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INSERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION]
In this case, the patients thyroid nodule was enlarged with suspicious features, such as size, it is hypoechoic and has intranodal vascularity. It is one among other nodules, which had not enlarged significantly. | Overturned | Experimental | Summary Reviewer 3
[INSERT FIRST TWO SENTENCES FROM SUMMARY REVIEW DETERMINATION] The physician reviewer found that the gene testing performed to gauge risk for thyroid cancer on 2/16/17 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Cytopathology of the 1.9 cm thyroid nodule was consistent with AUS. The risk of malignancy is 5-15% in AUS (Cibas, et al; Haugen, et al). The risk of malignancy decreases to less than 6% with benign findings by gene expression classifier (Haugen, et al; Alexander, et al). In this case, the patients thyroid nodule was enlarged with suspicious features, such as size, it is hypoechoic and has intranodal vascularity. It is one among other nodules, which had not enlarged significantly. In this clinical setting gene testing was appropriate to determine whether to perform a diagnostic hemithyroidectomy or an oncological thyroidectomy, if the result were suspicious. Therefore, the testing at issue has been established as 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.
| 1 |
A 50-year-old male has requested authorization and coverage for the LINX Reflux Management System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease.
flux. In this patients case, he has acid reflux as based on pH recording. | Upheld | Experimental | Summary Reviewer 2
A 50-year-old male has requested authorization and coverage for the LINX Reflux Management System. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees gastroesophageal reflux disease. The physician reviewer found the LINX device has been approved for patients with diagnosed gastroesophageal reflux disease as defined by abnormal pH testing, and who continue to have chronic gastroesophageal reflux symptoms despite maximal medical therapy for the treatment of reflux. In this patients case, he has acid reflux as based on pH recording. However, the records document that he has benefited to a significant degree from acid suppression treatment, and as such cannot be considered medically refractory when compliant with daily acid blocker drug use. Also, implantation of LINX in this setting must be approached with caution given his documented complaints of globus. Therefore, the requested LINX Reflux Management System is not likely to be of greater benefit than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 31-year-old female enrollee has requested reimbursement for osteochondral knee autograft CPT code 27416 performed on 3/7/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee who had injured her left knee. | Overturned | Experimental | Summary Reviewer 2
A 31-year-old female enrollee has requested reimbursement for osteochondral knee autograft CPT code 27416 performed on 3/7/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee who had injured her left knee. The physician reviewer found that cartilage grafts and/or transplantations remain controversial. Systematic reviews have yet to demonstrate the superiority of OATS over the more standard procedures in this clinical setting. The aim of the OATS technique is to slow down the development of osteoarthritis. There is some scientific evidence of effectiveness for patients with a singular, traumatically caused grade III or IV femoral condyle deficit who are under 40 years of age and have an active lifestyle. However, the available evidence from individually published case series is not sufficient to permit definitive conclusions concerning the effectiveness of the OATS procedure. Therefore, osteochondral knee autograft, CPT code 27416 performed on 3/7/17 was not likely to have been superior over the other treatment options available to this patient. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 63-year-old female enrollee has requested reimbursement for unlisted laboratory services provided on 7/02/19 and 1/28/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 3
A 63-year-old female enrollee has requested reimbursement for unlisted laboratory services provided on 7/02/19 and 1/28/20. 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 this patient had a standard therapeutic approach for the treatment of multiple myeloma. A new advance in the care of myeloma has been the analysis of minimal residual disease (MRD) by next generation sequencing. The test that is being used here is the ClonoSEQ testing. According to the National Comprehensive Cancer Network guidelines, the identification of the myeloma clone can be done at the time of diagnosis and also followed up during surveillance. The discussion within the National Comprehensive Cancer Network group and the current guidelines state, aMRD has been identified as an important prognostic factor. A prospective study of patients with newly diagnosed multiple myeloma evaluated MRD bone marrow samples and showed that had a median follow-up of 57 months MRD negativity after autologous stem cell transplant translated to significantly improved progression free survival and overall survival rates.a Based on the current medical evidence, the testing as ordered was appropriate for this patient. Therefore, unlisted laboratory services provided on 7/02/19 and 1/28/20 were likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 28-year-old female enrollee has requested reimbursement and prospective authorization and
coverage for ketamine infusions from 9/07/21 forward. The Health Insurer has denied this
request and reported that the services at issue were and are investigational for the treatment of
the enrollees medical condition.
The patient has been diagnosed with major depressive
disorder. Based on her failing at least two antidepressants plus psychotherapy, she qualifies for
a diagnosis of treatment-resistant depression. The patient has tried numerous somatic
treatments, such as transcranial magnetic stimulation and neurofeedback, still without remission
of her depressive symptoms. In the course of her recent ketamine infusions, the patients
depression lifted, as did her suicidality. | Overturned | Experimental | Summary Reviewer 1
A 28-year-old female enrollee has requested reimbursement and prospective authorization and
coverage for ketamine infusions from 9/07/21 forward. The Health Insurer has denied this
request and reported that the services at issue were and are investigational for the treatment of
the enrollees medical condition. The physician reviewer found that there is sufficient support for
the services at issue in this clinical setting. The patient has been diagnosed with major depressive
disorder. Based on her failing at least two antidepressants plus psychotherapy, she qualifies for
a diagnosis of treatment-resistant depression. The patient has tried numerous somatic
treatments, such as transcranial magnetic stimulation and neurofeedback, still without remission
of her depressive symptoms. In the course of her recent ketamine infusions, the patients
depression lifted, as did her suicidality. Intravenous ketamine has been found to have a rapid and
significant effect on depression and suicidality. Therefore, ketamine infusions from 9/07/21
forward were and are likely to be more beneficial than any available standard therapy.
| 1 |
A 43-year-old female enrollee has requested reimbursement for the screening digital breast tomosynthesis performed on 6/17/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees risk for breast cancer. | Overturned | Experimental | Summary Reviewer 3
A 43-year-old female enrollee has requested reimbursement for the screening digital breast tomosynthesis performed on 6/17/16. The Health Insurer has denied this request indicating that the diagnostic procedure 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 peer-reviewed literature. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 6/17/16 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 diagnostic procedure 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.
| 1 |
A 32-year-old female enrollee has requested reimbursement for the Prometheus Anser ADA testing performed on 4/10/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease. | Upheld | Experimental | Summary Reviewer 2
A 32-year-old female enrollee has requested reimbursement for the Prometheus Anser ADA testing performed on 4/10/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees Crohns disease. The physician reviewer found that in this case, Anser ADA was recommended to direct the management of this patients Crohns disease. The use of Anser ADA has not been clinically proven to improve patient outcomes. In addition, the effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with Humira may experience loss of response, but the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of antibodies and serum levels are retrospective or observational in nature (Karmiris, et al; Imaeda, et al; Lichtenstein, et al). The study by Karmiris and colleagues found no direct relationship between trough serum Humira (adalimumab) concentration or anti-adalimumab antibody and short-term treatment efficacy. Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. Given this lack of support, the Prometheus Anser ADA testing performed on 4/10/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 20-year-old female enrollee has requested reimbursement for unlisted procedure of the skin, mucous membrane and subcutaneous tissue (17999) performed on 11/26/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
This patient has documented gender dysphoria. His gender dysphoria included dysphoria about breasts. Che | Overturned | Medical Necessity | Summary Reviewer
A 20-year-old female enrollee has requested reimbursement for unlisted procedure of the skin, mucous membrane and subcutaneous tissue (17999) performed on 11/26/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the current medical evidence supports the services at issue in this clinical setting. This patient has documented gender dysphoria. His gender dysphoria included dysphoria about breasts. Chest surgery in a transgender male has been shown to be an effective treatment for gender dysphoria. The World Professional Association for Transgender Health (WPATH) noted that sex reassignment surgery is effective and medically necessary. Per WPATH, criteria for mastectomy and creation of a male chest in transgender male patients includes persistent gender dysphoria, capacity for informed consent, age of majority, and medically and psychiatrically stable for surgery. This patient meets these criteria. Therefore, the unlisted procedure of the skin, mucous membrane and subcutaneous tissue (17999) performed on 11/26/18 was medically necessary for the treatment of this patient. | 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. | Upheld | Experimental | 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.
| 0 |
A 53-year-old female enrollee has requested authorization and coverage for a powered upper extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), including microprocessor, sensors, all components and accessories, custom fabricated. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 1
A 53-year-old female enrollee has requested authorization and coverage for a powered upper extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), including microprocessor, sensors, all components and accessories, custom fabricated. The Health Insurer has denied this request and reported that the requested device is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that the standard of rehabilitative care in the setting of severe functional impairments due to central nervous system pathology such as stroke is to endeavor to address impairments, mitigate risks of complications, and to optimize overall function in all relevant domains with the assistance of services, such as physiatry, occupational therapy, orthotists, assistive technology providers, social workers, independent living counselors and vocational counselors, as appropriate. Increased independence can be pursued and achieved in this clinical setting using equipment such as assistive speech technology, smartphones, adaptive utensils, nonskid plates, gait/mobility implements, other adaptive equipment and accessibility/environmental modifications, if appropriate. When there are limits to function despite exhausting more direct interventions, or when efficiency or safety calls for it, caregivers may be called upon to otherwise meet a personas functional needs. There is no proven role of the MyoPro elbow-wrist-hand-finger orthosis in question in stroke management or rehabilitation. The proposed device does not replace the role of conventional (i.e., passive, light and custom-fitted) orthoses, which can be employed as needed to manage the effects of tone, to reinforce therapeutic positioning, and to enhance functionality when applicable. There are some potential functional benefits theoretically of the device in question, but these benefits have not been demonstrated in a clinically relevant setting. There is a lack of proven health benefits that can be attributed to use of this device. The available scientific evidence related to the type of orthotic device in question is limited to preclinical work and anecdotal literature. The potential benefits, importantly, have not been demonstrated to outweigh the potential adverse sequelae and safety issues. This type of device could potentially cause or exacerbate edema, skin injuries, musculoskeletal injuries or pain. Therefore, the requested powered upper extremity range of motion assist device, elbow, wrist, hand, finger, single or double upright(s), including microprocessor, sensors, all components and accessories, custom fabricated is not likely to be more beneficial than any available standard therapy.
| 1 |
A 59-year-old female enrollee has requested reimbursement for Harvoni. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees hepatitis C. | Overturned | Medical Necessity | Summary Reviewer
A 59-year-old female enrollee has requested reimbursement for Harvoni. The Health Insurer has denied this request indicating that the medication at issue was not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found the submitted documentation supports the medical necessity of the medication at issue. According to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and Infectious Diseases Society of America, all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with limited life expectancy less than 12 months due to non-liver-related conditions. The guidelines support Harvoni for treatment-naive patients with hepatitis C, genotype 1. It is advantageous to treat patients at an earlier stage of liver fibrosis. All told, Harvoni was medically indicated for the treatment of this patient. Therefore, the medication at issue was medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 43-year-old female enrollee has requested reimbursement for surgery performed by a non-participating provider on 6/15/17. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees back pain.
The patient has a foot drop and previous lumbar surgery with scarring. At the time of presentation on 6/15/17, the patient could have been safely treated by an in Plan spine provider.
Additionally, the records indicated that the patient was approved for a consultation with an in Plan spine surgeon. | Upheld | Medical Necessity | Summary Reviewer
A 43-year-old female enrollee has requested reimbursement for surgery performed by a non-participating provider on 6/15/17. The Health Insurer has denied this request indicating that the requested procedure is not medically necessary for treatment of the enrollees back pain. The physician reviewer found that the documentation provided does not support the services at issue in this clinical setting. The patient has a foot drop and previous lumbar surgery with scarring. At the time of presentation on 6/15/17, the patient could have been safely treated by an in Plan spine provider. There was no indication for fusion surgery by a non-participating provider at that time. The medical records did not show any evidence of lumbar fracture, instability, or tumor that would have necessitated the procedure at issue. Additionally, the records indicated that the patient was approved for a consultation with an in Plan spine surgeon. As such, the criteria for surgery on 6/15/17 were not met and the patient did not need out of network spine surgery. In sum, surgery performed by a non-participating provider on 6/15/17 was not medically necessary for treatment of this patients medical condition.
Therefore, for the reasons stated above, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
| 1 |
A 40-year-old female enrollee has requested authorization and coverage for Otezla 30 mg tablets, 60 per 30 days. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
SI response was maintained over 52 weeks with continued apremilast treatment. In | Overturned | Medical Necessity | Summary Reviewer
A 40-year-old female enrollee has requested authorization and coverage for Otezla 30 mg tablets, 60 per 30 days. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that Traditional systemic therapies for psoriasis, including methotrexate and cyclosporine, have a well-documented array of toxicities, particularly end-organ toxicities. Over the past several years, the use of anti-tumor necrosis factor (TNF) biologic therapies for the treatment of moderate to severe psoriasis has been a major clinical and research focus. Despite several difficulties with documenting risks, some systemic treatments for psoriasis have been linked with an increased risk of selected cancers. In addition, patients treated with anti-TNF drugs may develop adverse events such as infections, acute infusion and injection reactions, autoimmunity and cardiovascular effects. Otezla (apremilast) provides a novel therapeutic option for the treatment of patients with moderate to severe plaque psoriasis. ESTEEM 1 is the first phase III study confirming the efficacy of apremilast in psoriasis. Apremilast demonstrated significant improvements in mean percentage change in psoriasis area and severity index (PASI) score and in pruritus. PASI response was maintained over 52 weeks with continued apremilast treatment. In addition, apremilast demonstrated improvements in nail and scalp psoriasis, both difficult-to-treat forms of psoriasis. This patient has chronic plaque psoriasis that requires systemic treatment. The immunosuppressors and anti-TNF drugs can increase the risk for infection and malignancy. Otezla has been approved by the U.S. Food and Drug Administration (FDA) for treatments of such patients. Therefore, Otezla, which does not increase the risk of malignancy and infection, is medically appropriate in this case. Thus, Otezla 30 mg tablets, 60 per 30 days, are medically necessary for the treatment of this patient.
| 1 |
The parent of a 15-year-old female enrollee has requested reimbursement for mental health residential treatment provided from 12/24/15 through 4/08/16. 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.
harm, the patient scored 2. She demonstrated some risk of harm. She denied any suicidal ideation or homicidal ideation at the time of admission. However, her mother reported that the patient would have mild suicidal ideation with no intent or conscious plan. In terms of functional status, the patient scored 3. The records noted moderate functional impairment. There had been conflicts in the family over the patients new boyfriend. She reported some interpersonal conflicts with friends. Regarding comorbidity, the patient scored 3. The patient had a comorbidity of major depressive disorder, emotional dysregulation, and possibly abusing inhalants. The patients mother reports that she is using inhalants, but the patient denied this allegation. The patient was also sexual and physically assaulted by a boyfriend six month previous to being admitted. In terms of her recovery environment and environmental stress, she scored 3. The patients mother is supportive of the patient. However, there is significant conflict over the patient being able to see her boyfriend. | Upheld | Medical Necessity | Summary Reviewer
The parent of a 15-year-old female enrollee has requested reimbursement for mental health residential treatment provided from 12/24/15 through 4/08/16. 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 in order to objectively determine the appropriate level of care for the patient, the case was examined using the Child and Adolescent Level of Care Utilization System (CALOCUS). This is an accepted, national standard for determining the appropriate level of care for children and adolescents. In terms of risk of harm, the patient scored 2. She demonstrated some risk of harm. She denied any suicidal ideation or homicidal ideation at the time of admission. However, her mother reported that the patient would have mild suicidal ideation with no intent or conscious plan. In terms of functional status, the patient scored 3. The records noted moderate functional impairment. There had been conflicts in the family over the patients new boyfriend. She reported some interpersonal conflicts with friends. Regarding comorbidity, the patient scored 3. The patient had a comorbidity of major depressive disorder, emotional dysregulation, and possibly abusing inhalants. The patients mother reports that she is using inhalants, but the patient denied this allegation. The patient was also sexual and physically assaulted by a boyfriend six month previous to being admitted. In terms of her recovery environment and environmental stress, she scored 3. The patients mother is supportive of the patient. However, there is significant conflict over the patient being able to see her boyfriend. This is in part of what led to the patient requiring intensive treatment. In terms of environmental support, the records support a score of 2. The patient has supportive mother who was trying to help the patient. In general, other than sensitive topics, the patient and her mother have a good relationship. The family was willing to participate in treatment if requested. Regarding resiliency and treatment, the records support a score of 3. The patient has had prior treatment, but continued to have emotional dysregulation. The patient requires strong professional support to maintain recovery and emotional balance. Regarding acceptance and engagement, the patient scored 2. Per the records, she was able to develop positive relationships with clinicians and care providers. She was cooperative with staff and followed instruction. Thus, this patient has a composite score of 18. Based on these criteria, the patient continued to require treatment for her depression and mood dysregulation, but she could have been treated in a less restrictive environment in an intensive outpatient program. It is standard of care that patients be treated in the least restrictive environment possible. The current medical evidence does not support the services at issue in this clinical setting. All told, mental health residential treatment provided from 12/24/15 through 4/08/16 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 66-year-old female enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas obstructive sleep apnea. | Overturned | Experimental | Summary Reviewer 3
A 66-year-old female enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas obstructive sleep apnea. The physician reviewer found that the Inspire device has been approved by the FDA for the treatment of moderate to severe obstructive sleep apnea refractory to continuous positive airway pressure therapy. However, a meta-analysis by Kompelli and colleagues found that contemporary hypoglossal nerve stimulation research consisted of single-arm clinical trials and case series, with a high likelihood of publication bias and a lack of comparative trials of hypoglossal nerve stimulation versus existing alternatives, such as upper airway surgery. They concluded that hypoglossal nerve stimulation amay not be the definitive choice for second-line therapya for obstructive sleep apnea. Overall, there is insufficient high-quality, peer-reviewed evidence to support the use of hypoglossal nerve stimulation over other available therapies. Therefore, Inspire upper airway stimulation system is not likely to be more beneficial than any available standard therapy.
| 1 |
A 39-year-old male enrollee has requested authorization and coverage for Xeljanz. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition.
this patient has been treated with intralesional steroids, topical steroids, as well as systemic steroids. His area of involvement has been as severe as alopecia totalis, which affects scalp, eyebrows, and eyelashes. He received treatment with Xeljanz in the past and did well. It was the best at keeping him in remission. | Overturned | Experimental | Summary Reviewer 2
A 39-year-old male enrollee has requested authorization and coverage for Xeljanz. The Health Insurer has denied this request and reported that the requested medication is investigational for the treatment of the enrolleeas medical condition. The physician reviewer found that this patient has been treated with intralesional steroids, topical steroids, as well as systemic steroids. His area of involvement has been as severe as alopecia totalis, which affects scalp, eyebrows, and eyelashes. He received treatment with Xeljanz in the past and did well. It was the best at keeping him in remission. As this patient did have a documented improvement in the past with Xeljanz, it is reasonable to continue with that treatment plan. Therefore, Xeljanz is likely to be more beneficial than other available standard therapy.
| 1 |
The patient is a 12-year-old male with autism. The patients parent states that the patients therapy
was terminated due to non-coverage, so no additional records are available. The patients parent
has requested authorization and coverage for occupational therapy. The Health Insurer has denied
the requested services as not medically necessary.
