Answer:
The patient is a 67-year-old male who presented in 2021 with a prostate-specific antigen (PSA)
level of 5.64. The patient has requested authorization and coverage for proton beam therapy.

Context:
Summary Reviewer
The patient is a 67-year-old male who presented in 2021 with a prostate-specific antigen (PSA)
level of 5.64. The patient has requested authorization and coverage for proton beam therapy.
The physician reviewer found that the submitted documentation fails to demonstrate the
medical necessity of the requested services. There is a lack of strong medical evidence to
suggest that treatment with proton beam therapy is associated with a clinical benefit compared
to standard treatment. Currently, there is insufficient clinical data to discern whether treatment
with proton beam radiation offers a clinical benefit compared to conventional radiation therapy
techniques in the treatment of prostate cancer. Vapiwala and colleagues performed a recent
multi-institutional analysis of 1,850 patients with low or intermediate risk prostate cancer. The
authors compared groups receiving hypofractionated radiation proton therapy and intensity
modulated radiation therapy with photons. This analysis found no significant difference in
gastrointestinal or genitourinary toxicities between the two treatments. Furthermore, it found
no difference in disease control between the two modalities. The American Society of Radiation
Oncology (ASTRO) Model Policy stated, Proton beam therapy for primary treatment of
prostate cancer should only be performed within the context of a prospective clinical trial or
registry. At the present time, ASTRO believes the comparative efficacy evidence of proton
beam therapy with other prostate cancer treatments is still being developed, and thus the role
of proton beam therapy for localized prostate cancer within the current availability of
treatment options remains unclear. The National Comprehensive Cancer Network guidelines
endorse the position statement by ASTRO and state that no clear benefit of proton beam
therapy has been demonstrated over standard treatment with photons and intensity
modulated radiation therapy technique. Therefore, proton beam therapy is not medically
necessary for the treatment of this patient.

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


Answer: A 41-year-old male enrollee has requested authorization and coverage for a spine procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition.

Answer: In this case, the patient has chronic low back pain that has not responded to at least six months of conservative care. The patient has had multiple treatments, including lumbar epidural steroid injections, medial branch blocks, aquatic therapy, massage therapy, home exercise program, stretching, cryotherapy, transforaminal epidural steroid injection, chiropractic manipulation and medication management. There are also Type II Modic changes in the lumbar spine at the L3-4 and L4-5 levels.

Context:
Summary Reviewer 2

A 41-year-old male enrollee has requested authorization and coverage for a spine procedure. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that there is evidence-based support for this procedure. In this case, the patient has chronic low back pain that has not responded to at least six months of conservative care. The patient has had multiple treatments, including lumbar epidural steroid injections, medial branch blocks, aquatic therapy, massage therapy, home exercise program, stretching, cryotherapy, transforaminal epidural steroid injection, chiropractic manipulation and medication management. There are also Type II Modic changes in the lumbar spine at the L3-4 and L4-5 levels. There is sufficient evidence-based support for the requested services. There has been sufficient, documented, detailed, comprehensive and reasonable treatment provided prior to this request. Therefore, the requested spine procedure is likely to be more beneficial for the treatment of the patientas medical condition than any available standard therapy.

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


Answer: A 44-year-old female enrollee has requested reimbursement for monitored anesthesia care provided on 7/17/15.  The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition.

Context:
Summary Reviewer

A 44-year-old female enrollee has requested reimbursement for monitored anesthesia care provided on 7/17/15.  The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation fails to demonstrate the medical necessity of the services at issue.  The patient did not present with a significant history that would require monitored anesthesia care.  The standard of care for monitored anesthesia care for a minimally invasive procedure is airway difficulty, large fluid shifts and comorbid conditions that would put the patient at risk during the procedure.  There is no documentation of comorbid conditions that would place the patient at risk for complications requiring the need for monitored anesthesia care.  All told, monitored anesthesia care provided on 7/17/15 was not medically indicated for the treatment of this patient.  Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 64-year-old female enrollee has requested reimbursement for collagen crosslinks testing performed on 11/18/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis.

Answer: This patient has been taking Tymlos.

Context:
Summary Reviewer 2

A 64-year-old female enrollee has requested reimbursement for collagen crosslinks testing performed on 11/18/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees osteoporosis. The physician reviewer found that the submitted documentation fails to demonstrate the superior efficacy of the services at issue. This patient has been taking Tymlos. In this clinical setting, a dual-energy x-ray absorptiometry (DEXA) is appropriate at the end of the two-year treatment to assess the patients response to therapy. The value of monitoring therapy with the use of biochemical markers of bone turnover to aid in clinical decision making is controversial. The test performed can be variable and subject to timing, dietary intake as well as lack of assay standardization. In sum, collagen crosslinks testing performed on 11/18/17 was not likely to have been of greater benefit than other methods of evaluating this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: The patient is a three-year-old female who was transported by air ambulance from Childrens Hospital in Centennial, Colorado (CHCC) to Childrens Hospital in Millard, Nebraska (CHMC) on 6/30/15. The patient was born with a congenital diaphragmatic hernia on 1/29/15. She was intubated at birth. The patient underwent several surgeries. She remained with severe pulmonary hypertension. Multiple attempts to wean the child from the ventilator failed. It was determined that the patient no longer required the services of a level IV neonatal intensive care unit (NICU). The decision was made to transfer the patient to a level III NICU in Nebraska to be closer to her home. The ambulance was scheduled in advance on 6/29/15. The transport was initiated on 6/30/15, and no adverse events occurred during transport. The Health Insurer has denied reimbursement for air ambulance services provided on 6/30/15. Per the Health Insurer, the services at issue were not medically necessary for the treatment of this patient.

Context:
Summary Reviewer

The patient is a three-year-old female who was transported by air ambulance from Childrens Hospital in Centennial, Colorado (CHCC) to Childrens Hospital in Millard, Nebraska (CHMC) on 6/30/15. The patient was born with a congenital diaphragmatic hernia on 1/29/15. She was intubated at birth. The patient underwent several surgeries. She remained with severe pulmonary hypertension. Multiple attempts to wean the child from the ventilator failed. It was determined that the patient no longer required the services of a level IV neonatal intensive care unit (NICU). The decision was made to transfer the patient to a level III NICU in Nebraska to be closer to her home. The ambulance was scheduled in advance on 6/29/15. The transport was initiated on 6/30/15, and no adverse events occurred during transport. The Health Insurer has denied reimbursement for air ambulance services provided on 6/30/15. Per the Health Insurer, the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination.  Air ambulance services are considered medically necessary under certain circumstances. These circumstances include: the patients condition is such that any other means of transport would be medically contraindicated, the patients condition is such that the time necessary for transport by land poses a threat to the patients health, and the patient is transported to the nearest hospital with appropriate facilities for treatment. All of these criteria must be met in order for air ambulance transport to be medically necessary. In this case, the patient was being transferred from a level IV NICU to a level III NICU, a lower level of care. This transfer was planned in advance, not completed emergently. The patient was transferred to another state in order to be closer to home. There are other NICU facilities closer to CHCC than CHMC. All told, air ambulance services provided on 6/30/15 were not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: The parent of a 15-year-old female enrollee has requested authorization and coverage for an insulin pump (T-Slim). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.

Answer: In this case, the patient has a history of widely fluctuating blood glucose levels before meals, glycemic control that is suboptimal on a multi-dose insulin injection regimen, and variations in her daily activity schedule and eating plan

Answer: the patient and her family have adhered to frequent blood glucose monitoring, have kept appointments with the patients various health care providers, and have attempted to comply with dietary recommendations.

Answer: the patients previously prescribed OmniPod pump was never fully functional.

Answer: the OmniPod malfunctioned in this patient after a trial of a few months, as the patient experienced significant adverse skin reactions at the sites of the adhesive tape, making it impossible for her to continue to wear the pump. In addition, due to the nature of her active lifestyle, the pump dislodged too often to make it a viable tool to deliver insulin, and her glycemic control worsened due to unpredictable insulin delivery.

