pump inhibitor therapy is recommended in infants only when there are findings of erosive esophagitis or in the presence of certain anatomic abnormalities (such as repaired tracheoesophageal fistula/esophageal atresia). Given that esophagitis was not documented in this case, lansoprazole is not likely to be more effective than other treatment options.

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


Answer: The parent of a 10-month-old female enrollee has requested authorization and coverage for lansoprazole. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition.

Context:
Summary Reviewer 3

The parent of a 10-month-old female enrollee has requested authorization and coverage for lansoprazole. The Health Insurer has denied this request indicating that the requested medication is investigational for the treatment of the enrollees medical condition. The physician reviewer found that Lansoprazole may be indicated in select cases, such as patients with esophagitis and postoperative esophageal dysmotility. The article by Hassall and colleagues noted the presumed safety and efficacy of proton pump inhibitor therapy in this age-group, but this was in the setting of defined esophagitis. It is difficult to label an infant as having an acid-related disease based on clinical assessment alone. The trend has shifted away from routine use of prolonged acid suppression in otherwise healthy infants. There may be a role for empiric use in the setting of feeding aversions or poor weight gain, but neither of those situations were demonstrated here. Thus, lansoprazole is not likely to be superior over other treatment options.

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


Answer: A 48-year-old female enrollee has requested authorization and coverage for Gamunex-C (immune globulin (human) intravenous or subcutaneous solution, 10 gm/100 ml. 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: In this case, the patient has

Answer: been treated with prednisone

Answer: In this case, the patient has been diagnosed with dermatomyositis. Her treatment has included prednisone

Context:
Summary Reviewer

A 48-year-old female enrollee has requested authorization and coverage for Gamunex-C (immune globulin (human) intravenous or subcutaneous solution, 10 gm/100 ml. 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 dermatomyositis is an idiopathic inflammatory myopathy. In this case, the patient has been diagnosed with dermatomyositis. Her treatment has included prednisone alone. Initial therapy for individuals diagnosed with this disorder includes high-dose glucocorticoid therapy with a taper to the lowest effective dose. Generally, a glucocorticoid-sparing agent is used in combination with glucocorticoid therapy. Treatment includes prednisone in combination with methotrexate, azathioprine or CellCept. In this case, the patient has only been treated with prednisone, and the requested medication is not considered a first-line medication. There is no documentation that she has failed treatment with a glucocorticoid-sparing agent, such as methotrexate, azathioprine or CellCept, which are considered first-line medications. The requested medication, Gamunex-C is not medically indicated. Therefore, Gamunex-C (immune globulin (human) intravenous or subcutaneous solution, 10 gm/100 ml) is not medically necessary for the treatment of this patient.

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


Answer:
The patient is a 52-year-old female with a history of refractory back pain, depression, anxiety,
and chronic pain disorder status post pain pump placed in 2019. The provider has recommended
placement of a percutaneous implantation of spinal cord stimulator.

Answer:
at issue is whether the requested percutaneous implantation of neurostimulator
electrode array, epidural, is medically necessary for treatment of this patient.

Answer:
In this case, the patient has chronic low
back pain that has been non-responsive to medication management, physical therapy, epidural
steroid injections, cognitive therapy and intrathecal pain pump.

Context:
Summary
The patient is a 52-year-old female with a history of refractory back pain, depression, anxiety,
and chronic pain disorder status post pain pump placed in 2019. The provider has recommended
placement of a percutaneous implantation of spinal cord stimulator. The physician reviewer
found that at issue is whether the requested percutaneous implantation of neurostimulator
electrode array, epidural, is medically necessary for treatment of this patient. A prospective,
multicenter, randomized controlled trial was conducted evaluating the long-term quality of life
improvement for patients with chronic intractable back and leg pain using spinal cord stimulation
(Amirdelfan, et al.). The authors reported that of the 171 patients who received a permanent
spinal cord stimulation device implant, a higher proportion of spinal cord stimulation patients
had marked improvement of their disability on the Oswestry Disability Index (ODI) to a moderate
or minimal impact on their daily function versus the control group. The authors concluded that,
In  addition  to  superior  pain  relief,  10  kHz  spinal  cord  stimulation  provides  long-term
improvements in quality of life and functionality for subjects with chronic low-back and leg pain.
Similarly, a systematic review and meta-analysis performed by Head and colleagues evaluated a
variety of spinal cord stimulation systems and device parameters for use in patients with chronic
low back and leg pain. The authors concluded that data from level 1 randomized controlled trials
have elevated the status of spinal cord stimulation to a safe and effective alternative for the
treatment of neuropathic low back pain and leg pain. In this case, the patient has chronic low
back pain that has been non-responsive to medication management, physical therapy, epidural
steroid injections, cognitive therapy and intrathecal pain pump. Based on the level one evidence
to support the usage of spinal cord stimulation therapy for patients with chronic low back and
leg pain that is refractory to other forms of conservative care, the requested spinal cord
stimulation is appropriate for treatment of this patients chronic low back pain. Therefore, the
requested percutaneous implantation of neurostimulator electrode array, epidural, is medically
necessary for treatment of this patient.

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


Answer: A 47-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire upper airway stimulation system. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.

Answer: The records noted intolerance to the use of continuous positive airway pressure therapy. A sleep study documented symptoms of obstructive sleep apnea with an apnea-hypopnea index at the moderate to severe level of obstructive sleep apnea syndrome, with oxygen desaturation to 82%.