In this case, the patient started occupational therapy for the habilitative treatment of deficiencies
associated with an autism spectrum disorder. Specifically, the patient has motor coordination
problems and deficits in IADLs and ADLs, | Overturned | Medical Necessity | Summary
The patient is a 12-year-old male with autism. The patients parent states that the patients therapy
was terminated due to non-coverage, so no additional records are available. The patients parent
has requested authorization and coverage for occupational therapy. The Health Insurer has denied
the requested services as not medically necessary. This denial is the subject of this appeal and
determination. The physician reviewer found that the current peer-reviewed medical literature
supports the use of occupational therapy in the routine management of pediatric patients with
autism (Houtrow, et al.). In addition, occupational therapy is known to be effective in improving
functional outcomes for patients with autism with deficits as documented in this patients case
(Schoen, et al.; Schaaf, et al.). Kashefimehr and colleagues noted that their findings support the
effectiveness of occupational therapy with a sensory-integrated approach in improving
occupational performance in pediatric patients with autism spectrum disorders. Moreover,
occupational therapy is the most appropriate treatment modality to address the patients deficits.
In this case, the patient started occupational therapy for the habilitative treatment of deficiencies
associated with an autism spectrum disorder. Specifically, the patient has motor coordination
problems and deficits in IADLs and ADLs, which are planned to be addressed with the requested
occupational therapy. Therefore, the requested occupational therapy is medically necessary for the
treatment of this patient.
| 1 |
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.
. 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
. 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. | Overturned | Medical Necessity | 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.
| 1 |
The patient is a 38-year-old male with a history of low back and radicular leg pain associated with clinical and imaging evidence of a lumbar disc herniation. The patient has requested authorization and coverage for laminotomy surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient.
has a history of lumbar disc herniation associated with radiculopathy and leg pain greater than back pain. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 38-year-old male with a history of low back and radicular leg pain associated with clinical and imaging evidence of a lumbar disc herniation. The patient has requested authorization and coverage for laminotomy surgery. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that the patient has a history of lumbar disc herniation associated with radiculopathy and leg pain greater than back pain. There is documentation of conservative treatment, including four weeks of physical therapy, in addition to chiropractic care and medications. Although many patients improve with nonsurgical management, Lorio and colleagues noted, aResults from randomized controlled trials have shown that 35% to 54% of patients assigned to continued nonsurgical care undergo discectomy within six months due to persistent or aggravating symptoms.a Other randomized controlled trials show that discectomy provides faster and/or greater pain relief, and functional recovery as well as patient satisfaction compared to continued nonsurgical care. A review of the recent medical literature indicates that this patient is a good candidate for the requested surgical procedure. Therefore, the requested laminotomy surgery is medically necessary for the treatment of this patient. | 1 |
A 79-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas medical condition. | Overturned | Experimental | Summary Reviewer 2
A 79-year-old male enrollee has requested authorization and coverage for percutaneous transcatheter closure of the left atrial appendage with endocardial implant. 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 in this circumstance, atrial fibrillation treatment options include continuation of anticoagulation while accepting an increased bleeding risk or percutaneous left atrial appendage exclusion using a Watchman device. The Watchman device has been demonstrated in one trial to be non-inferior compared with warfarin and has also showed favorable preliminary results in another trial. However, device placement in these trials had a high rate of significant complications due to pericardial effusion and procedural stroke related to thromboembolism or air embolization. The Watchman device should still be considered investigational, especially in the subset of patients who are tolerating anticoagulation without bleeding side effects or evidence of recurrent strokes. This patient is tolerating Eliquis and has no documented bleeding episodes. Therefore, percutaneous transcatheter closure of the left atrial appendage with endocardial implant is not likely to be more beneficial than other available standard therapy.
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A 54-year-old female enrollee has requested reimbursement for emergency services provided on 1/26/16. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis.
Upon review of the submitted medical records, the patient presented for removal of scalp sutures due to a laceration nine days prior to her visit. She admitted to a lingering hangover feeling, but had no specific complaints of headache, vomiting, dizziness, blurry vision, or other symptoms of acute head injury. She denied any symptoms of wound infection. | Upheld | Medical Necessity | Summary Reviewer
A 54-year-old female enrollee has requested reimbursement for emergency services provided on 1/26/16. The Health Insurer has denied this request indicating the services at issue were not required on an emergent basis. The physician reviewer found the issue in this case is whether a prudent layperson in the patients circumstances would believe he or she was experiencing an emergency medical condition. California law defines an emergency medical condition as a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in any of the following: (1) Placing the patients health in serious jeopardy; (2) Serious impairment to bodily functions; (3) Serious dysfunction of any bodily organ or part. Review of the submitted documentation demonstrates that a prudent layperson would not have sought immediate medical attention on the date in question. Upon review of the submitted medical records, the patient presented for removal of scalp sutures due to a laceration nine days prior to her visit. She admitted to a lingering hangover feeling, but had no specific complaints of headache, vomiting, dizziness, blurry vision, or other symptoms of acute head injury. She denied any symptoms of wound infection. Moreover, the patient was not experiencing the sudden onset of acute symptoms. Based on the patients presenting complaints and symptoms, a prudent layperson in this circumstance would not reasonably believe she was suffering from a serious medical condition. In sum, the patient was not suffering from a serious medical condition that was likely to place the patients health in serious jeopardy, cause serious impairment to body functions or cause serious dysfunction to a body organ or part. Thus, the services provided on 1/26/16 did not meet prudent layperson criteria for emergency care.
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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.
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. | Overturned | Medical Necessity | 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.
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A 60-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/22/16. 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.
particular patient has breasts that have been described as extremely dense. | Overturned | Experimental | Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis performed on 9/22/16. 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 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, by separating the various layers of breast tissue, one can better detect abnormalities. This particular patient has breasts that have been described as extremely dense. It is specifically patients with dense breasts that can benefit most from tomosynthesis. The ability to separate out the overlapping structures better enables the possibility of demonstrating an otherwise occult tumor. The sonogram is also of value, as sonography will help visualize the cystic lesions. Thus, in this clinical setting, the use of the digital breast tomosynthesis performed on 9/22/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Based upon the information set forth above, the 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.
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The parent of a three-year-old female enrollee has requested authorization and coverage for homocysteine, Factor V Leiden, and methylene tetrahydrofolate reductase (MTHFR), testing performed on 6/4/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee whose parent was diagnosed with idiopathic venous embolism and was positive for the MTHFR mutation and Factor V Leiden deficiency. | Upheld | Experimental | Summary Reviewer 1
The parent of a three-year-old female enrollee has requested authorization and coverage for homocysteine, Factor V Leiden, and methylene tetrahydrofolate reductase (MTHFR), testing performed on 6/4/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee whose parent was diagnosed with idiopathic venous embolism and was positive for the MTHFR mutation and Factor V Leiden deficiency. The physician reviewer found that the documentation provided does not support the efficacy of the services at issue in this clinical setting. The medical literature suggests those who have idiopathic thromboembolism before the age of 45 years or at an unusual site may request homocysteine testing. While this may be the case for the patients mother, it is not the case for the patient herself. The American College of Medical Genetics and Genomics (ACMG) has prepared guidelines for FVL testing. This patient may have relatives diagnosed with FVL, but the patients mother is not diagnosed with this medical condition. This would indicate that this patient is not at risk for inheriting FVL from her. While the patient could inherit FVL from her father, there is no report of clotting disorder or FVL in the paternal family history. Moreover, this patient has not had a blood clot. With regards to MTHFR, ACMG recommends against testing for MTHFR polymorphisms in any patient, including in those with relatives with known MTHFR polymorphisms. The literature suggests that there is no risk associated with the A1298C polymorphism in the heterozygous or homozygous state. Further, it could have been predicted that this patient would have at least one copy of A1298C as her mother is homozygous. ACMG guideline suggests testing of homocysteine could be reasonable only in those with two copies of the C677T polymorphisms. In this clinical setting, this is not possible for this patient based on his mother's testing. In sum, homocysteine, FVL, and MTHFR tests performed on 6/4/16 were not likely to have been more beneficial than standard options for the evaluation of this patient. Therefore, for the reasons stated above, the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 27-year-old male who presented to his provider on 4/20/21. The patient has
requested reimbursement for rhinoplasty (CPT 30420) performed on 5/05/21.
Findings at surgery described a left laterally displaced nasal bone and
callus over the left nasal dorsum. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 27-year-old male who presented to his provider on 4/20/21. The patient has
requested reimbursement for rhinoplasty (CPT 30420) performed on 5/05/21. The physician
reviewer found that Friedman and colleagues stated, Understanding nasal anatomy and
physiology are the most important points for successful functional rhinoplasty. Anatomic
structures playing major roles in nasal breathing functions include the septum, and internal and
external nasal valves, so physical examination of these regions is essential. Planning for functional
rhinoplasty involves the identification of the sites of nasal airway obstruction or old trauma and
addressing those regions during the operation with a number of different techniques that have
been described. The submitted documentation fails to demonstrate the medical necessity of
rhinoplasty (CPT 30420). Findings at surgery described a left laterally displaced nasal bone and
callus over the left nasal dorsum. A laterally displaced bone would be expected to widen the nasal
airway and not intrinsically cause nasal airway obstruction. A callus is a bump on the outside of
the nasal bone that would be cosmetically visible but would not be expected to affect the airway.
There is no report of external bony nasal deviation causing breathing obstruction. There is no
photographic documentation of bony nasal deviation. Based on the medical information received
for review, rhinoplasty (CPT 30420) was not medically necessary for treatment of the patients
medical condition. 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. There is no report or documentation that the appearance of
the nose was not within the wide range of normal. The services at issue were not documented
to improve function, and the California Reconstructive Surgery Statute is not applicable.
Therefore, rhinoplasty (CPT 30420) performed on 5/05/21 was not reconstructive in nature.
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The patient is a 56-year-old male who sustained a ventricular fibrillation related cardiac arrest in the setting of an acute anterior ST-elevation myocardial infarction. The patient was hospitalized from 7/31/16 through 8/05/16. He was successfully resuscitated and treated with drug eluting stent to the left anterior descending artery. Following the procedure, additional episodes of ventricular fibrillation were documented, and he was treated with cardioversion and amiodarone. Thrombus was noted at the site of the recent left anterior descending artery stent placement which was treated with angioplasty, and critical right coronary artery lesion was subjected to percutaneous coronary intervention/stenting. The ejection fraction following the procedure was 47%. The patient has requested reimbursement for wearable cardioverter defibrillator. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of this patient. | Upheld | Experimental | Summary Reviewer 3
The patient is a 56-year-old male who sustained a ventricular fibrillation related cardiac arrest in the setting of an acute anterior ST-elevation myocardial infarction. The patient was hospitalized from 7/31/16 through 8/05/16. He was successfully resuscitated and treated with drug eluting stent to the left anterior descending artery. Following the procedure, additional episodes of ventricular fibrillation were documented, and he was treated with cardioversion and amiodarone. Thrombus was noted at the site of the recent left anterior descending artery stent placement which was treated with angioplasty, and critical right coronary artery lesion was subjected to percutaneous coronary intervention/stenting. The ejection fraction following the procedure was 47%. The patient has requested reimbursement for wearable cardioverter defibrillator. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of this patient. The medical evidence has not demonstrated the superior efficacy of the device at issue in this patients case. There is a lack of support for an improvement of health outcomes when a wearable cardioverter defibrillator is deployed in this clinical setting. Implantable cardioverter defibrillator placement can be undertaken 90 days after a percutaneous coronary intervention/stenting procedure if the ejection fraction remains below 35 percent or 40 days after a myocardial infarction if there is no intervention and the ejection fraction remains below 35 percent. There is lack of support for the device at issue in this case. Thus, the wearable cardioverter defibrillator was not likely to have been more effective than other treatment modalities. Based upon the information set forth above, the device 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.
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A 65-year-old male enrollee has requested authorization and coverage for Rytary. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees Parkinsons disease. | Upheld | Medical Necessity | Summary Reviewer
A 65-year-old male enrollee has requested authorization and coverage for Rytary. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees Parkinsons disease. The physician reviewer found that the submitted documentation fails to support the medical necessity for the requested medication. While Rytary is a medication that is commonly used for the treatment of patients with Parkinsons disease, it is prescribed after the patient has tried and failed extended release formulations. The documentation provided do not demonstrate that this has been administered in this patient. The patient has not been placed on extended release formulations of carbidopa/levodopa. As such, it would be appropriate for the patient to try the extended release formulations prior to being started on Rytary. Accordingly, Rytary is not currently medically necessary for treatment of this patient. Therefore, for the reasons stated above, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 39-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 9/6/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees breast examination. | Overturned | Experimental | Summary Reviewer 1
A 39-year-old female enrollee has requested reimbursement for the digital breast tomosynthesis provided on 9/6/16. The Health Insurer has denied this request indicating that the diagnostic procedure at issue was considered investigational for evaluation of the enrollees breast examination. The physician reviewer found that Tomosynthesis was approved by the U.S. Food and Drug Administration (FDA) for clinical use in 2011. Despite the lack of long-term studies proving an increased survival rate when tomosynthesis has been used as part of screening mammography, the American College of Radiology (ACR) urged the technique be removed from the investigational category in 2014 due to the advantages this new tomographic technique brings to radiologists interpreting mammograms. This technique often allows radiologists to separate dense glandular elements from underlying masses and architectural distortion resulting in a decrease in callbacks and increased detection of small cancers. Thus, the addition of tomosynthesis to the usual two-dimensional protocol was likely of greater benefit to this patient than had her exam been done with two-dimensional imaging alone. Accordingly, the breast tomosynthesis that was performed on 9/6/16 was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 22-year-old female enrollee has requested authorization and coverage for spine nerve treatment, procedure codes 64634 and 64633. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
, the patient has failed to progress with conservative therapy, injections and physical therapy. Prior treatment with thoracic radiofrequency rhizotomy provided the patient with nine months of pain relief, improved function and the ability to pursue full-time studies as a nursing student. | Overturned | Experimental | Summary Reviewer 1
A 22-year-old female enrollee has requested authorization and coverage for spine nerve treatment, procedure codes 64634 and 64633. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. According to the documentation submitted for review, the patient has failed to progress with conservative therapy, injections and physical therapy. Prior treatment with thoracic radiofrequency rhizotomy provided the patient with nine months of pain relief, improved function and the ability to pursue full-time studies as a nursing student. The available literature indicates that in well-selected patients that respond to thoracic blocks and subsequently radiofrequency treatment, that 6-8 months of analgesia is a positive and favorable response that indicates repeat procedure is indicated. Therefore, spine nerve treatment, procedure codes 64634 and 64633 have been established 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 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.
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A 30-year-old female enrollee has requested reimbursement for the intensive outpatient program (IOP) treatment provided from 5/26/16 through 6/2/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees bulimia nervosa and alcohol abuse.