Context:
Summary Reviewer

The parent of a 15-year-old female enrollee has requested authorization and coverage for an insulin pump (T-Slim). The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found the submitted documentation establishes the medical necessity of the requested services. In this case, the patient has a history of widely fluctuating blood glucose levels before meals, glycemic control that is suboptimal on a multi-dose insulin injection regimen, and variations in her daily activity schedule and eating plan such that a multiple dose injection regimen is unlikely to be adequate to maintain glycemic control and prevent severe hypoglycemia. Several studies in the peer-reviewed literature have shown that insulin pump therapy is safe and effective in children and adolescents with type 1 diabetes. Compared with conventional insulin treatment, continuous subcutaneous insulin infusion improves glycemic control, limits excessive weight gain, reduces the frequency of hypoglycemic events, and results in overall improved satisfaction in patients and their parents (Battelino; Plotnick, et al; Saha, et al). Finally, this patients caregivers have demonstrated that they possess the necessary tools to carry out an effective treatment and follow-up plan on insulin pump therapy. Specifically, the patient and her family have adhered to frequent blood glucose monitoring, have kept appointments with the patients various health care providers, and have attempted to comply with dietary recommendations. Pump therapy is medically necessary for treatment of this patients diabetes. Furthermore, the patients previously prescribed OmniPod pump was never fully functional. Although there was no mechanical failure of the OmniPod and it is not out of warranty, in effect, the OmniPod malfunctioned in this patient after a trial of a few months, as the patient experienced significant adverse skin reactions at the sites of the adhesive tape, making it impossible for her to continue to wear the pump. In addition, due to the nature of her active lifestyle, the pump dislodged too often to make it a viable tool to deliver insulin, and her glycemic control worsened due to unpredictable insulin delivery. The T-Slim pump delivers insulin via a catheter inserted under the skin instead of a pod; the insertion site is much smaller and does not require as much adhesive tape to stay in place. In addition, the thin catheter in the T-Slim is less likely to dislodge with vigorous physical activity than the pod in the OmniPod system. Thus, transition to the T-Slim pump is medically necessary based on the history of adverse reaction to the OmniPod. Moreover, the T-Slim pump has been shown to have an easy-to-read screen and reduced error rates and training time compared to other insulin pumps (Schaeffer, et al). Therefore, the requested services 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 28-year-old male enrollee has requested reimbursement for Foundation One gene test performed on 4/7/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with malignant peripheral nerve sheath tumor (MPNST).

Context:
Summary Reviewer 1

A 28-year-old male enrollee has requested reimbursement for Foundation One gene test performed on 4/7/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who was diagnosed with malignant peripheral nerve sheath tumor (MPNST). The physician reviewer found that the malignant peripheral nerve sheath tumors (MPNST) are an uncommon but devastating tumor of peripheral nerve. About 22 to 50 percent of MPNSTs occur in patients with neurofibromatosis type 1 (NF1). Having a NF1 mutation adds information for prognosis and aids in follow-up decision making. FoundationOne offers the advantage of testing for NF1 mutations as well as others that may help guide therapeutic decision making should the patient progress. FoundationOne testing is likely to be more beneficial than not testing and not knowing the prognosis of the patient. In sum, FoundationOne testing performed on 4/7/15 was likely to have been more effective over other methods of evaluating this patient.  Based upon the information set forth above, the services at issue were likely to have been more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 57-year-old male enrollee has requested reimbursement for Oncotype DX testing Prostate Cancer Assay provided on 9/15/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees elevated prostate specific antigen (PSA).

Context:
Summary Reviewer 1

A 57-year-old male enrollee has requested reimbursement for Oncotype DX testing Prostate Cancer Assay provided on 9/15/15. The Health Plan has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees elevated prostate specific antigen (PSA). The physician reviewer found THE testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. There is sufficient support in the peer-reviewed literature for the testing at issue in this clinical setting. Several tissue-based molecular assays have been developed in an effort to improve decision-making in newly diagnosed patients considering active surveillance and in treated men considering adjuvant therapy or treatment for recurrence. Patients with clinically localized disease may consider the use of tumor-based molecular assays. Retrospective case cohort studies have shown that molecular assays performed on biopsy or prostatectomy specimens provide prognostic information independent of National Comprehensive Cancer Network (NCCN) risk groups. These include, but are not limited to, likelihood of biochemical progression after radical prostatectomy or external beam therapy, and likelihood of developing metastasis after radical prostatectomy or salvage radiotherapy. In this case, the patient has low-risk localized prostate cancer and the testing at issue was indicated to assist with improve decision-making. All told, the Oncotype DX testing provided on 9/15/15 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: The parent of a four-year-old female enrollee has requested authorization and coverage for genetic testing. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition.

Context:
Summary Reviewer

The parent of a four-year-old female enrollee has requested authorization and coverage for genetic testing. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the evaluation of the enrollees medical condition. The physician reviewer found that Ataxia is an uncommon finding in children with a large number of causes. Genetic etiology can often be identified, particularly in those with early age of onset, family history of ataxia, or consanguineous parents. In this childs case, the very early age of onset indicated a high probability of an underlying genetic cause. Studies of whole exome sequencing (WES), which is more comprehensive than the panel requested here, have shown rates of identification of underlying genetic etiology ranging from 21% to 69%, depending on age and family history of those included. The rate of positive WES in 21% of adults with ataxia suggests a significant likelihood of finding a diagnosis for this child, either by panel test or by WES. Many authors currently recommend WES either as a follow-up test to non-diagnostic ataxia panel genetic testing, or as an initial molecular test due to its comprehensiveness. Specific treatments do exist for some hereditary ataxias, and more clinical trials and therapies are anticipated, increasing the benefits of confirming a molecular diagnosis. The current medical evidence supports genetic testing in this clinical setting. Therefore, the requested genetic testing is medically necessary for the evaluation of this patient.

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


Answer: A 63-year-old female enrollee has requested reimbursement for advanced lipoprotein testing performed on 10/19/20. 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 1

A 63-year-old female enrollee has requested reimbursement for advanced lipoprotein testing performed on 10/19/20. 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 the submitted documentation fails to demonstrate the superior efficacy of the services at issue. There are no widely accepted clinical studies demonstrating that treatment strategies directed at advanced lipoprotein testing parameters will improve clinical outcomes in individuals with dyslipidemias. Clinical trial data to date does not support the superiority of measurement of such parameters beyond what is known from a basic lipid panel in assessing treatment. This was also the conclusion of the American College of Cardiology/American Heart Association 2013 guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Risk in Adults. Therefore, advanced lipoprotein testing performed on 10/19/20 was not likely to have been more beneficial than other available standard methods of evaluation.

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


Answer: A 26-year-old male enrollee has requested authorization and coverage for the LINX reflux management system. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).

Answer: In this patients case, the records reflect that he has undergone

Answer: pre-operative assessment and that he has GERD based on pH recording.

Answer: neither his radiographic studies in 2011 nor 2015 evidenced gastroesophageal reflux.

Context:
Summary Reviewer 1

A 26-year-old male enrollee has requested authorization and coverage for the LINX reflux management system. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).   The physician reviewer found according to peer-reviewed published literature, there is only one lower esophageal sphincter (LES) augmentation device designed for the treatment of GERD at this time.  The LINX device has been approved for patients diagnosed with GERD as defined by abnormal pH testing, and who continue to have chronic GERD symptoms despite maximal medical therapy for the treatment of reflux. Patients with inadequate symptom control with acid suppression therapy may benefit from treatment with sphincter augmentation. Two post-approval studies are designed to evaluate the long-term effectiveness of the device and incidence of adverse events; however, comparative studies with other anti-reflux surgeries are still needed. While there is some medical literature in support of the use of the LINX device for patients with GERD, appropriate patient selection is crucial before anti-reflux procedures. Results of testing are combined to document the presence and extent of the disease and assist in planning the operative approach. In this patients case, the records reflect that he has undergone much of this pre-operative assessment and that he has GERD based on pH recording. However, neither his radiographic studies in 2011 nor 2015 evidenced gastroesophageal reflux. As such, he cannot be considered medically refractory given the intermittency of documented reflux. Also, implantation of LINX in this clinical setting must be approached with caution given the patients charted complaint of dysphagia.  As such, the LINX procedure is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested procedure 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: A 30-year-old male enrollee has requested reimbursement for substance use residential treatment provided from 7/04/18 through 7/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions.