Context:
Summary Reviewer 3

A 47-year-old male enrollee has requested authorization and coverage for hypoglossal nerve stimulation or Inspire upper airway stimulation system. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. The records noted intolerance to the use of continuous positive airway pressure therapy. A sleep study documented symptoms of obstructive sleep apnea with an apnea-hypopnea index at the moderate to severe level of obstructive sleep apnea syndrome, with oxygen desaturation to 82%. Hypoglossal nerve stimulation therapy has been demonstrated to be an effective modality for the treatment of obstructive sleep apnea in patients with tongue-based obstruction. The medical evidence supports the requested services for the treatment of this patient. Thus, the requested hypoglossal nerve stimulation or Inspire upper airway stimulation system is likely to be of greater benefit than other treatment options.

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


Answer: A year-old female enrollee has requested reimbursement for collagen crosslink testing provided on 4/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition.

Context:
Summary Reviewer 1

A year-old female enrollee has requested reimbursement for collagen crosslink testing provided on 4/17/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that Osteoporosis is a condition of thinning of the bones that leads to an increased risk of fracture.  It  is defined by the World Health Organization (WHO) as a bone mineral density of 2.5 standard deviations or more below the mean peak bone mass (average of young, healthy adults), as measured by dual-energy x-ray absorptiometry (DEXA). Bone mineral density assessment via DEXA is still the criterion standard for evaluation and diagnosis of osteoporosis. However, because changes in bone mass and density in response to antiresorptive therapy account for only a small portion of the predicted fracture risk reduction, markers of bone turnover may be a useful adjunct in monitoring of osteoporotic patients treated with antiresorptive agents. Medical evidence suggests that biochemical markers could be useful in making therapeutic decisions because, in general, the higher the bone remodeling and bone loss rates, the greater the concentration of bone biochemical markers in blood or urine. There is sufficient support for the services at issue in this clinical setting. Therefore, collagen crosslink testing provided on 4/17/19 was likely to have been more beneficial than other methods of evaluating this patient.

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


Answer: The parent of a 15-year-old male enrollee has requested reimbursement for residential mental health treatment services provided from 5/9/15 through 8/7/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder, and parent-child relational problem.

Context:
Summary Reviewer

The parent of a 15-year-old male enrollee has requested reimbursement for residential mental health treatment services provided from 5/9/15 through 8/7/15. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees attention deficit hyperactivity disorder (ADHD), oppositional defiant disorder, and parent-child relational problem.

 The physician reviewer found that the documentation provided for review does not support the medical necessity of residential mental health treatment services provided from 5/9/15 through 8/7/15. There is no evidence that treatment in a less restrictive setting would have been ineffective to manage the patient, since this had not been given an adequate trial. Similarly, there is a lack of objective evidence that continuation with a lesser intensity of care could not have provided improvement or prevention of deterioration. The patients level of symptomatology did not justify residential services. No suicidal ideations or homicidal ideations had been documented, but in one incident, which was assessed as an attempt to manipulate the staff. The patient was able to contract for safety and no additional intervention occurred. Further, continued residential services, especially at the highly intensive levels that were used, may have led to service dependency, which would be an adverse outcome. Therefore, this patient would have been more appropriately managed at a less restrictive, less intrusive intensity of services, such as outpatient care. For these reasons, the residential mental health treatment services provided from 5/9/15 through 8/7/15 were not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 64-year-old female enrollee has requested reimbursement for knee injections provided on 6/15/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees knee pain.

Answer: this patient presented on 6/15/18 with recurrent right knee pain and limitations in functional mobility and activities of daily living. Clinical examination findings were consistent with reported radiographic evidence of right knee degenerative joint disease. Reasonable conservative treatment, including medications, activity modification, weight loss, and physical therapy have failed to provide adequate symptom relief. She was status post previous injections on 12/19/16 and 9/22/17 which had provided sustained pain relief and functional improvement for longer than six months.

Context:
Summary Reviewer

A 64-year-old female enrollee has requested reimbursement for knee injections provided on 6/15/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees knee pain. The physician reviewer found that this patient presented on 6/15/18 with recurrent right knee pain and limitations in functional mobility and activities of daily living. Clinical examination findings were consistent with reported radiographic evidence of right knee degenerative joint disease. Reasonable conservative treatment, including medications, activity modification, weight loss, and physical therapy have failed to provide adequate symptom relief. She was status post previous injections on 12/19/16 and 9/22/17 which had provided sustained pain relief and functional improvement for longer than six months. Evidence-based peer-reviewed literature supports the use of viscosupplementation injections for the treatment of pain in patients with osteoarthritis of the knee. Repeat viscosupplementation injections have been found to be safe and effective and allow for delay of knee replacement surgery. Thus, knee injections provided on 6/15/18 were medically necessary for the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer: A 23-year-old female enrollee has requested authorization and coverage for FirstStep Plus Cytogenomic Constitutional (Genome-Wide) Microarray Analysis. The Health Insurer has denied this request indicating that the requested services are investigational for the evaluation of the enrollees medical condition.