/16 through 5/27/16. On 5/25/16, the patient was continuing to have thoughts of bingeing and purging. She was also struggling with body dysmorphia in the context of rigid and perfectionistic cognitive schemas which fueled anxiety and guilt-based self-criticality. The patient was absent on 5/24/16 and 5/26/16, but based on the longitudinal illness burden and her clinical status on 5/23/16, it was reasonable to have the patient come in to the program on 5/27/16. On that date, the patient continued to have a reluctance to increasing her dietary choices, and expressed guilt for certain meal selections. However, she was willing to increase her food variety, gain weight and address her food fears. By that date, she was tolerating her meal plan, her weight and appearance were healthy, and there was no mention of alcohol use. She was stable on her medications while her most recent mental status examination was unremarkable and included a euthymic mood with linear thought processing. | Overturned | Medical Necessity | Summary Reviewer
A 30-year-old female enrollee has requested reimbursement for the intensive outpatient program (IOP) treatment provided from 5/26/16 through 6/2/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees bulimia nervosa and alcohol abuse. The physician reviewer found that the records provided for review support the medical necessity of IOP services from 5/26/16 through 5/27/16. On 5/25/16, the patient was continuing to have thoughts of bingeing and purging. She was also struggling with body dysmorphia in the context of rigid and perfectionistic cognitive schemas which fueled anxiety and guilt-based self-criticality. The patient was absent on 5/24/16 and 5/26/16, but based on the longitudinal illness burden and her clinical status on 5/23/16, it was reasonable to have the patient come in to the program on 5/27/16. On that date, the patient continued to have a reluctance to increasing her dietary choices, and expressed guilt for certain meal selections. However, she was willing to increase her food variety, gain weight and address her food fears. By that date, she was tolerating her meal plan, her weight and appearance were healthy, and there was no mention of alcohol use. She was stable on her medications while her most recent mental status examination was unremarkable and included a euthymic mood with linear thought processing. Considering the patients improvement and motivation coupled with a three-month course of specialty care in supervised settings, transition to the outpatient level of care after completing services on 5/27/16 would have been safe, appropriate and consistent with good medical practice. Thus, the services in dispute were medically necessary from 5/26/16 through 5/27/16, but not thereafter. Based on the foregoing discussion, a portion of the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be partially overturned. | 1 |
A 41-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/26/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. | Upheld | Experimental | Summary Reviewer 1
A 41-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma testing performed on 5/26/20. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrolleeas medical condition. The physician reviewer found that the prognosis of cutaneous melanoma has classically been determined by applying the staging system spelled out by Balch. Mitotic index may add to these statistics. An additional methodology in looking at the prognosis is a molecular assay, DecisionDx-Melanoma testing. This looks at the molecular and genetic aspects of an individualas melanoma cells, and then classifies that melanoma based on the five-year risk of metastasis. It is not clear how the five year DecisionDx-Melanoma data compares to the ten-year Balch data. Most importantly, it has not been shown that one can use DecisionDx-Melanoma classification to make clinical decisions. In this case, the fact that the melanoma is greater than 1.0 mm, places it in a category for which sentinel node biopsy is recommended. DecisionDx-Melanoma testing does not add to this decision making. Therefore, DecisionDx-Melanoma testing performed on 5/26/20 was not likely to have been more beneficial than any available standard therapy.
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A 34-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health inpatient services provided from 6/30/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees depression, substance dependence, and suicidality.
Although this patient indicated after detoxification that he would attempt suicide via jumping off a bridge if he were discharged from acute hospital level of care, by 6/30/16 the patient no longer endorsed suicidal ideation and was in no acute distress. The statements made by the patient indicate that he has insight into his substance use disorder and longstanding family conflict. | Upheld | Medical Necessity | Summary Reviewer
A 34-year-old male enrollee has requested reimbursement and prospective authorization and coverage for mental health inpatient services provided from 6/30/16 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees depression, substance dependence, and suicidality. The physician reviewer found that in the medical literature, services are custodial when they do not require continued administration by trained medical personnel. Sharfstein noted that crisis stabilization, safety, and a focus on rapid discharge are the critical components of the acute inpatient stay. Although this patient indicated after detoxification that he would attempt suicide via jumping off a bridge if he were discharged from acute hospital level of care, by 6/30/16 the patient no longer endorsed suicidal ideation and was in no acute distress. The statements made by the patient indicate that he has insight into his substance use disorder and longstanding family conflict. Overall, there is a lack of documentation that the patients needs cannot be met in a less restrictive treatment setting. Accordingly, there is a lack of medical necessity for the 24-hour registered nurse on-site and 24-hour physician on-call services provided by acute inpatient hospital level of care from 6/30/16 forward for treatment of this patients medical condition. Based on these findings, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 44-year-old female enrollee has requested authorization and coverage for HP Acthar Gel 80. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of the enrollees medical condition. | Upheld | Medical Necessity | Summary Reviewer
A 44-year-old female enrollee has requested authorization and coverage for HP Acthar Gel 80. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that there is a lack of support for the requested medication in this clinical setting. There is a lack of randomized, double-blinded, placebo-controlled studies in support of Acthar for systemic lupus erythematosus. The current evidence consists of small reports. The study by Levine involved a small group of patients with myositis that responded favorably to Acthar. Although this is encouraging, it is not conclusive in that group of patients. The study by Fiechtner and Montroy included just ten patients, and patients were followed only over a 28-day period. This is an inadequate study to base approval of this medication for this patient. Pegrams study is inadequate, as it was a retrospective evaluation of four woman with lupus who were followed for 1.5, 3.5, 6 and 9 months each. At this time, the medical necessity of the requested medication has not been established. Therefore, HP Acthar Gel 80 unit/ml vial is not medically necessary for the treatment of this patient. | 1 |
A 63-year-old female enrollee has requested reimbursement for an Anser ADA test performed on 5/12/15. The Health Insurer has denied this request indicating that the procedure at issue was considered investigational for evaluation of the enrollees Crohns disease with ileostomy. | Upheld | Experimental | Summary Reviewer 2
A 63-year-old female enrollee has requested reimbursement for an Anser ADA test performed on 5/12/15. The Health Insurer has denied this request indicating that the procedure at issue was considered investigational for evaluation of the enrollees Crohns disease with ileostomy. The physician reviewer found that the use of Anser ADA has not been clinically proven to improve patient clinical outcomes, and has not definitively demonstrated clinical utility. The effectiveness of Anser ADA compared with conventional courses of action remains unproven. Patients being treated with adalimumab may experience loss of response, but the appropriate method for determination of the cause for loss of response is not clear. The published studies on the use of anti-adalimumab antibodies and serum levels are retrospective and/or observational in nature (Karmiris, et al; Imaeda, et al; Lichtenstein, et al). These small studies at best demonstrated correlations between treatment failure and the presence of anti-adalimumab antibodies, which do not allow firm conclusions regarding cause and effect. The Karmiris study found no direct relationship between trough serum adalimumab concentration or anti-adalimumab antibody and short-term treatment efficacy (Karmiris, et al). Prospective controlled trials providing evidence for the effectiveness of anti-adalimumab antibody testing and serum level testing as part of a clinical management strategy are lacking. Clinical guidelines for management of inflammatory bowel disease do not recommend testing for anti-drug antibody during clinical management (Lichtenstein, et al). A review article reported that the available data do not allow final conclusions about the relevance of anti-adalimumab antibodies to the clinical efficacy of adalimumab, and another concluded that prospective controlled trials are direly needed to investigate the optimal tailored management in individual patients who lose response (Assche, et al; Yanai, et al). All told, the Anser ADA performed on 5/12/15 was investigational for the purpose of evaluating this patients medical condition.
For the reasons set forth above, the procedure 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.
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The patient is a 48-year-old female who had previously undergone augmentation mammoplasty for apparent aesthetic concerns. She is noted to have evidence of bilateral silicone implant rupture, as documented on radiographic studies and confirmed on the operative report dated 12/11/17. The patient has requested reimbursement for removal of mammary implant material provided on 12/11/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
services at issue. The records document ruptured silicone implant. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 48-year-old female who had previously undergone augmentation mammoplasty for apparent aesthetic concerns. She is noted to have evidence of bilateral silicone implant rupture, as documented on radiographic studies and confirmed on the operative report dated 12/11/17. The patient has requested reimbursement for removal of mammary implant material provided on 12/11/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The submitted documentation supports the medical necessity of the services at issue. The records document ruptured silicone implant. The significance of a ruptured silicone implant is not known. Given this uncertainty, the U.S. Food and Drug Administration (FDA) recommends removal of ruptured silicone implants. It is well-known that free silicone can travel to lymph nodes and cause painful nodules. Thus, the services at issue were medically indicated. The fact that the original surgery was done for cosmetic reasons does not change the functional concern associated with ruptured silicone implants. All told, removal of mammary implant material provided on 12/11/17 was medically necessary of the treatment of this patient. Therefore, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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A 66-year-old male enrollee has requested reimbursement for LINX procedure/device performed on 7/27/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has history of belching and heartburn.
, he has gastroesophageal reflux disease (GERD) based on pH recording. | Upheld | Experimental | Summary Reviewer 1
A 66-year-old male enrollee has requested reimbursement for LINX procedure/device performed on 7/27/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollee, who has history of belching and heartburn. The physician reviewer found that in this patients case, he has gastroesophageal reflux disease (GERD) based on pH recording. However, the records indicate that his heartburn has benefited, to a significant degree, from acid suppression treatment and as such cannot be considered medically refractory to acid blocker drugs. Moreover, the patients issues with belching was not eliminated upon LINX placement. Therefore, in this patients case, the LINX procedure/device was not likely to be more beneficial than any available standard therapy for treatment of the patients medical condition. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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patient is a 57-year-old female with a history of chronic back pain, anxiety and hypertension. She presented to her primary care provider on 12/21/20 for a physical examination. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 57-year-old female with a history of chronic back pain, anxiety and hypertension. She presented to her primary care provider on 12/21/20 for a physical examination. The physician reviewer found that the clinical manifestations of vitamin D deficiency depend upon the severity and duration of the deficiency. The majority of patients with moderate to mild vitamin D deficiency are asymptomatic. With severe vitamin D deficiency, there can be hypocalcemia, which leads to bone disorders. Patient groups who are at risk for vitamin D insufficiency include those who have dark skin or are obese, those taking medications that accelerate the metabolism of vitamin D, hospitalized or institutionalized people, and patients who have limited effective sun exposure. Other people at high risk include those with osteoporosis or malabsorption, including inflammatory bowel disease and celiac disease. Screening of the general population is not recommended. Normal-risk adults do not need assessment. In this case, the records did not document any chronic medical conditions that would cause vitamin D deficiency or symptoms associated with vitamin D deficiency. There is a lack of support for the services at issue in this clinical setting. Therefore, vitamin D testing performed on 12/21/20 was not medically necessary for the evaluation of this patient.
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A 32-year-old female enrollee has requested reimbursement for laboratory testing performed on 6/26/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 32-year-old female enrollee has requested reimbursement for laboratory testing performed on 6/26/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that there is extensive literature supporting the services at issue in this clinical setting. The factor V mutation has the potential to induce hypercoagulopathy in the right environment, such as a long airplane flight or automobile trip, as in this patients case. Importantly, prothrombin G20210A mutation adds to this risk, such that compound heterozygous patients can have up to 20-fold increased odds of developing deep vein thrombosis. The testing performed was likely to directly alter the treatment recommendation. If this patient was found to be a carrier of multiple mutations predisposing to thrombosis, then a recurrent thrombotic event could be prevented with drugs and/or activity. Thus, laboratory testing performed on 6/26/19 was likely to have been more beneficial than other methods of evaluating this patient.
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The patient is a 45-year-old female who has been followed for a diagnosis of polymyositis with onset in early 2017. In a letter dated 7/17/20, the provider noted that the patientas disease has been difficult to control due to a poor response to medications and poor tolerance. She is currently on prednisone and intravenous immunoglobulin. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 45-year-old female who has been followed for a diagnosis of polymyositis with onset in early 2017. In a letter dated 7/17/20, the provider noted that the patientas disease has been difficult to control due to a poor response to medications and poor tolerance. She is currently on prednisone and intravenous immunoglobulin. The physician reviewer found that the idiopathic inflammatory myopathies (IIM) are a heterogeneous group of acquired disorders characterized by chronic inflammation of striated muscle leading to predominantly proximal muscle weakness. The most common subsets of IIM include adult polymyositis (PM), adult and juvenile dermatomyositis (DM), myositis in overlap with cancer or another connective tissue disease and inclusion body myositis (IBM). The general clinical consensus among physicians is to use high-dose corticosteroid therapy as the first-line option in patients with myositis. However, several patients discontinue steroid treatment early because of a lack of improvement and/or adverse events. In patients with myositis resistant to conventional treatment, the anti-CD20 monoclonal antibody rituximab is a potential treatment option.
The benefit of rituximab was demonstrated in the study by Oddis and colleagues. This study included 200 patients with polymyositis, dermatomyositis, or juvenile dermatomyositis not controlled by corticosteroids and other immunosuppressive agents. Patients were randomized to receive different regimens of rituximab (two infusions at baseline or 8 weeks later). Although the group treated with rituximab at onset did not improve significantly earlier than the group treated after a delay of 8 weeks (the primary endpoint), the majority of patients (83%) responded to rituximab treatment, and a significant steroid-sparing effect was reported. Fasano and colleagues reviewed 48 studies of refractory myositis patients treated with rituximab. They identified 458 patients with myositis treated with rituximab and found a rate of response to rituximab of 78.3%. They concluded that rituximab can play a role in the management of patients with myositis. In this case, the patient has polymyositis which has been poorly responsive to standard therapy. Based on the studies above, a majority of patients respond favorably to Rituxan and a significant steroid-sparing effect is noted. Therefore, the requested medication is medically necessary for the treatment of the patientas medical condition.
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patient is a 55-year-old female who presented to her provider on 9/12/22. The records noted a
history of post-menopausal osteoporosis. The patient has requested reimbursement for
complement antigen on 9/13/22. The Health Insurer has denied this request and reported that the
service at issue was not medically necessary for the evaluation of this patient.
The records note that
the provider ordered complement levels, C3 and C4, double stranded deoxyribonucleic acid
(dsDNA), | Overturned | Medical Necessity | Summary
The patient is a 55-year-old female who presented to her provider on 9/12/22. The records noted a
history of post-menopausal osteoporosis. The patient has requested reimbursement for
complement antigen on 9/13/22. The Health Insurer has denied this request and reported that the
service at issue was not medically necessary for the evaluation of this patient. This denial is the
subject of this appeal and determination. The physician reviewer found that the submitted
documentation supports the medical necessity of the service at issue. In this case, the blood work
at issue was an array of tests designed to screen for a variety of autoimmune and inflammatory
conditions such as lupus, rheumatoid arthritis, celiac disease, or autoimmune thyroiditis, that could
present with inflammation of the small joints, the PIP and MCP, of the hand. The records note that
the provider ordered complement levels, C3 and C4, double stranded deoxyribonucleic acid
(dsDNA), and a variety of cytoplasmic antigens such as RNP and Smith antigens to complete a
workup for systemic lupus. Given that these tests were required to rule out a diagnosis of systemic
lupus erythematosus, the service at issue was medically indicated. Therefore, complement antigen
on 9/13/22 was medically necessary for the evaluation of this patient.
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A 60-year-old male enrollee has requested reimbursement for inpatient services provided on 2/25/19. 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.
This patient symptomatically improved after treatment in the emergency department with morphine. He was hemodynamically stable, although bleeding from displaced rib
This patient had a traumatic motorcycle injury resulting in five rib fractures on the left and a hemopneumothorax. He had a history of hypertension and pre-diabetes. | Overturned | Medical Necessity | Summary Reviewer
A 60-year-old male enrollee has requested reimbursement for inpatient services provided on 2/25/19. 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 the submitted documentation supports the medical necessity of the services at issue. This patient symptomatically improved after treatment in the emergency department with morphine. He was hemodynamically stable, although bleeding from displaced rib fractures can be delayed. Per the medical evidence, three or more traumatic rib fractures meets criteria for an acute inpatient level of care. This patient had a traumatic motorcycle injury resulting in five rib fractures on the left and a hemopneumothorax. He had a history of hypertension and pre-diabetes. Due to his advanced age, medical comorbidities and the nature of the injury, acute inpatient level of care was appropriate. Therefore, inpatient services provided on 2/25/19 were medically necessary for the treatment of this patient. | 1 |
A 51-year-old female enrollee has requested authorization and coverage for the LINX reflux management system lower esophageal sphincter augmentation. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). | Upheld | Experimental | Summary Reviewer 2
A 51-year-old female enrollee has requested authorization and coverage for the LINX reflux management system lower esophageal sphincter augmentation. The Health Insurer has denied this request indicating that the requested service is considered investigational for treatment of the enrollees gastroesophageal reflux disease (GERD). The physician reviewer found that overall, there is a lack of randomized controlled trials with long-term follow-up demonstrating that LINX is safer or more effective than standard surgical anti-reflux procedures. One evidence review concluded that the long-term safety and efficacy of LINX - both alone and in comparison to current GERD therapies - remains to be determined (Sheu and Rattner). Another best-evidence review concluded that long-term comparative outcome data past one year are needed in order to further understand the efficacy of magnetic sphincter augmentation (Skubleny, et al). Adverse events, such as erosion through the esophagus, have been reported in the period after U.S. Food and Drug Administration (FDA) approval (Bauer, et al). Additionally, LINX more than surgical fundoplication is associated with severe dysphagia requiring endoscopic intervention (Sheu, et al). The currently available peer-reviewed literature does not support the conclusion that LINX is more likely to be beneficial in this case than standard treatment including surgical fundoplication (Sheu, et al). Further, the American College of Gastroenterology (ACG) guidelines for the management of reflux disease also state that more evidence is needed before LINX can be recommended (Katz, et al). For these reasons, the requested LINX reflux management system lower esophageal sphincter augmentation is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested service is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The parent of a 17-year-old female enrollee has requested reimbursement for autonomic testing performed on 8/24/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees chronic fatigue and presumed postural orthostatic tachycardia syndrome (POTS). | Overturned | Experimental | Summary Reviewer 1
The parent of a 17-year-old female enrollee has requested reimbursement for autonomic testing performed on 8/24/15. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees chronic fatigue and presumed postural orthostatic tachycardia syndrome (POTS). The physician reviewer found automatic testing encompasses multiple tests to evaluation autonomic function. Goals include evaluating the severity and distribution of autonomic function, diagnosing limited autonomic neuropathy, diagnosing and evaluating orthostatic intolerance, monitoring the course of dysautonomia, and monitoring response to treatment. Evaluations include tests of sudomotor function, tests of cardiovagal function, and tests of adrenergic function. The role of autonomic testing is to increase sensitivity and specificity in the detection of autonomic failure. The two work hand in glove and each enhances the other (Low, et al).