Answer: The patients abuse of alcohol was impairing his daily routine and contributing to significant impairment across multiple domains of functionality.

Answer: the patient completed an uncomplicated detoxification.  He was maintaining sobriety and was motivated for recovery. His girlfriend was supportive. He had safe housing.

Answer: the patient had no history of chemical dependency treatment

Answer: he had no impairment in memory, concentration or thought processing.

Answer: the patient had improved with the treatment intervention. He was autonomous and was maintaining motivation for sobriety.

Answer: he had not failed a less restrictive treatment course during the episode of illness.

Context:
Summary Reviewer

A 30-year-old male enrollee has requested reimbursement for substance use residential treatment provided from 7/04/18 through 7/20/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation supports the medical necessity of a portion of the services at issue. The patients abuse of alcohol was impairing his daily routine and contributing to significant impairment across multiple domains of functionality. As such, specialty care was indicated. However, the patient completed an uncomplicated detoxification.  He was maintaining sobriety and was motivated for recovery. His girlfriend was supportive. He had safe housing. Despite his comorbid obsessive-compulsive disorder, the patient did not have a psychiatric condition or medical illness that required placement at the residential level of care. Further, the patient had no history of chemical dependency treatment, such as sponsored community programming, outpatient counseling, anti-craving medication, intensive outpatient services, partial hospitalization or placement in a sober living environment.  This is significant in this case for two reasons. First, modern psychiatric practice favors treatment in the community, as outcome measures and therapeutic gains are optimized in this environment. Second, there was no evidence to suggest that similarly comprehensive, evidence-based services provided a less restrictive treatment setting for this stable, motivated and otherwise healthy patient would have been insufficient or inadequate at the time. With that said, discharge on a federal holiday would have incurred a needless gap in treatment and thus would have been inappropriate. The extra day also afforded opportunity to address his severe craving, as it appears that acamprosate was added the following day. On 7/05/18, the patients craving was mild. There was no mention of medication intolerability or non-adherence. His appearance was appropriate, and he had no impairment in memory, concentration or thought processing. In sum, the patient had improved with the treatment intervention. He was autonomous and was maintaining motivation for sobriety. Further, he had not failed a less restrictive treatment course during the episode of illness. As such, the substance abuse residential treatment services at issue were no longer medically necessary as of 7/05/18. Thus, substance use residential treatment provided on 7/04/18 was medically necessary, but not thereafter. Therefore, a portion of the services at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned.

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


Answer: A 41-year-old male enrollee has requested authorization and coverage for rituximab injections 100 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees pretibial myxedema.

Context:
Summary Reviewer

A 41-year-old male enrollee has requested authorization and coverage for rituximab injections 100 mg. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees pretibial myxedema. The physician reviewer found that the use of rituximab for ocular related findings associated with Graves disease is supported by peer-reviewed medical literature. However, there is a paucity of large, controlled studies demonstrating the safety and efficacy of rituximab for treatment of pretibial myxedema (Heyes, et al; Ferreira-Hermosillo, et al). As this patient does not have any documented ocular related findings associated with Graves disease, the requested rituximab injections 100 mg are not medically necessary for treatment of this patients medical condition. Based on the foregoing discussion, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer:
the records document that this patient
presents with a history of primary melanoma of the cervix with an erythroblastic oncogene B
(ERBB)2 V777L mutation. The patients provider has recommended treatment with Tukysa.

Answer:
The patient is a 53-year-old female with a history of primary melanoma of the cervix with an
erythroblastic oncogene B (ERBB)2 V777L mutation. In a letter dated 12/13/22, the provider
reported that the patient was diagnosed in April 2022. The records noted that the patient had
undergone initial treatment with four cycles of ipilimumab with nivolumab. The Health Insurer
has denied the requested medication as not medically necessary.

Context:
Summary
The patient is a 53-year-old female with a history of primary melanoma of the cervix with an
erythroblastic oncogene B (ERBB)2 V777L mutation. In a letter dated 12/13/22, the provider
reported that the patient was diagnosed in April 2022. The records noted that the patient had
undergone initial treatment with four cycles of ipilimumab with nivolumab. The Health Insurer
has denied the requested medication as not medically necessary. This denial is the subject of this
appeal and determination. The physician reviewer found that the records document that this patient
presents with a history of primary melanoma of the cervix with an erythroblastic oncogene B
(ERBB)2 V777L mutation. The patients provider has recommended treatment with Tukysa. Per
the  National  Comprehensive  Cancer  Network  (NCCN)  guidelines  for  melanoma,  mucosal
melanoma should be treated as diseases distinct from cutaneous melanoma, with care tailored to
the individual patient. The U.S. Food and Drug Administration (FDA) has approved Tukysa for
the treatment of patients with HER2 positive breast cancer or HER2 positive colon cancer, to be
taken in combination with other agents. However, there is a lack of FDA approved indication or
support for use of Tukysa for use as monotherapy in the treatment of this patients cancer. Strickler
and colleagues reported that studies are ongoing to evaluate the efficacy of Tukysa as monotherapy
and to validate the reported findings from their trial. Overall, there is a lack of data to suggest that
Tukysa as single agent therapy is safe and effective in this patients clinical setting. All told, the
requested Tukysa (tucatinib) 150 mg #120/30 days is not medically necessary for treatment of this
patient.

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


Answer: The patient is a 46-year-old female with severe cervical spondylosis with progressive involvement of C5-6 and C6-7 levels and associated radiculopathy. The patient has requested reimbursement for cervical artificial discectomy performed on 4/13/17. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational.

Context:
Summary Reviewer 1

The patient is a 46-year-old female with severe cervical spondylosis with progressive involvement of C5-6 and C6-7 levels and associated radiculopathy. The patient has requested reimbursement for cervical artificial discectomy performed on 4/13/17. The Health Insurer has denied this request indicating that the surgery at issue was considered investigational. Cervical disc arthroplasty has been approved by the US Food and Drug Administration (FDA) and has been demonstrated preserve some motion and provide decreased incidence of adjacent level disease when compared with anterior cervical discectomy and fusion. The need for revision surgery is also less than anterior cervical discectomy and fusion (Gao, et al; Wu, et al; Radcliff, et al). For these reasons, the cervical artificial discectomy performed on 4/13/17 was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the surgery at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: The patient is a 49-year-old male with a history of chronic low back pain. On 7/30/20, the records noted that the patient has a displaced lumbar disc and left lumbar radiculitis.

Answer: In this case, the patient has a

Answer: diagnosis of generalized anxiety disorder for which he is receiving medical treatment. The provider notes stated that the patient would undergo a lumbar epidural steroid injection but would require sedation because of a fear of needles. There is documentation from 2/16/18 showing that the patient suffered a severe case of vasovagal response during a lumbar medial branch block that was completed under local anesthetic only. He has a confirmed diagnosis of anxiety and known needle phobia which would make it difficult for him to undergo the epidural injection while remaining motionless. He also has a history of vasovagal response to previous injections done under local anesthetic only.