Context:
Summary Reviewer 2

A 23-year-old female enrollee has requested authorization and coverage for FirstStep Plus Cytogenomic Constitutional (Genome-Wide) Microarray Analysis. The Health Insurer has denied this request indicating that the requested services are investigational for the evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting.  Chromosomal microarray testing is an appropriate first-line test for patients with non-syndromic developmental delay/intellectual disability, as well as patients with autism spectrum disorders.  There are clear management implications that chromosomal microarray testing has provided for patients.  In sum, FirstStep Plus Cytogenomic Constitutional (Genome-Wide) Microarray Analysis is likely to be of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: The patient is a 25-year-old female with a history of chronic sinus problems. The provider reports the patient presented with symptoms of recurring sinus infections requiring antimicrobial treatment four times in the preceding four months. The patients symptoms included facial pressure, headache, generalized fatigue and nasal congestion. The physical examination documented clear mucus and nasal septal deviation suggestive of acute rhinitis, most likely to be of bacterial origin and the provider recommended use of a topical fluticasone nasal spray and nasal irrigations along with computed tomography (CT) imaging of the paranasal sinuses. On 2/13/18, a follow-up note documented that the patient had been evaluated for nasal airway obstruction due to deviated nasal septum and rhinorrhea. CT imaging on 12/27/16 demonstrated that the frontal, ethmoid, maxillary and sphenoid sinuses were clear and that the sphenoid and frontal sinuses were found to be hypoplastic. The ostiomeatal units were found to be patent. This was in comparison to the previous CT scan dated 8/18/16. The patient has requested reimbursement for the CT maxillofacial without contrast material provided on 12/27/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary.

Answer: the provider stated in the physical examination that the patient did have symptoms of recurrent acute sinusitis over four months or longer and had been placed on multiple different medical therapies including antibiotics and other medications, but still had repeated rhinosinusitis. The patient was found on physical examination to have persistent rhinorrhea in addition to nasal septal deviation

Context:
Summary Reviewer

The patient is a 25-year-old female with a history of chronic sinus problems. The provider reports the patient presented with symptoms of recurring sinus infections requiring antimicrobial treatment four times in the preceding four months. The patients symptoms included facial pressure, headache, generalized fatigue and nasal congestion. The physical examination documented clear mucus and nasal septal deviation suggestive of acute rhinitis, most likely to be of bacterial origin and the provider recommended use of a topical fluticasone nasal spray and nasal irrigations along with computed tomography (CT) imaging of the paranasal sinuses. On 2/13/18, a follow-up note documented that the patient had been evaluated for nasal airway obstruction due to deviated nasal septum and rhinorrhea. CT imaging on 12/27/16 demonstrated that the frontal, ethmoid, maxillary and sphenoid sinuses were clear and that the sphenoid and frontal sinuses were found to be hypoplastic. The ostiomeatal units were found to be patent. This was in comparison to the previous CT scan dated 8/18/16. The patient has requested reimbursement for the CT maxillofacial without contrast material provided on 12/27/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was not medically necessary. Upon the review of the documentation, the provider stated in the physical examination that the patient did have symptoms of recurrent acute sinusitis over four months or longer and had been placed on multiple different medical therapies including antibiotics and other medications, but still had repeated rhinosinusitis. The patient was found on physical examination to have persistent rhinorrhea in addition to nasal septal deviation, which is one of the physical findings on examination to meet criteria for CT scan imaging. Practice guidelines acknowledge that CT imaging, as opposed to the plain radiography or magnetic resonance imaging (MRI), is the diagnostic modality of choice for confirming chronic rhinosinusitis or as an alternative to nasal endoscopy. Thus, the CT maxillofacial without contrast material provided on 12/27/16 was medically necessary for evaluation of the patients medical condition. Based on the foregoing discussion, the diagnostic procedure at issue was medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer: A 20-year-old male enrollee has requested reimbursement for the Anser IFX testing provided on 10/26/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease status post resection.

Context:
Summary Reviewer 1

A 20-year-old male enrollee has requested reimbursement for the Anser IFX testing provided on 10/26/15. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees Crohns disease status post resection. The physician reviewer found that some evidence exists to suggest that low serum levels of infliximab and/or the presence of antibodies to infliximab may play a role in primary or secondary response failures. Antidrug antibodies develop in a substantial number of patients and may be responsible for acute drug infusion reactions as well as delayed hypersensitivity reactions. In a large percent of patients who develop antibodies, such antibodies may disappear after continued treatment. However, the reasons for therapeutic failures remain unclear. Some evidence exists that low serum levels of infliximab or the presence of infliximab antibodies have an adverse effect on the clinical outcome of a patients response to treatment. However, there are few well controlled clinical trials to confirm that use of the Anser IFX testing leads to improved patient outcomes or quality of life as opposed to the standard method of treatment (Steenholdt, et al; Nanda, et al). All told, the Anser IFX testing provided on 10/26/15 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 62-year-old male enrollee has requested authorization and coverage for insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition.

Answer: He has failed continuous positive airway pressure therapy

Context:
Summary Reviewer 3

A 62-year-old male enrollee has requested authorization and coverage for insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the requested services in this clinical setting. Although traditional upper airway surgical procedures target the anatomic component of obstruction, upper airway stimulation tackles the twin goals of improving anatomic and neuromuscular pathology. Hypoglossal nerve stimulator has been demonstrated to be safe and effective in a small subset of patients with obstructive sleep apnea who have failed continuous positive airway pressure, have nonconcentric airway collapse, an apnea-hypopnea index between 20 and 50, and a body mass index less than 32. This procedure has been approved by the U.S. Food and Drug Administration. With a body mass index of 26.6, apnea-hypopnea index of 19.3 and nonconcentric airway collapse, this patient meets the criteria. He has failed continuous positive airway pressure therapy, which is the gold standard treatment for obstructive sleep apnea. Thus, insertion of chest wall respiratory sensor electrode or electrode array, including connection to pulse generator is likely to be of greater benefit than other treatment options.

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


Answer: A 46-year-old male enrollee has requested authorization and coverage for an oral appliance. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees mild obstructive sleep apnea.