POTS is defined by a constellation of symptoms, including increase in heart rate of 30 beats per minute (40 for children and teenagers) from supine to standing, worsening symptoms with standing, symptoms lasting more than six months, and absence of other causes of orthostasis. Activities of daily living may exacerbate symptoms, with resulting fatigue. Cardiac complaints are common, such as chest pain and lightheadedness, as are non-cardiac complaints such as nausea, headache, poor sleep, and fatigue. Memory may be affected, as well as attention. Based on this patients clinical presentation, the differential diagnosis of chronic fatigue versus POTS, and need to establish an appropriate recovery plan, autonomic testing was appropriate. For these reasons, the autonomic testing performed on 8/24/15 was likely to be more beneficial for evaluation of the patients medical condition than any other available testing. 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.
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A 30-year-old female enrollee has requested reimbursement for gene expression profiling performed on 6/29/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees malignant melanoma. | Upheld | Experimental | Summary Reviewer 2
A 30-year-old female enrollee has requested reimbursement for gene expression profiling performed on 6/29/16. The Health Plan has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees malignant melanoma. The physician reviewer found the Decision Dx melanoma assay examines genes for certain markers and then the lesion can be further stratified to tell if it is high risk for metastasis. This test has shown some accuracy in thin melanomas. However, the patients treatment would not likely change based on the results of the exam. There is a lack of medical literature to support its use in patients with thin melanomas to effect health outcomes. Given the lack of published data to support the use of gene expression profiling, the testing performed on 6/29/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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A 38-year-old male enrollee has requested authorization and coverage for cardiac resynchronization therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who has a history of sarcoidosis and myocardial involvement. | Upheld | Medical Necessity | Summary Reviewer
A 38-year-old male enrollee has requested authorization and coverage for cardiac resynchronization therapy. The Health Insurer has denied this request indicating that the requested services are not medically necessary for treatment of the enrollee, who has a history of sarcoidosis and myocardial involvement. The physician reviewer found that in patients with cardiac sarcoidosis and ejection fraction greater than 35% who have an indication for pacemaker placement, it is reasonable to implant a defibrillator if meaningful survival of greater than one year is expected, such as with this patient. Since 2:1 atrioventricular block is continuous in this case, the patient will be right ventricular paced about 50% of the time once a pacemaker has been placed, raising a concern for chronic right ventricular pacing induced left ventricular dysfunction. There is some data to demonstrate worsening left ventricular dysfunction as a result of chronic right ventricular pacing, but only in patients with a history of heart failure and ejection fraction less than or equal to 50%, neither of which this patient has. Therefore, given this patients ejection fraction and no documented heart failure, biventricular pacing is not medically necessary. Thus, cardiac resynchronization therapy is not medically necessary 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. | 1 |
A 63-year-old female enrollee has requested reimbursement for breast magnetic resonance imaging (MRI) performed on 3/14/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.
This patient has a very strong family history of breast cancer with a lifetime risk of 26.4%. | Overturned | Experimental | Summary Reviewer 1
A 63-year-old female enrollee has requested reimbursement for breast magnetic resonance imaging (MRI) performed on 3/14/16. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this patients case. This patient has a very strong family history of breast cancer with a lifetime risk of 26.4%. Mammography is a first-line screening tool for breast cancer, but the technique has well-known limitations. In a patient with a lifetime risk exceeding 20-25%, the American Cancer Society has recommended annual MRI exams as an adjunct to mammography due to the increased sensitivity in detecting early cancer. In sum, MRI of the breasts performed on 3/14/16 was likely to have been superior over other methods of evaluating this patient. Based upon the information set forth above, the services at issue were likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 40-year-old female enrollee has requested authorization and coverage for Aimovig. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who has been diagnosed with chronic daily migraine.
This patient has taken several migraine prophylactic medications without success. However, the Health Insurer has requested that the patient fail two medications (for at least two months each) amongst a list of several options. | Upheld | Medical Necessity | Summary Reviewer
A 40-year-old female enrollee has requested authorization and coverage for Aimovig. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who has been diagnosed with chronic daily migraine. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the requested medication. This patient has taken several migraine prophylactic medications without success. However, the Health Insurer has requested that the patient fail two medications (for at least two months each) amongst a list of several options. With regards to these alternatives, the documentation provided shows the patient has failed onabotulinumtoxinA. While there is mention of topiramate in the submitted documentation, there is insufficient information regarding the parameters of this failure, including, but not limited to, length of therapy prior to failure. There is a lack of evidence indicating superiority of Aimovig compared to the alternatives offered by the Health Insurer. All told, Aimovig is not medically necessary for the treatment of this patient. Therefore, the requested medication is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 60-year-old female enrollee has requested authorization and coverage for Harvoni for 12 weeks. The Health Insurer has denied this request indicating that the requested medication quantity is not medically necessary for treatment of the enrollees hepatitis C.
the Health Insurer has offered coverage for Harvoni for eight weeks. | Upheld | Medical Necessity | Summary Reviewer
A 60-year-old female enrollee has requested authorization and coverage for Harvoni for 12 weeks. The Health Insurer has denied this request indicating that the requested medication quantity is not medically necessary for treatment of the enrollees hepatitis C. The physician reviewer found the requested medication quantity is not medically necessary for the treatment of this patient. Per the American Association for the Study of Liver Diseases and Infectious Diseases Society of America guidelines, all patients with chronic active hepatitis C should be treated regardless of fibrosis score. The medical evidence supports treatment in all patients with hepatitis C, except those with limited life expectancy less than 12 months due to non-liver-related comorbid conditions. However, in this patients case, the Health Insurer has offered coverage for Harvoni for eight weeks. Per the medical evidence, since the patients viral load is less than 6,000,000 IU/mL, Harvoni for eight weeks is medically appropriate. Therefore, the requested medication quantity is not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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The parent of a three-year-old female enrollee has requested reimbursement for acute care hospital admission from 7/01/18 through 7/02/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who experienced bleeding following tonsillectomy.
hydration. This patient underwent tonsillectomy, experiencing one episode of post-tonsillectomy bleeding with clot formation. She was referred to the emergency department by the surgeon, and was hemodynamically stable upon presentation. She was admitted, with no further episodes of bleeding. | Upheld | Medical Necessity | Summary Reviewer
The parent of a three-year-old female enrollee has requested reimbursement for acute care hospital admission from 7/01/18 through 7/02/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollee, who experienced bleeding following tonsillectomy. The physician reviewer found that an adenotonsillectomy is a common surgical procedure in children and is considered to be painful, particularly in the early postoperative period. Up to a week postoperative, children continue to complain of significant discomfort. Patients frequently seek out medical attention, with the majority of patients returning during the first postoperative week for evaluation of bleeding, pain, and dehydration. This patient underwent tonsillectomy, experiencing one episode of post-tonsillectomy bleeding with clot formation. She was referred to the emergency department by the surgeon, and was hemodynamically stable upon presentation. She was admitted, with no further episodes of bleeding. While it was reasonable to monitor her in the hospital post-hemorrhage to establish ability to tolerate food and fluids by mouth, to determine adequacy of pain management, and to ensure no further bleeding, she was overall stable and did not require acute inpatient management. She could have been safely managed at a lower level of care, such as observation. Thus, acute care hospital admission from 7/01/18 through 7/02/18 was not medically necessary for the treatment of this patient. Therefore, the services at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/14/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts.T | Overturned | Experimental | Summary Reviewer 1
A 55-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 7/14/16. The Health Insurer has denied this request indicating that the service at issue was considered investigational for evaluation of the enrollee, who was asymptomatic as to her breasts.The physician reviewer found that there is evidence based support for the service at issue in this clinical setting. This tomographic method often allows the reader to separate dense glandular elements from underlying mass/architectural distortion resulting in a decrease in callbacks and biopsies and an increase in detection of small cancers when compared to two dimensional imaging alone. Breast tomosynthesis provides advantages to radiologists interpreting mammograms. Therefore, the addition of digital breast tomosynthesis, to the usual two dimensional protocol was likely to be more effective than had the patients examination been performed using two dimensional imaging alone. Based upon the information set forth above, the service at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned
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A 62-year-old female enrollee has requested authorization and coverage for Lucentis (ranibizumab intravitreal solution pref syr 0.5 mg/0.05 ml). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
records, the patient has macular edema secondary to central retinal vein occlusion. As the patient has central retinal vein occlusion | Overturned | Medical Necessity | Summary Reviewer
A 62-year-old female enrollee has requested authorization and coverage for Lucentis (ranibizumab intravitreal solution pref syr 0.5 mg/0.05 ml). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that the submitted documentation supports the medical necessity of the requested medication. Gerding and colleagues reviewed outcomes studies on the use of ranibizumab and recommended early treatment of macular edema associated with retinal vein occlusion. Other studies have demonstrated that this medication is safe and effective for decreasing macular edema and improving visual acuity compared to the previous standard of care treatment, focal laser treatment. Intravitreal anti-VEGF drugs, such as ranibizumab, are the standard of care treatment for this patients disease. Based on the medical records, the patient has macular edema secondary to central retinal vein occlusion. As the patient has central retinal vein occlusion with macular edema, ranibizumab is an appropriate, clinically effective treatment and is medically necessary. Therefore, Lucentis (ranibizumab intravitreal solution prefilled syringe 0.5 mg/0.05 ml) is medically necessary for the treatment of this patient. | 1 |
A 62-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator performed on 7/25/18, 8/25/18 and 9/25/18. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 62-year-old male enrollee has requested reimbursement for a wearable cardioverter defibrillator performed on 7/25/18, 8/25/18 and 9/25/18. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that the current medical evidence supports the device at issue in this clinical setting. The high risk of sudden cardiac death in patients with severe left ventricular dysfunction has led to the recommendation of implantable cardioverter defibrillators in this group of patients. Current data from multiple trials and registries have advocated the use of a wearable cardioverter defibrillator after an initial diagnosis of severe left ventricular dysfunction (ejection fraction of 35% or less). This patients ejection fraction was 20%. Given the absence of significant coronary obstructive disease at catheterization, a diagnosis of non-ischemic cardiomyopathy was made. Current guidelines recommend against placement of an implantable cardioverter defibrillator within 40 days of an acute myocardial infarction, or within 90 days of an initial diagnosis of congestive heart failure in the presence of a severely depressed ejection fraction. Therefore, a wearable cardioverter defibrillator was appropriate for a period of 90 days (dates of service 7/25/18, 8/25/18 and 9/25/18), given the patients severely depressed ejection fraction. In sum, the wearable cardioverter defibrillator provided on 7/25/18, 8/25/18 and 9/25/18 was not likely to have been of greater benefit than other treatment options.
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A 66-year-old female enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas obstructive sleep apnea.
She has failed continuous positive airway pressure therapy and is not an optimal candidate for oral appliance therapy due to the severity of her obstructive sleep apnea. | Overturned | Experimental | Summary Reviewer 2
A 66-year-old female enrollee has requested authorization and coverage for Inspire upper airway stimulation system. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrolleeas obstructive sleep apnea. The physician reviewer found that there is sufficient support for the requested services in this patientas case. She has failed continuous positive airway pressure therapy and is not an optimal candidate for oral appliance therapy due to the severity of her obstructive sleep apnea. The alternative, no treatment, may lead to potential harms, such as increased medical comorbidities, including hypertension, diabetes, congestive heart failure, myocardial infarction, and stroke. There is sufficient evidence in the peer-reviewed literature to support the safety, efficacy, and long-term outcome in the treatment of obstructive sleep apnea with hypoglossal nerve stimulation or Inspire airway stimulation. Multiple published studies show clinically significant decreases in observed mean apnea-hypopnea index and Epworth Sleepiness Scale scores. The American Academy of Otolaryngology-Head and Neck Surgery considers upper airway stimulation via the hypoglossal nerve for the treatment of adult obstructive sleep apnea syndrome to be a safe and effective second-line treatment of moderate to severe obstructive sleep apnea in patients who are intolerant or unable to achieve benefit with positive pressure therapy. Therefore, Inspire upper airway stimulation system is likely to be more beneficial than any available standard therapy.
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The parent of a 14-year-old male enrollee has requested authorization and coverage for surgery for scoliosis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
The parent of a 14-year-old male enrollee has requested authorization and coverage for surgery for scoliosis. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found that the requested surgery is 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 supporting anterior vertebral body tethering (VBT), which is a fusionless treatment option for management of idiopathic adolescent scoliosis. The study by Samdani and colleagues is a retrospective chart review which evaluated the clinical and radiographic outcomes of anterior VBT at one-year follow-up. The authors concluded that the results indicate that anterior VBT is a safe and potentially effective treatment option for skeletally immature patients with idiopathic scoliosis. These patients experienced an improvement of their scoliosis with minimal major complications. Given the above, surgery for scoliosis is likely to be more beneficial for treatment of thepatients medical condition than any available standard therapy. Based upon the information set forth above, the requested services are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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patient is a 69-year-old male who presented to his provider on 8/5/21. The patient has
requested reimbursement for insertion of multi-component, inflatable penile prosthesis, including
placement of pump cylinders, and reservoir on 3/22/23. The Health Insurer has denied this request
and reported that the service at issue was not medically necessary for the treatment of this patient
and is not reconstructive in nature.
, given that the patient has tried and failed first and second line
therapies for erectile dysfunction, the service at issue was medically | Overturned | Medical Necessity | Summary
The patient is a 69-year-old male who presented to his provider on 8/5/21. The patient has
requested reimbursement for insertion of multi-component, inflatable penile prosthesis, including
placement of pump cylinders, and reservoir on 3/22/23. The Health Insurer has denied this request
and reported that the service at issue was not medically necessary for the treatment of this patient
and is not reconstructive in nature. This denial is the subject of this appeal and determination. The
physician reviewer found that he submitted documentation supports the medical necessity of the
service at issue. The American Urological Association (AUA) guidelines for the treatment of
erectile dysfunction support the placement of a penile prosthesis for the treatment of organic
erectile dysfunction. In this case, given that the patient has tried and failed first and second line
therapies for erectile dysfunction, the service at issue was medically indicated. Therefore, insertion
of multi-component, inflatable penile prosthesis, including placement of pump cylinders, and
reservoir on 3/22/23 was medically necessary for the treatment of this patient. 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. In
this case, the condition was caused by disease, prostate cancer, and its treatment, which disrupted
the nerves responsible for erectile function, resulting in organic erectile dysfunction. The abnormal
nerve function was due to disease, prostate cancer, and its treatment. The service at issue was
meant to improve function by improving organic erectile dysfunction and restored erectile function
for the patient. Therefore, insertion of multi-component, inflatable penile prosthesis, including
placement of pump cylinders, and reservoir on 3/22/23 was reconstructive in nature for treatment
of this patient.
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The parent of a 10-year-old male enrollee has requested reimbursement for the functional neuromuscular electrical stimulator-arms therapy system provided on 4/16/20. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
The parent of a 10-year-old male enrollee has requested reimbursement for the functional neuromuscular electrical stimulator-arms therapy system provided on 4/16/20. The Health Insurer has denied this request and reported that the device at issue was investigational for the treatment of the enrollees medical condition. The physician reviewer found that regardless of the etiology for transverse myelitis, flaccid myelitis and other infectious or post-infectious etiologies for spinal cord injury (SCI), the impact on activities of daily living are profound. These include, but are not limited to, loss of muscle mass, decreased bone density in affected limbs, abnormal blood flow and injuries incurred because of weakness and abnormal sensory input. While there is no currently available therapy to repair or replace affected spinal cord neurons, functional electrical stimulation provides trophic and functional support to muscles and limbs affected by SCI. Furthermore, this type of stimulation and therapy may preserve cortical representations of complex motor activity programs. While functional electrical stimulation cannot replace irrevocably injured or apoptotic spinal cord neurons, it can restore function below the level of injury. Hence, this represents best medical practice to restore/maintain this member's level of neurologic function. Therefore, the functional neuromuscular electrical stimulator-arms therapy system provided on 4/16/20 was likely to have been more beneficial than any available standard therapy.
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patient is a 63-year-old male who was diagnosed in 2015 with mild obstructive sleep apnea with an apnea-hypopnea index of 8 per hour. The patient failed oral appliance treatment. He was recently diagnosed with lung sarcoidosis.
This patient was diagnosed with obstructive sleep apnea by a home sleep study in 2015.