Context:
Summary Reviewer

The patient is a 49-year-old male with a history of chronic low back pain. On 7/30/20, the records noted that the patient has a displaced lumbar disc and left lumbar radiculitis. The physician reviewer found that the 2019 American Society of Interventional Pain Physicians (ASIPP) guidelines for use of sedation during routine pain management injections states, aGiven that patients undergoing pain procedures typically are anxious and in pain, mild to moderate sedation is acceptable for many patients.a The guidelines further state, aDeeper sedation should only be undertaken in the presence of anesthesia providers and for patients who have high anxiety, complex pharmacotherapy, or a low pain threshold when undergoing more painful interventional pain procedures. In special cases, the risk of patient movement during a procedure resulting in potential inadvertent injury may justify a deeper anesthetic state.a
The American Society of Anesthesiologists also published a statement regarding the use of sedation for pain management injections and concluded, aSignificant anxiety may be an indication for moderate (conscious) sedation or anesthesia services. In addition, procedures that require the patient to remain motionless for a prolonged period of time and/or remain in a painful position may require sedation or anesthesia services.a
In this case, the patient has a confirmed diagnosis of generalized anxiety disorder for which he is receiving medical treatment. The provider notes stated that the patient would undergo a lumbar epidural steroid injection but would require sedation because of a fear of needles. There is documentation from 2/16/18 showing that the patient suffered a severe case of vasovagal response during a lumbar medial branch block that was completed under local anesthetic only. He has a confirmed diagnosis of anxiety and known needle phobia which would make it difficult for him to undergo the epidural injection while remaining motionless. He also has a history of vasovagal response to previous injections done under local anesthetic only. Based on the medical records for review and current national guidelines, the request for monitored anesthesia care for the lumbar epidural steroid injection was medically indicated. Therefore, anesthesia for diagnostic or therapeutic nerve blocks and injections provided on 7/30/20 was medically necessary for the treatment of this patient.

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


Answer: The patient is a 23-year-old male who underwent septorhinoplasty, bilateral inferior turbinoplasty, and submucous resection of the nasal septum on 3/11/20. The patient has requested reimbursement for nasal surgery performed on 3/11/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary and were not reconstructive in nature.

Answer: Symptoms of nasal obstruction were fluctuating, with allergic rhinitis present seasonally from August through September.

Answer: Symptoms of breathing obstruction were poor sleeping and waking with a dry mouth.

Answer: The prior history of medical management included self-managed use of Claritin and Afrin.

Answer: Nasal deviation was mild

Answer: aThis patientas complaints for nasal surgery were not sleeping well and waking with a dry mouth. He has allergic rhinitis, a risk factor for obstructive sleep apnea syndrome. His nasal symptoms fluctuate seasonally

Context:
Summary Reviewer

The patient is a 23-year-old male who underwent septorhinoplasty, bilateral inferior turbinoplasty, and submucous resection of the nasal septum on 3/11/20. The patient has requested reimbursement for nasal surgery performed on 3/11/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary and were not reconstructive in nature. The physician reviewer found that while the provider reported simply that there was a severely deviated nasal septum, no further information was received for review. There is no physical description of the reported nasal deviation from either speculum view or from the performed nasal endoscopy. No imaging of the nasal septum was performed. Symptoms of nasal obstruction were fluctuating, with allergic rhinitis present seasonally from August through September. Fluctuating symptoms of nasal obstruction due to allergy are not diagnostic of a physical functional deformity of the nasal septum. Symptoms of breathing obstruction were poor sleeping and waking with a dry mouth. No symptoms of daytime breathing obstruction were received for review. The prior history of medical management included self-managed use of Claritin and Afrin. No documented history of attempted medical management of breathing obstruction, including the use of Flonase, was received for review. Nasal deviation was mild on the photographs received for review. Gottlieb and Punjabi stated that the most common presenting symptom of OSA is excessive sleepiness. In a study of internal nasal dimensions and obstructive sleep apnea syndrome (OSAS), Trindade and colleagues stated, aThere were no significant differences in the cross-sectional areas and nasal volumes between individuals with primary snoring-mild obstructive sleep apnea syndrome and moderate-severe obstructive sleep apnea syndrome. Differently to the raised hypothesis, our results suggest that there is no association between internal nasal dimensions and severity of obstructive sleep apnea syndrome.a Cao and colleagues stated, aThe co-existence of allergic rhinitis (AR) and obstructive sleep apnea (OSA) is a common phenomenon in clinical practice. AR has long been considered a risk factor for OSAaPatients with AR were more likely to become habitual snorers and had increasing risk of SDB (sleep disordered breathing).aThis patientas complaints for nasal surgery were not sleeping well and waking with a dry mouth. He has allergic rhinitis, a risk factor for obstructive sleep apnea syndrome. His nasal symptoms fluctuate seasonally and do not reflect a fixed nasal airway deformity. There is no history of medical treatment for allergic rhinitis, including the use of Flonase. There are no objective physical findings reported to support a diagnosis of a severely functionally deviated nasal septum. Photographs received for review do not document nasal deviation to a functionally significant extent to cause nasal breathing obstruction. Based on the medical history received for review, septorhinoplasty, bilateral inferior turbinoplasty, and submucous resection of the nasal septum were not medically necessary. The California reconstructive surgery statute requires health insurers to cover reconstructive surgeries, defined as surgery performed to correct or repair abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease to do either of the following: (1) to improve function; (2) to create a normal appearance, to the extent possible. The medical history received for review does not support that the patient has an abnormal structure of the body. There is a lack of medical history and physical findings to support a diagnosis of functional nasal airway obstruction. The California reconstructive surgery statute does not apply to this patient. Therefore, nasal surgery performed on 3/11/20 was not reconstructive in nature.

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


Answer: A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata.

Context:
Summary Reviewer 2

A 26-year-old female enrollee has requested authorization and coverage for Xeljanz 5 mg The Health Insurer has denied this request indicating that the requested medication is considered investigational for treatment of the enrollees alopecia areata. The physician reviewer found that Alopecia areata is autoimmune in nature and brings psychological manifestations as well as physical. The use of Xeljanz has shown some promise, with better results than any other available standard treatment, other than maybe long-term oral steroids, which are limited by their side effects. In this clinical setting, Xeljanz is likely to offer this patient the safest option to treat her ongoing disease. In sum, Xeljanz 5 mg are likely to be of greater benefit than other treatment modalities. Based upon the information set forth above, the requested medication is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. 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 is being treated for lumbar spinal stenosis with neurogenic claudication.

Context:
Summary Reviewer 2

A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. 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 interspinous spacers were developed to avoid the risks of a traditional laminectomy via a less invasive technique that is reversible. The device is placed percutaneously in the interspinous space with minimal disruption of the spinal anatomy. The goal is to limit extension of the spine, minimizing the effects of spinal degeneration and enlarging the spinal canal and neural foramina area. This patient is being treated for lumbar spinal stenosis with neurogenic claudication. While there are many interspinous devices on the market, none have high quality research to demonstrate superiority over the current standard of care, simple decompression. The use of an interspinous spacer for spinal stenosis as a minimally invasive, stand-alone procedure has shown high failure and complication rates.  Until data exists that demonstrate noninferiority of these devices to the current gold standard treatment, simple decompression, the use of the requested device as a standalone procedure should be considered investigational for the treatment of the patients condition. In sum, the requested surgical insertion of an interspinous process spacer is not likely to be more beneficial than other available standard therapy.

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


Answer: A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. 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 had a long history of neurogenic claudication. He has failed conservative treatment for over six months, including nonsteroidal anti-inflammatory drugs, opioids, physical therapy, epidural steroid injections, and bracing. His provider has recommended minimally invasive interspinous process spacer using the Superion device.

Context:
Summary Reviewer 3

A 63-year-old male enrollee has requested authorization and coverage for surgical insertion of an interspinous process spacer. 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 this patient had a long history of neurogenic claudication. He has failed conservative treatment for over six months, including nonsteroidal anti-inflammatory drugs, opioids, physical therapy, epidural steroid injections, and bracing. His provider has recommended minimally invasive interspinous process spacer using the Superion device. Nunley and colleagues presented a four-year follow-up of 89 patients who underwent the procedure for spinal stenosis. At four years after the procedure, 75 of 89 patients with Superion (84.3%) demonstrated clinical success in terms of back and leg pain. The minimally invasive implantation procedure of the Superion device provided relief of symptoms of intermittent neurogenic claudication in these patients with moderate lumbar spinal stenosis. The second article referenced is a five-year follow-up and indicated that 75 percent of these patients continued to do well and did not require any other treatment such as an open decompression/fusion procedure. Thus, the requested surgical insertion of an interspinous process spacer is likely to be more beneficial than other available standard therapy.