Answer: The patient has been diagnosed with mild obstructive sleep apnea. Per the records, treatment with CPAP was initially recommended. The clinical notes indicate that the patient is unable to tolerate CPAP therapy.

Context:
Summary Reviewer

A 46-year-old male enrollee has requested authorization and coverage for an oral appliance. The Health Insurer has denied this request indicating that the requested device is not medically necessary for treatment of the enrollees mild obstructive sleep apnea. The physician reviewer found that the submitted documentation supports the medical necessity of the requested device. The patient has been diagnosed with mild obstructive sleep apnea. Per the records, treatment with CPAP was initially recommended. The clinical notes indicate that the patient is unable to tolerate CPAP therapy. For patients who are unable to tolerate CPAP therapy, treatment with an oral appliance has been shown to improve symptoms of obstructive sleep apnea. The medical evidence supports the requested device in this clinical setting. Thus, the requested oral appliance is medically necessary for the treatment of this patient. Therefore, the requested device 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 31-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/11/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition.

Answer: this patient had an early stage melanoma.

Context:
Summary Reviewer 2

A 31-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/11/19. 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 this patient had an early stage melanoma. Commercially available gene expression profiling (GEP) tests are marketed as being able to classify cutaneous melanoma into separate categories based on risk of metastasis. However, it remains unclear whether these tests provide clinically actionable prognostic information when used in addition to or in comparison with known clinicopathologic factors or multivariable nomograms that incorporate patient sex, age, tumor location and thickness, ulceration, mitotic rate, lymphovascular invasion, microsatellites, and sentinel lymph node biopsy status. Furthermore, the impact of these tests on treatment outcomes or follow-up schedules has not been established. Newer prognostic molecular techniques should not replace standard staging procedures.  There is a lack of definitive data regarding its use for risk classification in patients with cutaneous melanoma, and this test does not currently have a role in determining which patients are candidates for adjuvant immunotherapy, either as a standard of care or as part of clinical trials. All told, DecisionDx-Melanoma testing performed on 12/11/19 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:
The patient is a 61-year-old male who was admitted for hospitalization on 8/5/21. The patient
has requested reimbursement for inpatient hospital level of care from 8/5/21 through 8/7/21.
The Health Insurer has denied this request and reported that the services at issue were not
medically necessary for the treatment of this patient.

Answer:
In this case,
the patient presented with non-ST-elevation myocardial infarction (NSTEMI), a form of heart
attack, and pulmonary edema in the setting of rapid atrial fibrillation requiring rate control by
continuous intravenous diltiazem infusion. At the time of presentation on 8/5/21, the patient
was at risk due to persisting rapid atrial fibrillation, worsening/evolving heart failure, respiratory
failure,  and  sudden  cardiac  death.

Context:
Summary Reviewer

The patient is a 61-year-old male who was admitted for hospitalization on 8/5/21. The patient
has requested reimbursement for inpatient hospital level of care from 8/5/21 through 8/7/21.
The Health Insurer has denied this request and reported that the services at issue were not
medically necessary for the treatment of this patient. The physician reviewer found that the
submitted documentation supports the medical necessity of the services at issue. In this case,
the patient presented with non-ST-elevation myocardial infarction (NSTEMI), a form of heart
attack, and pulmonary edema in the setting of rapid atrial fibrillation requiring rate control by
continuous intravenous diltiazem infusion. At the time of presentation on 8/5/21, the patient
was at risk due to persisting rapid atrial fibrillation, worsening/evolving heart failure, respiratory
failure,  and  sudden  cardiac  death.  Given  this  adverse  risk  profile,  the  patient  warranted
admission to inpatient status to facilitate intravenous diuresis or volume removal, close cardiac
monitoring with telemetry and repeat biomarkers, and continued intravenous infusion for rate
control to treat the underlying cause of his condition. Moreover, at the time of the inpatient
order, it was reasonable to anticipate the patient would cross two midnights while receiving
medically necessary care, often considered the benchmark for inpatient admission, which was
the case for this hospital stay. In addition, the patient required ICU level care due to (1) his
pulmonary edema and tenuous respiratory status, and (2) his need for continuous intravenous
infusion of diltiazem, which cannot be safely delivered on the regular medicine floor in most
hospital systems. Therefore, inpatient hospital level of care from 8/5/21 through 8/7/21 was
medically necessary for the treatment of this patient.

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


Answer: The parent of a five-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 30 hours per week of applied behavioral analysis (ABA) therapy provided from 6/5/15 through 12/3/15. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder (ASD).

Context:
Summary Reviewer

The parent of a five-year-old male enrollee has requested reimbursement and prospective authorization and coverage for 30 hours per week of applied behavioral analysis (ABA) therapy provided from 6/5/15 through 12/3/15. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees autism spectrum disorder (ASD). The physician reviewer found the review of the submitted documentation and relevant literature demonstrates the medical necessity of the services at issue. Reichow and colleagues performed a review showing that early intensive behavioral intervention is effective to increase IQ, improve communication and adaptive skills. Based on the documentation submitted for review, the patient presents with symptoms consistent with autism. Maladaptive behaviors including aggression and tantrums are difficult to treat with other interventions. The research shows that although medications including Risperdal can reduce some of the aggression in children with ASD it does not treat the core symptoms and does not provide long term benefits. Matson and Jang performed a literature review on treating aggression in persons with ASD and found that the most effective interventions were behavioral interventions including ABA therapy. Based on the support in the peer-reviewed literature and the documented regression in behaviors with a reduction of hours, the request for 30 hours per week of ABA was and is medically necessary for treatment of the patients medical condition. Therefore, the services at issue were and are 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 33-year-old female enrollee has requested reimbursement for exome sequence analysis (81415) provided on 8/15/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition.