. He failed oral appliance. The patient is symptomatic and has lung sarcoidosis, | Overturned | Medical Necessity | Summary Reviewer
The patient is a 63-year-old male who was diagnosed in 2015 with mild obstructive sleep apnea with an apnea-hypopnea index of 8 per hour. The patient failed oral appliance treatment. He was recently diagnosed with lung sarcoidosis. The physician reviewer found that the submitted documentation supports the requested services in this clinical setting. This patient was diagnosed with obstructive sleep apnea by a home sleep study in 2015. This type of testing can underestimate the severity of the patients disease. He failed oral appliance. The patient is symptomatic and has lung sarcoidosis, which may affect the accuracy of a new home sleep study. Per the records, CPT code 95811 is medically indicated to diagnose and treat this patient appropriately. Therefore, CPT 95811, split night sleep study, is medically necessary for the evaluation of this patient. | 1 |
A 31-year-old male enrollee has requested reimbursement for physical therapy provided from 9/29/17 through 2/23/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees back pain. | Upheld | Medical Necessity | Summary Reviewer
A 31-year-old male enrollee has requested reimbursement for physical therapy provided from 9/29/17 through 2/23/18. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees back pain. The physician reviewer found that soft-tissue and palliative interventions, e.g., self-massage using foam rollers or massage balls, and topical treatments such as ice or heat, during the time period under review. Although the patient had ongoing symptoms, there was no expectation of a marginally significant difference in clinical course or outcomes with the therapies in question over an independent program. Thus, physical therapy provided from 9/29/17 through 2/23/18 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. | 0 |
A 46-year-old female enrollee has requested reimbursement for CPT code 84999 performed on 1/12/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 1
A 46-year-old female enrollee has requested reimbursement for CPT code 84999 performed on 1/12/17. 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 the prognosis for cutaneous melanoma has classically been determined by applying the staging spelled out by Balch. Mitotic index has also been thought to add a bit more to these statistics. By Balch staging, this melanoma would be classified as a T1a (stage 1A), with an expected ten-year survival of at least 88%. DecisionDx is a study of 31 genes in an individuals melanoma cells. It then classifies that melanoma as either Class 1 (with a 90-92% disease-free survival at five years), or Class 2 (with a 48-77% five-year disease-free survival). Gerami reported on 217 cases, with good correlation between prognosis and DecisionDx classification, in patients who had undergone sentinel node biopsy. However, it is not clear how the five-year DecisionDx data compares to the ten-year Balch data, and, most importantly, whether it can be used additionally to make clinical decisions. This is especially true in this patient with an excellent prognosis. At this time, the superior effectiveness of CPT code 84999 performed on 1/12/17 has not been established. 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.
| 0 |
A 68-year-old male enrollee has requested reimbursement for proton beam radiation therapy. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 2
A 68-year-old male enrollee has requested reimbursement for proton beam radiation therapy. The Health Insurer has denied this request indicating that the services at issue were considered investigational for treatment of the enrollees medical condition. The physician reviewer found that the services at issue were not likely to be more effective for this patient than other available options. Protons have been used to treat prostate cancer for last several years. There is some support in the literature for the safety and efficacy of proton beam radiation therapy for prostate cancer. However, there is a lack of randomized trial suggesting superior clinical outcome of proton beam for prostate cancer over intensity-modulated radiation therapy (IMRT). For the reasons provided, the services at issue have not been established as likely to be more beneficial than standard medical therapy. Based upon the information set forth above, the services at issue were not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 0 |
A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Actemra provided from 7/14/15 through 12/15/15 and ongoing. The Health Insurer has denied this request indicating that the medication at issue was and is investigational for the treatment of the enrollees medical condition.
. In this case, the patient has received IVIG, Rituximab and pulse steroids for the treatment of his chronic active AMR which are acceptable treatments. However, the patient did not have plasmapheresis in an attempt to remove the DSAs, the latter probably associated with the AMR. | Upheld | Experimental | Summary Reviewer 2
A 56-year-old male enrollee has requested reimbursement and prospective authorization and coverage for Actemra provided from 7/14/15 through 12/15/15 and ongoing. The Health Insurer has denied this request indicating that the medication at issue was and is investigational for the treatment of the enrollees medical condition. The physician reviewer found that at this time there is an unmet need in the treatment of AMR for renal transplant recipients. In this case, the patient has received IVIG, Rituximab and pulse steroids for the treatment of his chronic active AMR which are acceptable treatments. However, the patient did not have plasmapheresis in an attempt to remove the DSAs, the latter probably associated with the AMR. Plasmapheresis is a standard treatment which is performed in most patients with AMR either alone or in conjunction with the therapies that this patient received. Also, there are several reports in the peer-reviewed literature of other potential therapies such as bortezomib and eculizumab in the treatment of patients with AMR. This patient has not been tried on these therapies. Moreover, there is a lack of studies on the use of tocilizumab in the treatment of AMR, except as an investigational drug. This is not a standard therapy for AMR and has not been recommended by the American Society of Transplantation or received U.S. Food and Drug Administration (FDA) approval for this indication. More randomized controlled trials are required comparing tocilizumab to the currently available anti-AMR therapies. In addition, the patients renal function has been stable and the usage of tocilizumab has not made it better thus far. For the reasons provided, the medication at issue was not and 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 medication at issue was not and 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.
| 1 |
A 60-year-old female enrollee has requested reimbursement for the gene test (gene expression profiling) CPT 84999 performed on 12/29/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 3
A 60-year-old female enrollee has requested reimbursement for the gene test (gene expression profiling) CPT 84999 performed on 12/29/16. The Health Insurer has denied this request indicating that the testing at issue is considered investigational for evaluation of the enrollees melanoma. The physician reviewer found that the gene test (gene expression profiling) CPT 84999 performed on 12/29/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The National Comprehensive Cancer Network (NCCN) guidelines indicate that genetic testing such as the DecisionDx Melanoma Gene assay should not be used outside of a clinical trial setting. The use of this type of testing is not considered to be standard of care in the treatment of the patients melanoma. Thus its usage is not expected to impact the treatment or outcome of the patients melanoma. For the reasons provided, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
The patient is a 57-year-old male with plaque psoriasis and psoriatic arthritis and a history of end
stage renal failure status post kidney transplant. The patient has requested authorization and
coverage for Otezla 30 mg tablets, taken twice daily. The Health Insurer has denied this request
and reported that the requested medication is not medically necessary for the treatment of this
patient.
this case, the patient is out of other treatment options as interleukin-23 (IL-
arthritis, and the records note that the patient has had recurrent infections on other
biologics. Otezla does not carry an infection risk. Given that the patient has failed all other
conventional therapy, has numerous comorbid issues, and as the records document that he has been
stable on the current combination of apremilast and ustekinumab, the | Overturned | Medical Necessity | Summary Reviewer
The patient is a 57-year-old male with plaque psoriasis and psoriatic arthritis and a history of end
stage renal failure status post kidney transplant. The patient has requested authorization and
coverage for Otezla 30 mg tablets, taken twice daily. The Health Insurer has denied this request
and reported 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 physician reviewer found
that the submitted documentation supports the medical necessity of the requested medication.
Takamura and colleagues report that combination therapy of apremilast and biologics could be a
safe, effective option for the management of patients with psoriasis showing biologic fatigue. In
this case, the patient is out of other treatment options as interleukin-23 (IL-23) inhibitors do not
work well for arthritis, and the records note that the patient has had recurrent infections on other
biologics. Otezla does not carry an infection risk. Given that the patient has failed all other
conventional therapy, has numerous comorbid issues, and as the records document that he has been
stable on the current combination of apremilast and ustekinumab, the requested medication is
medically indicated. Therefore, Otezla 30 mg tablets, taken twice daily, are medically necessary
for the treatment of this patient.
| 1 |
A 39-year-old male enrollee has requested authorization and coverage for corticotropin (H.P. Acthar Gel) injections, up to 40 units. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition.
that the patient has been on H.P. Acthar Gel for greater than one year. | Upheld | Experimental | Summary Reviewer 2
A 39-year-old male enrollee has requested authorization and coverage for corticotropin (H.P. Acthar Gel) injections, up to 40 units. The Health Insurer has denied this request indicating that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that the requested medication is not considered the standard of care for this patient. The 2015 American College of Rheumatology (ACR) guidelines recommended methotrexate with or without a tumor necrosis factor inhibitor as the next treatment in those who have failed methotrexate alone. There are also multiple studies demonstrating efficacy and safety of tumor necrosis factor inhibitors in treating moderate to severe rheumatoid arthritis. In this case, there is no documentation of failure of first-line therapy as recommended by the ACR or contraindication to such trials. There is evidence that a second tumor necrosis factor inhibitor is effective in those who have tried and failed a previous tumor necrosis factor inhibitor or have had adverse reactions to another tumor necrosis factor inhibitor. There is a lack of support for the use of corticotropin (H.P. Acthar Gel) injections in this clinical setting. The medical records note that the patient has been on H.P. Acthar Gel for greater than one year. Use beyond an acute exacerbation is not within the U.S. Food and Drug Administration (FDA) indication. In sum, corticotropin (H.P. Acthar Gel) injections, up to 40 units is not likely to be more beneficial than other available treatment options.
| 1 |
The patient is a 44-year-old transgender male who has documented gender dysphoria. The patient has requested authorization and coverage for CPT codes 15734 (muscle, myocutaneous, or fasciocutaneous flap; trunk), 54660 (insertion of testicular prosthesis), 55180 (scrotoplasty; complicated) and 14040 (adjacent tissue transfer or rearrangement, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; defect 10 square cm or less). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 44-year-old transgender male who has documented gender dysphoria. The patient has requested authorization and coverage for CPT codes 15734 (muscle, myocutaneous, or fasciocutaneous flap; trunk), 54660 (insertion of testicular prosthesis), 55180 (scrotoplasty; complicated) and 14040 (adjacent tissue transfer or rearrangement, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; defect 10 square cm or less). The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. The physician reviewer found that World Professional Association for Transgender Health (WPATH) states that scrotoplasty and testicular implants, as well as phalloplasty in general, are medically necessary treatments for gender dysphoria. WPATHas position statement notes, aIn addition to hormonal balancing, medically necessary gender affirming/confirming surgical procedures are described in section XI of the standards of care. These procedures include complete hysterectomy, bilateral mastectomy, chest reconstruction or augmentation as appropriate to each patient, including nipple resizing or placement of breast prostheses, as necessary; genital reconstruction by various techniques which must be appropriate to each patient, including, for example, skin flap hair removal, scrotoplasty, and penile and testicular prostheses, as necessary; facial hair removal, certain facial plastic reconstruction, voice therapy and/or surgery, and gender affirming counseling or psychotherapeutic treatment, as appropriate to the patient.a Coleman and colleagues noted that for treatment of gender dysphoria, phalloplasty includes, aa pedicled or free vascularized flap, vaginectomy, scrotoplasty, and implantation of erection and/or testicular prostheses.a The current medical evidence supports the requested services in this clinical setting. Therefore, CPT codes 15734 (muscle, myocutaneous, or fasciocutaneous flap; trunk), 54660 (insertion of testicular prosthesis), 55180 (scrotoplasty; complicated) and 14040 (adjacent tissue transfer or rearrangement, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; defect 10 square cm or less) are medically necessary for the treatment of this patient. | 1 |
The parent of a 12-year-old male enrollee has requested authorization and coverage for Otezla (Apremilast Tab Starter Therapy Pack 10 MG & 20 MG & 30 MG). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition.
This patient has been diagnosed with post-infectious encephalopathy and has a history of recurrent infections that have | Overturned | Medical Necessity | Summary Reviewer
The parent of a 12-year-old male enrollee has requested authorization and coverage for Otezla (Apremilast Tab Starter Therapy Pack 10 MG & 20 MG & 30 MG). The Health Insurer has denied this request and reported that the requested medication is not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that Apremilast is a phosphodiesterase-4 inhibitor that has been U.S. Food and Drug Administration (FDA) approved for the treatment of psoriatic arthritis. It targets the inflammatory cascade at an earlier point in time to have a broader pro-inflammatory response target. This medication has a low side effect profile and is well-tolerated by patients. It is particularly useful for patients who have failed other treatments because of side effects or lack of efficacy. It has been successfully used in adolescents, but is not yet FDA approved for that population. The problem with tumor necrosis factor inhibitor medications, such as Enbrel and Humira, is that patients are at significant risk of infection. Those particularly susceptible are individuals with chronic or recurrent infections. This patient has been diagnosed with post-infectious encephalopathy and has a history of recurrent infections that have exacerbated his neuropsychiatric symptoms. In this particular case, use of apremilast is medically necessary and appropriate. Therefore, Otezla (apremilast tablets starter therapy pack 10 mg and 20 mg and 30 mg) is medically necessary for the treatment of this patient. | 1 |
A 56-year-old male enrollee has requested reimbursement for ipilimumab (J9228) and pembrolizumab (J9271) injections administered on 7/19/16 and 9/13/16. The Health Insurer has denied this request indicating that the medications at issue were not medically necessary for treatment of the enrollees prostate cancer. | Upheld | Medical Necessity | Summary Reviewer
A 56-year-old male enrollee has requested reimbursement for ipilimumab (J9228) and pembrolizumab (J9271) injections administered on 7/19/16 and 9/13/16. The Health Insurer has denied this request indicating that the medications at issue were not medically necessary for treatment of the enrollees prostate cancer. The physician reviewer found that there is a lack of support in the medical literature for the medications at issue used in this clinical setting. Ipilimumab and pembrolizumab are not considered a standard treatment for prostate cancer either systemically or as localized therapy. They are not U.S. Food and Drug Administration approved and are not supported by major drug compendia or the medical literature. Yervoy and Keytruda are the ongoing subject of clinical trials that have not yet reached beyond phase I and II trials. As such, ipilimumab (J9228) and pembrolizumab (J9271) injections administered on 7/19/16 and 9/13/16 were not medically necessary for the treatment of this patients medical condition. Therefore, based on the above, the medications at issue were not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
A 57-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI). The Health Insurer has denied this request indicating that the requested service is not medically necessary for evaluation of the enrollees left-sided back pain. | Upheld | Medical Necessity | Summary Reviewer
A 57-year-old male enrollee has requested authorization and coverage for magnetic resonance imaging (MRI). The Health Insurer has denied this request indicating that the requested service is not medically necessary for evaluation of the enrollees left-sided back pain. The physician reviewer found that based on the findings on the 1/24/17, a repeat MRI is not medically necessary for further evaluation of this patients medical condition. If the first MRI study was inadequate due to motion, a repeat limited examination should have been performed at the original facility. However, the records provided for review do not demonstrate that the initial MRI study was inadequate as there is no description of artifact or inadequate imaging by the interpreting provider. Thus, the requested MRI is not supported as medically necessary. Based on the foregoing, the requested service is not medically necessary for evaluation of the patients medical condition. The Health Insurers denial should be upheld. | 1 |
The patient is a 55-year-old male who initially presented with sudden sensorineural hearing loss. Subsequently, he was diagnosed with autoimmune hearing loss. He has experienced fluctuating high frequency hearing loss, tinnitus, hyperacusis, and vertigo. He has been treated with prednisone since August 2017, has been treated successfully with intratympanic Simponi 50 injections. The patient has requested authorization and coverage for Simponi 50 mg injections once per month for one year (J1602). The Health Insurer has denied this request indicating that the requested medication is considered investigational. Simponi has been
. In addition, this patient has experienced positive response to prior treatment with Simponi. | Upheld | Experimental | Summary Reviewer 3
The patient is a 55-year-old male who initially presented with sudden sensorineural hearing loss. Subsequently, he was diagnosed with autoimmune hearing loss. He has experienced fluctuating high frequency hearing loss, tinnitus, hyperacusis, and vertigo. He has been treated with prednisone since August 2017, has been treated successfully with intratympanic Simponi 50 injections. The patient has requested authorization and coverage for Simponi 50 mg injections once per month for one year (J1602). The Health Insurer has denied this request indicating that the requested medication is considered investigational. Simponi has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis. Autoimmune inner ear disorder is one of a few types of sensorineural hearing loss that is treatable and potentially reversible. Treatment involves oral steroids and methotrexate, as well as other treatment modalities with variable success rates. These treatments are systemic, with inherent side effects limiting their effectiveness. Recently, tumor necrosis factor (TNF) alpha blockers have been suggested as a modality of treatment. In one study, Simponi stabilized hearing in three of seven per-protocol patients with autoimmune hearing loss and allowed a complete tapering off of prednisone in those patients. In addition, this patient has experienced positive response to prior treatment with Simponi. Accordingly, the requested Simponi 50 mg injections once per month for one year (J1602) are likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the requested 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.
| 1 |
A 38-year-old male enrollee has requested authorization and coverage for chemotherapy administration into the peritoneal cavity via indwelling port or catheter (hyperthermic intraperitoneal chemotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 1
A 38-year-old male enrollee has requested authorization and coverage for chemotherapy administration into the peritoneal cavity via indwelling port or catheter (hyperthermic intraperitoneal chemotherapy. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees medical condition. The physician reviewer found the use of hyperthermic intraperitoneal chemotherapy for peritoneal carcinomatosis for colon cancer remains controversial. It is suspected that about 25% of patients with metastatic colorectal cancer have disease limited to the peritoneal cavity and that perhaps this represents a different entity than metastatic disease involving the liver and lungs. Studies suggest a benefit from hyperthermic intraperitoneal chemotherapy in carefully selected patients. However, standard use remains the subject of ongoing clinical trials. At this time, there is a need for randomized clinical trials addressing the risks and benefits associated with this modality. At this time, the use of hyperthermic intraperitoneal chemotherapy has not been shown to be superior to standard chemotherapies for colorectal cancer. All told, the requested services are not likely to be superior over other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
| 1 |
A 61-year-old male enrollee has requested reimbursement for gene expression profiling performed on 5/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 2
A 61-year-old male enrollee has requested reimbursement for gene expression profiling performed on 5/10/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the medical evidence supports the services at issue in this clinical setting. The CxBladder test is used to rule out bladder cancer in patients with hematuria as a complement to cystoscopy. Lotan and colleagues performed a study of 803 patients undergoing surveillance for bladder cancer. The authors noted that CxBladder test had superior sensitivity and a negative predictive value compared with cytology, NMP22, and UroVysion. The use of CxBladder can potentially reduce the need for invasive diagnostic testing. All told, gene expression profiling performed on 5/10/19 was likely to have been more beneficial than other methods of evaluating this patient.
| 0 |
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 12/18/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.T
. However, the records noted a cyst which had increased in size from the 1.5 cm that was previously noted in 2009, to a size approaching 5 cm. | Overturned | Experimental | Summary Reviewer 3
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 12/18/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.The physician reviewer found breast tomosynthesis is a technique that was developed several years ago as a problem solving adjunct to routine mammography. Applying the same basic concept as computed tomography (CT) scanning, the logic is that by separating the various layers of breast tissue, one can better detect abnormalities. This has been shown to be most useful in the evaluation of dense breasts. In this case, the patients breasts were not particularly dense. However, the records noted a cyst which had increased in size from the 1.5 cm that was previously noted in 2009, to a size approaching 5 cm. The significant increase in size is concerning, and on occasion, breast tomosynthesis will provide significant information in terms of the contour or margination of a mass. The increase in size is a reasonable indication for breast tomosynthesis. 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.
| 1 |
A 56-year-old female enrollee has requested authorization and coverage for Vemlidy. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for treatment of the enrollees hepatitis B. | Overturned | Medical Necessity | Summary Reviewer
A 56-year-old female enrollee has requested authorization and coverage for Vemlidy. The Health Insurer has denied this request and reported that the requested medication is not medically necessary for treatment of the enrollees hepatitis B. The physician reviewer found that the guidlines for the treatment of hepatitis B from the American Association for the Study of Liver Disease (AASLD) recommend entecavir and tenofovir compared with alternatives for the treatment of chronic hepatitis B. In comparison with tenofovir disoproxil fumarate (Viread), which the patient is taking, the Vemlidy formulation of tenofovir is effective for hepatitis B, but is associated with lower incidence of side effects such as osteopenia and renal disease. For this reason, Vemlidy 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. | 1 |
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 12/18/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 54-year-old female enrollee has requested reimbursement for digital breast tomosynthesis performed on 12/18/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. The physician reviewer found the current medical evidence supports the services at issue in this patients case. According to Skaane and colleagues, the use of mammography plus tomosynthesis in a screening environment resulted in a significantly higher cancer detection rate and enabled the detection of more invasive cancers. Ciatto and colleagues noted that integrated two-dimensional and three-dimensional mammography improves breast cancer detection and has the potential to reduce false positive recalls. Thus, the medical literature supports the use of breast tomosynthesis over conventional mammogram due to improved cancer detection rate. In sum, digital breast tomosynthesis performed on 12/18/15 was likely to have been superior over other modalities. 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.
| 1 |
A 57-year-old female enrollee has requested reimbursement for partial hospitalization from 8/4/16 through 8/17/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition.
the treatment team recommended continued treatment at the partial hospital level of care. The treatment team noted that the patient did not command the skills needed to maintain weight and function with full autonomy in the outpatient setting.