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


Answer:
The patient is an 80-year-old male with a history of psoriatic arthritis and osteoarthritis of both
knees with associated chronic bilateral knee pain. The patient has requested reimbursement for
hyaluronan injections (Synvisc-One) performed on 9/09/21.

Answer:
In this case, the medical records dated 9/09/21 state that the patient had
received Synvisc-One injections into both knees in the past with good results.

Context:
Summary Reviewer

The patient is an 80-year-old male with a history of psoriatic arthritis and osteoarthritis of both
knees with associated chronic bilateral knee pain. The patient has requested reimbursement for
hyaluronan injections (Synvisc-One) performed on 9/09/21. The physician reviewer found that
an exhaustive review of the current medical literature pertaining to viscosupplementation
reveals mixed results. Evidence from eight systematic reviews and six randomized controlled
trials indicates that although viscosupplementation may relieve knee pain in some individuals
with osteoarthritis, it is not known as to which individuals will benefit. Different studies have
tried mixing hyaluronic acid with corticosteroids, platelet-rich plasma, and other agents to make
it more effective. Guidelines from organizations such as the American Academy of Orthopedic
Surgeons  indicate  that  the  evidence  is  not  conclusive.  In  light  of  the  foregoing,
viscosupplementation can only be recommended in individuals with a history of lasting benefit
from prior injections and in carefully selected cases where everything else has been tried and the
options are limited. In this case, the medical records dated 9/09/21 state that the patient had
received Synvisc-One injections into both knees in the past with good results. Therefore, he
presented with recurrent bilateral knee pain for additional injections. There is sufficient support
for the services at issue in this clinical setting. Therefore, hyaluronan injections (Synvisc-One)
performed on 9/09/21 were medically necessary for the treatment of this patient.

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


Answer: A 61-year-old female enrollee has requested authorization and coverage for endoscopic anti-reflux procedure (LINX). The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD).

Context:
Summary Reviewer 3

A 61-year-old female enrollee has requested authorization and coverage for endoscopic anti-reflux procedure (LINX). The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that there is a lack of randomized controlled trials comparing LINX with Nissen fundoplication or other surgical anti-reflux procedures. Sheu and colleagues in Current Opinion in Gastroenterology, concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined. Another best evidence review concluded that long-term comparative outcome data past 1 year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration approval (Bauer, et al). One peer reviewed journal published a letter stating that there are 11 reports of endoscopically confirmed LINX erosion through the esophagus in the publicly-accessible U.S. Food and Drug Administration (FDA) Adverse Events database (Bielefeldt, et al). Additionally, LINX (more than surgical fundoplication) is associated with severe dysphagia requiring endoscopic intervention (Sheu, et al in Surgical Endoscopy). The currently available peer reviewed literature does not definitively support the conclusion that LINX is more likely to be beneficial than standard treatment, surgical fundoplication. The American College of Gastroenterology guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). All told, the requested endoscopic anti-reflux procedure (LINX) is not likely to be more beneficial than the standard methods of treating this patients medical condition. Therefore, for the reasons stated above, the requested procedure 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: A 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 7/29/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer.

Context:
Summary Reviewer 1

A 56-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 7/29/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollees risk for breast cancer. The physician reviewer found that there is a lack of peer-reviewed literature that supports the use of three-dimensional breast tomosynthesis compared to currently available techniques, especially in a patient without an increased risk of breast cancer. Although breast tomosynthesis may be a promising technique, its clinical efficacy is yet to be substantiated in the peer-reviewed medical literature. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 7/29/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the service at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.

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


Answer: The patient is a 15-year-old male with a history of short stature. Per the submitted documentation, he underwent growth hormone stimulation testing in 2010, which showed that he was sufficient in growth hormone production. In March 2016, the predicted adult height was calculated to be 62.5 with the chronological age of 12 years and bone age of 12 years 6 months. The mid-parental height is 68.5. The records noted pretreatment growth velocity of 4.8 cm per year, which was low.  He was started on growth hormone therapy on 5/11/16 due to growth failure or low growth velocity and poor height prediction. The patients parent has requested coverage for Nutropin AQ. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of this patient.

Answer: This patient had improvement in growth velocity to 7.6 cm per year. This patient meets the criteria for idiopathic short stature. He was prescribed growth hormone therapy and has shown good response to growth hormone treatment with adequate monitoring and minimal side effects.

Context:
Summary Reviewer

The patient is a 15-year-old male with a history of short stature. Per the submitted documentation, he underwent growth hormone stimulation testing in 2010, which showed that he was sufficient in growth hormone production. In March 2016, the predicted adult height was calculated to be 62.5 with the chronological age of 12 years and bone age of 12 years 6 months. The mid-parental height is 68.5. The records noted pretreatment growth velocity of 4.8 cm per year, which was low.  He was started on growth hormone therapy on 5/11/16 due to growth failure or low growth velocity and poor height prediction. The patients parent has requested coverage for Nutropin AQ. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The submitted documentation supports the medical necessity of the requested medication. The U.S. Food and Drug Administration has approved the use of growth hormone therapy for idiopathic short stature or non-growth hormone-deficient short stature defined as height standard deviation less than or equal to -2.25 or less than or equal to 1.2nd percentile for age and gender. This patient had improvement in growth velocity to 7.6 cm per year. This patient meets the criteria for idiopathic short stature. He was prescribed growth hormone therapy and has shown good response to growth hormone treatment with adequate monitoring and minimal side effects. The medical evidence supports the requested medication in this clinical setting. Thus, Nutropin AQ is medically necessary for the treatment of this patient. Therefore, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.

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


Answer: A 63-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Optune therapy (E0766) from 6/19/18 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 glioblastoma multiforme.

Context:
Summary Reviewer

A 63-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Optune therapy (E0766) from 6/19/18 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 glioblastoma multiforme. The physician reviewer found that the current medical evidence supports the services at issue in this clinical setting. Optune (Novo-TTF) is a novel portable medical device which is worn on the scalp and generates low-intensity alternating electric fields. This was initially approved for use in the treatment of glioblastoma in 2011. Stupp and colleagues demonstrated that Optune is less toxic than Temodar, with the same overall survival statistics. The advantage of the combination of Optune with Temodar was reaffirmed in the review by Taphoorn and colleagues. All told, Optune therapy (E0766) from 6/19/18 forward was and is medically necessary for the treatment of this patient. 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 31-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the lumbar spine, cervical spine, and pelvis. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees back and neck pain.

Context:
Summary Reviewer

A 31-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI) of the lumbar spine, cervical spine, and pelvis. The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees back and neck pain. The physician reviewer found that the records provided for review do not support the medical necessity of the requested MRI studies. The physical examination on 5/16/18 does not detail which muscles are weak or hypotonic. In addition, the neurological examination was limited and the note of prior physical therapy does not include details as to duration, evaluation or outcome. Moreover, there are no laboratory values in the chart to support an indication for an inflammatory process such as sacroiliitis. All told, there is a lack of documentation supporting the medical necessity for MRI of the lumbar spine, cervical spine, and pelvis for evaluation of this patients medical condition. Based on the foregoing discussion, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 60-year-old female enrollee has requested reimbursement for laboratory services provided on 8/15/19. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrolleeas medical condition.