Context:
Summary Reviewer

A 33-year-old female enrollee has requested reimbursement for exome sequence analysis (81415) provided on 8/15/19. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that the Society for Maternal-Fetal Medicine indicates that routine use of prenatal sequencing as a diagnostic test is not currently supported due to insufficient validation data and knowledge about its benefits and pitfalls. Although the technology is promising in genetic evaluation of an anomalous fetus, many challenges remain for the routine clinical use of exome sequencing. Interpreting results from exome sequencing is a very lengthy process, and is challenging due to reliance on phenotypic data that may be incomplete. Additionally, there are many counseling and ethical issues related to prenatal exome sequencing, including determining when to report secondary or incidental findings, the ongoing need for reanalysis of results, and the challenges of interpreting results in meaningful ways for patients. Therefore, given the complexities involved in interpretation of results, timeliness of results, and patient/family counseling, the decision to proceed with this type of testing should be made in consultation with a provider specializing in genetic testing, such as a certified genetic counselor or medical geneticist and is currently not the standard of care or medically necessary as in this case. Thus, CPT 81415 (exome sequence analysis) performed on 8/15/19 was not medically necessary for the evaluation of this patient.

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


Answer: A 58-year-old male has requested authorization and coverage for proton beam therapy (77499). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees right tonsillar cancer.

Context:
Summary Reviewer 3
A 58-year-old male has requested authorization and coverage for proton beam therapy (77499). The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees right tonsillar cancer. The physician reviewer found that currently, there is a lack of clinical data in the medical literature to suggest that treatment with proton beam therapy offers a clinical benefit compared to conventional radiation therapy techniques for tumors of the head and neck area. In the majority of cases, the standard approach to treat this malignancy is with standard photon techniques using intensity modulated radiation therapy. A recent comparative analysis by Sio and colleagues found no significant difference in symptom burden in the acute and chronic phases of treatment with proton beam therapy when compared to photon therapy for head and neck cancer. Consensus group guidelines do not support the use of proton therapy in this setting. There is a lack of level I evidence to support the use of proton therapy for the treatment of head and neck cancer. Thus, the superior efficacy of the requested proton beam therapy (77499) has not been established in this patients case. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 50-year-old male enrollee has requested authorization and coverage for Korlym 300 mg tablets. 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.

Context:
Summary Reviewer

A 50-year-old male enrollee has requested authorization and coverage for Korlym 300 mg tablets. 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 current medical evidence supports the requested medication in this clinical setting. Meningiomas are more commonly positive for progesterone receptors than for estrogen receptors. Several studies have been conducted on long-term oral therapy of unresectable meningiomas with the antiprogesterone mifepristone (RU486). In the study by Grunberg and colleagues, fourteen patients received mifepristone in daily doses of 200 mg for periods ranging from two to greater than 31 months (greater than or equal to six months in 12 patients). Five patients demonstrated signs of objective response (reduced tumor measurement on computerized tomography scan or magnetic resonance imaging, or improved visual field examination). Three patients experienced subjective improvement (improved extraocular muscle function or relief from headache). The side effects of long-term mifepristone therapy were noted to have been mild. The authors noted that long-term therapy with mifepristone may have efficacy in cases of unresectable benign meningioma. There is sufficient support for the requested medication in this clinical setting. Therefore, Korlym 300 mg tablets are medically necessary for the treatment of this patient.

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


Answer: A 57-year-old female enrollee has requested reimbursement for the hysterectomy performed on 1/16/17. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees post-menopausal bleeding.

Answer: the records provided for review document that this patient presented with a history of post-menopausal bleeding that interfered with her activities of daily living and did not responded to medical management.

Answer: This patient was treated with conservative management, which was hormonal therapy

Context:
Summary Reviewer

A 57-year-old female enrollee has requested reimbursement for the hysterectomy performed on 1/16/17. The Health Insurer has denied this request indicating that the surgery at issue was not medically necessary for treatment of the enrollees post-menopausal bleeding. The physician reviewer found that the records provided for review document that this patient presented with a history of post-menopausal bleeding that interfered with her activities of daily living and did not responded to medical management. Per the American College of Obstetricians and Gynecologists (ACOG), late peri-menopausal patients may be treated with cyclic progestin therapy, low-dose oral contraceptive pills, the levonorgestrel intrauterine device (IUD), or cyclic hormone therapy. The ACOG further noted that women who have completed childbearing, in whom medical therapy has failed, or who have contraindications to medical therapy are candidates for hysterectomy without cervical preservation. Appropriate treatment includes an endometrial ablation or hysterectomy. Endometrial ablation is not definitive therapy and is generally considered for premenopausal women. This patient was treated with conservative management, which was hormonal therapy appropriate for her age. Given the ACOG recommendations for patients who have failed conservative therapy in this clinical setting, the hysterectomy performed on 1/16/17 was medically necessary for treatment of this patients post-menopausal bleeding. Based on the foregoing discussion, the surgery at issue was 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 53-year-old female enrollee has requested authorization and coverage for foam sclerosant/endovenous ablation. 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 patient has painful varicose veins bilaterally. She is status post radiofrequency ablation of left great saphenous vein and ultrasound-guided foam sclerotherapy.

Answer: For the left leg, the veins are residual after a prior thermal ablation. She continues to be symptomatic.

Answer: With regards to the right leg, the varicose veins are de novo. There is no saphenofemoral junction or saphenopopliteal junction reflux.