. On 8/4/16, the patient was demonstrating rigidity regarding her meal plan. She took small bites and took five minutes to finish the final bites of a sandwich. She was passive-aggressive in her attempts to bypass programmatic procedures and became irritated when called out. On 8/6/16, her anxiety spiked upon learning that her daughter had attempted suicide. On 8/8/16, she became panicked after the sensation of having food stuck in her esophagus, and was unable to eat afterwards. On 8/9/16, the patient reported more intense urges to exercise and restrict her diet. Additionally, the patients serotonergic medication was changed and benzodiazepine was reduced, while gabapentin, trazodone and atenolol were added. Considering | Overturned | Medical Necessity | Summary Reviewer
A 57-year-old female enrollee has requested reimbursement for partial hospitalization from 8/4/16 through 8/17/16. The Health Insurer has denied this request indicating that the services at issue were not medically necessary for treatment of the enrollees behavioral health condition. The physician reviewer found that there is sufficient support in the medical literature for the services at issue in this clinical setting. In general, community intervention settings offer optimization of treatment gains. However, transient placement in more restrictive settings is often clinically appropriate, as in this patients case. In this particular case, the treatment team recommended continued treatment at the partial hospital level of care. The treatment team noted that the patient did not command the skills needed to maintain weight and function with full autonomy in the outpatient setting. The treating team justified their determination within context of the partial hospital level of care guidelines developed by the American Psychiatric Association. Factors that warrant partial placement based on the assessment included patient status and environmental support, psychiatric comorbidity, preoccupation with intrusive repetitive thoughts, and the need for structure to help with weight management and dietary habits. On 8/4/16, the patient was demonstrating rigidity regarding her meal plan. She took small bites and took five minutes to finish the final bites of a sandwich. She was passive-aggressive in her attempts to bypass programmatic procedures and became irritated when called out. On 8/6/16, her anxiety spiked upon learning that her daughter had attempted suicide. On 8/8/16, she became panicked after the sensation of having food stuck in her esophagus, and was unable to eat afterwards. On 8/9/16, the patient reported more intense urges to exercise and restrict her diet. Additionally, the patients serotonergic medication was changed and benzodiazepine was reduced, while gabapentin, trazodone and atenolol were added. Considering these factors, the patient had not consolidated the treatment gains necessary to follow a meal plan and maintain a healthy weight in a less restrictive setting. She was at risk for undue morbidity and admission to a higher level of care in the absence of partial hospitalization. The setting was safe, appropriate and consistent with good medical practice. The patient received services that were reasonably expected to improve her condition and prevent a more serious episode of illness. As such, the services at issue from 8/4/16 through 8/17/16 were consistent with community standards and afforded opportunity for aggressive medication changes and arrangement of comprehensive aftercare in her community. Therefore, for the reasons stated above, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
| 1 |
A 48-year-old female enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation from 11/23/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions. | Upheld | Medical Necessity | Summary Reviewer
A 48-year-old female enrollee has requested reimbursement and prospective authorization and coverage for transcranial magnetic stimulation from 11/23/15 forward. The Health Insurer has denied this request indicating that the services at issue were not and are not medically necessary for treatment of the enrollees behavioral health conditions. The physician reviewer found that the submitted documentation fails to demonstrate the medical necessity of the services at issue. First, the clinical record indicates diagnoses of posttraumatic stress disorder and bipolar disorder. Transcranial magnetic stimulation is not indicated for these conditions. Additionally, for those with unilateral depressive illness, the safety and utility of long-term and/or maintenance treatment with transcranial magnetic stimulation has not yet been established by the scientific community. Although the American Psychiatric Association Practice Guideline for depression endorses transcranial magnetic stimulation for the acute phase treatment of major depressive disorder, it has not yet been endorsed for maintenance treatment or long-term therapy. There are a few small studies which demonstrate positivism for maintenance therapy. However, the statistical power and study designs render the findings inadequate to define definitive recommendations regarding the long-term use of the intervention at this time. All told, transcranial magnetic stimulation from 11/23/15 forward was not and is not medically indicated for the treatment of this patient. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy. | Upheld | Experimental | Summary Reviewer 1
A 62-year-old male enrollee has requested reimbursement for the Life Vest provided from 6/10/15 through 7/10/15. The Health Insurer has denied this request indicating that the device at issue was considered investigational for treatment of the enrollees dilated cardiomyopathy. The physician reviewer found that in selected patients with severe but potentially reversible cardiomyopathy, such as tachycardia or myocarditis associated cardiomyopathy, a wearable cardioverter defibrillator may be indicated. There is adequate data demonstrating the wearable cardioverter defibrillator may be useful for the prevention of sudden cardiac death due to ventricular arrhythmias while awaiting improvement in left ventricular function, implantable cardioverter defibrillator implantation, or if needed, cardiac transplantation. Given this patients severe left ventricular dysfunction and non-sustained ventricular tachycardia, it was reasonable to place the Life Vest while awaiting the recovery of the heart function. Thus, the Life Vest provided from 6/10/15 through 7/10/15 was likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, I have determined the device 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.
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The patient is a 20-year-old male with a history of opioid use disorder, amphetamine use disorder, sedative, hypnotic, or anxiolytic use disorder, major depressive disorder, and generalized anxiety disorder. The patients onset of substance use was at age 15 with opiates, benzodiazepines, cannabis, and amphetamines. He has a history of two prior residential admissions and an intensive outpatient program, which were quickly followed by relapse upon discharge. Prior to the admission in question, the patient reported using half a gram of heroin and unknown amount of cannabis daily for three to four months. He was admitted to a residential treatment program on 4/25/17 and discharged on 7/24/17. During admission, the patient participated in individual, group, family therapy and medication management. The patient has requested reimbursement for substance abuse residential treatment provided from 5/22/17 through 7/24/17. The Health Insurer denied this request and reported that the services at issue were not medically necessary for treatment of this patients medical condition.
by 5/22/17, the patient still remained symptomatic. The patient was documented as having strong urges to use, irritability, daily mood swings, anxiety, restlessness, and difficulty with sleep. He was described as being somewhat disengaged in the program. The patient was noted to have limited education and was homeless due to being kicked out of his sober living house. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 20-year-old male with a history of opioid use disorder, amphetamine use disorder, sedative, hypnotic, or anxiolytic use disorder, major depressive disorder, and generalized anxiety disorder. The patients onset of substance use was at age 15 with opiates, benzodiazepines, cannabis, and amphetamines. He has a history of two prior residential admissions and an intensive outpatient program, which were quickly followed by relapse upon discharge. Prior to the admission in question, the patient reported using half a gram of heroin and unknown amount of cannabis daily for three to four months. He was admitted to a residential treatment program on 4/25/17 and discharged on 7/24/17. During admission, the patient participated in individual, group, family therapy and medication management. The patient has requested reimbursement for substance abuse residential treatment provided from 5/22/17 through 7/24/17. The Health Insurer denied this request and reported that the services at issue were not medically necessary for treatment of this patients medical condition. This denial is the subject of this appeal and determination. The submitted documentation supports the services at issue in this clinical setting. Per the provided documentation, by 5/22/17, the patient still remained symptomatic. The patient was documented as having strong urges to use, irritability, daily mood swings, anxiety, restlessness, and difficulty with sleep. He was described as being somewhat disengaged in the program. The patient was noted to have limited education and was homeless due to being kicked out of his sober living house. The American Society of Addiction Medication (ASAM) Criteria, a set of objective guidelines used by clinicians to assist with treatment planning, advocates for service intensity provided in the least intensive environment but safe treatment setting (Mee-Lee and Shulman). The guidelines also recommend that length of service should be determined by the patients progress with his treatment plan as determined by the patient and treatment providers. The medical research indicate that individuals with substance use disorders often need longer term care due to the relapsing and chronic nature of the disorders (Manuel, 2017). By 5/22/17, this patients records did not demonstrate that he was ready to be discharged to a lower level of care. Residential substance abuse treatment has been shown to improve substance use outcomes (Manuel, et al, 2017). Based on current medical literature, ASAM criteria, and the patients documented clinical history, this patients admission to the residential level of care from 5/22/17 through 7/24/17 was medically necessary (Mee-Lee and Shulman; Ali et al; Gray and Squeglia; Manuel, et al).
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The patient is a 62-year-old female with a diagnosis of generalized anxiety disorder per the submitted documentation. The patient described her condition as complex trauma. It appears that the patient has been working with a therapist in the outpatient setting. The trauma history, longitudinal illness
medical records. The patient has requested reimbursement and prospective authorization and coverage for standard outpatient treatment two times per week from 9/05/17 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of this patient. The Health Insurer has approved standard outpatient treatment once per week from 9/05/17 forward as an alternative. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 62-year-old female with a diagnosis of generalized anxiety disorder per the submitted documentation. The patient described her condition as complex trauma. It appears that the patient has been working with a therapist in the outpatient setting. The trauma history, longitudinal illness burden, and extent and outcome of previous and/or concurrent treatment interventions were not included in the medical records. The patient has requested reimbursement and prospective authorization and coverage for standard outpatient treatment two times per week from 9/05/17 forward. The Health Insurer has denied this request and reported that the services at issue were not and are not medically necessary for the treatment of this patient. The Health Insurer has approved standard outpatient treatment once per week from 9/05/17 forward as an alternative. This denial is the subject of this appeal and determination. Psychotherapeutically, current practice emphasizes aggressive treatment of psychiatric symptoms in the acute phase of illness followed by less frequent services in the maintenance phase to foster patient autonomy and consolidate recovery. Thus, it is not uncommon for transient weekly, or even twice- and thrice-weekly, sessions to be medically necessary in the treatment of anxiety and trauma-related disorders. The contemporary treatment armamentarium for both conditions offers many different evidence-based psychotherapies, such as cognitive processing therapy, prolonged exposure, eye movement desensitization and reprocessing, cognitive behavioral therapy, psychodynamic psychotherapy, mindfulness training and interpersonal therapy. Regardless of the modality, any therapy must be reevaluated for effectiveness and goal progression during protracted treatment courses. With that in mind, the documentation provided in this particular case lacks critical clinical input to support the requested services. Most notably absent is a comprehensive treatment plan. An individualized and up-to-date treatment plan is a crucial patient-centric document that develops and organizes interventions aimed at maximizing functionality as well as helping a patient set specific goals and measurable objectives appropriate to his or her impairments and symptom severity. Based on the documentation provided, there is no evidence that less frequent clinical services, perhaps augmented with self-help programming and sub-clinical activities in the community, would be inadequate or unsafe to treat the patients condition. Further, weekly therapy visits align with community practice standards. Accordingly, standard outpatient treatment two times per week from 9/05/17 forward were not and are not medically necessary for the treatment of this patient. Therefore, the services at issue were not and are not medically necessary for treatment of the patients medical condition. The Health Insurers denial should be upheld.
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A 21-year-old male enrollee has requested reimbursement for a PET scan performed on 7/23/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 21-year-old male enrollee has requested reimbursement for a PET scan performed on 7/23/19. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that the records document the rare situation of a high grade soft tissue sarcoma of the heart in a young patient. There is a lack of specific guidelines as to the best way to follow him to detect recurrence. However, there is some literature concerning the use of positron emission tomography (PET) scanning in the follow-up of high grade sarcomas in general. Pastorini and colleagues concluded that PET scan is indeed useful, although Roberge and colleagues cast some doubt on the routine use of PET. Thus, it remains somewhat controversial. However, in this rare circumstance of a very high grade sarcoma in a young patient, PET was likely to have been of benefit to detect and/or rule out recurrent disease. Therefore, PET scan performed on 7/23/19 was likely to have been more beneficial than other methods of evaluating this patient.
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The patient is a 51-year-old female with neck pain. The patient has requested authorization and
coverage for insertion of a biomechanical device (PEEK cage). | Upheld | Medical Necessity | Summary Reviewer
The patient is a 51-year-old female with neck pain. The patient has requested authorization and
coverage for insertion of a biomechanical device (PEEK cage). The physician reviewer found that
anterior cervical discectomy and fusion is one of the most common surgical procedures
performed by the spine surgeon. It is used to treat cervical stenosis causing radiculopathy,
myelopathy, or both. The gold standard substance used to place in the disc space for arthrodesis
is iliac crest autograft. Due to the morbidity associated with collected iliac crest bone graft,
alternatives have been sought. Structural allograft and synthetic cages made of PEEK, titanium,
or other substances have been used widely. There is a paucity of evidence supporting the efficacy
of synthetic cages and their superiority over allograft. Moo and colleagues evaluated their 88
patient cohort comparing three-year follow up results for two-level anterior cervical discectomy
and fusion in whom allograft or synthetic cages were used. Although similar clinical outcomes
were achieved, subsidence rates were meaningfully higher in the synthetic cage group. Marrache
and colleagues evaluated private claims data in 26,754 patients who underwent anterior cervical
discectomy and fusion to study allograft versus synthetic cages (PEEK). There were no meaningful
differences in complication rates acutely. During a two-year follow-up period, synthetic cages
resulted in a significantly higher all cause reoperation rates versus allograft. Menon and
colleagues retrospectively reviewed a national research database of over 6,500 patients who
underwent anterior cervical discectomy and fusion with either allograft or synthetic cages. For
single level surgery, results were similar. However, revision surgery was significantly more
frequent in multilevel surgery where synthetic cages were used. Teton and colleagues sought to
evaluate pseudoarthrosis rates in their 81 patient series to compare allograft versus synthetic
cages (PEEK). They identified significantly higher rates of symptomatic pseudoarthrosis rates in
single level anterior cervical discectomy and fusion patients with synthetic cages. Buyuk and
colleagues reviewed over 200 patients who underwent one and two-level anterior cervical
discectomy and fusion using either structural allograft or synthetic cages (PEEK). Although
subsidence rates were similar, rates of symptomatic pseudoarthrosis were higher with synthetic
cages, although not statistically significant. Ryu and colleagues reviewed prospectively collected
data from 194 patients who underwent one up to three level anterior cervical discectomy and
fusion surgeries to compare outcomes with structural allograft and synthetic cages (PEEK). In
patients for whom synthetic cages were utilized, radiographic non-union rates were higher, and
in patients with multilevel surgeries, the risk of non-union was 5.8 times higher than with
structural allograft. Pirkle and colleagues performed a retrospective database review of a
national health plan database. They evaluated over 6,130 patients operated upon to compare
outcomes of structural allograft and synthetic cages used for anterior cervical discectomy and
fusion surgery. Non-union rates were significantly higher in patients in whom cages were used,
even when confounders were controlled (5.32% versus 1.97%). The authors concluded that
allograft was likely superior to synthetic cages for anterior cervical discectomy and fusion. Based
on the current medical evidence, the requested insertion of PEEK cage is not medically necessary
in the treatment of this patient in order to perform a three-level anterior cervical discectomy and
fusion. Therefore, the requested insertion of a biomechanical device (PEEK cage) is not medically
necessary for the treatment of this patient. | 1 |
The patient is a 52-year-old male who presented to his provider on 12/27/21. The records noted
sleep apnea diagnosed by sleep study in June 2021 and an apnea-hypopnea index (AHI) of 64. The
patient has requested authorization and coverage for hypoglossal nerve stimulation. The Health
Insurer has denied this request and reported that the requested service is not medically necessary
for the treatment of this patient.
of the device, at the time of FDA
approval, had noted that | Upheld | Medical Necessity | Summary Reviewer
The patient is a 52-year-old male who presented to his provider on 12/27/21. The records noted
sleep apnea diagnosed by sleep study in June 2021 and an apnea-hypopnea index (AHI) of 64. The
patient has requested authorization and coverage for hypoglossal nerve stimulation. The Health
Insurer has denied this request and reported that the requested service is not medically necessary
for the treatment of this patient. This denial is the subject of this appeal and determination. The
physician reviewer found that the submitted documentation does not support the medical necessity
of the requested service. The U.S. Food and Drug Administration (FDA) approves the use of the
Inspire Upper Airway Stimulator for the management of moderate to severe obstructive sleep
apnea, for patients with AHI greater than 15, aged 18 year and older, with an inability to tolerate
positive airway pressure (PAP) therapy. The manufacturer of the device, at the time of FDA
approval, had noted that this device had not been thoroughly tested in individuals with a BMI over
32 kg/m2. While the FDA approval does not exclude obese patients, current medical literature
includes only one study evaluating the Inspire implant in obese patients. Huntley and colleagues
concluded that there was no difference in patients with BMI above or below 32 kg/m2 in response
to the Inspire implant. However, there is a lack of other studies to support these findings of safety
in this population. A surgical assessment, performed via a drug induced sleep endoscopy (DISE),
did confirm anatomic findings which would be favorable and amenable to response from the
Inspire implant. In this case, while the patient meets a majority of criteria for the requested service,
including being over age 18, with anatomic findings on DISE amenable to Inspire treatment, an
inability to tolerate PAP therapy, and a diagnosis of severe obstructive sleep apnea, the patient has
a BMI of approximately 35 kg/m2. In this clinical setting, given that the patients BMI makes him
a poor candidate for surgical intervention based on the current available literature, the requested
service is not medically indicated. Therefore, hypoglossal nerve stimulation is not medically
necessary for the treatment of this patient.