Context:
Summary Reviewer 1

A 60-year-old female enrollee has requested reimbursement for laboratory services provided on 8/15/19. The Health Insurer indicates that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that FoundationOne assay explores possible mutations in 324 genes, as well as certain other abnormalities, in an individualas cancer cells. At this time, there is a lack of convincing evidence that therapy that is determined by the assay is superior to that which an oncologist would recommend from the literature and experience. Finding a mutation does not guarantee that a treatment directed at that will be effective. It has been estimated that the percentage of patients who would benefit from using the assay to select therapy is quite small. The National Comprehensive Cancer Network guidelines for treatment of ovarian cancer does not recommend using such an assay in the selection of therapy. Therefore, laboratory services provided on 8/15/19 were not likely to have been more beneficial than other available standard therapy.

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


Answer: A 32-year-old female enrollee has requested reimbursement for bilateral breast magnetic resonance imaging (MRI) performed on 1/28/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who tested positive for BRCA1 mutation.

Answer: She is alternating mammography/ultrasound with MRI every six months. Due to pregnancy and subsequent breastfeeding, she was unable to obtain her annual screening MRI, which would have been due February 2017.

Answer: This patient has a known BRCA1 gene mutation

Context:
Summary Reviewer 3

A 32-year-old female enrollee has requested reimbursement for bilateral breast magnetic resonance imaging (MRI) performed on 1/28/18. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollee, who tested positive for BRCA1 mutation. The physician reviewer found that contrast-enhanced breast MRI is more sensitive for the detection of breast cancer in the high risk population than both mammography and ultrasound. Screening breast MRI is recommended in women with BRCA gene mutations, their untested first-degree relatives, and women with a lifetime risk of greater than 20%. The American Cancer Society, American College of Radiology, and Society of Breast Imaging all recommend annual screening MRI in high-risk patients. A common screening protocol is alternating MRI with mammography/ultrasound every six months. This patient has a known BRCA1 gene mutation and is therefore considered one of the highest risk populations for breast cancer. She is alternating mammography/ultrasound with MRI every six months. Due to pregnancy and subsequent breastfeeding, she was unable to obtain her annual screening MRI, which would have been due February 2017. Therefore, MRI was appropriately performed in January 2018 after the cessation of breastfeeding, according to her screening schedule. Thus, bilateral breast MRI performed on 1/28/18 was likely to have been of more efficacious than other modalities for evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer:
The patient is  a  27-year-old male who was  admitted  for  hospitalization  on  8/13/21  after
presenting  with  progressively  worsening  abdominal  pain  with  vomiting.  The  patient  has
requested reimbursement for inpatient admission (hospital treatment services) from 8/13/21
through 8/15/21.

Answer:
In this case, the patient was hemodynamically stable and
afebrile at admission. After treatment in the emergency department, the patients symptoms of
pain and vomiting improved.

Answer:
He
was treated with a nasogastric tube for a short time but able to tolerate oral nutrition shortly
after  admission.

Context:
Summary Reviewer
The patient is  a  27-year-old male who was  admitted  for  hospitalization  on  8/13/21  after
presenting  with  progressively  worsening  abdominal  pain  with  vomiting.  The  patient  has
requested reimbursement for inpatient admission (hospital treatment services) from 8/13/21
through 8/15/21. The physician reviewer found that at issue is whether inpatient admission
(hospital treatment services) from 8/13/21 through 8/15/21 was medically necessary for the
treatment of this patient. The submitted documentation does not support the medical necessity
of the services at issue. Inpatient care may be necessary when a patients signs, symptoms, and
general medical condition can only be managed safely in an acute inpatient setting, when a
patient requires diagnostic studies in an inpatient setting, or when it is necessary for the patient
to remain in an acute inpatient setting. In this case, the patient was hemodynamically stable and
afebrile at admission. After treatment in the emergency department, the patients symptoms of
pain and vomiting improved. The records did not indicate that the patient required any urgent
procedures or surgical intervention. He did not have any significant electrolyte disturbances. He
was treated with a nasogastric tube for a short time but able to tolerate oral nutrition shortly
after  admission.  His  symptoms  improved  quickly  with  treatment  and  he  did  not  have
complications. Given that this patient was in stable condition at admission and could have been
treated at a lower level of care, the services at issue were not medically indicated. Therefore,
inpatient  admission  (hospital  treatment  services)  from  8/13/21  through  8/15/21  was  not
medically necessary for the treatment of this patient.

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


Answer: A 54-year-old female enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees persistent asthma.

Context:
Summary Reviewer 2

A 54-year-old female enrollee has requested authorization and coverage for bronchial thermoplasty. The Health Insurer has denied this request indicating that the requested procedure is considered investigational for treatment of the enrollees persistent asthma.   The physician reviewer found the most important considerations in the use of bronchial thermoplasty are the proper selection of patients and ensuring an experienced qualified provider is performing the procedure. Bronchial thermoplasty has adequate data on long-term safety and effectiveness in patients with asthma in terms of demonstrating improvement in symptoms and reduction in exacerbations. On the basis of daily symptoms, frequent rescue medication use, interference with daily activities and frequent exacerbations, this patient meets criteria for severe persistent asthma. However, there is not adequate information provided to determine two important considerations in the treatment of asthma. First, the records do not document that alternate diagnoses have been ruled out. The appearance of infiltrates and adenopathy on the computed tomography (CT) may indicate a secondary cause of wheezing. Secondly, there was not information provided to exclude other asthma therapies such as omalizumab or mepolizumab based on IgE levels or eosinophil counts. All told, there is a lack of documentation supporting the requested bronchial thermoplasty as 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 procedure 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: A 62-year-old male enrollee has requested reimbursement for long term acute care provided from 10/30/18 through 1/11/19. 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: the patient required hemodialysis, nutrition via a feeding tube and continued wound care

Context:
Summary Reviewer

A 62-year-old male enrollee has requested reimbursement for long term acute care provided from 10/30/18 through 1/11/19. 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 rehabilitation therapy services can be delivered in a wide variety of settings across the care continuum. Post-acute settings differ in the types of available rehabilitation therapies, intensity of therapy, and the level of medical and nursing support. Long-term acute care hospitals offer physical and occupational therapy, 24-hour skilled nursing care and a clinician available 24 hours per day. The medical providers are able to care for active/ongoing medical conditions requiring a clinician-level care (e.g., ventilator-dependent). The long-term acute care hospital setting is considered when the patients need for nursing and rehabilitative services are such that only an inpatient long-term acute care hospital setting can meet the requirements, and the expected length of stay is greater than 25 days. In this case, the documentation does not support that the patient required complex medical treatment (e.g., multiple and prolonged intravenous therapies; monitoring of significantly medically active conditions requiring clinical assessment six or more times a day; multiple and frequent intervention of at least six or more times a day, like ventilator management, cardiac monitoring, complex wound care for multiple wounds stages 3 and above; and the need for specialized high-tech equipment like cardiac monitors, on-site dialysis, or surgical suites) as of 10/30/18. The patient did not require services at the long-term acute care hospital setting that were not available at the acute care hospital or the skilled nursing facility. The requested treatments were not medically necessary at the long-term acute care hospital level of care from 10/30/18 through 1/10/19. Although the patient required hemodialysis, nutrition via a feeding tube and continued wound care, he was medically stable as of 10/30/18 and could have received services at a lower level of care. Therefore, long-term acute care provided from 10/30/18 through 1/11/19 was not medically necessary for the treatment of this patient.

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


Answer:
The patient is a 45-year-old female with a history of atopic dermatitis. The patient states that she
stopped treatment with Dupixent after experiencing a disruption in treatment from September to
November 2022. The patient has requested continued treatment with Dupixent. The Health Insurer
has denied the requested treatment as not medically necessary for the treatment of the patients
medical condition.

Answer:
The
records provided for review document that the patient has severe atopic dermatitis and atopic
neurodermatitis, with 20% BSA involvement. The provider noted that the patient has tried and
failed treatment with topical steroids, antibiotics, and tacrolimus. The patient has previously
undergone treatment with Dupixent with significant relief of symptoms.