Context:
Summary Reviewer 3

A 53-year-old female enrollee has requested authorization and coverage for foam sclerosant/endovenous ablation. 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 support for a portion of the services at issue. This patient has painful varicose veins bilaterally. She is status post radiofrequency ablation of left great saphenous vein and ultrasound-guided foam sclerotherapy. There is support for the requested services for the left leg. For the left leg, the veins are residual after a prior thermal ablation. She continues to be symptomatic. Thus, the requested services for the left leg are likely to be superior over other treatment options. With regards to the right leg, the varicose veins are de novo. There is no saphenofemoral junction or saphenopopliteal junction reflux. Per the medical evidence, endovenous thermal ablation is preferred to surgery and foam sclerotherapy in the treatment of small saphenous vein incompetence. In sum, the requested foam sclerosant/endovenous ablation of the left leg is likely to be of greater benefit than other treatment options.

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


Answer: Prior evaluation has documented the degree of obstructive sleep apnea to be severe. The patient had trialed CPAP therapy for airway management and was intolerant to the use of this device.

Answer: The patient is a 64-year-old female with severe obstructive sleep apnea. The medical records document a history of unsuccessful attempts to utilize

Answer: continuous positive airway pressure (CPAP) therapy. On 9/12/17, the records noted a body mass index of 20.2. On 9/26/17, septoplasty and bilateral inferior turbinate reduction was performed. On 10/12/17, a home sleep study confirmed that the patient had a total of 162 obstructive apnea episodes, without central apnea. The documentation noted an apnea-hypopnea index of 43.0 episodes per hour of sleep. The patient has requested coverage for an implanted nerve stimulator. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of this patient.

Context:
Summary Reviewer 2

The patient is a 64-year-old female with severe obstructive sleep apnea. The medical records document a history of unsuccessful attempts to utilize the gold standard treatment of continuous positive airway pressure (CPAP) therapy. On 9/12/17, the records noted a body mass index of 20.2. On 9/26/17, septoplasty and bilateral inferior turbinate reduction was performed. On 10/12/17, a home sleep study confirmed that the patient had a total of 162 obstructive apnea episodes, without central apnea. The documentation noted an apnea-hypopnea index of 43.0 episodes per hour of sleep. The patient has requested coverage for an implanted nerve stimulator. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of this patient.  There is sufficient support for the requested device in this clinical setting. This patient meets clinical criteria for consideration of surgical management of her obstructive sleep apnea symptoms. Prior evaluation has documented the degree of obstructive sleep apnea to be severe. The patient had trialed CPAP therapy for airway management and was intolerant to the use of this device. Clinical studies indicate that patients only benefit from this device when they have a body mass index less than 32, and the patient meets this criteria. Per the medical evidence, patients achieve a definite benefit from the implantation and electrical stimulation of the hypoglossal nerve for treatment of this disorder. All told, the requested implanted nerve stimulator is likely to be superior over other available treatment options. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 41-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/26/20. 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 41-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/26/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that 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. Therefore, DecisionDx-Melanoma testing performed on 5/26/20 was not likely to have been more beneficial than any available standard therapy.

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


Answer: A 38-year-old male enrollee has requested authorization and coverage for a cardioverter defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee, who has cardiac sarcoidosis.

Answer: this patient has a history of cardiac sarcoidosis and symptomatic 2:1 atrioventricular block in need of pacemaker placement.

Context:
Summary Reviewer 2

A 38-year-old male enrollee has requested authorization and coverage for a cardioverter defibrillator. The Health Insurer has denied this request indicating that the requested device is considered investigational for treatment of the enrollee, who has cardiac sarcoidosis. The physician reviewer found that this patient has a history of cardiac sarcoidosis and symptomatic 2:1 atrioventricular block in need of pacemaker placement. In this circumstance of cardiac sarcoidosis and ejection fraction greater than 35% with an indication for pacemaker placement, it is reasonable to implant a defibrillator if meaningful survival of greater than one year is expected. Some patients with cardiac sarcoidosis with normal ejection fraction and no heart failure symptoms have high arrhythmic event rates, especially when late gadolinium enhancement is identified on cardiac MRI or abnormal findings are seen on cardiac PET imaging, such as this patient. The medical evidence supports the requested device in this case. Therefore, the requested cardioverter defibrillator is likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 60-year-old male enrollee has requested authorization and coverage for verapamil. 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.

Context:
Summary Reviewer 2

A 60-year-old male enrollee has requested authorization and coverage for verapamil. 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 penile traction therapy is a therapeutic option for men with Peyronies disease. Penile traction may help to preserve or increase penile length and reduce penile curvature when used as monotherapy or as adjuvant therapy for surgical and intralesional treatments. There is paucity of clinical justification regarding the efficacy of injection therapy with verapamil. Furthermore, addition of verapamil to oral therapy or other nonsurgical therapies does not appear to provide significant improvement. In sum, verapamil is not likely to be superior over other treatment options.

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


Answer:
A 63-year-old female enrollee has requested reimbursement of liquid CDx laboratory testing by
FoundationOne on 4/29/22. The Health Insurer has denied this request and reported that the service
at issue was investigational for the evaluation of the enrollees lung cancer. At issue is whether
CDx laboratory testing by FoundationOne on 4/29/22 was likely to have been more beneficial for
evaluation of the enrollee's condition than any available standard therapy.