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A 43-year-old male enrollee has requested reimbursement for injection(s), platelet rich plasma,
any site, including image guidance, harvesting, and preparation when performed, on 3/7/22. The
Health Insurer has denied this request and reported that the service at issue was investigational
for the treatment of the enrollees left elbow pain and bicipital tendinitis of the left shoulder.
. In fact, in a
follow-up visit dated 4/30/22, the records noted no significant improvement of pain post
injection and the provider recommended a functional assessment with physical therapy. Notes
dated 6/13/22 reported that the physical therapy program provided addressed specific
musculoskeletal dynamics along with the provision of a home program. | Upheld | Experimental | Summary Reviewer 2
A 43-year-old male enrollee has requested reimbursement for injection(s), platelet rich plasma,
any site, including image guidance, harvesting, and preparation when performed, on 3/7/22. The
Health Insurer has denied this request and reported that the service at issue was investigational
for the treatment of the enrollees left elbow pain and bicipital tendinitis of the left shoulder. The
physician reviewer found that in this clinical setting, the PRP injection at issue was not likely to have been more beneficial than standard therapy with a physical therapy program. In fact, in a
follow-up visit dated 4/30/22, the records noted no significant improvement of pain post
injection and the provider recommended a functional assessment with physical therapy. Notes
dated 6/13/22 reported that the physical therapy program provided addressed specific
musculoskeletal dynamics along with the provision of a home program. Case reports on the use
of PRP injections for tendinitis generally show resolution of symptoms over time, however, the
reported outcomes do not state that the injections treated the primary etiology of the
tendinopathies. Rather, there is an association inferred between the time of injections and
reported symptom relief. There are no current guidelines regarding the use of PRP injections for
tendinopathies. In a review of current literature on PRP for elbow pathologies, Kwapisz and
colleagues report that their results showed that more studies on larger cohorts, with comparable
formulations, and with longer follow-up are required to give optimal suggestions concerning the
use of PRP in elbow pathologies. More research is needed regarding the indications, efficacy,
post injection therapy services, and specific techniques of harvest and delivery of the service at
issue. Therefore, injection(s), PRP, any site, including image guidance, harvesting, and
preparation when performed, on 3/7/22, was not likely to have been more beneficial for
treatment of the patients condition than any available standard therapy.
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A 57-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 8/17/17. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees melanoma. | Upheld | Experimental | Summary Reviewer 3
A 57-year-old male enrollee has requested reimbursement for DecisionDx-Melanoma test performed on 8/17/17. 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 there is a lack of support for the services at issue in this patients case. DecisionDx-Melanoma is a 31-gene expression profile test for predicting the risk of recurrence of skin melanoma. The National Comprehensive Cancer Network guidelines note that while there is interest in newer prognostic molecular techniques, such as gene expression profiling, routine prognostic genetic testing of primary cutaneous melanoma before or after sentinel node biopsy is not recommended outside of a clinical trial. The current medical evidence has not demonstrated that the test is more beneficial than standard of care. Thus, DecisionDx-Melanoma test performed on 8/17/17 was not likely to have been superior over 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. | 1 |
A 39-year-old male enrollee has requested reimbursement for Anser IFX testing provided on 4/23/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition. | Upheld | Experimental | Summary Reviewer 3
A 39-year-old male enrollee has requested reimbursement for Anser IFX testing provided on 4/23/14. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees medical condition.The physician reviewer found the effectiveness of Anser IFX in the management of Crohns disease compared with conventional courses of action remains unproven in controlled clinical trials. The presence of antibodies alone does not necessarily result in loss of response to infliximab, nor have threshold levels been established. Studies have found that anti-infliximab antibodies can be transient, and disappear over time, with many patients who have these antibodies maintaining their response. Although loss of response to infliximab is common, there were no standard guidelines defining a therapeutic strategy at the time of testing. Based on the clinical literature, Anser IFX testing performed on 4/23/14 was not likely to have been more effective than other modalities. 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. | 0 |
A 62-year-old female has requested authorization and coverage for spine nerve treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees back pain.
Per the records, this patient has received only a single set of diagnostic lumbar medial branch blocks. | Upheld | Experimental | Summary Reviewer 1
A 62-year-old female has requested authorization and coverage for spine nerve treatment. The Health Insurer has denied this request indicating that the requested services are considered investigational for treatment of the enrollees back pain. The physician reviewer found the current medical evidence does not support the requested services in this clinical setting. Per the records, this patient has received only a single set of diagnostic lumbar medial branch blocks. Manchikanti and colleagues noted the evidence for diagnostic lumbar facet joint nerve blocks and diagnostic sacroiliac intraarticular injections is good with 75% to 100% pain relief as criterion standard with controlled local anesthetic or placebo blocks. Additionally, the literature supports the use of a second set of diagnostic medial branch blocks. In this patients case, the pain relief did not exceed 75%, and a second set of diagnostic medial branch blocks was not performed. Therefore, the requested spine nerve treatment is not likely to be more efficacious than other treatment options. Based upon the information set forth above, the requested services are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a 52-year-old female who was initially admitted on 4/07/21 for treatment of alcohol use disorder. The patient has requested reimbursement for residential treatment services (ASAM 3.5) provided from 4/13/21 through 5/05/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
, the patient was treated for alcohol withdrawal earlier in her course of treatment.
2, the patient is status post gastric bypass surgery and has hypertension. The patientas biomedical problems were stable and did
3, the patient was noted to complain of mild depression due to her weight gain after gastric bypass surgery. She had stopped drinking for approximately seven days prior to this admission and has a history of 90 days of sobriety. She was not suicidal or homicidal. She participated in groups. | Upheld | Medical Necessity | Summary Reviewer
The patient is a 52-year-old female who was initially admitted on 4/07/21 for treatment of alcohol use disorder. The patient has requested reimbursement for residential treatment services (ASAM 3.5) provided from 4/13/21 through 5/05/21. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that per the American Society of Addiction Medicine (ASAM) criteria, this patient does not meet Level 3.5 criteria for residential treatment services from 4/13/21 through 5/05/21. The ASAM criteria focuses on six dimensions to determine the appropriate level of care. For dimension 1, the patient was treated for alcohol withdrawal earlier in her course of treatment. Based on clinical findings, the patientas withdrawal needs could have been met in Level 3.5 setting. This criteria is met. For dimension 2, the patient is status post gastric bypass surgery and has hypertension. The patientas biomedical problems were stable and did not require medical or nurse monitoring. This criteria is met. For dimension 3, the patient was noted to complain of mild depression due to her weight gain after gastric bypass surgery. She had stopped drinking for approximately seven days prior to this admission and has a history of 90 days of sobriety. She was not suicidal or homicidal. She participated in groups. The patient meets sub-criteria of amental status is stable to permit participation,a but she does not meet any of the other qualifying criteria including aunable to control her use of alcohol and drugs with attendant probability of imminent danger,a or ademonstrates repeated inability to control her impulses to use alcohol and other drugs and is in imminent danger of relapse, with attendant likelihood of harm to self, others, or property,a or ademonstrates antisocial behavior patterns,a or ahas significant functional deficits, which are likely to respond to staff interventions...of pervasive nature requiring treatment that is primarily habilitative in focus; they do not require medical monitoring and management,a or aconcomitant personality disorders of such severity that the accompanying dysfunctional behaviors provide opportunities to promote continuous boundary setting interventions.a This criteria is not met.
For dimension 4, the patient admitted herself for treatment voluntarily as she was concerned about the effect alcohol was having on her marriage and health. She actively participated in treatment and was developing insight into her addiction. The patient does not meet the sub-criteria of alimited insight and little awareness of the need for continuing care...,a or ahas marked difficulty in understanding the relationship between her substance use, mental health, or life problems and her impaired coping skills and level of functioning, often blaming others for his addiction problems,a or ademonstrates passive or active opposition to addressing the severity of her addiction problem,a or arequires structured therapy and a 24-hour programmatic milieu because motivational interventions have not succeeded at less intensive levels of care,a or aperspective impairs her ability to make behavior changes without repeated, structured motivational interventions,a or aexpresses little to no interest in changing,a or aattributes her alcohol, drug or mental health problem to other persons or external events.a The patient does not meet this criteria. For dimension 5, the patient was drinking 8 mixed drinks daily. She had relapsed in January 2021. She has tried outpatient and IOP, but not in the past three years. She has previously been sober for 90 days. She recognized the need for treatment and continuing care. She had no suicidal ideation or homicidal ideation. She has never attempted suicide nor been aggressive. She was on medications for cravings. The patient does not meet criteria of alacks insight into benefits of continuing care and is therefore not committed to treatment,a or aunable to control use of alcohol or drugs with attendant probability of harm to self or others,a or aexperiencing craving...with the situation posing an imminent danger of harm to self or others in the absence of close 24-hour monitoring and structured support,a or ain imminent danger of relapse with dangerous emotional, behavioral, or cognitive consequences as a result of a crisis situation,a or adespite recent active participation in treatment at a less intensive level of care, the patient continues to use alcohol or drugs,a or ademonstrates a lifetime history of repeated incarceration.a The patient does not meet this criteria. For dimension 6, the patient is married and lives with her husband and son. Her husband is requesting that she stop drinking and is supportive. The patient works as a social worker. The patient does not meet sub-criteria of aliving in an environment that is characterized by a moderately high risk of neglect, physical, sexual, or emotional abuse or...endemic substance abuse,a or apatientas social network includes regular users of alcohol and other drugs such that recovery goals are assessed as unachievable at a less intensive level of care,a or apatientas social network is characterized by significant social isolation or withdrawal such that recovery goals are assessed as inconsistently unachievable at a less intensive level of care,a or apatientas social network involves living with an individual who is a regular user or dealer of other drugsa or apatient is unable to cope, for even limited periods of time, outside of a 24-hour care.a The patient does not meet this criteria. Thus, this patient does not meet Level 3.5 residential treatment criteria for dimensions 3, 4, 5 and 6. Therefore, residential treatment services (ASAM 3.5) provided from 4/13/21 through 5/05/21 were not medically necessary for the treatment of this patient.
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The patient is a 46-year-old female with an onset of left hip, groin, and flank pain in spring 2016. She was diagnosed with a kidney stone and underwent removal with residual left hip/groin pain. She additionally underwent a gynecological and gastrointestinal work-ups. It was determined that she had a musculoskeletal problem causing the left hip/groin pain. She was referred to physical therapy and completed two months of therapy without resolution of symptoms. The 12/28/16 left hip magnetic resonance imaging with and without contrast impression documented a complex tear of the anterior left acetabular labrum, involving virtually the full thickness of the labral base. There was a reactive subcortical cyst in the proximal left femur at the anterolateral femoral head-neck junction, which could be the sequela of femoroacetabular impingement. The 1/3/17 orthopedic report cited complaints of left sided groin pain for over a year, and a fair amount of flank pain. She had tried Advil and Tylenol with little relief of her pain. Physical examination showed a positive impingement sign. There was no palpation tenderness in the bilateral groins, no right hip pain, no palpable trochanteric bursal tenderness, and no sciatic notch tenderness. The diagnosis was symptomatic left acetabular labral tear. The treatment plan | Overturned | Experimental | Summary Reviewer 1
The patient is a 46-year-old female with an onset of left hip, groin, and flank pain in spring 2016. She was diagnosed with a kidney stone and underwent removal with residual left hip/groin pain. She additionally underwent a gynecological and gastrointestinal work-ups. It was determined that she had a musculoskeletal problem causing the left hip/groin pain. She was referred to physical therapy and completed two months of therapy without resolution of symptoms. The 12/28/16 left hip magnetic resonance imaging with and without contrast impression documented a complex tear of the anterior left acetabular labrum, involving virtually the full thickness of the labral base. There was a reactive subcortical cyst in the proximal left femur at the anterolateral femoral head-neck junction, which could be the sequela of femoroacetabular impingement. The 1/3/17 orthopedic report cited complaints of left sided groin pain for over a year, and a fair amount of flank pain. She had tried Advil and Tylenol with little relief of her pain. Physical examination showed a positive impingement sign. There was no palpation tenderness in the bilateral groins, no right hip pain, no palpable trochanteric bursal tenderness, and no sciatic notch tenderness. The diagnosis was symptomatic left acetabular labral tear. The treatment plan recommended a fluoroscopically guided intraarticular injection to assess pain relief and symptoms generated from the labral tear. The 1/4/17 second opinion orthopedic report indicated a recommendation for an intraarticular injection of the left hip for diagnostic purposes. It was noted that if she obtained significant relief from the injection, then a hip scope would be considered. The 1/4/17 procedure note indicated that a fluoroscopically guided intraarticular left hip corticosteroid injection was performed. It was noted that her physical therapy had included activities for hip range of motion, hip strengthening and overall gait activities without a reduction in her hip/groin symptoms. Additional physical therapy for the left hip was not recommended. The 1/11/17 orthopedic report cited on going left hip pain that was worse with sitting, standing, climbing stairs, and all activity. She had experienced night pain but no instability. Most of the pain localized to the C sign area, with the pain extending into the abdomen and left lower lumbar region. Radiographs and imaging were reviewed and showed a complex labral tear and cam impingement. The diagnosis was left hip labral degenerative tear, and hip impingement syndrome. Even though she had an atypical pain pattern, because she had full improvement of all of her symptoms with the injection, a hip scope was recommended. The 1/31/17 operative report documented a diagnosis of left hip degenerative labral tearing and pincer type impingement. She had an intraarticular corticosteroid injection which relieved her symptoms dramatically temporarily. A diagnostic hip arthroscopy had been recommended based on her response to the injection and her magnetic resonance imaging findings of a complex labral tear along with possible Cam-type impingement. It was noted that she had atypical pain pattern, specifically the orthopedic surgeon did not think her flank pain would be affected by a labral tear. Operative examination confirmed a pincer lesion and mild degenerative joint changes of the left hip. The surgical procedure was documented as left hip arthroscopic pincer lesion resection and labral debridement. The patient has requested reimbursement for reimbursement for hip surgery performed on 1/31/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the treatment of this patients medical condition. Current peer reviewed literature support surgical management of femoroacetabular impingement syndrome when nonsurgical treatment methods fail. In this case, the patient presented with an approximate one year history of left hip, groin and flank pain. She had been diagnosed with kidney stones and underwent removal without resolution of the hip/groin pain. The patient additionally underwent gynecological and gastrointestinal workups without significant findings. She continued to report persistent pain interfering with her work duties and activities of daily living, and interrupted her sleep. She was referred for left hip MRI and orthopedic consult. Clinical examination findings were consistent with radiographic and imaging evidence of a left hip complex labral tear and impingement syndrome. She failed over six months of conservative treatment including activity modification, analgesics, anti-inflammatory medications, and physical therapy. She underwent a diagnostic intra-articular left hip injection with complete temporary resolution of her symptoms. X-ray findings documented no signs of joint space narrowing, and no erosive or prolific arthritic changes. She underwent left hip arthroscopic pincer lesion resection and labral debridement on 1/31/17. Operative findings confirmed the presence of a pincer lesion. Therefore, the hip surgery performed on 1/31/17 was likely to have been more beneficial for treatment of the patients medical condition than any available standard therapy. Based upon the information set forth above, the services at issue were likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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The patient is an 18-year-old female with a history of major depressive disorder, recurrent severe without psychosis. The patient was admitted to an inpatient facility on 1/11/18 after reporting three weeks of worsening suicidal ideation and plan to jump off a bridge. The patients history is significant for self injurious behavior from ages 12 to 15, an overdose attempt in June 2017 without hospitalization, an inpatient psychiatric hospitalization in August 2017 due to suicidal ideation, two months of intensive outpatient program treatment in October 2017, outpatient mental health treatment with a psychiatrist and therapist and medication trials of sertraline and escitalopram. During the patients recent inpatient admission, the patient was treated with venlafaxine ER, bupropion XL, mirtazapine, hydroxyzine, aripiprazole, and vortioxetine. She was discharged from the inpatient facility on 2/5/18 with plan to attend the Transitional Age Youth Intensive Outpatient Program. The patient has requested reimbursement for mental health inpatient stay from 1/29/18 through 2/5/18. The Health Insurer has denied this request and reported that the services at issue were not medically
the medical records, the patient was not stabilized and remained symptomatic on 1/29/18. On 1/28/18, the patient was documented as refusing meals. She was noted to have a flat affect and was withdrawn. The patient reported continued feelings of depression, guilt, and hopelessness with suicidal ideation. On 1/29/18, the patient was documented as being depressed and withdrawn and feeling hopeless and helpless. The patient endorsed continued suicidal ideation, isolated from peers, and was not fully participating in group activities. The patient continued to report depressive symptoms
recurrent suicidal ideation and anxiety symptoms up until the point of discharge at which time she reported improvement in her mood. The patient had medication dose adjustments and changes
her persistent symptoms. Research has shown that patients, with similar histories to the patient in this case, are at risk for early readmission | Overturned | Medical Necessity | Summary Reviewer
The patient is an 18-year-old female with a history of major depressive disorder, recurrent severe without psychosis. The patient was admitted to an inpatient facility on 1/11/18 after reporting three weeks of worsening suicidal ideation and plan to jump off a bridge. The patients history is significant for self injurious behavior from ages 12 to 15, an overdose attempt in June 2017 without hospitalization, an inpatient psychiatric hospitalization in August 2017 due to suicidal ideation, two months of intensive outpatient program treatment in October 2017, outpatient mental health treatment with a psychiatrist and therapist and medication trials of sertraline and escitalopram. During the patients recent inpatient admission, the patient was treated with venlafaxine ER, bupropion XL, mirtazapine, hydroxyzine, aripiprazole, and vortioxetine. She was discharged from the inpatient facility on 2/5/18 with plan to attend the Transitional Age Youth Intensive Outpatient Program. The patient has requested reimbursement for mental health inpatient stay from 1/29/18 through 2/5/18. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for treatment of the patients behavioral health condition. This denial is the subject of this appeal and determination. The submitted documentation supports the services at issue in this clinical setting. Based on a review of the medical records, the patient was not stabilized and remained symptomatic on 1/29/18. On 1/28/18, the patient was documented as refusing meals. She was noted to have a flat affect and was withdrawn. The patient reported continued feelings of depression, guilt, and hopelessness with suicidal ideation. On 1/29/18, the patient was documented as being depressed and withdrawn and feeling hopeless and helpless. The patient endorsed continued suicidal ideation, isolated from peers, and was not fully participating in group activities. The patient continued to report depressive symptoms including recurrent suicidal ideation and anxiety symptoms up until the point of discharge at which time she reported improvement in her mood. The patient had medication dose adjustments and changes to address her persistent symptoms. Research has shown that patients, with similar histories to the patient in this case, are at risk for early readmission especially if not stabilized at the time of discharge (Donisi, et al). The patients clinical status, in addition to current medical literature, support the mental health inpatient stay from 1/29/18 through 2/5/18 as medically necessary. Therefore, for the reasons stated above, the services at issue were medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The patient is a 48-year-old male who reports left leg pain. The patient has requested authorization and coverage for endovenous ablation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 48-year-old male who reports left leg pain. The patient has requested authorization and coverage for endovenous ablation. The Health Insurer has denied this request and reported that the requested services are not medically necessary for the treatment of this patient. This denial is the subject of this appeal and determination. The physician reviewer found that the documentation supports the medical necessity of the requested services. The records note pain in the left lower extremity that is impacting the patients quality of life and activities. There is documentation of significant reflux in the vein to be treated and an absence of deep vein thrombosis. There is documentation of adequate arterial perfusion to the lower extremities bilaterally. Additionally, the notes document that the symptoms have been recalcitrant to conservative efforts. Therefore, the requested endovenous ablation is medically necessary for the treatment of this patient.