Context:
Summary
The patient is a 45-year-old female with a history of atopic dermatitis. The patient states that she
stopped treatment with Dupixent after experiencing a disruption in treatment from September to
November 2022. The patient has requested continued treatment with Dupixent. The Health Insurer
has denied the requested treatment 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 U.S. Food and Drug Administration (FDA) has approved Dupixent for the
treatment of patients with moderate-to-severe atopic dermatitis whose disease is not adequately
controlled with topical therapies. A recent consensus article on atopic dermatitis by Boguniewicz
and colleagues defined moderate-to-severe atopic dermatitis as more than 10% BSA involvement
and/or involvement of highly visible areas or those important for function and significantly
impaired quality of life. On review of the current medical literature, Dupixent has the highest-
quality clinical trial evidence for safety and efficacy in atopic dermatitis (Siegels, et al.). The
records provided for review document that the patient has severe atopic dermatitis and atopic
neurodermatitis, with 20% BSA involvement. The provider noted that the patient has tried and
failed treatment with topical steroids, antibiotics, and tacrolimus. The patient has previously
undergone treatment with Dupixent with significant relief of symptoms. Given these findings, the
requested Dupixent 300 mg/2 mL, four pens per 28 days is medically necessary for the treatment
of this patient.

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


Answer: A 49-year-old female enrollee has requested authorization and coverage for breast susceptibility gene (BRCA) testing.  The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition.

Context:
Summary Reviewer

A 49-year-old female enrollee has requested authorization and coverage for breast susceptibility gene (BRCA) testing.  The Health Insurer has denied this request indicating that the requested services are not medically necessary for evaluation of the enrollees medical condition. The physician reviewer found BRCA mutations are associated with a high incidence of both breast and ovarian cancer. Being BRCA positive has several implications for measures to be considered by the patient.  With regards to breast cancer, she can consider more intense screening with magnetic resonance imaging or even bilateral mastectomies.  With regards to ovarian cancer, it is recommended that such women have bilateral salpingo-oophorectomy at the appropriate age.  Thus BRCA is a genetic test of great potential importance and value.  However, there is a lack of support for the requested services in this patients case.  U.S. Preventative Services Task Force indicates that testing is recommended for women who have a family history including three or more first-degree or second-degree relatives with breast cancer, regardless of age of their diagnosis.  Additionally, there is support for BRCA testing for patients who have a close relative diagnosed with breast cancer under the age of 50.  None of these criteria appear to apply to this patient.  All told, the requested breast susceptibility gene (BRCA) testing is not medically indicated for the evaluation of this patient.  Therefore, the requested services are not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer: A 62-year-old male enrollee has requested reimbursement for the RT300 functional electrical stimulator (FES) cycle provided on 2/10/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees quadriplegia.

Context:
Summary Reviewer 2

A 62-year-old male enrollee has requested reimbursement for the RT300 functional electrical stimulator (FES) cycle provided on 2/10/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees quadriplegia.   The physician reviewer found that currently, there is a paucity of proven significant health or functional benefits of exogenous neurostimulation therapy of paralyzed muscles using FES cycle ergometry for use in this clinical setting. There have been a number of case reports and series providing some preliminary data suggesting possible benefits, but larger studies designed to evaluate the actual clinical efficacy of passive exercise such as FES cycle ergometry in the setting of spinal cord injury are lacking. While repeated bouts of exogenous neurostimulation of paralyzed muscle may potentially retard or reverse muscle atrophy in paralyzed muscle, there is no proven significant health or functional benefit of this achievement in patients with spinal cord injury because the muscle tissue that is gained or spared does not protect against pressure ulcers or provide any other clinically or functionally relevant benefit. Passive cycling may be an option to provide passive range of motion therapy to prevent contractures or mitigate spasticity, but this is considered a custodial use of the device (Reichenfelser, et al). The other purported benefits of passive cycling have not been sufficiently investigated to allow conclusions related to clinically relevant outcomes. To date, the limited available data provide mixed results regarding health measures. Given that the RT300 FES cycle is not active exercise and not an appropriate substitute for active exercise, its use in this patients care was not indicated. Thus, the RT300 FES cycle provided on 2/10/16 was not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the equipment at issue was 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 62-year-old male enrollee has requested reimbursement for the RT300 functional electrical stimulator (FES) cycle provided on 2/10/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees quadriplegia.

Context:
Summary Reviewer 3

A 62-year-old male enrollee has requested reimbursement for the RT300 functional electrical stimulator (FES) cycle provided on 2/10/16. The Health Insurer has denied this request indicating that the equipment at issue was considered investigational for treatment of the enrollees quadriplegia.   The physician reviewer found the RT300 FES is a primary at-home internet linked and remote-clinician monitored intervention for patients with spinal cord injury (SCI) that provides intense electrical stimulation to intact peripheral nerves below the level of the SCI to evoke muscle contractions. Physical activities, like FES, that provide adequate stress to bone, can play a role in the improvement in bone mineral density with the possible prevention or reduction of osteoporosis and a decrease in fractures, two disabling and costly conditions for persons with paralysis due to SCI (Dolbow, et al). In addition, Fazio noted that repeated use of FES can lead to sensorimotor improvements as well as cortical reorganization, changes that cannot be accomplished with passive range of motion alone due to lack of sensory or motor input or activation of motor units, which is essential for motor relearning and neuromuscular reeducation. Thus, the intended in-home use of the RT300 FES cycle will help to remove many of the physical barriers to exercise which is a key factor in promoting regular physical activity in the SCI patient. For these reasons, the RT300 FES cycle provided on 2/10/16 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 equipment at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.

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


Answer: A 49-year-old female enrollee has requested reimbursement for a digital breast tomosynthesis that was performed on 3/22/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for the enrollees breast examination

Answer: In this particular patient, her breasts have been described as extremely dense.

Context:
Summary Reviewer 3

A 49-year-old female enrollee has requested reimbursement for a digital breast tomosynthesis that was performed on 3/22/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for the enrollees breast examination 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. In this particular patient, her breasts have been described as extremely dense. It is specifically those patients who have dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures enables the possibility of demonstrating an otherwise occult tumor. Therefore, digital breast tomosynthesis performed on 3/22/16 was likely to have been of greater benefit than other modalities for evaluating this patient. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned

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


Answer: A 60-year-old male enrollee has requested authorization and coverage for 18F-NaF positron emission tomography/computed tomography (PET/CT) scan. The Health Insurer has denied this request indicating that the requested diagnostic procedure is considered investigational for evaluation of the enrollees prostate cancer.

Answer: In this patient with a rising PSA after radical prostatectomy, the possibility of subtle skeletal metastatic disease is possible

Context:
Summary Reviewer 1

A 60-year-old male enrollee has requested authorization and coverage for 18F-NaF positron emission tomography/computed tomography (PET/CT) scan. The Health Insurer has denied this request indicating that the requested diagnostic procedure is considered investigational for evaluation of the enrollees prostate cancer. The physician reviewer found that based upon the recommendations of the National Oncologic PET Registry, the Centers for Medicare and Medicaid Services (CMS) revised its guidelines concerning coverage for PET scans in patients with solid tumors allowing up to three scans in each patient for diagnosis, staging and surveillance. While the use of this compound has proven to be of use in prostate cancer, the re-approval of 18F-NaF as a pharmaceutical has proven of greater benefit to patients with rising PSA levels where bone metastases are possible. The reason is the proven marked increased sensitivity of the technique compared to standard technetium bone scans in the detection and localization of skeletal metastatic deposits. In this patient with a rising PSA after radical prostatectomy, the possibility of subtle skeletal metastatic disease is possible and the requested 18F-NaF PET/CT scan is the most sensitive means with which to evaluate this patient.  Based upon the information set forth above, I have determined the requested diagnostic procedure is 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 48-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/12/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma.