Context:
Summary Reviewer 1

A 63-year-old female enrollee has requested reimbursement of liquid CDx laboratory testing by
FoundationOne on 4/29/22. The Health Insurer has denied this request and reported that the service
at issue was investigational for the evaluation of the enrollees lung cancer. At issue is whether
CDx laboratory testing by FoundationOne on 4/29/22 was likely to have been more beneficial for
evaluation of the enrollee's condition than any available standard therapy. The physician reviewer
found that the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of
non-small cell lung cancer (NSCLC) note that there is growing recognition of the molecular
mechanisms of resistance to therapy. Retesting a sample from a tumor that is actively progressing
while exposed to targeted therapy can shed light on appropriate next therapeutic steps. Broad
genomic profiling may be the most informative approach to examining potential mechanisms of
resistance, which may require more than one instance of such profiling over the course of an
individual patients therapy. While liquid biopsy should not be used in lieu of tissue-based testing,
Rolfo  and  colleagues  note  that  isolation  and  analysis  of  circulating  cell-free  tumor
deoxyribonucleic acid (DNA) in plasma is a powerful tool with considerable potential to improve
clinical outcomes across multiple cancer types, including NSCLC. Cell-free tumor DNA testing
generally has very high specificity. While it may also have significantly compromised sensitivity,
with up to a 30% false-negative rate, current medical literature supports complementary testing to
reduce turnaround time and increase the yield of targetable alteration detection. This is especially
true with procedures that typically have a low yield of tissue such as endobronchial ultrasound
(EBUS). Therefore, the service at issue was likely to have been more beneficial for treatment of
the patients medical condition than standard therapy with tissue-based testing alone. Therefore,
CDx laboratory testing by FoundationOne on 4/29/22 was likely to have been more beneficial for
evaluation of the patients condition than any available standard therapy.

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


Answer:
A 63-year-old female enrollee has requested reimbursement of liquid CDx laboratory testing by
FoundationOne on 4/29/22. The Health Insurer has denied this request and reported that the service
at issue was investigational for the evaluation of the enrollees lung cancer.

Answer:
In this case, notes dated 7/27/22 reported that the patient underwent a repeat
biopsy on 4/12/22 by EBUS to confirm recurrent disease. Molecular testing and FoundationOne
CDx liquid testing were requested from this sample at the same time.

Context:
Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement of liquid CDx laboratory testing by
FoundationOne on 4/29/22. The Health Insurer has denied this request and reported that the service
at issue was investigational for the evaluation of the enrollees lung cancer. At issue is whether
CDx laboratory testing by FoundationOne on 4/29/22 was likely to have been more beneficial for
evaluation of the enrollee's condition than any available standard therapy. The physician reviewer
found that Metastatic adenocarcinoma of the lung is an incurable disease, but many advances have
been made with targeted therapies to help extend survival. Multiple guidelines including by the
NCCN,  College  of  American  Pathologists  (CAP),  American  Society  of  Clinical  Oncology
(ASCO), and European Society for Medical Oncology (ESMO), recommend testing for mutations
such as epidermal growth factor receptor (EGFR), KRAS, anaplastic lymphoma kinase (ALK),
and c-ros oncogene (ROS1) on tumor samples to help direct therapy options. If patients are not fit
for biopsy, or if the tissue sample is insufficient for testing, then cell-free testing may help identify
mutations.  Cell-free tests, such as the FoundationOne CDx liquid test at issue, are very specific
but not as sensitive as tissue testing for mutations and are not a substitute when appropriate tissue
can be obtained. In this case, notes dated 7/27/22 reported that the patient underwent a repeat
biopsy on 4/12/22 by EBUS to confirm recurrent disease. Molecular testing and FoundationOne
CDx liquid testing were requested from this sample at the same time. In this clinical setting, given
that the tissue sample is considered more sensitive/specific than liquid biopsy and is the standard
for diagnostic management, the service at issue was not likely to have been more beneficial than
the standard management. Therefore, CDx laboratory testing by FoundationOne on 4/29/22 was
not likely to have been more beneficial for evaluation of the patients condition than any available
standard therapy.

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


Answer: The parent of a 12-year-old male enrollee has requested authorization and coverage for Remicade 400 mg for two weeks and then once monthly for one year. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees juvenile dermatomyositis (JDMS).

Answer: the patient has juvenile dermatomyositis

Context:
Summary Reviewer 3

The parent of a 12-year-old male enrollee has requested authorization and coverage for Remicade 400 mg for two weeks and then once monthly for one year. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees juvenile dermatomyositis (JDMS). The physician reviewer found the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based on the documentation submitted for review, the patient has juvenile dermatomyositis which is moderate to severe and a biologic such as Remicade (infliximab) would likely be beneficial for this patient. Moreover, infliximab has been shown to be safe and effective in children with juvenile dermatomyositis. Riley and colleagues assessed the response of five refractory juvenile dermatomyositis patients to infliximab. The authors reported Improvements in all five patients as shown by positive changes in physician visual analogue scale (VAS), Childhood Myositis Assessment Score (CMAS), Childhood Health Assessment Questionnaire (CHAQ), joint range of movement and, in some, regression of calcinosis and skin signs. There were no major side effects observed with addition of infliximab to the therapeutic regime. For the reasons provided, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 1/26/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.

Context:
Summary Reviewer 1

A 48-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 1/26/16.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this patients case.  According to 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 noted integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls.  In sum, breast tomosynthesis performed on 1/26/16 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: The patient is a 62-year-old male with a progressive group of symptoms consistent with a neurodegenerative disorder.  He has developed dysarthria, ataxia and possibly cognitive abnormalities of executive functioning. Per the records, magnetic resonance imaging (MRI) of the brain showed atrophy of the cerebellum, cerebellar peduncles, and pons and medulla consistent with multisystem atrophy or possibly spinocerebellar degeneration. The provider recommended dopamine transporter single photon emission computed tomography (DaT SPECT). The patient has requested reimbursement for DaT SPECT scan of the brain performed on 9/23/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.