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A 54-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. | Overturned | Medical Necessity | Summary Reviewer
A 54-year-old male enrollee has requested authorization and coverage for Harvoni. The Health Insurer has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollees hepatitis C virus. The physician reviewer found according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. Per guidelines, Harvoni is first-line therapy for treatment-naive genotype 1 patients. Non-cirrhotic patients with a viral load below six million IU/mL can be treated with Harvoni for eight weeks. These guideline recommendations are based on multiple randomized clinical trials, and the medication is U.S. Food and Drug Administration (FDA) approved for all patients with chronic hepatitis C genotype 1 regardless of fibrosis stage (Kowdley, et al; Afdhal, et al). AASLD guidelines also cite data showing increased survival with earlier treatment (Jezequel, et al). For these reasons, Harvoni should be approved as medically necessary based on national guidelines. For the reasons provided, the requested medication is medically necessary for treatment of the patients medical condition. The Health Insurers denial should be overturned.
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The patient is a 39-year-old female with a child diagnosed with Coffin-Siris syndrome. She underwent testing during a subsequent pregnancy. She has requested reimbursement for SMARCA4 gene mutation and chromosome testing performed on 8/14/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient.
This patient desired screening for her risk of trisomy, given her advanced maternal age. She also wished to screen for the SMARCA4 gene mutation given a history of a child with a | Overturned | Experimental | Summary Reviewer 2
The patient is a 39-year-old female with a child diagnosed with Coffin-Siris syndrome. She underwent testing during a subsequent pregnancy. She has requested reimbursement for SMARCA4 gene mutation and chromosome testing performed on 8/14/17. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of this patient. There is sufficient support for the services at issue in this clinical setting. When counseling patients with the sole risk factor of advanced maternal age, in the first trimester of pregnancy, several genetic testing options are discussed. These options include no testing or a first trimester screen, usually called the QUAD screen, which consists of serum markers typically done between 15 and 19 weeks. Both tests would also be appropriate to discuss with women under the age of 35. Additionally, for women over the age of 35, since their individual risk of genetic abnormalities increases, additional screening options and invasive testing such as amniocentesis or chorionic villus sampling should be offered along with genetic counseling. This patient desired screening for her risk of trisomy, given her advanced maternal age. She also wished to screen for the SMARCA4 gene mutation given a history of a child with a syndrome related to this gene mutation. Given this patients age, previous pregnancy/birth history, and increased risk above the population risk for a specific gene mutation that can have significant and grave consequences, the services at issue were medically appropriate. In sum, SMARCA4 gene mutation and chromosome testing performed on 8/14/17 were 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 likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be overturned.
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A 59-year-old female enrollee has requested authorization and coverage for heart surgery to correct the heart valve using a catheter (transcatheter valve repair). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 3
A 59-year-old female enrollee has requested authorization and coverage for heart surgery to correct the heart valve using a catheter (transcatheter valve repair). The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. The physician reviewer found that there is sufficient support for the requested services in this clinical setting. In patients with symptomatic severe aortic regurgitation, surgical aortic valve replacement is the treatment of choice. Transcatheter aortic valve replacement is currently approved and indicated for individuals with severe aortic stenosis who are considered high risk for surgical valve replacement. There is no current U.S. Food and Drug Administration (FDA) approved prosthetic valve procedure using a transcatheter approach for patients with pure aortic regurgitation. The JenaValve is in the active recruitment phase for patients with severe aortic regurgitation and heart failure of New York Heart Association (NYHA) class II or higher, using transcatheter aortic valve replacement with a pericardial valve. This patient meets criteria in terms of prohibitive surgical risk and symptoms. There is a lack of treatment alternatives in this patients case. Thus, the requested heart surgery to correct the heart valve using a catheter (transcatheter valve repair) is likely to be more beneficial than other treatment options.
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A 54-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 2/5/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. | Upheld | Experimental | Summary Reviewer 2
A 54-year-old male enrollee has requested reimbursement for the DecisionDx melanoma assay provided on 2/5/16. The Health Insurer has denied this request indicating that the testing at issue was considered investigational for evaluation of the enrollees cutaneous melanoma. The physician reviewer found that Melanoma staging is characterized by the American Joint Committee on Cancer (AJCC)) system that defines cutaneous melanoma stages 0-IV. While the majority of clinical stage I patients will be disease-free at five years, some stage I patients will develop advanced disease. As patients diagnosed with stage I or II melanoma are generally viewed as having a low risk of metastasis, treatment planning is limited to surgical excision of the primary tumor followed by routine skin examinations and clinical examination. In contrast, patients diagnosed with stage III melanoma receive complete lymph node dissection, active surveillance measures and often, referral to medical oncology for adjuvant medical therapy and clinical trial participation. DecisionDx melanoma assesses the expression of 31 genes that have been associated with metastasis and classifies tumors as Class 1 consistent with a low risk of metastasis or Class 2 suggestive of a high risk of metastasis. One peer-reviewed publication indicated that there was a statistically significant association of a Class 1 signature by DecisionDx melanoma assay for primary dermal melanoma (PDM), whereas cutaneous metastatic melanoma (CMM) were more frequently class 2 (Sidiropoulos, et al). The authors concluded that the melanoma prognostic assay may be a useful tool for distinguishing PDM from CMM. According to the results of analysis of this patients melanoma performed with DecisionDx melanoma assay, the tumor was classified as Class 1 with a low risk of near-term (within five years) metastatic disease. Therefore, DecisionDx melanoma signature may be an independent predictor of metastasis risk. However, there is a lack of peer-reviewed published studies confirming this hypothesis. All told, the DecisionDx melanoma assay performed on 2/5/16 was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Based upon the information set forth above, the testing at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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The patient is a now deceased female who was transported by air ambulance from Lenox Hill Hospital in New York to Providence Tarzana Medical Center in Tarzana, California on 2/24/20. The patientas representative has requested reimbursement for air ambulance transport provided on 2/24/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient.
patient is transported to the nearest hospital with appropriate facilities for
In this case, the medical records document that the patient was transported from New York to her home state of California in order to receive continuity of care from her oncologist. | Upheld | Medical Necessity | Summary Reviewer
The patient is a now deceased female who was transported by air ambulance from Lenox Hill Hospital in New York to Providence Tarzana Medical Center in Tarzana, California on 2/24/20. The patientas representative has requested reimbursement for air ambulance transport provided on 2/24/20. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of this patient. The physician reviewer found that in order for air medical transport to be medically necessary, specific criteria must be met. These criteria include the following: the patientas condition must be such that any form of transportation other than ambulance would be medically contraindicated; the patientas condition is such that time needed to transport by ground poses a threat to the patientas survival; the patient is transported to the nearest hospital with appropriate facilities for treatment; and there is a medical condition that is life-threatening. When transporting from one facility to another, the above criteria must be met, and the first hospital should not have the required services and facilities to treat the patient. In this case, the medical records document that the patient was transported from New York to her home state of California in order to receive continuity of care from her oncologist. This does not meet criteria for medical necessity, as the transferring facility was capable of providing the necessary care. The patient chose to be transferred to receive care from the providers she preferred. Therefore, medical necessity criteria for air ambulance transport are not met. Thus, air ambulance transport provided on 2/24/20 was not medically necessary for the treatment of this patient. | 1 |
A 38-year-old male enrollee has requested reimbursement for genetic testing performed on 5/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 38-year-old male enrollee has requested reimbursement for genetic testing performed on 5/31/18. The Health Insurer has denied this request and reported that the services at issue were investigational for the evaluation of the enrollees medical condition. The physician reviewer found that while a fine needle aspiration biopsy of a suspicious thyroid nodule is typically an accurate means of assessing whether the nodule is benign or malignant, approximately 15% of fine needle aspiration biopsy results are considered to be indeterminate. Until recently, the only way to establish whether the nodule was thyroid cancer was via surgical excision, even though the majority of the cases turn out to be benign. The relatively new development of molecular techniques and the identification of genetic alterations associated with different follicular cell-derived cancers in the thyroid have led to the introduction of several commercially available tests. Among these tests is ThyGenX, which analyzes a panel of DNA mutations and RNA translocation fusion markers to assess the risk of malignancy with good negative and positive predictive value, thereby obviating the need for unnecessary surgeries. Therefore, genetic testing performed on 5/31/18 was likely to have been more beneficial than other methods of evaluating this patient.
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A 28-year-old male enrollee has requested reimbursement for 30140 (submucous resection inferior turbinate) and 30465 (repair of nasal vestibular stenosis) performed on 8/31/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition.
records did not document that the patient had a prior sleep study evaluation. | Upheld | Medical Necessity | Summary Reviewer
A 28-year-old male enrollee has requested reimbursement for 30140 (submucous resection inferior turbinate) and 30465 (repair of nasal vestibular stenosis) performed on 8/31/17. The Health Insurer has denied this request and reported that the services at issue were not medically necessary for the treatment of the enrollees medical condition. The physician reviewer found that a diagnosis of obstructive sleep apnea requires a preliminary polysomnogram (sleep study) and a trial and failure of medical management of the sleep disorder with continuous positive airway pressure therapy. The submitted records did not document that the patient had a prior sleep study evaluation. Bilateral submucous resection (CPT code 30140) is a technique to improve the airway and has been beneficial in patients with severe obstruction noted on physical examination as well as in patients with allergic symptomatology. However, there is only modest clinical documentation that shows that this technique improves sleep apnea. Uvulopalatopharyngoplasty (CPT code 42145) may be appropriate for patients with symptoms of obstructive sleep apnea on polysomnogram who have failed adequate control with continuous positive airway pressure therapy. In this case, there was no polysomnogram available for clinical review. Therefore, 30140 (submucous resection inferior turbinate), 30465 (repair of nasal vestibular stenosis) and 42145 performed on 8/31/17 were not medically necessary for the treatment of this patient. | 1 |
patient is a 35-year-old male with a history of ulcerative colitis. Anser ADA testing on 6/10/19 showed a Humira level of 6.7 ug/mL and lack of anti-Humira antibodies.
that this patient was taking Humira, an anti-tumor necrosis factor (TNF) medication, for the treatment of ulcerative colitis. In this case, Humira levels and anti-Humira antibody levels were checked after the patient had uncontrolled symptoms of ulcerative colitis.
In this case, the patient was stabilized on Humira, and then had a loss of response, which requested prednisone therapy. | Overturned | Medical Necessity | Summary Reviewer
The patient is a 35-year-old male with a history of ulcerative colitis. Anser ADA testing on 6/10/19 showed a Humira level of 6.7 ug/mL and lack of anti-Humira antibodies. The physician reviewer found that this patient was taking Humira, an anti-tumor necrosis factor (TNF) medication, for the treatment of ulcerative colitis. In this case, Humira levels and anti-Humira antibody levels were checked after the patient had uncontrolled symptoms of ulcerative colitis. According to the American Gastroenterological Association (AGA) Guideline on Therapeutic Drug Monitoring in Inflammatory Bowel Disease, In adults with active inflammatory bowel disease treated with anti-tumor necrosis factor agents, the AGA suggests reactive therapeutic drug monitoring to guide treatment changes. The current medical literature supports drug level monitoring based on studies showing that anti-TNF drug levels predict response to therapy. In this case, the patient was stabilized on Humira, and then had a loss of response, which requested prednisone therapy. Testing for Humira drug level and for anti-Humira antibodies is supported by guidelines in that situation. Therefore, Anser ADA diagnostic testing performed on 6/10/19 was medically necessary for the evaluation of this patient. | 1 |
A 53-year-old female enrollee has requested authorization and coverage for autologous cultured chondrocytes implant knee. The Health Insurer has denied this request and reported that the requested services are investigational for the treatment of the enrollees medical condition. | Overturned | Experimental | Summary Reviewer 1
A 53-year-old female enrollee has requested authorization and coverage for autologous cultured chondrocytes implant knee. 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 autologous chondrocyte implantation is a proven method for salvage of large articular cartilage defects of the patellofemoral joint in the long-term. Focal chondral defects of the knee can significantly impair knee function, cause chronic pain, and affect the quality of life. The autologous chondrocyte implantation technique has evolved over the past 20 years. The newest technique is the third-generation technique called matrix-induced autologous chondrocyte implantation, which has been recommended in this patients case. Physical examination, imaging studies, and arthroscopic findings have been utilized in this case to identify the articular defects. Conservative measures have been exhausted, and surgical treatment is indicated for the patellofemoral joint. Patients treated with matrix-induced autologous chondrocyte implantation have demonstrated significant clinical improvement and good quality repair tissue five years after surgery. This procedure has been shown to be a safe and effective treatment for symptomatic, traumatic chondral knee defects, particularly involving the patellofemoral joint, as in this case. Therefore, autologous cultured chondrocyte implantation in the knee is likely to be more beneficial than other treatment options.
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A 42-year-old female enrollee has requested reimbursement for the Ova 1 test performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees risk for ovarian cancer. | Overturned | Experimental | Summary Reviewer 3
A 42-year-old female enrollee has requested reimbursement for the Ova 1 test performed on 1/16/15. The Health Insurer has denied this request indicating that the services at issue were considered investigational for evaluation of the enrollees risk for ovarian cancer. The physician reviewer found that the Ova 1 assay consists of measurement of the levels of five tumor markers and their analysis using a predefined algorithm. The Ova 1 has been shown to be predictive of the risk of malignancy in the evaluation of un-biopsied ovarian masses. The National Comprehensive Cancer Network (NCCN) guidelines include a brief discussion of the Ova 1 assay, and conclude that all patients should undergo surgery by an experienced gynecological oncologist in this clinical setting. This is also consistent with the recommendations from the American College of Obstetricians and Gynecologists (ACOG). As such, the use of Ova 1 would not be recommended as a standard of care for the patients condition and its use was not likely to have yielded additional data beyond that expected with standard available testing. Based upon the information set forth above, I have determined the services at issue were not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Insurers denial should be upheld.
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