Context:
Summary Reviewer 3

A 48-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 12/12/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that Melanoma is a cancer that is curable in its earliest stages. Cutaneous melanoma is initially treated by wide surgical excision and sampling of sentinel lymph nodes for those with high depth of invasion, 0.76-1.0 mm. Metastases to regional lymph nodes may be amenable to excision, but this suggests a high risk for the development of metastatic disease in the future. Such patients may be observed or treated with interferon-alpha. The data on the DecisionDx-Melanoma testing for melanoma has not made it part of routine analysis after sentinel lymph node biopsy. There has also been some lack of consistency between various genes being used as biomarkers. As such, the test is novel, and it is unclear how best to incorporate it into the treatment algorithm beyond standard staging techniques. Thus, DecisionDx-Melanoma testing performed on 12/12/17 was not likely to have been more effective 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 58-year-old male enrollee has requested reimbursement for therapeutic phlebotomy from
1/6/21 through 1/26/21. The Health Insurer has denied this request and reported that the service
at issue was investigational for the treatment of the enrollees hereditary hemochromatosis.

Answer:
In this case, laboratory results dated 12/14/20 showed a ferritin of 369 ng/mL and an iron
saturation over 85%.

Context:
Summary Reviewer 2

A 58-year-old male enrollee has requested reimbursement for therapeutic phlebotomy from
1/6/21 through 1/26/21. The Health Insurer has denied this request and reported that the service
at issue was investigational for the treatment of the enrollees hereditary hemochromatosis. The
physician reviewer found that therapeutic phlebotomy is the preferred approach to removing
iron in patients with hereditary hemochromatosis because it is highly effective and relatively
devoid of toxicities. In this case, phlebotomy was indicated as the records noted a biopsy proven
iron overload. While there is a range of ferritin and iron saturation goals, the recommended
ferritin goal is 30 to 150 ng/mL and the recommended iron saturation goal is greater than 20%.
In this case, laboratory results dated 12/14/20 showed a ferritin of 369 ng/mL and an iron
saturation over 85%. Therefore, therapeutic phlebotomy from 1/6/21 through 1/26/21 was likely
to have been more beneficial for treatment of the enrollee's condition than any available
standard therapy.

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


Answer: A 58-year-old male enrollee has requested authorization and coverage for epidural steroid injections. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition.

Answer: The patients physical examination and lumbar magnetic resonance imaging (MRI) do not show evidence of lumbar radiculopathy/radiculitis.

Context:
Summary Reviewer

A 58-year-old male enrollee has requested authorization and coverage for epidural steroid injections. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested services.  The patients physical examination and lumbar magnetic resonance imaging (MRI) do not show evidence of lumbar radiculopathy/radiculitis.  The peer-reviewed medical literature provides evidence for epidural steroid injections in documented cases of nerve root compression or radiculitis.  The patients chronic pain condition is not consistent with such a diagnosis.  There is a lack of support for the requested services in this clinical setting.  All told, the requested epidural steroid injections are not medically indicated for the treatment of this patient.  Therefore, the requested services are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.

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


Answer:
The parent of a 16-year-old male enrollee has requested reimbursement for immunoassay for
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise
specified and adalimumab on 8/6/21. The Health Insurer has denied this request indicating that the
service and medication at issue were investigational for the treatment of the enrollees ulcerative
colitis.

Answer:
In this case, the patient had
symptoms of active ulcerative colitis despite being on Humira.

Answer:
he was at risk for complications from ulcerative colitis such as toxic megacolon,
hospitalization, need for surgery, or colonic dysplasia leading to colorectal cancer.

Context:
Summary Reviewer 3

The parent of a 16-year-old male enrollee has requested reimbursement for immunoassay for
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise
specified and adalimumab on 8/6/21. The Health Insurer has denied this request indicating that the
service and medication at issue were investigational for the treatment of the enrollees ulcerative
colitis. The physician reviewer found that the use of testing for Humira drug levels and anti-Humira
antibody levels is supported by guidelines in this clinical setting. In this case, the patient had
symptoms of active ulcerative colitis despite being on Humira. The American Gastroenterological
Association (AGA) guideline on therapeutic drug monitoring in inflammatory bowel disease
suggests reactive therapeutic drug monitoring to guide treatment changes in adults with active
inflammatory bowel disease treated with anti-TNF agents. The guideline suggests target trough
concentrations of 7.5 mg/mL for adalimumab. Drug concentration and anti-drug antibody levels
should be checked if there is a loss of response to an anti-TNF medication such as Humira,
allowing for a subsequent change in management including a switch within drug classes, assessing
for inflammation, or increasing the dose. The AGA guidelines for the management of ulcerative
colitis also recommend drug level testing, noting that the patient with nonresponse or loss of
response to therapy should be assessed with therapeutic drug monitoring to identify the reason for
lack of response and whether to optimize the existing therapy or to select an alternate therapy. In
this case, given that the patients symptoms that were consistent with active or uncontrolled
ulcerative colitis, he was at risk for complications from ulcerative colitis such as toxic megacolon,
hospitalization, need for surgery, or colonic dysplasia leading to colorectal cancer. In this clinical
setting,  testing  for  Humira  drug  level  and  anti-Humira  antibody  level  was  appropriate  per
guidelines for the assessment of whether the patients Humira dose should be increased or changed
to an alternative therapy. As the guidelines do not recommend any alternative therapy, the testing
at issue was likely to have been more beneficial than a standard approach of changing Humira to
another therapy, which could be ineffective and result in entirely uncontrolled disease and severe
complications such as hospitalization, surgery, and toxic megacolon. Therefore, immunoassay for
analyte other than infectious agent antibody or infectious agent antigen; quantitative, not otherwise
specified, and adalimumab on 8/6/21 was likely to have been more beneficial for treatment of the
patient's condition than any available standard therapy.

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


Answer: A 61-year-old female enrollee has requested coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees left hip and buttock pain.

Answer: In this case, the patient presents with chronic left hip/buttocks pain with significant functional limitation. Detailed evidence of at least six months of reasonable and/or comprehensive non-operative treatment protocol trial and failure has been submitted. Clinical exam findings have documented significant tenderness at the SI joint with six positive SI joint provocative tests. There is radiographic evidence of bilateral joint arthrosis with joint space narrowing. There is no imaging evidence of lumbosacral spine neural compression pathology. Multiple bilateral SI joint injections have produced 90% pain relief.

Context:
Summary Reviewer 1

A 61-year-old female enrollee has requested coverage for sacroiliac (SI) joint fusion. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees left hip and buttock pain. The physician reviewer found that the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The evidence based peer-reviewed literature support SI joint fusion in this clinical setting. Polly and colleagues concluded in their study that minimally invasive SI joint fusion using triangular titanium implants was more effective than nonsurgical management at one year in relieving pain, improving function, and improving quality of life in patients with SI joint dysfunction caused by degenerative sacroiliitis or SI joint disruptions. The authors noted that pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment. The International Society for Advancement of Spine Surgery (ISASS) policy statement for minimally invasive SI joint fusion provide specific indications for surgery. The criteria include: significant SI joint pain or significant limitations in activities of daily living because of SI joint pain; SI joint pain confirmed by at least three positive SI joint provocative tests; confirmation of the SI joint as a pain generator with at least 75% decrease in pain following fluoroscopically guided diagnostic intra-articular SI joint block in the immediate post-injection period; failure to respond to at least six months of non-surgical treatment including medications, rest, physical therapy, and SI joint steroid injection or rhizotomy; and, additional or alternative diagnoses that could be responsible for the patients ongoing pain or disability have been clearly considered, investigated and ruled-out. In this case, the patient presents with chronic left hip/buttocks pain with significant functional limitation. Detailed evidence of at least six months of reasonable and/or comprehensive non-operative treatment protocol trial and failure has been submitted. Clinical exam findings have documented significant tenderness at the SI joint with six positive SI joint provocative tests. There is radiographic evidence of bilateral joint arthrosis with joint space narrowing. There is no imaging evidence of lumbosacral spine neural compression pathology. Multiple bilateral SI joint injections have produced 90% pain relief. The peer-reviewed supports the requested SI joint fusion as likely to be more beneficial for treatment of the patients medical condition than any available standard therapy in this clinical setting. 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?