Context:
Summary Reviewer 1

The patient is a 62-year-old male with a progressive group of symptoms consistent with a neurodegenerative disorder.  He has developed dysarthria, ataxia and possibly cognitive abnormalities of executive functioning. Per the records, magnetic resonance imaging (MRI) of the brain showed atrophy of the cerebellum, cerebellar peduncles, and pons and medulla consistent with multisystem atrophy or possibly spinocerebellar degeneration. The provider recommended dopamine transporter single photon emission computed tomography (DaT SPECT). The patient has requested reimbursement for DaT SPECT scan of the brain performed on 9/23/16. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.  There is a lack of support for the services at issue in this clinical setting.  The differential diagnosis of spinocerebellar degeneration versus multiple system atrophy is established by clinical grounds. There is a lack of data demonstrating adequate sensitivity or specificity of DaT SPECT scanning in this clinical setting.  Therefore, DaT SPECT scan of the brain performed on 9/23/16 was not likely to have been more efficacious than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: A 62-year-old female enrollee has requested reimbursement for Prolia injection performed on 8/27/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition.

Answer: the patient has a history of osteoporosis and multiple non-traumatic fractures.

Answer: This patient has been treated with Fosamax, with no benefit on the patients bone mineral density.  The medical notes indicate that the patients markers of bone turnover were elevated

Context:
Summary Reviewer 3

A 62-year-old female enrollee has requested reimbursement for Prolia injection performed on 8/27/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found the patient has a history of osteoporosis and multiple non-traumatic fractures.  The patient is at a high risk for a major osteoporotic fracture, and pharmacological therapy is recommended.  The medical evidence supports Prolia in this clinical setting.  This patient has been treated with Fosamax, with no benefit on the patients bone mineral density.  The medical notes indicate that the patients markers of bone turnover were elevated, indicating poor absorption or increased bone turnover from rheumatoid arthritis while on Fosamax therapy.  Thus, the Prolia injection provided on 8/27/15 was likely to have been more effective than other treatment options.  Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 38-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/13/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.

Context:
Summary Reviewer 1

A 38-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/13/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found there is sufficient support for the services at issue in this clinical setting.  According to 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 noted that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls.  The medical literature supports the use of breast tomosynthesis over conventional mammogram due to improved cancer detection rate.  All told, breast tomosynthesis performed on 7/13/15 was likely to have been of greater benefit than other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 38-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/13/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.

Answer: in this case, the patients presenting symptom was breast pain.

Answer: her breast density was described as containing scattered areas of fibroglandular elements.

Context:
Summary Reviewer 3

A 38-year-old female enrollee has requested reimbursement for breast tomosynthesis performed on 7/13/15.  The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography.  Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities.  This has been shown to be most useful in the evaluation of dense breasts.  However, in this case, the patients presenting symptom was breast pain.  Breast pain is rarely associated with breast cancer, especially without a recognizable mass.  In addition, her breast density was described as containing scattered areas of fibroglandular elements.  Her breasts were not particularly dense.  Breast tomosynthesis has not been shown to provide significant increased value in this clinical setting.  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 64-year-old female enrollee has requested reimbursement for repair of cartilage in the left ankle joint performed on 11/14/18. 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.

Answer: In this case, the lesion had remained symptomatic for over two years before the second surgery.

Context:
Summary Reviewer

A 64-year-old female enrollee has requested reimbursement for repair of cartilage in the left ankle joint performed on 11/14/18. 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 Osteochondral lesions of the talus occur in up to 70% of acute ankle sprains and fractures. These lesions have become increasingly recognized with the advancements in magnetic resonance imaging (MRI) scans. A fair number of these lesions can remain symptomatic and necessitate surgery. In this case, the lesion had remained symptomatic for over two years before the second surgery. Thus, additional surgery was needed. The type of surgery has included either reparative procedures, such as bone marrow stimulation, or replacement procedures, such as autologous osteochondral transplantation. Reparative procedures are generally indicated for smaller lesions, such as this one. The reparative techniques include debridement and bone marrow stimulation techniques, such as microdrilling and microfracture. Regenerative techniques include autologous osteochondral transplants utilized for larger lesions. A review of the current literature indicates drilling, microfracture and insertion of micronized cartilage and bone marrow aspirate concentrate appears to be a safe and effective treatment option for osteochondral lesions of the talus. The addition of bone marrow aspirate concentrate and micronized cartilage does not result in an increase in ankle or donor site morbidity. It is a well-tolerated therapy that significantly promotes healing and decreases revision rates for treatment of the osteochondral lesions when compared to debridement and microfracture alone. Therefore, repair of cartilage in the left ankle joint performed on 11/14/18 was medically necessary for the treatment of this patient.

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


Answer: A 39-year-old male enrollee has requested reimbursement for Anser IFX testing provided on 4/23/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.

Context:
Summary Reviewer 1

A 39-year-old male enrollee has requested reimbursement for Anser IFX testing provided on 4/23/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the superior efficacy of the services at issue.  The medical evidence has not established whether therapy guided by following trough drug levels and drug antibodies is superior to routine good clinical care.  The data available are uncontrolled and come from retrospective analyses.  In general, for a patient failing therapy, there is a trend toward lower trough drug levels with or without the presence of antibody.  However, many patients fail therapy with a normal drug level for a variety of reasons.  All told, Anser IFX testing performed on 4/23/14 was not likely to have been more effective than other methods of evaluation.  Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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